CN106794030B - 用于执行子宫内膜消融术的***和方法 - Google Patents

用于执行子宫内膜消融术的***和方法 Download PDF

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CN106794030B
CN106794030B CN201580038367.5A CN201580038367A CN106794030B CN 106794030 B CN106794030 B CN 106794030B CN 201580038367 A CN201580038367 A CN 201580038367A CN 106794030 B CN106794030 B CN 106794030B
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U·H·奇
R·B·派力克斯
H·E·马根
D·W·古斯基斯
S·R·巴斯驰
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Abstract

提供了一种向患者的子宫提供治疗的方法和***，其可包括任何数量的特征。该方法可包括将子宫装置***子宫内并执行子宫完整性测试以判断子宫是否完好无损并且未穿孔的步骤。如果判断子宫未穿孔，则执行通畅性测试以判断子宫装置是否未被堵塞或被包埋在组织中。如果子宫完好无损并且装置未被堵塞或包埋在组织中，则可使用子宫装置——即，子宫消融装置——治疗子宫。还公开了用于实施这些方法的***。

Description

用于执行子宫内膜消融术的***和方法
相关申请的交叉引用
本申请要求在2014年5月22日提交的、标题为“Systems and Methods forPerforming Endometrial Ablation(用于执行子宫内膜消融术的***和方法)”的美国临时申请No.62/002,082的权益，该临时申请通过引用并入本文中。
结合引用
通过引用将本说明书中提到的所有公报和专利申请全文并入本申请中，合并范围与每个单独的公报或专利申请特别地和单独地表示为通过引用被合并相同。
技术领域
本公开总体上涉及加入了可供内窥镜手术或其它可视化***如超声波或荧光镜检查使用的扩张介质如流体或气体的子宫手术。本公开特别适合于子宫内膜的子宫内膜消融术。更具体地，本公开涉及一种使用经加热的蒸气的子宫内膜消融术。
背景技术
子宫内膜消融术(即，子宫的子宫内膜的移除或破坏)被用作用于治疗月经过多或其它子宫疾病的子宫切除的替代方案。一种现有的用于执行子宫内膜消融术的技术采用经输卵管***子宫内的电切镜(即，带有内置钢丝圈或其它消融装置的子宫镜)，并使用射频电流(RF电流)来移除或凝结子宫内膜组织。这些标准技术通常在医院环境中执行并且在治疗子宫内膜的同时大量采用子宫镜检查以使手术可视化。
一些方法利用加热的流体来消融子宫内膜。例如，早期的期刊文献描述了使用蒸汽来治疗子宫出血。基于该目的蒸汽的使用后来被摒弃，显然是由于患者发病率和死亡率。参看，例如，Fuller的美国专利No.6,139,571。已说明最近对将热流体注入子宫内的使用的记载。采用内装的流体的子宫疗法也有过记载。
为了简化手术，已研发不需要同时的宫腔镜可视化的方法。在实践中，这些技术中的许多技术推荐医生或用户在执行子宫内膜消融术之前采用宫腔镜以使子宫腔可视化并进行检查。此外，作为一种检查子宫腔后处理的方法，可在子宫内膜消融术结束时采用宫腔镜检查。在该宫腔镜检查期间，医生检验子宫腔是否穿孔，尽管即使利用宫腔镜可视化穿孔也可能不是很明显。一般而言，出于多种原因——包括对邻近器官的非故意损伤的可能性以及为了在子宫内膜消融术的情况下将治疗区域具体地保持或限制在子宫腔，医生尽力避免穿孔。
在外科手术期间不需要主动的宫腔镜可视化的子宫内膜消融技术一般被称为“盲”技术，因为医生利用触感或子宫内膜消融装置上的标记来指示该装置在子宫腔中的正确安放。这些特定装置之一采用一种基于球囊的***，该***利用加热的盐水来作为用于组织消融的热能来源。还已使用高频或射频(RF)能量来执行子宫内膜组织的热消融。当前用于执行子宫内膜消融术的产品包括新泽西州Somerville的Ethicon公司在商标下销售的procedure和***。低温消融，或“冷冻消融”，诸如来自American Medical Systems,Inc.的HER是另一种子宫内膜治疗方法。所有上述产品都被表征为“盲”或在治疗期间不需要直接的宫腔镜可视化。
在利用不需要宫腔镜可视化的子宫内膜消融技术时，在执行治疗之前采用测试来验证子宫腔是否完好无损或未穿孔将是有益的。此类测试被称为子宫完整性测试并且这些测试可使用子宫内膜消融术和子宫或对空心体腔或器官的任何手术执行。此外，这些测试可供宫腔镜手术使用，这是因为即使在直接视觉下也不可能容易地检测到穿孔。
