CN100418484C - 具有不同的切割表面的介入导管 - Google Patents

具有不同的切割表面的介入导管 Download PDF

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CN100418484C
CN100418484C CNB2004800065049A CN200480006504A CN100418484C CN 100418484 C CN100418484 C CN 100418484C CN B2004800065049 A CNB2004800065049 A CN B2004800065049A CN 200480006504 A CN200480006504 A CN 200480006504A CN 100418484 C CN100418484 C CN 100418484C
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interposing catheter
cutting
catheter assembly
cutting component
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E·伍尔夫曼
C·托兰斯
B·尼斯塔尔
S·尤曼斯
M·赫夫纳
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Boston Scientific Ltd Barbados
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    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
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    • A61M2039/062Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
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Abstract

一种介入导管包括可前进、可旋转的操作头或切割器组件(50、72、80、120、140),该操作头或切割器组件具有一个或多个位于远端的倾斜角小于90度的不同的切割表面(52、74、82、124、145、154、164),倾斜角是切割表面与切割器组件圆周的切线相交的角度。固定的刀片切割器组件(50、72、80、120、140)具有多个带大口(68、125、143)的不同的切割表面(52、74、82、124、145、154、164),大口提供在邻近的不同的切割刀片之间,提供了通向密封腔和抽吸系统的路径。还提供了具有固定的刀片切割器组件(200)和可调节的刀片切割器组件(210)的双切割器组件。驱动轴从驱动系统为切割器组件提供旋转和转矩,且可以通过铰接轴承组件(250)连接到切割器组件。

Description

具有不同的切割表面的介入导管
参照相关申请
本申请要求在2003年3月10日提交的序号为No.60/453,846的美国专利申请,在2003年5月20日提交的序号为No.10/442,888的美国专利申请和在2004年1月20日提交的序号为No.10/760,759的美国专利申请的优先权。
技术领域
本发明涉及用于从哺乳动物对象的内腔或空腔,例如血管、胃肠道的一部分、与脊髓相关联的硬脊膜空间等处移除例如阻塞物和部分阻塞物的物质的系统。更特定地,本发明涉及具有可前进可旋转并包括不同的切割表面的操作头的介入导管。
背景技术
从内体腔或空腔中移除诸如动脉粥样硬化斑块、血栓和其他类型的阻塞物和部分阻塞物等疾病是沿用已久的介入技术。众多的介入导管被设计并开发出来。这些系统中的大多数需要在引入介入导管并在目标操作位置放置介入导管之前放置导向导管和导向线。可前进的旋转操作头已用于切割和/或切除阻塞物。许多这样的现有技术的系统包括抽吸系统以从该位置移除已切除的物质。
尽管移除物质的系统很多且多样,在提供用于从例如血管的内腔中安全地、可靠地且不造成并发症地移除物质的系统中存在很多挑战。系统的安全性和可靠性显然是关键的。回收在物质移除操作中生产的碎片,或将碎片浸软到不造成血管损伤或栓塞事故的微粒尺寸是必要的。介入导管的柔性和尺寸也是重要的特征。系统必须足够小和足够柔性,以能在有时是曲折的内部结构和通道,例如血管中行进,以放置在目标介入位置。介入导管还必须具有足够的刚度和完整性,使得在高旋转速度下操作可靠并允许在该位置抽吸和/或灌输流体。
在使用“切割头”的介入导管中,在操作头进出介入目标位置的行进中,任何切割器结构必须是的良性的,还要在操作中有效的移除物质。另外,切割器结构必须有效的移除疾病或不希望的物质而不损伤脆弱的邻近组织,例如血管壁或其他健康组织,这些组织经常围绕并可能连结在不希望的物质上。因此对于介入导管的切割器结构重要的是精确和可靠地区分疾病或不希望的物质和健康的组织。
根据不同的切割的原理操作的切割器组件已经被开发。不同的切割刀片在相对硬的基质上施加高的剪力以切割或切除相对硬的、非弹性的物质。较软的、弹性的结构,例如健康组织、血管壁等变形而不被不同的切割刀片切割,这降低了剪力并保护了弹性结构不致损伤。弹性较小的物质在被不同的切割刀片接触时不变形,剪应力因此施加在弹性较小的物质上以切割或刮掉并切除物质而不损伤附近的弹性组织。通过该方式,疾病的碎块、不希望的物质被不同的切割刀片移除,而更具弹性的、健康的组织不受损伤。
