CN110022778B - 可线性驱动的导管、系统和方法 - Google Patents

可线性驱动的导管、系统和方法 Download PDF

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CN110022778B
CN110022778B CN201780072386.9A CN201780072386A CN110022778B CN 110022778 B CN110022778 B CN 110022778B CN 201780072386 A CN201780072386 A CN 201780072386A CN 110022778 B CN110022778 B CN 110022778B
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郑鹏
A·辛格
D·迪帕
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Abstract

本文在一些实施例中提供了一种导管组件，该导管组件包括：芯线，该芯线设置成线性驱动；以及环绕芯线的阻尼机构。芯线包括近端，该近端有声波连接器，该声波连接器设置成与超声波产生机构连接。芯线包括远端，该远端设置成利用来自超声波发生机构的振动能量来修补血管内病变。阻尼机构包括垫圈系统和保持器，该保持器用于将垫圈系统保持在导管组件的阻尼机构孔中。阻尼机构环绕芯线的近端部分，其中，该阻尼系统能够提供压缩力，该压缩力足够阻尼在芯线的近端部分中的、产生横向波的振动能量，而不限制芯线穿过阻尼机构的线性驱动，包括芯线穿过阻尼机构的延伸和缩回。

Description

可线性驱动的导管、系统和方法
交叉引用
本申请要求美国专利申请No.15/360834的优先权，该美国专利申请No.15/360834的申请日为2016年11月23日，标题为“CATHETER WITH RETRACTABLE SHEATH AND METHODSTHEREOF”，该申请整个被本文参引。
背景技术
动脉粥样硬化的特征在于局部由斑块形成的一个或多个血管内病变，包括血液携带的物质，例如脂肪、胆固醇和钙。血管内病变例如动脉病变能够在动脉管腔的壁上形成，并横过管腔扩展至它的相对壁上。最后的开放点通常发生在动脉病变和动脉管腔的相对壁之间的边界处。用于动脉粥样硬化的外科手术(例如血管成形术或粥样斑块切除术)能够用于恢复一个或多个血管内病变所损失的开放性和血流。
动脉粥样硬化外科手术可能涉及使得一个或多个腔内装置前进至血管内病变处，以便修补血管内病变。例如，血管成形术或粥样斑块切除术可能涉及使得腔内装置在导丝上前进至血管内病变处，用于进行修补。不过，使得腔内装置在导丝上前进至血管内病变处可能由于装置复杂而导致手术复杂，特别是在曲折解剖结构中，其中，腔内装置的尖端可能挂住和从导丝上脱轨。本文在一些实施例中提供了可线性驱动的导管、系统和方法，它们解决了前述问题。
发明内容
本文在一些实施例中提供了一种导管组件，该导管组件包括：芯线，该芯线设置成用于线性驱动；以及环绕芯线的阻尼机构，该阻尼机构设置成阻尼振动能量。芯线包括近端，该近端有声波连接器，该声波连接器设置成与超声波产生机构连接，该超声波产生机构用于向芯线施加振动能量。芯线包括远端，该远端设置成利用振动能量来修补血管内病变。阻尼机构包括垫圈系统和保持器，该保持器用于将垫圈系统保持在导管组件的阻尼机构孔中。阻尼机构环绕芯线的近端部分，其中，该阻尼机构设置成在芯线的近端部分中阻尼产生横向波的振动能量。垫圈系统提供足够的压缩力，以便阻尼在芯线的近端部分中的、产生横向波的振动能量，而不限制芯线穿过阻尼机构的线性驱动，线性驱动包括芯线穿过阻尼机构的延伸和缩回。
在这样的实施例中，导管组件还包括线性驱动机构，该线性驱动机构设置成使得芯线从芯线的完全缩回状态延伸以及使得芯线从芯线的完全延伸状态缩回。在完全延伸状态中，芯线的远端和距离环绕芯线的护壳的远端直到大约20cm的、芯线的工作段暴露。在完全缩回状态中，芯线的工作段(直到至少芯线的远端)隐藏在护壳中。
在这样的实施例中，垫圈系统的中心定位在芯线上面，其中，芯线经受最小的、产生横向波的振动能量，从而减少摩擦热量和省略散热器。
