CN102458276A - 容易清洁的粥样斑块切除导管及其使用方法 - Google Patents

容易清洁的粥样斑块切除导管及其使用方法 Download PDF

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CN102458276A
CN102458276A CN201080027813XA CN201080027813A CN102458276A CN 102458276 A CN102458276 A CN 102458276A CN 201080027813X A CN201080027813X A CN 201080027813XA CN 201080027813 A CN201080027813 A CN 201080027813A CN 102458276 A CN102458276 A CN 102458276A
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tissue
collecting chamber
conduit
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CN102458276B (zh
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J·莫伯格
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Covidien LP
Fox Hollow Technologies Inc
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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
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • 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
    • 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
    • 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
    • A61B2017/320716—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material
    • 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
    • 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

本发明提供一种具有能够以简单、快速和有效方式清洁干净的组织收集室的粥样斑块切除导管，还提供使用所述导管来从血管管腔去除材料的方法。在一个实施例中，所述组织收集室具有可扩张端头，所述可扩张端头具有能够将材料保持在所述材料收集室中的第一闭合位置，并且具有可允许材料从所述材料收集室排出的第二打开位置。在第二实施例中，所述组织收集室具有可移动端头，所述可移动端头具有用于将材料保持在所述材料收集室中的第一闭合位置，并且具有允许材料从所述材料收集室排出的第二打开位置。

Description

容易清洁的粥样斑块切除导管及其使用方法
本申请要求2009年5月14日提交的名称为“容易清洁的粥样斑块切除导管及其使用方法(Easily Cleaned Atherectomy Catheters andMethods of Use)”的美国临时专利申请No.61/178,119的权益，所述专利申请的内容在此以引用方式并入本文中。
技术领域
本发明涉及用于从体腔中某个位置去除材料的导管。更具体地，本发明涉及存储在这样的导管中的材料的去除。
背景技术
动脉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，粥样斑块沉积物可能变得足够大，以至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(走路时或休息时)、皮肤溃疡、心绞痛(自发型或劳力型)和其他症状。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动脉粥样硬化血管的血流。粥样斑块沉积物可通过充气球囊、膨胀支架和其他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他方法粉碎。但是仅仅粉碎粥样斑块材料会使微栓流动到下游，并且积聚在远端血管床中，进一步危及受该疾病影响的组织的血流。粥样斑块切除导管可用于从血管去除粥样斑块沉积物，并且可在将从血管去除的沉积物捕获并从身体去除时提供理想的解决方案。捕获和去除这样的沉积物的一种方式是将沉积物存储在导管中，并且随后将导管从身体取出。
