CN104869924A - 具有可旋转切削件的组织移除导管 - Google Patents

具有可旋转切削件的组织移除导管 Download PDF

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CN104869924A
CN104869924A CN201380065722.9A CN201380065722A CN104869924A CN 104869924 A CN104869924 A CN 104869924A CN 201380065722 A CN201380065722 A CN 201380065722A CN 104869924 A CN104869924 A CN 104869924A
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cutting element
longitudinal axis
tissue displacement
outstanding
cutting edge
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E·A·古根海默
L·施耐德
T·麦克皮克
B·弗鲁兰德
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Nellcor Puritan Bennett LLC
Covidien LP
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    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
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    • A—HUMAN NECESSITIES
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    • 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

一种组织移除导管，其包括切削元件。在操作期间，切削元件能够延伸通过窗口，以使得当切削元件围绕其纵向轴线旋转时，径向前壁的不足全部的径向部分穿过窗口。切削元件的突出元件的径向前壁的径向最内侧部分可以与纵向轴线间隔开一径向距离，所述径向距离小于环形切削刃的半径的66％。多个研磨构件可以形成在切削元件的内表面的至少中央部分上，以便当切削元件围绕其纵向轴线旋转时研磨硬化的组织。突出元件的径向前刃的径向最外侧部分可以与切削元件的内表面径向间隔开。

Description

具有可旋转切削件的组织移除导管
技术领域
本发明主要涉及一种具有可旋转切削件的组织移除导管。
背景技术
导管用于从体内移除不需要的组织。作为示例，粥样斑块切除导管用于从血管中移除一些物质以疏通血管并且改善流过血管的血流。
发明内容
在一方面，一种组织移除导管主要包括长形导管本体，所述长形导管本体具有相对的远侧部分和近侧部分，并且尺寸和形状构造成用于引入到目标对象的体腔中。驱动轴在导管本体内纵向延伸。驱动轴能够相对于导管本体围绕驱动轴的纵向轴线旋转。长形导管本体的远侧部分处的切削元件具有相对的近端和远端以及在近端和远端之间延伸的纵向轴线。切削元件操作性地连接到驱动轴以用于围绕切削元件的纵向轴线旋转。切削元件包括在切削元件的远端处围绕切削元件的纵向轴线的环形切削刃。环形切削刃具有源自切削元件的纵向轴线的半径。切削元件的内表面从切削刃向近侧延伸并且限定了内腔。切削元件的内腔中的至少一个突出元件从内表面大体纵向向外延伸。至少一个突出元件包括径向前壁，所述径向前壁大体径向向内地朝向切削元件的纵向轴线延伸。径向前壁具有相对于切削元件的纵向轴线的径向最外侧部分、相对于切削元件的纵向轴线的径向最内侧部分以及在径向最外侧部分和径向最内侧部分之间延伸的径向长度。径向前壁的径向最内侧部分与纵向轴线间隔开的径向距离小于环形切削刃的半径的66％。
在另一方面，一种组织移除导管主要包括长形导管本体，所述长形导管本体具有相对的远侧部分和近侧部分，并且尺寸和形状构造成用于引入到目标对象的体腔中。导管本体在其远侧部分处具有窗口。驱动轴在导管本体内纵向延伸。驱动轴能够相对于导管本体围绕驱动轴的纵向轴线旋转。长形导管本体的远侧部分处的切削元件毗邻窗口。切削元件具有相对的近端和远端以及在近端和远端之间延伸的纵向轴线，所述切削元件操作性地连接到驱动轴以用于围绕切削元件的纵向轴线旋转。切削元件包括在切削元件的远端处围绕切削元件的纵向轴线的环形切削刃，所述环形切削刃具有源自切削元件的纵向轴线的半径。切削元件的内表面从切削刃向近侧延伸并且限定了内腔。内腔中的至少一个突出元件具有径向前壁，所述径向前壁大体径向向内地朝向切削元件的纵向轴线延伸。切削元件能够在操作期间延伸通过窗口，以使得当切削元件围绕其纵向轴线旋转时，径向前壁的不足全部的径向部分穿过窗口。
在另一方面，一种组织移除导管主要包括长形导管本体，所述长形导管本体具有相对的远侧部分和近侧部分，并且尺寸和形状构造成用于引入到目标对象的体腔中。驱动轴在导管本体内纵向延伸，其中，驱动轴能够相对于导管本体围绕驱动轴的纵向轴线旋转。长形导管本体的远侧部分处的切削元件具有相对的近端和远端以及在近端和远端之间延伸的纵向轴线。切削元件操作性地连接到驱动轴以用于围绕切削元件的纵向轴线旋转。切削元件包括在切削元件的远端处围绕切削元件的纵向轴线的环形切削刃。环形切削刃具有源自切削元件的纵向轴线的半径。切削元件的内表面从切削刃向近侧延伸并且限定了内腔。内腔中的至少一个突出元件从内表面大体纵向向外延伸。至少一个突出元件包括径向前壁，所述径向前壁大体径向向内地朝向切削元件的纵向轴线延伸。径向前壁具有相对于切削元件的纵向轴线的径向最外侧部分、相对于切削元件的纵向轴线的径向最内侧部分以及在径向最外侧部分和径向最内侧部分之间延伸的径向长度。径向最外侧部分与切削元件的内表面径向间隔开。