在这样的实施例中，垫圈系统包括在阻尼机构孔中的多个轴向和径向压缩的O形环，该O形环提供环绕芯线的压缩力。该多个O形环在阻尼机构孔中通过阻尼机构孔的远端和固定在阻尼机构孔的近端的保持器来轴向压缩。该多个O形环通过阻尼机构孔的内壁来径向压缩。
在这样的实施例中，导管组件还包括注射器，该注射器设置成将冲洗剂注入导管组件的冲洗口中。环绕芯线的压缩力还足以防止冲洗液的冲洗回流，而并不限制芯线穿过阻尼机构的延伸或缩回。
在这样的实施例中，导管组件还包括聚合物套筒，该聚合物套筒环绕在声波连接器和保持器之间的芯线近端部分的暴露部分。聚合物套筒还环绕在阻尼机构中的芯线近端部分，且聚合物套筒包括润滑表面，以便于芯线穿过阻尼机构的延伸和缩回。
在这样的实施例中，导管组件还包括在芯线近端处的超声波换能器，该超声波换能器形成超声波产生机构的一部分，用于向芯线施加振动能量。
本文还在一些实施例中提供了一种导管组件，该导管组件包括：线性驱动机构；芯线，该芯线设置成由线性驱动机构来线性驱动，以及环绕芯线的阻尼机构，该阻尼机构设置成阻尼振动能量。芯线包括近端，该近端有声波连接器，该声波连接器设置成接收施加于其上的振动能量。芯线还包括远端，该远端有尖端部件，该尖端部件设置成利用振动能量来修补血管内病变。阻尼机构包括垫圈系统和保持垫片，该保持垫片用于将垫圈系统保持在导管组件的阻尼机构孔中。阻尼机构环绕芯线的近端部分，其中，阻尼机构设置成在芯线的近端部分中阻尼产生横向波的振动能量。垫圈系统提供压缩力，该压缩力足以阻尼在芯线的近端部分中的、产生横向波的振动能量，而并不限制芯线穿过阻尼机构的线性驱动，线性驱动包括芯线穿过阻尼机构的延伸和缩回。
在这样的实施例中，线性驱动机构设置成使得芯线从芯线的完全缩回状态延伸，以及使得芯线从芯线的完全延伸状态缩回。在完全延伸状态中，尖端部件和芯线的工作段(离环绕芯线的护壳的远端直到大约20cm)暴露。在完全缩回状态中，芯线的工作段(直到至少尖端部件)隐藏在护壳中。
在这样的实施例中，垫圈系统包括在阻尼机构孔中的多个轴向和径向压缩的O形环，该O形环提供环绕芯线的压缩力。该压缩力还足以防止冲洗剂的冲洗回流，而并不限制芯线穿过阻尼机构的延伸或缩回。该多个O形环在阻尼机构孔中通过阻尼机构孔的远端和固定在阻尼机构孔的近端的保持垫片来轴向压缩。该多个O形环通过阻尼机构孔的内壁来径向压缩。
在这样的实施例中，导管组件还包括聚合物套筒，该聚合物套筒环绕在阻尼机构中的芯线近端部分。该聚合物套筒包括润滑表面，以便于芯线穿过阻尼机构的全范围线性驱动。
在这样的实施例中，导管组件还包括在芯线近端处的超声波换能器，该超声波换能器形成超声波产生机构的一部分，用于向芯线施加振动能量。
在这样的实施例中，超声波换能器设置成通过线性驱动机构来线性驱动。超声波换能器的线性驱动与芯线的线性驱动同步，以便通过声波连接器来保持在超声波换能器和芯线之间的声波连接。
本文还在一些实施例中提供了一种系统，该系统包括导管组件和超声波能量产生机构。导管组件包括：线性驱动机构；芯线，该芯线设置成由线性驱动机构来线性驱动，以及环绕芯线的阻尼机构，该阻尼机构设置成阻尼振动能量。芯线包括近端，该近端有声波连接器，该声波连接器设置成接收施加于其上的振动能量。芯线还包括远端，该远端有尖端部件，该尖端部件设置成利用振动能量来修补血管内病变。阻尼机构包括垫圈系统和保持垫片，该保持垫片用于将垫圈系统保持在导管组件的阻尼机构孔中。阻尼机构环绕芯线的近端部分，其中，阻尼机构设置成在芯线的近端部分中阻尼产生横向波的振动能量。垫圈系统提供压缩力，该压缩力足以阻尼在芯线的近端部分中的、产生横向波的振动能量，而并不限制芯线穿过阻尼机构的线性驱动，线性驱动包括芯线穿过阻尼机构的延伸和缩回。超声波能量产生机构包括超声波发生器和超声波换能器。超声波换能器设置成将振动能量施加给在芯线近端处的声波连接器。
在这样的实施例中，线性驱动机构设置成使得芯线从芯线的完全缩回状态延伸，以及使得芯线从芯线的完全延伸状态缩回。在完全延伸状态中，尖端部件和芯线的工作段(离环绕芯线的护壳的远端直到大约20cm)暴露。在完全缩回状态中，芯线的工作段(直到至少尖端部件)隐藏在护壳中。
在这样的实施例中，垫圈系统包括在阻尼机构孔中的多个轴向和径向压缩的O形环，该O形环提供环绕芯线的压缩力。该压缩力还足以防止冲洗剂的冲洗回流，而并不限制芯线穿过阻尼机构的延伸或缩回。该多个O形环在阻尼机构孔中通过阻尼机构孔的远端和固定在阻尼机构孔的近端的保持垫片来轴向压缩。该多个O形环通过阻尼机构孔的内壁来径向压缩。
