CN104244854A - 冷冻治疗导管内具有卸压件的杆及相关装置、系统和方法 - Google Patents

冷冻治疗导管内具有卸压件的杆及相关装置、系统和方法 Download PDF

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CN104244854A
CN104244854A CN201380022045.2A CN201380022045A CN104244854A CN 104244854 A CN104244854 A CN 104244854A CN 201380022045 A CN201380022045 A CN 201380022045A CN 104244854 A CN104244854 A CN 104244854A
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S·纳什
G·凯利
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Medtronic Ardian Luxembourg SARL
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Abstract

本文公开了具有可促进在排出通道阻塞情况下卸压的特征的冷冻治疗系统以及相关装置、系统和方法。根据特定实施例构造的冷冻治疗系统可包括具有远部和远部近侧的卸压部的细长杆。冷冻治疗系统还可包括供给内腔、排出通道和构造成从供给内腔接收制冷剂并将制冷剂排出到排出通道的囊体。卸压部可构造成当排出通道内的制冷剂压力超过小于囊体的压力额定值的阈值压力时从排出通道释放制冷剂。卸压部例如可包括构造成在约所述阈值压力下破裂的破裂件。

Description

冷冻治疗导管内具有卸压件的杆及相关装置、系统和方法
技术领域
本技术总地涉及冷冻治疗装置(例如包括构造成在患者的脉管系统内扩张的囊体的冷冻治疗导管)。具体来说，几个实施例涉及在冷冻治疗导管内具有卸压件的杆以及相关装置、系统和方法。
背景技术
冷冻治疗在广泛的基于导管的介入手术中会是一种有用的治疗方式。例如，冷冻治疗冷却可用于调节神经或影响身体内邻近解剖血管或其它内腔或空腔的其它组织。这可减少不希望的神经活动来实现治疗益处。可使用利用冷冻治疗的基于导管的神经调制例如来调制神经并由此减轻疼痛、局部交感神经活动、全身交感神经活动、相关病状或其它状况。冷冻治疗也可用于消融肿瘤、治疗狭窄以及其它引用。在某些冷冻治疗程序中，其可用于经由在解剖脉管或内腔内可扩张的囊体来递送冷冻治疗。这些囊体可以操作地连接到体外支撑部件(例如制冷剂源)。随着用于外科干预冷冻治疗的应用不断扩大，需要相关装置、系统和方法的创新(例如关于效能、效率和/或可靠性)。这种创新有可能进一步扩大作为改善患者健康的工具的冷冻治疗的作用。
附图说明
参照以下附图可更好地理解本发明的多个方面。图中的各部件不一定是按比例的。而是，重点在于清楚示出本技术的原理。此外，在某些视图中部件可示出为透明的，仅是为了说明而不是表示所示部件必需透明。
图1是示出根据本技术实施例构造的冷冻治疗系统的立体图。
图2是图1的冷冻治疗系统的剖视图。
图3-6是示出根据本技术其它实施例构造的冷冻治疗系统的剖视图。
具体实施方式
本文参照图1-6描述本技术的几个实施例的具体细节。总体来说，除非上下文另有说明，本说明书中的术语“远侧”和“近侧”是指相对于制冷剂源、操作者和/或到患者体内入口点的位置。为了便于参考，整个本公开中，相同的附图标记用于标示类似或相似部件或特征，但使用相同的附图标记并不暗示这些部件应当结构相同。实际上，在本文所述的多个实例中，相同标号的部件在结构和/或功能上是不同的。
