CN107427213A - 用于接触质量的评估的系统和方法 - Google Patents

用于接触质量的评估的系统和方法 Download PDF

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CN107427213A
CN107427213A CN201580068293.XA CN201580068293A CN107427213A CN 107427213 A CN107427213 A CN 107427213A CN 201580068293 A CN201580068293 A CN 201580068293A CN 107427213 A CN107427213 A CN 107427213A
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CN107427213B (zh
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T·J·兰斯伯里
K·C·阿姆斯特朗
O·阿米拉纳
C·拉森
J·鲍温
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Laks Kaiser LLC
LUXCATH LLC
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
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    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
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    • A61B2218/002—Irrigation

Abstract

提供了评估导管与组织之间的接触质量的消融和可视化系统及方法。在一些实施例中，本公开的用于监测组织消融的方法包括使消融导管的远侧尖端前进到需要消融的组织；用UV光照射组织以激发组织中的NADH，其中组织在径向方向、轴向方向或两个方向上被照射；根据被照射的组织中的NADH荧光的水平确定何时导管的远侧尖端与组织接触；以及将消融能量输送到组织以在组织中形成损伤。

Description

用于接触质量的评估的系统和方法
相关申请
本申请要求于2014年11月3日提交的序号为No.62/074,615的美国临时申请的权益和优先权，该申请以其全文作为参考并入本文。
技术领域
本公开一般而言涉及评估导管和组织之间的接触质量的消融和可视化系统及方法。
背景技术
心房颤动(AF)是世界上最常见的持续性心律失常，目前影响数百万人。在美国，预计到2050年AF将影响1000万人。AF与增加的死亡率、发病率和受损的生活质量相关联，并且是中风的独立风险因素。发展中的AF的严重寿命风险突显该疾病的公共健康负担，仅仅在美国，其年治疗费用就超过了70亿美元。
已知AF患者的大多数发作是由源自延伸到肺静脉(PV)中的肌袖内的病灶电活动引发的。心房颤动还可以由上腔静脉或其它心房结构(即，心脏的传导系统内的其它心脏组织)内的病灶活动引发。这些病灶引发物还可以造成由可重入的电活动(或转动体(rotor))驱动的心房心动过速，所述可重入的电活动(或转动体)然后可能分裂成作为心房颤动的特性的多个电小波。此外，长时间的AF可以造成心脏细胞膜中的功能改变，并且这些变化进一步延续心房颤动。
射频消融(RFA)、激光消融和冷冻消融是医师用于治疗心房颤动的最常见的基于导管的映射和消融系统的技术。医师使用导管来指引能量，以破坏病灶引发物或者形成将引发物与心脏的剩余传导系统隔离的电隔离线。后一种技术通常用于所谓的肺静脉隔离(PVI)。但是，AF消融手术(procedure)的成功率保持相对停滞，术后一年复发的估计高达30％至50％。导管消融后复发的最常见原因是PVI线中的一个或多个间隙。所述间隙通常是低效或不完全损伤(lesion)的结果，所述低效或不完全损伤可能在手术期间临时阻断电信号但是随时间推移而愈合并促进心房颤动的复发。
低效或不完全的损伤常常是导管与心肌接触不良的结果。由于接触不良，能量从导管到心肌的转移对于引起适当的损伤而言是低效的并且常常是不足的。间歇性接触还可能是不安全的。
