CN114948106A - 具有导丝隔离衬套的组织移除导管 - Google Patents

具有导丝隔离衬套的组织移除导管 Download PDF

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CN114948106A
CN114948106A CN202210588358.5A CN202210588358A CN114948106A CN 114948106 A CN114948106 A CN 114948106A CN 202210588358 A CN202210588358 A CN 202210588358A CN 114948106 A CN114948106 A CN 114948106A
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tissue
section
bushing
removing element
outer layer
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A·詹莫斯
J·凯利
C·麦克马伦
M·弗莱明
C·米德
G·卡罗尔
P·莫顿
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Medtronic Vascular Inc
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Medtronic Vascular Inc
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Abstract

一种用于移除体腔中的组织的组织移除导管(10)包括细长主体(12)和安装于细长主体(12)的近端部分的手柄(40)。手柄(40)可操作成引起细长主体(12)的旋转。组织移除元件(20)安装在细长主体(12)的远端部分上。组织移除元件(20)构造成，随着该组织移除元件(20)在体腔内由细长主体(12)旋转而移除组织。内衬套(14)被接纳在细长主体(12)内，并且在内衬套(14)的近端部分处联接于手柄(40)。内衬套(14)限定有导丝(26)内腔。内衬套(14)在内衬套(14)的远端部分处联接于组织移除元件(20)，使得内衬套(14)在体腔中的平移运动引起组织移除元件(20)的对应平移运动。

Description

具有导丝隔离衬套的组织移除导管
本发明专利申请是申请号为202110467434.2的发明专利申请的分案申请，该申请是国际申请号为PCT/US2018/030965、国际申请日为2018年5月3日、进入中国国家阶段的申请号为201880029543.2、名称为“具有导丝隔离衬套的组织移除导管”的发明专利申请的分案。
技术领域
本公开总体地涉及一种组织移除导管，并且更具体地，涉及一种用于组织移除导管的隔离衬套和组织移除元件。
背景技术
组织移除导管用于移除体腔中不想要的组织。作为示例，旋切术导管用于从血管中移除材料以打开血管并改善通过血管的血液流动。该过程可以用于为患者冠状动脉内的病变作准备，以有助于在患有严重钙化冠状动脉病变的患者体内进行经皮冠状动脉成形术(PTCA)或支架递送。动脉粥样硬化切除术导管通常采用旋转元件，该旋转元件用于磨削或以其它方式破坏不想要的组织。
发明内容
在一个方面，一种用于移除体腔中的组织的组织移除导管通常包括细长主体，该细长主体具有轴线以及沿着该轴线彼此间隔开的近端部分和远端部分。细长主体的尺寸和形状设定成其被接纳在体腔中。手柄安装于细长主体的近端部分并且可操作成引起细长主体的旋转。组织移除元件安装在细长主体的远端部分上。组织移除元件构造成，随着该组织移除元件在体腔内由细长主体旋转而移除组织。内衬套被接纳在细长主体内，并且在内衬套的近端部分处联接于手柄。内衬套限定有导丝内腔。内衬套在内衬套的远端部分处联接于组织移除元件，使得内衬套在体腔中的平移运动引起组织移除元件的对应平移运动。
