CN102695463B - 具有提高的材料捕获效率的材料去除装置及使用方法 - Google Patents

具有提高的材料捕获效率的材料去除装置及使用方法 Download PDF

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CN102695463B
CN102695463B CN201080055972.0A CN201080055972A CN102695463B CN 102695463 B CN102695463 B CN 102695463B CN 201080055972 A CN201080055972 A CN 201080055972A CN 102695463 B CN102695463 B CN 102695463B
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cutting element
tube chamber
conduit
fluid
collecting room
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CN102695463A (zh
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张志勇
J·莫伯格
H·朗瓦拉
T·麦克皮克
W·惠伦
R·库斯雷卡
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Covidien LP
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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
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00685—Archimedes screw
    • 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
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A61B2017/320032—Details of the rotating or oscillating shaft, e.g. using a flexible shaft
    • 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
    • A61B2017/320064—Surgical cutting instruments with tissue or sample retaining means
    • 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

本发明提供一种改进的粥样硬化斑块切除导管，其具有用于将由切割元件产生的颗粒导向到组织收集室中的装置。还提供了将切割的材料从血管管腔导向到组织收集室的方法。

Description

具有提高的材料捕获效率的材料去除装置及使用方法
交叉引用
本申请要求2009年12月11日提交的名称为“Material RemovalDevice Having Improved Material Capture Efficiency and Methods ofUse”的美国临时专利申请No.61/285,768的权益，其内容在此以引用的方式并入本文中。
技术领域
本发明涉及用于从身体管腔中某个位置去除材料的导管。更具体地，本发明涉及能够捕获从所述位置去除的材料的导管。
背景技术
粥样硬化是血管系统的进行性疾病，其中，粥样斑块沉积在血管内壁上。随时间推移，粥样硬化沉积物可能变得足够大，以致于减小或堵塞通过血管的血流，导致低血流量症状，例如腿痛（走路时或静止时）、皮肤溃疡、心绞痛（静止时或劳力型）和其它症状。为了治疗该疾病，并且改善或消除这些症状，期望恢复或改善通过血管的血流。
多种装置用于恢复或改善通过粥样硬化血管的血流。粥样斑块沉积物可通过充气球囊、膨胀支架和其它方法将血管径向扩张来移走。但是，这些方法不合期望地撕裂和拉伸血管，在很大比例的患者中造成瘢痕形成。这种瘢痕组织（再狭窄材料）一旦形成，就会阻挡血管中的血流并且常常需要去除。该沉积物可使用激光或其它方法粉碎。但是仅仅粉碎粥样硬化材料会使微栓流动到下游，并且积聚在远端血管床中，进一步危及受疾病影响的组织的血流。粥样硬化斑块切除导管可用于从血管去除粥样硬化沉积物，并且当捕获从血管去除的粥样硬化碎片以及将其从身体去除时，可提供理想的解决方法。
当将材料从血管去除时出现的一个问题是，材料碎片可能由去除装置在一些情况下由切割器产生，并且这样的碎片可能留在体内，这样的碎片可能在体内栓塞并且造成问题。期望在材料从血管壁去除时，从身体去除形成的所有材料碎片。一些导管设计用于通过将材料颗粒导向到收集室而从身体去除材料，但是这些收集工作不总是100%有效。需要改进的颗粒收集装置。
发明内容
