CN107205743B - 取回用线定心装置 - Google Patents
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Abstract
一种封闭的植入系统可包括:具有延伸经过其中的管腔的导管;可滑动地且可旋转地设置在管腔内部的芯线,该芯线具有设置在远端的螺纹构件;和具有可扩张支架(210)的医用植入物(200);设置在支架上的封闭元件;和联接到支架近端部的螺纹插入物(230),其中螺纹构件可移除地联接到该螺纹插入物。
Description
技术领域
本发明总体上涉及经皮医疗器械,更具体地涉及用于植入心脏左心耳
(LAA)的经皮医疗器械。
背景技术
心房纤颤(AF)是最常见的持续性心律失常,在世界范围内影响了超过550万的人。心房纤颤是心脏上腔室的不规则的紊乱跳动。电脉冲如此快速地放电以致心房肌发生颤动或纤维性颤动。心房纤颤的发作可持续达几分钟或数天。心房纤颤的最严重后果是缺血性脑卒中。已有人估计,高达20%的全部脑卒与心房纤颤有关。大部分心房纤颤患者,无论他们的症状严重程度或发作频率如何,需要进行治疗以降低脑卒中的危险性。左心耳(LAA)是以类似于荷包的延长物形式连接于心脏左心房的小器官。在罹患心房纤颤的患者中,左心耳会不适当地与左心房接触,从而导致淤血汇聚在其内部,这会导致在左心耳内部的不良的血栓形成。形成于左心耳中的血栓会从该区域脱离并进入血流。经过血管而移动的血栓最终会堵塞下游的较小血管,由此导致脑卒中或心脏病发作。临床研究已证明,在患有心房纤颤的患者中大部分的血块是发现于左心耳中。作为治疗,已开发出了位于左心耳中且用于隔绝左心耳的口的医疗器械。随着时间的推移,跨越左心耳的口的暴露表面变得被组织覆盖(被称作内皮化的过程),从而有效地将左心耳从循环系统中移除并且减小或消除可从左心耳进入血流的血栓的量。
对于用于控制罹患心房纤颤患者的左心耳内部的血栓形成的、改进的医疗器械和方法存在着需求。
发明内容
医用植入物可包括:构造成在收拢构型与扩张构型之间动作的支架、和覆盖至少一部分的支架的封闭元件;其中支架的近端形成大体管状部,该管状部构造成附接到芯线的远端,并且其中支架的管状部包括与之联接的螺纹插入物。
封闭的植入系统可包括:具有在其中延伸经过的管腔的导管;可滑动地且可旋转地设置在管腔内部的芯线,该芯线具有被设置在其远端的螺纹构件;和具有可扩张支架的医用植入物;被设置在支架上的封闭元件;和联接到支架近端部的螺纹插入物,其中将螺纹构件可移除地联接到该螺纹插入物。
制造定心芯线的方法可包括:获得具有设置在其远端的螺纹构件的细长芯线;获得具有设置在其中的孔口或管腔的导向元件;将细长芯线的近端插入孔口或管腔;使导向元件在细长芯线的上方向远侧滑动至与螺纹构件接触;和将聚合物护套顺着所述细长芯线从所述近端施加至所述导向元件;其中聚合物护套将导向元件保持在抵接螺纹构件的状态。
附图说明
图1是一个示例性医用植入物和输送组件的侧视图;
图2是被设置在输送组件内部的一个示例性医用植入物的局部剖视图;
图3是示例性医用植入物的透视图;
图3A是图3的示例性医用植入物的局部剖视图;
图4是示例性医用植入物的透视图;
图4A是图4的示例性医用植入物的局部剖视图;
图5A和图5B示出了在图1的输送组件的某些元件之间相对运动的范围;
图6是被回缩进入输送导管中的示例性医用植入物的局部剖视图;
图7是示例性导向元件的侧视图;
图8是示例性导向元件的侧视图;
图9是示例性导向元件的侧视图;
图10是连接到具有图7的示例性导向元件的示例性芯线的示例性医用植入物的侧视图;
图10A是与示例性输送导管腔未对准的图10的示例性医用植入物的侧视图;
图11是中心对准示例性输送导管腔的图10的示例性医用植入物的侧视图。
