CN113543691B - 用于能量递送的系统和方法 - Google Patents

用于能量递送的系统和方法 Download PDF

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CN113543691B
CN113543691B CN202080019794.XA CN202080019794A CN113543691B CN 113543691 B CN113543691 B CN 113543691B CN 202080019794 A CN202080019794 A CN 202080019794A CN 113543691 B CN113543691 B CN 113543691B
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CN113543691A (zh
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M·沙宁
M·泰尔
L·明焦內
R·舍费尔克
N·卡特拉娜
M·汤姆
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NeuWave Medical Inc
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Abstract

本发明涉及柔性护套组件以及相关的系统和方法，该柔性护套组件能够在涉及使用穿过柔性护套插入和抽出医疗工具的医学规程期间在期望的组织区域处保持期望的定位。

Description

用于能量递送的系统和方法
技术领域
本发明涉及柔性护套组件以及相关的系统和方法，该柔性护套组件能够在涉及使用穿过柔性护套插入和抽出医疗工具的医学规程期间将期望的定位保持在期望的组织区域处。
背景技术
用作工具放置引导件的内窥镜护套需要具有极大柔性，以便导航通过可能包括曲折路径的周边位置，尤其是在支气管镜的情况下。一旦处于期望的位置，随着工具(例如，闭塞器、柔性消融探头、其它支气管镜工具等)被交换和/或重新定位，护套的端部难以保持在适当位置。由于呼吸引起的患者移动另外造成了护套的移动。
需要能够通过使用柔性护套(例如，在涉及使用穿过护套插入和抽出的医疗工具的医学规程期间)来保持期望的定位的新型柔性护套。
本发明解决了这种需要。
发明内容
本发明涉及柔性护套组件以及相关的系统和方法，该柔性护套组件能够在涉及使用穿过柔性护套插入和抽出医疗工具的医学规程期间将期望的定位保持在期望的组织区域处。
在某些实施方案中，本发明提供了用于内窥镜检查程序的柔性护套。
此类柔性护套不限于具体特性或设计。
在一些实施方案中，柔性护套包括细长管状主体，该细长管状主体包括a)具有近侧端部开口的细长管状主体近侧端部和具有远侧端部开口的细长管状主体远侧端部，以及b)细长管状主体内部部分和细长管状主体外部部分，其中细长管状主体内部部分从细长管状主体近侧端部延伸到细长管状主体远侧端部，其中细长管状主体外部部分从细长管状主体近侧端部延伸到细长管状主体远侧端部；其中细长管状主体内部部分包括中空端口，该中空端口延伸到近侧端部开口中、穿过细长管状主体近侧端部、穿过细长管状主体远侧端部并延伸出远侧端部开口，其中中空端口的尺寸使得中空部分能够适应适当尺寸的工具进入中空端口、穿过中空端口并离开中空端口；其中柔性护套的直径小于5mm。
在一些实施方案中，细长管状主体内部部分还包括细长管状主体冷却剂进入通道、细长管状主体远侧端部容纳区域和细长管状主体冷却剂排出通道，其中细长管状主体远侧端部容纳区域定位在细长管状主体远侧端部处，其中细长管状主体内部部分被构造成a)经由细长管状主体冷却剂进入通道将冷却剂接收到细长管状主体近侧端部中，b)使所接收的冷却剂穿过细长管状主体冷却剂进入通道循环到细长管状主体远侧端部容纳区域，以及c)使冷却剂从细长管状主体远侧端部容纳区域循环穿过细长管状主体排出通道并离开细长管状主体近侧端部。
在一些实施方案中，细长管状主体排出通道的直径大于细长管状主体进入通道的直径，或者细长管状主体排出通道的直径小于细长管状主体进入通道的直径，或者细长管状主体排出通道的直径和细长管状主体进入通道的直径相同。
在一些实施方案中，中空端口、细长管状主体进入通道和细长管状主体排出通道以多轴方式定位，或者中空端口、细长管状主体进入通道和细长管状主体排出通道以同轴方式同心地定位。
在一些实施方案中，冷却剂选自水、二醇、空气、惰性气体、二氧化碳、氮气、氦气、六氟化硫、离子溶液(例如，具有或不具有钾离子和其它离子的氯化钠)、葡萄糖水溶液、林格氏乳酸盐、有机化学溶液(例如，乙二醇、二甘醇或丙二醇)、油(例如，矿物油、硅油、氟碳油)、液体金属、氟利昂、卤代甲烷、液化丙烷、其它卤代烷烃、无水氨、二氧化硫和在其临界点或接近其临界点压缩的冷却剂气体。
在一些实施方案中，细长管状主体外部部分的远侧端部包括一个或多个高热导率区域或一个或多个柔性-刚性区域。