本发明提供一种粥样硬化斑块切除导管，包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件的远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和管腔，其构造用于将流体导向到所述组织收集室中。
本发明提供一种粥样硬化斑块切除导管，包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和用于在所述组织收集室中向远侧推进流体的部件，所述部件选自包括以下部件的组：（i）驱动轴，其具有近端和远侧部分，所述近端附接到所述切割元件，推进器附接到所述远侧部分；和（ii）桨叶，其附接到所述切割元件。
本发明提供一种在粥样硬化斑块切除导管中再循环流体的方法，包括：提供一种粥样硬化斑块切除导管，所述粥样硬化斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件的远侧，所述组织收集室具有排放孔；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和使流体通过所述排放孔移出组织收集室，以在组织收集室内部形成负压，并且该负压使流体通过所述导管的主体的开口进入所述组织收集室中。
本发明提供一种从身体管腔去除材料的方法，所述方法包括：提供一种粥样硬化斑块切除导管，所述粥样硬化斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和管腔，其构造用于将流体导向到所述组织收集室；将所述导管放置在所述身体管腔中；和在所述身体管腔中移动所述导管，以将所述切割元件与所述身体管腔中的材料接触。
本发明提供一种从身体管腔去除材料的方法，所述方法包括：提供一种粥样硬化斑块切除导管，所述粥样硬化斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和用于在所述组织收集室中向远侧推进流体的部件，所述部件选自包括以下部件的组：（i）驱动轴，其具有近端和远侧部分，所述近端附接到所述切割元件，推进器附接到所述远侧部分；和（ii）桨叶，其附接到所述切割元件；将所述导管放置到所述身体管腔中；和将所述导管在所述身体管腔中移动，以使所述切割元件与所述身体管腔中的材料接触。
从下面对优选实施例的描述、附图和权利要求，本发明的这些和其它方面将变得显而易见。本发明的一个或多个实施例的详细内容将在下面的附图和描述中说明。本发明的其它特征、目的和优点将通过所述描述和附图，并且通过所述权利要求变得显而易见。
附图说明
图1示出粥样硬化斑块切除导管的局部等距视图。
图2示出图1中所示的粥样硬化斑块切除导管在切割元件处于存储位置中的情况下的一部分的等距剖视图。
图3示出图1中所示的粥样硬化斑块切除导管在切割元件处于工作位置中的情况下的一部分的等距剖视图。
图4示出切割元件的一个实施例的等距视图。
图5，6和7示出具有改进的材料收集的导管的实施例的远侧部分的局部剖视图。
图7A示出图7中所示的导管的一部分的局部剖视侧视图。
图8示出切割元件的另一个实施例的等距视图。
图8A示出图8中所示的切割元件的剖视图。
图9示出具有改进的材料收集的导管的一个实施例的远侧部分的局部剖视图。
图9A，9B和9C示出用于图9中所示的导管的替代部件的局部剖视侧视图。
图10A和10B示出在血管中使用的图9中所示的导管。
具体实施方式
本发明提供一种粥样硬化斑块切除导管，包括主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和管腔，其构造用于将流体导向到所述组织收集室中。在一个实施例中，所述管腔沿向远侧方向将流体导向到组织收集室中。在一个实施例中，切割元件具有杯状表面，所述杯状表面构造用于在所述杯状表面沿向远侧方向移动时，沿向远侧方向重新导向由所述切割边缘切割的组织。在一个实施例中，所述管腔在所述切割元件的杯状表面上具有远侧开口。在一个实施例中，所述管腔包括位于所述切割元件中的第一管腔部分，和位于所述可旋转轴中的第二管腔部分。在一个实施例中，所述远侧开口设置在所述切割元件的纵轴线处。在一个实施例中，所述管腔具有远侧开口，并且所述远侧开口不设置在所述切割元件的杯状表面上。在一个实施例中，所述远侧开口与所述切割元件的杯状表面相邻设置。
在一个实施例中，向管腔提供流体的流体源附接到导管的近侧部分。在一个实施例中，由流体源供给的流体为食盐水。在一个实施例中，由流体源供给的流体包含不透射线物质。
在一个实施例中，管腔的近侧开口设置在导管的远侧部分处，但是在切割元件的杯状表面近侧。在一个实施例中，所述近侧开口设置在可旋转轴上。在一个实施例中，可旋转轴包括管腔的两个或更多个近侧开口。在一个实施例中，可旋转轴包括在所述近侧开口近侧的推进器，所述推进器在可旋转轴旋转时，将流体推入近侧开口中。在一个实施例中，推进器具有1到10个螺旋圈。在一个实施例中，管腔在切割元件的杯状表面上具有远侧开口。在一个实施例中，远侧开口设置在所述切割元件的纵轴线处。
