CN110573099A - 组织移除导管 - Google Patents

组织移除导管 Download PDF

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CN110573099A
CN110573099A CN201880028658.XA CN201880028658A CN110573099A CN 110573099 A CN110573099 A CN 110573099A CN 201880028658 A CN201880028658 A CN 201880028658A CN 110573099 A CN110573099 A CN 110573099A
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tissue
catheter
guidewire
lumen
gear
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CN110573099B (zh
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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
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Middleton Livas Coller Co
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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)，该细长主体的尺寸和形状设计成接纳在体腔中。手柄(40)安装在导管(10)的近端部分处并且可操作以使得细长主体(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。导丝内腔(24)从导管(10)的远端延伸穿过细长主体(12)至导管(10)上的中间位置，该中间位置与导管(10)的近端部分向远侧间隔开。导丝内腔构造成接纳导丝(26)，使得可以在不从体腔中移除导丝(26)的情况下通过沿着导丝(26)牵拉导管(10)来将导管(10)从体腔中移除。

Description

组织移除导管
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快速交换导丝组件。
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。手柄安装在导管的近端部分处并且可操作以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。导丝内腔从导管的远端延伸穿过细长主体至导管上的中间位置，该中间位置与导管的近端部分向远侧间隔开。导丝内腔构造成接纳导丝，使得可以在不从体腔中移除导丝的情况下通过沿着导丝牵拉导管来将导管从体腔中移除。
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。细长主体是可旋转的，并且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。导丝内腔从导管的远端延伸穿过细长主体至导管上的中间位置，该中间位置与导管的近端向远侧间隔开。导丝内腔构造成接纳导丝，使得可以在不从体腔中移除导丝的情况下通过沿着导丝牵拉导管来将导管从体腔中移除。
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位于细长主体内的导丝内腔，导丝在导管前进期间设置在导丝内腔中。该方法还包括使用可操作地连接于细长主体和组织移除元件的马达和驱动件来使导管的细长主体和组织移除元件旋转以移除组织。以及使用位于沿导管的中间位置处的齿轮组件将扭矩从马达和驱动件传递至细长主体和组织移除元件。
附图简介
图1是本公开的导管的立面图；
图2是导管的远端部分的放大立面图，该附图示出了接纳在引导导管中的导管；
图3是导管的中间部分的放大局部立面图；
图4是接纳在引导导管中的导管的中间部分的局部放大立体图，并且引导导管示出为是透明的；
图5是图3中的导管的中间部分的放大局部纵向垂直剖视图；
图6是沿图3中的线6-6剖取的导管的中间部分的放大局部纵向水平剖视图，其中移除线圈齿轮的一部分以示出下面的细节；
图7是沿图4中的线7-7剖取的放大剖视图；
图8是导管的接线盒(junction box)的放大立体图，其中接线盒显示为透明，以示出在接线盒内部的齿轮组件；
图9是齿轮组件的立体图；
图10是齿轮组件的小齿轮的放大立体图；
图11是小齿轮的剖视图；
图12是齿轮组件的线圈齿轮的放大立体图；
图13是线圈齿轮的剖视图；
图14是图2中的导管的远端部分的放大局部纵向剖视图；
图15是通过图2中的线5-5剖取的剖视图；
图16是导管的隔离衬套的局部立面图，其中一些部分被剖开以显示内部细节；
图17是导管的组织移除元件的放大纵向剖视图；
图18是另一种实施例的导管的局部立体图，接线盒的壳体示出为透明的，以示出内部细节；