当将材料或沉积物存储在导管中时，出现的一个问题是，导管可能具有不充足的存储容量。血管的待处理的部分可能范围非常大。例如，血管的待处理部分可在200mm或更长的血管长度上延伸。如果导管中的存储室由材料充满时，则必须从身体取出导管，将沉积物从导管去除，将导管再插入身体进行更多的沉积物去除和存储。但是，现有的用于从导管收集室去除沉积物的方法可能太费时。
所需要的是具有简单、快速和有效从导管收集室去除沉积物的方式的导管。
发明内容
本发明提供一种具有能够以简单、快速和有效方式清洁干净的组织收集室的粥样斑块切除导管，还提供使用所述导管来从血管管腔去除材料的方法。在一个实施例中，所述组织收集室具有可扩张端头，所述可扩张端头具有能够将材料保持在所述组织收集室中的第一闭合位置，并且具有可允许材料从所述组织收集室排出的第二打开位置。在第二实施例中，所述组织收集室具有可移动端头，所述可移动端头具有用于将材料保持在所述材料收集室中的第一闭合位置，并且具有用于允许材料从所述材料收集室排出的第二打开位置。
本发明提供一种粥样斑块切除导管，包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织。所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置。所述组织收集室包括在所述导管远端区域处的可扩张端头，所述可扩张端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从在所述组织收集室远端处的远端开口排出的第二打开位置。
本发明提供一种粥样斑块切除导管，包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织。所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置。所述组织收集室包括在所述导管远端区域处的可移动端头，所述可移动端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，所述可移动端头在所述第一闭合位置和第二打开位置中都附接到所述粥样斑块切除导管。
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：提供一种粥样斑块切除导管，所述粥样斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且其中，所述组织收集室包括在所述导管远端区域处的可扩张端头，所述可扩张端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从在所述组织收集室远端处的远端开口排出的第二打开位置；将所述导管放置在身体管腔中；和在身体管腔中移动所述导管，以使所述切割元件与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：提供一种粥样斑块切除导管，所述粥样斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且其中，所述组织收集室包括在所述导管远端区域处的可移动端头，所述可移动端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，所述可移动端头在所述第一闭合位置和第二打开位置中都附接到所述粥样斑块切除导管；将所述导管放置在身体管腔中；和在身体管腔中移动所述导管，以使所述切割元件与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，本发明的这些和其他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。本发明的其他特征、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示出粥样斑块切除导管的等距视图。
图2显示了图1中示出的粥样斑块切除导管的一部分的等距剖视图，其中切割元件处于存储位置中。
图3显示了图1中示出的粥样斑块切除导管的一部分的等距剖视图，其中切割元件处于工作位置中。
图4示出切割元件的一个实施例的等距视图。
图5示出切割元件的一个实施例的端视图。
图6和图7示出粥样斑块切除导管的一部分的局部剖视图。
图6A显示了图6中示出的粥样斑块切除导管的端视图。
图8显示了图6、图6A和图7中示出的导管的一部分的侧视图。
图9、图10和图11显示了图6、图6A、图7和图8中示出的粥样斑块切除导管的一部分的处于各使用阶段的局部剖视图。