在一个实施例中，管腔的近侧开口设置在切割元件上。在一个实施例中，近侧开口设置在切割元件的外边缘处。在一个实施例中，切割元件具有杯状表面，所述杯状表面构造用于在杯状表面沿向远侧方向移动时，沿向远侧方向重新导向由所述切割边缘切割的组织，并且管腔在所述切割元件的杯状表面上具有远侧开口。在一个实施例中，远侧开口设置在切割元件的纵轴线处。
在一个实施例中，组织收集室包括排放孔。在一个实施例中，组织收集室包括10到200个排放孔。在一个实施例中，排放孔具有从25微米到100微米的直径。在一个实施例中，切割元件可相对于所述开口在存储位置和切割位置之间移动。
本发明提供一种粥样硬化斑块切除导管，包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和用于在组织收集室中向远侧推进流体的部件，所述部件选自包括以下部件的组：（i）驱动轴，其具有近端和远侧部分，所述近端附接到所述切割元件，推进器附接到所述远侧部分；和（ii）桨叶，其附接到所述切割元件。在一个实施例中，切割元件具有杯状表面，所述杯状表面构造用于在所述杯状表面沿向远侧方向移动时，沿向远侧方向重新导向由切割边缘切割的组织。在一个实施例中，用于在组织收集室中向远侧推进流体的部件选自包括以下部件的组：（i）驱动轴，其具有近端和远侧部分，所述近端附接到所述切割元件的杯状表面，推进器附接到所述远侧部分；（ii）桨叶，其附接到所述切割元件的杯状表面。
在一个实施例中，用于在组织收集室中向远侧推进流体的部件是驱动轴，其具有近端和远侧部分，所述近端附接到所述切割元件，推进器附接到所述远侧部分。在一个实施例中，所述推进器设置在所述开口的远侧，并且设置在所述收集室的远端的近侧。在一个实施例中，推进器紧接地设置在所述开口的远侧。在一个实施例中，所述推进器设置在所述收集室的远侧半部中。在一个实施例中，驱动轴的近端附接到切割元件的杯状表面，所述杯状表面构造用于在杯状表面沿向远侧方向移动时，沿向远侧方向重新导向由切割边缘切割的组织。
在一个实施例中，用于在组织收集室中向远侧推进流体的部件为桨叶，其附接到切割元件。在一个实施例中，桨叶为以螺旋结构扭绞的金属丝。在一个实施例中，金属丝具有矩形横截面。在一个实施例中，金属丝的厚度为0.002到0.020英寸（0.0051到0.051cm）。在一个实施例中，金属丝的宽度为0.010到0.075英寸（0.025到0.19cm）。在一个实施例中，桨叶的金属丝宽度为收集室内径的百分之20到95。在一个实施例中，桨叶的纵向长度为收集室的纵向长度的至少百分之50。在一个实施例中，桨叶的纵向长度为收集室的纵向长度的至少百分之70。在一个实施例中，组织收集室包括排放孔。在一个实施例中，组织收集室包括10到200个排放孔。在一个实施例中，排放孔的直径为25到200微米。在一个实施例中，桨叶附接到切割元件的杯状表面，所述杯状表面构造用于在所述杯状表面沿向远侧方向移动时，沿向远侧方向重新导向由所述切割边缘切割的组织。
在一个实施例中，收集室包括在远端的部分，其可打开来去除切割的材料和颗粒。在一个实施例中，切割元件可在存储位置和切割位置之间相对于开口移动。
本发明提供一种在粥样硬化斑块切除导管中再循环流体的方法，包括：提供一种粥样硬化斑块切除导管，所述粥样硬化斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件的远侧，所述组织收集室具有排放孔；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和使流体通过所述排放孔移出组织收集室，以在组织收集室内部形成负压，并且该负压使流体通过所述导管的主体的开口进入所述组织收集室中。在一个实施例中，所述导管包括管腔，其构造用于将流体导向到所述组织收集室中。在一个实施例中，所述导管包括用于在所述组织收集室中向远侧推进流体的部件，所述部件选自包括以下部件的组：（i）驱动轴，其具有近端和远侧部分，所述近端附接到所述切割元件，推进器附接到所述远侧部分；和（ii）桨叶，其附接到所述切割元件。
本发明提供一种从身体管腔去除材料的方法，所述方法包括：提供一种粥样硬化斑块切除导管，所述粥样硬化斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件的远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和管腔，其构造用于将流体导向到所述组织收集室中；将所述导管放置到身体管腔中；和在身体管腔中移动所述导管来将所述切割元件与身体管腔中的材料接触。在一个实施例中，所述导管沿向远侧方向移动，以使切割边缘与身体管腔中的材料接触。在一个实施例中，在切割元件处于存储位置中的情况下，将导管放置在身体管腔中，并且在所述切割元件处于切割位置中的情况下，移动所述导管来与材料接触。在一个实施例中，身体管腔为血管。
