CN103096825B - 用于血管内治疗器械的手柄组件以及相关系统和方法 - Google Patents
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Abstract
本发明包括用于血管内治疗器械的手柄组件。在一个实施例中,手柄组件包括致动器,该致动器用于使血管内治疗器械的远侧区域偏转。在一个实施例中,手柄组件包括转动器,该转动器用于使血管内治疗器械独立于手柄组件而转动。在一个实施例中,手柄组件包括转动限制元件,该转动限制元件用于限制血管内治疗器械相对于手柄组件的独立转动。还提供了用于血管内治疗器械经由本发明手柄组件的血管内输送、偏转以及放置的方法和系统。
Description
相关申请的交叉引用
本申请是2009年12月22日提交的专利合作条约(PCT)申请PCT/US09/69334的部分继续申请,该申请PCT/US09/69334要求以下申请的优先权:
(a)在2009年8月14日提交的欧洲专利申请09168202.1;
(b)在2009年8月14日提交的欧洲专利申请09168204.7;
(c)在2009年8月14日提交的欧洲专利申请09167937.3;以及
(d)在2008年12月31日提交的美国临时专利申请61/142,128。
在2009年12月22日提交的专利合作条约(PCT)申请PCT/US09/69334也是以下申请的部分继续申请。
(e)在2009年8月21日提交的美国专利申请12/545648;以及
(f)在2009年6月30日提交的美国专利申请12/495,691。
所有这些申请的全文都以参见的方式纳入本文。
技术领域
在本申请中所披露的技术总地涉及用于血管内治疗器械的手柄组件以及相关联系统和方法。具体地说,若干实施例涉及用于实现血管内、热诱发肾神经调节的血管内治疗器械的手柄组件。
背景技术
高血压、心力衰竭、慢性肾疾病代表重要和日益增长的全球健康问题。这些病症的当前治疗包括非药物学、药物学和基于器械的方法。尽管治疗方案不同,但血压控制率和对防止心力衰减和慢性肾病恶化的治疗努力仍然不令人满意。尽管所述情况的原因有多种并且包括与前述治疗不相符的问题,功效和不良事件概况和其它方面的反应异质性,显然需要替代方案来补充当前对这些病症的治疗处理方案。
交感神经肾神经活性的降低(如通过去神经支配)能反转所述过程。加利福尼亚州、帕罗奥图的阿迪安公司已发现:包括和包含电场的能量场能经由不可逆的电穿孔、电熔、凋亡、坏死、消融、热蚀变、基因表达的差异或者其它合适药症所引起的去神经支配来进行肾神经调节。
附图说明
图1是用于实现血管内热诱发肾神经调节的系统的局部示意图。
图2A是根据本发明一实施例构造的治疗器械所使用的手柄组件的等轴立体图。
图2B是图2A所示手柄组件的分解立体图。
图2C是图2B所示手柄组件的致动器和O形圈的详细立体图。
图3A和3B是图2A所示手柄组件的侧视剖视图。
图3C-3E提供图3A和3B所示手柄组件的详细侧视剖视图,说明致动器相对于壳体组件的协调角转动和支架相对于壳体组件的直线移动。
图4A是图2A所示手柄组件的前部的立体图,而图4B是手柄组件的前部处的多个内部部件的立体图。
图5A和5B是图2A-2C和3A-3E所示手柄组件的侧视剖视图,说明用于限制看护者致使致动器260的转动和/或用于在此种看护者致动过程中增大摩擦的可选结构。
图6是图2A-5B所示手柄组件的替代实施例的分解立体图,该手柄组件具有用于在看护者致动过程中产生摩擦的替代机构。
图7A和7B示出用于手柄组件的替代转动限制元件和转动控制机构。
图8示出手柄组件的操作以操纵肾动脉内的治疗器械。
图9A-9D示出包括根据本发明一实施例构造的手柄组件的治疗器械的血管内输送、放置、偏转、转动、抽出、重新定位以及使用,以实现从肾动脉内的热诱发肾神经调节。
图10A和10B示出在治疗器械的中间柔性区域偏置的情形下热构件的径向和纵向移动。
图11示出手柄组件的替代实施例。
具体实施方式
I.概述
本发明描述了用于血管内治疗器械的手柄组件以及相关联系统和方法。
虽然以下描述提供了对于以下示例的特定细节,以使相关技术领域的技术人员能实践、制造和使用这些示例,然而下文描述的若干细节和优点可无需实践本发明的特定示例和方法。此外,本发明可以包括其它实例和方法,这些实例和方法落在权利要求的范围内,虽然对其没有进行详细描述。
在该整篇说明书中,对“一个实例”、“一实例”、“一个实施例”或“一实施例”的参照意味着结合实例描述的特定特征、结构或特性包括在本发明的至少一个实例中。所以,该通篇说明书多处出现的措词“在一个实例中”、“在一实例中”、“一个实施例”或“一实施例”并不一定都是指相同的实例。另外,特定的特征、结构、程序、步骤或特性可以任何合适的方式组合在本发明的一个或多个实例中。这里给出的标题只是为了方便叙述,而不应解释为限制或解释本发明所要求的发明的范围或涵义。
II.血管内治疗器械的实施例以及相关系统和方法
图1示出用于通过血管内通道、例如对左肾丛和/或右肾丛(RP)进行热诱发神经调节的系统10。左肾丛和/或右肾丛(RP)围绕相对应的左肾动脉和/或右肾动脉。肾丛(RP)与相对应肾动脉紧密相关联地延伸到肾物质中。该系统可通过通到相对应左肾丛或右肾丛中的血管内通道而对肾丛(RP)进行热诱发神经调节。
该系统10包括血管内治疗器械12。治疗器械12包括细长轴杆16,该细长轴杆16具有近端区域18和远端区域20。如图8、9和10所示,治疗器械12通过引至相对应肾动脉的血管内通路提供例如通至肾丛(RP)的通道。
在使用时,细长轴杆16的不同部段用于不同机械功能。因此,这些部段在它们的尺寸、构造以及机械特性方面理想地是不同的,用以(i)通过小直径的通道点经皮引到股动脉中;(ii)无损地通过曲折的血管内通路、通过髂动脉、进入主动脉并进入相对应的左肾动脉/右肾动脉,包括(iii)在左肾动脉/右肾动脉和主动脉的结合部附近显著挠曲,以进入相对应的左肾动脉或右肾动脉;(iv)控制相对应肾动脉内的移动、偏转和/或转动,以与相对应肾动脉的内壁相接近并且理想地对准;以及(v)将由远端区域20承载的至少一个热元件24(例如,生热元件)放置成与内壁上的组织相接触。该热元件24将尺寸和构造设计成用于在肾动脉内进行操纵和使用。
细长轴杆16的近端区域18包括手柄组件200。手柄组件200将尺寸和构造设计成由看护者(例如,参见图16a)固定地保持定位在患者外部或人体工程学地操纵,在治疗器械12的远端区域20横穿的血管内通路外部以通达肾动脉。通过从血管内通路外侧对手柄组件200进行操纵,看护者能使细长轴杆16行进通过曲折的血管内通路14,并且远程地操纵或致动远端区域20。诸如CT之类的影像引导或另一种合适的引导器械或者它们的组合可用于辅助看护者的操纵。
细长轴杆16的远端区域20能以充足的方式挠曲,以通过细长轴杆16的操纵而例如经由引导导管(未示出)内的通道进入相对应的左肾动脉/右肾动脉。一旦进入肾动脉,则远端区域20和生热元件24在相对应肾动脉内的进一步操纵使得生热元件24和沿着相对应肾动脉的内壁的组织之间相互接近并对准。在一些实施例中,远端区域20的操纵还会便于使生热元件24和肾动脉的壁之间接触。
系统10还包括生热器26(例如,热能发生器)。在看护者的控制或者自动控制算法102的控制下,生热器26产生选定形式和量值的热量。可操作地附连于手柄组件200的缆线28将生热元件24电连接于生热器26。沿细长轴杆16或者通过细长轴杆16中的内腔、从手柄组件200通至生热元件24的至少一根电源线(例如,参见图3A))将热能传送至生热元件24。诸如脚踏板100之类的控制机构可选地连接于(例如,气动连接或电连接于)生热器26,以使操作者能启动、终止生热器和可选地调节生热器的各种操作特征,包括但不局限于动力输送。
对于经由生热元件24提供单极电场输送的系统来说,中性或离散电极38能电连接于生热器26。此外,一个或多个传感器52(例如,参见图9)可位于生热元件附近或者位于生热元件内,并且连接于一根或多根电源线,这些传感器例如一个或多个温度传感器(例如,热电偶、热敏电阻之类)、阻抗传感器、压力传感器、光学传感器、流量传感器、化学传感器或其它传感器。采用两根电源线,则一根电源线能将能量传送至生热元件,而一根电源线能传递来自传感器的信号。或者,两根线都可将能量传递给生热元件。
