CN103313671B - 用于神经调节治疗的估算及反馈的装置、系统及方法 - Google Patents
用于神经调节治疗的估算及反馈的装置、系统及方法 Download PDFInfo
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Abstract
本发明是关于用于估算应用于患者组织的治疗(诸如用于神经调节与肾动脉相关联的神经的射频消融治疗)成功性的装置、系统及方法。系统监测在治疗过程期间产生的参数或值。向操作者提供的反馈是基于这些监测值且涉及对完全治疗在技术上成功的可能性的评估。在其它实施例中,可估算在不完全治疗(例如由于高温或高阻抗条件)过程期间产生的参数或值以向操作者提供其它指令或反馈。
Description
相关申请案的交叉引用
本申请主张以下未决申请的权益:
(a)于2010年10月25日递交的美国临时申请第61/406,531号;
(b)于2011年8月26日递交的美国临时申请第61/528,108号;
(c)于2011年8月26日递交的美国临时申请第61/528,091号;及
(d)于2011年8月29日递交的美国临时申请第61/528,684号。
所有以上申请均以全文引用的方式并入本文中。另外,以引用的方式并入本文中的申请中所公开的实施例的组分及特征可与本申请中所公开及主张的各种组分及特征组合。
技术领域
本发明是关于神经调节治疗,更具体地是关于用于向提供神经调节治疗的装置的操作者提供估算及反馈的装置、系统及方法。
背景技术
交感神经系统(SNS)为通常与压迫反应相关的主要非自主身体控制系统。SNS的纤维神经支配人类身体几乎每一器官系统中的组织且可影响诸如瞳孔直径、肠动力及尿排出量的特征。该调节作用可适用于维持动态平衡或为身体对环境因素作出快速反应做好准备。然而,SNS的慢性活化为一种常见的不适反应,其可驱使许多疾病的病况发展。尤其已在实验上且在人类中确定肾SNS过度活化可能导致高血压、容量负荷过重状态(诸如心脏衰竭)及进行性肾病的复杂病理生理学。举例而言,放射性示踪剂稀释已表明原发性高血压患者体内肾脏去甲肾上腺素(NE)溢出率增加。
心-肾交感神经亢进在心脏衰竭患者体内可能尤为显著。举例而言,在这些患者体内常可见自心脏及肾脏至血浆的NE溢出加重。增强的SNS活化通常为慢性及晚期肾病的特征。在晚期肾病患者中,高于中值的NE血浆含量已被表明可预示心血管疾病及为死亡的若干原因。对于糖尿病或造影剂肾病变患者而言亦为如此。有证据表明,源自病变肾脏的感觉传入信号为引发及维持高中枢交感神经流出的主要因素。
神经支配肾脏的交感神经终止于血管、近肾小球器及肾小管中。刺激肾交感神经可导致肾素释放增加、钠(Na+)再吸收增加及肾血流量减少。肾功能的这些神经调节组分在特征为交感神经张力升高的疾病病况中受显著的刺激,且可能导致高血压患者的血压增加。由于肾交感神经传出刺激而导致的肾血流量及肾小球滤过率的减少可能成为心-肾症候群中肾功能丧失(亦即作为慢性心脏衰竭的进行性并发症的肾功能障碍)的基础。阻止肾传出交感神经刺激后果的药理学策略包括作用于中枢神经的抑交感神经作用药物、β阻断剂(欲减少肾素释放)、血管收缩素转化酶抑制剂及受体阻断剂(欲阻断由肾素释放所引起的血管收缩素II作用及醛固酮活化)以及利尿剂(欲对抗肾交感神经介导的钠及水滞留)。然而,这些药理学策略具有显著局限性,包括功效有限、顺应性问题、副作用及其它限制。因此,公共卫生强烈需要替代性的治疗策略。
附图说明
参考以下图式可更佳地理解本发明的诸多态样。图式中的组分不必按比例。实际上,重在明确说明本发明的原则。
图1说明根据本发明技术的一个实施例设置的肾神经调节系统。
图2说明用根据本技术的一个实施例的导管设备调节肾神经。
图3为描绘根据本技术的一个实施例可结合图1系统使用的能量传递算法的图。
图4及5为说明根据本发明技术的实施例用于估算治疗的算法的方块图。
图6为说明根据本发明技术的一个实施例用于在出现高温条件时为操作者提供反馈的算法的方块图。
图7为说明根据本发明技术的一个实施例用于在出现高阻抗条件时为操作者提供反馈的算法的方块图。
图8为说明根据本发明技术的一个实施例用于在出现高度血管收缩时为操作者提供反馈的算法的方块图。
图9A为说明根据本发明技术的一个实施例用于在出现异常心跳速率条件时为操作者提供反馈的算法的方块图。
图9B为说明根据本发明技术的一个实施例用于在出现低血流量条件时为操作者提供反馈的算法的方块图。
图10A及10B为说明根据本发明技术的几方面设置的代表性发生器显示屏幕的屏幕撷取画面。
图11为对交感神经系统(SNS)以及大脑如何经由SNS与身体通信的概念性说明。
图12为神经支配左肾以在左肾动脉周围形成肾丛的神经的放大解剖图。
图13A及13B提供分别描绘大脑与肾脏的间的神经传出与传入通信的人体解剖图及概念图。
图14A及14B分别为人类动脉及静脉血管结构的解剖图。
发明内容
本发明的技术主要是关于用于为执行手术(诸如电及/或热诱导的肾神经调节(亦即致使神经支配肾脏的神经纤维为惰性或失活或以其它方式使其功能完全或部分减少))的临床医师或其它从业者提供有用的估算及反馈的装置、系统及方法。举例而言,在一实施例中,反馈涉及完成的治疗,且尤其涉及对治疗在技术上成功的可能性的评估。在某些实施例中,可基于所定义的标准来分析在治疗过程期间监测的一个或多个参数(诸如与温度、阻抗、血管收缩、心跳速率、血流量及/或患者运动相关的参数)。基于该分析,可为操作者提供基于治疗的技术成功可能性,该治疗的可接受性或缺乏可接受性的指示。
在其它实施例中,可为操作者提供关于无法完成的治疗(诸如由于与超过预定及/或计算临界值温度或阻抗相关的监测值或经测定超出预定及/或计算范围的值而中断的程序)的反馈及/或指令。在这些实施例中,可基于定义的标准来分析在不完全治疗过程期间监测的一或多个参数(诸如与温度、阻抗及/或患者运动相关的参数)。基于该分析,可为操作者提供其它指令或反馈,诸如是否应对治疗部位成像以评估治疗装置是否无意中移动,或是否可进行其它治疗尝试等。
具体实施方式
下文参考图1至14B描述本技术若干实施例的具体细节。尽管下文描述关于用以估算神经调节治疗的装置、系统及方法的诸多实施例,但除本文所述以外的其它应用及其它实施例亦在本技术的范围内。另外,本技术的若干其它实施例可具有与本文所述不同的设置、组分或程序。因此,本领域技术人员将相应了解本技术可具有含其它要素的其它实施例,或本技术可具有无下文参考图1至14B所示及所述的若干特征的其它实施例。
术语“远端的”及“近端的”在下文描述中是关于相对于治疗临床医师的位置或方向使用。“远端的”或“远端地”为远离临床医师或在远离临床医师方向上的位置。“近端的”或“近端地”为靠近临床医师或在朝向临床医师方向上的位置。
I.肾神经调节
肾神经调节使神经支配肾脏的神经部分或完全丧失能力或以其它方式进行有效破坏。特定而言,肾神经调节包含抑制、减少及/或阻断沿神经支配肾脏的神经纤维(亦即传出及/或传入神经纤维)的神经通信。丧失能力可为长期(例如永久性或历时数月、数年或数十年的时间)或短期的(例如历时数分钟、数小时、数天或数周的时间)。预期肾神经调节可有效治疗特征为总体交感神经活性增加的若干临床病状,且特别是与中枢交感神经过度刺激相关联的病况,诸如高血压、心脏衰竭、急性心肌梗塞、代谢症候群、胰岛素抗性、糖尿病、左心室肥大、慢性及晚期肾病、心脏衰竭中的不当体液滞留、心-肾症候群及猝死。传入神经信号减少对交感神经张力/传动全身性减少有贡献,且预期肾神经调节适用于治疗与全身性交感神过度活性或亢进相关联的若干病况。肾神经调节可潜在地有益于受交感神经神经支配的各种器官及身体结构。举例而言,中枢交感神经传动减少可降低折磨代谢症候群及II型糖尿病患者的胰岛素抗性。另外,骨质疏松症可由交感神经活化且可得益于伴随肾神经调节的交感神经传动下调。下文第IV部分中提供相关患者解剖学及生理学的更详细描述。
可使用各种技术使神经路径(诸如神经支配肾脏的神经路径)部分或完全丧失能力。藉由能量传递组件将能量(例如电能、热能)有目的地应用于组织可诱发肾动脉局部区域及肾丛RP相邻区域(其紧密地位于肾动脉外膜内或与其相邻)上的一或多种可取的热加热效应。对该热加热效应的有目的的应用可沿整个肾丛RP或其一部分达成神经调节作用。
热加热效应可包括热消融与非消融热改变或损坏(例如经由持续加热及/或电阻加热)。所要的热加热效应可包括将目标神经纤维的温度升高至所要临界值以上以达成非消融热改变,或升高至更高温度以上以达成消融热改变。举例而言,对于非消融热改变而言目标温度可高于体温(例如约37℃)但小于约45℃,或对于消融热改变而言目标温度可为约45℃或更高。
更特定而言,暴露于超过约37℃体温但低于约45℃温度的热能(热)可经由适度加热目标神经纤维或适度加热灌注目标纤维的血管结构而诱发热改变。在血管结构受影响的情况下,目标神经纤维拒绝灌注,导致神经组织坏死。举例而言,此可诱发纤维或结构的非消融热改变。暴露于高于约45℃温度或高于约60℃的热可经由实质上加热纤维或结构而诱发热改变。举例而言,这些较高温度可热消融目标神经纤维或血管结构。在某些患者中,可能需要达到使目标神经纤维或血管结构热消融、但小于约90℃或小于约85℃或小于约80℃及/或小于约75℃的温度。无论用以诱发热神经调节的热暴露类型如何,均希望肾交感神经活性(“RSNA”)减小。下文第IV部分中提供相关患者解剖学及生理学的更详细描述。
II.肾神经调节的系统及方法
图1说明根据本发明技术的一实施例配置的肾神经调节系统10(“系统10”)。系统10包括可操作地耦接至能源或能量发生器26的血管内治疗装置12。在图1所示的实施例中,治疗装置12(例如导管)包括一延伸杆16,该延伸杆16具有一近端部分18、一位于近端部分18的近端区域的手柄组件集合34及一相对于近端部分18向远端延伸的远端部分20。治疗装置12进一步包括一治疗组件集合或治疗区22,其包括一位于杆16的远端部分20处或附近的能量传递元件24(例如电极)。在所说明的实施例中,第二能量传递元件24以虚线说明以表明本文所揭示的系统及方法可与具有一或多个能量传递元件24的治疗装置一起使用。另外,应能了解尽管仅展示了两个能量传递元件24,治疗装置12可以包括更多的能量传递元件24。