完整性测试采用盐水或气体、优选二氧化碳气体作为试剂以关于保持流体或气体压力来验证子宫腔是否完好无损。气体或流体在压力下供给到子宫腔并且可识别子宫腔中的泄漏，判断这种泄漏是穿孔还是未密封的子宫颈管，亦或是过量流体离开输卵管的效应。Stern等人(US 5,562,720)和Sampson等人(US 6,554,780、US 6,743,184、US 6,872,183和US 7,063,670)记载了此类压力技术，而其它方法利用容积测量来检查输入源与输出收集器之间的流体不平衡。其它方法提到使用流量和压力测量。
为了在手术期间监测治疗能量应用，一些技术监测安放在子宫内的球囊内的加热的盐水的内部压力，或子宫壁内的射频能量的阻抗。这些技术在压力、阻抗或容积水平达到特定阈值的情况下具有自动终止步骤。在所有上述***的手术开始时，医生在子宫腔内不准确地安放和管理治疗装置会降低执行安全和一致的消融术的能力。对于这些技术而言，该装置执行完整的子宫内膜消融术的能力就安放深度或实现内部内膜与输送机构的充分接触而言取决于医生的触觉动作和对装置的安放。例如，射频装置在子宫腔部署RF阵列。***深度会因患者和医生而异。如果不在更远侧或近侧的位置接触子宫内膜，则手术的效力会改变或受影响。对于热球囊术而言，由于装置的安放深度，会发生类似的效应。对于这两种技术而言，***无法提供用于装置在子宫腔内的正确和一致安放的信息或评估。作为替代，诸如加热的盐水的自由流动的无定形消融技术不具有这种物理局限性，然而，这种已知为Hydro Thermo Ablation或HTA的技术甚至严重依赖于医生对装置的安放以防止子宫颈内管的外漏。
一种依赖于医生在手术期间的操纵或干预的***已被表征为“技术敏感”。要求医生在子宫内膜消融术之前和期间正确地操纵输送装置并作出反应会引起不良事件或不可靠的患者术后效果的增加。这在手术之前和期间的阈值落入需要医生干预或调节的范围内时特别明显。
以下说明一种克服了针对提供蒸气能量的技术的这些缺陷的控制***，该技术与设计成确保患者安全和手术一致性的一定数量的独特和排序的步骤相结合地使用。当可能需要子宫颈处的密封球囊内的附加压力时，该控制***还通过为医生提供信息来评估输送装置在子宫腔和子宫颈内管内的安放和密封。
发明内容
一种子宫内膜蒸气消融***，包括：蒸气发生器；与蒸气发生器联接的子宫消融装置，该子宫消融装置构造成用于***患者的子宫腔内；与子宫消融装置和蒸气发生器联接的控制***(电子控制器)，该控制***构造成自动执行对蒸气发生器和子宫消融装置的术前消毒，该控制***构造成准备子宫消融装置以进行蒸气输送，该控制***构造成在子宫消融装置***患者体内前后检查子宫消融装置的安全构件，该控制***构造成监测蒸气能量的施加、监测子宫消融装置上的被识别位置处的温度读数，并且该控制***构造成实施蒸气发生器在蒸气输送之后的关断。
在一些实施例中，电子控制器构造成在术前消毒未能开始或完成的情况下提醒子宫消融装置的终端用户。
在另一实施例中，电子控制器构造成在安全构件的测试指示***错误的情况下提醒子宫消融装置的终端用户。
在一些实施例中，该***还包括配置在子宫消融装置的轴上的远侧锚定球囊、中央密封球囊和近侧定位球囊。
在一个实施例中，该***还包括位于中央密封球囊附近并且构造成测量患者子宫颈内膜内的温度的温度传感器。
在又一实施例中，该***还包括构造成测量远侧锚定球囊、中央密封球囊和近侧定位球囊中的每一者的压力的一个或多个压力传感器。
提供了一种向患者的子宫提供蒸气治疗的方法，该方法包括以下步骤：感测蒸气发生器的液位；加热蒸气发生器以准备可冷凝蒸气；使可冷凝蒸气充填经过与蒸气发生器联接的子宫消融装置以为子宫消融装置消毒；将子宫消融装置内的压力传感器值与蒸气发生器内的压力传感器值进行比较；验证子宫消融装置的多个定位和密封球囊的完整性；将可冷凝蒸气从子宫消融装置输送到子宫内；以及在输送步骤期间，监测患者子宫颈内的温度并且在该温度超过阈值的情况下自动终止可冷凝蒸气的输送。
在一些实施例中，阈值包括44摄氏度。
附图说明
图1A-1D示出子宫消融装置的一个实施例。
图2示出***子宫内的子宫消融装置的一个实施例。
图3示出子宫消融装置的完整性测试。
图4示出子宫消融装置的通畅性测试。
图5用图表表示出流阀压力、子宫腔压力和通过子宫消融装置的流量之间的关系。
具体实施方式
