CN109475368A - 具有可拆卸远端的导管装置 - Google Patents

具有可拆卸远端的导管装置 Download PDF

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CN109475368A
CN109475368A CN201780044608.6A CN201780044608A CN109475368A CN 109475368 A CN109475368 A CN 109475368A CN 201780044608 A CN201780044608 A CN 201780044608A CN 109475368 A CN109475368 A CN 109475368A
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nose cone
distal end
proximal
atherectomy
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A·J·费南德兹
R·R·纽豪瑟
H·N·帕特尔
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Avinger Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00473—Distal part, e.g. tip or head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320064—Surgical cutting instruments with tissue or sample retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • A61B2017/320791—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter with cutter extending outside the cutting window

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Abstract

一种粥样斑块切除导管，其包括细长导管主体、位于导管主体的远端的切割器，以及附接至导管主体的远端的头锥。切割器构造为从身体切除组织。头锥构造为保持从切割器切除的组织。头锥包括远侧段侧段、近侧段侧段和连接机构，连接机构构造为允许远侧段侧段在使用期间与近侧段侧段附接和分离。远侧段侧段包括塞子，其构造为当近侧段侧段连接至远侧段侧段时，位于近侧段侧段的内径内。

Description

具有可拆卸远端的导管装置
相关申请的交叉引用
本申请要求2016年6月3日提交的题为“DETACHING NOSECONE FOR CATHETERDEVICE”的美国临时专利申请62/345,483号的优先权，其整体以引用方式并入本文。
本申请可以与2013年3月15日提交的题为“TISSUE COLLECTION DEVICE FORCATHETER”的PCT申请WO2014/142954相关，该申请整体以引用方式并入本文。本申请还可以涉及2011年7月1日提交的题为“ATHERECTOMY CATHETERS WITH LONGITUDINALLYDISPLACEABLE DRIVE SHAFTS”的美国专利申请13/175,232号，现为美国专利9,345,510号的优先权，其整体以引用方式并入本文。
以引用方式并入
在本说明书中提及的所有公开和专利申请通过引用整体并入本文，如同具体地且单独地表明各个单独的公开或专利申请通过引用并入。
技术领域
本申请涉及能够与诸如粥样斑块切除导管等闭塞横穿装置或系统一起使用的组织收集装置。特别地，本文描述了能够与导管装置一起使用的头锥，其中，连接不会干涉导管装置切割器及其切割和清除压实组织的功能。
背景技术
外周动脉疾病(PAD)仅在美国就影响了数百万人。PAD是一种沉默、危险的疾病，如不治疗，可能会产生灾难性后果。PAD是50岁以上患者截肢的主要原因，每年在美国导致约160,000例截肢。
外周动脉疾病(PAD)是血管的逐渐变窄，最常见的原因是动脉粥样硬化，斑块或脂肪物质沿动脉壁的内衬聚集。随着时间的推移，这种物质变硬并变厚，可能会干涉到手臂、腿部、胃部和肾脏的血液循环。这种变窄形成闭塞，完全或部分地限制通过动脉的流。到大脑或心脏的血液循环可能减少，从而增加中风和心脏病风险。