能量发生器26(例如RF能量发生器)被配置为产生所选的形式及量值的能量,经由能量传递元件24传递至目标治疗部位。能量发生器26可经由电缆28电耦接至治疗装置12。至少一根电源线(未展示)沿延伸杆16或通过其中的内腔到达能量传递元件24且输送治疗能量至能量传递元件24。控制机构(诸如脚踏板32)可连接(例如气动连接或电连接)至能量发生器26以使得操作者可起始、终止及可选地视情况调整能量发生器的各种操作特征,包括(但不限于)功率传递。能量发生器26可经设置以经由自动控制算法30及/或在临床医师控制下传递治疗能量。另外,可对系统10的处理器执行一或多种估算/反馈算法31。这些估算/反馈算法31在结合治疗操作执行时可向系统10的使用者提供反馈,例如经由与系统10相关联的显示器33。反馈或估算可使系统10的操作者能确定给定治疗的成功性及/或估算可能失败条件。因此,该反馈可用于帮助操作者学习在进行治疗时如何增加成功可能性。下文参考图3至10B描述关于合适的控制算法30及估算/反馈算法31的其它详情。
在某些实施例中,系统10可配置为以经由能量传递元件24提供单极电场传递。在这些实施例中,中性或分散电极38可电连接至能量发生器26且附接至患者外部(如图2中所示)。另外,一个或多个感应器(未展示),例如一个或多个温度(例如热电偶、热敏电阻等)、阻抗、压力、光学、流量、化学或其它感应器,可位于接近能量传递元件24处或其内部且连接至一或多根电源线(未展示)。举例而言,总计可包括两根电源线,其中两根线均可自感应器输送信号,且一根线可用于达成双重目的且亦可将能量传送至能量传递元件24。或者,两根线均可将能量输送至能量传递元件24。
在包括多个能量传递元件24的实施例中,能量传递元件24可独立地同时、选择性或相继传递功率(亦即可以单极方式使用),及/或可在任何所要组件组合的间传递功率(亦即可以双极方式使用)。此外,必要时,视情况可允许临床医师可选地可选择使用何种能量传递元件24进行功率传递以在肾动脉内形成高度定制的损害。
在上面实施系统10的计算装置可包括中央处理器单元、内存、输入装置(例如键盘及指向装置)、输出装置(例如显示装置)及储存装置(例如磁盘驱动器)。输出装置可配置为以与治疗装置12通信(例如经由电缆28),从而控制到达能量传递元件24的功率及/或从能量传递元件24或任何相关联的感应器获得信号。显示装置可配置为提供关于功率水平或感应器数据的标示(诸如音讯、视觉或其它标示),或可配置为将信息传达至另一装置。
内存及储存装置为可由实施目标权限实施系统的计算机可执行指令编码的计算机可读介质,其意谓含有这些指令的计算机可读介质。另外,指令、数据结构及信息结构可经储存或经由数据输送介质(例如通信链路上的信号)输送且可经加密。可使用各种通信链路,诸如因特网、局域网络、广域网络、点对点拨号连接、行动电话网络等等。
系统10的实施例可在各种操作环境中实施及使用,包括个人计算机、服务器计算机、手持型或膝上型装置、多处理器系统、基于微处理器的系统、可程序化消费型电子产品、数字摄影机、网络PC、小型计算机、大型计算机、包括任何以上系统或装置的计算环境等。
系统10可被描述于由一或多个计算机或其它装置执行的计算机可执行指令(诸如程序模块)的一般背景下。程序模块一般包括执行特定任务或实施特定抽象数据类型的例程、程序、对象、组件、数据结构等。程序模块的功能在各种实施例中视需要通常可组合或分配。
图2(且参考图12)说明用系统10的一个实施例调节肾神经。治疗装置12经由血管内路径进入肾丛RP,诸如自股(如图示)、臂、桡或腋动脉中的经皮进入部位至各自肾动脉RA内的目标治疗部位。如图所示,杆16的近端部分18的一部分暴露于患者外部。藉由自血管内路径外部操纵杆16的近端部分18(例如经由手柄组件集合34),临床医师可使杆16经由有时弯曲的血管内路径前进且远端操纵或致动杆的远端部分20。影像引导,例如计算机断层摄影(CT)、荧光透视、血管内超音波(IVUS)、光学相干断层摄影(OCT)或另一适合的引导模态或其组合可用以帮助临床医师进行操纵。另外,在某些实施例中,影像引导元件(例如IVUS、OCT)可并入治疗装置12本身中。一旦在各自肾动脉内,能量传递元件24与组织的间接近、对准及接触,则藉由能量传递元件24将来自能量发生器26的能量有目的地应用于组织,其在肾动脉的局部区域及肾丛RP的相邻区域(其紧密地位于肾动脉外膜内、与其相邻或紧密接近)上诱发一或多种所要的神经调节效应。有目的地应用能量可沿整个肾丛RP或其一部分达成神经调节作用。
神经调节效应一般至少部分地是功率、时间、能量传递元件24与血管壁的间的接触及流经血管的血流量的函数。神经调节效应可包括去神经支配、热消融及非消融热改变或损坏(例如经由持续加热及/或电阻加热)。可取的热加热效应可包括将目标神经纤维的温度升高至所要临界值以上以达成非消融热改变,或升高至更高温度以上以达成消融热改变。举例而言,对于非消融热改变而言目标温度可高于体温(例如约37℃)但小于约45℃,或对于消融热改变而言目标温度可为约45℃或更高。所要非热神经调节效应可包括改变神经中输送的电信号。
III.肾神经调节治疗的估算
A.综述
在一个实施例中,使用系统10施加治疗包括经由一个或多个能量传递组件(例如电极)向肾动脉内壁传递能量,历时预定时间量(例如120秒)。可对左及右肾动脉施加多次治疗(例如4至6次)以达成所要的覆盖范围。举例而言,治疗的技术目标可为将至少约3mm深度的组织加热至将损害神经的温度(例如约65℃)。该手术的临床目标为神经调节(例如损害)足够数量的肾神经(交感神经肾丛的传出或传入神经)以使交感神经张力减少。若达成治疗的技术目标(例如将约3mm深度的组织加热至约65℃),则形成肾神经组织损害的机率为高。技术上成功治疗的次数愈多,调节足够比例肾神经的机率愈大,因此临床成功的机率愈大。
在整个治疗期间,可存在多种状态显示治疗不成功的可能性。在某些实施例中,基于这些状态的指示,可停止或修改系统10的操作。举例而言,某些指示可导致能量传递中断且(在例如显示器33上)可显示适当信息。可产生显示信息及/或导致治疗方案中断或修改的因素包括(但不限于)指示超出可接受或预期临界值及/或可预定或计算范围的阻抗、血流量及/或温度测量值或变化。信息可指示诸如患者病状类型(例如异常患者病况)、超出可接受或预期临界值的参数类型及/或值、对临床医师的建议动作的指示或对能量传递已停止的指示信息。然而,若未观察到非预期或异常测量值,可继续根据程序化概况(profile)在目标部位处传递能量历时指定持续时间,达成完全治疗。在完全治疗之后,停止能量传递且可显示指示治疗完成的信息。
然而,可在不引起异常患者病状指示的情况下完成治疗,然而,仍可能发生改变(例如降低)技术上成功的治疗的机率的事件或事件组合。举例而言,传递能量的电极可能移动或无意中置放使得电极与肾动脉壁之间的接触不充分,藉此导致损害深度或温度不足。因此,即使在未有异常患者病状指示的情形下完成治疗,仍可能难以估算治疗的技术成功性。同样,在异常患者病况的指示可由系统10报导所达的程度上,可能难以了解异常患者病况的原因(例如在预期范围以外的温度及/或阻抗值)。
如上文所述,可提供在系统10的基于处理器的元件(例如与发生器26一起提供的一个或多个元件)上执行的一或多种估算/反馈算法31。在这些实施例中,该一种或多种估算/反馈算法31可能为使用者提供有意义的反馈,此反馈可用于估算给定治疗及/或可用于了解某些类型的异常患者病状的重要性及如何减少这些病况的发生率。举例而言,若特定参数(例如阻抗或温度值)引起或显示治疗未如预期进行且(在某些情况下)可导致技术上不成功的治疗,则系统10可提供反馈(例如经由显示器33)以警示临床医师。对临床医师的警示范围可为对不成功治疗的简单通知至在后续治疗中修改特定治疗参数(例如治疗期间的阻抗值、能量传递元件24在患者体内的置放等)的建议。系统10可因此自完全治疗循环获得知识且基于该知识修改后续治疗参数以改良功效。该一或多种估算/反馈算法31可考虑的测量值的非详尽实例包括与以下有关的测量值:指定时间内的温度变化、最大温度、最大平均温度、最小温度、在预定或计算时间相对于预定或计算温度的温度、指定时间内的平均温度、最大血流量、最小血流量、在预定或计算时间相对于预定或计算血流量的血流量、随时间的平均血流量、最大阻抗、最小阻抗、在预定或计算时间相对于预定或计算阻抗的阻抗、指定时间内的阻抗变化或指定时间内相对于温度变化的阻抗变化。可在一或多个预定时间、时间范围、计算时间及/或测量事件发生时或相对于其发生时的时间进行测量。将了解,以上清单仅提供几个不同测量值的实例,且可使用其它合适的测量值。
B.所应用的能量的控制
使用本文公开的治疗向目标组织传递治疗,可有益于将能量以受控方式传递至目标神经结构。受控能量传递将使热治疗区能够延伸至肾筋膜内,同时减少对血管壁的不利能量传递或热效应。受控能量传递亦可达成更加一致、可预测且有效的总体治疗。因此,发生器26可取地包括处理器,该处理器包括具有用于执行算法30(参见图1)指令的内存元件以控制功率和能量传递至能量传递装置。算法30(其代表性实施例描绘于图3中)可作为由耦接至发生器26的处理器执行的常见计算机程序来实施。使用逐步指令的临床医师亦可手动实施算法30。
根据算法监测的操作参数可包括例如温度、时间、阻抗、功率、血流量、流动速度、体积流动速率、血压、心跳速率等。温度的离散值可用于触发功率或能量传递的变化。举例而言,高温度值(例如85℃)可指示组织脱水,在此情形下算法可减少或停止功率及能量传递以防止对目标或非目标组织的不良热效应。或者或另外,可使用时间来防止对非目标组织的不良热改变。对于每一治疗而言,检查设定时间(例如2分钟)以防止不确定的功率传递。
