CN1901851A - 血管植入件 - Google Patents

血管植入件 Download PDF

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CN1901851A
CN1901851A CNA2004800393715A CN200480039371A CN1901851A CN 1901851 A CN1901851 A CN 1901851A CN A2004800393715 A CNA2004800393715 A CN A2004800393715A CN 200480039371 A CN200480039371 A CN 200480039371A CN 1901851 A CN1901851 A CN 1901851A
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implantation piece
ring
inner chamber
sheath
body passage
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什穆埃尔·本-穆夫哈尔
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NEOVASC MEDICAL Inc
Neovasc Medical Ltd
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Abstract

一种医疗植入件(20),包括第一和第二环形元件(22,24),每个环形元件包括具有大致圆柱形的弹性框架(26)。管状套管(28)被固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成穿过环形元件的内腔(32)。收缩元件(30)在第一和第二环形元件的中间位置处围绕套管安装,以便减小内腔在该位置处的直径。

Description

血管植入件
技术领域
本发明总体涉及一种可植入治疗装置,具体涉及血管内植入件。
背景技术
支架植入件通常被用于治疗动脉狭窄和其它不希望出现的身体管道的收缩。支架通常包括金属线圈或网。例如,动脉支架穿过血管系统到达动脉的狭窄点。当支架就位时,其展开使动脉打开到希望的直径。
另一方面,也有一些需要支架植入件以收缩血管直径的场合。例如,Ruiz在美国专利US 6,120,534中描述了一种具有可调节收缩的管腔内支架,其公开内容在此被引作参考。该支架包括具有锥形部和可收缩区的可变形网,该可收缩区形成限流收缩部。支架在血管内被释放和展开。然后,网的收缩区可选择地放大以便在血管中调节流阻。Ruiz特别描述了使用其支架以减小在肺动脉中的血流量,如用于具有复杂先天心脏畸形的婴儿的减轻治疗。
在Shalev等人的PCT公开文献WO 01/72239中描述了其它类型的收缩支架和这些支架的应用,其公开内容在此被引作参考。这些公开具体描述了在冠状窦中使用减流植入件,以便改善心肌的血管生成(angiogenesis)。植入件通过导管穿过中央静脉,例如颈静脉进入冠状窦中。当植入件就位时,其可以弹性展开或利用球囊塑性展开。
发明内容
本发明的实施例提供了一种制造简单、价格低廉的收缩植入件,这种植入件在血管以及其它身体管道中很容易展开。这种植入件包括:一对大致为圆柱形的环形元件,它们被固定到管状套管上从而形成穿过环形元件和套管的内腔。每个环形元件包括由弹性材料制成的框架,在植入件被插入到血管中的希望位置时该框架可被压缩,然后弹性地或塑性地展开至血管的大致完全直径。套管包括柔性材料,例如织物。环形元件沿着套管纵向定位为在两个环形元件之间具有纵向间隙。在所述间隙处围绕套管安装一收缩元件,以便将内腔在两环形元件之间的直径减小到小于血管的直径。
因此,当植入件插入血管(或其它身体通道)中时,环形元件与它们固定到套管上的部分一起扩展。但是,套管在环形元件之间的间隙中的部分由于收缩元件而保持收缩。内腔的收缩区域通常减小了通过血管的血流量。如上述PCT公开文献中所述,该植入件对于限制冠状窦中的血流量尤其有用,但是其同样也可用于静脉或动脉以及其它医疗应用中。在一些实施例中,当不再希望收缩时,所述收缩元件可在血管内就地打开,从而允许植入件的直径增大。