美国专利4,445,509中联系动脉粥样斑块旋切术装置描述了不同的切割。该专利描述了具有多个切割凹槽的切割器组件,每个切割凹槽具有根据不同的切割原理操作的刀片表面。凹槽的密度和刀片的倾斜角被披露是提供有效不同的切割的关键。特别地,在与组织的接触点,倾斜角或切割面和圆周的相交角度至少为90度并优选地为110度。切割凹槽的面还具有微小的凹陷曲率。
一些介入导管在切割表面上使用金刚砂粒以力图提供高度分割的小微粒尺寸的碎片。然而金刚砂粒不作为不同的切割器操作,因为根据它们在切割表面上的定位,它们的暴露的表面形成了随机的倾斜角或迎角,在不同的与组织接触点产生了不同的切割特征。因为不是所有的金刚砂粒表面都以不同的切割机理操作,金刚砂粒更可能损伤弹性的健康的组织,例如血管壁。
疾病或形成阻塞的不希望的物质的范围和坚固性在介入前经常不能很好的定性。因此虽然可以提供具有不同尺寸和物质移除特性的介入导管和切割器组件,甚至在物质移除系统中介入导管和切割器组件是可互换的,但是在插入装置前,很难确定哪种特征的组合在任何特定介入时将是最有效。已开发了不同的快速连接系统,以允许在单个的外科介入过程中移除和安装多个操作导管。这是不理想的,因为互换、收回和插入多个介入导管耗费时间,可能导致介入中失血的增加并增加操作的风险。很希望在单个介入操作导管中使用具有不同尺寸和不同物质移除特性的多个切割器组件。
特别地,希望使用在导管插入和移除程序中具有小直径,而当定位在目标位置时在操作程序中具有扩张以提供较大直径的切割器的切割器组件的介入导管。已经开发出许多用于介入导管的可扩张切割器组件。如下的美国专利披露了多个可扩张切割器组件的处理方法:6,565,588B1;5,540,707;5,192,291;5,224,945;5,766,192;5,158,564;4,895,560;5,308,354;5,030,201;5,217,474;5,100,425和4,966,604。
发明内容
本发明中的介入导管在其远端包括物质移除部件,此处被称为“切割器”或“切割器组件”或“操作头”。切割器组件可操作地连接在可旋转和可轴向平移的驱动轴和导管系统、驱动系统和控制系统上。“切割器组件”包括一个或多个位于远端的切割或切除表面或刀片,其可根据不同的切割原理操作。切割表面或刀片优选地充分的刚性,且多个刀片或切割表面优选地径向对称。不同的切割表面或刀片具有一个或多个有斜面的边缘,边缘具有小于90度的倾斜角或迎角,以提供有效的不同的切割。
在对不同的部件的描述中所使用的“近端”一词指沿着驱动轴和导管系统的路径朝向系统控制和操作者的方向,所使用的“远端”一词指沿着驱动轴和导管系统的路径朝向或超过切割器组件末端的远离系统控制和操作者的方向。通常,本发明的介入导管包括切割器组件,该切割器组件包括至少一个位于介入导管系统远端处或远端附近处的不同的切割表面。
虽然本发明的介入导管的“切割”表面或刀片可以是锋利的且可以实际上在目标位置“切”物质,但此处使用的术语“切”或“切割”指以切割、刮掉、切除、浸软和其他方法将不希望的物质分解为可移除微粒或较小的可移除物质单元。同样地,“切割器”、“切割器组件”、“切割表面”和“刀片”同样地指用于切割、刮掉、切除、浸软和其他方法将物质分解为较小块的结构。
本发明的切割器组件可以包括至少一个不同的切割表面,并通常包括多个不同的切割刀片。切割器组件可以具有固定的刀片和/或可调节的刀片。在一个实施例中,固定的刀片切割器组件包括多个不同的切割刀片和多个形成在相邻的不同的切割刀片之间的通常大的抽吸口。虽然在固定的刀片切割器组件中不同的切割表面是不可调节的,但是固定的刀片切割器组件由于通常卵圆形的或圆锥形的切割器组件外形,可以提供一个切割直径的范围。在另一个实施例中,多个可枢转的不同的切割刀片合并在可扩张的切割器组件上,该可扩张的切割器组件以较小直径状态行进到介入位置,然后在操作中在目标位置调节成较大的直径状态,并且最后以较小直径状态从介入位置收回。在另一个实施例中,本发明的切割器组件在双切割器组件中或复合切割器组件中包括固定的不同的切割刀片和可枢转的不同的切割刀片。
驱动轴从驱动系统向切割器组件传递旋转和转矩,它必须足够小和足够柔性,以在切割器组件行进到目标移除位置时通过小的和曲折的通道行进,且它还必须具有充分的机械完整性以传送高旋转和转矩负荷并在高真空度的抽吸回收环境中操作。在多种类型的具有可旋转操作头的介入导管中,多丝的螺旋线圈用作驱动轴。几个优选的驱动轴实施例将在下文中描述。
本发明的介入导管优选地含有抽吸系统,以从介入位置移除碎片,通常通过切割器组件处或在切割器组件附近的另一个部件中提供的一个或多个物质移除口抽吸。在物质移除操作中产生的碎片被流体(例如血液)带走,含有碎片的吸出物流体通过经由物质移除口抽吸并经由介入导管的密封腔回收被移除。密封腔可与真空源和吸出物收集系统连接。物质移除口可以布置在切割器组件的刀片表面之间并优选地具有大表面面积。
在切割器组件附近除抽吸外或作为抽吸的替代可提供液体注入。注入液体可用于提供附加的液体体积用来移除碎片,或运送润滑流体、治疗剂、对照剂等。在物质移除操作区域附近注入流体可能是希望的,因为这趋向于减小被移除物质的粘性,因此便于通过相对小直径的腔进行移除。注入液体还如希望地趋向于在移除物质操作中减少移除的血液的体积。根据一个实施例,形成在切割器组件驱动轴和导管之间的密封腔可以替代地和选择地用作吸出物移除系统和注入系统。密封腔因此可选择地连接在真空源和用于抽吸的吸出物收集系统上,以及用于注入液体的注入源上。因此可选择性地使用切割器组件上的口或附近的口作为抽吸和注入口。