虽然本发明适合于各种修改和替代形式,但已通过附图中的例子揭示了其细节并且将在下面进行更详细的描述。然而,应当理解的是,本发明并非意图将本发明局限于所描述的具体实施例。相反,本发明意图是涵盖落在本发明精神和范围内所有修改、等同物、和替代物。
具体实施方式
就以下所定义的术语而言,应采用这些定义,除非在权利要求或本说明书中的别处给出不同的定义。
术语“上游”和“下游”是指相对于经过特定元件或部位(例如血管(即,主动脉)、心脏瓣膜(即,主动脉瓣)等)的血流方向的位置或部位。
术语“近侧”和“远侧”应通常是指从使用医疗器械的临床医生的视角看,元件或操作相对于彼此的相对位置、方位、或方向。虽然这些术语并非意图是限制性的,但“近侧”可通常被认为是更加靠近临床医生或者患者的外部,“远侧”可通常被认为是沿医疗器械的长度更加远离临床医生。
术语“整体的”和“单一的”应通常是指由单一的结构或基本单元/元件所制成或组成的一个元件或多个元件。整体的和/或单一的元件应排除通过将多个分离的元件组装或连接到一起所制成的结构和/或特征。
假设本文中的所有数值可被术语“大约”所修饰,无论是否明确地指出。在数值的语境中,术语“大约”通常是指本领域技术人员将会认为等同于所列举值(即,具有相同的功能或结果)的一系列数字。在许多情况下,术语“大约(about)”可包括被四舍五入为最近的有效数字的数字。除非另有说明,术语“大约(about)”的其它使用(即,在除数值外的语境中)可假设具有它们的普通和通常的定义,正如基于本说明书的上下文并与其一致所理解的。
重量百分率、采用重量的百分率、wt%、wt-%、采用重量的%等是指代物质浓度(即,将该物质的重量除以组合物的重量并乘以100)的同义词。
利用端点对数值范围的叙述包括在该范围内的所有数字,包括端点在内(例如,1至5包括1、1.5、2、2.75、3、3.80、4、和5)。
在本说明书和所附权利要求中所使用的单数形式“一”、“一个”、和“该”包括复数所指对象,除非上下文中明确指出。在本说明书和所附权利要求中所使用的术语“或者”通常是以包括“和/或”的含义而使用,除非上下文中明确指出。
以下的描述应当参照附图来阅读,其中在全部数个视图中类似的附图标记表示类似的元件。详细描述和附图意图是用于说明但并不限制请求保护的本发明。本领域技术人员将认识到,在不背离本发明范围的前提下所描述和/或图示的各种元件可采用各种组合和构型而布置。下面所描述的各种单独元件,即使未明确地在特定的组合中进行图示,但可想到可以彼此组合或布置而形成其它附加实施例或者补充和/或充实所描述的实施例,正如本领域的技术人员将会理解的。
在心房纤颤期间在左心耳(LAA)中血栓的发生可以是由于血池在LAA中的停滞所导致。仍然可由左心室将血液从左心房中吸出,然而由于由心房纤颤所导致的左心房不规则收缩因而不能十分有效地将血液吸出。因此,代替通过收缩左心房和左心耳对血液流动的主动支持,左心室的充盈可主要地或仅仅取决于由左心室所形成的抽吸效应。此外,左心耳的收缩可以不与左心室的心动周期同步。例如,左心耳的收缩可与左心室有多达180度的相位差,这会对期望的血液流动产生显著的阻力。此外,大部分的左心耳几何形状是复杂且高度可变的,并且具有大的不规则表面积和与左心耳的深度相比较为狭窄的口或开口。这些方面以及其它方面,单独地或者采用各种组合的形式,会导致对从左心耳中流出血液的高流动阻力。
为了降低在左心耳中的血栓形成的发生并防止血栓从左心耳内部进入血流,已开发出了将左心耳与心脏和/或循环系统隔离的医疗器械,由此降低由于溶血栓物质从左心耳进入血流所导致的脑卒中的危险。在所述医疗器械的置入期间所遇到的困难会偶尔需要实施取出和/或重捕过程。为了使重捕过程变容易和/或提供适合于长期植入的医疗器械,已开发出了有利的新特征。