可使用阻抗来测量组织变化。阻抗显示治疗部位的电特性。在热诱发实施例中,当对治疗部位施加电场时,随着组织细胞对电流的电阻变小,阻抗将减小。若施加过多能量,则电极附近可能发生组织脱水或凝固,随着细胞损失保水性及/或电极表面积减少(例如经由凝固物积聚),将增加阻抗。因此,组织阻抗增加可显示或预示对目标或非目标组织的不良热改变。在其它实施例中,可使用阻抗值来评估能量传递元件24与组织的接触。对于多电极设置(例如当能量传递元件24包括两个或更多个电极时)而言,个别电极阻抗值之间的相对小的差异可显示与组织的良好接触。对于单电极设置而言,稳定值可显示接触良好。因此,来自该一或多个电极的阻抗信息可提供给下游监测者,继而可为临床医师提供关于与组织接触的能量传递元件24的质量的指示。
或者或另外,功率为控制疗法传递中的有效监测参数。功率为电压与电流的函数。算法30可修改电压及/或电流以达成所要功率。
亦可使用前述参数的导数(例如变化速率)来触发功率或能量传递的变化。举例而言,可监测温度的变化速率以使得在侦测到温度突然升高的情况下减少功率输出。同样,可监测阻抗的变化速率以使得在侦测到阻抗突然升高的情况下减少功率输出。
如图3中可见,当临床医师开始治疗(例如经由图1中说明的脚踏板32)时,控制算法30包括对发生器26的指令以在第一时间段t1(例如15秒)内将其功率输出逐渐调整至第一功率水平P1(例如5瓦特(watt))。第一时间段期间的功率增加通常为线性的。因此,发生器26以P1/t1的主要恒定的速率增加其功率输出。或者,功率增加可为非线性的(例如呈指数或呈抛物线),具有可变增加速率。一旦达到P1及t1,则算法可保持在P1,直至新时间t2,历时预定时间段t2-t1(例如3秒)。在t2,功率在预定时间段t3-t2(例如1秒)内以预定增量(例如1瓦特)增加至P2。预定时间段内约1瓦特的预定增量的此功率上升可持续,直至达到最大功率PMAX或满足某些其它条件。在一实施例中,PMAX为8瓦特。在另一实施例中,PMAX为10瓦特。可选地,功率可维持在最大功率PMAX,历时所要时间段或长达所要总治疗时间(例如长达约120秒)。
在图3中,算法30例示性地包括功率控制算法。然而,应了解算法30或者可包括温度控制算法。举例而言,功率可逐渐增加,直至获得所要温度达所要持续时间。在另一实施例中,可提供功率控制与温度控制算法的组合。
如上所述,算法30包括监测某些操作参数(例如温度、时间、阻抗、功率、流动速度、体积流动速率、血压、心跳速率等)。这些操作参数可被连续或周期性地监测。算法30针对预定参数概况检查所监测参数以确定这些参数各自或组合在一起是否在预定参数概况所设定的范围内。若所监测参数在预定参数概况所设定的范围内,则可以已要求的功率输出继续治疗。若所监测参数不在预定参数概况所设定的范围内,则算法30相应调整所要求的功率输出。举例而言,若达到目标温度(例如65℃),则功率传递保持恒定,直至总治疗时间(例如120秒)期满。若达到或超过第一温度临界值(例如70℃),则以预定增量(例如0.5瓦特、1.0瓦特等)减少功率,直至达到目标温度。若达到或超过第二功率临界值(例如85℃),藉此指示不良病状,则可能终止功率传递。系统可装配各种可听及可视警报以警示某些病况的操作者。
以下为算法30可以调整及/或终止/中断所要求的功率输出的情况的非详尽清单:
(1)所测量温度超过最大温度临界值(例如约70℃至约85℃)。
(2)源自所测量温度的平均温度超过平均温度临界值(例如约65℃)。
(3)所测量温度的变化速率超过变化速率临界值。
(4)当发生器26具有非零输出时,一定时间段内温度升高低于最小温度变化临界值。能量传递元件24与动脉壁之间的不良接触可导致此类状况。
(5)所测量阻抗超过或超出阻抗临界值(例如<20奥姆(Ohm)或>500奥姆)。
(6)所测量阻抗超过相对临界值(例如阻抗自起始或基线值减小,随后升高至该基线值以上)。
(7)所测量功率超过功率临界值(例如>8瓦特或>10瓦特)。
(8)所测量功率传递持续时间超过时间临界值(例如>120秒)。
例如与电生理学治疗中用以达成心脏组织消融的功率水平(例如大于约15瓦特、大于约30瓦特等的功率水平)相比,在根据本发明技术的肾神经调节治疗期间传递的最大功率量值可能相对较低(例如小于约15瓦特、小于约10瓦特、小于约8瓦特等)。由于可使用相对低的功率水平来达成该肾神经调节作用,因此在功率传递期间将能量传递组件及/或非目标组织维持在所要温度或所要温度以下(例如在约50℃或50℃以下,例如或在约45℃或45℃以下)所需的血管内注射液的流动速率及/或总体积亦可相对低于例如在电生理学治疗中使用的较高功率水平(例如高于约15瓦特的功率水平)时所要求的值。在使用主动冷却的实施例中,血管内输注液的流动速率及/或总体积的相对减少有利地促使在禁忌使用较高功率水平,因此相应较高输液速率/体积的较高风险患者群组(例如患有心脏病、心脏衰竭、肾功能不全及/或糖尿病的患者)中使用血管内输液。
C.治疗的技术估算
图4为根据本发明技术的一个实施例设置的治疗算法80的方块图。算法80经设置以估算治疗中的事件、确定治疗技术成功的机率及显示信息,由此为系统10(或另一适合治疗系统)的操作者提供反馈。若确定治疗具有比最佳技术成功的预定机率低的技术成功机率,则可显示指示治疗未如预期进行的信息。替代实施例可将治疗分类为若干范围的成功机率,诸如1至5级的成功机率。类似地,在某些实施例中,算法80可估算治疗是否属于高成功机率类、极低成功机率类或介于其间的某一类。
表征治疗且可由算法80用于估算治疗的变量包括(但不限于):时间(亦即治疗持续时间)、功率、温度变化、最大温度、平均温度、血流量、温度或阻抗的标准偏差、阻抗变化,或以上这些或其它变量的组合。举例而言,某些或所有这些变量可提供给算法80作为治疗数据82。在算法80的这一概括性描述中,治疗数据80可基于标准84的不同分类或程度的级别或级数来评估。根据标准84的一对治疗数据82进行有利评估可导致显示(区块86)指示治疗可接受或成功的信息。根据标准84发现治疗资料82不可接受可导致治疗数据进入下一估算标准84。
在所述实施例中,根据所有标准84发现治疗数据均不可接受可导致执行其它估算,诸如所述分析及计分步骤88。可估算分析及计分步骤的输出(例如分值90)(区块92)。基于该估算92,治疗可认为可接受,且显示相应屏幕(区块86);或不可接受,且显示指示治疗未如预期进行的屏幕94。在其它实施例中,算法80可包括对治疗未如预期进行的指示做出反应的自动行为(例如供应给能源的功率水平自动减少)。
图4描绘治疗估算算法的概括性及简化实施例,而图5描绘治疗估算算法100的一个实施例的更详细实例。治疗估算算法100可在可耗时120秒(如所描绘的)或某个其它适合的持续时间的完全治疗(区块102)之后且使用在治疗过程期间产生的数据及/或测量值进行计算。
在所述实施例中,可能认为出现小于理想治疗的最大机率在电极与血管壁未紧密接触时发生。因此,流程图中的决策区块104、106、108及110与不同标准相关,且基于在完全治疗过程中观测或测量的资料102,筛检出似乎具有一或多个在预定范围以外的标准(亦即不具有高成功机率)的那些治疗。在所述实施例中,在决策区块104、106、108及110处未筛检出的那些治疗进入线性判别分析(LDA)112以进一步估算治疗。在其它实施例中,可进行其它适合的分析来替代所述LDA。分配给每一步骤的值(亦即根据各自标准的估算)及LDA中所用的系数114可由自若干治疗收集的资料及/或自动物研究获取的经验得出。
在所述实施例中,第一决策区块104藉由检查在第一个15秒内的平均温度变化是否大于14℃来估算对能量传递的初始温度反应。在一个实施例中,平均温度指在短时间(例如3秒)内的平均值,其基本上滤除由脉动血流引起的高频率大波动。如所了解的,治疗电极的温度升高为自组织至电极的传热结果。若电极与血管壁未充分接触,则能量传递至在其周围流动的血液且电极温度不会增加如此多。谨记此点,若第一个15秒内的平均温度变化大于例如14℃,则该初始温度反应可指示充分电极接触、接触力及/或血流速率(至少在治疗开始时),且若在剩余治疗中未遇到治疗未如预期进行的指示,则治疗不如最佳或技术上不成功的机率不高。因此,决策区块104处的肯定回答导致显示「治疗完成」信息120。然而,若第一个15秒内的平均温度变化小于或等于例如14℃,则该初始温度反应可显示电极与血管壁未充分接触。因此,决策区块104处的否定回答导致进入标准106以进一步估算。
在决策区块106处,藉由检查最大平均温度是否大于例如56℃来估算最热温度。无论持续时间如何,温度升高至临界值水平(例如56℃)以上均足以允许技术成功。因此,高于临界值的温度可足以指示成功损害形成,而不管决策区块104处的初始温度升高未指示充分接触。举例而言,电极初始时可未充分接触,但随后可至少接触足以使血管壁发热,使得电极内的温度感应器读数高于56℃的时间。决策区块106处的肯定结果导致显示「治疗完成」信息120。然而,决策区块106处的否定结果指示最大平均温度未充分升高。因此,算法100进入决策区块108以进一步估算。
在决策区块108处,估算功率维持其最大量的时间段内的平均温度(亦即自平均计算值减去上升期)。在一实施例中,该估算由确定45秒至120秒的时间段内,平均实时温度是否大于53℃组成。以此方式,该标准进行检查以确定温度是否在某持续时间内高于临界值。若决策区块108作出肯定判别,则不管初始温度反应及最大平均温度不足以指示技术成功性(亦即决策区块104及106失败),最后75秒内的平均温度均指示充分接触足够时间。举例而言,可能产生足够损害,但由于血流自电极吸取高热量,因此在电极中测量的最大平均温度不大于56℃。因此,决策区块108处的肯定结果导致显示「治疗完成」信息120。然而,决策区块108处的否定结果指示持续功率阶段的平均实时温度不足且算法100进入决策区块110以进一步估算治疗。
在决策区块110处,藉由检查预定时间段(例如45秒至114秒)内的阻抗变化百分比是否大于初始阻抗的预定值(例如14%)来估算阻抗变化。初始阻抗测定为在治疗开始后不久(例如6秒时)的阻抗以消除在此时间段之前阻抗测量值的可能错读(例如由于造影剂注射)。如所了解,组织对射频(RF)电流的阻抗随组织温度增加而减小,直至组织充分加热至导致其脱水,此时其阻抗开始上升。因此,组织阻抗减小可指示组织温度上升。持续功率阶段期间的实时阻抗变化百分比可如下计算:
