CN102579155A - 可活动连接的锚 - Google Patents

可活动连接的锚 Download PDF

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CN102579155A
CN102579155A CN2011103969583A CN201110396958A CN102579155A CN 102579155 A CN102579155 A CN 102579155A CN 2011103969583 A CN2011103969583 A CN 2011103969583A CN 201110396958 A CN201110396958 A CN 201110396958A CN 102579155 A CN102579155 A CN 102579155A
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anchor
implantable device
lumen
valve
allow
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CN102579155B (zh
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J·库特斯科
S·易
C·L·菲格
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Jieruishi Co ltd
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
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Abstract

一种用于布置在组织腔管中的可植入装置，所述装置包括：闭塞装置，以及具有多个臂的锚，其中所述臂能够收缩和延伸，所述锚被配置为以允许所述锚关于所述闭塞装置可活动连接的方式将所述闭塞装置紧固到腔管内。

Description

可活动连接的锚
本申请是提交于2007年3月30日、申请号为200780019455.6的名为“可活动连接的锚”的专利申请的分案申请。
相关申请
本申请要求2006年3月31号提交的美国临时专利申请60/787,995号以及2006年10月24号提交的美国临时专利申请11/585,415号的权益，该两个申请在此通过引用的方式将其全部纳入本说明书。
技术领域
本发明总体涉及肺部治疗领域，并且具体而言涉及用于治疗病人的肺或其一部分的系统、装置和方法。
背景技术
在美国，慢性阻塞性肺病(“COPD”)已经成为发病和死亡的主要原因。COPD的典型特征是因慢性支气管炎或肺气肿而存在气流阻塞。COPD中的气流阻塞主要是由于肺中更小的气道结构异常。
死亡率、健康相关的花费以及受到COPD的不良影响的人口群是可观的。COPD是一种可以严重影响人们完成正常工作的能力的进行性疾病。治疗COPD的一种方法是将单向阀插入肺内的腔管中。这些阀阻止吸入，但允许已经在肺内的空气呼出。肺在安装这种阀方面面临一些挑战，因为肺中的腔管在一有用距离上很少是直的。因此，需要一种装置，使得能够在肺中的非直线腔管中安装阀。
发明内容
因此，本发明的一个方面包括一种可植入装置，用于提供穿过人体的人肺中的腔管的基本单向的空气流动，以减少肺的病变部分中滞留的空气量。该可植入装置阻塞腔管，以基本防止吸入，同时基本允许所述肺的病变部分呼出。该可植入装置可利用导管布置到腔管中。
根据本发明的一个方面，提供了一种用于布置在组织腔管中的可植入装置，所述装置包括：
闭塞装置，以及
锚，包括多个臂，其中所述臂能够收缩和延伸，所述锚被配置为以允许所述锚关于所述闭塞装置可活动连接的方式将所述闭塞装置紧固到腔管内。
根据本发明的另一方面，提供了一种可植入装置，被配置为通过闭塞一个组织腔管来提供穿过该腔管的单向气流，所述可植入装置可利用导管布置到腔管中，所述装置包括：
一个阀，可收缩以收容在导管内，并且当被布置时可就地展开，所述阀限定了纵向轴线，还包括：
多个金属支杆，
包裹所述金属支杆的至少一部分并且由它们支撑的弹性薄膜，以及
中心柱，其第一部分从所述多个金属支杆的汇接点延伸，该柱在远离支杆汇接点的末端具有凸缘；
锚，包括多个臂；以及
将单向阀连接到所述锚的机构，该机构被配置为允许所述阀在布置时与所述锚成一角度取向，从而允许所述锚定位于定位于腔管的一部分中，该腔管的部分与其中布置有所述单向阀的所述腔管的一部分成一角度。
根据本发明的又一方面，提供了一种用于布置在组织腔管中的可植入装置，所述装置包括：
闭塞装置，以及
