CN110573098A - 组织移除导管 - Google Patents
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Abstract
一种用于移除体腔中的组织的组织移除导管包括细长主体(12),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(12)的尺寸和形状设定成接纳在体腔中。手柄(40)安装于细长主体(12)的近端部分并且可操作成使得细长主体的旋转。组织移除元件安装在细长主体(12)的远端部分上。内衬套(14)接纳在细长主体(12)内,并且在内衬套(14)的近端处联接于手柄(40)。传感器相对于细长主体(12)和内衬套(14)布置并构造成检测由细长主体(12)在使用期间接触内衬套(14)引起的内衬套(14)的磨损。
Description
领域
本公开总地涉及组织移除导管,并且更具体地涉及用于组织移除导管的隔离衬套磨损传感器。
背景
组织移除导管用于移除体腔中不想要的组织。例如,旋切术导管用于从血管中移除物质以疏通血管并改善通过血管的血液流动。该过程可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。
概述
在一个方面,一种用于移除体腔中的组织的组织移除导管基本包括细长主体,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使得细长主体的旋转。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。内衬套接纳在细长主体内,并且在内衬套的近端处联接于手柄。内衬套限定导丝内腔。传感器相对于细长主体和内衬套布置,并且构造成检测由细长主体在使用期间接触内衬套引起的内衬套的磨损。
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基本包括细长主体,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。内衬套接纳在细长主体内。内衬套限定导丝内腔。传感器相对于细长主体和内衬套布置,并且构造成检测由细长主体在使用期间接触内衬套引起的内衬套的磨损。
在又一个方面,一种移除体腔中的组织的方法基本包括:使组织移除导管在导丝上前进到体腔中,以将导管的远端定位成与组织相邻,并将导管的近端部分定位在体腔的外部。该导管包括细长主体、安装在细长主体的远端部分上的组织移除元件以及设置在细长主体内的内衬套。内衬套限定导丝内腔,在导管前进期间导丝设置在导丝内腔中。该方法还包括使导管的细长主体和组织移除元件旋转以移除组织。以及检测在使用期间由细长主体接触内衬套引起的内衬套的磨损。
附图简介
图1是本公开的导管的立面图;
图1A是导管的衬套磨损传感器电路的示意图;
图2是导管的远端部分的放大立面图;
图3是导管的近端部分的放大立面图;
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中的线5-5剖取的剖视图;
图6是导管的隔离衬套的局部立面图,其中一些部分剖开以显示内部细节;
图7是导管的远端部分的放大立面图,示出了内衬套上的非创伤性末端;
图8是导管的远端部分的放大立面图,示出了内衬套上的渐缩末端;以及
图9是导管的组织移除元件的放大纵向剖视图。
在附图中对应的附图标记表示对应的部件。
详述
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(例如,冠状动脉壁等)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,移除这种物质可以有益于维持体腔的通畅。
导管10的尺寸设计成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于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、狭窄或增生物质中穿透和/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设置的细长外层12(广义上是细长主体)。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设置在外层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(图1)绕外层12设置。外层12和内衬套14两者构造成相对于套管22平移。外层12和内衬套14还构造成相对于彼此平移。导管10的尺寸和形状设计成可***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设置在手柄中的马达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支承的驱动件48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可设置在导管16的近端10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49(图1A),以将导丝26相对于手柄锁定就位。