本发明提供一种从身体管腔去除材料的方法，所述方法包括：提供一种粥样硬化斑块切除导管，所述粥样硬化斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体；组织收集室，其联接到所述主体，并且设置在切割元件的远侧；切割元件，其联接到所述可旋转轴，所述切割元件具有切割边缘；和用于在所述组织收集室中向远侧推进流体的部件，所述部件选自包括以下部件的组：（i）驱动轴，其具有近端和远侧部分，所述近端附接到所述切割元件，推进器附接到所述远侧部分；和（ii）桨叶，其附接到所述切割元件；将所述导管放置到身体管腔中；和在身体管腔中移动所述导管来使所述切割元件与身体管腔中的材料接触。在一个实施例中，所述导管沿向远侧方向移动，以使切割边缘与身体管腔中的材料接触。在一个实施例中，在切割元件处于存储位置中的情况下，将导管放置在身体管腔中，并且在所述切割元件处于切割位置中的情况下，移动所述导管来与材料接触。在一个实施例中，身体管腔为血管。
本发明提供一种改进的粥样硬化斑块切除导管，其具有用于将由切割元件产生的颗粒导向到组织收集室中的结构特征。还提供了将被切割的材料从血管管腔导向到组织收集室的方法。所述切割元件具有围绕杯状表面的锋利的切割边缘。被切割的材料由所述杯状表面和流体流导向到所述组织收集室中。
参照图1到4，显示了粥样硬化斑块切除导管2，其具有切割元件4，所述切割元件4用于从血流管腔例如血管切割材料。切割元件4可在存储位置（图2）和切割位置（图3）之间在导管2的主体8中相对于开口6移动。切割元件4相对于开口6向外移动，以使元件4的一部分通过开口6从主体8向外延伸。在一个实施例中，切割元件4可相对于主体8和开口6设置成使得切割元件4的小于90度的部分露出来切割组织。在其它实施例中，更大部分的切割元件4可露出而不偏离本发明的多个方面。
导管2的远端在切割元件4处于存储位置的情况下靠近血管的处理位置设置。然后在切割元件4处于工作或切割位置中的情况下，将导管2向远侧移动通过血管，如下面进一步详细所述。当导管2在切割元件4处于工作或切割位置中的情况下移动通过血管时，组织材料由切割元件4切割，并且被导向到设置在切割元件4远侧的组织收集室12中。组织收集室12可略微细长，以容纳已经切割的组织。
为了通过开口6露出切割元件4，切割元件4从存储位置向近侧移动，以使切割元件4上的凸轮表面14与导管2的主体8上的斜坡16接合。凸轮表面14和斜坡16之间的相互作用使切割元件4移动到切割位置，并且还使端头18偏转，所述偏转倾向于朝向待切割组织移动切割元件4。
切割元件4具有杯状表面24，其将由切割边缘22切割的组织导向到组织收集室12中。切割边缘22可处于切割元件4的径向外边缘23处。在一些实施例中，对于从纵轴线LA到切割边缘22的外径的距离的至少一半而言，杯状表面24可以是没有通孔、齿、翅片或其它结构特征的光滑连续的表面，而这些通孔、齿、翅片或其它结构特征会破坏表面24的光滑属性。在一些实施例中，杯状表面24还可以在整个相对于纵轴线LA至少300度的区域没有任何这样的结构特征。在其它实施例中，杯状表面可具有有限数量的通孔、齿、翅片或其它结构特征，如下面进一步详细描述的。一个或多个突起元件26可从杯状表面24向外延伸，图4显示了两个突起元件26。突起元件26是材料构成的小楔，其从杯状表面24相对陡峭地凸起。突起元件26有助于通过向硬组织或斑块施加相对钝的冲击力来破坏硬组织或斑块，因为使用切割边缘22切割这样的组织可能不是很有效，并且这样的硬组织条可能不够柔软来由杯状表面24重新导向到组织收集室12中。全部突起元件26占据杯状表面24的较小的部分。通过以该方式设置突起元件26的尺寸和位置，突起元件26不会妨碍切割元件4的杯状表面24的切割和将大条组织重新导向到组织收集室的能力，同时仍能提供使用突起元件26破碎硬组织和斑块的能力。
切割元件4联接到轴20，所述轴20延伸穿过导管2的管腔21。导管2联接到示例性的切割器驱动装置5。切割器驱动装置5包括马达11、电源15（例如一个或多个电池）、微开关（未示出）、壳体17（如图所示，壳体的上半部被去除）、杆13和用于将轴20连接到驱动马达11的连接组件（未示出）。切割器驱动装置5可用作用于使用者操纵导管2的手柄。当杆13被致动来闭合微开关时，杆13将电源15电连接到马达11，由此使切割元件4转动。当轴20旋转时，切割元件4围绕纵轴线LA旋转。切割元件4以约1到160,000rpm的速度旋转，但是可以任何其它适当的速度旋转，取决于特定应用。类似于导管2的导管的进一步描述可见于授予Patel等人的名称为“DebulkingCatheter”的美国专利申请公开号US 2002/0077642A1，其内容在此以引用的方式并入本文中。
使用中，导管2以相对大的条从血管壁切割较柔软的斑块，杯状表面24将这些条导向通过开口6进入组织收集室12中。在一些情况下，在较硬的或钙化斑块的去除过程中产生的较小的颗粒可由杯状表面24朝向开口6导向，并且在一些情况下也可沿与旋转的切割元件外边缘23相切的方向被导向经过开口6，在该情况下没有收集到组织收集室12中。
现在参照图5，显示了导管2A，其中，导管2A的相同或相似的附图标记指代管2的相同或相似的结构，并且与导管2的相同或相似结构特征相关的所有讨论可等同应用到这里，除非另外说明。与导管2相比较，导管2A具有改进的材料收集能力，并且另外包括切割元件4中的管腔4A、连接轴20中的管腔20A、切割驱动器5处的旋转接头（未示出）、流体源（未示出）和收集室12的壁中的排放孔31。切割元件4和连接轴20通过粘合、焊接、模压、压装配合、衬垫机械密封或其它方式附接，以在管腔4A和20A之间形成防渗漏流体连接。切割器驱动器5处的旋转接头以类似方式附接到连接轴20和流体源，以在流体源和旋转连接轴20之间形成防渗漏流体连接。在一些实施例中，管腔直径和长度的尺寸使得在50psi（345千帕）下允许0.5到50cc/min的流体流动速率，包括0.5，1，2，5，10，20，或50cc/min，或其它流动速率。在其它实施例中，这些流动速率在1，5，10，20，100或150psi（6.9，35，69，140，690或1000千帕）的驱动压力下或在其之间的压力下获得。
