CN102625673B - 用于切割和研磨组织的方法及装置 - Google Patents

用于切割和研磨组织的方法及装置 Download PDF

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CN102625673B
CN102625673B CN201080026742.1A CN201080026742A CN102625673B CN 102625673 B CN102625673 B CN 102625673B CN 201080026742 A CN201080026742 A CN 201080026742A CN 102625673 B CN102625673 B CN 102625673B
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cutting element
conduit
lapped face
described cutting
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J·莫伯格
A·杨
C·布罗德
W·惠伦
K·李
P·然
D·杜德
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783Atherectomy 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
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    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783Atherectomy 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
    • A61B2017/320791Atherectomy 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

本发明提供了一种具有切割元件的旋切术导管,所述切割元件能够切割软组织和硬组织,并且本发明提供了使用旋转的切割元件从血管腔管切割材料的方法。切割元件具有围绕杯状表面的锋利的切割刃以及至少一个研磨材料的表面。杯状表面将切割的材料引导到组织腔中。切割刃和杯状表面一起特别适于从血管切割和移除较软的组织。研磨材料表面与切割元件相结合特别适于从血管研磨和移除硬材料。

Description

用于切割和研磨组织的方法及装置
相关申请的交叉引用
本申请要求2009年4月29日提交的名称为“用于切割/研磨组织的方法及装置”的美国临时专利申请No.61/173,845的权益,该申请的内容在此通过参引的方式并入本文。
技术领域
本发明涉及用于从身体腔管中的位置移除材料的导管。更具体地,本发明涉及能够从该位置移除软材料和硬材料的切割装置。
背景技术
动脉粥样硬化是一种血管系统的渐进性疾病,其中动脉粥样化沉积在血管的内壁上。随着时间推移,动脉粥样化沉积物可能变大到足以减小或栓塞血液流过血管,从而引致低血流量的症状,比如腿部中的疼痛(在走动或休息时)、皮肤溃疡、心绞痛(在休息或劳累时)、以及其他症状。为了治疗这种病症并且改进或消除这些症状,理想的是恢复或提高通过血管的血流量。
多种方法被用于恢复或提高通过动脉粥状硬化血管的血流量。动脉粥状化沉积物能够通过利用充气囊、扩展支架以及其他方法径向地扩展血管而移位。但是,这些方法不理想地撕扯和拉伸血管,从而在较高百分比的病人中导致疤痕形成。这种疤痕组织(再收窄材料)一旦形成就阻塞血管中的流动而常常需要被移除。能够使用激光和其他方法来粉碎沉积物。但是,仅仅粉碎动脉粥状化材料允许微栓子向下游流动并且停留在远侧血管床中,从而进一步危及血液向受该疾病影响的组织流动。旋切术导管能够用于将动脉粥样化沉积物从血管移除并且能够在从血管移除的动脉粥样化碎片被捕获且被从身体移除时呈现为理想的解决方案。
在将材料从血管移除时出现的一个问题是材料可能为软的或硬的。通常,再收窄疤痕是软而韧的,而动脉粥样化在织构上从软且小的结构变化到软而纤维化、到密集纤维化(硬)。这些再收窄的或动脉粥样化组织中的任一个或全部均可以钙化,并且钙化的组织可能极硬。需要从血管切除的材料的硬度和韧性可以沿着血管的长度改变、绕血管的周向改变、或者既沿着血管的长度改变也绕血管的周向改变。另外,待治疗的血管部分可能非常广。例如,待治疗的血管部分可能在200mm或更长的血管长度上延伸。这样,旋切术导管的切割元件应当能够切割硬组织和软组织。
发明内容
本发明提供了一种旋切术导管,包括:具有开口的本体;联接到所述本体上的可旋转轴;组织收集腔,所述组织收集腔联接到所述本体上并且在所述切割元件远侧定位;以及切割元件,所述切割元件联接到所述可旋转轴上,用于使所述轴绕纵向轴线旋转,所述切割元件具有杯状表面和切割刃,所述杯状表面构造为当所述杯状表面沿远侧方向移动时沿所述远侧方向再引导被所述切割刃切割的组织,并且所述切割元件具有至少一个研磨表面。本发明还提供了一种从身体腔管移除材料的方法,所述方法包括:提供旋切术导管,将所述导管置于身体腔管中;以及在所述身体腔管中移动所述导管,以使所述切割元件与所述身体腔管中的材料相接触。