图12和图13示出另一种粥样斑块切除导管的一部分的局部剖视图。
图14和图15显示了图12和图13中示出的粥样斑块切除导管的一部分的处于各使用阶段的局部剖视图。
具体实施方式
本发明提供一种粥样斑块切除导管，包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织。所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置。所述组织收集室包括在所述导管远端区域处的可扩张端头，所述可扩张端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从在所述组织收集室远端处的远端开口排出的第二打开位置。在一个实施例中，所述组织收集室包括具有管腔的外套。
在一个实施例中，所述组织收集室包括在所述外套的远端区域中的一个或多个槽。在另一个实施例中，所述组织收集室包括在所述外套的远端区域中的两个或更多个槽。所述外套的远端区域可包括2、3、4、6、8、12或16个槽。在一个实施例中，所述外套的远端区域具有朝向远端逐渐减小的直径。在一个实施例中，所述组织收集室具有处于第一闭合位置中的远端开口。
在一个实施例中，所述组织收集室包括布置在所述外套的管腔中的衬套，所述衬套可相对于所述外套轴向滑动，并且所述衬套具有管腔。在一个实施例中，所述衬套可包括窗口。在一个实施例中，所述切割元件可通过所述衬套窗口和所述导管的开口布署。在一个实施例中，所述外套的远端区域可通过将所述衬套朝向远端移动来扩张。在一个实施例中，所述外套预编程来呈现所述第一闭合位置。
在一个实施例中，所述切割元件可通过所述衬套的管腔朝向远端延伸。在一个实施例中，所述切割元件可在所述组织收集室处于第二打开位置中时，通过所述外套的远端开口朝向远端延伸。在一个实施例中，所述组织收集室包括导引丝管腔。
在一个实施例中，所述组织收集室在所述外套的远端区域中包括一个或多个槽，所述外套的远端区域具有朝向远端逐渐减小的直径，并且所述组织收集室包括布置在所述外套中的衬套，所述衬套可相对于所述外套沿轴向滑动，并且所述衬套具有管腔。在一个实施例中，所述外套的远端区域可通过将所述衬套朝向远端移动而扩张。
本发明提供一种粥样斑块切除导管，包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴可围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织。所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置。所述组织收集室包括在所述导管的远端区域处的可移动端头，所述可移动端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，所述可移动端头在所述第一闭合位置和第二打开位置中都附接到所述粥样斑块切除导管。在一个实施例中，所述组织收集室包括具有管腔的外套。在一个实施例中，所述可移动端头能相对于所述外套沿轴向滑动。在一个实施例中，所述可移动端头布置在推动轴上，所述推动轴能相对于所述外套沿轴向滑动。在一个实施例中，所述推动轴接纳在所述外套的管腔中。在一个实施例中，所述推动轴具有部分圆形的横截面。在一个实施例中，所述推动轴具有近似于半圆的横截面。
在一个实施例中，所述可移动端头的近端部分具有减小的直径，并且能够接纳在所述外套的管腔中。在一个实施例中，所述可移动端头的远端区域具有朝向远端逐渐减小的直径。
在一个实施例中，所述切割边缘为所述切割元件的径向外边缘。在一个实施例中，所述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。在一个实施例中，所述切割元件可通过抵靠凸轮表面滑动所述切割元件在所述存储位置和所述切割位置之间移动。在一个实施例中，所述导管的相对于近端部分的远端部分通过抵靠所述凸轮表面滑动所述切割边缘来偏转。
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：提供一种粥样斑块切除导管，所述粥样斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴可围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且其中，所述组织收集室包括在所述导管的远端区域处的可扩张端头，所述可扩张端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从在所述组织收集室远端处的远端开口排出的第二打开位置；将所述导管放置在身体管腔中；和在身体管腔中移动所述导管，以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，所述导管沿远端方向移动来使所述切割边缘与身体管腔中的材料接触。在一个实施例中，在所述切割元件处于存储位置中的情况下，将所述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，将所述导管移动来与材料接触。