在冷冻治疗过程中，可能理想的是以高选择性施加冷却。减少非目标结构和组织的冷却可提高冷却效率并减少并发症。尽管高压制冷剂和低温制冷剂都能用于冷冻治疗，但高压制冷剂会尤其适于向体内的具体部位递送强烈、有针对性的冷却，尤其在相对小直径的导管内。在许多情况下，高压制冷剂的冷却能力在通过导管输送期间比低温制冷剂更易于保持。例如，合适的强壁导管可用于以相对少的冷却能力损失从体外源将高压制冷剂输送到导管远端处的递送部位，因为冷却作用在制冷剂在导管远端处膨胀时发生。相反，当低温制冷剂沿导管移动时，其会难以防止低温制冷剂从周围结构和组织吸热。热隔离可用于一定程度上控制这种热传递，但足够热隔离在用于现代小直径导管是过于笨重。
尽管在许多方面是有利的，使用高压制冷剂会对导管构造造成某些限制。例如，构造成运载制冷剂源的管子由金属、硬质聚合物(例如聚酰亚胺)或其它合适材料构成，并具有允许管子具有高于其构造成运输制冷剂的压力的压力额定值。在高压制冷剂经受膨胀和冷却之后，其压力会显著降低。因此，含有膨胀后制冷剂的导管部件并不限于压力额定值高于膨胀前制冷剂压力的强壁管子和类似高压结构。此外，某些冷冻治疗过程使用囊体，因为它们在不充胀时可相对紧凑，由此允许通过窄解剖脉管和内腔进行递送，且它们可膨胀成大致符合治疗部位的尺寸和形状。囊体还可以具有适于冷冻治疗热传递的相对薄壁。但薄壁冷冻治疗囊体通常具有相对低的压力额定值。例如，冷冻治疗囊体通常具有低于适当高压制冷剂的供给压力的压力额定值。
在本技术的某些实施例中，高压制冷剂可沿导管长度的至少一部分输送，并然后经由仅焦耳-汤姆逊效应或与政法冷却的组合膨胀到相对低温和低压的状态。导管可构造成使得膨胀可在囊体处或附近发生。由于充分的压降，可实现从近环境温度到冷冻温度的冷却。用于冷冻治疗装置的加压和膨胀的合适制冷剂包括例如N2O、CO2和氢氟烃(如氟里昂致冷剂，R-410A等)、等等。为了保持囊体内的压降，可设置从囊体到大气或到低压储存容器的排出通道。由于膨胀的制冷剂比高压制冷剂具有更低密度，排出通道会具有比相应供给内腔更大的自由通过面积。在正常操作期间，经由排出通道的膨胀制冷剂的排放将囊体内的压力保持到充分低于与制冷剂源相关的高压。
如果阻塞排出通道，同时高压制冷剂源到囊体的供给继续，则囊体内的压力会累积直到其与供给内腔的压力平衡为止。类似地，如果排出通道局部阻塞，则囊体内的压力可接近较低但仍然升高的压力。排出通道可由于操作者错误(例如如果运载排出通道的体外线路扭结或挤压或者如果背压控制阀意外关闭)而部分或完全阻塞。在这些或其它这种情形下，可能囊体内的压力会超过囊体的压力额定值，这会与囊体可能失效的压力相关。囊体故障可包括例如爆裂、泄露、过度膨胀(例如超过周围解剖脉管或内腔的弹性公差)或其组合。在某些情况下，囊体的压力额定值可对应于囊体的爆裂压力。出于几个原因，不希望的是囊体在程序期间失效。
根据本技术各实施例构造的冷冻治疗装置、系统和方法可包括降低囊体失效(例如与由于排出通道的部分或完全阻塞囊体内的过度压力积聚有关)可能性的一个或多个特征。例如，某些实施例可包括构造成当囊体内的压力相对于囊体的压力额定值或其它压力水平即将达到、实现或超过预定阈值时自动卸压的一个或多个特征。这些特征可防止或至少减轻不希望的囊体失效。
图1-2分别示出了根据本技术的实施例构造的冷冻治疗系统100的立体图和剖视图。冷冻治疗系统100可包括引导导管102和治疗导管104。如图1-2所示，治疗导管104可构造成插入或穿过引导导管102。在某些实施例中，引导导管102可以是8弗伦奇或更小(例如7弗伦奇、6弗伦奇或更小)。引导导管102可包括引导通道125，治疗导管104可穿过该引导通道125轴向行进和缩回。冷冻治疗系统100还可包括可便于将引导导管102和/或治疗导管104引入脉管或内腔内所需部位的导丝113。例如，在治疗过程期间，导丝113可经皮或穿过患者的自然解剖结构孔引入并沿合适的插管路径行进。可使用成像(例如超声、荧光或其它合适的成像形式)来辅助对导丝113进行导航。一旦就位，引导导管102可套在导丝113上行进，且治疗导管104可随后穿过引导通道125并套在导丝113上行进。在其它实施例中，引导导管102和导丝113可同时引入。在又一些实施例中，引导导管102和治疗导管104可构造成没有导丝113来进行使用。