本发明的介入导管还可以包括铰接轴承,其改进系统的柔性并便于在导向到介入位置和从介入位置导向出时切割器组件通过曲折的通道行进。轴承系统将本发明的切割器组件和操作头与驱动轴相连接,使得转矩和旋转从驱动轴到切割器组件传递。轴承系统还将切割器组件或操作头与静态导管系统,或外鞘相连接,外鞘提供密封腔并通常在介入导管的操作中不旋转。轴承系统在连接操作头、驱动轴和导管的连接处提供了增加的柔性,也提供了抽吸和/或注入流体的通道。
附图说明
图1示出了具有操作头的本发明的介入导管组件的典型部件,该操作头包括不同的切割表面和铰接轴承。
图2示出了在美国专利4,445,509中描述的现有技术的不同的切割器组件,其中不同的切割器刀片具有大于90度的倾斜角。
图3A示出了本发明的典型的固定的刀片切割器组件的放大的侧视图,该切割器组件具有多个不同的切割表面和抽吸口。
图3B示出了图3A中固定的刀片不同的切割器组件的放大的透视图。
图3C示出了图3A和3B中固定的刀片不同的切割器组件的放大的截面图,图示了具有小于90度倾斜角的不同的切割表面。
图4A和4B为示意图,该示意图图示了在相对弹性的表面上具有90度倾斜角(图4A)的不同的切割表面的效果,如应用于现有技术的装置上,还图示了具有60度倾斜角(图4B)的不同的切割表面,如应用于本发明的切割器组件上。
图5A和图5B示意性的图示了本发明的不同的切割器组件的截面图,该切割器组件具有三个不同的切割表面(图5A)和六个不同的切割表面(图5B)。
图6A和图6B图示了另一个具有多个不同的切割表面的固定直径切割器组件的实施例。图6A示意性的示出了切割器组件的等轴视图,图6B示意性的示出了切割器组件的远端视图。
图7A和图7B分别示意性地图示了另一个本发明的具有多个不同的切割表面的固定的刀片切割器组件实施例的远端和近端视图。
图8A和图8B图示了本发明包括不同的切割表面的附加类型的切割器刀片。
图9A和图9B示出了放大的本发明的在双切割器上包括两种类型的不同的切割表面的复合切割器组件示意图,切割器组件近端安装在铰接轴承上。图9A示出了装配状态下的不同的切割器和轴承组件,而图9B示出了分解的、未装配状态下的不同的切割器和轴承组件。
图10A和图10B是具有移除位置的冠状动脉的荧光分析X射线图像,其中图10A描述了在操作移除系统前几乎全部地广泛地阻塞的动脉,图10B描述了使用本发明的介入导管组件后清除过的动脉。
图11A-11C示出了在例2中描述的具有多种特征的切割器组件在实验室染色的牛大动脉模型上的操作结果。图11A示出了在操作具有多个倾斜角为90度的切割表面的切割器组件后对牛大动脉的损伤。图11B示出了在操作外操作表面上具有随机定位的金刚砂粒微粒的切割器组件后对牛大动脉的损伤。图11C示出了操作具有多个倾斜角为60度的不同的切割表面的切割器组件的结果,并论证牛大动脉没有因该切割器组件而受到损伤。
图12A-12F示出了在例3中描述的在猪血管中操作具有多种特征的切割器组件的结果。
具体实施方式
适合于与本发明的部件联合使用的典型的介入导管和物质移除系统、部件和子组件在通过参考合并在此处的公布中已披露和描述,包括美国专利6,565,588B1和PCT专利公布WO 01/76680。此处描述的切割器组件和轴承组件可与具有多种驱动、控制和其他系统的介入导管共同使用。切割器组件在介入导管的远端处或远端附近提供,经过内部通道,例如血管导向到希望的物质移除位置或从希望的物质移除位置导向出,如本领域中的普通技术人员所知。在目标移除位置,切割器组件被开动进行切割、磨碎或切除,或其他分离,以及分解不希望的阻塞物质。在许多实施例中,阻塞物质通过抽吸系统或其他碎片移除系统从该位置移除。
图1图示了典型的本发明的介入导管和操作系统。在图1所示的介入导管和控制系统中,提供控制台单元102以容纳某些动力、控制和显示功能。控制台102可以具有可调节的控制,它允许操作者调节介入导管的操作参数。控制特征可以包括系统开/关开动器、用于调节切割器组件的旋转转矩的可选择转矩按键、在切割器组件开动中提供固定和/或可变旋转速度的可选择旋转特征、切割器组件在开动中实时旋转速度的显示、用于显示实际切割器操作时间长度的定时器控制和/或开动时间计数器、仅控制激活或关闭旋转驱动系统而不影响抽吸和/或注入的电动机、仅控制激活或关闭抽吸和/或注入功能而不影响旋转驱动的抽吸和/或注入等。
在图1所示的实施例中,抽吸或真空电动机104安装在控制台102上或控制台102内,同样地安装液体/碎片收集容器106和液体供给108。动力连接器110为其他介入导管部件提供动力。提供合适的电气和液体流管道以在控制台102和导管控制模块112之间实现可操作的连通。在本实施例中,控制模块112容纳用于旋转介入导管的切割器组件的电动机驱动器,控制模块112还合并某些连接器和系统,用于传达转矩和旋转到具有操作头的驱动轴上,例如安装在驱动轴远端或远端附近的可旋转切割器组件,和用于方便液体注入到操作头和/或从操作头移除液体和碎片。控制模块112还包括通常以114标出的、便于轴向平移介入导管的系统,和操作头116,例如具有至少一个不同的切割表面的可旋转、可前进的进出内部目标移除位置的切割器组件。此处描述的铰接轴承可以合并在操作头附近,以在介入导管的远端部分提供更大的柔性。