图19是图18中的导管的立面图；
图20是图19中的导管的纵向垂直剖视图；
图21是图18中的导管的小齿轮的放大立体图；
图22是图21中的小齿轮的剖视图；
图23是图18中的导管的线圈齿轮的放大立体图；以及
图24是图23中的线圈齿轮的剖视图。
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、淋巴管等。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1-3，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沿着导管的第一纵向轴线LA1从导管的接线盒15延伸至远端部分18。接线盒15位于沿着导管10的中间位置处。在一种实施例中，接线盒15设置在距导管10的远端约20至约30厘米处。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和2)绕外层12设置。导管10的尺寸和形状设计成可插入到对象的体腔中。套管22将体腔与外层12和内衬套14的至少一部分隔离。套管22、外层12和内衬套14从接线盒15向远侧延伸。内衬套14至少部分地限定导丝内腔24，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。接线盒15限定导丝端口39，该导丝端口39还可限定导丝内腔24的一部分。导丝端口39在导管10上的中间位置处为导丝提供出口位置。导丝26可以是标准的0.014英寸外径的导丝。然而，接线盒15允许较短的导丝与导管10一起使用，因为导丝在导管的中间位置处离开导管10，而不是沿着导管的整个工作长度延伸。在一种实施例中，长度小于约200厘米(79英寸)的导丝可与导管10一起使用。在一种实施例中，可使用长度在约150厘米(59英寸)至约190厘米(75英寸)之间的导丝。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的接线盒15延伸穿过远端部分18，使得导丝26可仅沿着导管10的工作长度的一部分延伸。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，以驱动从马达延伸至接线盒15的驱动件48的旋转。驱动件48可具有约100厘米的长度，以使接线盒15与手柄40间隔开。驱动件48可具有其它长度，而不脱离本公开的范围。在所示的实施例中，驱动件48是线圈轴。驱动管27包封驱动件48并从手柄40延伸至接线盒15，以将体腔与旋转的驱动件隔离。驱动管27和驱动件48沿着导管10的第二纵向轴线LA2从手柄40延伸至接线盒15。第二纵向轴线LA2平行于第一纵向轴线LA1延伸并且与第一纵向轴线LA1间隔开。如以下将更详细解释的，接线盒15将驱动件48的扭矩传递至外层12，以使安装在外层的远端的组织移除元件20旋转。灌注端口46也可设置在导管16的近端部分10处。灌注端口46与引导导管128(图4和7)和驱动管27之间的空间连通，以在使用期间递送流体(例如，盐水)以冷却接线盒15中的旋转的部件和旋转的外层12。
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(未示出)。在其它实施例中，动力供应可来自外源。
参照图1、3-5和8-13，接线盒15包括壳体90，该壳体90封围齿轮组件92，用于将驱动件48可操作地连接至外层12。接线盒15中的齿轮组件92构造成有效地从马达43传递高达约13毫牛·米(mN.m)的马达扭矩。在扭矩传递期间，齿轮组件92的齿轮可旋转高达每分钟10,000转，甚至高达每分钟100,000转。壳体90包括大致围绕齿轮组件92的刚性中心部分94，以及柔性的近端部分和远端部分96，该近端部分和远端部分96为壳体提供应变释放功能，以当导管10在使用期间弯曲时减轻施加至接线盒15的近端和远端的张力。刚性中心部分94包括外壳98以及分别安装在外壳的近端和远端上的第一轴承保持件100和第二轴承保持件102。外壳98可由聚醚醚酮(PEEK)形成。
齿轮组件92包括与线圈齿轮106(广义上是第二齿轮)啮合的小齿轮104(广义上是第一齿轮)。小齿轮104附连于驱动件48，使得驱动件的旋转引起小齿轮的旋转，小齿轮的旋转又使线圈齿轮旋转。线圈齿轮106附连于外层12，使得线圈齿轮的旋转引起外层的旋转。具体地，小齿轮104近侧附连部分108、远端部分110和中间齿轮部分112。近侧附连部分108包括接纳部114，该接纳部114接纳驱动件48的远端部分。驱动件48的远端部分固定在接纳部114内，以将驱动件附连至小齿轮104。在所示的实施例中，中间齿轮部分112包括十(10)个齿113。中间齿轮部分112可具有约0.8毫米(约0.03英寸)的外径，并且中间齿轮部分的齿113可具有大约0.6毫米(约0.02英寸)的节圆直径和约20度的压力角度。还可以设想小齿轮104的其它尺寸。第一对宝石轴承116分别绕小齿轮104的近端部分108和远端部分110被接纳，并有助于小齿轮在接线盒15中的旋转。