现在转向附图,图1中示出了示例性的输送组件和/或植入系统10,该系统包括被设置在示例性芯线30的远端32的示例性医用植入物20。可将该芯线30可滑动地和/或可旋转地设置在输送导管40的管腔42的内部。在一些实施例中,芯线30的近端34可延伸到输送导管40的近端的远侧,以便临床医生或实施者的手动操作。在一些实施例中,可将示例性医用植入物20可移除地附接、连接、或者联接到示例性芯线30的远端32。示例性医用植入物20可构造成当从输送导管40向远侧延伸时(或之后)从收拢构型动作到扩张构型,例如图1中所见。图2中示出了处于收拢构型的、被设置在输送导管40的管腔42的远端部内部的示例性医用植入物20。可以想到,本文中所公开的任何和/或全部示例性医用植入物可使用于上述示例性输送组件和/或植入系统10并且/或者与之相结合而使用。
图3和图3A中示出了一个示例性医用植入物100,该医用植入物100具有构造成在收拢构型与扩张构型之间动作的支架110。在一些实施例中,示例性医用植入物100可包括封闭元件120,该封闭元件设置在支架110的至少一部分上面、上方、周围、或者将其覆盖。在一些实施例中,可将封闭元件120设置在支架110的外(或面朝外的)表面的至少一部分上面、上方、周围、或者将其覆盖。在一些实施例中,支架110的近端可形成大体管状部112,该大体管状部112构造成附接到或联接到芯线30的远端。在一些实施例中,支架110的大体管状部112可包括与之联接的螺纹插入物130。在一些实施例中,可将螺纹插入物130至少部分地设置在支架110的大体管状部112的内部。在一些实施例中,螺纹插入物130可构造成并且/或者适合于与设置在芯线30的远端32的螺纹构件36联接、连接、配合、或者接合。
在一些实施例中,可将封闭元件120的第一部分设置在螺纹插入物130与大体管状部112之间。在一些实施例中,可将封闭元件120的第一部分夹在或固定在螺纹插入物130与大体管状部112之间。在一些实施例中,螺纹插入物130可包括弯曲或倾斜的面朝近侧的表面132,该表面从形成于螺纹插入物130的中心内部的螺纹径向地向外延伸。在一些实施例中,弯曲或倾斜的面向近侧表面132可向处于扩张构型和/或收拢构型中的封闭元件120的近侧延伸。在一些实施例中,弯曲或倾斜的面向近侧表面132可具有从封闭元件120的第一部和/或大体管状部112径向地向外设置的外延部。在一些实施例中,支架110可包括多个面向近侧的钩118,这些钩绕处于扩张构型中的支架110的外周设置。在一些实施例中,多个面向近侧的钩118可提供锚固机构,用以帮助将布置好的医用植入物100保持在患者解剖结构(即,例如左心耳)内部的靶部位。
图4和图4A中示出了示例性医用植入物200,该医用植入物200具有构造成在收拢构型与扩张构型之间动作的支架210。在一些实施例中,示例性医用植入物200可包括封闭元件220,将该封闭元件设置在至少一部分的支架210上面、上方、周围、或者将其覆盖。在一些实施例中,可将封闭元件220设置在支架210的外(或面朝外的)表面的至少一部分上面、上方、周围、或者将其覆盖。在一些实施例中,支架210的近端可形成大体管状部212,该大体管状部212构造成附接到或联接到芯线30的远端32。在一些实施例中,支架210的大体管状部212可包括与之联接的螺纹插入物230。在一些实施例中,支架210可包括环形套管构件240,该套管构件240至少部分地被设置在大体管状部212的内部并与之联接。在一些实施例中,螺纹插入物230可联接到环形套管构件240。在一些实施例中,螺纹插入物230可至少部分地被设置在环形套管构件240的内部。在一些实施例中,销元件250可将环形套管构件240和/或螺纹插入物230联接到支架210并且/或者彼此联接。