锚，用于以允许所述锚关于所述闭塞装置可活动连接的方式将所述闭塞装置紧固到所述腔管内，所述锚包括将所述锚连接到所述闭塞装置的机构，所述机构包括在第一端的至少一个连接件以将所述机构连接到至少一个锚部件。
根据本发明的还一个方面，提供了一种可植入装置，被配置为通过闭塞一个组织腔管来提供穿过该腔管的单向气流，所述可植入装置可利用导管布置到腔管中，所述装置包括：
一个单向阀，可收缩以收容在导管内，并且当被布置时可就地展开，所述阀限定了纵向轴线，还包括：
多个金属支杆，
包裹所述金属支杆的至少一部分并且由它们支撑的薄膜，以及
中心柱，其第一部分从所述多个金属支杆的汇接点延伸，该柱在远离支杆汇接点的末端具有凸缘；
可活动连接的锚；以及
将所述单向阀连接到所述锚的机构，该机构包括在第一端的至少一个连接件以将所述机构连接到所述阀，且该机构被配置为允许所述阀在布置时与所述锚成一角度取向，从而允许所述锚定位于腔管的一部分中，该腔管的部分与其中布置有所述单向阀的所述腔管的一部分成一角度。
所述可植入装置的实施方案的一个方面可以包括大致伞状构型的单向阀。该阀是可收缩的以收容在输送导管内，并且当被布置时可以就地展开。该阀基本闭塞腔管。配置该阀以便在其沿一取向布置以基本阻止吸入时，通过将吸入空气捕获在伞状阀内而阻止该空气流过该阀进入所述肺。该空气在伞形状上施加了向外的力，并迫使所述阀与腔管紧密接合。该阀被配置为允许在该阀的周边和腔管之间发生呼出。
该阀还限定了纵向轴线，并且包括限定大致钟形框架的多个金属支杆。每个支杆都具有第一端和第二端，该第一端在布置时朝向所述可植入装置的纵向轴线轻微向内弯曲，以及该第二端靠近其它支杆的第二端的汇接点(junction)，所述阀还具有包裹金属支杆的至少一部分并且由它们支撑的弹性薄膜。该薄膜从多个金属支杆的汇接点向所述支杆的第一端延伸。所述阀还包括中心柱，该中心柱的第一部分在所述薄膜内从钟形框架的中心处的所述多个金属支杆的汇接点延伸。该柱在远离支杆汇接点的末端具有凸缘。该凸缘被配置为允许布置、定位以及取回所述可植入装置。所述中心柱还包括在所述薄膜外部轴向延伸的第二部分。
本发明的另一个方面包括锚，用于在可植入装置一旦被布置就通过阻止该可植入装置迁移来将该可植入装置10紧固在腔管内。所述锚包括从所述中心柱的第二部分向外和径向延伸的多个弹性臂。每个所述臂被配置为可收缩的以收容在输送导管内，并且当布置就位时可展开来接合腔管。每个臂都包括大致锥形的远端以允许臂穿入腔管的壁。所述臂还包括靠近锥形远端并且相对于臂成角度定位的平面元件，以通过接触所述腔管壁的表面来限制所述臂进入腔管壁。
本发明的另一个方面包括一个将所述单向阀连接到所述锚，并且当装置处于收缩状态时大致沿纵向轴线布置的机构。该机构被配置为允许所述阀在布置时与所述锚成一角度取向，从而允许所述锚定位于与其中布置有单向阀的所述腔管的一部分成一角度的腔管的一部分中。所述机构包括在第一端的至少一个连接件，以将所述机构连接到所述阀。在一些实施方案中，所述机构包括被配置为可活动连接(articulable)的柔性元件，以允许锚成一角度取向。在一些实施方案中，所述柔性元件包括螺旋弹簧。在一些实施方案中，所述柔性元件包括大致圆柱形的网孔。
在所述连接件的一些实施方案中，所述机构的第二端包括大致球形的连接件。在一些实施方案中，所述机构的第二端位于所述锚内的腔中。在一些实施方案中，所述腔是细长的。在一些实施方案中，所述机构的第一端包括大致球形的连接件。
在一些实施方案中，一个腔位于所述锚中，其中所述机构的第一端可以驻留在该腔内。在一些实施方案中，所述可植入装置包括所述机构的第二端，其包括大致球形的连接件。在一些实施方案中，所述机构的第二端位于所述阀中的腔中。在一些实施方案中，至少一个所述腔是细长的。
实施方案的另一个方面是一种用于布置在组织腔管中的可植入装置，其中所述装置包括闭塞装置(occluding device)和可活动连接的锚，用于以允许所述锚关于所述闭塞装置基本活动连接的方式将该闭塞装置紧固在腔管内。所述可活动连接的锚包括将所述锚连接到闭塞装置的机构。另外，所述机构包括在第一端的至少一个连接件，以将所述机构连接到至少一个锚定元件，并且所述可活动连接的锚包括腔。
附图说明
图1是具有单向阀、锚和连接件的可植入装置的立体图；
图2是具有可活动连接的锚的可植入装置的侧视图；
图3是图2的装置的横截面视图；
图4是空气通路以及具有跨越分叉空气通路的可活动连接的锚的可植入装置的横截面视图；
图5是根据另一个实施方案的具有可活动连接的锚的可植入装置的横截面视图；
图6是根据另一个实施方案的具有可活动连接的锚的可植入装置的横截面视图；
图7是根据另一个实施方案的具有可活动连接的锚的可植入装置的侧视图：