在另一个方面，一种用于移除体腔中的组织的组织移除导管通常包括细长主体，该细长主体具有轴线以及沿着该轴线彼此间隔开的近端部分和远端部分，其中，细长主体的尺寸和形状设计成，其被接纳在体腔中。组织移除元件安装在细长主体的远端部分上。组织移除元件构造成，随着该组织移除元件在体腔内由细长主体旋转而移除组织。内衬套被接纳在细长主体内。内衬套限定有导丝内腔。内衬套在内衬套的远端部分处联接于组织移除元件，使得内衬套在体腔中的平移运动引起组织移除元件的对应平移运动。
在又一个方面，一种移除体腔中的组织的方法总体上包括使细长主体和安装在细长主体的远端部分上的组织移除元件前进通过体腔，以将组织移除元件定位成与组织相邻，并且将细长主体的近端部分定位在体腔外部。使配置在细长主体内的内衬套前进通过体腔，以将内衬套的远端部分定位成与组织相邻，并将内衬套的近端部分定位在体腔外部。内衬套限定有导丝内腔。在内衬套的远端部分处将内衬套联接至组织移除元件，使得内衬套在体腔中的平移运动引起组织移除元件的对应平移运动。
附图说明
图1是本公开的导管的正视图；
图2是导管的远端部分的放大正视图；
图3是导管的近端部分的放大正视图；
图4是图2中的导管的远端部分的放大局部纵向剖视图；
图5是通过图2的线5-5剖取的剖视图；
图6是导管的隔离衬套的局部正视图，其中一些部分被剖开以显示内部细节；
图7是导管的组织移除元件的放大纵向剖视图；
图8是导管的轴衬的立体图；
图9是导管的第一轴承的立体图；以及
图10是导管的第二轴承的立体图。
在附图中对应的附图标记表示对应的部件。
具体实施方式
参照附图，并且具体地是图1，用于移除体腔中的组织的旋转组织移除导管总体上以附图标记10表示。图示的导管10是旋切术装置，其适合于从血管壁移除(例如，磨削、切割、切除、消融等)闭塞组织(例如，栓塞组织、斑块组织、动脉粥样硬化、溶栓组织、狭窄组织、增生组织、赘生性组织等)。导管10可用于促进经皮冠状血管成形术(PTCA)或随后的支架递送。所公开的实施例的特征还可适合于治疗血管的慢性完全闭塞(CTO)，以及其它体腔的狭窄和在其它体腔中的其它增生和赘生性疾病的狭窄，其它体腔比如是输尿管、胆道、呼吸道、胰管、***等。围绕并侵入体腔的肿瘤常常会导致赘生性细胞的生长。因此，移除这种材料可以有益于维持体腔的通畅。
导管10的尺寸设计成被接纳在对象的血管中。因此，导管10的最大尺寸可为3、4、5、6、7、8、9、10或12弗伦奇(French)(1、1.3、1.7、2、2.3、2.7、3、3.3或4毫米)，并且根据体腔，工作长度可为20、30、40、60、80、100、120、150、180或210厘米。虽然其余的讨论针对的是用于移除血管中的组织的导管，但应当理解的是，本公开的教导还适用于其它类型的组织移除导管，包括但不限于用于从各种体腔中的各种闭塞、狭窄或增生材料中穿透和/或移除组织的导管。
参照图1和2，导管10包括绕细长内衬套14配置的细长外层12。外层12和内衬套14沿着导管的纵向轴线LA从导管的近端部分16延伸至远端部分18。组织移除元件20配置在外层12的远端上，并且构造成旋转，以从体腔移除组织，如以下将更详细地说明的。套管22绕外层12配置。外层12和内衬套14两者构造成相对于套管22平移。导管10的尺寸和形状设计成，其可***到对象的体腔中。套管22将体腔与外层12和内衬套14的至少一部分隔离。内衬套14限定有导丝内腔24(图5)，用于在导丝内腔24中可滑动地接纳导丝26，使得导管10可以通过沿着导丝行进而前进穿过体腔。导丝可以是标准的0.014英寸外径、300厘米长的导丝。在某些实施例中，内衬套14可具有用于在导丝26上滑动的润滑内表面(例如，润滑表面可由润滑聚合物层或润滑涂层来提供)。在所示的实施例中，导丝内腔24从导管10的近端部分16延伸穿过远端部分18，使得导丝26可沿着导管10的整个工作长度延伸。在一种实施例中，导管10的总工作长度可在大约135厘米(53英寸)至大约142厘米(56英寸)之间。