在一些实施例中,环形套管构件240和/或螺纹插入物230可固定地附接到支架210的大体管状部212并且/或者与之联接并且/或者彼此联接。在一些实施例中,可将环形套管构件240和/或螺纹插入物230永久地附接到支架210的大体管状部212并且/或者与之联接并且/或者彼此联接。在一些实施例中,可将环形套管构件240和/或螺纹插入物230可移除地附接到支架210的大体管状部212并且/或者与之联接并且/或者彼此联接。在一些实施例中,螺纹插入物230可构造成并且/或者适合于可逆地和/或可移除地与设置在芯线30的远端32的螺纹构件36联接、连接、配合、或者接合。
在一些实施例中,可将封闭元件220的第一部分设置在螺纹插入物230与环形套管构件240之间。在一些实施例中,可将封闭元件220的第一部夹在或固定在螺纹插入物230与环形套管构件240之间。在一些实施例中,可将螺纹插入物230设置在一部分的封闭元件220的远侧,该封闭元件220被设置在处于扩张构型和/或收拢构型中的环形套管构件240的外侧。在一些实施例中,可将封闭元件220的外侧部分定义为封闭元件220的设置在环形套管构件240外侧的部分。在一些实施例中,扩张构型中,封闭元件220的外侧部分从螺纹插入物230径向地向外设置。在一些实施例中,支架210可包括多个朝向近侧的钩218,在扩张构型中这些钩218绕支架210的外周设置。在一些实施例中,多个朝向近侧的钩218可提供锚固机构,用以帮助将布置的医用植入物200保持在患者解剖结构内部的靶部位(即,例如左心耳)。
在一些实施例中,图4的医用植入物200可具有的在螺纹插入物处的暴露材料(即,金属材料)的量与图3的医用植入物100相比减小。申请人已发现减少暴露于血流的金属材料的量可提供某些优点,例如减少血栓形成和/或使内皮化更快速。
如图5A和图5B中所示,在一些实施例中,芯线30可具有显著地小于输送导管40的管腔42的最小内直径的最大外直径。输送导管40的管腔42的内直径的尺寸可被设计成将处于收拢构型中的医用植入物20容纳在管腔42内部。芯线30的外直径的尺寸可被设计成给芯线30和输送组件和/或植入系统10提供充分的灵活性,以便经过患者的脉管系统引导至靶部位(即,例如左心耳)同时维持期望水平的扭矩传导性和/或推送性。
正如从图5A和图5B中可见,在芯线30与管腔42之间的尺寸差异可允许大量的“游隙”、或者相对于管腔42的中心轴线在芯线30与输送导管40之间的侧向移动。因此,例如在医用植入物20的布置期间和/或在医用植入物20的取出或重捕期间,在从管腔42向远侧延伸之后,医用植入物20和/或芯线30的远端32会变得与输送导管40的管腔42不对准。在一些过程期间,在最初的置入之后,在将医用植入物20从芯线30中释放出来之前,会需要抽出和/或重捕医用植入物20。例如,如果在医用植入物20与周围组织(即,例如左心耳的口)之间实现不充分的密封,那么实施者可重捕医用植入物20并将其再次布置以确保正确的置入。可替代地,在患者解剖结构内部的布置和释放之后,会需要在一些点处移除医用植入物。在重捕过程期间,输送导管40的远端44会变得与设置在其上的医用植入物20和/或封闭元件接触,如图6中所示。如果医用植入物20不被大体上定心在管腔42的远侧开口内,那么使支架从扩张构型动作到收拢构型所需的力会增加,并且在一些情况下该力会足够大从而导致封闭元件的撕裂或损坏,因为封闭元件夹在支架与输送导管40之间,因此在继续手术之前需要将植入物20从患者中完全取出和替换。因此,至少在一些情况下,可导致植入物20定心在管腔42内的一个特征会是有利的。