因此，需要用于形成和验证适当的导管接触和稳定性以改善结果并降低成本的系统和方法。
发明内容
本公开一般而言涉及评估导管和组织之间的接触质量的消融和可视化系统及方法。
根据本公开的一些方面，提供了本公开的用于监视组织消融的方法，所述方法包括使消融导管的远侧尖端前进到需要消融的组织；用UV光照射组织以激发组织中的NADH，其中组织在径向方向、轴向方向或两个方向上被照射；根据被照射的组织中的NADH荧光的水平确定何时导管的远侧尖端与组织接触；以及将消融能量输送到组织以在组织中形成损伤。
根据本公开的一些方面，提供了一种用于监视组织消融的系统，所述系统包括导管，所述导管包括导管体；以及位于所述导管体的远端处的远侧尖端，所述远侧尖端限定具有用于在照射腔和组织之间交换光能的一个或多个开口的照射腔；消融系统，与远侧尖端连通以向远侧尖端输送消融能量；可视化系统，所述可视化系统包括光源、光测量仪器，以及一根或多根光纤，所述光纤与光源和光测量仪器连通并且通过所述导管体延伸到所述远侧尖端的照射腔中的，其中所述一根或多根光纤被配置为将光能传入和传出照射室；处理器，与消融能量源、光源和光测量仪器通信，所述处理器被编程为：从用通过导管的远侧尖端的UV光照射的组织接收NADH荧光数据，其中组织在径向方向、轴向方向或两个方向上被照射；根据被照射的组织中的NADH荧光的水平确定何时导管的远侧尖端与组织接触；以及在确定远侧尖端与组织接触时，(自动地或者通过提示用户)使消融能量输送到组织以在组织中形成损伤。
附图说明
将参考附图进一步解释本公开的实施例，其中贯穿若干视图，相同的结构由相同的标号表示。所示出的附图不一定是按比例的，而是一般将重点放在说明本公开的实施例的原理上。
图1A图示了本公开的消融可视化和监视系统的实施例。
图1B是用于与本公开的消融可视化和监视系统结合使用的可视化系统的实施例的图。
图1C图示了适于与本公开的系统和方法结合使用的示例性计算机系统。
图2A-2E图示了本公开的导管的各种实施例。
图3图示了根据本公开的、用于监视导管和组织之间的接触的示例性荧光光谱图。
图4图示了各种组织成分的示例性光谱图。
图5A和图5B图示了根据本公开的、用于监视导管的稳定性的示例性荧光光谱图。
图6A和图6B图示了根据本公开的、用于监视导管的稳定性的示例性荧光光谱图。
图7是在施加消融能量期间随时间比较fNADH与阻抗的曲线图。
虽然上述附图阐述了本公开的实施例，但是如在讨论中所指出的，其它实施例也是所预期的。本公开以代表且非限制的方式来呈现说明性的实施例。本领域技术人员可以设计出众多其它修改和实施例，这些修改和实施例落入本公开实施例的原理的范围和精神内。
具体实施方式
本公开提供了用于损伤评估的方法和系统。在一些实施例中，本公开的系统包括被配置为起两个功能的导管：将消融治疗输送到目标组织的治疗功能以及从导管和组织的接触点收集特征光谱以访问损伤的诊断功能。在一些实施例中，本公开的系统和方法可被用于使用烟酰胺腺嘌呤二核苷酸氢(NADH)荧光(fNADH)对组织进行成像。一般而言，所述系统可以包括具有光学系统的导管，用于在组织和导管之间交换光。在一些实施例中，本系统允许由紫外线(UV)激发诱导的组织的NADH荧光或其缺乏的直接可视化。从组织返回的NADH荧光特征可以被用来确定组织和导管系统之间的接触质量。
在一些实施例中，导管在其远端处包括消融治疗系统并且所述导管耦接到包括光源(诸如激光器之类)和光谱仪的诊断单元。导管可以包括从光源和光谱仪延伸到导管的远侧尖端的一根或多根光纤，以向导管和组织之间的接触点提供照射光并且接收并从接触点向光谱仪输送特征NADH光谱。特征NADH光谱可以被用来评估目标组织中的损伤。在一些实施例中，本公开的方法包括照射具有损伤的组织、接收组织的特征光谱、以及基于来自组织的特征光谱对损伤执行定性评估。分析可以在消融损伤形成之前、期间和之后实时地发生。应当注意的是，虽然结合心脏组织和NADH光谱描述了本公开的系统和方法，但是本公开的系统和方法可以与其它类型的组织和其它类型的荧光结合使用。
系统：诊断单元
参考图1A，用于提供消融治疗的系统100可以包括消融治疗系统110、可视化系统120以及导管140。在一些实施例中，系统100还可以包括冲洗系统170、超声系统190以及导引(navigation)系统200中的一个或多个。所述系统还可以包括显示器180，其可以是单独的显示器或可视化系统120的一部分，如下所述。在一些实施例中，该系统包括RF发生器、冲洗泵170、被冲洗的尖端消融导管140以及可视化系统120。