在下文中，其它的特征将部分地显而易见以及部分地明确指出。
附图说明
图1是粥样斑块切除导管的远端的透视图；
图2是图1的粥样斑块切除导管的放大的局部剖视图，其中，切削元件处于存放位置；
图3是图1的放大的局部剖视图，但是其中，切削元件处于工作位置；
图4是切削元件的实施例的透视图；
图5是切削元件的放大的端视图；
图6是图4的切削元件的纵向剖视图；
图7是切削元件的另一个实施例的端视图，所述切削元件可以与图1中示出的粥样斑块切除导管一起使用；
图8是图7的切削元件的透视图；
图8A是图8的放大细节图，其示出了切削元件的突出元件中的一个；
图9是切削元件的另一个实施例的端视图，所述切削元件可以与图1中示出的粥样斑块切除导管一起使用；
图10是在图9中图解的切削元件的实施例的透视图；
图10A是图10的放大细节图，其示出了切削元件实施例的突出元件；
图11是图8中图解的切削元件实施例的变型方案的透视图；
图11A是图11的放大细节图，其示出了突出元件中的一个；
图12是切削元件的另一个实施例的透视图；
图13是图12的切削元件的端视图；
图14与图13相类似，但是有所放大并且包括假象圆以用于确定径向距离和径向长度；
图15是图14的放大的局部视图；
图16与图13相类似，但是包括导管本体的示意性表示；
图17与图16相类似，只是以虚线示出了导管本体的示意性表示；
图18是包括图12的切削元件的、从体腔移除组织的导管的局部纵向剖视图；
图19是切削元件的另一个实施例的透视图；
图20是切削元件的另一个实施例的透视图；
图21是切削元件的另一个实施例的透视图；
图22是图21的切削元件的端视图；
图23是在包含图22中的线23-23的平面中截取的、切削元件的放大的局部剖视图；
图24是图21的切削元件的突出元件的放大视图；以及
图25是图23的进一步放大的局部视图。
在附图中，对应的附图标记始终表示对应的部件。
具体实施方式
现在参照附图，公开了用于从体腔移除组织的组织移除导管的若干实施例。特别地，图解的导管实施例适于从体腔壁移除组织，并且尤为适于从血管壁(例如，周围动脉壁或者周围静脉壁)移除(即切除)斑块组织。然而，公开的实施例的特征也可以适于治疗血管尤其是周围动脉和其它体腔的狭窄部中的慢性闭塞病变(CTO)，以及适于治疗其它体腔(例如输尿管、胆管、呼吸道、胰管、淋巴管等)中的增生和肿瘤症状。常常因肿块包围并且侵入到体腔中而导致肿瘤细胞的生长。因此移除这些物质能够有助于保持体腔畅通。尽管以下的讨论内容涉及用于从血管移除组织并且穿透血管中的闭塞(例如，动脉中的粥样硬化或血栓性的闭塞物质或者静脉中的其它闭塞)的导管，但是应当理解的是，本公开的教导可以等同地应用于其它类型的组织移除导管，包括但不限于用于穿透各种体腔中的各种闭塞、狭窄部或增生材料和/或从中移除组织的导管。
参照图1至图4，粥样硬化切除导管2具有用于从血管腔切削材料的切削元件4。导管具有长形本体8，所述长形本体8具有远侧部分和近侧部分，并且尺寸和形状构造成用于插入到目标对象的体腔中。切削元件4能够在存储位置(图2)和切削位置(图3)之间相对于导管本体8中的毗邻远侧部分的窗口或开口6运动。切削元件4相对于开口6向外运动，以使得元件4的暴露部分通过开口6延伸到导管本体8的外部。切削元件4可以相对于本体8和开口6定位成使得暴露出切削元件4的小于90度的部分以切削组织。当然，在不背离本发明的各个方面的前提下，可以暴露出更多的切削元件4。
导管2可以具有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)的最大尺寸，并且可以根据准备使用导管的解剖位置的要求具有约20、30、40、60、80、100、120、150、180或210cm的工作长度。切削件4优选地具有略小于导管2的最大尺寸的直径，通常为0.010″(0.025cm)、0.015″(0.038cm)、0.020″(0.051cm)、0.025″(0.064cm)或0.030″(0.076cm)或者更小。然而，这些相对尺寸并不意味着是限制性的。
如在下文更加详细描述的那样，导管2通过血管向远侧运动，其中切削元件4处于工作位置或切削位置。当导管2运动通过血管时，组织被切削元件4切削并且被引导到位于切削元件4远侧的组织室12中。组织室12可以在一定程度上为长形，以容纳已被切下的组织。
切削元件4从存储位置向近侧运动，以使切削元件4上的凸轮表面14接合导管2的本体8上的斜坡16。凸轮表面14和斜坡16之间的相互作用致使切削元件4运动到切削位置而且还致使末端18偏移，这倾向于使切削元件4朝向要切削的组织运动。
切削元件4联接到驱动轴20，所述驱动轴20延伸通过导管2中的管腔21。切削元件4在驱动轴围绕其纵向轴线旋转时围绕纵向轴线LA旋转。切削元件以大约1至160,000rpm的转速旋转，但是也可以根据具体应用以任何适当的转速旋转。
