CN110167473A - 经会阴蒸汽消融系统及方法 - Google Patents

经会阴蒸汽消融系统及方法 Download PDF

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CN110167473A
CN110167473A CN201880006169.4A CN201880006169A CN110167473A CN 110167473 A CN110167473 A CN 110167473A CN 201880006169 A CN201880006169 A CN 201880006169A CN 110167473 A CN110167473 A CN 110167473A
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prostate
tissue
steam
electrode
delivery apparatus
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埃里克·杰克
迈克尔·赫伊
理查德·查尔斯·克拉维克
马克·施洛姆
马修·伯恩
罗杰·诺埃尔·黑斯廷斯
格兰特·毛赫
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Boston Scientific Scimed Inc
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Nxthera Inc
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Abstract

提供了一种蒸汽递送针，其可包括许多特性中的任何一个。能量递送探针的一个特性是它可以将可冷凝的蒸汽能量施加到例如前列腺的组织，以使前列腺组织收缩、损坏或变性。还涵盖了与能量递送探针的使用相关联的方法。

Description

经会阴蒸汽消融系统及方法
相关申请的交叉引用
本申请要求2017年1月6日提交的美国临时申请号62/443,555的优先权权益，其通过引用并入本文。
本申请与以下申请有关：2015年9月9日提交的美国申请号14/773,853和2016年12月19日提交的国际申请号PCT/US2016/067558，两者均通过引用整体并入本文。
通过引用并入
本说明书中提及的所有出版物(包括专利和专利申请)均通过引用整体并入本文，其程度如同每个单独的出版物被具体和单独地指出通过引用并入。
技术领域
本发明涉及用于使用微创方法治疗前列腺的装置和相关方法。
背景技术
生命早期的前列腺是胡桃的尺寸和形状，并且在由BPH引起的增大之前，重约20克。前列腺增大似乎是一个正常的过程。随着年龄的增长，前列腺的尺寸逐渐增加到其正常尺寸的两倍以上。前列腺外囊的纤维肌性组织在腺体达到一定尺寸后限制扩张。由于这种对扩张的限制，囊内组织将挤压并收缩前列腺尿道，从而引起尿流阻力。
前列腺可分为三个区域：周边区、移行区和中心区。周边区(PZ)占男性前列腺体积的约70％。前列腺后部的这个子囊部分围绕远端尿道，并且70％至80％的癌症源于周边区组织。中心区(CZ)围绕射精管并且包含约20-25％的前列腺体积。中心区通常是炎症过程的部位。移行区(TZ)是良性前列腺增生发展的部位，并且包含正常前列腺中腺体元素的体积的约5-10％，但在BPH的情况下可占该体积的多达80％。移行区包括两个前列腺侧叶和尿道周围腺体区域。在移行区周围存在天然屏障，即前列腺尿道、前纤维肌性基质FS和移行区与周边区之间的纤维平面FP。前纤维肌性基质FS或纤维肌性区主要是纤维肌性组织。
大约70％至80％的前列腺癌源于前列腺的周边区，并且可能局限于周边区。近年来，前列腺癌的局部治疗越来越受到关注，其仅治疗在活检后其中发现了癌症的组织区域。现有技术的局部疗法治疗，例如RF消融能量，可以不将治疗局限于周边区组织。
发明内容
公开了用于消融周边区组织而不消融非周边区组织的系统和方法。经会阴方法使用蒸汽递送装置进入并治疗周边区组织。