在一些实施例中，消融治疗系统110被设计为向导管140供应消融能量。消融治疗系统110可以包括一个或多个能量源，这些能量源可以生成射频(RF)能、微波能、电能、电磁能、冷能(cryoenergy)、激光能、超声能、声能、化学能、热能或者可以被用来对组织进行消融的任何其它类型的能量。在一些实施例中，导管140适于消融能量，消融能量是RF能、冷能、激光、化学、电穿孔、高强度聚焦超声或超声以及微波中的一种或多种。
参考图1B，可视化系统120可以包括光源122、光测量仪器124和计算机系统126。
在一些实施例中，光源122可以具有在目标荧光团(在一些实施例中是NADH)吸收范围内的输出波长，以便在健康心肌细胞中诱导荧光。在一些实施例中，光源122是可以生成UV光以激发NADH荧光的固态激光器。在一些实施例中，波长可以是大约355nm或355nm+/-30nm。在一些实施例中，光源122可以是UV激光器。激光器生成的UV光可以提供更多用于照射的功率，并且可以更有效地耦接到基于光纤的照射系统中，如在导管140的一些实施例中所使用的。在一些实施例中，本系统可以使用具有上至150mW的可调节功率的激光器。
光源122上的波长范围可以由所关注的解剖结构界定，用户具体选择造成最大NADH荧光而不激发胶原蛋白的过度荧光的波长，其在仅稍短的波长处表现出吸收峰。在一些实施例中，光源122具有从300nm至400nm的波长。在一些实施例中，光源122具有从330nm至370nm的波长。在一些实施例中，光源122具有从330nm到355nm的波长。在一些实施例中，可以使用窄带355nm的源。光源122的输出功率可以足够高，以产生可恢复的组织荧光特征，但并未高到导致细胞损害。如下面将要描述的，光源122可以耦接到光纤，以将光输送到导管140。
在一些实施例中，本公开的系统可以利用光谱仪作为光测量仪器124，但是可以采用其它光测量仪器。
光纤可以将收集的光输送到长通滤光片(long pass filter)，所述长通滤光片阻挡355nm的反射激发波长，但是使得从组织发射的在高于滤光片的截点的波长处的荧光通过。然后可以由光测量仪器124捕获并分析来自组织的经滤波的光。计算机系统126从光测量仪器124获取信息并向医师显示所述信息。
再次参考图1A，在一些实施例中，本公开的系统100还可以包括超声系统190。导管140可以配备有与超声系统190通信的超声换能器。在一些实施例中，超声可以示出组织深度，其与损伤的深度或代谢活动相结合可以被用来确定损伤是否事实上是透壁的。在一些实施例中，超声换能器可以位于导管140的远侧区段中，并且可选地位于远侧电极的尖端中。超声换能器可以被配置为评估在导管尖端的下方或者邻近导管尖端处的组织厚度。在一些实施例中，导管140可以包括适于提供涵盖导管尖端相对垂直于心肌或相对平行于心肌的情况的深度信息的多个换能器。
参考图1A，如上面所指出的，系统100还可以包括冲洗系统170。在一些实施例中，冲洗系统170将盐水泵入导管140中，以在消融治疗期间冷却尖端电极。这可以有助于防止形成蒸汽爆裂(steam pops)和炭(char)(即，附着到尖端的凝块，所述凝块最终可以被排出并造成溶栓事件)。在一些实施例中，冲洗流体相对于导管140外侧的压力被维持在正压力，用于连续地冲刷一个或多个开口154。
参考图1A，系统100还可以包括用于定位和导引导管140的导引系统200。在一些实施例中，导管140可以包括与导引系统200通信的一个或多个电磁位置传感器。在一些实施例中，电磁位置传感器可以被用来在导引系统200中定位导管的尖端。传感器从源位置拾取电磁能，并通过三角测量或其它手段计算位置。在一些实施例中，导管140包括适于将导管体142的位置和导管体的弯曲度呈现在导引系统显示器上的多于一个的换能器。在一些实施例中，导引系统200可以包括一个或多个磁体，并且由磁体在电磁传感器上产生的磁场的变化可以将导管的尖端偏转到期望的方向。还可以采用其它导引系统，包括手动导引。