治疗导管104可包括细长杆108和轴杆108的远部112处的囊体110。杆108可构造成将远部112定位在人类患者的脉管或内腔内。治疗导管104还可包括沿杆108的至少一部分延伸的引导内腔114和供给内腔116，且供给内腔116可具有囊体110内的孔口118。囊体100可从远部112的台阶下降段120延伸到引导内腔114的外表面。供给内腔116可构造成经由孔口118将高压制冷剂供给到囊体110。高压制冷剂可在囊体110内从液体相变到气体，这可将囊体110膨胀并冷却。治疗导管104也可具有沿杆108的至少一部分(例如引导内腔114和供给内腔116周围)从囊体110向近侧延伸到大气或体外储存容器(未示出)的排出通道112。操作期间，制冷剂经由排出通道122流过供给内腔116并流出囊体110。排出通道122可具有比供给内腔116更大的自由通过面积，以便适应相对于供给内腔116内高压制冷剂密度较低的膨胀制冷剂。
如图1-2所示，治疗导管104可构造成延伸超过引导导管102的远侧开口123。例如，在治疗过程期间，杆108的远部112的至少一部分可延伸超过远侧开口123，以便将囊体110定位在与远侧开口123间隔开的所需治疗位置。当囊体110在引导导管102的引导通道125外时，囊体100的直径可径向膨胀到大于引导通道125的直径。
杆108还可包括相对于远部112位于近侧的卸压部124。在某些实施例中，远部112可沿治疗导管104的整个长度在卸压部124与囊体110之间延伸。在其它实施例中，杆108可包括卸压部124与远部112之间的中间部(未示出)。卸压部124可构造成当排出通道122的至少一部分(例如卸压部124处或附近的部分)、囊体110或两者内的制冷剂压力超过阈值压力时从排出通道122释放制冷剂(例如释放到治疗导管104与引导导管102之间的引导通道125内的空间)。阈值压力例如可低于囊体110的压力额定值(例如对应于囊体110的爆裂压力的压力额定值)。
如图1-2所示，远部112可包括杆108的第一段108a，且卸压部124可包括杆108的第二段108b。第一和第二段108a-b可在搭接接头126处彼此附连(例如经由压接、粘结剂粘合、热焊接或其它合适的附连机构)。例如，在搭接接头126处，第一段108a的近端128可在第二段108b内。在其它实施例中，在搭接接头126处，第二段108a的近端130可在第二端108b内。如图1-2所示，第一段108a的直径可小于第二段108b的直径。相应地，第一段108a的自由通过面积可小于第二段108b的自由通过面积。第一段108a的自由通过面积可限定整个排出通路122的自由通过面积。由于制冷剂可随着其沿排出通道122向近侧行进而变热并膨胀，第一段108a的相对于第二段108b的自由通过面积的较小自由通过面积可对通过排出通道122的流量几乎没有或完全没有影响。
搭接接头126可提供第一与第二段108a-b之间尤其牢固的连接，但也可使用其它连接。例如，图3示出了类似于图1-2所示冷冻治疗系统100的根据本技术实施例构造的冷冻治疗系统300的剖视图。冷冻治疗系统300可包括治疗导管302，该治疗导管302具有细长杆304，该细长杆304具有经由代替图1-2所示搭接接头126的对接接头306连接到近侧第二段304b的远侧第一段304a。杆304可包括由第二段304b限定的卸压部308，第二段304b的直径至少约等于第一段304a的直径。第一段304a可以是远部112的部件。对接接头306可通过第一与第二段304a-b之间的粘合剂粘合、热焊接或其它合适附连机构而形成。
