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CN113974766B - Thrombolysis catheter - Google Patents

Thrombolysis catheter Download PDF

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Publication number
CN113974766B
CN113974766B CN202111270425.0A CN202111270425A CN113974766B CN 113974766 B CN113974766 B CN 113974766B CN 202111270425 A CN202111270425 A CN 202111270425A CN 113974766 B CN113974766 B CN 113974766B
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thrombus
cavity
tube
sheath
dense mesh
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CN113974766A (en
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葛泉波
陆信武
叶开创
吴常生
裴强
张壮利
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Shanghai Weiyu Medical Technology Co ltd
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Leo Medical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065Functions of balloons
    • A61B2017/22067Blocking; Occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明提供一种取栓导管,其包括:阻断鞘、扩张器和取栓器;阻断鞘包括鞘管,鞘管的远端设有球囊,近端设有开口部,鞘管内设有至少两个腔体,第一腔体的远端与所述球囊的内腔相连通,第二腔体与开口部轴向相通;扩张器可从开口部伸入鞘管的第二腔体内;取栓器可从手柄的开口部伸入第二腔体内,其包括同轴套设的外管和内管,以及密网状取栓件,密网状取栓件一端与内管的远端相连,密网状取栓件另一端与外管的远端相连,抽拉内管可使密网状取栓件膨胀或松弛。本发明的取栓导管可有效提升血栓清除率和降低失血量。

The present invention provides a thrombus removal catheter, which includes: a blocking sheath, a dilator and a thrombus removal device; the blocking sheath includes a sheath tube, a balloon is provided at the distal end of the sheath tube, an opening is provided at the proximal end, at least two cavities are provided in the sheath tube, the distal end of the first cavity is connected to the inner cavity of the balloon, and the second cavity is axially connected to the opening; the dilator can extend into the second cavity of the sheath tube from the opening; the thrombus removal device can extend into the second cavity from the opening of the handle, and includes a coaxially sleeved outer tube and an inner tube, and a dense mesh thrombus removal device, one end of the dense mesh thrombus removal device is connected to the distal end of the inner tube, and the other end of the dense mesh thrombus removal device is connected to the distal end of the outer tube, and pulling the inner tube can expand or relax the dense mesh thrombus removal device. The thrombus removal catheter of the present invention can effectively improve the thrombus removal rate and reduce blood loss.

Description

取栓导管Embolectomy catheter

本分案申请的母案申请日为2018年1月19日,申请号为201810052511.6,发明名称为“取栓导管以及用于取栓导管的取栓器”。The filing date of the parent application of this divisional application is January 19, 2018, the application number is 201810052511.6, and the name of the invention is "Thrombectomy catheter and thrombectomy device for thrombectomy catheter".

技术领域Technical Field

本发明涉及一种取栓技术领域,特别是涉及一种取栓导管。The present invention relates to the technical field of thrombus removal, and in particular to a thrombus removal catheter.

背景技术Background technique

血栓栓塞性疾病包括动脉栓塞、动脉血栓形成以及静脉血栓栓塞症,现有的治疗方法主要包括血管切开取栓术、导管接触性溶栓术和经皮穿刺机械吸栓术,切开取栓术需要解剖分离并切开血管,如股动脉、股静脉或肱动脉切开等,随着腔内介入技术的发展和材料的革新,这一开放性手术方式逐步被微创介入腔内治疗取代,也就是导管接触性溶栓术和经皮穿刺机械吸栓术,导管接触性溶栓术由于溶栓药物出血风险高,手术适应症极其严格,很大一部分患者具有导管接触性溶栓的禁忌症,因此很多患者并不能从中获益。Thromboembolic diseases include arterial embolism, arterial thrombosis and venous thromboembolism. Existing treatment methods mainly include vascular embolectomy, catheter-directed thrombolysis and percutaneous mechanical thrombectomy. Open embolectomy requires anatomical separation and vascular incision, such as femoral artery, femoral vein or brachial artery incision. With the development of intravascular interventional technology and the innovation of materials, this open surgical method has gradually been replaced by minimally invasive interventional intravascular treatment, namely catheter-directed thrombolysis and percutaneous mechanical thrombectomy. Catheter-directed thrombolysis has a high risk of bleeding due to thrombolytic drugs and extremely strict surgical indications. A large proportion of patients have contraindications to catheter-directed thrombolysis, so many patients cannot benefit from it.