如图8和9所示(并且在下文进行更详细地描述),看护者可通过在由远端区域横穿的血管内通路外部操纵定位于患者外部的手柄组件200来操纵细长轴杆16的远端区域20进入期望的血管内位置。细长轴杆16可包括力传递部段30,该力传递部段30将力从手柄组件200传递至远端区域20。远端区域20可包括近侧柔性区32,该近侧柔性区适应左/右肾动脉和主动脉的结合部处的显著挠曲,以进入相对应的左侧或右侧肾动脉。此外,远端区域可包括中间柔性区34。使用手柄组件200,中间柔性区能轴向地移动到相对应的肾动脉中,并且以受控方式在相对应的肾动脉内远程地偏转和/或转动,以实现与相对应肾动脉的内壁相接近和所希望的对准。远端区域还可包括远侧柔性区44,该远侧柔性区44被动地弯曲,以将生热元件24放置成与相对应肾动脉的内壁上的组织相接触。
由细长轴杆16的远端区域20的近侧柔性区32、中间柔性区24以及远侧柔性区44所形成的复杂多弯曲结构在生热元件24和相对应肾动脉内的组织之间产生恒定且可靠的有效接触表面积。一旦在相对应的肾动脉内、生热元件24和组织之间相互接近、对准和接触,则通过生热元件24将来自生热器26的能量有目的地应用于组织会在肾动脉的局部区域和肾丛(RP)的相邻区域上引起一种或多种所希望的生热效果,而肾丛紧密地位于肾动脉的外膜内或者附近。有目的应用生热效果能实现沿RP的所有部分或一部分的神经调节。
生热效果可既包括热烧蚀蚀变或损坏又包括非热烧蚀蚀变或损坏(例如,经由持续加热和/或电阻性加热)。理想的生热效果可包括使目标神经纤维的温度上升至所希望的阈值以上,以实现非烧蚀热蚀变,或者使该温度上升至较高温度以上,以实现烧蚀热蚀变。例如,对于非烧蚀热蚀变来说,目标温度可以在体温(例如约37°C)以上但低于约45°C,而对于烧蚀热蚀变来说,目标温度可以是约45°C或以上。
III.用于血管内治疗器械的手柄组件以及相关系统和方法
参见图2A,描述系统10的手柄组件200的示例性实施例。在手柄组件200定位在患者外部的条件下,看护者能使手柄组件移动,以使细长轴杆16的远端区域20通过血管内通路移动至相对应的肾动脉内的位置。然后,看护者能操作手柄组件200的致动器260,以使生热元件24绕中间柔性区34偏转,从而在肾动脉的内壁和生热元件之间建立接触。看护者还能操作手柄组件200上的转动器230,以使细长轴杆16及其远端区域20转动,而不使整个手柄组件200转动。
细长轴杆16在中间柔性区34在相对应肾动脉内偏转时的转动使生热元件24在相对应肾动脉内转动,从而易于实现与脉管壁的接触并确定是否存在壁接触(尤其是在存在不良血管造影术的平面中),和/或使生热元件进行重新角定位。转动可与生热元件24的移动组合起来,用以将生热元件在相对应肾动脉内重新定位在不同的角度和纵向位置处,以在肾动脉内的多个位置处输送能量。由于存在从手柄组件行进通过器械的轴杆的线缆和线(例如,致动线/线缆、输电线、热电偶线等等),理想的是限制轴杆相对于这些线的转动,以避免这些线发生不必要的缠结和扭转;因此手柄组件200包括转动限制元件,这在下文会进行更详细地描述。
如图2B的分解视图所示,手柄组件200可包括近侧应变释放件202、远侧应变释放件204、内部止动环210、外部止动环220、转动器230、具有上部外壳242和下部外壳244的外壳组件240、致动器260和支架280以及可选的O形圈275。上部外壳和下部外壳包括连结在一起的一个或多个匹配件246(例如,经由摩擦锁定的阴阳匹配件和/或经由粘合剂),以形成手柄外壳组件240。致动器、O形圈以及支架在外壳组件240的组装构造中、定位在上部外壳242和下部外壳244之间。
在下文将更详细进行描述的是,在已组装构造中,致动器260和支架280以便于使致动器的角转动和支架的直线移动协调的方式、限制在外壳组件240内。在下文还将更详细进行描述的是,支架280通过看护者使致动器260朝近侧转动而产生的近侧直线移动致使生热元件24绕细长轴杆16的远端区域20的中间柔性区34偏转。定位在致动器260和下部外壳244之间的可选O形圈275可在看护者转动致动器的过程中、为该看护者提供触觉反馈或抵抗,和/或可将该致动器保持在近侧转动位置。替代的致动机构可包括直接或间接地连接于控制线的滑动致动器,其中看护者使滑动致动器滑动,这导致控制线相对于外壳组件发生移动,并且使生热元件绕中间柔性区偏转。另一替代的致动机构可包括直接或间接地连接于控制线的转动致动器,其中看护者使转动致动器转动,这导致控制线相对于外壳组件发生移动,并且使生热元件绕中间柔性区偏转。
在外壳240组装之后,内部止动环210同心地定位在外壳组件240的远侧部分上,外部止动环220同心地定位在内部止动环210上,而转动器同心地定位在外部止动环220上。近侧应变释放件202粘附于外壳组件240的近侧部分,而远侧应变释放件204粘附于转动器230的远侧部分。在下文将更详细进行描述的是,内部止动环210、外部止动环220以及转动器230与外壳组件240一致地作用,以便于使细长轴杆16在手柄组件200不转动的条件下转动,以及限制细长轴杆的转动。
治疗器械12包括控制线40,该控制线从近端区域18的手柄组件200到远端区域20的中间柔性区34延伸细长轴杆16的长度(例如,沿细长轴杆的长度或者在细长轴杆内延伸)。控制线在远侧终止于远端区域20中,而如图3所示在近侧终止于手柄组件200的支架280处。如下文更详细描述的,控制线可通过简单地围绕支架上的一个或多个夹板或附连点和/或经由粘合剂或焊接件的附连件而附连于支架280。支架280相对于外壳组件240(且由此相对于细长轴杆16)近侧移动相对于细长轴杆16朝近侧抽回控制线,这在中间柔性区34上施加弯曲力矩,而该弯曲力矩致使该中间柔性区弯曲或者相对于细长轴杆16的纵向轴线偏转。这便于使生热元件24相对于相对应的肾动脉定位在所希望的位置。
可选的是,控制线40可以是弹性的和/或可连接于诸如弹簧之类的弹性元件,以衰减由于支架280移动而施加于控制线的力,由此衰减施加于中间柔性区34的弯折或弯曲力矩。这可以在生热元件24和脉管壁之间提供更恒定的接触力。这还可便于在脉管壁相对于细长轴杆运动时维持稳定的接触。
通过使致动器260朝近侧转动,看护者可使支架280相对于外壳组件240朝近侧移动,以相对于细长轴杆16朝近侧抽出控制线40,由此使远端区域20的中间柔性区34偏转。致动器260包括致动器本体262和凸轮266,该致动器本体262具有枢转件264,而凸轮266定位在致动器面向已组装构造中上部外壳242和支架280的表面上。
致动器260还具有致动器按钮270,该致动器按钮270经由致动器按钮臂272联接于致动器本体。致动器按钮臂272用作在致动器260的转动过程中、提供附加扭矩和机械优点的连杆臂。致动器按钮270可选地具有比致动器按钮臂272较大的宽度,以便于由看护者触觉操纵和人体工程学操纵致动器按钮。致动器按钮270首先相对于外壳组件240定位在前方或后方位置。看护者可向后(即,朝近侧)拉动按钮270,以使致动器260相对于外壳组件朝近侧转动,并且使远端区域20的中间柔性区34偏转。以如下方式确定致动器按钮270在看护者操纵手柄组件200的过程中、与转动器230分开的距离范围:即使当致动器按钮270相对于外壳组件240定位在其最近或最远位置时,便于符合人体工程学地单手使用手柄组件200。
外壳组件240(说明性地,下部外壳244)包括致动器柱部248,该致动器柱部放置在致动器枢转件264内。致动器柱部248限制致动器260相对于外壳组件240的移动,同时便于致动器绕致动器柱部248和致动器枢转件264的角转动,该致动器枢转件264作为致动器转动轴线。致动器柱部248便于致动器260相对于外壳组件240和支架280适当对准,并且可降低在致动器角转动过程中致动器粘结的风险。致动器柱部248还可包括外壳组件240的匹配件246。
