CN107205770B - 蒸汽消融***和方法 - Google Patents
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Abstract
提供了适于治疗***组织的蒸汽输送***和方法。所述蒸汽输送***包括构造成向组织输送可冷凝的蒸汽能量的蒸汽输送针。在一种方法中,所述蒸汽输送***经尿道前移到患者内以到达***组织。所述蒸汽输送***包括用以产生用于向组织输送的高品质蒸汽的发生器单元和感应加热***。还提供了使用方法。
Description
相关申请的交叉引用
本申请要求于2015年1月29日提交的标题为“蒸汽消融***和方法(VAPORABLATION SYSTEMS AND METHODS)”的美国临时专利申请No.62/109,540的权益,该申请的全文通过引用的方式结合在本文中。
引用的结合
在本说明书中提及的所有出版物和专利申请都同等程度地通过引用的方式结合至本文中,就像每个单独出版物或专利申请都是专门地和单独地被提及以通过引用的方式结合在本文中。
技术领域
本发明涉及使用微创方法来治疗良性***增生的装置和相关方法。更具体地,本发明涉及使用传送至***的蒸汽来治疗良性***增生。
背景技术
良性***增生(BPH)是中老年男性的常见病,其患病率随着年龄而增长。在年龄为50岁时,多于一半的男性具有BPH症状,在年龄为70岁时,近90%的男性具有***肥大的微观证据。该症状的严重程度还随着年龄而增长,60-70岁年龄段的患者中有27%具有中重度症状,70多岁的患者中有37%具有中重度症状。
在生命的早期,***具有胡桃的尺寸和形状,在由BPH导致肥大之前约重20克。***扩大看上去是正常过程。随着年龄的增长,***的尺寸逐步增大到其正常尺寸的两倍或更多。在腺体达到一定尺寸之后,外***囊的纤维肌性组织限制扩张。由于对扩张的这种限制,囊内组织将压靠和限制***尿道,由此导致对尿流的阻力。
在男性泌尿生殖***解剖学中,***腺体定位在膀胱和膀胱颈下方。膀胱壁可以扩张和收缩以导致尿流经尿道,该尿道从膀胱延伸经过***和***。尿道的被***腺体包围的部分被称为***尿道。***还包围***管,该***管在***尿道中具有开口终端。在性激励期间,输精管将***从睾丸输送到***,***提供与***结合的流体以在***期间形成***。输精管和精囊在***的各侧连接,以形成被称作***管的单管。因此,各***管将精囊分泌物和***输送到***尿道中。
***腺体结构可以划分成三个区域:***区、过渡区和中心区。***区PZ包括约70%的年轻男性的***的体积。***腺体的后方的该包膜下部分包围远侧尿道,并且70-80%的癌症起源于***区组织。中心区CZ包围***管并包括约20-25%的***体积。中心区通常是炎症过程的部位。过渡区TZ是良性***增生在其中发展的部位,并且在正常***中包括腺体元素的约5-10%的体积,但是在BPH的情况下可以构成高达80%的该体积。过渡区包括两个侧向***叶和尿道周围腺体区域。在过渡区周围存在天然屏障,即***尿道、前纤维肌性基质和过渡区与***区之间的纤维平面。前纤维肌性基质或纤维肌性区域主要是纤维肌性组织。
BPH通常是当患者抱怨麻烦的排尿困难而寻求药物治疗时诊断的。BPH的主要症状是尿频和尿急,以及在排尿期间流速的显著下降。BPH还可能导致尿液滞留在膀胱中,这进而可能导致下***(LUTI)。在多种情况下,LUTI然后可能上升到肾脏中并导致慢性肾盂肾炎,最终可能导致肾机能不全。BPH还可能导致与由严重的排尿困难引起的睡眠障碍或心理焦虑相关的性功能障碍。因此,随着男性群体年龄的增长,BPH可能显著地改变生活质量。