排放孔31允许流体流出组织收集室12的内部68，而不使大量的材料颗粒从其通过。在一个实施例中，排放孔直径为50微米。在其它实施例中，排放孔直径为25到200微米，包括25，35，65，80，100，150或200微米。排放孔31的数量、间距和分布可改变。在各实施例中，可设计10到200个排放孔，并且排放孔的数量可以为从10到200，包括10，20，30，50，75，100或200。排放孔可在组织收集室12的外表面上非均匀或均匀分布。在一个实施例中，大于一半的孔分布在组织收集室12的外表面的近侧半部上，以使得当组织收集室的排放孔由颗粒和碎片堵塞时，仍维持从组织收集室12的内部68的流动。在另一个实施例中，为了促使流体优先流出排放孔31而不是流出开口6，经过全部排放孔的流体的总液压阻力小于经过开口6的流体的液压阻力。
操作中，导管2A在切割元件4通过开口6露出的情况下前进通过血管V。切割元件4将粥样硬化斑块材料M的大碎片F从血管V的管腔表面LS分离，并且切割元件4的杯状表面24将所述碎片导向通过开口6进入组织收集室12的内部68中。流体源在切割元件4旋转之前、旋转过程中或旋转之后，或在切割元件旋转之前、旋转过程中或旋转之后的任意组合时间推动加压流体（例如生理食盐水）通过管腔20A，4A。流体沿箭头A的方向离开切割元件4的管腔4A，流入组织收集室12的内部68中，并且流出排放孔31。由作用在材料M上的切割元件4产生的小颗粒P由流体流运送到组织收集室12的内部68的远侧区域68d中。
参照图6，显示了另一种导管2B，其中，导管2B的相同或相似的附图标记指代管2的相同或相似的结构，并且与导管2的相同或相似结构特征相关的所有讨论可等同应用到这里，除非另外说明。与导管2相比较，导管2B具有改进的材料收集能力，并且另外包括管7、流体源（未示出）和收集室12的壁中的排放孔31。管7在切割器驱动器5附近通过防渗漏流体连接，例如衬垫机械密封，附接到流体源。在一些实施例中，流体源仅在切割器4旋转时例如通过阀提供流动，以防止过多的流体注入患者中。流体源可在切割元件4旋转之前、旋转过程中或旋转后，或在切割元件旋转之前、旋转过程中或旋转之后的任意组合时间提供流动。在其它实施例中，流体包含不透射线物质，例如造影剂，以便于组织收集室中的材料量可视化。管7的远端可沿从朝向组织收集室12的侧壁到朝向组织收集室12的最远端这些方向范围内的任何方向取向。在一个实施例中，管7的远端朝向组织收集室12的内部68的远侧区域68d取向。在其它实施例中，管7具有单通阀，其允许向远侧通过所述管的流动，但是防止向近侧通过所述管的流动，以防止血液或碎片进入管7中，并且防止可能的对管7管腔的阻塞。在一些实施例中，管7的管腔直径和长度的尺寸使得允许50psi（345千帕）的驱动压力下0.5到50cc/min的流体流动速率，包括0.5，1，2，5，10，20，或50cc/min，或其它流动速率。在其它实施例中，这些流动速率在1，5，10，20，100或150psi（6.9，35，69，140，690或1000千帕）的驱动压力下或在其之间的压力下获得。排放孔31具有如上面针对导管2A所述的结构和功能特性。
在导管2B的另一个实施例中，流体通过导管2的管腔21注入，而不是通过管7的管腔注入。在该实施例中，流体通道（未示出）可设置在斜坡16中，以使流体向远侧流动通过斜坡16，并且从斜坡16离开进入组织收集室12的内部68中。
操作中，导管2B在切割元件4通过开口6露出的情况下前进通过血管V。切割元件4将粥样硬化斑块材料M的大碎片F从血管V的管腔表面LS分离，并且切割元件4的杯状表面24将所述碎片导向通过开口6进入组织收集室12的内部68中。流体源在切割元件4旋转之前、旋转过程中或旋转之后，或在切割元件旋转之前、旋转过程中或旋转之后的任意组合时间推动加压流体（例如生理食盐水）通过管7。在一些实施例中，流体包含不透射线染料，并且端头中的斑块量可视化。流体沿箭头B的方向离开管7的管腔，流入组织收集室12的内部68中，并且流出排放孔31。由作用在材料M上的切割元件4产生的小颗粒P由流体流运送到组织收集室12的内部68的远侧区域68d中。
参照图7，显示了另一种导管2C，其中，导管2C的相同或相似的附图标记指代管2的相同或相似的结构，并且与导管2的相同或相似结构特征相关的所有讨论可等同应用到这里，除非另外说明。与导管2相比较，导管2C具有改进的材料收集能力，并且另外包括切割元件4中的管腔4C、连接轴20中的管腔20C和孔20D、推进器9、导管2中的入口孔32和收集室12的壁中的排放孔31。切割元件4和连接轴20通过粘合、焊接、模压、压装配合、衬垫机械密封或其它方式附接，以在管腔4C和20C之间形成防渗漏流体连接。孔32允许流体从血管V的管腔L传送到管腔21中，孔20D允许流体从管腔21传送到管腔20C中。在一些实施例中，管腔直径和长度的尺寸允许在50psi（345千帕）的驱动压力下0.5到50cc/min的流体流动速率，包括0.5，1，2，5，10，20，或50cc/min，或其它流动速率。在其它实施例中，这些流动速率在1，5，10，20，100或150psi（6.9，35，69，140，690或1000千帕）的驱动压力下或在其之间的压力下获得。推进器9通过粘合剂粘合、焊接、机械互锁或其它方式牢固地附接到连接轴20。
