CN109069064A - 用于确定体腔的完整性的方法和设备 - Google Patents
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Abstract
提供了一种向患者的子宫提供治疗的方法和系统,其可包括任何数量的特征。该方法可包括将子宫装置插入到子宫内并进行子宫完整性测试以判定子宫是否完好且未穿孔的步骤。还公开了用于以受监测的流量并且与患者相对于压力源的高度无关地来执行这些方法的系统。
Description
相关申请的交叉引用
本申请根据35 U.S.C.119要求在2016年2月19日提交的、标题为“Methods andApparatus for Determining the Integrity of a Bodily Cavity(用于确定体腔的完整性的方法和设备)”的美国临时专利申请No.62/297,643的权益,并且是在2012年10月9日提交的、标题为“Integrity Testing Method and Apparatus for Delivering Vapor tothe Uterus(完整性测试方法及用于向子宫输送蒸气的装置)”的美国专利申请No.13/648,132的部分继续申请,所述两个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并入本申请中,并入范围与每个单独的公报或专利申请特别和单独地表示为通过引用被并入相同。
技术领域
本公开总体上涉及引入了可供内窥镜手术或其它可视化系统如超声波或荧光镜系统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,但可以用于将在其它体腔内和身体管腔中有用的治疗以及系统完整性的检查,所述其它体腔诸如肺、尿道、膀胱,所述身体管腔诸如食道、胃肠系统、输尿管、鼻气道、胃和动脉/静脉/淋巴系统。更具体地,本公开涉及使用经加热的蒸气的子宫内膜消融术,并且具体地涉及完整性和通畅性测试系统,其向医生用户提供关于被治疗的体腔的完整性和初始完整性测试结果的可靠性两者的信息。
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插入子宫内的电切镜(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,尽管穿孔即使利用宫腔镜可视化也可能不是很明显。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系统,该系统利用超声波作为能量源。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Somervilie的Ethicon公司在商标下销售的procedure和系统。低温消融,或“冷冻消融”,诸如来自AmericanMedical Systems,Inc.的,是另一种子宫内膜治疗方法。所有上述产品都被表征为“盲”的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对子宫或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、优选地盐水和具体地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。
发明内容
通畅性测试的进一步改进是流体流量的实时控制。例如,如果初始通畅性测试结果显示低流体流量或接近阈值的流体流量,则可以瞬间增加流体流量以试图疏通子宫消融装置的管腔。管腔可能被血液、组织或碎屑堵塞,并且这种增加的流体流的爆发将试图从管腔清除干扰通畅性测试的材料。如果增加的流体流未提高通畅性测试评估中的流量,则将子宫消融装置从患者体内移除,并检查装置是否有堵塞材料,并且开始包括完整性和随后的通畅性测试的装置插入的整个过程。然而,如果增加的流体流成功地移除了堵塞材料,则可以重复子宫腔完整性测试,随后进行确定的通畅性测试,而无需移除装置和重新插入。在这种情况下,通过消除对装置移除和重新插入的需求,成功应用增加的流体流导致更少的手术时间、更低的手术风险和患者的不适。
在实践中,可以通过结合另外的机构来改进完整性和通畅性测试,所述另外的机构将消除对在子宫上方的架高盐水袋的高度之间的高度差制定或建立以提供盐水冲洗源的要求。尤其是因为它涉及变化的水位,因为在手术期间冲洗流体源被耗尽。
应用完整性系统的准确性和易用性的进一步改进对于医生用户是有益的,或者通过移除前面公开的系统中所需的附属构件来使整个系统更便宜。所描述的系统呈现了改进的完整性和通畅性测试系统,改进的完整性和通畅性测试系统消除了对系统内的内部压力传感器或集成式流量计的要求。
此外,在实践中,其中控制完整性和通畅性测试系统内的实际流量的系统为系统提供了使得整个测试更加稳健和准确的新益处。
在另一实施例中,该系统利用子宫插入装置的手柄内的加压流体储器,该手柄构造成用于将治疗剂输送到子宫腔,所述手柄为例如用于与患者相对于流体源的身高无关地输送蒸气并且因此在进行完整性测试之前不需要进行患者身高测量的手柄。使用空气压力调节器来设定小储器内的流体或液体压力,并且通过流体供给系统来将储器中的流体料位/液位控制或保持在适当水平或阈值。使用储器中的一个或多个传感器来测量流体料位。当储器中的流体料位下降时,流体供给系统将更多流体喷射到储器中并且在达到阈值或流体料位时停止将流体放入储器中。流体供给系统在它将流体供给到储器中时测量流量。
或者,监视达到阈值的时间以推定流量。所使用的流体为液体,诸如盐水、水、蒸馏水等。
在一个实施例中,流体供给系统为驱动注射器柱塞以形成注射泵的步进电机、注射泵或齿轮泵,并且所述一个或多个传感器是监测小储器中的流体料位的红外传感器。
本文描述了可以单独地或结合地用于执行完整性测试和随后的通畅性测试的另外的实施例和系统元件。
提供了一种对患者的子宫执行完整性测试的方法,其包括以下步骤:将子宫消融装置插入患者的子宫内;启动流体供给系统以将流体输送到设置在所述子宫消融装置上或所述子宫消融装置中的储器内;当储器中的流体料位达到上限阈值时停闭流体供给系统;使用通过压力调节器作用的压力源将储器中的流体加压,以将流体从子宫消融装置的储器输送到子宫内;使用储器的一个或多个传感器监测储器中的流体的流体料位;当储器中的流体料位达到下限阈值时重新启动流体供给系统;以及基于流体供给系统的流量来判定子宫中是否存在泄漏。