在一些实施方案中，一个或多个高热导率区域被构造成在与组织区域接触时与组织区域选择性地附接，使得细长管状主体远侧端部相对于组织区域稳定在期望的位置；其中在一个或多个高热导率区域与组织区域附接时，一个或多个高热导率区域被构造成与组织区域选择性地分离，使得细长管状主体远侧端部相对于组织区域从期望的位置失稳。
在一些实施方案中，一个或多个高热导率区域被构造成获得并保持导致组织区域冻结的温度，以有利于将组织区域附接到高热导率区域，以便将细长管状主体远侧端部相对于组织区域稳定在期望的位置。
在一些实施方案中，通过冷却剂进入和离开细长管状主体容纳区域的循环来调节一个或多个高热导率区域的温度。
在一些实施方案中，通过冷却剂经由焦耳-汤普森效应、吸热化学反应或放热化学反应而进入和离开细长管状主体容纳区域的循环来调节一个或多个高热导率区域的温度。
在一些实施方案中，一个或多个高热导率区域包含金属、塑料、陶瓷或它们的混合物中的一者或多者。
在一些实施方案中，一个或多个高热导率区域是柔性的。
在一些实施方案中，一个或多个柔性-刚性区域被构造成在柔性状态和刚性状态之间选择性地交替。
在一些实施方案中，如果一个或多个柔性-刚性区域处于刚性状态，则细长管状主体远侧端部相对于与柔性-刚性区域接触的组织区域稳定在期望的位置；
在一些实施方案中，如果一个或多个柔性-刚性区域处于柔性状态，则细长管状主体远侧端部相对于与柔性-刚性区域接触的组织区域不稳定。
在一些实施方案中，一个或多个柔性-刚性区域包含具有约15摄氏度至25摄氏度的适当玻璃化转变温度的热塑性聚合物。
在一些实施方案中，该热塑性聚合物包括乳酸和己内酯的共聚物。
在一些实施方案中，该热塑性聚合物包括L-丙交酯和己内酯的共聚物，诸如L-丙交酯单体与己内酯单体的比率为70:30或更小的聚(L-丙交酯-共-己内酯)。
在一些实施方案中，热塑性区域可以PLC-7015从荷兰的PuracBiomaterials of Gorinchem商购获得。
在一些实施方案中，通过冷却剂进入和离开细长管状主体容纳区域的循环来调节一个或多个柔性-刚性区域的温度，其中柔性-刚性区域温度维持在约-40摄氏度导致一个或多个柔性-刚性区域处于柔性状态，其中柔性-刚性区域温度维持在约-5摄氏度导致一个或多个柔性-刚性区域处于刚性状态。
在一些实施方案中，通过冷却剂经由焦耳-汤普森效应、吸热化学反应或放热化学反应而进入和离开细长管状主体容纳区域的循环来调节一个或多个柔性-刚性区域的温度。
在一些实施方案中，适当尺寸的工具选自闭塞器、消融探头、能量递送装置、活检工具等。
在一些实施方案中，柔性护套具有足够的柔性以进入穿过受检者的迂回路线(例如，穿过分支结构、穿过支气管树、穿过身体的任何区域以到达期望的位置)。
在一些实施方案中，细长管状主体的组成为聚合物材料。
在一些实施方案中，细长管状主体的组成为较高温度等级的聚合物材料。
在一些实施方案中，细长管状主体的组成为氟化乙丙烯(FEP)或热塑性共聚酯(例如，Arnitel)。
在一些实施方案中，细长管状主体的组成为含氟聚合物。在一些实施方案中，含氟聚合物为全氟甲基烷氧基烷烃(MFA)或全氟烷氧基烷烃(PFA)。
在一些实施方案中，细长管状主体内部区域还包括被构造成允许使用者以任何期望的方式使柔性护套转向的可转向拉环。
在一些实施方案中，柔性护套被设计成在微波场或微波区内操作(例如，柔性护套是微波兼容的)而不遭受与微波场或微波区相关的损坏。
在一些实施方案中，柔性护套被设计成在经受高温的组织区域内操作(例如，柔性护套是耐热的)而不遭受与高温相关的损坏。
在某些实施方案中，本发明提供包括主导管、如上所述的柔性护套和能量递送装置的系统。在一些实施方案中，主导管为内窥镜。在一些实施方案中，能量递送装置为微波能量递送装置。
在某些实施方案中，本发明提供了治疗组织区域的方法，该方法包括提供如上所述的系统，将主导管插入组织区域中，将柔性护套穿过主导管插入到期望的待治疗组织区域，经由一个或多个高热导率区域或一个或多个柔性-刚性区域将柔性护套固定在期望的待治疗组织区域处，将能量递送装置穿过柔性护套插入到期望的待治疗组织区域，以及使用能量递送装置治疗待治疗组织区域。在一些实施方案中，待治疗的组织区域位于受检者体内。在一些实施方案中，受检者是人类受检者。
本文描述了附加的实施方案。
附图说明
图1至图4示出了各种柔性护套实施方案。
具体实施方式
治疗性内窥镜检查或介入性内窥镜检查涉及内窥镜检查程序，在此期间经由内窥镜执行治疗(例如，组织消融)(例如，组织收集)。这与诊断性内窥镜检查相反，该程序的目的仅仅是为了可视化身体的内部部分(例如，胃肠区域、呼吸区域、尿道区域等)以帮助诊断。在实施过程中，以诊断性内窥镜检查开始的程序可根据发现而变成治疗性内窥镜检查。
一般来讲，治疗性内窥镜检查涉及将内窥镜(“主导管”)施用到身体区域中，直到达到自然停止定位(例如，直到身体区域的周长抑制内窥镜的进一步推进)。接着，将周长小于内窥镜的周长的柔性护套推进穿过内窥镜并到达期望的身体区域位置。接着，将周长小于柔性护套的直径的治疗工具(例如，消融能量递送工具)(例如，组织收集工具)穿过柔性护套推进到期望的身体区域位置。接着，将消融能量递送到期望的身体区域位置。在完成治疗性内窥镜检查时，将消融能量递送工具穿过柔性护套撤回，将柔性护套穿过内窥镜撤回，并将内窥镜从受检者撤回。