在上部外壳242和下部外壳244匹配以形成外壳组件240的条件下,致动器260的致动器按钮臂272座落在致动器沟道250内,且该致动器沟道250通过上部外壳和下部外壳的匹配而形成(参见图2A)。该致动器沟道250为看护者提供从手柄组件240的外部、通至致动器按钮270的通道,使得看护者能在致动器本体262设置在外壳组件内的同时、经由致动器按钮使致动器260相对于外壳组件转动。支架280也定位在外壳组件内;支架与致动器260和外壳组件240相互作用,以将致动器的转动转换成支架相对于外壳组件的移动,且由此转换成控制线40相对于细长轴杆16的移动。
支架280包括第一外壳柱部282a和第二外壳柱部282b,且第一外壳柱部282a和第二外壳柱部282b分别定位在外壳组件240的下部外壳244的第一纵向沟道252a和第二纵向沟道252b内。支架280还包括翼部281,该翼部定位在下部外壳244的沟道251内。该支架具有座落在致动器凸轮266内的凸轮柱部286。此外,支架还包括一个或多个附连点或结构288,控制线40在这些附连点或结构处在近侧联接于支架280。如图3B所示,在控制线朝近侧延伸时,该控制线可相对于细长轴杆16保持轴向,直到到达支架的弧形部段289为止,在此控制线改变方向并且在支架附连点288处附连于支架。该支架还可包括沟道或空隙284,该沟道或空隙用于使下部外壳的致动器柱部248穿过其中(参见图3),和/或用以使匹配件246穿过其中,该匹配件从上部外壳242延伸并且与下部外壳的致动器柱部248匹配。
支架的第一和第二外壳柱部282a和282b定位在下部外壳的第一和第二纵向沟道252a和252b内并且支架的翼部281定位在下部外壳的沟道251内,这限制了支架280相对于外壳组件240的转动,同时便于支架相对于外壳组件的纵向轴线移动。可选的是,由于支架的外壳柱部邻抵于下部外壳纵向沟道的近端和/或远端,支架的第一和第二外壳柱部与外壳组件的第一和第二纵向沟道的接触可限制支架相对于外壳组件的此种纵向移动的程度。此外,这还可限制细长轴杆16的远端区域20的中间柔性区34经由控制线40与支架280的近侧连接和控制线与中间柔性区的远侧连接而产生的偏转,和/或可限制致动器由于支架的凸轮柱部286和致动器图表266之间的相互作用(下文详细描述)而相对于外壳组件的转动。
如上所述,支架的凸轮柱部286定位在致动器凸轮266内。如图3C所示,当致动器按钮270相对于外壳组件240定位在其最远位置时,支架的凸轮柱部286定位在致动器凸轮266的内表面处或附近。如图3D和3E所示,在看护者使致动器按钮270相对于外壳组件朝近侧转动时,致动器260的转动致使支架的凸轮柱部286朝致动器凸轮266的上表面运动。如图3D所示,致动器转动轴线(即,枢转件264)和致动器凸轮266的下表面之间的距离D1小于枢转件和凸轮的上表面之间的距离D2。
在看护者使致动器按钮270相对于外壳组件240从较远侧位置(如图3A和3C所示)转动至较近侧位置(如图3B和3E所示)的过程中,支架的凸轮柱部286从下方到上方横穿致动器凸轮266时,致动器的枢转件264和致动器的凸轮266从下方到上方的增大距离致使致动器的凸轮266对定位在其中的支架凸轮柱部286施加力。该力使致动器枢转件264和支架的凸轮柱部286之间的距离增大。由于支架280相对于外壳组件240的转动经由支架的第一和第二外壳柱部282a和282b与下部外壳的第一和第二纵向沟道252a和252b的相互作用所限制,因而由致动器的凸轮266在致动器260相对于外壳组件240朝近侧转动的过程中、对支架的凸轮柱部286所施加的力使支架相对于外壳组件的纵向轴线朝近侧移动。这使得远端区域20的中间柔性区34通过由支架施加给控制线40的张力而偏转。
与此相反,在看护者使致动器按钮270相对于外壳组件240从近侧位置转动至远侧位置的过程中,支架的凸轮柱部286从上方到下方横穿致动器凸轮266时,致动器的枢转件264和凸轮266从上方到的下方减小距离致使致动器的凸轮266对定位在致动器凸轮中的支架凸轮柱部286施加力。该力使致动器的枢转件264和定位在致动器凸轮266内的支架凸轮柱部286之间的距离减小,并使支架280相对于外壳组件240的纵向轴线朝远侧移动。支架相对于外壳组件的此种远侧移动使得中间柔性区34通过将由支架施加给控制线40的张力去除而伸直。或者,当支架(例如,通过所偏转的中间柔性区34经由控制线40施加给支架的回复力)朝远侧移动时,支架的凸轮柱部286可对致动器凸轮266施加力,该力使得凸轮柱部286在致动器凸轮266内从上方运动至下方,并且使致动器按钮270朝远侧转动。
本领域技术人员显而易见的是,外壳组件的第一和/或第二纵向沟道252a和252b的长度可选地能限制支架280相对于外壳组件240的纵向移动。此外,距离D2和D1之间的差值(即,D2-D1)可选地能限定支架280相对于外壳组件240的最大移动距离。更进一步,致动器凸轮266的几何形状可选地能改变,以改变支架280由于致动器260给定的角转动量而引起的直线移动量,反之亦然。
凸轮266的几何形状可选地能构造成与凸轮柱部286相互作用,以在致动器260转动的过程中对看护者提供可变阻力。例如,当致动器转动至较近侧时,阻力会增大。这样,此种增大阻力可用作阻止致动器相对于外壳组件进一步朝近侧转动的制动件。
如前所述,控制线40从细长轴杆16的远端区域20延伸至支架280的附连结构288。支架280相对于外壳组件240的近侧纵向移动(即,致动器260相对于外壳组件进行近侧转动)使得控制线40张紧,这会使中间柔性区34偏转。与此相反,支架280相对于外壳组件240的远侧纵向移动(即,致动器260相对于外壳组件进行远侧转动)减小或消除控制线中的张力,这会减小或消除中间柔性区34的偏转。在致动器按钮臂272邻抵致动器沟道250的任一端时,由外壳组件的致动器沟道250的长度与致动器260的转动轴线和致动器按钮臂272之间的距离组合所限定的几何约束可选地能限定在致动器绕外壳的致动器柱部248转动期间由致动器横穿的最大弧长以及转动角度,这另外还可限定远端区域20的中间柔性区34的最大偏转。替代地/附加地,限制中间柔性区34偏转的几何约束可通过致动器与支架的相互作用(例如,支架的凸轮柱部286邻抵致动器凸轮266的任一端)来限定,通过支架与外壳组件的相互作用(例如,支架的第一和/或第二外壳柱部282a和282b分别邻抵下部外壳的第一和/或第二纵向沟道252a和252b,和/或下部外壳的致动器柱部248或外壳匹配件246邻抵支架沟道284的任一端)来限定,和/或通过在经由附连于支架280的控制线40传送至手柄组件时远端区域20的中间柔性区34的最大偏转能力来限定。
致动器260可选地能在致动器面向已组装构造中的下部外壳244的表面上包括阳O形圈附连轮廓274(参见图27)。轮廓274较佳地与致动器的枢转件264同心。该阳O形圈附连轮廓可具有略小于O形圈275的内直径的最大外部横截面尺寸。该阳附连轮廓可选地能例如绕轮廓274的肋部是略微非圆形的或略尖的。
类似的是,下部外壳244可选地能包括可选的阴O形圈附连轮廓249。该阴O形圈附连轮廓可具有略大于O形圈275的外直径的最大内部横截面尺寸。该阴附连轮廓249可选地可以是略微非圆形的或略尖的,以及例如可具有与致动器的阳附连轮廓274类似的轮廓。
在上部外壳242和下部外壳244匹配以形成外壳组件240的条件下,O形圈275定位在下部外壳244的阴O形圈附连轮廓249内并且定位在致动器260的阳O形圈附连轮廓274上。在致动器相对于外壳组件朝远侧定位的条件下,非圆形的阳O形圈附连轮廓和阴O形圈附连轮廓较佳地是同心的,使得O形圈在运输和存储过程中处于无应力状态。
当致动器按钮270在致动器沟槽250内从较远侧位置转动至较近侧位置时,致动器的阳附连轮廓274不再与下部外壳的阴附连轮廓249同心。这可致使O形圈275配合在致动器的阳附连轮廓274和下部外壳的阴附连轮廓249的相对较尖部段之间。此种O形圈配合增大摩擦,这可为看护者提供触觉反馈和/或可提供摩擦锁定,该摩擦锁定暂时保持致动器260相对于外壳组件240的转动位置(以及由此支架280和控制线40的移动位置)。