图1A示出尺寸确定并且构造成到达子宫的子宫内膜并且将经加热的蒸气输送到子宫以消融子宫组织的子宫消融装置100。该装置可构造成作为子宫切除术的替代方案消融和治疗子宫的子宫内膜以用于治疗月经过多或其它子宫疾病。在一些实施例中，装置100可构造成通过***穿过套管或宫腔镜来实现对子宫的接近。装置100可包括轴102、手柄104、远侧末端106、蒸气端口107、远侧锚或远侧球囊108、中央或密封球囊110、近侧或定位球囊112、和连接管腔118，连接管腔118可将子宫消融装置与控制***(未示出)联接，所述控制***包括计算机、蒸气发生***和构造成使球囊充胀和泄放并且控制完整性气体/流体和蒸气的输送和从装置的移除的机构。此外，连接管腔118可将装置100与蒸气发生器或蒸气源121、气体/流体源122、压力调节器124和(多个)流量计126连接。在一些实施例中，蒸气发生器121可包括构造成控制子宫消融装置的各个方面——包括蒸气发生和输送——的一体式电子控制器。在另一些实施例中，该控制器位于装置的其它构件中，或包括单独的控制单元，例如与装置电子地联接的计算机、智能电话或平板电脑。该装置的远侧末端106附近的蒸气端口107可经由流入和流出管腔(未示出)与连接管腔118流体地联接。蒸气端口、流入和流出管腔、连接管腔、气体/流体源、压力调节器和流量计可构造成测试患者子宫的完整性、装置的正确安放以及验证装置的流入和流出管腔之间有无流动。热电偶和/或温度传感器可配置在子宫消融装置内外的各种位置，包括该装置的流入和流出管腔内或附近。热电偶可构造成测量与该装置中的流体流和/或气流有关的温度，以及患者体腔内的温度。
该流量计可以是本领域中已知的任何流量计，包括热质量流量计、超声波流量计、桨轮或变截面流量计。在一个实施例中，利用通过时间和多普勒流量读数的超声波流量计是有利的，这是因为它是不需要与在完整性测试中采用的流体或气体介质物理地相互作用的非接触***。超声波流量计可容易地适配为流入管腔的外部尺寸。此外，流入管腔内的滴注室可用于在完整性测试指示密封的子宫腔时手动地可视化或记录来自流体源的滴数或流量。在一些子宫手术中，可能有利的是使用除盐水以外的其它类型的流体，包括乳酸林格氏液、用于某些电外科手术的非等张溶液、凝胶、泡沫、用于一些超声波检查程序的不同粘度的流体或用于子宫手术中的其它流体。
在一个实施例中，可在流量计相对于气体/流体源的任一侧将一个单向阀安放在流入管腔中。单向阀可允许气体/流体(例如，盐水)从气体/流体源流到装置和子宫腔。单向阀不应当干涉流量计的工作及其读数。在实践中，子宫腔是在完整性和通畅性测试期间会经历显著收缩的肌肉。这些收缩可将流体反推回通过盐水管腔并经过流量计。这样一来，流量计测量结果会变成难以解释或可能在输出读数中产生正弦波。单向阀安放在流入管腔中可消除逆流流体流并且稳定流量计在子宫收缩症状期间的读数。
手柄104可以是人机工程学手柄并且可包括用于使用该装置的特征和控制结构(例如，按钮、杆、用于提供***深度的反馈的标记、阀等)，包括用于控制球囊108、110和112的充胀以及用于控制完整性测试气体/流体和经加热的蒸气的输送和从装置的移除的特征结构。该手柄还可包括用于测试患者子宫的完整性、装置的正确安放以及验证装置的流入和流出管腔之间有无流动的特征和控制结构。
本文中描述的球囊可以是任意类型的柔性球囊，例如橡胶、乳胶、乌拉坦、硅树脂、PET、LDPE、聚对二甲苯、尼龙、PE、这些聚合物的组合，或可由本领域中公知的任何其它合适的材料制成。应当指出的是，在一些实施例中，远侧锚包括球囊，但在另一些实施例中，远侧锚包括可扩张锚或扩张机构，例如可扩张框架、过滤器、网或壳架，或扩大子宫消融装置的轴的直径的不可扩张构件。然而，出于本公开的目的，远侧锚可被称为远侧锚或远侧球囊。
轴102可构造成将来自远处的锅炉(未示出)的经加热的蒸气输送通过该装置并从远侧末端106中的蒸气端口107传出。该轴也可构造成使已离开该装置的蒸气——包含体液、子宫材料和冷凝物——经蒸气端口返回到轴内。在图1A中，蒸气端口107被图示为包括蒸气输送端口和蒸气返回端口两者。然而，在另一些实施例中，蒸气输送端口可与蒸气返回端口分离并且截然不同。例如，蒸气输送端口用于经空腔提供经加热的蒸气的均匀分配，并且可包括位于轴端部上的小管腔或孔。相比之下，蒸气返回端口用于使被用过的蒸气和冷凝物返回，并且可包括更大的槽以防止血液、组织等阻塞或堵塞返回管腔。该装置包括流入和流出气体和/或流体输送通道以进行子宫完整性和通畅性测试。在一些实施例中，用以输送和返回蒸气的管腔与用以输送和返回用于子宫完整性和通畅性测试的气体和/或流体的通道相同。
再参照图1A，子宫消融装置100被示出呈塌缩的输送构型，其中远侧球囊108、密封球囊110和定位球囊112被泄放以缩小该装置的截面直径并且在***期间的直径可为6mm或更小。当该装置处于输送构型时，缩小的轮廓允许更容易经***、子宫颈管和子宫颈而接近子宫，并且在***期间减少患者的不适。在一些实施例中，子宫消融装置的外部尺寸是这样的：即，可以在不需要在装置导入之前对子宫内口(os)进行机械或药理学扩张的情况下实现装置向子宫腔内的导入。