PAD的介入治疗可以包括动脉内膜切除术和/或粥样斑块切除术。与其它替代疗法相比，粥样斑块切除术具有简单机械优势。去除大部分斑块质量(例如，压实)可以产生更大的初始腔并显著提高动脉壁的顺应性。结果，支架部署大大增强。
虽然粥样斑块切除术可提供微创解决方案清除障碍，以在最初阻塞的动脉内放置支架，但目前可用的粥样斑块切除导管的某些方面仍有待改善。例如，从动脉中收集组织和/或移除组织是粥样斑块切除术过程中常见的挑战。用于处理压实组织的一种机制是将组织收集在装置的远侧头锥或收集室中。然而，从收集室移除组织或清洁收集室仍然非常困难。因此，需要一种解决这些问题中的一些问题的粥样斑块切除导管。
发明内容
一般地，在一个实施例中，粥样斑块切除导管包括细长导管主体、位于导管主体的远端的切割器，以及附接至导管主体的远端的头锥。切割器构造为从身体切除组织。头锥构造为保持从切割器切除的组织。头锥包括远侧段、近侧段和连接机构，连接机构构造为允许远侧段在使用期间与近侧段附接和分离。远侧段包括塞子，塞子构造为当近侧段连接至远侧段时，位于近侧段的内径内。
该实施例及其它实施例可以包括一个或多个下述特征。头锥可以进一步包括中空内部，中空内部构造为容纳切除的组织。头锥可以是柔性的。粥样斑块切除导管可以进一步包括沿头锥的外部设置的导丝通道。导丝通道可以包括远侧部分和近侧部分，远侧部分沿头锥的远侧段延伸，近侧部分沿头锥的近侧段延伸。远侧部分和近侧部分可以构造为在近侧段和远侧段连接在一起时对准。远侧部分和近侧部分可以构造为当导丝穿过近侧段和远侧段设置时，防止近侧段和远侧段相对于彼此旋转。连接机构可以进一步包括突片，其构造为通过头锥的远侧段被抓握，以使远侧段相对于近侧段旋转，以启用或停用连接机构。连接机构可以进一步包括凸轮和滚珠轴承，其构造为相对于远侧段锁定和解锁近侧段。连接机构可以包括多个卡扣臂，其构造为延伸至近侧段中并与近侧段上的孔互锁。每个卡扣臂可以分别包括构造为适配在孔内的突片。突片可以沿侧缘倒角，从而使远侧段朝倒角边缘的旋转使得远侧段从近侧段自动解锁。头锥可以构造为远离细长导管主体枢转以进一步暴露切割器。切割器可以构造为轴向移动至头锥中以打包(pack)组织。
一般地，在一个实施例中，粥样斑块切除导管包括导管主体，其具有导管主体近端、导管主体远端、切割窗、可通过切割窗暴露的切割器、头锥和轴环。头锥具有头锥近端和头锥远端。头锥近端构造为与头锥远端联接和分离。轴环具有轴环内表面，其构造为在头锥近端与头锥远端之间保持可拆卸连接。
该实施例及其它实施例可以包括一个或多个下述特征。头锥可以进一步包括中空内部，其构造为容纳切除的组织。粥样斑块切除导管可以进一步包括锁定机构，用于保持头锥近端与头锥远端之间的连接。锁定机构构件可以设置在头锥近端、轴环、头锥远端或其组合上。锁定机构可以利用对应螺纹将可拆卸头锥近端与头锥远端相配合。锁定机构可以利用至少一个突片和对应孔将可拆卸头锥远端与头锥近端相配合。锁定机构可以不干涉切割器延伸经过锁定机构的能力。头锥可以是刚性的。头锥可以是柔性的。头锥可以包括柔性和刚性区域。粥样斑块切除导管可以进一步包括设置在头锥和导管主体上的导丝通道。
一般地，粥样斑块切除导管包括导管主体，其具有导管主体近端、导管主体远端、切割窗、可通过切割窗暴露的切割器、头锥、轴环和用于保持头锥近端和头锥远端之间连接的锁定机构。头锥具有头锥近端和头锥远端。头锥近端构造为能够与头锥远端联接和分离。轴环构造为保持头锥近端与头锥远端之间的连接。锁定机构构件设置在头锥近端、轴环、头锥远端或其组合上。
该实施例及其它实施例可以包括一个或多个下述特征。头锥可以进一步包括中空内部，其构造为容纳切除的组织。锁定机构可以利用对应螺纹将头锥近端与头锥远端相配合。锁定机构可以利用至少一个突片和对应孔将头锥近端与可拆卸头锥远端相配合。锁定机构不会干涉切割器延伸经过锁定机构的能力。头锥可以是刚性的。头锥可以是柔性的。头锥可以包括柔性和刚性区域。
一般地，粥样斑块切除导管包括导管主体，其具有导管主体近端、导管主体远端、切割窗、可通过切割窗暴露的切割器、头锥、轴环和用于保持可拆卸头锥和导管主体之间连接的锁定机构。头锥具有头锥近端和头锥远端。头锥近端构造为能够与头锥远端联接和分离。轴环构造为保持可拆卸头锥与导管主体之间的连接。锁定机构包括轴环、头锥近端或头锥远端上的对应螺纹，其适于联接头锥的近端和远端。
一般地，在一个实施例中，粥样斑块切除导管包括导管主体，其具有导管主体近端、导管主体远端、切割窗、可通过切割窗暴露的切割器、头锥、轴环和用于保持头锥近端和头锥远端之间连接的锁定机构。头锥具有头锥近端和头锥远端。头锥近端构造为能够与头锥远端联接和分离。轴环构造为能够保持可拆卸头锥与导管主体之间的连接。锁定机构包括设置在轴环上的至少一个突片，锁定机构具有适于配合头锥的近端和远端的对应孔。