在这样的实施例中，该系统还包括聚合物套筒，该聚合物套筒环绕在阻尼机构中的芯线近端部分。该聚合物套筒包括润滑表面，以便于芯线穿过阻尼机构的全范围线性驱动。
在这样的实施例中，该系统还包括控制台，该控制台包括脚踏开关和超声波能量产生机构，该超声波能量产生机构包括超声波发生器和超声波换能器。脚踏开关设置成驱动和停用超声波能量产生机构。
在这样的实施例中，该系统还包括控制台，该控制台包括脚踏开关和超声波能量产生机构的超声波发生器。导管组件还包括超声波能量产生机构的超声波换能器。脚踏开关设置成驱动和停用超声波能量产生机构。
在这样的实施例中，超声波换能器设置成通过线性驱动机构来线性驱动。超声波换能器的线性驱动与芯线的线性驱动同步，以便通过声波连接器来保持在超声波换能器和芯线之间的声波连接。
本文还在一些实施例中提供了一种方法，该方法包括模制导管组件的筒体以及将环绕芯线的阻尼机构装配在筒体中。模制筒体包括模制具有阻尼机构孔的筒体。将环绕芯线的阻尼机构装配在筒体中包括将芯线布置成穿过阻尼机构孔的中心，该阻尼机构孔的中心与筒体的旋转轴线重合。多个O形环环绕芯线布置在阻尼机构孔中，且垫片固定在阻尼机构孔的近端中，以便形成环绕芯线的阻尼机构。垫片固定在阻尼机构孔的近端中将产生在芯线上的径向压缩力(由于多个O形环抵靠阻尼机构孔的远端轴向压缩)。多个O形环抵靠阻尼机构孔的远端轴向压缩再在芯线上产生径向压缩力(由于多个O形环抵靠阻尼机构孔、与芯线相对的内壁径向压缩)。该径向压缩力足以阻尼施加至芯线的近端部分上的、产生横向波的振动能量，而并不限制芯线穿过阻尼机构的线性驱动。
在这样的实施例中，该方法还包括将芯线布置在聚合物套筒中并均匀加热该聚合物套筒，以便在芯线布置成穿过阻尼机构孔的中心之前使得聚合物套筒环绕芯线收缩。聚合物套筒由润滑聚合物形成，以便于芯线穿过阻尼机构的全范围线性驱动。
在这样的实施例中，该方法还包括模制导管组件的壳体；将筒体布置在导管组件的壳体中，该筒体有环绕芯线的阻尼机构；以及使得芯线与导管组件的线性驱动机构连接。因此，导管组件的芯线设置成穿过阻尼机构来进行线性驱动。
参考附图、说明书和附加权利要求可以更好地理解本文提供的概念的这些和其它特征。
附图说明
图1提供了表示根据一些实施例的系统的示意图。
图2A提供了表示根据一些实施例的导管组件的示意图，该导管组件有线性驱动机构，该线性驱动机构设置成使得芯线从芯线的第一完全缩回状态延伸。
图2B提供了表示根据一些实施例的导管组件的示意图，该导管组件有线性驱动机构，该线性驱动机构设置成使得芯线从芯线的第二完全延伸状态缩回。
图3A提供了表示根据一些实施例的阻尼机构的示意图，该阻尼机构设置成用于阻尼和线性驱动芯线。
图3B提供了表示根据一些实施例的阻尼机构的示意图，该阻尼机构设置成用于阻尼和线性驱动芯线。
具体实施方式
在更详细地提供一些特殊实施例之前，应当理解，本文提供的特殊实施例并不限制本文提供的概念的范围。还应当理解，本文提供的特殊实施例的特征能够很容易地与该特殊实施例分离，并选择地与本文提供的多个其它实施例中的任意一个的特征组合或替代该特征。
关于本文使用的术语，还应当理解，术语是用于介绍一些特殊实施例的目的，且该术语并不限制本文提供的概念的范围。除非另外说明，否则序号(例如，第一、第二、第三等)将用于区分或识别一组特征或步骤中的不同特征或步骤，而并不提供系列或数字的限制。例如，“第一”、“第二”和“第三”特征或步骤并不必须以该顺序出现，包括这些特征或步骤的特殊实施例并不必须局限于这三个特征或步骤。还应当理解，除非另外说明，否则任何标记例如“左”、“右”、“前”、“后”、“顶部”、“底部”、“向前”、“反向”、“顺时针”、“逆时针”、“向上”、“向下”或其它类似术语例如“上”、“下”、“后”、“前”、“竖直”、“水平”、“近侧”、“远侧”等是为了方便而使用，并不暗示例如任何特殊的固定位置、方位或方向。相反，这些标记用于反映例如相对位置、方位或方向。还应当理解，除非上下文另外明确规定，否则单数形式的“一”、“一个”和“该”包括复数指代。
