CN112891018B - 管腔支架 - Google Patents
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- CN112891018B CN112891018B CN201911222571.9A CN201911222571A CN112891018B CN 112891018 B CN112891018 B CN 112891018B CN 201911222571 A CN201911222571 A CN 201911222571A CN 112891018 B CN112891018 B CN 112891018B
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- A—HUMAN NECESSITIES
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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
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Abstract
本发明公开了一种管腔支架,包括管状主体,以及连接在所述管状主体上的半释放装置,所述半释放装置包括限位杆,以及缠绕在所述管状主体外的束缚线,所述限位杆位于所述管状主体内,所述束缚线上设置有至少两个锁定部,所述至少两个锁定部以可分离的方式与所述限位杆连接,所述管状主体上设置有至少两个线孔,所述束缚线通过所述线孔进入所述管状主体内,当所述至少两个锁定部与所述限位杆连接时,所述限位杆与所述管状主体分离设置,所述束缚线对所述管状主体进行周向约束。通过将限位杆设置在管腔支架内,可避免限位杆在管腔支架定位调整的过程中损伤血管,降低限位杆的端部触碰血管发生折弯的风险,且不占用管腔支架与血管壁之间的调整空间。
Description
技术领域
本发明涉及介入医疗器械技术领域,尤其涉及一种管腔支架。
背景技术
近十余年来,主动脉覆膜支架腔内隔绝术已广泛应用于胸、腹主动脉的动脉瘤和动脉夹层等病变,其疗效确切、创伤小、恢复快、并发症少,已成为一线的治疗方法。手术时,在X线透视监视下,通过相应的输送***将覆膜支架送到病变位置,覆膜支架将血流与病变位置隔绝,消除血压对病变位置的影响,以达到治愈的目的。
为了解决覆膜支架在体内的定位问题,通常会在支架的关键位置做显影标记,利用显影标记对覆膜支架的轴向和周向进行定位。但是,当覆膜支架压缩在输送鞘管内时,其周向具有压缩褶皱,且轴向处于伸长状态,若此时通过显影标记定位,会存在较大的周向和轴向偏差。
发明内容
本发明要解决的技术问题在于,针对现有技术的上述缺陷,提供一种管腔支架。
本发明解决其技术问题所采用的技术方案是:
提供一种管腔支架,包括管状主体,以及连接在所述管状主体上的半释放装置,所述半释放装置包括限位杆,以及缠绕在所述管状主体外的束缚线,所述限位杆位于所述管状主体内,所述束缚线上设置有至少两个锁定部,所述至少两个锁定部以可分离的方式与所述限位杆连接,所述管状主体上设置有至少两个线孔,所述束缚线通过所述线孔进入所述管状主体内,当所述至少两个锁定部与所述限位杆连接时,所述限位杆与所述管状主体分离设置,所述束缚线对所述管状主体进行周向约束。
在本发明所述的管腔支架中,所述锁定部包括与所述限位杆连接的连接件,以及封堵所述线孔的封堵件。
在本发明所述的管腔支架中,所述半释放装置还包括限位环扣,所述限位环扣设置在所述管状主体的外表面。
在本发明所述的管腔支架中,所述管状主体包括多圈波形环状物,所述波形环状物包括多个波峰、多个波谷及多个分别连接相邻的所述波峰与所述波谷的连接杆;
所述限位环扣的数量为多个,在自然状态下,相邻的所述限位环扣的直线距离为e,所述限位环扣的固定点与位于所述限位环扣下方、且距所述限位环扣最近的波谷之间的垂直距离为f,e与f满足e≤2f。