支架型取栓术是新近出现的一种机械取栓方法,这种方法即是在医疗影像学技术的辅助下,经导管将支架型取栓器送至血管栓塞处并令其释放,支架型取栓器自行展开,并依靠自身的扩张力与血栓嵌合,然后回收取栓器,将血栓带出。Stent-type thrombectomy is a recently emerged mechanical thrombectomy method. With the assistance of medical imaging technology, this method delivers a stent-type thrombectomy device to the site of vascular embolism via a catheter and releases it. The stent-type thrombectomy device unfolds on its own and relies on its own expansion force to engage with the thrombus. The thrombectomy device is then retrieved and the thrombus is removed.

中国发明专利CN103417257B公开了一种颅内血管取栓导管,该取栓导管的螺旋形网环单元的分布密度不同,远端分布较密,而近端分布则相对稀疏,可以有效防止小血栓脱落。中国发明专利CN103997976A公开了一种具有细长轴线和圆周的取栓笼,包括共同限定多个开放单元的细长构件,该取栓笼可以有效的移除栓塞。中国发明专利CN105726088A公开了一种血栓取出装置,包括网状的自膨式的支架和芯丝,支架膨胀状态为圆筒形,近端具有开口,远端封闭,该血栓取出装置可将血栓均匀嵌挂于支架轴向网孔,产生的血栓碎片通过支架近端开口进入其内部,并被封闭的远端收集。Chinese invention patent CN103417257B discloses an intracranial vascular thrombectomy catheter, the spiral mesh ring units of which have different distribution densities, with denser distribution at the distal end and relatively sparse distribution at the proximal end, which can effectively prevent small thrombi from falling off. Chinese invention patent CN103997976A discloses a thrombectomy cage with a slender axis and a circumference, including slender components that together define a plurality of open units, and the thrombectomy cage can effectively remove emboli. Chinese invention patent CN105726088A discloses a thrombus removal device, including a mesh self-expanding stent and a core wire, the stent is cylindrical in the expanded state, has an opening at the proximal end, and is closed at the distal end, the thrombus removal device can evenly embed the thrombus in the axial mesh of the stent, and the generated thrombus fragments enter the interior through the proximal opening of the stent and are collected by the closed distal end.

如上所述,目前的支架型取栓器或取栓导管由于结构所限,单纯采用稀疏支架杆抓捕血栓或负压抽吸的方式,并拉动血栓将血栓带出体外,但是在取栓时,支架型取栓器或取栓导管作用在血栓上的力不均匀,血栓容易从取栓器上脱落,或是产生血栓碎块堵塞远端血管,或者进入其他血管处,长时间的负压也会导致失血量过多。另外,目前的支架型取栓器或取栓导管对于对陈旧性血栓以及大范围栓塞效果不佳。基于已有医学认知,深静脉血栓形成往往容量大,急性期血栓质感柔软易碎;动脉血栓形成往往容量小,急性期血栓质感柔软,陈旧性血栓往往粘附在血管壁上。目前稀疏结构的支架型取栓导管通常是针对动脉血栓而开发,对于大容量静脉血栓形成往往效果不理想。因此,需要一种易于取栓的取栓导管。As mentioned above, due to structural limitations, the current stent-type thrombectomy device or thrombectomy catheter simply uses a sparse stent rod to capture the thrombus or negative pressure suction, and pulls the thrombus to bring the thrombus out of the body. However, when removing the thrombus, the force exerted by the stent-type thrombectomy device or thrombectomy catheter on the thrombus is uneven, and the thrombus is easy to fall off the thrombectomy device, or thrombus fragments are generated to block the distal blood vessels, or enter other blood vessels. Long-term negative pressure will also lead to excessive blood loss. In addition, the current stent-type thrombectomy device or thrombectomy catheter is not effective for old thrombi and large-scale embolism. Based on existing medical knowledge, deep vein thrombosis often has a large volume, and the acute thrombus is soft and fragile; arterial thrombosis often has a small volume, and the acute thrombus is soft, and old thrombi often adhere to the blood vessel wall. At present, the sparsely structured stent-type thrombectomy catheter is usually developed for arterial thrombi, and the effect is often not ideal for large-volume venous thrombosis. Therefore, a thrombectomy catheter that is easy to remove thrombi is needed.