图1B示出全部三个球囊——包括远侧球囊108、中央密封球囊110和定位球囊112——都充胀的图1A的子宫消融装置100。中央球囊可使用诸如盐水的流体充胀，或可替代地，可使用空气充胀。尽管在图1B中示出了三个球囊，但在另一些变型中，可设置一个、两个、四个或更多个球囊，并且可使用其它球囊形状。定位球囊可使用室温介质、冷却介质或可替代地加热介质充胀。在一些实施例中，中央密封球囊包括大致15mm至25mm的沿轴102的长度。中央球囊可在远侧球囊或锚与近侧球囊之间配置在轴上。在一些实施例中，中央球囊与远侧球囊和近侧球囊两者相邻。在另一些实施例中，在球囊中的一个或多个之间存在小的间隙或空间。中央球囊在轴上的长度和定位确保了在充胀时，中央球囊在子宫内口附近使子宫颈与子宫阻隔开，但球囊不会伸入患者的子宫或***内。中央和近侧球囊可包括任何直径，但优选应当具有足够大以接合普通女性患者的子宫颈和/或***的壁的直径。例如，中央球囊在实际使用中可具有10mm的充胀外径并且容纳9.5psi的压力。近侧球囊可具有诸如17mm的更大直径和7psi的较低充胀压力。
图1C是包括一些附加特征的子宫消融装置100的另一视图。止回阀144可将蒸气输送导管与装置的手柄连接，从而允许蒸气或其它消融介质被输送到手柄中。阀128c可以是构造成控制流经装置的流出管腔的介质的流量的球囊阀。流出管腔可例如用于将气体或流体介质从子宫移除到废弃物容器中，下文将更详细地描述。把持钩稳定器146也可位于装置100上并且可构造成提供保持把持钩和蒸气探针手柄的机构以维持相对于子宫颈的位置。
图1D是子宫消融装置100的另一视图，进一步示出了配置在装置的轴的远侧部分——包括远侧、中央和密封球囊，以及蒸气端口和远侧末端——上的末端盖148。末端盖可用于在将装置***患者体内之前的术前压力传感器和球囊检查中，在下文将更详细地加以说明。
现在将说明术前检查的一个实施例。在一个实施例中，子宫消融装置由用户启动并且将必要的附件和装置安装在蒸气发生器上。在装置手柄被安装在发生器上时，附件由子宫消融装置的电子控制器感测到并进行登记。装置中的各种传感器如水离子传感器和液位传感器可提供所感测的数据以确保已向蒸气发生器和气体/流体源添加适当的流体和流体量。子宫消融装置然后可准备蒸气发生器以通过将发生器加热至其工作水平来执行消融术并且在从1至5分钟的范围内的规定时间段内遍及***的内部通路充填蒸气。内部通路可包括子宫消融装置内的输送和返回蒸气路径。蒸气在规定的时间段内以适当的温度和压力遍及内部设备行进确保了对设备消毒以用于医疗手术中。在一个实施例中，在该消毒过程中，***可防止装置的蒸气输送导管的连接以避免消毒循环的破坏。
一旦消毒完成并且连接蒸气输送导管，则该蒸气输送导管可被锁定到位以防止在手术的其余过程中的非故意破坏或分离。子宫消融装置的蒸气输送导管然后可通过允许蒸气在蒸气输送导管内循环而被预热。然后可通过发生器的返回路径或子宫消融装置的返回路径中的热电偶监测温度。一旦完成，该装置就可通知用户发生器单元已准备好进行准备过程的下一个步骤，或该装置可自动转入准备过程的下一个步骤。
在消毒或蒸气充填过程正在发生的同时，子宫消融装置的压力传感器可被记录，并且可将来自传感器的压力读数与发生器单元内的基准传感器进行比较。此外，控制器可测试装置上的三个球囊(例如，远侧、中央和密封球囊)的完整性。除非全部经测试的参数都满足规范，否则该***不会允许该过程继续。在一个实施例中，远侧、中央和密封球囊可在末端罩盖148内充胀至测试压力并检查泄漏。末端罩盖在运输和手术室内的操纵期间可被供给到子宫消融装置上以同样保护产品。在末端罩盖就位并且远侧、中央和密封球囊充胀的情况下，末端罩盖内部形成的空腔经装置的管腔而利用空气加压，将该装置的压力传感器读数与蒸气发生器中的基准压力传感器进行比较。
电子控制器可构造成在蒸气发生器或子宫消融装置的术前消毒未正确地开始或完成的情况下提醒用户。控制器也可构造成在远侧、中央和密封球囊发生泄漏的情况下或者在压力和/或温度传感器指示子宫消融装置或蒸气发生器有问题的情况下提醒用户。在一些实施例中，电子控制器可在任何术前检查或准备步骤指示问题或无法完成的情况下防止向患者输送可冷凝蒸气。
在通过上述术前检查的测试后，控制器和蒸气发生器可执行流体充填操作以使盐水或另一种流体运行通过准备***患者体内的子宫消融装置。在流体充填期间，可通过检查流体传感器中的信号强度并且确立基准零流量来验证装置的正确工作。***然后可通知用户可将子宫消融***患者体内。在***之前将末端罩盖从装置的远端移除。
现在将说明图1A-1D的消融装置的安放。消融装置的远侧末端可经子宫外口***患者的子宫颈管内，并且经过患者的子宫内口以实现对子宫的接近。在一个实施例中，远侧球囊可位于子宫内口远侧的子宫内，密封球囊可位于子宫内口处或其近侧并且伸入子宫颈管内，并且定位球囊可位于子宫颈管内并且在近侧伸入***中或朝***延伸。
在消融装置的远侧末端恰好在子宫内口远侧配置在子宫内之后，远侧球囊可被充胀至期望压力。在一些实施例中，球囊可被充胀至高达约20至30psi的压力以便防止消融装置从子宫的意外撤回。应当指出的是，此时，远侧球囊定位成稍微越过子宫颈的子宫内口。远侧球囊的充胀后面可用作锚以防止该装置在近侧从子宫滑出。用户或医生可在装置上轻微拖曳以确认远侧球囊位于子宫腔中。