本发明提供了一种具有切割元件的旋切术导管,所述切割元件能够切割软组织和硬组织;并且本发明提供了使用旋转切割元件从血管腔管切割材料的方法。所述切割元件具有围绕杯状表面的锋锐的切割刃以及至少一个研磨材料的表面。所述杯状表面将切割的材料引导到组织腔中。周向切割刃和杯状表面一起特别适于从血管切割和移除较软的组织。研磨材料表面与切割元件相结合特别适于从血管研磨和移除硬材料。
从下面对优选实施例、附图和权利要求的描述,本发明的这些和其他方面将变得明显。在下面的附图和说明中对本发明的一个或更多个实施例的细节进行阐述。本发明的其他特征、目的和优点从说明书和附图及权利要求而明显。
附图说明
图1示出了旋切术导管的等距视图;
图2示出了切割元件处于存储位置中的图1中所示的旋切术导管的一部分的等距截面图;
图3示出了切割元件处于工作位置中的图1中所示的旋切术导管的一部分的等距截面图;
图4示出了切割元件的一实施例的等距视图;
图5示出了切割元件的一实施例的端视图;
图6示出了切割元件的一实施例的等距截面图;
图7示出了可以与图1的旋切术导管一起使用的切割元件的另一实施例的端视图;
图8和图8A示出了图7的切割元件的突起元件的等距视图;
图9示出了切割元件的另一实施例处于工作位置中的图1中所示的旋切术导管的一部分的等距侧视图,其中;
图10示出了图9中所示的切割元件的等距视图;
图11示出了适于与图1中所示的旋切术导管一起使用的切割元件的又一实施例的等距视图;
图12示出了用于制造图1中所示的切割元件的子组件的一个实施例的等距视图;
图13A、图13B、图14A、图14B、图15A和图15B示出了适于与图1中所示的旋切术导管一起使用的切割装置及切割装置子组件的其他实施例的等距视图;
图16A和图16B示出了适于与图1中所示的旋切术导管一起使用的切割装置和子组件的又一实施例的等距视图;
图17示出了用于制造图11中所示的切割元件的子组件的另一实施例的等距视图;
图18A、图18B和图18C示出了在人体中使用具有切割元件的多个实施例的导管的方法的示意图。
具体实施方式
本发明提供了一种旋切术导管,包括:具有开口的本体;联接到本体上的可旋转轴;组织收集腔,该组织收集腔联接到本体上并且在切割元件远侧定位;以及切割元件,该切割元件联接到可旋转轴上,用于使轴绕纵向轴线旋转,切割元件具有杯状表面和切割刃,杯状表面构造为当杯状表面沿远侧方向移动时沿远侧方向再引导被切割刃切割的组织;并且切割元件具有至少一个研磨表面。在一个实施例中,切割刃是切割元件的径向外刃。在一实施例中,导管包括从切割元件的杯状表面向外延伸的突起元件。在一个实施例中,切割刃是切割元件的径向外刃,并且当沿着纵向轴线看去时,突起元件从切割刃向近侧凹入。
在一实施例中,切割元件能够相对于开口在存储位置与切割位置之间移动。在一个实施例中,通过使切割元件抵靠凸轮面滑动而使切割元件在存储位置与切割位置之间移动。在一实施例中,通过使切割元件抵靠凸轮面滑动,而使导管的相对于近侧部分的远侧部分偏转。
在本发明的实施例中,研磨表面相对于相邻的非研磨切割元件表面为平齐的、凹入的、或凸起的。在本发明的一实施例中,切割元件具有处于0.030”到0.100”(0.076cm到0.25cm)范围内的大直径D。在一个实施例中,切割元件具有0.061”(0.15cm)的大直径D。在一实施例中,切割元件包括一个研磨表面,而在另一实施例中,切割元件包括两个或更多个研磨表面。两个或更多个研磨表面能够包括至少两个具有不同研磨特性的表面。在一个实施例中,研磨表面包括已经附接到切割元件上的研磨材料。研磨材料可以包括金刚石板。在一个实施例中,研磨材料具有10微米到800微米的颗粒尺寸。在一个实施例中,研磨表面已经被制造而没有研磨材料附接到切割元件上。研磨表面能够通过滚花、喷砂、蚀刻、或激光烧蚀而被制造。
在本发明的一实施例中,研磨表面位于切割元件的外部大直径表面的至少一部分上。外部大直径表面可以与切割元件的纵向轴线LA平行。在一个实施例中,研磨表面位于切割元件的近侧肩表面上。在一实施例中,一个或更多个研磨表面位于切割元件的整个外部大直径表面上。在本发明的一实施例中,研磨表面位于至少杯状表面上。在另一实施例中,研磨表面位于突起元件上。在另一实施例中,切割元件包括两个或更多个具有不同研磨特性的研磨表面,并且该至少两个具有不同研磨特性的表面均位于切割元件的外部大直径表面的一部分上。
本发明还提供一种从身体腔管移除材料的方法,所述方法包括:提供旋切术导管,将该导管置于身体腔管中;并且在身体腔管中移动导管,以使切割元件与身体腔管中的材料相接触。在一个实施例中,导管沿远侧方向移动,以使切割刃与身体腔管中的材料相接触。在另一实施例中,导管沿近侧方向移动,以使研磨表面与身体腔管中的材料相接触。在一实施例中,研磨表面位于切割元件的近侧肩表面上。在一实施例中,导管在切割元件处于存储位置中时被置于身体腔管中,并且移动导管以使材料与处于切割位置中的切割元件相接触。