参照图2、4和5，示出了切削元件4。如本文所使用的术语“沿着纵向轴线”应该是指图5的视图在沿着纵向轴线方向和/或旋转轴线方向观察时示出了切削元件4的远端。切削元件4具有环形切削刃22，所述环形切削刃22可以是连续的、不间断的圆形刃，不过在不背离本发明的范围的前提下环形切削刃也可以包括脊状件、齿、锯齿或者其它的特征。当切削元件4处于切削位置时，切削刃22可以位于切削元件4的径向外刃23处。切削元件4的圆周内表面25从切削刃22延伸并且倒角或斜切。
切削元件4具有杯状内表面24，所述杯状内表面24将由切削刃22切下的组织引导到组织室12中。在图解的实施例中，圆周内表面和杯状内表面24限定了切削元件4的内腔。杯状表面24可以是没有通孔、齿、翅片或其它特征的光滑和连续的表面，这样的特征会针对从纵向轴线LA到切削刃22处的外半径的距离的至少一半破坏表面24的光滑性质。杯状表面24也可以在相对于纵向轴线LA的至少300度的区域中没有任何这样的特征。
切削件4可以由钢、碳化钨、钨碳钴合金、钨碳钼合金、碳化硅、氮化硅、陶瓷、非晶态金属或其它材料构成，并且可以通过这样的方法制成，所述方法包括车削、研磨、烧结、放电式机加工(EDM)、激光切削、热处理、淀积硬化、铸造或者其它方法。
参照图4至图6，一个或多个突出元件26从杯状表面24向外延伸，其中图5示出了两个突出元件26。突出元件26是小楔状材料，从杯状表面24相对突兀地突出。突出元件26具有第一壁30和第二壁32，所述第一壁30和第二壁32均径向延伸并且在其间形成大约20度的角度，以使两个突出元件26一起占据大约40度的区域并且总共可以小于60度。第三壁34在第一和第二壁30、32的径向内部分之间延伸。突出元件26有助于通过将相对钝的力施加到硬组织或斑块来粉碎组织和斑块，这是因为用切削刃22切削这样的组织经常是无效的。
突出元件26总共占据杯状表面24的相对较小的部分。突出元件26一共可以占据切削元件4的小于5％的表面区域。如本文中所使用的术语“切削元件的表面区域”应该表示这样的表面区域，所述表面区域从外刃或切削刃22径向向内并且当沿着纵向轴线LA观察时露出。换言之，当沿着纵向轴线观察时，切削元件的表面区域中的至少95％是光滑的杯状表面。然而，突出元件的表面区域可以占据杯的整个表面区域中的更多的部分。通过以这种方式成形和定位突出元件26，突出元件26不会干扰切削元件4的切削组织以及将组织重定向到组织室中的能力，同时仍能提供利用突出元件26粉碎硬组织和斑块的能力。
突出元件26可以从切削刃22纵向和/或径向地下凹。突出元件26可以从切削刃(沿着轴线LA)纵向地下凹0.0010至0.0020英寸(0.0025cm至0.0051cm)并且可以下凹大约0.0015英寸(0.0038cm)。突出元件26可以从切削刃22径向下凹大约相同的量。切削元件4的远侧壁38形成垂直于纵向轴线LA的平坦表面40，以使整个表面从切削刃下凹相同的距离。远侧壁38可以采用任何其它的形状例如弯曲的形状，或者可以如本文所述地倾斜、偏斜或斜切。在本发明的范围内，突出元件可以具有其它的形状、尺寸和位置。
参照图7、8和8A，示出了另一个切削元件4A，其中，相同或者相似的附图标记表示相同或者相似的结构，并且关于切削元件4的相同或类似特征的讨论都等同地适用，除非另有说明。切削元件4A具有切削刃22A，所述切削刃22A可以是连续的、不间断的圆形刃，不过在不背离本发明的范围的前提下也可以包括脊状件、齿、锯齿或者其它特征。当切削元件4A处于切削位置时，切削刃22A可以位于切削元件4A的径向外刃23A处。切削元件4A具有杯状表面24A，所述杯状表面24A将由切削刃22A切下的组织引导到组织室12中(参见图2)。正如结合切削元件4在上文描述的那样，杯状表面24A可以是基本光滑且连续的表面。
一个或多个突出元件26A从杯状表面24A向外延伸。图8示出了四个突出元件26A，但是可以包括任何数量例如1、2、3、4、6或者8个突出元件。突出元件26A是小楔形材料，其从杯状表面24A相对突兀地突出。突出元件26A具有第一壁30A和第二壁32A，所述第一壁30A和第二壁32A在一个实施例中均径向延伸并且其间形成约1至30度的角度，使得四个突出元件26A一起占据约4至60度的区域并且总共可以小于60度。第三壁34A在第一和第二壁30A、32A的径向内部分之间延伸。在一些实施例中，突出元件26A可以占据杯状表面24A的相对较小的部分，并且能够以结合切削元件4在上文描述的方式从切削刃22A下凹。在其它实施例中，切削元件的表面区域的至少60％、70％、80％或90％是光滑的杯状表面。
切削元件4A的远侧壁38A具有表面40A，所述表面40A相对于纵向轴线LA形成大约30至90度的角度。整个表面40A仍然可以在一定程度上靠近切削刃22A而且从其下凹，使得整个表面40A距离切削刃至少0.0010、0.0020、0.0030、0.0040或0.0050英寸(0.0025、0.0051、0.0076、0.0101或0.0127cm)。形成在壁30A和远侧壁38A的交线处的前刃50较之形成在壁32A和远侧壁38A的交线处的刃52更靠近切削刃22A。切削元件4A可以双向旋转，以使突出刃50可以是前刃或后刃。在一些实施例中，突出刃与切削刃相距的距离可以介于0.0010至0.0020英寸(0.0025至0.0051cm)之间。突出元件26A可以全部以相同的方式形成或者以相互不同的方式形成。例如，元件26A中的一些能够沿着不同方向成一定角度，使得元件中的两个具有作为前刃的突出刃50且元件26A中的两个具有作为后刃的突出刃50。在不背离本发明的各个方面的前提下，突出元件26A还可以对向不同的角度、具有不同的高度或者具有不同的径向长度。