图8是在具有可活动连接的锚的可植入装置中使用的柔性连接件的侧视图；
图9是具有可活动连接的锚的可植入装置的侧视图，其中在阻塞元件(obstruction member)和锚系统之间放置了偏置元件和连接件；
图10-12是具有可活动连接的元件的可植入装置的框架的替代实施方案的侧视图，其中可活动连接的元件被具体化为柔性连接件；以及
图13是空气通路以及位于空气通路中的柔性可植入装置的横截面视图。
具体实施方式
图1图示了处于展开状态的可植入装置。可植入装置10被配置用于影响肺中的空气的通路中的气流。可植入装置包括锚12和阻塞元件14。连接机构16将锚12耦合到阻塞元件14。图示的可植入装置包括可以形成可植入装置10的框架的支撑结构18。锚12、连接机构16以及阻塞元件14的至少一部分可以由支撑结构18形成。细长元件20穿过阻塞元件14轴向延伸，并且可以直接或间接耦合到支撑结构18。
阻塞元件14围绕细长元件20的至少一部分，并且被配置用于与诸如空气通路的组织腔管相互作用以调节通过腔管的流体流动。阻塞元件14可以有效地起到单向阀的作用。阻塞元件的一个例子是闭塞装置。
锚12包括从连接机构16延伸的多个锚元件22。在图示的实施方案中，每个锚元件22都是细长元件，其从连接机构16径向向外延伸，并在刺穿端24终止，尽管锚元件22可以具有任何数量的刺穿端。可以沿每个锚元件22定位一个或多个止挡件26，优选定位在刺穿元件24附近的某点放置。止挡件26可以被配置用于限制刺穿元件24刺入肺组织超过一期望深度。
可以通过劈开锚元件22的远端形成止挡件26。其中一个劈开部分可以向下弯曲以形成止挡件26，而使第二劈开部分向外延伸以形成刺穿元件24。尽管止挡件26可以与锚元件22一体成形，但是止挡件26也可以在后续过程中增加。例如，每个止挡件26都可以是一片安装到锚元件22的金属。因此，每个锚元件22都可以是整体式或多件式结构。
可以使用任意数量的锚元件22来限制那被植入到一期望的布置位置处的可植入装置10的移动。图示的可植入装置10包括五个耦合到连接机构16的锚元件22。然而，在各种构型中，锚12可以包括任何合适数量的锚元件。技术人员可以基于空气通路的大小、锚的设计等来选择锚元件22的数量。可以以规则或不规则的间隔来定位放置锚元件22。当锚12就位时，刺穿元件24可以接合肺的空气通路的壁组织，以将可植入装置保持在一期望位置处。当至少一个刺穿元件刺入空气通路壁时就发生一个属这一种的非限制性的接合例。
继续参照图1，阻塞元件14大致伞状，并且包括承载薄膜32的阻塞元件框架28。阻塞框架28包括支撑薄膜32的多个弧形支杆30。
通过每对支杆30之间的阻塞元件14可以限定多个路径。当可植入装置10被牢固地锚定在肺通路中时，支杆30可以将阻塞元件14向外偏置到空气通路的壁上。在每对支杆30之间，薄膜32可以限定通路，该通路允许粘液通过相关联的空气通路越过阻塞元件14输送。
可以保持正常的黏膜纤毛的机能，以确保呼吸系统在已经布置可植入装置之后继续自清洁。为了维持黏膜纤毛传输，薄膜32可以远离空气通路壁向内折叠，尤其是在呼出期间，当可植入装置10具有位于末端的锚12时。薄膜32可以轻轻地压靠在空气通路的壁上，以便使得可以实现纤毛作用，使粘液移动穿过薄膜32。当然，可植入装置可以具有允许粘液传输的其它构型。
可以对薄膜32进行处理以增强密封、改进生物稳定度和/或增强粘液传输。为了将阀作用增强，可以利用一材料对薄膜32加以处理以提高性能，所述材料与空气通路壁相互作用。薄膜上的涂层可以减少空气通路和接合该空气通路壁的展开薄膜之间的至少一个方向上的气流。该涂层可以是帮助薄膜32粘接到空气通路壁的水凝胶，以进一步限制沿至少一个方向从可植入装置穿过的气流。根据希望的应用，可以将其它涂覆材料施加到薄膜或可植入装置的其它部分。可以在将可植入装置放置在通路中之前、期间或之后施加该涂层。
在一些实施方案中，薄膜32可以被涂以光滑材料，以限制到空气通路的粘连。另外，当经受快速压力变化时，可植入装置可以部分或完全折叠，诸如，当人咳嗽时。如果薄膜折叠在一起，光滑材料可以阻止薄膜自己粘连在一起，以便可植入装置可以快速重新展开以再次有效起作用。
可植入装置可以被调整通过输送管腔来协助移动。为了降低可植入装置和输送器具管腔之间的摩擦力，可以向可植入装置施加脱离剂。该脱离剂可以降低如上详细所述的将可植入装置排出管腔所需的力。
支杆可以具有连接到所述连接机构116的第一支杆端以及相对的第二支杆端。支杆的近侧尖端可以朝向可植入装置10的纵向轴线径向向内弯曲。
继续参照图1，细长元件20包括连接到所述连接机构16和夹头36的杆34。杆34大致为圆柱形体，沿可植入装置10的纵向轴线延伸，尽管杆34可以处于其它适当位置。例如，杆34可以与可植入装置10的纵向轴线成角度或偏离。
