CN113395942A - 组织去除导管 - Google Patents

组织去除导管 Download PDF

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CN113395942A
CN113395942A CN202080013121.3A CN202080013121A CN113395942A CN 113395942 A CN113395942 A CN 113395942A CN 202080013121 A CN202080013121 A CN 202080013121A CN 113395942 A CN113395942 A CN 113395942A
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catheter
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housing
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T·K·凯利
J·凯利
A·詹莫斯
M·弗莱明
R·芬恩
B·汉森
N·凯利
D·G·坎尼夫
T·海登
J·克理福德
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Medtronic Vascular Inc
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    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
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    • 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
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Abstract

一种用于去除体腔中的组织的组织去除导管包含导管主体组合件，所述导管主体组合件具有轴线以及沿所述轴线彼此间隔开的近端部分和远端部分。所述导管主体组合件的至少一部分的大小和形状被设定成收纳在所述体腔中。手柄(40)安装到所述导管主体组合件的所述近端部分并且可操作以使所述导管主体组合件旋转。所述手柄包含与所述导管主体组合件介接的内部手柄组件。所述内部手柄组件提供沿所述导管主体组合件轴向间隔的至少四个接口位置(251，253，255，257)。组织去除元件(20)安装在所述导管主体组合件的所述远端部分上。所述组织去除元件被配置成在所述组织去除元件通过所述体腔内的所述导管主体组合件旋转时去除所述组织。

Description

组织去除导管
相关申请的交叉引用
本申请要求于2019年5月17日提交的美国临时专利申请序列号62/849,627的优先权，所述美国临时专利申请特此通过引用整体并入本文。
技术领域
本公开总体上涉及一种组织去除导管，并且更具体地，涉及一种组织去除导管的手柄。
背景技术
组织去除导管用于去除体腔中不需要的组织。作为实例，粥样斑块切除术导管用于将材料从血管中去除以打开血管并改善通过血管的血液流动。这个过程可以用于制备患者的冠状动脉内的病变，以促进对具有冠状动脉严重钙化病变的患者进行经皮冠状动脉成形术(PTCA)或支架递送。粥样斑块切除术导管通常采用旋转元件，所述旋转元件用于磨损或以其它方式破坏不需要的组织。
发明内容
一方面，一种用于去除体腔中的组织的组织去除导管通常包括导管主体组合件，所述导管主体组合件具有轴线以及沿所述轴线彼此间隔开的近端部分和远端部分。所述导管主体组合件的至少一部分的大小和形状被设定成收纳在所述体腔中。手柄安装到所述导管主体组合件的所述近端部分并且可操作以使所述导管主体组合件旋转。所述手柄包含与所述导管主体组合件介接的内部手柄组件。所述内部手柄组件提供沿所述导管主体组合件轴向间隔的至少四个接口位置。组织去除元件安装在所述导管主体组合件的所述远端部分上。所述组织去除元件被配置成在所述组织去除元件通过所述体腔内的所述导管主体组合件旋转时去除所述组织。
另一方面，一种用于去除体腔中的组织的组织去除导管的手柄可操作以使所述组织去除导管的导管主体组合件旋转。所述手柄包括壳体以及所述壳体内的内部组件，所述内部组件被配置成与所述导管主体组合件介接。所述内部手柄组件提供沿所述导管主体组合件轴向间隔的至少四个接口位置。
又另一方面，一种用于去除体腔中的组织的组织去除导管通常包括导管主体组合件，所述导管主体组合件包含细长主体，所述细长主体具有轴线以及沿所述轴线彼此间隔开的近端部分和远端部分。所述细长主体的大小和形状被设定成收纳在所述体腔中。衬套组合件收纳在所述细长主体内并且限定导丝管腔。所述衬套组合件将所述导丝管腔的内部与所述细长主体隔离，使得当在操作所述组织去除导管期间旋转所述细长主体时，旋转和扭转力不会从所述细长主体传递到所述导丝管腔的所述内部。手柄安装到所述导管主体组合件的所述近端部分并且可操作以使所述细长主体旋转。所述手柄包含内部手柄组件，所述内部手柄组件与所述衬套组合件和所述细长主体介接，以使所述衬套组合件和所述细长主体稳定并对准以将所述衬套组合件在所述细长主体内居中，以便促进所述衬套组合件的所述导丝管腔的所述内部与所述细长主体隔离。
附图说明
图1是本公开的导管的示意性图示；
图2是导管的远端部分的放大正视图；
图3是导管的手柄的顶部透视图；
图4是手柄的底部透视图；
图5A是手柄的顶部透视图，其中顶部壳体区段被去除；
图5B是图5A中的手柄的俯视图；
图6是手柄的横截面；
图7是手柄的侧视图，其中中间壳体区段被去除并且顶部和底部壳体区段示出为透明的；
图8是手柄的透视图，其中壳体区段和一些内部组件被去除；
图9A是手柄的放大片段顶部透视图，其中壳体区段和一些内部组件被去除；
图9B是手柄的放大片段底部透视图，其中壳体区段和一些内部组件被去除；
图10A是导管的组件和手柄的内部组件的后部透视图；
图10B是图10A中的组件的前部透视图；
图11是导管的组件和手柄的内部组件的侧视图；
图12是导管的组件和手柄的内部组件的另一个侧视图；
图13是手柄中的齿轮组合件的后部透视图；
图14是齿轮组合件的前部透视图；
图15是齿轮组合件的前壳体区段的透视图；
图16是齿轮组合件的齿轮的透视图；
图17是手柄中的从动齿轮和驱动组合件的透视图；
图18是图17中的从动齿轮和驱动组合件的分解视图；
图19是驱动组合件的分解截面，示出了收纳在其中的驱动线圈；
图20是驱动组合件的局部分解截面，示出了收纳在其中的驱动线圈和附接到管插入件的锁；
图21是驱动组合件的截面，示出了收纳在其中的驱动线圈以及管插入件和附接到齿轮插入件的锁；
图22A是另一个实施例的驱动组合件的放大片段透视图；
图22B是另一个实施例的驱动组合件的片段截面；
图22C是图22B中的驱动组合件的锁的一部分的片段截面；
图23是手柄中的行进护套接口组合件的截面；
图24是图23的放大片段截面；
图25是手柄中的推进器框架的透视图；
图26是图2中的导管的远端部分的放大片段纵向横截面；
图27是沿图2中的线27-27截取的横截面；
图28是导管的隔离衬套的片段正视图，其中部分被拆除以示出内部细节；
图29是手柄的远端的横截面；
图30是手柄中的隔离护套接口组合件的透视图；
图31是隔离护套接口组合件的分解视图；
图32是隔离护套接口组合件的接口壳体的透视图；
图33是隔离护套接口组合件的横截面，示出了收纳在接口壳体中的密封件；
图34是接口壳体的横截面，其中密封件被去除；
图35是隔离衬套接口组合件和衬套组合件的透视图；
图36是隔离衬套接口组合件和衬套组合件的端视图；
图37是衬套组合件的片段透视图；
图38是衬套组合件的衬套键的透视图；
图39是衬套键的横截面；
图40是另一个实施例的手柄的顶部透视图；
图41是图40的手柄的顶部透视图，其中顶部壳体区段被去除；