使用超声和针位置传感器引导，蒸汽可以沿着针的路径在多个位置递送。
蒸汽递送针能够沿其路径受控制地移动，包括停止递送蒸汽。公开了用于以数字步进控制针移动到其触及范围内的任何位置的系统和方法。
大多数前列腺癌出现在周边区。通过针递送到周边区的蒸汽不会穿过组织屏障到达可能不存在癌症的前列腺的其他区。
提供了一种治疗患者前列腺癌的方法，其包括用尿道冷却导管冷却患者的尿道，通过注射冷冻液冷却患者前列腺附近的组织，对前列腺进行实时成像，将蒸汽递送装置经会阴推进到前列腺中，在蒸汽递送装置中感应地产生蒸汽，并通过蒸汽递送装置将蒸汽递送到前列腺。
在一些实施例中，该方法还包括测量蒸汽递送装置的远端尖端处的组织的第一电阻抗和相移。该方法可以进一步基于所测量的第一电阻抗和相移确定远端尖端是否插入患者的前列腺中。
另外，该方法可测量蒸汽递送装置的、靠近远端尖端的部分处的组织的第二电阻抗和相移，并基于所测量的第二电阻抗和相移确定蒸汽递送装置的、靠近远端尖端的部分是否插入到患者前列腺中。
该方法可以进一步包括主动地使蒸汽递送装置的、与患者的会阴组织相邻的部分绝缘。主动绝缘可用于保护敏感组织免受加热的蒸汽递送装置的影响。主动绝缘步骤可包括在围绕蒸汽递送装置的细长轴的多个管中形成绝缘空气空间。
还提供了一种将蒸汽递送装置定位在前列腺中的方法，其包括将蒸汽递送装置经会阴推进到前列腺中，测量接触蒸汽递送装置的尖端电极的组织的第一电阻抗和相移，测量接触蒸汽递送装置的环形电极的组织的第二电阻抗和相移，其中环形电极靠近尖端电极，确定尖端电极和环形电极是否设置在前列腺内，并且如果尖端电极和环形电极设置在前列腺内则将蒸汽递送到前列腺。
该方法可以包括施加频率在1-100MHz之间的交流电，以确定优化前列腺内、外组织之间的阻抗和相位对比的工作频率。
另外，该方法还可以包括向使用者提供尖端电极和环形电极设置在前列腺内的指示。
还提供了一种蒸汽递送装置，其包括细长轴；远端尖端电极，其被配置成测量接触远端尖端电极的组织的第一电阻抗和相移；环形电极，其靠近远端尖端电极设置在细长轴上，并被配置成测量接触该环形电极的组织的第二电阻抗和相移；电绝缘部分，其设置在远端尖端电极和环形电极之间；以及电子控制器，其被配置为基于第一和第二电阻抗和相移确定尖端电极和环形电极是否被设置在前列腺内。
该装置还可以包括电路，其被配置为提供频率在1-100MHz之间的交流电，以确定优化前列腺内、外组织之间的阻抗和相位对比的工作频率。
还提供了一种蒸汽递送系统，其包括RF发生器控制台；适于插入RF发生器控制台的注射器，该注射器包括注射器手柄、柱塞、设置在注射器手柄上的手柄磁体以及设置在柱塞中的柱塞磁体；耦合到注射器的流体源；以及设置在RF发生器中并配置成与柱塞磁体对准以推进和撤回柱塞磁体的发生器磁体，其中RF发生器控制台被配置成通过推进和撤回发生器磁体来自动地用来自流体源的流体重新填充注射器。
在一个实施例中，该系统还包括单向止回阀，其被配置成允许流体从流体源流入注射器，并且可选地包括第二单向止回阀，其被配置成允许流体从注射器流到蒸汽递送装置。
附图说明
为了更好地理解本发明并了解其在实践中如何实施，接下来仅通过非限制性实施例的方式参考附图来描述一些优选实施方案，其中，相似的附图标记在附图中的类似实施方案中始终表示相应的特征。
图1A-1B示出了经会阴蒸汽递送系统。
图2A、2B和2C示出了与递送系统一起使用的注射器。
图3A、3B、3C、3D、3E、3F、3G和3H示出了与递送系统一起使用的蒸汽发生器。
图4A、4B、4C和4D示出了蒸汽递送针。
图5示出了利用超声成像引导将针正确地放置在前列腺中的不确定性。
图6示出了分离的导体之间的电压和电流和电压信号。
图7示出了尿道冷却导管。
图8提供了用经会阴蒸汽递送系统治疗前列腺癌的方法。
具体实施方式
提供了经会阴蒸汽递送系统，用于治疗前列腺癌。如图1A所示，经会阴蒸汽递送系统100包括RF发生器102、辅助控制器控制台104、蒸汽发生和递送手柄106、蒸汽递送针(未示出)、用于递送生理盐水以冷却并保护前列腺外侧周围神经的冷却针(未示出)、通过警告使用者高温来进一步保护神经和其它前列腺周围组织的热电偶针(未示出)、使冷却的盐水109循环通过放置在前列腺尿道中的冷却导管110以保护该组织的尿道冷却系统108，以及超声成像系统111(例如经直肠超声(TRUS)成像系统)。该系统可以进一步包括盐水线112、热电偶线114和116以及成像线118，以分别连接冷却系统、热电偶针和超声成像系统。来自超声成像系统111的图像可以显示在显示器120上。
