CN107530118B - 用于使用可冷凝蒸气治疗膀胱的系统和方法 - Google Patents

用于使用可冷凝蒸气治疗膀胱的系统和方法 Download PDF

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CN107530118B
CN107530118B CN201680027124.6A CN201680027124A CN107530118B CN 107530118 B CN107530118 B CN 107530118B CN 201680027124 A CN201680027124 A CN 201680027124A CN 107530118 B CN107530118 B CN 107530118B
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M·赫伊
M·D·菲奥里
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Boston Scientific Scimed Inc
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Abstract

本发明提供了一种适合消融膀胱组织以治疗膀胱过度活动症(OAB)的蒸气输送系统和方法。该蒸气输送系统包括锚尖，该锚尖构造成在向目标组织输送可冷凝蒸气的同时将系统锚固在膀胱中。在一种方法中，经尿道向患者体内推进蒸气输送系统以达到膀胱的目标组织，该目标组织包括膀胱的用于产生急迫性尿失禁感觉的表面感受器。蒸气输送系统包括提供向组织输送的高品质蒸气的蒸气源。

Description

用于使用可冷凝蒸气治疗膀胱的系统和方法
相关申请的交叉引用
本申请要求2015年5月13日提交的、标题为“SYSTEMS AND METHODS FOR TREATINGTHE BLADDER WITH CONDENSABLE VAPOR(用于使用可冷凝蒸气治疗膀胱的系统和方法)”的美国临时专利申请No.62/160,963的权益，该申请通过引用的方式被整体并入本文中。引用的结合
本说明书中提及的所有出版物和专利申请通过引用结合在本文中，如同明确地和单独地指出各出版物或专利申请通过引用而被结合。
技术领域
本发明涉及使用微创方法来治疗膀胱的装置和相关方法。更具体地，本发明涉及使用可冷凝蒸气来治疗膀胱过度活动症。
背景技术
膀胱过度活动症(OAB)是影响数百万人的病症。症状包括不可控的尿急和尿失禁。频繁且突然的尿急会负面地影响受该疾病影响的人的生活质量。
当前对OAB的治疗包括生活方式变化，包括流体限制、避免咖啡因以及骨盆底肌肉锻炼。药物也可以治疗OAB的一些症状，但仅仅是轻度有效的。还已经使用了外科手术，包括肉毒毒素注射或膀胱的电刺激，但是这些治疗的长期有效性是未知的。
假定OAB由逼尿平滑肌和神经的连接性和兴奋性增加而引起。排尿中所涉及的增加的神经兴奋性和连接性依赖于协调神经可塑性的生长因子。神经递质、前列腺素和生长因子如神经生长因子提供用于肌肉或尿路上皮与神经之间的双向连通的机制，从而导致具有或不具有急迫性尿失禁的OAB。
发明内容
提供了一种用于治疗膀胱过度活动症的方法，该方法包括以下步骤：将蒸气输送系统插入到患者的尿道中；将所述蒸气输送系统的远侧部分推进到患者的膀胱；使用配置在所述蒸气输送系统上或其内的摄像机观察所述蒸气输送系统的远侧部分；将蒸气输送末端从所述蒸气输送系统部署到所述膀胱组织中，以在不穿透所述组织的情况下使所述组织变形；以及向膀胱组织中输送蒸气，以损坏膀胱中的神经、平滑肌尿道上皮和其它可兴奋组织。
在一些实施例中，输送步骤包括基于使可兴奋组织陷入坏死以缓解膀胱过度活动症、膀胱疼痛综合症和/或间质性膀胱炎的症状的想法而在多个位置处向膀胱中输送1卡路里至500卡路里的能量。