若决策区块110产生肯定判别,则不管先前三个决策区块未展示温度充分上升(亦即决策区块104、106及108失败),阻抗变化均可指示组织已经被充分加热,但电极中的温度感应器未充分上升。举例而言,即使组织已经被加热,但极高的血流量仍可导致电极温度维持相对较低。因此,决策区块110处的肯定结果导致显示「治疗完成」信息120。然而,决策区块110处的否定结果导致算法100进入执行LDA112。
在LDA112处,连同每一事件的重要性等级来估算这些事件的组合。举例而言,在所述实施例中,在决策区块104、106、108、110处估算的标准均包括于LDA112中。另外,在该实施例中,可包括三个其它标准:(1)平均温度的标准偏差(其可提供关于由呼吸引起的滑动程度的指示);(2)实时温度的标准偏差(其可提供关于可变血流量及/或接触力及/或间断性接触的指示);及(3)治疗结束时调整的平均阻抗变化(其可进一步表征阻抗变化且提供关于组织温度变化的指示)。若该分析确定这些变量的组合对减少技术成功性具有显著影响(例如在决策区块122处LDA分值<0),则显示「非预期治疗」信息124。否则,显示「治疗完成」信息120。
应了解,上述各种参数仅为与算法100的一实施例相关的代表性实例,且一个或多个这些参数在其它实施例中可以变化。此外,上文关于特定治疗部分所述特定值在其它实施例中可基于例如不同装置设置、电极设置、治疗方案等而修改/变化。
如上所述,算法100经设置以估算治疗且显示指示治疗完成或者治疗未如预期进行的信息。基于描述治疗估算的信息,临床医师(或使用自动化技术的系统)随后可决定是否需要进一步治疗及/或一个或多个参数在后续治疗中是否应修改。举例而言,在上述实例中,算法100可估算大量一般与电极与血管壁的间的不良接触有关的情形以有助于确定治疗是否未达到最佳。举例而言,当电极随患者呼吸及动脉移动而前后滑动时,当电极在患者移动时移位时,当无意中移动导管时,当导管未偏斜至使电极与血管壁的间充分接触或有充足接触力所需的程度时,及/或当电极置放于不稳定位置时,可能发生不良接触。此外,如上文所述,若特定参数或参数组可引起或导致未达最佳的治疗时,系统10(图1)可提供反馈以警示临床医师在后续治疗期间修改一或多个治疗参数。预期治疗的该估算及反馈有助于临床医师学习改良其置放技术以获得更佳接触且降低技术上不成功治疗的频率。
D与高温条件相关的反馈
尽管前文描述治疗技术成功性的概括性估算,但可用于系统10(图1)操作者的另一种反馈形式为与患者或治疗病状的特定类型相关的反馈。举例而言,系统10可产生与高温条件相关的信息。特定而言,在传递能量的治疗期间,组织温度可增加至特定水平以上。安置于电极中或其附近的温度感应器(例如热电偶、热敏电阻等)提供关于电极中温度的指示,且某种程度上提供关于组织温度的指示。在能量传递至组织时电极不直接加热。实际上,组织经加热且热量传导至电极及电极中的温度感应器。在一实施例中,若实时温度上升至预定最大温度(例如85℃)以上,则系统10可中断能量传递。在此情形下,系统可产生指示高温条件的信息。然而,视情况而定,临床医师的不同的动作可能为适当的。
若组织过热,则可超过已确立的温度临界值。高组织温度暗示可能动脉急剧收缩或动脉壁突起。这种情况可能在注意到出现高温且产生信息后即刻或短时间内(例如约50秒至约100秒)发生。在该情形下,可指令临床医师对治疗部位成像以在起始另一治疗的前注意收缩或突起。
例如图6为说明根据本发明技术的一实施例用于在侦测到高温条件时为操作者提供反馈的算法150的方块图。在一实施例中,算法150是响应于高温条件(区块152)而执行且估算(决策区块154)来自治疗的数据以确定该高温条件涉及包括突发不稳定性的情形还是不涉及此情形。突发不稳定性可由例如患者或导管的突然移动引起,由此引起电极更猛烈地推至(亦即接触力增加)血管壁中,亦可伴随有移动至另一位置。在决策区块154处未侦测到突发不稳定性的情形下,可显示第一信息(区块156),诸如侦测到高温的指示及对治疗部位成像以确定该部位是否受损的指令。在决策区块154处侦测到突发不稳定性的情形下,可显示另一信息(区块158),除指示出现高温及指令临床医师对治疗部位成像以外,亦可指示电极可能自其原始部位移动。该反馈可提示临床医师比较先前影像且避免在原始部位或电极移至的部位再次治疗。
E.与高阻抗相关的反馈
如同高温一样,在某些情况下系统10(图1)可产生与出现高阻抗有关的信息。如所了解的,对由治疗电极穿过身体至分散返回电极的RF电流的阻抗可提供关于与治疗电极接触的组织特征的指示。举例而言,安置于肾动脉血流中的电极可测量与接触血管壁的电极相比较低的阻抗。此外,当组织温度升高时,其阻抗减小。然而,若组织过热,则其可脱水且其阻抗可增加。在逐渐加热组织的治疗期间,预期阻抗将减小。阻抗显著升高可为诸如组织脱水或电极移动的不利情形的结果。在某些实施例中,若实时阻抗升高高于自起始阻抗的预定最大阻抗变化,则系统10可经设置以中断能量传递。
例如图7为说明根据本发明技术的一个实施例用于在出现高阻抗条件时为操作者提供反馈的算法170的方块图。在所述实施例中,算法170估算来自治疗的数据且确定侦测高阻抗事件(区块172)是否可能涉及以下情形:(a)组织温度高且可能脱水;(b)电极移动;或(c)电极与血管壁接触不良或未接触。算法170估算数据以确定该三种情形中(若出现了)哪一种且相应显示三种信息174、176或178中的一种。
根据算法170的一个实施例,在侦测到高阻抗(区块172)时,估算治疗期间的最大平均温度(决策区块180)。若该温度在某临界值以上(例如在60℃或60℃以上),则高阻抗可归因于由脱水导致的高组织温度。在此情形下,可显示信息174,指令临床医师检查收缩或突起(亦即对治疗部位成像)且避免在同一位置再次治疗。相反,若温度低于临界值(例如低于60℃),则算法170进入决策区块182。
在所述实施例中,在决策区块182处,算法170估算高阻抗事件是否在治疗早期(例如在能量传递的最初20秒内)当功率相对较低时发生。若是,则组织温度不可能高,且更可能为电极初始时接触不良或无接触且随后建立更佳接触,导致阻抗跳变。在此情形下,可显示信息176,指令临床医师尝试建立更佳接触且在同一部位重复治疗。然而,若该事件在治疗稍后期(例如在20秒以上过去后)发生,则算法170进入决策区块184。
在决策区块184处,算法170估算在治疗期间何时发生高阻抗事件。举例而言,若该事件在预定时间段(例如45秒)的后发生,则当功率达到高水平时,算法进入决策区块186。然而,若该事件在功率上升且未处于其最高值时(例如在20秒与45秒之间)发生,则算法进入决策区块188。
在决策区块186处,算法170计算在高阻抗事件时与特定时间(例如45秒)的阻抗相比阻抗变化百分比(%ΔZ)。此为功率维持于高水平下的时间段。在一实施例中,阻抗变化百分比如下计算:
若ΔZ%大于或等于预定量(例如7%),则组织可能由于高温开始脱水。在此情形下,可显示信息174,指令临床医师检查收缩或突起(亦即对治疗部位成像)且避免在同一位置再次治疗。否则,组织脱水不太可能且更可能为电极移动导致高阻抗事件。在此情形下,可显示信息178,告知临床医师电极可能已移动。在电极已移动或可能已移动的情形下,组织温度不可能达到高水平。因此,预期若无其它位置或仅有有限的其它位置进行另一治疗,则可在同一位置进行治疗。
在决策区块188处,算法170可确定是否出现突发不稳定性。若存在该不稳定性,则电极可能移动。在此情形下,可显示信息178,提示临床医师电极可能已移动。如上文论述,临床医师可小心谨慎且避免治疗原始位置或电极移至的位置,或若无其它部位或仅有有限数目的部位可用于进一步治疗,则临床医师可选择治疗同一位置。否则,若未出现突发不稳定性,则更可能为电极接触不良。在此情形下,可显示信息176,指令临床医师尝试建立更佳接触且治疗同一部位是安全的。
使用替代的测量值及计算,可达成侦测高阻抗条件的相同目标。举例而言,在算法170的另一实施例中,获取样品时间间隔(例如20秒)的温度及阻抗数据。在较短时间间隔(例如每1.5秒)下,计算阻抗及温度数据的标准偏差。对于一个间隔的第一标准温度计算为温度的标准偏差除以初始时间间隔下的温度标准偏差。若阻抗测量值的标准偏差大于或等于预定值(例如10奥姆)且第一标准温度大于预定临界值(例如3),则算法170可显示信息176,指示电极接触不良。然而,若阻抗测量值的标准偏差在可接受范围以外,但第一标准温度在可接受范围以内,则将显示信息178以警示临床医师存在电极不稳定性。
根据算法170的另一实施例,两个或两个以上的电极24(例如安置于图1中导管12的治疗区22上)的阻抗可提供各自独立的阻抗读数。在将治疗组件集合22传递至治疗部位(例如肾动脉内)期间,电极24的阻抗读数通常由于血管结构解剖学而不同,这是因为导管12将遵照受阻最小的路径,常在血管结构弯曲处弯曲以仅接触肾动脉的一个壁。在某些实施例中,治疗组件集合22一经就位用于治疗,治疗组件集合22即可圆周形扩张以接触肾动脉壁区段的整个圆周表面。此扩张可使多个电极24与肾动脉壁接触。随着治疗组件集合22扩张成治疗设置且电极24与肾动脉壁的接触增加,个别电极24的阻抗值可增加及/或接近同一值。在良好稳定的接触下,阻抗值的波动亦如上所述地减小。能量发生器26可不断或连续地监测个别阻抗值。随后可比较这些值以确定何时建立有效接触,作为成功治疗的指示。在其它实施例中,可将阻抗的移动平均值与阻抗值的预定变化范围相比较,且设定限制以引导稳定性测量。
F.与血管收缩相关的反馈
在其它实施例中,系统10可产生与发生血管收缩相关的信息。特定而言,当传递治疗时,血管可收缩至非最佳的直径。收缩的血管可导致血流量减少、治疗部位温度增加及血压增加。可藉由对实时温度数据的幅度(“包络线”)取样来测量血管收缩。可将现有包络线与先前获取的包络线样品(例如200ms的前)相比较。若现有包络线与先前时间点包络线的差值小于预定值(例如小于-0.5℃,或换言的,目前包络线值与先前时间点的包络线值相比减小不足0.5度),则在未来时间点获取测量值(例如在5秒内)。若未来时间点与现有时间点的平均温度差值大于给定温度临界值(例如大于1℃),则算法800可确定存在不利的高程度收缩,且可中断/改变能量传递。在该情形下,系统10可产生指示高收缩条件的信息。然而,视情况而定,临床医师的不同动作可以为适当的。
