CN104490454A - 用于切割组织的方法和装置 - Google Patents
用于切割组织的方法和装置 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
- A61B17/320758—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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
- A61B2017/320775—Morcellators, impeller or propeller like means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
Abstract
本发明提供了一种导管,所述导管包括切割元件(4B),所述切割元件具有一个或多个凸出元件(26B)。切割元件在远端处具有杯形表面,所述杯形表面除了凸出元件之外是光滑且连续的。凸出元件具有弯曲表面(30B),当所述弯曲表面旋转,所述弯曲表面适于重新引导所述切割下的材料颗粒,以使得产生朝向切割元件的旋转轴线、导管的轴线、或颗粒物收集室中的一个或多个引导切割下的颗粒的流体涡旋。在本发明的其它方面中,切割元件沿着大体平行于切割元件的旋转轴线的方向振动。
Description
本分案申请是基于中国发明专利申请号201080054485.2(国际申请号PCT/US2010/058654)、发明名称“用于切割组织的方法和装置”、申请日2010年12月2日的专利申请的分案申请。
技术领域
本发明涉及用于粥样硬化切除导管的切割元件以及使用旋转切割元件从血流腔切割材料的方法。
背景技术
导管被用于从身体上移除不想要的组织。粥样硬化切除导管被用于从血管移除材料,以便使血管通畅并且提高通过血管的血流量。
在从血管移除材料时发生的一个问题是材料可以是软的或者硬的,并且可以在切割过程中发生变化。因此,切割元件应当既能够切割硬组织又能够切割软组织。在使用旋转切割件时发生的另一个问题是材料颗粒趋于远离导管以及远离基于导管的颗粒收集结构沿着切向于切割件的方向发生位移。因此,也期望的是朝向导管并且尤其朝向基于导管的颗粒收集结构引导切割下的颗粒。
发明内容
本发明提供了一种粥样硬化切除导管,所述粥样硬化切除导管包括:主体,所述主体具有开口;能够旋转的轴,所述能够旋转的轴联接到所述主体;组织收集室,所述组织收集室联接到所述主体并且定位在切割元件的远侧处;切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有杯形表面和切割刃,所述杯形表面构造成当所述杯形表面沿着远侧方向运动时沿着远侧方向重新引导由所述切割刃切割下的组织;以及凸出元件,所述凸出元件从所述切割元件的所述杯形表面向外延伸,所述凸出元件构造成朝向所述切割元件的所述旋转轴线、导管的纵向轴线、或者所述组织收集室中的一个或多个引导切割下的材料颗粒。
本发明提供了一种粥样硬化切除导管,所述粥样硬化切除导管包括:主体,所述主体具有开口;能够旋转的轴,所述能够旋转的轴联接到所述主体;组织收集室,所述组织收集室联接到所述主体并且定位于所述切割元件的远侧处;和切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有切割刃,并且所述切割元件构造成沿着基本平行于所述切割元件的所述旋转轴线的方向振动。
本发明提供了一种从体腔中移除材料的方法,所述方法包括:提供粥样硬化切除导管,所述粥样硬化切除导管包括:具有开口的主体;联接到所述主体的能够旋转的轴;联接到所述主体并且定位在切割元件的远侧处的组织收集室;切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有杯形表面和切割刃,所述杯形表面构造成当所述杯形表面沿着远侧方向运动时沿着所述远侧方向重新引导被所述切割刃切割下的组织;以及凸出元件,所述凸出元件从所述切割元件的所述杯形表面向外延伸,所述凸出元件构造成朝向所述切割元件的所述旋转轴线、导管的纵向轴线、或者所述组织收集室中的一个或多个引导切割下的材料颗粒;将所述导管放置在体腔中;以及使所述导管在所述体腔中运动,以便使所述切割元件与所述体腔中的所述材料相接触。
本发明提供了一种从体腔移除材料的方法,所述方法包括:提供粥样硬化切除导管,所述粥样硬化切除导管包括:具有开口的主体;联接到所述主体的能够旋转的轴;联接到所述主体并且定位到所述切割元件的远侧处的组织收集室;和切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有切割刃,并且所述切割元件构造成沿着基本平行于所述切割元件的所述旋转轴线的方向振动;将所述导管放置在所述体腔中;以及使所述导管在所述体腔中运动,以便使所述切割元件与所述体腔中的所述材料相接触。在一个实施例中,使所述导管沿着远侧方向运动,以便使所述切割刃与所述体腔中的所述材料相接触。