图42是图41的手柄的片段透视图；
图43是图40的手柄的横截面；
图44是图43的手柄的放大片段视图；
图45是图44的手柄的放大片段视图；
图46是图43的手柄的放大片段视图；
图47是图40的导管的示意性图示；
图48是手柄的组件和延伸通过手柄的导管组合件的后部透视图；
图49是图48的组件的前部透视图；
图50是手柄的组件和延伸通过手柄的导管组合件的后部透视图；
图51是图50的放大片段透视图；
图52是图50的组件的放大片段透视图；
图53是图50的放大片段透视图；
图54是手柄的组件和延伸通过手柄的导管组合件的后部透视图；
图55是图54的放大片段透视图；
图56是手柄和导管组合件的组件的侧视图；
图57是手柄中的从动齿轮和驱动组合件的透视图；
图58是图57的从动齿轮和驱动组合件的分解视图；
图59是图57的驱动组合件的从动齿轮和齿轮延伸部的透视图；
图60是图59的从动齿轮和齿轮延伸部的横截面；
图61是图59的从动齿轮和齿轮延伸部的端视图；
图62是图57的驱动组合件的齿轮锁的透视图；
图63是图62的齿轮锁的侧视图；
图64是导向管和收纳在导向管中的衬套组合件的片段透视图；
图65是内衬套组合件的片段透视图；
图66是导向管和远端止挡件的片段透视图；
图67是导向管和远端止挡件的片段截面，示出了收纳在其中的衬套组合件；
图68是导向管和远端止挡件的另一个片段截面，示出了收纳在其中的衬套组合件；
图69A是远端止挡件的前部透视图；
图69B是远端止挡件的后部透视图；
图70是远端止挡件的截面；
图71是远端止挡件的左侧视图；
图72是远端止挡件的右侧视图；
图73是图40的手柄的隔离护套接口组合件的透视图；并且
图74是图73的隔离护套接口组合件的分解视图。
对应附图标记指示贯穿附图的对应部件。
具体实施方式
参考附图，并且具体地图1，用于去除体腔中的组织的旋转式组织去除导管总体以附图标记10指示。所展示的导管10是适合于将闭塞组织(例如，栓塞性组织、斑块组织、粥样斑块、溶栓性组织、狭窄性组织、增生性组织、赘生性组织等)从血管壁(例如，冠状动脉壁等)去除(例如，磨损、切割、切除、摘除等)的旋转式粥样斑块切除术装置。导管10可以用于促进经皮冠状动脉成形术(PTCA)或随后的支架递送。所公开的实施例的特征也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其它体腔(如输尿管、胆管、呼吸道、胰腺管、淋巴管等)的其它增生性和赘生性病状。赘生性细胞生长通常将会由于围绕体腔并且引入到体腔中的肿瘤而发生。因此，去除此材料可以有利于维持体腔的通畅性。
导管10的大小被设定成用于收纳在受试者的血管中。因此，导管10的最大大小可以为3、4、5、6、7、8、9、10或12French(1、1.3、1.7、2、2.3、2.7、3、3.3或4mm)并且工作长度可以为20、30、40、60、80、100、120、150、180或210cm，这取决于体腔。虽然以下讨论针对用于去除血管中的组织的导管，但是应当理解，本公开的教导也适用于其它类型的组织去除导管，包含但不限于用于穿透和/或去除各种体腔中的各种闭塞性、狭窄性或增生性材料的导管。
参考图1和2，导管10包括围绕细长内衬套14安置的细长驱动线圈12(广义地，细长主体)。驱动线圈12和内衬套14沿导管的纵向轴线LA从导管的近端部分16延伸到远端部分18。组织去除元件20安置在驱动线圈12的远端上并且被配置成用于旋转以将组织从体腔中去除，如下文将更详细地解释的。隔离护套22(图1)围绕驱动线圈12安置。驱动线圈12和内衬套14两者均被配置成相对于隔离护套22平移。导管10的大小和形状被设定成用于插入到受试者的体腔中。隔离护套22将体腔与驱动线圈12和内衬套14的至少一部分隔离。内衬套14限定导丝管腔24(图27)以将导丝26可滑动地收纳在其中，使得导管10可以通过沿导丝行进而被推进通过体腔。导丝可以是标准的外径0.014英寸、长300cm的导丝。在某些实施例中，内衬套14可以具有用于在导丝26之上滑动的润滑内表面(例如，润滑表面可以由润滑聚合物层或润滑涂层提供)。在所展示的实施例中，导丝管腔24一直延伸通过内衬套14的长度，使得导丝26可沿导管10的整个工作长度延伸。在一个实施例中，导管10的总工作长度可以介于约135cm(53英寸)与约142cm(56英寸)之间。在使用中，导丝26可以延伸超过内衬套14的远端约40mm(1.6英寸)。
参考图1和图3-7，导管10进一步包括固定在隔离护套22的近端处的手柄40。手柄40包括支撑手柄的组件的壳体41。壳体41具有大致细长蛋形状并且包含固定在一起以围封手柄40的内部组件的多个壳体区段。在所展示的实施例中，壳体41包含底部壳体区段41A、固定到所述底部壳体区段的顶部的中间壳体区段41B以及固定到中间壳体区段的顶部的顶部壳体区段41C。中间壳体区段41B具有大致跑道形状，并且底部和顶部壳体区段41A、41C大致呈圆顶形状。底部壳体区段41A具有用于将壳体41搁置在支撑表面上的平坦底表面。模式选择器51通常安装在中间壳体区段41B与顶部壳体区段41C之间并且限定壳体41的一部分。如下文将更详细地解释的，模式选择器51被配置成以多种模式选择性地放置导管10并且以所述模式中的至少一种模式将导丝锁定适当的位置。中间壳体区段41B在每一侧上具有凹陷区域53以提供用于壳体41的抓握区域。在一个实施例中，底部壳体区段41A可从中间壳体区段41B中去除，以提供用户到壳体41的内部中的手柄40的组件的通路。应当理解，在不脱离本公开的范围的情况下，壳体41可以具有其它形状和配置。
参考图1、图3、图5A-11和图13-16，壳体41支撑被配置成用于选择性地致动安置在手柄中的用于驱动驱动线圈12旋转的马达43以及安装在驱动线圈的远端处的组织去除元件20的致动器42(例如，杠杆、按钮、拨盘、开关或其它装置)。马达43被配置成以大于约80,000RPM的速度旋转驱动线圈12和组织去除元件20。马达43通过支撑在壳体41内的齿轮组合件44和驱动组合件48耦接到驱动线圈12。齿轮组合件44包括齿轮箱壳体55，所述齿轮箱壳体安装并且至少部分地围封一对齿轮，以将马达43的轴的旋转传递到驱动线圈12。齿轮箱壳体55包含主壳体区段61和前壳体区段63。前壳体区段63通过多个紧固件65固定到主壳体区段61。夹子67进一步将前壳体区段63固定到主壳体区段61。在一个实施例中，主壳体区段61和前壳体区段63可以具有使壳体区段相对于彼此定位并且防止壳体区段相对于彼此进行角度旋转的键接合。例如，键接合可以包括壳体区段61、63中的每个壳体区段上的多个凸出部和凹陷表面，由此主壳体区段上的凸出部被收纳在前壳体区段上的凹陷表面处，并且前壳体区段的凸出部被收纳在主壳体区段上的凹陷表面处。为此，壳体区段61、63中的一个壳体区段上的凸出部将邻近于所述壳体区段中另一个壳体区段上的凸出部定位，从而大致防止一个壳体区段相对于另一个壳体区段旋转。主壳体区段61在主壳体区段的近侧上包含套筒部分69，所述套筒部分收纳扣管71的端部。主壳体区段61还通过紧固件75附接到托架或推进器框架73，以使马达43和齿轮组合件44在壳体41内移动。进一步地，将齿轮箱壳体55附接到推进器框架73的远端将马达43固定在推进器框架中，使得马达与推进器框架一起移动。前壳体区段63在前壳体区段的远侧上具有套筒部分77，所述套筒部分收纳用于围绕驱动组合件48安置的垫圈(未示出)。驱动器齿轮81附接到马达轴(未示出)，使得驱动器齿轮在马达43被激活时与马达轴一起旋转。从动齿轮83(图16)与驱动器齿轮81啮合，使得驱动器齿轮的旋转使从动齿轮在相反方向上旋转。驱动组合件48将从动齿轮83附接到驱动线圈12，使得从动齿轮的旋转使驱动线圈旋转。控制器50可以设置在手柄40中。控制器50可以被编程成控制导管的操作。
应当理解，在其它实施例中，其它适合的致动器(包含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)可以适合于选择性地致动马达。在一些实施例中，电源可以来自手柄40内所含有的电池(未示出)。电池可以为导丝检测电路提供电流源。在其它实施例中，电源可以来自外部源。