因此,根据本发明的一个实施例,提供一种医疗植入件,其包括:
第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;
管状套管,其固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成穿过环形元件的内腔;以及
收缩元件,其在第一和第二环形元件的中间位置处围绕套管安装,以便减小内腔在该位置处的直径。
所述框架可包括被弯曲成曲折形状的丝。通常,所述环形元件适于以径向压缩的形式插入并穿过身体通道到达通道内的目标位置,然后在目标位置处径向展开从而打开其通过的内腔。所述框架包括弹性材料,其可压缩以提供环形元件的径向压缩形式,并且当在目标位置被释放时径向展开。
在一实施例中,所述植入件包括与套管并排的一或多个纵向支承件,所述纵向支承件被固定到第一和第二环形元件的框架上以便将第一和第二环形元件接合在一起。
在另一实施例中,所述套管包括织物,织物被缝合到第一和第二环形元件的框架上。
在又一实施例中,穿过第一和第二环形元件的所述内腔具有第一端部和第二端部,其中所述框架被设计成在所述内腔的一个或多个端部提供细长突起。所述套管在对应于所述突起的一个或多个第一端部和第二端部处被切割。例如,所述套管在对应于所述突起的第一端部处被切割,而所述套管在所述第二端部处覆盖所述突起以及内腔的第二端部处的突起之间的缝隙。
所述植入件可适于植入病人的冠状窦中,从而使通过冠状窦的血流被内腔的减小的直径抑止。
根据本发明的另一方面,所述收缩元件适于在向外径向力的作用下展开以使内腔的减小的直径增大。在一个实施例中,所述收缩元件包括弹性丝,其具有被紧密封闭的弯曲部以提供减小的直径,并且所述弯曲部适于在向外的径向力作用下打开。
因此,根据本发明的一个实施例,提供一种生产医疗植入件的方法,包括:
提供第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;
将一管状套管固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成穿过环形元件的内腔;以及
在第一和第二环形元件的中间位置处围绕套管安装一收缩元件,以便减小内腔在该位置处的直径。
根据本发明的一个实施例,还提供一种限制通过身体通道的流体流量的方法,包括:
提供植入件,所述植入件包括:第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;管状套管,其固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成穿过环形元件的内腔;以及收缩元件,其在第一和第二环形元件的中间位置处围绕所述套管安装,以便减小内腔在该位置处的直径;
以径向压缩的方式将植入件穿过身体通道到达身体通道内的目标位置;
使植入件在目标位置处径向展开以打开其通过的内腔。
通常,通过植入件包括将植入件装入导管内,使导管穿过身体通道,并且,使植入件展开包括将植入件通过在导管末端的孔排出。在一些实施例中,导管的末端具有大致锥形,并且排出植入件包括展开末端以便打开孔从而使植入件可通过。可选地,排出植入件包括撕开末端以便打开孔从而使植入件可通过。另外,可选地,导管的末端包括弹性插塞,当导管穿过身体通道时插塞封闭所述孔,并且,排出植入件包括径向压缩所述插塞以便打开所述孔并允许植入件的内腔通过所述插塞。
根据本发明的另一方面,该方法包括在植入件已经在目标位置展开后从植入件内部施加向外径向压力,从而打开收缩元件,从而允许内腔的减小的直径增大。通常,施加向外径向力包括将球囊插入内腔中,并使球囊膨胀。
根据本发明的一个实施例,还提供一种将植入件输送到身体通道中的目标位置的装置,所述装置包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有由弹性材料制成的末端,所述末端大致为锥形并且其中形成有孔;以及
排出器,其适于沿末端方向对植入件施力,从而扩展弹性材料以便张开所述孔,从而使植入件穿过所述孔。
此外,根据本发明的一个实施例,还提供一种将植入件输送到身体通道中的目标位置的装置,所述装置包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有大致为锥形形状的末端,所述末端中形成有孔;以及