用作工具放置引导件的此类柔性护套需要具有极大柔性，以便导航通过可能包括曲折路径的周边位置，尤其是在支气管镜的情况下。一旦处于期望的位置，随着工具(例如，闭塞器、柔性消融探头、其它支气管镜工具等)被交换和/或重新定位，柔性护套的端部难以保持在适当位置，并且自然的患者移动(例如，呼吸)促成柔性护套从期望的组织区域(例如，正在进行医学规程的组织区域)发生不期望的移动。
因此，需要能够在涉及使用插入和抽出医疗工具的医学规程期间在期望的组织区域处保持期望的定位的新型柔性护套。
本发明通过提供能够在涉及使用插入和抽出医疗工具的医学规程期间在期望的组织区域处保持期望的定位的柔性护套以及通过患者身体移动解决了此需求。此类柔性护套组件被构造成用于任何种类的内窥镜能量递送程序(例如，组织消融、切除、烧灼、血管血栓形成、心律失常和节律障碍的治疗、电外科、组织获取等)。
因此，本发明涉及柔性护套组件以及相关的系统和方法，该柔性护套组件能够在涉及使用穿过柔性护套插入和抽出医疗工具的医学规程期间在期望的组织区域处保持期望的定位。
本发明的柔性护套不限于特定尺寸大小。实际上，在一些实施方案中，柔性护套的尺寸大小使得其能够装配在主导管(例如，内窥镜)的管腔内并穿过主导管的管腔。在一些实施方案中，柔性护套具有足够的直径(例如，1mm...2mm...3mm...4mm...5mm)以在其内部内并穿过其内部容纳一个或多个合适的工具(例如，能量递送装置、可转向导航导管)。在一些实施方案中，柔性护套具有足够的长度(例如，50cm...75cm...1m...1.5m...2m...10m...25m等)以从插入部位(例如，口部、受检者的身体中的切口等)延伸到活体内的期望目标区域。在一些实施方案中，柔性护套具有足够的长度以延伸穿过主导管(例如，内窥镜)并超过主导管的范围以到达治疗部位(例如，外周肺组织、心脏组织、胃肠组织等)(例如，活体内的任何期望位置)。
本发明的柔性护套不限于穿过主导管和/或穿过身体区域的特定导航方式。在一些实施方案中，柔性护套包括导航和/或转向机构。在一些实施方案中，柔性护套没有独立的导航、位置识别或操纵手段。在一些实施方案中，柔性护套依赖于主导管(例如，内窥镜)或可转向导航导管来放置。
图1示出了本发明的柔性护套1实施方案。柔性护套1不限于特定的设计或构型。在一些实施方案中，柔性护套1的设计或构型使得该柔性护套在涉及使用穿过柔性护套插入和抽出医疗工具的医学规程期间能够定位在期望的组织区域处并保持该期望的定位。在一些实施方案中，柔性护套1具有足够的柔性以进入穿过受检者的迂回路线(例如，穿过分支结构、穿过支气管树、穿过身体的任何区域以到达期望的位置)。
在某些实施方案中，如图1所示，柔性护套1具有细长管状主体2，该细长管状主体包括具有近侧端部开口4的细长管状主体近侧端部3、具有远侧端部开口6的细长管状主体远侧端部5、从细长管状主体近侧端部3延伸到细长管状主体远侧端部5的细长管状主体内部部分7、以及从细长管状主体近侧端部3延伸到细长管状主体远侧端部5的细长管状主体外部部分8。在一些实施方案中，细长管状主体近侧端部3、近侧端部开口4、细长管状主体远侧端部5、远侧端部开口6、细长管状主体内部部分7和细长管状主体外部部分8在细长管状主体2内的布置和定位不受限制。在一些实施方案中，细长管状主体近侧端部3、近侧端部开口4、细长管状主体远侧端部5、远侧端部开口6、细长管状主体内部部分7和细长管状主体外部部分8在细长管状主体2内的布置和定位使得其致使柔性护套1能够在涉及使用穿过柔性护套1插入和抽出医疗工具的医学规程期间定位在期望的组织区域处并保持该期望的定位。
仍然参见图1，细长管状主体2不限于特定组成。在一些实施方案中，细长管状主体2的组成为致使柔性护套1能够在涉及使用穿过柔性护套1插入和抽出医疗工具的医学规程期间定位在期望的组织区域处并保持该期望的定位的任何组成。在一些实施方案中，细长管状主体2的组成为聚合物材料。在一些实施方案中，细长管状主体2的组成为较高温度等级的聚合物材料。此类实施方案不限于特定的较高温度等级的聚合物材料。在一些实施方案中，较高温度等级的聚合物材料为氟化乙丙烯(FEP)。在一些实施方案中，较高温度等级的聚合物材料为热塑性共聚酯。在一些实施方案中，热塑性共聚酯为Arnitel。在一些实施方案中，较高温度等级的聚合物材料为含氟聚合物。此类实施方案不限于特定的含氟聚合物。在一些实施方案中，含氟聚合物为全氟甲基烷氧基烷烃(MFA)。在一些实施方案中，含氟聚合物为全氟烷氧基烷烃(PFA)。在一些实施方案中，细长管状主体2的仅一部分(5％、10％、25％、50％、75％、77％、79％、85％、88％、90％、94％、98％、99％、99.999％)具有较高温度等级的聚合物材料的组成。在一些实施方案中，从细长管状主体远侧端部5开始的仅一部分(5％、10％、25％、50％、75％、77％、79％、85％、88％、90％、94％、98％、99％、99.999％)具有较高温度等级的聚合物材料的组成。在一些实施方案中，整个细长管状主体2具有较高温度等级的聚合物材料的组成。