线圈齿轮106包括远侧附连部分118、近侧部分120和中间齿轮部分122。远侧附连部分118附连于外层12。具体地，远侧附连部分118的一部分接纳在外层12的近端中并且固定地附连于该近端上。在所示的实施例中，中间齿轮部分122包括十七(17)个齿123。中间齿轮部分122可具有约1.3毫米(约0.05英寸)的外径。中间齿轮部分122的齿123可具有约1.1毫米(约0.04英寸)的节圆直径和约20度的压力角度。还可以设想线圈齿轮106的其它尺寸。
在一种实施例中，齿轮组件92的齿轮比在约1比1与约2比1之间。在一种实施例中，齿轮组件92具有约1.7比1的齿轮比。线圈齿轮106具有比小齿轮104更大的齿数意味着与驱动件48和小齿轮104的旋转速度相比，齿轮组件92将降低线圈齿轮106和外层12的旋转速度。但是，转速降低将导致力或扭矩输出增加。因此，与驱动件48相比，线圈齿轮106、并由此外层12和组织移除元件20将以增加的力/扭矩旋转。这将允许组织移除元件20更好地移除体腔中的闭塞组织，以将组织与体腔壁分开。
第二对宝石轴承124分别绕线圈齿轮106的远端部分118和近端部分120被接纳，并有助于线圈齿轮在接线盒15中的旋转。通道126延伸穿过线圈齿轮106并接纳内衬套14的近端部分。第一轴承保持件100绕齿轮104、106的近端部分108、120围绕轴承116、124布置，并且第二轴承保持件102绕齿轮的远端部分110、118围绕轴承116、124布置。轴承116、124可以由青铜制成。然而，还可以设想其它材料。例如，轴承还可以由氧化锆制成。
接线盒15的壳体90的尺寸设计成使得导管10可接纳在引导导管128内，因此在接线盒的相对的侧向侧上提供有间隙(图7)，以允许在引导导管128与导管10之间灌注盐水或对比剂。具体地，壳体90的中心部分94具有平坦的侧表面，这些侧表面在中心部分的侧面与引导导管128的弯曲内壁之间形成间隙129。在一种实施例中，壳体90的尺寸设计成使得导管10可以接纳在7F(约2毫米)或更小直径的导管中。在另一种实施例中，壳体90的尺寸设计成使得导管10可以接纳在6F(约1.8毫米)或更小直径的导管中。
参照图6－8，可在驱动管27中提供流体端口130，用于将冲洗/润滑流体引入到齿轮组件92中。在所示的实施例中，端口130位于驱动管27的远端部分中，并且设置成与小齿轮104的近侧附连部分108配准。在导管10的近端处引入的流体通过引导导管128递送，并且可以引导到流体端口130中并且递送至小齿轮104的中间齿轮部分112，在此小齿轮的旋转将流体围绕小齿轮传递并传递至线圈齿轮106的中间齿轮部分122。由小齿轮104的旋转引起的线圈齿轮的旋转使流体绕线圈齿轮106运动，并且将流体输送至线圈齿轮的远侧附连部分118，在此流体可以引入到套管22与外层12之间的空间中。因此，接线盒15中的齿轮组件92构造成将流体从接线盒的近端输送至接线盒的远端，以用流体冷却齿轮组件92。此外，通过将流体递送通过接线盒15，可以将在接线盒的近端处引入的流体递送至接线盒的远端，并泵入套管22与外层12之间的空间。此外，轴承保持件100、102的非对称构型有助于流体从接线盒15的近端流向远端。
参照图5、8和9，套筒132还可绕线圈齿轮106的近端部分120设置。套筒132构造成减小由推力在线圈齿轮106上产生的摩擦，该推力通过使导管10前进穿过体腔而引起。套筒132可由石墨或其它低摩擦材料制成。套筒132构造成在导管10的使用期间响应于在线圈齿轮106处经受的推力而磨蚀。通过降低线圈齿轮106周围的摩擦力，可使接线盒15的效率最大化。
参照图1-4和15，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。在一种实施例中，套管22具有大约0.050英寸(1.27毫米)的内径和0.055英寸(1.4毫米)的外径。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可包括多层构型。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1-4、14和15，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和齿轮组件92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，线圈构型允许外层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的线圈构型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1-4和14-16，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与与线圈齿轮106、外层12和组织移除元件20隔离。内衬套14可穿过接线盒15延伸至导管10的远端。在一种实施例中，内衬套14固定地附连于接线盒15。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线圈齿轮和外层隔离而保护导丝免受由线圈齿轮和106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的绕导丝旋转的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。线圈齿轮106、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以及约7.9英寸(200毫米)至约15.7英寸(400毫米)之间的长度。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为线圈齿轮106、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(图2)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。