杆34连接到位于由薄膜32限定的腔室外部的夹头36。杆34从开口延伸，以便夹头36从被薄膜32限定的开口向外扩展。细长元件20可以具有这样的长度，该长度使得当可植入装置10占据展开位置时细长元件延伸超过支杆的第二端。当夹头36与支杆和薄膜32的近侧端有间隔时，移除装置(未示出)可以很容易地夹住暴露的夹头36。在替代实施方案中，杆34终端处形成定位于开口内侧的夹头36，所述开口由元件32限定。夹头36的其它实施方案可以包括夹头36的形状和大小的各种变化，以配合不同的耦合机构。
细长元件20还可以具有这样的长度，该长度使得当可植入装置10处于完全折叠状态(未示出)时，细长元件20和支杆30从连接机构16延伸基本相同的距离。支杆30可以沿杆34平躺，以形成低形貌构型。夹头36优选保持暴露，以便可以通过简单地向夹头36施加力来将可植入装置10推出输送器。
可以使用各种移除装置来接合可植入装置，以例如重新放置、重新植入，或如上所述移除可植入装置。可以设计加大的夹头36以方便通过本领域已知的众多提取装置或方法中的任意一种移除可植入装置。移除夹头36可以由移除装置(诸如镊子、提取器、牵引器、夹具或用于夹住可植入装置10的一部分的其它合适的装置)夹住。可以施加足够的近侧力，以将植入的可植入装置10从植入位置移位。图示的夹头36是外直径大于杆34的外直径的有些像圆柱形的把手。夹头36可以具有用于接合移除装置的其它构型。示例性的夹头可以包括钩、环、加大部分、连接件(例如，快速连接件(snap connector)、螺纹连接件等)，或用于永久或临时耦合到移除装置的其它结构。
图2是可植入装置50的实施方案的侧视图。阻塞元件58通过连接机构52与锚56耦合。在图示的实施方案中，连接机构52包括连接元件54。连接机构52允许在阻塞元件58和锚56之间进行活动连接。在图示的形态，阻塞元件58和锚56沿可植入装置50的纵向轴线共线。通过连接机构52的活动连接(articulation)，阻塞元件58和锚56可以被配置为不再沿可植入装置50的纵向轴线共线。作为一个非限制性例子，阻塞元件58可以保持在未改变的方向上，而连接机构52，通过旋转或挠曲，可以在锚56移动到不同于阻塞元件58的方向的同时继续将阻塞元件58耦合到锚56。在一些实施方案中，连接机构52可以允许轴向移动，改变阻塞元件58的远端和锚56的近端之间的距离。在一些实施方案中，连接机构52的活动连接通过不连续的枢轴方向改变来实现。在其它的实施方案中，连接机构52被配置为通过连续弯曲，例如通过柔性元件的弯曲，来实现活动连接。在其它实施方案中，连接机构52可以被配置为，当连接结构51并未刚性耦合到所述阻塞元件58和锚56两个部件时，通过阻塞元件58和锚56之间的有限间隔来允许阻塞元件58和锚56之间的方向改变。在这些实施方案中，连接机构52可以包括系链或其它限制部件。
图3是可植入装置100的另一个实施方案的横截面视图。可植入装置100被配置成允许一成角度的形态。可植入装置100可以定位在肺中自然成角度的空气通路(例如，分叉空气通路、弯曲空气通路等)中。可植入装置100具有足以可活动连接的锚，以便允许在成角度的空气通路内布置可植入装置100，而不基本改变空气通路的自然几何形状。可植入装置100可以有效起作用，即使阻塞元件102与空气通路的自然形状一致。可植入装置100可以整体上类似于图1的可植入装置10，并且因此，可植入装置100的下列描述可以同样应用于下述的多个可植入装置，除非另有说明。
如在此所使用的，术语“可植入装置”是宽泛的术语，并且使用其通常意思，并且包括且不限于活动连接的可植入装置、可活动连接的可植入装置以及其他具有一个或多个用于提供锚和功能元件(如阻塞元件)之间的活动连接、驱动或柔性的机构的可植入装置。可植入装置可以具有任何数量的枢轴点或柔性部分。这些可植入装置可以沿弯曲的路径放置，所述路径如基本沿其长度弯曲的肺通路的一部分。一些实施方案包括用于提供柔性的装置，这些装置包括偏置元件(biasing member)、柔性的元件、球窝装置、关节、链接、铰链和/或柔性连接件的任何组合。如此，柔性可植入装置可以沿其长度选择性地弯曲或成角度，以匹配空气通路的形状。
图示的可植入装置100包括可活动连接并枢轴地连接到锚系统104的阻塞元件102。锚系统104可以根据装置100的功能应用相对于阻塞元件102移动到期望位置。活动连接的连接部分106连接在阻塞元件102和锚系统104之间并允许阻塞元件102和锚系统104移动。活动连接的连接部分106允许装置100活动连接，以便装置100可以被植入弯曲的空气通路，而不明显改变空气通路的自然几何形状。例如，可植入装置100可以跨越肺的支气管分支部分。可植入装置100可以反复地活动连接(例如，在正常的肺起作用期间)，而对肺或可植入装置100没有明显损伤。传统的用于植入到空气通路中的基于支架的装置(stent-based devices)通常是刚性的细长的结构，其并不适于放置在分叉或基本弯曲的空气通路中。这些基于支架的装置保持了其线形构型，因此使得它们不适合在这些类型的空气通路中使用。