仍然参见图1，柔性护套1被构造成使得装置(例如，医疗装置)可穿过细长管状主体内部部分7插入和抽出。可穿过细长管状主体内部部分7插入和抽出的此类装置的示例包括但不限于闭塞器、消融探头、能量递送装置、活检工具等。
仍然参见图1，细长管状主体内部部分7不限于允许插入和抽出装置的特定构型。在一些实施方案中，细长管状主体内部部分7中具有中空端口9，该中空端口从近侧端部开口4延伸，穿过细长管状主体近侧端部3，穿过细长管状主体远侧端部5，并延伸出远侧端部开口6。中空端口9不限于特定尺寸。在一些实施方案中，中空端口9的尺寸使得其可适应穿过其整体插入和抽出适当尺寸的装置(例如，周长小于中空端口9的周长的装置)。在一些实施方案中，中空端口9的尺寸使得其可适应穿过其整体插入和抽出适当尺寸的装置(例如，周长小于中空端口9的周长的装置)，而不损害柔性护套1在医学规程期间定位在期望的组织区域处并保持该期望的定位的能力。
仍然参见图1，细长管状主体内部部分7被构造成使冷却剂循环，以用于将细长管状主体远侧端部5的远侧端部保持在期望的温度。细长管状主体内部部分7不限于循环冷却剂的特定方式，以用于将细长管状主体远侧端部5的远侧端部保持在期望的温度。在一些实施方案中，如图1所示，细长管状主体内部部分7能够循环冷却剂，以用于通过使用细长管状主体冷却剂进入通道10、定位在细长管状主体远侧端部5处的细长管状主体远侧端部容纳区域11以及细长管状主体冷却剂排出通道12，将细长管状主体远侧端部5的远侧端部保持在期望的温度。实际上，在一些实施方案中，细长管状主体内部部分7被构造成：a)经由细长管状主体冷却剂进入通道10将冷却剂接收到细长管状主体近侧端部3中，b)使所接收的冷却剂穿过细长管状主体冷却剂进入通道10循环到细长管状主体远侧端部容纳区域11，以及c)使冷却剂从细长管状主体远侧端部容纳区域11循环穿过细长管状主体排出通道12并离开细长管状主体近侧端部3。
中空管9、细长管状主体冷却剂进入通道10、细长管状主体远侧端部容纳区域11和细长管状主体冷却剂排出通道12不限于细长管状主体内部部分7内的特定定位。在一些实施方案中，如图1所示，中空管9、细长管状主体冷却剂进入通道10、细长管状主体远侧端部容纳区域11和细长管状主体冷却剂排出通道12以多轴关系定位。在一些实施方案中，如图2所示，中空管9、细长管状主体冷却剂进入通道10、细长管状主体远侧端部容纳区域11和细长管状主体冷却剂排出通道12以与例如中空管9和细长管状主体远侧端部容纳区域11同心的关系定位，该中空管被细长管状主体冷却剂排出通道12围绕，该细长管状主体冷却剂排出通道被细长管状主体冷却剂进入通道10围绕，该细长管状主体远侧端部容纳区域定位在细长管状主体外部8的远侧端部处。
细长管状主体冷却剂进入通道10和细长管状主体冷却剂排出通道12不限于特定尺寸。在一些实施方案中，细长管状主体排出通道12的直径大于细长管状主体进入通道10的直径。在一些实施方案中，细长管状主体排出通道12的直径小于细长管状主体进入通道10的直径。在一些实施方案中，细长管状主体排出通道12的直径和细长管状主体进入通道10的直径相同。
细长管状主体远侧端部容纳区域11不限于特定尺寸。在一些实施方案中，细长管状主体远侧端部容纳区域11的尺寸使得其能够容纳穿过细长管状主体冷却剂进入通道10循环的冷却剂，以用于将细长管状主体远侧端部5的远侧端部保持在期望的温度(下文更详细地描述)。
此类实施方案不限于具体类型或种类的冷却剂的使用。在一些实施方案中，冷却剂选自水、二醇、空气、惰性气体、二氧化碳、氮气、氦气、六氟化硫、离子溶液(例如，具有或不具有钾离子和其它离子的氯化钠)、葡萄糖水溶液、林格氏乳酸盐、有机化学溶液(例如，乙二醇、二甘醇或丙二醇)、油(例如，矿物油、硅油、氟碳油)、液体金属、氟利昂、卤代甲烷、液化丙烷、其它卤代烷烃、无水氨、二氧化硫和在其临界点或接近其临界点压缩的冷却剂气体。
图3示出了柔性护套1，其中细长管状主体外部部分5的远侧端部包括一个或多个高热导率区域13(如图3所示，存在一个高热导率区域13)。在一些实施方案中，高热导率区域13被构造成在与组织区域接触时与组织区域选择性地附接，使得细长管状主体远侧端部5相对于组织区域稳定在期望的位置。
高热导率区域13不限于沿细长管状主体外部部分8的远侧端部的特定定位。在一些实施方案中，如图3所示，高热导率区域13包裹细长管状主体外部部分8的远侧端部的一部分(例如，1％、5％、10％、25％、45％、49.9％、50％、55％、62％、70％、79.5％、85％、90％、92％、93.5％、98％、99％、99.99％)。在一些实施方案中，高热导率区域13仅覆盖细长管状主体外部部分8的远侧端部的一部分(例如，1％、5％、10％、25％、45％、49.9％、50％、55％、62％、70％、79.5％、85％、90％、92％、93.5％、98％、99％、99.99％)，但不包裹细长管状主体外部部分8的整个远侧端部。