参照图1、2和17，组织移除元件20沿着第一纵向轴线LA1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插入到体腔中并且致动马达43使驱动件48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，驱动件48使齿轮组件92旋转，齿轮组件92随后将马达扭矩传递至外层12，从而使组织移除元件20旋转。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插入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的近端部分插入穿过内衬套14的导丝内腔24并穿过接线盒15，使得延伸穿过接线盒中的导丝端口39以离开导管10。导丝端口39允许导管10用于快速交换和单个操作者快速程序中。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，以使驱动件48、齿轮组件92、外层12以及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，医师可选择性地使导管10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。医师还可使导管10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与旋转的线圈齿轮106、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构造成承受旋转的线圈齿轮106、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的操作后，可以从体腔中移除导管。因为导丝内腔24比导管10的总长度短得多，所以可以通过快速交换或单操作者交换程序来从体腔中移除导管，而无需将导丝26与导管一起从体腔中拉出，因为从对象突出的导丝的长度比导管的导丝内腔24的长度更长。因此，导丝26的至少一部分一直暴露，并且可由医师抓持。
参照图18-24，另一种实施例的导管总体地以10'表示。导管10'包括与第一实施例的接线盒15相似的接线盒15'。接线盒15'包括壳体90'，该壳体90'封围齿轮组件92'，以用于将驱动件48'可操作地连接至外层12'。壳体90'包括大致围绕齿轮组件92'的刚性中心部分94'，以及近端部分和远端部分96'，该近端部分和远端部分96'为壳体提供应变释放功能，以当导管10'在使用期间弯曲时减轻施加至接线盒15'的近端和远端的张力。
齿轮组件92包括与线圈齿轮106'啮合的小齿轮104'。小齿轮104'附连于驱动件48'，使得驱动件的旋转引起小齿轮的旋转，小齿轮的旋转又使线圈齿轮106'旋转。线圈齿轮附连于外层12'，使得线圈齿轮的旋转引起外层的旋转。小齿轮104'近侧附连部分108'、远端部分110'和中间齿轮部分112'。驱动件48'接纳在近侧附连部分108'中。驱动件48固定在近侧附连部分108'内，以将驱动件附连至小齿轮104'。在所示的实施例中，中间齿轮部分112'包括八(8)个齿113'。中间齿轮部分112'可具有约0.8毫米(约0.03英寸)的外径，并且中间齿轮部分的齿113'可具有大约0.6毫米(约0.02英寸)的节圆直径和约20度的压力角度。还可以设想小齿轮104'的其它尺寸。
线圈齿轮106'包括附连部分118'和齿轮部分122'。通道126'延伸穿过线圈齿轮106'并接纳内衬套14'和外层12'的近端部分。附连部分118'附连于外层12'的近端。具体地，外层12'接纳在线圈齿轮106'的附连部分118'中并且固定地附连于该附连部分118'。在所示的实施例中，齿轮部分122'包括十四(14)个齿123'。齿轮部分122'可具有约1.3毫米(约0.05英寸)的外径。齿轮部分122'的齿123'可具有约1.1毫米(约0.04英寸)的节圆直径和约20度的压力角度。还可以设想线圈齿轮106'的其它尺寸。在一种实施例中，齿轮组件92'的齿轮比在约1比1与约2比1之间。在一种实施例中，齿轮组件92'具有约1.75至1的齿轮比。