当致动器按钮270在致动器沟道250内朝近侧转动、由此支架280朝近侧移动且远端区域20的中间柔性区34经由控制线40偏转时,该中间柔性区34可通过控制线和支架将回复力矩传送至致动器260。该回复力矩可试图使中间柔性区的偏转反向,并使致动器按钮270在致动器沟道250内返回转动至较远位置。由O形圈275配合所提供的增大摩擦会对中间柔性区的回复力矩起反作用,以暂时保持中间柔性区34的偏转。可提供现有技术中已知的替代摩擦和锁定机构。
如前所述,系统10的线缆28可操作地附连于手柄组件200,并且将细长轴杆16的远端区域20处的生热元件24电连接于发电器26。线缆28能可拆除地附连于(例如,经由插头或其它线缆连接件)或永久地附连于(例如,经由粘合剂和/或焊接件)手柄组件200。可选的是,线缆可包括转动电联接件,该转动电联接件便于手柄组件200相对于线缆28独立地转动。如图3A和3B所示,线缆28通过手柄组件200的近侧内腔进入该手柄组件内部,该近侧内腔通过近侧应变释放件202和外壳组件240而形成。线缆28中止在手柄组件内,并且电连接于至少一根电源线29。电源线将治疗能量从生热器26和线缆28传送至生热元件24和/或发送来自一个或多个传感器52(参见图9)的信号,例如一个或多个温度传感器(例如,热电偶、热敏电阻之类)、阻抗传感器、压力传感器、光学传感器、流量传感器、化学传感器或其它传感器,且这些传感器位于生热元件24附近或之内并且连接于电源线。
在图3所示的实施例中,线缆28经由电路板290电连接于电源线29。然而,应理解,可替代的是,线缆可直接连接于电源线29和/或电源线可在手柄组件200近侧的线缆28内朝近侧、例如一直延伸至生热器26,而无需附加地电连接于线缆28。除了将电源线电连接于线缆以外,电路板290可选地能包括程序或者一个或多个回路,用以控制、测量、改变或者以其它方式与经由生热器26所输送的治疗能量和/或通过电源线从定位于远侧的传感器所发送的信号相互作用。
在图3中,外壳组件240包括一个或多个曲折通路构造245,线缆28在终止于电路板290之前通过该曲折通路构造行进。构造245可提供充足的摩擦,以将线缆28安装在外壳组件240内,而无需例如经由粘合剂将线缆辅助地固定于外壳,但应理解,也可提供辅助固定。此外,还可提供其它机械锁定件,例如夹持件或套筒,该夹持件或套筒压接或者以其它方式粘结于线缆,并且在外壳组件240内定位成阻止从外壳组件中拆除该夹持件/套筒。电路板290还可摩擦装配在外壳组件内和/或可经由诸如粘合剂之类的辅助固定附连于外壳组件。
电源线29从电路板290朝远侧延伸。连同控制线40一起,电源线29通过手柄组件200的远侧内腔,然后沿细长轴杆16或通过细长轴杆16中的内腔从手柄组件200延伸至生热元件24,而手柄组件200的远侧内腔通过手柄组件240、转动器230以及远侧应变释放件204形成。细长轴杆16朝近侧联接于转动器230和/或联接于远侧应变释放件204(并由此联接于转动器)。
如下文将进一步详细描述的,理想的是在生热元件24与脉管壁接触之后,使治疗器械12的细长轴杆16的远端区域20在肾动脉内转动。然而,临床医生在器械12的近端处转动整个手柄组件200会麻烦且不便,尤其是给定肾结构尺寸的情形下。转动器230相对于外壳组件240的转动致使细长轴杆16在手柄组件200不转动的条件下(即,在外壳组件240不转动的条件下)绕其纵向轴线转动。
由于控制线40和电源线29朝近侧终止于外壳组件240内,因而细长轴杆相对于外壳组件的显著独立转动会致使这些线变得绕彼此显著扭转和/或破损。可选的是,可提供一个或多个机械和/或机电转动联接件,以将控制线40中连接于支架的较近侧部分连接于控制线中行进通过细长轴杆16的较远侧部分,和/或将电源线29处于细长轴杆16中的较远侧部分连接于电源线处于外壳组件240中的较近侧部分。转动联接件可便于细长轴杆相对于外壳组件独立地转动,而不会产生显著的控制线和/或电源线扭曲,同时保持沿着电源线整个长度的导电性。
附加地或替代地,可提供转动限制元件,以限制细长轴杆16相对于手柄组件200的独立转动。现在参见图2-4,更详细地描述外壳组件240、转动器230、外部止动环220以及内部止动环210的相互作用。这些相互作用便于使细长轴杆16相对于手柄组件200独立转动,同时提供限制此种独立转动的转动限制元件,由此降低控制线和/或电源线发生缠结或破损的风险。
如前所述,内部止动环210同心地定位在外壳组件240的远侧部分上,外部止动环220同心地定位在内部止动环210上,而转动器230同心地定位在外部止动环220上。外壳组件240的远侧部分包括圆柱形部段254,且内部止动环210绕该圆柱形部段245同心地定位。该圆柱形部段相对于外壳组件240的就在该圆柱形部段254近侧的表面241具有减小直径,使得内部止动环210的近侧表面、外部止动环220以及转动器230邻接于外壳组件240的表面241。这些邻抵件可限制内部止动环210、外部止动环220和/或转动器230相对于外壳组件240的近侧移动。
内部止动环210的内直径仅略大于外壳组件的圆柱形部段254的外直径,使得内部止动环能绕圆柱形部段同心地转动。类似的是,外部止动环220的外圆柱形部段222的内直径略大于内部止动环210的内圆柱形部段212的外直径,使得外部止动环能绕内部止动环同心地转动。最后,转动器230近侧区域的内直径略大于外部止动环220在外部凸台224处的最外直径,使得转动器能绕外部止动环同心地转动。
手柄组件200的几何形状构造便于转动器230相对于外壳组件独立转动,同时限制转动器相对于外壳组件的纵向移动。通过连接于转动器,该细长轴杆16类似地可在不转动手柄组件200的条件下(即,在不转动外壳组件240的条件下)转动,同时手柄组件的移动还使细长轴杆移动。外壳组件240的远侧部分包括具有内腔257的外壳轴杆256(定位在外侧并且相对于外壳组件的圆柱形部段254具有减小的横截面)。转动器230包括转动器轴杆232,该转动器轴杆232具有内腔233并且构造成在转动器230附连于外壳组件240时定位在外壳轴杆256的内腔257内,以便于使转动器相对于外壳组件独立转动。
转动器230可选地能包括一个或多个转动器元件234,这些转动器元件配合或擦靠于外壳组件240的圆柱形部段254,从而在转动器相对于外壳组件240转动的过程中为看护者提供触觉反馈。圆柱形部段254的所有部分或一部分可选地可以包括与转动器元件234相互作用的表面轮廓或配合构造255,以提供此种触觉反馈(参见图4A和4B)。例如,表面轮廓255可包括交替的部段,其中圆柱形部段254的半径略增大然后减小。当看护者使转动器230转动时,在转动器元件234穿过增大直径部段时,阻力略微增大,而在转动器元件234穿过减小直径部段时,阻力略微减小。表面轮廓255的这些交替部段可绕圆柱形部段254的周缘穿过已知角部段。看护者可监测转动器元件234绕表面轮廓255的交替部段转动的过程中所提供的触觉反馈,以监测细长轴杆16的角转动程度。在一代表性实施例中,表面轮廓255在外壳组件240和转动器230之间每相对转动45度即提供触觉反馈(例如,增大和减小直径的交替部段之间的过渡),但此种触觉反馈替代地能以任何其它所希望的相对转动值所提供。
转动器元件234附加地或替代地可邻抵内部止动环210和/或外部止动环220,并且限制该内部止动环210和/或外部止动环220相对于转动器230的远侧移动,由此限制外壳组件240相对于转动器的远侧移动。外壳组件240相对于转动器230的移动附加地或替代地可经由配合元件235所限制,这些配合元件235从转动器元件234径向向内伸出,并且座落在外壳组件圆柱形部段254的减小直径的圆柱形沟道259内。配合元件235可包括单向阀,这些单向阀使得转动器能压靠于外壳组件上,且配合元件235在圆柱形沟道259内锁定就位。配合元件235便于转动器相对于外壳组件转动,同时限制外壳组件相对于转动器的近侧(和可选的远侧)移动。