对于例如护壳或芯线的“近侧”“近侧部分”或“近端部分”，分别包括护壳或芯线的、当系统按预期使用时靠近系统操作人员的部分。同样地，例如护壳或芯线的“近侧段”分别包括护壳或芯线的、当系统按预期使用时靠近系统操作人员的段。例如护壳或芯线的“近端”分别包括护壳或芯线的、当系统按预期使用时靠近系统操作人员的端部。护壳或芯线的近侧部分、近端部分或近侧段能够包括护壳或芯线的近端；不过，护壳或芯线的近侧部分、近端部分或近侧段并不必须包括护壳或芯线的近端。也就是，除非上下文另外说明，否则护壳或芯线的近侧部分、近端部分或近侧段并不是护壳或芯线的末端部分或末端段。
对于例如护壳或芯线的“远侧”“远侧部分”或“远端部分”，分别包括护壳或芯线的、当系统按预期使用时远离系统操作人员的部分。同样地，例如护壳或芯线的“远侧段”分别包括护壳或芯线的、当系统按预期使用时远离系统操作人员的段。例如护壳或芯线的“远端”分别包括护壳或芯线的、当系统按预期使用时远离系统操作人员的端部。护壳或芯线的远侧部分、远端部分或远侧段能够包括护壳或芯线的远端；不过，护壳或芯线的远侧部分、远端部分或远侧段并不必须包括护壳或芯线的远端。也就是，除非上下文另外说明，否则护壳或芯线的远侧部分、远端部分或远侧段并不是护壳或芯线的末端部分或末端段。
除非另外定义，否则本文使用的所有技术和科学术语具有与本领域普通技术人员的通常理解相同的含义。
动脉粥样硬化外科手术能够涉及使得一个或多个腔内装置前进至血管内病变处，以便修补血管内病变。例如，血管成形术或粥样斑块切除术能够涉及使得腔内装置在导丝上面前进至血管内病变处，用于进行修补。不过，使得腔内装置在导丝上面前进至血管内病变处可能由于装置复杂而导致手术复杂，特别是在曲折解剖结构中，其中，腔内装置的尖端可能挂住和从导丝上脱轨。本文在一些实施例中提供了可线性驱动的导管、系统和方法，它们解决了前述问题。
图1提供了表示根据一些实施例的系统100的示意图。系统100包括控制台110，该控制台110与导管组件160连接，该导管组件160设置成用于修补血管内病变，包括横过血管内病变、切除血管内病变、或者横过和切除血管内病变的组合。
如图1中所示，系统100包括控制台110。该控制台110向系统操作人员提供用于监视和控制系统100和多个子系统以及它们的功能的仪器。控制台110包括超声波能量产生机构，该超声波能量产生机构包括超声波发生器120和超声波换能器130。也可选择，控制台110包括超声波发生器120，导管组件160包括超声波换能器130，且超声波能量产生机构在控制器110和导管组件160之间分开。超声波能量产生机构设置成将电流转换成振动能量。例如，超声波发生器120设置成将交流电(例如与市电相连的电流)转换为高频电流(例如具有与超声波换能器130的操作频率相当的频率的电流)，该超声波换能器130再设置成将高频电流转换为振动能量(例如，>20kHz，例如20.5kHz±500Hz)。
控制台110还可选地包括脚踏开关140，该脚踏开关140设置成驱动和停用系统100，例如驱动和停用导管组件160的芯线184(例如镍钛诺芯线)。芯线184布置在导管组件160的护壳182的芯线管腔183中。芯线184的近端与超声波换能器130振动连接，芯线184的远端与病变修补尖端部件186振动连接，或者病变修补尖端186由芯线184的远端形成。因此，芯线184设置成将来自超声波换能器130的振动能量传递给尖端部件或尖端186，用于修补血管内病变。当系统100通电但未驱动时，脚踏开关140用于驱动系统100，从而驱动导管组件160的尖端部件或尖端186、超声波换能器130和芯线184。当系统100通电并驱动时，脚踏开关140用于停用系统100，从而停用导管组件160的尖端部件或尖端186、超声波换能器130和芯线184。
控制台110还可选地包括注射器150，该注射器150设置成将冲洗剂注射至导管组件160的冲洗口172中。冲洗剂包括例如无菌液体(例如水、盐水、肝素化盐水等)，用于冲洗经历血管内病变修补过程(例如，横过血管内病变、切除血管内病变等)的解剖区域、冷却导管组件160的芯线184、或者它们的组合。
控制台110还可选地包括脚踏开关140和注射器150。在这样的实施例中，脚踏开关140还设置成当系统100分别通过脚踏开关140而驱动和停用时驱动和停用注射器150。