参照图1至图4,示出了具有切割元件4的旋切术导管2,该切割元件4用于从诸如血管之类的血液流动腔管中切割材料。切割元件4能够相对于导管2的本体8中的开口6在存储位置(图2)与切割位置(图3)之间移动。切割元件4相对于开口6向外移动,以使元件4的一部分从本体8向外延伸穿过开口6。在一个实施例中,切割元件4可以相对于本体8和开口6设置,以使切割元件4的小于90度的部分被暴露来切割组织。在其他实施例中,切割元件4的更多部分可以被暴露而不会偏离本发明的多个方面。
在切割元件4处于存储位置中的情况下将导管2的远端部设置在血管的治疗位点附近。随后在切割元件4处于工作或切割位置中的情况下使导管2向远侧移动穿过血管,如在下面进一步详细描述的。当在切割元件4处于工作或切割位置中的情况下导管2移动穿过血管时,组织材料被切割元件4切割并且被引导到在切割元件4远侧设置的组织腔12中。组织腔12可以一定程度地伸长以容纳已被切割的组织。
为了通过开口6来暴露切割元件4,切割元件4从存储位置向近侧移动,以使切割元件4上的凸轮面14与导管2的本体8上的斜面16接合。凸轮面14与斜面16之间的相互作用导致切割元件4移动到切割位置并且还导致尖端18偏转,这趋于使切割元件4朝向待切割的组织移动。
切割元件4联接到延伸穿过导管2中的腔管21的轴20上。导管2联接到示例性的切割装置驱动器5上。切割装置驱动器5包括马达11、电源15(例如,一个或更多个电池)、微动开关(未示出)、壳体17(如所示,壳体的上半部被移除)、操纵杆13、以及用于将轴20连接到驱动器马达11上的连接组件(未示出)。切割装置驱动器5能够用作使用者操纵导管2的把手。操纵杆13在被致动以闭合微动开关时将电源15电连接到马达11上,从而导致切割元件4旋转。当轴20旋转时,切割元件4绕纵向轴线LA旋转。切割元件4以大约1rpm到160,000rpm的速度旋转,但是根据具体的应用可以以任意其他合适的速度旋转。对与导管2相似的导管的进一步描述在Patel等人的名称为“减积导管(debulking catheter)”的US专利申请序列No.10/027,418(公布为US 2002/0077642A1)中发现,该申请的内容通过参引的方式并入本文。
参照图5,示出了沿纵向轴线LA看去时的切割元件4。如在本文中使用的术语“沿纵向轴线”应当意指例如图5的视图,其示出了沿纵向轴线和/或旋转轴线的方向看去时的切割元件4的远端部。切割元件4具有切割刃22,该切割刃22可以为连续的、不中断的环状刃,尽管其也可以包括脊、齿、锯齿或其他特征而不偏离本发明的范围。当切割元件4处于切割位置中时,切割刃22可以位于切割元件4的径向外刃23处。
切割元件4具有杯状表面24,该杯状表面24将被切割刃22切割的组织引导到组织腔12内。杯状表面24在从纵向轴线LA到切割刃22处的外半径的距离的至少一半距离上可以为平滑的和连续的表面而没有通孔、齿、翅或其他特征,这些特征中断表面24的平滑性。杯状表面24还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种特征。
参照图4至图6,一个或更多个突起元件26从杯状表面24向外延伸,其中图5示出了两个突起元件26。突起元件26是从杯状表面24相对陡峭地突起的小的楔形材料。突起元件26具有第一壁30和第二壁32,它们均径向延伸并且在它们之间形成大约20度的角,以使两个突起元件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。突起元件26通过向硬组织或斑施加较钝的力而有助于打碎硬组织和斑,这是因为利用切割刃22来切割这种组织常常是低效的。
突起元件26总共占据杯状表面24的较小部分。突起元件26一起可以占据切割元件4的小于5%的表面区域。如本文使用的术语“切割元件的表面区域”应当意指当沿着纵向轴线LA看去时从外部或切割刃22径向向内并且被暴露的表面区域。换言之,当沿着纵向轴线看去时,切割元件的至少95%的表面区域为平滑的杯状表面。通过以这种方式来使突起元件26定尺寸和定位,突起元件26不会干扰切割元件4切割组织且将组织再引导到组织腔中的能力,同时还利用突起元件26提供将硬组织和硬斑打碎的能力。
突起元件26可以从切割刃22纵向地和/或径向地凹入。突起元件26可以从切割刃纵向地凹入0.0010英寸到0.0020英寸(0.0025cm到0.0051cm)、并且可以为大约0.0015英寸(0.0038cm)。突起元件26可以从切割刃22径向地凹入大约相同的量。切割元件4的远侧壁38形成与纵向轴线LA垂直的平直表面40,以使整个表面从切割刃凹入相同的距离。远侧壁38可以采取诸如弯曲形状之类的任何其他形状,或者可以为现在描述的倾侧的、倾斜的或斜切的。
参照图7和图8,示出了另一切割元件4A,其中相同或相似的附图标记指示相同或相似的结构,并且关于切割元件4的相同或相似特征的所有描述在这里等同地适用。切割元件4A具有切割刃22A,该切割刃22A可以为连续的、不中断的环状刃,尽管其也可以包括脊、齿、锯齿或其他特征而不偏离本发明的范围。当切割元件4A处于切割位置中时,切割刃22A可以位于切割元件4A的径向外刃22A处。切割元件4A具有杯状表面24A,该杯状表面24A将被切割刃22A切割的组织引导到组织腔12内(参见图2)。如上面结合切割元件4描述的,杯状表面24A可以为基本平滑的和连续的表面。