该实施例及其它实施例可以包括一个或多个下述特征。粥样斑块切除导管可以进一步包括驱动系统，其构造为能够使切割器在头锥内伸缩。
附图说明
本发明的新颖特征在权利要求书中具体列出。具体实施方式中列出了利用本发明原理的一些示例性实施例，结合具体实施方式和附图，可以更好地理解本发明的特征和优势，在附图中：
图1A示出粥样斑块切除导管的远端，其具有组织连接头锥，该头锥具有可拆卸远端。
图1B是用于联接头锥的可拆卸近侧段和远侧段的示例性联接机构的透视图。图1C示出图1B的联接机构的横截面图。图1D是图1B的联接机构的第一联接元件的透视图。图1E和1F示出图1B的联接机构的第二联接元件的透视图。
图2A和2B示出头锥的替代示例性联接机构。图2A示出包括两个突片的联接元件。图2B示出包括对应孔并且构造为与图2A的联接元件一起锁定的联接元件。
图3A示出具有头锥的部分粥样斑块切除导管的顶部透视图，头锥具有通过单突片联接机构连接的可拆卸远端。
图3B示出图3A的部分粥样斑块切除导管的底部透视图。
图4A示出具有可拆卸远端的部分头锥的侧视图，该远端通过扭转机构连接。
图4B示出图4A的部分头锥的底视图。
图4C-4E示出图4A的头锥，其中移除了轴环，以使近端与远端之间的扭转/对准特征可见。
图5A示出具有可拆卸远端的示例性头锥，该远端通过凸轮和滚珠机构启用。
图5B示出凸轮和滚珠机构。
图5C示出位于锁定位置的图5A的头锥的放大图，清楚起见，移除了头锥的远侧部分。
图5D示出穿过图5C中所示的锁定头锥的横截面图。
图5E示出位于解锁位置的图5A的头锥的放大图，清楚起见，移除了头锥的远侧部分。
图5F示出穿过图5E中所示的解锁头锥的横截面图。
图5G示出图5A的头锥，其中远端与近端分离。
图5H示出穿过图5B的横截面图，以更清楚地示出凸轮路径。
图6A示出具有可拆卸远端的示例性头锥，该可拆卸远端通过卡扣机构启用。
图6B示出近端和远端断开连接。
图6C是示出连接的近端和远端的横截面。
图7示出具有单轨导丝腔的可分离头锥。
具体实施方式
本文描述了粥样斑块切除导管，其包括细长主体、切割器和构造为收集压实(debulked)组织的头锥。头锥包括无创伤远端、连接至导管主体的其余部分的近端，以及用于收集切除组织的内部区域。头锥的近侧部分可从远侧部分拆卸，以便于在粥样斑块切除术过程中清洁和/或快速更换头锥的远侧部分。
本文描述的头锥包括允许头锥的近端和远端轻松联接、同时在使用期间防止不期望分离的特征。此外，具有可拆卸的远侧/近侧部分的头锥的内表面可以大致平滑，以允许切割器在其中延伸(例如，以打包组织)而没有障碍。
示例性粥样斑块切除导管1200的远端在图1A中示出。粥样斑块切除导管包括导管主体1201、中空头锥1204、环形可旋转切割器1210和切割器窗1207，切割器可以通过切割器窗1207对组织进行压实。中空头锥1204可以构造为随着组织在身体中被移除而收集组织。此外，在一些实施例中，切割器1210可以轴向移动至头锥1204中以在其中打包组织。此外，在一些实施例中，头锥1204可以相对于导管主体1201铰接，例如在枢轴点处铰接。如图1A所示，在一些实施例中，头锥可以包括孔1244用于通气。头锥1204的远侧段或远端1205可以构造为在附接/分离点1226处从头锥1200的近侧部分1206分离，以允许轻松移除收集的或打包的组织。附接/分离点1226可以包括例如一个或多个联接元件。本文描述了联接元件的各种实施例。
图1B-1F示出示例性联接机构111，其包括第一联接元件925，第一联接元件925构造为与对应联接元件1024交接，用于锁定和解锁头锥(如头锥1204)的近侧和远侧部分。
图1D示出联接元件925，其包括近端930和远端928。联接元件925包括大体圆柱形主体，其具有位于近端与远端之间的内腔。穿过主体的壁形成槽或切口932a-b。虽然图中示出具有大体矩形形状的两个槽，但联接元件925可以具有任意形状的任意数量的槽。主体的形状设计为插入对应联接元件1024中以进行附接。
图1E和1F示出构造为可释放地附接至联接元件925的对应联接元件1024。对应联接元件1024定形至联接元件924，从而使联接元件925可以插入对应联接元件1024中以形成紧密配合(如图1B-1C所示)。对应联接元件1024具有内壁1038，其在适配时接触联接元件925的外壁934。此外，对应联接元件1024包括突起，其示出为从其主体朝中心突出的突片1036a-b。在一些实施例中，突片1036a-b以一定角度朝主体的中心突出，并且构造为延伸至接收槽932a-b中。
