CN102159144B - 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 PDF

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CN102159144B
CN102159144B CN200980107019.3A CN200980107019A CN102159144B CN 102159144 B CN102159144 B CN 102159144B CN 200980107019 A CN200980107019 A CN 200980107019A CN 102159144 B CN102159144 B CN 102159144B
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protruding part
cutting member
cut edge
wall
cup surface
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CN102159144A (zh
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K·李
菲莉斯·袁
达伦·杜德
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Ev3 Co
Covidien LP
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Tyco Healthcare Group LP
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    • 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
    • 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
    • A61B17/320725Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B17/320783Atherectomy 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
    • 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
    • A61B17/32075Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
    • 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
    • A61B17/320783Atherectomy 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

Abstract

提供一种导管,该导管包括具有一个或多个凸出件的切割件。该切割件在远侧具有杯形表面,该表面除了凸出件之外可以是光滑且连续的。

Description

用于切割组织的方法和装置
相关专利申请的交叉引用
该申请是2008年9月9日提交的美国序列号第12/283,224号的继续申请,并要求2008年2月25日提交的临时申请序列号第61/067,238号的权益,每个申请的内容以参见的方式纳入本文。
背景技术
切割术导管用于从血管取出材料以打开血管并改进穿过血管的血流。
在从血管取出材料时发生的一个问题是材料可能是软的或硬的,并可能在切割过程中发生变化。这样,切割件应当能够切割硬组织和软组织。
本发明涉及一种用于切割术导管的切割件以及使用旋切件从血流内腔切割材料的方法。
发明内容
