CN101252887A - 组织锚及其使用方法 - Google Patents
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Abstract
本发明涉及一种组织锚(10),其包括由大致柔性材料形成的锚部件(14)。可以是张力调整部件(12)的致动部件使得锚部件(14)的近端部分和远端部分(14a,14b)朝向彼此移动成适于抵靠着组织(20)锚定的缩短结构。组织锚(10)可通过使用导管装置(50)任选地部署和致动。
Description
技术领域
本发明总体上涉及组织锚,更特别地,涉及锚及使用这种锚以固定元件或为生物组织提供锚点和/或将至少两个组织部分固定在一起的方法。
背景技术
许多不同的外科手术过程需要使用锚,以便相对于患者的组织部位为其他固定元件或装置建立强连接点、和/或将两个或更多个组织层(即,部分)固定在一起。在这点上,在此使用的术语“锚”不局限于任何特殊类型的组织紧固或固定应用,而是包括任何硬和/或软的组织-组织固定、组织-装置固定或任何其他组织固定应用。
近年受到关注的一个特殊领域是基于导管的外科手术过程。为了使用基于导管的技术进行部署和固定,已经研发出了各种组织锚。然而,现有技术中仍然存在局限性。例如,插入尺寸与部署尺寸相比必须得到严格控制,这是由于导管直径需要维持得相当小。许多基于导管的组织锚系统具有非常专门的用途,且在许多不同的组织紧固或固定操作中不通用。
总体上,需要一种更简单、更通用的组织锚,其可以在基于导管的操作或非基于导管的操作中部署和可靠地紧固到组织。
发明内容
在一方面中,本发明提供了一种组织锚,包括:大致柔性锚部件,所述大致柔性锚部件能够插入穿过组织、且在细长结构与适于抵靠着组织的至少一侧锚定的缩短结构之间变动。锚部件包括近端部分、远端部分、以及在近端部分与远端部分之间的可压缩中间部分。张力调整部件可操作地连接到锚部件,使得锚部件可相对于张力调整部件滑动。张力调整部件可被拉拔,以使锚部件相对于张力调整部件从细长结构变动到缩短结构。在缩短结构下,锚部件的可压缩中间部分可压缩或缩短,从而适应近端部分和远端部分之间的组织厚度。
在本发明的另一方面中,提供了一种组织锚,包括:平坦的大致柔性锚部件,所述平坦的大致柔性锚部件能够在适于部署的细长结构与适于抵靠着组织锚定的缩短结构之间变动。张力调整部件可操作地连接到锚部件,使得锚部件可相对于张力调整部件滑动。张力调整部件能够被拉拔,以使锚部件相对于张力调整部件从细长结构变动到缩短结构。
在本发明的又一方面中,提供了一种组织锚,包括:平坦锚部件,所述平坦锚部件由织物材料的条带形成,且能够在适于部署的细长结构与适于抵靠着组织锚定的缩短结构之间变动。张力调整部件可操作地连接到锚部件,使得锚部件可相对于张力调整部件滑动。张力调整部件能够被拉拔,以使锚部件相对于张力调整部件从细长结构变动到缩短结构。提供了锁定部件,所述锁定部件用于将锚部件固定成缩短结构。
在本发明的另一方面中,提供了一种组织锚,包括:平坦的大致柔性锚部件,所述平坦的大致柔性锚部件能够插入穿过组织,且在适于通过导管部署的细长结构与适于抵靠着组织锚定的缩短结构之间变动。张力调整部件可操作地连接到锚部件,使得锚部件可相对于张力调整部件滑动。张力调整部件能够被拉拔,以使锚部件相对于张力调整部件从细长结构变动到抵靠着组织的缩短结构。
在本发明的还一方面中,提供了一种组织锚,包括:平坦细长条带,所述平坦细长条带由大致柔性材料形成,且具有近端部分和远端部分。具有第一端和第二端的张力调整部件可操作地连接到细长条带,使得拉拔张力调整部件的第一端使细长条带的近端部分和远端部分朝向彼此移动成适于抵靠着组织锚定的缩短结构。
在某些方面中,锚部件有利地被形成为平坦的大致柔性材料条带,但在其他方面,它不必是平坦条带,而可以是能够或不能够呈现平坦形状的其他形状例如管状。各种可选特征可以包含到组织锚的任何或所有各种实施例中。例如,组织锚可以由选自以下材料中的至少一种材料形成:天然纤维、合成纤维、聚合物和金属。这种材料可以是可吸收或不可吸收的,且可以是辐射不可透过的或至少部分辐射不可透过的。张力调整部件还可包括缝合线或任何其他合适的柔性、半刚性或刚性张力调整部件。张力调整部件可以包括与锚部件接合的止动部件例如张力调整部件中的结节,或者可与锚部件接合的分离的止动部件(例如,卷曲件)。张力调整部件可以例如在近端部分和远端部分之间的多个位置处延伸穿过锚部件。张力调整部件和锚部件的这种连接可以以许多不同的方式构造,这例如取决于在拉拔张力调整部件并将锚部件变动到缩短结构时锚部件的所需结构。在一个实施例中,当拉拔张力调整部件时形成至少一个皱折。可以以大致锯齿形或手风琴样式形成多个皱折。可以设置锁定部件,其可与张力调整部件接合,以将锚部件保持成缩短结构。组织锚可以在锚部件和张力调整部件中的一个或两个上包括至少一个辐射不可透过标记。例如,第一辐射不可透过标记可设置成当锚部件处于缩短结构时接近近端部分,第二辐射不可透过标记可设置成当锚部件处于缩短结构时接近远端部分。锚部件的远端部分可包括与锚部件相比刚性相对较大的末端,且所述末端具有与锚部件的邻近部分相比减小的宽度。锚部件本身可以以多种方式中的任何一种方式设计,包括:沿着其长度具有均匀宽度的设计和沿着其长度具有变化宽度的设计。可以包括其他特征,例如比锚部件的中心区域刚性稍大的边缘部分。锚部件的所有节段与其折叠线部分相比刚性可能相对较大,但仍然产生大致柔性锚部件。如果必要,可以将例如活动铰链的铰链部分设计在锚部件中,以使得锚部件可实现折叠或者其他缩短动作。虽然在此为了致动目的(即,将锚部件从细长结构致动到缩短结构)特别公开了张力调整部件,但本发明在各种组合方案中也可以利用其他类型的致动,例如压缩致动。