参照图7A，推进器9由金属、塑料或其它材料构造，包括但不限于不锈钢、镍钛合金、聚甲醛（可以商标商购获得）、聚醚嵌段酰胺（可以商标商购获得）、聚酰胺、尼龙12、聚酯或其它材料。推进器可以是通过焊接、粘合剂粘合或其它方式附接到连接轴20的单独构造的部件，或可由所述轴一体形成。在一些实施例中，推进器包括1到10个或更多个螺旋圈，包括1，2，3，4，6，8，或10个螺旋圈（图7A中示出四个螺旋圈9e）。可设计10到75度的螺距角9a，包括10，20，30，45，60或75度，螺距9b沿推进器长度可相同或变化。在一些实施例中，推进器9的外径和导管2的内径之间的间隙9d可为0.000到0.010英寸（0.000到0.025cm），包括0.000，0.001，0.002，0.003，0.004，0.007或0.010英寸（0.000，0.0025，0.0051，0.0076，0.010，0.018，或0.025cm）或为在其之间的值。在其它实施例中，在推进器9的外径和导管2的内径之间可以是过盈配合或负间隙9d，大小为0.0005到0.002英寸（0.0013到0.0051cm），包括0.0005，0.001或0.002英寸（0.0013，0.0025或0.0051cm），或在其之间的值。在其它实施例中，推进器9的尺寸和管腔21的直径可改变，以当推进器以1000，2000，4000，8000，16000或24000RPM或以在其之间的旋转速度旋转时，产生0.5到50cc/min的流体流动速率，包括0.5，1，2，5，10，20，或50cm/min，或其它流动速率。排放孔31具有如上面针对导管2A所述的结构和功能特性。
操作中，导管2C在切割元件4通过开口6露出的情况下前进通过血管V。切割元件将粥样硬化斑块材料M的大碎片F从血管V的管腔表面LS分离，并且切割元件4的杯状表面24将所述碎片导向通过开口6进入组织收集室12的内部68中。在切割元件4旋转过程中，沿由箭头D指示的方向旋转的推进器9将流体（例如血液）从血管的管腔L抽吸通过孔32，进入管腔21中，为流体加压，并且将加压的流体推动通过孔20D、管腔20C和管腔4C。流体沿箭头C的方向离开切割元件4的管腔4C，流入组织收集室12的内部68中，并且流出排放孔31。由作用在材料M上的切割元件4产生的小颗粒P由流体流运送到组织收集室12的内部68的远侧区域68d中。
可使用切割元件40（参见图8和8A）代替导管2，2A，2B，2C或2D中的任一个的切割元件4。切割元件40类似于切割元件4，其中，切割元件40的相同或相似的附图标记指代切割元件4的相同或相似的结构，并且与切割元件4的所述相同或相似结构特征相关的全部讨论可等同应用到这里，除非另外说明。与切割元件4相比较，切割元件40另外包括一个或多个通道42和一个或多个孔44。在切割元件40沿方向E的旋转过程中，流体（例如血液）在切割元件40的外边缘23处进入通道42中，并且向远侧通过孔44离开。通道42和孔44可通过钻孔、放电加工（EDM）或其它方式构造在切割器40中。在一个实施例中，切割元件40以2件制成，一个具有在其中切割出的通道，另一个具有切割边缘22、杯状表面24、突起元件26（如果使用）和形成于其中的孔44，所述两件通过焊接、软钎焊、硬钎焊、粘合剂粘合、机械互锁或其它方式顺序地联接在一起。在一些实施例中，孔44没有沿切割元件40的轴线LA设置。通道和孔的数量、通道宽度42W、通道长度42L和孔44直径可改变，以在切割元件40以1000，2000，4000，8000，16000或24000RPM或其间的转速旋转时，产生0.5到50cc/min的流体流动速率，包括0.5，1，2，5，10，20或50cc/min，或其它流动速率。
如之前例如针对导管2A描述的，操作中，切割元件40在用于血管V中的过程中沿箭头E的方向旋转。切割元件40将粥样硬化斑块材料M的大碎片F从血管V的管腔表面LS分离，并且切割元件4的杯状表面24将所述碎片通过开口6导向进入组织收集室12的内部68中。在切割元件的旋转过程中，沿由箭头E指示的方向旋转的切割元件40将来自血管V的管腔L的流体（例如血液）推动到通道42中，进入孔44内。流体沿大体上纵轴线LA的方向离开切割元件40的孔44，流入组织收集室12的内部68中，并且流出排放孔31。由作用在材料M上的切割元件40产生的小颗粒P由流体流运送到组织收集室12的内部68的远侧区域68d中。