计算机系统126可以被编程为控制系统100的各种模块，包括例如对光源122的控制，对光测量仪器124的控制，应用专用软件的执行，对超声、导引和冲洗系统的控制，以及类似操作。以示例的方式，图1C示出了可以结合本公开的方法和系统使用的典型处理架构308的图。计算机处理设备340可以耦接到用于图形输出的显示器340AA。处理器342可以是能够执行软件的计算机处理器342。典型的示例可以是计算机处理器(诸如或处理器之类)、ASIC、微处理器等。处理器342可以耦接到存储器346，存储器346典型地可以是用于在处理器342执行时存储指令和数据的易失性RAM存储器。处理器342还可以耦接到存储设备348，存储设备348可以是非易失性存储介质，诸如硬驱动器、FLASH驱动器、带驱动器、DVDROM或类似设备。虽然没有示出，但是计算机处理设备340典型地包括各种形式的输入和输出。I/O可以包括网络适配器、USB适配器、蓝牙无线电收发装置、鼠标、键盘、触摸板、显示器、触摸屏、LED、振动设备、扬声器、麦克风、传感器，或用于与计算机处理设备340一起使用的任何其它输入或输出设备。处理器342还可以耦接到其它类型的计算机可读介质，包括但不限于能够为处理器(诸如处理器342)提供计算机可读指令的电子、光学、磁性或其它存储或传输设备。各种其它形式的计算机可读介质可以向计算机发送或运送指令，包括有线的和无线的这两者的路由器、专用或公共网络、或者其它传输设备或信道。指令可以包括来自任何计算机编程语言的代码，包括例如C、C++、C#、Visual Basic、Java、Python、Perl和JavaScript。
程序349可以是包含指令和/或数据的计算机程序或计算机可读代码，并且可以存储在存储设备348上。指令可以包括来自任何计算机编程语言的代码，包括例如C、C++、C#、Visual Basic、Java、Python、Perl和JavaScript。在典型的场景中，处理器204可以将程序349的一些或全部指令和/或数据加载到存储器346中，以供执行。程序349可以是任何计算机程序或过程，包括但不限于web浏览器、浏览器应用、地址注册过程、应用或者任何其它计算机应用或过程。程序349可以包括各种指令和子例程，当其被加载到存储器346中并由处理器342执行时，使得处理器342执行各种操作，所述操作中的一些或全部操作可以实现本文公开的用于管理医疗护理的方法。程序349可以存储在任何类型的非暂态计算机可读介质上，诸如但不限于硬驱动器、可移除驱动器、CD、DVD或任何其它类型的计算机可读介质。
在一些实施例中，计算机系统可以被编程为执行本公开的方法的步骤，并控制本系统的各个部分，以执行必要的操作来实现本公开的方法。在一些实施例中，处理器可以被编程为从用通过导管的远侧尖端的UV光照射的组织接收NADH荧光数据，其中组织在径向方向、轴向方向或两个方向上被照射；根据被照射的组织中的NADH荧光的水平确定何时导管的远侧尖端与组织接触；以及在确定远侧尖端与组织接触时，(自动地或者通过提示用户)使消融能量输送到组织以在组织中形成损伤。
处理器还可以被编程为在输送消融能量期间监视NADH荧光的水平，以确认远侧尖端保持与组织接触。在一些实施例中，在输送消融能量期间监视NADH荧光的水平可以被用来确定远侧尖端和组织之间的接触的稳定性。在一些实施例中，当远侧尖端和组织之间的接触不稳定时，可以停止组织的消融。在一些实施例中，处理器还可以被编程为收集从被照射的组织反射的荧光的光谱以区分组织类型。
在一些实施例中，利用具有在大约300nm和大约400nm之间的波长的光照射组织。在一些实施例中，监视具有在大约450nm和470nm之间的波长的反射光的水平。在一些实施例中，被监视的光谱可以在410nm和520nm之间。附加地或替代地，可以监视更宽的光谱，诸如(以非限制性示例的方式)在375nm和575nm之间。在一些实施例中，可以同时向用户显示NADH荧光光谱和更宽的光谱。在一些实施例中，可以通过消融能量来创建损伤，所述消融能量选自包括射频(RF)能、微波能、电能、电磁能、冷能、激光能、超声能、声能、化学能、热能及其组合的组。在一些实施例中，当检测到NADH荧光峰时可以(由处理器或通过由处理器提示用户)开始手术，因此可以在整个手术过程中监视NADH荧光。如上面所指出的，处理器可以结合其它诊断方法(诸如超声监视)来执行这些方法。
系统：导管
如上面所讨论的，导管140可以基于标准消融导管，具有容纳用于照射和光谱分析的光纤的容纳空间。在一些实施例中，导管140是可转向的、被冲洗的RF消融导管，其可以经由标准的经中隔过程和常见的接近工具(access tools)通过鞘管输送到心内膜空间。在导管147的手柄上，为了治疗，可以存在用于标准RF发生器和冲洗系统170的连接。导管手柄147还使光纤通过，然后光纤连接到诊断单元以获得组织测量结果。