从以下优选实施例的描述、附图以及权利要求中本发明的这些和其它方面将变得显而易见。在附图和以下描述中陈述了本发明的一个或多个实施例的细节。从描述和附图,以及从权利要求中本发明的其它特征、目的和优势将变得显而易见。
附图说明
图1示出了粥样硬化切除导管的远端的等距视图;
图2是图1的粥样硬化切除导管的一部分的等距剖视图,且切割元件处于储存位置中;
图3是图1的粥样硬化切除导管的一部分的等距剖视图,且切割元件处于工作位置中;
图4示出了切割元件的实施例的等距视图;
图5示出了切割元件的实施例的端视图;
图6是切割元件的实施例的等距剖视图;
图7示出了切割元件的另一个实施例的端视图,所述切割元件可以与图1所示的粥样硬化切除导管一起使用;
图8示出了图7中图解的切割元件的实施例的等距视图;
图8A示出了图8中图解的切割元件实施例的凸出元件中的一个的等距视图;
图9示出了切割元件的另一个实施例的端视图,所述切割元件可以与图1所示的粥样硬化切除导管一起使用;
图10示出了图9中图解的切割元件的实施例的等距视图;
图10A示出了图10中图解的切割元件实施例的凸出元件中的一个的等距视图;
图11示出了图8中图解的切割元件的实施例的变型的等距视图;
图11A示出了图11中图解的切割元件实施例的凸出元件中的一个的等距视图;
图12图解了粥样硬化切除导管的具有切割元件的部分的等距剖视图,所述切割元件在大体沿着切割元件的轴线的方向上振动;
图13图解了图12所示的导管的部件的等距视图。
具体实施方式
本发明提供了一种粥样硬化切除导管,所述粥样硬化切除导管包括:主体,所述主体具有开口;能够旋转的轴,所述能够旋转的轴联接到所述主体;组织收集室,所述组织收集室联接到所述主体并且定位在切割元件的远侧处;切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有杯形表面和切割刃,所述杯形表面构造成当所述杯形表面沿着远侧方向运动时沿着远侧方向重新引导由所述切割刃切割下的组织;以及凸出元件,所述凸出元件从所述切割元件的所述杯形表面向外延伸,所述凸出元件构造成朝向所述切割元件的所述旋转轴线、导管的纵向轴线、或者所述组织收集室中的一个或多个引导切割下的材料颗粒。在实施例中,所述凸出元件构造成朝向所述切割元件的所述旋转轴线引导切割下的材料颗粒。在一个实施例中,所述切割刃位于所述切割元件的径向外边缘处。在实施例中,所述凸出元件包括弯曲凸出元件切割刃。在实施例中,所述凸出元件包括第一壁,所述第一壁从所述弯曲凸出元件切割刃延伸到所述杯形表面,所述第一壁朝向所述切割元件的旋转轴线引导切割下的材料颗粒。
在实施例中,所述第一壁从在所述切割元件的径向外边缘处与所述切割刃成相对切向的角度弯曲到更靠近所述切割元件的所述旋转轴线的相对径向的角度。在一个实施例中,所述凸出元件包括远侧壁,所述远侧壁从第一弯曲凸出元件切割刃延伸到第二边缘,所述远侧壁相对于所述切割元件的所述旋转轴线形成小于90度的角。在实施例中,所述第一弯曲凸出元件切割刃与所述第二边缘相比位于更远侧。在一个实施例中,所述第一弯曲凸出元件切割刃和所述切割元件的切割刃之间的最小径向距离小于所述第二边缘和所述切割元件的所述切割刃之间的最小径向距离。在一个实施例中,其中,所述第一壁和所述远侧壁之间的夹角是钝角。
在一个实施例中,所述凸出元件从所述切割刃向近侧凹陷一纵向距离。例如,所述凸出元件能够从所述切割刃向近侧凹陷0.0010至0.0050英寸(0.0025至0.0127cm)的纵向距离。在实施例中,所述凸出元件从所述切割刃凹陷0.0010至0.0050英寸(0.0025至0.0127cm)的径向距离。
在一个实施例中,所述凸出元件包括第一壁,所述第一壁从凸出元件切割刃延伸到杯形表面,所述第一壁朝向所述切割元件的所述旋转轴线引导切割下的材料颗粒,并且其中,所述第一壁与所述杯形表面形成锐角,以便形成底切。在实施例中,所述凸出元件包括远侧壁,所述远侧壁从所述第一凸出元件切割刃延伸到第二边缘,所述远侧壁相对于所述切割元件的所述旋转轴线形成小于90度的角。在一个实施例中,所述第一凸出元件切割刃与所述第二边缘相比位于更远侧。在实施例中,所述第一凸出元件切割刃和所述切割元件的切割刃之间的最小径向距离小于所述第二边缘和所述切割元件的所述切割刃之间的最小径向距离。在实施例中,具有前角的壁散置在所述第一壁和所述远侧壁的相交部之间。在一个实施例中,所述前角是负的。