提供了一种用于治疗患者的膀胱过度活动症的方法，该方法包括以下步骤：将蒸气输送导管插入患者的尿道中；将所述蒸气输送导管的远侧锚尖经尿道推进到患者的膀胱中；将所述远侧锚尖定位在目标组织上或该目标组织附近，所述目标组织包括膀胱的用于产生尿失禁感觉的表面感受器；向所述目标组织中推进所述远侧锚尖，以使膀胱变形而不会刺破膀胱；以及经所述蒸气输送系统向目标组织输送蒸气，以消融包括所述表面感受器的目标组织。
在一些实施例中，所述方法还包括向所述目标组织输送1卡路里至500卡路里的能量。
在另一些实施例中，该方法还包括将所述远侧锚尖推进进入目标组织10mm以下。
在替代性实施例中，该方法还包括将所述远侧锚尖推进进入目标组织5mm以下。
在一个实施例中，所述远侧锚尖延伸进入目标组织不超出5mm。
在另一实施例中，所述远侧锚尖延伸进入目标组织不超出1-2mm。
在一些实施例中，所述推进步骤还包括向所述目标组织中推进所述远侧锚尖的针。
在另一实施例中，输送步骤还包括经配置在所述蒸气输送系统的导管远端上的蒸气输送口输送蒸气。
在另一些实施例中，所述输送步骤还包括经配置在所述蒸气输送系统的所述远侧锚尖上的至少一个蒸气输送口输送蒸气。
在一个实施例中，经所述蒸气输送口输送蒸气，以产生构造成在目标组织中形成同心处理环的一个或多个同心喷射图案。
在一些实施例中，所述方法还包括消融目标组织至1-3mm的深度。
还提供了一种蒸气输送系统，其包括：手柄部；与手柄部连接的细长的柔性轴，所述细长的柔性轴包括构造成将所述细长的柔性轴锚固到患者的膀胱中而不会刺穿膀胱的远侧锚尖；蒸气源；至少一个蒸气输送口，其配置在所述细长的柔性轴上并与蒸气源流体联接；和电子控制器，其与所述蒸气源操作性地连接并且构造成经所述至少一个蒸气输送口输送蒸气以消融膀胱。
在一些实施例中，所述远侧锚尖具有圆锥形的形状。
在另一些实施例中，所述远侧锚尖具有棱锥形的形状。
在替代性实施例中，所述远侧锚尖包括针尖。
在一个实施例中，所述针尖构造成在插入患者体内期间退回到所述细长的柔性轴中并且构造成在蒸气输送之前从所述细长的柔性轴移出。
在一些实施例中，所述至少一个蒸气输送口设置成产生构造成在膀胱中形成同心处理环的一个或多个同心喷射图案。
在另一些实施例中，所述远侧锚尖是可操纵的。
在一些实施例中，所述远侧锚尖延伸进入膀胱不超出10mm。
在另外的实施例中，所述远侧锚尖延伸进入膀胱不超出1-5mm。
附图说明
为了更好地理解本发明和领会本发明在实践中如何实施，下面参考附图仅通过非限制性示例描述一些优选实施例，在附图中的全部类似实施例中，图中相似的附图标记表示相应的特征。
图1示出蒸气输送系统的一个实施例。
图2示出蒸气输送系统的远侧部分的放大视图。
图3示出蒸气输送系统的远侧部分的另一实施例。
图4示出蒸气输送系统的远侧部分的又一实施例。
图5A-5B示出使用蒸气输送系统的一种治疗方法。
图6是图示使用蒸气输送系统的治疗方法的流程图。
具体实施方式
一般而言，一种用于治疗膀胱过度活动症的方法包括引导经加热的蒸气进入与膀胱中产生急迫性尿失禁感觉的膀胱上皮表面附近的可兴奋组织的接触。该方法可引起膀胱组织的局部消融以最大限度地缓解急迫性尿失禁或膀胱过度活动症(OAB)、膀胱疼痛综合症(PBS)和/或间质性膀胱炎。本发明涉及OAB的治疗，并且更具体地用于经尿道消融膀胱中对急迫性尿失禁负责的可兴奋组织结构。
该系统可包括输送蒸气介质(包括水蒸气)的蒸气输送机构。该系统可利用蒸气源，该蒸气源构造成提供具有至少60-140℃的温度的蒸气。在另一实施例中，该系统还包括计算机控制器，该计算机控制器构造成以在1秒到30秒的范围内的间隔输送蒸气。
在一些实施例中，该系统还包括药剂或其它化学剂或化合物的源以用于与蒸气一起输送。这些剂包括但不限于麻醉剂、抗生素或诸如