参照图9、10和10A，示出了另一个切削元件4B，其中，相同或者类似的附图标记指的是相同或者类似的结构，并且关于切削元件4的相同或类似特征的讨论都等同地适用，除非另有说明。切削元件4B具有切削刃22B，所述切削刃22B可以是连续的、不间断的圆形刃，不过在不背离本发明的范围的前提下也可以包括脊状件、齿、锯齿或者其它特征。当切削元件4B处于切削位置时，切削刃22B可以位于切削元件4B的径向外刃23B处。切削元件4B具有杯状表面24B，所述杯状表面24B将由切削刃22B切下的组织引导到组织室12中(参见图2)。在一个实施例中，正如结合切削元件4在上文描述的那样，杯状表面24B可以是基本光滑且连续的表面。
一个或多个突出元件26B从杯状表面24B向外延伸。图9和图10示出了四个突出元件26B，但是可以包括任何数量例如1、2、3、4、6或者8个突出元件。突出元件26B是小楔形材料，其从杯状表面24B相对突兀地突出并且相对于轴线LA对向大约1至30度的圆弧，所述四个突出元件26B一共对向大约4至60度的圆弧。突出元件26B具有第一壁30B，所述第一壁30B在弯曲的前刃50B和杯状表面24B之间延伸，而且还具有第二壁32B，所述第二壁32B相对于轴线LA径向延伸。第三壁34B在第一和第二壁30B、32B的径向内部分之间延伸。在一些实施例中，突出元件26B可以占据杯状表面24B的相对较小的部分，并且能够以结合切削元件4在上文描述的方式从切削刃22B下凹。在其它实施例中，切削元件的表面区域的至少60％、70％、80％或90％是光滑的杯状表面。
切削元件4B的远侧壁38B具有表面40B，所述表面40B相对于纵向轴线LA形成小于90度的角度。在一些实施例中，表面40B成一定的角度，使得刃50B较之刃52B在更远侧。整个表面40B仍然可以在一定程度上靠近切削刃22B而且从切削刃22B下凹，使得整个表面40B与切削刃相距的距离介于0.0010至0.0050英寸之间(0.0025至0.0127cm之间)，包括0.0010、0.0020、0.0030、0.0040或0.0050英寸(0.0025、0.0051、0.0076、0.0101或0.0127cm)。形成在壁30B和远侧壁38B的交线处的刃50B较之形成在壁32B和远侧壁38B的交线处的刃52B更加靠近切削刃22B。在刃50B附近，壁30B和表面40B之间的夹角大于90度。切削元件4B可以沿着两个方向旋转，使得突出刃50B可以是前刃或后刃。在一个实施例中，切削件4B沿着箭头R的方向旋转，使得刃50B是前刃。突出刃50B、52B可以与切削刃相距0.0010至0.0020英寸(0.0025至0.0051cm)。突出元件26B可以全部以相同的方式形成或者以彼此不同的方式形成。例如，元件26B中的一些能够沿着不同的方向成一定角度，以使元件中的两个具有作为前刃的突出刃50B而元件26A中的两个元件具有作为后刃的突出刃50B。在不背离本发明的各个方面的情况下，突出元件26B还可以对向不同的角度、具有不同的高度或者具有不同的径向长度。
在一个实施例中，切削件4B沿着箭头R的方向旋转并且被向远侧推动，以便迫使杯状表面24B和突出元件26B与诸如粉瘤或者斑块这样的物质相接触。突出元件26B将因切削件轴线LA和表面40B之间的后角而倾向于沿着刃50B集中切削力。切削件4B将因壁30B和表面40B之间的在刃50B附近的钝夹角而倾向于刮擦掉诸如粉瘤或者斑块这样的物质而非切入到该物质中。由突出元件26B接触的材料将倾向于被表面30B朝向轴线LA引导，所述表面30B从刃22B附近的相对切向角弯曲至刃34B附近的相对径向角。
参照图11和11A，示出了另一个切削元件4C。切削元件4C是切削元件4A的变型方案。该变型包括向一个或多个突出元件26A的前表面增加底切部41C，由此得到变型的突出元件26C。当切削件4C沿着箭头T的方向旋转时，底切部将物质颗粒引导到由切削件的杯状表面24A限定的凹腔中，并且朝向切削件的轴线LA引导。可选地，底切部能够分别应用于切削元件4、4B的一个或多个突出元件26、26B的前表面以及应用于切削元件4A的一个或多个突出元件26A。
底切部41C由壁30C限定，所述壁30C取向成相对于表面40A成锐角，所述表面40A与杯状表面24A相交并与壁34A汇合。壁30C的平面还以小于5、10、15或20度的角度与轴线LA相交，以使得当切削件4C沿着方向T旋转时，物质颗粒倾向于在远离切削刃22A并且朝向轴线LA的方向上沿着壁30C行进。在一些实施例中，壁43C可以插置在壁30C和壁40A的交线之间。壁43C能够以任何理想的倾角定向，例如在突出元件倾向于不会掘入到正在被切削的材料中的情况下为负倾角。
参照图12至图18，用4D整体示出了切削元件的另一个实施例。切削元件4D与切削元件4B类似，除了如下所述，整体用26D表示的突出元件的径向长度大于切削元件4B的突出元件26B的径向长度。切削元件4D具有环形切削刃22D，所述环形切削刃22D可以是连续的、不间断的弧形刃，不过在不背离本发明的范围的前提下其还可以包括脊状件、齿、锯齿或者其它特征。在图解的实施例中，切削元件4D的内表面限定了切削元件的内腔。内表面包括：从切削刃22延伸的倒角或斜切的圆周内表面25D；和中央杯状表面24D，所述中央杯状表面24D将由切削刃22D切下的组织引导到组织室12中(参见图2)。当切削元件处于切削位置时，切削刃22D可以位于切削元件4D的径向外表面23D处。在一个实施例中，正如结合切削元件4描述的那样，杯状表面24D可以是基本光滑且连续的表面。如在下文的另一个实施例中公开的那样(图19和图20)，杯状表面24D可以是磨蚀性的。在其它的实施例中，通孔(未示出)可以纵向延伸穿过杯状表面24D，以便将移除的组织向近侧引导通过切削元件4D。