BPH是***的腺细胞的连续产生和自然死亡(细胞凋亡)之间失衡的结果。这些细胞的过度产生导致***的尺寸增大,最明显地是在横穿***尿道的过渡区中。
在BPH的早期情况下,药物治疗可以缓解一些症状。例如,α-受体阻滞剂通过使在***和膀胱颈中发现的平滑肌组织舒张来治疗BPH,这还允许尿更容易地流出膀胱。这类药物在腺体元素引起***中极度细胞生长之前能被证明是有效的。
然而,BPH的较晚期仅可以通过手术或微创热消融装置介入治疗。已开发出利用电外科学或机械组织抽吸(抽取)和对囊内***组织的热消融或冷冻消融的多种方法。在多种情况下,这类介入仅提供了短暂的缓解,并且这些治疗通常导致显著的手术期间的不适和发病率。
在一种热消融方法中,经由穿透到***叶中的多个部位中的细长的RF针向***组织输送RF能量。细长的RF针通常长约20mm,连同穿透到该叶中的绝缘体。产生的RF治疗由此将组织从***尿道切除,而不以靠近或平行于该***尿道的组织为目标。RF能量的施加通常延长1至3分钟或更长时间,这允许RF能量的热扩散以将组织切除到囊周边。这种RF能量输送方法可能不产生持效性,因为没有在***尿道周围或过渡区中均匀地消融平滑肌组织和α肾上腺素受体。结果,***叶中的组织可以继续增长并压迫尿道,由此限制治疗的长期效果。
发明内容
提供了一种蒸汽输送***,其包括:发生器单元,所述发生器单元包括支架;注射器组件,所述注射器组件配置在所述支架中并且构造成与所述支架相互作用以在受控速率下输送流体;感应加热***,所述感应加热***与所述注射器组件流体连接并且构造成从所述注射器组件接收流体;力传感器,所述力传感器配置在所述支架中并且构造成与所述支架和/或注射器组件接触以生成与由所述支架和/或注射器组件在所述力传感器上施加的力成比例的电信号;和电子控制器,所述电子控制器配置成控制流体和RF功率向用于产生蒸汽的所述感应加热***的输送,所述电子控制器还配置成将所述电信号校准为代表所述注射器组件内的流体压力,所述电子控制器还配置成在所述流体压力处于期望的流体压力范围以外时停止向所述感应加热***输送流体和/或RF功率。
在一些实施例中,所述支架设置成使得,当所述注射器组件被***所述支架中时,所述注射器组件的远端被保持在比所述注射器组件的近端高的高度处。
在一个实施例中,所述支架构造成在其中流体从所述注射器组件被压送通过所述蒸汽输送***的灌注步骤期间从所述注射器组件扫除任何空气。
在另一实施例中,所述支架还包括与线性电机联接的活塞,其中所述活塞与所述注射器组件的柱塞相互作用以从所述注射器组件输送流体。
在一些实施例中,在所述注射器组件***所述支架中时启动接触开关。
在一个实施例中,所述感应加热***包括由外侧导电线圈包围的内侧流体盘管。
提供了一种控制蒸汽的流量的方法,其包括:将注射器组件接纳在发生器单元的支架中;以受控速率将流体从所述注射器组件输送至与所述注射器组件流体联接的感应加热***;测量施加在力传感器上的力,所述力传感器配置在所述支架中并且构造成在流体输送期间与所述支架和/或注射器组件接触;和使用电子控制器校准测定的力以代表所述注射器组件内的流体压力;以及在所述流体压力处于期望的流体压力范围以外时停止向所述感应加热***输送流体。
提供了一种治疗***组织的方法,其包括:将蒸汽输送***经尿道***患者内以到达患者的***尿道;使蒸汽输送针大体横向于所述蒸汽输送***前移通过***尿道并进入***的过渡区;以及经所述蒸汽输送针的面向远侧的蒸汽输送口输送蒸汽以将蒸汽从所述装置向远侧引导到***中。
附图说明
为了更好地理解本发明和领会本发明在实际中如何实施,下面仅参考附图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示出蒸汽输送***的一个实施例。