图2A提供了表示根据一些实施例的导管组件160的示意图，该导管组件160有延伸-缩回机构或线性驱动机构174，该延伸-缩回机构或线性驱动机构174设置成使芯线184从芯线184的第一完全缩回位置或状态延伸。图2B提供了表示根据一些实施例的导管组件160的示意图，该导管组件160有延伸-缩回机构或线性驱动机构174，该延伸-缩回机构或线性驱动机构174设置成使得芯线184从芯线184的第二完全延伸位置或状态缩回。导管组件160包括：壳体270，该壳体270与导管本体180连接(见图1)，该导管本体180包括护壳182以及芯线184，该芯线184设置成用于修补血管内病变，包括横过血管内病变、切除血管内病变、或者横过和切除血管内病变的组合。
如图2A和2B中所示，壳体270包括毂形部276和锁定轴环278，锁定轴环用于将壳体270锁定到超声波换能器130上。(冲洗口172在图2A和2B中未示出，因为冲洗口172在一些实施例中是可选的。)将壳体270锁定在超声波换能器130上保证芯线184的近端与超声波换能器130充分地振动连接，以便修补血管内病变。再有，也可选择，导管组件160包括超声波换能器130，这使得超声波能量产生机构在控制台110和导管组件160之间分开。在这样的实施例中，壳体270还包括布置在芯线的近端处的超声波换能器130，从而省略了图2A和2B中所示的锁定轴环276。还在这样的实施例中，超声波换能器130设置成通过线性驱动机构174而线性驱动。超声波换能器130的线性驱动与芯线184的线性驱动同步，以便通过声波连接器385来保持在超声波换能器130和芯线184之间的声波连接。(见图3A和3B，对于声波连接器385)。
线性驱动机构174设置成使得芯线184从芯线184的第一完全缩回位置或状态延伸，如图2A中所示。在芯线184的完全缩回状态中，芯线184的远侧部分(包括尖端部件或尖端186)完全布置在护壳管腔183内。也可选择，在芯线184的完全缩回状态中，尖端部件或尖端186暴露，芯线184的剩余远侧部分完全布置在护壳管腔183内。线性驱动机构174还设置成使得芯线184从芯线184的第二完全延伸位置或状态缩回，如图2B中所示。在芯线184的完全延伸状态中，芯线184的、包括尖端部件或尖端186的最大工作段lw(max)暴露在护壳管腔183的外部。
应当理解，线性驱动机构174设置成使得芯线184沿远侧方向延伸以及使得芯线184沿近侧方向缩回。而且，线性驱动机构174设置成线性地驱动芯线184自身，而不是用于芯线184的任何其它运动的任何其它线(例如，用于芯线铰接的牵引线，例如芯线184偏转通过一定角度)。
如图2A和2B中所示，壳体270设置成容纳芯线184的近侧段，且线性驱动机构174设置成使得芯线184的近侧段从壳体270伸出，并暴露芯线184的远侧部分的工作段lw，用于通过芯线184的工作段lw来基于超声波修补一个或多个血管内病变。芯线184的最大工作段lw(max)由芯线184上的点从第一完全缩回状态延伸至第二完全延伸状态的延伸距离来确定。芯线184的最大工作段lw(max)也由壳体270中的槽段ls来确定，该壳体270设置成在第一状态中容纳芯线184的近侧段。芯线184的工作段lw在大约5和200mm之间，包括在大约5和100mm之间或在大约100和200mm之间；不过，芯线184的工作段lw并不局限于此。应当理解，更短的工作段lw和更小的导管本体型面在某些情况下很有利，而更长的工作段lw和更大的导管本体型面在某些其它情况下(例如身材较大的患者)很有利。
线性驱动机构174是手动驱动，如图2A和2B中所示，或者线性驱动机构174是马达驱动。无论是手动还是马达驱动，线性驱动机构174设置成i)使得芯线184从芯线184的第一完全缩回状态延伸，ii)使得芯线184从芯线184的第二完全延伸状态缩回，iii)使得芯线184延伸或缩回至在第一状态和第二状态之间的中间位置或状态，或者iv)它们的任何组合。芯线184延伸和缩回至前述中间位置提供了用于不同解剖结构和血管内病变所需的可定制性。
芯线184的远端部分的、超过其护壳182或护壳管腔183的工作段lw设置成用于移动，以便实现血管内病变修补。根据芯线184的型面和振动能量(例如>20kHz，例如20.5kHz±500Hz)，该移动包括纵向、横向或者纵向和横向移动。芯线184的工作段lw的纵向移动导致微运动，例如空穴化，而芯线184的工作段lw的横向移动导致宏运动。微运动用于横过血管内病变。宏运动及微运动用于切除血管内病变，从而使得病变破碎成微小碎片，并恢复开放性和血流。