在本发明所述的管腔支架中,所述限位杆的数量为至少两个。
在本发明所述的管腔支架中,所述线孔外覆盖有密封膜,所述密封膜与所述管状主体之间具有通道,所述束缚线通过所述通道进入所述管状主体内。
在本发明所述的管腔支架中,所述通道位于所述密封膜的远端。
在本发明所述的管腔支架中,所述束缚线为两端封闭的环状结构;或者,所述束缚线呈螺旋状缠绕在所述管状主体外。
在本发明所述的管腔支架中,所述束缚线上设置有固定部,所述束缚线通过所述固定部固定在所述管状主体的外表面。
在本发明所述的管腔支架中,所述管腔支架处于半释放状态时的横截面的外接圆直径与所述管腔支架完全展开时的横截面的外接圆直径的比值为0.6~0.8。
综上所述,实施本发明的一种管腔支架,具有以下有益效果:本申请通过在管腔支架上设置半释放装置,该半释放装置可以提高管腔支架的轴向和周向定位的准确性,并且将半释放装置的限位杆设置在管腔支架内,可避免限位杆在管腔支架定位调整的过程中损伤血管,降低限位杆的端部触碰血管发生折弯的风险,且不占用管腔支架与血管壁之间的调整空间,特别是对于腔内结构复杂的情况,利于管腔支架的调整定位。
附图说明
下面将结合附图及实施例对本发明作进一步说明,附图中:
图1是本发明实施例之一提供的管腔支架处于半释放状态时的示意图;
图2是图1所示管腔支架的俯视图;
图3是图1所示管腔支架的A部放大图;
图4是图1所示管腔支架完全展开时的示意图;
图5是图4所示管腔支架的俯视图;
图6是图1所示管腔支架的封堵件封堵线孔的示意图;
图7是图1所示管腔支架的束缚线越过波谷时的示意图;
图8是图1所示管腔支架的限位环扣的示意图;
图9是图1所示管腔支架的束缚线未越过波谷时的示意图;
图10是本发明实施例之二提供的管腔支架处于半释放状态时的示意图;
图11是图10所示管腔支架的俯视图;
图12是本发明实施例之二提供的管腔支架处于半释放状态时的示意图;
图13是图12所示管腔支架解除一级约束后的示意图;
图14是图12所示管腔支架解除二级约束后的示意图;
图15是本发明实施例之三提供的管腔支架处于半释放状态时的示意图;
图16是图15所示管腔支架的密封膜的示意图;
图17是本发明实施例之四提供的管腔支架处于半释放状态时的示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施的限制。
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明目的,并不表示是唯一的实施方式。
除非另有定义,本文所使用的所有技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的,不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
在介入医疗领域,通常定义管腔支架在释放后距心脏近的一端为近端,距心脏远的一端为远端。
请参阅图1,本申请实施例之一提供了一种管腔支架100,其包括裸支架,以及连接在裸支架上的覆膜102。管腔支架100为中空的管腔结构,管腔支架100的管腔构成血流流通的通道。
其中,裸支架采用具有良好生物相容性的材料制成,如镍钛、不锈钢等材料。覆膜102采用具有良好生物相容性的高分子材料制成,如PTFE、FEP、PET等。裸支架包括多圈波形环状物101(如图8所示),每圈波形环状物101包括多个波峰、多个波谷及多个分别连接相邻波峰与波谷的连接杆,多圈波形环状物101从近端到远端依次排布,优选为平行间隔排布。波形环状物101为闭合圆柱状结构,多圈波形环状物101间可以具有相同或相似的波形形状,可以理解的是,本实施例并不限定波形环状物101的具体结构,波形环状物101的波形可以根据需要设置,同时每圈波形环状物101中的波形个数以及波形高度均可根据需要设置。