图2A-2B示出包括蒸汽输送针的蒸汽输送***的远侧部分的放大视图。
图2C-2D示出正常***和使用蒸汽输送***处理过的扩大***。
图3A-3B示出包括用于产生高品质的可冷凝蒸汽的感应加热***的蒸汽输送***。
图4示出构造成控制感应加热***中的蒸汽的产生的发生器单元。
图5示出与发生器单元相互作用的注射器组件的一个实施例。
图6示出发生器单元的注射器支架和注射器组件的截面图。
图7是蒸汽输送***的轴的截面图。
具体实施方式
通常,一种用于治疗BPH的方法包括填隙地(interstitially)将热蒸汽引入***内部,其中,蒸汽可控制地消融***组织。在基于诊所的治疗中,针对每次蒸汽治疗(假设对于每个***叶进行多次治疗),该方法可以利用蒸汽施加介于50卡路里和300卡路里之间的热能。该方法可以实现***组织的局部消融,更具体地,蒸汽施加的热能可以被局限成消融与尿道相邻的组织,而不损坏不与尿道相邻的***组织。
本发明涉及BPH的治疗,更具体地用于消融过渡区***组织,而不消融中心区或***区***组织。在一个实施例中,本发明涉及在邻近***尿道的区域使用对流加热来治疗***。该消融治疗方法构造成以平滑肌组织、α肾上腺素能受体、交感神经结构和在膀胱颈区域和精阜区域之间平行于***尿道的脉管***下少于2cm的深度为目标。
该***可以包括输送蒸汽介质(包括水蒸气)的蒸汽输送机构。该***可以利用一蒸汽源,该蒸汽源构造成提供具有至少60℃-140℃的温度的蒸汽。在另一实施例中,该***还包括一计算机控制器,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汽。
在一些实施例中,该***还包括药剂或其它化学剂或化合物的源以用于与蒸汽一起输送。这些剂包括但不限于麻醉剂、抗生素或诸如的毒素,或可以处理癌组织细胞的化学剂。该剂还可以是密封剂、粘合剂、胶水、超强力胶水等。
图1示出蒸汽输送***的一个实施例。蒸汽输送***100可具有构造成用于***患者的尿道的细长的轴102和供人手抓握的手柄部分104。蒸汽输送***100可包括布置在构造成从细长的轴102的远侧部分伸出的轴中的蒸汽输送针106。蒸汽输送针可大致垂直于或横向于该轴延伸,并且可包括一个或多个蒸汽输送口,该蒸汽输送口构造成将蒸汽介质流从针输送到***组织中。蒸汽输送***100还可包括构造成致动所述***的多种功能的一个或多个触发器、按钮、控制杆或致动机构107。例如,致动机构可构造成伸出/缩回蒸汽输送针、以及开始/停止蒸汽、抽吸物和诸如生理盐水的冷却和/或冲洗液的流动。
在一些实施例中,触发器或致动机构107能以控制蒸汽和/或冲洗液的不同程度或流速这样的方式***纵。在一个特定实施例中,触发器或致动机构107可包括构造成伸出/缩回蒸汽输送针的第一触发器、构造成开始/停止蒸汽的流动的第二触发器以及构造成提供诸如生理盐水的冷却和/或冲洗液的第三触发器。在另一实施例中,单个触发器或致动机构既可以伸出/缩回蒸汽输送针,又可以开始/停止蒸汽的流动。在一个实施例中,其中一个触发器——例如提供冷却和/或冲洗液的触发器——的单次按压或下压可提供标准灌洗,而该触发器的快速两次按压或下压可提供其中冲洗流量与标准冲洗流量相比增大的“快速”灌洗。此特征例如在医师遇到堵塞、需要另外的冷却或在尿道和/或***中的能见度由于血液或其它体液的积聚而下降的情况下会是有用的。