参照图1-3，在某些实施例中，远部112的壁强度可大于卸压部124、308的壁强度(例如屈服强度或极限拉伸强度)。例如，第一段108a、304a的壁强度可大于第二段108b、304b的壁强度。卸压部124、308的全部或一部分或第二段108b、304b的壁强度例如可小于远部112或第一段108a、304a的壁强度的约80％(例如小于约60％或小于约40％)。不同构造和/或成分可造成不同的壁强度。例如，卸压部124、308或第二段108b、304b可包括较薄的壁和/或由比远部112或第一段108a、304a的壁弱的材料制成。在某些实施例中，卸压部124、308或第二段108b、304b可由聚酰胺制成，且远部112或第一段108a、304a可由聚酰亚胺制成。在其它实施例中，卸压部124、308或第二段108b、304b可在第一厚度处由聚酰亚胺制成，而远部112或第一段108a、304a可在大于第一厚度的第二厚度处由聚酰亚胺制成。当卸压部124、308或第二段108b、304b被编织时，编织模式或密度可选择成使壁强度低于远部112或第一段108a、304a。类似地，当卸压部124、308或第二段108b、304b包括多层时，层数可选择成使壁强度低于远部112或第一段108a、304a。也可能有各种其它合适的材料和构造。
卸压部124、308或第二段108b、304b的壁强度可选择成使卸压部124、308或第二段108b、304b在约阈值压力下破裂。因而，卸压部124、308或第二段108b、304b可以是牺牲性的和/或以其它方式构造成在囊体110内的压力意外增加的故障期间囊体110失效之前就失效。卸压部124、308或第二段108b、304b的失效会允许制冷剂快速流入杆108与引导导管102之间引导通道125内的空间内。该空间内制冷剂的至少一部分然后可向近侧移动到引导导管102的近侧开口(未示出)。在某些实施例中，卸压部124、308或第二段108b、304b可构造成相对快速地破裂。例如，卸压部124、308或第二段108b、304b可包括相对脆性的材料，诸如具有破裂时小于约50％的伸长率的材料(例如小于约30％或小于约20％)。在其它实施例中，卸压部124、308或第二段108b、304b可构造成更慢地破裂。
在图1-3中所示的冷冻系统100、300镇南关，可能难以预料卸压部124、308或第二段108b、304b会沿排出通道122牺牲性地释放压力的情况。这样，可能理想的是在沿装置的各具体部位控制制冷剂的释放。图4示出了根据本技术另一实施例构造的冷冻系统400的一实例的剖视图，其包括治疗导管402，该治疗导管402具有带相对短卸压部406的杆404。杆404还可包括卸压部406近侧的近部408、远部112与卸压部406之间的第一搭接接头410、以及卸压部406与近部408之间的第二搭接接头412。在其它实施例中，第一和第二搭接接头410、412可用对接接头或其它合适的连接代替。卸压部406可具有比远部112、近部408和囊体110低的压力额定值，使得卸压部406优先在沿装置特定位置处失效。
图5示出了具有另一卸压构造的根据本技术实施例构造的冷冻治疗系统500的剖视图。冷冻治疗系统500可包括治疗导管502，治疗导管502具有杆504，杆504具有包括破裂件508的卸压部506。在图5所示的实施例中，破裂件508不围绕杆504的整个外周延伸。在其它实施例中，破裂件508可以是环形或可围绕杆504的整个外周延伸。破裂件508可包括隔膜(嵌入卸压部506的壁内)、卸压部506的壁的弱化(例如刻痕和/或减薄)部分，或构造成预期地响应于压力破裂的其它适当结构。破裂件508例如可构造成响应于排出通道122的相邻部分内的压力接近或超过阈值压力而破裂。破裂件508的尺寸可选择成控制制冷剂从排出通道122释放到引导通道125内空间的速率。
参考图1-5，卸压部124、308、406、506和/或其各部分(例如卸压部124、308的第一段108a、304a和卸压部506的破裂件508)的位置可选择成控制制冷剂释放到引导通道125内空间内的部位。在某些实施例中，治疗过程期间，释放位置可在患者脉管或内腔外部。例如，这些释放部位可在相对于脉管或内腔的进入点的近侧，且在某些情况下，在相应引导导管102的近侧到近侧开口。这些释放位置可降低制冷剂将经由引导导管102的远侧开口123释放到脉管或内腔内的可能性。但更靠近囊体110的位置会用于降低沿排出通道122的释放点与囊体110之间的压差和/或延迟。这可改进卸压部124、308、406、506对囊体110内压力快速增加的响应性。此外，在某些情况下，当卸压部124、308、406、506与囊体110之间发生相应排出通道的阻塞时，卸压部124、308、406、506可具有有限的效率。减小卸压部124、308、406、506与囊体110之间的距离可降低这种阻塞的可能性。在某些实施例中，卸压部124、308、406、506可与囊体110近侧间隔开，使得卸压部124、308、406、506就在相应引导通道125内。