参考图17-22C，驱动组合件48包括收纳在从动齿轮83中的齿轮插入件85、收纳在齿轮插入件中的管插入件87和附接到管插入件的远端的锁89。在一个实施例中，齿轮插入件85压配合到从动齿轮83中。齿轮插入件85包括圆柱形构件，所述圆柱形构件具有沿所述圆柱形构件的长度延伸并且围绕所述圆柱形构件周向延伸的均匀外径。圆柱形构件的内表面包含多个周向间隔的通道91，所述多个周向间隔的通道沿圆柱形构件的长度延伸并且由此限定圆柱形构件的不均匀的内径。通道91从圆柱形构件的远端延伸到圆柱形构件的远端与近端之间的中间位置。在通道91的端部处的是环形凹部93。圆柱形构件的内表面在近端处逐渐变窄，从而形成环形肩部95以及近端处减小的内径。齿轮插入件85可以由任何适合的材料形成，包含但不限于不锈钢和Peek。在所展示的实施例中，齿轮插入件85与从动齿轮83分开形成。然而，齿轮插入件85可以与从动齿轮83一体地形成。
管插入件87包括管状构件，所述管状构件具有减小的外径近端边沿，从而在管插入件的近端附近形成肩部97。多个周向间隔的凸出部99沿管插入件87的远端边沿延伸。在所展示的实施例中，有四个凸出部99，各自具有三角形横截面。在不脱离本公开的范围的情况下，可以使用其它数量的凸出部99。突出部99在凸出部之间限定周向间隔的间隙101。管插入件87的外径的大小被设定成使得其可以被收纳在齿轮插入件85中。当管插入件87插入到齿轮插入件85中时，管插入件上的肩部97接合齿轮插入件中的肩部95，以提供用于将管插入件定位在齿轮插入件中的止挡件。当驱动线圈12和驱动组合件48被放置处于压缩状态时，硬止挡件将管插入件87保持在齿轮插入件85中的适当位置。管插入件87还限定纵向延伸通过管插入件并且其大小被设定成收纳驱动线圈12的通路。驱动线圈12如通过焊接固定地附接到管插入件87。管插入件87可以由任何适合的材料形成，包含但不限于不锈钢。齿轮插入件85和管插入件87可以一起广义地被认为是齿轮延伸部。齿轮延伸部可以包含齿轮插入件85和管插入件87两者或仅其中之一。
锁89包括管状部分105和从管状部分的近端凸出的多个指状件107。在所展示的实施例中，有四个指状件107。然而，在不脱离本公开的范围的情况下，可以使用其它数量的指状件107。指状件107中的每个指状件具有细长部分109和从细长部分远离锁89的中心轴线侧向凸出的钩部分111。在将管插入件87插入到齿轮插入件85中之前，通过将指状件107插入管插入件中的间隙101中而将锁89与管插入件接合(图20)。因此，当管插入件87插入到齿轮插入件85中时，指状件107将向内弯曲并沿着齿轮插入件中的通道91行进，直到所述指状件到达通道的端部处的环形凹部93，在所述环形凹部处，指状件然后被允许向外弯曲，使得钩部分111卡入到凹槽中以将锁89固定在齿轮插入件中。因此，锁89将驱动线圈12耦接到手柄40中的齿轮组合件44。这种配置提供了锁89与齿轮插入件85和管插入件87的重叠，这有助于更好地将旋转传递到驱动线圈12并允许驱动组合件48更好地承受施加到驱动组合件的扭矩。当驱动线圈12和驱动组合件被放置处于张紧状态时，锁89与齿轮插入件85之间的连接也将驱动组合件48保持在一起。锁89的管状部分105还限定其大小被设定成收纳驱动线圈12的通路。锁89可以由任何适合的材料形成，包含但不限于不锈钢和Peek。驱动组合件48的配置还允许通过将驱动组合件插入通过齿轮组合件的远端而将驱动组合件连接到齿轮组合件44。这会防止需要接近手柄40的近端或需要在常规自动卡盘机构的组装中所需的另外的部件。在所展示的实施例中，环形凹部93示出在齿轮插入件85中。然而，齿轮插入件85可以包含通道91的端部处的用于收纳锁89的钩部分111的多个离散的接受器。
在一个实施例中(图21)，钩部分111从细长部分109凸出，使得钩部分的齿轮插入件接合表面115从细长部分以钝角延伸。在这个实施例中，锁89可以通过在管状部分105上施加足够的拉力以将指状件107从齿轮插入件撤回而与齿轮插入件85脱离。然而，在使用期间，成角度的面使用从驱动线圈12通过管插入件87传送到锁89的拉力来向锁的卡扣特征提供额外的强度以实现拉力要求。在另一个实施例中(图22A)，齿轮插入件接合表面115A从指状件107A的细长部分109A正交延伸。在这个实施例中，齿轮插入件85A中的凹部93A可以在齿轮插入件的外表面处敞开，以允许工具插入到接受器中以将钩部分111A从接收器中释放。齿轮惰性件85A中的凹部93A的壁117A被配置成与指状件107A的齿轮插入件接合表面115A匹配，使得在锁89A与齿轮插入件85A之间形成良好的锁定连接。在图22B和22C中，钩部分111B具有第一区段119和第二区段121B，所述第一区段被配置成被收纳在齿轮插入件85B中的凹部93B中，所述第二区段被配置成在所述第一区段被收纳在接受器中时接合齿轮插入件中的通道91B。
进一步地，驱动组合件48使用于与驱动线圈12介接以将手柄40耦接到导管主体的组件的数量减少。驱动组合件48还能够通过仅需要通过齿轮箱55接近齿轮轴的远端来组装和拆卸驱动组合件。这意味着可以封闭手柄40以保护内部组件，如内部电子器件。另外地，驱动组合件48的设计有助于导管主体组件与手柄40解耦。因此，手柄40可以与另一个导管主体重新耦接和/或可以在手柄上执行任何重新加工任务。因此，在使用后，手柄40不必与导管主体一起被丢弃。
参考图14，传感器131可以安装到齿轮箱壳体55并且被配置成检测驱动器齿轮81的旋转。例如，传感器131可以向驱动器齿轮81的表面发射信号以检测驱动器齿轮的旋转。齿轮旋转可以用于确定马达43的可操作性。
参考图6、图7、图10B-12、图23和图24，行进护套接口组合件134安装在齿轮箱壳体55的前壳体区段63的远侧上并且将行进护套136固定在手柄40中。行进护套接口组合件134包括附接到齿轮箱壳体55的前壳体区段63的套筒部分77的远端的行进护套连接器142以及被收纳在套筒部分与行进护套连接器之间的密封件(例如，O形环)144。行进护套连接器142卡扣配合到齿轮箱壳体55的前壳体区段63的套筒部分77上。行进护套连接器142包含板部分154、从板部分的中心向近侧延伸的插入部分156以及在板部分的外周处也从板部分向近侧延伸的一对臂158。插入部分156限定收纳密封件144的环形凹槽160。每个臂158在其自由端部具有钩162。臂158沿套筒部分77的侧边延伸，并且钩162围绕套筒部分的侧边夹住，以通过卡扣配合接合将行进护套连接器142附接到套筒部分。钩162从臂158的纵向延伸部侧向向内凸出，使得钩的齿轮箱保持表面164与臂的纵向轴线成约45度角延伸。这有助于以足够的远侧拉力将行进护套连接器142从套筒部分77去除。每个臂158上的斜坡表面166与臂的纵向轴线成约30度角延伸，以有助于将行进护套连接器142附接到套筒部分77。斜坡表面166被配置成越过套筒部分77上的第一倾斜表面168。齿轮箱保持表面164沿套筒部分上的第二倾斜表面170向下滑动以将行进护套连接器142夹到套筒部分上。在行进护套连接器142附接到套筒部分77的情况下，O形环144向齿轮箱提供密封件。通路172延伸通过行进护套接口组合件134并且由齿轮箱壳体55的前壳体区段63的套筒部分77和行进护套连接器142中的对准的轴向孔限定。行进护套136固定地收纳在行进护套连接器142中的轴向孔中以将行进护套附接到行进护套接口组合件134。行进护套136的大小被设定成将驱动线圈12收纳在行进护套的内部并且从行进护套接口组合件134延伸到隔离护套接口组合件185。行进护套组合件134(包含行进护套136)对准并稳定驱动线圈12，使得驱动线圈的延伸在导管10的操作期间沿轴线维持。行进护套136可以被认为是行进护套组合件134的部件。