图1B是蒸汽产生和递送手柄106、蒸汽递送针122、冷却针124、热电偶针126、冷却导管110和超声成像系统111的特写视图。蒸汽递送针122被配置用于经会阴插入前列腺中以将加热的可冷凝蒸汽递送到前列腺中以治疗前列腺癌。冷却针124连同冷却导管被配置成将冷却的盐水递送到靠近前列腺的组织中，以防止对邻近组织(例如尿道和肛门)的消融损伤。热电偶针126被配置成在蒸汽递送期间测量组织(包括前列腺组织)的温度。
RF发生器的主要功能是向蒸汽递送装置加热元件提供无菌水和RF功率。当操作员按下递送装置上的蒸汽递送按钮时，RF发生器递送蒸汽。RF发生器还向针提供盐水，用于输注到前列腺周围的组织中。盐水提供冷却，但也用于填充空间并在疗法递送期间提供前列腺和敏感的直肠组织之间的分离。
图1A中的辅助控制器控制台包含定制设计的帕耳帖效应(Peltier effect)冷却器，用于使冷却的盐水循环通过在图1B中的前列腺尿道中看到的定制设计的尿道冷却导管。用于冷却器的盐水由盐水袋储存器提供，该盐水袋储存器也向RF发生器供应盐水，用于通过盐水输注针递送到前列腺外的组织。辅助控制器控制台还追踪前列腺外多个点的温度，以确保不会超过可能损害前列腺周围组织的温度。
图1A中所示的辅助控制器控制台在疗法期间使水冷却并循环以冷却尿道。它还监测沿着插入前列腺外组织的针长度的热电偶位置的温度，并在任何温度超过指定界限时阻止疗法递送。每个热电偶针包含三个或更多个沿其长度间隔开的热电偶。此外，辅助控制器控制台监测蒸汽递送尖端电极和环形电极处的电阻抗和相移，并且与操作者互动以在递送疗法之前确定蒸汽递送针尖是否邻近前列腺组织。如图1A所示，可以将邻近针尖的组织状态的定制显示合并到辅助控制器中的实时超声成像上，并且在操作员优选的位置处的工作区中的监视器上显示。
RF发生器
对于癌症蒸汽疗法系统(其可以比BPH系统以更高的速率和更长的时间递送许多剂量的蒸汽)的要求包括向较大总体积的无菌水提供足够的功率。图1A-1B的系统可以在300至600kHz的频率范围内提供高达500瓦的RF功率。
提供较大量的无菌水用于产生蒸汽的一种解决方案是在RF发生器中使用大型蒸汽注射器。该解决方案需要线性电机来驱动在给定的水流速下以较低的速度移动的注射器柱塞。在降低的柱塞速度下确保精确的水流速可能是困难的。另外，对于较大直径的注射器，注射器的顺应性可能增加，这也降低了递送水的准确性。注射器长度受RF发生器的长度限制，这受到临床需要的限制。
为了克服对更多水的需要，本公开提供了一种在用完水时自动重新填充的无菌水注射器。注射器在图2A中显示为组装图，并在图2B中组装。在图2A中，无菌水注射器128包括注射器筒130、注射器柱塞132、注射器手柄134、衬套136、O形环138、鲁尔接头(luerfitting)140、注射器柱塞磁体142、螺钉144、手柄磁体146和粘合剂148。
图2C示出了插入RF发生器102中的无菌水注射器128，并且还示出了注射器手柄134、注射器柱塞磁体142、手柄磁体146、注射器柱塞132。无菌水注射器可通过水线连接到递送手柄内的蒸汽发生器，所述水线包含单向止回阀141(其允许水流入递送装置但不从递送装置流出)和第二单向阀141(其允许水从无菌水存储器流出但不流入无菌水存储器)。在手术结束时，操作者通过拉动以克服注射器柱塞磁体和RF发生器轴柱塞磁体之间的磁吸引力来使无菌水注射器脱离。
图2A-2C中所示的手动操作的柱塞132和手柄134通过手柄磁体146和注射器柱塞磁体142之间的磁吸引力与注射器筒接合。操作者将注射器放入无菌水中并向后拉以填充注射器。然后操作者可以通过继续拉动手柄以克服磁吸引力来使手柄脱离。当将填充的注射器插入RF发生器中时，与RF发生器内的注射器柱塞轴对准的磁体(与磁体146相同，因为它在RF发生器内部而未示出)与注射器柱塞磁体接合，这使得系统能够推进和撤回注射器。