组织锚的每个实施例可以是基于导管的锚定系统的一部分,所述系统具有传送导管、和与传送导管关联且可操作以将锚部件从传送导管中伸出的合适部署装置。部署装置还可包括部署导管,所述部署导管至少部分容纳锚部件、且至少部分地被容纳在传送导管内。
如在此大致所述,本发明还提供了各种锚定组织方法。例如,在一个方面中,提供了一种锚定组织方法,包括:将大致柔性细长锚部件插入穿过组织;以及拉拔被连接成相对于第一锚部件滑动移动的张力调整部件的第一端,以将近端部分和远端部分朝向彼此牵拉、以及将中间部分压缩成缩短结构,使得近端部分和远端部分中的至少一个抵靠着组织接合。
在本发明的另一方面中,提供了一种组织锚定方法,包括:将具有近端部分和远端部分的大致柔性平坦细长条带插入穿过组织;以及拉拔可操作地连接到条带的张力调整部件的第一端,以将条带的近端部分和远端部分朝向彼此牵拉成抵靠着组织接合的缩短结构。
在又一方面中,提供了一种组织锚定方法,包括:将具有近端部分和远端部分的大致柔性平坦细长条带插入穿过组织;以及拉拔可操作地连接到条带的张力调整部件的第一端,以将条带的至少一部分构造成抵靠着组织接合的缩短结构。
在每个实施例中,锚部件抵靠着组织的接合可以是抵靠着至少一个组织层的相反侧的接合,或者是抵靠着至少一个组织层的仅一侧的接合。
在参看下面结合附图对示例性实施例所作的详细描述之后,本发明的其他特征和优点对于本领域普通技术人员将变得显而易见。
附图说明
图1是根据本发明的第一实施例构建的组织锚的透视图。
图2A是图1中所示的组织锚的侧视图,其中组织锚被部署穿过组织层。
图2B是类似于图2A的侧视图,但是示出了正向组织层移动的组织锚的远端部分。
图2C是类似于图2B的侧视图,但是示出了抵靠着组织层完全压缩和接合的远端部分。
图2D是类似于图2C的侧视图,但是示出了正向组织层移动的组织锚的近端部分。
图2E示出了抵靠着组织层的相反侧完全压缩的组织锚的近端部分和远端部分。
图2F是放大剖视图,示出了组织层在近端部分与远端锚部分之间的被完全部署和固定的锚。
图3是类似于图2F的侧剖视图,但是示出了将两个组织层紧固在近端部分与远端锚部分之间。
图4A-4F是透视图,示出了利用第一实施例的组织锚在患者二尖瓣上进行的瓣环成形术过程中的相继步骤。
图5A-5E是透视图,示出了利用根据本发明的第二实施例构建的组织锚的二尖瓣瓣环成形术过程。
图6是侧视图,示出了根据第二实施例构建的组织锚。
图7是锚的细长条带部分的前视图。
图7A是类似于图7的前视图,但是示出了用在细长条带上的辐射不可透过标记的一个实施例。
图7B是沿着其长度具有变化宽度的可选锚条带的前视图。
图7C是利用通过活动铰链分离的刚性较大折叠部分的另一可选锚条带的侧视图。
图8A-8D是示出了用于将第二实施例的组织锚固定到组织层的一系列步骤的相应侧视图。
图8E类似于图8D的视图,但是示出了可选末端和张力调整部件配置。
图9A-9C是示出了瓣环成形术过程的相应侧视图,其中,第二实施例的两个组织锚链接在一起,单一张力调整部件在更综合过程中使组织在锚之间皱褶。
图10A和10B是示出了用于在组织层的仅一侧上提供锚或固定部位的第二实施例的组织锚的相应侧视图。
具体实施方式
首先参看图1,根据本发明的第一实施例构建的组织锚10通常包括诸如缝合线的张力调整部件12,该张力调整部件12延伸穿过沿着由诸如外科级织物的柔性材料制成的平坦细长条带14的间隔开的点。可以理解,张力调整部件12可以采取不同于缝合线材料的其他形式,例如具有足够高的抗拉强度以用于预期锚定用途的缆或任何其他小直径部件。细长条带14还可以采取诸如纺织物或无纺布、聚合物、金属或其他合适材料或材料组合物的各种形式。一个或多个分离的纱布或其他固定部件(未示出)可与细长条带14结合使用,用于增加固定和/或隐藏细长条带14,例如从而防止血液凝固在将在条带14中形成的皱折内或附近。
纺织材料或无纺材料可以包括附加材料例如线、珠子或其他元件,它们使得条带14的至少多个部分不可透过辐射。当前,由诸如Dacron的聚酯构成的外科级织物期望用于构造条带14。用于构造条带14的许多可选材料中的一种材料是聚四氟乙烯(PTFE)。根据预期用途,组织锚10可以部分或完全由随着时间吸收在患者组织中的材料形成。可以例如通过涂覆有将纤维锁定在位的材料合适地修改条带14的边缘和/或其他部分以阻止磨损,或者以将纤维至少在条带14的边缘处锁定在位的方式修改。