导管10还包括固定在导管的近端部分16处的手柄40。手柄40支承致动器42(例如，杆、按钮、拨盘、开关或其它装置)，该致动器42构造成用于选择性地致动配置在手柄中的马达43，以驱动外层12以及安装在外层的远端处的组织移除元件20旋转。马达43通过齿轮组件44和由手柄40支承的驱动器48来联接于外层12。滑动件或前进件45定位在手柄40上，并且可操作地联接于外层12，以使外层相对于手柄运动，从而使外层和组织移除元件20前进和后退。手柄40限定有狭槽(未示出)，该狭槽限制滑动件45相对于手柄的运动。因此，狭槽的长度确定了外层12与手柄40之间的相对运动量。灌注端口46可配置在导管10的近端16处。端口46与套管22和外层12之间的空间连通，用于递送流体(例如盐水)以在使用期间冷却旋转的外层。近侧端口47允许导丝26和内衬套14通过手柄40的近端。可以在手柄40上提供导丝锁定件(未示出)，以将导丝26相对于手柄锁定就位。
应当理解的是，在其它实施例中，其它合适的致动器，包括但不限于触摸屏致动器、无线控制致动器、由控制器引导的自动致动器等，可适合于选择性地致动马达。在一些实施例中，动力供应可来自于容纳在手柄40内的电池(未示出)。在其它实施例中，动力供应可来自外源。
参照图1和图3，外套管22包括管状套筒，该管状套筒被构造成将对象体腔内的动脉组织与旋转的外层12隔离并进行保护。套管22在套管的近端处固定于手柄40并且不旋转。安装在套管22的近端上的接口52将套管附连至手柄40。接口52包括锁定特征部54(例如，螺纹鲁尔锁)，该锁定特征部54用于配合手柄40以将套管22附连至手柄。套管22为外层12和内衬套14在套管内运动提供了部分封闭。套管22的内径的尺寸设计成，为外层12提供间隙。套管22与外层12之间的空间允许外层在套管内旋转，并为套管与外层之间的盐水灌注提供区域。套管22的外径的尺寸设计成，提供与引导导管(未示出)的内径的间隙，该引导导管用于将导管10递送至体腔中的期望位置。应变释放件56设置在套管22的近端处，以当套管在导管10的使用期间弯曲时，减轻施加至套管22的近端的张力。在一种实施例中，套管22具有约0.050英寸(1.27毫米)的内径、约0.055英寸(1.4毫米)的外径和约1500毫米(59英寸)的长度。套管22可以具有其它尺寸，而不脱离本公开的范围。在一种实施例中，外套管22由聚四氟乙烯(PTFE)制成。替代地，外套管22可包括多层构造。例如，外套管22可包括全氟烷氧基(PFA)的内层、中间编织线层以及Pebax的外层。
参照图1、2、4和5，外层12可包括管状不锈钢线圈，该管状不锈钢线圈构造成将旋转和扭矩从马达43传递至组织移除元件20。将外层12构造为盘绕结构为外层提供了柔性，该柔性有助于将导管10递送通过体腔。此外，当导管10横穿弯曲路径时，线圈构造允许外层12的旋转和扭矩被施加至组织移除元件20。外层12的刚度还影响线圈横穿体腔的容易程度以及线圈有效地将扭矩传递至组织移除元件20的能力。在一种实施例中，外层12是相对刚性的，使得在导管10穿过体腔的运动期间，线圈的轴向压缩和延伸被最小化。外层12的线圈构造还构造成，当线圈旋转时扩大其内径，使得在导管10的操作期间外层与内衬套14保持间隔开。在一种实施例中，外层12具有大约0.023英寸(0.6毫米)的内径和0.035英寸(0.9毫米)的外径。外层12可具有单层构造。例如，外层可包括具有约30度的布设角度的7丝(即，线)线圈。替代地，外层12可以由多层构造成，而不脱离本公开的范围。例如，外层12可包括基础线圈层和配置在该基础层之上的护套(例如，TecothaneTM)。在一种实施例中，外层包括具有约45度的布设角度的15丝线圈。TecothaneTM护套可配置在该线圈之上。替代地，外层12可包括双线圈层构造，该双线圈层构造还包括在两个线圈层之上的附加护套层。例如，外层可包括内线圈层和外线圈层，内线圈层包括具有约45度的布设角度的15丝线圈，外盘绕件层包括具有约10度的布设角度的19丝盘绕件。还可以设想具有其它构造的外层。
参照图1、2和4-6，内衬套14包括多层管状主体，所述多层管状主体构造成将导丝26的至少一部分与外层12和组织移除元件20隔离。内衬套14可从手柄近侧的位置延伸穿过手柄40至手柄远侧的位置。在一种实施例中，内衬套14联接于手柄40，但并未固定地附连于手柄40，以允许内衬套相对于手柄平移。在该实施例中，并不禁止内衬套14的旋转。然而，内衬套14与外层12之间的间隙以及内衬套与组织移除元件20中的联接组件57的附连防止了由外层和组织移除元件的旋转所引起的内衬套的任何旋转。在该实施例中，内衬套14和外层12均被允许相对于手柄40平移。