在一个实施例中,在启动步骤之前使储器与大气联通。
在另一实施例中,在停闭步骤之后使储器与大气隔绝。
在一些实施例中,如果流体供给系统的流量下降到流量阈值之下持续预定时间,则判定为子宫内不存在泄漏。在一个实施例中,流量阈值为5mL/min并且预定时间为15秒。
在另一实施例中,如果在完整性测试时间限度的过程中流体供给系统的流量未下降到流量阈值之下持续预定时间,则判定为子宫内存在泄漏。在一个实施例中,所述流量阈值为5mL/min,所述预定时间为15秒,并且所述完整性测试时间限度为60秒。
在一些实施例中,所述一个或多个传感器包括红外传感器、接触传感器、磁传感器或离子传感器。
在一个实施例中,所述压力源被加压至55mmHg。
在另一实施例中,子宫腔内的压力与患者相对于压力源的高度无关。
提供了一种子宫治疗装置,其包括:尺寸设置和构造成用于插入患者的子宫内的轴;沿着轴的长度设置的流入和流出管腔;设置在流入管腔的远端处的至少一个流入端口;设置在流出管腔的远端处的至少一个流出端口;可操作地联接到流入和流出管腔的流体储器;构造成监测流体储器中的流体料位的一个或多个传感器;连接到流体储器的流体供给系统,该流体供给系统构造成将流体输送到流体储器中;连接到流体储器的压力源,该压力源构造成将流体储器中的流体加压以将流体从储器输送到患者的子宫内;设置在压力源与流体储器之间的压力调节器,该压力调节器构造成将来自压力源的压力降低至预定压力值;和控制器,该控制器构造成启动流体供给系统以将流体输送到流体储器中并且在流体料位达到上限阈值时停闭流体供给系统,该控制器还构造成基于流体供给系统的流量来判断子宫内是否存在泄漏。
在一个实施例中,控制器构造成如果流体供给系统的流量下降到流量阈值之下持续预定时间,则判定为子宫内不存在泄漏。在另一实施例中,所述流量阈值为5mL/min,所述预定时间为15秒。
在一个实施例中,控制器构造成如果在完整性测试时间限度的过程中流体供给系统的流量未下降到流量阈值之下持续预定时间,则判定为子宫内存在泄漏。在一个实施例中,所述流量阈值为5mL/min,所述预定时间为15秒,所述完整性测试时间限度为60秒。
附图说明
图1A-1B示出子宫消融装置的一个实施例。
图2示出子宫消融装置的完整性测试。
图3示出子宫完整性测试期间的设备的一个构型。
图4示出子宫通畅性测试期间的设备的一个构型。
图5示出蒸气治疗操作期间子宫消融装置的一个构型。
图6A示出子宫完整性测试期间设备的一个构型。
图6B示出子宫完整性测试期间设备的另一个构型。
图7A-7B示出子宫完整性和通畅性测试的一个构型的算法。
图8示出消除了完整性和通畅性测试期间对冲洗源的特定高度要求的需求的系统。
图9示出利用球或囊以便于气液界面的检测的实施例。
图10示出利用了确定子宫内膜消融装置相对于患者的高度的压力计的系统。
图11示出利用泄压阀的又一实施例。
图12A-B示出流量与子宫内压力的曲线图。
图13示出了具有可再充装的注射器的系统,该注射器输送流体通过蒸气探针以用于执行完整性和通畅性测试以及用于提供流体以产生蒸气。
图14示出用于在遇到失败的通畅性测试时通过增加流体流量来改善通畅性测试的过程。
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可构造成通过插入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、远侧锚固件或远侧囊108、中央或密封囊110、近侧或定位囊112、和连接管腔118,连接管腔118可将子宫消融装置与控制系统(未示出)联接,所述控制系统包括计算机、蒸气发生系统和构造成使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与气体/流体源122、压力调节器124和(多个)流量计126连接。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。
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系统。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,自气体/流体源恰好在流量计的远侧或经过流量计可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,子宫腔是在存在子宫膨胀的情况下或在子宫腔充填有气体/流体且特别是诸如盐水的流体时会经历显著收缩的肌肉。这些收缩可将流体反推回使其通过盐水管腔和经过流量计。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。单向阀安放在该位置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、用于提供插入深度的反馈的标记、阀等),包括用于控制囊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。
本文中描述的囊可以是任意类型的柔性囊,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,远侧锚固件包括囊,但在另一些实施例中,远侧锚固件包括可扩张锚固件或扩张机构,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,远侧锚固件可被称为远侧锚固件或远侧囊。