在实施例中,当沿着所述切割元件的所述旋转轴线观察时,所述切割元件的所述杯形表面在至少300度的整个区域上是光滑且不间断的。在一个实施例中,当沿着所述切割元件的所述旋转轴线观察时,对于所述切割元件的表面面积的至少90%来说,所述切割元件的所述杯形表面是光滑且不间断的。在实施例中,当沿着所述切割元件的所述旋转轴线观察时,所述切割元件的所述杯形表面具有外半径,所述杯形表面从所述旋转轴线到距所述外半径的距离的至少一半处是连续且不间断的。在一个实施例中,所述粥样硬化切除导管还包括多个凸出元件,当沿着所述切割元件的所述旋转轴线观察时,所述多个凸出元件共同占据小于60度且小于表面面积的5%的区域,并且对于所述表面面积的至少90%来说,所述杯形表面是光滑且不间断的。在一个实施例中,粥样硬化切除导管包括多个凸出元件,所述多个凸出元件从所述杯形表面向外延伸,所述多个凸出元件是1、2、3、4、6或8个凸出元件。
在一个实施例中,所述切割元件能够相对于所述开口在储存位置和切割位置之间运动。在实施例中,所述切割元件通过抵靠凸轮表面滑动所述切割元件而在所述储存位置和所述切割位置之间运动。在实施例中,所述导管的相对于近侧部分的远侧部分通过抵靠所述凸轮表面滑动所述切割元件而偏斜。在实施例中,所述切割元件构造成沿着基本平行于所述切割元件的所述旋转轴线的方向振动。
本发明提供了一种粥样硬化切除导管,所述粥样硬化切除导管包括:主体,所述主体具有开口;能够旋转的轴,所述能够旋转的轴联接到所述主体;组织收集室,所述组织收集室联接到所述主体并且定位于所述切割元件的远侧处;和切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有切割刃,并且所述切割元件构造成沿着基本平行于所述切割元件的所述旋转轴线的方向振动。在一个实施例中,所述粥样硬化切除导管包括具有一个或多个凹陷部的斜坡,所述切割元件包括在所述切割元件的凸轮表面上的一个或多个凸出部分,当所述凸出部分和所述凹陷部对准时,所述一个或多个凸出部分配合在所述一个或多个凹陷部中,并且当所述切割元件旋转时所述凸出部分离开和进入所述凹陷部,从而致使所述切割元件振动。在一个实施例中,所述粥样硬化切除导管包括具有一个或多个凸出部分的斜坡,所述切割元件包括在所述切割元件的凸轮表面上的一个或多个凹陷部,当所述凸出部分和所述凹陷部对准时,所述一个或多个凸出部分配合在所述一个或多个凹陷部中,并且当所述切割元件旋转时所述凸出部分离开和进入所述凹陷部,从而致使所述切割元件振动。在一个实施例中,所述粥样硬化切除导管包括具有一个或多个凸出部分的斜坡,所述切割元件包括在所述切割元件的凸轮表面上的一个或多个凸出部分,并且当所述切割元件旋转时,所述凸出部分致使所述切割元件振动。
在一个实施例中,所述切割元件具有杯形表面,所述杯形表面构造成当所述杯形表面沿着远侧方向运动时沿着所述远侧方向重新引导由所述切割刃切割下的组织。在实施例中,所述切割刃是所述切割元件的径向外边缘。在实施例中,所述导管包括凸出元件,所述凸出元件从所述切割元件的所述杯形表面向外延伸。在实施例中,所述切割刃是所述切割元件的径向外边缘,并且当沿着所述切割元件的旋转轴线观察时,所述凸出元件从所述切割刃向近侧凹陷。在一个实施例中,所述切割元件能够相对于所述开口在储存位置和切割位置之间运动。在一个实施例中,所述切割元件通过抵靠凸轮表面滑动所述切割元件而在所述储存位置和所述切割位置之间运动。在一个实施例中,所述导管的相对于近侧部分的远侧部分通过抵靠所述凸轮表面滑动所述切割元件而偏斜。
本发明提供了一种从体腔中移除材料的方法,所述方法包括:提供粥样硬化切除导管,所述粥样硬化切除导管包括:具有开口的主体;联接到所述主体的能够旋转的轴;联接到所述主体并且定位在切割元件的远侧处的组织收集室;切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有杯形表面和切割刃,所述杯形表面构造成当所述杯形表面沿着远侧方向运动时沿着所述远侧方向重新引导被所述切割刃切割下的组织;以及凸出元件,所述凸出元件从所述切割元件的所述杯形表面向外延伸,所述凸出元件构造成朝向所述切割元件的所述旋转轴线、导管的纵向轴线、或者所述组织收集室中的一个或多个引导切割下的材料颗粒;将所述导管放置在体腔中;以及使所述导管在所述体腔中运动,以便使所述切割元件与所述体腔中的所述材料相接触。在一个实施例中,所述导管沿着远侧方向运动,以便使所述切割刃与所述体腔中的所述材料相接触。在一个实施例中,所述导管放置在所述体腔中且所述切割元件位于储存位置中,并且使所述导管运动,以便使所述材料与处于切割位置中的所述切割元件相接触。在一个实施例中,体腔是血管。
本发明提供了一种从体腔移除材料的方法,所述方法包括:提供粥样硬化切除导管,所述粥样硬化切除导管包括:具有开口的主体;联接到所述主体的能够旋转的轴;联接到所述主体并且定位到所述切割元件的远侧处的组织收集室;和切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有切割刃,并且所述切割元件构造成沿着基本平行于所述切割元件的所述旋转轴线的方向振动;将所述导管放置在所述体腔中;以及使所述导管在所述体腔中运动,以便使所述切割元件与所述体腔中的所述材料相接触。在一个实施例中,使所述导管沿着远侧方向运动,以便使所述切割刃与所述体腔中的所述材料相接触。在实施例中,将所述导管放置在所述体腔中且所述切割元件处于储存位置中,并且使所述导管运动,以便使所述材料与处于切割位置中的所述切割元件相接触。在实施例中,所述体腔是血管。