在充胀远侧球囊之后，近侧球囊可被充胀以使该装置采取定位构型，其中远侧球囊完全座靠在子宫内口上，并且定位或近侧球囊在子宫颈内扩张并经子宫外口伸入***内。随着近侧球囊充胀，球囊可从子宫颈向外扩张到***的相对不受约束的空间中，这形成了向近侧拉动该装置和远侧球囊以靠着子宫内口(也已知为宫颈口或子宫颈口)的内部接合的压缩力。
图2示出利用球囊108、110和112在如上所述充胀的状态下***患者的子宫内的消融装置100。一旦远侧和近侧球囊充胀，则中央球囊可充胀以提供沿子宫颈管的长度的附加密封。中央球囊也可以是构造成感测子宫颈中的温度读数的热电偶或温度传感器的位置。如果这些温度读数达到阈值，例如在44摄氏度以上，则控制器可自动暂停蒸气输送以避免患者损伤。该热电偶可由控制器在手术开始时测试或验证，所述控制器在热电偶被安放在患者体内之后查询热电偶以确保热电偶被连接并且读取温度。
在定位消融装置之后但在蒸气的输送之前，有利的是，通过执行完整性测试和通畅性测试评估子宫的完整性，以测试装置的蒸气输送末端是否定位在密封的子宫内并且测试流入和流出管腔之间是否存在流动。流入子宫腔内的流体的量和速率可为医生提供子宫腔的尺寸和该装置是否处于错误通路中的指示。完整性测试可评估子宫是否被密封，并且确定1)来源于子宫壁的穿孔的泄漏，或2)子宫颈处的不严密封引起的泄漏，或3)来自输卵管的泄漏。
进行通畅性评估的第二测试/试验——称为装置管腔通畅性测试或通畅性测试——可向医生提供该装置是否被碎屑堵塞或是否安放在错误通路内的指示。提供给医生的这种附加信息在“盲”子宫内膜消融术期间可与完整性测试相结合地向医生提供装置位置的更大保证。
在临床应用中，子宫完整性和通畅性测试除子宫消融术外还可用于其它子宫手术，例如装置、植入物或诊断剂或治疗剂的植入。在这些情况下，可与单独的子宫腔引导器先后地、单独地或独立地采用可进行子宫完整性和通畅性测试的单独单元或模块，而不使用子宫消融装置或***。
在一个实施例中，子宫完整性测试可包含以下要素和步骤。参照图1A-1B和图2，气体/流体源122可与包括要么一个调节器要么另外的背压调节器的压力调节器124连接。例如，气体/流体源可包含诸如CO2或惰性气体的气体或诸如盐水、林格氏液、非等张溶液、甘油和矿物油的流体。调节器124可构造成保持外部气源的压力在安全阈值以下。在一个实施例中，安全阈值可以是约70mm Hg。可能不或者可能不需要检测实际压力量或等级。来自气体/流体源122的流体或气体可在由安全阈值界定(例如，可由在治疗期间子宫将承受的最大压力界定，例如70mm Hg)的恒定压力下被驱动。此外，可能有用的是在进行子宫内膜消融术或其它子宫手术所需的压力以上的压力下操作子宫完整性测试。
在一个实施例中，可通过将气体/流体源122提升至子宫腔上方的一定高度处以形成压力来实现气体/流体压力。可通过量尺、卷尺或激光来验证该高度提升。用于盐水袋的临床使用的高度的一个示例将是患者的子宫上方的至少30英寸。在该高度处，该压力将介于50与70mmHg之间。该压力足够低而在所报道的输卵管的打开压力以下。此外，子宫腔内的压力传感器可验证是否正在对完整性测试和通畅性测试施加适量压力。可采用自调节反馈机构以响应于从子宫腔内获取的压力测量值而提高或降低盐水源的压力。作为例子，该反馈机构可响应于从子宫腔内获取的压力测量值而提高或降低盐水源的高度。
在一些实施例中，该***可在子宫完整性测试期间测量离开子宫装置或子宫消融装置的远侧管腔的气体/流体的流量。该流量也可用于确定气体/流体源的适当压力或高度。例如，可在气体/流体源处于特定高度并且子宫装置维持在已知状态下或自由空间中的同时获取流量读数。随着气体/流体源的高度提高或降低，气体/流体的流量将相应地作出响应，直至气体/流体源被安放在期望流量下的高度处，或被加压至期望量。同样，气体/流体源可响应于测得的流量而由自调节反馈机构提高或降低。
在一些实施例中，子宫消融装置还可包括具有针对终端用户的读取机构(未示出)的流量计126。在一个实施例中，该流量计可包括超声波传感器，或构造成感测气体/流体的滴注流量的光学传感器。在一些实施例中，流量计可配置在该装置的远侧末端106附近。在另一些实施例中，流量计可配置在装置的流出管腔内。在又一实施例中，流量计可配置在装置的外部，但沿着气体/流体源122与消融装置之间的流动路径。流量计可构造成在其移动通过或离开子宫消融装置时测量和报告流体/气体或蒸气的流量。读取机构可基于数字、图形或图标。另一些变型包括各种音频和视频信号、标记、定性标记、警报和颜色标识符。过滤器可安装或不安装到流量计上。