轴102可构造成将来自远处的沸器(未示出)的经加热的蒸气输送通过所述装置并从远侧末端106中的蒸气端口107输出。该轴也可构造成使已离开所述装置的蒸气——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被示出为呈塌缩输送构型,其中远侧囊108、密封囊110和定位囊112被泄放以缩小该装置的截面直径并且在插入期间的直径可为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阴道、子宫颈管和子宫颈而接近子宫,并且在插入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示出全部三个囊——包括远侧囊108、中央密封囊110和定位囊112——都充胀的图1A的子宫消融装置100。中央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中示出了三个囊,但在另一些变型中,可设置一个、两个、四个或更多个囊,并且可使用其它囊形状。定位囊可使用室温介质、冷却介质或可替代地加热介质充胀。在一些实施例中,中央密封囊包括沿轴102大致15mm至25mm的长度。中央囊可在远侧囊或锚固件与近侧囊之间配置在轴上。在一些实施例中,中央囊与远侧囊和近侧囊两者相邻。在另一些实施例中,一个或多个囊之间具有小的间隙或空间。中央囊在轴上的长度和定位确保了在充胀时,中央囊在子宫内口(os)附近使子宫颈与子宫阻隔开,但囊不会伸入患者的子宫或阴道内。中央和近侧囊可包括任何直径,但优选应当具有足够大以接合普通女性患者的子宫颈的壁的直径。例如,中央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。近侧囊可具有诸如17mm的较大直径和7psi的较低充胀压力。
现在将说明图1A-1B的消融装置的安放。消融装置的远侧末端可经子宫外口插入患者的子宫颈管内,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,远侧囊可位于子宫内口远侧的子宫内,密封囊可位于子宫内口处或其近侧并且伸入子宫颈管内,并且定位囊可位于子宫颈管内并且在近侧伸入阴道中或朝阴道延伸。
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,远侧囊可被充胀至期望压力。在一些实施例中,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退出。应当指出的是,此时,远侧囊定位成稍微超过子宫颈的子宫内口。远侧囊的充胀可在之后用作锚固件以防止该装置朝近侧从子宫滑出。
在充胀远侧囊之后,近侧囊可被充胀以使该装置采取被定位的构型,其中远侧囊完全座靠在子宫内口上,并且定位或近侧囊在子宫颈内扩张并经子宫外口伸入阴道内。随着近侧囊充胀,囊可从子宫颈向外扩张到阴道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示出插入患者的子宫内的消融装置100,其中囊108、110和112如上述那样地被充胀。
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在错误通路内的指示。提供给医生的这种附加信息在“盲”的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对于除了子宫消融术之外的另外的子宫手术可能是有用的,所述另外的子宫手术例如装置、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系统。
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、消毒水和矿物油的流体。调节器124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70mmHg。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70mmHg)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。
在使用中,可通过将气体/流体源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高度上方的32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在完整性和通畅性测试之前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。
或者,该子宫完整性测试可通过在已知条件下检测子宫装置或子宫消融装置的远侧管腔的流量来进行,以确定气体/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。在一些实施例中,流量计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(未示出)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。流量计可构造成测量和报告通过子宫消融装置的流体/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。
参照图2和3,为了执行子宫完整性测试,可将诸如C02的气体或诸如盐水的流体从气体/流体源122经压力调节器124并经流量计126输送到子宫消融装置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903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。
子宫消融装置的控制器(未示出)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。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。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。如果流量降低到完整性流量阈值之下,则控制器可以判定为子宫是密封的。在一些实施例中,该完整性流量阈值可以是约5ml/min。
气体/流体可以离开装置的蒸气端口107并进入子宫腔。这些蒸气出口端口也可被称为流体输注末端和流体流出末端,如上所述的,对于完整性测试,子宫切除装置的流入管腔和流出管腔两者可以用来向子宫腔提供流体/气体。当子宫内的压力增加时,通过子宫消融装置流体或气体的流量应减少到零值或低于完整性流量阈值的值,这在子宫内的压力等于系统的驱动压力时发生。在装置插入患者的过程中使用流入管腔和流出管腔两者用于气体/流体的流动可以帮助防止蒸气端口在插入过程中被堵塞或阻塞。
对于通畅性测试,流入管腔可用于气体/流体流入子宫,而流出管腔用于气体/流体从子宫返回。