再参照图3，活动连接的连接部分106可以具有各种结构，用于允许锚系统104和阻塞元件102之间的相对移动。在一些实施方案中，包括图示的实施方案，活动连接的连接部分106包括至少一个球窝装置。图示的锚系统104具有锚承窝120，该锚承窝包括保持连接杆124的一端的大致球形的腔，而阻塞元件102具有保持连接杆124的另一端的阻塞承窝122。
连接杆124具有第一端128以及相对的第二端126。每个端126、128大致为球形并且尺寸被加工为由对应的承窝122、120接收。球形端126、128可以与连接杆124成整体，或大致球形的元件可以被耦合或安装到端部126、128上。第一端128旋转安装在阻塞承窝122中。第二端126旋转安装到锚承窝120中。如此，承窝120、122可以围绕连接杆124的端部自由旋转。因此，可植入装置100具有允许活动连接的多个接合处。对于具体的应用，可植入装置可具有任何数量的可活动连接的连接部分。
为了减少球和承窝的磨损，承窝和/或端部126、128的表面可被涂以一材料，以减少由摩擦产生的相互作用。例如，锚承窝120的内部表面130可以包括下列一个或多个：稍微光滑的材料(例如，特氟隆
Figure BDA0000115515780000101
)、陶瓷、金属、聚合物(优选硬聚合物)或其组合。然而，可以利用其它材料来限制或阻止连接杆124和阻塞元件102和/或锚系统104之间的磨损。当可植入装置100被布置在肺中时，锚承窝120在正常呼吸期间可以相对于第二端126的球移动，优选地稍微移动。抗磨损表面可以最小化碎屑的积累，碎屑的积累可能妨碍可植入装置100的性能。借鉴本公开，本领域的普通技术人员可以确定球窝装置的材料、几何形状的适当组合，以及连接杆124的长度，以实现可植入装置100的期望定位。
连接杆124可以具有整体式或多件式结构。在一些实施方案中，连接杆体142和端部126、128由单一材料制成(例如，诸如镍钛诺或钛的金属)。在其它实施方案中，连接杆体142由柔性材料制成，端部126、128是由有点硬的、刚性材料制成，诸如陶瓷。
连接杆124可大致是直的，如图3所示。然而，连接杆124可以基于临床需要具有其它构型。例如，图8的连接杆124具有成角度的形状，该形状允许将可植入装置放入形状复杂的气道中(例如，具有急转弯、分支部分的气道等)。
继续参照图3，细长元件134包括具有端部分140的杆138，所述端部分140连接到阻塞元件框架136。可以通过一个或多个机械紧固件、黏合剂、焊接、拼接(boarding)、紧配合、螺纹或其他适合用于将杆138牢固地耦合到框架136的耦合方式，将端部分140连接到所述框架136。在一些实施方案中，包括图示的实施方案，杆138被连接到支杆110的内部部分，尽管杆可以被连接到框架136的其它部分。杆138还可以与框架的至少一部分一体成形。
如图4所示，可植入装置150可以放置在支气管树的分支空气通路。阻塞元件152在近侧通路160中，并且锚系统154位于远侧子分支空气通路162中。因此，可植入装置150可以跨越肺的空气通路的汇接点164，并且因此，允许了装置150定位的灵活性。空气通路可以大致维持其自然形状，诸如在植入可植入装置150之前的形状，以最小化对肺组织的损伤。可植入装置的取向并不仅限于图示的取向。可植入装置150可以与图示取向相反，以便锚位于阻塞元件的近侧。因此，可植入装置150可以被定向为允许在任何期望方向上的空气流。
可植入装置150还可以被植入到肺的非分支部分。如果希望，可植入装置150可以被植入到大致直的、弯曲的、成角度的或具有任何其他构型的连续空气通路中。因为可植入装置150可以采取各种构型，所以在选择布置位置上具有相当的灵活性。可植入装置150还可以被植入到具有基本恒定的或变化的横截面的空气通路中。有利地，医生可以将可植入装置150植入遍及肺的各种位置，以治疗肺的特定部分。如果可植入装置是以闭塞装置或流调节装置的形式(例如，单向阀、流阻器等)，这些装置可以靠近和邻近肺的病变部分植入，从而最大化可以起作用的健康肺组织的量，即使病变肺组织在支气管树的远端部分。
图5图示了包括锚系统202的可植入装置200，所述锚系统202枢轴耦合到穿过阻塞元件206延伸的细长元件204。细长元件204具有大致球形的元件208，该大致球形的元件旋转安装到锚系统202的锚承窝210上。阻塞元件206可以固定附接到沿细长元件204的某点上。