发明内容Summary of the invention

鉴于以上所述现有技术的缺点,本发明的目的在于提供一种取栓导管,用于解决现有技术中支架取栓器使用时血栓脱落外溢及失血过多的问题。In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide a thrombus removal catheter for solving the problems of thrombus shedding and excessive bleeding when using the stent thrombus removal device in the prior art.

为实现上述目的及其他相关目的,本发明提供一种取栓导管,其包括:To achieve the above objectives and other related objectives, the present invention provides a thrombectomy catheter, which includes:

阻断鞘,包括鞘管,所述鞘管的远端设有球囊,所述鞘管的近端设有开口部;所述鞘管内设有至少两个轴向延伸的腔体,第一腔体的远端与所述球囊的内腔相通,第二腔体与所述开口部轴向相通;The blocking sheath comprises a sheath tube, wherein a balloon is arranged at the distal end of the sheath tube, and an opening is arranged at the proximal end of the sheath tube; at least two axially extending cavities are arranged in the sheath tube, wherein the distal end of the first cavity is communicated with the inner cavity of the balloon, and the second cavity is axially communicated with the opening;

扩张器,所述扩张器可从所述开口部伸入所述第二腔体内,所述扩张器的远端从所述第二腔体内穿出并且将其封堵;a dilator, the dilator being extendable from the opening into the second cavity, the distal end of the dilator passing through the second cavity and blocking the second cavity;

取栓器,包括同轴套设的外管和内管,以及可膨胀的密网状取栓件,所述内管可相对外管沿轴向移动,所述密网状取栓件一端与所述内管的远端相连,所述密网状取栓件另一端与所述外管的远端相连,抽拉所述内管可使所述密网状取栓件膨胀或松弛;所述取栓器可从所述开口部伸入所述第二腔体内,所述外管的远端从所述第二腔体内穿出,所述外管的近端外露于所述开口部的外侧。The thrombus remover comprises an outer tube and an inner tube which are coaxially sleeved, and an expandable dense mesh thrombus remover. The inner tube can move axially relative to the outer tube, one end of the dense mesh thrombus remover is connected to the distal end of the inner tube, and the other end of the dense mesh thrombus remover is connected to the distal end of the outer tube. Pulling the inner tube can expand or relax the dense mesh thrombus remover. The thrombus remover can be extended into the second cavity from the opening, the distal end of the outer tube passes through the second cavity, and the proximal end of the outer tube is exposed outside the opening.

优选的,所述鞘管的近端连设手柄,所述开口部设置于所述手柄上;所述第一腔体将所述球囊的内腔和连设在所述手柄上的球囊充盈接头相连通;所述第二腔体的近端与连设在手柄上的负压抽吸装置相连通。Preferably, the proximal end of the sheath is connected to a handle, and the opening is arranged on the handle; the first cavity connects the inner cavity of the balloon and the balloon filling connector connected to the handle; the proximal end of the second cavity is connected to the negative pressure suction device connected to the handle.

优选的,所述手柄的开口部处设有连接卡扣,所述扩张器的近端连设一手持部,手持部上设有与所述连接卡扣配合固定的连接部。Preferably, a connecting buckle is provided at the opening of the handle, a hand-held portion is connected to the proximal end of the expander, and a connecting portion that cooperates and is fixed with the connecting buckle is provided on the hand-held portion.

优选的,所述扩张器的外径与所述第二腔体的内径相匹配。Preferably, the outer diameter of the expander matches the inner diameter of the second cavity.