对于完整性测试,通过用流量计126测量进入子宫的气体或流体的流量,更具体地,通过测量进入子宫的气体/流体的下降的流量或子宫中的稳态流量,系统或用户可以确定子宫的状态和装置在子宫中的正确定位。例如,1)如果流量未下降或下降到高于阈值流量如5ml/min的流量,则要么在子宫或者装置中存在泄漏,要么该装置在子宫内未正确定位;2)如果流量立即下降至零,则子宫消融装置的远侧末端可能被堵塞或包埋在组织中;3)如果流量下降到零以上的水平并保持该水平(例如,~30mL/min),则可能存在小的泄漏。泄漏的大小可以与所测量的流量成比例;4)如果流量在低水平和高水平之间振荡,则可能存在在较低压力下密封或闭合但在较高压力下打开的孔或泄漏;和5)如果流量在由最小时间和最大时间两者界定的一定的时间期限内下降至低于阈值或下降至零,则该装置正确地定位在密封的子宫内。在一实施例中,用于确定在密封的子宫内的正确定位的最小和最大时间可以发生在10至60秒的测试窗内,其中优选15秒的测试窗。流量阈值可设定为数值5ml/min,其中在时间窗内降低至低于5ml/min的流量可以作为用于密封的子宫腔的阈值使用,而大于或等于5ml/min的流量可以作为用于检测泄漏或未密封的子宫腔的阈值使用。作为用于完整性测试的密封的阈值或未密封的阈值的数值5ml/min已被证明对利用蒸气的子宫消融装置是有效的。在测试子宫中有意形成的穿孔被证明在低于5ml/min的值时不允许蒸气横穿该穿孔。建立用于密封的或未密封的子宫腔的阈值必须考虑到流量传感器和计量器的分辨率的限制,以及子宫腔中的盐水吸收速率。
在分析用于泄漏阈值或非完整阈值的完整性测试数据时,经验测试表明,在确定为“通过”(流量<5ml/min)或“失败”(流量>5ml/min)的测试之间具有在统计上的显著差异。盐水流量的平均最小变化与最大盐水流量是显著不同的,这表明完整性测试可以有效辨别在穿孔被有意施加到测试子宫腔的测试环境中是否存在泄漏,如下面的表格中所示的。当通过使用单向阀消除负流量值时,这种统计上的显著的差异进一步改进(对于最小Δ流量P<.001,对于最大流量p<.001)。基于这种分析,可以建立用于泄漏检测的5ml/min完整性测试阈值并应用于临床使用。此外,可以为了其确定子宫完整性的能力而开发自动分析数据的算法。
表1:具有有意地形成的穿孔的测试子宫中的子宫腔完整性测试结果:
在表1中,最小Δ流量指的是在15秒的流量窗中流量的最小变化,以ml/min示出。最大流量指的是在15秒的流量窗中观察到的最大流量,以ml/min示出。无负流量值指的是只计算正的流量的数据点。当单向阀就位时不会出现负流量值。
作为另一考虑因素,子宫的尺寸和/或形状在完整性测试期间将可能发生变化。因此,在某些实施例中,可以使用平均流量来确定子宫的完整性或装置的定位。例如,在一实施例中,如果在例如5秒的预定时间段内的平均流量是零或低于阈值流量,则子宫很可能是密封的。在另一变型中,可以采用15秒的时间窗,其中对于每15秒时间增量列出伴随的数据点的平均值。其它时间窗增量可以用作数据收集的标准。
在一些实施例中,返回通道包括阀128c,诸如电磁阀,所述阀可在完整性测试开始时启动以阻止气体/流体经返回通道进出(egress)。替代地,可以利用单向泵。当利用阀阻止气体/流体通过返回通道的回流时,可以通过在输入线路上的流量计126检测流量的变化。除了确定是否存在泄漏或装置是否正确定位,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)在一些情况下可以提供以下指示:a)子宫腔的尺寸;和b)系统中存在泄漏或缺乏完整性。例如在其中子宫尺寸不同的临床使用中,流量随时间变化的图形曲线下的积分提供了子宫腔的尺寸的体积评估。体积的量可以向医生提供的信息不仅与子宫的尺寸相关,而且还与装置是否被不适当地埋入在错误通路中(较小的体积量)或者埋入在腹膜腔中(较大的体积量)。
参见图4,在一些实施例中,流入和流出通道中的流量值可以用来确定是否存在可在消融手术期间影响蒸气的流动的障碍物。基于这种确定或通畅性测试,该装置可以在输送蒸气之前被重新定位或被取代。例如,在一个实施例中,仍参见图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(也称作流体输注末端)输送至子宫中;通过子宫装置的流出管腔131(也称作流体流出末端)从子宫去除气体或流体;以及如果在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,则确定子宫装置未被堵塞或包埋在组织中。在图3和图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,阀128c控制气体/流体从流出管腔131进入流出罐或废弃物容器133的流量。对阀128a和128b和128c的控制可以通过示出为123的单独的控制器和软件单元来执行。
如果已经基于所执行的并在图3中描述的完整性测试确定子宫是密封的,则控制器还可以构造成执行通畅性测试。在一个实施例中,参见图4,控制器可以构造成打开阀128b和128c,但关闭阀128a。这允许气体或流体从源122流出,流经流量计126、单向阀127和阀128b,并进入流入管腔129。气体或流体可通过流出管腔131、阀128c被去除,并经由管道135进入废弃物容器133。当气体或流体进入子宫和从子宫去除时,流量计可以测量气体或流体的通畅性流量。如果通畅性流量保持在高于通畅性流量阈值,则控制器可以确定该装置未被堵塞或包埋在组织中。在一些实施例中,观察或测量流体或气体在流出管腔131中的流量可用于确定该装置是否被堵塞或包埋在组织中。
也可以用压力驱动系统或流动驱动系统修改通畅性测试。例如,如果子宫消融装置的远端被血液、组织或碎屑浸没或堵塞,则可以输送更高的流量或压力以清除子宫消融装置的远端从而消除堵塞源。在通畅性测试期间,这种较高的流量/压力可以维持,或者它随后可下降至较低的值。重要的是,来缓解堵塞的施加更高的流量或更高的压力的要求可能需要重复证明完整性,随后应用通畅性测试。