为了将阻塞元件206紧固到细长元件204，阻塞元件框架212和/或薄膜的一部分可以被耦合到细长元件204。在图示的实施方案中，阻塞元件框架212的支杆和薄膜214都耦合到细长元件204的外表面。
一旦被布置，图5中图示的可植入装置100就可以被锚系统202保持在适当位置。可植入装置200可以定位在非直线的腔管中，诸如图4所示的腔管，因为锚系统202可以保持在一第一取向，而同时阻塞元件206通过大致球形的元件208和锚承窝210被枢轴转动到一第二取向。阻塞元件206可以被配置为通过沿细长元件204行进而从锚系统202轴向移动，可以限制该移动以防止可植入装置200的低效率工作。
图6是具有允许锚系统254和阻塞元件256之间的轴向移动的可活动连接的连接部分252的可植入装置250的横截面视图。连接部分252包括锚系统254的保持架260以及阻塞元件256的保持架262。每个保持架260、262都被配置为接收连接件264的端部。图示的连接件264具有加大的末端，该末端由保持架260、262保持。保持架260、262的腔室268、278分别允许连接件264轴向移动。由保持架260、262保持的连接件264的加大端还可以被构造成允许除了轴向移动之外的枢轴运动。
装置250的锚系统254和阻塞元件256可以彼此朝向或远离地自由移动。然而，一个或多个偏置元件(未示出)可以定位在可植入装置的锚系统和阻塞元件之间，以调节可植入装置的位置。偏置元件可以配合连接部分，以确保可植入装置保持在期望位置。
图7图示了具有活动连接的连接部分302的可植入装置300，该活动连接的连接部分302包括连接到锚系统306和阻塞元件308的柔性元件304。柔性元件304可以包括有点柔性的细长元件(例如，实心杆、中空管、带等)，并且可以包括金属、聚合物(优选有点刚性的聚合物)、长丝等。优选地，当柔性元件304被施加了轴向力时，基本不伸展或弯折。替代地，柔性元件304可以被配置为允许锚系统306和阻塞元件308之间明显的轴向移动。例如，柔性元件304可以是保持在一起并限制锚系统306远离阻塞元件308轴向移动的系链。然而，当锚系统306朝向阻塞元件308移动时，柔性元件304可以很容易地收缩。柔性元件304可以包括绳、线、长丝或其它合适的元件，用于提供锚系统306和阻塞元件308之间的相对移动。
参照图8，连接杆350可以具有或弯曲成具有成角度的中央部分352，所述成角度的中央部分限定了角度θ。长度L1和L2可以被选择，以实现可植入装置的期望取向和大小。如果可植入装置被布置在空气通路的急转弯处，角度θ可以匹配该弯曲的角度，以大致将锚系统的纵向轴线与其中一个通道对齐，并将阻塞元件的纵向轴线与另一个通道对齐。可植入装置，例如，可以包括用于布置在空气通路中的连接杆，它们共同形成锐角。因此，可以基于目标布置位置选择连接杆350的构型。
如图9所示，可植入装置400可以具有位于阻塞元件404和锚系统406之间的偏置元件402。这样的偏置元件的一个例子是螺旋弹簧。在图示的实施方案中，系链408穿过在阻塞元件404和锚系统406之间的偏置元件402延伸。其它实施方案可以具有如下的连接阻塞元件404和锚系统406的系链408，该系链并不延伸穿过偏置元件402，而是至少部分经过偏置元件402的外部。替代地，柔性圆柱形元件(未示出)可以在阻塞元件404和锚系统之间延伸，基本完全包围偏置元件402。系链还可以是诸如图7中所示的连接件。
图10-12图示了可植入装置的支撑框架的各种实施方案，每个具有用于挠曲的机构。每个支撑框架都具有允许锚系统和阻塞元件框架之间的相对移动的柔性连接部分。图示的框架并不具有薄膜；然而，可以将各种类型薄膜中的任何一种施加到所述阻塞元件框架上。图10图示了包括柔性连接部分452的框架支撑450，该柔性连接部分的形式是具有交替模式的狭槽。连接部分452可以是具有框架的整体件，如图所示，或可以被耦合或安装到锚系统和阻塞框架456。柔性连接部分452可以通过将管切出狭槽来形成。狭槽的数量和大小可以选择，以实现期望的柔性。另外，可以选择用于构造连接部分的材料以实现其柔性特性。
图11图示了大致类似于图10的框架支撑450的框架支撑500。在图示的实施方案中，框架支撑500包括柔性连接部分502，该柔性连接部分502是沿框架支撑500的纵向轴线轴向延伸的弹簧元件的形式。如此，弹簧元件可以围绕柔性连接部分502的纵向轴线的以螺旋形式布置。图示的弹簧元件是螺旋弹簧的形式，尽管可以利用其它类型的弹簧或弹性元件。弹簧可以包括单独的连接元件或可以用作偏置元件，如上所述。另外，如上所述，弹簧可以与框架一体成形，或用作锚系统和阻塞元件的耦合器。