缝合线12可以从织物条带14的近端部分14a延伸至远端部分14b,然后通过织物条带14的间隔开的点返回至近端部分14a,出于下文将描述的理由,结节16或其他止动部件在该处定位。将显而易见的是,缝合线12延伸穿过沿着细长条带14的间隔开的部位,从而在张力调整部件12处于拉紧或拉拔状态下时,缝合线12或其他张力调整部件的张紧将使细长条带14形成折叠部分14c。因而,以这种方式使细长条带14在诸如图1所示的大致细长部署方位或结构与缩短结构例如与细长部署结构相比至少在一个维度上具有扩大宽度的折叠或缩短结构之间致动。可以理解,由于条带14的柔性特性,部署方位可以采取各种形式,尤其当使用高柔性织物或其他材料时。例如,织物材料或其他相似柔性材料可以为了携带目的和/或在部署到组织部位的过程中在导管内折叠或变形,然后在组织部位处合适地致动。
更特别地参看图2A-2E,细长条带14和已加装的缝合线12初始插入穿过至少一个组织层20,如图2A中大致所示。然后拉拔缝合线12的一端或部分12a,从而使得处于张紧状态下。可以理解,对于基于导管的手术过程,缝合线部分12a可以延伸至患者体外的位置,用于拉拔或进行张力调整,或者它可以由合适的机构被保持在导管内且被拉拔或张紧。拉拔缝合线部分12a可能初始地将细长条带14的远端部分14b向组织层20牵拉,如图2B中所示。一旦将远端部分14b抵靠着组织层20压缩,近端部分14a开始被牵拉且抵靠着组织20的近侧压缩,如图2C-2E中所示。这种情况的发生是因为向下拉拔缝合线12的端部12a(出于讨论目的,如图2C-2E中所示),以及由于缝合线12反向回绕通过细长条带14的远端部分14b,缝合线12的端部处的结节16向上移动且带动细长条带14的近端部分14a。通过这种方式,细长条带14的近端部分14a被折叠且沿着缝合线12向着组织层20牵拉,随后稳固地抵靠着组织层20的近侧压缩,如图2E中所示。如图2F进一步所示,诸如卷曲部件22的合适锁定元件、结节或其他元件可以用于将缝合线12和细长条带14保持在图2F中所示的位置,从而可靠地将已折叠的细长条带14的近端部分14a和远端部分14b抵靠着组织20的相反侧锚定。
如图3中进一步所示,可以使用相同的基本过程,以通过初始使细长条带14和张力调整部件12延伸穿过至少两个组织层30、32将两个不同的组织层30、32固定在一起。通过这种方式,例如,可以将两个组织层30、32可靠地紧固在一起。例如,这可以包括两个完全不同的层、甚至不同类型的组织或者已被折叠起来以有效地形成两个组织层(即部分)的相同组织层。
图4A-4E示意性地示出了利用根据第一实施例的上述组织锚10在心脏42的二尖瓣40上执行的瓣环成形术过程。瓣环成形术过程的执行可以具有许多种变化方式,但是通常被举例说明为:通过设置至少两个组织锚10并例如利用之间的一个或多个张力调整部件12将两个锚10固定在一起。为了另外示例性地描述可以利用属于本发明范围内的任何组织锚的基于导管的瓣环成形术过程,可参看2004年9月24日提交的授予本发明的受让人的美国专利申请No.10/948922,该申请的公开通过引用整体包括在此。
如图4A中所示,第一组织锚10通过导管装置50部署,所述导管装置50例如可以具有被接收在外部管形部件54或传送导管内的内部管形部件52或部署导管。组织锚10和张力调整部件12被承载在内部管形部件52内,且从其远端52a部署。为了确保施加合适的力以刺穿组织,在已将内部管形部件52插入穿过二尖瓣40的环40a处的组织之后,组织锚10可以部署或延伸。这最好参见于图4B。在致动细长条带14的远端部分14b之前、期间或之后,从环组织40a中抽出内部管形部件52。如前面所述,通过拉拔缝合线12致动(例如,压缩、折叠或缩短)细长条带14使得远端部分14b、然后近端部分14a被可靠地抵靠着环组织40a的相反侧压缩和折叠。该过程至少另外再重复一次,以将另外的组织锚10可靠地紧固在与初始位置间隔开的位置处。例如,初始位置可以位于二尖瓣环40的部位P2处,而第二位置可以在部位P2的任一侧间隔开。导管装置50可以以各种方式插入环40a的部位中,但是被示为:向下插入穿过动脉瓣53进入左心室55,且向着二尖瓣环40a向上弯曲。
在图4E所示的示例中,三个组织锚10已被部署且可靠地紧固到环组织40a。如图4F所示,在已将组织锚10拉拔得互相靠近从而使组织40a在锚10之间皱褶后,此时缝合线锁定件56可以部署,且用于保持分别相应于三个组织锚10的三个张力调整部件或缝合线12中的每一个之间的相对位置和张紧状态。这大致缩短了瓣环40a,且将后瓣60向着前瓣62拉动,以防止通过瓣40的泄漏,即在心脏收缩期间实现前瓣和后瓣60、62的更好接合。