一个或更多个突起元件26A从杯状表面24A向外延伸。图8示出了四个突起元件26A但是可以包括诸如2、3、4、6或8之类的任意数目的突起元件。突起元件26A是从杯状表面24A相对陡地突起的小的楔形材料。突起元件26A具有第一壁30A和第二壁32A,它们均径向地延伸并且在它们之间形成大约1度到30度的角,以使四个突起元件26A一起占据大约4度到60度的区域并且总共一起可以小于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。突起元件26A可以占据杯状表面24A的较小部分,并且可以以如上结合切割元件4描述的方式从切割刃22A凹入。
切割元件4A的远侧壁38A具有相对于纵向轴线LA形成大约30度到90度角的表面40A。整个表面40A可以仍然在一定程度上靠近切割刃22A但是从切割刃22A凹入,以使整个表面40A距切割刃为0.0010英寸到0.0050英寸(0.0025cm到0.013cm)。在壁30A与远侧壁38A的相交处形成的刃50比在壁32A与远侧壁38A的相交处形成的刃52更靠近切割刃22A。切割元件4A可以沿任一方向旋转,以使突起刃50可以为前刃或后刃。突起刃可以距切割刃为0.0010英寸到0.0020英寸。突起元件26A可以全部以相同的方式形成或者可以彼此不同地形成。例如,元件26A中的一些能够沿不同的方向成角,以使元件中的两个具有作为前刃的突起刃50,而元件26A中的两个具有作为后刃的突起刃50。突起元件26A还可以对向不同的角、为不同的高度或者可以具有不同的径向长度而不偏离本发明的不同方面。
现在结合切割元件4来说明导管2的使用,但是能够等同地适用于导管2与切割元件4A一起的使用。以使用导丝(未示出)等传统的方式将导管2引入病人内。在切割元件处于图2的存储位置中的情况下导管2通过导丝行进而直到导管设置在要移除材料的位置处。切割元件4随后向近侧移动,以使斜面16和凸轮面14接合以将切割元件4移动至图3的切割位置并且使导管2的尖端偏转以将切割元件4朝向待切割的组织移动。切割元件4绕纵向轴线LA旋转,并且导管2随后向远侧移动穿过血管,以使切割元件4切割组织。已被切割的组织被引导到组织腔12内。
图9至图17示出了切割元件的其他实施例,它们特别适于从血管切割和移除较软的组织和较硬的组织。切割元件90、100、130、140、150a、150b、160中的任一个均可以替代导管2的切割元件4、4A。在一个示例中,图9示出了组装到导管2中的切割元件90,其中切割元件90在工作或切割位置中通过窗口6暴露。在图9、图10、图11、图13A、图14A、图15A、图15B、图16A和图17中,研磨表面92、102、102’、132、142、152a、152b、162a、162b借助于未按比例绘制的交叉影线而示意性地示出。在不同的实施例中,研磨表面相对于相邻的非研磨切割元件表面平齐、凸出或凹入。
切割元件90、100、130、140、150a、150b、160包括切割刀片22、研磨表面92、102、102’、132、142、152a、152b、162a、162b、切割装置坯体96、106、106’、136、146、156a、156b、166,并且可以包括研磨材料94、104、104’、134、144、154a、154b、164a、164b。切割元件大直径D(参见例如图10)构想为处于0.030”到0.100”(0.076cm到0.25cm)的范围内。在一个实施例中,切割元件大直径为0.061”(0.15cm)。在其他实施例中,切割元件大直径为0.035”、0.040”、0.043”、0.050”、0.055”、0.065”、0.069”、0.075”、0.080”、或0.090”(0.089cm、0.10cm、0.11cm、0.13cm、0.14cm、0.17cm、0.18cm、0.19cm、0.20cm、或0.23cm)。尽管切割元件90、100、130、140、150a、150b、160大直径D(例如,参见图10)通常示出为包括具有平行侧面的圆筒,但是可以构想的是位于大直径的邻近区域中的研磨表面可以朝向轴线LA-LA凹入、朝向轴线LA-LA凸出、或者可以具有其他形状。
切割刀片22可以包括硬的、韧的、耐磨材料,比如钢、碳化钨、载有5%到20%镍的碳化钨、碳化硅、氮化钛、或其他材料,并且可以通过包括热处理、离子注入、研磨、珩磨、磨锐、静电放电机加工(EDM)和其他工艺在内的工艺来制造。在一个实施例中,切割刀片22包括载有15%镍的碳化钨。切割装置坯体96、106、106’、136、146、156a、156b、166可以包括硬化钢、不锈钢、钛及钛合金、或者其他材料,并且可以包括一个或更多个凹入的或减小的直径(当与切割元件大直径D相比时——参见例如图10)区域107、137、147、167a、167b,研磨材料可以固定在这些区域内。在一个实施例中,切割装置坯体包括全硬化#465不锈钢。