流体或冲洗液源可经所述轴内的单独的内腔提供诸如生理盐水的流体,以在******期间和在向组织输送蒸汽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尿道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汽输送***的轴这两种方式向患者的尿道提供冷却。在损伤形成期间可以使用尿道冲洗。在一个实施例中,冲洗速率可为约80mL/min、或在20至400mL/min的范围内。冲洗速率的变化将改变进入至尿道和***的组织冷却量(深度),这可能影响损伤的大小。
图2A示出蒸汽输送***100的轴的远侧部分的放大视图,该蒸汽输送***100包括超出所述轴延伸并露出蒸汽输送口108的蒸汽输送针106。蒸汽输送口108可呈在特定应用中优化蒸汽向组织的传送的图案排列。例如,在针对BPH的治疗设计的***中,输送口108包括多排多个蒸汽输送口。在一个特定实施例中,输送口108可成120度间隔在针的圆周周围,其中一排输送端口如图2B所示从针的前缘面向远侧,以确保***尿道附近的组织的消融。通常,蒸汽输送口各自都可以具有唯一的直径。在一个实施例中,蒸汽输送口全都具有相同直径。
图2C示出正常、健康的***,而图2D示出使用蒸汽输送***100处理过的扩大***。在一个实施例中,蒸汽输送***可以***尿道中并且通过经尿道法前移至***尿道。蒸汽输送针106可大体横向于蒸汽输送***的轴前移并进入***组织中。蒸汽可以由蒸汽输送***产生并经蒸汽输送针输送到***中。如上所述,蒸汽输送针可以包括在蒸汽输送针横向于所述装置的轴延伸时从所述装置指向远侧的一排蒸汽输送口。参照图2D,蒸汽可经这些面向远侧的蒸汽输送口输送到***以消融***中远离蒸汽输送针位置的***组织。蒸汽输送针和蒸汽输送口的位置可允许消融从蒸汽输送针的位置向远侧延伸的***的过渡区组织。例如,在图2D中,在无法由输送装置针安全地穿透的膀胱肌肉组织下方延伸的过渡区组织被处理。
蒸汽输送***100可以包括蒸汽源、抽吸物源、流体冷却或冲洗液源、光源和/或电子控制器,该电子控制器配置成控制蒸汽的产生以及从蒸汽源经所述轴的内腔、经蒸汽输送针向***组织中的输送。在一些实施例中,电子控制器可以配置在蒸汽输送***上或其中,而在另一些实施例中,电子控制器可以与***分开配置。
蒸汽源可设置用于产生蒸汽介质并经蒸汽输送针输送蒸汽介质以消融组织。在一个实施例中,蒸汽源可以是可输送诸如水蒸汽的蒸汽介质的蒸汽发生器,所述蒸汽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,蒸汽源可以包括配置在蒸汽输送***中(例如,手柄中)的感应加热***,流动介质在该感应加热***中被感应地加热以产生诸如水蒸汽的可冷凝蒸汽。
图3A-3B示出包括由外侧导电线圈324(图3B)包围的内侧流体盘管322(在图3A中示出)的感应加热***320的一个实施例。内侧流体盘管可以由可进行退火处理的钢管构成。内侧流体盘管可被软钎焊或包括钎焊条以确保盘管绕组之间的导电性。外侧导电线圈可以是导电材料,例如具有在18号至22号的范围内的总直径的电绝缘铜绞合线。如图所示,感应加热***320可配置在蒸汽输送***内,例如手柄内。内侧流体盘管322的入口部分326可以从外部流体源接收诸如无菌水的流体。随着AC或RF电流经由电连接部325施加至外侧导电线圈324,流体可以经过内侧流体盘管322。在外侧导电线圈中流动的电流可以引起电流在内侧流体盘管中流动,从而电阻地加热内侧流体盘管内的流体以便产生高品质的可冷凝蒸汽,该蒸汽然后经由出口部分328输送至蒸汽输送针。