控制器50可设置在手柄40中。控制器50可编程为检测指示导丝26与外层12之间已经发生接触的信号。这种接触可能是由于内衬套14的一部分在使用期间磨损而导致的。控制器50可构造成当检测到外层与导丝接触时产生警报信号(例如,可听见的声音、视觉指示等)。可通过在外层12中创建正极端子和负极端子中的一个并在导丝26中创建正极端子和负极端子中的另一个来实现衬套磨损检测。内衬套14设置在导丝26与外层12之间。因此,如果内衬套14是完好无损的,则衬套将使导丝26和外层12间隔开,并由此将与导丝相关联的端子和与外层相关联的端子间隔开,从而防止电路构成。然而,由于内衬套14中的任何磨损导致内衬套的材料退化到一定程度,使得导丝26能够在内衬套的磨损区域接触外层12,然后导丝和外层的金属与金属的接触将会把端子放置成电接触并构成衬套磨损电路。控制器50与端子电连通,使得控制器可以识别出完整的电路,该电路指示衬套的至少一部分已经磨损。然后,控制器50可信号通知警报部件57以信号通知衬套磨损已经发生。替代地,警报部件57也可以是如图1A所示的电路的一部分,使得当电路闭合时,警报自动发出信号。
参照图1和1A,导丝锁定件49可包括用于与导丝26相关联的端子59,例如负极端子。这样,当使导丝锁定件配合49以将导丝26锁定就位时,导丝锁定件与导丝接触,使得导丝锁定件中的端子59也与导丝电接触。驱动件48的驱动轴55上的驱动键53还可包括用于与外层12相关联的端子61,例如正极端子。驱动键53与外层12接触并且将外层连接至驱动轴55和马达43。因此,在导管10的正常操作期间,内衬套14将导丝26与外层12间隔且隔离开,从而防止端子彼此电接触。这在电流不在端子之间流动的情况下形成开路。然而,如果内衬套14磨损成导丝26能够接触外层12的程度,则部件之间的金属与金属的接触将使端子处于电连通,在电连通状态下电流在闭合电路的两个端子之间流动。在电路闭合的情况下,警报部件57向用户警告衬套磨损状况。
替代地,包括端子的连接器(未示出)可以附连于导丝锁定件49。例如,连接器可在导丝锁定件49上附连至手柄40的近端,以将连接器中的端子放置成与导丝26接触。
在一些实施例中,作为内衬套14的附加或替代,可将隔离涂层涂布至导丝26。衬套磨损电路还可用于指示导丝涂层已磨损。在该实施例中,如上所述,正端子和负端子中的一个与导丝26相关联,而正端子和负端子中的另一个则与外层12相关联。
附加地或替代地,正极端子和负极端子中的一个可与内衬套14相关联,而正极端子和负极端子中的另一个则可与外层12相关联。例如,与内衬套14相关联的端子可附连于衬套的诸如中间层62之类的内部或内表面,并且与外层12相关联的端子可附连于驱动轴55和驱动键53。在该实施例中,内衬套14的外表面上的外层12的摩擦可能磨损衬套,从而暴露出衬套的内部或内表面,由此形成金属与金属的接触以构成衬套磨损电路。
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,动力供应可来自容纳在手柄40内的电池63。电池63可以为衬套磨损电路提供电流源。在其它实施例中,动力供应也可来自外源。
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54(例如,螺纹鲁尔锁),该锁定特征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,由此为外层提供了柔性,该柔性有助于导管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可具有单层构型。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设置在基础层之上的护套(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护套可设置在该线圈之上。替代地,外层12可包括双线圈层构型,该双线圈层构型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型的外层。
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,内衬套14的旋转并未被阻止。然而,内衬套14与外层12之间的间隙防止了由外层的旋转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均允许相对于手柄40平移。当向外层施加力以使外层在体腔内运动时,允许内衬套14和外层12的这种共同平移使盘绕的外层14的压缩和延伸最小化。在另一种实施例中,内衬套14可固定地附连于手柄40,以防止内衬套与手柄之间的相对运动。因此,在该实施例中,内衬套14保持静止并且防止内衬套14相对于手柄40平移。此外,内衬套14的所有旋转均被阻止。在该实施例中,外层12在静止的内衬套14上平移。