柔性护套不限于特定数量的高热导率区域13。在一些实施方案中，存在一个高热导率区域13，如图3所示。在一些实施方案中，存在沿细长管状主体外部部分8的远侧端部定位的2个、3个、5个、8个、10个、25个、100个、1000个等高热导率区域13。
高热导率区域13不限于在与组织区域接触时与组织区域选择性地附接以使得细长管状主体远侧端部5相对于组织区域稳定在期望的位置的特定方式。在一些实施方案中，高热导率区域13能够在与组织区域接触时与组织区域选择性地附接，使得通过高热导率区域13的选择性温度调节，细长管状主体远侧端部5相对于组织区域稳定在期望的位置。例如，在一些实施方案中，在将柔性护套1定位到期望的位置时，高热导率区域13的选择性减小允许组织区域冻结在高热导率区域13上，从而将细长管状主体远侧端部5固定到该期望的位置。在一些实施方案中，高热导率区域13的选择性减小允许组织区域冻结在高热导率区域13上，从而在穿过中空端口9插入和抽出装置期间将细长管状主体远侧端部5固定到该期望的位置。在其中高热导率区域13与组织区域固定在一起的一些实施方案中，选择性地升高高热导率区域13的温度导致组织区域与高热导率区域13的分离(例如，未冻结)。
柔性护套1不限于选择性地保持高热导率区域13的温度的特定方式。在一些实施方案中，通过进入和离开细长管状主体远侧端部容纳区域11的循环冷却剂来保持和/或调节高热导率区域13的温度。实际上，高热导率区域13的定位使得循环到细长管状主体远侧端部容纳区域11中的冷却剂导致高热导率区域13的温度调节/保持。例如，在一些实施方案中，在将柔性护套1定位在期望的组织位置处时，冷却剂循环到细长管状主体远侧端部容纳区域11中，使得高热导率区域13的温度降至其中组织区域附接(例如，冻结)到高热导率区域上的水平。例如，保持组织区域与高热导率区域13的附接是通过保持冷却剂充分循环到细长管状主体远侧端部容纳区域11中以将高热导率区域13保持在允许此类附接的温度来实现的。例如，通过减少冷却剂到细长管状主体远侧端部容纳区域11中的循环来升高高热导率区域13的温度有利于组织区域与高热导率区域13的分离。例如，通过增加较高温度的冷却剂到细长管状主体远侧端部容纳区域11中的循环来升高高热导率区域13的温度有利于组织区域与高热导率区域13的分离。
在一些实施方案中，通过冷却剂经由焦耳-汤普森效应、吸热化学反应或放热化学反应而进入和离开细长管状主体容纳区域11的循环来调节高热导率区域13的温度。
在一些实施方案中，高热导率区域13的材料包括金属、塑料、陶瓷或它们的混合物中的一者或多者。在一些实施方案中，高热导率区域13的材料是柔性的(例如，与柔性护套1的其余部分一样柔性)。
图4示出了柔性护套1，其中细长管状主体外部部分5的远侧端部包括柔性-刚性区域14。在一些实施方案中，柔性-刚性区域14被构造成在柔性状态和刚性状态之间选择性地交替。在一些实施方案中，柔性-刚性区域14被构造成在柔性状态和刚性状态之间选择性地交替，以用于相对于与柔性-刚性区域14接触的组织区域稳定细长管状主体远侧端部5。
柔性-刚性区域14不限于沿细长管状主体外部部分8的远侧端部的特定定位。在一些实施方案中，如图4所示，柔性-刚性区域14包裹细长管状主体外部部分8的远侧端部的一部分(例如，1％、5％、10％、25％、45％、49.9％、50％、55％、62％、70％、79.5％、85％、90％、92％、93.5％、98％、99％、99.99％)。在一些实施方案中，柔性-刚性区域14仅覆盖细长管状主体外部部分8的远侧端部的一部分(例如，1％、5％、10％、25％、45％、49.9％、50％、55％、62％、70％、79.5％、85％、90％、92％、93.5％、98％、99％、99.99％)，但不包裹细长管状主体外部部分8的整个远侧端部。
柔性-刚性区域14不限于相对于与柔性-刚性区域14接触的组织区域选择性地稳定细长管状主体远侧端部5的特定方式。在一些实施方案中，柔性-刚性区域14能够通过柔性-刚性区域14的选择性温度调节而相对于与柔性-刚性区域14接触的组织区域选择性地稳定细长管状主体远侧端部5。例如，在一些实施方案中，在将柔性护套1定位到期望的位置时，选择性地升高柔性-刚性区域14的温度使得柔性-刚性区域14呈刚性状态，这有利于将细长管状主体远侧端部5锚固在期望的位置处。例如，在一些实施方案中，在将柔性护套1定位到期望的位置时，选择性地升高柔性-刚性区域14的温度使得柔性-刚性区域14呈刚性状态，这有利于在穿过中空端口9插入和抽出装置期间将细长管状主体远侧端部5锚固在期望的位置处。在其中柔性-刚性区域14被锚固在组织区域处(例如，柔性-刚性区域14处于刚性状态)的一些实施方案中，选择性地降低柔性-刚性区域14的温度导致柔性-刚性区域14转变为柔性状态，从而从与组织区域的锚固释放细长管状主体远侧端部5。
柔性护套1不限于为了在柔性状态或刚性状态之间交替而选择性地保持柔性-刚性区域14的温度的特定方式。在一些实施方案中，通过冷却剂进入和离开细长管状主体远侧端部容纳区域11的循环来保持和/或调节柔性-刚性区域14的温度。实际上，柔性-刚性区域14的定位使得循环到细长管状主体远侧端部容纳区域11中的冷却剂导致柔性-刚性区域14的温度调节/保持。例如，在一些实施方案中，在将柔性护套1定位在期望的组织位置处时，冷却剂循环到细长管状主体远侧端部容纳区域11中，使得柔性-刚性区域14的温度升高或降低或保持以实现柔性-刚性区域14的期望的刚性或柔性，从而实现与组织区域的锚固或与组织区域的解除锚固。