3A和3B提供了表示根据一些实施例的阻尼机构390的示意图，该阻尼机构390设置成阻尼芯线184中的振动能量和芯线184穿过它的线性驱动。
芯线184包括在芯线184近端处的声波连接器385，该声波连接器385设置成与超声波产生机构连接，用于向芯线施加振动能量，用于通过芯线184的工作段lw来基于超声波修补一个或多个血管内病变。声波连接器385设置成通过超声波换能器130或插入的超声波变幅杆(ultrasonic horn)(未示出)而与超声波产生机构连接。芯线184的远端与病变修补尖端部件186振动连接，或者病变修补尖端186由芯线184的远端形成，用于基于超声波修补一个或多个血管内病变。
导管组件160包括环绕芯线184的近端部分的阻尼机构390，该阻尼机构390设置成阻尼环绕芯线184的近端部分的、产生横向波的振动能量，有利于产生纵向波的振动能量，且不限制芯线184穿过阻尼机构390的延伸或缩回。阻尼机构390包括：垫圈系统394，该垫圈系统394设置成环绕芯线184施加压缩力；以及保持器396，该保持器396设置成使得垫圈系统394保持在导管组件160的筒体391的阻尼机构孔398内。
垫圈系统394包括多个O形环399。O形环399的数量范围为从1个O形环到12个O形环，包括2个O形环，例如4个O形环，例如，6个O形环。该多个O形环399通过保持器396而在筒体391的阻尼机构孔398中轴向压缩和保持在阻尼机构孔398中(例如，垫片如保持垫片，例如，外部的星形垫片)。该多个O形环399的轴向压缩产生在芯线184上的径向压缩，该径向压缩足以阻尼产生横向波的振动能量，有利于环绕芯线184的近端部分的、产生纵向波的振动能量。
阻尼机构390还包括环绕芯线184的套筒392。(也可选择，套筒392认为是线性驱动机构174的一部分，其中它方便芯线184穿过阻尼机构390的延伸和缩回。)套筒392至少在声波连接器385和保持器398之间环绕芯线184的近端部分。当没有由套筒392包围时，该芯线184将在声波连接器385和保持器398之间包括芯线184的近端部分的暴露部分。在声波连接器385和保持器398之间环绕芯线184的近端部分的套筒392防止在它们之间的芯线184疲劳。套筒392还至少环绕芯线184的、在阻尼机构390中的近端部分，以及环绕在阻尼机构390远侧的芯线184，直到至少与芯线184的工作段lw相当的一段。套筒392不仅防止芯线184疲劳，该套筒392还有助于芯线184穿过阻尼机构390的延伸和缩回。套筒392包括聚合物或者由聚合物形成，该聚合物提供相对润滑表面，该润滑表面有助于芯线392穿过阻尼机构390的延伸和缩回。
环绕芯线184的套筒392以工程配合来包围芯线184，该工程配合从间隙配合、过渡配合和过盈配合中选择。间隙配合是相当松的配合，使得芯线184能够在套筒392内自由地旋转或滑动；过渡配合使得芯线184在套筒392内牢固地保持就位，但并不牢固成使得芯线184不能从套筒392中移除；而过盈配合使得芯线184在套筒392内牢固地保持就位，以使得芯线184不能在不损坏芯线184、套筒392或者芯线184和套筒392的情况下从套筒392中移除。在一些实施例中，套筒392以过渡配合或过盈配合包围芯线184。过渡配合和过盈配合通过例如在导管组件160的装配过程中热收缩合适尺寸的套筒来实现，用于环绕芯线184的合适配合。环绕芯线184的套筒392是聚合物套筒例，如聚四氟乙烯(“PTFE”)套筒。
阻尼机构390定心在芯线184的振动节点上或是振动节点，或者芯线184能够调节，以使得阻尼机构390在芯线184的振动节点上或是振动节点。这使得由于阻尼产生横向波的振动能量而引起的摩擦热量最小，因此在导管组件160的阻尼机构中不需要散热器。在包括注射器150的系统100的实施例中，垫圈系统394防止冲洗剂通过导管组件160(例如穿过阻尼机构)而冲洗回流和进入超声波产生机构的超声波换能器130。垫圈系统394进一步防止冲洗回流，而并不限制芯线184穿过阻尼机构390的延伸或缩回。
制造阻尼机构390包括模制导管组件160的筒体391和随后将环绕芯线184的阻尼机构390装配在筒体391中，该阻尼机构390设置成阻尼芯线184中的振动能量以及线性驱动穿过它的芯线184。