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。由此,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、以及聚酰亚胺外层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。聚酰亚胺外层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。此外,可将诸如硅树脂之类的润滑膜添加至内衬套14以减少内衬套与外层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。
在所示的实施例中,标记带66设置在内衬套14的远端的外表面上。标记带66将内衬套14的末端构造成在荧光透视下可见,这允许医师在医疗程序中验证衬套的位置。在该实施例中,可对内衬套14的远端进行激光切割以提供低轮廓的末端。在一种实施例中,标记带66包括铂铱条带。
在不脱离本公开的范围的情况下,还可以设想内衬套14的远端可以具有其它构型。例如,非创伤性末端68可附连于内衬套14的远端(图7)。非创伤性末端68提供柔软的低轮廓远端,以有助于内衬套14通过体腔递送而不引起创伤。非创伤性末端68可具有约0.02英寸(0.6毫米)的最大外径。还可以设想非创伤性末端的其它尺寸。在另一种实施例中,渐缩末端70可附连于内衬套14的远端(图8)。渐缩末端70可由构造成保护内衬套14的远端的材料的层形成。
参照图1、2和9,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。在一种实施例中,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可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。在一种实施例中,组织移除元件包括不锈钢球体,该球体的外表面包括5微米的暴露的金刚石晶体。组织移除元件20还可以是不透射线的,以允许组织移除元件在荧光透视下可见。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。
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开口。空腔72接纳外层12的一部分,以用于将组织移除元件20安装至外层。空腔72包括从组织移除元件20的近端延伸的第一直径部分74、从第一直径部分朝向组织移除元件的远端延伸的渐缩直径部分76、以及从渐缩直径部分延伸至组织移除元件的远端的第二直径部分78。第一直径部分74和第二直径部分78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。在一种实施例中,第一直径部分74的直径D1约为0.035英寸(0.9毫米),并且第二直径部分78的直径D2约为0.022英寸(0.56毫米)。渐缩直径部分76在第一直径部分74与第二直径部分78之间提供过渡。外层12接纳在第一直径部分74中,并且外层的远端邻接渐缩直径部分76。组织移除元件20可以通过任何合适的方式固定地附连于外层12的远端。在一种实施例中,粘合剂将组织移除元件20结合至外层12。内衬套14延伸穿过外层12和组织移除元件20的第二直径部分78。第二直径部分78的尺寸设计成以使内衬套14通过以具有小的间隙。内径D2在组织移除元件20与内衬套14之间提供间隙,以减小部件之间的摩擦并允许有盐水灌注的空间。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。
组织移除元件20的外表面包括近侧部段80、中间部段82和远侧部段84。近侧部段80的直径从组织移除元件20的近端增大至中间部段82。中间部段具有恒定的直径,并且从近侧部段80延伸至远侧部段84。远侧部段84的直径从中间部段82渐缩至组织移除元件20的远端。渐缩的远侧部段84为组织移除元件20提供大致楔形的形状,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疏通通道。组织移除元件20的远端还是磨圆的,以为组织移除元件提供钝的远端。
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,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。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 (20)
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,所述细长主体的尺寸和形状设计成容纳在所述体腔中;
手柄,所述手柄安装于所述细长主体的所述近端部分并且能够操作成使得所述细长主体的旋转;