排出器,其适于沿末端方向对植入件施力,从而使护套的末端撕开以便张开所述孔,从而使植入件穿过所述孔。
所述护套的末端被划有线,护套沿着所述线撕开。
此外,根据本发明的一个实施例,还提供一种将植入件输送到身体通道中的目标位置的装置,所述装置包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有其中形成有孔的末端;
内腔,其纵向穿过护套以及容纳在护套中的植入件,使得内腔在护套末端处的部分扩张从而插入所述孔,同时护套穿过身体通道,内腔的扩张部分包括柔性材料;以及
排出器,其适于沿末端方向对植入件施力,从而将植入件通过所述孔排出,并压缩内腔的扩张部分,从而使植入件穿过内腔到达身体通道内的目标位置。
此外,根据本发明的一个实施例,还提供一种使身体通道变窄的装置,所述装置包括:
变窄植入件,其包括:
第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;
管状套管,其固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成通过环形元件的内腔;以及
收缩元件,其在第一和第二环形元件的中间位置围绕套管安装,以便减小内腔在该位置处的直径;以及
用于将植入件输送到身体通道中的目标位置的导管。
此外,根据本发明的一个实施例,还提供一种用于植入内腔中的支架,包括:
多个支杆,在所述支杆之间具有插入孔;以及
窄的连接件,它们桥接至少一些孔以将支杆相互连接起来,
其中,在支杆上施加第一向外径向力使得通过打开支杆之间的插入孔将支杆打开至第一直径,以及,
所述窄的连接件适于在对支杆施加比第一向外径向力大的第二向外径向力的作用时断裂,从而将支架打开至比第一直径大的第二直径。
此外,根据本发明的一个实施例,还提供一种使血管变窄的方法,包括:
将导管插入血管中;
将夹子从导管向外展开,从而使夹子的第一端部和第二端部分别与血管壁上的第一点和第二点配合;以及
在夹子的第一端部和第二端部已经与第一点和第二点配合后,将夹子从导管中排出,从而使夹子的端部彼此拉近,从而将第一点和第二点夹在一起。
附图说明
本发明的其他优点和特征将根据通过例子形式并参考附图的一些说明性实施例的描述而变得清楚。
图1是根据本发明的一个实施例的用于限制血管中流量的可植入装置的示意图;
图2是图1中装置沿直线II-II所截取的剖视图;
图3是图1中的装置植入到血管中的侧视示意图;
图4是根据本发明的另一个实施例的、植入到血管中的用于限制流量的装置的示意图;
图5是根据本发明的又一个实施例的用于限制血管中流量的可植入装置的示意图;
图6A和6B是根据本发明的一个实施例的、用于将可植入装置输送到血管中的目标位置的导管的侧视示意图;
图7A和7B是根据本发明的另一个实施例的、用于将可植入装置输送到血管中的目标位置的导管的侧视示意图;
图8A,8B和8C是根据本发明的又一个实施例的、用于将可植入装置输送到血管中的目标位置的导管的侧视示意图;
图9A是根据本发明的一个实施例的收缩环的示意图;
图9B和9C是详细示出根据本发明实施例的收缩环的侧视示意图;
图10是根据本发明的一个实施例的、已经打开的收缩环的示意图;
图11是根据本发明的一个可替换实施例的支架的详细示意图;
图12是根据本发明的一个实施例的血管结构的侧视示意图,其中插入一导管用于收缩夹的展开;
图13A-C是沿图12中的XIII-XIII所截取的血管结构的剖视图,其显示了根据本发明的一个实施例的收缩夹的展开步骤。
具体实施方式
现在参照图1和2,它们示意性地示出了根据本发明的一个实施例的、用于植入身体通道的装置20。图1是该装置的示意图,图2是沿图1中的直线II-II所截取的剖视图。装置20特别适用于限制通过冠状窦的血流量,如在上述PCT公开文献WO 01/72239中所描述的。作为选择,根据本发明的原理的装置可植入血管系统和身体其它通道的其它位置。但是,为了清楚简明,下面参照本发明的实施例来描述将流量收缩装置植入在血管,例如冠状窦中,但本发明并不限于此。