为设置和灌注系统，操作员被指示执行以下步骤：1)手动用盐水填充蒸汽注射器并放入RF发生器，与磁体接合。2)将双向鲁尔接头连接到注射器，该注射器具有：到蒸汽发生和递送手柄的出口(OUT)单向阀，来自无菌水存储器的进口(IN)单向阀。3)接合递送装置疗法递送按钮以使RF发生器驱动柱塞以递送无菌水以灌注系统，并递送RF功率以产生蒸汽。4)之后，发生器通过轴柱塞磁体和注射器柱塞磁体之间的磁吸引力使柱塞撤回。单向阀阻止递送管线中的水返回注射器。当柱塞撤回时，第二单向阀允许来自储存器的水重新填充注射器。5)之后，发生器柱塞轴向前移动，直到它感应到5磅正压，这表明柱塞已接合并正在将水递送到递送系统。6)接合递送装置疗法递送按钮以将蒸汽的测试喷射递送入空气中，之后系统进入低功率空转状态，等待疗法递送。7)在疗法递送后，如果注射器柱塞移动到注射器的末端，则自动触发再填充程序并且柱塞撤回。8)操作员可以通过按下发生器屏幕上的按钮随时重新填充注射器。在一些实施方案中，注射器的初始填充，步骤1)是自动完成的。在该模式中，操作者将空注射器放入发生器中，将双向鲁尔接头连接到注射器，并且注射器的初始填充由系统自动执行。
蒸汽递送装置
图3A-3B中所示的蒸汽产生和递送手柄106包括手柄部分150、疗法递送按钮152、用于蒸汽递送针的鲁尔接头154、以及将蒸汽产生和递送手柄连接到RF发生器的电缆和连接器156。如图3B所示，蒸汽产生和递送手柄还包括加热元件158以及与放置在病人体内的针附接的鲁尔接头，所述加热元件158具有带有挤出的PFA高温绝缘材料的利兹线的RF线圈和具有线圈和出口热电偶的镍铬铁合金(Inconel)625内部线圈。
蒸汽递送装置中的加热元件158可以处理高温，用于在高达500瓦的情况下进行长时间的治疗。加热元件可包括外部RF线圈和内部蒸汽管线圈。当RF电流施加到外部RF线圈时，它感应地加热流过内部蒸汽管线圈的流体。
内部蒸汽管线圈和外部RF线圈结构可以是从水输入端悬臂式的，使得没有材料暴露于内部蒸汽管线圈的热蒸汽端。镍铬铁合金625内部线圈可以包括沿线圈两侧的绕组之间的微熔接(micro welds)。这确保了不会发生绕组分离以及随后在疗法递送中的变化。如图1B所示，手柄在预先插入的蒸汽递送针之间移动，用于疗法。
加热元件外部RF线圈160在图3C-3D中示出。加热元件可包括RF线圈安装夹具162。在一个优选实施方案中，外部RF线圈包括单独漆包的44规格铜线股，其总体相当于#24线规。44规格绞合(stranding)适用于在350至850kHz范围内(更具体地在440至480kHz的优选范围内)的工作频率下避免皮肤效应问题。利兹线具有整体挤出的0.002”厚的PFA(全氟烷氧基)绝缘涂层。该绝缘的额定连续使用温度高达250℃，这对于邻近内部线圈热蒸汽端的绕组尤其重要。
作为粘合剂的替代，可以通过将电线的近端穿过RF线圈安装夹具中的孔164而将电线的近端机械地保持在适当的位置。通过将远端电线穿过图3B中所示的电线保持环166中的孔，将远端电线保持在适当的位置。图3C中示出了RF线圈组装的断开，其示出了缠绕在薄壁、高温聚酰亚胺管上的RF线圈线，其通过远端电线保持环而附接RF线圈安装夹具。通过使电线穿过RF线圈安装夹具中的孔，将通向线圈的去向和返回利兹线引线机械地固定在适当的位置。
内部蒸汽管线圈168在图3E中示出，其在绕组之间具有两条微熔接(例如激光熔接)线。在绕组之间保持良好的电接触是很重要的，这由该熔接保证。两条熔接线提供机械强度以有助于确保绕组不会弯曲并从而失去电接触。
图3F示出了外部RF线圈160的分解图，其包括高温聚酰亚胺管172和RF线圈安装夹具162。图3G示出了从组装轮毂(assembly hub)170悬臂伸出的内部蒸汽管线圈。内部蒸汽管线圈是插入外部RF线圈中的，但为了说明的目的，在图3G中与RF线圈分开示出。在该设计中，内部蒸汽管线圈的远端接触高温聚酰亚胺管172，但是不接触可能无法抵抗高温(高达400℃)的其他材料，当线圈的远端不含水时，至少暂时可以达到高温。