在图1中图示的介入导管系统中,某些动力、控制和显示功能在控制台102和导管控制模块112中分开提供。被认识的是这些动力、控制和显示功能可以在单个单元中提供,或可以被分开在多个控制单元中。类似地被认识的是本发明的切割器组件和不同的切割表面可以合并在具有不同类型动力、显示和控制系统并提供不同功能的介入导管中。本发明的不同的切割表面可以合并在任何类型的用于移除位于人或动物体内不希望的物质的介入导管中。
本发明的介入导管的操作头可以包括多种切割装置或组件中的任何一种,这些切割装置或组件具有一个或多个坚硬的和/或锋利的切割表面,用于在目标移除位置附近切割、分裂、研磨、切除、刮掉、磨碎或其他操作,以减小不希望物质的尺寸和/或从健康组织,例如血管壁分离不希望物质。例如切割表面可以含有刀片、弹簧、金属或陶瓷或具有至少一个根据不同的切割原理操作的表面的复合表面的一个或组合。
一些典型的构建切割器组件的切割表面的材料包含金属、金属合金、陶瓷和金属陶瓷材料,例如但不局限于多种类型的、例如300和/或400系列的不锈钢、钒钢、镍钛合金、钛、含钛金属和氧化物陶瓷。对金属材料,例如不锈钢可以使用已知的技术进行硬化。通常切割器表面由坚硬的材料构建,并可以经处理被赋予切割器表面更高的硬度。通常提供由比用于构建血管支架材料更硬的材料构建的切割器表面。切割器组件或切割器组件的子部件,例如切割表面,可以涂覆有射线不能穿透的材料,例如金、铂、墨等,以使得可扩张的切割器组件具有放射观察可见性并辅助医疗专业人员相对于阻塞导向和定位切割器组件。
图2图示了放大的现有技术的根据美国专利4,445,509(以下称为“‘509专利”)不同的切割器表面的截面图。提供了多个带有相应的切割面18的切割凹槽14。提供了流体口15作为具有向后方或纵向部件的通道,且意图用于从介入位置回收流体和碎片到腔40。切割器组件如图示在移除物质的操作中在顺时针方向旋转。倾斜角图示为角α,是切割面18与圆周C相交的角度,或与切割器组件圆周C切线相交的角度。根据‘509专利,倾斜角大约110度,倾斜角从110度偏离大约20度提供可接受的不同的切割特性。
图3A-3C图示了根据本发明的具有多个不同的切割表面的固定的刀片切割器组件。切割器组件50包括多个相对于切割器组件中央纵轴线径向对称布置的切割器刀片52。切割器刀片52的每个在远端连接,以形成远端孔54,当在物质移除操作中使用了导向线时,它用作导向线的旋转轴承。在使用中不利用导向线导向的切割器组件中,切割器刀片52可选择地在其远端终止为钝的或尖的结构,而不形成远端孔。切割器刀片52在其近端终止在近端环状圈55中,该圈安装在驱动轴、导管系统或中间的轴承结构上,该中间的轴承结构在切割器组件、驱动轴和导管系统之间提供可操作的连接。
切割器组件50的总外部构造通常在轴向图中是圆形的,在剖视图中是椭园形或截头圆锥形。切割器刀片52的外缘沿在直径较小的远端孔54和直径较大的近端圈55之间的曲线逐渐减少。该构造允许切割器组件的直径较小的远端穿过阻塞物或部分阻塞物,且当切割器组件前进通过阻塞物时,因为切割器组件的直径朝向其远端方向增大,提供了逐渐增大的孔。刀片轮廓的内部弯曲的形状通常与刀片的外部弯曲轮廓相符合。在许多实施例中,切割器刀片52在近端圈55和远端孔54之间具有通常不变的弦,提供了坚固而薄的刀片。
由邻近的切割器刀片52对和远端和近端环的边界形成的口68是大的且通常为具有曲边的三角形构造。口68提供了通向内部空间和在物质移除操作中用于移除流体和碎片的抽吸腔的路径。因为本发明的包括不同的切割表面的切割器刀片可被提供为薄刀片,口的尺寸可以最大化。口的总截面积与本发明的切割器组件中切割器刀片内表面总截面相比通常至少为1.5∶1,优选地至少为2∶1,更优选地为至少2.5∶1,更优选地还为至少3∶1。
切割器刀片52的每个具有不同的切割器表面56,当物质移除操作中切割器组件50被旋转时它与待移除的物质相接触。在图3A-3C中示出的切割器组件的实施例中,切割器组件50构造为在逆时针方向旋转。本发明的不同的切割器表面具有倾斜角α,该角是切割器表面56与切割器组件圆周的切线相交的角度,小于90度。在本发明的一些切割器表面实施例中,倾斜角小于80度;在本发明的其他切割器表面实施例中,倾斜角小于70度;还在本发明的其他切割器表面实施例中,倾斜角小于60度;在本发明的可替代的切割器表面实施例中,倾斜角小于50度;仍然在本发明的其他切割器表面实施例中,倾斜角小于40度。倾斜角通常大于15度,可以大于25度,且经常大于30度或40度。
对于用于不同类型的切割环境、不同的被移除物质的类型和不同的应用,通过提供不同的倾斜角,不同的切割器表面可以被优化,只要不同的切割的倾斜角小于90度。由于具有小于90度的倾斜角的不同的切割器表面提供更有效的不同的切割,在移除物质的操作中可以需要较少的切割器表面。通常在具有较少的刀片的切割器组件中,刀片具有薄的截面尺寸,允许较大的抽吸口和更高的抽吸效率。本发明的切割器组件在提供对弹性较小的、疾病组织的有效移除并提供用于移除碎片的高抽吸速率时,对健康的、弹性的组织是良性的。
切割器表面56可以提供在为平坦表面的前缘刀片表面58上。后缘刀片表面60可以包括由两个或多个邻接的、互相具有角度的表面62和64所组成的复合表面。在图3A-3C中示出的实施例中,前缘刀片表面58比后缘刀片表面60长,且前缘刀片表面58在内部区域以大致直角与后缘刀片表面60相交。刀片52的外终端缘66形成在切割器表面56和后缘刀片表面60的相交处,优选地相互形成锐角并优选地被磨锋利。在本发明的切割器组件的许多实施例中,前缘刀片表面和后缘刀片表面都不相对于切割器组件纵轴线径向对齐。