再参照图5，冷冻治疗系统500还可包括引导导管510，该引导导管510具有围绕引导通道125的周界的流动限制器512。在其它实施例中，治疗导管502可包括在卸压部506远侧位置处的流动限制器512。流动限制器512可构造成引导通道125内通过远侧开口123释放到患者脉管或内腔内制冷剂的远侧流量。而是，用于释放的制冷剂的最小阻力的路径可向近侧延伸穿过引导通道125到达脉管或内腔外引导导管510的近侧开口。在某些实施例中，流动限制器512可以是至少部分环形的和/或可压缩的并构造成符合杆504。此外，流动限制器512可构造成除了降低或防止远侧制冷剂流动之外还减少或防止引导导管510内的近侧血液流动。其它实施例可包括用于减少或防止释放的制冷剂的远侧流动的不同特征。例如，图2所示的冷冻治疗系统200可调制成使得第二段108b在搭接接头126处在第一段108a内，且远部112的直径比卸压部124大。这可减小围绕远部112的引导通道125内的空间并由此促进释放的制冷剂沿近侧方向流动。在某些实施例中，通过远侧开口123释放到患者脉管或内腔内的制冷剂可比由于囊体失效造成的制冷剂释放有更少问题，由此减少流动限制器512的有用性。此外，卸压部506可比引导导管510的远侧开口更靠近引导导管510的近侧开口定位，这会延迟或防止制冷剂通过远侧开口123释放到患者的脉管或内腔。
在某些实施例中，治疗导管502的直径和/或引导导管510的直径可选择成其间引导通道125内空间的尺寸。例如，杆504的外径与引导通道125的内径之差可沿从卸压部506向近侧延伸的杆504的至少约10cm大于约0.5mm(例如大于约0.3mm或大于约0.4mm)。然而，在某些情况下，其可用于减小引导通道125内的空间尺寸以利于增加杆504的尺寸。例如，较大直径杆可支持更大的冷却。图6示出了根据本技术实施例构造的冷冻治疗系统600的剖视图，其包括治疗导管602和引导导管603。治疗导管602可包括具有卸压部606的杆604，卸压部606具有破裂件608。与图1-5所示实施例相比，引导导管603可以更小和/或杆604可以更大以提供相对紧密配合，这限制制冷剂沿引导通道125内空间的远侧流动。
卸压部606和杆604的靠近卸压部606的各部分可具有比远部112小的直径，使得在杆604的近部与引导导管602之间有更多的空间。这可促进制冷剂沿引导通道125内的空间的近侧流动(例如沿大致连续路径从破裂件608近侧的释放位置到引导导管603的近侧开口)。该路径例如可长度大于约100cm(例如大于约200cm或大于约300cm)并可从破裂件608向近侧延伸。在某些实施例中，卸压部606可构造成从第一状态(未示出)变形到第二状态，在第一状态中卸压部606的直径类似于远部112的直径，在第二状态中破裂件608破裂且卸压部606向内变形。卸压部606可例如响应于引导通道125内空间内的压力超过阈值压力而变形。如图6所示，在某些实施例中，卸压部606可大致均匀地变形。在其它实施例中，卸压部606和杆604的卸压部606近侧的各部分可构造成选择性地变形(例如沿通道)。变形可例如由于杆604的壁的至少一部分的可逆或不可逆压缩或膨胀而发生。例如，杆604可至少部分是弹性的、折叠的、铰接的或以其它方式构造成响应于引导通道125内的压力而膨胀或收缩。在其它各实施例中，杆604可具有足够低的总体或局部壁强度以允许杆604响应于引导通道125内的压力向内变形。