因此，在操作中，对应联接元件1024放置在联接元件925的外壁924上。对应联接元件1024的近端1032在联接元件925的远端928上推进。然后，对应联接元件1024(或联接元件925)相对于另一元件旋转，以使突片1036a-b与槽932a-b对准。为了锁定联接元件，槽932a-b的边缘滑入凹槽1031a-b中，直到联接元件925的部分主体保持在突片表面与对应联接元件1024的内壁之间。图1B-1C示出围绕联接元件925的对应联接元件1024，其中，突片1036a-b与槽932a-b接合。突片1036a-b通过槽932a-b容纳在联接元件925内部。槽932a-b的边缘滑入凹槽1031a-b中，以在对应联接元件1024内保持并锁定联接元件925的横向朝向。如图所示，逆时针旋转对应联接元件使联接元件分离并将联接元件彼此释放。
图2A和2B示出图1B-1F中所示的联接元件的变型。例如，图2A示出具有两个突片1136a-b和多个孔1105的对应联接元件1124。在一些实施例中，孔提供流体压力释放。图2B示出具有槽1132a-c的联接元件1125，例如，槽1132a-c构造为能够与图2A的突片1136a-b相互作用。虽然图1B-1F和2A-2B的联接元件示出为具有两个或三个突片/槽，但应当理解的是，可以使用任意数量的配合结构来形成可拆卸组织收集装置。
图3A示出可以与粥样斑块切除导管一起使用的头锥204的另一实施例。头锥204包括远端205，其可以在联接机构211处从近端206分离。头锥远端205是无创伤的。
头锥204进一步包括切割孔207，其允许装置的切割器(例如，环形切割器)从中暴露以切割和移除组织。头锥近端206构造为与导管主体的其余部分联接，例如，在连接点202处联接。例如，导管主体201可以与位于切割孔207近侧的头锥204联接。在一些实施例中，头锥204可以在铰接点处连接，以远离导管主体进行铰接运动。
参见图3A和3B，头锥204远端205和近端206之间的联接可以包括轴环211。如图所示，轴环211继而可以永久附接至头锥近端106。轴环211可以包括轴环孔212，轴环孔212能够联接至头锥204的近端105上的对应特征部(例如，突片119或其它突起)。突片219可以构造为包括一定量的柔性，使得用户能够将轴环211的端部推过突片219以对准突片219和轴环孔212。可以通过轴环211的成角度或倾斜的远侧边缘来辅助将远端205插入轴环211中。
一旦与轴环孔212对准，突片219可以通过轴环211上的延伸部221接合或锁定在孔212中。延伸部221构造为接触突片219，使突片219枢转(例如，在弯曲点处)，其中，突片219的近端朝轴环211的中心轴线径向移动，并且突片219的远端远离轴环211的中心轴线径向移动以接合/附接在轴环孔212中并将突片219锁定就位。一旦突片219被锁定就位，头锥的近端206和远端205将连接和/或锁定在一起。为了使轴环211与头锥204的远端205分离，用户可以推动突片以使突片从轴环孔212中脱离并使轴环211远离头锥204的远端205轴向滑动。
在替代实施例中，轴环211可以永久附接至头锥204的远端205而非近端206。这里，头锥204的近端206可以包括对应特征部，其中，轴环211包括突片，其具有能够配合的对应孔、能够旋拧在一起的对应螺纹等。
在一些其它变型中，轴环211可以与头锥近端206和头锥远端205完全分离。在该设计中，轴环211可以具有两个及以上联接特征部，用于将头锥近端206与头锥远端205相配合。在该实例中，轴环211上的联接特征部也可以用于使头锥近端206与头锥远端205正确对准。例如，轴环可以具有与头锥远端205和头锥近端206上的对应突片接受器配合的突片，用于将两个构件保持在一起，但另外，轴环211还可以具有有助于确保头锥远端205与头锥近端206正确对准的附加特征部。附加特征部可以包括但不限于突起和对应孔或槽。
转到图4A-4E，其示出位于头锥304的远端305和近端306之间的另一联接机构310。用于头锥304的联接机构310采用扭转型运动以使头锥远端305与头锥近端306接合和分离。扭转联接机构310在图4C-4E中最佳示出(清楚起见，这些图中的轴环311已移除)。扭转联接机构310包括位于远端305上的钩状、弯曲或c形延伸部315，其在近端306和远端305相对于彼此旋转时与近端306上的对应钩状、弯曲或c形延伸部316互锁或配合。每个延伸部315、316包括与相对侧上的对应凸起326、325配合的波浪状弯曲部或凸起326、325。要连接近侧和远侧部分306、305时，这两个部分可以相对于彼此旋转。要释放时，可以沿相反方向旋转。