再次参考图1A，导管140包括具有近端144和远端146的导管体142。导管体142可以由生物相容性材料制成，并且可以足够柔软以使导管140能够转向并前进到消融的部位。在一些实施例中，导管体142可以具有可变刚度的区域。例如，导管140的刚度可以从近端144朝着远端146增加。在一些实施例中，导管体142的刚度被选择为使得能够将导管140输送到期望的心脏位置。在一些实施例中，导管140可以是可转向的、被冲洗的射频(RF)消融导管，其可以通过鞘管被输送到心内膜空间，并且在心脏左侧的情况下，使用常见的接近工具经由标准经中隔过程被输送。导管140可以包括在近端144处的手柄147。手柄147可以与导管的一个或多个管腔(lumen)连通，以允许仪器或材料通过导管140。在一些实施例中，为了治疗，手柄147可以包括用于标准RF发生器和冲洗系统170的连接。在一些实施例中，导管140还可以包括被配置为容纳用于照射和光谱分析的光纤的一个或多个接合器(adapter)。
参考图1A，在远端146处，导管140可以包括远侧尖端148，所述远侧尖端148具有侧壁156和前壁158。前壁158可以是例如扁平的、锥形的或圆顶形的。在一些实施例中，远侧尖端148可以被配置为充当用于诊断目的(诸如用于电描记图感测之类)、用于治疗目的(诸如用于发射消融能量之类)或这二者的电极。在需要消融能量的一些实施例中，导管140的远侧尖端148可以充当消融电极或消融元件。
在实现RF能量的实施例中，将远侧尖端148耦接到(在导管的外部的)RF能量源的接线可以通过导管的管腔。远侧尖端148可以包括与导管的一个或多个管腔连通的端口。远侧尖端148可以由任何生物相容性材料制成。在一些实施例中，如果远侧尖端148被配置为充当电极，则远侧尖端148可以由金属制成，包括但不限于铂、铂铱、不锈钢、钛或类似材料。
参考图2A，光纤或成像束150可以经过可视化系统120、通过导管体142，并进入由远侧尖端148限定的照射腔或隔室152。远侧尖端148可以设有用于在照射腔152与组织之间交换光能的一个或多个开口154。在一些实施例中，即使具有多个开口154，远侧尖端148作为消融电极的功能也不受损害。开口可以设置在前壁156上、在侧壁158上或二者上。开口154还可以用作冲洗端口。光被光纤150输送到远侧尖端148，在远侧尖端148处所述光照射远侧尖端148附近的组织。该照射光被反射或者使组织发荧光。由组织反射和从组织发荧光的光可以由远侧尖端148内的光纤150收集并被运送回可视化系统120。在一些实施例中，相同的光纤或光纤束150可以被用来既将光指引到远侧尖端的照射室以照射导管140外侧的组织，又收集来自所述组织的光。
参考图2A，在一些实施例中，导管140可以具有可视化管腔160，光纤150通过该可视化管腔可以前进通过导管体142。光纤150可以通过可视化管腔161前进到照射腔152中，以照射组织并通过开口154接收反射光。根据需要，光纤150可以通过开口154前进超过照射腔152。
如图2A和图2B中所示，除了可视化管腔161，导管140还可以包括用于使冲洗流体从冲洗系统170经过到远侧尖端148中的开口154(冲洗端口)的冲洗管腔163和用于使消融能量从消融治疗系统110经过到远侧尖端148(诸如例如借助于经过穿过用于RF消融能量的消融管腔164的接线)的消融管腔164。应当注意的是，导管的管腔可以被用于多个目的，并且可以为相同的目的使用多于一个管腔。此外，虽然图2A和图2B示出管腔是同心的，但是可以利用管腔的其它配置。
如图2A和图2B中所示，在一些实施例中，导管的中心管腔可以被用作可视化管腔161。在一些实施例中，如图2C中所示，可视化管腔161可以相对于导管140的中心通路偏移。
在一些实施例中，光还可以在侧壁156中径向地被指引到开口154之外，替代地或附加地通过前壁158中的开口被指引。以这种方式，照射腔152和组织之间的光能交换可以相对于导管的纵向中心轴线轴向地、径向地或两者兼有地在多条路径上发生，如图2E中所示。当解剖结构不允许导管尖端与目标部位正交时，这是有用的。当需要增加的照射时，这也会是有用的。在一些实施例中，附加的光纤150可以被使用并且可以相对于导管140在径向方向上偏转，以允许照射和返回的光沿着导管的长度离开和进入。