在切削元件4D的内腔中，突出元件26D大体从杯状表面24B纵向向外延伸。在图12至18中图解的实施例包括四个突出元件26D，但是切削元件4D也可以包括例如1、2、3、4、6或8个这样任何数量的突出元件。每个突出元件26D均为小楔形材料，从内表面(例如杯状表面24D)相对突兀地突出并且相对于轴线LA对向大约1至30度的圆弧，所述四个突出元件26D总共对向大约4至60度的圆弧。参照图13，每个突出元件26D均具有径向前壁(泛指第一壁)30D、径向后壁(泛指第二壁)32D、径向内端壁34D(泛指第三壁)和远侧壁(泛指第四壁)38D。径向后壁30D具有在远侧壁38D和杯状表面24D之间相对于切削件4D纵向延伸的深度以及从切削元件4D的切削刃22D附近大体向内延伸的径向长度RL(图15)，正如在下文更加详细描述的那样。径向前壁30D沿着其深度弯曲(即相对于切削元件4D纵向弯曲)而且还沿着其径向长度RL弯曲。切削元件26D的前刃50D被限定在径向前壁30D和远侧壁38D的交线处。前刃50D相对于切削件4D径向弯曲。在一些实施例中，突出元件26D可以占据杯状表面24D的相对较小的部分并且能够以结合切削元件4在上文描述的方式从切削刃22D下凹。在其它实施例中，切削元件的表面区域的至少60％、70％、80％是光滑的杯状表面。
切削元件4D的远侧壁38D相对于纵向轴线LA形成小于90度的角度。在一些实施例中，壁38D成一定角度，以使得刃50D较之形成在远侧壁38D和后壁32D的交线处的刃位于更远侧。整个远侧壁38D可以毗邻切削刃22D而且从其纵向下凹，使得远侧壁与切削刃间隔开的最小纵向距离介于大约0.0010至大约0.0050英寸(0.0025至0.0127cm)，包括约0.0010、约0.0020、约0.0030、约0.0040或者约0.0050英寸(0.0025、0.0051、0.0076、0.0101或者0.0127cm)。径向前壁30D和远侧壁38D之间的位于前刃50D附近的夹角可以大于90度。切削元件4D沿着方向R旋转(图13)，以使前刃50D接合待移除的组织。如图15所示，突出元件26D的前刃50D可以与切削刃22D间隔开介于大约0.0010至大约0.0020英寸(0.0025至0.0051cm)之间的径向距离d1。能够以相同的方式或不同的方式形成全部的突出元件26D。在不背离本发明的各个方面的前提下，突出元件26D还可以对向不同的角度，具有不同的高度和不同的径向长度或者与切削刃间隔开不同的距离(包括零)。
参照图14和15，每个突出元件26D的径向前壁30D的径向长度RL由径向前壁的径向最外侧部分P1和径向最内侧部分P2之间的径向距离限定。在图15中，分别使用同心的外接和内接虚拟圆C1、C2来测量径向壁30D的径向长度R1，每个虚拟圆均具有中心，所述中心与纵向轴线LA相符。径向前壁30D的径向最外侧部分P1位于外虚拟圆C1的圆周上，而径向最内侧部分P2位于内虚拟圆C2的圆周上。在图解的实施例中，径向前壁30D的每个径向最外侧部分P1均位于同一外虚拟圆C1的圆周上，而每个径向最内侧部分P2均位于同一内虚拟圆C2的圆周上，不过应该理解的是，在不背离本发明的范围的前提下，径向最外侧和最内侧部分可以各自不位于同一虚拟圆上。在图解的实施例中，径向内端壁34D成弧形，使得基本整个径向内端壁位于内虚拟圆C2的圆周上，不过这在其它实施例中并不是必须的。外虚拟圆C1和内虚拟圆C2的圆周之间的径向距离分别确定了径向前壁30D的径向长度RL，如图15所示。在一个示例中，径向前壁30D的径向长度可以介于0.0050英寸至大约0.0200英寸之间，或者介于大约0.0075英寸至大约0.0175英寸之间，或者介于大约0.0100英寸至大约0.0150英寸之间。在一个示例中，径向前壁的径向长度RL可以至少为切削刃22D的半径R(图15)的大约33％、或者至少大约40％、或者至少大约50％、或者至少大约60％、或者至少大约70％、或者至少大约80％。
仍然参照图15，每个突出元件26D的径向前壁30D的径向最内侧部分P2与切削元件4D的纵向轴线LA间隔开一径向距离d2。如上所述，径向前壁30D的径向最内侧部分P2位于内虚拟圆C2的圆周上。纵向轴线LA和内虚拟圆C2的圆周之间的径向距离确定了纵向轴线和径向前壁30D的径向最内侧部分P2之间的径向距离d2。在一个示例中，纵向轴线和径向前壁30D的径向最内侧部分P2之间的径向距离可以介于大约0.0150英寸至大约0.0300英寸之间、或者介于大约0.0175英寸至大约0.0275英寸之间、或者介于大约0.0200英寸至大约0.0250英寸之间。在一个示例中，径向距离d2可以小于环形切削刃22D的半径R的大约66％、或者小于大约60％、或者小于大约55％、或者小于大约50％、或者小于大约45％、或者小于大约40％、或者小于大约35％，如图15所示。在一个实施例中，径向距离d2可以介于环形切削刃22D的半径R的大约15％至大约66％之间、或者介于大约20％至大约60％之间、或者介于大约25％至大约50％之间、或者介于大约30％至大约40％之间。