在经验性实验室测试中,已证明:当测量通过子宫装置的气体源或流体源的流量时,子宫装置的管腔内存在血液和组织可能提供子宫腔完整性的错误结果。在这些情况下,随后的通畅性测试证明完整性测试结果是假阳性,并且用户将被警告通畅性测试失败并且不允许手术继续以使子宫腔消融。子宫装置的管腔内的血液和组织的聚集可在插入期间或在子宫装置的远端被包埋在组织壁内时发生。这对于子宫消融手术尤其重要,因为该患者群体的特征在于活动或不受控制的出血以及子宫异常,所述子宫异常可能导致更大量的子宫内膜或组织、血液和凝块以及子宫腔内的松散碎片或组织。诸如在异常出血的患者中经常遇到的纤维瘤、肌瘤或息肉的存在的基础疾病也构成有挑战性的解剖学配置,其使得子宫装置的插入和放置困难并且增加了子宫装置内的管腔堵塞的风险。
图7A-7B描述了一用于将子宫完整性和通畅性测试用于子宫消融手术的算法的示例。首先,可以将如上所述的子宫装置插入到患者的子宫内。在一些实施例中,在子宫消融装置插入患者体内期间,盐水可以流经流量计和子宫消融装置的流入管腔和流出管腔。一旦该装置已经被放置在子宫腔中,子宫颈可由一个或多个囊如上述的远侧、中间和近侧囊进行密封。在密封子宫颈之后,可以启动完整性测试。如上所述,可以用流量计来测量来自子宫消融装置的气体/流体的流量,并且该系统可以监测通过流量传感器的流量以降低至流量阈值。一旦达到流量阈值,(例如,在一个实施例中为5ml/min),则可以确定子宫是密封的,然后系统可以开始通畅性测试。通畅性测试利用装置的流入管腔维持进入子宫腔内的流,但打开流出管腔以将气体/流体从子宫腔去除到废弃物容器内。然后在通畅性测试期间监测流量阈值。高于通畅性测试阈值的流量(例如,在一个实施例中大于5ml/min)可以指示管腔未被堵塞或子宫消融装置的远侧端部未被包埋在组织。如果不满足通畅性测试阈值,医生应在开始子宫消融之前重复插入步骤并重复完整性测试和通畅性测试。如果满足所述通畅性测试阈值,子宫消融治疗可以开始,如图7A-7B所示。
在一些另外的实施例中,用于完整性测试的返回通道与在治疗模式中使用以从子宫排出蒸气和体液/组织的返回线路可以是相同的线路或可以是不相同的线路。更具体地,在一些实施例中,所述装置可以具有其自身的专门用于进行完整性测试的专用返回通道系统。在另一实施例中,返回通道可以具有其自身的被动或被动的流出调节器。在又一实施例中,返回通道可以具有第二流量计(未示出),其能用于将进入子宫腔的流量(经由流量计126)与从子宫腔的出口上监测的流量(经由返回通道内的第二流量计)进行比较。比较流出量与流入量可以提供对子宫中是否存在泄漏或是否缺乏完整性的动态测量。
在另一实施例中,可以采用在返回通道中结合有电磁阀和第二流量计两者的系统。在该实施例中,由电磁阀关闭一系列返回通道与在开放循环期间测量流量结合能提供子宫腔完整性和该空间中的体积量的指示。在一些实施例中,可以结合记录和数据分析系统以分析流量测量值,并基于子宫的完整性和消融装置的位置提供动作的自动化。该分析系统记录了治疗的不同阶段的流量,并向用户和消融装置提供适当的反馈。
一旦装置已经正确地定位并且完整性测试和通畅性测试确定子宫是密封的,则该装置被正确地放置并且输送管腔与返回管腔之间存在开放式连通,可以将加热的可冷凝蒸气从消融装置100的远侧末端106通过(图1A-1B的)蒸气端口107输送至子宫以消融子宫组织。图5示出了向子宫输送蒸气的消融装置的另一视图。在一实施例中,蒸气可以经由蒸气源123被输送至消融装置。在另一未示出的实施例中,气体/流体源122可以用来向装置提供例如盐水的流体,流体然后在装置中可以转化为蒸气以输送至子宫。一旦蒸气已通过流入管腔129被输送至子宫,蒸气可以从子宫经流出管腔131被去除,并经由管道135沉积在废弃物容器133中。
可以执行或不执行在完整性和通畅性测试期间以及恰在蒸气治疗开始之前维持子宫扩张或宫腔内的压力而不收缩。在一些实施例中,在低于70mmHg压力下扩张而不收缩的子宫腔将在治疗之前在子宫消融装置的流入管腔和流出管腔内经历较少的血和碎屑聚集。减少血和碎屑在返回或流出管腔中的聚集将减少手术时间并提高治疗效率。减少返回或流出管腔中血液和碎屑的聚集可持续一段时间,该时间涵盖将装置插入到子宫腔内以开始消融处理,在一些情况下持续时间可以是1至5分钟。较长的持续时间还受益于减少的血和碎屑的聚集。
蒸气治疗的启动可以在完成完整性和通畅性测试之后立即开始。在一些实施例中,该动作可以通过主发生器单元内的软件进行控制。替代地,完整性和通畅性测试可以由独立于主发生器的单元或模块进行,单元或模块提供治疗手术已准备好利用图7所示的算法开始进行的指示。各个管腔在完整性和通畅性测试过程中的打开和关闭可通过夹断所述管腔的电磁阀或囊来执行。
在一个实施例中,利用盐水代替气体作为用于执行完整性和通畅性测试的介质具有以下优点。已据经验确定的是,在完整性测试期间,施用加热的蒸气可能无法贯穿子宫腔中有意设置的穿孔,而盐水介质可以贯穿同样有意设置的穿孔。此外,在测试条件下的活体患者的子宫腔中,活动性出血可阻挡或阻碍气体贯穿有意设置的穿孔的能力,从而向医生提供子宫完整性的错误指示。例如,穿孔器具可以是直径3mm的宫颈扩张器并且穿孔的角度可以是与子宫表面的法线或垂线成15度。也可以使用较小和较大直径的器具。
盐水在临床使用中也容易获得。在实践中,气体如二氧化碳在通常低于100ml/min的安全阈值流量内被施用至患者,在该流量下的气体在去除子宫腔中的可能挡住或阻碍潜在的穿孔的显现的血或其它碎屑方面可能是无效的。
此外,在临床使用中,在气体中结合盐水来作为用于完整性和通畅性测试的介质提供了用于体内管腔的冲洗源。该冲洗或稀释作用可在蒸气治疗前促进子宫消融装置的输入管腔和输出管腔之间的开放连通。盐水的使用特别适合于稀释可能聚集在子宫装置的管腔内的血液。
或者,可使用完全流动驱动的系统执行完整性和通畅性测试。在流动驱动的系统中,如图6A中所示,流体950可朝向装置和子宫向远侧输送。流体950可以是例如盐水。流体950可以容纳在容器951中。容器951可以已知或可变速率驱动流体。例如,在一个实施例中,容器951可以是注射器或蠕动泵。流体950可以是气体,容器951可以包桨叶以推进流体。具有设定的裂开/断裂压力(crack pressure)的阀952可以定位成在流量传感器901的近侧。阀952可具有例如设定在60-70mmHg的裂开压力。在子宫中的压力达到阀952的裂开压力之前,流量传感器901可以感测到非零的流量值。一旦子宫907内的压力等于阀952的裂开压力,则流体950将停止流入子宫907内,并且可替代地流入管腔953内。管腔953可以退出到大气中,并且不提供背压。持续的非零流量值可以指示不密封的子宫。如果容器951处的流量值是已知的或已测量的,流量传感器可以替代地定位于线路953上。将流量传感器定位在线路953上可有利于将流量传感器953保持在无菌区域以外。可以在不监测或测量子宫腔内的压力的情况下执行本文所描述的流驱动系统。