优选的,所述扩张器采用热塑性弹性体制成,且热塑性弹性体内填充有含显影剂材质硫酸钡、氧化铋或氯氧化铋。Preferably, the expander is made of a thermoplastic elastomer, and the thermoplastic elastomer is filled with a developer-containing material such as barium sulfate, bismuth oxide or bismuth oxychloride.

优选的,所述密网状取栓件由超弹记忆镍钛合金丝混合铂铱合金丝、黄金丝或不锈钢丝编织而成,铂铱合金丝、黄金丝或不锈钢丝用于X光机下显影。Preferably, the dense mesh thrombus removal member is woven from superelastic memory nickel-titanium alloy wire mixed with platinum-iridium alloy wire, gold wire or stainless steel wire, and the platinum-iridium alloy wire, gold wire or stainless steel wire is used for development under an X-ray machine.

优选的,所述外管的近端连设一手持件,且所述手持件上设有锁定所述内管的定位部。Preferably, a hand piece is connected to the proximal end of the outer tube, and a positioning portion for locking the inner tube is provided on the hand piece.

优选的,所述内管的两端均外露于所述外管的两端之外,所述内管的近端连设有抽拉手柄。Preferably, both ends of the inner tube are exposed outside the two ends of the outer tube, and the proximal end of the inner tube is connected to a pull-out handle.

优选的,所述鞘管、所述内管和所述外管均采用聚酰胺类热塑性弹性体制成。Preferably, the sheath tube, the inner tube and the outer tube are all made of polyamide thermoplastic elastomer.

优选的,所述鞘管、所述内管的远端为锥形。Preferably, the distal ends of the sheath tube and the inner tube are tapered.

如上所述,本发明的取栓导管,具有以下有益效果:通过鞘管远端的球囊充盈来阻断血流,实现将血栓围在密网状取栓件和球囊之间,易于取栓,同时密网状取栓件可使血液通过其上网孔,在进行取栓操作时可以有效避免血栓栓子在取出过程中向其他部位血管的外溢,密网状取栓件和阻断球囊取栓的同时配合负压抽吸将失血量降至最低限度;取栓器具有尖端较细的内管和管身较细的外管,可以到达血栓更深的位置;适合大中型血管的取栓,包括相对陈旧性病变,特别适合用于对肢体上的血栓进行吸取,如静脉中容量较大的血栓;本发明的取栓导管为无源取栓器械,成本低,操作简单,可大幅降低取栓手术费用。As described above, the thrombus removal catheter of the present invention has the following beneficial effects: blood flow is blocked by filling the balloon at the distal end of the sheath, so that the thrombus is surrounded by the dense mesh thrombus removal component and the balloon, which makes it easy to remove the thrombus. At the same time, the dense mesh thrombus removal component allows blood to pass through the mesh holes on it, which can effectively prevent the thrombus from overflowing to other blood vessels during the thrombus removal process. The dense mesh thrombus removal component and the blocking balloon can simultaneously cooperate with negative pressure suction to reduce the blood loss to a minimum. The thrombus removal device has an inner tube with a thinner tip and an outer tube with a thinner body, which can reach deeper positions of the thrombus. It is suitable for thrombus removal of large and medium-sized blood vessels, including relatively old lesions, and is particularly suitable for absorbing thrombi on limbs, such as thrombi with larger volumes in veins. The thrombus removal catheter of the present invention is a passive thrombus removal device with low cost and simple operation, which can greatly reduce the cost of thrombus removal surgery.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

图1显示为本发明的扩张器插设在阻断鞘内的示意图。FIG. 1 is a schematic diagram showing the dilator of the present invention being inserted into a blocking sheath.

图2显示为沿图1中AA线的截面图。FIG. 2 is a cross-sectional view taken along line AA in FIG. 1 .

图3显示为本发明的阻断鞘示意图。FIG. 3 is a schematic diagram of a blocking sheath according to the present invention.

图4显示为本发明的扩张器示意图。FIG. 4 is a schematic diagram of a dilator according to the present invention.