请参阅图1,管腔支架100包括管状主体11,以及连接在管状主体11上、对管状主体11进行周向约束的半释放装置20。半释放装置20包括位于管状主体11内的限位杆21,以及缠绕在管状主体11外的束缚线22。
请参阅图1、图2和图3,束缚线22上设置有两个锁定部221,管状主体11上设置有两个与其内腔相连通的线孔111,束缚线22通过线孔111进入管状主体11内部、并使两个锁定部221与限位杆21以可分离的方式连接。当限位杆21与两个锁定部221连接时,限位杆21与管状主体11分离设置,束缚线22对管状主体11进行周向约束。请参阅图4和图5,当限位杆21与两个锁定部221分离时,限位杆21对锁定部221的束缚解除,束缚线22在管状主体11的径向支撑力的作用下从线孔111处向管状主体11的外表面运动,直至管状主体11完全展开。
本申请通过在管腔支架100上设置半释放装置20,当管腔支架100从输送鞘管中释放后,在该半释放装置20的约束下,管腔支架100处于半释放状态,此时管腔支架100与血管壁不贴合,操作者仍可对管腔支架100的轴向和周向位置进行调整,待定位准确后,再将半释放装置20的约束解除,使管腔支架100展开贴壁。
并且,本申请半释放装置20的限位杆21位于管腔支架100内,可避免限位杆21在管腔支架100定位调整的过程中损伤血管,降低限位杆21的端部触碰血管发生折弯的风险,且不占用管腔支架100与血管壁之间的调整空间,特别是对于腔内结构复杂的情况,利于管腔支架100的调整定位。
可以理解的是,若管腔支架100处于半释放状态时,其横截面的外接圆直径过大,则支架容易贴壁,不利于对其进行轴向和周向的调整;若管腔支架100处于半释放状态时,其横截面的外接圆直径过小,则半释放的作用不大,仍存在较大的周向和轴向的定位偏差。故,在本实施例中,管腔支架100处于半释放状态时的横截面的外接圆直径与管腔支架100展开时的横截面的外接圆直径的比值为0.6~0.8。
请再次参阅图3,锁定部221包括相连的连接件222和封堵件223,连接件222用于与限位杆21连接,封堵件223用于封堵线孔111。其中,连接件222优选为环扣结构或一根束缚线22对折形成的半圆环结构,限位杆21可从该环扣结构或半圆环结构中穿设。封堵件223的外接圆直径大于线孔111的孔径,封堵件223可以通过打结的方式形成。
请参阅图6,当管状主体11完全展开后,封堵件223堵在线孔111处,可避免线孔111处出现渗漏。优选的,当管状主体11完全展开后,束缚线22上仅封堵件223位于管腔支架100内,且堵在线孔111处,束缚线22上的其他部分完全撤离管腔支架100的腔内,从而避免束缚线22滞留在管腔支架100内导致血栓形成的风险。
请再次参阅图1,半释放装置20还包括限位环扣23,限位环扣23设置在管状主体11的外表面,束缚线22从限位环扣23中穿设,可使束缚线22均匀压缩管状主体11,提高支架整体定位的准确性。并且,当管腔支架100被压缩在输送鞘管内或束缚线22对管腔支架100的约束解除后,该限位环扣23还可避免束缚线22发生轴向移位。
请参阅图7,若两个限位环扣23的间距过长,当管腔支架100在输送鞘管内处于完全径向压缩状态时,束缚线22处于松散状态,两个限位环扣23之间的束缚线22会轴向移位,甚至越过波形环状物101的波谷并勾挂在该波谷上。当管腔支架100从输送鞘管中完全释放后,束缚线22钩挂在波形环状物101上,会导致管腔支架100无法正常展开。
请参阅图8和图9,在自然状态下(即管腔支架100完全释放时),相邻的两个限位环扣23的直线距离为e,限位环扣23的固定点与位于该限位环扣23下方、且距该限位环扣23最近的波谷之间的垂直距离为f,其中e与f满足e≤2f,以避免管腔支架100处于径向压缩状态时束缚线22越过波形环状物101的波谷。