正如以上在本文中公开的那样，在展开的构造中，切削元件4D延伸通过末端18中的窗口或者开口6。在该实施例中，每个突出元件26D构造成使得当切削元件4D旋转360度时，始终只有不足全部的径向前壁30D通过开口6露出。换言之，每个突出元件26D的径向外部分循环地通过开口6露出，而径向前壁的径向内部分从不会穿过开口(即从不会露出)。在图17中示出了该特征，其中，由附图标记S表示的圆限定了末端18的紧邻窗口6的外表面(还可参见图16)。正如从图17可见的那样，虚线L示出了这样的位置，在所述位置处，切削元件4D的径向部分最大程度地暴露在导管本体外侧。然而，正如从该图可见的那样，处于虚线L处的切削元件26D的径向前壁30D的径向内部分并未越过暴露平面EP交叉并且也没有通过窗口6。
切削件4D沿着箭头R的方向旋转并且被向远侧推动，以便迫使杯状表面24D和突出元件26D与诸如粉瘤或者斑块这样的物质相互接触。突出元件26D因径向前壁30D的负倾角而倾向于沿着刃50D集中切削力。切削件4D因刃50D附近的壁30D和远侧壁38D之间的钝夹角而倾向于刮擦掉诸如粉瘤或者斑块这样的物质而非切入到该物质中。由突出元件26D接触的材料将倾向于被表面30D朝向轴线LA引导，所述表面30D从刃22D附近的更大的圆周范围弯曲到刃34D附近的更大的径向范围。而且，可以确信的是，将一个或多个突出元件26D构造成使得径向前壁30D的仅仅一部分间歇性地穿过窗口6(即，暴露出径向前壁的仅仅一部分而非全部)并且间歇性地露出(如上所述)，通过确保突出元件26D接合可以进入到窗口6中的组织来帮助切削和/或破坏硬化的组织(例如钙化组织)，如图18所示。径向前壁30D还更加可靠地将移除的物质朝向轴线LA引导或定向。
能够以诸如一体化为单一整体件构造的适当方式来形成切削元件4D。例如，切削元件4D可以由钢、碳化钨、钨碳钴合金、钨碳钼合金、碳化硅、氮化硅、陶瓷、非晶态金属或其它材料构成，并且可以通过这样的方法制成，所述方法包括车削、研磨、烧结、放电式机加工(EDM)、激光切削、热处理、淀积硬化、铸造或者其它方法。
参照图19和20，(分别)示出了切削元件4E和4F。切削元件4E和4F包括突出元件26E、26F，所述突出元件26E、26F可以与先前在上文公开的切削元件4A至4D中的任意一个的突出元件26A至26D相同或者具有不同的构造。因此，上述突出元件26A至26D的教导并入本实施例中。与先前公开的切削元件相反，切削元件4E和4F均具有磨蚀性的杯状表面24E、24F。在一个实施例中，除了磨蚀性的杯状表面24E、24F之外，切削元件4E和4F与切削元件4D相同，包括与突出元件26D相同的突出元件26E。因此，在本实施例中，切削元件4E和4F中的每一个均包括切削元件4D和磨蚀性杯状表面24E、24F中的相应的一个。参照图19，切削元件4E包括杯状表面24E的隆起区域，包括凸起、成菱形的研磨构件100。参照图20，切削元件4F包括杯状表面24F的凹窝区域，所述凹窝区域包括下凹部分102。在每个实施例中，磨蚀性的杯状表面24E、24F研磨硬化的组织(例如钙化组织)，特别地，磨蚀性的杯状表面研磨未被突出元件26E接合的硬化的组织。因此，可以确信，与没有研磨表面的切削元件4相比，切削元件4E和4F可以更为有效地移除硬化的组织。
切削元件4E和4F均可一体化地形成为单一的整体件构造或者可以形成为多件式构造。作为示例，每个切削元件4E和4F均可以由钢、碳化钨、钨碳钴合金、钨碳钼合金、碳化硅、氮化硅、陶瓷、非晶态金属或其它材料构成，并且可以通过这样的方法制成，所述方法包括车削、研磨、烧结、放电式机加工(EDM)、激光切削、热处理、淀积硬化、铸造或者其它方法。
参照图21至25，整体用4G表示切削元件的另一个实施例。切削元件4G与切削元件4B相类似，并且因此，由相似的附图标记表示相同的部件，并且关于切削元件4B阐述的教导同样应用于这个实施例。简要地说，切削元件4G的每个突出元件26G均具有前壁30G、径向内端壁34G、远侧壁38G和前刃50G。对于本公开的目的而言，本切削元件4G和先前的切削元件4B之间的主要区别在于每个突出元件26G的前刃50G和本切削元件4G的切削刃22G之间的径向距离大于每个突出元件26B的前刃50B和切削元件4B的切削刃22B之前的径向距离。应当理解的是，在此针对切削元件4G所述的教导同样适用于其它的切削元件4A至4F。
在图解的示例中，本切削元件4G在毗邻切削刃22G的每个突出元件26G中包括底切部(例如，槽、凹陷部、凹口或切口)106。底切部106延伸通过每个突出元件26G的前壁30G、前刃50G和远侧壁38G。底切部106大体在突出元件的径向最外侧部分处径向延伸到突出元件26G中。正如在图24中清楚可见的那样，底切部106具有几乎垂直于壁30G的圆周范围。底切部106的深度远离前刃50G沿着周向略微变浅。与此相比，图11和11A中的底切部41C沿着周向延伸到突出元件26C中并且沿着壁30C具有大体径向的范围。正如图25清楚示出的那样，由于底切部106，切削元件4G的前刃50G的径向最外侧部分P1与切削元件的倒角的圆周内表面25G(泛指内表面)径向间隔开一径向距离D1(图25)。在一个示例中，径向距离D1可以介于从大于0.0000英寸至大约0.0100英寸之间，或者介于从大于0.0000英寸至大约0.0050英寸之间，或者介于从大约0.0005英寸至大约0.0015英寸之间。前刃50G的径向最外侧部分P1与切削元件4G的切削刃22G径向间隔开一距离D2，该距离D2大于切削元件4B的前刃50B和切削刃22B之间的径向距离。在一个示例中，该距离D2可以介于从大于0.0000英寸至大约0.01000英寸之间，或者介于从大于0.0000英寸至大约0.0050英寸之间，或者介于从大约0.0005英寸至大约0.0020英寸之间。而且，切削元件4G的前刃50G可以与切削元件22G间隔开最小的纵向距离D3。在一个示例中，该距离D3可以介于从大约0.0000英寸至大约0.0020英寸之间。在一个示例中，前刃50G与前刃50B类似，区别在于底切部106，因此，从前刃50G延伸的虚拟外推线在部分P3处与切削元件4G的倒角内表面25G相交(图24)，所述部分P3与突出元件26B的径向最外侧部分P1的位置基本相同(参见例如图14)。