本发明提供一种切割术导管,该切割术导管具有能够切割软组织和硬组织两者的切割件。该切割件具有尖锐切割边缘,该切割边缘围绕杯形表面。杯形表面将已切割的材料引导到组织腔内。周向切割边缘和杯形表面共同适于切割和去除相对软的组织。
在本发明的一方面,提供一种切割术导管,该切割术导管具有从杯形表面延伸的一个或多个凸出件。该凸出件可从外切割边缘纵向和径向凹陷诸如0.0010-0.0020英寸的受控距离,但其当然可根据具体应用更靠近或更远离外切割边缘。这些凸出件有助于断开诸如钙化斑块之类的硬组织。这些凸出件从远端稍微凹陷,使切割边缘保持露出以切割软组织。当切割边缘遇到太硬而不能通过切割边缘充分切割的组织时,这些凸出件有助于用更钝的施加力来断开较硬组织。
在本发明的另一方面,凸出件有些小,使得杯形表面的相对大的部分是光滑且无间断的。这样,凸出件不会过度抑制切割件用杯形表面将组织引导到组织腔内的能力。例如,当沿纵向轴线观察时,这些凸出件可占据小于60度的区域。换而言之,当沿纵向轴线观察时,切割件的杯形表面在整个至少300度光滑且无间断。再换而言之,当沿纵向轴线观察时,杯形表面在切割件的表面面积的至少95%光滑且无间断。
这些和其它方面在较佳实施例的描述、附图和权利要求书中是显而易见的。
在以下的附图和说明中阐述本发明的一个或多个实施例的细节。本发明的其它特征、目的和优点会从说明书和附图以及权利要求书中显现出来。
附图说明
图1示出切割术导管的远端。
图2是切割件处于储存位置的切割术导管的剖视图。
图3是切割件处于作业位置的剖视图;
图4示出切割件的实施例;
图5示出切割件的实施例的端视图;
图6示出切割件的实施例的剖视图;
图7示出可用于切割术导管的切割件的另一实施例;
图8示出图7的切割件的实施例,且图8A示出切割件实施例的凸出件之一。
具体实施方式
参照图1-4,示出切割术导管2具有用于从血流内腔切割材料的切割件4。该切割件4可相对于导管2的本体8内的开口6在储存位置(图2)与切割位置(图3)之间运动。切割件8相对于开口6向外运动,使得切割件4的一部分通过开口6从本体8向外伸出。切割件4可相对于本体8和开口6定位成露出小于90度的切割件4来切割组织。当然,可露出更多切割件4而不偏离本发明的多个方面。
导管2向远侧移动穿过血管,切割件4处于作业或切割位置,如下文更详细描述那样。当导管2移动穿过血管时,通过切割件4切割组织并将组织引导到位于切割件4远侧的组织腔12内。组织腔12可稍微细长以容纳已切割的组织。
该切割件4从储存位置向近侧移动,使得切割件4上的凸轮表面14与导管2的本体8上的斜坡16配合。凸轮表面14与斜坡16之间的相互作用使切割件4移动到切割位置并还使末梢18偏移,这趋于将切割件4朝向所要切割的组织移动。
切割件4联接到轴20,该轴20延伸穿过导管2内的内腔21。当轴转动时,切割件4围绕纵向轴线LA转动。切割件4以约1-160,000转/分钟的转速转动,但根据具体应用也可以以任何其它合适的转速转动。
参照图2、4和5,示出沿纵向轴线LA观察的切割件4。本文所使用的术语“沿纵向轴线”意思应当是示出沿纵向轴线和/或转动轴线方向观察时切割件4的远端的图5的视图。切割件4具有切割边缘22,切割边缘22可以是连续无间断的圆形边缘,尽管其也可包括脊、齿、锯齿或其它结构而不偏离本发明的范围。当切割件4处于切割位置时,切割边缘22可以在切割件4的径向外边缘23处。
切割件4具有杯形表面24,该杯形表面将由切割边缘22切割的组织引导到组织腔12内。杯形表面24可以是没有通孔、齿、翅片或其它结构的光滑连续表面,这些通孔、齿、翅片或其它结构会在从纵向轴线LA到切割边缘22处外径的至少一半距离处中断表面24的光滑特性。杯形表面24也可在相对于纵向轴线LA整个至少300度的区域没有任何这种结构。