在一个实施例中，所述方法还包括将所述材料收集到所述组织收集室中，将所述导管从身体管腔取出，和在所述导管已经从身体管腔取出之后将所述材料从所述组织收集室去除。在一个实施例中，在所述组织收集室处于第一闭合位置中的情况下，将所述导管从身体管腔取出，并且在所述组织收集室处于能够允许切割的组织从所述组织收集室排出的第二打开位置中的情况下将所述材料从所述组织收集室去除。
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：提供一种粥样斑块切除导管，所述粥样斑块切除导管包括：主体，其具有开口；可旋转轴，其联接到所述主体，所述可旋转轴可围绕所述轴的纵轴线旋转；组织收集室，其联接到所述主体，并且位于切割元件远端；和切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且其中，所述组织收集室包括在所述导管远端区域处的可移动端头，所述可移动端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，所述可移动端头在所述第一闭合位置和第二打开位置中都附接到所述粥样斑块切除导管；将所述导管放置在身体管腔中；和在身体管腔中移动所述导管，以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，所述导管沿远端方向移动，以使所述切割边缘与身体管腔中的材料接触。在一个实施例中，在所述切割元件处于存储位置中的情况下，将所述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，将所述导管移动来与材料接触。
在一个实施例中，所述组织收集室包括具有管腔的导管。在一个实施例中，所述可移动端头可相对于所述外套沿轴向滑动。
在一个实施例中，所述方法还包括将所述材料收集到所述组织收集室中，将所述导管从身体管腔取出，和在所述导管已经从身体管腔取出之后将所述材料从所述组织收集室去除。在一个实施例中，在所述组织收集室处于第一闭合位置中的情况下，将所述导管从身体管腔取出，并且在所述组织收集室处于能够允许切割的组织从所述组织收集室排出的第二打开位置中的情况下将所述材料从所述组织收集室去除。
参照图1到图4，显示了粥样斑块切除导管2，其具有切割元件4，所述切割元件4用于从例如血管等血液流动管腔切割材料。切割元件4可相对于导管2的主体8中的开口6在存储位置(图2)和切割位置(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的一部分从主体8通过开口6向外伸出。在一个实施例中，切割元件4可相对于主体8和开口6设置成使切割元件4的小于90度的部分露出来切割组织。在其他实施例中，切割元件4的更多部分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处于存储位置中的情况下靠近血管中的处理位置设置。然后导管2在切割元件4处于工作或切割位置中的情况下向远端移动通过血管，如下面进一步详细描述的。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切割并且被引导到设置在切割元件4远端的组织室12中。组织室12可为略微细长状以适应已切割的组织。
在一些实施例中，导管2具有30到200cm的工作长度。在一个实施例中，导管2具有135cm的工作长度。在一些实施例中，导管2具有4Fr到12Fr(1.3mm到4mm)的直径。在一个实施例中，导管2具有7Fr(2.3mm)的直径。
为了将切割元件4通过开口6露出，切割元件4从存储位置向近端移动，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，所述偏转倾向于将切割元件4朝向待切割组织移动。
切割元件4联接到轴20，轴20延伸穿过导管2中的管腔21。导管2联接到示例性刀具驱动器5。刀具驱动器5包括马达11、电源15(例如一个或多个电池)、微型开关(未示出)、壳体17(如图所示，壳体的上半部分去除)、杆13和连接组件(未示出)，所述连接组件用于将轴20连接到驱动马达11。刀具驱动器5可用作用于使用者操纵导管2的手柄。当致动来闭合微型开关时，杆13将电源15电连接到马达11，由此使切割元件4旋转。切割元件4在轴20旋转时围绕纵轴线LA旋转。切割元件4以约1到160,000rpm的转速旋转，但是可以任何其他适当的速度旋转，取决于具体应用。对类似于导管2的导管的进一步的描述可在授予Patel等人的名称为“Debulking Catheter”的美国专利申请序列号No.10/027,418(以US 2002/0077642A1公开)中找到，所述专利申请的内容以引用的方式并入本文中。