内部蒸汽管线圈可以由镍铬铁合金625构成，这是一种非磁性不锈钢，其电阻率几乎与内部线圈遇到的温度范围(20℃至400℃)内的温度无关。这些性质确保了喷射与喷射之间以及设备与设备之间的一致的蒸汽和卡路里递送。特别是，通常用于海波管的300系列不锈钢具有这样的残余磁导率，其可以在不同批次的管之间变化，并且可以随热循环而变化。可变磁导率对于固定的发生器输入功率产生可变的卡路里输出。300系列不锈钢的电阻率可以随热循环以不可预测的方式改变，这也产生可变的卡路里输出。当材料被冷加工或热循环时，这些性质可归因于奥氏体和马氏体之间的材料相变。
内部线圈热电偶的位置如图3H所示。线圈热电偶174可以熔接到最远端线圈绕组的内部。这是内部线圈上最热的点，因为在这个位置可能很少有水或没有水来蒸发和带走热量。然而，该位置位于RF线圈下方并且被感应地加热。这类似于锅中的沸水，其保持在水的沸腾温度直到水全部沸腾掉，此时其温度迅速升高。出口热电偶176远离RF线圈，并且接收来自出口管内的蒸汽的热量输入，以及从蒸汽线圈(施加热量之处)沿着出口管向热电偶传导的热量。引线178可以连接到热电偶并且通过内部蒸汽管线圈的内部布线。
蒸汽递送针
前列腺癌蒸汽递送针需要刺穿会阴、刺穿前列腺囊并且仅向前列腺递送蒸汽而不灼伤会阴组织。这些要求在本发明中通过以下方法来解决：使位于邻近会阴组织的针的一部分绝缘，以及通过测量针尖周围组织的电特性来确认针在前列腺组织中，然后再递送蒸汽。
已经设计并实施了一种独特的蒸汽递送针绝缘系统，以阻止针附近的非前列腺组织过热。它包括一系列围绕中心蒸汽针的小的聚酰亚胺管以在热针和会阴组织之间提供绝缘空气空间。还开发了真空针。
蒸汽递送针具有两个电极，用于感测周围组织的电特性。针尖和与针尖绝缘并靠近针尖的环是电极。独特的警报系统最初测量前列腺外部和内部的组织电特性，并且此后能够确定针是在内部还是外部，并阻止蒸汽被递送到前列腺的外部。
蒸汽递送针122在图4A和4C中示出。该针包括具有成形和尖锐的尖端123的中空钢针，用于将蒸汽递送到前列腺组织的尖端中的孔，通过电绝缘部分180与尖端分离的环形电极182，保护会阴组织的绝热部分125，带有用于尖端电极和环形电极的连接器的引线，以及用于将针连接到蒸汽产生和递送手柄的鲁尔接头。
在一个优选实施方案中，在两个同心钢管之间产生真空，以使针外表面与穿过内管的热蒸汽绝缘。在图4D中详细示出的另一个优选实施方案中，使用夹在覆盖钢蒸汽管的内管186和与会阴组织接触的外管188之间的充气微型管184的圆形阵列实现绝热。内管、外管和绝缘管优选由聚酰亚胺构成。三种管的优选尺寸(以英寸计)为：
描述ID x壁x OD
.051x.0025x.056内管
.009x.00075x.0105微型管
.080x.0025x.085外管
组织感测电极的一种可包括针尖本身，其可熔接到内部钢针管，如图4B所示。可以在内部钢针的近端处用穿过电连接器到达辅助控制器控制台的引线进行电接触。第二电极是图4C中所示的环形电极，其通过绝缘间隔物与尖端电极电绝缘。环形电极通过内部聚酰亚胺管与钢针内管电绝缘。在优选实施方案中，环形电极的引线可以穿过微型管中的一个到达近端电连接器。
生物电容组织传感和引导
在对前列腺癌进行蒸汽疗法时，要求医生将蒸汽递送针的尖端放置在患者前列腺的周边和/或移行区内。为此，将针通过患者的会阴处插入，并利用超声引导导航至前列腺的适当区域。在一些情况下，使用单个针进行多次蒸汽疗法，如此进行：将针放置在适当位置，进行治疗，将针拉回到前列腺的顶端或向前推向前列腺的基部，然后，进行另一治疗。重复该过程，直到围绕针的轴线产生连续的治疗组织区域。
如果针的发射孔完全包含在前列腺内，则治疗期间递送的蒸汽将保留在前列腺内，因为前列腺囊是对流屏障(convective barrier)。然而，如果一个或多个发射孔位于前列腺囊之外，则蒸汽将行进到前列腺外部，这是不希望的。
因为前列腺是3D器官但是超声数据最终被描绘成2D图像，所以对于医生而言确认蒸汽发射孔完全包含在前列腺内可能是具有挑战性的。当将针拉回会阴部以进行顶部治疗时尤其如此。图5在视觉上展示了这个概念。垂直段表示由超声波探查并由医生观察的前列腺平面。
