CN105395297B - 血管支架及其输送球囊、植入系统 - Google Patents

血管支架及其输送球囊、植入系统 Download PDF

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CN105395297B
CN105395297B CN201510997585.3A CN201510997585A CN105395297B CN 105395297 B CN105395297 B CN 105395297B CN 201510997585 A CN201510997585 A CN 201510997585A CN 105395297 B CN105395297 B CN 105395297B
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intravascular stent
implant system
soft light
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CN105395297A (zh
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李雷
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Evans Technology (Beijing) Co., Ltd.
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Priority to US16/064,821 priority patent/US11026819B2/en
Priority to PCT/CN2016/102621 priority patent/WO2017107633A1/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/94Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • A61F2/945Stents retaining their form, i.e. not being deformable, after placement in the predetermined place hardenable, e.g. stents formed in situ
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823Stents, different from stent-grafts, adapted to cover an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0085Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
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Abstract

本发明公开了一种血管支架及其输送球囊、植入系统,血管支架包括柔性透光本体(1),所述柔性透光本体(1)具有可硬化通道(2),该可硬化通道(2)沿所述柔性透光本体(1)的周向和轴向布置,其中所述可硬化通道(2)用于填充液态光固化支撑物(3),该液态光固化支撑物(3)受光照后固化以对所述柔性透光本体(1)进行径向支撑。本发明创新地采用了液态的光固化材料在受光照后硬化为固定的材料特性,来对柔性透光本体进行径向支撑,通过沿周向和轴向延伸的可硬化通道,可以保证植入完成的血管支架具有较好的径向支撑能力,并且本发明提供的血管支架结构简单,植入方便并且相比金属支架成本较低。

