CN114010260B - 一种血管内切割支架 - Google Patents

一种血管内切割支架 Download PDF

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CN114010260B
CN114010260B CN202111350917.0A CN202111350917A CN114010260B CN 114010260 B CN114010260 B CN 114010260B CN 202111350917 A CN202111350917 A CN 202111350917A CN 114010260 B CN114010260 B CN 114010260B
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陈宏涛
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—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
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22081—Treatment of vulnerable plaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing

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  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgical Instruments (AREA)

Abstract

本发明公开了一种血管内切割支架，涉及医疗器械领域。所述血管内切割支架为记忆合金材质，由外层的主支架和内层的切割支架组成，主支架两侧为开环结构网格，中间为闭环结构网格，近端与推送杆连接，主支架上有切割窗口，其内边缘锐利；切割支架为闭环结构网格，纵截面呈双V形，近端焊接在主支架根部；所述切割支架的切割头与主支架紧密贴合，边缘锐利，切割支架在微导管释放和回收支架时可在主支架内前后移动。本血管内切割支架通过微导管驱动切割支架对附着于血管壁上的血栓和半脱落状态的血管内膜等赘生物进行切割去除。

Description

一种血管内切割支架
技术领域
本发明涉及医疗器械技术领域，尤其涉及一种具有切割功能的血管内治疗支架。
背景技术
脑梗死是我国最常见的疾病，具有高发病率、高患病率、高致残率的特点，且发病率逐年上升。现有的治疗方案中，静脉溶栓是急性期唯一被证实有效的药物治疗方法。但是静脉溶栓有继发出血的风险，对大血管堵塞导致的梗死再通率不到10％，且静脉注射溶栓的时间窗只有6小时。自从机械开通技术应用临床以来，已经取得了很好的效果，机械开通是根据血管造影确定血管闭塞位置，然后将微导管由微导丝送达血管栓塞位置，通过交换导丝将支架通过导入鞘送入微导管，到达血栓位置后，回撤微导管，使血管内切割支架释放，从而将血栓取出体外，或者通过抽吸导管将血栓吸出。
然而现有的血管内支架和抽吸导管对较为顽固的附壁血栓、斑块和半脱落状态的血管内膜等赘生物导致的血管重度狭窄和闭塞效果不佳，反复支架拉栓和抽吸还易引起栓子逃逸，损伤血管壁，导致血管出现夹层或破裂出血，从而造成更严重的后果。
因此，神经介入领域的医务人员迫切需要开发一种能够解决相关难题的血管内治疗装置，能对引起血管闭塞的相关因素进行去除。
发明内容
鉴于现有技术的上述缺陷，本发明所要解决的技术问题是：如何解决传统血管内治疗装置对重度狭窄、顽固的附壁血栓、斑块和半脱落状态的血管内膜等赘生物导致的血管堵塞无能为力的技术难题。
为实现上述目的，本发明提供了一种血管内切割支架，本支架材料为记忆合金，横截面为非封闭的圆形，由外层的主支架和内层的切割支架组成，主支架两侧为开环结构的网格，中间为闭环结构的网格，近端与推送杆连接，主支架中段有切割窗口，其支架框较粗，内边缘锐利。
进一步地，所述主支架两侧为开环结构网格，约占总长三分之一，网格小，中间为闭环结构网格，约占总长三分之二，大网格为切割窗，均等分布于支架切割段周围，支架框粗，网格前后缘及支架前后缘均有标记点，网格下边缘平直，边缘锐利。
进一步地，所述切割支架网格为闭环结构，长度为主支架三分之一左右，纵切面呈双V形，近端焊接在主支架根部；所述切割支架的近端与切割头处的直径最大，与主支架紧密贴合，切割头位置的支架框较粗，外边缘锐利，切割头远端部分直径变小，并具有适合相互切割的支撑结构，所述切割支架在微导管回收力的驱动下可在主支架内移动，切割支架远端部分直径呈锥形缩小，上述功能由制作时的工艺来保证。
与现有申请文件202010424509.4的“一种网格可调节的双层取栓支架”和202110491956.6的“一种血管内斑块切割装置”等相比，本发明至少具有如下独特的有益技术效果：本发明提供的切割支架，通过对金属网格的合理设计使其在传统取栓支架的基础上具有切割结构，既有普通支架的所有优点，又增加了对赘生物的去除功能，从而比较容易应对各种血管堵塞，且不明显增加介入手术的风险和难度，易于为临床医师接受。
申请文件202010424509.4只是单纯网格调节，既增加成本，对临床又没意义，因为支架取栓主要是靠金属网格嵌入血栓内固定血栓后取出，而不是改变网格大小；申请文件202110491956.6的血管内斑块切割装置是金属杆式的推拉刀片，只适合血管外科的局部应用，与本方案差别很大。
因此，本发明具有如下独特的有益技术效果：本发明提供的血管内切割支架，通过对金属网格的合理设计使其在传统血管内支架的基础上具有切割结构，既有普通支架的所有优点，又增加了对血管壁赘生物和附壁血栓去除功能，从而比较容易应对各种血管堵塞，且不明显增加介入手术的风险和难度，易于为临床医师接受。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果，附图大小及各部分比例仅作为技术原理的展示，并非实际产品的缩图。
附图说明
图1是支架的侧面及内部结构示意图；
图2是主支架侧面结构示意图；
图3是支架中段横切面示意图
其中：1-主支架；2-主支架切割窗；3-切割支架切割头；4-切割支架；5-切割支架固定端； 6-支架推送杆；7-主支架开环网格；8-主支架闭环网格。
具体实施方式
以下参考说明书附图介绍本发明的一个实施例的使用，使其技术内容更加清楚和便于理解，描述中的远端背离术者，近端靠近术者。
如图1-1所示，本发明中所涉及的血管内切割支架由记忆合金制成，热定型后具有一定的自膨胀能力，能被压握成细束并在释放后恢复为网筒结构。本实施例血管内切割支架的网格均为菱形，由外层的主支架1和内层的切割支架4组成。主支架两侧为开环结构，有利于与血管壁充分融合并固主支架，中间为闭环结构，切割窗所在的网线粗，网格下边缘平直，边缘锐利，以上特点使其有利于较大血栓或血管赘生物等进入，径向支撑力强可帮助切割动作完成，网格前后缘及支架前后缘均有标记点，方便术中查看支架位置，切割支架为闭环结构，切割头与主支架紧密贴合，其网格形状与主支架网格配合成剪刀型，网格粗，网格上边缘平直，边缘锐利，以上特点使其径向支撑力强，有利于切割动作完成。
本支架的主要使用过程如下：血管内切割支架平时放于输送管内，术者在介入手术中通过输送管和微导管将血管内切割支架送至血管堵塞处，查看标记点处于血栓两侧后，释放支架，停留3分钟后，推动微导管以完成两支架的切割动作后拉出，推动微导管同时，术者在外用注射器通过颅内血管支撑导管进行抽吸，以吸出脱落血栓。如拉出不顺利，则再次释放支架完成二次切割，再次造影，如果血管复通良好，结束手术，如果仍无明显改善，检查支架性能完好后再次重复上述步骤，并通过标记点适当调整支架位置和角度，使血栓或赘生物位于可切割的最佳位置，再次推拉切割支架，直至血管复通成功，如果推拉切割支架阻力大，则更换位置再试，如仍无法完成切割，则放弃手术撤出。
以上详细描述了本发明的一个实施例。容易理解，本领域的技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化,比如改变网格形状，将切割支架外形由V型改为弧形，在支架最前端增加防栓子逃逸网格等。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者合理想象可以得到的技术方案，皆在权利要求书所确定的保护范围内。