参考图1、图5B、图8和图25，滑动件或推进器45定位于手柄40上并且可操作地耦接到驱动线圈12以用于使驱动线圈相对于手柄移动，以推进和缩回驱动线圈和组织去除元件20。手柄40的壳体41可以限定狭槽186，所述狭槽限制滑动件45相对于手柄的移动。因此，狭槽的长度决定驱动线圈12与手柄40之间的相对移动量。在一个实施例中，狭槽的长度为约70mm(2.8英寸)。滑动件45可操作地附接到推进器框架73，使得滑动件的移动使推进器框架移动。推进器框架73包括弓形形状的主体，所述弓形形状的主体包含后区段137、中间区段139和前区段141。后区段137包含弓形部分142，所述弓形部分从框架73的第一侧大致延伸到框架的相反的第二侧和其中形成有开口145的板部分143。在所展示的实施例中，开口145是圆形的以用于收纳马达43的端部。中间区段139包含限定主体部分之间的敞开空间的多个周向间隔的主体部分147。前区段141包含从框架73的第一侧延伸到第二侧的弓形部分148。框架73的弓形形状的主体被配置成可滑动地收纳圆柱形形状的马达43，使得马达在马达的端部保持在后区段中的开口145内的情况下从前区段141延伸到后区段137。第一对轴承149(图8)分别在框架73的第一侧上安装在后和前区段137、141的底部处。轴承149位于中间壳体区段41B上的横挡151(图5B)上，使得轴承可以沿横挡滑动以有助于框架73在壳体41中移动。第二对轴承151(图8)分别在中间区段139和前区段141上安装在框架73的第二侧的顶部处。臂153从后区段137和中间区段139延伸并且具有安装在其上的轴承155。臂73上的轴承155(图8)接合顶部壳体区段41C的下侧以有助于框架73在壳体41中移动。
参考图3、图5A、图5B和图8-9B，模式选择器51包括由壳体41支撑的导向部分157、附接到导向部分并且可致动以相对于壳体移动导向部分的杠杆159以及可操作地连接到导向部分以用于使马达43基于导向部分的定位改变其操作状态的马达切换部分161。在所展示的实施例中，导向部分157位于中间壳体区段41B的底板163上并且相对于中间壳体区段枢转。也设想了模式选择器51与壳体41之间有助于模式选择器的相同或其它形式的移动的其它接合。在一个实施例中，杠杆159可致动以将马达43放置处于“待机模式”中，其中马达被停用并且导丝26被解锁，使得导丝可以相对于导管10移动。在一个实施例中，“待机模式”通过枢转杠杆159以接合壳体41上的止挡件169中的一个止挡件来启动。杠杆159可进一步致动以将马达43放置处于“轨道模式”中，其中马达被激活以产生第一输出并且导宽26保持解锁。第一马达输出可以是降低输出，其生成脉冲输出和/或驱动线圈12的相对较慢的旋转。“轨道模式”可以在导管10正在导航通过特别曲折的通路时被启动。在所展示的实施例中，“轨道模式”通过将杠杆159枢转到止挡件169之间的中间定位而被启动。杠杆159也可致动以将马达43放置处于“磨损模式”中，其中马达被激活以产生第二输出并且导丝26相对于导管10被锁定。第二马达输出可以是比第一输出增加的操作输出，使得驱动线圈12的相对高速的旋转实现。在一个实施例中，马达43产生约100,000RPM的旋转。“磨损模式”可以在导管10正在操作以将闭塞性组织从血管壁去除时启动。在一个实施例中，“磨损模式”通过枢转杠杆159以接合壳体41上的止挡件169中的另一个止挡件来启动。杠杆159移动到这个定位还将使锁定销173压靠导丝26，从而将导丝锁定在适当位置。
导丝锁49(图8-9B)可以设置在手柄40中以将导丝26相对于手柄锁定在适当位置。导丝锁49包括保持在中间壳体区段41B中的锁定销173和围绕锁定销收纳的弹簧175。锁定销173的头部接合模式选择器51的导向部分157的下侧。弹簧175将锁定销偏置远离导丝26。导向部分157的下侧包含第一区段179、从所述第一区段延伸的斜坡区段181以及第二区段183，所述第二区段从斜坡区段延伸使得所述第二区段在所述第一区段下面凹陷。在所展示的实施例中，当模式选择器在不同定位之间移动时，锁定销173的头部被定位成由导向部分157的下侧上的区段179、181、183接合。例如，模式选择器51移动到第一定位使锁定销173的头部与升高的第一区段179相对，从而允许弹簧175自由地压靠锁定销的头部以间隔锁定销的轴不接合导丝26，因此允许导丝相对于导管10移动。模式选择器51移动到第二定位使锁定销173的头部与凹陷的第二区段183相对，从而使导向部分157抵抗弹簧175的偏置下压在锁定销173上，从而使锁定销向下移动以使轴与导丝26摩擦接合以将导丝26锁定在适当位置。在一个实施例中，当模式选择器51移动以将导管10放置处于磨损模式中时，导丝锁49接合导丝26以将导丝锁定在适当位置。
参考图29-34，隔离护套接口组合件185安置在手柄40的远端处。组合件185包括接口壳体187、收纳在接口壳体的近端部分191中的密封件(例如，O形环)189以及附接到接口壳体的近端以将密封件保持到接口壳体的保持器193。保持器193包含板部分195以及从板部分向远侧延伸的一对臂197。每个臂197在其自由端部具有钩199。臂197沿接口壳体187的近端部分191的侧边延伸，并且钩199围绕近端部分的远端夹住，以通过卡扣配合接合将保持器193附接到接口壳体。在保持器193附接到接口壳体187的情况下，板部分195接合密封件189以将密封件保持在适当位置。接口壳体187进一步包含在壳体的顶部上的被收纳在壳体41的中间区段41B中的狭槽203中的第一接片201，以及在壳体的底部上并被收纳在壳体的底部区段41A中的狭槽207中的第二接片205、近端部分191和安置在中间壳体区段41A与底部壳体区段41B之间的远端部分209。接口壳体187的接片201、205和远端部分209与壳体41的接合将隔离护套接口组合件185安装到壳体。远端部分209还延伸到安装在隔离护套22的近端上的毂52中的通路中以将毂附接到手柄40。毂52在壳体41的远端与从壳体延伸的导管组件之间的接合部处提供应变消除功能。
接口壳体187还限定从接口壳体的近端延伸到接口壳体的远端的纵向通路211。纵向通路211将行进护套136和驱动线圈12收纳在接口壳体的近端处，并且驱动线圈完全延伸通过壳体到壳体的远端。密封件189也被收纳在纵向通路211中并且围绕行进护套136延伸，以提供流体密封以抵抗流体向近侧行进经过密封件。纵向通路211还将隔离护套22收纳在接口壳体187的远端处，并且隔离护套延伸到接口壳体的近端与远端之间的中间位置。横向通路213从纵向通路211延伸到接口壳体187中的横向开口215。接口壳体187还限定用于在驱动线圈12和隔离护套22之间递送流体(例如，盐水)的灌注端口46。横向通路213延伸通过灌注端口46并且因此将灌注流体连通到纵向通路211。因此，通过端口46的横向通路213同隔离护套22与驱动线圈12之间的空间连通，以用于将流体递送到旋转的驱动线圈。在一个实施例中，微型泵217(图8和9A)可以连接到流体(例如，盐水)袋，以用于通过装管将流体泵送到灌注端口。壳体41中的近侧端口47(图1、3和4)允许导丝26穿过手柄40的近端。
参考图1和27，隔离护套22包括管状套筒，所述管状套筒被配置成将体腔内的受试者的动脉组织与旋转的驱动线圈12隔离并保护所述动脉组织。隔离护套22在护套的近端处固定到手柄40并且不旋转。隔离护套接口组合件185将护套附接到手柄40。护套22被收纳在接口壳体187的远端部分209中以将护套附接到手柄。隔离护套22为驱动线圈12和内衬套14提供部分包围以在护套内移动。隔离护套22的内径的大小被设定成为驱动线圈12提供余隙。隔离护套22与驱动线圈12之间的空间允许驱动线圈在护套内旋转并在护套与驱动线圈之间提供用于盐水灌注的区域。隔离护套22的外径的大小被设定成提供与导向导管(未示出)的内径的余隙，以用于将导管10递送到体腔中的期望位置。在一个实施例中，隔离护套22的内径为约0.050英寸(1.27mm)，外径为约0.055英寸(1.4mm)并且长度为约1500mm(59英寸)。在不脱离本公开的范围的情况下，隔离护套22可以具有其它尺寸。在一个实施例中，隔离护套22由聚四氟乙烯(PTFE)制成。可替代地，隔离护套22可以包括多层构造。例如，隔离护套22可以包括全氟烷氧(PFA)内层、中间编织线层和Pebax外层。