例如图8为说明根据本发明技术的一实施例用于在侦测到高度血管收缩时为操作者提供反馈的算法800的方块图。在一实施例中,算法800响应于高收缩程度(例如血管收缩在某一直径或某一直径以下)(区块802)而执行且估算(决策区块804)来自治疗的数据以确定高收缩程度涉及包括突发不稳定性的情形还是不涉及此情形。突发不稳定性的显示可显示电极24移动。
在决策区块804处未侦测到突发不稳定性的情形下,可显示第一信息(区块806),诸如已侦测到高收缩程度的显示及让临床医师减小治疗功率的指令。在其它实施例中,能量水平可响应于所侦测的收缩程度而自动改变。在决策区块804处侦测到突发不稳定性的情形下,可显示另一信息(区块808),除显示出现高收缩程度及对临床医师的指令以外,亦可显示电极24可能自其原始部位移动。该反馈可提示临床医师改变或中断治疗。
G.与心脏因素相关的反馈
1.与异常心跳速率相关的反馈
如同上文提及的其它生理学条件,在某些情形下,系统10可能产生与出现异常心跳速率相关的信息。具体而言,当传递治疗时,心跳速率可超出或低于可取的条件(例如暂时程序性或慢性心动徐缓)。可藉由测量实时温度及阻抗来确定瞬时心跳速率。更具体而言,可使用二级Butterworth滤波器滤除例如0.5Hz与2.5Hz之间的实时温度读数。确定滤除信号的局部最大值。局部最大值为所侦测的实时温度信号峰值。当信号峰值对应于心脏循环中的周期变化时,瞬时心率为峰值间的间隔。
在一个实施例中,若心跳速率在可取的范围以外,则系统10可中断/改变能量传递。在该情形下,系统可产生指示不利心跳速率条件的信息。然而,视情况而定,临床医师的不同行动可以为适当的。
例如图9A为说明根据本发明技术的一个实施例用于在侦测到异常心跳速率条件时为操作者提供反馈/指令的算法900的方块图。举例而言,在一个实施例中,算法900可响应于异常心跳速率条件(例如高于或低于预定临界值)而执行(区块902)。在决策区块904处,算法900估算来自治疗的数据以确定所侦测的异常心跳速率条件是否涉及包括突发不稳定性的情形。突发不稳定性的显示可显示电极移动。
在决策区块904处未侦测到突发不稳定性的情形下,可对临床医师显示第一信息(区块906),诸如已侦测到异常心跳速率的显示及让临床医师减小治疗功率的指令。在其它实施例中,能量水平可响应于所侦测的不利心跳速率而自动改变。在决策区块904处侦测到突发不稳定性的情形下,可显示另一信息(区块908),除指示发生异常心跳速率及对临床医师的指令以外,亦可显示电极可能自其原始部位移动。该反馈可提示临床医师改变或中断治疗。
2.与低血流量相关的反馈
系统10亦可经设置以产生与低血流量条件相关的信息。举例而言,若治疗期间血流量降至某一水平以下(或若血管不利地狭窄),则对流热自电极24移除且组织表面减小。过高的组织温度可导致上述消极后果,诸如血栓形成、炭化、不可靠的损害尺寸等。自发生器26减少功率以防止组织达到不可接受的温度可导致损害深度不足,且神经可能未加热至足够的消融温度。可使用算法来测量血流量或血流热损失。在一个实施例中,可用置放于肾动脉中另一导管上或治疗导管12上的流量计或都卜勒感应器(Doppler sensor)来测量血流量。在另一实施例中,可藉由传递能量(例如RF能量)使血液、组织或基质温度上升来测量热损失或热衰减。能量可被切断且算法可包括监测作为热衰减的量度的温度。快速热衰减可表示血流量充足,而缓速热衰减可表示低血流量。举例而言,在一个实施例中,若实时温度测量值相对于起始温度的斜率超过预设临界值(例如2.75)且其平均温度大于预设温度(例如65℃),则算法910可显示低血流量。在其它实施例中,可藉由测量传递RF或电阻热的电极的温度振荡来表征热衰减及/或血流量。在给定温度或功率传递幅度/量值下,狭窄的振荡范围可指示相对低的热衰减/血流量。
例如图9B为说明根据本发明技术的一个实施例在出现低血流量条件时为操作者提供反馈/指令的算法910的方块图。在一个实施例中,算法910响应于所侦测的低血流量条件(例如流量低于预定临界值)而执行(区块912)。在区块914处,算法910估算来自治疗的资料以确定低血流量条件是否涉及包括突发不稳定性的情形。在决策区块914处未侦测到突发不稳定性的情形下,可显示第一信息(区块916),例如已侦测到低血流量的显示及让临床医师减小治疗功率的指令。在侦测到突发不稳定性的情形下,可显示另一信息(区块918),除显示发生低血流量及对临床医师的指令以外,亦可显示电极可能已自其原始部位移动。如上所述,该反馈可促使临床医师改变或中断治疗。
在其它实施例中,若血流量或热衰减值低于典型或预定临界值,则能量传递算法910可包括自动改变治疗或导管的一个或多个条件或特征以改良血流量。举例而言,在一个实施例中,算法910可藉由以脉冲形式提供能量至能量传递元件24而非提供连续能量来回应于低血流量。这样可使得较低血流量可更充足地自组织表面移除热量,同时仍产生足够深的损害以消融神经。
在另一实施例中,算法910可包括藉由冷却电极来响应低血流量,如2011年4月26日递交的国际专利申请案第PCT/US2011/033491号及2010年8月30日递交的美国专利申请案第12/874,457号中进一步详述。以上申请案以全文引用的方式并入本文中。
在另一实施例中,算法910可藉由需要向该区域手动增加血流量来响应低血流量。举例而言,非阻塞性气球可在腹主动脉中膨胀,藉此增加肾动脉中的压力及流量。该气球可并入治疗导管或另一导管上。
H.反馈显示
图10A及10B为说明根据本发明技术的态样设置的代表性发生器显示屏幕的屏幕撷取画面。例如图10A为治疗期间追踪增强阻抗的显示屏幕1100。显示器1100包括在选定时间段(例如100秒)内实时追踪阻抗测量值的图形显示1110。例如该图形显示1110可为以周期性间隔更新的动态、滚动显示,为操作者提供阻抗测量值的瞬时及历史追踪。显示1110亦可包括具有目前阻抗的阻抗显示1120以及关于阻抗的标准偏差指示1122。在一实施例中,标准偏差指示1122经设置为当该值大于10时闪烁。此类指示可警示造影剂注射的操作者造影剂注射影响测量或电极可能不稳定。下文描述关于造影剂注射指示的其它信息。
例如图10B为具有用于操作者的额外信息的另一代表性显示屏幕1130。在该实例中,显示屏幕1130经设置以警示造影剂注射的操作者且系统在开始的前正等待造影至清晰(例如停用RF约1至2秒,直至造影清晰)。在另一实施例中,显示屏幕1130可经设置以提供其它警示信息(例如「可能不稳定电极」等)。预期上述显示屏幕1110及1130中提供的额外信息可在RF开启之前改良接触评估,且改良治疗效率及功效。
上文参考图10A及10B描述的额外信息可基于本文所述算法或其它适合算法产生。举例而言,在一个实施例中,算法可不断检查RF开启之前时期的造影剂注射/稳定性。若电极稳定且历时≥1秒无造影,则将基线阻抗Z设定为等于1秒内的平均阻抗Z。在一特定实例中,将实时阻抗与一秒窗口内的平均阻抗值的两个标准偏差相比较。在另一特定实例中,可将实时阻抗与固定值相比较(例如确定标准偏差是否大于10)。在其它实例中,可使用其它配置。
若实时阻抗测量值在此范围内,则不显示信息。然而,若实时阻抗不在平均值的两个标准偏差内,则电极可能为不稳定的(亦即漂移、移动等)且可对使用者显示上文参考图10A及10B描述的一或两种信息(例如“等待造影至清晰”、“可能不稳定电极”)。举例而言,对于造影剂注射侦测而言,除阻抗的标准偏差以外,算法可经设置为将实时温度测量值的标准偏差化为因子以寻求实时温度偏移至起始体温以下。温度偏移截止点的精确值可变化。在一特定实例中,系统可经设置以使得若伴随实时温度下降,阻抗增加(例如标准偏差>10),则系统将标示造影侦测事件,导致对操作者显示“等待造影至清晰”信息。然而在其它实例中,可使用其它算法及/或范围来确定造影剂注射事件及/或电极的稳定性。另外,在其它实施例中,系统可基于所侦测的条件修改/调整各种治疗参数,而不对临床医师显示这些信息。
IV.相关解剖学及生理学
以下论述提供关于相关患者解剖学及生理学的其它详情。此部分欲补充及扩展先前关于相关解剖学及生理学的论述,且提供关于与肾去神经支配相关的公开的技术及治疗益处的额外内容。举例而言,如前文所提及,肾血管结构的若干特性可告知用于经由血管内通道达成肾神经调节的治疗装置及相关方法的设计,且对这些装置强加特定设计要求。特定设计要求可包括评估肾动脉、促使这些装置的能量传递组件与肾动脉的管腔表面或壁之间稳定接触及/或用神经调节装置有效调节肾神经。
A.交感神经系统
交感神经系统(SNS)为除肠神经系统及副交感神经系统以外自主神经系统的分支。其在基础水平下始终具有活性(称作交感神经张力),且在压力时间期间更具活性。如同神经系统的其它部分,交感神经系统经由一系列相互连接的神经元运作。交感神经元常被认为是周边神经系统(PNS)的一部分,尽管有许多在中枢神经系统(CNS)内。脊髓(其为CNS的一部分)的交感神经元经由一系列交感神经节与周边交感神经元通信。在神经节内,脊髓交感神经元经由突触接合周边交感神经元。因此,脊髓交感神经元称作突触前(或节前)神经元,而周边交感神经元称作突触后(或节后)神经元。
在交感神经节内的突触处,节前交感神经元释放乙酰胆碱,其为一种结合且激活节后神经元上的烟碱型乙酰胆碱受体的化学信使。响应于此刺激,节后神经元主要释放去甲肾上腺素(正肾上腺素)。长时期激活可引发从肾上腺髓质释放肾上腺素。
一经释放,去甲肾上腺素及肾上腺素即刻结合周边组织上的肾上腺素激导性受体。与肾上腺素激导性受体的结合会引起神经元和激素反应。生理学表现包括瞳孔放大、心跳速率增加、偶发性呕吐及血压增加。由于结合汗腺的胆碱激导性受体,故亦可见发汗增加。
交感神经系统负责活的生物体中许多体内平衡机制的上调和下调。来自SNS的纤维神经支配几乎每个器官系统中的组织,为广泛的事物(诸如瞳孔直径、肠能动性和尿排出量)提供至少一些调节功能。此反应也称为身体的交感-肾上腺反应,因为末端在肾上腺髓质内的神经节前交感纤维(以及所有其他交感纤维)分泌乙酰胆碱,其激活肾上腺素(肾上腺素)的分泌,而在较低程度上激活去甲肾上腺素(去甲肾上腺素)的分泌。因此,主要作用于心血管系统的此反应直接地通过经交感神经系统传导的冲动进行介导,并且间接地通过肾上腺髓质分泌的儿茶酚胺进行介导。