作为另一实施例,用于执行完整性测试的系统可以独立于压力,例如,去掉对将盐水源的高度设置于已知水平的要求。此外,某些实施例可以去除在具有已知裂开压力的系统内放置压力释放阀的要求。为了说明该实施例,如图6B所示,流体950的输送流量是已知的并可例如通过泵951设定在恒定值,然后可以将对流体具有已知阻力的孔口960放置在流体源和子宫907之间。孔口960可以是具有已知的孔口或孔径的任意部件,例如,诸如具有已知口径和内径的皮下注射针。孔口960可定位在相对于子宫907的已知高度处。例如,孔口960可放置在子宫内装置的手柄中。孔口960可以通过流体的流动被调节,以便在子宫907中产生可预测的压力。例如,如果流体950以10ml/min流动,孔口具有0.01英寸的内径和0.5英寸的长度,那么子宫内压力可能决不会超过例如60mmHg的阈值。例如,当子宫内的压力为零(表压)时,大部分的流体950可流入子宫907内。由于子宫907填充有流体950,子宫907中的压力可能会增加并且多余的流体950可以替代地流经孔口960。最终,所有流体950可流经孔口960。流量传感器901可以如图6B所示地放置,或者可以被放置在管腔953上以便测量例如流经孔口的流量。管腔953和/或流量传感器901可以完全和/或部分地在无菌区域之外。完整性测试可通过使用流量传感器901监测流体950的流动来执行。例如,如果所有流体950都通过孔口960转向,则子宫可以被认为是完全密封的。
图8示出子宫消融装置的一个实施例,其可包括图1A-1B的子宫消融装置的一些或基本上全部构件。在图8中,子宫消融装置100包括流体储器501,该流体储器501由经由导管502连接到空气压力调节器500并由空气压力调节器500控制的空气或压力源507加压。空气或压力源507可包括例如加压气体或空气罐。在另一些实施例中,空气或压力源可以替代地是恒力弹簧或具有已知恒定力以提供加压空气源的其它元件。在一个具体实施例中,弹性管件如薄壁乳胶、PVC囊或其它柔顺囊也可以通过在使用空气扩张的同时膨胀并利用囊中产生的压力来代替弹簧和/或加压空气源以供给加压空气源。
在一个实施例中,流体储器501可位于子宫插入装置100的手柄104内,该手柄104构造成用于将蒸气输送到子宫腔。此构型特别适合于手柄104,该手柄104与患者子宫(未示出)相对于流体储器501的高度无关地输送蒸汽。在执行完整性测试之前,所描述的系统不需要相对于子宫消融装置100的流体储器501进行患者子宫高度测量。
空气压力调节器500可用于经由导管502设定流体储器501内的流体或液体压力。流体储器501中的空气-流体界面处的流体料位550由一个或多个传感器552监测。传感器552可包括对流体料位的检测作出响应的例如光学传感器、流量传感器、红外传感器、接触传感器、磁传感器、离子传感器或类似传感器。被监测的流体料位550在反馈回路中被传送到装置的控制器,以将流体料位维持在适当的水平。当如传感器552所示流体储器501中的流体料位550下降到下限阈值时,流体供给系统504由控制器控制以将更多流体注入到储器中,直至达到流体料位550的上限阈值。
流体供给系统504包含注射器505和步进马达或泵540以输送流体。在一些实施例中,流体供给系统504在经由导管503将流体供应到流体储器501中时测量流体的流量。可以使用传感器测量流量,或者可基于注射泵的操作(循环速度)来确定流量。在另一实施例中,传感器552可用于通过监测流体料位在低于下限阈值之后达到上限阈值所花费的时间量来推定流量。流体供给系统可包括诸如盐水、水、蒸馏水等流体。
使用图8的实施例的方法包括以下步骤:
1)使流体储器501与大气联通(例如,空气压力源507和空气压力调节器500不连接和/或没有经由导管502加压。)
2)操作流体供给系统504,直至流体料位550达到流体储器501中的上限阈值。在实践中,该传感器552可以是对流体料位的检测作出响应的红外传感器、触觉传感器、接触传感器、磁传感器、离子传感器或类似传感器。
3)使流体储器501与大气隔绝。
4)使用空气压力调节器500将压力源加压,以将流体储器501加压至52mmHg至60mmHg的优选范围,从而促使流体储器501中的流体经子宫消融装置100的手柄104离开。取决于临床应用和正被检查完整性的体腔,流体储器501的其它压力范围是可能的。
5)如果流体下降到下限阈值之下(例如在传感器552感测的范围之下),则可推进注射器,直至流体料位上升到上限阈值(其可以与下限阈值相同和/或不同)之上。控制器使用算法来响应于测量注射器的动作而检测泄漏:例如,如果流体未下降到下限阈值之下持续>15秒,或者平均注射器流量<5mL/min持续15秒(例如,计数步数、监测电流/电压等)。
6)如果系统未在预定时间段(例如,60秒)内通过完整性测试,则子宫消融设备通知用户完整性测试失败。拉出装置并检查装置状况,而且还检查患者是否有任何症状。
在一个替代实施例中,上述子宫消融装置100以相同的步骤工作,除了流体储器501不需要与大气连通和隔绝,因此不需要进行步骤1和3。
如果在子宫腔或系统内发生泄漏,则流体供给系统将继续操作以将流体储器填充至阈值水平。一旦达到阈值或预定水平,步进马达或泵将停止推进。可以通过评估注射器或步进马达/泵的操作来执行流量的确定。在模拟硅酮子宫模型中使用上述系统的实验证明在泄漏检测方面的高准确度和灵敏度。
图9示出另一实施例,其提高了使用传感器552感测流体储器501内的流体料位550的灵敏度。在该实施例中,充气囊553可以被放置在流体储器501中的液体和空气之间。如上所述,经由空气导管502将加压空气供给到小储器501,并且到达充气囊553。充气囊553在流体储器501中的位置限定了流体料位550。与空气导管502相对的流体导管503将流体供给到流体储器501,同样如上所述。
在实践中,充气囊553停留在流体料位550处并且通过传感器552来提供对流体-空气界面变化的更大检测。可选地,充气囊553可以由具有浮力的固体塑料或用于改进检测的金属材料或用于检测的替代机构的内部RF发射器制成为球体。使用充气囊553强化流体料位550提供了以下益处:
1)在流体料位550处较少的空气和液体混合减少了空气进入子宫的机会。