参考图1、26和27，驱动线圈12可以包括管状不锈钢线圈，所述管状不锈钢线圈被配置成将旋转和扭矩从马达43传递到组织去除元件20。将驱动线圈12配置为盘绕结构为驱动线圈提供了有助于导管10递送通过体腔的柔性。另外，当导管10横越弯曲路径时，线圈配置允许驱动线圈12的旋转和扭矩施加到组织去除元件20。驱动线圈12的硬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到组织去除元件20的能力。在一个实施例中，驱动线圈12相对较硬，使得线圈的轴向压缩和延伸在导管10移动通过体腔期间被最小化。驱动线圈12的线圈配置还被配置成在线圈旋转时扩展其内径，使得驱动线圈在导管10的操作期间保持与内衬套14间隔。在一个实施例中，驱动线圈12的内径为约0.023英寸(0.6mm)并且外径为约0.035英寸(0.9mm)的。驱动线圈12可以具有单层构造。例如，驱动线圈可以包括具有约30度的捻角的7丝线(即，导线)线圈。可替代地，在不脱离本公开的范围的情况下，驱动线圈12可以由多层配置。例如，驱动线圈12可以包括基础线圈层和安置在基础层之上的夹套(例如，TecothaneTM)。在一个实施例中，驱动线圈包括具有约45度的捻角的15丝线线圈。TecothaneTM夹套可以安置在线圈之上。可替代地，驱动线圈12可以包括双线圈层配置，所述双线圈层配置还包含在两个线圈层之上的另外的夹套层。例如，驱动线圈可以包括包括具有约45度的捻角的15丝线线圈的内线圈层以及包括具有约10度的捻角的19丝线线圈的外线圈层。还设想了具有其它配置的驱动线圈。
参考图1和图26-28，内衬套14包括多层管状主体，所述多层管状主体被配置成将导丝26与驱动线圈12和组织去除元件20隔离。内衬套14可延伸通过手柄40从手柄内的定位到手柄远侧的定位。在一个实施例中，内衬套14耦接到手柄40内的组件，但不固定地附接到壳体41，以允许内衬套相对于壳体平移。内衬套14的内径的大小被设定成可以经过导丝26。内衬套14通过将导丝与可旋转驱动线圈隔离来保护导丝免于因驱动线圈12的旋转而损坏。内衬套14还可以延伸经过组织去除元件20以保护导丝26免受旋转的组织去除元件的影响。因此，内衬套14被配置成防止导丝26与导管10的旋转组件之间的任何接触。因此，内衬套14消除了任何金属与金属的接合。驱动线圈12和组织去除元件20与导丝26的这种隔离还确保驱动线圈和组织去除元件的旋转不会被传递或传送到导丝。因此，标准导丝26可以与导管10一起使用，因为导丝不必被配置成承受旋转组件的扭转效应。另外地，通过延伸通过组织去除元件20并经过组织去除元件的远端，内衬套14通过提供用于使组织去除元件绕内衬套旋转的中心轴线来稳定组织去除元件。
在所展示的实施例中，内衬套14包括内PTFE层60、包含不锈钢的中间编织层62以及聚酰亚胺外层64。PTFE内层60为内衬套14提供了润滑内部，这有助于导丝26穿过内衬套。编织不锈钢中间层62为内衬套14提供了刚度和强度，使得衬套能够承受由驱动线圈12施加在内衬套上的扭转力。在一个实施例中，中间层62由304不锈钢形成。聚酰亚胺外层64提供耐磨性以及具有减少内衬套14与驱动线圈12之间的摩擦的润滑质量。另外地，润滑膜(如硅树脂)可以添加到内衬套14以减少内衬套与驱动线圈12之间的摩擦。在一个实施例中，内衬套14的内径ID为约0.016英寸(0.4mm)，外径OD为约0.019英寸(0.5mm)并且长度为约59英寸(1500mm)。内衬套14的内径ID为标准0.014英寸导丝26提供了余隙。内衬套14的外径OD为驱动线圈12和组织去除元件20提供了余隙。在内衬套14和驱动线圈12之间具有空间减少了两个组件之间的摩擦并且允许组件之间的盐水灌注。
参考图35-39，衬套键221附接到衬套14的近端并且被收纳在固定地安装在手柄40中的导向管223中。衬套14和衬套键221可以广义地为衬套组合件224。衬套键221和导向管223之间的接合允许衬套键和衬套14相对于导向管平移，但防止衬套键和衬套相对于导向管旋转。衬套键221包括半圆柱形构件225和从半圆柱形构件的远端向远侧延伸的细长管状构件227。通道229延伸通过衬套键221。通道229在半圆柱形构件中形成的内径D1为约0.8mm并且在管状构件中形成的内径D2为约0.55mm。在一个实施例中，半圆柱形构件225的长度L介于约6mm与约8mm之间。在一个实施例中，半圆柱形构件225的长度L为约7mm。衬套14的近端被收纳和保持在细长管状构件227中的通道229的区段中。衬套14可以通过任何适合的方式(包含但不限于胶水、热结合和机械结合)保持在衬套键221中。衬套14的近端坐靠衬套键221中的底板231以将衬套定位于衬套键中。因此，衬套键221和衬套14彼此共同平移。在所展示的实施例中，导向管223具有圆形通路223。可替代地，导向管223可以具有由顶部和底部弯曲壁区段以及在顶部壁区段与底部壁区段之间延伸的一对侧平面壁区段限定的非圆形内部通路。
半圆柱形构件225包括一对顶部和底部弯曲表面239和一对相对的平坦表面241，使得导向管和衬套键221的尺寸防止相对旋转。在一个实施例中，在半圆柱形构件225的平台表面241之间延伸的宽度W1为约1.4mm，并且在顶部弯曲表面与底部弯曲表面239之间延伸的高度H1为约1.7mm。在一个实施例中，导向管223的内部通路的直径D3为约1.74mm。可替代地，在其中导向管包含侧平面壁区段的实施例中，导向管223的内部通路233的宽度可以为约1.5mm，并且高度可以为约1.74mm。因此，内部通路233提供了足够的余隙来收纳衬套键221以使导向管中的衬套键进行轴向移动，但不允许所述衬套键旋转移动。衬套键221和导向管223的配置还减少了推进和缩回衬套期间衬套14上的摩擦。在一个实施例中，允许至少约70mm的轴向平移。衬套键221的配置还通过允许键插入通过齿轮箱壳体55来有助于手柄40的组装。
可以设想，衬套键221和导向管223可以具有允许相对平移和防止相对旋转的过度配置。例如，衬套键221可以是大致矩形的，并且导向管223可以具有匹配的矩形内部通路。在本公开的范围内还设想了仍其它配置。进一步地，任何适合的材料都可以用于衬套键221和导向管223。例如，衬套键221可由Peek、聚甲醛(POM)或聚碳酸酯(PC)形成。内衬套14和衬套键221可以广义地被认为是衬套键组合件。
参考图7、11和12，手柄40在手柄的内部组件和延伸通过手柄的纵向延伸的导管组件(广义上，导管主体组合件)之间提供四个接触或接口位置。第一接口251在衬套组合件224与导向管223之间出现。第二接口253在驱动线圈12与驱动组合件48之间出现。第三接口255在驱动线圈与行进护套接口组合件134之间出现。第四接口257在隔离护套22与隔离护套接口组合件185之间出现。应当理解，手柄40的内部组件可以在其它位置处与导管主体组合件介接。
接口251、253、255、257沿导管组件的纵向延伸轴向对准。当导管主体组合件穿过手柄40时，接口251、253、255、257为导管主体组合件提供对准和稳定性。具体地，衬套键组合件224与导向管223之间的第一接口251对准并稳定衬套14。这有助于防止衬套14在衬套14在手柄40中移动期间压曲。因此，衬套14的延伸维持沿线性轴线。进一步地，第二接口253将驱动线圈12稳定在壳体40内。因此，驱动线圈12的延伸在驱动线圈旋转期间维持绕线性轴线，所述线性轴线大致平行于衬套14的延伸的轴线并与其重合。因此，在导管10的整个操作过程中维持驱动线圈12与衬套14之间的间距，使得衬套适当地庇护导丝26免受旋转的驱动线圈12的影响。第三接口255在驱动线圈延伸通过行进护套接口组合件134的整个过程中稳定并保持驱动线圈12对准。因此，驱动线圈的线性延伸维持沿手柄40的远侧部分。第四接口257用于稳定驱动线圈12以及隔离护套22以在旋转期间维持驱动线圈与内衬套14对准。