装置20包括环形元件22和24,每个环形元件包括弹性框架26。每个框架限定大致圆柱形形状,尽管如下所述该装置的机械收缩会使该形状发生变化。因此,所述圆柱趋向于在装置20的端部变宽而朝向中间处变窄,如图1所示。在所示实施例中,框架26包括被弯曲成曲折形状的丝或细杆。通常,所述框架包括弹性材料,其可被压缩或弯曲,但是随后返回到原始形状,如图所示。超弹性材料例如镍钛诺可用于这种用途。可选择地,所述框架可包括弹性可变形材料,例如适合的金属或塑料。另外可选择地或可附加的,每个框架26可包括现有技术中公知的网或线圈。在所有情况中,此处所用的术语“弹性”是指当装置20在身体通道内展开时,框架26具有足够的机械强度以现有技术中的支架方式承受由通道壁以及通道内的流动流体施加的法向力。
环形元件22和24被固定到通常为管形的柔性套管28上。通常,套管28包括生物相容的织物,例如Gore-Tex或Dacron,其被缝制或以其它方式紧固到框架26上。可选择地,也可使用其它套管材料,例如薄的塑料或橡胶材料。套管被以如下方式固定到环形元件上,即,形成通过装置20的内腔32(图2)。套管在内腔的每一端由其中一个环形元件支承,在套管中两环形元件的内部端之间留有纵向间隙,所述纵向间隙通常是几微米长。由于环形元件相对刚硬(相对于框架26的弹性),装置20可在套管的间隙区内自由弯曲和变形。
收缩元件30在所述间隙区内围绕套管28安装。由图2可看出,该收缩元件的作用是将内腔32的直径减小到预定尺寸,该尺寸小于环形元件22和24的展开直径。收缩元件30可只包括被系绕在套管上的线,或可选择包括由塑料或金属制成的封闭环。后一种类型的收缩环如图9A所示,下面将参照其进行描述。
图3是植入血管40内之后的装置20的示意图。通常,利用合适的经皮导管(图中未示出),装置20穿过血管系统到达适宜位置(例如冠状窦)。用于此目的的合适的导管插入方法是现有技术中公知的。在插入过程中,装置20被径向压缩,从而使其外径大致小于其必须通过的血管的直径。如上所述,装置20可在环形元件22和24之间的间隙区中,即收缩元件30的位置处自由弯曲。这种弯曲能力通常使操作导管的手术师容易将装置穿过血管中的弯曲部。
一旦到达血管40中的希望位置,装置20被从导管中释放。如果框架26由弹性材料,例如镍钛诺制成,该装置将由于其自身的弹性会一经释放即自己展开。可选择地,如果框架26包括可延展材料,球囊可在每个环形元件22和24内膨胀,或可使用现有技术中其它公知的方式使框架展开。上述PCT公开文献描述了可用于此目的的特殊类型的球囊。如图1和3中所示,框架26的曲折形状产生细长的“指状件”,所述“指状件”在装置20的端部伸出。当环形元件已经展开后,这些指状件向外压靠血管壁,从而将装置20锚定就位。血管40中的血液流过内腔32,但流量在收缩元件30处被收缩限制。如果装置20在冠状窦中展开,例如流量限制使冠状静脉中的压力增加,从而改善心肌的血管生成。
装置20可基本以图3所示的形式不确定地留在适当位置。可选择地,在一些情况下,其可能希望消除由该装置产生的流量限制。在这些情况下,没有必要从体内去除装置20,而可以将带有合适切割工具的导管经皮插入到该装置的位置,然后切割工具可用于切割收缩元件30。这样内腔32的直径的收缩将自动打开。
图4是根据本发明的另一实施例的可植入装置50在植入血管40内之后的侧视示意图。在图中假设血管40中的血液从左边流到右边。除了套管28的形状,装置50基本与上述装置20相同。在装置20中,套管28被修整以便套管的端部具有与框架26的“指状件”基本相同的形状。但是,在装置50中,套管28被修整为在装置的上游(左侧)大致为直边,覆盖指状件之间的缝隙以及指状件本身。直的上游边可用于减少围绕装置侧面的血液泄漏,从而提供更完善和可靠的流量限制。套管的不均匀形状保持在下游边,以便克服由血管中的血液流施加的压力,从而可靠地将装置50锚定到血管40的壁上。可选择地,套管28可被切割成医学和机械学中容易想到的其它结构。
图5是根据本发明的又一个实施例的可植入装置60的示意图。除了附加了纵向支承件62和65之外,装置60与如上所述的装置20基本相同。支承件与环形元件22和24结合以增强装置60的机械强度和稳定性。尽管图5示出了两个纵向支承件,但根据所需要的类型可使用更多或更少的支承件。但是注意,在环形元件之间的间隙处,套管28与支承件脱离,从而使内腔32的直径仍可通过收缩元件30减小。
图6A和6B是以剖视方式示出的根据本发明的一个实施例的、用于将装置20输送到血管40中的目标位置的导管70的侧视示意图。如图6A所示,导管70具有管状外壳72和中心腔74。在输送前,装置20保持在壳70内,并且中心腔74穿过装置20的内腔32。壳72的末端76具有大致的锥形,并具有围绕内腔32的小排出孔78。