模制该筒体391包括模制有阻尼机构孔398的筒体391。这种模制包括但不局限于压缩模制、注射模制、热成型或者它们的组合。
将环绕芯线184的阻尼机构391装配在筒体391中包括将芯线184布置成穿过阻尼机构孔398的中心，该中心与筒体391的旋转轴线重合。在将芯线184布置成穿过阻尼机构孔398的中心之前，芯线184布置在可热收缩的聚合物套筒中，并均匀加热以使得可热收缩的聚合物套筒环绕芯线184收缩，以便环绕芯线184形成聚合物套筒392。聚合物套筒392由润滑聚合物(例如PTFE)形成，以方便芯线184穿过阻尼机构390的全范围线性驱动(即，从第一完全缩回状态线性驱动至第二完全延伸状态，再返回)。
将环绕芯线184的阻尼机构390装配在筒体391中还包括将多个O形环399环绕芯线184布置在阻尼机构孔398中，以及将保持器396(例如外部星形垫片)固定在阻尼机构孔398的近端中，以便形成环绕芯线184的阻尼机构390。将保持器396固定在阻尼机构孔398的近端中产生在芯线184上的径向压缩力。径向压缩力由在多个O形环399上的轴向压缩力来产生，该轴向压缩力由在阻尼机构孔398的近端中的保持器396将该多个O形环399轴向压靠在阻尼机构孔398的远端上而产生。轴向压缩力又通过多个O形环399的径向膨胀而在芯线184上产生径向压缩力，从而将该多个O形环399径向压靠在阻尼机构孔398的、与芯线184相对的内壁上以及芯线184自身上。径向压缩力足以阻尼施加在芯线184的近端部分上的、产生横向波的振动能量，而并不限制芯线184穿过阻尼机构390的线性驱动。
制造导管组件160包括模制导管组件160的壳体，随后将包括环绕芯线184的阻尼机构390的筒体391布置在壳体中，以便形成导管组件160。将筒体391布置在壳体中包括使得芯线184与导管组件160的线性驱动机构174连接。因此，导管组件160的芯线184设置成穿过阻尼机构390线性驱动。
尽管本文已经提供了一些特殊实施例，且该特殊实施例已经提供了某些细节，但是该特殊实施例并不用于限制本文提出的概念的范围。本领域普通技术人员能够想到其它改变和/或变化形式，且在更广义方面，也包括这些改变和/或变化形式。因此，在不脱离本文提供的概念的范围的情况下，可以偏离本文提供的特殊实施例。

Claims (19)

1.一种导管组件，包括：
芯线，所述芯线设置成用于包括延伸和缩回的线性驱动，其中：
芯线的近端包括声波连接器，所述声波连接器设置成与超声波产生机构连接，所述超声波产生机构用于向芯线施加振动能量，以及
芯线的远端设置成利用振动能量来修补血管内病变；以及
阻尼机构，所述阻尼机构环绕芯线的近端部分，并设置成阻尼在芯线的近端部分中的、产生横向波的振动能量，所述阻尼机构包括：
垫圈系统，所述垫圈系统包括环绕芯线的多个O形环；以及
保持器，用于将O形环保持在导管组件的阻尼机构孔中，使得保持器沿轴向压缩O形环，所述阻尼机构孔的外周的尺寸设置成约束O形环由于保持器的轴向压缩所产生的径向膨胀，从而O形环向芯线施加径向压缩力，所述径向压缩力足以阻尼在芯线的近端部分中的、产生横向波的振动能量。
2.根据权利要求1所述的导管组件，还包括：
线性驱动机构，所述线性驱动机构设置成：
使得芯线从芯线的完全缩回状态延伸，以及
使得芯线从芯线的完全延伸状态缩回，其中：
芯线的远端和从芯线的远端到环绕芯线的护壳的远端大约20cm的、芯线的工作段在完全延伸状态中暴露，以及
芯线的远端及芯线的所述工作段在完全缩回状态中隐藏在护壳中。
3.根据权利要求1或2所述的导管组件，其中：
垫圈系统的中心位于芯线上面并在芯线经受最小的产生横向波的振动能量的位置处，从而减少摩擦热量并省略散热器。
4.根据权利要求1或2所述的导管组件，其中：
垫圈系统还包括收缩配合的套筒，所述套筒位于O形环和芯线之间，从而压缩力通过收缩配合的套筒施加到芯线。
5.根据权利要求1或2所述的导管组件，还包括：
注射器，所述注射器设置成将冲洗剂注射至导管组件的冲洗口内，
其中，环绕芯线的压缩力还足以防止冲洗剂的冲洗回流，而不限制芯线穿过阻尼机构的延伸或缩回。
6.根据权利要求1或2所述的导管组件，还包括：
聚合物套筒，所述聚合物套筒在声波连接器和保持器之间环绕芯线的近端部分的暴露部分。
7.根据权利要求6所述的导管组件，其中：
聚合物套筒还在阻尼机构中环绕芯线的近端部分；以及
聚合物套筒包括润滑表面，以方便芯线穿过阻尼机构的延伸和缩回。