图12图示了包括柔性连接部分552的框架支撑550，所述柔性连接部分包括网孔。连接部分552可以包括各种尺寸的网孔，其中具有大或小的网孔间隔。另外，网孔可以由各种材料制成，诸如金属、人工合成材料或任何其它弹性材料。如上所述，随着当阻塞框架554和锚系统556被定位于不同取向上时，网孔可以允许挠曲。在一些实施方案中，网孔还可以允许沿框架支撑550的纵向轴线的轴向压缩。如上所述，网孔可以与框架一体成形，或其任一端被安装或耦合到阻塞元件554和锚系统556。
图10-12中图示的支杆600每个都具有两个通过弯曲件(bend)连接的整体细长的直线部分。支杆还可以具有类似于上述支杆的连续弯曲的构型。框架支撑可以承载薄膜以形成阻塞元件，诸如适于用作阀(优选单向阀)的阻塞元件。连接部分可以增强空气通路中阻塞元件的固定以增强阀的作用。
参照图13，图示的可植入装置700具有诸如图11中所示出的柔性连接部分702。可植入装置700被布置并植入空气通路708中，并且被其锚系统704保持在适当位置。柔性连接部分702可以向可植入装置700的阻塞元件706施加力，以增强阻塞元件的薄膜和壁708之间的固定。因此，柔性连接部分702的偏置可以确保阻塞元件706和壁708之间保持有效密封，从而限制或防止空气流从远侧穿过可植入装置700。有利地，当可植入装置700的压力差足够高时，可植入装置700可以允许空气从近侧穿过阻塞元件706。当空气流从近侧穿过阻塞元件706时，柔性连接部分702的偏置件可以施加朝向远侧的力。当压力差降低了足够的量时，阻塞元件706被朝向远侧拉靠到空气通路的壁708，以再次形成与空气通路壁的密封。因此，在正常肺工作期间，阻塞元件706可以稍微移动，同时锚系统704可以保持牢固固定在适当位置。因此，柔性连接部分702可以增强可植入装置700的阀作用。
如果需要，连接部分702还可以用于在肺内沿弯曲路径定位锚704和阻塞元件706，如上面图4所示。连接部分702可以沿急转弯放置，诸如基于支架的装置之类的刚性阀不适合所述急转弯。
在此提及的所有专利和公开都通过引用的方式全文纳入本说明书。除了在此进一步描述之外，在一些实施方案中，在此描述的实施方案、特征、系统、装置、材料、方法和技术可以类似于在下述专利申请中描述的实施方案、特征、系统、装置、材料、方法和技术中的任意一个或多个：2003年4月8日提交的美国专利申请10/409,798(美国公开号2004-0200484)；2003年3月13日提交的09/951,105(美国公开号2003/0050648A1)；2004年5月17日提交的10/848,571；2004年5月17日提交的10/847,554；2003年4月17日提交的10/418,929；2002年2月21日提交的10/081,712(美国公开号2002-0112729)；2002年6月21日提交的10/178,073(美国公开号2003-0154988)；2002年12月11日提交的10/317,667(美国公开号2003-0158515)；2002年3月20日提交的10/103,487(美国公开号2003-0181922)；2002年4月16日提交的10/124,790(美国公开号2003-0195385)；2002年3月9日提交的10/143,353(美国公开号2003-0212412)；2002年5月17日提交的10/150,547(美国公开号2003/0216769)；2002年7月15日提交的10/196,513(美国公开号2004-0010209)；2002年9月24日提交的10/254,392(美国公开号2004/0059263)；2003年3月12日提交的10/387,963(美国公开号2004-0210248)；2003年12月22日提交的10/745,401；美国专利6,293,951；6,258,100；6722360；6,592,594，在此通过引用的方式将它们纳入本说明书，并且构成本说明书的一部分。另外，在特定实施方案中，在此描述的实施方案、特征、系统、装置、材料、方法和技术可以结合上述纳入的申请和专利中公开的一个或多个实施方案、特征、系统、装置、材料、方法和技术而被应用或使用。
在此公开的制品可以通过任何适当的方式形成。上述各种方法和技术提供了多种实施本发明的方式。当然，应当理解，根据此处描述的任何特定实施方案不必实现上述所有目的和优点。因此，例如，本领域的普通技术人员将意识到可以以实现或优化此处所教导的一个优点或一组优点的方式来执行这些方法，而不必实现这里所教导或暗示的其它目的或优点。