参考图2D，为了使得能够经多条路径(相对于导管的纵向中心轴线轴向地和径向地)在照射腔152与组织之间进行光能交换，可以在照射腔152中提供光指引构件160。光指引构件160可以将照射光指引到组织，并且通过远侧尖端148内的一个或多个开口154将返回的光指引到光纤150。光指引构件160还可以由任何生物相容性材料(诸如例如不锈钢、铂、铂合金、石英、蓝宝石、熔融石英、镀金属塑料或其它类似材料)制成，并具有反射光或可以被修改成反射光的表面。光指引构件160可以是锥形(即，光滑的)或具有任意数量的侧面的刻面。光指引构件160可以被成形为使光以任何期望的角度弯曲。在一些实施例中，光指引构件160可以被成形为仅通过一个或多个开口反射光。在一些实施例中，光指引构件160可以包括3或4个等距刻面，但是可以使用更多或更少的刻面。在一些实施例中，刻面的数量可以对应于侧壁156中的开口154的数量。在一些实施例中，可以存在比侧壁156中的开口154更少的刻面。在一些实施例中，刻面可以相对于光指引构件160的中心轴线以45度(相对于导管的轴线135度)定位。在一些实施例中，刻面166可以按比45度更大或更小的角度定位，以便将光指引向更远或更近。
在一些实施例中，用于光指引构件160的材料选自当暴露于310nm至370nm之间的照射时不发荧光的材料。在一些实施例中，如图2D中所示，光指引构件160可以包括通过镜的中心线的一个或多个孔162，这些孔允许照射光和反射光直接与导管140一致地在两个方向都轴向地通过。当远侧尖端148的最远表面与解剖结构接触时，这种轴向路径会是有用的。当解剖结构不允许远侧尖端148的最远表面与目标部位接触时，如有时候在治疗心房颤动时常见的肺静脉隔离手术期间患者的左心房中的情况下，替代的径向路径(如图2E中所示)会是有用的。在一些实施例中，透镜(lensing)可能不是在所有路径中都是需要的，并且随着光通过冷却流体(其常常是盐水)，光学系统与冲洗系统170相兼容。冲洗系统170还可以用来从孔162冲刷血液，从而保持光学部件清洁。
使用的方法
在一些实施例中，提供了用于监视组织消融的方法。这种方法可以通过显示NADH荧光的水平来提供关于各种因素的实时视觉反馈，所述因素可以影响损伤形成，如下所述。
在一些实施例中，用于监视本公开的组织消融的方法包括使消融导管的远侧尖端前进到需要消融的组织；用UV光照射组织以激发组织中的NADH，其中组织在径向方向、轴向方向或两个方向上被照射；根据被照射的组织中的NADH荧光的水平确定何时导管的远侧尖端与组织接触；以及在建立这种接触之后，将消融能量输送到组织以在组织中形成损伤。所述方法还可以包括在输送消融能量期间监视NADH荧光的水平，以确认远侧尖端保持与组织接触。在一些实施例中，在输送消融能量期间监视NADH荧光的水平可以被用来确定远侧尖端和组织之间的接触的稳定性。在一些实施例中，当远侧尖端和组织之间的接触不稳定时，可以停止组织的消融。在一些实施例中，所述方法还包括收集从被照射的组织反射的荧光的光谱以区分组织类型。
在一些实施例中，利用具有在大约300nm和大约400nm之间的波长的光照射组织。在一些实施例中，监视具有在大约450nm和470nm之间的波长的反射光的水平。在一些实施例中，被监视的光谱可以在410nm和520nm之间。附加地或替代地，可以监视更宽的光谱，诸如(以非限制性示例的方式)在375nm和575nm之间。在一些实施例中，可以通过消融能量来创建损伤，所述消融能量选自包括射频(RF)能、微波能、电能、电磁能、冷能、激光能、超声能、声能、化学能、热能及其组合的组。在一些实施例中，当检测到NADH荧光峰时，可以开始所述方法，因此可以在整个手术过程中被监视。如上面所指出的，这些方法可以与其它诊断方法(诸如超声监视之类)相结合使用。
接触评估
随着导管的尖端与解剖结构(诸如心内膜或心外膜心肌之类)相接触，组织的特性和状态在返回的光谱中被揭示。如图3中所示，对于血液(低幅度)、先前消融的组织与健康组织，400nm和600nm之间的光谱是不同的。当用355nm波长照射时，健康组织的特征以在从400nm到600nm处并且集中在大约460nm-470nm的波长的NADH荧光为主。这可以有助于确定何时导管被适当地定位并且与需要消融的组织接触。而且，将导管进一步推向抵靠表面会导致荧光升高，并且光谱特征偏移到基线以上。这种反馈的使用可以帮助降低导管消融和操纵期间穿孔的风险，并且可以帮助避免在次优的组织接触部位的消融，并因此减少RF消融时间。