在该实施例中，因为超声波不测量蒸汽针所在的确切平面，所以使用者可能错误地认为前列腺伸展得比它在蒸汽针的轴线中实际伸展得(这由虚线表示)更远。在右侧蒸汽针的情况下，这是可以接受的，因为发射孔仍然完全包含在前列腺内。然而，在左侧蒸汽针的情况下，这种可视化的挑战将导致蒸汽被递送到前列腺囊之外。因此，需要针尖在前列腺内的位置的辅助指示以补充超声可视化。
生物电容操作原理
本发明将电极结合到蒸汽递送针尖中。在电极之间通过高频电流，并且测量在电极之间产生的电压以及电压和电流之间的相移。这些测量取决于针尖周围组织的性质。组织可以是电阻性的和/或电容性的，这取决于其含量。具体地，这些测量将前列腺组织与周围组织区分开，使得能够明确地确定蒸汽递送针在前列腺中，然后再递送蒸汽。
在电子学中，电容器是一种以电荷的形式临时存储电场中的电能的电路元件。电容器具有多种形状、尺寸和类型，它们都具有由绝缘介电材料隔开的两个电导体的共同形式。介电材料通过分离和存储电荷来放大电容。在高水平，给定电容器的电容幅值(magnitude)由导体表面积与它们之间材料的介电常数的乘积除以导体之间的间隔确定。对于给定的介电材料，由非常靠近在一起的大导体组成的电容器将比由相距很远的小导体组成的电容器具有更大的电容。在交流电路中，电容具有使电压信号滞后于电流信号的效应。电压滞后电流的程度在-90°和90°之间以度为单位测量，并通常称为“相移”。图6示出了电流信号和电压信号。
类似地，人体细胞的结构使得它们可以被认为是电容元件。细胞膜由介电的脂质双层构成，该脂质双层将导电的细胞内液与导电的细胞外液分开，它们一起构成了形成电容器的必要元件：被介电材料隔开的两个电导体。在活细胞组织中，离子泵在细胞膜内起作用，将电荷主动地传输穿过膜，以维持对生命必不可少的跨活细胞膜电势。由此保留了跨膜的电荷分离，并且电荷分离有助于提供活组织电容。通常，组织除了电容之外还可以具有电阻，并且由组织分开的电极构成“漏电电容器(leaky capacitor)”，其具有电阻和电容两者。相比电容性，不含活细胞的组织通常更具电阻性。理论上，人们可以使用一段生物组织的电容测量作为构成该组织的细胞类型的指标。这可以被认为是测量组织的生物学电容或生物电容。在本公开中，生物电容测量确定蒸汽针的尖端何时在前列腺内与何时在前列腺外并且相应地通知医生。
前列腺本身主要包含基质(平滑肌)细胞和腺体组织细胞，由于它们的尺寸和结构，其通常以中等阻抗和中到高电容为特征。另一方面，紧邻前列腺周围的区域通常含有流体-其包括电解质、氨基酸和脂肪酸，因此在阻抗和电容方面都很低。
前列腺周围还有多种筋膜，它们是由长链蛋白质形成的胶原组成的组织的纤维鞘。由于其长而薄的结构，这种胶原具有比前列腺内的基质和腺体组织更低的阻抗和电容，但是具有比前列腺外部的流体更高的阻抗和电容，这使其缺乏粘性结构。前列腺囊也是筋膜。进一步远离前列腺但仍然位于针的路径中的是皮肤和脂肪细胞，由于它们的结构，其阻抗和电容更类似于前列腺内的基质和腺体组织。表I示出了疗法针从会阴到前列腺的路径上的组织的理论阻抗和电容的近似图。
表I：根据位置的阻抗和电容
<u>测量</u> <u>皮肤</u> <u>脂肪</u> <u>筋膜</u> <u>流体</u> <u>前列腺囊</u> <u>前列腺</u>
<u>阻抗</u> <u>中</u> <u>高</u> <u>低</u> <u>非常低</u> <u>低</u> <u>中</u>
<u>电容</u> <u>高</u> <u>高</u> <u>低</u> <u>非常低</u> <u>低</u> <u>高</u>
生物电容系统详细说明
图4C示出了蒸汽递送针的尖端123，其具有3列4个发射孔，所述发射孔在疗法期间排出蒸汽。尖端本身是第一电极，用于生物电容测量。第二电极是环形电极180，其通过PTFE绝缘体182的一部分与针尖电隔离。将绝缘的镍线熔接到该电极上并沿针的长度向下延伸。在蒸汽针组件的内部，将两个电极焊接到MMCV同轴电缆的6”段，其终止于MMCX公头连接器。蒸汽针通过8’MMCX同轴延长电缆和连向N型适配器的MMXC连接到系统发生器内的矢量电压表电路。该电路提供频率可以从1到100MHz变化的交流电，并执行初始频率扫描以确定优化前列腺内、外组织之间的阻抗和相位对比的工作频率。阻抗振幅和相位是在系统计算机中分析的矢量电压表电路的输出。