本发明提供了一种粥样硬化切除导管,所述粥样硬化切除导管具有能够既切除软组织也能够切除硬组织的切割元件。切割元件具有环绕杯形表面的锋利的切割刃。杯形表面将已切割的材料引导到组织室中。周向切割刃和杯形表面一起也适于切割并且移除相对较软的组织。
在本发明的一个方面中,提供了一种粥样硬化切除导管,所述粥样硬化切除导管具有从杯形表面延伸的一个或多个凸出元件。凸出元件可以从外切割刃纵向地和径向地凹陷诸如0.0010-0.0020英寸(0.0025至0.0051cm)的受控距离,但是在另一个实施例中,取决于应用,所述凸出元件可以更加靠近或更加远离外切割刃。凸出元件有助于打碎诸如钙化斑的硬组织。凸出元件略微从远端凹陷,以便使切割刃保持露出,以切割软组织。当切割元件遭遇太硬无法用切割刃充分切割的组织时,凸出元件施加更钝的力来帮助破坏较硬的组织。
在本发明的另一个方面中,凸出元件略微较小,以便杯形表面的相对较大的部分光滑并且不间断。这样,凸出元件不会过度妨碍切割元件利用杯形表面将组织引导到组织室中的能力。例如,当沿着纵向轴线观察时,凸出元件可以占据小于60度的区域。换言之,当沿着纵向轴线观察时,切割元件的杯形表面在至少300度的整个区域上是光滑且不间断的。换言之,当沿着纵向轴线观察时,对于切割元件的表面面积的至少95%来说,杯形表面可以是光滑且不间断的。
在本发明的又一个方面中,凸出元件具有的表面趋于朝向切割件的旋转轴线、导管轴线、或颗粒收集室中的一个或多个引导切割下的材料颗粒。
在本发明的再一个方面中,切割件沿着大体平行于所述切割件的轴线的方向振动,以便将力施加在切割下的材料颗粒上,这将沿着远侧方向朝向收集室引导所述切割下的材料颗粒或者双向引导所述切割下的材料颗粒。
参照图1至图4,示出了粥样硬化切除导管2,所述粥样硬化切除导管2具有用于从血流腔切割材料的切割元件4。切割元件4能够相对于导管2的主体8中的开口6在储存位置(图2)和切割位置(图3)之间运动。切割元件4相对于开口6向外运动,使得元件4的一部分从主体8向外延伸通过开口6。切割元件4可以相对于主体8和开口6定位,使得切割元件4小于90度露出以切割组织。当然,在不背离本发明的多个方面的前提下,可以露出切割元件4的更多部分。
取决于预期使用导管的解剖位置的要求,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)的最大尺寸以及可以具有在20、30、40、60、80、100、120、150、180或210cm的范围内变化的工作长度。切割件4的直径优选地略小于最大尺寸的导管2的直径,典型地小于0.010″(0.025cm)、0.015″(0.038cm)、0.020″(0.051cm)、0.025″(0.064cm)或0.030″(0.076cm)。然而,这些相对的尺寸并不意味着是限制。
导管2向远侧运动通过血管,其中切割元件4处于如以下进一步详细描述的工作或切割位置中。当导管2运动通过血管时,组织由切割元件4切割并被引导到定位于切割元件4的远侧处的组织室12中。组织室12可以是略微细长的,以便容纳已切割的组织。
切割元件4从储存位置向近侧运动,以便切割元件4上的凸轮表面14接合导管2的主体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割元件4运动到切割位置,并且也致使尖端18发生偏斜,这趋于使切割元件4朝向待切割的组织运动。
切割元件4联接到轴20,所述轴20延伸通过导管2中的管腔21。当轴旋转时,切割元件4围绕纵向轴线LA旋转。切割元件4以大约1至160,000转/分旋转,但是取决于具体应用,也可以以任何适当的速度旋转。
参照图2、4和5,示出了切割元件4。本文所使用的术语“沿着纵向轴线”将指的是图5的视图,所述视图示出了当沿着纵向轴线和/或旋转轴线的方向观察时切割元件4的远端。切割元件4具有切割刃22,所述切割刃22可以是连续无间断的圆形边缘,尽管在不背离本发明的范围的前提下,所述切割刃22也可以包括脊、齿、锯齿或其它特征。当切割元件4处于切割位置时,切割刃22可以位于切割元件4的径向外边缘23处。
切割元件4具有杯形表面24,所述杯形表面24将由切割刃22切割下的组织引导到组织室12中。杯形表面24可以是光滑且连续的表面,没有从纵向轴线LA到距切割刃22的外半径的距离的至少一半处中断表面24的光滑特性的通孔、齿、翅片或其它特征。杯形表面24也可以在相对于纵向轴线LA的至少300度的整个区域中没有任何这种特征。
切割件4可以由钢、碳化钨、碳化钨钴、碳化钨钼、碳化硅、氮化硅、陶瓷、非晶态金属或其它材料构成,以及可以通过包括车削、磨削、烧结、放电加工(EDM)、激光切割、热处理、沉淀硬化、铸造的方法或其它方法制造而成。