Claims (1)

1.一种血管内切割支架，其特征在于，所述血管内切割支架为记忆合金材质，由外层的主支架和内层的切割支架组成，所述切割支架在微导管驱动下可在主支架内前后移动；主支架与切割支架同轴，横截面为半封闭的圆形；主支架两侧为开环结构的网格，中间为闭环结构的网格，近端与推送杆连接，主支架中段有切割窗口，其支架框较粗，内边缘锐利；切割支架为闭环结构网格，纵切面呈双V形，近端焊接在主支架根部；所述切割支架的近端与切割头处的直径最大，与主支架紧密贴合，切割头位置的支架框较粗，外边缘锐利，切割支架远端部分直径呈锥形缩小。
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CN209548046U (zh) * 2018-02-11 2019-10-29 南京普微森医疗科技有限公司 一种编织支架系统
CN111973325A (zh) * 2020-08-13 2020-11-24 首都医科大学附属北京天坛医院 一种颅内动脉斑块回收切割支架

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US8876882B2 (en) * 2003-10-10 2014-11-04 Mark Gelido Barongan Cutting stent
WO2018161959A1 (zh) * 2017-03-10 2018-09-13 上海心玮医疗科技有限公司 一种取栓器系统

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Publication number Priority date Publication date Assignee Title
CN209548046U (zh) * 2018-02-11 2019-10-29 南京普微森医疗科技有限公司 一种编织支架系统
CN111973325A (zh) * 2020-08-13 2020-11-24 首都医科大学附属北京天坛医院 一种颅内动脉斑块回收切割支架

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