参照图5，显示出当沿纵轴线LA看时的切割元件4。在此所用的术语“沿纵轴线LA”意思是沿当纵轴线和/或旋转轴线的方向看时，例如图5的视图，其显示了切割元件4的远端。切割元件4具有切割边缘22，其可以是连续的、不间断的圆形边缘，但是其也可包括脊、齿、锯齿状突起或其他结构而不偏离本发明的范围。当切割元件4处于切割位置中时，切割边缘22可位于切割元件4的径向外边缘23处。
切割元件4具有杯状表面24，其将由切割边缘22切割的组织引导到组织室12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可以是光滑连续表面，无通孔、齿、翅片或破坏所述表面24的光滑本性的其他结构。所述杯状表面24也可以在遍及相对于纵轴线LA至少300度的区域内没有任何这样的结构。任选地，一个或多个凸起元件26从杯状表面24向外延伸，图5显示了两个凸起元件26。凸起元件26是材料构成的小楔，其从杯状表面24相对陡峭地凸起。任选地，刀具中的一些部分或全部可包括研磨表面。可用作导管2中的刀具的其他实施例的进一步的描述可在授予Moberg等人的名称为“Methods And Devices For Cutting/AbradingTissue”的美国专利申请序列号No.61/173,845中找到，所述专利申请的内容以引用的方式并入本文中。
图6、图6A、图7和图8示出易于清洁的组织室的一个实施例。组织收集室12包括具有向里延伸边缘61a、一个或多个槽61b和远端开口64的外部套61，还包括具有管腔68和窗口63w的衬套63。衬套63可相对于外部套61轴向滑动，且内边缘61a限制衬套63的最远偏移。刀具4可滑动地接纳在衬套63的管腔68内，并且可延伸通过窗口63w和窗口6。衬套63的在窗口63w远端侧的部分的横截面为圆形，以当衬套63向远端前进时，促使远端区域65均匀地沿周向扩张，并且在靠近窗口6处的横截面为部分圆形，以允许导管2在斜坡16(参见图9)附近弯曲。外部套61的远端区域65由于存在槽61b，具有可扩张的直径。远端区域65形成可扩张端头。在多个实施例中，可设计2、3、4、6、8、12、16或更多的槽61b。在一些实施例中，外部套61可预编程来呈现通常闭合位置，在该通常闭合位置中，远端开口64较小，并且功能性闭合，以使收集在组织室12中的沉积物不能通过远端开口64出来。在衬套63处于第一位置(图6)中的情况下，外部套远端区域65具有朝向远端逐渐减小的直径，可任选地具有远端开口64。在衬套63处于第二位置(图7和图8)的情况下，外部套远端区域65具有增大的外径，刀具4通过其可滑动地被接纳。在一些实施例中，在衬套63处于第二位置(图8)中的情况下，由于槽61b的增大的宽度和外套61的增大的远端直径，刀具4可伸出外部套的远端开口64。在一些实施例中，室12还包括具有近端开口66p和远端开口66d的导引丝管腔66。
外部套61可包含热塑性聚合物、热固性聚合物、热塑性弹性体、橡胶、尼龙、聚酰胺、聚氨酯或其他材料，并且可还包括弹性材料例如镍钛合金或不锈钢构成的骨架。例如挤压成形等工艺或其他工艺可用于制造外部套61。例如嵌件模制、聚合物回流、加压模制等工艺或其他工艺可用于制造外部套61的远端。向里边缘61a可通过使边缘向里变形、在变形位置中加热该边缘和去除热使边缘冷却并且保持变形状态来形成。槽61b可通过切割、冲压、激光切割形成，可模制于其中，或可通过其他工艺形成。衬套63可包含刚性聚合物或金属，例如聚醚醚酮(PEEK)、聚酰胺、聚酯、液晶聚合物、镍钛合金、不锈钢或其他材料，并且可通过例如挤压成形等工艺制造。导引丝管腔66可包括结合到外套61外部的管。在另一个实施例中，外套61可包括双管腔管。导引丝66可包括至少部分使用热工艺由外部套61的壁形成的管腔。
现在描述使用包括组织室的粥样斑块切除导管2来从患者身体切割和去除材料的示例性方法。使用本领域已知的技术，将导引丝GW经皮插入患者身体中，并且前进到患者血管V中的所关注区域。使用例如荧光透视检查法等成像技术识别血管的病态部分，并且选择包括具有用于处理位置T的适当特性的组织室12的粥样斑块切除导管(例如导管2)。衬套63设置成使窗口63w和窗口6对准。导管2在切割元件处于存储位置(图2)的情况下在导引丝上前进到处理位置。使用例如荧光透视检查法等成像技术，将切割元件相对于处理位置(在一些方法中靠近处理位置)设置在期望位置处。