内衬套14具有内径，该内径的尺寸设计成使导丝26经过。内衬套14通过使导丝与可旋转的外层隔离而保护导丝免受由外层12的旋转造成的损坏。内衬套14还延伸经过组织移除元件20，以保护导丝26免受旋转的组织移除元件的伤害。因此，内衬套14构造成防止导丝26与导管10的旋转部件之间的任何接触。因此，内衬套14消除了任何金属与金属的配合。外层12和组织移除元件20与导丝26的这种隔离还确保了外层和组织移除元件的旋转不被传递或传输至导丝。结果，标准导丝26可以与导管10一起使用，因为导丝不必构造成承受旋转部件的扭转作用。此外，通过延伸穿过组织移除元件20并经过组织移除元件的远端，内衬套14通过提供用于使组织移除元件绕内衬套旋转的定心轴线来稳定组织移除元件。
在所示的实施例中，内衬套14包括内PTFE层60、由不锈钢组成的中间编织层62和聚酰亚胺的外层64。PTFE内层60为内衬套14提供了润滑的内部，该润滑的内部有助于使导丝26穿过内衬套。编织的不锈钢中间层62为内衬套14提供刚性和强度，使得衬套可以承受由外层12施加在内衬套上的扭转力。在一种实施例中，中间层62由304不锈钢形成。外聚酰亚胺层64提供耐磨性并且具有润滑性，该润滑性减小了内衬套14与外层12之间的摩擦。在一种实施例中，内衬套14具有约0.016英寸(0.4毫米)的内径ID、约0.019英寸(0.5毫米)的外径OD和约59英寸(1500毫米)的长度。内衬套14的内径ID为标准的0.014英寸导丝26提供间隙。内衬套14的外径OD为外层12和组织移除元件20提供间隙。在内衬套14与外层12之间具有的空间减小了两个部件之间的摩擦并且允许部件之间的盐水灌注。
参照图1、2、5和7，组织移除元件20沿着纵向轴线LA从与外层12的远端部分相邻的近端延伸至相对的远端。组织移除元件20可操作地连接于马达43，以由马达旋转。当将导管10***到体腔中并且马达43使组织移除元件20旋转时，组织移除元件构造成移除体腔中的闭塞组织，以将组织与体腔壁分开。在一种或多种实施例中，可使用用于在体腔旋转时移除体腔中的组织的任何合适的组织移除元件。在所示的实施例中，组织移除元件20包括磨削锉具，该磨削锉具构造成当马达43使磨削锉具旋转时磨削体腔中的组织。磨削锉具20具有例如通过金刚石砂砾涂覆、表面蚀刻等形成的磨削外表面。在其它实施例中，组织移除元件可以包括一个或多个具有平滑或锯齿状切割边缘的切割元件、浸渍器、血栓切除线等。
参照图7，空腔72纵向延伸穿过组织移除元件20，使得组织移除元件在其近端和远端处限定有开口。空腔72包括从组织移除元件20的近端向远侧延伸的第一直径部分74和从第一直径部分向远侧延伸的第二直径部分78，形成设置在第一直径部分与第二直径部分之间的第一肩部80。第三直径部分82从第二直径部分78向远侧延伸，并在第二直径部分与第三直径部分之间形成第二肩部84。第四直径部分86从第三直径部分向远侧延伸至组织移除元件的远端，并且在第三直径部分与第四直径部分之间形成第三肩部88。第一直径部分74、第二直径部分78、第三直径部分82和第四直径部分86的直径沿着它们的长度是恒定的。在所示的实施例中，第一直径部分74的直径D1大于第二直径部分78的直径D2，直径D2大于第三直径部分82的直径D3，并且直径D3大于第四直径部分86的直径D4。在一种实施例中，第一直径部分74的直径D1约为0.037英寸(0.95毫米)，第二直径部分78的直径D2约为0.035英寸(0.9毫米)，第三直径部分82的直径D3约为0.033英寸(0.85毫米)，并且第四直径部分86的直径D4约为0.031英寸(0.8毫米)。还可以设想其它横截面尺寸，而不脱离本公开的范围。