研磨材料94、104、104’、134、144、154a、154b、164a、164b可以包括诸如金刚石、碳化硅、氧化铝、碳化钨、金属、硬化钢或其它材料的硬的颗粒材料,具有一定范围的颗粒尺寸,并且可以通过磨料粒度限定。在一个实施例中,研磨材料具有40微米的颗粒尺寸。在其他实施例中,可以构想出具有10微米、20微米、75微米、100微米、200微米、300微米、400微米、500微米、600微米、700微米或800微米的颗粒尺寸的研磨材料。在一些实施例中,研磨材料的磨料粒度范围为从ISO标准6344定义的P2000到P24或者它们之间的任意值。在另外的实施例中,研磨材料的磨料粒度范围为从由涂装研磨制造商协会(Coated AbrasiveManufacturers Institute(CAMI))定义的1000到24或它们之间的任意值。在一些实施例中,研磨材料可以借助于粘结剂粘合、钎焊、铜焊、焊接、烧结、扩散结合、喷镀、压配合或其他方法附接到切割装置坯体96、106、106’、136、146、156a、156b、166上。在一些实施例中,研磨表面92、102、102’、132、142、152a、152b、162a、162b通过诸如滚花、喷砂、蚀刻、激光烧蚀和其它工艺的工艺形成到切割装置坯体96、106、106’、136、146、156a、156b、166中而不使用研磨材料。在一个实施例中,研磨材料94、104、104’、134、144、154a、154b、164、164b包括金刚石板。
在另一实施例中,图17示出了用于制造切割元件90、100、130、140、150a、150b、160的示例性的方法。尽管所述方法在附图中示出为使用切割元件100作为示例,但是可以构想出具有较小变型的方法能够用于制造此处描述的其他切割元件。在所述方法中,切割元件100包括切割装置预成型件101、研磨材料预成型件103和切割装置坯体106’。切割装置预成型件101、研磨材料预成型件103和切割装置坯体106’分别包括与以上对于切割刀片22、研磨材料94、104、104’、134、144、154a、154b、164a、164b和切割装置坯体96、106、106’、136、146、156a、156b、166进行描述的相同的材料和工艺。切割装置预成型件101还包括通孔109,而切割装置坯体106’还包括可滑动地接收在通孔109内的指状部108。指状部108构造为在预成型件103的内径内滑动。
为了使用图17中所示的方法来组装切割元件100,切割装置预成型件101、研磨材料预成型件103和切割装置坯体106’被预先制造为单独的部件。随后,研磨材料预成型件103在指状部108上滑动,而切割装置预成型件101在指状部108上滑动,其中指状部108可滑动地接收在通孔109中,从而将研磨材料预成型件103夹在切割装置预成型件101与切割装置坯体106’之间。指状部随后借助于诸如粘结剂粘合、钎焊、铜焊、焊接、烧结、扩散结合、使指状部机械变形或其它工艺的工艺或工艺的组合而固定到切割装置预成型件101上。所述组装方法的优点在于切割装置预成型件101、研磨材料预成型件103和切割装置坯体106’能够包括不同的材料,并且能够通过不同的方法进行加工。同样通过使用本方法,诸如切割元件100之类的切割元件能够从相对不昂贵的部件组装成。
切割元件90、100、130、140、150a、150b、160的一个或更多个表面可以包括研磨表面92、102、102’、132、142、152a、152b、162a、162b,这些研磨表面包括但不限于若出现的外直径、大直径、小直径、凹表面、凸轮面、突起元件、以及其他表面。下面对具有不同构型的研磨表面的示例切割装置进行说明和讨论。
图9和图10示出了切割元件90,其包括切割刀片22和位于大直径91a的一部分及近侧面对肩部91b上的研磨表面94。当组装到导管2内而切割元件90在工作或切割位置中通过窗口6暴露时,切割元件90能够在绕轴线LA-LA旋转的同时向远侧行进,从而借助于刀片22切割软材料,并且能够在绕轴线LA-LA旋转的同时向近侧缩回,从而借助于研磨表面94切割或研磨硬材料。切割元件90能够用于有选择地移除软材料、硬材料、或者这两者。
图11示出了切割元件100,其包括切割刀片22和位于大直径101a的一部分上的研磨表面104。当组装到导管2中而切割元件100在工作或切割位置中通过窗口6暴露时,切割元件100能够在绕轴线LA-LA旋转的同时向远侧行进,从而借助于刀片22切割软材料,并且能够在绕轴线LA-LA旋转的同时向近侧缩回,从而借助于研磨表面104切割或研磨硬材料。切割元件100能够用于有选择地移除软材料、硬材料、或者这两者。图12示出了切割装置坯体106。
图13A示出了切割元件130,其包括切割刀片22和位于整个大直径131a及面向近侧的肩部131b上的研磨表面134。当组装到导管2中而切割元件130在工作或切割位置中通过窗口6暴露时,切割元件130能够在绕轴线LA-LA旋转的同时向远侧行进,从而借助于刀片22切割软材料,并且能够在绕轴线LA-LA旋转的同时向近侧缩回,从而借助于研磨表面134切割或研磨硬材料。切割元件130能够用于有选择地移除软材料、硬材料、或者这两者,并且因覆盖有研磨材料的较大表面区域而能够在每次经过时研磨较大量的材料。图13B示出了切割装置坯体136。
图14A示出了切割元件140,其包括切割刀片22和位于面向近侧的肩部141b上的研磨表面144。当组装到导管2中而切割元件140在工作或切割位置中通过窗口6暴露时,切割元件140能够在绕轴线LA-LA旋转的同时向远侧行进,从而借助于刀片22切割软材料,并且能够在绕轴线LA-LA旋转的同时向近侧缩回,从而借助于研磨表面144切割或研磨硬材料。切割元件140能够用于有选择地移除软材料、硬材料、或者这两者,并且对于给定的研磨材料磨料粒度、表面速度及通过窗口的暴露而言,在每次经过时研磨的材料比切割元件130少。图14B示出了切割装置坯体146。