使用者工作流程通过手动识别位于前列腺外部和内部的组织开始。在此步骤中，系统扫描频率并搜索1到100MHz之间的、显示前列腺内、外组织之间阻抗幅值和相位的最大分离的频率。使用下表2中的公式进行相位和振幅分数的计算。分数从零(针在前列腺外部)到100(针在前列腺内部)，并且基于前列腺内、外组织的相位和幅值的初始校准。一旦校准步骤完成，系统就可以全面实时识别针尖处的组织类型，这可以在显示器上显示给使用者。当确定两个阻抗测量值都表明尖端电极和环形电极都在前列腺内时，蒸汽才能被递送到组织。用户被告知只有一个电极在前列腺内部的情况，以及当两个电极都在前列腺外部时的情况。
表2：生物电容分数计算
权重可通过使用者界面上的滑动比例进行调整，以允许使用者偏向组合分数以或多或少地关注相位与幅值。
尿道冷却系统
将图1B中所示的尿道冷却导管110穿过尿道插入直到尖端在膀胱中。通过10cc注射器用盐水使固定球囊113膨胀以固定尖端。将导管拉回以使固定球囊113抵靠膀胱的内壁。这些步骤类似于插入Foley导管。
冷却导管110在图7中更详细地示出。中央内腔允许在导丝上插入导管，并提供用于膀胱引流的内腔。冷冻水通过导管内腔循环进入固定球囊113的远端，沿着冷却球囊的长度向下流动并通过导管的外腔流出。通过循环冷冻水将前列腺内蒸汽疗法产生的热量从尿道壁导出。
冷冻水循环通过图1A中所示的冷冻盐水109并返回导管。将冷冻盐水插入位于辅助控制器控制台内的帕耳帖效应冷却器中。蠕动泵以约150ml/分钟的速率循环冷冻水。冷冻水流速的优选范围是125ml/分钟至175ml/分钟。水在约5℃的温度下离开冷冻盐水109。离开冷却器的理想温度是1℃，并且低于10℃的温度是优选的。
使用经会阴前列腺癌治疗系统的方法
可以基于治疗前MRI和/或超声图像以及前列腺的活组织检查来预先计划蒸汽疗法治疗。治疗计划可包括将蒸汽递送针放置在已被诊断为癌性的前列腺区域中。单个针可以对给定区域施用多个疗法喷射。一个经验法则是蒸汽治疗的组织对超声波的透明度低于未治疗的组织，因此首先治疗离超声波换能器最远的组织以确保对于随后的疗法喷射的最佳可视化。
蒸汽的一个独特特性是它不会跨越前列腺区域边界。这为被治疗区域外的组织提供了独特的保护。然而，热量可以跨组织边界层传导，这是一个依赖时间的过程。如果施加蒸汽疗法足够长的时间以使足够的热量跨越分离边界层传导，则可以在相邻区域组织或前列腺囊外部的组织中达到消融温度。因此，根据治疗区域的尺寸，蒸汽疗法最多施用15秒或最多10秒。
蒸汽具有与超声能量相呼应的独特性质，并且在疗法期间蒸汽的行进是容易可视化的。蒸汽在疗法的第一秒内到达大部分待治疗的组织，但是通常可以随时间推移进一步行进。操作者可以在确定已经治疗了足够体积的组织的任何时间终止疗法。治疗时间可以在5至10秒的范围内或在5至15秒的范围内。如果操作者察觉到问题，可以随时停止治疗。施加多次疗法喷射直到已经治疗了期望的组织体积，其通常可以包括整个前列腺区域或区域的一部分。
图8显示了用蒸汽疗法治疗前列腺癌的方法的框图。该方法于步骤800开始治疗计划，其基于治疗前图像和活组织检查，并且可以包括刚好在治疗之前采集的TRUS图像。该计划包括识别癌性的且需要被治疗的前列腺区域，包括例如周边区和移行区。
在步骤802，接下来根据治疗计划放置针。针可以在超声或MRI引导下放置。在MRI引导下，手术中使用的所有器械必须是非磁性的，并且必须注意提供RF治疗和MR图像之间的电磁兼容性。在该步骤中放置蒸汽、盐水输注和热电偶针。
接下来，计划第一次蒸汽疗法喷射，包括将针定位在离TRUS换能器最远的未治疗组织中以获得最佳成像。基于预期待治疗的组织区域的尺寸，最大治疗时间通常选择为10或15秒。选择疗法RF功率和无菌水流速以使蒸汽在当前喷射下在整个预期要治疗的组织中扩展。采用图7的生物电容方法以确保在疗法递送之前蒸汽针已经在前列腺组织中。