参照图2和3，为了执行子宫完整性测试，可将诸如CO2的气体或诸如盐水的流体从气体/流体源122输送通过压力调节器，并经流量计126输送到盐水消融装置100中。如图3所示，气体/流体可经由流入管腔129和流出管腔131两者输送到子宫内。在一个特定实施例中，在子宫完整性测试期间可将诸如0.9％NaCl的盐水输送到子宫内，以在消融术期间判断子宫或子宫颈管中是否存在可供蒸气逸出的泄漏。子宫消融装置100可与能量发生器124和控制器123联接以用于子宫消融治疗。蒸气(能量)发生器可以是例如蒸气发生器(如图所示)，但也可以是任何其它类型的能量发生器，例如RF能量发生器、冷疗发生器等。在执行本文中所述的完整性和通畅性测试之后可使用任何类型的能量形态来消融或治疗子宫。能量发生器124也可包括构造成将空气供给到***中的各种球囊如远侧、中央和近侧球囊或球囊阀的气泵。
在一个实施例中，如图3所示的单向阀127可位于流量计126与子宫消融装置100之间。在另一些变型中，单向阀127可位于子宫消融装置100的手柄中以及诸如流量计126和阀128a、128b、128c的其它构件中。单向阀可在子宫收缩期间减小或消除盐水的逆流。单向阀被表征为对沿一个方向(朝子宫腔)的流动提供低阻力并且对沿逆流方向(朝气体/流体源)的流动提供高阻力。有利地，单向阀可稳定流量值，因为逆流流量值被消除。通过减少可能由子宫收缩或放松、患者的运动或医生或医务人员对流入管路或患者自身的偶然操纵引起的正弦波波形，缩短了手术时间。负流量值的这种滤除隔离了流量的正分量，降低了流量值中的噪音，由此加速了流量数据的解译并且缩短了手术时间。fiso空气管路可将基准压力换能器125与完整性测试盐水流动通道的流出管路连接。
集成在要么装置中要么与装置联接的蒸气发生器中的子宫消融装置的控制器可构造成打开和关闭阀128a、128b和128c，以允许气体或流体从源122流入消融装置100的流入管腔129和流出管腔131中。阀128a、128b和128c可以是本领域中公知的任何类型的阀，例如电磁阀、可充胀球囊、气缸或电动/液压致动器或凸轮和齿轮。在子宫完整性测试期间，控制器可构造成打开阀128a和128b并且关闭阀128c，以防止气体/流体进入废弃物容器133。这允许气体或流体从源122流经流量计126，流经单向阀127以及阀128a和128b，并进入流入管腔129和流出管腔131。当气体或流体进入子宫时，流量计可测量气体或流体的完整性流量。
在一个实施例中，子宫消融装置或蒸气发生器的控制器可运行完整性测试算法以判断子宫是否密封。该算法可在气体/流体被输送到子宫内时在完整性测试期间分析来自流量计的数据。具体地，该算法可在完整性测试时间窗期间分析最大流量和最小流量。该完整性测试时间窗可以是例如预先选择的持续时间的滚动时间窗。在一个特定实施例中，该算法在滚动的15秒完整性测试时间窗期间连续分析最大流量和最小流量。针对每个滚动的完整性测试时间窗，可计算最大和最小流量。可算出每个完整性测试时间窗中的最小和最大流量之差以产生可被用作流动稳定性的指标的Δ流量值(最大流量-最小流量)。例如，Δ流量值越大，气体/流体的流动越不稳定，而Δ流量值越小，气体/流体的流动越稳定。如果气体或流体的最大流量和Δ流量值稳定在完整性阈值以下，则控制器可判定子宫是密封的。重要的是，该测试包含在将Δ流量值与完整性阈值进行比较的第二算法的同时执行的将流量与完整性阈值进行比较的两个算法，并且使用这两种比较来确定完整性测试的最终结果。这两种比较的应用提供了测试结果中的更大灵敏度。
在一些实施例中，该完整性流量Δ阈值可以是约5ml/min。因此，在一些实施例中，如果在滚动的完整性测试时间窗期间最大流量和完整性流量Δ阈值两者都在5ml/min以下，则认为子宫“通过”子宫完整性测试。可替代地，该测试可包含用于最大流量和Δ流量值的不同阈值。
在一些实施例中，子宫完整性测试可运行预设的时间。例如，该测试可运行60秒，并且可分析随后的15秒滚动窗以判断子宫在60秒时间段内是否密封。在另一实施例中，Δ流量值可定义为与阈值进行比较的平均流量的标准偏差。然后可将该Δ流量值与阈值进行比较以判断子宫是否密封。
在一些实施例中，返回通道包括阀128c，例如电磁阀、气缸、电/液压致动器、凸轮和齿轮或泵/可充胀球囊，所述阀可在完整性测试开始时启动以阻止气体/流体经子宫消融装置的返回通道进出(egress)。当利用阀阻止气体/流体经返回通道回流时，可通过输入管路上的流量计126来检测流量的变化。除判断是否存在泄漏或装置是否正确定位以外，流量变化的特性(例如，流量对利用阀封闭返回管路如何反应)在一些情况下可提供以下指示：a)子宫腔的尺寸；和b)***中存在泄漏或缺乏完整性。例如，在供不同尺寸的子宫的临床应用中，流量与时间关系的图形曲线下的积分提供了子宫腔的尺寸的容积评估。容积量可提供不仅与子宫的尺寸有关而且与装置是否不正确地嵌入错误通路(容积量较小)中或腹腔(容积量较大)中有关的物理信息。