图15A示出了切割元件150a,其包括切割刀片22、可选的突起元件26、26A、以及位于杯状表面24上及可选地位于突起元件26、26A的任意或全部表面上的研磨表面154a。当组装到导管2内而切割元件150a在工作或切割位置中通过窗口6暴露时,切割元件150a能够在绕轴线LA-LA旋转的同时向远侧行进,从而借助于刀片22切割软材料,并且还借助于研磨表面154a和(可选的)突起元件26、26A切割或研磨硬材料。通过切割元件150a如此切割的材料将借助于切割元件150a的杯状表面24引导到组织腔12内。
图15B示出了切割元件150b,其包括切割刀片22、可选的突起元件26、26A、和位于杯状表面24上的、可选地位于突起元件26、26A的任意或全部表面上的、位于大直径151a的至少一部分处以及面向近侧的肩部151b上的研磨表面154b。当组装到导管2内而切割元件150b在工作或切割位置中通过窗口6暴露时,切割元件150b能够在绕轴线LA-LA旋转的同时向远侧行进,从而借助于刀片22切割软材料且还借助于研磨表面154b和(可选的)突起元件26、26A切割或研磨硬材料,并且能够在绕轴线LA-LA旋转的同时向近侧缩回,从而借助于位于肩部151b和大直径151a上的研磨表面154a来切割或研磨硬材料。通过切割元件150b的向远侧行进而切割的材料将借助于切割元件150b的杯状表面24引导到组织腔12内。
图16A示出了切割元件160,其包括切割刀片22和位于大直径161a的一部分上的研磨表面164a、164b。当组装到导管2内而切割元件160在工作或切割位置中通过窗口6暴露时,切割元件160能够在绕轴线LA-LA旋转的同时向远侧行进,从而借助于刀片22切割软材料,并且能够在绕轴线LA-LA旋转的同时向近侧缩回,从而借助于研磨表面164a、164b切割或研磨硬材料。在一个实施例中,研磨表面164a比研磨表面164b更强劲(aggressive),并且将快速地研磨从血管V的腔管表面LS延伸较大距离的较大的材料沉积物LD,而研磨表面164b将慢速地研磨从血管V的腔管表面LS延伸较短距离的较小的材料沉积物SD。而且,在该实施例中,因为研磨表面164b不如研磨表面164a强劲,所以研磨表面164b对血管V的腔管表面LS的伤害比研磨表面164a小。另外,在一些实施例中,研磨表面164b可以用于抛光在血管中的沉积物的腔管表面。图16B示出了切割装置坯体166。
在一些实施例中,切割元件160可以包括位于大直径161a上的多于两个的不同研磨特性的表面。例如,切割元件160可以包括不同研磨特性的3、4、5、6或更多个表面。在一个实施例中,切割元件160包括从大直径161a上的较不强劲表面连续地变化到较强劲表面的研磨表面。在一些实施例中,连续变化的研磨表面在表面的最远端处最不强劲,或者在表面的最远端处最强劲。
在另一实施例中,包括具有切割刀片和研磨表面的切割元件90、100、130、140、150a、150b、160的导管2可以还包括能够使切割元件以两种或更多种速度旋转的切割装置驱动器5。在一个实施例中,切割装置驱动器5构想为当利用切割刀片22切割时使切割元件以第一速度旋转,而当利用研磨表面92、102、102’、132、142、152a、152b、162a、162b研磨时使切割元件以第二速度旋转。在一些实施例中,第一速度选取为使得切割装置表面速度对于切割软材料是高效的,而第二速度选取为使得研磨表面速度对于快速研磨硬材料是高效的。在其他实施例中,切割装置驱动器5使切割元件90、100、130、140、150a、150b、160以可变速度旋转。切割元件第一和第二速度构想为处于1,000RPM到160,000RPM的范围内。在一个实施例中,切割元件第一和第二速度为8,000RPM。在其他实施例中,切割元件第一和第二速度为1,000RPM、2,000RPM、4,000RPM、16,000RPM、32,000RPM、64,000RPM、80,000RPM或120,000RPM。在一些实施例中,切割元件第二速度构想为处于比切割元件第一速度大1,000RPM到100,000RPM的范围内。在一个实施例中,切割元件第二速度比切割元件第一速度大50,000RPM。在其他实施例中,切割元件第二速度比切割元件第一速度大5,000RPM、10,000RPM、20,000RPM、40,000RPM、或75,000RPM。在另外的实施例中,切割元件表面相对血管壁材料的速度构想为处于50表面英尺每分钟(SFM)到4,150SFM的范围内。在一个实施例中,切割元件表面速度为1,500SFM。在其他实施例中,切割元件表面速度为100SFM、200SFM、800SFM、2,000SFM或3,000SFM。在其他实施例中,在切割元件第二速度(RPM)下处的切割元件表面速度构想为比在切割元件第一速度(RPM)下的切割元件表面速度大100SFM到3,000SFM的范围内。在一个实施例中,切割元件第二表面速度比切割元件第一表面速度大2,000SFM。在其他实施例中,切割元件第二表面速度比切割元件第一表面速度大200SFM、500SFM、1,000SFM或2,500SFM。切割元件可变速度范围(RPM和SFM)均构想为在与切割元件第一和第二速度相同的范围内改变。