Figure BDA0001463433210000041
的毒素，或可以处理癌组织细胞的化学剂。该剂也可以是密封剂、粘接剂、胶水、超强力胶水、抗炎药、抗生素等。
图1示出蒸气输送系统的一个实施例。蒸气输送系统100可具有构造成用于插入患者的尿道的细长的柔性轴102和供人手抓握的手柄部104。蒸气系统100可包括导管远端106，该导管远端包括锚尖108和一个或多个蒸气输送口110。在一些实施例中，导管远端可以是可变形的和/或可操纵的。
一个或多个蒸气输送口110与蒸气源流体联接并且可构造成将蒸气介质流从蒸气源250经细长的蒸气柔性轴102输送到膀胱组织中。该蒸气输送系统还可包括抽吸源320，该抽吸源构造成从患者抽吸组织和/或流体(例如，经蒸气输送口或经导管远端中的单独的抽吸口)，并且还可包括构造成在蒸气输送之前、蒸气输送期间和/或蒸气输送之后向组织输送流体或冷却冲洗液的流体源300。
图1的蒸气输送系统100可包括多个致动装置107，例如触发器、按钮或杆，其可构造成致动系统的各种功能。例如，致动装置可构造成操纵导管远端，以及开始/停止蒸气的流动、抽吸和/或冷却冲洗液。
蒸气源250设置成用于产生蒸气介质和/或经导管远端输送蒸气介质以消融或损坏组织。该蒸气源可以是可输送诸如水蒸气的蒸气介质的蒸气发生器，所述蒸气介质具有精确地控制的品质以提供例如以卡路里/秒为单位测定的精确的热能输送量。在一些实施例中，该蒸气源可包括感应式加热系统，其中流动介质被感应加热以产生可冷凝蒸气。蒸气源可位于蒸气输送系统的外部，或替代性地可集成在蒸气输送系统的手柄和/或细长的柔性轴中。
控制器255可被设定成控制蒸气输送的各种参数，例如，控制器可被设定成以选定的治疗间隔、选定的压力或选定的蒸气品质输送蒸气介质。在美国专利No.8,273,079和PCT出版物WO2013/040209中可以找到关于蒸气输送系统、蒸气发生器和如何将蒸气和流体输送到组织中的进一步的细节，这两个文献全部通过引用的方式结合在本文中。在一些实施例中，电子控制器还可控制蒸气输送系统的抽吸和/或冷却冲洗功能。
如上所述，蒸气输送系统可与蒸气源250、抽吸源320、流体或冲洗液源300、光源140和电子控制器255连接，电子控制器255构造成控制蒸气从蒸气源的产生和从蒸气源经轴的内腔、经导管远端到组织中的输送。在一些实施例中，电子控制器可配置在蒸气输送系统上或配置在蒸气输送系统中，在另一些实施例中，电子控制器可以配置成与系统分离。
仍参照图1，流体或冲洗液源300可经所述轴内的单独的内腔提供诸如盐水的流体，以在系统插入期间和在向组织输送蒸气期间向组织提供冲洗和清洗。在一些实施例中，可使用冲洗液从组织内腔清除血液和碎屑以提高能见度。冲洗液还可经由冲洗液流体与组织的直接接触和随着流体经由轴从冲洗液源流出并与组织接触来冷却蒸气输送系统的轴这两种方式向患者的尿道和/或膀胱提供冷却。
图2示出蒸气输送系统的导管远端106的放大视图。细长的轴和导管远端尺寸确定和构造成插入到柔性膀胱镜的内腔中。导管远端还可包括远侧锚尖108，该远侧锚尖108构造成被部分压入或锚固到膀胱的组织中以使得组织变形而不会刺穿组织。当远侧锚尖108使膀胱变形时，它可将蒸气输送系统锚固在膀胱的目标组织中。在一个实施例中，尖端可以是圆锥形或棱锥形的尖端。在尖端是棱锥形尖端的实施例中，棱锥形可包括两个、三个或更多个面。通过使组织变形而不会刺穿组织，锚尖端可在要处理的目标神经或感受器附近被锚固在膀胱组织中而不会损害膀胱的结构完整性。
当锚尖端被锚固在膀胱组织中时，蒸气可从蒸气源经一个或多个蒸气输送口110被输送到膀胱组织。在一些实施例中，蒸气口可在锚尖108的近侧配置在轴上。在另一些实施例中，蒸气口也可配置在锚尖自身上。