参照图4至图6,一个或多个凸出元件26从杯形表面24向外延伸,其中图5示出了两个凸出元件26。突出元件26是从杯形表面24突然相对凸起的小楔形材料。凸出元件26具有第一壁30和第二壁32,所述第一壁30和所述第二壁32皆径向延伸并且在所述第一壁30和所述第二壁32之间形成大约20度的角,使得两个凸出元件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在第一壁30和第二壁32的径向内部分之间延伸。凸出元件26通过将相对较钝的力施加到硬组织或斑块上而有助于打碎硬组织和斑块,这是因为利用切割刃22切割这种组织通常并不有效。
凸出元件26总共占据杯形表面24的相对较小的部分。凸出元件26可以共同占据切割元件4的小于5%的表面区域。在本文中使用的术语“切割元件的表面区域”应当指的是从外部或切割刃22径向向内并且当沿着纵向轴线LA观察时露出的表面区域。换言之,当沿着纵向轴线观察时,切割元件的表面区域的至少95%是光滑的杯形表面。通过以此种方式设定凸出元件26的尺寸和定位,凸出元件26不会干扰切割元件4切割组织并且将所述组织重新引导到组织室中的能力,同时仍然利用凸出元件26提供打碎硬组织和斑块的能力。
凸出元件26可以从切割刃22纵向和/或径向地凹陷。凸出元件26可以从切割刃纵向(沿着轴线LA)凹陷0.0010至0.0020英寸(0.0025至0.0051cm)以及可以凹陷大约0.0015英寸(0.0038cm)。凸出元件26可以从切割刃22径向地凹陷大约相同的量。切割元件4的远侧壁38形成平坦表面40,所述平坦表面40垂直于纵向轴线LA,以便整个表面从切割刃凹陷相同的距离。远侧壁38可以呈现任何其它形状,诸如本文所述的弯曲形状或可以是有倾度、有斜度或有坡度的形状。
参照图7、8和8A,示出了另一个切割元件4A,其中,相同或相似的附图标记指代相同或相似的结构,并且除非另有说明,关于切割元件4的相同或相似特征的所有讨论均同样可应用于此。切割元件4A具有切割刃22A,所述切割刃22A可以是连续不间断的圆形边缘,尽管在不背离本发明的范围的前提下,所述切割刃22A也可以包括脊、齿、锯齿或其它特征。当切割元件4A位于切割位置时,切割刃22A可以位于切割元件4A的径向外边缘23A处。切割元件4A具有杯形表面24A,所述杯形表面24A将由切割刃22A切割下的组织引导到组织室12中(见图2)。杯形表面24A可以是如上关于切割元件4所述的基本光滑并且连续的表面。
一个或多个凸出元件26A从杯形表面24A向外延伸。图8示出了四个凸出元件26A,但是可以包括诸如1、2、3、4、6或8个的任何数量的凸出元件。凸出元件26A是从杯形表面24A突然相对凸起的小楔形材料。凸出元件26A具有第一壁30A和第二壁32A,所述第一壁30A和所述第二壁32A在一个实施例中皆径向延伸并且在所述第一壁30A和所述第二壁32A之间形成大约1至30度的角,使得四个凸出元件26A共同占据大约4至60度的区域并且总共可以小于60度。第三壁34A在第一壁30A和第二壁32A的径向内部分之间延伸。在一些实施例中,凸出元件26A可以占据杯形表面24A的相对较小的部分,并且按照如上关于切割元件4所述的方式,所述凸出元件26A可以从切割刃22A凹陷。在其它实施例中,切割元件的表面区域的至少60%、70%、80%或90%是光滑的杯形表面。
切割元件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。整个表面40A仍可略微靠近切割刃22A但是从切割刃22A凹陷,使得整个表面40A距切割刃至少0.0010、0.0020、0.0030、0.0040或0.0050英寸(0.0025、0.0051、0.0076、0.0101、或0.0127cm)。与形成在壁32A和远侧壁38A的相交部处的边缘52相比,形成在壁30A和远侧壁38A的相交部处的边缘50更靠近切割刃22A。切割元件4A可以沿着任意方向旋转,使得凸出边缘50可以是前边缘或后边缘。在一些实施例中,凸出边缘可以距切割刃0.0010至0.0020英寸(0.0025至0.0051cm)。凸出元件26A可以全部以相同的方式形成或者彼此不同。例如,元件26A中的一些能够沿着不同的方向成角度,使得元件中的两个具有作为前边缘的凸出边缘50以及元件26A中的两个具有作为后边缘的凸出边缘50。在不背离本发明的各方面的前提下,凸出元件26A也可以对着不同的角度,具有不同高度或可以具有不同的径向长度。
参照图9、10和10A,示出了另一个切割元件4B,其中,相同或相似的附图标记指代相同或相似的结构,并且除非另有说明,关于切割元件4的相同或相似的特征的所有讨论同样可应用于此。切割元件4B具有切割刃22B,所述切割刃22B可以是连续不间断的圆形边缘,尽管在不背离本发明的范围的前提下,所述切割刃22B也可以包括脊、齿、锯齿或其它特征。当切割元件4B位于切割位置时,切割刃22B可以位于切割元件4B的径向外边缘23B处。切割元件4B具有杯形表面24B,所述杯形表面24B将由切割刃22B切割下的组织引导到组织室12中(见图2)。在一个实施例中,杯形表面24B可以是如以上关于切割元件4所述的基本光滑且连续的表面。
