CN107296668A - 一种非覆膜血管支架及其释放方法 - Google Patents
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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Abstract
一种非覆膜血管支架,包括直接或由医用高分子缝合线、金属圈、高分子血管布一种或几种交替连接为一体的Z型支架和网格支架,支架表面无高分子覆膜材料。非覆膜血管支架为直筒型、膨出式结、或渐细型结构设计,具有优良的柔顺性和较好的径向支撑力,以便重塑血管真腔、减小假腔体积、促进假腔血栓的形成。该非覆膜血管支架采用前端后释放结构,可实现精确定位;该血管支架远端最后一节网格支架尾端的波谷处穿过一圈控制线,释放血管支架时放松控制线,回收血管支架时收紧控制线,可实现支架的回收。
Description
技术领域
本发明属于医疗器械领域,特别涉及一种无覆膜材料的微创介入血管支架,所述非覆膜血管支架可以在完全释放前全部回收,调整释放位置后再次进行释放。
背景技术
近年来随着腔内血管外科的快速发展,主动脉夹层腔内修复技术已成为B型主动脉夹层的主要治疗措施。
目前,市场上常见的覆膜支架一般采用120-200mm的覆膜长度设计,此种支架既可有效封堵B型主动脉夹层的第一破口,又能防止胸8-12椎体平面肋间动脉的封堵,减少造成截瘫的风险。但是对于假腔累及腹主动脉、髂动脉,如果出现真腔受压明显,或者已经出现脊髓或腹腔脏器供血障碍的病例,往往需要更长的支架来撑开被压缩的真腔以保证腹腔脏器和下肢的供血。另外,部分患者腹腔脏器分支血管以下远心端破口较大,导致远心端假腔术后持续扩张而无法有效形成血栓,进而形成远端瘤样扩张。对于上述问题,目前临床上一般采用在覆膜支架远心端再放置一个自膨式裸支架,能够保证对血管真腔的有效扩张,防止肋间动脉、腹腔干、肾动脉等分支血管的封堵,但此方式柔顺性不佳,会造成继发性血管损伤的危险。此外,对于髂静脉压迫综合症患者,因髂静脉受压或存在腔内异常粘连结构而引起下肢和盆腔静脉回流障碍性疾病,该疾病易导致下肢静脉高压,成为下肢静脉瓣膜功能不全和浅静脉曲张的原因之一,而且可继发下肢深静脉血栓形成(DVT),进而使髂股静脉长期处于闭塞状态。目前,静脉支架植入术是治疗髂静脉压迫综合症的有效方法,但是市场上的静脉支架是全网格支架,此种支架植入时存在定位不准确、发生轴向伸长、径向支撑力减小、引发髂股静脉再狭窄闭塞等诸多问题,同时此种支架释放后,不能回收调整释放位置,对医生临床经验要求较高。
发明内容
本发明的目的在于提供一种非覆膜血管支架,其可以改善一些假腔累及腹腔脏器动脉,且真腔受压明显患者的供血情况,同时也可以介入治疗髂股静脉狭窄闭塞,改善髂股静脉供血情况。为实现上述目的,本发明采取以下技术方案:
一种非覆膜血管支架,所述非覆膜血管支架1包括Z型支架2和网格支架3,所述非覆膜血管支架1表面无高分子覆膜材料;所述Z型支架2和网格支架3交替连接为一体;所述非覆膜血管支架1的近心端第一节为Z型支架2,远心端最后一节为网格支架3。
进一步,所述Z型支架2的波谷穿过相邻网格支架3的头端波峰直接连接,或Z型支架2的波谷与相邻网格支架3的头端波峰通过高分子血管布4、高分子缝合线5、金属圈的一种或多种进行连接。
进一步,所述高分子血管布4宽度为1-5mm。
进一步,所述非覆膜血管支架1为Z型支架2膨出式结构或网格支架3膨出式结构,当为Z型支架2膨出式结构时,单一或多个Z型支架2的直径大于相邻的网格支架3的直径,当为网格支架3膨出式结构时,单一或多个网格支架3的直径大于相邻的Z型支架2的直径。
进一步,Z型支架2膨出式结构的最大直径比相邻的网格支架3的直径大2-10mm;网格支架3膨出式结构的最大直径比相邻的Z型支架2的直径大2-10mm。