此外，普通技术人员将意识到各种特征在此处所公开的不同实施方案中的互换性。类似地，上述各种特征和步骤，以及每个这种特征或步骤的其它已知等同对象，可以被本领域的普通技术人员混合或匹配，以根据此处描述的原理来执行这些方法。另外，在此描述和图示的这些方法并不限于所描述的确切的操作顺序，它们也不必须限于所阐述的所有操作的实施。事件或操作的其它顺序，或少于所有这些事件，或这些时间事件同时发生，在实施本发明的实施方案中可以使用。
尽管在某些实施方案和实施例的上下文中已经公开了本发明，但是本领域的普通技术人员将理解，本发明从具体公开的实施方案延伸到其它替代实施方案，和/或使用及其明显的修改或其等同对象。因此，本发明并不意在由此处具体公开的优选实施方案来加以限制。

Claims (15)

1.一种用于布置在组织腔管中的可植入装置，所述装置包括：
闭塞装置，以及
锚，包括多个臂，其中所述臂能够收缩和延伸，所述锚被配置为以允许所述锚关于所述闭塞装置可活动连接的方式将所述闭塞装置紧固到腔管内。
2.根据权利要求1所述的可植入装置，其中所述可活动连接的锚包括将所述锚连接到所述闭塞装置的机构。
3.根据权利要求2所述的可植入装置，其中所述机构包括在第一端的至少一个连接件，以将所述机构连接到至少一个锚部件。
4.根据权利要求2所述的可植入装置，其中所述可活动连接的锚包括一个腔。
5.一种可植入装置，被配置为通过闭塞一个组织腔管来提供穿过该腔管的单向气流，所述可植入装置可利用导管布置到腔管中，所述装置包括：
一个阀，可收缩以收容在导管内，并且当被布置时可就地展开，所述阀限定了纵向轴线，还包括：
多个金属支杆，
包裹所述金属支杆的至少一部分并且由它们支撑的弹性薄膜，以及
中心柱，其第一部分从所述多个金属支杆的汇接点延伸，该柱在远离支杆汇接点的末端具有凸缘；
锚，包括多个臂；以及
将单向阀连接到所述锚的机构，该机构被配置为允许所述阀在布置时与所述锚成一角度取向，从而允许所述锚定位于定位于腔管的一部分中，该腔管的部分与其中布置有所述单向阀的所述腔管的一部分成一角度。
6.根据权利要求5所述的可植入装置，其中所述机构包括在第一端的至少一个连接件，以将所述机构连接到所述阀。
7.根据权利要求6所述的可植入装置，其中当所述装置处于收缩状态时，所述机构大致沿纵向轴线布置。
8.根据权利要求5所述的可植入装置，其中在布置之后，所述锚紧固所述可植入装置。
9.根据权利要求5所述的可植入装置，其中所述多个弹性臂中的每个都从所述中心柱向外且径向延伸。
10.根据权利要求5所述的可植入装置，其中所述多个弹性臂中的每个被配置为可收缩的，以收容在输送导管内，并且当被布置就位时可展开以接合腔管。
11.根据权利要求5所述的可植入装置，其中所述多个弹性臂中的每个都包括大致锥形的远端，以允许所述臂穿入所述腔管的壁。
12.根据权利要求5所述的可植入装置，其中所述多个弹性臂中的每个包括一个靠近所述锥形远端的平面部件，被配置为通过接触所述腔管壁的表面来限制所述臂进入腔管壁。
13.一种用于布置在组织腔管中的可植入装置，所述装置包括：
闭塞装置，以及
锚，用于以允许所述锚关于所述闭塞装置可活动连接的方式将所述闭塞装置紧固到所述腔管内，所述锚包括将所述锚连接到所述闭塞装置的机构，所述机构包括在第一端的至少一个连接件以将所述机构连接到至少一个锚部件。
14.一种可植入装置，被配置为通过闭塞一个组织腔管来提供穿过该腔管的单向气流，所述可植入装置可利用导管布置到腔管中，所述装置包括：
一个单向阀，可收缩以收容在导管内，并且当被布置时可就地展开，所述阀限定了纵向轴线，还包括：
多个金属支杆，
包裹所述金属支杆的至少一部分并且由它们支撑的薄膜，以及
中心柱，其第一部分从所述多个金属支杆的汇接点延伸，该柱在远离支杆汇接点的末端具有凸缘；
可活动连接的锚；以及
将所述单向阀连接到所述锚的机构，该机构包括在第一端的至少一个连接件以将所述机构连接到所述阀，且该机构被配置为允许所述阀在布置时与所述锚成一角度取向，从而允许所述锚定位于腔管的一部分中，该腔管的部分与其中布置有所述单向阀的所述腔管的一部分成一角度。
15.根据权利要求14所述的可植入装置，其中当所述装置处于收缩状态时，所述机构大致沿纵向轴线布置。
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CA2648142A1 (en) 2007-11-01
US20160199066A1 (en) 2016-07-14
US20140107802A1 (en) 2014-04-17
US20120209308A1 (en) 2012-08-16
WO2007123690A2 (en) 2007-11-01
US20070232992A1 (en) 2007-10-04

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