作为限制外壳组件相对于转动器的近侧移动的另一技术,转动器的轴杆232的一部分可选地能略扩开,而外壳轴杆内腔257的远侧部分可相对于该内腔的较近侧部分(未示出)具有减小的横截面。转动器轴杆的扩开部可具有与外壳轴杆内腔的减小横截面部分相同的横截面或者略大的横截面。在手柄200的组装过程中,在转动器230联接于外壳组件240使得转动器的轴杆232定位在外壳轴杆256的内腔257内时,转动器轴杆的扩开部能与外壳轴杆内腔257的减小横截面部分配合并向该减小横截面部分施加摩擦。在手柄200的组装过程中,外壳轴杆内腔257的减小横截面部分相对于转动器轴杆232的扩开部的持续远侧行进可将外壳轴杆内腔的减小横截面部分定位在转动器轴杆扩开部的远侧。在此种构造中,转动器轴杆的扩开部可用作压配件,该压配件限制外壳组件240相对于转动器230的近侧移动,同时仍允许转动器230相对于外壳组件240转动,即经由定位在外壳轴杆256的内腔257内的转动器轴杆232的转动来实现。
能以各种方式来限制外壳组件240相对于转动器230的远侧移动,包括上文已描述的方式。作为另一示例,外壳轴杆256的远端可邻抵转动器230的远侧部分。替代地或附加地,转动器230的近侧区域可邻抵外壳组件240的表面241。作为又一示例,转动器的内表面可包括一个或多个结构或脊部236,这些结构或脊部从转动器的内表面径向向内延伸;且这些脊部可邻抵外部止动环220和/或内部止动环210的远侧表面,以限制外部止动环和/或内部止动环相对于转动器230的远侧移动,由此限制这些止动环和外壳组件240相对于转动器230的远侧移动。
细长轴杆16相对于手柄组件200的转动能以各种方式进行限制,例如能以各种方式限制成使细长轴杆相对于手柄组件转动预定或者较佳圈数。在图2-4中,经由设置在圆柱形部段254上的外壳突块258和外壳组件240的邻抵表面240(参见图4A)、经由内部止动环的既径向向外又朝内部止动环的内圆柱形部段212的近侧纵向延伸的内部弧形突出部214、经由外部止动环220的径向向外且沿外部止动环的外圆柱形部段222的长度纵向延伸的外部突出部224以及经由在转动器的近端处或附近从转动器230的内壁径向向内延伸的转动器突出部238来实现细长轴杆的转动限制。
下文将更详细进行描述的是,看护者致使转动器230相对于外壳组件240的转动会致使转动器突出部邻抵外部突出部224,从而限制转动器相对于外部止动环220的进一步转动;可致使外部突出部224邻抵内部弧形突出部214,从而限制外部止动环相对于内部止动环210的进一步转动;并且可致使内部弧形突出部214邻抵外壳突块258,从而限制内部止动环相对于外壳组件240的进一步转动,由此限制转动器相对于外壳组件的进一步转动。由于细长轴杆16联接于转动器230,因此还限制细长轴杆相对于手柄组件的转动。
在图3A和4B中最佳示出,在手柄200的已组装构造中(即,内部止动环210绕外壳组件240的圆柱形表面254同心地定位,外部止动环220绕内部止动环同心地定位,且转动器230绕外部止动环同心地定位),内部止动环210的内部弧形突出部214、外部止动环220的外部突出部224以及转动器230的转动器突出部238邻抵外壳组件240的表面241。如前所述,内部止动环210的内直径略大于外壳组件240的圆柱形部段254的外直径,便于使内部止动环相对于外壳组件转动,且内部止动环绕该圆柱形部段同心地定位。然而,当朝内部止动环210的内圆柱形部段212的近侧纵向延伸的内部弧形突出部214与从外壳组件240的圆柱形表面254径向向外延伸的外壳突块258转动对准时,内部弧形突出部邻抵外壳突块;此种邻抵靠限制内部止动环相对于外壳组件的进一步转动。注意到,外壳组件240的圆柱形部段254上的外壳突块258不会径向向外延伸到与外部止动环220或与转动器230相互作用的程度(即,外壳头不会延伸超出内部止动环210的内圆柱形部段212的外直径)。
此外如前所述,外部部止动环220的外圆柱形部段222的内直径略大于内部止动环210的内圆柱形部段212的外直径,便于使外部止动环相对于内部止动环转动,而该外部止动环的外圆柱形部段绕该内部止动环的内圆柱形部段同心地定位。然而,内部止动环210在内部弧形突出部214处的最外直径大于内部止动环的内圆柱形部段212的外直径(确切地说,内部止动环210在内部弧形突出部214处的最外直径粗略地等于外部止动环220的外圆柱形部段222的外直径;因此,该内部弧形突出部并不与转动器230相互作用)。因此,当外部止动环的沿外部止动环的外圆柱形部段222并且朝该外圆柱形部段的近侧延伸的外部突出部224与内部止动环210的内部弧形突出部214转动对准时,该内部止动环的内部弧形突出部214邻抵外部止动环的外部突出部224;此种邻抵限制外部止动环相对于内部止动环的进一步转动。
此外,如前所述,转动器230近侧区域的内直径略大于外部止动环220在外部突出部224处的最外直径,便于使转动器相对于外部止动环转动。外部止动环220的外圆柱形部段222的外直径小于外部止动环230在外部突出部224处的最外直径。可以从转动器230的内表面上的其中一个脊部236朝近侧纵向延伸的转动器突出部238从转动器230的内表面径向向内延伸。转动器230在转动器突出部238处的最内直径小于外部止动环220在外部突出部224处的最外直径,但却大于外部止动环220的外圆柱形部段222的外直径。因此,当转动器的转动器突出部238与外部止动环的外部突出部224转动对准时,该转动器突出部邻抵外部突出部;此种邻抵限制转动器230相对于外部止动环220的进一步转动。
注意到,转动器突出部238并不径向向内延伸与转动器230的脊部236相同的程度。这样,虽然在手柄200的组装构造中,外部止动环220的圆柱形部段222的远侧表面可邻抵脊部236,外圆柱形部段可与转动器突出部238同心地定位在转动器230内。然而,将外部止动环220在外部突出部224处的最外半径设计成,转动器230相对于外部止动环转动直到转动器突出部238与外部突出部224对准为止,从而致使转动器突出部邻抵外部突出部,由此限制转动器230相对于外部止动环220的进一步转动。
转动器230的转动器突出部238与外部止动环220的外部突出部224的邻抵、外部突出部224与内部止动环210的内部弧形突出部214的邻抵以及内部弧形突出部214与外壳组件240的圆柱形部段254的外壳突块258的邻抵限制转动器230相对于外壳组件240的转动。看护者致使转动器230沿给定方向相对于外壳组件240的持续转动会致使转动器突出部238邻抵外部突出部224,从而限制转动器沿给定方向相对于外部止动环220的进一步转动;可致使外部突出部224邻抵内部弧形突出部214,从而限制外部止动环沿给定方向相对于内部止动环210的进一步转动;并且可致使内部弧形突出部214邻抵外壳突块258,从而限制内部止动环沿给定方向相对于外壳组件240的进一步转动,由此限制转动器沿给定方向相对于外壳组件的进一步转动。由于细长轴杆16联接于转动器230,因此还限制细长轴杆相对于手柄组件的转动。
转动器230能在其转动器突出部238邻抵外部止动环220的外部突出部224之前沿给定方向大约转动一整圈。转动器230沿给定方向的持续转动使外部止动环220跟随转动器转动,直到外部止动环的外部突出物224邻抵内部止动环210的内部弧形突出部214为止。转动器230沿给定方向的进一步持续转动使外部止动环和内部止动环都跟随转动器转动,直到内部弧形突出部214邻抵外壳组件240的圆柱形表面254的外壳突块258为止,阻止转动器沿给定方向的任何进一步转动。转动器沿相反方向的转动在转动沿该相反方向被限制之前能进行相同数量的圈数。
外部止动环220相对于内部止动环210的转动度数和内部止动环210相对于外壳组件240的转动度数由内部止动环210的内部弧形突出部214的弧长所确定。在图2-4所示的实施例中,内部弧形突出部包括大约180°的弧长。这样,外部止动环可相对于内部止动环转动大约1/2圈,而内部止动环可相对于外壳组件转动大约1/2圈。因此,转动器230(由此细长轴杆16)相对于外壳组件240的转动被限制成大约两整圈。