参考图1、2和26，组织去除元件20沿纵向轴线LA从邻近驱动线圈12的远端部分的近端延伸到相对的远端。组织去除元件20可操作地连接到马达43以被马达旋转。当导管10插入到体腔中并且马达43正在旋转组织去除元件20时(例如，处于磨损模式中)，组织去除元件被配置成去除体腔中的闭塞性组织以将组织与体腔的壁分开。在一个或多个实施例中，可以使用用于在其旋转时去除体腔中的组织的任何适合的组织去除元件。在一个实施例中，组织去除元件20包括磨损性毛刺，所述磨损性毛刺被配置成当马达43旋转磨损性毛刺时磨损体腔中的组织。磨损性毛刺20可以具有例如通过金刚石砂砾涂层、表面蚀刻等形成的磨损性外表面。在一个实施例中，组织去除元件包括不锈钢球状体，其外表面包含5μm的暴露的金刚石晶体。组织去除元件20也可以是不透射线的，以允许组织去除元件在荧光镜检查下可见。在其它实施例中，组织去除元件可以包括具有光滑或锯齿状切割边缘的一个或多个切割元件、浸渍器、血栓切除导线等。
参考图1和2，为了去除受试者的体腔中的组织，从业者将导丝26插入到受试者的体腔中到达要去除的组织远侧的位置。随后，从业者将导丝26的近端部分插入通过内衬套14的导丝管腔24并通过手柄40，使得导丝延伸通过手柄中的近侧端口47。在导管10装载到导丝26上的情况下，从业者沿导丝推进导管，直到组织去除元件20被定位靠近且邻近组织为止。最初，导管10可以通过模式选择器51的致动被放置处于“待机”模式中。在这个模式下，马达43被停用并且导丝26被解锁，使得导管10可以相对于导丝移动。当导管10横穿身体时，模式选择器51可以移动到“轨道模式”，其中马达43被激活以产生第一输出并且导丝26保持解锁。组织去除元件20在马达43的第一输出处缓慢旋转可能有利于导引导管10通过曲折路径。当组织去除元件20被定位靠近且邻近组织时，可以操作模式选择器51以将导管10放置处于“磨损模式”，以在第二输出处操作马达43以使驱动线圈12和安装在驱动线圈上的组织去除元件以较高的速率旋转，以用于磨损(或以其它方式去除)体腔中的组织。这也将导丝26锁定在适当位置。当组织去除元件20旋转时，从业者可以选择性地将驱动线圈12沿导丝26向远侧移动，以磨损组织并且例如增加通过体腔的通路的大小。从业者还可以将驱动线圈12沿导丝26向近侧移动，并且可以在远侧和近侧方向上重复地移动组件，以获得组织去除元件20跨组织的来回运动。在磨损过程中，内衬套14将导丝26与旋转的驱动线圈12和组织去除元件20隔离，以保护导丝免于因旋转的组件而损坏。因此，内衬套14被配置成承受旋转的驱动线圈12和组织去除元件20的扭转和摩擦效应，而不将这些效应传递到导丝26。当从业者完成使用导管10时，可以通过将导管沿导丝向近侧滑动而将导管从体腔中撤回并从导丝26卸载。用于磨损过程的导丝26可以保持在体腔中以用于随后的程序。
参考图40-74，另一个实施例的手柄通常以40'指示。手柄40'与先前实施例的手柄40类似并且操作方式与手柄40大致相同。例如，手柄40'也在手柄的内部组件和延伸通过手柄的纵向延伸的导管主体组合件10之间提供四个接触或接口点。因此，当导管主体组合件10穿过手柄40时，手柄40'为所述导管主体组合件提供对准和稳定性。然而，壳体40'的内部组件的具体配置在一些方面不同于壳体的内部组件。下面讨论了壳体40'的内部组件的细节。
参考图40-42，手柄40'包括支撑手柄的组件的壳体41'，并且包含固定在一起以围封手柄的内部组件的多个壳体区段。模式选择器51'安装在壳体41'中并且限定壳体的一部分。如在较早的实施例中，模式选择器51'被配置成以多种模式选择性地放置导管10并且将导丝锁定在适当的位置。
参考图43-50和图52，马达43'通过支撑在壳体41'内的齿轮组合件44'和驱动组合件48'耦接到驱动线圈12。齿轮组合件44包括齿轮箱壳体55'，所述齿轮箱壳体安装并且至少部分地围封一对齿轮，以将马达43'的轴124'的旋转传递到驱动线圈12。齿轮箱壳体55'包含后壳体区段61'和前壳体区段63'，所述前壳体区段与所述后壳体区段一体地形成，使得齿轮箱壳体包括单个壳体结构。后壳体区段61'包含在后壳体区段的近侧上的收纳马达43'的远端部分的马达套筒120'以及在后壳体区段的近侧上的收纳扣管71'的远端部分和导向管223'上的远端止挡件122'的管套筒部分69'(图66)。后壳体区段61还通过紧固件75附接到托架或推进器框架73'，以使马达43'和齿轮组合件44'在壳体41'内移动。前壳体区段63'具有收纳驱动组合件48'的一部分的远侧套筒部分77'(图55)。驱动器齿轮81'附接到马达轴124'(图49)，使得驱动器齿轮在马达43'被激活时与马达轴一起旋转。在一个实施例中，驱动器齿轮81'压配合到马达轴124'上。从动齿轮83(图55)与驱动器齿轮81啮合，使得驱动器齿轮的旋转使从动齿轮在相反方向上旋转。驱动组合件48'将从动齿轮83'附接到驱动线圈12，使得从动齿轮的旋转使驱动线圈旋转。
参考图57-63，驱动组合件48'包括延伸通过从动齿轮83'的齿轮插入件85'(广义地，齿轮延伸部)和收纳在齿轮插入件的远端中的锁89'。在一个实施例中，齿轮插入件85'压配合到从动齿轮83'中。可替代地，齿轮插入件85'可以与从动齿轮83'一体地形成。齿轮插入件85'具有延伸通过从动齿轮83'并从从动齿轮向近侧延伸的近侧部分130'以及从从动齿轮向远侧延伸的远侧部分132'。近侧部分130包括具有沿其长度延伸的均匀外径的圆柱形构件。近侧部分130的内部空间134'(图60)具有大致矩形的横截面。远侧部分132'包括限定四个平面侧的中空矩形凸出部。所述侧中的每个侧中的开口135'与远侧部分132'的内部连通。四个侧的内部侧上的斜坡表面138'从远侧部分132'的远端延伸到远侧部分中的相应的轴向表面140'。开口135'延伸通过轴向表面140'。齿轮插入件85'可以由任何适合的材料形成，包含但不限于不锈钢和Peek。
锁89'包括基座部分105'、从基座部分的远端凸出的一对臂106'和从臂的远端侧向凸出的指状件107'。基座部分105'具有大致矩形的横截面。在所展示的实施例中，有两个臂106'，每个臂具有从其延伸的两个指状件107'。然而，在不脱离本公开的范围的情况下，可以使用其它数量的臂106'和指状件107'。指状件107'中的每个指状件具有细长部分109'和从细长部分远离锁89'的中心轴线侧向凸出的钩部分111'。在所展示的实施例中，钩部分111'从细长部分109'正交凸出。每个臂106'上的钩部分111'在沿相反方向上延伸。斜坡112'(广义上，锁扣)从指状件107'之间的臂106'侧向向外延伸。锁89'可以由任何适合的材料形成，包含但不限于不锈钢。
锁89'的基座部分105'插入到齿轮插入件85'的远侧部分132'和内部空间134'中以将锁固定到齿轮插入件。当锁89'插入到齿轮插入件85'中时，锁上的斜坡112'将接合齿轮插入件中的斜坡表面138'，从而使臂106'向内弯曲，从而允许锁进一步插入到齿轮插入件中，直到斜坡被收纳在齿轮插入件中的相应的开口135'中。斜坡112'的远端表面与开口135'的边缘相对，从而防止锁被拉回出齿轮插入件85'。在锁89'完全插入的情况下，指状件107的钩部分111'与齿轮插入件85'的远端相对。当驱动线圈12和驱动组合件48'被放置处于压缩状态时，钩部分111'与齿轮插入件85'的远端之间的接合将锁89'保持在齿轮插入件85'中的适当位置。当驱动线圈12和驱动组合件被放置处于张紧状态时，锁89'上的斜坡112'与齿轮插入件85'之间的连接也将驱动组合件48'保持在一起。虽然在所展示的实施例中示出了斜坡112'，但是可以设想可以使用具有其它配置的锁扣。例如，可以使用没有倾斜的斜坡表面的凸出部，如矩形凸出部。在本公开的范围内还设想了仍其它锁扣配置。轴承146'(图54和55)围绕齿轮插入件85'的近侧部分130'安置。轴承146'为旋转的齿轮组合件48'提供另外的稳定性。基座部分105'的近端上的凸出部150'(广义地，焊接特征)提供用于将锁89'焊接到驱动线圈12的表面。