参照图9，显示了另一种导管2D，其中导管2D的相同或相似的附图标记指代管2的相同或相似的结构，并且与导管2的相同或相似结构特征相关的所有讨论可等同应用到这里，除非另外说明。与导管2相比较，导管2D具有改进的材料收集能力，并且另外包括驱动轴33和一个或多个推进器34。在各实施例中，驱动轴33和推进器34可由例如不锈钢、钴-铬-镍-钼-铁合金（可以商标商购获得）等金属，或其它金属，或例如聚酯、聚酰胺、尼龙12、液晶聚合物等聚合物或其它聚合物构造。在一些实施例中，通过焊接、硬钎焊、软钎焊、包覆模制、机械互锁、粘合剂粘合或其它附接方式，将驱动轴33附接到切割元件4的杯状表面24和将推进器34附接到驱动轴33。在一个实施例中，驱动轴33沿纵轴线LA附接到切割元件4的杯状表面24。驱动轴33具有的柔性足够在切割元件的轴线LA和收集室12的纵轴线LACC之间弯曲。在一个实施例中（图9），驱动轴33的长度足够将推进器34靠近收集室12的远端设置。在另一个实施例中（图10A），驱动轴的长度仅足够将推进器34紧接着开口6的远侧设置。驱动轴33可以具有在这两个极端位置处或之间的任何长度。推进器34取向为沿向远侧方向推进流体（例如血液）。推进器34的螺距可改变，以当推进器以1000，2000，4000，8000，16000或24000RPM或以在其之间的旋转速度旋转时，产生0.5到50cc/min的流体流动速率，包括0.5，1，2，5，10，20，或50cm/min，或其它流动速率。排放孔31具有如上面针对导管2A所述的结构和功能特性。
操作中，导管2D在切割元件4通过开口6露出的情况下前进通过血管V。切割元件4将粥样硬化斑块材料M的大碎片F从血管V的管腔表面LS分离，并且切割元件4的杯状表面24将所述碎片导向通过开口6进入收集室12的内部68中。推进器34在组织收集室12的内部68中向远侧推进流体，并且将流体通过排放孔31排出，由此使流体（例如血液）通过开口6抽吸入收集室12中。进入开口6的流体流将由作用在材料M上的切割元件4产生的小颗粒P运送到收集室12的内部68的远侧区域68d中。
在导管2D的另一个实施例中，桨叶附接到切割元件4的杯状表面24，而不是将驱动轴33和推进器34附接到杯状表面24。桨叶的一些实施例示出在图9A，9B和9C中，并且分别以桨叶35A，35B和35C标示。桨叶35A，35B，35C在切割器4处于存储位置中的情况下示出。桨叶可由金属丝构成，所述金属丝在一些实施例中具有矩形横截面。金属丝扭绞为图中所示的螺旋结构。桨叶35A，35B和35C使组织收集室12内部68中的流体在切割元件4旋转过程中向远侧移动。在一些实施例中，金属丝宽度（金属丝的在垂直于导管纵轴线的平面中的部分之间的最大距离）、长度和厚度以及螺旋的螺距可改变，以当推进器以1000，2000，4000，8000，16000或24000RPM或以在其之间的旋转速度旋转时，产生0.5到50cc/min的流体流动速率，包括0.5，1，2，5，10，20，或50cm/min，或其它流动速率。在一些实施例中，金属丝厚度可为0.002到0.020英寸（0.0051到0.051cm），包括0.002，0.003，0.004，0.005，0.007，0.009，0.011，0.015或0.020英寸（0.0051，0.0076，0.010，0.013，0.018，0.023，0.028，0.038或0.051cm），金属丝宽度可以是0.010到0.075英寸（0.025到0.19cm），包括0.010，0.015，0.020，0.025，0.030，0.040，0.050或0.075英寸（0.025，0.038，0.051，0.064，0.076，0.10，0.13或0.19cm），或在其之间的厚度、金属丝宽度或在其之间的厚度和金属丝宽度。
在一个示例性实施例中，图9A示出桨叶35A，其由已经扭绞为约与组织收集室12一样长的螺旋的矩形横截面金属丝构成，金属丝宽度D1为收集室内径的40%，并且在整个桨叶长度上具有均匀的螺距长度P1。在另一个示例性实施例中，图9B示出桨叶35B，其由已经扭绞为组织收集室12的长度的60%的螺旋的矩形横截面金属丝构成，所述桨叶35B在桨叶近侧部分上具有的金属丝宽度D2为收集室内径的40%，在桨叶远侧部分上具有的金属丝宽度D3为收集室内径的80%，并且其在桨叶长度上具有均匀的螺距长度P2。应可预期，其它实施例可具有3个或更多个不同的金属丝宽度，或金属丝宽度可在桨叶35B的至少一些部分上连续改变。而且，可设计金属丝宽度为组织收集室的内径的20%到组织收集室的内径的95%。图9C示出桨叶35C，其由已经扭绞为组织收集室12的长度的70%的螺旋的矩形横截面金属丝构成，所述桨叶35C在整个桨叶长度上具有的金属丝宽度D4为收集室内径的30%，在桨叶近侧部分上具有螺距长度P3，在桨叶远侧部分上具有螺距长度P4。应可预期，其它实施例可具有3个或更多个不同的螺距长度，或螺距长度可在桨叶35C的至少一些部分上连续改变。在其它实施例中，金属丝宽度和螺距长度可都在桨叶长度上连续或离散地变化。
可任选地，在一些实施例中，导管2，2A，2B或2C可另外包括驱动轴33和推进器34。在其它实施例中，导管2，2A，2B或2C可另外包括桨叶35A，35B或35C。