对于本领域那些技术人员显而易见的是,通过改变内部弧形突出部214的弧长,转动器230相对于外壳组件240转动的整圈数可在约1整圈和3整圈之间改变为任何所希望的值(接近360°的弧长将完整转动限制为约1圈,而接近0°的弧长会允许接近3整圈)。对于本领域那些技术人员会显而易见的是,可使用附加止动环和突出部来进一步扩大转动圈数。
在图2A中最佳示出,转动器230可选地能包括视觉指示器234,该视觉指示器可例如在细长轴杆16的远端区域20处与生热元件24径向对准。看护者可使用视觉指示器231来监测生热元件24的定向和/或监测生热元件的转动度数。
现在参见图5,手柄组件200可包括一个或多个可选结构,用以限制致动器260由于看护者而产生的转动(且由此限制支架的移动以及生热元件24的偏转),和/或用于增大摩擦以在此种看护者致动过程中提供触觉反馈或摩擦锁定。如图5所示,外壳组件240可包括远侧硬面止动垫片300,该远侧硬面止动垫片与致动器按钮臂272配合并且限制致动器260的远侧转动(参见图5A)。附加地或替代地,外壳组件可包括可调近侧硬面止动件302,该可调近侧硬面止动件可用于动态地调节致动器260的许可转动度数。在图5A中,可调近侧硬面止动件302并不延伸且并不限制致动器的近侧转动。在图5B中,止动件302延伸所希望的量值,并且减小致动器260的可实现的近侧转动度数。
外壳组件240还可包括弹簧制动件310,该弹簧制动件310具有定位在下部外壳244的沟道251的任一侧上的弹簧312(例如,悬臂式压簧)。如前所述,支架280的翼部281定位在下部外壳的沟道251内。在使用弹簧制动件310时,定位在支架的翼部281的任一侧上的弹簧312在支架280的移动期间压靠于翼部并且增大摩擦。可根据需要确定施加于支架280的摩擦力(静态或滑动)的数值,例如通过选择支架和弹簧的材料来获得所期望的摩擦系数,通过指定用在弹簧制动件310中的弹簧312的弹簧常数,和/或通过弹簧制动件310和支架翼部281的相对定位(即,通过指定施加于翼部281的法向力)。在另一实施例中,弹簧制动件310可包括单个弹簧312,该单个弹簧可定位在下部外壳沟道251和支架翼部281的任一侧上。
参见图6,描述一种手柄组件200的替代实施例,该手柄组件具有在致动器260的看护者致动过程中产生摩擦的替代摩擦产生机构。在图6所示的实施例中,手柄组件不再包括O形圈275,致动器260不具有阳附连轮廓274,且下部外壳244不具有阴附连轮廓249。反而,致动器260包括与下部外壳244的摩擦表面253配合的摩擦臂268。当致动器按钮270在致动器沟槽250内从较远侧位置转动至较近侧位置时,摩擦臂268可与外壳的摩擦表面253配合,擦靠于该表面和/或挠曲以与致动器本体262接触,由此增大摩擦。增大摩擦这可为看护者提供触觉反馈和/或可提供摩擦锁定,该摩擦锁定暂时保持致动器260相对于外壳组件240的转动位置(以及由此支架280和控制线40的移动位置)。
当致动器按钮270在致动器沟道250内朝近侧转动、由此支架280朝近侧移动且远端区域20的中间柔性区34经由控制线40偏转时,该中间柔性区34可通过控制线和支架将回复力矩传送至致动器260。该回复力矩可试图使中间柔性区的偏转反向,并使致动器按钮270在致动器沟道250内返回转动至较远位置。由摩擦臂268抵靠摩擦表面253的配合所提供的增大摩擦会对中间柔性区的回复力矩起反作用,以暂时保持中间柔性区34的偏转。可提供现有技术中已知的附加替代摩擦和锁定机构。
如前所述,由于存在从手柄组件200行进通过治疗器械12的细长轴杆16的线缆和线(例如,控制线40和电源线29,例如输电线、热电偶线等等),理想的是限制细长轴杆16相对于这些线的转动,以避免这些线发生不必要的缠结和扭转。之前描述的手柄组件200的转动限制元件满足此种需求。图7示出用于手柄组件200的替代转动限制元件和转动控制机构。
在图7所示的实施例中,手柄组件并不包括内部止动环210或外部止动环220。反而,转动器230包括轴向沟槽116,而手柄组件240的远侧部分包括具有螺旋沟槽120的装配接合部118。包括不锈钢或其它金属或聚合物的球122放置在装配接合部118内,从而在转动器转动的条件下,该球能同时在装配接合部118的螺旋沟槽120内并且沿转动器的轴向沟槽116行进。当球122到达沟道和/或沟槽的端部时,该球将不再运动,由此转动器将无法沿该方向进一步转动。
在给定结构或尺寸约束(例如,线)的条件下,转动器230和手柄组件240能构造成使得轴杆16具有较佳的回转数。手柄组件的部件可例如构造成使得轴杆独立于手柄组件转两圈。可例如通过将外壳组件240的螺旋沟道120的直线长度指定为转动器230在轴向沟槽116附近的内圆周的所希望部分或多个内圆周(例如,螺旋沟道120的直线长度可以是转动器230在轴向沟槽116附近的内圆周的大约两倍)来实现将轴杆的转动限制成较佳数量的回转。附加地或替代地,附加球122(未示出)可定位在轴向沟槽116内并与第一球122隔开,使得该附加球与第一球隔开地在螺旋沟道120内行进。在此种实施例中,附加球会在该球到达沟道的一端时限制沿一个方向的转动,同时第一球会在该球到达沟道的另一端时限制沿另一方向的转动。这样,这两个球会将转动器的转动限制成一定弧长,而该弧长比另外由螺旋沟道120的直线长度所提供的弧长短。
现在参见图8,简要地描述手柄组件200的操作以操纵肾动脉内的治疗器械12。如已进行描述并且将在下文进行更详细描述的,通过血管内通道,看护者能操纵手柄组件200,以将细长轴杆16的远端区域20定位在相对应肾动脉内。然后,看护者能操作手柄组件200的致动器260,以使生热元件24绕中间柔性区34偏转。看护者还能操作手柄组件200上的转动器230,以沿细长轴杆16施加转动力。
细长轴杆16在中间柔性区34于相对应肾动脉内偏转时的转动使生热元件24在相对应肾动脉内转动,从而易于实现与脉管壁的接触并确定是否存在壁接触,尤其是在存在不良血管造影术的平面中。转动可与生热元件24的移动组合起来,用以将生热元件在相对应肾动脉内定位在不同的径向和纵向位置处,以在肾动脉内的多个位置处输送能量。
如图8所示,看护者由此能够将手柄组件200的近侧部分保持转动地稳定在一只手中,而利用相同的手或不同的手将扭转力施加给转动器230,以使细长轴杆16转动。这使得转动器260能保持易于被触及,用以控制细长轴杆16的远端区域20的中间柔性区34的偏转。诸如上文所述的转动限制元件限制轴杆16相对于手柄组件200的转动,以避免控制线和电源线产生不必要的缠结和扭转。
在所披露技术的另一方面,手柄组件200可构造成使操作者/看护者最小程度地对在患者体内的器械进行操纵。如图2-7所示,手柄组件200还可包括基本上适应于下方表面(例如,操作台)的一个或多个表面243。在图2-7中被示作基本上平坦的表面243,根据下方表面的构造和/或几何形状,还可以是弯曲的、成形的或角形的。当治疗器械12位于患者体内时,该适应表面243使得看护者能保持手柄组件200稳定。为了使器械在位于患者内部时转动,该操作者能简单地拨动转动器230,而无需提升手柄组件200。当操作者希望收回器械以进行随后的治疗时,该操作者能简单地使手柄组件沿下方表面滑至下一位置。同样,这使得由于操作者对于治疗器械的误操纵或过操纵所引起的伤害风险减轻。附加地或替代地,适应表面243能使用夹持件、织物结构、粘合剂等等与下方表面配合。
对于在此所披露的转动机构的附加改进包括在转动器230上提供触觉和/或视觉反馈,使得操作者能在转动该器械时能行使更大的控制和维护。转动器230还能选择性地锁定于接合部,由此如果操作者希望将治疗器械保持于特定角位置的话,能防止进一步转动。此外,转动器230可选地能经由转动齿轮机构联接于细长轴杆16,使得转动器230的转动角度成一定比例,以使细长轴杆16产生或大或小的转动。