在一些实施方案中，柔性-刚性区域14包含具有约15摄氏度至25摄氏度的适当玻璃化转变温度的热塑性聚合物。在一些实施方案中，该热塑性聚合物包括乳酸和己内酯的共聚物。在一些实施方案中，该热塑性聚合物包括L-丙交酯和己内酯的共聚物，诸如L-丙交酯单体与己内酯单体的比率为70:30或更小的聚(L-丙交酯-共-己内酯)。在一些实施方案中，热塑性区域可以PLC-7015从荷兰的Purac Biomaterials ofGorinchem商购获得。
在一些实施方案中，通过冷却剂经由焦耳-汤普森效应、吸热化学反应或放热化学反应而进入和离开细长管状主体容纳区域11的循环来调节柔性-刚性区域14的温度。
在一些实施方案中，柔性护套还包括可转向拉环。此类实施方案不限于可转向拉环的特定构型。在一些实施方案中，可转向拉环具有允许使用者经由操纵可转向拉环手动转向柔性护套的任何构型(例如，操纵线材中的一根或两根线材导致护套弯曲或转向)。
在一些实施方案中，可转向拉环允许柔性护套以任何期望的方式或方向转向。例如，在一些实施方案中，可转向拉环允许柔性护套以任何期望的弯曲角度(例如，1度至180度)转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的弯曲角度(例如，1度至360度)转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的弯曲半径(例如，1度至360度)转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的弯曲直径转向。在一些实施方案中，可转向拉环允许柔性护套在任何期望的范围(例如，0.1mm至100mm)转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的卷曲转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的掠角转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的曲线(例如，对称或非对称)(例如，多曲线或复合曲线)转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的环转向。在一些实施方案中，可转向拉环允许柔性护套以任何期望的挠曲(例如，面上挠曲、面外挠曲)转向。
在一些实施方案中，本发明提供了用于治疗性内窥镜检查程序的系统，其中提供了如本文所述的柔性护套、主导管和一个或多个合适的工具(例如，能量递送装置、可转向导航导管)。
此类实施方案不限于特定类型或种类的主导管。在一些实施方案中，本发明的主导管为内窥镜。在一些实施方案中，本领域技术人员已知的任何合适的内窥镜都可用作本发明的主导管。在一些实施方案中，主导管采用本领域已知的一个或多个内窥镜和/或支气管镜的特性，以及本文所述的特性。一种类型的常规柔性支气管镜在美国专利4,880,015中有所描述，该专利全文以引用方式并入本文。支气管镜测量为790mm的长度，并且具有两个主要部分，即工作头和插入管。工作头包括目镜；具有屈光度调节环的眼镜片；用于抽吸管、抽吸阀和光源的附接件；以及接入端口或活检入口，各种装置和流体可以通过该接入端口或活检入口进入工作通道并离开支气管镜的远侧端部。工作头附接到插入管，该插入管通常测量为580mm的长度和6.3mm的直径。插入管包括光纤束、光导和工作通道，该光纤束终止于远侧末端处的物镜镜头。可用于本发明的实施方案中的其它内窥镜和支气管镜或可与本发明一起使用的其它内窥镜和支气管镜的部分描述于以下专利中：美国专利7,473,219；美国专利6,086,529；美国专利4,586,491；美国专利7,263,997；美国专利7,233,820；以及美国专利6,174,307。
此类实施方案不限于特定类型或种类的可转向导航导管。在一些实施方案中，可转向导航导管被构造成装配在主导管(例如，内窥镜)的管腔和柔性护套内。在一些实施方案中，可转向导航导管具有足够的长度(例如，50cm...75cm...1m...1.5m...2m...5m...15m)以从插入部位(例如，口部、受检者的身体中的切口等)延伸到治疗部位。在一些实施方案中，通道导管具有足够的长度以延伸超过主导管(例如，内窥镜)的范围以到达治疗部位(例如，外周肺组织)。在一些实施方案中，可转向导航导管接合柔性护套，使得可转向导航导管的移动导致柔性护套的同步移动。在一些实施方案中，当可转向导航导管沿着受检者体内的路径插入时，围绕可转向导航导管的柔性护套与其一起移动。在一些实施方案中，柔性护套通过可转向导航导管放置在受检者体内。在一些实施方案中，可转向导航导管可与柔性护套脱离接合。在一些实施方案中，可转向导航导管和柔性护套的脱离接合允许可转向导航导管进一步沿着路径移动，而柔性护套不移动。在一些实施方案中，可转向导航导管和柔性护套的脱离接合允许可转向导航导管穿过柔性护套回缩，而柔性护套不移动。