一个或多个凸出元件26B从杯形表面24B向外延伸。图9和图10示出了四个凸出元件26B,但是可以包括诸如1、2、3、4、6或8个的任何数量的凸出元件。凸出元件26B是从杯形表面24B突然相对凸起的小楔形材料并且对着相对于轴线LA大约为1至30度的弧,四个凸出元件26B总共对着大约4至60度的弧。凸出元件26B具有第一壁30B,所述第一壁30B在弯曲的切割刃50B和杯形表面24B之间延伸,并且所述凸出元件26B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在第一壁30B和第二壁32B的径向内部分之间延伸。在一些实施例中,凸出元件26B可以占据杯形表面24B的相对较小的部分并且按照如上关于切割元件4所述的方式从切割刃22B凹陷。在其它实施例中,切割元件的表面区域的至少60%、70%、80%或90%是光滑的杯形表面。
切割元件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。在一些实施例中,表面40B所成的角度使得与边缘52B相比,边缘50B处于更远侧。整个表面40B仍可略微靠近切割刃22B但是从切割刃22B凹陷,使得整个表面40B与切割刃相距0.0010至0.0050英寸(0.0025至0.0127cm)的距离,所述距离包括0.0010、0.0020、0.0030、0.0040或0.0050英寸(0.0025、0.0051、0.0076、0.0101、或0.0127cm)。与形成在壁32B和远侧壁38B的相交部处的边缘52B相比,形成在壁30B和远侧壁38B的相交部处的边缘50B更靠近切割刃22B。在边缘50B附近,壁30B和表面40B之间的夹角大于90度。切割元件4B可以沿着任意方向旋转,使得凸出边缘50B可以是前边缘或后边缘。在一个实施例中,切割件4B沿着箭头R的方向旋转,使得边缘50B是前边缘。凸出边缘50B、52B可以距切割刃0.0010至0.0020英寸(0.0025至0.0051cm)。凸出元件26B可以全部以相同的方式形成或者彼此不同。例如,元件26B中的一些能够沿着不同的方向成角度,使得所述元件中的两个具有作为前边缘的凸出边缘50B以及元件26A中的两个具有作为后边缘的凸出边缘50B。在不背离本发明的各方面的前提下,凸出元件26B也可以对着不同的角度,具有不同高度或可以具有不同的径向长度。
在一个实施例中,切割件4B沿着箭头R的方向旋转,并且被向远侧推动,以便迫使杯形表面24B和凸出元件26B与诸如粥瘤或斑块的材料相接触。由于切割件轴线LA和表面40B之间的后角(reliefangle),因此凸出元件26B将趋于沿着边缘50B集中切割力。由于在边缘50B附近,壁30B和表面40B之间的夹角是钝角,因此切割件4B将趋于刮离诸如粥瘤或斑块的材料,而非切割进这种材料中。凸出元件26B所接触的材料将趋于被表面30B朝向轴线LA引导,所述表面30B从靠近边缘22B的相对切向的角度弯曲成靠近边缘34B的相对径向的角度。
参照图11和11A,示出了另一个切割元件4C。切割元件4C是切割元件4A的变型。该变型包括将底切41C添加到一个或多个凸出元件26A的前沿面,从而导致修改的凸出元件26C。当切割件4C沿着箭头T的方向旋转时,底切将材料颗粒引导到由切割件的杯形表面24A所限定的凹腔中并且朝向切割件的轴线LA。任选地,能够将底切分别应用到切割元件4、4B的一个或多个凸出元件26、26B的前沿面以及应用到切割元件4A的一个或多个凸出元件26A。
底切41C由壁30C限定,所述壁30C定向成与表面40A成锐角,所述表面40A与杯形表面24A相交并且与壁34A汇合。壁30C的平面也与轴线LA以小于5、10、15、或20度相交,使得当切割件4C沿着方向T旋转时,材料颗粒趋于在远离切割刃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可以散置在壁30C和壁40A的相交部之间。可以以任何期望的前角定向壁43C,诸如例如,在凸出元件将趋于不刺入正被切割的材料的情况下,所述前角是负前角。
现在结合切割元件4来描述导管2的使用,但是这同样可应用于具有切割元件4A、切割元件4B、或者切割元件4C的导管2的使用。使用导丝(未示出)等以传统方式将导管2引入到患者体内。在切割元件处于图2的储存位置的情况下使导管2行进,直到导管定位于接近材料待移除的位置为止。然后,使切割元件4向近侧运动,使得斜坡16和凸轮表面14接合,以便使切割元件4运动到图3的切割位置,并且使导管2的尖端偏斜以使切割元件4朝向待切割的组织运动。切割元件4围绕纵向轴线LA旋转,并且然后导管2向远侧运动通过血管,使得切割元件4切割组织。由杯形表面24、一个或多个凸出元件26、由(切割元件4B的)弯曲表面30B、或由杯形表面、凸出元件、或弯曲表面的任何组合将已切割的组织引导到组织室12中。