能够使切割元件90、100、130、140、150a、150b、160以第一速度和第二速度旋转的切割装置驱动器5可以包括双位置微动开关或其它装置,该开光将一个电池电连接到马达11上从而导致马达11以第一速度旋转,并且将两个电池连接到马达11上从而导致马达以第二速度旋转。能够使切割元件90、100、130、140、150a、150b、160以可变速度旋转的切割装置驱动器5可以包括可变电阻微动开关或其它装置,该开关将可变电阻连接在电池与马达11之间从而导致马达11可变速度的旋转。
现在将对使用包括具有切割刀片和研磨表面的切割元件的旋切术导管来从病人的身体切割和移除材料的示例性方法进行描述。
使用现有领域中已知的技术,导丝GW经皮插入病人的身体内并且行进至病人的血管V中的关注区域。使用诸如荧光透视法之类的成像技术,识别血管的病变部分并且选取具有用于治疗位点T的合适性能的旋切术导管(比如导管2),该导管包括切割元件CE,例如切割元件90、100、130、140、150b、160。参照图18A,导管2在切割元件处于存储位置中的情况下通过导丝行进至治疗位点。使用诸如荧光透视法之类的成像技术,将切割元件设置在相对于治疗位点(在一些方法中,在近侧)的期望位置处。
将导管轴20保持静止,将切割元件CE操控到切割位置(即,通过窗口6暴露)并且使用操纵杆13启动切割元件旋转。导管轴20向远侧行进,从而导致切割装置刀片22从血管V的腔管表面LS切割材料M。杯状表面24将材料M的切割碎片通过窗口6引导到收集腔12内(图18B)。导管轴20向近侧缩回,并且研磨表面AS例如研磨表面92、102、102’、132、142、152a、152b、162a、162b从血管V的腔管表面LS研磨材料M(图18C)。停止切割元件的旋转,使切割元件返回到存储位置并且将导管2从治疗位点T收回。
在一些方法中,当从血管V的腔管表面LS切割材料M时,切割元件以第一速度旋转,而当从血管V的腔管表面LS研磨材料M时,切割元件以第二速度旋转。在一些方法中,第二速度比第一速度大。
在另一方法中,导丝GW经皮插入病人的身体内并且行进至病人的血管V中的关注区域。使用诸如荧光透视法之类的成像技术,识别血管的病变部分并且选取具有用于治疗位点T的合适性能的旋切术导管(比如导管2),该导管包括切割元件CE例如切割元件150b。参照图18A,导管2在切割元件处于存储位置中的情况下通过导丝行进至治疗位点。使用诸如荧光透视法之类的成像技术,将切割元件相对于治疗位点(在一些方法中,在近侧)设置在期望的位置中。
导管轴20保持静止,将切割元件操控到切割位置(即,通过窗口6暴露)并且使用操纵杆13启动切割元件旋转。导管轴20向远侧行进,从而导致切割装置刀片22从血管V的腔管表面LS切割材料M而研磨表面AS研磨材料M。杯状表面24将切割和研磨的材料M碎片通过窗口6引导到收集腔12内(图18B)。导管轴20向近侧缩回,并且研磨表面AS例如研磨表面152b从血管V的腔管表面LS研磨材料M(图18C)。停止切割元件的旋转,使切割元件返回到存储位置并且将导管2从治疗位点T收回。
在一些方法中,当从血管V的腔管表面LS切割材料M时,切割元件以第一速度旋转,而当从血管V的腔管表面LS研磨材料M时,切割元件以第二速度旋转。在一些方法中,第二速度比第一速度大。
在又一方法中,导丝GW经皮插入病人的身体内并且行进至病人的血管V中的关注区域。使用诸如荧光透视法之类的成像技术,识别血管的病变部分并且选取具有用于治疗位点T的合适性能的旋切术导管(比如导管2),该导管包括切割元件CE例如切割元件150a。参照图18A,导管2在切割元件处于存储位置中的情况下通过导丝行进至治疗位点。使用诸如荧光透视法之类的成像技术,将切割元件相对于治疗位点(在一些方法中,在近侧)设置在期望的位置中。
将导管轴20保持静止,将切割元件操控到切割位置(即,通过窗口6暴露)并且使用操纵杆13启动切割元件旋转。导管轴20向远侧行进,从而导致切割装置刀片22从血管V的腔管表面LS切割材料M而研磨表面AS研磨材料M。杯状表面24将切割和研磨的材料M碎片通过窗口6引导到收集腔12内(图18B)。停止切割元件的旋转,使切割元件返回到存储位置并且将导管2从治疗位点T收回。
在一些方法中,当从血管V的腔管表面LS切割材料M时,切割元件以第一速度旋转,而当从血管V的腔管表面LS研磨材料M时,切割元件以第二速度旋转。在一些方法中,第二速度比第一速度大。
除了使用在血管中,本发明预想为用于移除在诸如天然或人工移植物、支架移植物、吻合位点、管状器官或其他血液流动腔管的血液流动腔管中的栓塞物。
已经结合优选实施例对本发明进行了描述,但是,本发明当然可以偏离上述实施例而被实践。例如,可以设置三个或更多个突起元件或者切割刃可以为锯齿状而不会偏离本发明的多个方面。
提供以上描述和附图用于描述本发明的实施例而并非意在以任何方式限定本发明的范围。对于本领域的技术人员而言明显的是,不同的变型和改变能够被实施而不会偏离本发明的精神或范围。由此,本发明意在包括本发明的变型和改变,只要这些变型和改变落在所附权利要求及它们的等同物的范围内。另外,尽管在上面可能已经就特定的实施例对材料和构型的选择进行了描述,但是本领域的普通技术人员应当明白,所述材料和构型能够在实施例中交叉应用。