此类实施方案不限于特定类型或种类的能量递送装置(例如，消融装置、外科装置等)(参见例如美国专利7,101,369、7,033,352、6,893,436、6,878,147、6,823,218、6,817,999、6,635,055、6,471,696、6,383,182、6,312,427、6,287,302、6,277,113、6,251,128、6,245,062、6,026,331、6,016,811、5,810,803、5,800,494、5,788,692、5,405,346、4,494,539，美国专利申请序列号11/728,460、11/728,457、11/728,428、11/237,136、11/236,985、10/980,699、10/961,994、10/961,761、10/834,802、10/370,179、09/847,181；英国专利申请2,406,521、2,388,039；欧洲专利1395190；以及国际专利申请WO 06/008481、WO 06/002943、WO05/034783、WO 04/112628、WO 04/033039、WO 04/026122、WO03/088858、WO 03/039385WO 95/04385；这些专利各自全文以引用方式并入本文)。此类能量递送装置不限于发射特定种类的能量。在一些实施方案中，能量递送装置能够发射射频能量。在一些实施方案中，能量递送装置能够发射微波能量。此类装置包括被构造用于能量发射的任何和所有医学、兽医学和研究应用装置，以及用于农业环境、制造环境、机械环境或其中将递送能量的任何其它应用中的装置。
本发明的用于治疗性内窥镜检查程序的系统不限于特定用途。实际上，本发明的此类系统被设计成用于其中能量发射适用的任何环境。此类用途包括任何和所有医疗应用、兽医应用和研究应用。此外，本发明的系统和装置可用于农业环境、制造环境、机械环境或待递送能量的任何其它应用中。
在一些实施方案中，该系统被构造用于其中可使用本文所述的柔性护套的任何类型的规程。例如，该系统用于开放式外科手术、经皮、血管内、心内、管腔内、内窥镜、腹腔镜或外科能量递送。
本发明不受靶组织或区域的性质的限制。用途包括但不限于治疗心律失常、肿瘤消融(良性和恶性)、控制外科手术期间及创伤后的出血、用于任何其它出血控制、移除软组织、组织切除和获取、治疗静脉曲张、管腔内组织消融(例如，治疗食道病理，诸如巴雷特氏食道癌和食道腺癌)，骨肿瘤及正常骨和良性骨病症的治疗、眼内用途、美容外科手术中的用途、中枢神经系统病理(包括脑肿瘤和电干扰)的治疗、灭菌程序(例如输卵管的消融)以及出于任何目的血管或组织的烧灼。在一些实施方案中，外科应用包括消融治疗(例如，以实现促凝坏死)。在一些实施方案中，外科应用包括肿瘤消融以靶向例如转移性肿瘤。在一些实施方案中，包括本文所述的柔性护套的系统被构造用于在对组织或生物体造成最小损伤的情况下移动和定位在任何期望的位置处，包括但不限于肺部、脑、颈部、胸部、腹部和骨盆。在一些实施方案中，系统被构造用于例如通过计算机断层扫描、超声、磁共振成像、荧光镜透视检查等引导递送。实际上，在一些实施方案中，此类系统的所有插入部件被构造用于沿着穿过受检者(例如，穿过分支结构、穿过支气管树等)的狭窄和迂回路径移动。
在某些实施方案中，本发明提供了治疗组织区域的方法，包括：提供组织区域和本文所述的系统(例如，主导管(例如，内窥镜)、如本文所述的柔性护套和能量递送装置(例如，微波消融导管)，以及下列部件中的至少一者：处理器、功率源、温度监测器、成像器、调谐系统、降温系统和/或装置放置系统)；将能量递送装置的一部分定位在组织区域的附近，并利用该装置向组织区域递送一定量的能量。在一些实施方案中，组织区域为肿瘤。在一些实施方案中，能量的递送导致例如组织区域的消融和/或血管的血栓形成和/或组织区域的电穿孔。在一些实施方案中，组织区域为肿瘤。在一些实施方案中，组织区域包括肺、心脏、肝脏、生殖器、胃、肺、大肠、小肠、脑、颈部、骨、肾、肌肉、肌腱、血管、前列腺、膀胱和脊髓中的一者或多者。
上面的说明书中提及的所有出版物、和专利均全文以引用方式并入以用于所有目的。在不脱离所述技术的范围和实质的情况下，所述技术的组合物、方法和用途的各种修改形式和变型形式对于本领域的技术人员将是显而易见的。尽管已结合具体的示例性实施方案描述了本技术，但应当理解，受权利要求书保护的本发明不应不当地受到此类具体实施方案的限制。实际上，对本领域的技术人员显而易见的对用于实施本发明的所述模式的各种修改旨在落入以下权利要求书的范围内。

Claims (15)

1.一种用于内窥镜检查规程中的柔性护套，
其中所述柔性护套包括细长管状主体，所述细长管状主体包括a)具有近侧端部开口的细长管状主体近侧端部和具有远侧端部开口的细长管状主体远侧端部，以及b)细长管状主体内部部分和细长管状主体外部部分，其中所述细长管状主体内部部分从所述细长管状主体近侧端部延伸到所述细长管状主体远侧端部，其中所述细长管状主体外部部分从所述细长管状主体近侧端部延伸到所述细长管状主体远侧端部；