紧接在执行上述完整性测试之后，流入和流出通道中的流量可在通畅性测试中进行测量并用于判断是否存在可能影响蒸气在消融术期间流动的障碍物。基于该判断或通畅性测试，装置可在蒸气的输送之前重新定位或更换。例如，在一个实施例中，参照图4，执行通畅性测试的方法可包括：将气体或流体从子宫装置的流入管腔129(也称为流体输注末端)输送到子宫中；利用子宫装置的流出管腔131(也称为流体流出末端)从子宫移除气体或流体；以及在于子宫装置的流入管腔的流量计中观察到气体或流体的流量的情况下判定子宫装置未被堵塞或包埋在组织中。在图3-4中，阀128a和128b控制通向子宫消融装置100的气体/流体的流量并且阀128c控制从流出管腔131进入流出罐或废弃物容器133的气体/流体的流量。可通过作为123示出的单独的控制器和软件单元来执行对阀128a和128b和128c的控制。
如果已基于在图3中执行和描述的完整性测试判断子宫密封，则控制器也可构造成执行通畅性测试。在一个实施例中，参照图4，控制器可构造成打开阀128b和128c，但关闭阀128a。这允许气体或流体从源122流经流量计126、单向阀127和阀128b并进入流入管腔129。气体或流体可经流出管腔131、阀128c被移除到废弃物容器133中。当气体或流体进入子宫和从子宫被移除时，流量计可测量气体或流体的通畅性流量。如果通畅性流量维持在通畅性流量阈值以上，则控制器可判断装置未被堵塞或包埋在组织中。在一些实施例中，观察或测量进入流出管腔131中的流体或气体的流量可用于判断装置是否未被堵塞或包埋在组织中。滚动的通畅性测试时间窗期间的在通畅性测试阈值以上的流量可指示管腔未被堵塞或子宫消融装置的远端未被包埋在组织中。
在一个特定实施例中，通畅性测试阈值可大于5ml/min，并且滚动的通畅性测试时间窗可以是5秒时间。因此，流量计可测量滚动的通畅性时间窗(例如，5秒滚动的时间段)内的通畅性流量并且控制器可分析测得的流量。如果在滚动的通畅性时间窗期间通畅性流量维持在通畅性测试阈值(例如，5ml/min)以上，则认为通过通畅性测试并且可停止该测试。通过通畅性测试表示子宫消融装置未被阻塞或安放在错误通路中。如果不满足通畅性测试阈值，则医生在开始子宫消融之前应当重复***步骤和/或重复完整性测试和通畅性测试。当在滚动的通畅性测试时间窗期间通畅性流量在5ml/min的阈值以下时，子宫消融装置可能需要重新定位。
在从完整性测试结束向通畅性测试开始的过渡期间，子宫腔可基本上充满在完整性测试提供的气体/流体。如上所述，在完整性测试期间关闭的流出阀防止气体或流体离开子宫腔进入废弃物容器133。在一个实施例中，期望阀128c对于5ml/min以上40ml/min以下的流量而言仅以20-50％打开的程度/范围部分地打开，因此在用通畅性测试检查子宫消融装置的开流(open flow)时，在完整性测试期间实现的子宫腔扩张暂时维持。某些类型的阀更适合部分打开。例如，球囊阀可被脉冲控制为呈现各种占空比以部分地打开该阀。占空比越高，阀可打开得越快。阀的部分打开防止了子宫腔在子宫消融装置的末端周围过快塌缩，在一些情况下，这种过快的塌缩可能导致通畅性测试的假阳性失败(false positivefailure)。在一个实施例中，可通过以指定占空比脉冲控制打开阀直至(蒸气)开始流经蒸气探针或可替代地直至子宫压力开始下降来实现阀的部分打开。在另一实施例中，阀128c可刚好在开始流经阀之前快速打开。可通过最初以高占空比脉冲控制阀然后随着阀接近开始流经阀的范围而缩短脉冲控制(或降低占空比)来实现阀的这种快速下降/压力下降打开。一旦通畅性流量提高到阈值以上(或提高一定比例)，则阀可保持。
在一个特定实施例中，阀128c可以是充填至接近20psig以闭塞通向废弃物容器133的管子的球囊。在球囊压力下降为低至5psig之前，球囊阀可被脉冲控制为每200毫秒打开40毫秒。阀打开时间然后可进一步缩短，直至球囊压力下降至3-4psig之间。可对阀继续进行脉冲控制，直至流量上升0.20ml/min的水平或流量上升到阈值以上(例如，5ml/min以上)。
图5示出流出阀(例如，图3的阀128c)包括可充胀球囊的一个特定实施例。充胀球囊引起子宫消融装置的流出管腔的阻塞，而泄放球囊允许流量从装置流出并进入废弃物容器中。图5示出在典型的通畅性测试期间的流出阀压力136(mmHg)、从子宫消融装置通过的流量138(ml/min)和子宫腔压力140(mmHg)。在典型的完整性测试完成时，腔压力应当在52mmHg以上，流出阀压力约为20psi，并且从子宫消融装置通过的流量接近零。在通畅性测试的前几秒内，流出阀压力快速降低，然后泄放速度随着流经装置开始而降至零，如箭头142所示。腔压力随着流量增大而逐渐下降。通畅性算法可与流出阀的泄放同时运行。在一些实施例中，流出阀的泄放时间通常是3至40毫秒。
在成功完成完整性和通畅性测试之后，子宫消融装置的控制器可自动开始治疗过程。该治疗过程可包括经子宫消融装置的流出管腔和蒸气端口输送蒸气。为了收集消融过程的冷凝物、碎屑和副产物以及自由流动的蒸气，返回管腔可在其远端处包括微孔过滤器。光纤压力传感器可位于过滤器内以确保治疗压力保持在规定范围内。可通过自动接合和分离一系列阀来实现压力控制以将治疗压力维持在规定范围内。如果压力传感器记录过低或过高的值，则该装置可自动暂停蒸气输送并且提醒医生导致蒸气输送中止的状态。