图4示意性地图示了具有90度倾斜角的刀片70在逆时针方向旋转的切割动作(图4A)和具有60度倾斜角的刀片71在逆时针方向旋转的切割动作(图4B)。具有60度倾斜角的不同的切割刀片71,如图4B中所示,当它接触到有弹性的表面时是柔和的、良性的,但是它有效地切割和切除弹性较小的物质以提供有效的疾病物质移除,例如斑块、钙化物质和血栓。具有90度的倾斜角的切割刀片70,如图4A中所示,可能对弹性表面造成相当的损害。在下文中的例2中描述的实验室试验提供了确认具有60度倾斜角的切割刀片与具有90度倾斜角的切割刀片相比特性改善的数据。
图5A和图5B图示了具有不同个数和布置的不同的切割表面的切割器组件。在本发明的切割器组件和介入导管中可以使用任何个数的切割器刀片。具有三个、五个、六个和七个径向对称的切割器刀片的切割器组件对于许多应用是特别优选的。
图5A示出了具有三个径向对称切割器刀片74的切割器组件72,当切割器组件72在顺时针方向被旋转时,切割器刀片74可提供不同的切割。切割器刀片74在远端终止于远端孔75,在近端终止于近端圈。切割器表面77具有小于90度的倾斜角α。在为平坦表面的前缘刀片表面78上提供切割器表面77。后缘刀片表面79具有渐缩的构造。在图5A所示的实施例中,前缘刀片表面78比后缘刀片表面79长,且前缘刀片表面78在内部区域中以钝角与后缘刀片表面79相交。
图5B示出了具有六个径向对称的切割器刀片82的切割器组件80的实施例,当切割器组件80在顺时针方向被旋转时,切割器刀片82提供不同的切割。切割器刀片82在远端终止于远端孔83,在近端终止于近端圈。切割器表面85具有小于90度的倾斜角α。在为平坦表面的前缘刀片表面86上提供切割器表面85。后缘刀片表面87具有渐缩的或复合的构造。在图5B所示的实施例中,前缘刀片表面86在内部区域中以锐角与后缘刀片表面87相交。
图6A和图6B又图示了另一个具有多个切割刀片122的切割器组件120,为每个切割刀片提供有不同的切割表面124。切割器组件120具有七个以径向对称布置提供的切割器刀片,在每个邻近的切割器刀片对之间提供有口125。口125是大的且通常具有带弯曲壁的卵圆形的构造。切割器组件120在顺时针方向上可旋转,以提供不同的切割。
切割器刀片122在远端终止于远端孔126,在近端终止于近端圈128。切割器表面124具有小于90度的倾斜角α。在为平坦表面的前缘刀片表面131上提供切割器表面124。后缘刀片表面130具有渐缩的或复合的构造。在图6A和图6B所示的实施例中,切割器表面124的缘129在它们最大直径点延伸超过近端圈128的直径。缘129沿着它的在远端孔126和近端圈128之间的长度具有弯曲的形状,该弯曲形状延伸到比近端圈128更大的直径,然后渐缩以连接到近端圈128。切割器刀片形状允许有效的移除物质,以形成穿过阻塞物的通道,其在直径上比切割器组件的近端圈大并促进侧面切割。对于用于其中切割器组件由远程操纵技术导向而非在导向线上向前移动的介入导管系统中,该切割器刀片形状可以是特别有利的。
图7A和7B又图示了另一个具有多个不同的切割刀片142和抽吸口143的切割器组件140。在这个实施例中,前缘刀片表面144和后缘刀片表面146提供了不同的切割表面,且前缘刀片表面和后缘刀片表面都可以是复合表面。前缘刀片表面144形成了不同的切割表面145,而后缘刀片表面146形成了不同的切割表面147。不同的切割表面145和147都具有小于90度的倾斜角α,以提供有效和安全的不同的切割特性。
当切割器组件140分别在顺时针和逆时针方向被旋转时,不同的切割表面145和147操作。当与双向电动机驱动器联合使用时,在切割刀片的前缘刀片表面和后缘刀片表面上提供不同的切割表面显著地增加了切割器组件的多功能性。在优选的实施例中,不同的切割表面145和147具有不同的倾斜角以提供区别的不同的切割特性。不同的切割表面145可以具有大于大约70度而小于90度的倾斜角,而不同的切割表面147可以具有大于30度而小于70度的倾斜角。操作者可以选择驱动轴和切割器组件旋转的方向,以在物质移除过程中使用具有最适合移除特定物质的不同的切割特性的不同的切割器刀片。可以在具有双不同的切割表面的不同的切割刀片中使用不同的切割器刀片和具有各种倾斜角的不同的切割表面的各种组合。
上文中描述的固定的刀片切割器组件具有多个切割器刀片和多个不同的切割器表面。切割器组件和切割器刀片可以以各种构造提供,呈现出各种外部形状,且具有各种口表面积与内部刀片表面积的比值。通常,在每个刀片上具有单一的不同的切割表面的切割器组件中提供多个不同的切割表面,每个不同的切割表面具有相同的倾斜角。在可替代的实施例中,不同的倾斜角可以提供在形成切割器组件的单独的切割刀片上的单一不同的切割表面上。因此,例如可以提供具有六个径向对称的切割器刀片的固定的刀片切割器组件,它具有三个带有具有小于90度的第一倾斜角的不同的切割表面的切割器刀片,且具有三个带有具有小于90度并与第一倾斜角不同的第二倾斜角的不同的切割表面的切割器刀片。具有带有不同倾斜角的不同的切割表面的切割器刀片优选地的提供在替代的布置中。