进一步,所述非覆膜血管支架1为渐细型结构,其其远心端最小处直径是近心端最大处直径的59%-99%。
进一步,所述非覆膜血管支架1远心端最后一节网格支架3尾端的波谷处穿过一圈控制线8,所述控制线8材料为高分子或金属。
进一步,所述Z型支架2所用材料为不锈钢丝或记忆合金丝,高度为4-20mm,波峰数量为5-10,丝材丝径0.1-0.5mm;所述网格支架3所用材料为记忆合金丝,高度为10-40mm,丝材丝径0.1-0.5mm。
本发明的目的还在于提供一种非覆膜血管支架的释放方法,其在完全释放前可以全部回收,调整释放位置后可再次进行释放。
覆膜血管支架1介入时,采用近心端后释放的方式,以增加其定位准确性,非覆膜血管支架1远心端的最后一节网格支架3尾端的波谷处穿过一圈控制线8,释放非覆膜血管支架1后撤输送器外鞘管9,并放松控制线8,使得非覆膜血管支架1整体扩张;当非覆膜血管支架1植入位置不合适时,收紧控制线8,使得最后一节网格支架3尾端收缩,进而进入外鞘管9,通过网格支架3收缩带动相邻Z型支架2进行收缩,进而实现非覆膜血管支架1的完全回收;当非覆膜血管支架1完全正确释放后,再撤出控制线8,使得控制线8完全脱离最后一节网格支架3,最后打开后释放机构10,将非覆膜血管支架1的第一节Z型支架2完全释放。
本发明的有益效果是:
1、较之全网格支架,本发明提供的非覆膜血管支架具有更好的径向支撑力、定位更加准确;
2、较之全金属切割支架,本发明提供的非覆膜血管支架具有更好的柔顺性,进而降低继发性血管损伤的危险;
3、本发明提供的非覆膜血管支架设计成膨出式结构,可以起到有效重塑真腔、减小假腔体积、增加假腔远期凝血等效果。
附图说明
图1是本发明的直筒型非覆膜血管支架的结构示意图;
图2是本发明的Z型支架膨出式非覆膜血管支架的结构示意图;
图3是本发明的网格支架膨出式非覆膜血管的结构示意图;
图4是本发明的渐细型非覆膜血管支架的结构示意图;
图5是B型主动脉夹层使用常规血管支架介入治疗后的示意图;
图6是B型主动脉夹层使用常规血管支架和Z型支架膨出式非覆膜血管支架进行介入治疗后的示意图;
图7是B型主动脉夹层使用常规血管支架、Z型支架膨出式和网格支架膨出式非覆膜血管支架进行介入治疗后的示意图;
图8是B型主动脉夹层使用常规血管支架介入治疗和渐细型非覆膜血管支架进行介入治疗后的示意图;
图9是髂股静脉狭窄闭塞示意图;
图10是髂股静脉植入本发明的非覆膜血管支架的示意图;
图11是本发明的非覆膜血管支架从输送器外鞘管释放的示意图;
图12是本发明的非覆膜血管支架从外鞘管释放后再回收的过程示意图;
图13是本发明的非覆膜血管支架完全释放的示意图。
附图标记说明
1-非覆膜血管支架,2-Z型支架,3-网格支架,4-高分子血管布,5-高分子缝合线,6-覆膜血管支架,7-髂股静脉,8-控制线,9-外鞘管,10-后释放机构。
具体实施方式
为使本发明实施的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行更加详细的描述。在附图中,自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。所描述的实施例是本发明一部分实施例,而不是全部的实施例。下面通过参考附图描述的实施例是示例性的,旨在用于解释本发明,而不能理解为对本发明的限制。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。下面结合附图对本发明的实施例进行详细说明。
为了更好的理解本发明,下面参照附图对本发明的优先实施例作进一步说明。
本发明中术语“近心端”是指沿血流方向靠近心脏的一端,“远心端”是指沿血流方向远离心脏的一端。