科学界通常将SNS视为自主调节系统,即,在无有意识的思维干涉下工作的系统。一些进化理论家认为在早期生物体中交感神经系统工作以维持存活,因为交感神经系统负责使身体准备好动作。此准备的一个实例是在觉醒前的时刻,其中在为动作进行准备时交感传出自发增加。
1.交感链
如图11中所示,SNS提供使脑能够与身体交流的神经网络。交感神经起源于脊柱内部,朝向中间外侧细胞柱(或侧角)内的脊髓中部,起始于脊髓的第一胸段,并且被认为延伸至第二或第三腰段。因为它的细胞起始于脊髓的胸区和腰区内,故认为SNS具有胸腰传出。这些神经的轴突经过前小根/前根离开脊髓。它们经过脊(感觉)神经节附近,从该处它们进入脊神经的前支。然而,不同于体细胞神经支配,它们快速通过白支通支(white ramiconnector)分开,该白支通支连接至沿着脊柱延伸的脊柱旁神经节(位于脊柱附近)或椎前(位于主动脉杈附近)神经节。
为了达到靶器官和靶腺体,轴突应在体内延伸长距离,并且,为实现此目的,许多轴突通过突触传递将它们的信号传达至第二细胞。轴突的末端穿过间隙、突触连接至第二细胞的树突。第一细胞(突触前细胞)发送神经递质,穿过突触间隙,在其中它激活第二细胞(突触后细胞)。然后信号被传递至最终终点。
在SNS及外周神经系统的其他组元中,这些突触在称为神经节的部位产生。发送其纤维的细胞称为神经节前细胞,而其纤维离开神经节的细胞称为神经节后细胞。如前所述,SNS的神经节前细胞位于脊髓的第一胸段(T1)与第三腰段(L3)之间。神经节后细胞使它们的细胞体在神经节内并且将它们的轴突发送至靶器官或靶腺体。
神经节不仅包括交感干,还包括颈神经节(颈上神经节、颈中神经节和颈下神经节),其将交感神经纤维送至头和胸器官,以及腹神经节和肠系膜神经节(将交感纤维送至肠)。
2.肾脏的神经支配
如图12所示,肾脏受到与肾动脉紧密相连的肾丛RP的神经支配。肾丛是围绕肾动脉的自主神经丛,并且嵌入在肾动脉的外膜内。肾丛RP沿着肾动脉延伸直至它到达肾实质。促成肾丛的纤维起源于腹腔神经节、肠系膜上神经节、主动脉肾神经节和主动脉丛。肾丛RP,也称为肾神经,主要包括交感组元。不存在(或者至少非常少)肾脏的副交感神经支配。
神经节前神经元细胞体位于脊髓的中间外侧细胞柱中。神经节前轴突经过脊柱旁神经节(它们不突触)而成为内脏小神经,内脏最小神经,第一腰内脏神经、第二腰内脏神经,而后到达腹腔神经节、肠系膜上神经节和主动脉肾神经节。神经节后神经元细胞体离开腹腔神经节、肠系膜上神经节和主动脉肾神经节到达肾丛RP,并且分布至肾脉管系统。
3.肾交感神经活动
信号以双向流通过SNS传播。传出的信号可引发在身体不同部分中的同时变化。例如,交感神经系统可加速心率;扩大支气管通道;降低大肠的能动性(运动);收缩血管;增大食道中的蠕动;引起瞳孔扩大、立毛(鸡皮疙瘩)和出汗(发汗);以及血压升高。传入的信号将来自体内的各种器官和感受器的信号传递至其他器官,特别是脑。
高血压、心力衰竭和慢性肾病是由SNS特别是肾交感神经系统的慢性激活引起的许多疾病状态中的几种。SNS的慢性激活是驱动这些疾病状态的进展的适应不良性反应。肾素-血管紧张素-醛固酮系统(RAAS)的药学管理已是降低SNS的过度活动的长期但有点无效的方法。
如上所述,肾交感神经系统已根据试验和在人类中被确认为高血压、容量超负荷状态(例如心力衰竭)和进行性肾病的复杂病理生理学的主要促成因素。利用放射示踪物稀释法测量去甲肾上腺素从肾脏至血浆的溢流的研究揭示,在原发性高血压患者中,肾去甲肾上腺素(NE)溢出率增大,在年轻高血压对象中,特别如此,与从心脏的NE溢出增大一致,与通常在早期高血压中观察到的血液动力学图一致,并且具有心率、心输出量和肾血管阻力增大的特征。现在已知,原发性高血压经常是神经原性,常伴随明显的交感神经系统过度活动。
心肾交感神经活动的激活在心力衰竭中甚至更明显,正如在此患者组中从心脏和肾脏至血浆的NE溢流过分增大所示。与此看法一致,最近证实,在充血性心力衰竭患者中在全因死亡率和心脏移植上肾交感激活的强阴性预测值,其独立于总交感活性、肾小球滤过率和左心室射血分数。这些结果支持了设计的降低肾交感刺激的治疗方案具有改进心力衰竭患者的存活率的潜力的看法。
慢性和末期肾病均以交感神经活动升高为特征。在末期肾病患者中,血浆去甲肾上腺素水平高于中值已被证实为可预测全因死亡和心血管病所致的死亡。对于患有糖尿病性肾病或造影剂肾病的患者而言也是如此。令人信服的证据表明,起源于患病肾脏的感觉传入信号是此患者组中升高的中枢交感流出的起始和保持的主要促成因素;这促进慢性交感过度活动的公知有害后果,例如高血压、左心室肥厚、室性心律失常、心脏性猝死、胰岛素抵抗、糖尿病和代谢综合征的出现。
(i)肾交感传出活动
交感神经至肾脏终止在血管、肾小球旁器和肾小管。刺激肾交感神经导致肾素释放增大、钠(Na+)重吸收增大以及肾血流量减少。肾功能的神经调节的这些组元在以升高的交感紧张为特征的疾病状态中受到相当大的刺激,并且明显地促成高血压患者中的血压升高。因肾交感传出刺激所致的肾血流量和肾小球滤过率的降低可能是心-肾综合征中肾功能丧失的基础,即肾功能不全,作为慢性心力衰竭的进行性并发症,伴有通常随着患者的临床状态和治疗而波动的临床过程。阻挠肾传出交感刺激的后果的药理学策略包括中枢作用的抗交感神经药、β阻滞药(旨在降低肾素释放)、血管紧张素转化酶抑制剂和受体阻滞药(旨在阻滞继肾素释放之后发生的血管紧张素II激活和醛固酮激活)和利尿剂(旨在抵消肾交感介导的钠和水潴留)。然而,目前的药理学策略具有明显的局限,包括有限的效能、顺应性问题、副作用等。
(ii)肾感觉传入神经活动
肾脏通过肾感觉传入神经与中枢神经系统中的整体结构交流。“肾损伤”的几种形式可引发感觉传入信号的激活。例如,肾缺血、心搏量或肾血流量减小,或者丰富的腺苷酶可触发传入神经交流的活动。如图13A和13B中所示,此传入交流可以是从肾脏至脑,或者可以是从一个肾脏至另一个肾脏(通过中枢神经系统)。这些传入信号是中枢整合的,并且可导致增高的交感流出。此交感驱动导向肾脏,由此激活RAAS并引发增高的肾素分泌、钠潴留、容量滞留和血管收缩。中枢交感过度活动还影响受交感神经神经支配的其他器官和身体结构例如心脏和外周脉管系统,造成所述的交感激活的有害影响,其若干方面还促成血压升高。
因此,生理学表明:(i)具有传出交感神经的组织的调制可减少不适当的肾素释放、盐潴留和肾血流量的减低,以及(ii)具有传入感觉神经的组织的调制可通过其对后下丘脑及对侧肾脏的直接影响来减少对高血压以及与增高的中枢交感紧张相关的其他疾病状态的系统性贡献。除了传入肾去神经的中枢降压效应之外,可以预期到至各种其他交感神经支配的器官例如心脏和脉管系统的中枢交感流出的可取的减少。
B.肾去神经的其他临床益处
如上所述,肾去神经可能在以增高的总活动特别是肾交感活动为特征的几种临床病症例如高血压、代谢综合征、胰岛素抵抗、糖尿病、左心室肥厚、慢性末期肾病、心力衰竭中的不合适的流体潴留、心-肾综合征和猝死的治疗中有价值。由于传入神经信号的减少促成交感紧张/驱动的系统性减少,肾去神经还可用于治疗与系统性交感过度活动相关的其他病症。因此,肾去神经还可有益于受交感神经神经支配的其他器官或身体结构,包括图11中所示的那些。例如,如前所述,中枢交感驱动的减小可减轻折磨患有代谢综合征和II型糖尿病者的胰岛素抵抗。此外,骨质疏松的患者也是交感激活的,并且也可受益于伴随肾去神经的交感驱动的下调。
C.获得到达肾动脉的血管内通路
根据本技术,左肾丛和/或右肾丛RP的神经调制,与左肾动脉和/或右肾动脉紧密相关,可通过血管内通路实现。如图14A所示,受心脏收缩驱动的血液通过主动脉从左心室被输送。主动脉下行经过胸和分支进入左肾动脉和右肾动脉。在肾动脉下,主动脉在左和右髂骨动脉分为两支。左和右髂骨动脉下行,分别经过左腿和右腿并且连接左和右股动脉。
如图14B所示,血液聚集在静脉中并且返回至心脏,经过股静脉进入髂骨静脉,进入下腔静脉。下腔静脉分支成左肾静脉和右肾静脉。在肾静脉上,下腔静脉上行而将血液输送入右心房。从右心房,血液被泵送,经过右心室,进入肺,在其中被充氧。从肺,充氧血被输送入左心房。从左心房,充氧血被左心室输送回主动脉。
如下文中更详细的描述,可在股三角的基部,正好在腹股沟韧带的中点下方,接近并将套管插入股动脉。导管可被插入,经过此接近部位透皮进入股动脉,并且进入髂骨动脉和主动脉,被置于左肾动脉或右肾动脉中。这包括血管内通路,其提供通向各肾动脉和/或其他肾血管的微创通路(minimally invasive access)。
腕、上臂和肩部提供用于将导管插入动脉系统的其他部位。例如,在选定的情况中可利用桡动脉、肱动脉或腋动脉的导管插入术。利用标准的血管造影技术,通过这些插入点插入的导管可穿过在左侧上的锁骨下动脉(或者穿过在右侧上的锁骨下动脉和头臂动脉),经过主动脉弓,沿着降主动脉下行,进入肾动脉。
D.肾脉管系统的性质和特征
由于左肾丛和/或右肾丛RP的神经调制可根据本技术通过血管内通路实现,肾脉管系统的性质和特征可对用于实现所述肾神经调制的装置、系统和方法的设计加以限制和/或提供信息。这些性质和特征中的一些可随着患者群和/或在特定患者内随着时间,以及响应于疾病状态例如高血压、慢性肾病、血管疾病、末期肾病、胰岛素抵抗、糖尿病、代谢综合征等而改变。这些性质和特征,如本文中所述,可能与所述方法的效能以及所述血管内装置的特定设计有关。相关的性质可包括,例如,材料性质/机械性质、间隙性质、流体动力学性质/血液动力学性质和/或热力学性质。
如前所述,导管可通过微创血管内通路透皮前进进入左肾动脉或右肾动脉。然而,微创肾动脉通路可能是挑战,例如,因为,与利用导管常规进入的一些其他动脉相比,肾动脉通常极其曲折,可能具有相对小的直径,和/或可能具有相对短的长度。此外,肾动脉粥样硬化症在许多患者,特别是患有心血管疾病的那些中常见。肾动脉解剖学也可能因不同的患者而显著不同,进一步复杂化微创通路。例如,在相对弯曲度、直径、长度和/或动脉粥样硬化斑块负荷以及在肾动脉从主动脉分支处的出射角(take-off angle),可观察到患者之间的显著差异。用于通过血管内通路实现肾神经调制的装置、系统和方法在微创进入肾动脉时应该考虑这些以及肾动脉解剖学的其他方面及其在患者群中的差异。