在某些实施例中，所公开的卸压特征对于用于防止囊体故障的其它特征来说可以是冗余的。例如，图1-6所示的冷冻治疗系统可包括一个或多个压力传感器(未示出)和控制器(未示出)，压力传感器构造成监测囊体110内的压力，控制器构造成如果监测到的压力增加到阈值压力以上则停止制冷剂到囊体110的流动。在其它实施例中，所公开的卸压特征可代替压力监测。此外，降低囊体故障可能性可允许囊体构造和组成的更大自由度。在某些实施例中，正常操作期间囊体110可具有小于囊体110内稳态压力的约400％(例如小于约300％或小于约200％)的压力额定值。这可例如便于使用具有较薄壁和更大弹性的囊体110。
实例
1.一种冷冻治疗系统，包括：
细长杆，所述细长杆包括远部和卸压部，所述杆构造成将所述远部定位在人类患者的脉管或内腔内；
供给内腔，所述供给内腔沿所述杆的至少一部分延伸并具有第一自由通过面积；
排出通道，所述排出通道沿所述杆的至少一部分延伸并具有第二自由通过面积；以及
囊体，所述囊体构造成从所述供给内腔接收制冷剂并向所述排出通道排出制冷剂，所述囊体具有压力额定值，其中——
所述囊体在所述远部的近侧，以及
所述卸压部构造成当所述卸压部处或附近所述排出通道内的制冷剂压力超过阈值压力时从所述排出通道释放制冷剂。
2.如实例1所述的冷冻治疗系统，其中，所述远部沿所述杆在所述卸压部与所述囊体之间的长度延伸。
3.如实例1或实例2所述的冷冻治疗系统，其中，所述阈值压力小于所述囊体的所述压力额定值。
4.如实例1-3中任一个所述的冷冻治疗系统，其中所述第二自由通过面积大于所述第一自由通过面积。
5.如实例1-4中任一个所述的冷冻治疗系统，其中所述远部和所述卸压部构造成适配在8弗伦奇或更小的引导导管内。
6.如实例1-5中任一个所述的冷冻治疗系统，其中所述压力额定值对应于所述囊体的爆裂压力。
7.如实例1-6中任一个所述的冷冻治疗系统，其中所述卸压部包括构造成在约所述阈值压力下破裂的破裂件。
8.如实例7所述的冷冻治疗系统，其中，所述杆沿长度大于约100cm的路径可变形并从所述破裂件向近侧延伸。
9.如实例1-8中任一个所述的冷冻治疗系统，其中——
所述远部包括所述杆的具有第一壁长度的第一段，以及
所述卸压部包括所述杆的具有小于所述第一壁强度的第二壁强度的第二段。
10.如实例9所述的冷冻治疗系统，其中，所述第二壁强度选择成使所述第二段在约所述阈值压力下破裂。
11.如实例9或实例10所述的冷冻治疗系统，其特征在于，所述第一段在对接接头处附连到所述第二段。
12.如实例9-11中任一个所述的冷冻治疗系统，其中——
所述第一段限定所述第二自由通过面积，以及
所述第二段具有大于所述第二自由通过面积的第三自由通过面积。
13.如实例9、10或12中任一个所述的冷冻治疗系统，其中——所述第一段在搭接接头处附连到所述第二段。
14.如实例13所述的冷冻治疗系统，其中，所述第一段包括所述搭接接头处所述第二段内的近端。
15.一种冷冻治疗系统，包括：
引导导管，所述引导导管包括远侧开口、近侧开口和在所述远侧开口与所述近侧开口之间延伸的引导通道；
细长杆，所述细长杆构造成在所述引导通道内轴向移动，并包括远部和所述远部近侧的卸压部，所述杆构造成将所述远部定位在人类患者的脉管或内腔内；
供给内腔，所述供给内腔沿所述杆的至少一部分延伸；
排出通道，所述排出通道沿所述杆的至少一部分延伸；以及
囊体，所述囊体构造成从所述供给内腔接收制冷剂并向所述排出通道排出制冷剂，所述囊体具有压力额定值，其中——
所述远部在所述卸压部与所述囊体之间延伸，以及
所述卸压部构造成当所述排出通道的至少一部分、所述囊体或两者内的制冷剂压力接近和/或超过与所述囊体的所述压力额定值相关的阈值压力时从所述排出通道向所述杆与所述引导导管之间的空间释放制冷剂。
16.如实例15所述的冷冻治疗系统，其中，所述引导导管为8弗伦奇或更小。
17.如实例15或实例16所述的冷冻治疗系统，其特征在于，所述杆的外径与所述引导通道的内径之差沿所述杆从所述卸压部向近侧延伸的至少约100cm大于约0.2mm。
18.如实例15-17中任一个所述的冷冻治疗系统，其中——
所述阈值压力为第一阈值压力，以及
当所述空间内的压力超过第二阈值压力时，所述杆至少可部分地变形。