如图1-4所示,在本发明的一个宽泛实施例中,一种非覆膜血管支架1,包括Z型支架2、网格支架3,其中,
非覆膜血管支架1表面无高分子覆膜材料;
Z型支架2和网格支架3交替连接为一体,具体地,Z型支架2的波谷穿过相邻网格支架3的头端波峰直接连接,或者,通过连接材料进行连接;
上述交替连接的方式可增加支架整体的柔顺性,较之全网格支架具有更好的径向支撑力;
优选地,Z型支架2为不锈钢丝或记忆合金丝,高度为4-20mm,波峰数量为5-10,所用丝材丝径为0.1-0.5mm;
优选地,网格支架3为记忆合金丝,高度为10-40mm,所用丝材丝径为0.1-0.5mm;
所述连接材料可以选择高分子血管布4、高分子缝合线5、金属圈(未示出)中的一种或多种;
优选地,连接材料可以选择高分子血管布4,所述高分子血管布4宽度为1-5mm,此时,Z型支架2的波谷和相邻网格支架3的头端波峰通过高分子血管布4均匀缝合连接;
上述实施例中,非覆膜血管支架1的近心端第一节为Z型支架2,远心端最后一节支架为网格支架3;
上述实施例中,非覆膜血管支架1的Z型支架2和网格支架3各设置为5个;
应当意识到,上述仅是举例,可以根据实际需求选择任意合适的方式。
下面结合附图1-4对非覆膜血管支架1的几种优选实施例分别进行详细描述。
如图1所示,一种非覆膜血管支架1,所述非覆膜血管支架1为直筒型结构,Z型支架2和网格支架3直径相同;
如图2所示,一种非覆膜血管支架1,所述非覆膜血管支架1为Z型支架2膨出式结构,单一或多个Z型支架2的直径大于相邻的网格支架3的直径;
如图3所示,一种非覆膜血管支架1,所述非覆膜血管支架1为网格支架3膨出式结构,单一或多个网格支架3的直径大于相邻的Z型支架2的直径;
Z型支架2膨出式结构的最大直径比相邻的网格支架3的直径大2~10mm;
网格支架3膨出式结构的最大直径比相邻的Z型支架2的直径大2-10mm;
如图4所示,一种非覆膜血管支架1,所述非覆膜血管支架1为渐细型结构,其远心端最小处直径是近心端最大处直径的59%-99%。
下面结合图5-8,对B型主动脉夹层患者介入治疗方法进行详细描述。
如图5所示,对于假腔累及腹主动脉、髂动脉且真腔受压明显的B型主动脉夹层患者,可以先植入常规的覆膜血管支架6;
如图6-8所示,在所述覆膜血管支架6的远心端植入非覆膜血管支架1,使得非覆膜血管支架1与覆膜血管支架6有1-2节的重叠区,所述非覆膜血管支架1经过腹腔脏器动脉,既能保证腹腔脏器动脉具有良好的供血通路,又能重塑真腔、减小假腔体积、促进血栓的形成;
非覆膜血管支架1的第一节为Z型支架2,释放时与覆膜血管支架6的后两节Z型支架重叠,可以增加两血管支架的连接稳定性;最后一节支架为网格支架3,既便于非覆膜血管支架1释放后的再回收,又减小非覆膜血管支架1远心端的径向支撑力,降低继发性血管损伤的危险;
如图6和图7所示,设置膨出式结构的非覆膜血管支架1,可以有效起到重塑真腔、减小假腔体积、增加假腔远期凝血等效果;
如图8所示,设置渐细性结构的非覆膜血管支架1,可以顺应人体血管的自然形态,降低非覆膜血管支架1远心端的过度扩张。
下面结合图9和图10,对髂股静脉植入本发明的非覆膜血管支架1进行详细描述,即对于髂股静脉7狭窄闭塞的患者,可以植入非覆膜血管支架1,以扩展血管通路。
下面结合图11-13,对本发明的非覆膜血管支架1从输送器外鞘管9释放和回收过程进行详细描述。
所述非覆膜血管支架1远心端最后一节网格支架3尾端的波谷处穿过一圈控制线,释放非覆膜血管支架时放松控制线,回收非覆膜血管支架时收紧控制线,所述控制线材料为高分子或金属。
如图11所示,非覆膜血管支架1介入时,采用近心端后释放的方式,以增加其定位准确性,非覆膜血管支架1远心端的最后一节网格支架3尾端的波谷处穿过一圈控制线8,释放非覆膜血管支架1后撤输送器外鞘管9,并放松控制线8,使得非覆膜血管支架1整体扩张;