2)可能改善的无菌性,因为与流体接触的空气供给不需要过滤器或无菌空气屏障。无菌空气屏障的一个例子是0.2微米过滤器。
3)对取向的较少依赖,而不会使空气进入子宫,因为小储器501在包含于子宫消融装置(未示出)的手柄内的情况下可以侧向倾斜、上下翻转或总体移动。
4)充气囊将使流体料位550更容易检测,因为与小储器501和液体发生运动时可能发生变化的料位相对。
5)液体进入空气管线内的风险降低。当充气囊553在小储器中形成密封时,充气囊553可防止逆行流体进入空气导管502。小储器中的密封可以通过在小储器501中靠近空气导管502的渐缩或减小的内径来增强,从而防止液体在小储器501中的进一步前进。
尽管图9示出流体储器501和相应的流体料位550处于水平位置或水平排列,但是空气-流体界面可以是直立的或竖向的、水平的或成角度的,因为流体料位552对于小储器510的排列是不可知的。另外,在流体储器501的远侧放置单向阀可有利地减少或消除子宫收缩对流体储器501内的流体料位550的影响。
图10示出子宫消融装置100的另一实施例,其利用由流体导管610和611限定的压力计来确定子宫消融装置100的手柄104相对于加压流体源635的高度620的高度621。加压流体源可以包括例如盐水袋或单独的流体柱620。压力计可以测量加压流体源635的压力或高度620。
在实践中,基于压力计结果来升高加压流体源,使得加压流体源635的高度在子宫或手柄104的高度上方约32英寸处。具有预定流量或液滴尺寸(例如,10滴/mL)的滴注室630与流体导管610和加压流体源635串联定位。液滴计数器631(例如红外光束传感器、红外传感器、声学传感器等)可以被放置在滴注室630处,以在完整性测试期间监测水的流量。在一个实施例中,如果通过滴注室的流量<5mL/min持续>15秒,则可以通过完整性测试。
图11示出子宫消融装置的另一实施例,其包括在手柄104内的泄压阀701,该泄压阀701构造成消除在执行完整性测试之前测量手柄104相对于流体源的高度的需求。包括注射器505和步进马达或泵540的流体供给系统504构造成如上所述供给流体。经过流体导管503并进入手柄104的流体的流量测量可以通过对步进马达的步数或泵的循环进行计数来确定。
泄压阀701构造成在工厂设定压力(例如,60mmHg)下打开。流体供给系统504以指定流量将流体驱动到子宫内,直至泄压阀701打开以泄放来自子宫腔的过量压力。在实践中,所描述的系统可使用以下原则操作:
1)步进马达或泵540以一定速度运转,借此泄压阀701使内部隔膜或插塞打开或移位,并且使用步数计数值来推定流量;或者
2)流体供给系统504以“通过”流量(例如,<5mmHg)输送流体,并且必须观察流出泄压阀701的流体。通过来自步进马达或泵540的流量降低到预定阈值以下来指示通过完整性测试。
图12A示出了由升高的盐水袋供给的重力供给系统的曲线图,该盐水袋的高度大于正在测量子宫内压力的装置的高度。在流体源上,监测进入子宫的流体的流量。该曲线图显示了子宫内压力801与流量802的关系。对于完好的子宫腔和升高的子宫内压力801,相应的流量802稳定地降低。子宫内压力801的上端达到由盐水袋的高度限定的平台。
图12B示出改进的压力或流量实时控制的曲线图。该曲线表明,控制流体流量802,例如,流量802的稳定控制,可更快地升高区段803中的子宫内压力801,以减少执行完整性测试的时间量。另外,如在区段804和805中所见,流量801的急剧下降可用于进一步询问子宫完整性和子宫内压力801。
图13示出包括注射器200的子宫消融系统的另一实施例,注射器200可用于输送流体通过子宫消融装置100。该流体可用于执行子宫腔完整性测试、通畅性测试以及产生用于热消融的蒸气。如上所述,注射器200可以通过由步进马达或泵202引起的注射器柱塞201的移位来供给流体。流体从注射器200经由导管210进入子宫消融装置100。
在一个实施例中,加热线圈215设置在子宫消融装置中并加热流体以产生可被输送通过装置的远侧出口216的蒸汽。加热线圈215可以由发生器218经由导线217供能、监测和控制。
在实践中,注射器200可能需要从流体源203供给比注射器200正在使用的流体体积大的流体体积。还经常需要使通过注射器200供给流体的延迟最小化。为了实现准确输送,可以使用步进马达或泵202来控制注射器200中的注射器柱塞201的位置。在一个实施例中,在注射器200远侧的单向阀远端205允许注射器200在不将注射器与子宫消融装置断开的情况下从供给容器203进行再填充。另外,注射器200与供给容器203之间的单向阀206防止流体回流到供给容器203,同时容许流体从供给容器203流到注射器200。在操作中,单向阀206在注射器再填充步骤中被启动,所述注射器再填充步骤可由终端用户手动致动或由控制子宫消融装置100的发生器(未示出)自动致动。
或者,与上述一个注射器200相反,可以并列/并联使用两个注射器,从而当第一注射器被清空时,第二注射器可立即开始输送流体。同时,第一注射器可以处于通过流体供给源的再填充的状态。对于两个注射器的构型,在相应的注射器柱塞上需要两个单独的传送机构来控制每个注射器的柱塞运动。在另一实施例中,两个注射器可以面对相反的方向定位,并且一个注射器可以在另一个注射器清空时填充。利用这种构型,仅需要一个传送机构,但是注射器柱塞将需要彼此连接并与传送机构连接。
或者,注射器200可包括多个腔室,使得当注射器正从一个腔室输送流体时,另一个腔室可同时使用来自供给容器的流体再填充。这将引起流体被输送通过子宫消融装置的最小时间滞后。在该实施例中,诸如步进马达或泵的一个共同的传送机构实现了在一腔室被再填充时由另一腔室同时输送。多腔室注射器对每个腔室可具有两个或更多个端口:一个端口用于再填充,一个端口用于输送流体。可以在每个端口上放置单向阀以控制流量,如上面首先所述的。可以主动和/或被动地控制阀。例如,可以利用机械运动电动地和/或经由压差来控制各阀。双作用注射器的一个腔室可以比另一端更容易清除气泡。某些操作可能比其它操作对流体路径中的气泡更敏感。因此,对于一些操作,可以使用两个腔室(例如,在装置插入患者体内期间),而对于其它操作,可以仅使用清除侧(例如,在蒸气输送期间)。