通常,为了将装置20植入血管40中,手术者将导向丝80穿过病人血管系统的一部分到达目标位置,如现有技术所公知的。例如,导向丝可穿过颈静脉进入冠状窦。当导向丝就位时,手术者将腔74滑过导向丝从而将导管70的末端76引导到目标位置。比较介质可喷射通过腔74或其它平行腔(未示出)以帮助手术者在使用现有技术中公知的荧光仪的过程中观察血管40。
当末端76到达目标位置时,手术者使用排出器82在导管的末端中将装置20通过孔78推出。本实施例中的末端76由具有足够弹性的材料制成以便使孔自由打开至装置20的直径。一旦装置被排出,其展开至血管40的直径,如图3所示,并将自身锚定就位。然后手术者抽出导管70,并且末端76大体回缩至其原始形状。
图7A和7B是根据本发明的一个可选实施例的、用于输送装置20的另一导管90的侧视示意图。图7A示出在输送装置20之前的导管,而图7B示出在输送后的导管。在该实施例中,末端76包括薄的护套,当排出器82将装置推出导管之外时护套撕开。可选地,如图7A所示,末端沿着线92划线,从而当装置20被排出时,末端以可预测方式干净利落地撕开。当装置20被排出后,末端可在其撕开的位置处保持打开状态,但打开的末端与沿着丝80抽回导管90不发生干涉。
图8A,8B和8C是根据本发明的又一个实施例的、用于输送装置20的导管100的侧视示意图。在该实施例中,末端76具有孔102,孔102足够大以便当装置被从导管中排出时适应(压缩的)装置20的直径。但是,孔一直被穿过导管的腔106的扩张部104封闭,直到导管到达目标位置,如图8A所示。腔通常用于容纳导向丝和/或注入比较介质,如上所述。扩张部104由柔性材料制成,其可以是弹性的或可延展性的,并成形为可插入孔102。
当末端76到达目标位置时,腔106前进(和/或导管100抽回)以便打开孔102,如图8B所示。然后排出器82将装置20通过该孔推出。如图8C所示,扩张部104具有足够的柔性以便当通过装置20的腔32的窄的间隙区通过它时,扩张部104封闭以便腔32可滑过它。一旦装置20已经被植入目标位置,扩张部104恢复其先前形状,腔106可沿最接近的方向被拉回以便封闭孔102。然后导管100从身体中抽回。
图9A是根据本发明的一个实施例的收缩环120的示意图。该环可用作装置20中的收缩元件,占据前述示图中元件30的位置。环120包括柔性的弹性122。例如,122可包括超弹性材料,例如镍钛诺。122形成有多个弯曲部,通常为曲折形状,如图9A所示。一些弯曲部为封闭弯曲部,在该处弯曲部相反两侧的丝段被固定在一起,这样使环120的整个圆周变窄。当环120被安装在装置20的元件30的适当位置时,环的变窄的圆周收缩所述腔32的直径,如图1和2所示。
图9B和9C是详细示出根据本发明的两个示意性实施例的环120中的其中一个封闭弯曲部124的详细示意图。在图9B的实施例中,122的相反段被拉到一起,然后在紧固点126处通过焊接、粘接或其它手段固定。现有技术中公知的激光微焊也可用于此目的。在图9C中,连接元件128,例如微型环,在弯曲部每一侧的丝段之间被以焊接或其它方式固定就位。在每一种情况下,弯曲部124通常都充分微弱地封闭,以便使紧固点或连接元件在向外的径向压力作用下打开。
图10是根据本发明的一个实施例的、在打开封闭弯曲部124后的环120的示意图。在装置20已经被植入到血管中之后,封闭弯曲部可在原处打开。为此,例如,球囊导管可插入装置20的腔32中,并且可使球囊膨胀具有足够的压力以打开至少一些弯曲部124的紧固点。由于丝122的弹性,于是环120就扩展到图10所示的大直径,相应的,腔32将打开。由于不再需要或希望装置20,当收缩时可使用这种过程以允许血液通过血管40的自由流动。
图11是根据本发明的另一实施例的支架130的一部分的详细示意图。本实施例也利用了上述血管内植入件的径向展开的原理。支架130包括带有插入孔134中的支杆结构132。一些孔被窄的连接件136桥接。支架130初始折叠并卷曲在球囊上以插入目标血管。使球囊膨胀至第一中间压力使得支架径向向外展开,从而支架132之间的孔134打开成如图11所示的结构。然后将球囊抽回。支架可用于这种结构中以便例如打开阻塞的动脉或其它身体腔。