在本实施例中,束缚线22的数量为多条,每条束缚线22为两端封闭的环状结构,多条束缚线22沿轴向间隔分布。束缚线22可以为抗拉伸性能强的柔性线,如聚酯缝合线等。束缚线22可以由单根柔性线组成,也可以由多根柔性线组成。限位环扣23均设置在波形环状物101上,不仅有利于径向压缩支架,还可降低束缚线22对覆膜的损伤风险。优选的,限位环扣23位于波形环状物101的连接杆的中部,以使波形环状物101的受力均匀。
本领域的普通技术人员应当知晓,本实施例的管腔支架仅用作举例,并不对本申请进行限制,本申请的植入物可以为任意的带裸支架的覆膜管腔支架,包括但不限于胸主动脉支架、腹主动脉支架、胸腹主动脉支架等。
请参阅图10和图11,本申请实施例之二提供了一种管腔支架100,其与实施例之一的管腔支架大体上相同,管腔支架100包括管状主体11,及连接在该管状主体11外表面的半释放装置20,半释放装置20包括位于管状主体11内的限位杆21,以及缠绕在管状主体11外的束缚线22。
实施例之二与实施例之一的不同之处在于,束缚线22上设置有三个锁定部221,管状主体11上设置有三个与其内腔相连通的线孔111,束缚线22通过线孔111进入管状主体11内部、并使三个锁定部221与限位杆21以可分离的方式连接。
本实施例通过设置多个锁定部221与线孔111,当限位杆21与锁定部221分离时,束缚线22可从多个线孔111处向管状主体11的外表面运动,使管腔支架100更加快速的展开贴壁。
可以理解的是,本申请并不限定锁定部221与线孔111的数量,只要锁定部221与线孔111的数量相对应,使每一个锁定部221对应一个线孔111即可。
请参阅图12、图13和图14,本申请实施例之三提供了一种管腔支架100,其与实施例之一的管腔支架大体上相同,管腔支架100包括管状主体11,及连接在该管状主体11外表面的半释放装置20,半释放装置20包括位于管状主体11内的限位杆21,以及缠绕在管状主体11外的束缚线22。
实施例之三与实施例之一的不同之处在于,限位杆21包括两个,分别为第一限位杆21a和第二限位杆21b。束缚线22上设置有四个锁定部221,管状主体11上设置有四个与其内腔相连通的线孔111,束缚线22通过线孔111进入管状主体11内部。其中,四个锁定部221中的两个锁定部221与第一限位杆21a以可分离的方式连接,四个锁定部221中的另外两个锁定部221与第二限位杆21b以可分离的方式连接。
本实施例通过设置至少两个限位杆21,可以对管腔支架100的半释放功能进行分级调节,一次定位准确后,解除一级约束,再进行二次定位,解除二级约束。
图12为管腔支架100从输送鞘管内释放后的示意图,此时两个限位杆21分别与四个锁定部221连接。图13为管腔支架100解除一级约束后的示意图,此时仅一个限位杆21与两个锁定部221连接。图14为管腔支架100解除二级约束后的示意图,此时两个限位杆21与四个锁定部221分离,管腔支架100完全展开。
请参阅图15和图16,本申请实施例之四提供了一种管腔支架100,其与实施例之一的管腔支架大体上相同,管腔支架100包括管状主体11,及连接在该管状主体11外表面的半释放装置20,半释放装置20包括位于管状主体11内的限位杆21,以及缠绕在管状主体11外的束缚线22。其中,束缚线22上设置有两个锁定部221,管状主体11上设置有两个与其内腔相连通的线孔111,束缚线22通过线孔111进入管状主体11内部、并使两个锁定部221与限位杆21以可分离的方式连接。
实施例之四与实施例之一的不同之处在于,线孔111外覆盖有密封膜112,以避免线孔111处出现渗漏。密封膜112连接在管状主体11上,密封膜112与管状主体11之间具有通道,束缚线22通过该通道进入管腔支架100内部。此时,锁定部221上可不设置封堵件,当管状主体11完全展开后,束缚线22可全部从管腔支架100的腔内撤离,避免部分束缚线22滞留在管腔支架100内导致血栓形成的风险。若锁定部221上设置有封堵件,当管状主体11完全展开后,封堵件位于密封膜112与管状主体11之间。