参照图4-6,一个或多个凸出件26从杯形表面24向外延伸,图5示出两个凸出件26。凸出件26是从杯形表面24突然相对凸起的材料的小楔形件。凸起件26具有第一壁30和第二壁32,两壁都径向延伸且其间形成约20度的夹角,使得两个凸起件26共同占据约40度的区域且总共小于60度。第三壁34在第一壁30和第二壁32的径向内部之间延伸。凸出件26通过在硬组织或斑块上施加相对钝的力而有助于断开硬组织和斑块,因为用切割边缘22切割这种组织通常效果较差。
凸起件26总共占据杯形表面24的相对小的部分。凸起件26可能共同占据切割件4的小于5%的表面面积。本文使用的术语“切割件的表面面积”意思应当是从外部或切割边缘22径向向内且在沿纵向轴线LA观察时露出的表面面积。换而言之,沿纵向轴线看时,切割件的至少95%的表面面积是光滑的杯形表面。通过这样设定凸出件26的尺寸和位置,凸出件26在提供用凸出件26断开硬组织和斑块的能力的同时不影响切割件4切割组织并将组织再引导到组织腔内的能力。
凸出件26可从切割边缘22纵向地和/或径向地凹陷。凸出件26可从切割边缘纵向地凹陷0.0010至0.0020英寸,且可以是约0.0015英寸。凸出件26可从切割边缘22径向地凹陷约相同的量。切割件4的远侧壁38形成平坦表面40,该平坦表面40垂直于纵向轴线LA,从而整个表面从切割边缘凹陷相同距离。远侧壁38可采用任何其它形状,诸如曲线形,或可以是有倾度、有斜度或有坡度的,如本文所述。
参照图7、8和8A,示出另一切割件4A,其中相同或类似的附图标记指示相同或类似的结构,且关于切割件4的相同或类似特征的所有讨论同样可应用于此。切割件4A具有切割边缘22A,切割边缘22A可以是连续无间断的圆形边缘,尽管其也可包括脊、齿、锯齿或其它结构而不偏离本发明的范围。当切割件4A处于切割位置时,切割边缘22A可以在切割件4的径向外边缘23A处。切割件4A具有杯形表面24A,该杯形表面将由切割边缘22A切割的组织引导到组织腔12内(见图2)。杯形表面24A可以是以上结合切割件4所述的大致光滑和连续的表面。
一个或多个凸出件26A从杯形表面24A向外延伸。图8示出四个凸出件26A,但可包括任何数量,诸如2、3、4、6或8个凸出件。凸出件26A是从杯形表面24A突然相对凸起的材料的小楔形件。凸起件26A具有第一壁30A和第二壁32A,两壁都径向延伸且其间形成约1至30度的夹角,使得四个凸起件26共同占据约4至60度的区域且总共可能小于60度。第三壁34A在第一壁30A和第二壁32A的径向内部之间延伸。凸出件26A可占据杯形表面24A的相对小的部分并可以以上文结合切割件4描述的方式从切割边缘22A凹陷。
切割件4A的远侧壁38A具有相对于纵向轴线LA形成约30-90度角的表面40A。整个表面40A仍可稍微靠近切割边缘22A但从该切割边缘22A凹陷,使得整个表面40A距离切割边缘0.0010至0.0050英寸。形成在壁30A与远侧壁38A相交处的边缘50比形成在壁32A与远侧壁38A相交处的边缘52更靠近切割边缘22A。切割件4A可沿任一方向转动,使得凸出边缘50可以是前边缘或后边缘。凸出边缘可距离切割边缘0.0010至0.0020英寸。凸出件26A可都以相同方式形成或可彼此不同。例如,某些凸出件26A可沿不同方向倾斜,从而凸出件中的两个具有作为前边缘的凸出边缘50,且凸出件26A中的两个具有作为后边缘的凸出边缘50。凸出边缘26A还可对向于不同角度,具有不同高度或可具有不同的径向长度而不偏离本发明的各方面。
现结合切割件4来描述导管2的使用,但使用带有切割件4A的导管2是同样适用的。使用导丝(未示出)等以常规方式将导管2引入患者体内。在切割件在图2的储存位置内时将导管2前移,直到导管定位在所要取出的材料所在位置为止。然后向近侧移动切割件4,使得斜坡16和凸轮表面14配合以将切割件4移动到图3的切割位置,并使导管2的末梢偏移以将切割件4朝向所要切割的组织移动。切割件4围绕纵向轴线LA转动,且然后导管向远侧移动通过脉管,从而切割件4切割组织。将已切割的组织引导到组织腔12内。
已经结合较佳实施例描述了本发明,但当然也可不同于上述实施例来实践本发明。例如,可提供三个或多个凸出件,或者切割边缘可以是带锯齿的,而不偏离本发明的多个方面。