再次参见图4A-4B，轴环311可以夹持在扭转机构310上，以防止延伸部315、316在使用过程中旋转分开。轴环311可以永久附接至近端(如图3A-3B所示)或远端。当附接至近端时，轴环311可以具有倾斜或成角度的远侧边缘，以辅助将远端305插入其中。
头锥504的另一示例性实施例在图5A-5H中示出。如图5A所示，头锥504包括近端506和可拆卸远端505。头锥504进一步包括联接机构515，其构造为允许头锥504的远端505附接和分离。参见图5B和5G，联接机构515包括实心塞571，其密封地适配在头锥504的近端506的内径中。联接机构515进一步包括环形轴环573，其构造为永久附接至头锥的近端505。联接机构515通过扭转可旋转突片525(其固定至轴环573)而连接在一起，以启动凸轮577。当远端505锁定至近端506时(如图5C和5D所示)，滚珠轴承527位于外窗533中。然而，当解锁时，滚珠轴承525被拉回窗533内部并被拉入内槽531中(如图5E-5F所示)。
在使用中，用户可以抓住突片525(例如，通过远端505的柔性部分)，将塞子571插入远端505，并旋转突片525。如图5G所示，这样做将导致凸轮577的顶部将滚珠527从窗531推向窗533。一旦接合在窗533中，滚珠527将防止近端和远端506、507未来相对于彼此移动。要解锁时，用户可以沿相反方向旋转突片525。这将使滚珠527一直向后移动至内窗531中，从而允许远离近端506朝远侧拉动远端505。
联接机构515设置为靠近头锥504的远侧末端(如1-2英寸，例如，远离切割窗507的远侧边缘约1.5英寸)。这可以有利地为近侧部分506内部的组织填充提供充足的空间，并在填充组织时防止联接机构515干涉切割器。
头锥604的另一个示例性实施例在图6A-6C中示出。头锥604包括近端606和可拆卸远端605。头锥604进一步包括构造为允许远端605与近端606附接和分离的联接机构622。联接机构622包括密封地适配在头锥的近端606的内径中的实心塞671。联接机构622进一步包括远离塞子671向近侧延伸的两个卡扣臂623a、623b。卡扣臂623a、623b可以进一步包括径向延伸突片625a、625b，径向延伸突片625a、625b构造为卡扣至近端606上的对应卡扣窗624a、624b中。在一些实施例中，用户可以通过推动突片625a、625b释放远端605。此外，在一些实施例中，突片625a、625b可以在一个边缘处倒角，从而使顺时针或逆时针旋转可以自动推动突片625a、625b以释放联接机构622。
同样，联接机构622设置为靠近头锥604的远侧末端(例如，从切割器窗607的远侧边缘到卡扣臂的近端可以有大约1-2英寸，如1.5英寸)。这可以有利地为近侧部分606内部的组织填充提供充足的空间，并在填充组织时防止联接机构622干涉切割器。
参照图7，在本文所述的任意实施例中，导丝腔755可以沿头锥的侧面向下延伸。导丝腔755可以包括能够互连的两段(一段附接至近端706，另一段附接至远端705)。通过腔755插入导丝可以有助于将头锥的近端和远端706、705保持在一起。也就是说，当使用可旋转或扭转锁定机构710来解锁时(例如，本文所述的包括扭转或旋转以解锁的任意实施例)，通过腔755插入导丝可以有助于防止近端和远端706、705相对于彼此旋转。
在一些实施例中，头锥远端和头锥近端上的特征部可以帮助用户正确地对准头锥近端与头锥远端。例如，在一些情况下，头锥近端和头锥远端可以成角度或偏置，从而使其适配在一起。为了进一步确保这两个构件的正确对准或附接，头锥近端和导管远端可以进一步包括构造为相配合的成角度或偏置端面上的特征部。在其它实例中，在头锥近端和导管主体远端上可以存在视觉指示器，以帮助用户对准两个部分。
在一些实施例中，附接特征部可以包括指示头锥的近端和远端连接的听觉或物理信号(例如，棘爪特征部可以发出咔哒声以指示锁定)。
在一些实施例中，本文所述的附接机构和头锥的远端可以是可重复使用的。在其它实施例中，头锥的远端意味着作为单次使用，并且附接机构不能分离然后重新附接。例如，突片特征部可以构造为在分离后断裂或变为不可用。
图3A-6C所示的附接机构具有大致平滑的内周(即，头锥的内侧)，并且没有向内径向延伸至头锥内的突片或机构。这可以有利地防止在切割器移动至头锥中时(即用于填充)附接机构干涉切割器的移动和/或防止切除的斑块或组织碎片缠绕在附接机构的径向向内突出的延伸部上。
在一些实施例中，本文所述的头锥附接机构与切割窗相距设定距离，以进一步消除对切割器的干涉。因此，附接机构与切割窗之间的距离可以是，例如0.5”-1.0”，如0.6”-0.8”，如约0.68”或0.70”。在一些实施例中，当完全展开时，切割器的远侧边缘可以恰好定位在附接机构的近侧。