图8A和图8B又图示了附加类型的不同的切割刀片150和160,它们可以作为枢转不同的切割刀片用于例如可扩张的切割组件类型中,这将在下文中更详细的描述。不同的切割刀片150通常包括在其外围缘上具有不同的切割表面154的平坦表面152。平坦表面152可以安装在或整合在用于将刀片150安装在切割器组件结构上的安装片或杆156上。不同的切割刀片160包括在外围缘上具有不同的切割表面164的通常平坦的表面162,和用于将刀片160安装在切割器组件结构上的安装杆166。不同的切割表面154和164具有如上定义的小于90度的倾斜角。
不同的切割表面的形状可以是对称的,如以图8A中的不同的切割表面154为例,或是不对称的,如以图8B中的不同的切割表面164为例。尽管可以使用各种不对称表面构造,但通常提供当组装在切割器组件上时在切割器刀片的远端面168附近具有较大直径形状的不对称切割表面。不同的切割表面优选地大致沿着切割刀片150和160的外围缘提供,且可以延伸例如超过切割器刀片162的远端面168。切割器刀片152和162可以具有大致遍及其本体的恒定的厚度,在不同的切割表面154和164上分别减小厚度,在切割表面的外围缘形成锋利的缘。可替代地,切割器刀片152和162可以具有遍及其本体的变化的厚度,且可以连续地或可变地朝向不同的切割表面154和164逐渐减少。
与平坦表面152和162相对的表面(未绘出)可以在其整个表面上是平坦的并没有逐渐减小而终止于外围表面154和164。可替代地,相对的表面在其外围缘附近可以具有不同的切割表面,以提供具有双不同的切割器表面的切割器刀片150和160。在双不同的切割器构造中,切割器刀片可以在驱动电动机的任一旋转方向以不同的切割表面运转。如上所述,在双不同的切割器构造中,相对切割器表面可以具有不同的、全都小于90度的倾斜角,以提供增加的切割器组件的多功能性。虽然切割器刀片150和160如图示具有实心表面,且这个实施例优选于许多应用中,但可以提供可替代的实施例,其中切割器刀片150和160在其平坦表面上具有切下的部分或空腔。
图9A和图9B图示了双不同的切割器组件,该双不同的切割器组件具有固定的不同的切割器组件200,以扩张直径状态示出的、其中刀片以径向构造的可调节不同的切割器组件210和在切割器组件、驱动轴和导管组件之间连接的轴承250。固定切割器组件200优选地提供在组件的远端,可调节的切割器组件210近端安装到固定切割器组件。合适的固定切割器组件在上文中已经描述。在图9A和图9B中所示的实施例中,提供在固定的切割器组件和不同的切割器组件上的不同的切割刀片具有近似相等的长度。在可替代的实施例中,在固定或可调节的刀片切割器中任一上的不同的切割刀片可以具有不同的长度。
可调节的直径不同的切割器组件210包括多个通常为平坦的切割器刀片212,每个刀片具有至少一个大致沿外围缘延伸的不同的切割表面214。不同的切割表面214具有小于90度的倾斜角,如上文中详细描述。通常,在可调节切割器组件210上可以提供从三个到七个或更多的可枢转不同的切割刀片。不同的切割表面214的倾斜角可以与提供在固定的不同的切割器组件200上的不同的切割表面的倾斜角相同或不同。在优选的实施例中,不同的切割表面214的倾斜角小于提供在固定的不同的切割器组件200上的不同的切割表面的倾斜角。
切割器刀片212的安装杆216枢转地安装在可调节切割器支撑件220的配合槽218中,可调节切割器支撑件220具有与远端切割器中央孔和轴承组件250的中央孔连通的中央通道222。中央通道222通常形成抽吸和/或注入腔的一部分。切割器支撑件220构造为在切向位置支撑切割器刀片212,其中切割器刀片平躺靠在支撑面上,以呈现较小直径外形,并构造为在径向位置支撑切割器刀片212,其中切割器刀片沿径向延伸,以呈现较大直径、不同的切割的外形。切割器刀片可以在切向和径向定位之间通过改变驱动系统的旋转方向来调节,或使用替代机构来调节。抽吸和/或注入口可以提供在切割器支撑件220中。附加的涉及此类可调节切割器组件的结构和功能的细节在美国专利6,565,588B1和PCT国际专利公布WO 01/76680A1上有描述。
轴承组件250提供了可操作的连接,将操作头,例如双切割器组件200和210直接地或间接地连接到为操作头传送转矩和旋转的驱动轴。轴承组件还可以直接地或间接地可操作地连接到提供了抽吸和/或注入液体的密封腔的静态(不旋转)导管系统。轴承系统250以铰接连接,当操作头出入物质移除位置行进时,以提高操作头的总的柔性和导向性,并且提供了通过轴承系统的抽吸和/和注入液体的内部通道。
轴承系统250包括在近端262直接地或间接地连接在驱动轴上,而在远端264直接地或间接地连接在操作头上的内轴260。轴承系统250另外包括作为外轴套提供的圆柱形的静态构件280,它在近端或近端附近固定地连接到导管系统的远端,以提供密封腔和导管系统。内轴260和静态构件280可操作地通过一个或多个连接结构连接,例如保持在形成在静态构件280内的槽284中的杆282。
静态构件280安装在内轴260的外围表面上,使得杆282保持在槽284中且安放在形成在内轴260上的弯曲的环形座266中。弯曲的环形座266具有可变直径,中央较小的直径部分在远端和近端方向分别张开为较大直径远端和近端边界268和270。杆282安放在弯曲的环形座中以提供内轴260和操作头相对于静态构件280和导管组件的有限的枢转。弯曲的环形座的形状和深度可以调节且构造为提供希望的铰接角度。轴承系统因此提供了操作头相对于导管组件的有限的铰接,并便于操作头出入目标物质移除位置的行进,还便于在目标物质位置操作操作头以切除阻塞物质。