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组织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,所述内衬套接纳在所述细长主体内,并且在所述内衬套的近端处联接于所述手柄,所述内衬套限定导丝内腔;以及
传感器,所述传感器相对于所述细长主体和所述内衬套布置,并且构造成检测由所述细长主体在使用期间接触所述内衬套引起的所述内衬套的磨损。
2.如权利要求1所述的组织移除导管,其特征在于,所述传感器提供以下至少一项的指示:所述细长主体何时与接纳在所述内衬套的所述导丝内腔中的导丝接触,以及所述内衬套的一部分何时与接纳在所述内衬套的所述导丝内腔中的导丝接触。
3.如权利要求2所述的组织移除导管,其特征在于,所述传感器包括与所述细长主体相关联的第一触头和与所述导丝相关联的第二触头,所述第一触头与所述第二触头电连通以指示所述内衬套的磨损。
4.如权利要求3所述的组织移除导管,其特征在于,所述手柄包括马达和驱动件,所述驱动件能操作地将所述马达连接至所述细长主体以使所述细长主体旋转,所述第一触头附连于所述驱动件。
5.如权利要求4所述的组织移除导管,其特征在于,所述手柄包括导丝锁定件,所述导丝锁定件构造成相对于所述手柄将所述导丝锁定就位,所述第二触头附连于所述导丝锁定件。
6.如权利要求5所述的组织移除导管,其特征在于,所述第二触头直接附连于所述导丝锁定件。
7.如权利要求5所述的组织移除导管,其特征在于,还包括附连于所述手柄的连接器,其中,所述第二触头直接附连于所述连接器。
8.如权利要求4所述的组织移除导管,其特征在于,所述驱动件包括驱动轴和连接于所述驱动轴的驱动键,所述第一触头附连于所述驱动键。
9.如权利要求2所述的组织移除导管,其特征在于,所述传感器包括与所述内衬套相关联的第一触头和与所述导丝相关联的第二触头,所述第一触头与所述第二触头电连通以指示所述内衬套的磨损。
10.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。
11.如权利要求1所述的组织移除导管,其特征在于,还包括马达,所述马达位于所述手柄中并且能操作地与所述细长主体配合,用以驱动所述细长主体和安装在所述细长主体上的所述组织移除元件的旋转。
12.一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,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组织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,所述内衬套接纳在所述细长主体内,所述内衬套限定导丝内腔;以及
传感器,所述传感器相对于所述细长主体和所述内衬套布置,并且构造成检测由所述细长主体在使用期间接触所述内衬套引起的所述内衬套的磨损。
13.如权利要求12所述的组织移除导管,其特征在于,所述传感器提供以下至少一项的指示:所述细长主体何时与接纳在所述内衬套的所述导丝内腔中的导丝接触,以及所述内衬套的一部分何时与接纳在所述内衬套的所述导丝内腔中的导丝接触。
14.如权利要求13所述的组织移除导管,其特征在于,所述传感器包括与所述细长主体相关联的第一触头和与所述导丝相关联的第二触头,所述第一触头与所述第二触头电连通以指示所述内衬套的磨损。
15.如权利要求14所述的组织移除导管,其特征在于,还包括马达和驱动件,所述驱动件能操作地将所述马达连接至所述细长主体以使所述细长主体旋转,所述第一触头附连于所述驱动件。
16.如权利要求15所述的组织移除导管,其特征在于,还包括导丝锁定件,所述导丝锁定件构造成将所述导丝锁定就位,所述第二触头附连于所述导丝锁定件。
17.如权利要求16所述的组织移除导管,其特征在于,所述驱动件包括驱动轴和连接于所述驱动轴的驱动键,所述第一触头附连于所述驱动键。
18.如权利要求13所述的组织移除导管,其特征在于,所述传感器包括与所述内衬套相关联的第一触头和与所述导丝相关联的第二触头,所述第一触头与所述第二触头电连通以指示所述内衬套的磨损。
19.一种移除体腔中的组织的方法,所述方法包括:
使组织移除导管在所述体腔中的导丝上前进,以将所述导管的远端定位成与所述组织相邻,并将所述导管的近端部分定位在体腔外部,所述导管包括细长主体、安装在所述细长主体的远端部分上的组织移除元件、以及设置在所述细长主体内的内衬套,所述内衬套限定导丝内腔,在所述导管前进期间所述导丝设置在所述导丝内腔中;
使所述导管的所述细长主体和所述组织移除元件旋转,以移除所述组织;以及
检测在使用期间由所述细长主体接触所述内衬套引起的所述内衬套的磨损。
20.如权利要求19所述的方法,其特征在于,还包括使用相对于所述细长主体和所述内衬套布置的传感器来检测所述内衬套的磨损,其中,所述传感器包括与所述细长主体和所述内衬套中的一个相关联的第一触头以及与所述导丝相关联的第二触头,所述第一触头与所述第二触头电连通,以指示所述内衬套的磨损。
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