应当理解的是，可以使用任意合适机构或手段(如摩擦配合、匹配配合、螺纹配合、钩、固定件等)补充或替换本文所述的附接机构，以将部分或整个组织收集装置与另一装置分离。
附加地，可以使用任意合适材料，如镍钛诺、不锈钢(如304级)或钛或合金等形成附接机构。包含金或铂的涂层可以用于提高射线不透性。
可以组合使用本文描述的组织收集装置的任意特征而不脱离本发明。
具有可拆卸段的头锥可以有利地用于冲洗或以其它方式将切除组织从头锥中清除。也就是说，在将组织切除并收集在头锥中后(例如，通过切割器的轴向运动将其填充至头锥中)，可以移除头锥的远端或远侧段，从而允许冲洗近端(例如，从切割窗穿过开口远端)和/或允许用组织移除工具轻松清理近端或远端。
虽然上述联接机构已经描述为用于与部分头锥附接和分离，但其也可用于联接导管的其它部分。例如，在一些实施例中，可以使用本文所述的联接机构之一从导管的其余部分移除头锥的整个组织收集部分。
所描述的任意组织收集装置可以与粥样斑块切除术或其它闭塞横穿装置一起使用。在这种情况下，粥样斑块切除装置通常包括细长主体和可旋转末端(具有切割器)，可旋转末端位于细长主体的第一远端处并且构造为相对于细长主体旋转。在2012年5月14日提交的题为“ATHERECTOMY CATHETERS WITH IMAGING”的美国专利申请61/646,843号、2012年3月28日提交的题为“OCCLUSION-CROSSING DEVICES,IMAGING,AND ATHERECTOMY DEVICES”的美国专利申请13/433,049号，2011年7月1日提交的题为“ATHERECTOMY CATHETERS WITHLONGITUDINALLY DISPLACEABLE DRIVE SHAFTS”的美国专利申请13/175,232号、2010年7月1日提交的题为“ATHERECTOMY CATHETER WITH LATERALLY-DISPLACEABLE TIP”的美国专利申请12/829,277号、2010年7月1日提交的题为“CATHETER-BASED OFF-AXIS OPTICALCOHERENCE TOMOGRAPHY IMAGING SYSTEM”的美国专利申请12/829,267号、2015年2月5日提交的题为“ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES”的国际专利申请PCT/US2015/014613号、2016年3月16日提交的题为“ATHERECTOMY CATHETERS DEVICESHAVING MULTI-CHANNEL BUSHINGS”的美国专利申请15/072,272号、2016年3月21日提交的题为“ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES”的美国专利申请15/076,568号中描述了此类装置，所有这些专利申请整体以引用方式并入本文。
在本文中，当特征或元件描述为在另一特征或元件“上”时，其可以直接位于其它特征或元件上，或者也可以存在中间特征和/或元件。相反地，当特征或元件描述为“直接位于”另一特征或元件“上”时，不存在中间特征或元件。同样应当理解的是，当特征或元件描述为“连接”、“附接”或“联接”至另一特征或元件时，其可以直接连接、附接或联接至另一特征或元件，或者可以存在中间特征或者元件。相反地，当特征或元件描述为“直接连接”、“直接附接”或“直接联接”至另一特征或元件时，不存在中间特征或元件。虽然描述或图示是针对一个实施例，但所描述或所图示的特征和元件可以应用于其它实施例。本领域技术人员同样应当理解的是，提到的设置为“靠近”另一特征的结构或特征可以具有与邻近特征重叠或位于其下的部分。
本文所用术语仅于描述特定实施例，并非旨在限定本发明。例如，除非上下文中有明确说明，否则如本文中所使用的，单数形式“一个”、“一”和“所述”旨在同样包含复数形式。应当进一步理解的是，本申请书中使用的术语“包括”及/或“包含”表示存在所述特征、步骤、操作、元件及/或组件，但不排除存在或添加一个或多个其它特征、步骤、操作、元件、组件及/或其组合。如本文中所使用的，术语“和/或”包括列出的相关项目中的一个或多个的任意或全部组合，并且可以缩写为“/”。