图5A-5E示出了利用组织锚70的第二实施例及一种修改的部署和致动方法对二尖瓣40执行的类似瓣环成形术过程。通常,下面将描述锚70和锚10之间的差别,但可以理解,与锚70相关的所有其他特性、选择和特征可能与以上对锚10所作的描述相同。如图5A所示,在该实施例中,张力调整部件72也用于致动具有近端和远端部分74a、74b的柔性细长平坦条带74。条带74包括被形成或以另外方式固定在远端部分74b上的末端76。张力调整部件72和末端76设置成使得张力调整部件72相对于末端76滑动。更特别地,张力调整部件72可以穿过末端76。与条带74的其他柔性部分相比,末端76被使得具有相对较大刚性,且具有比条带74的宽度小的直径。因而,末端76当内部管形部件52和细长条带74延伸穿过组织40a时有助于刺穿环组织40a。可以使用丝73将末端76在所需时刻推出管形部件52。当组织40a被穿刺时,末端76可以稍从内部管形部件52突出,以帮助刺入组织40a。末端76也可以帮助使得条带74的远侧部分或半部分74b变成折叠或缩短结构。为了有助于在将内部管形部件52从环组织40a中抽回时防止细长条带的远侧部分74b向回拉拔通过组织40a,在内部管形部件52仍刺穿通过组织40a并从左心室55进入左心房80时拉拔张力调整部件72的自由端。这使得远侧部分74b形成折叠或缩短结构,如图5B中所示。然后,可以抽回内部管形部件52,而不会使细长柔性条带74一同抽回,如图5C中所示。然后,通过进一步沿近侧方向拉拔内部管形部件52部署细长条带74的近侧部分74a,从而暴露出条带74的整个长度。拉拔或张紧该张力调整部件72,以将细长条带74的近侧部分74a牵拉和压缩成抵靠着环组织40a的下侧的折叠、缩短状态,如图5D中所示。对于使用组织锚10的第一实施例的前述瓣环成形术过程,如果必要,这也重复数次,以创建所需数量的组织皱褶。图5E通过三个相继的组织锚固定位置的示例性视图示出了这一过程,其中,组织锚70可牵拉在一起,并且锁定在位以实现和保持结合图4F所述的皱褶。这种皱褶在心脏收缩期间减小或闭合后瓣和前瓣60、62之间的缝隙。
图6是针对图5A-5E的瓣环成形术过程所示和所述的组织锚70的侧视图。除了远侧末端76用于组织穿刺目的以外,该实施例与第一实施例还存在众多方面不同。例如,细长条带74稍短于第一实施例中所使用的细长条带14。例如,条带74可以约40mm长,约3mm宽。当然,根据应用要求,可以使用任何其他所需尺寸和形状。这可能是实现具有较少皱折的较低的轮廓部署和连接结构所需的,这种结构可实现更通用的应用、较少发生血液凝结、更容易的使用等。另外,相应的近侧和远侧辐射不可透过带90、92固定到位于条带74的近端部分处的缝合线72、和远侧末端76的内部或外部。在荧光镜检查的情况下,这些带或其他标记90、92将向外科医生显示:在手术过程期间,根据需要,已经部署、致动和完全压缩和/或紧固锚70。可选地,末端76本身可以由辐射不可透过材料形成。在该第二实施例中,形成在缝合线72或其他张力调整部件中的结节94是滑动结节,在组织锚70的致动期间,缝合线72的另一部分从中滑动通过。可以理解,该滑动结节94可以由起着大致相同作用但采用不同形式的另一种元件代替,例如采用小管形元件或在功能上类似于滑动结节的其他结构特征的形式。
如图6和图7中进一步所示,张力调整部件或缝合线72可有利地延伸穿过成大致沙漏(hourglass)结构的细长条带74的相应折叠部分74c。具体地讲,位于条带74的近端部分74a和远端部分74b附近的缝合线72的邻近部分比位于条带74中部的缝合线72的邻近部分间隔得更开。如图7A中进一步所示,辐射不可透过标记例如不同的点域95可以用于使外科医生在细长条带74的部署和固定期间能够看见细长条带74的皱折。这些点或其他辐射不可透过标记可以印刷在条带74上。例如,点95或其他标记可以由铂粉基墨水或辐射不可透过且生物兼容的其他合适材料形成。该辐射不可透过材料也可以增加折叠部分74c的刚度,从而帮助维持折叠部分74c平坦,且增加在组织上的保持力。同时,折叠部分74c之间的折叠线74d可保持高度柔性,以产生小弯折叠线。如图7中进一步所示,在将张力调整部件或缝合线72与细长条带74组装期间,张力调整部件或缝合线72被接收通过的每个孔96可以由环绕每个孔96的圆环98或者其他用于视觉目的的标记标示。任选地,可以不用孔96,且缝合线72通过使用针穿过条带74。例如,也可以选择沿着条带74的不同组的孔96,用于接收张力调整部件或缝合线72,从而根据应用需求或外科医生的需要而改变皱折的宽度和/或皱折的数量。张力调整部件或缝合线72可以以任意多种方式沿着条带74穿过或加装,所述方式包括例如x-图案或者其他交叉图案、锯齿形图案等,这些方式可以将锚的折叠或缩短或压缩形状改变成各种有益形状,诸如花形、圆形或其他圆滑状、球形或其他结构。沿着条带74的长度穿过或加装张力调整部件或缝合线72的方式的修改方案可以使得压缩锚需要更高或更低的张紧力和/或产生可以有助于将锚保持在压缩或缩短结构下的更高或更低的摩擦保持力。细长条带74’的宽度可以沿着其长度变化,例如通过沿着条带14的长度形成锥形、成阶梯状或形成沙漏形状。例如,如图7B中所示,沿着条带74’的长度,近端部分75和远端部分77比中间或中部部分79具有更宽的尺寸,这将使得在使用期间这些较宽部分75、77可以覆盖更多的中间折叠部分79、且防止与相邻组织之间的非必要接触。可以理解,在所有实施例中,相同的附图标记在此用于表示相同的元件,且具有右上角标记(’)或双右上角标记(”)的附图标记表示已以在此所述的或在相关附图中所示的方式修改的相同元件。条带74可以具有可变化的刚度,包括例如相对刚性的周边或相对刚性的边缘74e、74f(图7)或由柔性部分例如活动铰链74d”分离的间断相对刚性部分74c”,它们可有助于将细长条带74”折叠或固定成折叠状态(图7C)。