在植入支架后,有问题的身体腔经常会发生再次收缩,例如由于支架内的材料的增长。在这种情况下,球囊被再一次插入支架130内,并膨胀至第二较高压力。这样,球囊在支架130上施加向外的径向力,使得一个或多个连接件136打开。这样,支架130(和其支承的腔)的直径简便安全地增大。
尽管在上述实施例中,所示的框架26和套管28具有特定的形状,但在本发明的范围内,可考虑使这些元件具有对于本领域技术人员是公知的替换形状或形式。类似地,上述通用型的导管不但可用于输送装置20,还可输送上述以及本领域技术人员公知的其它可植入装置。另一方面,尽管此处所示的导管提供了输送根据本发明的植入件的方便装置,但这种植入件也可以利用其它手段,包括尽量小的侵入性手段(通常为经皮)和侵入性(即外科手术)的手段。
通过外科手段减小血管结构的直径或周长的方法是公知的现有技术。这种方法例如在美国专利5,593,424和6,561,969中被描述,其公开内容在此被引作参考。这些方法通常需要缝合血管组织,这是非常困难和费时的。
与这些方法和前述实施例相比,图12示意性地示出根据本发明的一个可选实施例的、收缩血管结构的直径的方法,其中没有使用缝合或支架。此处所描述的实施例减小了病人的冠状窦的直径,不过这种方法还可用于其它血管结构。导管142被插入穿过病人的右心房144进入冠状窦140。如图所示,导管在其末端具有弯曲部,从而方便收缩夹146的展开,如下所述。
图13A-C是沿图12中的XIII-XIII所截取的冠状窦的剖视图,其显示了根据本发明的一个实施例的收缩夹146的展开步骤。夹146通常包括超弹性材料,其形成为在放松状态下具有近似封闭的形式,例如如图13C所示。但是,在将导管142插入冠状窦的过程中,夹146被压入导管142的末端内,如图13A所示。
当导管142已经前进到冠状窦140中时,致动一展开机构,例如导管内的推动器(未示出),以便使夹146行进到导管的末端之外。结果,夹被打开成图13B所示的结构。夹的端部148在冠状窦的壁上的彼此间隔开的两点处承载冠状窦140的组织。夹146的弹性使得当夹进一步行进到导管外时,夹的端部被朝向一起拉,如箭头150所示。最后,当夹行进到从导管的端部完全出来时,端部148彼此拉近并将血管组织位于夹的端部之间的部分夹在一起。结果,如图13C所示,冠状窦140的有效直径减小了。
容易理解上述实施例只是作为示例,本发明并不限于上述具体的图示和说明。本发明的保护范围包括上述各种特征的组合和子组合,以及现有技术中没有公开的、本领域人员根据本发明容易想到的变化或修改。

Claims (40)

1.一种医疗植入件,包括:
第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;
管状套管,其固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成穿过环形元件的内腔;以及
收缩元件,其在第一和第二环形元件的中间位置处围绕套管安装,以便减小内腔在该位置处的直径。
2.根据权利要求1所述的植入件,其特征在于,所述框架包括被弯曲成曲折形状的丝。
3.根据权利要求1所述的植入件,其特征在于,所述环形元件适于以径向压缩的形式插入并穿过身体通道到达通道内的目标位置,然后在目标位置处径向展开从而打开其通过的内腔。
4.根据权利要求3所述的植入件,其特征在于,所述框架包括弹性材料,其可压缩以提供环形元件的径向压缩形式,并且当在目标位置被释放时径向展开。
5.根据权利要求1所述的植入件,其特征在于,还包括与套管并排的一或多个纵向支承件,所述纵向支承件被固定到第一和第二环形元件的框架上以便将第一和第二环形元件接合在一起。
6.根据权利要求1所述的植入件,其特征在于,所述套管包括织物。
7.根据权利要求6所述的植入件,其特征在于,所述织物被缝合到第一和第二环形元件的框架上。
8.根据权利要求1所述的植入件,其特征在于,穿过第一和第二环形元件的所述内腔具有第一端部和第二端部,其中所述框架被设计成在所述内腔的一个或多个端部提供细长突起。
9.根据权利要求8所述的植入件,其特征在于,所述套管在对应于所述突起的一个或多个第一端部和第二端部处被切割。
10.根据权利要求9所述的植入件,其特征在于,所述套管在对应于所述突起的第一端部处被切割,而所述套管在所述第二端部处覆盖所述突起以及内腔的第二端部处的突起之间的缝隙。