蒸气口相对于锚尖的位置决定蒸气喷射图案，可根据组织中的期望热消融来调整和设计该蒸气喷射图案。在一个实施例中，蒸气口能同心地设置在末端和/或轴上以产生构造成在膀胱组织中形成同心处理环的一个或多个同心喷射图案。蒸气可被输送到膀胱以将组织消融至特定深度，该特定深度使得损坏目标膀胱感受器而不会消融膀胱组织的全部厚度。例如，在一些实施例中，蒸气可被输送至膀胱组织以消融1-6mm深度的膀胱组织。希望仅处理小深度的组织以实现损坏感受器而不完全消融整个膀胱组织的目标。
导管远端可任选地包括可视化特征112，其可以是导管末端上的标记。可视化特征112可以包括例如直接配置在导管远端上的条带、形状、颜色或其它可视特征。当导管远端在消融步骤期间伸出超过膀胱镜时，可以在膀胱镜的视野(例如，利用摄像机)下观察可视化特征以确定导管远端何时前移超出膀胱镜适当距离。此外，导管上的标记也可用于引导临床医师将导管安放在适当的取向上以在规定的模式下输送蒸气图案。例如，可视化特征可包括用于指示蒸气输送口在导管远端上的何处取向的特征，或可视化特征可仅在其上布置有蒸气输送口的区段被配置在轴上。
蒸气输送系统的锚尖端在临床医师将蒸气输送系统向膀胱中推进时防止滑动并锚固蒸气输送系统。随着临床医师更用力推进，蒸气输送系统在它继续伸出超过膀胱镜时使膀胱变形。临床医师可通过观察可视化特征离膀胱镜的距离来确定膀胱的变形水平。膀胱变形量还决定蒸气从蒸气输送口堆积到膀胱组织上的图案。当实现适合的蒸气堆积图案时，蒸气可从蒸气输送系统被输送到膀胱组织上或被输送到膀胱组织中。
图3示出导管远端106的一个替代实施例，该导管远端106包括构造成被压入膀胱的组织中以使组织变形而不会完全穿透组织的锚针尖114。锚针尖114能以与上述锚尖端相似的方式操作。在一些实施例中，锚针尖114可包括配置在针中或针上或配置在针的极远端处的一个或多个蒸气输送口。
在一些实施例中，锚针尖可在行进至膀胱期间退回到导管远端中，并从导管末端移出以锚固蒸气输送系统。例如，蒸气输送系统上的致动装置可控制针的前移和退回。在一些实施例中，针可设计成从导管的远侧末端前移有限距离以便不完全穿透或刺穿膀胱组织。例如，膀胱组织的厚度通常在5-15mm的范围内。在一些实施例中，锚针尖114延伸进入组织不超出10mm以便不刺穿膀胱组织。在一些实施例中，临床医师可确定患者的膀胱的厚度(例如利用可视化)并将锚针尖的长度调节为小于膀胱的厚度。在另一些实施例中，锚针尖延伸进入组织不超出1-5mm，这可足以将导管末端锚固在膀胱组织中，但不会太长以刺穿绝大多数潜在患者的膀胱组织。一旦利用锚针尖将系统锚固在组织中，便可经蒸气输送口110向膀胱组织输送蒸气。
图4示出与图3中的上述实施例相似的具有锚针尖114的导管远端106的另一实施例。然而，在本实施例中，蒸气输送口110位于锚针尖114自身上或其中，而不是位于导管轴上。例如，蒸气输送口110可位于锚针尖114的远端处。此构型允许锚针尖114将导管远端锚固在组织中，并且将蒸气经蒸气输送口110直接输送到膀胱组织中。
参照图5，本发明的装置和方法提供了对膀胱中的组织的精确、受控的热消融处理以治疗OAB。特别地，该消融处理构造成消融膀胱中或其附近形成急迫性尿失禁的表面感受器以治疗OAB。
对尿意的感官感知可由两个膀胱感受器传递/介导。位于膀胱三角区和后尿道处的第一感受器对小的压力变化敏感并且可用作膀胱充盈的早期预警系统。当早期预警系统失效并且仅在第二感受器被刺激之后不久发生逼尿肌收缩时，产生一些急迫性尿失禁的情形。因此，两种形式的急迫性尿失禁可与第一感受器的损失相关联：一种形式具有相关联的频度且另一种形式不具有相关联的频度，差别是逼尿肌不稳定的有或无。本文中描述的方法描述了一种使用蒸气来消融感受器以实现最大限度地缓解急迫性尿失禁或OAB的永久效果的技术。