可以确信的是，通过使突出元件26G的前刃50G与切削元件4G的倒角内圆周部分25G间隔开，在保持切削刃22G和突出元件的前刃之间的适当的最小纵向距离的同时，突出元件26G比切削元件4B更好地与组织接合，而且并未牺牲切削元件的切削效率。
切削元件4G可以一体地形成为单一的整体件构造或者可以形成为多件式构造。作为示例，切削元件4G可以由钢、碳化钨、钨碳钴合金、钨碳钼合金、碳化硅、氮化硅、陶瓷、非晶态金属或其它材料构成，并且可以通过这样的方法制造而成，所述方法包括车削、研磨、烧结、放电式机加工(EDM)、激光切削、热处理、淀积硬化、铸造或者其它方法。
现在结合切削元件4描述导管2的用法，而且同样可以适用于导管2与切削元件4A、切削元件4B或切削元件4C中的任意一个一起使用。利用导丝(未示出)或类似部件以常规方式将导管2引入到患者体内。导管2在切削元件处于图2中的存储位置的情况下前进，直到导管定位在待移除物质的部位附近为止。然后切削元件4向近侧运动，使得斜坡16和凸轮表面14接合，以便使得切削元件4运动到图3的切削位置并且使得导管2的末端偏转，以使切削元件4朝向待切削的组织运动。切削元件4围绕纵向轴线LA旋转，然后导管2向远侧运动通过血管，使得切削元件4切削组织。已经切下的组织通过杯状表面24、一个或多个突出元件26、(切削元件4B的)曲面30B或者通过杯状表面、突出元件或曲面的任意组合而被引导到组织室12中。用于收集切下的组织的位置在本发明的范围内可以不同于所述的位置。
更加具体地，当使用切削元件4B并使切削元件沿着箭头R的方向(图9)旋转时，切削刃22B切下较柔软的材料，并且杯状表面将切下的材料引导到组织室12中；后角确保作用在导管上的向远侧指向的力集中在突出元件的刃50B上而非分散在壁38B上；由于刃50B附近的径向前壁30B和远侧壁38B之间的钝夹角，因此突出元件26B将倾向于刮擦掉或者研磨掉较硬的物质例如钙；曲面30B将物质颗粒朝向切削件的轴线LA引导；并且当旋转时曲面30B产生流体涡流，所述流体涡流倾向于将物质颗粒朝向切削件的轴线LA引导并且将物质颗粒向远侧引导到组织室12中。
更具体地，当使用诸如图示用于切削元件4C的底切部并使切削元件沿着箭头T的方向(图11)旋转时，底切部41C沿着杯状表面朝向切削元件的轴线LA引导物质离开切削刃22A，并且径向地朝向切削元件的轴线LA引导。
更加具体地，当如上所述地使用其突出元件26D具有径向前壁30D的切削元件4D时，通过确保突出元件26D接合可以进入窗口6的组织而使突出元件有助于切削和/或破坏硬化的组织(例如钙化组织)，如图18所示。
当使用切削元件4E或4F时，磨蚀性的杯状表面24E、24F研磨硬化的组织(例如钙化组织)，特别地，磨蚀性的杯状表面研磨未被突出元件26E接合的硬化的组织。
当使用切削元件4G时，与切削元件4B相比，改进了突出元件26G与组织的接合，而且并未牺牲切削元件的切削效率。
通过详细描述本发明，应当理解的是，在不背离由所附权利要求限定的本发明的范围的前提下，各种修改方案和变型方案是可行的。
当介绍本发明或其优选实施例中的要素时，冠词“一”、“一个”、“这个”和“所述”旨在表示存在一个或多个所述的要素。术语“包括”、“包含”和“具有”应理解为包括在内并且表示除了所列举的要素之外还可以存在其它的要素。
在不背离本发明的范围的前提下，可以对上述构造、产品和方法做出多种修改，应当理解的是，包含在以上的描述中并且在附图中示出的所有内容都应解读为说明性而非限制性的。

Claims (25)

1.一种组织移除导管，包括：
长形导管本体，所述长形导管本体具有相对的远侧部分和近侧部分，并且尺寸和形状构造成用于引入到目标对象的体腔中，所述导管本体在其远侧部分处具有窗口；
驱动轴，所述驱动轴在所述导管本体内纵向延伸，其中，所述驱动轴能够相对于所述导管本体围绕所述驱动轴的纵向轴线旋转；
切削元件，所述切削元件在所述长形导管本体远侧部分处毗邻所述窗口，所述切削元件具有相对的近端和远端以及在近端和远端之间延伸的纵向轴线，所述切削元件操作性地连接到所述驱动轴以用于围绕所述切削元件的纵向轴线旋转，所述切削元件包括：
环形切削刃，所述环形切削刃在所述切削元件的远端处围绕所述切削元件的纵向轴线，所述环形切削刃具有源自所述切削元件的纵向轴线的半径；
内表面，所述内表面从所述环形切削刃向近侧延伸并且限定了内腔；
位于所述内腔中的至少一个突出元件，所述至少一个突出元件具有径向前壁，所述径向前壁大体径向向内地朝向所述切削元件的纵向轴线延伸，
其中，所述切削元件能够在操作期间延伸通过所述窗口，以使得当所述切削元件围绕其纵向轴线旋转时，所述径向前壁的不足全部的径向部分穿过所述窗口。
2.根据权利要求1所述的组织移除导管，其中，所述径向前壁具有：相对于所述切削元件的纵向轴线的径向最外侧部分；相对于所述切削元件的纵向轴线的径向最内侧部分；以及在所述径向最外侧部分和所述径向最内侧部分之间延伸的径向长度，其中，所述径向前壁的径向最内侧部分与所述纵向轴线间隔开一径向距离，该径向距离小于所述环形切削刃的半径的约66％。
3.根据权利要求2所述的组织移除导管，其中，所述径向距离介于所述环形切削刃的半径的约15％至小于66％之间。