11.根据权利要求1至10中任一所述的植入件,其特征在于,所述植入件适于被植入病人的冠状窦中,从而使通过冠状窦的血流被内腔的减小的直径抑止。
12.根据权利要求1至10中任一所述的植入件,其特征在于,所述收缩元件适于在向外径向力的作用下展开以使内腔的减小的直径增大。
13.根据权利要求12所述的植入件,其特征在于,所述收缩元件包括弹性丝,其具有被紧密封闭的弯曲部以提供减小的直径,并且所述弯曲部适于在向外的径向力作用下打开。
14.一种生产医疗植入件的方法,包括:
提供第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;
将一管状套管固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成穿过环形元件的内腔;以及
在第一和第二环形元件的中间位置处围绕套管安装一收缩元件,以便减小内腔在该位置处的直径。
15.根据权利要求14所述的方法,其特征在于,提供框架包括将丝弯曲成曲折形状。
16.根据权利要求15所述的方法,其特征在于,穿过第一和第二环形元件的内腔具有第一端部和第二端部,并且弯曲所述丝包括在内腔的一个或多个端部处产生框架的细长突起。
17.根据权利要求14所述的方法,其特征在于,还包括将一个或多个纵向支承件与所述套管并排地固定到第一和第二环形元件的框架上,以便将第一和第二环形元件接合在一起。
18.根据权利要求14至17中任一所述的方法,其特征在于,固定所述套管包括将织物缝合到第一和第二环形元件的框架上。
19.根据权利要求14至17中任一所述的方法,其特征在于,安装所述收缩元件包括将所述收缩元件设计成在向外径向力的作用下展开以使内腔的减小的直径增大。
20.根据权利要求19所述的方法,其特征在于,所述收缩元件包括弹性丝,其具有被紧密封闭的弯曲部以提供减小的直径,并且所述弯曲部适于在向外的径向力作用下打开。
21.一种限制通过身体通道的流体流量的方法,包括:
提供植入件,所述植入件包括:第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;管状套管,其固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成穿过环形元件的内腔;以及收缩元件,其在第一和第二环形元件的中间位置处围绕所述套管安装,以便减小内腔在该位置处的直径;
以径向压缩的方式将植入件穿过身体通道到达身体通道内的目标位置;
使植入件在目标位置处径向展开以打开其通过的内腔。
22.根据权利要求21所述的方法,其特征在于,所述框架包括弹性材料,其可压缩以提供径向压缩形式,并且当在目标位置释放时径向展开。
23.根据权利要求21所述的方法,其特征在于,穿过第一和第二环形元件的内腔具有第一端部和第二端部,其中所述框架被设计成在内腔的一个或多个端部提供细长突起,并且,使所述植入件展开包括利用细长突起将植入件锚定在目标位置。
24.根据权利要求21所述的方法,其特征在于,所述身体通道是病人的冠状窦,其中由于内腔的减小的直径,所述植入件抑止了通过冠状窦的血液的流量。
25.根据权利要求21至24中任一所述的方法,其特征在于,通过植入件包括将植入件装入导管内,使导管穿过身体通道,并且,使植入件展开包括将植入件通过在导管末端的孔排出。
26.根据权利要求25所述的方法,其特征在于,导管的末端具有大致锥形,并且排出植入件包括展开末端以便打开孔从而使植入件可通过。
27.根据权利要求25所述的方法,其特征在于,导管的末端具有大致锥形,并且排出植入件包括撕开末端以便打开孔从而使植入件可通过。
28.根据权利要求25所述的方法,其特征在于,导管的末端包括弹性插塞,当导管穿过身体通道时插塞封闭所述孔,并且,排出植入件包括径向压缩所述插塞以便打开所述孔并允许植入件的内腔通过所述插塞。
29.根据权利要求21至24中任一所述的方法,其特征在于,还包括在植入件已经在目标位置展开后从植入件内部施加向外径向压力,从而打开收缩元件,从而允许内腔的减小的直径增大。
30.根据权利要求29所述的方法,其特征在于,施加向外径向力包括将球囊插入内腔中,并使球囊膨胀。