参照图4和7-10，轴衬90被接纳在组织移除元件20的空腔72中并且围绕内衬套14。轴衬90包括中心环部分92、从中心环部分向近侧延伸的近侧环部分94以及从中心环部分向远侧延伸的远侧环部分96。轴衬90的各环部分限定有延伸穿过轴衬的通道99，该通道99接纳内衬套14的一部分。在所示的实施例中，中心环部分92的外径大于近侧环部分94和远侧环部分96的外径。中心环部分92被配置在空腔72的第二直径部分78中，近侧环部分94被配置在第一直径部分74中，并且远侧环部分96被配置在第二直径部分78和第三直径部分82中在一种实施例中，轴衬90由聚醚醚酮(PEEK)和聚四氟乙烯(PTFE)制成。然而，在不脱离本公开的范围的情况下，衬套90可以由其它材料形成。
第一轴承98绕轴承90的近侧环部分94配置，并且第二轴承100绕轴承的远侧环部分96配置。第一轴承98的外径D5大于第二轴承100的外径D6。在一种实施例中，轴承98、100由氧化锆制成。第一轴承98配置成与组织移除元件20中的空腔72的第一直径部分74对准，并且安置在第一轴承的近端处的外层12的远端与第一轴承的远端处的轴衬90的中心环部分92和第一肩部80之间。第二轴承100配置成与空腔72的第二直径部分78对准，并且安置在第二轴承的远端处的第二肩部84与轴衬90的在第二轴承的近端处的中心环部分92之间。由此，轴衬90和轴承98、100保持在组织移除元件20的空腔72内。大体上来说，轴衬90和轴承98、100可被认为是用于将内衬套14联接至组织移除元件20的联接组件57。
参照图4，轴衬90的内表面固定地附连于内衬套14，使得内衬套通过轴衬联接于组织移除元件20。在一种实施例中，诸如环氧树脂胶之类的粘合剂将轴衬90结合至内衬套14。由此，轴衬90不绕内衬套14旋转。外层12直接且固定地附连于组织移除元件20。组织移除元件20可以通过任何合适的手段固定地附连于外层12的远端。在一种实施例中，粘合剂将外层12结合至组织移除元件20。外层12被接纳在空腔72的第一直径部分74中，并且外层的远端抵接第一轴承98。然而，外层12并未直接附连于轴衬90、轴承98和100或内衬套12。因此，外层12和组织移除元件20的旋转不被传递至内衬套14以使内衬套也旋转。相反，组织移除元件20绕轴衬90和轴承98、100旋转。并且由于内衬套牢固地附连于由外层12保持在组织移除元件20的空腔72内的轴衬90，因此内衬套14通过轴衬和轴承布置而联接于外层。因此，外层12的平移运动被传递至内衬套14，使得当内层和外层中的一个在体腔内前进或缩回时，内衬套和外层将一起平移。这种构造防止外层12和组织移除元件20前进经过内衬套14的远端并接触导丝26。结果，防止了如下的构造：在该构造中，内衬套14没有定位成将导丝26与外层12和组织移除元件20隔离。
内衬套14延伸穿过外层12并经过组织移除元件20的远端。空腔72的第四直径部分86的尺寸设计成，使内衬套14以小间隙通过。内径D4在组织移除元件20与内衬套14之间提供间隙，以减小各部件之间的摩擦。因此，组织移除元件20的成形为并布置成绕内衬套14和外层12的至少一部分延伸，并因此提供了相对紧凑的组件，用于在导管10的远端部分处磨削组织。
参照图7，组织移除元件20的主体的外表面包括近侧部段102、中间部段104和远侧部段106。近侧部段102的直径从组织移除元件20的近端增大至中间部段104。中间部段具有恒定的直径，并且从近侧部段102延伸至远侧部段106。远侧部段106的直径从中间部段104渐缩至组织移除元件20的远端。近侧部段102与中间部段104之间的过渡部在近侧部段与中间部段之间形成第一角度α。在一种实施例中，角度α小于约170度。在一种实施例中，角度α为约165度。类似地，中间部段104与远侧部段106之间的过渡部在中间部段与远侧部段之间形成第二角度β。在一种实施例中，角度β小于约170度。在一种实施例中，角度β为约165度。渐缩的近侧部分102和远侧部分106为组织移除元件20提供了大致的前楔形和后楔形构造，以将收窄的组织通道楔开，因为它同时通过使用组织移除元件的磨削作用移除组织而打开通道。