导管2的主体保持固定，然后将切割元件4向近端移动，以使斜坡16和凸轮表面14接合来将切割元件4移动到图3的切割位置(即通过窗口6和63w露出)，并且使导管2的端头偏转来将切割元件4朝向待切割组织移动。使用杆13致动切割元件围绕纵轴线LA的旋转。导管2向远端前进，使得切割刀片22从血管V的管腔表面LS切割材料M。杯状表面24将材料M的切割碎片F引导通过窗口6和63w进入组织收集室12(图9)的管腔68中。
当导管操作者决定从组织收集室12倒空碎片时，刀具4向远端前进，以将刀具4移入存储位置中，并且停止切割元件的旋转(图10)。导管2向近端收回，并且从身体取出。接下来使衬套63向远端前进来偏转外套61的远端部分，使开口64增大，并且使槽61b的宽度变宽。在一些方法中，衬套63前进到与外套61的向里边缘61a接触。刀具4可然后前进来将碎片F从收集室12的管腔68通过远端开口64排出(图11)。
如果期望从处理位置T去除更多材料，则切割元件4可撤回到存储位置中，衬套63可撤回到第一位置，由此使外套61的远端区域65返回到闭合位置。导管2可于是重新插入血管V中，并且可如上所述从管腔表面LS去除更多材料。
图12和图13示出易于清洁的组织室的另一个实施例。组织收集室12’包括外部套121，外部套121具有管腔128和附接到端头125的推动轴123。推动轴123可相对于外部套121沿轴向滑动，横截面近似为半圆，并且接纳在外套121的管腔128中。端头125具有直径减小的近端部分125p，其可滑动地接纳在外套121的管腔128中。刀具4可滑动地接纳在外套121的管腔128中，同时，推动轴123也在管腔128中。推动轴123可旋转对准，以使窗口6不被推动轴128阻挡。端头125的远端区域125d可逐渐减小到比端头125p的近端部分更小的直径。在推动轴123和端头125处于第一位置的情况下(图12)，端头近端部分125p可滑动地接纳在外套121的管腔128中，并且从血管的管腔壁去除的材料碎片不可能从外套121的远端121d排出管腔128。在推动轴123在第二位置中的情况下(图13)，端头125从外套121的远端121d移动距离D，并且从血管的管腔表面去除的材料碎片可通过外套121的远端121d排出管腔128。在一些实施例中，刀具4可伸出外部套121的远端121d，以将碎片从管腔128移走。在一些实施例中，组织收集室12’还包括导引丝管腔126，其具有近端部分126p和远端部分126d。
外部套121可包含热塑性聚合物、热固性聚合物、聚酰胺、聚醚醚酮(PEEK)、尼龙或其他材料。例如挤压成形等工艺或其他工艺可用于制造外部套121。推动轴123可包含硬聚合物或金属，例如PEEK、聚酰胺、聚酯、液晶聚合物、镍钛合金、不锈钢或其他材料，并且可通过例如挤压成形等工艺制造。端头125可包含热塑性弹性体、聚醚嵌段酰胺(PEBAX)、硅橡胶或其他材料，并且可通过例如挤压成形、模制、嵌件模制、浸渍、机加工或其他工艺制造。导引丝管腔126可包括结合到外套121和端头125外部的管。在另一个实施例中，外套121可包括双管腔管，并且在又一个实施例中，端头125可包括贯穿其的导引丝管腔。导引丝管腔126可还包括至少部分使用热工艺由外部套121的壁形成的管腔。
现在描述使用用于从患者身体切割和去除材料的包括组织室12’的粥样斑块切除导管2的示例性方法。使用本领域已知的技术，将导引丝GW经皮插入患者身体中，并且前进到患者血管V中所关注的区域。使用例如荧光透视检查法等成像技术识别血管的病态部分，并且选择包括具有用于处理位置T的适当特性的组织室12’的粥样斑块切除导管(例如导管2)。将推动轴123撤回到第一位置，以使外套121的远端121d由端头125密封地关闭。导管2在切割元件处于存储位置中(图2)的情况下在导引丝上前进到处理位置。使用例如荧光透视检查法等成像技术，将切割元件相对于处理位置(在一些方法中靠近处理位置)设置在期望位置处。
导管2的主体保持固定，然后将切割元件4向近端移动，以使斜坡16和凸轮表面14接合来将切割元件4移动到图3的切割位置(即通过窗口6露出)，并且使导管2的端头偏转来将切割元件4朝向待切割组织移动。使用杆13致动切割元件围绕纵轴线LA的旋转。导管2向远端前进，使得切割边缘22从血管V的管腔表面LS切割材料M。使用类似于图9中示出的方法的方法，杯状表面24将材料M的切割碎片F引导通过窗口6进入组织收集室12’的管腔128中。
当导管操作者决定从组织收集室12倒空碎片时，刀具4向远端前进，以将刀具4移入存储位置中，并且停止切割元件的旋转(图14)。导管2向近端收回，并且从身体取出。接下来推动轴123向远端前进来将端头125与外套121的远端121d分开距离D，允许碎片F从管腔128的远端排出。在一些方法中，刀具4可前进来将碎片F从组织收集室12’的管腔128排出(图15)。
如果期望从治理位置T去除更多材料，则切割元件4可撤回到存储位置中，推动轴123可撤回到第一位置，由此使端头125返回到闭合位置。导管2可于是重新插入血管V中，并且可如上所述从管腔表面LS去除更多材料。