参考图4，在一些实施例中，可以在更宽的光谱上收集光谱特征。例如，胶原蛋白组织的光谱图样不同于在健康心肌上观察到的光谱图样。当在这种情况下用355nm UV光源照射时，由于胶原蛋白荧光的增加的影响，当在对胶原蛋白组织成像时，光谱的峰向左偏移(从大约470nm到大约445nm)到更短的波长。这可以被用户用来识别被视为主要是心肌或者被胶原蛋白覆盖的、更难消融的区域。
在一些实施例中，可以监视光谱特征以确定损伤形成期间的导管稳定性和动作。
参考图5A和图5B，示出了导管和心肌的间歇性接触的示例。当导管从心肌向上和向下弹离时，fNADH信号的幅度随时间而变化，如由噪声光谱特征所指示的。这种光谱特征会指示不良的接触稳定性。另一方面，平滑的响应对应于稳定的导管，因为fNADH强度的逐渐降低指示随着时间消融损伤的形成。
参考图6A和图6B，在时间段1中施加RF能量的持续时间期间，fNADH的幅度相对平滑。时间段1还示出fNADH的减小，这指示成功的损伤形成，因为经消融的组织具有较少或没有fNADH，如上所述。但是，随着在RF能量被施加以形成线性损伤的同时拉动导管，因为导管的消融尖端遇到新的且未消融的心肌，所以在fNADH中存在新的峰。随后，从该点起fNADH的幅度稳定，并且信号幅度的减小示出了RF能量对心肌的影响。
在消融手术期间，存在与返回到医师的光谱的信息内容相关联的潜在益处。示出在375nm至600nm范围中的显著幅度的光学特征的分析可以与导管和心肌更好的接触相关，并从而改善特定消融损伤的质量，并因此改善手术结果。可以使用从导管或具体而言在导管的远侧尖端处的消融电极将光耦接到组织中的技术来确定和评估导管或电极与组织接触的质量。此外，在消融能量部署之前知道关于被消融的组织的类型或者所述组织中要被消融的胶原蛋白的存在与否以及有可能的程度的更多信息，可以影响由医师使用的针对那个损伤的最佳创建的消融策略和技术。例如，在存在胶原蛋白的情况下，医师可以选择一个消融能量源而不是另一个(激光优于冷冻，或者冷冻优于RF)，并且在已知被消融的组织的胶原性质的情况下，功率或持续时间或温度限制可以被调节得更高以获取更深的损伤。
本系统允许医师确信所选择的能量量将是安全而有效的。允许医师在整个输送消融能量以创建损伤期间直接评估接触有助于医师确保导管在损伤创建期间没有移离组织，考虑到心脏在跳动的同时经受的持续运动的严酷环境，所述移离会带来挑战。消融期间组织的光学性质改变是输送到组织并被组织吸收的能量量的优异指标。在消融期间以及紧随消融能量输送停止之后，组织的不明显改变包括组织如何吸收所输送的光以及组织如何散射光、对光作出反应并将光发送回(或者，在NADH荧光的情况下，不将光发送回)。
与阻抗的比较
以非限制性示例的方式，图7对比在损伤形成期间的fNADH响应与治疗阻抗。阻抗是全世界在消融手术期间使用的标准指标。典型地是从导管的尖端到粘附到患者躯干的消融地垫进行测量。医师期望在消融能量开始后的前2或3秒内看到大约10至15欧姆的下降。如果阻抗不下降，则医师知道这可能是由于导管与心肌接触不良并且损伤尝试被中断并且导管被重新定位。可以使用上述方法来确保导管和组织之间的更好接触。如果阻抗确实下降并维持新的水平，则医师继续施加损伤形成能量典型地达固定的时间(30至60秒或更长时间)。如果阻抗随着时间而上升，则这是在导管的尖端处可能过热的指示，并且如果不减退的话会导致蒸汽形成的危险情况，从而导致可能离开原位并变成栓体的在导管的尖端累积的炭或心脏壁破裂。
参考图7，与治疗阻抗SNR相比，fNADH光学响应的信噪比(SNR)将表明fNADH是导管接触的良好指标。fNADH量值的幅度变化大约为80％，而归一化的阻抗中的相同下降小于10％。光学特征与阻抗的这种比较还指示相对于阻抗的组织中活动的更直接的反映，因为阻抗常常是从电极通过血液池到地垫的电路径的大得多的反映。使用光学方法，如果维持良好的接触，则所有的光特征都来自组织而没有光特征源自血液池。因此，与阻抗特征相比，光学特征更能反映组织中的活动。
已经仅仅是为了说明本公开的各种非限制性实施例而不是要作为限制阐述了前述公开。由于本领域普通技术人员可以想到结合本公开的精神和实质的所公开实施例的修改，因此本公开的实施例应当被解释为包括在所附权利要求及其等同物的范围内的所有内容。本申请中引用的所有参考文献都以其整体作为引用并入本文。

Claims (22)

1.一种用于监视组织消融的方法，包括：
使消融导管的远侧尖端前进到需要消融的组织；
照射组织，以激发组织中的NADH，其中组织在径向方向、轴向方向或两个方向上被照射；