19.如实例18所述的冷冻治疗系统，其中，所述第二阈值压力大于所述第一阈值压力。
20.如实例15-19中任一个所述的冷冻治疗系统，还包括流动限制器，所述流动限制器构造成防止制冷剂从所述空间向远侧通过所述引导导管的所述远侧开口流动。
21.如实例20所述的冷冻治疗系统，其中，所述流动限制器至少部分是环形的且可压缩的。
22.一种方法，包括：
将引导导管引入人类患者的脉管或内腔中；
沿所述引导导管的引导通道轴向移动治疗导管，所述治疗导管包括供给内腔、排出通道以及囊体；
通过所述供给内腔将制冷剂供给到所述囊体；
从所述囊体通过所述排出通道排出制冷剂；以及
当所述排出通道的至少一部分内的制冷剂压力超过小于所述囊体的压力额定值的阈值压力时，将制冷剂释放到所述治疗导管与所述引导导管之间的空间内。
23.如实例22所述的方法，其中，将制冷剂释放到所述空间内包括使破裂件破裂，所述破裂件构造成在约所述阈值压力下破裂。
24.如实例22或实例23所述的方法，其中，将制冷剂释放到所述空间内包括——
在释放位置将制冷剂释放到所述空间内，以及
将制冷剂通过所述空间从所述释放位置向近侧排出。
25.如实例24所述的方法，其中，所述释放位置在所述脉管或内腔内。
26.如实例24所述的方法，其中，所述释放位置在所述脉管或内腔外。
27.如实例24-26中任一个所述的方法，还包括使所述治疗导管沿大致连续路径从所述释放位置变形到所述引导导管的近侧开口。
结论
本技术的以上详细描述仅是为了说明目的且并不意图排他或将本技术限于上文公开的特定形式。在本技术的范围内可能有各种等同改型，如相关领域的技术人员会认识到的。例如，尽管各阶段以给定顺序呈现，但各替代实施例可以不同顺序执行各阶段。本文所述的各实施例和其各构件也可组合以提供更多实施例。在某些情况下，已知结构和功能尚未详细示出以避免不必要地使本技术各实施例的描述不清楚。
在上下文允许的情况下，单数或复数术语也可分别包括复数或单数术语。此外，关于两项或多项的列表，除非单词“或”明确表示限于排除其它项的单项，则在该列表中使用“或”应诠释为包括(a)列表中的任何单项，(b)列表中的所有项，或者(c)列表中各项的任意组合。此外，术语“包括”和类似用于在整个本公开中用于表示包括至少记载的特征，从而并不排除任何更大数量的相同特征和/或其它类型的其它特征。还应理解，可对所述实施例作出各种改型而不偏离本技术。此外，尽管已经在这些实施例的上下文中描述了本技术的某些实施例相关的优点，但其它实施例也可呈现这些优点，且并非所有实施例需要必需呈现这些优点以落入本技术的范围内。因而，本公开和相关技术和包含本文未明确示出或描述的其它各实施例。

Claims (27)

1.一种冷冻治疗系统，包括：
细长杆，所述细长杆包括远部和卸压部，所述杆构造成将所述远部定位在人类患者的脉管或内腔内；
供给内腔，所述供给内腔沿所述杆的至少一部分延伸并具有第一自由通过面积；
排出通道，所述排出通道沿所述杆的至少一部分延伸并具有第二自由通过面积；以及
囊体，所述囊体构造成从所述供给内腔接收制冷剂并向所述排出通道排出制冷剂，所述囊体具有压力额定值，其中——
所述囊体在所述远部的近侧，以及
所述卸压部构造成，当所述卸压部处或附近所述排出通道内的制冷剂压力超过阈值压力时，从所述排出通道释放制冷剂。
2.如权利要求1所述的冷冻治疗系统，其特征在于，所述远部沿所述杆在所述卸压部与所述囊体之间的长度延伸。
3.如权利要求1所述的冷冻治疗系统，其特征在于，所述阈值压力小于所述囊体的所述压力额定值。
4.如权利要求1所述的冷冻治疗系统，其特征在于，所述第二自由通过面积大于所述第一自由通过面积。
5.如权利要求1所述的冷冻治疗系统，其特征在于，所述远部和所述卸压部构造成适配在8弗伦奇或更小的引导导管内。
6.如权利要求1所述的冷冻治疗系统，其特征在于，所述压力额定值对应于所述囊体的爆裂压力。
7.如权利要求1所述的冷冻治疗系统，其特征在于，所述卸压部包括构造成在约所述阈值压力下破裂的破裂件。