除了用于血管中，本发明可用于去除其他管腔，例如天然或人造移植物、支架移植物、吻合部位、瘘管或其他管腔中的堵塞物。
虽然本发明已经结合优选实施例进行了描述，但是当然可不按照上述实施例来实现。
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方式。

Claims (46)

1.一种粥样斑块切除导管，包括：
主体，其具有开口；
可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述可旋转轴的纵轴线旋转；
组织收集室，其联接到所述主体，并且位于切割元件远端；和
切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，
其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且
其中，所述组织收集室包括在所述导管的远端区域处的可扩张端头，所述可扩张端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从在所述组织收集室远端处的远端开口排出的第二打开位置。
2.根据权利要求1所述的导管，其中，所述组织收集室包括具有管腔的外套。
3.根据权利要求2所述的导管，其中，所述组织收集室包括在所述外套的远端区域中的一个或多个槽。
4.根据权利要求2所述的导管，其中，所述组织收集室包括在所述外套的远端区域中的两个或更多个槽。
5.根据权利要求2所述的导管，其中，所述外套的远端区域具有朝向远端逐渐减小的直径。
6.根据权利要求3所述的导管，其中，所述组织收集室具有处于第一闭合位置中的远端开口。
7.根据权利要求2所述的导管，其中，所述组织收集室包括布置在所述外套的管腔中的衬套，所述衬套能相对于所述外套轴向滑动，并且所述衬套具有管腔。
8.根据权利要求7所述的导管，其中，所述衬套包括窗口。
9.根据权利要求8所述的导管，其中，所述切割元件能通过所述衬套窗口和所述导管的开口布署。
10.根据权利要求7所述的导管，其中，所述外套的远端区域能通过将所述衬套朝向远端移动来扩张。
11.根据权利要求3所述的导管，其中，所述外套的远端区域包括2、3、4、6、8、12或16个槽。
12.根据权利要求2所述的导管，其中，所述外套预编程来呈现第一闭合位置。
13.根据权利要求7所述的导管，其中，所述切割元件能通过所述衬套的管腔朝向远端延伸。
14.根据权利要求13所述的导管，其中，所述切割元件能在所述组织收集室处于第二打开位置中时，通过所述外套的远端开口朝向远端延伸。
15.根据权利要求1所述的导管，其中，所述组织收集室包括导引丝管腔。
16.根据权利要求2所述的导管，其中，所述组织收集室在所述外套的远端区域中包括一个或多个槽，所述外套的远端区域具有朝向远端逐渐减小的直径，并且所述组织收集室包括布置在所述外套中的衬套，所述衬套能相对于所述外套沿轴向滑动，并且所述衬套具有管腔。
17.根据权利要求16所述的导管，其中，所述外套的远端区域能通过将所述衬套朝向远端移动而扩张。
18.根据权利要求1所述的导管，其中，所述切割边缘是所述切割元件的径向外边缘。
19.根据权利要求1所述的导管，其中，所述切割元件能相对于所述开口在存储位置和切割位置之间移动。
20.根据权利要求19所述的导管，其中，所述切割元件能通过抵靠凸轮表面滑动所述切割元件来在所述存储位置和所述切割位置之间移动。
21.根据权利要求20所述的导管，其中，所述导管的相对于近端部分的远端部分通过抵靠所述凸轮表面滑动所述切割元件来偏转。
22.一种粥样斑块切除导管，包括：
主体，其具有开口；
可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；
组织收集室，其联接到所述主体，并且位于切割元件远端；和
切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，
其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且
其中，所述组织收集室包括在所述导管的远端区域处的可移动端头，所述可移动端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，所述可移动端头在所述第一闭合位置和第二打开位置中都附接到所述粥样斑块切除导管。
23.根据权利要求22所述的导管，其中，所述组织收集室包括具有管腔的外套。
24.根据权利要求23所述的导管，其中，所述可移动端头能相对于所述外套沿轴向滑动。
25.根据权利要求24所述的导管，其中，所述可移动端头布置在推动轴上，所述推动轴能相对于所述外套沿轴向滑动。
26.根据权利要求25所述的导管，其中，所述推动轴接纳在所述外套的管腔中。