另外,还需要以所需精度输送流体,所述精度可受到输送流体的注射器的总体积容量和注射器柱塞位移的精度的影响。为了改进柱塞位移的测量,可以监测(例如,由步进马达或泵)施加至注射器的压力。例如,压力传感器可以与注射器中的流体接触,或者可以将应变仪放置在注射器(或其它流体接触构件)上。用于驱动注射器的力可以用于预测内部压力。
图14示出描述由本文描述的子宫消融装置执行以执行完整性和通畅性两种测试的方法步骤的流程图。在图14的步骤400,启动完整性测试。为了通过完整性测试,马达的速度必须低于特定阈值持续预定时间段(例如,15秒),如在步骤402中所示。在完整性测试期间不断调整马达的速度(步骤404),从而维持预定的子宫内压力(例如,RPM=(55mmHg-子宫内压)*常数)。完整性测试窗在预定时间段(例如,60秒)之后到期,但是操作员可以根据需要重复测试,如在步骤406中所示。
如果在步骤402通过完整性测试,则在步骤408开始通畅性测试。如果完整性测试失败,则重复步骤402、404和406。
为了通过通畅性测试,马达的速度必须高于特定阈值持续5秒,如在步骤412中所示。不断调整马达的速度以维持预定的子宫内压力(例如,RPM=(55mmHg-子宫内压)*常数),如在步骤414中所示。如果通过通畅性测试,则在步骤416开始消融。如果通畅性步骤失败,则系统可以通过运行通过装置以尝试疏通该装置的增加的流量来尝试疏通该装置。然后可以重复步骤412和414。
可以利用反馈环来执行上述完整性测试,以利用使用压力传感器的子宫内压力监测器将子宫保持在目标压力。或者,子宫内压力传感器可用于确定所需驱动流量,所述驱动流量被定义为:
驱动流量(mL/min)=(55mmHg-子宫内压力测量值)*2;
如果子宫内压力为55mmHg,则注射器停止排液。
此外,系统可以将所需驱动流量转换为步进马达的步进速度。例如,1mL/min=500步/秒。
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。就通常或逻辑上采用的另外条款而言,同样的道理也适用于以本发明的方法为基础的方面。此外,可以设想,所述的有创造性的变型的任意可选特征可被独立地阐述和要求权利或与任意一个或多个本文所述的特征组合。同样地,参考单个项目包括存在多个相同项目的可能性。更具体地,如本文和所附权利要求中所使用的,单数形式的“一”、“和”、“所述”和“该”包括复数对象,除非上下文另有明确规定。还应注意的是,权利要求可被撰写成排除任何可选的元素。因此,这种陈述意图用于作为使用这种与引用权利要求的元素或使用“负面”限制相关联的排他的术语如“仅”、“只”等的引用基础。除非本文另行限定,否则本文使用的所有技术和科学术语在本文中具有与被本发明所属领域的技术人员所通常理解含义相同的含义。本发明的范围并不受本说明书所限制,而是仅由所采用的权利要求项的明确含义限定。
Claims (18)
1.一种用于对患者的子宫进行完整性测试的方法,包括以下步骤:
将子宫消融装置插入到患者的子宫内;
启动流体供给系统,从而将流体输送到设置在所述子宫消融装置上或所述子宫消融装置中的储器内;
当所述储器中的流体料位达到上限阈值时停闭所述流体供给系统;
使用通过压力调节器作用的压力源将所述储器中的流体加压,从而将流体从所述子宫消融装置的储器输送到子宫内;
使用所述储器的一个或多个传感器监测所述储器中的流体的流体料位;
当所述储器中的流体料位达到下限阈值时重新启动所述流体供给系统;以及
基于所述流体供给系统的流量来判定子宫内是否存在泄漏。
2.根据权利要求1所述的方法,其中,在所述启动步骤之前使所述储器与大气连通。
3.根据权利要求1所述的方法,其中,在所述停闭步骤之后使所述储器与大气隔绝。
4.根据权利要求1所述的方法,其中,如果所述流体供给系统的流量下降到流量阈值之下持续预定时间,则判定为子宫内不存在泄漏。
5.根据权利要求4所述的方法,其中,所述流量阈值为5mL/min并且所述预定时间为15秒。
6.根据权利要求1所述的方法,其中,如果在完整性测试时间限度的过程中所述流体供给系统的流量未下降到流量阈值之下持续预定时间,则判定为子宫内存在泄漏。
7.根据权利要求6所述的方法,其中,所述流量阈值为5mL/min,所述预定时间为15秒,所述完整性测试时间限度为60秒。
8.根据权利要求1所述的方法,其中,所述一个或多个传感器包括红外传感器。
9.根据权利要求1所述的方法,其中,所述一个或多个传感器包括接触传感器。
10.根据权利要求1所述的方法,其中,所述一个或多个传感器包括磁传感器。
11.根据权利要求1所述的方法,其中,所述一个或多个传感器包括离子传感器。
12.根据权利要求1所述的方法,其中,所述压力源被加压至55mmHg。
13.根据权利要求1所述的方法,其中,子宫腔内的压力与患者相对于压力源的高度无关。
14.一种子宫治疗装置,包括:
轴,其尺寸设置和被构造为用于插入到患者的子宫内;
沿着所述轴的长度设置的流入管腔和流出管腔;
设置在所述流入管腔的远端处的至少一个流入端口;
设置在所述流出管腔的远端处的至少一个流出端口;
与所述流入管腔和流出管腔可操作地联接的流体储器;
一个或多个传感器,其构造成监测所述流体储器中的流体料位;
连接到所述流体储器的流体供给系统,所述流体供给系统构造成将流体输送到所述流体储器中;
连接到所述流体储器的压力源,所述压力源构造成将所述流体储器中的流体加压以将流体从所述储器输送到患者的子宫内;
设置在所述压力源与所述流体储器之间的压力调节器,所述压力调节器构造成将来自所述压力供给源的压力降低至预定压力值;和
控制器,其构造成启动流体供给系统以将流体输送到所述流体储器中并在流体料位达到上限阈值时停闭所述流体供给系统,所述控制器还构造成基于所述流体供给系统的流量来判定子宫内是否存在泄漏。
15.根据权利要求14所述的装置,其中,所述控制器配置成,如果所述流体供给系统的流量下降到流量阈值之下持续预定时间,则判定为子宫内不存在泄漏。
16.根据权利要求15所述的装置,其中,所述流量阈值为5mL/min,所述预定时间为15秒。
17.根据权利要求14所述的装置,其中,所述控制器构造成,如果在完整性测试时间限度的过程中所述流体供给系统的流量未下降到流量阈值之下持续预定时间,则判定为子宫内存在泄漏。
18.根据权利要求17所述的装置,其中,所述流量阈值为5mL/min,所述预定时间为15秒,所述完整性测试时间限度为60秒。
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