图4示出构造成向感应加热***提供电力和流体以产生蒸汽的发生器单元40。该发生器单元也可以与上述蒸汽输送***100连接以向***提供电力和对操作来说至关重要的其它构件,例如冲洗/冷却液、抽吸物等。该发生器单元可包括电子控制器和图形用户接口(GUI)434以在蒸汽治疗期间向用户提供操作参数和控制。该发生器单元可以包括注射器支架430,该注射器支架适合保持注射器组件536以向感应加热***提供诸如无菌水的流体。
该发生器单元还可包括电连接器432,该电连接器432可提供通向感应加热***的rf电流、往来于蒸汽输送***的开关107的电信号、例如感应加热***的温度的测量值以及往来于蒸汽输送***的例如位于其电连接器中的控制器的电信号,以识别蒸汽输送***、跟踪其蒸汽输送记录、以及防止特定蒸汽输送***的过渡使用。发生器单元40还可包含向蒸汽输送***提供诸如生理盐水的冷却/冲洗液流的蠕动泵435。在操作中,柔性管437可从无菌生理盐水袋穿过蠕动泵并穿过管道进入蒸汽输送***中。在蠕动泵435上可以设置有引导器或标记以在泵正常启动时确保该管***在提供沿从生理盐水袋进入蒸汽输送***的方向的流动的路径中。
图5示出向蒸汽输送***100提供精确量的诸如无菌水的流体以转化为蒸汽的注射器组件536。注射器组件536包括注射器537,该注射器537具有偏离注射器的中心线的出射口541,该注射器组件536具有与蒸汽输送***上的无菌水管连接的鲁尔配件542、在注射器中向前移动以射出水并且在注射器中向后移动以将注射器充填水的柱塞538、以及在***设置期间可移除地附接至柱塞538以充填注射器537的副杆540。当注射器537已被充填流体时,副杆540被丢弃,并且充填的注射器537***发生器单元的支架中。
图6示出图4的注射器支架430的截面图,其中图5的注射器组件536***支架430中。在注射器537***支架430中时启用接触开关654以确保在电力输送至蒸汽输送***时注射器就位。通过电引线652来感测接触开关的状态。力传感器644以使得它与支架和/或注射器组件537接触并相互作用的方式配置在支架中。当电子控制器被命令向蒸汽输送***输送无菌水时,支架的活塞642与注射器柱塞538接合,并且附接至活塞642的线性电机以精确控制的速率将无菌水从注射器537经鲁尔配件542向外输送到与感应加热***连接的流体管中。随着无菌水被压送,注射器537撞击在支架430上,该支架430在发生器40内横向地自由移动。支架430随着它撞击在力传感器644上而被阻止向前移动。力传感器644的微观横向移动转换为与支架430施加在力传感器644上的力成比例的电信号。该电信号经引线648传导至电子控制器并且被校准作为注射器537内以及遍及流体管——包括感应加热***的内侧盘管内——的水压力。水压力由发生器单元40的电子控制器监测,并且该电子控制器可配置成在流体压力处于期望压力范围以外的情况下——例如,在流体压力过低(例如由于水管路中的泄漏)或过高(例如由于水管路中的堵塞)的情况下——停止向感应加热***输送RF功率和流体。
支架430构造成在其中水从注射器被压出并且充填和冲洗***水管路和蒸汽管路然后从蒸汽输送装置的蒸汽输送口离开的灌注步骤期间从流体管扫除任何空气。如图6所示,支架430被设计成保持注射器537的远端在***支架中时处于比其近端高的高度处,并且保持注射器的偏心出射口541处于注射器的顶部。这种设计迫使注射器中的任何空气在灌注步骤期间在重力的影响下移动到注射器的上侧远端并离开注射器以从流体管被扫除。从流体管除去空气防止了感应加热***的过度加热,并且防止了水体积的损失以及因此输送至组织的热量的损失。
发生器单元的电子控制器能被设定成控制蒸汽输送的各种参数,例如,该控制器可被设定成以选定的流量、选定的压力或选定的蒸汽品质针对选定的治疗间隔输送蒸汽介质。与蒸汽输送***、蒸汽发生器以及蒸汽和流体如何输送至组织有关的更多细节可以在经通过引用的方式并入的美国专利No.8,273,079和PCT公报No.WO 2013/040209中找到。在一些实施例中,该电子控制器还可控制蒸汽输送***的抽吸和/或冷却冲洗功能。