图8A-8D示出了用于将第二实施例的组织锚70部署并可靠地紧固到组织层100的一系列步骤。通常,如图8A所示,细长条带74和拉力调整部件或缝合线72的组合部署穿过组织层100。随后,拉拔延伸穿过滑动结节94的缝合线72的一端或一部分72a。这使细长条带74的远侧部分74b抵靠着组织层100的远侧折叠或压缩。如图8B中所示,进一步拉拔张力调整部件72使滑动结节94沿着缝合线72向上或向远侧行进,并且抵靠着细长条带74的近侧部分74a,从而将近侧部分74a抵靠着组织层100的近侧折叠和压缩,如图8C中所示。如图8D中所示,可以使用合适的卷曲或锁定元件102将滑动结节94相对于延伸穿过其的缝合线或张力调整部件段可靠地锁定在位。这将整个锚70锁定在位,其中相应的近侧和远侧折叠条带部分74a、74b将组织层100可靠地保持在它们之间。图8D示出了末端76,其在远端部分74b的顶部上充当限位件,以协助将远端部分74b保持在位。图8E示出了可选方案,其中,张力调整部件穿过较居中地位于末端中的至少一个孔76a。另一可选方案是,将张力调整部件穿过两个居中定位的孔,而不是如图8E所示穿过末端76的近端和一个中心定位孔76a。这些可选方案使得末端76可更像“T”-棒,使力以与条带74的远端部分74b更为垂直或正交的方式作用。
图9A-9C示出了例如在二尖瓣环40a上实施瓣环成形术期间使用的皱褶过程的另一可选实施例。在这点上,诸如缝合线103或其他部件的单个张力调整部件可以用于使至少两个分离的组织锚110部署、紧固和牵拉在一起。如图9A中所示,第一和第二组织锚110可分别在沿着二尖瓣环40a的间隔开的位置部署。每个组织锚110包括由柔性材料例如如上所述的织物或其他材料制成的细长条带114、以及延伸穿过每个细长条带114的缝合线103或张力调整部件。一旦将两个组织锚110在间隔开的位置部署穿过组织层40,拉拔缝合线103或张力调整部件的自由端,从而可靠地紧固第一组织锚110,如图9A和9B中所示,随后将第二组织锚110可靠地紧固到环组织40a。一旦进一步拉拔或张紧缝合线103,将组织锚110牵拉在一起,以使组织40在它们之间皱褶,如图9C中所示。然后,卷曲或其他锁定部件116可用于通过卷曲到缝合线103位于第一组织锚110的滑动结节94附近的自由端上以所需皱褶量锁定,如图9C中所示。然后,切割缝合线103的自由端,以去除或减少缝合线尾部的长度。
图10A和10B示出了第二实施例的组织锚70,其例如用于在组织层120的仅一侧上提供锚定或固定定位。在这点上,组织锚70可以全部延伸穿过组织层120。然后,向近侧拉拔缝合线或张力调整部件72的自由端,以将细长条带74抵靠着组织层120的远侧压缩和折叠,如图10B中所示。可以理解,条带74的致动类似于其他所述实施例,除了致动后部分(即,折叠或缩短部分)完全位于组织层120的一侧上以外。如图所示,锚部件的近端部分与远端部分之间的中间或中部部分缩短,以适应包括在它们之间的组织量(如果有),或者在组织的仅一侧上的压缩过程期间缩短。
虽然已通过描述各种示例性实施例说明了本发明、以及虽然已经在较详细地描述了这些实施例,但申请人的目的并非将权利要求书的范围限定或者以任何方式限制为这样的细节。另外优点和修改方案对于本领域技术人员而言显而易见。根据使用者的需求和偏爱,本发明的各种特征可以单独或者以多种组合方式使用。
Claims (55)
1、一种组织锚,包括:
大致柔性锚部件,所述大致柔性锚部件能够插入穿过组织、且能够在细长结构与适于抵靠着组织的至少一侧锚定的缩短结构之间变动,所述锚部件具有近端部分、远端部分和位于所述近端部分与所述远端部分之间的可压缩中间部分;以及
张力调整部件,所述张力调整部件可操作地连接到所述锚部件,使得所述锚部件可相对于所述张力调整部件滑动,所述张力调整部件能够被拉拔,以使所述锚部件相对于所述张力调整部件从所述细长结构变动到所述缩短结构,其中,可压缩中间部分可压缩,从而适应近端部分与远端部分之间的组织厚度。
2、根据权利要求1所述的组织锚,其特征在于,所述大致柔性锚部件由选自下列材料中的至少一种材料形成:天然纤维、合成纤维、聚合物和金属。
3、根据权利要求2所述的组织锚,其特征在于,所述张力调整部件还包括缝合线。
4、根据权利要求1所述的组织锚,其特征在于,所述张力调整部件还包括缝合线。
5、根据权利要求1所述的组织锚,其特征在于,所述张力调整部件包括可与所述锚部件接合的止动部件。
6、根据权利要求5所述的组织锚,其特征在于,所述止动部件还包括所述张力调整部件中的结节。
7、根据权利要求1所述的组织锚,其特征在于,所述张力调整部件在近端部分与远端部分之间的多个位置处延伸穿过所述锚部件。