除了复杂化肾动脉通路之外,肾解剖学的特性也使神经调制装置与肾动脉的管腔表面或壁之间稳定接触的确立复杂化。在神经调制装置包括能量传递元件(例如电极)时,对于可预测性而言,由该能量传递元件向管壁施加的稳定的定位和合适的接触力是重要的。然而,肾动脉内的紧密间隙以及动脉的弯曲度妨碍导航。此外,患者运动、呼吸和/或心搏周期使确立稳定的接触复杂化,因为这些因素可能导致肾动脉相对于主动脉的明显运动,并且心搏周期可短暂地使肾动脉扩张(即使动脉壁搏动)。
即使在进入肾动脉并且促成神经调制装置与动脉的管腔表面之间的稳定接触后,应通过所述神经调制装置安全地调制在动脉的外膜(adventia)内和围绕动脉外膜的神经。考虑到与该治疗相关的潜在的临床并发症,从肾动脉内有效地施加热治疗并非小事。例如,肾动脉的内膜和中间层极易受到热损伤的伤害。如下文中更详细地论述,分隔血管管腔与其外膜的内膜-中间层厚度意味着靶肾神经可以距离动脉的管腔表面许多毫米。足够的能量应被提供至该靶肾神经或将热从其移除以调制该靶肾神经而不过度冷却或加热管壁达到管壁被冻住、失水、或以其他方式对其有可能造成不希望的影响的程度。一种与过分加热有关的可能的临床并发症为由流过动脉的血液凝结造成的血栓形成。考虑到这种血栓有可能导致肾梗塞,从而对肾脏造成不可逆转的伤害,应该小心使用从肾动脉内进行的热治疗。因此,在治疗期间,该肾动脉中存在的复杂流体力学和热力学状况,特别是可影响在治疗部位的传热动力学的那些,在从肾动脉内施加能量(例如加热的热能)和/或从组织移除热(例如冷却热环境)时,可能是重要的。
还应设置所述神经调制装置,从而可调整在肾动脉内能量传递元件的定位和重新定位,因为治疗的位置也可影响临床安全和效能。例如,考虑到肾神经可环绕肾动脉,令人感兴趣的是,从肾动脉内施加全周缘治疗。在一些情形中,可能由连续周缘治疗造成的全圆形损伤可能潜在地与肾动脉狭窄风险相关。因此,通过在此描述的网状(mesh)结构沿着肾动脉的纵向维度形成更复杂的损伤,和/或使所述神经调制装置重新定位至多个治疗位置可能是可取的。然而,应注意,产生环形消融的益处可比潜在的肾动脉狭窄更重要,或者用某些实施方式或在某些患者中可减小风险,并且产生环形消融可以是一个目标。此外,所述神经调制装置的可变的定位和重新定位可能在肾动脉特别弯曲的情形或者存在离开肾动脉主干血管的近分支血管时被证明有用,使得在某些位置的治疗具有挑战性。在肾动脉中的装置的操作还应考虑由该装置强加于该肾动脉的机械损伤。装置在动脉中的运动,例如通过插入、操作、越过弯曲处等,可能促成剥离、穿孔、裸露内膜或者破坏内弹性膜。
经过肾动脉的血流可被短暂地阻塞伴有最少或没有并发症。然而,应避免显著长时间的闭塞以防对肾脏的损伤例如缺血。完全避免闭塞可能是有益的,或者若闭塞有益于所述实施方式,限制闭塞的持续时间(例如至2-5分钟)。
根据上述挑战:(1)肾动脉介入,(2)紧靠管壁一致且稳定地安置所述治疗元件,(3)穿过管壁有效施用治疗,(4)将治疗装置定位并且可能重新定位至多个治疗位置,以及(5)避免或限制血流闭塞的持续时间,可关注的肾脉管系统的各种非独立的和独立的性质包括,例如,(a)血管的直径、血管长度、内膜-中间层厚度、磨擦系数和弯曲度;(b)管壁的扩张性、硬度和弹性模量;(c)峰值收缩和舒张末期血液流速,以及平均收缩-舒张峰值血液流速、平均/最大体积血液流速;(d)血液和/或管壁的比热容、血液和/或管壁的导热性、经过管壁治疗部位的血流的热对流性和/或辐射传热;(e)由呼吸、患者运动和/或血流搏动引起的肾动脉相对于主动脉的运动;以及(f)肾动脉相对于主动脉的出射角。针对肾动脉,在下文中更详细地讨论这些性质。然而,取决于用来实现肾神经调制的装置、系统和方法,肾动脉的这样的性质还可指导和/或限制设计特征。
如上文所述,置于肾动脉内的装置应符合该动脉的几何形状。肾动脉血管直径DRA通常在约2-10mm的范围内,患者群体中的大多数具有约4mm至约8mm且平均约6mm的DRA。肾动脉血管长度LRA,在主动脉/肾动脉交接处它的开口与其远侧分支之间,一般在约5-70mm的范围内,且显著部分的患者群体在约20-50mm的范围内。由于靶肾丛嵌入在肾动脉的外膜内,复合内膜-中间层厚度IMT(即从动脉的管腔表面至包含靶神经结构的外膜的径向向外距离)也是显著的,并且一般在约0.5-2.5mm的范围内,平均约1.5mm。虽然为了到达靶神经纤维特定的治疗深度是重要的,但是该治疗不应太深(例如自肾动脉的内壁起>5mm)以避免非靶的组织和解剖结构例如肾静脉。
可关注的肾动脉另一性质是由呼吸和/或血流搏动引起的相对于主动脉的肾运动程度。患者的肾脏,位于肾动脉的远端,可随着呼吸幅度相对于颅骨移动达4″。这可赋予连接主动脉和肾脏的肾动脉明显的运动,由此对神经调制装置要求硬度与柔性的独特平衡从而在呼吸周期期间在热治疗元件与管壁之间保持接触。此外,肾动脉与主动脉之间的出射角可在患者之间显著变化,并且由于例如肾脏运动也可在患者内动态地变化。所述出射角一般可在约30°-135°的范围内。
V.结论
本技术实施例的以上详细描述不欲为详尽的,或不欲将本技术限于上文揭示的确切形式。尽管上文为达成说明目的而描述本技术的特定实施例及实例,但如相关领域技术人员所了解,各种等同修改在本技术范畴内为可能的。举例而言,尽管步骤以给定次序呈现,但替代实施例可以以不同次序执行各步骤。本文所述的各种实施例亦可组合以提供其它实施例。
由上文将了解,本文为达成说明目的而描述本技术的特定实施方式,但熟知结构及功能未被详细显示或描述以避免不必要地模糊本技术实施例的描述。若上下文允许,则单数或复数术语亦可各别包括复数或单数术语。举例而言,如前文所示,尽管本文的诸多揭示内容以单数形式描述能量传递元件24(例如电极),但应了解,本发明不排除两个或两个以上能量传递元件或电极。
此外,在提及两个或两个以上项目的清单时,除非明确限制词汇“或”仅意指排除其它项目的单一项目,否则在该清单中使用“或”应解释为包括(a)该清单中的任何单一项目、(b)该清单中的所有项目或(c)该清单中项目的任意组合。另外,全文使用的术语“包含”意指至少包括所述特征,以使得不排除任何更多数目的相同特征及/或其它类型的其它特征。亦应了解,本文为达成说明目的而描述特定实施例,但在不偏离本技术的情况下可进行各种修改。此外,尽管与本技术某些实施例相关的优势已在那些实施例的情况中加以描述,但其它实施例亦可展示这些优势,且并非所有实施例均需要一定展示这些优势才能在本技术的范畴内。因此,本发明及相关技术可包含本文中未明确显示或描述的其它实施例。
本公开可由一个或多个以下条款来定义:
1.一种用于肾神经调节的系统,该系统包含:
一导管,其包含一具有一近端部分及一远端部分的延伸杆,其中该远端部分包含一经设置以置放于肾血管中的能量传递组件;
一能量源,其耦接至该能量传递组件且经设置以经由该能量传递组件将能量传递至接近该肾血管壁的目标神经纤维,
其中该能量源包含一元件,其经设置以
在第一时间段内使能量传递增加至预定第一功率水平;
将能量传递维持在该第一功率水平历时第二时间段;及
若在该第二时间段的后温度值小于预设临界值温度,则将能量传递增加至第二预定功率水平;且
其中该能量源进一步包含一元件,其经设置以
获得一组对应于使用该导管、该能量源及该能量传递组件进行的完全治疗的治疗数据;
根据一或多个标准估算该组治疗数据以确定该完全治疗的评估是否可能在预定范围内;及
提供关于该完全治疗的该估值是否可能在该预定范围内的显示。
2.如条款1的系统,其中该组治疗数据为对应于第一完全治疗的第一组治疗数据,且其中该系统经进一步设置以
至少部分地基于对该第一治疗资料的该估算及关于该第一完全治疗的该估值是否在该预定范围内的该显示修改该第一预定功率水平、该第一时间段、该第二时间段及/或该第二预定功率水平;
使用该经修改的第一预定功率水平、经修改的第一时间段、经修改的第二时间段及/或经修改的第二预定功率水平进行第二治疗;及
获得对应于第二完全治疗的第二组治疗资料。
3.如条款1的系统,其中该组治疗数据包含关于基于温度的测量值、基于阻抗的测量值、基于血流量的测量值或基于移动的测定值中的一个或多个的资料。
4.如条款1的系统,其中该组治疗数据包含一个或多个关于以下的测量值:指定时间内的温度变化、最大温度、最大平均温度、最小温度、在预定或计算时间相对于预定或计算温度的温度、指定时间内的平均温度、最大血流量、最小血流量、在预定或计算时间相对于预定或计算血流量的血流量、随时间变化的平均血流量、最大阻抗、最小阻抗、在预定或计算时间相对于预定或计算阻抗的阻抗、指定时间内的阻抗变化或指定时间内相对于温度变化的阻抗变化。
5.如条款1的系统,其中:
该能量传递组件包含一第一能量传递组件,且其中该导管进一步包含一耦接至该能源且经设置以将能量传递至该目标神经纤维的第二能量传递;且
该组治疗数据包含关于该第一能量传递组件的基于阻抗的测量值的第一组数据及关于该第二能量传递组件的基于阻抗的测量值的第二组资料。
6.如条款5的系统,其中根据一个或多个标准估算该组治疗数据包含将该第一组数据与该第二组数据相比较。
7.如条款1的系统,其中估算该组治疗数据包含产生一用以确定该完全治疗是否成功的分值。
8.如条款1的系统,其中估算该组治疗数据包含执行线性判别分析。
9.如条款8的系统,其中该线性判别分析产生一用以确定该完全治疗是否成功的分值。
10.如条款1的系统,其进一步包含一显示屏幕,且其中该提供的指示包含在该显示屏幕上显示的信息。
11.如条款10的系统,其进一步包含一用于测量治疗部位或电极的阻抗的阻抗感应器,且其中该能源经进一步设置以在选定时间段内追踪实时阻抗测量值且在该显示屏幕上显示该实时阻抗测量值。
12.一种计算机可读储存介质,其含有在由一计算机执行时执行包含以下的操作的指令:
增加由一导管载运的一能量传递元件的能量传递,其中在第一时间段内使能量传递增加至预定第一功率水平,且其中该能量传递元件经定位以将能量传递至接近人类患者的肾血管壁的目标神经纤维;