27.根据权利要求26所述的导管，其中，所述推动轴具有部分圆形的横截面。
28.根据权利要求26所述的导管，其中，所述推动轴具有近似于半圆的横截面。
29.根据权利要求24所述的导管，其中，所述可移动端头的近端部分具有减小的直径，并且能够接纳在所述外套的管腔中。
30.根据权利要求24所述的导管，其中，所述可移动端头的远端区域具有朝向远端逐渐减小的直径。
31.根据权利要求22所述的导管，其中，所述切割边缘为所述切割元件的径向外边缘。
32.根据权利要求22所述的导管，其中，所述切割元件能相对于所述开口在存储位置和切割位置之间移动。
33.根据权利要求32所述的导管，其中，所述切割元件能通过抵靠凸轮表面滑动所述切割元件在所述存储位置和所述切割位置之间移动。
34.根据权利要求33所述的导管，其中，所述导管的相对于近端部分的远端部分通过抵靠所述凸轮表面滑动所述切割边缘来偏转。
35.一种从身体管腔去除材料的方法，所述方法包括：
提供一种粥样斑块切除导管，所述粥样斑块切除导管包括：
主体，其具有开口；
可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；
组织收集室，其联接到所述主体，并且位于切割元件远端；和
切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且其中，所述组织收集室包括在所述导管的远端区域处的可扩张端头，所述可扩张端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从在所述组织收集室远端处的远端开口排出的第二打开位置；
将所述导管放置在身体管腔中；和
在身体管腔中移动所述导管，以使所述切割元件与身体管腔中的材料接触。
36.根据权利要求35所述的方法，其中，所述导管沿远端方向移动来使所述切割边缘与身体管腔中的材料接触。
37.根据权利要求35所述的方法，其中，在所述切割元件处于存储位置中的情况下，将所述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，将所述导管移动来与材料接触。
38.根据权利要求35所述的方法，还包括将所述材料收集到所述组织收集室中，将所述导管从身体管腔取出，和在所述导管已经从身体管腔取出之后将所述材料从所述组织收集室去除。
39.根据权利要求38所述的方法，其中，在所述组织收集室处于第一闭合位置中的情况下，将所述导管从身体管腔取出，并且在所述组织收集室处于能够允许切割的组织从所述组织收集室排出的第二打开位置中的情况下将所述材料从所述组织收集室去除。
40.一种从身体管腔去除材料的方法，所述方法包括：
提供一种粥样斑块切除导管，所述粥样斑块切除导管包括：
主体，其具有开口；
可旋转轴，其联接到所述主体，所述可旋转轴能围绕所述轴的纵轴线旋转；
组织收集室，其联接到所述主体，并且位于切割元件远端；和
切割元件，其联接到所述可旋转轴，所述切割元件具有杯状表面和切割边缘，所述杯状表面构造用于在所述杯状表面沿远端方向移动时沿远端方向重新引导由所述切割边缘切割的组织，其中，所述组织收集室具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，并且其中，所述组织收集室包括在所述导管的远端区域处的可移动端头，所述可移动端头具有能够将切割的组织保持在所述组织收集室中的第一闭合位置，和能够允许切割的组织从所述组织收集室排出的第二打开位置，所述可移动端头在所述第一闭合位置和第二打开位置中都附接到所述粥样斑块切除导管；
将所述导管放置在身体管腔中；和
在身体管腔中移动所述导管，以使所述切割元件与身体管腔中的材料接触。
41.根据权利要求40所述的方法，其中，所述导管沿远端方向移动，以使所述切割边缘与身体管腔中的材料接触。
42.根据权利要求40所述的方法，其中，在所述切割元件处于存储位置中的情况下，将所述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，将所述导管移动来与材料接触。
43.根据权利要求40所述的方法，其中，所述组织收集室包括具有管腔的外套。
44.根据权利要求43所述的方法，其中，所述可移动端头能相对于所述外套沿轴向滑动。
45.根据权利要求40所述的方法，还包括将所述材料收集到所述组织收集室中，将所述导管从身体管腔取出，和在所述导管已经从身体管腔取出之后将所述材料从所述组织收集室去除。
46.根据权利要求45所述的方法，其中，在所述组织收集室处于第一闭合位置中的情况下，将所述导管从身体管腔取出，并且在所述组织收集室处于能够允许切割的组织从所述组织收集室排出的第二打开位置中的情况下将所述材料从所述组织收集室去除。
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