其中所述细长管状主体内部部分包括中空端口，所述中空端口延伸到所述近侧端部开口中、穿过所述细长管状主体近侧端部、穿过所述细长管状主体远侧端部并延伸出所述远侧端部开口，其中所述中空端口的尺寸使得它能够适应适当尺寸的工具进入所述中空端口、穿过所述中空端口和离开所述中空端口；
其中所述柔性护套的直径小于5mm；
其中一个或多个柔性-刚性区域设置在所述细长管状主体外部部分的所述远侧端部的最外部区域上；
其中所述一个或多个柔性-刚性区域构造成在柔性状态和刚性状态之间选择性地交替；
其中如果所述一个或多个柔性-刚性区域处于刚性状态，则所述细长管状主体远侧端部相对于与所述柔性-刚性区域接触的组织区域稳定在期望的位置；
其中如果所述一个或多个柔性-刚性区域处于柔性状态，则所述细长管状主体远侧端部相对于与所述柔性-刚性区域接触的组织区域不稳定，并且
其中所述一个或多个柔性-刚性区域包裹所述细长管状主体外部部分的所述远侧端部，且未覆盖整个所述细长管状主体外部部分的所述远侧端部。
2.根据权利要求1所述的柔性护套，
其中所述细长管状主体内部部分还包括细长管状主体冷却剂进入通道、细长管状主体远侧端部容纳区域和细长管状主体冷却剂排出通道，
其中所述细长管状主体远侧端部容纳区域定位在所述细长管状主体远侧端部处，
其中所述细长管状主体内部部分构造成：a)经由所述细长管状主体冷却剂进入通道将冷却剂接收到所述细长管状主体近侧端部中，b)使所接收的冷却剂穿过所述细长管状主体冷却剂进入通道循环到所述细长管状主体远侧端部容纳区域，以及c)使所述冷却剂从所述细长管状主体远侧端部容纳区域循环穿过所述细长管状主体冷却剂排出通道并离开所述细长管状主体近侧端部，
其中
所述细长管状主体冷却剂排出通道的直径大于所述细长管状主体冷却剂进入通道的直径，或者
所述细长管状主体冷却剂排出通道的直径小于所述细长管状主体冷却剂进入通道的直径，或者
所述细长管状主体冷却剂排出通道的直径和所述细长管状主体冷却剂进入通道的直径相同，
其中
所述中空端口、所述细长管状主体冷却剂进入通道和所述细长管状主体冷却剂排出通道以多轴方式定位，或者
所述中空端口、所述细长管状主体冷却剂进入通道和所述细长管状主体冷却剂排出通道以同轴方式同心地定位，
其中所述冷却剂选自水、二醇、空气、惰性气体、二氧化碳、氮气、六氟化硫、无机离子溶液、有机化学溶液、油、液体金属、液化丙烷、卤代烷烃、无水氨和二氧化硫。
3.根据权利要求2所述的柔性护套，其中所述无机离子溶液包括具有钾离子或不具有钾离子的氯化钠和林格氏乳酸盐中的一者或两者。
4.根据权利要求2所述的柔性护套，其中有机化学溶液包括葡萄糖水溶液、乙二醇、二甘醇和丙二醇中的一者或多者。
5.根据权利要求2所述的柔性护套，其中所述油包括矿物油、硅油和氟碳油中的一者或多者。
6.根据权利要求2所述的柔性护套，其中所述一个或多个柔性-刚性区域包含具有15-25摄氏度的适当玻璃化转变温度的热塑性聚合物。
7.根据权利要求6所述的柔性护套，
其中所述热塑性聚合物包括乳酸和己内酯的共聚物，
其中所述热塑性聚合物包括L-丙交酯和己内酯的共聚物。
8.根据权利要求7所述的柔性护套，其中所述L-丙交酯和己内酯的共聚物为L-丙交酯单体与己内酯单体的比率为70:30或更小的聚(L-丙交酯-共-己内酯)。
9.根据权利要求6所述的柔性护套，其中所述热塑性聚合物可为从荷兰的PuracBiomaterials ofGorinchem商购获得的PLC-7015。
10.根据权利要求6所述的柔性护套，
其中通过冷却剂进入和离开所述细长管状主体远侧端部容纳区域的循环来调节所述一个或多个柔性-刚性区域的温度，
其中将柔性-刚性区域温度保持在约-40摄氏度导致所述一个或多个柔性-刚性区域处于柔性状态，
其中将柔性-刚性区域温度保持在约-5摄氏度导致所述一个或多个柔性-刚性区域处于刚性状态，
其中通过冷却剂经由焦耳-汤普森效应、吸热化学反应或放热化学反应进入和离开所述细长管状主体远侧端部容纳区域的循环来调节所述一个或多个柔性-刚性区域的温度，
其中所述细长管状主体的内部区域还包括构造成允许使用者以任何期望的方式使所述柔性护套转向的可转向拉环，
其中所述柔性护套设计成在微波场或微波区内操作而不遭受与微波场或微波区相关的损坏，其中所述柔性护套设计成在经受高温的组织区域内操作而不遭受与高温相关的损坏。
11.根据权利要求1所述的柔性护套，
其中所述适当尺寸的工具选自闭塞器和能量递送装置，
其中所述柔性护套具有足够的柔性以进入穿过受检者的迂回路线，
其中所述细长管状主体的组成为聚合物材料。
12.根据权利要求11所述的柔性护套，其中所述能量递送装置包括消融探头。
13.一种系统，所述系统包括主导管、根据权利要求1所述的柔性护套以及能量递送装置。
14.根据权利要求13所述的系统，其中所述主导管为内窥镜。
15.根据权利要求13所述的系统，其中所述能量递送装置为微波能量递送装置。
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