将能量传递维持在该第一功率水平历时第二时间段;
若在该第二时间段的后温度值小于预设临界值温度,则将能量传递增加至第二预定功率水平;
获得一组对应于使用该能量传递组件进行的完全治疗的治疗数据;
根据一个或多个标准估算该组治疗数据以确定该完全治疗的估值是否可能在预定范围内;及
提供关于该完全治疗的该估值是否在该预定范围内的显示。
13.如条款12的计算机可读储存介质,其中该组治疗数据包含关于基于温度的测量值、基于阻抗的测量值、基于血流量的测量值或基于移动的测定值中的一个或多个的数据。
14.如条款12的计算机可读储存介质,其中操作参数包含温度、时间、阻抗、功率、血流量、流动速度、体积流动速率、血压或心跳速率中之一或多者。
15.如条款12的计算机可读储存介质,其中该组治疗数据包含一个或多个关于以下的测量值:指定时间内的温度变化、最大温度、最大平均温度、最小温度、在预定或计算时间相对于预定或计算温度的温度、指定时间内的平均温度、最大血流量、最小血流量、在预定或计算时间相对于预定或计算血流量的血流量、随时间变化的平均血流量、最大阻抗、最小阻抗、在预定或计算时间相对于预定或计算阻抗的阻抗、指定时间内的阻抗变化或指定时间内相对于温度变化的阻抗变化。
16.如条款12的计算机可读储存介质,其中该组治疗数据包含对应于第一完全治疗的第一组治疗数据,且其中这些操作进一步包含:
至少部分地基于对该第一治疗资料的估算及关于该第一完全治疗的该估值是否在该预定范围内的该显示修改该第一预定功率水平、该第一时间段、该第二时间段及/或该第二预定功率水平;
使用该经修改的第一预定功率水平、经修改的第一时间段、经修改的第二时间段及/或经修改的第二预定功率水平进行第二治疗;及
获得对应于第二完全治疗的第二组治疗数据。
17.如条款12的计算机可读储存介质,其中估算该组治疗数据包含产生一个用以确定该完全治疗是否在该预定范围内或该完全治疗是否未如预期进行的分值。
18.如条款12的计算机可读储存介质,其中估算该组治疗数据包含执行线性判别分析。
19.如条款17的计算机可读储存介质,其中该线性判别分析产生一个用以确定该完全治疗是否在该预定范围内的分值。
20.如条款12的计算机可读储存介质,其中该提供的显示包含显示在用于投与该完全治疗的一个系统的一个显示屏幕上的信息。
21.如条款20的计算机可读储存介质,其中提供关于该完全治疗是否在该预定范围内的显示包含:
若该治疗的该估值在该预定范围内,则在该显示屏幕上显示第一信息;及
若该治疗的该估值显示治疗未如预期进行,则在该显示屏幕上显示第二不同信息。
22.如条款12的计算机可读储存介质,其中若操作参数超出预定范围,则将能量传递增加至预定第二功率水平包含若第一能量传递组件与第二能量传递组件的阻抗值差异超出预定范围,则将能量传递增加至预定第二功率水平。
Claims (23)
1.一种用于肾神经调节的系统,该系统包含:
导管,其包含具有近端部分及远端部分的延伸杆,其中该远端部分包含经设置以置放于肾血管中的能量传递组件;
能量源,其耦接至该能量传递组件且经设置以经由该能量传递组件将能量传递至接近该肾血管壁的目标神经纤维,
其中该能量源包含一元件,其经设置以
在第一时间段内使能量传递增加至第一预定功率水平;
将能量传递维持在该第一预定功率水平历时第二时间段;及
若在该第二时间段的后温度值小于预设临界值温度,则将能量传递增加至第二预定功率水平;且
其中该能量源进一步包含一元件,其经设置以
获得一组对应于使用该导管、该能量源及该能量传递组件进行的完成的治疗的治疗数据;
根据一或多个标准估算该组治疗数据以确定该完成的治疗的评估是否可能在预定范围内;及
提供关于该完成的治疗的估值是否可能在该预定范围内的指示。
2.如权利要求1所述的系统,其中该组治疗数据为对应于第一完成的治疗的第一组治疗数据,且其中该系统经进一步设置以
至少部分地基于对该第一组治疗数据的估算及关于该第一完成的治疗的估值是否在预定范围内的指示来修改该第一预定功率水平、该第一时间段、该第二时间段及/或该第二预定功率水平;
使用经修改的第一预定功率水平、经修改的第一时间段、经修改的第二时间段及/或经修改的第二预定功率水平进行第二治疗;及
获得对应于第二完成的治疗的第二组治疗资料。
3.如权利要求1所述的系统,其中该组治疗数据包含关于基于温度的测量值、基于阻抗的测量值、基于血流量的测量值或基于移动的测定值中的一个或多个的资料。
4.如权利要求1所述的系统,其中该组治疗数据包含一个或多个关于以下的测量值:指定时间内的温度变化、最大温度、最大平均温度、最小温度、在预定或计算时间相对于预定或计算温度的温度、指定时间内的平均温度、最大血流量、最小血流量、在预定或计算时间相对于预定或计算血流量的血流量、随时间变化的平均血流量、最大阻抗、最小阻抗、在预定或计算时间相对于预定或计算阻抗的阻抗、指定时间内的阻抗变化或指定时间内相对于温度变化的阻抗变化。
5.如权利要求1所述的系统,其中:
该能量传递组件包含第一能量传递组件,且其中该导管进一步包含耦接至该能量源且经设置以将能量传递至这些目标神经纤维的第二能量传递;且
该组治疗数据包含关于该第一能量传递组件的基于阻抗的测量值的第一组数据及关于该第二能量传递组件的基于阻抗的测量值的第二组数据。
6.如权利要求5所述的系统,其中根据一个或多个标准估算该组治疗数据包含将该第一组数据与该第二组数据相比较。
7.如权利要求1所述的系统,其中估算该组治疗数据包含产生一个用以确定该完成的治疗是否成功的分值。
8.如权利要求1所述的系统,其中估算该组治疗数据包含执行线性判别分析。
9.如权利要求8所述的系统,其中该线性判别分析产生一个用以确定该完成的治疗是否成功的分值。
10.如权利要求1所述的系统,其进一步包含显示屏幕,且其中所提供的指示包含在该显示屏幕上显示的信息。
11.如权利要求10所述的系统,其进一步包含用于测量治疗部位或电极的阻抗的阻抗感应器,且其中该能量源经进一步设置以在选定时间段内追踪实时阻抗测量值且在该显示屏幕上显示该实时阻抗测量值。
12.一种计算机实现的系统,包括:
用于增加由导管载运的能量传递元件的能量传递的装置,其中在第一时间段内使能量传递增加至第一预定功率水平,且其中该能量传递元件经定位以将能量传递至接近人类患者的肾血管壁的目标神经纤维;
用于将能量传递维持在该第一预定功率水平历时第二时间段的装置;
用于若在该第二时间段的后温度值小于预设临界值温度,则将能量传递增加至第二预定功率水平的装置;
用于获得一组对应于使用该能量传递组件进行的完成的治疗的治疗数据的装置;
用于根据一个或多个标准估算该组治疗数据以确定该完成的治疗的估值是否可能在预定范围内的装置;及
用于提供关于该完成的治疗的该估值是否在该预定范围内的指示的装置。
13.如权利要求12所述的计算机实现的系统,其中该组治疗数据包含关于基于温度的测量值、基于阻抗的测量值、基于血流量的测量值或基于移动的测定值中的一个或多个的数据。
14.如权利要求12所述的计算机实现的系统,其中该组治疗数据包含一个或多个关于以下的测量值:指定时间内的温度变化、最大温度、最大平均温度、最小温度、在预定或计算时间相对于预定或计算温度的温度、指定时间内的平均温度、最大血流量、最小血流量、在预定或计算时间相对于预定或计算血流量的血流量、随时间变化的平均血流量、最大阻抗、最小阻抗、在预定或计算时间相对于预定或计算阻抗的阻抗、指定时间内的阻抗变化或指定时间内相对于温度变化的阻抗变化。
15.如权利要求12所述的计算机实现的系统,其中该组治疗数据包含对应于第一完成的治疗的第一组治疗数据,且其中所述计算机实现的系统进一步包含:
用于至少部分地基于对该第一组治疗数据的估算及关于该第一完成的治疗的估值是否在预定范围内的指示来修改该第一预定功率水平、该第一时间段、该第二时间段及/或该第二预定功率水平的装置;
用于使用经修改的第一预定功率水平、经修改的第一时间段、经修改的第二时间段及/或经修改的第二预定功率水平进行第二治疗的装置;及
用于获得对应于第二完成的治疗的第二组治疗资料的装置。
16.如权利要求12所述的计算机实现的系统,其中用于估算该组治疗数据的装置包含:用于产生一个用以确定该完成的治疗是否在该预定范围内或该完成的治疗是否未如预期进行的分值的装置。
17.如权利要求12所述的计算机实现的系统,其中用于估算该组治疗数据的装置包含:用于执行线性判别分析的装置。
18.如权利要求17所述的计算机实现的系统,其中该线性判别分析产生一个用以确定该完成的治疗是否在该预定范围内的分值。
19.如权利要求12所述的计算机实现的系统,其中该提供的指示包含显示在用于管理该完成的治疗的系统的显示屏幕上的信息。
20.如权利要求19所述的计算机实现的系统,其中用于提供关于该完成的治疗是否在该预定范围内的指示的装置包含:用于若该治疗的该估值在该预定范围内,则在该显示屏幕上显示第一信息的装置;及用于若该治疗的该估值显示治疗未如预期进行,则在该显示屏幕上显示第二不同信息的装置。
21.如权利要求12所述的计算机实现的系统,其中所述计算机实现的系统进一步包含:用于若操作参数超出预定范围,则将能量传递增加至预定第二功率水平的装置。
22.如权利要求21所述的计算机实现的系统,其中所述用于若操作参数超出预定范围,则将能量传递增加至预定第二功率水平的装置进一步包含:用于若第一能量传递组件与第二能量传递组件的阻抗值差异超出预定范围,则将能量传递增加至预定第二功率水平的装置。
23.如权利要求21所述的计算机实现的系统,其中所述操作参数包含温度、时间、阻抗、功率、血流量、流动速度、体积流动速率、血压或心跳速率中之一或多者。
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JP2013544130A (ja) | 2013-12-12 |
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CN103313671A (zh) | 2013-09-18 |
US9750560B2 (en) | 2017-09-05 |
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