与先前的实施例类似，这种配置提供了锁89'与齿轮插入件85'的重叠，这有助于更好地将旋转传递到驱动线圈12并允许驱动组合件48'更好地承受施加到驱动组合件的扭矩。当驱动线圈12和驱动组合件被放置处于张紧状态时，锁89'和齿轮插入件85'之间的连接也将驱动组合件48'保持在一起。进一步地，齿轮插入件85'的内部空间134'的矩形横截面收纳焊接到驱动线圈12的锁89'的矩形基座部分105'。因此，锁89'与和齿轮插入件85'之间的接合防止组件的相对旋转，这提供了从从动齿轮83'到驱动线圈12的更好的扭矩传递。在一个实施例中，锁89'由不锈钢形成。然而，在不脱离本公开的范围的情况下，可以使用其它适合的材料。
另外地，驱动组合件48'甚至进一步使用于与驱动线圈12介接以将手柄40'耦接到导管主体的组件的数量进一步减少。驱动组合件48'还能够通过仅需要通过齿轮箱壳体55'接近齿轮轴的远端来组装和拆卸驱动组合件。
参考图64和65，衬套键221'附接到衬套14的近端并且被收纳在固定地安装在手柄40中的导向管223'中。正如在先前的实施例中，衬套键221'与导向管223'之间的接合允许衬套键和衬套14相对于导向管平移，但防止衬套键和衬套相对于导向管旋转。衬套键221'包括矩形构件225'和从矩形构件的远端向远侧延伸的细长管状构件227'。衬套14的近端被收纳和保持在细长管状构件227'中。衬套14可以通过任何适合的方式(包含但不限于胶水、热结合和机械结合)保持在衬套键221中。因此，衬套键221'和衬套14彼此共同平移。在所展示的实施例中，导向管223'具有矩形通路252'，使得导向管和衬套键221'的尺寸防止相对旋转。衬套键221'和导向管223'的配置还减少了推进和缩回衬套期间衬套14上的摩擦。可替代地，导向管223'可具有大致圆形的内部通路。衬套键221'的配置还通过允许键插入通过齿轮箱壳体55'来有助于手柄40'的组装。可以设想，衬套键221'和导向管223'可以具有允许相对平移和防止相对旋转的其它配置。进一步地，任何适合的材料都可以用于衬套键221'和导向管223'。例如，衬套键221可由Peek、聚甲醛(POM)或聚碳酸酯(PC)形成。内衬套14和衬套键221'可以广义地被认为是衬套组合件224'。
参考图47、50和51，导丝端口47'安装在导向管223'的近端上。导丝端口47'在手柄40'中提供结构以在手柄的近端处支撑导丝。导丝端口47'限定导丝26延伸穿过的轴向通路152'。导丝端口47'还限定开口165'，所述开口经过将导丝锁定在适当位置的锁定销173'。导丝端口47'的远端上的凸缘167'邻接导向管223'的近端，从而覆盖导向管的近侧开口的至少一部分。因此，凸缘167'防止衬套键221'从导向管223'的近端撤回。通过导丝端口47'的通路152'将手柄40'的外部与导向管223'的内部连通。因此，导丝端口47'有助于从手柄40'的近端冲洗衬套14。另外，导向管223'与衬套键221'之间的更紧密的公差有助于将冲洗流体引导到衬套14。
参考图47、54和66-72，远端止挡件122'附接到导向管223'的远端。在一个实施例中，远端止挡件122'压配合到导向管223'的远端的外表面上。然而，远端止挡件122'可以通过任何适合的方式附接到导向管223'。远端止挡件122'限制衬套键221'移出从导向管223'的远端，并且被配置成允许衬套键以任何进入角度进入远端止挡件。远端止挡件122'还使导向管223'在扣管71'内居中，所述扣管进而使衬套14在驱动线圈12内居中并对准。因此，防止衬套14因驱动线圈12围绕衬套旋转而损坏。
远端止挡件122'包括细长构件，所述细长构件具有限定四个平面侧表面174'的大致矩形形状。细长构件的拐角被截短，从而限定连接相邻侧表面174'的四个成角度的拐角表面176'。远端止挡件122'包含近侧部分178'和从近侧部分向远侧延伸的远侧部分180'。在所展示的实施例中，内部肋182'沿近侧部分178'的内部延伸。内部肋182'提供用于将导向管223'压配合在远端止挡件122'中的接合表面。近侧部分178'限定远端止挡件122'的基座并且远侧部分180'包括从基座延伸的多个延伸臂。一对顶部和底部臂184A'在远侧部分180'的约中间宽度处居中并且仅沿远侧部分的宽度的一部分侧向延伸。支撑延伸部190'从顶部和底部臂184A'的侧边在相反方向上侧向延伸到远侧部分180'的相对侧。支撑延伸部190'向顶部和底部臂提供结构刚度。一对侧臂184B'在远侧部分180'的约中间高度处居中并且仅沿远侧部分的高度的一部分侧向延伸。因此，纵向间隙在侧臂184B'与顶部和底部臂184A'之间延伸。臂184A'、184B'的自由端部径向向内凸出并且一起限定远端止挡件122'内的内部端表面192'。衬套键221'被配置成在衬套14在手柄40'中向远侧移动时接合内部端表面192'，从而防止衬套键移出导向管223'。每个臂184A'、184B'还包含从内部端表面192'径向向外逐渐变窄的成角度的入口表面194'。成角度的表面194'在远端止挡件122'的远端处提供入口引导，使得在组装期间，衬套键221'可以以任何角度插入到远端止挡件的远端中以将衬套组合件224'固定到导向管223'和远端止挡件。侧臂184B'被配置成向外弯曲以提供用于插入衬套键221'的余隙。一旦衬套键221'的矩形构件225'插入经过侧臂184B的自由端部，臂将弯曲回到其自然状态，从而将衬套键捕获在远端止挡件122'内并防止衬套键被拉回出远端止挡件的远端。
外肋196'沿远端止挡件122'的顶部和底部纵向延伸。每个外肋196'分别沿顶部和底部臂184A从近侧部分178'延伸到远侧部分180'。在所展示的实施例中，外肋196'具有圆形外表面。旋钮198'安置在拐角表面176'上，大致位于近侧部分178'与远侧部分180'之间。在所展示的实施例中，旋钮198'是圆顶形状的，使得它们也具有圆形的外表面。旋钮198'和外肋196'提供具有提供与扣管71'的内径的紧密公差的有效直径的有效圆形轮廓，以将远端止挡件122'在扣管内居中，并且由此使衬套键221'和衬套14在扣管内居中。因此，衬套14将在驱动线圈12内居中，从而防止衬套因驱动线圈围绕衬套旋转而损坏。应当理解，在不脱离本公开的范围的情况下，远端止挡件122'可以具有过度形状。另外地或可替代地，导向管223'的长度可以使得防止衬套14和衬套键221'在手柄20中的移动将衬套键带出导向管223'和/或与接合导丝端口47'和远端止挡件122'。
参考图47、图49、图52和图54-56，行进护套接口组合件134'安装在齿轮箱壳体55'的前壳体区段63'的远侧上并且将行进护套136'固定在手柄40中。因此，行进护套接口组合件134'将行进护套136'连接到齿轮箱壳体55'，使得行进护套随齿轮箱壳体移动。行进护套接口组合件134'还在推进和缩回导管组件期间提供灌注密封。
行进护套接口组合件134'包括附接到齿轮箱壳体55'的前壳体区段63'的远侧套筒部分77'的远端的行进护套连接器142'。行进护套连接器142'包含板部分154'以及在板部分的外周处从板部分向近侧延伸的一对臂158'。行进护套连接器142'卡扣配合到齿轮箱壳体55'的前壳体区段63'的远侧套筒部分77'上。这有助于以足够的远侧拉力将行进护套连接器142'从远侧套筒部分77'去除。通路172'延伸通过行进护套接口组合件134并收纳行进护套136'。行进护套136'的大小被设定成将驱动线圈12收纳在行进护套的内部并且从行进护套接口组合件134'延伸到隔离护套接口组合件185'。行进护套136'保护驱动线圈12并在旋转期间保持线圈轴向对准。在一个实施例中，行进护套连接器142'包覆模制在行进护套136上。