8.如权利要求7所述的冷冻治疗系统，其特征在于，所述杆沿长度大于约100cm的路径可变形并从所述破裂件向近侧延伸。
9.如权利要求1所述的冷冻治疗系统，其特征在于——
所述远部包括所述杆的具有第一壁长度的第一段，以及
所述卸压部包括所述杆的具有小于所述第一壁强度的第二壁强度的第二段。
10.如权利要求9所述的冷冻治疗系统，其特征在于，所述第二壁强度选择成使所述第二段在约所述阈值压力下破裂。
11.如权利要求9所述的冷冻治疗系统，其特征在于，所述第一段在对接接头处附连到所述第二段。
12.如权利要求9所述的冷冻治疗系统，其特征在于——
所述第一段限定所述第二自由通过面积，以及
所述第二段具有大于所述第二自由通过面积的第三自由通过面积。
13.如权利要求9所述的冷冻治疗系统，其特征在于，所述第一段在搭接接头处附连到所述第二段。
14.如权利要求13所述的冷冻治疗系统，其特征在于，所述第一段包括在所述搭接接头处的所述第二段内的近端。
15.一种冷冻治疗系统，包括：
引导导管，所述引导导管包括远侧开口、近侧开口和在所述远侧开口与所述近侧开口之间延伸的引导通道；
细长杆，所述细长杆构造成在所述引导通道内轴向移动，并包括远部和所述远部近侧的卸压部，所述杆构造成将所述远部定位在人类患者的脉管或内腔内；
供给内腔，所述供给内腔沿所述杆的至少一部分延伸；
排出通道，所述排出通道沿所述杆的至少一部分延伸；以及
囊体，所述囊体构造成从所述供给内腔接收制冷剂并向所述排出通道排出制冷剂，所述囊体具有压力额定值，其中——
所述远部在所述卸压部与所述囊体之间延伸，以及
所述卸压部构造成，当所述排出通道的至少一部分、所述囊体或两者内的制冷剂压力接近和/或超过与所述囊体的所述压力额定值相关的阈值压力时，从所述排出通道向所述杆与所述引导导管之间的空间释放制冷剂。
16.如权利要求15所述的冷冻治疗系统，其特征在于，所述引导导管为8弗伦奇或更小。
17.如权利要求15所述的冷冻治疗系统，其特征在于，所述杆的外径与所述引导通道的内径之差沿所述杆从所述卸压部向近侧延伸的至少约100cm大于约0.2mm。
18.如权利要求15所述的冷冻治疗系统，其特征在于——
所述阈值压力为第一阈值压力，以及
当所述空间内的压力超过第二阈值压力时，所述杆至少可部分地变形。
19.如权利要求18所述的冷冻治疗系统，其特征在于，所述第二阈值压力大于所述第一阈值压力。
20.如权利要求15所述的冷冻治疗系统，其特征在于，还包括：流动限制器，所述流动限制器构造成防止制冷剂从所述空间向远侧通过所述引导导管的所述远侧开口流动。
21.如权利要求20所述的冷冻治疗系统，其特征在于，所述流动限制器至少部分是环形的且可压缩的。
22.一种方法，包括：
将引导导管引入人类患者的脉管或内腔中；
沿所述引导导管的引导通道轴向移动治疗导管，所述治疗导管包括供给内腔、排出通道以及囊体；
通过所述供给内腔将制冷剂供给到所述囊体；
从所述囊体通过所述排出通道排出制冷剂；以及
当所述排出通道的至少一部分内的制冷剂压力超过小于所述囊体的压力额定值的阈值压力时，将制冷剂释放到所述治疗导管与所述引导导管之间的空间内。
23.如权利要求22所述的方法，其特征在于，将制冷剂释放到所述空间内包括使破裂件破裂，所述破裂件构造成在约所述阈值压力下破裂。
24.如权利要求22所述的方法，其特征在于，将制冷剂释放到所述空间内包括——
在释放位置将制冷剂释放到所述空间内，以及
将制冷剂通过所述空间从所述释放位置向近侧排出。
25.如权利要求24所述的方法，其特征在于，所述释放位置在所述脉管或内腔内。
26.如权利要求24所述的方法，其特征在于，所述释放位置在所述脉管或内腔外。
27.如权利要求24所述的方法，其特征在于，还包括：使所述治疗导管沿大致连续路径从所述释放位置变形到所述引导导管的近侧开口。
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US9241752B2 (en) 2016-01-26

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