在图16所示的实施例中,密封膜112缝合在管状主体11的内表面,密封膜112的远端不缝合,使束缚线22从密封膜112的远端穿出,即通道位于密封膜112的远端。本实施例根据血流方向将通道设置在密封膜112的远端,有利于避免内漏,更好的实现封堵。
可以理解的是,在其它实施例中,密封膜112还可以覆盖在管状主体11的外表面,密封膜112还可以通过其他方式与管状主体11连接,如粘接等。
请参阅图17,本申请实施例之五提供了一种管腔支架100,其与实施例之一的管腔支架大体上相同,管腔支架100包括管状主体11,及连接在该管状主体11外表面的半释放装置20,半释放装置20包括位于管状主体11内的限位杆21,以及缠绕在管状主体11外的束缚线22。
实施例之五与实施例之一的不同之处在于,束缚线22呈螺旋状缠绕在管状主体11外,两个锁定部221分设在束缚线22的两端。管状主体11上设置有两个与其内腔相连通的线孔111,束缚线22通过线孔111进入管状主体11内部。
由于束缚线22呈螺旋状缠绕在管状主体11外,本实施例可通过一根束缚线22实现对整个管腔支架100的均匀压缩。
多个限位环扣23呈螺旋状分布在管状主体11的外表面,限位环扣23可限制束缚线22的轴向位置,保证束缚线22更好的实现对管腔支架100的螺旋均匀压缩。
束缚线22上还包括至少一个固定部24,束缚线22通过固定部221固定在管状主体11上,当束缚线22从全部限位环扣24中滑落时,该固定部221可避免束缚线22脱离管腔支架100进入下游血管。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (9)
1.一种管腔支架,包括管状主体,以及连接在所述管状主体上的半释放装置,所述半释放装置包括限位杆,以及缠绕在所述管状主体外的束缚线,其特征在于,所述限位杆位于所述管状主体内,所述束缚线上设置有至少两个锁定部,所述至少两个锁定部以可分离的方式与所述限位杆连接,所述管状主体上设置有至少两个线孔,所述束缚线通过所述线孔进入所述管状主体内;当所述至少两个锁定部与所述限位杆连接时,所述限位杆与所述管状主体之间存在间隙,所述束缚线设置在所述管状主体上的部分为带有至少两个缺口的圆环状,所述缺口与所述锁定部数量相等,且每个所述缺口与每个所述锁定部一一对应,所述束缚线对所述管状主体进行周向约束;
所述锁定部包括与所述限位杆连接的连接件,以及封堵所述线孔的封堵件,所述连接件为一根所述束缚线对折形成的半圆环结构,所述限位杆从所述半圆环结构中穿设。
2.根据权利要求1所述的管腔支架,其特征在于,所述半释放装置还包括限位环扣,所述限位环扣设置在所述管状主体的外表面。
3.根据权利要求2所述的管腔支架,其特征在于,所述管状主体包括多圈波形环状物,所述波形环状物包括多个波峰、多个波谷及多个分别连接相邻的所述波峰与所述波谷的连接杆;
所述限位环扣的数量为多个,在自然状态下,相邻的所述限位环扣的直线距离为e,所述限位环扣的固定点与位于所述限位环扣下方、且距所述限位环扣最近的波谷之间的垂直距离为f,e与f满足e≤2f。
4.根据权利要求1所述的管腔支架,其特征在于,所述限位杆的数量为至少两个。
5.根据权利要求1所述的管腔支架,其特征在于,所述线孔外覆盖有密封膜,所述密封膜与所述管状主体之间具有通道,所述束缚线通过所述通道进入所述管状主体内。
6.根据权利要求5所述的管腔支架,其特征在于,所述通道位于所述密封膜的远端。
7.根据权利要求1所述的管腔支架,其特征在于,所述束缚线为两端封闭的环状结构。
8.根据权利要求1所述的管腔支架,其特征在于,所述束缚线上设置有固定部,所述束缚线通过所述固定部固定在所述管状主体的外表面。
9.根据权利要求1所述的管腔支架,其特征在于,所述管腔支架处于半释放状态时的横截面的外接圆直径与所述管腔支架完全展开时的横截面的外接圆直径的比值为0.6~0.8。
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