Description

血管支架及其输送球囊、植入系统
技术领域
本发明涉及介入治疗医疗器械领域,具体地,涉及一种血管支架及其输送球囊、植入系统。
背景技术
血管支架的介入治疗在血管阻塞等心脑血管疾病的治疗中应用广泛。例如在主动脉等大血管中经常需要植入覆膜支架,以及其他小血管的金属支架等等。金属支架通过本身的结构实现径向支撑,而覆膜支架包括具有径向支撑作用的金属支架以及套设在金属支架外的柔性覆膜,从而通过金属支架的支撑力将柔性覆膜紧贴在血管壁上。其中金属支架的成本较高,比使得现有的覆膜支架成本也较高,并且不方便植入。
发明内容
本发明的目的是提供一种血管支架,用于输送该血管支架的输送球囊和用于植入该血管支架的植入系统,该血管支架的结构简单,在不设置金属支架的情况下具有有效的径向支撑效果,并且植入操作简单,成本较低。
为了实现上述目的,根据本发明的一个方面,提供一种血管支架,所述血管支架包括柔性透光本体,所述柔性透光本体具有可硬化通道,该可硬化通道沿所述柔性透光本体的周向和轴向布置,其中所述可硬化通道用于填充液态光固化支撑物,该液态光固化支撑物在光照后固化以对所述柔性透光本体进行径向支撑。
优选地,所述液态光固化支撑物为UV树脂。
优选地,所述可硬化通道为沿所述柔性透光本体的侧壁延伸的螺旋管状结构。
优选地,所述可硬化通道为沿所述柔性透光本体的侧壁布置的网状结构。
优选地,所述血管支架为主动脉血管支架。
优选地,所述柔性透光本体由聚偏氟乙烯材料制成。
根据本发明的另一方面,提供一种本发明提供的血管支架的输送球囊,包括球囊本体和为该球囊本体充气或充液的控制管路,所述球囊本体内设置有光源,并且所述球囊本体的侧壁由透光材料形成。
根据本发明的再一方面,提供一种血管支架的植入系统,该植入系统包括可释放地收纳所述血管支架的支架输送装置,所述血管支架为本发明提供的血管支架,所述植入系统包括照射该血管支架的光源,以及用于输送所述液态光固化支撑物的供液管,该供液管可解脱地连接在所述血管支架上。
优选地,所述支架输送装置为输送球囊,该输送球囊包括球囊本体和为该球囊本体充气或充液的控制管路,所述球囊本体内设置有所述光源,并且所述球囊本体的侧壁由透光材料形成。
优选地,所述植入系统还包括切管组件,该切管组件包括顶芯和切割丝,所述顶芯的远端面形成有切槽,所述切割丝的两端分别从所述切槽沿轴向可移动地贯穿该顶芯并从近端伸出,并且所述供液管从所述切割丝和所述切槽之间穿过。
通过上述技术方案,本发明创新地采用了液态的光固化材料在受光照后硬化为固定的材料特性,来对柔性透光本体进行径向支撑,通过沿周向和轴向延伸的可硬化通道,可以保证植入完成的血管支架具有较好的径向支撑能力,并且本发明提供的血管支架结构简单,植入方便并且相比金属支架成本较低。
本发明的其他特征和优点将在随后的具体实施方式部分予以详细说明。
附图说明
附图是用来提供对本发明的进一步理解,并且构成说明书的一部分,与下面的具体实施方式一起用于解释本发明,但并不构成对本发明的限制。在附图中:
图1是本发明实施方式提供的血管支架的结构示意图;
图2是图1的血管支架的剖视结构示意图。
图3是本发明实施方式提供的植入系统的结构示意图;
图4是本发明实施方式提供的输送球囊的结构示意图;
图5是本发明实施方式提供的切管组件的剖视结构示意图,其中供液管穿过切割丝;
图6是本发明实施方式提供的切管组件的端部示意图,其中供液管穿过切割丝,并且切割丝为剖视显示。
附图标记说明
1 柔性透光本体 2 可硬化通道
3 液态光固化支撑物 4 球囊本体
5 光源 6 光柱
7 发光LED 8 供液管
91 切槽 92 顶芯
93 切割丝 94 导引孔
具体实施方式
以下结合附图对本发明的具体实施方式进行详细说明。应当理解的是,此处所描述的具体实施方式仅用于说明和解释本发明,并不用于限制本发明。
在本发明中,在未作相反说明的情况下,使用的方位词如“远、近”是以进行血管支架植入治疗时的人体的介入点为基础定义的,即远离介入点的方向为远,接近介入点的方向为近。另外“内、外”是以相应对象轮廓的内和外定义的。
如图1和图2所示,本发明提供一种血管支架及其输送球囊、植入系统,其中,血管支架包括柔性透光本体1,柔性透光本体1具有可硬化通道2,该可硬化通道2沿柔性透光本体1的周向和轴向布置,其中可硬化通道2填充有液态光固化支撑物3,该液态光固化支撑物3具有在光照后固化的特性,从而能够对柔性透光本体1进行径向支撑。这样,在植入血管支架的过程中,柔性透光本体可以被压缩从而完成输送,而在输送到指定位置时,通过向柔性透光本体1中输送液态光固化支撑物3可以使得柔性透光本体1膨胀而与血管内壁贴合。然后通过光照透过柔性透光本体1来固化液态光固化支撑物3,从而起到对血管的径向支撑作用。
其中,该血管支架的应用领域可以与覆膜支架类似,特别可以作为主动脉血管支架使用。该柔性透光本体1可以采用与现有的覆膜支架的覆膜相同的材质,例如聚偏氟乙烯PVDF制成,此外还可以采用聚四氟乙烯PDFE等能够加工出具有柔性和透光性的柔性透光本体即可。另外本发明提供的血管支架类似于覆膜支架的应用领域外,也可以应用在普通金属支架领域,从而有效改善介入治疗的成本和效率。
这样,本发明创新地采用了光固化材料来对柔性透光本体进行径向支撑,通过沿周向和轴向延伸的可硬化通道,可以保证植入完成的血管支架具有较好的径向支撑能力,并且本发明提供的血管支架结构简单,植入方便并且成本较低。其中,在本发明实施方式中,能够具有上述特性的液态光固化支撑物3为UV树脂等各种能够在光照后固化的光固化材料,以实现本发明的目的。
另外,为了提供良好的径向支撑力,如图1所示,作为一种实施例,可硬化通道2可以为沿柔性透光本体1的侧壁延伸的螺旋管状结构。螺旋结构能够很好地轴向和周向延伸的特征,能够提供良好的径向支撑力。此外在其他实施例中,可硬化通道2为沿柔性透光本体1的侧壁布置的网状结构,同样能够提供良好的径向支撑力,其中所述网状结构可以通过两条以上的螺栓管状结构错开连接而成,或者通过多个环状管和轴向管相连而成。另外为了方便加入液态光固化支撑物3,网状结构的各个部分相互连通,这样可以便于通过一个加入口向网状结构中注入液态光固化支撑物3。
另外完成该血管支架的植入,即实现在柔性透光本体定位后的光固化过程,本发明提供的一种送该血管支架的输送球囊,如图3和图4所示,包括球囊本体4和用于为球囊本体4充液或充气的控制管路41,球囊本体4内设置有光源5,并且球囊本体4的侧壁由透光材料形成。这样,通过控制光源5的发光即可以通过球囊本体4的侧壁对柔性透光本体1进行照射,从而完成液态光固化支撑物3的固化。
在本实施方式中,如图4所示,光源5包括位于球囊本体4内的光柱6,该光柱6的外壁上布置有多个发光LED7,其中多个发光LED7的电源线可以在光柱6的内部和控制管路中延伸,从而在体外端实现对光源的控制。另外,在其他可能的实施方式中,只要尺寸允许,还可以在光柱6内容纳有微型电池和无线接收器。从而在充分利用空间的同时,可以在体外通过遥控器进行光源5的操作开闭,还可以采用有线的方式进行操作,此时相应的线路可以容纳在球囊的控制管路41中,该控制管路41可以用于输送气体或液体以实现球囊的膨胀。本实施方式中,球囊为二氧化碳充气球囊。
在本发明提供的血管支架的植入系统中,该植入系统包括可释放地收纳血管支架的支架输送装置,其中,该支架输送装置为任意可以将未充液态光固化支撑物3的柔性透光本体1输送到指定位置的输送装置,例如球囊等。此外为了完成支架定位后的液态光固化支撑物3的输送,植入系统还包括用于照射血管支架的光源5,以及用于输送液态光固化支撑物3的供液管8,并且该供液管8可解脱地连接在血管支架上。从而完成血管支架的输送、膨胀和固化,其中供液管8优选为两个,一个用于进液,一个用于出气,从而顺利完成液态光固化支撑物3的填充过程,在其他实施方式中,供液管8还可以为其他数量,只要能够完成液态光固化支撑物3的填充即可。另外,光源5可以以各种方式进入到指定位置以用于照射血管支架,其中在在本发明的优选实施方式中,输送装置和光源为一体结构,即输送装置为本发明提供的上述输送球囊,光源5置于球囊本体内,从而简化结构,便于操作以提升效率。
其中,在血管支架的植入完成后,需要将供液管8从血管支架上解脱,从而实现血管支架的内置。具体地,在本实施方式中,如图5和图6所示,本植入系统还包括切管组件,该切管组件包括顶芯92和切割丝93,顶芯的远端面形成有切槽91,切割丝的两端分别从切槽91沿轴向可移动地贯穿该顶芯92并从近端伸出,并且供液管8从切割丝93和切槽91之间穿过。这样,可以在顶芯92的远端面形成类似于铡刀的切管结构,通过控制切割丝93位于近端的两个端部,可以使得切割丝93将位于切槽91和切割丝93之间的供液管8切断。具体的工作过程如下:
在血管支架进行植入的过程中,可以首先将供液管8穿过切割丝93,并且顶芯92可以形成有导引孔94,该导引孔可以用于血管支架植入过程中的主体导丝穿过,从而可以控制顶芯92随血管支架的植入而移动到指定位置,在通过供液管8进行供液的过程中,切管组件不工作。而当供液结束后,可以控制切割丝朝向供液管8移动,并可以首先勒紧供液管8,使得该勒紧点没有液态光固化支撑物3,此时进行光照作业,待血管支架内部的光固化支撑物完全固化后,再进一步用力通过切割丝93在切槽的端面上将供液管8切断,从而完成供液管8和血管支架的解脱。
在其他实施方式中,还可以通过在血管支架上设置单向阀,并且在单向阀的进液口螺纹连接供液管8。这样,由于单向阀可以阻止液态光固化支撑物3外泄出柔性透光本体1,此时便可以通过在体外端旋拧供液管8而完成供液管8与血管支架的解脱,从而完成柔性透光本体1的固化。
以上结合附图详细描述了本发明的优选实施方式,但是,本发明并不限于上述实施方式中的具体细节,在本发明的技术构思范围内,可以对本发明的技术方案进行多种简单变型,这些简单变型均属于本发明的保护范围。
另外需要说明的是,在上述具体实施方式中所描述的各个具体技术特征,在不矛盾的情况下,可以通过任何合适的方式进行组合,为了避免不必要的重复,本发明对各种可能的组合方式不再另行说明。
此外,本发明的各种不同的实施方式之间也可以进行任意组合,只要其不违背本发明的思想,其同样应当视为本发明所公开的内容。