8、根据权利要求1所述的组织锚,其特征在于,所述锚部件和所述张力调整部件构造成使所述锚部件在拉拔所述张力调整部件的所述第一端时形成至少一个皱折。
9、根据权利要求1所述的组织锚,其特征在于,它还包括锁定部件,所述锁定部件可与所述张力调整部件接合,以将所述锚部件保持成缩短结构。
10、根据权利要求1所述的组织锚,其特征在于,它还包括位于所述锚部件和所述张力调整部件中的至少一个上的至少一个辐射不可透过标记。
11、根据权利要求10所述的组织锚,其特征在于,它还包括当所述锚部件处于缩短结构时接近所述近端部分定位的第一辐射不可透过标记、以及当所述锚部件处于缩短结构时接近所述远端部分定位的第二辐射不可透过标记。
12、根据权利要求1所述的组织锚,其特征在于,所述远端部分包括相对刚性的末端,所述末端具有相对于所述锚部件的邻近部分减小的宽度。
13、根据权利要求12所述的组织锚,其特征在于,所述末端充当压缩力施加部件,所述压缩力施加部件在所述锚部件处于缩短结构时抵靠着所述锚部件的所述远端部分。
14、根据权利要求1所述的组织锚,其特征在于,所述锚部件当处于细长结构时其宽度沿着其长度改变。
15、根据权利要求1所述的组织锚,其特征在于,所述锚部件包括比其中心区域具有更大刚性的边缘部分。
16、一种组织锚,包括:
平坦的大致柔性锚部件,所述平坦的大致柔性锚部件能够在适于部署的细长结构与适于抵靠着组织锚定的缩短结构之间变动;以及
张力调整部件,所述张力调整部件可操作地连接到所述锚部件,使得所述锚部件可相对于所述张力调整部件滑动,所述张力调整部件能够被拉拔,以使所述锚部件相对于所述张力调整部件从所述细长结构变动到所述缩短结构。
17、一种组织锚,包括:
平坦锚部件,所述平坦锚部件由织物材料的条带形成,且能够在适于部署的细长结构与适于抵靠着组织锚定的缩短结构之间变动;
张力调整部件,所述张力调整部件可操作地连接到所述锚部件,使得所述锚部件可相对于所述张力调整部件滑动,所述张力调整部件能够被拉拔,以使所述锚部件相对于所述张力调整部件从所述细长结构变动到所述缩短结构;以及
锁定部件,所述锁定部件能够将锚部件固定成缩短结构。
18、一种组织锚,包括:
平坦的大致柔性锚部件,所述平坦的大致柔性锚部件能够插入穿过组织,且能够在适于通过导管部署的细长结构与适于抵靠着组织锚定的缩短结构之间变动;以及
张力调整部件,所述张力调整部件可操作地连接到所述锚部件,使得所述锚部件可相对于所述张力调整部件滑动,所述张力调整部件能够被拉拔,以使所述锚部件相对于所述张力调整部件从所述细长结构变动到抵靠着组织的所述缩短结构。
19、一种组织锚,包括:
平坦细长条带,所述平坦细长条带由大致柔性材料形成,且具有近端部分和远端部分;以及
具有第一端和第二端的张力调整部件,所述张力调整部件可操作地连接到所述细长条带,使得拉拔所述张力调整部件的所述第一端使所述细长条带的所述近端部分和远端部分朝向彼此移动成适于抵靠着组织锚定的缩短结构。
20、一种组织锚,包括:
大致柔性平坦锚条带,所述大致柔性平坦锚条带能够在细长结构下插入穿过组织、且可变动到适于抵靠着组织的至少一侧锚定的缩短的折叠结构;以及
致动部件,所述致动部件可操作地连接到所述锚条带,且可操作以将锚条带从细长结构变动到缩短的折叠结构。
21、根据权利要求20所述的组织锚,其特征在于,所述缩短的折叠结构还包括锯齿状折叠图案。
22、一种组织锚定系统,包括:
传送导管;
大致柔性锚部件,所述大致柔性锚部件能够插入穿过组织、且能够在细长结构与适于抵靠着组织的至少一侧锚定的缩短结构之间变动,所述锚部件具有近端部分、远端部分、以及位于所述近端部分与所述远端部分之间的可压缩中间部分;
部署装置,所述部署装置可操作地与所述传送导管关联,且可操作以将所述锚部件从所述传送导管中伸出;以及
张力调整部件,所述张力调整部件可操作地连接到所述锚部件,使得所述锚部件可相对于所述张力调整部件滑动,所述张力调整部件能够被拉拔,以使所述锚部件相对于所述张力调整部件从所述细长结构变动到所述缩短结构,其中,可压缩中间部分可以压缩,从而适应近端部分与远端部分之间的组织层的厚度。
23、根据权利要求22所述的系统,其特征在于,所述部署装置还包括部署导管,所述部署导管至少部分容纳所述锚部件、且至少部分被容纳在所述传送导管中。
24、根据权利要求22所述的系统,其特征在于,所述锚部件由选自以下材料中的至少一种材料形成:天然纤维、合成纤维、聚合物和金属。
25、根据权利要求24所述的系统,其特征在于,所述张力调整部件还包括缝合线。
26、根据权利要求22所述的系统,其特征在于,所述张力调整部件还包括缝合线。
27、根据权利要求22所述的系统,其特征在于,所述张力调整部件包括可与所述锚部件接合的止动部件。
28、根据权利要求27所述的系统,其特征在于,所述止动部件还包括所述张力调整部件中的结节。
29、根据权利要求22所述的系统,其特征在于,所述张力调整部件在近端部分与远端部分之间的多个位置处延伸穿过所述锚部件。
30、根据权利要求22所述的系统,其特征在于,所述锚部件和所述张力调整部件构造成使所述锚部件在拉拔所述张力调整部件的所述第一端时形成至少一个皱折。