空间相对术语，如“下”、“下方”、“更低”、“上方”、“更高”等，在本文中可以用于方便描述附图中所示的一个元件或特征与另一元件或特征的相对关系。应当理解的是，空间相对术语旨在包含除附图中所示方位外，设备使用或操作中的不同方位。例如，如果附图中的设备是翻转的，描述为在其它元件或特征“下”或“下面”的元件将随之定向为在所述其它元件或特征的“上方”。因此，示例性术语“下”可以同时包括上下方向。设备可以以其它方式取向(旋转90度或处于其它朝向)，并且本文使用的空间相对描述也应进行相应的解读。类似地，除非另有明确说明，否则本文使用的术语“向上”、“向下”、“竖直”、“水平”等仅在于解释说明。
虽然本文中使用的“第一”、“第二”可以用于描述不同的特征/元件(包括步骤)，除非上下文中另有说明，否则这些特征/元件不应被这些术语限制。这些术语可以用于一个特征/元件与另一特征/元件的区分。因此，在不偏离本发明教导的情况下，文中讨论的第一特征/元件也可以定义为第二特征/元件，类似地，文中讨论的第二特征/元件也可以定义为第一特征/元件。
在整个申请书和权利要求书中，除非上下文另有要求，否则“包括”一词及其变型意指可以在方法或物品中联合采用的各种组件(如包括设备和方法的组合和装置)。例如，术语“包括”应理解为包含任意所述元件或步骤，但不排除任意其它元件或步骤。
如申请书和权利要求中所用的，包括实例中所用的，除非另有明确说明，否则所有数字均可以解读为以“约”或“大约”一词开头，即使术语没有明确表现出来。“约”或“大约”一词可以在描述量和/或位置时使用，以指示所述值和/或位置在值和/或位置的合理期望范围内。例如，数值可以具有所述数值(或数值范围)+/-0.1％、所述数值(或数值范围)+/-1％、所述数值(或数值范围)+/-2％、所述数值(或数值范围)+/-5％、所述数值(或数值范围)+/-10％等的值。本文中列出的任意数值范围均旨在包括其中所包含的所有子范围。
虽然上文中描述了各种说明性实施例，但可以不偏离权利要求书所描述的本发明范围对各种实施例进行任意数量的改变。例如，在替代性实施例中经常可以改变所描述的执行各种方法步骤的顺序，并且在其它替代性实施例中，可以完全跳过一个或多个方法步骤。各种设备和系统实施例的可选特征可以包含在一些实施例中而不包含在其它实施例中。因此，提供上述描述主要旨在示例性目的，并且不应理解为限制权利要求书中所阐述的本发明的范围。
本文中的实例和说明以说明而非限定的方式示出可以实践主题的特定实施例。如前所述，可以使用并从中衍生出其它实施例，从而不偏离本公开范围进行结构和合理替换及改变。如果实际上公开了多于一个发明或发明构思，本发明主题的此类实施例可以用术语“发明”单独或共同指代，这样仅仅是为了方便，而非旨在主动将本申请的范围限制为任意单个发明或发明构思。因此，虽然本文示出并描述了特定实施例，但旨在实现相同目的的任何布置均可以替代所示的特定实施例。本公开旨在涵盖各种实施例的任意及所有适应性修改或变型。在阅读上述说明的基础上，本文中没有特别描述的上述实施例及其它实施例的组合对于本领域技术人员来说是显而易见的。

Claims (34)

1.一种粥样斑块切除导管，包括:
细长导管主体；
切割器，其位于所述导管主体的远端，并且构造为能够从身体切除组织；以及
头锥，其附接至所述导管主体的远端，并且构造为能够保持从所述切割器切除的组织，其中，所述头锥包括远侧段、近侧段和所述远侧段与所述近侧段之间的连接机构，所述连接机构构造为允许所述远侧段在使用期间与所述近侧段附接和分离，进一步地，其中，所述远侧段包括塞子，所述塞子构造为当所述近侧段连接至所述远侧段时位于所述近侧段的内径内。
2.根据权利要求1所述的粥样斑块切除导管，其中，所述头锥进一步包括构造为能够容纳切除的组织的中空内部。
3.根据权利要求1所述的粥样斑块切除导管，其中，所述头锥是柔性的。
4.根据权利要求1所述的粥样斑块切除导管，进一步包括沿所述头锥的外部设置的导丝通道。
5.根据权利要求4所述的粥样斑块切除导管，其中，所述导丝通道包括远侧部分和近侧部分，所述远侧部分沿所述头锥的远侧段延伸，所述近侧部分沿所述头锥的近侧段延伸，所述远侧部分和所述近侧部分构造为在所述近侧段和所述远侧段连接在一起时对准。
6.根据权利要求5所述的粥样斑块切除导管，进一步地，其中，所述远侧部分和所述近侧部分构造为当导丝穿过所述近侧段和所述远侧段设置时，防止所述近侧段和所述远侧段相对于彼此旋转。
7.根据权利要求1所述的粥样斑块切除导管，其中，所述连接机构进一步包括突片，其构造为能够通过所述头锥的远侧段被抓握，以使所述远侧段相对于所述近侧段旋转，以启用或停用所述连接机构。
8.根据权利要求1所述的粥样斑块切除导管，其中，所述连接机构进一步包括构造为能够相对于所述远侧段锁定和解锁所述近侧段的凸轮和滚珠轴承。
9.根据权利要求1所述的粥样斑块切除装置，其中，所述连接机构包括多个卡扣臂，所述多个卡扣臂构造为能够延伸至所述近侧段中并与所述近侧段上的孔互锁。