疗法在步骤804递送，并且随着蒸汽通过治疗区域扩展，在步骤806，在TRUS图像上观察治疗，或者随着温度前沿(temperature front)推进在MRI热图像上观察治疗。可以通过释放手柄上的疗法按钮随时停止疗法。否则治疗进行到所选的最大时间。通过观察TRUS图像上的蒸汽推进，或通过MRI热图像上的消融区域的边缘来记录治疗组织的范围。利用该信息，再次在成像和生物电容引导下，可以在步骤808选择下一个疗法区域并且移动蒸汽针。重复该步骤直至治疗整个前列腺区。在步骤810将递送装置手柄移动到下一个治疗针，并且重复该过程直到已经治疗了所有计划的前列腺区域。
尽管上面已经详细描述了本发明的特定实施方案，但是应该理解，该描述仅用于说明的目的，并且本发明的上述描述并非详尽无遗。在一些附图中示出了本发明的具体特征而在其他附图中没有示出，这仅是为了方便，并且根据本发明可以将任何特征与另一个特征组合。对于本领域普通技术人员来说，许多变化和替代方案将是显而易见的。这些替代和变化旨在包括在权利要求的范围内。在从属权利要求中呈现的特定特征可以组合并且落入本发明的范围内。本发明也包括从权被改写为引用其他独权的多项引用从权形式的实施方案。

Claims (15)

1.一种治疗患者前列腺癌的方法，其包括：
用尿道冷却导管冷却患者的尿道；
通过注射冷冻液，冷却邻近患者前列腺的组织；
实时成像前列腺；
将蒸汽递送装置经会阴推进到前列腺中；
在蒸汽递送装置中感应地产生蒸汽；以及
通过蒸汽递送装置，将蒸汽递送到前列腺。
2.根据权利要求1所述的方法，其还包括测量蒸汽递送装置的远端尖端处的组织的第一电阻抗和相移。
3.根据权利要求2所述的方法，其还包括基于测量的第一电阻抗和相移，确定远端尖端是否插入患者的前列腺中。
4.根据权利要求2所述的方法，其还包括测量蒸汽递送装置的、靠近远端尖端的部分处的组织的第二电阻抗和相移。
5.根据权利要求4所述的方法，其还包括基于测量的第二电阻抗和相移，确定蒸汽递送装置的、靠近远端尖端的部分是否插入患者的前列腺中。
6.根据权利要求1所述的方法，其还包括主动地使蒸汽递送装置的、与患者的会阴组织相邻的部分绝缘。
7.根据权利要求6所述的方法，其中主动绝缘包括在围绕所述蒸汽递送装置的细长轴的多个管中形成绝缘空气空间。
8.一种将蒸汽递送装置定位在前列腺中的方法，其包括：
将蒸汽递送装置经会阴推进到前列腺中；
测量接触蒸汽递送装置的尖端电极的组织的第一电阻抗和相移；
测量接触蒸汽递送装置的环形电极的组织的第二电阻抗和相移，所述环形电极靠近所述尖端电极；
确定尖端电极和环形电极是否设置在前列腺内；以及
如果尖端电极和环形电极设置在前列腺内，则将蒸汽递送到前列腺。
9.根据权利要求8所述的方法，其还包括施加频率在1-100 MHz之间的交流电以确定优化前列腺内、外组织之间的阻抗和相位对比的工作频率。
10.根据权利要求8所述的方法，其还包括向使用者提供尖端电极和环形电极设置在前列腺内的指示。
11.一种蒸汽递送装置，其包括：
细长轴；
远端尖端电极，其被配置为测量接触远端尖端电极的组织的第一电阻抗和相移；
环形电极，其靠近远端尖端电极设置在细长轴上，所述环形电极被配置成测量接触环形电极的组织的第二电阻抗和相移；
电绝缘部分，其被设置在远端尖端电极和环形电极之间；以及
电子控制器，其被配置为基于第一和第二电阻抗和相移，确定尖端电极和环电极是否被设置在前列腺内。
12.根据权利要求11所述的装置，其包括电路，所述电路被配置为提供频率在1-100MHz之间的交流电，以确定优化前列腺内、外组织之间的阻抗和相位对比的工作频率。
13.一种蒸汽递送系统，其包括：
RF发生器控制台；
注射器，其适于插入RF发生器控制台，所述注射器包括注射器手柄、柱塞、设置在注射器手柄上的手柄磁体以及设置在柱塞中的柱塞磁体；
流体源，其与注射器耦合；以及
发生器磁体，其被设置在RF发生器中并被配置为与柱塞磁体对准以推进和撤回柱塞磁体；
其中，所述RF发生器控制台被配置成通过推进和撤回发生器磁体而自动地用来自流体源的流体重新填充注射器。
14.根据权利要求13所述的系统，其还包括单向止回阀，所述单向止回阀被配置成允许流体从流体源流入注射器。
15.根据权利要求14所述的系统，其还包括第二单向止回阀，所述第二单向止回阀被配置成允许流体从注射器流到蒸汽递送装置。
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