31、根据权利要求22所述的系统,其特征在于,它还包括锁定部件,所述锁定部件可与所述张力调整部件接合,以将所述锚部件保持成缩短结构。
32、根据权利要求22所述的系统,其特征在于,它还包括位于所述锚部件和所述张力调整部件中的至少一个上的至少一个辐射不可透过标记。
33、根据权利要求32所述的系统,其特征在于,它还包括当所述锚部件处于缩短结构时接近所述近端部分定位的第一辐射不可透过标记、以及当所述锚部件处于缩短结构时接近所述远端部分定位的第二辐射不可透过标记。
34、根据权利要求22所述的系统,其特征在于,所述远端部分包括相对刚性的末端,所述末端具有相对于所述锚部件的邻近部分减小的宽度。
35、根据权利要求34所述的系统,其特征在于,所述末端充当压缩力施加部件,所述压缩力施加部件在锚部件处于缩短结构时抵靠着锚部件的远端部分。
36、根据权利要求22所述的系统,其特征在于,所述锚部件当处于细长结构时其宽度沿着其长度改变。
37、根据权利要求22所述的系统,其特征在于,所述锚部件包括比其中心区域具有更大刚性的边缘部分。
38、一种利用第一大致柔性细长锚部件锚定组织的方法,所述锚部件具有近端部分、远端部分和位于近端部分和远端部分之间的可压缩中间部分,且可在细长结构与缩短结构之间变动,所述方法包括:
将第一大致柔性细长锚部件插入穿过组织;以及
拉拔被连接成相对于第一锚部件滑动移动的张力调整部件的第一端,以将近端部分和远端部分朝向彼此牵拉、以及将中间部分压缩成缩短结构,使得近端部分和远端部分中的至少一个抵靠着组织接合。
39、根据权利要求38所述的方法,其特征在于,所述组织包括单个组织层。
40、根据权利要求38所述的方法,其特征在于,所述组织包括至少两个离散的组织部分,且所述方法还包括将两个组织部分在第一锚部件的近端部分与远端部分之间连接在一起。
41、根据权利要求38所述的方法,其特征在于,它还包括:
使第一锚部件抵靠着所述组织的仅一侧接合。
42、根据权利要求38所述的方法,其特征在于,它还包括:
使第一锚部件抵靠着组织的相反侧接合。
43、根据权利要求38所述的方法,其特征在于,它还包括:
使第二大致柔性细长锚部件在与第一锚部件间隔开的位置处插入穿过组织;
使第二锚部件抵靠着所述组织接合;
将第一部件和第二部件朝向彼此牵拉,以使组织在第一锚部件与第二锚部件之间皱褶;以及
将第一锚部件和第二锚部件相对于彼此锁定在位,使得组织在它们之间皱褶。
44、根据权利要求43所述的方法,其特征在于,所述组织包括二尖瓣的环组织,且第一锚部件和第二锚部件朝向彼此的牵拉使环组织在第一锚部件与第二锚部件之间皱褶。
45、根据权利要求38所述的方法,其特征在于,拉拔所述张力调整部件的第一端使得在第一锚部件中形成至少一个皱折。
46、根据权利要求38所述的方法,其特征在于,拉拔所述张力调整部件的第一端使得沿着锚部件形成多个皱折。
47、一种组织锚定方法,包括:
将具有近端部分和远端部分的第一大致柔性平坦细长条带插入穿过组织;以及
拉拔可操作地连接到第一条带的张力调整部件的第一端,以将第一条带的近端部分和远端部分朝向彼此牵拉成抵靠着组织接合的缩短结构。
48、根据权利要求47所述的方法,其特征在于,所述组织包括单层组织。
49、根据权利要求47所述的方法,其特征在于,所述组织包括至少两个离散的组织部分,且所述方法还包括将两个组织部分在第一锚部件的近端部分与远端部分之间连接在一起。
50、根据权利要求47所述的方法,其特征在于,它还包括:
使第一条带抵靠着组织的仅一侧接合。
51、根据权利要求47所述的方法,其特征在于,它还包括:
使第一条带抵靠着组织的相反侧接合。
52、根据权利要求47所述的方法,其特征在于,它还包括:
将具有第一端和第二端的第二大致柔性平坦细长条带在与第一条带间隔开的位置处插入穿过组织;
拉拔可操作地连接到第二条带的第二张力调整部件的第一端,以将第二条带的第一和第二端朝向彼此牵拉成抵靠着组织接合的缩短结构;
张拉第一和第二张力调整部件,以使第一和第二条带朝向彼此牵拉而使组织在第一与第二条带之间皱褶;以及
将第一和第二张力调整部件彼此锁定。
53、根据权利要求52所述的方法,其特征在于,所述组织包括二尖瓣的环组织,且第一条带和第二条带朝向彼此的牵拉使环组织在第一条带与第二条带之间皱褶。
54、根据权利要求47所述的方法,其特征在于,它还包括:
将具有第一端和第二端的第二大致柔性平坦细长条带在与第一条带间隔开的位置处插入穿过组织;
将第二条带的第一端和第二端朝向彼此牵拉成抵靠着组织接合的缩短结构;
将第一条带和第二条带朝向彼此牵拉,以使组织在第一条带与第二条带之间皱褶;以及
将第一条带和第二条带相对彼此锁定在位。
55、一种组织锚定方法,包括:
将具有近端部分和远端部分的第一大致柔性平坦细长条带插入穿过组织;以及
拉拔可操作地连接到第一条带的张力调整部件的第一端,以将条带的至少一部分构造成抵靠着组织接合的缩短结构。
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2005