其它可选的改进包括沿轴杆/手柄组件提供距离标记,以使操作者能在收回治疗器械时规整距离。又一可选改进包括提供替代的致动器,该致动器将细长轴杆相对于外壳组件的控制与细长轴杆远侧区域偏转的控制组合起来。又一种可选改进包括在手柄组件上提供致动器,用以控制能量输送、获取测量值或者致动传感器。另一可选改进包括提供音频或视频信号,该音频或视频信号指示传感器反馈或者偏转或转动的量。
IV.系统的使用
A.治疗器械的血管内输送、偏转和放置
可使用传统的套线技术在引导线上对在此所描述的治疗器械12的任一实施例进行输送。当以此方式进行输送时(为示出),细长轴杆16包括容纳引导线通过的通道或内腔。
或者,能使用传统的引导导管或者预弯曲的肾引导导管(未示出)来使用在此所描述的任一治疗器械12。
当使用引导导管时,在股三角的基部处露出股动脉并且使用传统技术对股动脉进行插管。在一示例性方案中,引导线(未示出)通过通入位点插入并使用影像引导通过股动脉、进入髂动脉和主动脉并进入左侧肾动脉或右侧肾动脉。引导导管可在引导线上通到所通入的肾动脉中。然后,去除引导线。或者,可使用特定地将形状和构造设计成通入肾动脉的肾引导导管,以避免使用引导线。又或者,该治疗器械可使用血管造影术从股动脉行进至肾动脉,而无需使用引导导管。
当使用引导导管时,可使用至少三种输送方案。在一个示例性方案中,一种或多种前述输送技术可用于将引导导管定位在就在肾动脉入口远侧的肾动脉内。然后,治疗器械经由引导导管行进到肾动脉中。一旦治疗器械适当地定位在肾动脉内,则引导导管从肾动脉抽出并进入腹主动脉中。在此种方案中,引导导管应将尺寸和构造设计成容纳治疗器械通过。例如,可使用6弗伦奇的引导导管。
在第二示例性方案中,第一引导导管(利用或不利用引导线)放置在肾动脉的入口处。该第二引导导管(借助或不借助引导线)经由第一引导导管通到肾动脉中。然后,治疗器械经由第二引导导管行进到肾动脉中。一旦治疗器械适当地定位在肾动脉内,则将第二引导导管抽出,而第一引导导管留在肾动脉的入口处。在此种方案中,第一引导导管和第二引导导管应将尺寸和构造设计成容纳第二引导导管通过第一引导导管内(即,第一引导导管的内直径应大于第二引导导管的外直径)。例如,第一引导导管在尺寸上可以是8弗伦奇,而第二引导导管在尺寸上可以是5弗伦奇。
在第三示例性方案中,肾引导导管定位在腹主动脉内,并且就在肾动脉的入口近侧。在此所描述的治疗器械12通过引导导管并进入所通入的肾动脉。细长轴杆16响应于通过手柄组件200施加给力传递部段30的力而无损地通过引导导管。近侧柔性区32容纳左/右肾动脉和主动脉的结合部处的显著挠曲,以通过引导导管进入相对应的左侧或右侧肾动脉。
如图9A所示,位于细长轴杆16的远端部分上的中间柔性区34现在能轴向地移动到相对应的肾动脉中,并且以受控方式在相对应的肾动脉内被远程地偏转和/或转动,以实现与相对应肾动脉的内壁相接近和所希望的对准。远侧柔性区44弯曲以将生热元件24放置成与肾动脉的内壁上的组织相接触。
如图9B所示,由细长轴杆16的远端区域20的近侧柔性区32、中间柔性区34以及远侧柔性区44所形成的复杂多弯曲结构在生热元件24和相对应肾动脉内的组织之间产生恒定且可靠的有效接触表面积。现在,能通过生热元件24施加热能,以在沿相对应肾动脉的组织的局部区域上引起一个或多个生热效果。
B.便于与脉管壁接触
如前所述,致动控制线40以使中间柔性区34偏转有助于将生热元件24定位成与脉管壁相接触。当治疗器械12的远端区域20被输送到肾动脉中时,这尤其有用。由于(可选)肾引导导管的弯曲和放置以及治疗器械12的定向,因而治疗器械的远端区域20在第一次被输送到肾动脉中时向上定向成抵靠于脉管壁的上方区域。如图9A所示,一旦该远端区域定位在主肾动脉的最远位置处时,操作者能经由联接于支架280和控制线40的致动器260使中间柔性区34偏转,以使生热元件24定位成在更下方的位置处与脉管壁相接触。中间柔性区34的此种偏转经由远侧柔性区44建立壁接触,并且在生热元件24和脉管壁之间提供稳定力,以将生热元件定位成与脉管壁相接触。然而,操作者可在该大体下方(底部)位置开始治疗,或者如图9C所示经由转动器230转动该治疗器械12用于替代的治疗位置。
不仅通过致动器260的操作、而且通过中间柔性区34的近侧区域和肾动脉的上方区域之间的接触来便于使中间柔性区34主动偏转。如图9A所示,该接触区域124通常发生在中间柔性区34的弯曲顶点处。该接触区域124与由于中间柔性区34偏转而在生热元件24和脉管壁之间产生的接触径向相对。接触区域124处的反作用力还有利于由中间柔性区34提供给生热元件24的稳定力。如图9C所示,即使当操作者转动治疗器械以使生热元件周向地重新定位时,该反作用力仍会保持,只是保持在不同的周向位置处。图9D示出生热元件24从与病变部98(a)相对应的第一治疗位置周向地转动至与病变部98(b)相对应的第二治疗位置,以及中间柔性区34周向地移动至新的接触区域124。然而,应注意的是,虽然接触区域124处的此种对向接触有利于壁接触和稳定力,但通常不需要在生热元件24和脉管壁之间实现接触。
在某些实施例中,在中间柔性区处或附近,使导管设备装备有第二生热元件(未示出),这也会是有利的。将第二生热元件放置在中间柔性区上或近侧可允许在接触区域124处或周围产生受热影响的组织区域(即,脉管壁与中间柔性区相接触的部分)。在导管设备的单次放置过程中,致动第一生热元件和第二生热元件会使得操作者能产生周向和纵向偏离的两个治疗区域。
C:产生受热影响的组织区域
如前所述,生热元件24能通过沿近侧柔性区32弯曲而定位在相对应肾动脉内的第一所希望轴向位置处。如图9A所示,生热元件24能通过中间柔性区34的偏转而朝脉管壁径向定位。此外如图9A所示,生热元件24能通过使远侧柔性区44的进一步偏转而被放置到与脉管壁具有较佳表面积接触的状况。
一旦生热元件24通过中间柔性区34的偏转、远侧柔性区44的偏转以及导管的转动的组合而定位在所希望位置,则可实施第一次局部治疗。通过经由生热元件24施加能量,如图9B所示可形成第一受热影响的组织区域98(a)。在所说明的实施例中,受热影响的区域98(a)采取在相对应肾动脉的脉管壁上具有病变部的形式。
在形成第一受热影响的组织区域98(a)之后,导管需要重新定位以进行另一次热治疗。理想的是,产生沿肾动脉的纵向轴线周向隔开的多个病灶性损伤。为此,抽回导管并且可选地转动,以沿血管的纵向轴线朝近侧来定位生热元件。例如经由转动器230相对于外壳组件240的转动,细长轴杆16在通入位点外部的转动(参见图9C)用于使生热元件24绕肾动脉重新轴向定位。
一旦生热元件24在肾动脉内定位在与如图9C和9D所示第一所述轴向位置隔开的第二轴向和周向位置(例如,98(b)),则可实施另一次病灶性治疗。通过重复刚才描述的操纵步骤,看护者能在脉管壁上产生轴向和周向隔开的若干受热影响的组织区域,且第一受热影响的组织区域98(a)是最远的,而紧随的受热影响的组织区域是较近的(反之亦然)。若干周向和轴向隔开的治疗能提供基本上周向的覆盖,并且由此对肾神经产生神经调节作用。临床研究指出:每个病变部会覆盖围绕肾动脉的周向区域的大约20%-30%。在其它实施例中,每个病变部的周向覆盖可以是50%。
(v)附加的实施例
A.在偏转过程中保持纵向位置
如上所述,临床治疗医师希望使用治疗器械来沿着血管的纵向轴线产生多个受热影响的治疗区域。通常,能首先产生最远的治疗区域,并且将治疗器械纵向地抽出,以将治疗器械的生热元件沿着血管的纵向轴线定位在相继的近侧位置中。在某些构造中,有利的是以特定距离(例如,5mm)将一系列治疗区域隔开。为了在连续的治疗区域之间实现精确且一致的间隔,治疗医师可依赖于生热元件离开之前治疗区域的定位来作为参照点而确定。
如图10A所示,在治疗器械的远端区域处于基本上平直构造中时,生热元件24首先在血管内定位在远侧位置160处。在操作致动器260时,中间柔性区34可偏转,以使生热元件移动并且将生热元件定位成在位置162处与脉管壁接触。如图10B所示,生热元件的移动具有两个分量:径向远离远端区域的轴线的移动(Y)和沿着血管的纵向轴线的移动(X)。如果在产生治疗区域之后治疗器械的远端区域返回至基本上平直构造(例如,通过使致动器260返回至其初始位置),则生热元件返回至位置160,且生热元件现在纵向地位于治疗区域远侧的距离X处(即,位置160和162之间的纵向间隔是X)。该距离X会影响生热元件在后续近侧治疗中的精确定位,因为治疗医师会将位置160用作参照点。