4.根据权利要求3所述的组织移除导管，其中，所述径向距离介于所述环形切削刃的半径的约20％至约60％之间。
5.根据权利要求4所述的组织移除导管，其中，所述径向距离介于所述环形切削刃的半径的约30％至约40％之间。
6.根据权利要求2所述的组织移除导管，其中，所述径向前壁的径向长度是所述环形切削刃的半径的至少约33％。
7.根据权利要求1所述的组织移除导管，其中，所述径向最外侧部分与所述切削元件的内表面径向间隔开。
8.根据权利要求7所述的组织移除导管，其中，所述径向最外侧部分与所述切削元件的内表面间隔开一径向距离，该径向距离介于大于0.0000英寸(0.0000mm)至约0.0100英寸(0.254mm)之间。
9.根据权利要求7所述的组织移除导管，其中，所述切削元件包括底切部，所述底切部大体径向延伸到所述突出元件中，以使得所述径向最外侧部分与所述切削元件的内表面径向间隔开。
10.根据权利要求1所述的组织移除导管，其中，所述至少一个突出元件包括多个突出元件。
11.根据权利要求1所述的组织移除导管，其中，所述内表面的至少中央部分为大体杯状。
12.根据权利要求11所述的组织移除导管，其中，所述内表面的中央部分包括研磨区域，所述研磨区域适于在所述切削元件围绕其纵向轴线旋转时研磨硬化的组织。
13.根据权利要求12所述的组织移除导管，其中，所述研磨区域包括突出的成菱形的研磨构件。
14.根据权利要求12所述的组织移除导管，其中，所述研磨区域包括具有凹陷部分的凹窝区域。
15.一种组织移除导管，包括：
长形导管本体，所述长形导管本体具有相对的远侧部分和近侧部分，并且尺寸和形状构造成用于引入到目标对象的体腔中；
驱动轴，所述驱动轴在所述导管本体内纵向延伸，其中，所述驱动轴能够相对于所述导管本体围绕所述驱动轴的纵向轴线旋转；
切削元件，所述切削元件位于所述长形导管本体的远侧部分处，所述切削元件具有相对的近端和远端以及在近端和远端之间延伸的纵向轴线，所述切削元件操作性地连接到所述驱动轴以用于围绕所述切削元件的纵向轴线旋转，所述切削元件包括：
环形切削刃，所述环形切削刃在所述切削元件的远端处围绕所述切削元件的纵向轴线，所述环形切削刃具有源自所述切削元件的纵向轴线的半径；
内表面，所述内表面从所述环形切削刃向近侧延伸并且限定了内腔；
在所述内腔中从所述内表面大体纵向向外延伸的至少一个突出元件，所述至少一个突出元件包括径向前壁，所述径向前壁大体径向向内地朝向所述切削元件的纵向轴线延伸，所述径向前壁具有：相对于所述切削元件的纵向轴线的径向最外侧部分、相对于所述切削元件的纵向轴线的径向最内侧部分、以及在所述径向最外侧部分和所述径向最内侧部分之间延伸的径向长度，其中，所述径向最外侧部分与所述切削元件的内表面径向间隔开。
16.根据权利要求15所述的组织移除导管，其中，所述径向最外侧部分与所述切削元件的内表面间隔开一径向距离，该径向距离介于大于0.0000英寸(0.0000mm)至约0.0100英寸(0.2540mm)之间。
17.根据权利要求15所述的组织移除导管，其中，所述切削元件包括底切部，所述底切部大体径向延伸到所述突出元件中，以使得所述径向最外侧部分与所述切削元件的内表面径向间隔开。
18.一种组织移除导管，包括：
长形导管本体，所述长形导管本体具有相对的远侧部分和近侧部分，并且尺寸和形状构造成用于引入到目标对象的体腔中；
驱动轴，所述驱动轴在所述导管本体内纵向延伸，其中，所述驱动轴能够相对于所述导管本体围绕所述驱动轴的纵向轴线旋转；
切削元件，所述切削元件位于所述长形导管本体的远侧部分处，所述切削元件具有相对的近端和远端以及在近端和远端之间延伸的纵向轴线，所述切削元件操作性地连接到所述驱动轴以用于围绕所述切削元件的纵向轴线旋转，所述切削元件包括：
环形切削刃，所述环形切削刃在所述切削元件的远端处围绕所述切削元件的纵向轴线，所述环形切削刃具有源自所述切削元件的纵向轴线的半径；
内表面，所述内表面从所述环形切削刃向近侧延伸并且限定了内腔；
在所述内腔中从所述内表面大体纵向向外延伸的至少一个突出元件，所述至少一个突出元件包括径向前壁，所述径向前壁大体径向向内地朝向所述切削元件的纵向轴线延伸，所述径向前壁具有：相对于所述切削元件的纵向轴线的径向最外侧部分、相对于所述切削元件的纵向轴线的径向最内侧部分、以及在所述径向最外侧部分和所述径向最内侧部分之间延伸的径向长度，
其中，所述径向前壁的径向最内侧部分与所述纵向轴线间隔开一径向距离，该径向距离小于所述环形切削刃的半径的约66％。
19.根据权利要求18所述的组织移除导管，其中，所述径向距离介于所述环形切削刃的半径的约15％至小于66％之间。
20.根据权利要求19所述的组织移除导管，其中，所述径向距离介于所述环形切削刃的半径的约20％至约60％之间。
21.根据权利要求20所述的组织移除导管，其中，所述径向距离介于所述环形切削刃的半径的约30％至约40％之间。
22.根据权利要求18所述组织移除导管，其中，所述径向前壁的径向长度是所述环形切削刃的半径的至少约33％。
23.根据权利要求18所述的组织移除导管，其中，所述径向最外侧部分与所述切削元件的内表面径向间隔开。
24.根据权利要求18所述的组织移除导管，其中，所述至少一个突出元件包括多个突出元件。
25.根据权利要求18所述的组织移除导管，其中，所述内表面的至少中央部分为大体杯状，所述组织移除导管还包括形成在所述内表面的至少中央部分上的多个研磨构件，其中，所述研磨构件适于在所述切削元件围绕其纵向轴线旋转时研磨硬化的组织。
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