更加具体地,当使用切割元件4B并且沿着箭头R的方向(图9)旋转切割元件时,切割刃22B切下较软的材料并且杯形表面将切下的材料引导到组织室12中;后角确保作用于导管上向远侧引导的力集中在凸出元件的边缘50B处而非分布在表面40B上;由于在边缘50B附近壁30B和表面40B之间的夹角是钝角,因此凸出元件26B将趋于刮离或粉碎诸如钙的较硬材料;弯曲表面30B朝向切割件轴线LA引导材料颗粒;并且弯曲表面30B在旋转时产生流体涡旋,所述流体涡旋趋于朝向切割件轴线LA引导材料颗粒并且向远侧进入组织室12中。
更加具体地,当使用诸如示出用于切割元件4C的底切并且沿着箭头T的方向旋转切割元件时(图11),底切41C朝向轴线LA沿着杯形表面远离切割刃22A、并且朝向切割元件的轴线LA径向地引导材料。
在另一个实施例中,图12和图13示出了具有切割元件104的粥样硬化切除导管102,所述切割元件104在大体沿着切割元件的轴线LA的方向上振动。粥样硬化切除导管102与粥样硬化切除导管2相似,其中相同或相似的附图标记指代相同或相似的结构,并且除非另有说明,关于粥样硬化切除导管2的相同或相似特征的所有讨论同样可应用于此。
粥样硬化切除导管102包括斜坡116和切割件104。切割元件104从储存位置向近侧运动(图12),使得切割元件104上的凸轮表面14接合导管102的主体8上的斜坡116。凸轮表面14和斜坡116之间的相互作用致使切割元件104运动到切割位置(图3)并且还致使尖端18发生偏斜,这趋于使切割元件104朝向待切割的组织运动。
切割件104包括凸轮表面14上的一个或多个凸出部分14a;此外,斜坡116包括斜坡表面116b中的一个或多个凹陷部116a。凹陷部和凸出部分的相对尺寸设计成使得凸出部分14a能够配合在凹陷部116a中。凹陷部116a还包括至少一个边缘116c。切割元件104的凸轮表面14被预载成与斜坡116压力接触。在一个实施例中,组装导管102,其中通过本领域中已知的手段使轴20处于拉伸状态以及导管主体8处于压缩状态,以便提供这种预载。在另一个实施例中,导管102包括弹簧(未示出),所述弹簧迫使凸出部分14a抵靠在斜坡表面116b上。切割件104包括杯形表面24和切割刃22并且可以以凸出元件26、26A、26B、或26C的任何混合和组合的方式包括0、1、2、3、4、6、或8个凸出元件。
在替代实施例中(未示出),切割件104包括一个或多个凸轮表面14上的凹陷部,并且斜坡116包括一个或多个斜坡表面116b上的凸出部分。在又一个实施例中(未示出),切割件104包括一个或多个凸轮表面14上的凸出部分,并且斜坡116包括一个或多个斜坡表面116b上的凸出部分。
在使用期间,使用导丝(未示出)等以传统方式将导管102引入到患者体内。导管2在切割元件处于图12的储存位置的情况下行进,直到导管定位在材料待移除的位置处。然后,使切割元件104向近侧运动,使得斜坡116和凸轮表面14接合,以使切割元件104运动到切割位置,并且使导管2的尖端偏斜,以便使切割元件104朝向待切割的组织运动(图3)。切割元件104围绕纵向轴线LA旋转,并且然后,导管102向远侧运动通过血管,以使切割元件104切割组织。杯形表面24将已切割的组织引导到组织室12中。在切割元件104围绕纵向轴线LA(沿着例如箭头S的方向)旋转的同时,凸出部分14a将沿着斜坡116的表面116b滑动,直到切割件104抵靠斜坡116的预载致使凸出部分14a进入到斜坡116的凹陷部116a中。切割元件104的进一步旋转致使凸出部分14a接触凹陷边缘116c并且从斜坡116的凹陷部116a弹出,从而使得切割件104对待移除的材料产生锤击状撞击。在待移除的材料具有易碎特征的情况中,材料将被压碎成更小的颗粒,从而有助于其移除。切割件104的重复旋转将使切割件104对待移除的材料产生重复锤击状击打。沿着大体平行于切割元件的轴线方向的振动将力施加在切割下的材料颗粒上,这将所述切割下的材料颗粒沿着远侧方向朝向收集室引导或者沿着双向引导。
以上描述和附图用于描述本发明的实施例并且并不旨在以任何方式限制本发明的范围。对本领域中的那些技术人员显而易见的是,在不背离本发明的精神和范围的前提下,可以做出多种变型和修改。因此,这表示,如果变型和修改落入随附权利要求及其等同物的范围内,则本发明涵盖该发明的变型和修改。而且,尽管相对于特定实施例,以上已经描述了材料和构造的选择方案,但是本领域的技术人员将理解的是,所述材料和构造可应用到所有实施例中。
Claims (14)
1.一种粥样硬化切除导管,所述粥样硬化切除导管包括:
主体,所述主体具有开口;
能够旋转的轴,所述能够旋转的轴联接到所述主体;