Claims (8)

1.一种血管支架的植入系统,该植入系统包括可释放地收纳所述血管支架的支架输送装置,其特征在于,所述植入系统还包括照射该血管支架的光源(5),以及用于输送所述液态光固化支撑物的供液管(8),该供液管可解脱地连接在所述血管支架上,所述血管支架包括柔性透光本体(1),所述柔性透光本体(1)具有可硬化通道(2),该可硬化通道(2)沿所述柔性透光本体(1)的周向和轴向布置,其中所述可硬化通道(2)用于填充液态光固化支撑物(3),该液态光固化支撑物在光照后固化以对所述柔性透光本体(1)进行径向支撑。
2.根据权利要求1所述的植入系统,其特征在于,所述液态光固化支撑物(3)为UV树脂。
3.根据权利要求1所述的植入系统,其特征在于,所述可硬化通道(2)为沿所述柔性透光本体(1)的侧壁延伸的螺旋管状结构。
4.根据权利要求1所述的植入系统,其特征在于,所述可硬化通道(2)为沿所述柔性透光本体(1)的侧壁布置的网状结构。
5.根据权利要求1所述的植入系统,其特征在于,所述血管支架为主动脉血管支架。
6.根据权利要求1所述的植入系统,其特征在于,所述柔性透光本体(1)由聚偏氟乙烯材料制成。
7.根据权利要求1所述的植入系统,其特征在于,所述支架输送装置为输送球囊,该输送球囊包括球囊本体(4)和为该球囊本体(4)充气或充液的控制管路(41),所述球囊本体(4)内设置有所述光源(5),并且所述球囊本体(4)的侧壁由透光材料形成。
8.根据权利要求1或7所述的植入系统,其特征在于,所述植入系统还包括切管组件,该切管组件包括顶芯(92)和切割丝(93),所述顶芯的远端面形成有切槽(91),所述切割丝的两端分别从所述切槽(91)沿轴向可移动地贯穿该顶芯(92)并从近端伸出,并且所述供液管(8)从所述切割丝(93)和所述切槽(91)之间穿过。
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