Claims (25)

1.一种旋切术导管,包括:
具有开口的本体;
联接到所述本体上的可旋转轴;
组织收集腔,所述组织收集腔联接到所述本体上;以及
切割元件,所述切割元件联接到所述可旋转轴上,用于使所述切割元件绕纵向轴线旋转,所述切割元件具有外部大直径表面、杯状表面、切割刃、以及位于所述切割元件的外部大直径表面的至少一部分上的至少一个研磨表面,其中所述杯状表面构造成将通过所述切割刃切割的组织引导到所述组织收集腔内。
2.如权利要求1所述的导管,其中,所述切割刃是所述切割元件的径向外刃。
3.如权利要求1所述的导管,其中,所述切割元件包括从所述切割元件的所述杯状表面向外延伸的突起元件。
4.如权利要求3所述的导管,其中,
所述切割刃是所述切割元件的径向外刃;并且
当沿着纵向轴线看去时,所述突起元件从所述切割刃向近侧凹入。
5.如权利要求1所述的导管,其中,所述切割元件能够相对于所述开口在存储位置与切割位置之间移动。
6.如权利要求5所述的导管,其中,通过使所述切割元件抵靠凸轮面滑动,而使所述切割元件在所述存储位置与所述切割位置之间移动。
7.如权利要求6所述的导管,其中,通过使所述切割元件抵靠所述凸轮面滑动,而使所述导管的相对于近侧部分的远侧部分偏转。
8.如权利要求1所述的导管,其中,所述切割元件具有与位于所述切割元件的所述外部大直径表面上的至少一个研磨表面相邻的非研磨表面,其中所述研磨表面相对于至少一个非研磨表面平齐。
9.如权利要求1所述的导管,其中,所述切割元件具有与位于所述切割元件的所述外部大直径表面上的至少一个研磨表面相邻的至少一个非研磨表面,其中所述研磨表面相对于所述至少一个非研磨表面凹入。
10.如权利要求1所述的导管,其中,所述切割元件具有与位于所述切割元件的所述外部大直径表面上的至少一个研磨表面相邻的至少一个非研磨表面,其中所述研磨表面相对于所述至少一个非研磨表面凸出。
11.如权利要求1所述的导管,其中,所述切割元件具有处于0.030”到0.100”(0.076cm到0.25cm)的范围内的大直径D。
12.如权利要求1所述的导管,其中,所述切割元件具有0.061”(0.15cm)的大直径D。
13.如权利要求1所述的导管,其中,所述至少一个研磨表面包括单个研磨表面。
14.如权利要求1所述的导管,其中,所述至少一个研磨表面包括两个或更多个研磨表面。
15.如权利要求14所述的导管,其中,所述两个或更多个研磨表面包括至少两个具有不同研磨特性的表面。
16.如权利要求1所述的导管,其中,所述研磨表面包括已经附接到所述切割元件上的研磨材料。
17.如权利要求16所述的导管,其中,所述研磨材料包括金刚石板。
18.如权利要求16所述的导管,其中,所述研磨材料具有10微米到800微米的颗粒尺寸。
19.如权利要求1所述的导管,其中,所述研磨表面已经被制造而没有研磨材料附接到所述切割元件上。
20.如权利要求19所述的导管,其中,所述研磨表面已经通过滚花、喷砂、蚀刻或激光烧蚀而被制造。
21.如权利要求1所述的导管,其中,位于所述外部大直径表面上的所述研磨表面与所述切割元件的纵向轴线LA平行。
22.如权利要求1所述的导管,其中,所述切割元件包括近侧肩表面,所述研磨表面位于所述切割元件的所述近侧肩表面上。
23.如权利要求1所述的导管,其中,所述研磨表面也位于所述杯状表面上。
24.如权利要求3所述的导管,其中,所述研磨表面也位于所述突起元件上。
25.如权利要求24所述的导管,其中,所述研磨表面也位于所述杯状表面上。
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JP5579830B2 (ja) 2014-08-27
US9687266B2 (en) 2017-06-27
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RU2509537C2 (ru) 2014-03-20
CN102625673A (zh) 2012-08-01
US20170265888A1 (en) 2017-09-21
EP2424450B1 (en) 2014-12-17
US20100312263A1 (en) 2010-12-09
AU2010241801B2 (en) 2013-04-11
KR20120011058A (ko) 2012-02-06
EP2424450A1 (en) 2012-03-07
AU2010241801A1 (en) 2011-11-17
WO2010126882A1 (en) 2010-11-04
CA2760449A1 (en) 2010-11-04
BRPI1014721A2 (pt) 2016-04-12
JP2012525221A (ja) 2012-10-22
ES2532407T3 (es) 2015-03-26
US10555753B2 (en) 2020-02-11

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