该子宫消融装置还可包括中断按钮和屏幕上按钮，以在手术期间的任何时点在必要的情况下暂停手术。如上所述，热电偶可位于使蒸气从子宫腔排出的管腔中。该热电偶可提供有关流经流出管路并进入废弃物容器的副产物的温度的反馈。该温度提供已循环经过空腔并经返回管腔和流出管离开的蒸气的量的指示。
通过在足够长的持续时间内对子宫内膜组织施加升高的温度以引起细胞坏死来实现消融。水蒸气的独特特征是作为气相特征的高浓度热能。借助于冷凝轻易提取浓缩的热能使得能向子宫腔的壁施加高速率的传热。蒸气以规定的压力范围和比水的正常沸点高约一度的饱和温度输送到子宫腔内。子宫表面温度比蒸气的温度低，从而引起持续的冷凝。
可通过冷凝速度和热渗入子宫组织的速度来自动调节所使用的蒸气的流量。如果输送的蒸气流量超过自动调节的值，则蒸气将经装置的返回管腔和流出管离开子宫腔。通过冷凝沉积在子宫壁上的热能通过两种输送机制渗入子宫组织。机制之一是热传导，其是所有介质固有的分子级过程。第二输送机制归因于血液灌注，其是类似于渗漏的过程。热由灌注的血液携带，也称为“热沉”效应。通过在子宫的内表面维持升高的温度实现了治疗用细胞坏死，又通过维持升高的温度足够长的时间实现了期望的消融深度。由于在实现消融的程序期间以规定压力和时间段供给了过量蒸气，所以大范围的腔尺寸可被均匀地治疗至期望的深度而不需要调节治疗参数。通过连续供给在经返回管腔和流出管离开之前在腔内循环的蒸气而实现了腔内覆盖范围的均匀性。
当治疗在预定时间——在一个实施例中，其可在140秒以下——完成时，通过控制器和发生器单元停止蒸气的输送。在蒸气输送中止之后，发生器可查询子宫内的压力传感器以确保内部压力值现在已下降。在达到满意的水平之后，***自动泄放将装置保持在子宫颈中的球囊并且可通知医生输送装置现在已准备好从患者体内移除。在此步骤之后，***可从发生器解锁子宫消融装置并且可丢弃输送装置。
一旦治疗完成，***便可提醒终端用户是否有另一名患者即将接收治疗。如果有，则***重复上述步骤。如果没有待治疗的另一名患者，则可从发生器排出过剩的流体。
至于属于本发明的其它细节，可在相关领域的技术人员的水平内采用材料和制造技术。在共同或逻辑上采用的附加方案方面，关于本发明的基于方法的方面同样如此。而且，预期可单独地或结合一个或多个文中所述的特征来阐述和要求保护所描述的本发明的变型的任何可选特征。同样，对单数部件的提及包括存在多个相同部件的可能性。更具体地，如文中和所附权利要求中所用，单数形式“一”、“一个”、“所述的”和“该”包括多个指代物，除非上下文明显以别的方式指示。还要注意，权利要求可以是以排斥任何可选元件的方式撰写的。由此，此声明旨在结合权利要求元件的引用或“否定”限制的使用而用作使用这样的排斥性术语如“单独地”、“仅”的前置基础。除非文中以别的方式限定，否则文中所有科技术语具有与本发明所属领域的普通技术人员普通地理解的那样相同的含义。本发明的范围并非由所涉及的说明书限制，而是仅由所采用的权利要求术语的一般含义限制。

Claims (5)

1.一种子宫内膜蒸气消融***，包括：
蒸气发生器，所述蒸气发生器包括第一压力传感器；
与所述蒸气发生器联接的子宫消融装置(100)，所述子宫消融装置包括：
构造成被***患者的子宫腔内的轴(102)；
设置在所述轴中并联接至所述蒸气发生器的流入管腔(129)和流出管腔(131)；
第二压力传感器；
设置在所述轴上的至少一个球囊(108,110,112)；和
设置在所述轴和所述至少一个球囊上的末端罩盖(148)，以及
与所述子宫消融装置和所述蒸气发生器联接的控制***，所述控制***构造成自动执行对所述蒸气发生器和所述子宫消融装置的术前消毒，所述控制***构造成对所述末端罩盖进行加压，并将所述第一压力传感器的感测压力与所述第二压力传感器的感测压力进行比较以检查所述至少一个球囊中的泄漏，以及所述控制***构造成在移除所述末端罩盖之后，监测蒸气能量的施加、监测所述子宫消融装置上的被识别位置处的温度读数，并且实施所述蒸气发生器在蒸气输送之后的关断。
2.根据权利要求1所述的***，其中，所述控制***构造成在所述术前消毒未能开始或完成的情况下提醒所述子宫消融装置(100)的终端用户。
3.根据权利要求1所述的***，其中，还包括设置在所述子宫消融装置(100)的所述轴(102)上的远侧锚定球囊(108)、中央密封球囊(110)和近侧定位球囊(112)。
4.根据权利要求3所述的***，还包括位于所述中央密封球囊(110)附近并且构造成测量患者子宫颈内膜内的温度的温度传感器。
5.根据权利要求3所述的***，还包括构造成测量所述远侧锚定球囊(108)、所述中央密封球囊(110)和所述近侧定位球囊(112)中的每一者的压力的一个或多个压力传感器。
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