第一轴承116'绕内衬套14'和小齿轮104'的近端部分108'被接纳。第一轴承116'包括用于接纳小齿轮104'的近端部分108'的第一孔和用于接纳内衬套14'的第二孔。第二轴承124'分别绕小齿轮104'的远端部分110'和线圈齿轮106'的远端部分118'被接纳。第二轴承124'包括用于接纳小齿轮104'的远端部分110'的第一孔和用于接纳线圈齿轮106'的远端部分118'的第二孔。轴承116'、124'可以由青铜制成。然而，还可以设想其它材料。例如，轴承116'、124'还可以由氧化锆制成。
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、系统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接纳在所述体腔中；
手柄，所述手柄安装在所述导管的近端部分处并且能够操作以使得所述细长主体旋转；
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；以及
导丝内腔，所述导丝内腔从所述导管的远端延伸穿过所述细长主体至位于所述导管上的中间位置，所述中间位置与所述导管的所述近端部分向远侧间隔开，所述导丝内腔构造成接纳导丝，使得在不从所述体腔移除所述导丝的情况下通过沿着所述导丝牵拉所述导管，能够从所述体腔移除所述导管。
2.如权利要求1所述的组织移除导管，其特征在于，还包括接纳在所述细长主体内的内衬套，所述内衬套限定所述导丝内腔的至少一部分。
3.如权利要求2所述的组织移除导管，其特征在于，还包括位于所述导管的所述中间位置处的接线盒，所述接线盒限定用于接纳所述导丝的导丝端口。
4.如权利要求3所述的组织移除导管，其特征在于，还包括设置在所述接线盒中的齿轮组件，所述齿轮组件与所述细长主体配合以使所述细长主体旋转。
5.如权利要求4所述的组织移除导管，其特征在于，还包括位于所述手柄中的马达和从所述马达向远侧延伸至所述接线盒的驱动件，所述驱动件配合所述齿轮组件以使所述齿轮组件旋转，从而使所述细长主体和安装在所述细长主体上的组织移除元件旋转。
6.如权利要求5所述的组织移除导管，其特征在于，所述驱动件限定纵向轴线，所述纵向轴线与所述细长主体的纵向轴线平行且间隔开。
7.如权利要求5所述的组织移除导管，其特征在于，还包括从所述手柄延伸至所述接线盒的驱动管，所述驱动管限定用于将流体引入到所述齿轮组件中的流体端口。
8.如权利要求5所述的组织移除导管，其特征在于，还包括致动器，所述致动器定位在所述手柄上并且构造成选择性地致动所述马达，以驱动所述细长主体和所述组织移除元件的旋转。
9.如权利要求3所述的组织移除导管，其特征在于，所述齿轮组件包括第一齿轮和第二齿轮，所述第一齿轮固定地附连于所述驱动件，所述第二齿轮与所述第一齿轮啮合并且固定地附连于细长构件。
10.如权利要求9所述的组织移除导管，其特征在于，所述第二齿轮限定用于接纳所述内衬套的通道。
11.如权利要求2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。
12.如权利要求1所述的组织移除导管，其特征在于，所述组织移除元件包括磨削锉具。
13.一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，所述细长主体能够旋转，并且尺寸和形状设计成接纳在所述体腔中；以及
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；以及
导丝内腔，所述导丝内腔从所述导管的远端延伸穿过所述细长主体至位于所述导管上的中间位置，所述中间位置与所述导管的近端向远侧间隔开，所述导丝内腔构造成接纳导丝，使得在不从所述体腔移除所述导丝的情况下通过沿着所述导丝牵拉所述导管，能够从所述体腔移除所述导管。
14.如权利要求13所述的组织移除导管，其特征在于，还包括接纳在所述细长主体内的内衬套，所述内衬套限定所述导丝内腔的至少一部分。
15.如权利要求14所述的组织移除导管，其特征在于，还包括位于所述导管的所述中间位置处的接线盒，所述接线盒限定用于接纳所述导丝的导丝端口。
16.如权利要求15所述的组织移除导管，其特征在于，还包括设置在所述接线盒中的齿轮组件，所述齿轮组件与所述细长主体配合以使所述细长主体旋转。
17.如权利要求16所述的组织移除导管，其特征在于，所述齿轮组件包括固定地附连于细长构件的齿轮，所述齿轮限定用于接纳所述内衬套的通道。
18.一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、以及位于所述细长主体内的导丝内腔，在所述导管前进期间所述导丝设置在所述导丝内腔中；
使用可操作地连接于所述细长主体和所述组织移除元件的马达和驱动件来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
使用位于沿着所述导管的中间位置处的齿轮组件将扭矩从所述马达和所述驱动件传递至所述细长主体和所述组织移除元件。
19.如权利要求18所述的方法，其特征在于，还包括使所述导丝仅沿着所述导管的一部分延伸，使得所述导丝在所述中间位置处离开所述导管。
20.如权利要求18所述的方法，其特征在于，还包括在不从所述体腔移除所述导丝的情况下通过沿着所述导丝牵拉所述导管来从所述体腔移除所述导管。
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