图7-图9中示出了具有在远端32的螺纹构件36的示例性芯线30。在一些实施例中,螺纹构件36可构造成并且/或者适合于与示例性医用植入物20的螺纹插入物接合、附接、连接、和/或配合。示例性芯线30可包括导向元件35,该导向元件35被设置成在与螺纹构件36的近端相邻处围绕着芯线30。导向元件35可被成形和/或构造成将芯线30和/或医用植入物20定心在输送导管40的管腔42的内部。在一些实施例中,导向元件35可包括弯曲的、凸形的近侧表面和大体上为平直的远侧表面,例如图7中所示。在一些实施例中,导向元件35可包括圆锥形的近侧表面和大体上为平直的远侧表面,例如图8中所示。在一些实施例中,导向元件35可包括大体上为圆形的、球形的、凸形的外表面,例如图9中所示。在一些实施例中,导向元件35的远侧表面可构造成和/或适合于当使螺纹构件36与螺纹插入物接合、附接、连接、和/或配合时与医用植入物20接触或接合,例如在图10-图11中所见。在一些实施例中,当使螺纹构件36与螺纹插入物接合、附接、连接、和/或配合时,导向元件35的远侧表面可以不与医用植入物20接触或接合,并且导向元件35的远侧表面可与医用植入物20隔开。
在一些实施例中,封闭性植入系统10可包括:具有从其中延伸经过的管腔42的输送导管40;可滑动地和/或可旋转地被设置在管腔42内部的芯线30;具有被设置在其远端32的螺纹构件36的芯线30;和具有可扩张支架的医用植入物20;被设置在支架上的封闭元件;和联接到支架近端部的螺纹插入物,其中可将螺纹构件36可移除地连接到该螺纹插入物,例如图10-图11中所示。在这里所提供的示例性附图中,示例性芯线30被图示为附接到本文中所描述的示例性医用植入物200。然而,该示例性芯线30也可适用于本文中所描述的示例性医用植入物100或者其它类似的医用植入物/器械。在一些实施例中,支架可在收拢构型与扩张构型之间动作。在一些实施例中,支架可以是自我扩张的。在一些实施例中,可手动地使支架从收拢构型动作到扩张构型。在一些实施例中,可将一部分的封闭元件设置在螺纹插入物与支架的近端部之间。在一些实施例中,一部分的封闭元件可向螺纹插入物的近侧延伸。在一些实施例中,医用植入物20可包括环形套管构件,该套管构件被设置在支架的近端部与螺纹插入物之间。在一些实施例中,可利用销元件将环形套管构件和/或螺纹插入物可移除地和/或可逆地与支架的近端部联接、附接、连接、和/或接合。在一些实施例中,环形套管构件和/或螺纹插入物可固定地和/或永久地与支架的近端部联接、附接、连接、和/或接合,例如通过粘接、焊接、机械紧固等。
在一些实施例中,芯线30可包括导向元件35,该导向元件35被设置在与螺纹构件36的近端相邻的位置。在一些实施例中,导向元件35可构造成和/或适合于将芯线30定心在输送导管40的管腔42的内部。在一些实施例中,可将导向元件35可绕芯线30可滑动地设置。在一些实施例中,可将导向元件35定位成抵接螺纹构件36并且利用设置在芯线30上方和/或上面的的聚合物护套38被轴向地保持就位,且聚合物护套38的远端与导向元件35接触的聚合物护套38。在一些实施例中,可将导向元件35固定地和/或永久地附接到芯线30,例如通过粘接、焊接、机械紧固等。在一些实施例中,导向元件35可作为整体单元而与芯线30一体形成。在一些实施例中,可将标记带37绕芯线30设置为与导向元件35相邻。在一些实施例中,可将标记带37设置在聚合物护套38的上方并且可将覆盖芯线30的聚合物护套38的远端部压接到芯线30上。在一些实施例中,可将聚合物材料39的分离块设置在标记带37的上方,例如图7-图9中所示。在一些实施例中,可将材料39的分离块加热并且/或者连接到聚合物护套38(例如通过回流),从而形成单个聚合物覆盖构件。在一些实施例中,标记带37可至少部分地被聚合物护套38、聚合物材料39的分离块、和/或聚合物覆盖构件所包封。在一些实施例中,聚合物材料39的分离块可构成导向元件35,例如在图9中所示。