用于本发明的介入导管的驱动轴通常包括螺旋线圈或编织轴,可以包括在沿轴长度的不同部分具有可变柔性和/或转矩输送能力的复合驱动轴。在一个实施例中,提供了螺旋线圈驱动轴,它在近端部分具有较小的柔性和较大的转矩输送能力,在远端部分具有较大的柔性和较小的转矩输送能力。驱动轴的近端部分可以包括与形成驱动轴远端部分的螺旋线圈轴相比具有更多线(file)的螺旋线圈轴。在一个实施例中,近端驱动轴部分包括三丝或四丝的螺旋线圈,而远端驱动轴部分包括双丝或三丝的螺旋线圈。在具有编织结构的驱动轴中,近端驱动轴部分比远端驱动轴部分包括更多的股。
在另一个实施例中,近端驱动轴部分包括多丝的螺旋线圈,其中邻近的线间距紧密,而远端驱动轴部分包括单丝或多丝的螺旋线圈,其中邻近的线相互之间的间距至少对应于线的直径。根据远端驱动轴部分柔性和转矩承载的需求,间距可以更大。优选的驱动轴可以包括具有带有分离布置的线并在线上安装有密封构件的螺旋线圈的远端部分。密封构件优选地不粗于驱动轴线的直径,并由可耐久的、柔性的塑料材料例如聚四氟乙烯(PFTE)构成。可以安装可热缩的PFTE管并使其收缩,以通常适应远端驱动轴的分离布置的线的构造,以提供密封的远端驱动轴腔并改进远端驱动轴部分在出入目标物质移除位置行进中的润滑性。外部密封层可以从驱动轴远端处延伸从大约2cm到大约40cm的距离,更优选地从驱动轴远端处延伸从大约5cm到大约15cm的距离。
已使用如此处所述的具有不同切割表面的介入导管进行了多个试验。例如,该系统被用于治疗天然冠状动脉中的急性冠状动脉综合征和急性心肌梗塞。另外,该系统已被用于准备闭塞的隐静脉移植,以容纳支架。如下描述的例1示出了物质移除操作前后血管的图像,例2描述了证明本发明的介入导管组件的抽吸效率的实验室试验。
例1
图10A和图10B是显示了使用本发明的介入导管组件的结果的荧光分析X射线图像。图10A示出了几乎全部地广泛地阻塞的、具有冠状动脉搭桥移植的动脉。为患者注射离子对照剂以显示血流和阻塞。
本发明的介入导管系统用于清除阻塞物,通常随后插入支架。导向导管插入到患者体内,导向线被引导到动脉内的目标位置。切割器以35000到40000rpm的转速旋转并在目标位置抽吸。切割器以施加的小力前进进入病变持续大约3秒钟,速率为每秒1mm。暂停前进移动,以使得切割微粒被抽吸到切割器组件内部然后重复进行前进移动。在该区域内施加对照剂以显示切割的中间结果并决定在进一步进入目标位置时是否使用可调节切割器的扩张直径。在目标位置插入支架。图10B示出了图10A中相同的动脉和冠状动脉搭桥移植,随后使用此处所述的介入导管组件移除阻塞物,随后插入支架。
例2
图11A-图11C示出了在实验室染色的牛大动脉模型中操作具有多种特征的切割器组件的结果。牛大动脉的纵向切片用作试验样本。用水润滑组织表面。切割器组件相对于组织表面45度角定位。切割器偏置进入组织表面并前后运行2到3次。组织以传统绿色食物着色染色并观察。在其他试验中,硝酸银可用作染色剂。
图11A示出了在操作具有多个倾斜角为90度的切割表面的切割器组件后对牛大动脉的损伤。图11B示出了在操作具有外部操作表面上带有随机定向的金刚砂粒微粒的切割器组件后对牛大动脉的损伤。图11C示出了具有多个具有60度倾斜角的不同的切割表面的切割器组件的操作结果,并证明了该切割器组件没有对牛大动脉造成损伤。所有切割器组件具有固定的最大直径1.75mm。
例3
图12A-图12F示出了在没有病变的猪血管内操作具有多种特征的切割器组件对血管壁的损伤结果。在5个猪动物对象的右侧冠状动脉和左回旋枝动脉上使用了根据本发明的双不同的切割器组件。对象的左前降枝动脉用作控制。
开动切割器组件以在目标位置旋转切割器并执行抽吸。固定切割器首先以直径1.75mm用作主要切割器。切割器行进2.5至5mm行程然后收回。在目标位置注射标准对照剂以检测血管的痉挛。当检测到血管痉挛后,过程暂停或在该位置注射硝化甘油以缓解痉挛。可调节的切割器用作主要切割器,用于下面以2.5mm直径通过。
令动物存活28天以允许任何血管损伤或再狭窄得以出现。将动物处死并作血管的截面切片。通过荧光透视法成像。血管病理学显示非常小的血管壁损伤。所有动脉完全地治愈,看来没有出现发炎变化或血栓的迹象。
本发明已根据特定的实施例和图进行描述。特定的实施例不应该解释为对发明范围的限制,而仅是对典型的实施例的阐述。进一步需要理解的是可对描述的介入导管和控制系统进行许多的变形、附加和替代,而不偏离本发明的广泛范围。

Claims (31)

1. 一种介入导管组件,其包括
a.可操作的与驱动系统连接的可旋转驱动轴;以及
b.包括至少一个倾斜角小于90度的不同的切割表面的切割器组件,倾斜角是切割表面与切割器组件圆周的切线相交的角度。
2. 如权利要求1所述的介入导管组件,另外包括将切割器组件连接到驱动轴和介入导管的密封腔的轴承系统,轴承系统提供切割器组件相对于驱动轴轴线的有限的铰接。
3. 如权利要求1所述的介入导管组件,其中切割器组件包括固定的刀片切割器组件,其具有多个固定的切割器刀片,每个具有至少一个不同的切割表面,该不同的切割表面相对于切割器组件中央纵轴线径向对称布置。
4. 如权利要求3所述的介入导管组件,其中固定的刀片切割器组件的外部形状在剖视图上看为卵圆形或圆锥形。
5. 如权利要求3所述的介入导管组件,其中固定的不同的切割表面沿切割器组件的较小直径的远端和较大直径的近端之间的弯曲线逐渐缩小。