31.一种将植入件输送到身体通道中的目标位置的装置,所述装置包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有由弹性材料制成的末端,所述末端大致为锥形并且其中形成有孔;以及
排出器,其适于沿末端方向对植入件施力,从而扩展弹性材料以便张开所述孔,从而使植入件穿过所述孔。
32.一种将植入件输送到身体通道中的目标位置的装置,所述装置包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有大致为锥形形状的末端,所述末端中形成有孔;以及
排出器,其适于沿末端方向对植入件施力,从而使护套的末端撕开以便张开所述孔,从而使植入件穿过所述孔。
33.根据权利要求32所述的装置,其特征在于,所述护套的末端被划有线,护套沿着所述线撕开。
34.一种将植入件输送到身体通道中的目标位置的装置,所述装置包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有其中形成有孔的末端;
内腔,其纵向穿过护套以及容纳在护套中的植入件,使得内腔在护套末端处的部分扩张从而插入所述孔,同时护套穿过身体通道,内腔的扩张部分包括柔性材料;以及
排出器,其适于沿末端方向对植入件施力,从而将植入件通过所述孔排出,并压缩内腔的扩张部分,从而使植入件穿过内腔到达身体通道内的目标位置。
35.一种使身体通道变窄的装置,所述装置包括:
变窄植入件,其包括:
第一和第二环形元件,每个环形元件包括具有大致圆柱形的弹性框架;
管状套管,其固定到第一和第二环形元件上,以便将环形元件保持为彼此纵向对齐,从而形成通过环形元件的内腔;以及
收缩元件,其在第一和第二环形元件的中间位置处围绕套管安装,以便减小内腔在该位置处的直径;以及
用于将植入件输送到身体通道中的目标位置的导管。
36.根据权利要求35所述的装置,其特征在于,所述导管包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有大致为锥形形状的末端,末端中形成有孔;以及
排出器,其适于沿末端方向对植入件施力,从而扩展弹性材料以便张开所述孔,从而使植入件穿过所述孔并被植入到目标位置。
37.根据权利要求35所述的装置,其特征在于,所述导管包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有大致为锥形形状的末端,末端中形成有孔;以及
排出器,其适于沿末端方向对植入件施力,从而使护套的末端撕开以便张开所述孔,从而使植入件穿过所述孔并被植入到目标位置。
38.根据权利要求35所述的装置,其特征在于,所述导管包括:
细长、管状的护套,其适于在将植入件以压缩状态容纳在护套内的同时穿过身体通道,其中,护套具有其中形成有孔的末端;
内腔,其纵向穿过护套以及容纳在护套中的植入件,使得内腔在护套末端处的部分扩张从而插入所述孔,同时护套穿过身体通道,内腔的扩张部分包括柔性材料;以及
排出器,其适于沿末端方向对植入件施力,从而将植入件通过所述孔排出,并压缩内腔的扩张部分,从而使植入件穿过内腔到达身体通道内的目标位置。
39.一种用于植入内腔中的支架,包括:
多个支杆,在所述支杆之间具有插入孔;以及
窄的连接件,它们桥接至少一些孔以将支杆相互连接起来,
其中,在支杆上施加第一向外径向力使得通过打开支杆之间的插入孔将支杆打开至第一直径,以及,
所述窄的连接件适于在对支杆施加比第一向外径向力大的第二向外径向力的作用时断裂,从而将支架打开至比第一直径大的第二直径。
40.一种使血管变窄的方法,包括:
将导管插入血管中;
将夹子从导管向外展开,从而使夹子的第一端部和第二端部分别与血管壁上的第一点和第二点配合;以及
在夹子的第一端部和第二端部已经与第一点和第二点配合后,将夹子从导管中排出,从而使夹子的端部彼此拉近,从而将第一点和第二点夹在一起。
CNA2004800393715A 2003-11-19 2004-11-18 血管植入件 Pending CN1901851A (zh)

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CN112022261A (zh) * 2020-08-24 2020-12-04 上海长海医院 一种异常血管通道封堵装置

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