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2006
- 2006-06-27 ES ES15180303.8T patent/ES2625845T3/es active Active
- 2006-06-27 EP EP06774051.4A patent/EP1898802B1/en active Active
- 2006-06-27 CA CA2614228A patent/CA2614228C/en active Active
- 2006-06-27 JP JP2008520269A patent/JP5009288B2/ja not_active Expired - Fee Related
- 2006-06-27 PT PT151803038T patent/PT2979647T/pt unknown
- 2006-06-27 EP EP17162017.2A patent/EP3210543A1/en not_active Withdrawn
- 2006-06-27 WO PCT/US2006/024897 patent/WO2007005394A1/en active Application Filing
- 2006-06-27 PT PT67740514T patent/PT1898802E/pt unknown
- 2006-06-27 EP EP15180303.8A patent/EP2979647B1/en active Active
- 2006-06-27 CN CNA2006800312539A patent/CN101252887A/zh active Pending
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2008
- 2008-11-19 US US12/273,670 patent/US8951286B2/en active Active
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2013
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2014
- 2014-12-23 US US14/581,264 patent/US9814454B2/en active Active
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2017
- 2017-08-18 US US15/680,742 patent/US10695046B2/en active Active
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2020
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US20070010857A1 (en) | 2007-01-11 |
EP2979647A1 (en) | 2016-02-03 |
US9259218B2 (en) | 2016-02-16 |
US20150173740A1 (en) | 2015-06-25 |
US20090076547A1 (en) | 2009-03-19 |
CA2614228C (en) | 2015-01-13 |
US10695046B2 (en) | 2020-06-30 |
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JP5009288B2 (ja) | 2012-08-22 |
US8951285B2 (en) | 2015-02-10 |
EP2979647B1 (en) | 2017-03-29 |
US20200330088A1 (en) | 2020-10-22 |
EP1898802A1 (en) | 2008-03-19 |
EP3210543A1 (en) | 2017-08-30 |
PT2979647T (pt) | 2017-06-02 |
WO2007005394A1 (en) | 2007-01-11 |
CA2614228A1 (en) | 2007-01-11 |
US20180028171A1 (en) | 2018-02-01 |
PT1898802E (pt) | 2015-10-27 |
EP1898802B1 (en) | 2015-09-23 |
US20140243859A1 (en) | 2014-08-28 |
US8951286B2 (en) | 2015-02-10 |
JP2009500105A (ja) | 2009-01-08 |
ES2625845T3 (es) | 2017-07-20 |
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