参照图1和图2，为了移除对象的体腔中的组织，医师将导丝26***到对象的体腔中至要移除的组织远侧的位置。随后，医师将导丝26的近端部分***穿过内衬套14的导丝内腔24并穿过手柄40，使得导丝延伸穿过手柄中的近侧端口47。内衬套14还可延伸穿过手柄40并从近侧端口47延伸出来。在将导管10加载到导丝26上的情况下，医师使导管沿着导丝前进，直到组织移除元件20定位在组织的近侧并与组织相邻。当组织移除元件20定位在组织的近侧并且与组织相邻时，医师使用致动器42来致动马达43，以使外层12和安装在外层上的组织移除元件旋转。随着组织移除元件的旋转，组织移除元件20磨削(或以其它方式移除)体腔中的组织。在组织移除元件20旋转的同时，医师可选择性地使外层12和内衬套14沿着导丝26向远侧运动以磨削组织，并且例如增大通过体腔的通道的尺寸。医师还可使外层12和内衬套14沿着导丝26向近侧运动，并且可使部件沿远侧方向和近侧方向重复地运动，以获得组织移除元件20在整个组织上的来回运动。在磨削过程期间，轴衬90和轴承98、100将内衬套14联接至外层12，并允许外层和组织移除元件绕内衬套旋转。内衬套14将导丝26与旋转的外层12和组织移除元件20隔离，以保护导丝不受旋转部件的损坏。由此，内衬套14构造成承受旋转的外层12和组织移除元件20的扭转和摩擦作用，而不将那些作用传递至导丝26。此外，内衬套14和组织移除元件20的联接允许将内衬套的运动、比如在体腔内的平移运动传递至外层12和组织移除元件，以使外层和组织移除元件与内衬套一起运动通过体腔。当医师完成使用导管10的操作时，可以通过使导管沿着导丝向近侧滑动来将导管从体腔中抽出并从导丝26上卸下。用于磨削过程的导丝26可保留在体腔中，以用于后续程序。
当介绍本发明的元件或其一种或多种实施例时，冠词“一”、“一个”、“该”和“所述”意在表示存在一个或多个元件。术语“包括”、“包含”和“具有”意在为包含性的并表示可能有除所列元件外的附加元件。
由于在不脱离本发明的范围的情况下可以对上述设备、***和方法进行各种改变，所以意味着包含在以上描述中并且在附图中示出的所有内容应被诠释为说明性的而非限制性含义。

Claims (7)

1.一种用于移除体腔中的组织的组织移除导管，所述组织移除导管包括：
细长主体，所述细长主体具有轴线以及沿着所述轴线彼此间隔开的近端部分和远端部分，其中，所述细长主体的尺寸和形状设计成容纳在所述体腔中；
组织移除元件，所述组织移除元件安装在所述细长主体的所述远端部分上，所述组织移除元件构造成，当所述细长主体在所述体腔内使所述组织移除元件旋转时，移除所述组织；
内衬套，所述内衬套被接纳在所述细长主体内，所述内衬套限定有导丝内腔，所述内衬套在所述内衬套的远端部分处联接于所述组织移除元件，使得所述内衬套在所述体腔内的平移运动引起所述组织移除元件的对应平移运动；
穿过所述组织移除元件而从所述组织移除元件的近端延伸到远端的空腔，其中，所述空腔包括从所述组织移除元件的所述近端向远侧延伸的第一区段以及从所述第一区段向远侧延伸的第二区段，所述第一区段所具有的横截面尺寸大于所述第二区段的横截面尺寸。
2.如权利要求1所述的组织移除导管，其特征在于，还包括轴衬，所述轴衬配置在所述空腔中，所述轴衬包括中心环部分、从所述中心环部分向近侧延伸的近侧环部分以及从所述中心环部分向远侧延伸的远侧环部分，所述中心环部分被配置在所述空腔的所述第二区段中。
3.如权利要求2所述的组织移除导管，其特征在于，还包括绕所述轴衬的所述近侧环部分配置的第一轴承以及绕所述轴衬的所述远侧环部分配置的第二轴承，所述第一轴承被配置在所述空腔的所述第一区段中，并且所述第二轴承被配置在所述空腔的所述第二区段中。
4.如权利要求3所述的组织移除导管，其特征在于，所述空腔包括从所述第二区段向远侧延伸的第三区段和从所述第三区段向远侧延伸至所述组织移除元件的所述远端的第四区段，所述第三区段所具有的横截面尺寸大于所述第四区段的横截面尺寸。
5.如权利要求4所述的组织移除导管，其特征在于，所述轴衬的所述近侧环部分被配置在所述空腔的所述第一区段中，并且所述轴衬的所述远侧环部分被配置在所述空腔的所述第二区段和所述第三区段中。
6.如权利要求1所述的组织移除导管，其特征在于，所述内衬套的远端向所述组织移除元件的远侧延伸。
7.如权利要求1所述的组织移除导管，其特征在于，所述内衬套向所述轴衬的远侧延伸。
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