根据被照射的组织中的NADH荧光的水平确定何时导管的远侧尖端与组织接触；以及
当确定远侧尖端与组织接触后，将消融能量输送到组织以在组织中形成损伤。
2.如权利要求1所述的方法，还包括在输送消融能量期间监视NADH荧光的水平，以确认远侧尖端保持与组织接触。
3.如权利要求1至2中任一项所述的方法，还包括在输送消融能量期间监视NADH荧光的水平，以确定远侧尖端和组织之间的接触的稳定性。
4.如权利要求3所述的方法，还包括当远侧尖端和组织之间的接触不稳定时停止组织的消融。
5.如权利要求1至4中任一项所述的方法，还包括收集从被照射的组织反射的荧光的光谱，以区分组织类型。
6.如权利要求1至5中任一项所述的方法，其中用具有在大约300nm和大约400nm之间的波长的光照射组织。
7.如权利要求1至6中任一项所述的方法，其中确定步骤包括监视具有在大约450nm和大约470nm之间的波长的反射光的水平，以识别NADH荧光峰。
8.如权利要求1至7中任一项所述的方法，其中所述消融能量选自包括射频(RF)能、微波能、电能、电磁能、冷能、激光能、超声能、声能、化学能、热能及其组合的组。
9.如权利要求1至8中任一项所述的方法，其中所述导管包括：导管体；位于所述导管体的远端处的远侧尖端，用于向组织输送消融能量，所述远侧尖端限定具有用于在照射腔和组织之间交换光的一个或多个开口的照射腔；以及一根或多根光纤，所述光纤通过所述导管体延伸到所述远侧尖端的照射腔中，所述一根或多根光纤与光源和光测量仪器连通，以照射组织并将从组织反射的光能中继到光测量仪器。
10.如权利要求1至9中任一项所述的方法，还包括相对于所述导管的纵向轴线在径向方向和轴向方向上照射组织。
11.如权利要求1至10中任一项所述的方法，还包括通过显示NADH荧光的水平来提供关于损伤形成的实时视觉反馈。
12.如权利要求1至11中任一项所述的方法，其中，当检测到NADH荧光峰时，施加消融能量。
13.如权利要求1至13中任一项所述的方法，还包括结合监视NADH荧光的水平来执行组织的超声评估。
14.一种用于监视组织消融的系统，包括：
导管，包括：
导管体；以及
位于所述导管体的远端处的远侧尖端，所述远侧尖端限定具有用于在照射腔和组织之间交换光能的一个或多个开口的照射腔；
消融系统，与远侧尖端连通以向远侧尖端输送消融能量；
可视化系统，包括光源、光测量仪器，以及一根或多根光纤，所述光纤与光源和光测量仪器连通并且通过所述导管体延伸到所述远侧尖端的照射腔中，其中所述一根或多根光纤被配置为将光能传入和传出照射室；
处理器，与消融能量源、光源和光测量仪器通信，所述处理器被编程为：
从用通过导管的远侧尖端的光照射的组织接收NADH荧光数据，其中组织在径向方向、轴向方向或两个方向上被照射；
根据被照射的组织中的NADH荧光的水平确定何时导管的远侧尖端与组织接触；以及
在确定远侧尖端与组织接触时，使消融能量输送到组织以在组织中形成损伤。
15.如权利要求14所述的系统，其中处理器被编程为在输送消融能量期间监视NADH荧光的水平，以确认远侧尖端保持与组织接触。
16.如权利要求14至15中任一项所述的系统，其中处理器还被编程为在输送消融能量期间监视NADH荧光的水平，以确定远侧尖端和组织之间的接触的稳定性。
17.如权利要求14至16中任一项所述的系统，其中用具有在大约300nm和大约400nm之间的波长的光照射组织。
18.如权利要求14至17中任一项所述的系统，其中处理器监视具有在大约450nm和大约470nm之间的波长的反射光的水平。
19.如权利要求14至18中任一项所述的系统，其中所述消融能量选自包括射频(RF)能、微波能、电能、电磁能、冷能、激光能、超声能、声能、化学能、热能及其组合的组。
20.如权利要求14至19中任一项所述的系统，其中所述导管被配置为相对于所述导管的纵向轴线在径向方向和轴向方向上照射组织。
21.如权利要求14至20中任一项所述的系统，其中所述导管还包括一个或多个超声换能器和一个或多个电磁位置传感器，并且所述系统还包括与所述一个或多个超声换能器通信的超声系统，用于组织的超声评估。
22.如权利要求14至22中任一项所述的系统，其中所述导管还包括一个或多个电磁位置传感器，并且所述系统还包括与所述一个或多个电磁位置传感器通信的导引系统，用于定位和导引导管。
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