参考图46、图47-50、图53、图56、图73和图74，隔离护套接口组合件185'安置在手柄40'的远端处。组合件185'包括接口壳体187'、收纳在接口壳体的近端部分191'中的凸缘密封件189'以及附接到接口壳体的近端以将密封件保持到接口壳体的保持器193'。保持器193'包含板部分195'以及从板部分向远侧延伸的一对臂197'。每个臂197'在其自由端部具有钩199'。臂197'沿接口壳体187'的近端部分191'的侧边延伸，并且钩199'围绕近端部分的远端夹住，以通过卡扣配合接合将保持器193'附接到接口壳体。接口壳体187'进一步包含在壳体的顶部上的被收纳在壳体41'中的狭槽203'中的接片201'。接口壳体187'进一步包含延伸通过壳体41'的远端的远端部分209'。接口壳体187'的接片201'和远端部分209'与手柄40'的壳体41'的接合将隔离护套接口组合件185'安装到手柄。远端部分209'还延伸到安装在隔离护套22的近端上的毂52中的通路中以将毂附接到手柄40'。壳体41'与接口壳体187'之间的接合要求接口壳体在手柄40'的壳体组件可以连接在一起之前正确地坐置在手柄的壳体41'内。
接口壳体187'还限定从接口壳体的近端延伸到接口壳体的远端的纵向通路211'。纵向通路211'将行进护套136'和驱动线圈12收纳在接口壳体的近端处，并且驱动线圈完全延伸通过壳体到壳体的远端。纵向通路211'还将隔离护套22收纳在接口壳体187'的远端处，并且隔离护套延伸到接口壳体的近端与远端之间的中间位置。横向通路213'从纵向通路211延伸到接口壳体187'中的横向开口215'。接口壳体187'还限定用于在驱动线圈12和隔离护套22之间递送流体(例如，盐水)的灌注端口46'。横向通路213'延伸通过灌注端口46并且因此将灌注流体连通到纵向通路211'。因此，通过端口46'的横向通路213'同隔离护套22与驱动线圈12之间的空间连通，以用于将流体递送到旋转驱动线圈。在一个实施例中，微型泵217'(图42和47)可以连接到流体(例如，盐水)袋，以用于通过装管200'将流体泵送到灌注端口。在所展示的实施例中，护套22、毂52和接口壳体187'是分开形成的。在一个实施例中，隔离护套22、毂52和接口壳体187'形成为一个整体单元，如通过包覆模制。
当介绍本发明或其一个或多个实施例的元件时，冠词“一个(a)”、“一种(an)”、“所述(the)”和“所述(said)”旨在表示存在元件中的一个或多个元件。术语“包括”、“包含”和“具有”旨在为包含性的并且意味着可存在除所列元件之外的额外元件。
由于在不脱离本发明的范围的情况下可以在以上设备、系统和方法中进行各种改变，因此旨在以上描述中所含有的以及在附图中所示出的所有内容应被解释为说明性的而非限制性的含义。

Claims (20)

1.一种用于去除体腔中的组织的组织去除导管，所述组织去除导管包括：
导管主体组合件，所述导管主体组合件具有轴线以及沿所述轴线彼此间隔开的近端部分和远端部分，所述导管主体组合件的至少一部分的大小和形状被设定成收纳在所述体腔中；
手柄，所述手柄安装到所述导管主体组合件的所述近端部分并且能够操作以使所述导管主体组合件旋转，所述手柄包含与所述导管主体组合件介接的内部手柄组件，所述内部手柄组件提供沿所述导管主体组合件轴向间隔的至少四个接口位置；以及
组织去除元件，所述组织去除元件安装在所述导管主体组合件的所述远端部分上，所述组织去除元件被配置成在所述组织去除元件通过所述体腔内的所述导管主体组合件旋转时去除所述组织。
2.根据权利要求1所述的组织去除导管，其中所述导管主体组合件包含细长主体、内衬套组合件以及隔离护套，所述细长主体的大小和形状被设定成收纳在所述体腔内，所述内衬套组合件的一部分被收纳在所述细长主体内并且限定导丝管腔，所述隔离护套围绕所述细长主体的区段安置，所述内部手柄组件与所述导管主体组合件的所述内衬套组合件、所述细长主体和所述隔离护套介接。
3.根据权利要求2所述的组织去除导管，其中所述内部手柄组件包括导向管、驱动组合件、行进护套接口组合件以及隔离护套接口组合件，所述导向管与所述内衬套组合件介接，所述驱动组合件与所述细长主体介接，所述行进护套接口组合件与所述细长主体介接，所述隔离护套接口组合件与所述隔离护套介接。
4.根据权利要求3所述的组织去除导管，其进一步包括所述手柄中的齿轮组合件，其中所述驱动组合件包括从所述齿轮组合件延伸的齿轮延伸部以及固定到所述齿轮延伸部的锁，所述驱动组合件被配置成将旋转从所述齿轮传递到所述细长主体。
5.根据权利要求4所述的组织去除导管，其中所述行进护套接口组合件包括连接器以及行进护套，所述行进护套固定地附接到所述连接器并且围绕所述细长主体延伸。
6.根据权利要求5所述的组织去除导管，其进一步包括齿轮壳体，所述齿轮壳体围封所述齿轮组合件的至少一部分，所述连接器附接到所述齿轮壳体。
7.根据权利要求3所述的组织去除导管，其中所述隔离护套接口组合件包括接口壳体，所述接口壳体收纳所述隔离护套的近端。
8.根据权利要求3所述的组织去除导管，其中所述内衬套组合件包括内衬套以及衬套键，所述衬套键附接到所述内衬套的近端，所述导向管以非旋转的滑动接合方式收纳所述衬套键。
9.根据权利要求8所述的组织去除导管，其进一步包括远端止挡件，所述远端止挡件附接到所述导向管的远端，以限制所述内衬套组合件移出所述导向管。
10.一种用于去除体腔中的组织的组织去除导管的手柄，所述手柄能够操作以使所述组织去除导管的导管主体组合件旋转，所述手柄包括壳体以及所述壳体内的内部组件，所述内部组件被配置成与所述导管主体组合件介接，所述内部手柄组件提供沿所述导管主体组合件轴向间隔的至少四个接口位置。
11.根据权利要求10所述的手柄，其中所述内部手柄组件被定位和布置成与所述导管主体组合件的内衬套组合件、细长主体和隔离护套介接。
12.根据权利要求11所述的手柄，其中所述内部手柄组件包括导向管、驱动组合件、行进护套接口组合件以及隔离护套接口组合件，所述导向管被配置成与所述内衬套组合件介接，所述驱动组合件被配置成与所述细长主体介接，所述行进护套接口组合件被配置成与所述细长主体介接，所述隔离护套接口组合件被配置成与所述隔离护套介接。
13.根据权利要求12所述的手柄，其中所述驱动组合件包括齿轮延伸部以及固定到所述齿轮延伸部的锁，所述驱动组合件被配置成向所述细长主体施加旋转。
14.根据权利要求12所述的手柄，其中所述行进护套接口组合件包括连接器以及行进护套，所述行进护套固定地附接到所述连接器。
15.根据权利要求14所述的手柄，其进一步包括齿轮组合件以及齿轮壳体，所述齿轮壳体围封所述齿轮组合件的至少一部分，所述连接器附接到所述齿轮壳体。
16.根据权利要求12所述的手柄，其中所述隔离护套接口组合件包括接口壳体，所述接口壳体被配置成收纳所述隔离护套的近端。
17.根据权利要求12所述的手柄，其中所述导向管被配置成以非旋转的滑动接合方式收纳所述内衬套组合件。
18.根据权利要求12所述的手柄，其进一步包括远端止挡件，所述远端止挡件附接到所述导向管的远端，以限制所述内衬套组合件移出所述导向管。
19.一种用于去除体腔中的组织的组织去除导管，所述组织去除导管包括：
导管主体组合件，所述导管主体组合件包含：细长主体，所述细长主体具有轴线以及沿所述轴线彼此间隔开的近端部分和远端部分，所述细长主体的大小和形状被设定成收纳在所述体腔中；以及衬套组合件，所述衬套组合件收纳在所述细长主体内并且限定导丝管腔，所述衬套组合件将所述导丝管腔的内部与所述细长主体隔离，使得当在操作所述组织去除导管期间旋转所述细长主体时，旋转和扭转力不从所述细长主体传递到所述导丝管腔的所述内部；以及
手柄，所述手柄安装到所述导管主体组合件的所述近端部分并且能够操作以使所述细长主体旋转，所述手柄包含内部手柄组件，所述内部手柄组件与所述衬套组合件和所述细长主体介接，以使所述衬套组合件和所述细长主体稳定并且将所述衬套组合件对准在所述细长主体内，以便促进所述衬套组合件的所述导丝管腔的所述内部与所述细长主体隔离。
20.根据权利要求19所述的组织去除导管，其中所述内部手柄组件与所述衬套组合件介接，以允许所述衬套组合件滑动移动并且阻止所述衬套组合件旋转移动。
CN202080013121.3A 2019-05-17 2020-05-15 组织去除导管 Pending CN113395942A (zh)

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