操作中，在切割元件4通过开口6露出的情况下，配备有桨叶35A，35B或35C而不是轴33和推进器34的导管2D前进通过血管V。切割元件4将粥样硬化斑块材料M的大碎片F从血管V的管腔表面LS分离，并且切割元件4的杯状表面24将所述碎片导向通过开口6进入收集室12的内部68中。桨叶35A，35B或35C在组织收集室12的内部68中向远侧推进流体，并且将流体通过排放孔31排出，由此使流体（例如血液）通过开口6抽吸入收集室12中。进入开口6的流体流将由作用在材料M上的切割元件4产生的小颗粒P运送到收集室12的内部68的远侧区域68d中。桨叶35也将碎片F运送到收集室12的内部68的远侧区域68d中。
在另一个实施例中，通过在收集室12的远端处设置开口，然后旋转桨叶34或桨叶35以由此排出碎屑，来将碎片F和颗粒P从收集室12的内部68去除。对在收集室12的远端处设置有开口的导管的进一步的描述可见于授予Simpson等人的名称为“Debulking Catheter andMethods”的美国专利申请公开号US 2005/0222663A1中，其内容在此以引用的方式并入本文中。参见[0117]到[0146]段。其它实施例中，导管2，2A，2B或2C可另外包括轴33和推进器34或桨叶35A，35B或35C，并且收集室12的内部可如上面针对导管2D所述地清除碎屑。
在导管2A，2B，2C或2D的一些实施例中，可建立流体再循环回路。这在血管中向远侧流动全部或几乎全部阻塞的情况下特别期望（参见图10A），其中，例如材料M完全堵塞材料去除导管远侧的血管。为了建立流体再循环回路，流出排放孔31的流体的流动速率必须超过通过管腔4A（导管2A）、通过管7（导管2B）、通过管腔4C（导管2C）、通过切割元件40的孔44或通过这些结构的组合（在使用的情况下）进入收集器12的内部68中的流体的体积。当出现该流动状况时，将在收集室12的内部68中建立负压，流体将通过开口6流入收集室12中，由此将由切割元件产生的颗粒P抽吸入收集室12的内部68中（图10A和10B）。
除了用于血管中，可设想本发明可用于去除其它血流管腔例如天然或人造植入物、支架植入物、吻合口、瘘管或其它血流管腔中的堵塞物。
上面的描述和附图出于描述本发明的实施例而提供，不旨在以任何方式限制本发明的范围。对本领域技术人员显而易见的是，可进行各种修改和改变而不偏离本发明的精神或范围。因而，本发明旨在覆盖落在所附权利要求及其等同方案的范围内的本发明的所有修改形式和变形形式。而且，虽然上面已经针对一些实施例描述了对材料和结构的选择，但是本领域的普通技术人员将理解，所述的材料和结构可适用于全部实施例。

Claims (17)

1.一种粥样硬化斑块切除导管，包括：
主体，所述主体具有开口和可偏转端头；
可旋转轴，所述可旋转轴联接到所述主体；
切割元件，所述切割元件联接到所述可旋转轴，所述切割元件具有用于从身体管腔去除材料的切割边缘，其中，所述切割元件能够移动以在所述切割元件的切割位置使所述切割元件的一部分从所述主体通过所述开口向外延伸；
组织收集室，所述组织收集室位于所述可偏转端头中，并且当所述切割元件处于所述切割位置时所述组织收集室设置在切割元件的远侧；和
管腔，所述管腔构造用于当所述切割元件处于所述切割位置时将流体导向到所述组织收集室中。
2.根据权利要求1所述的导管，其中，所述管腔将流体沿向远侧方向导向到所述组织收集室中。
3.根据权利要求1所述的导管，其中，所述切割元件具有杯状表面，所述杯状表面构造用于在所述杯状表面沿向远侧方向移动时，沿向远侧方向重新导向由所述切割边缘切割的组织。
4.根据权利要求3所述的导管，其中，所述管腔在所述切割元件的杯状表面上具有远侧开口。
5.根据权利要求4所述的导管，其中，所述管腔包括在所述切割元件中的第一管腔部分和在所述可旋转轴中的第二管腔部分。
6.根据权利要求4所述的导管，其中，所述远侧开口设置在所述切割元件的纵轴线处。
7.根据权利要求3所述的导管，其中，所述管腔具有远侧开口，并且所述远侧开口不设置在所述切割元件的杯状表面上。
8.根据权利要求7所述的导管，其中，所述远侧开口与所述切割元件的杯状表面相邻设置。
9.根据权利要求3所述的导管，其中，所述管腔的近侧开口设置在所述导管的远侧部分处，但是在所述切割元件的杯状表面的近侧。
10.根据权利要求9所述的导管，其中，所述近侧开口设置在所述可旋转轴上。
11.根据权利要求10所述的导管，其中，所述可旋转轴包括在所述近侧开口近侧的推进器，当所述可旋转轴旋转时，所述推进器推动流体进入所述近侧开口中。
12.根据权利要求9所述的导管，其中，所述管腔在所述切割元件的杯状表面上具有远侧开口。
13.根据权利要求1所述的导管，其中，所述管腔的近侧开口设置在所述切割元件上。
14.根据权利要求13所述的导管，其中，所述近侧开口设置在所述切割元件的外边缘处。
15.根据权利要求14所述的导管，其中，所述切割元件具有杯状表面，所述杯状表面构造用于在所述杯状表面沿向远侧方向移动时，沿向远侧方向重新导向由所述切割边缘切割的组织，所述管腔在所述切割元件的杯状表面上具有远侧开口。
16.根据权利要求1所述的导管，其中，所述组织收集室包括排放孔。
17.根据权利要求1所述的导管，其中，生理盐水源与所述管腔流体连通，以用于通过所述管腔朝着所述组织收集室输送生理盐水。
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