如图12所示,当非覆膜血管支架1植入血管位置不合适时,可以收紧控制线8,使得最后一节网格支架3尾端收缩,进而可以进入外鞘管9,通过网格支架3良好的收缩性带动相邻Z型支架2进行收缩,进而实现非覆膜血管支架1的完全回收;
如图13所示,当非覆膜血管支架1完全正确释放后,再撤出控制线8,使得控制线8完全脱离最后一节网格支架3,最后打开后释放机构10,将非覆膜血管支架1的第一节Z型支架2完全释放。
最后需要指出的是:以上实施例仅用以说明本发明的技术方案,而非对其限制。尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
Claims (9)
1.一种非覆膜血管支架,其特征在于,所述非覆膜血管支架(1)包括Z型支架(2)和网格支架(3),
所述非覆膜血管支架(1)表面无高分子覆膜材料;
所述Z型支架(2)和网格支架(3)交替连接为一体;
所述非覆膜血管支架(1)的近心端第一节为Z型支架(2),远心端最后一节为网格支架(3)。
2.根据权利要求1所述的非覆膜血管支架,其特征在于,所述Z型支架(2)的波谷穿过相邻网格支架(3)的头端波峰直接连接,或Z型支架(2)的波谷与相邻网格支架(3)的头端波峰通过高分子血管布(4)、高分子缝合线(5)、金属圈的一种或多种进行连接。
3.根据权利要求2所述的非覆膜血管支架,其特征在于,所述高分子血管布(4)宽度为1-5mm。
4.根据权利要求1所述的非覆膜血管支架,其特征在于,所述非覆膜血管支架(1)为Z型支架(2)膨出式结构或网格支架(3)膨出式结构,当为Z型支架(2)膨出式结构时,单一或多个Z型支架(2)的直径大于相邻的网格支架(3)的直径,当为网格支架(3)膨出式结构时,单一或多个网格支架(3)的直径大于相邻的Z型支架(2)的直径。
5.根据权利要求4所述的非覆膜血管支架,其特征在于,Z型支架(2)膨出式结构的最大直径比相邻的网格支架(3)的直径大2-10mm;网格支架(3)膨出式结构的最大直径比相邻的Z型支架(2)的直径大2-10mm。
6.根据权利要求1所述的非覆膜血管支架,其特征在于,所述非覆膜血管支架(1为渐细型结构,其其远心端最小处直径是近心端最大处直径的59%-99%。
7.根据权利要求1所述的非覆膜血管支架,其特征在于,所述非覆膜血管支架(1)远心端最后一节网格支架(3)尾端的波谷处穿过一圈控制线(8),所述控制线(8)材料为高分子或金属。
8.根据权利要求1所述的非覆膜血管支架,其特征在于,所述Z型支架(2)所用材料为不锈钢丝或记忆合金丝,高度为4-20mm,波峰数量为5-10,丝材丝径0.1-0.5mm;所述网格支架(3)所用材料为记忆合金丝,高度为10-40mm,丝材丝径0.1-0.5mm。
9.一种如权利要求1-8所述的非覆膜血管支架的释放方法,其特征在于,覆膜血管支架(1)介入时,采用近心端后释放的方式,以增加其定位准确性,非覆膜血管支架(1)远心端的最后一节网格支架(3)尾端的波谷处穿过一圈控制线(8),释放非覆膜血管支架(1)后撤输送器外鞘管(9),并放松控制线(8),使得非覆膜血管支架(1)整体扩张;当非覆膜血管支架(1)植入位置不合适时,收紧控制线(8),使得最后一节网格支架(3)尾端收缩,进而进入外鞘管(9),通过网格支架(3)收缩带动相邻Z型支架(2)进行收缩,进而实现非覆膜血管支架(1)的完全回收;当非覆膜血管支架(1)完全正确释放后,再撤出控制线(8),使得控制线(8)完全脱离最后一节网格支架(3),最后打开后释放机构(10),将非覆膜血管支架(1)的第一节Z型支架(2)完全释放。
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