图7提供了图1-2的蒸汽输送***100的细长轴102的截面图。内腔148可以构造成容纳上文和图1-2中描述的蒸汽输送针,以允许在蒸汽输送期间从该轴推进该蒸汽输送针。管112中形成的内腔115可具有在约2至5mm的范围内的直径,以容纳各种内窥镜118,同时提供环形空间138以允许冲洗液流体在内腔115中流动和从该轴向外流出到远侧尿道和膀胱中。内腔115的大小被设计成容纳内窥镜或摄像机以向医师提供另外的观察和反馈。该内窥镜或摄像机可提供轴的远端的观察,包括展开时的蒸汽输送针的观察。如图7可见,内腔115的尺寸被设计成适于提供空间138以供流体冲洗液围绕内窥镜118流动。在一些实施例中,环形空间138可以是供冲洗液流体流动的、围绕内窥镜的单独的同心内腔。环形空间138允许冲洗液流体从蒸汽输送***流入组织中,并且还在蒸汽从蒸汽输送针(布置在内腔148中)输送到组织中时向轴提供冷却。图7中的材料144可将热从蒸汽输送针传导到在环形空间138中流动的冲洗液/冷却流体,或替代地,可将冷量从冲洗液/冷却流体传导到蒸汽输送针,以在蒸汽治疗期间防止患者(具体地,尿道)过热。
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。本发明还包括多个实施,就像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。
Claims (10)
1.一种蒸汽输送***,包括:
发生器单元,所述发生器单元包括支架;
注射器组件,所述注射器组件配置在所述支架中并且构造成与所述支架相互作用以在受控速率下输送流体;
感应加热***,所述感应加热***与所述注射器组件流体连接并且构造成从所述注射器组件接收流体;
力传感器,所述力传感器配置在所述支架中并且构造成与所述支架和/或所述注射器组件接触以生成与由所述支架和/或所述注射器组件沿横向方向在所述力传感器上施加的横向力成比例的电信号,其中所述横向方向是与所述注射器组件的纵向轴线成一定角度的方向;和
电子控制器,所述电子控制器配置成控制流体和RF功率向用于产生蒸汽的所述感应加热***的输送,将所述电信号校准为代表所述注射器组件内的流体压力,并且在所述流体压力处于期望的流体压力范围以外时停止向所述感应加热***输送流体和/或RF功率。
2.根据权利要求1所述的***,其中,所述支架设置成使得,当所述注射器组件被***所述支架中时,所述注射器组件的远端被保持在比所述注射器组件的近端高的高度处。
3.根据权利要求2所述的***,其中,所述支架构造成在其中流体从所述注射器组件被压送通过所述蒸汽输送***的灌注步骤期间从所述注射器组件扫除任何空气。
4.根据权利要求1所述的***,其中,所述支架还包括与线性电机联接的活塞,其中所述活塞与所述注射器组件的柱塞相互作用以从所述注射器组件输送流体。
5.根据权利要求1所述的***,其中,在所述注射器组件***所述支架中时启动接触开关。
6.根据权利要求1所述的***,其中,所述感应加热***包括由外侧导电线圈包围的内侧流体盘管。
7.根据权利要求1所述的***,其中,所述支架在发生器单元内自由横向地移动。
8.根据权利要求7所述的***,其中,所述支架的向前移动被阻止。
9.根据权利要求1所述的***,其中,所述注射器组件接触所述力传感器。
10.根据权利要求1所述的***,其中,所述支架接触所述力传感器。
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