8.根据权利要求1或2所述的导管组件，还包括：
在芯线的近端处的超声波换能器，所述超声波换能器形成用于向芯线施加振动能量的超声波产生机构的一部分。
9.一种可线性驱动的系统，包括：
导管组件，所述导管组件包括：
线性驱动机构；以及
芯线，所述芯线设置成由线性驱动机构来线性驱动，其中：
芯线的近端包括声波连接器，所述声波连接器设置成接受施加给它的振动能量，以及
芯线的远端包括尖端部件，所述尖端部件设置成利用振动能量来修补血管内病变；以及
阻尼机构，所述阻尼机构环绕芯线的近端部分，设置成阻尼在芯线的近端部分中的、产生横向波的振动能量，其中，所述阻尼机构包括：
垫圈系统，所述垫圈系统包括环绕芯线的多个O形环；以及
保持垫片，用于将O形环保持在导管组件的阻尼机构孔中，使得保持垫片沿轴向压缩O形环，所述阻尼机构孔的外周的尺寸设置成约束O形环由于保持垫片的轴向压缩所产生的径向膨胀，从而O形环向芯线施加径向压缩力，所述径向压缩力足以阻尼在芯线的近端部分中的、产生横向波的振动能量，而不会限制芯线穿过阻尼机构的线性驱动；以及
超声波能量产生机构，所述超声波能量产生机构包括：
超声波发生器；以及
超声波换能器，其中，超声波换能器设置成将振动能量施加给在芯线近端处的声波连接器。
10.根据权利要求9所述的系统，其中：
线性驱动机构设置成：
使得芯线从芯线的完全缩回状态延伸，以及
使得芯线从芯线的完全延伸状态缩回，
芯线的尖端部件和从芯线的尖端部件到环绕芯线的护壳的远端大约20cm的、芯线的工作段在完全延伸状态中暴露，以及
芯线的尖端部件及芯线的工作段在完全缩回状态中隐藏在护壳中。
11.根据权利要求9或10所述的系统，其中：
垫圈系统包括多个位于阻尼机构孔中的轴向和径向压缩的O形环，这些O形环提供环绕芯线的压缩力，以及
所述压缩力还足以防止冲洗剂的冲洗回流，而并不限制芯线穿过阻尼机构的延伸或缩回。
12.根据权利要求11所述的系统，其中：
所述多个O形环通过阻尼机构孔的远端和固定在阻尼机构孔的近端中的保持垫片而在阻尼机构孔中轴向压缩；以及
所述多个O形环由阻尼机构孔的内壁径向压缩。
13.根据权利要求9或10所述的系统，还包括：
聚合物套筒，所述聚合物套筒在阻尼机构中环绕芯线的近端部分，其中，聚合物套筒包括润滑表面，以方便芯线穿过阻尼机构的全范围的线性驱动。
14.根据权利要求9或10所述的系统，还包括：
控制台，所述控制台包括脚踏开关和超声波能量产生机构，所述超声波能量产生机构包括超声波发生器和超声波换能器，其中脚踏开关设置成驱动和停用超声波能量产生机构。
15.根据权利要求9或10所述的系统，还包括：
控制台，所述控制台包括脚踏开关和超声波能量产生机构的超声波发生器，其中：
导管组件还包括超声波能量产生机构的超声波换能器，以及
脚踏开关设置成驱动和停用超声波能量产生机构。
16.根据权利要求15所述的系统，其中：
超声波换能器设置成由线性驱动机构来线性驱动，以及
超声波换能器的线性驱动与芯线的线性驱动同步，以便通过声波连接器来保持在超声波换能器和芯线之间的声波连接。
17.一种可线性驱动的方法，包括：
模制包括阻尼机构孔的筒体；
将芯线布置成通过阻尼机构孔的中心，所述中心与筒体的旋转轴线重合；
将多个O形环环绕芯线布置在阻尼机构孔中；以及
将垫片固定在阻尼机构孔的近端中，以便形成环绕芯线的阻尼机构，其中：
使得垫片固定在阻尼机构孔的近端处产生轴向压缩力，使得垫片沿轴向压缩O形环，所述阻尼机构孔的外周的尺寸设置成约束O形环由于垫片的轴向压缩所产生的径向膨胀，从而O形环向芯线施加径向压缩力，所述径向压缩力足以阻尼芯线的近端部分上的、产生横向波的振动能量，而并不限制芯线穿过阻尼机构的线性驱动。
18.根据权利要求17所述的方法，还包括：
将芯线布置在聚合物套筒中；以及
在将芯线布置成穿过阻尼机构孔的中心之前均匀加热聚合物套筒，以使得聚合物套筒环绕芯线收缩，其中，聚合物套筒由润滑聚合物形成，以方便芯线穿过阻尼机构的全范围的线性驱动。
19.根据权利要求17或18所述的方法，还包括：
模制导管组件的壳体；
将具有环绕芯线的阻尼机构的筒体布置在导管组件的壳体中；以及
连接芯线与导管组件的线性驱动机构，从而将芯线设置成穿过阻尼机构来线性驱动。
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