6. 如权利要求1和3至5中任一项所述的介入导管组件,另外包括含有可连接到真空源的密封腔的抽吸系统,其中切割器组件另外包括多个口,提供通向密封腔的路径。
7. 如权利要求6所述的介入导管组件,其中口的总横截面积与内部切割器刀片表面的总横截面积之比至少为1.5∶1。
8. 如权利要求3所述的介入导管组件,其中每个不同的切割表面提供在平坦的前缘刀片表面上。
9. 如权利要求3所述的介入导管组件,其中每个不同的切割表面提供在切割器刀片的外终端缘上,且在不同的切割表面和后缘刀片表面之间形成的角是锐角。
10. 如权利要求9所述的介入导管组件,其中使每个切割器刀片的外终端缘锋利。
11. 如权利要求3所述的介入导管组件,其中每个不同的切割表面提供在切割器刀片上,每个切割器刀片在近端终止于近端圈,每个不同的切割表面具有的外部形状在其最大直径处大于近端圈的直径。
12. 如权利要求1所述的介入导管组件,其中至少一个不同的切割表面提供在平坦的刀片表面的外围缘上,平坦的刀片表面可枢转地安装在切割器组件结构上。
13. 如权利要求12所述的介入导管组件,其中不同的切割表面沿其长度关于切割器组件中央轴线对称。
14. 如权利要求1所述的介入导管组件,其中切割器组件为双不同的切割器组件,该双不同的切割器组件具有包括多个倾斜角小于90度的不同的切割表面的固定的刀片切割器组件,还具有带有多个可调节的刀片的可调节的刀片切割器组件。
15. 如权利要求14所述的介入导管组件,其中可调节的刀片切割器组件具有多个径向布置的、可在切向和径向之间枢转调节的切割器刀片。
16. 如权利要求14所述的介入导管组件,其中可调节的刀片具有不同的切割表面,且固定的刀片切割器组件上的不同的切割表面和可调节的刀片切割器组件上的不同的切割表面具有不同的倾斜角。
17. 如权利要求1所述的介入导管组件,其中驱动轴在近端部分具有较小的柔性和较大的转矩输送能力,在远端部分具有较大的柔性和较小的转矩输送能力。
18. 如权利要求17所述的介入导管组件,其中驱动轴为螺旋线圈,且在驱动轴远端部分,组成螺旋线圈的线相互之间分离的间距至少对应于线的直径。
19. 如权利要求18所述的介入导管组件,另外包括安装在驱动轴远端部分上的密封构件,其中密封构件与驱动轴远端部分紧密接触但不结合在驱动轴远端部分上。
20. 如权利要求19所述的介入导管组件,其中密封构件由可耐久的柔性塑料材料形成。
21. 如权利要求20所述的介入导管组件,其中密封构件由聚四氟乙烯形成。
22. 如权利要求1所述的介入导管组件,另外包括与可旋转驱动轴连接的控制台单元,其中控制台单元容纳动力、控制和显示功能。
23. 如权利要求1所述的介入导管组件,另外包括控制模块,其中控制模块容纳可操作的与可旋转驱动轴连接的驱动电动机。
24. 如权利要求1所述的介入导管组件,包括至少一个倾斜角小于70度的不同的切割表面。
25. 如权利要求1所述的介入导管组件,另外包括用于操作驱动轴和切割器组件的控制系统,其中控制系统包括可选择的转矩特征部,以调节切割器组件的旋转转矩。
26. 如权利要求1所述的介入导管组件,另外包括用于操作驱动轴和切割器组件的控制系统,其中控制系统包括可选择的旋转特征部,以在切割器组件开动中提供固定的和/或可变的旋转速度。
27. 如权利要求1所述的介入导管组件,另外包括用于操作驱动轴和切割器组件的控制系统,其中控制系统包括仅控制激活或关闭驱动轴而不影响抽吸和/或注入流体的电动机。
28. 如权利要求1所述的介入导管组件,另外包括用于操作驱动轴和切割器组件的控制系统,其中控制系统包括仅控制激活或关闭抽吸和/或注入流体而不影响驱动轴的控制功能。
29. 如权利要求1所述的介入导管组件,其中切割器组件包括具有多个相对于切割器组件中央纵轴线径向对称布置的可调节的不同的切割表面的可调节的刀片切割器组件。
30. 如权利要求29所述的介入导管组件,另外包括控制特征部,用于在较大直径和小直径状态之间调节刀片切割器组件。
31. 如权利要求1-5的任一项所述的介入导管组件,另外包括用于在切割器组件附近注入液体的液体注入系统。
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ATE405226T1 (de) 2008-09-15
US7344546B2 (en) 2008-03-18
US20080228208A1 (en) 2008-09-18
US7674272B2 (en) 2010-03-09
US10149698B2 (en) 2018-12-11
US20040006358A1 (en) 2004-01-08
US20040220519A1 (en) 2004-11-04
US7485127B2 (en) 2009-02-03
US20110112562A1 (en) 2011-05-12
US7713231B2 (en) 2010-05-11
US20130345676A1 (en) 2013-12-26
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US8951224B2 (en) 2015-02-10
US8323240B2 (en) 2012-12-04
US20040236312A1 (en) 2004-11-25
US20150164542A1 (en) 2015-06-18

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