Claims (17)

1.一种切割术导管,包括:
本体,所述本体具有开口;
可转动轴,所述可转动轴联接到所述本体;
切割件,所述切割件联接到所述可转动轴,用于使所述切割件绕纵向轴线转动,所述切割件具有杯形表面和切割边缘,所述切割边缘是所述切割件的径向外边缘,所述杯形表面构造成当所述杯形表面朝远侧方向移动时朝所述远侧方向重新引导由所述切割边缘切割的组织;
组织收集腔,所述组织收集腔联接到所述本体并在切割件远侧定位;以及
凸出件,所述凸出件从所述切割件的所述杯形表面向远侧延伸,所述凸出件具有大致径向延伸的第一壁、径向延伸的第二壁、在所述第一壁和第二壁的径向内部之间延伸的第三壁、以及远侧壁,该远侧壁包括与第一壁相交以形成第一凸出边缘并与第二壁相交以形成第二凸出边缘的远侧表面,其中所述凸出件的远侧表面从切割边缘向近侧凹陷。
2.如权利要求1所述的导管,其特征在于,
所述凸出件从所述切割边缘向近侧凹陷0.0010-0.0020英寸的纵向距离。
3.如权利要求1所述的导管,其特征在于,
所述凸出件与所述切割边缘隔开0.0010-0.0020英寸的径向距离。
4.如权利要求1所述的导管,其特征在于,
当沿所述纵向轴线观察时,所述切割件的所述杯形表面在所述切割件的表面面积的至少95%上光滑且无间断。
5.如权利要求1所述的导管,其特征在于,
当沿所述纵向轴线观察时,所述切割件的所述杯形表面具有外径,所述杯形表面从所述纵向轴线到所述外径的至少一半距离处连续且无间断。
6.如权利要求1所述的导管,其特征在于,还包括:
多个凸出件,当沿所述纵向轴线观察时,所述多个凸出件总共占据所述切割件的小于5%的表面面积;
所述杯形表面在所述切割件的表面面积的至少95%上光滑且无间断。
7.如权利要求1所述的导管,其特征在于,
多个凸出件,所述多个凸出件从所述杯形表面向外延伸,所述多个凸出件是2-6个凸出件。
8.如权利要求1所述的导管,其特征在于,
所述凸出件的所述第一凸出边缘从所述切割边缘凹陷0.0010-0.0020英寸的纵向距离。
9.如权利要求1所述的导管,其特征在于,
所述凸出件的所述第一凸出边缘和所述第二凸出边缘中的每一个均沿纵向方向从所述切割边缘凹陷0.0010至0.0050英寸。
10.如权利要求1所述的导管,其特征在于,
所述远侧表面与所述纵向轴线形成30至90度角。
11.一种切割术导管,包括:
本体,所述本体具有开口;
可转动轴,所述可转动轴联接到所述本体;
切割件,所述切割件联接到所述可转动轴,用于使所述切割件绕纵向轴线转动,所述切割件具有杯形表面和切割边缘,所述杯形表面是没有通孔的、光滑且无间断的,所述杯形表面的尺寸和形状设定成重新引导由所述切割边缘切割的组织,当所述杯形表面朝远侧方向移动时所述杯形表面朝所述远侧方向重新引导所述组织;
组织收集腔,所述组织收集腔联接到所述本体并在所述切割件远侧定位;
凸出件,所述凸出件从所述杯形表面向外延伸,所述凸出件具有大致径向延伸并向外延伸的第一壁、径向延伸的第二壁、在所述第一壁和第二壁的径向内部之间延伸的第三壁、以及远侧壁,该远侧壁包括与第一壁相交以形成第一凸出边缘并与第二壁相交以形成第二凸出边缘的远侧表面,所述凸出件的远侧表面从所述切割边缘向近侧凹陷0.0010-0.0020英寸的纵向距离。
12.如权利要求11所述的导管,其特征在于,
所述凸出件从所述切割边缘径向向内隔开0.0010-0.0020英寸的径向距离。
13.如权利要求11所述的导管,其特征在于,
当沿所述纵向轴线观察时,所述杯形表面具有外径,所述杯形表面从所述纵向轴线到所述外径的至少一半距离处连续且无间断。
14.如权利要求11所述的导管,其特征在于,
多个凸出件,所述多个凸出件从所述杯形表面向外延伸,所述多个凸出件是2-6个凸出件。
15.如权利要求11所述的导管,其特征在于,
所述凸出件的所述第一凸出边缘从所述切割边缘凹陷0.0010-0.0020英寸的纵向距离。
16.如权利要求11所述的导管,其特征在于,
所述凸出件的所述第一凸出边缘和所述第二凸出边缘中的每一个均沿纵向方向从所述切割边缘凹陷0.0010至0.0050英寸。
17.如权利要求16所述的导管,其特征在于,
所述远侧表面与所述纵向轴线形成30至90度角。
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US10219824B2 (en) 2019-03-05
ES2424451T3 (es) 2013-10-02
US20090216180A1 (en) 2009-08-27
CN104490453B (zh) 2017-04-12
WO2009108489A1 (en) 2009-09-03
ES2523900T3 (es) 2014-12-02
EP2252220A1 (en) 2010-11-24
CN102159144A (zh) 2011-08-17
US8784440B2 (en) 2014-07-22
US20150018858A1 (en) 2015-01-15
US9445834B2 (en) 2016-09-20
EP2633824A1 (en) 2013-09-04
CN104490453A (zh) 2015-04-08
EP2633824B1 (en) 2014-09-17
EP2252220B1 (en) 2013-05-08

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