图5A-5B示出了插入患者的膀胱中的蒸气输送系统100和锚尖108。图5B示出锚尖的放大视图。图6示出描述了用于治疗患者的膀胱过度活动症的方法的流程图，该方法可包括以下步骤：首先(在图6中的流程图600的步骤602)，可将包括诸如上述的蒸气输送系统100的锚尖108的轴插入到患者的尿道中。在一些实施例中，将蒸气输送系统的轴插入到膀胱镜中，该膀胱镜被插入到患者的尿道中。在另一些实施例中，可将蒸气输送系统的轴自身插入到尿道中。
接下来(在图6中的流程图600的步骤604)，可将蒸气输送系统和/或膀胱镜经尿道插入患者体内，直至蒸气输送系统的包括锚尖的远侧部分和/或膀胱镜位于膀胱内。
接下来(在图6中的流程图600的步骤606)，可推进蒸气输送系统的远侧锚尖并将其定位在目标位置上或其附近，所述目标位置包括膀胱的用于产生急迫性尿失禁感觉的表面感受器。在使用膀胱镜的实施例中，蒸气输送系统的远侧锚尖可在经由膀胱镜的视野下伸出超过膀胱镜的端部。
接下来(在图6中的流程图600的步骤608)，可将远侧锚尖推进到表面感受器上或其附近的膀胱组织中以使该膀胱组织变形而不会刺穿该膀胱组织。在一些实施例中，远侧锚尖是可操纵的，并且可转动或变形以将末端精确地锚固在待处理的表面感受器上或其附近。
最后(在图6中的流程图600的步骤610)，可经蒸气输送系统向包括表面感受器的目标组织输送蒸气以消融表面感受器。可通过蒸气向表面感受器输送充分能量以消融表面感受器而不会对膀胱产生伤害。在一些实施例中，蒸气输送系统构造成向目标组织输送1-500卡路里的能量。可对膀胱中的其它表面感受器重复该过程，直至全部目标表面感受器已被处理。
尽管上文已经详细描述了本发明的特定实施例，但是应理解的是，该描述仅仅出于说明的目的，并且上文对本发明的描述是不详尽的。本发明的特定特征在一些图中被示出而在其它图中未被示出，这仅仅是为了方便，并且根据本发明，任何特征可以与另一特征结合。多种变型和替代方案对于本领域的普通技术人员而言将显而易见。这些替代方案和变型旨在被涵盖在权利要求的范围内。从属权利要求中提出的具体特征可以被结合并落入本发明的范围内。本发明还包括如多个从属权利要求替代地书写成引用其它独立权利要求的多项从属权利要求的格式的实施例。

Claims (9)

1.一种蒸气输送系统，包括：
手柄部；
蒸气源；
与所述手柄部连接的细长的柔性轴，其中在所述细长的柔性轴上配置至少一个蒸气输送口，其中所述至少一个蒸气输送口与所述蒸气源流体联接，其中所述细长的柔性轴包括远侧尖端，所述远侧尖端包括针，其中所述针被构造成在插入患者体内期间退回到所述细长的柔性轴中并且被构造成在蒸气输送之前从所述细长的柔性轴移出，并且其中所述针从所述细长的柔性轴的移出受到限制，使得所述针被构造成仅穿透膀胱组织的部分厚度，以将所述细长的柔性轴锚固在患者的膀胱组织而不会刺穿所述组织，使得所述至少一个蒸气输送口被定位成将蒸气输送到组织的表面；和
与所述蒸气源操作性地联接并且构造成经所述至少一个蒸气输送口输送蒸气以消融膀胱组织的表面的电子控制器。
2.根据权利要求1所述的系统，其中，所述至少一个蒸气输送口设置成产生构造成在膀胱中形成同心处理环的一个或多个同心喷射图案。
3.根据权利要求1所述的系统，其中，所述远侧尖端是可操纵的。
4.根据权利要求1所述的系统，其中，所述远侧尖端延伸进入膀胱不超出10mm。
5.根据权利要求1所述的系统，其中，所述远侧尖端延伸进入膀胱不超出1-5mm。
6.根据权利要求1所述的系统，其还包括抽吸源，所述抽吸源被构造成从患者抽吸组织和/或流体。
7.根据权利要求6所述的系统，其中所述抽吸源被构造成通过所述至少一个蒸气输送口抽吸所述组织或所述流体。
8.根据权利要求6所述的系统，其中所述抽吸源被构造成通过所述远侧尖端的中的抽吸口抽吸组织或流体，其中所述抽吸口与所述至少一个蒸气输送口是分开的。
9.根据权利要求6所述的系统，其还包括冲洗液源，所述冲洗液源被构造成将冲洗液递送至膀胱。
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