在一些实施例中,芯线30可包括与设置在远端32的螺纹构件36相邻位置的阶梯形外直径部和/或变窄的远侧部,如在图10-图11中可见。可将设置在芯线30上方和/或上面的聚合物护套38成形、压接、或推动就位在变窄的远侧部的上方,从而导致一部分的聚合物护套38被机械锁定就位并且防止聚合物护套38相对于芯线30向近侧滑动。在一些实施例中,标记带37可将聚合物护套38相对于芯线30机械锁定就位。该机械锁定可在存在或不存在设置在与螺纹构件36相邻位置的导向元件35的情况下实施。
制造定心芯线的方法可包括部分或全部的以下步骤:
获得或提供具有设置在其远端32的螺纹构件36的细长芯线30;
获得或提供具有设置在其中的孔口或管腔的导向元件35;
将细长芯线30的近端34插入管腔的孔口,以便导向元件35的朝近侧的表面提供在从芯线30径向向外和远侧方向上的大体呈锥形、倾斜、或凸形的表面;
使导向元件35顺着细长芯线30向远侧滑动至与螺纹构件36的近端接触;
顺着所述细长芯线30将聚合物护套38从细长芯线30的近端34施加至导向元件35,其中聚合物护套38轴向地将导向元件35固定和/或保持在抵接螺纹构件36的状态;
将标记带37设置在与导向元件35相邻的聚合物护套38的上方;
将标记带37压接到细长芯线30上,从而将聚合物护套38沿细长芯线30固定就位;
将聚合物材料块39围着标记带37设置;和
将聚合物护套38和聚合物材料块39加热,以便通过回流将聚合物护套38与合物材料块39连接到一起从而形成聚合物覆盖构件。
在该方法的一些实施例中,通过聚合物护套38和聚合物材料块39的回流可至少部分地将标记带37加以包封。换句话说,可利用通过聚合物护套38和聚合物材料块39的回流所形成的聚合物覆盖构件,至少部分地将标记带37加以包封。在该方法的一些实施例中,细长芯线30可包括与螺纹构件36相邻的阶梯形外直径部和/或变窄部分,以便提供芯线30与聚合物护套38之间的机械互锁。
图3和图4中示出了示例性医用植入物,该医用植入物具有设置在至少一部分的支架上方的膜或封闭元件。在一些实施例中,至少部分的多个朝近侧的钩突出经过该膜或封闭元件。在一些实施例中,该膜或封闭元件可在各朝近侧的钩处附接到支架,例如通使各朝近侧的钩穿过该膜或封闭元件(例如穿过孔或孔口)。在一些实施例中,可利用其它合适的附接手段(例如但不限于胶粘剂、缝合或螺纹、焊接或锡焊、或者其组合)将膜或封闭元件附接到支架。在一些实施例中,膜或封闭元件对血液和/或其它流体(例如水)可以是可渗透的或者不可渗透的。在一些实施例中,膜或封闭元件可包括聚合物膜、金属或聚合物网、多孔的类似过滤器的材料、或者其它合适的构造。在一些实施例中,膜或封闭元件防止血栓(即血块等)通过膜或封闭元件并且从左心耳中进入血流。在一些实施例中,膜或封闭元件促进植入后的内皮化,由此有效地将左心耳从患者的循环系统中移除。
支架可以是柔顺性的,并且在扩张构型中大体上与左心耳侧壁的形状和/或几何形状一致并且/或者密封接合。在一些实施例中,医用植入物可扩张到小于或不同于由周围组织和/或左心耳侧壁所确定的最大无约束范围的尺寸、范围、或形状。减小多个撑材的厚度可提高支架和/或植入物的挠性和柔顺性,由此使植入物能够与其周围的组织一致,而不是迫使组织与植入物一致。
在一些实施例中,支架的多个撑材、多个面向近侧的钩、和/或芯线可由以下材料构成或者包含:金属材料、金属合金、陶瓷材料、刚性或高性能聚合物、金属-聚合物复合材料、及其组合,等。一些合适材料的一些例子可包括:金属材料和/或合金,如不锈钢(例如,303、304v、或316L不锈钢)、镍-钛合金(例如,镍钛合金,如超弹性或线性弹性镍钛合金)、镍-铬合金、镍-铬-铁合金、钴合金、镍、钛、铂;或者可替代地,聚合物材料,例如高性能聚合物,或者其它合适材料,等。词语“镍钛合金(nitinol)”是由美国海军条例试验室(NOL)的一组研究人员所创造,这些研究人员首次观察到该材料的形状记忆性能。词语“镍钛合金(nitinol)”是包括用于镍的化学符号(Ni)和用于钛的化学符号(Ti)的缩写词,和标示海军条例试验室(NOL)的缩写词。