可通过重新构造手柄、并且尤其是外壳组件240、细长轴杆16、控制线40以及支架280的设计来解决上述可能的定位顾虑。在之前描述的实施例中,通过操作致动器260朝近侧抽出支架280,以向控制线40施加张力并且相对于细长轴杆16轴向地抽出控制线40。该张力会致使中间柔性区34偏转和/或弯曲,由此便于使生热元件24移动。在图11所示的替代实施例中,手柄200构造成使得控制线40无法相对于外壳组件240轴向运动。更确切地说,细长轴杆16联接于支架280,从而支架280相对于外壳组件240的轴向远端致使细长轴杆16相对于控制线40轴向运动。如图11所示,致动器260在近侧位置启动,从而致动器按钮270的远侧运动致使支架280和细长轴杆16进行远侧轴向运动。细长轴杆16相对于控制线40的远侧运动会在治疗器械的远端区域中产生张力,由此致使中间柔性区偏转和/或弯曲。由于控制线40无法相对于外壳组件240轴向运动,中间柔性区34在此种构造中会发生偏转,而不会使生热元件产生显著的纵向移动。
B.组合的致动器和转动器
虽然上述实施例会便于对生热元件进行精确地定位和分隔来用于连续的治疗区域,将细长轴杆联接于致动器组件的支架会影响轴杆相对于手柄的独立转动。解决此种问题的一种可能的改进会是将转动联接件(例如,夹环连接件)包含到手柄组件中,以使得细长轴杆能独立于外壳组件而转动。
在一替代实施例中,外壳组件可构造有远侧区域和近侧区域,其中远侧区域包括转动器,以便于使远侧区域独立于近侧区域而转动。在该实施例中,远侧区域还包括致动器组件,该致动器组件包括致动器和支架,其中支架固定地联接于支架。在该构造中,外壳组件的远侧区域可使细长轴杆独立于外壳组件的近侧区域而转动。
结论
本发明实施例的上述详细描述并不想要是穷举或将本发明限制于上述的准确形式。尽管为了说明的目的而描述了本发明的特定实施例和例子,在本发明的范围之内可以有各种等效的变型,如那些熟悉本领域的人们会认识到的那样。例如,尽管以给定的顺序提出各步骤,但替代的实施例可以不同的顺序来执行这些步骤。作为另一示例,系统10可具有不同的构造和/或包括不同的结构,例如可使用诸如多电极笼状物或其它可膨胀气囊装置之类的多生热元件装置,以在不与脉管壁接触的条件下在血管内输送神经调节治疗。还可以组合本文所述的各种实施例来提供另外的实施例。
从上文中,应意识到在此已描述了本发明的特定实施例来进行说明,但并未示出或详细描述已知结构和功能,以避免不必要地模糊对本发明实施例的描述。只要内容允许,单数或复数也可分别包括复数或单数。此外,除非单词“或者”显著地被限定成仅仅意味单个术语,而非与一列两个或多个术语相关的其它术语,则在此种列表中使用“或者”应被解释成包括(a)该列表中的任何单个术语,(b)该列表中的所有术语,或者(c)该列表中术语的任何组合。此外,术语“包括”在全文用于意味着至少包括所描述的特征,从而并不排除任何更多数量的相同特征和/或附加类型的其它特征。还应理解的是,本文已描述了特定实施例来进行说明,但可在不偏离本发明的条件下进行各种改变。因此,本发明仅仅由所附权利要求所限定。
Claims (13)
1.一种用于实现血管内热诱发肾神经调节的血管内治疗器械的手柄组件,包括:
外壳(240);
转动器(230),所述转动器联接于细长轴杆(16)的近侧区域,所述细长轴杆构造成定位在肾动脉内,并沿着轴线延伸并且具有可偏转远侧区域;以及
致动器(260),所述致动器可操作地联接于所述细长轴杆的可偏转远侧区域,
其中所述致动器(260)构造成使所述细长轴杆(16)的可偏转远侧区域(20)偏转,
所述转动器(230)构造成在不使所述外壳(240)转动的情形下使所述细长轴杆(16)绕所述轴线转动,
所述手柄组件(200)包括转动限制元件(122,210,220),所述转动限制元件构造成防止所述细长轴杆(16)转动超出预定数量的圈数,
所述致动器(260)可操作地连接于控制线(40),所述控制线沿着所述细长轴杆(16)从所述手柄组件(200)延伸至所述可偏转远侧区域(20),
所述致动器(260)构造成向所述控制线(40)施加张力,以使所述细长轴杆(16)的可偏转远侧区域(20)偏转,
所述手柄组件(200)还包括:
支架(280),所述支架联接于所述致动器(260),
其中,所述控制线(40)联接于所述支架(280),以及
所述致动器(260)构造成使所述支架(280)相对于所述外壳(240)运动,以向所述控制线(40)施加张力。
2.如权利要求1所述的手柄组件,其特征在于,所述控制线(40)在所述细长轴杆(16)的内腔内延伸。
3.如权利要求1所述的手柄组件,其特征在于,所述致动器(260)构造成使所述支架(280)相对于所述外壳(240)朝近侧移动,以向所述控制线(40)施加张力。
4.如权利要求3所述的手柄组件,其特征在于,所述致动器(260)构造成相对于所述外壳(240)转动,其中所述支架(280)以将所述致动器(260)转动转换成所述支架(280)移动的方式联接于所述致动器(260)。
5.如权利要求4所述的手柄组件,其特征在于,所述致动器(260)和所述支架(280)的联接件包括凸轮(266),所述凸轮将所述致动器(260)的转动转换成所述支架(280)的移动。
6.如权利要求1所述的手柄组件,其特征在于,所述致动器(260)在所述外壳(240)内联接于所述支架(280)。
7.如权利要求1所述的手柄组件,其特征在于,所述转动限制元件(122,210,220)构造成将所述细长轴杆(16)的转动限制成预定数量或圈数,所述预定数量的圈数在1圈至3圈的范围内,
或者,所述转动限制元件(122,210,220)构造成防止所述细长轴杆(16)转动超出2圈。
8.如权利要求1所述的手柄组件,其特征在于,所述转动限制元件(122,210,220)包括对于所述转动器的持续转动的几何约束,所述几何约束防止所述细长轴杆(16)转动超出预定数量的圈数。
9.如权利要求8所述的手柄组件,其特征在于,所述几何约束包括所述转动器(230)和所述外壳(240)的邻抵件。
10.如权利要求9所述的手柄组件,其特征在于,所述邻抵件还包括至少一个转动止动环(210,220),所述至少一个转动止动环定位在所述转动器(230)和所述外壳(240)之间,并且构造成将所述细长轴杆(16)的转动扩展为所述预定数量的圈数。
11.如权利要求9所述的手柄组件,其特征在于,所述邻抵件还包括球(122),所述球定位在形成于所述转动器(230)和所述外壳(240)之间的定长螺旋通道(120)内。
12.如权利要求1所述的手柄组件,其特征在于,所述外壳(240)还包括适应表面(243),所述适应表面基本上与在使用期间其上放置有所述手柄组件(200)的表面相适应。
13.如权利要求1所述的手柄组件,其特征在于,所述细长轴杆(16)还包括血管内治疗器械(12)。
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WO2011130005A3 (en) | 2012-01-05 |
CN103096825A (zh) | 2013-05-08 |
EP2558015B1 (en) | 2018-12-19 |
ES2715642T3 (es) | 2019-06-05 |
WO2011130005A2 (en) | 2011-10-20 |
EP2558015A2 (en) | 2013-02-20 |
US20100249773A1 (en) | 2010-09-30 |
US8808345B2 (en) | 2014-08-19 |
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