切割元件,所述切割元件联接到所述能够旋转的轴,以用于使所述切割元件围绕旋转轴线旋转,所述切割元件具有切割刃;
组织收集室,所述组织收集室联接到所述主体并且定位于切割元件的远侧处;和
所述粥样硬化切除导管的特征在于,所述切割元件构造成沿着基本平行于所述切割元件的所述旋转轴线的方向振动。
2.根据权利要求1所述的粥样硬化切除导管,所述粥样硬化切除导管还包括具有一个或多个凹陷部的斜坡,
其中,所述切割元件包括在所述切割元件的凸轮表面上的一个或多个凸出部分,当所述凸出部分和所述凹陷部对准时,所述一个或多个凸出部分配合在所述一个或多个凹陷部中,并且当所述切割元件旋转时所述凸出部分离开和进入所述凹陷部,从而致使所述切割元件振动。
3.根据权利要求2所述的粥样硬化切除导管,其中,所述切割元件的凸轮表面被预载成与所述斜坡压力接触。
4.根据权利要求1所述的粥样硬化切除导管,所述粥样硬化切除导管还包括:
具有一个或多个凸出部分的斜坡,
其中,所述切割元件包括在所述切割元件的凸轮表面上的一个或多个凹陷部,当所述凸出部分和所述凹陷部对准时,所述一个或多个凸出部分配合在所述一个或多个凹陷部中,并且当所述切割元件旋转时所述凸出部分离开和进入所述凹陷部,从而致使所述切割元件振动。
5.根据权利要求4所述的粥样硬化切除导管,其中,所述切割元件的凸轮表面被预载成与所述斜坡压力接触。
6.根据权利要求1所述的粥样硬化切除导管,所述粥样硬化切除导管还包括:
具有一个或多个凸出部分的斜坡,
其中,所述切割元件包括在所述切割元件的凸轮表面上的一个或多个凸出部分,并且当所述切割元件旋转时,所述凸出部分彼此接合,从而致使所述切割元件振动。
7.根据权利要求6所述的粥样硬化切除导管,其中,所述切割元件的凸轮表面被预载成与所述斜坡压力接触。
8.根据权利要求1所述的粥样硬化切除导管,其中,所述切割元件具有杯形表面,所述杯形表面构造成当所述杯形表面沿着远侧方向运动时沿着所述远侧方向重新引导由所述切割刃切割下的组织。
9.根据权利要求8所述的粥样硬化切除导管,其中,所述切割刃是所述切割元件的径向外边缘。
10.根据权利要求8所述的粥样硬化切除导管,其中,所述导管包括凸出元件,所述凸出元件从所述切割元件的所述杯形表面向外延伸。
11.根据权利要求10所述的粥样硬化切除导管,其中,所述切割刃是所述切割元件的径向外边缘,并且当沿着所述切割元件的旋转轴线观察时,所述凸出元件从所述切割刃向近侧凹陷。
12.根据权利要求1所述的粥样硬化切除导管,其中,所述切割元件能够相对于所述开口在储存位置和切割位置之间运动。
13.根据权利要求12所述的粥样硬化切除导管,其中,所述切割元件通过抵靠凸轮表面滑动所述切割元件而在所述储存位置和所述切割位置之间运动。
14.根据权利要求13所述的粥样硬化切除导管,其中,所述导管的相对于近侧部分的远侧部分通过抵靠所述凸轮表面滑动所述切割元件而偏斜。
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WO2011068932A1 (en) | 2011-06-09 |
US20170281223A1 (en) | 2017-10-05 |
AU2010326063B2 (en) | 2013-07-04 |
JP2013512736A (ja) | 2013-04-18 |
EP2913013A1 (en) | 2015-09-02 |
CA2781046A1 (en) | 2011-06-09 |
CN102695462B (zh) | 2015-01-14 |
CA2781046C (en) | 2014-09-16 |
AU2010326063A1 (en) | 2012-06-07 |
US20110130777A1 (en) | 2011-06-02 |
BR112012013389A2 (pt) | 2018-03-06 |
CN102695462A (zh) | 2012-09-26 |
US9687267B2 (en) | 2017-06-27 |
RU2526915C2 (ru) | 2014-08-27 |
EP2913013B1 (en) | 2016-11-09 |
EP2506783A1 (en) | 2012-10-10 |
US8496677B2 (en) | 2013-07-30 |
RU2012121387A (ru) | 2014-01-20 |
JP5499180B2 (ja) | 2014-05-21 |
KR20120079479A (ko) | 2012-07-12 |
US20140163590A1 (en) | 2014-06-12 |
US10499947B2 (en) | 2019-12-10 |
EP2506783B1 (en) | 2016-06-29 |
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