在一些实施例中,可用不透射线材料与支架的多个撑材、多个面向近侧的钩、和/或标记带加以混合、掺杂、涂覆,或者包含该不透射线材料。不透射线材料应被理解成是能够在医疗程序期间在荧光屏上或者另一种成像技术(例如X射线)产生相对较明亮图像的材料。该相对较明亮的图像帮助该器械的使用者确定其部位。合适的不透射线材料可包括但不限于:次碳酸铋、碘、金、铂、钯、钽、钨或钨合金,等。
在一些实施例中,膜或封闭元件可由以下材料构成或者包含:聚合物材料、金属或金属合金材料、金属-聚合物复合材料、其组合,等。在一些实施例中,膜或封闭元件优选地由以下材料所构成:聚对苯二甲酸乙二醇酯(PET)(如)、或者膨体聚四氟乙烯(ePTFE)。合适聚合物的其它例子可包括:聚氨酯、聚醚-酯(例如,从DSM工程塑料公司购得的)、聚酯(例如,从DuPont公司购得的)、线性低密度聚乙烯(例如)、聚酰胺(例如从Bayer公司购得的、或从Elf Atochem公司购得的)、弹性聚酰胺、聚酰胺/醚嵌段共聚物、聚醚-酰胺共聚物(例如,以商品名称购得的PEBA)、硅酮类、聚乙烯、Marlex高密度聚乙烯、聚四氟乙烯(PTFE)、聚醚醚酮(PEEK)、聚酰亚胺(PI)、和聚醚酰亚胺(PEI)、液晶聚合物(LCP)(单独地或与其它材料混合)。
在一些实施例中,输送导管和/或医用植入物可由提供平滑、光滑外表面的材料所制成、与其混合、用该材料进行涂覆,或者可包含该材料。在一些实施例中,输送导管和/或医用植入物可包括光滑涂层、亲水性涂层、疏水性涂层、药物洗脱材料、抗血栓涂层、或者基于预定用途或应用的其它合适的涂层,或者用这些材料进行涂覆。
应当理解的是,尽管以上描述的重点在于在患者血管系统内部所使用的医疗器械和方法,但根据本发明的医疗器械或方法的其它实施例也可以适合于且构造成使用于患者解剖结构的其它部分。例如,根据本发明的器械和方法可以适合于使用于消化道或胃肠道,例如口腔、咽喉、小肠和大肠、结肠、直肠等。例如,这些器械和方法可以适合于且构造成使用于呼吸道中,例如口、鼻、喉、支气管路、鼻路、肺等。类似地,本文中关于经皮布置所描述的装置和/或医疗器械视情况也可使用于其它类型的手术操作。例如,在一些实施例中,该医疗器械可用于非经皮手术,例如心脏直视手术。根据本发明的器械和方法也可以适合于且用于在解剖结构内部的其它用途。
应当理解的是,本发明在许多方面只是说明性的。可在不超出本发明范围的前提下在细节中作出变更,尤其是在形状、尺寸、和步骤的安排方面。当然,本发明的范围被限定于其中表述所附权利要求的用语中。
Claims (11)
1.一种医用植入物,包括:
构造成在收拢构型与扩张构型之间动作的支架;和
覆盖所述支架的至少一部分的封闭元件;
其中所述支架的近端形成大体管状部,所述管状部构造成附接到芯线的远端;
其中所述支架的所述大体管状部包括与之联接的螺纹插入物,
其中所述支架包括环形套管构件,所述环形套管构件至少部分地被设置在所述管状部的内部并且与之联接,所述螺纹插入物联接到所述环形套管构件,
其中所述螺纹插入物设置在所述环形套管构件的内部,且
其中所述封闭元件的一部分设置在所述螺纹插入物与所述环形套管构件之间,且其中所述封闭元件的外侧部分被定义为所述封闭元件的设置在所述环形套管构件的外侧的部分,其中在所述扩张构型中,所述封闭元件的外侧部分从所述螺纹插入物中径向向外设置。