10.根据权利要求9所述的粥样斑块切除装置，其中，每个所述卡扣臂分别包括构造为能够适配在所述孔内的突片。
11.根据权利要求10所述的粥样斑块切除装置，其中，所述突片沿侧缘倒角，从而使所述远侧段朝倒角边缘的旋转使得所述远侧段从所述近侧段自动解锁。
12.根据权利要求1所述的粥样斑块切除装置，其中，所述头锥构造为能够远离所述细长导管主体枢转以进一步暴露所述切割器。
13.根据权利要求1所述的粥样斑块切除装置，其中，所述切割器构造为能够轴向移动至所述头锥中以填充组织。
14.一种粥样斑块切除导管，包括：
导管主体，其具有导管主体近端、导管主体远端、切割窗和能够通过所述切割窗暴露的切割器；
头锥，其具有头锥近端和头锥远端，其中，所述头锥近端构造为能够与所述头锥远端联接和分离；以及
轴环，其具有轴环内表面，所述轴环内表面构造为能够在所述头锥近端与所述头锥远端之间保持可拆卸连接。
15.根据权利要求14所述的粥样斑块切除导管，其中，所述头锥进一步包括构造为能够容纳切除的组织的中空内部。
16.根据权利要求14所述的粥样斑块切除导管，进一步包括用于保持所述头锥近端与所述头锥远端之间的连接的锁定机构，其中，所述锁定机构构件设置在所述头锥近端、所述轴环、所述头锥远端或其组合上。
17.根据权利要求16所述的粥样斑块切除导管，其中，所述锁定机构利用对应螺纹将可拆卸头锥近端与所述头锥远端相配合。
18.根据权利要求16所述的粥样斑块切除导管，其中，所述锁定机构利用至少一个突片和对应孔将所述可拆卸头锥远端与所述头锥近端相配合。
19.根据权利要求17或18所述的粥样斑块切除导管，其中，所述锁定机构不干涉所述切割器延伸经过所述锁定机构的能力。
20.根据权利要求14所述的粥样斑块切除导管，其中，所述头锥是刚性的。
21.根据权利要求14所述的粥样斑块切除导管，其中，所述头锥是柔性的。
22.根据权利要求14所述的粥样斑块切除导管，其中，所述头锥包括柔性区域和刚性区域。
23.根据权利要求14所述的粥样斑块切除导管，进一步包括设置在所述头锥和所述导管主体上的导丝通道。
24.一种粥样斑块切除导管，包括：
导管主体，其具有导管主体近端、导管主体远端、切割窗和能够通过所述切割窗暴露的切割器；
头锥，其具有头锥近端和头锥远端，其中，所述头锥近端构造为能够与所述头锥远端联接和分离；以及
轴环，其构造为能够保持所述头锥近端与所述头锥远端之间的连接；以及
锁定机构，其用于保持所述头锥的近端与远端之间的连接，其中，所述锁定机构构件设置在所述头锥近端、所述轴环、所述头锥远端或其组合上。
25.根据权利要求24所述的粥样斑块切除导管，其中，所述头锥进一步包括构造为能够容纳切除的组织的中空内部。
26.根据权利要求24所述的粥样斑块切除导管，其中，所述锁定机构利用对应螺纹将所述头锥近端与所述头锥远端相配合。
27.根据权利要求16所述的粥样斑块切除导管，其中，所述锁定机构利用至少一个突片和对应孔将所述头锥近端与所述可拆卸头锥远端相配合。
28.根据权利要求26或27所述的粥样斑块切除导管，其中，所述锁定机构不干涉所述切割器延伸经过所述锁定机构的能力。
29.根据权利要求24所述的粥样斑块切除导管，其中，所述头锥是刚性的。
30.根据权利要求24所述的粥样斑块切除导管，其中，所述头锥是柔性的。
31.根据权利要求24所述的粥样斑块切除导管，其中，所述头锥包括柔性区域和刚性区域。
32.一种粥样斑块切除导管，所述装置包括：
导管主体，其具有导管主体近端、导管主体远端、切割窗和能够通过所述切割窗暴露的切割器；
头锥，其具有头锥近端和头锥远端，其中，所述头锥近端构造为能够与所述头锥远端联接和分离；以及
轴环，其构造为能够保持所述可拆卸头锥与所述导管主体之间的连接；以及
锁定机构，其用于保持所述可拆卸头锥与所述导管主体之间的连接，其中，所述锁定机构包括所述轴环、所述头锥近端或所述头锥远端上的适于联接所述头锥的近端和远端的对应螺纹。
33.一种粥样斑块切除导管，包括：
导管主体，其具有导管主体近端、导管主体远端、切割窗和能够通过所述切割窗暴露的切割器；
头锥，其具有头锥近端和头锥远端，其中，所述头锥近端构造为能够与所述头锥远端联接和分离；
轴环，其构造为能够保持所述可拆卸头锥与所述导管主体之间的连接；以及
锁定机构，其用于保持所述头锥的近端与远端之间的连接，其中，所述锁定机构包括设置在所述轴环上的至少一个突片，所述轴环具有适于将所述头锥的近端与远端相配合的对应孔。
34.根据前述任意一项权利要求所述的粥样斑块切除导管，进一步包括驱动系统，所述驱动系统构造为能够使所述切割器在所述头锥内伸缩。
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