2.如权利要求1所述的植入物,还包括将所述环形套管构件联接到所述支架的销元件。
3.如权利要求1所述的植入物,其中所述支架包括多个朝近侧的钩,在所述扩张构型中,所述钩绕所述支架的外周设置。
4.如权利要求1所述的植入物,其中将所述螺纹插入物设置在所述封闭元件的设置在所述环形套管构件外侧的一部分的远侧。
5.如权利要求1所述的植入物,其中所述芯线的远端包括螺纹构件,所述螺纹构件构造成与所述螺纹插入物相配合。
6.一种封闭植入系统,包括:
具有延伸经过其中的管腔的导管;
可滑动地且可旋转地设置在所述管腔内的芯线,所述芯线具有设置在其远端的螺纹构件;和
医用植入物,所述医用植入物具有可扩张支架、设置在所述可扩张支架上的封闭元件、和联接到所述可扩张支架的近端部的螺纹插入物;
其中所述螺纹构件可移除地联接到所述螺纹插入物,
其中所述可扩张支架包括环形套管构件,所述环形套管构件至少部分地被设置在所述可扩张支架的近端部并且与之联接,所述螺纹插入物联接到所述环形套管构件,
其中所述螺纹插入物设置在所述环形套管构件的内部,且
其中所述封闭元件的一部分设置在所述螺纹插入物与所述环形套管构件之间,且其中所述封闭元件的外侧部分被定义为所述封闭元件的设置在所述环形套管构件的外侧的部分,其中在所述可扩张支架的扩张构型中,所述封闭元件的外侧部分从所述螺纹插入物中径向向外设置。
7.如权利要求6所述的封闭植入系统,其中所述封闭元件的一部分设置在所述螺纹插入物与所述可扩张支架的近端部之间。
8.如权利要求6所述的封闭植入系统,其中所述封闭元件的一部分向所述螺纹插入物的近侧延伸。
9.如权利要求6所述的封闭植入系统,其中所述芯线包括设置在与所述螺纹构件的近端相邻位置的导向元件,所述导向元件构造成将所述芯线定心在所述导管之内。
10.如权利要求9所述的封闭植入系统,其中所述导向元件包括凸形的近侧表面和大体上为平的远侧表面。
11.如权利要求9所述的封闭植入系统,其中所述导向元件包括圆锥形的近侧表面和大体上为平的远侧表面。
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2019
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Also Published As
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CN107205743A (zh) | 2017-09-26 |
EP4349279A2 (en) | 2024-04-10 |
US20220346804A1 (en) | 2022-11-03 |
JP2017502788A (ja) | 2017-01-26 |
EP3094263A2 (en) | 2016-11-23 |
US20170303932A1 (en) | 2017-10-26 |
JP6268300B2 (ja) | 2018-01-24 |
US11413047B2 (en) | 2022-08-16 |
US20150196300A1 (en) | 2015-07-16 |
WO2015109235A3 (en) | 2015-09-17 |
US10463377B2 (en) | 2019-11-05 |
EP3094263B1 (en) | 2024-02-28 |
US9730701B2 (en) | 2017-08-15 |
US20200038033A1 (en) | 2020-02-06 |
WO2015109235A2 (en) | 2015-07-23 |
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