图5显示为本发明的取栓器示意图。FIG. 5 is a schematic diagram of the thrombus remover of the present invention.

图6显示为沿图5中BB线的剖视图。FIG. 6 is a cross-sectional view taken along line BB in FIG. 5 .

图7显示为本发明的取栓器穿设在阻断鞘内且为松弛状态的示意图。FIG. 7 is a schematic diagram showing the thrombus remover of the present invention being inserted into the blocking sheath and in a relaxed state.

图8显示为本发明的取栓器穿设在阻断鞘内且为膨胀状态的示意图。FIG. 8 is a schematic diagram showing the thrombus remover of the present invention being inserted into the blocking sheath and in an expanded state.

元件标号说明:Component number description:

1 扩张器1 Dilator

2 显影标记2 Development Mark

3 球囊3 Balloon

4 鞘管4 Sheath

5 负压抽吸装置5 Negative pressure suction device

6 手柄6 Handle

7 球囊充盈接头7 Balloon inflation connector

8 手持部8 Handheld

9 二通9 Two-way

10 连接管10 Connecting pipe

11 连接卡扣11 Connection buckle

12 连接部12 Connection

121 凹口121 Notch

13 密网状取栓件13 dense mesh thrombus remover

14 外管14 Outer tube

15 手持件15 Handpiece

16 内管16 Inner tube

17 抽拉手柄17 Pull-out handle

具体实施方式Detailed ways

以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

请参阅图1至图8。须知,本说明书所附图中所绘示的结构、比例、大小等,均仅用以配合说明书所揭示的内容,以供熟悉此技术的人士了解与阅读,并非用以限定本发明可实施的限定条件,故不具技术上的实质意义,任何结构的修饰、比例关系的改变或大小的调整,在不影响本发明所能产生的功效及所能达成的目的下,均应仍落在本发明所揭示的技术内容所能涵盖的范围内。同时,本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语,亦仅为便于叙述的明了,而非用以限定本发明可实施的范围,其相对关系的改变或调整,在无实质变更技术内容下,当亦视为本发明可实施的范畴。Please refer to Figures 1 to 8. It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. The change or adjustment of their relative relationship should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

为便于描述,本说明书中取栓导管沿其长度方向,在使用时,远离操作者的一端定义为远端,操作者手持的一端为近端。For ease of description, in this specification, the end of the embolectomy catheter along its length, when in use, that is away from the operator is defined as the distal end, and the end held by the operator is defined as the proximal end.

如图1至图8所示,本发明提供一种取栓导管,其包括:As shown in FIGS. 1 to 8 , the present invention provides a thrombectomy catheter, which includes:

阻断鞘,见图3所示,包括鞘管4,鞘管4的远端设有球囊3,优选的,鞘管4的近端连设手柄6;鞘管4内设有至少两个轴向延伸的腔体,第一腔体的远端与所述球囊3的内腔相通,优选的,第一腔体的近端与连设在手柄6上的球囊充盈接头7相通,优选的,在球囊3两侧的鞘管4上设有显影标记2;优选的,第二腔体的近端与连设在手柄6上的负压抽吸装置5相连通,并且所述手柄6上还设有与所述第二腔体轴向相通的开口部;The blocking sheath, as shown in FIG3 , comprises a sheath tube 4, a balloon 3 is provided at the distal end of the sheath tube 4, and preferably, a handle 6 is connected to the proximal end of the sheath tube 4; at least two axially extending cavities are provided in the sheath tube 4, the distal end of the first cavity is communicated with the inner cavity of the balloon 3, preferably, the proximal end of the first cavity is communicated with the balloon filling joint 7 connected to the handle 6, preferably, developing marks 2 are provided on the sheath tube 4 on both sides of the balloon 3; preferably, the proximal end of the second cavity is communicated with the negative pressure suction device 5 connected to the handle 6, and the handle 6 is also provided with an opening portion axially communicated with the second cavity;

扩张器1,优选的,扩张器1的外径与所述鞘管4的第二腔体内径匹配,可从所述手柄6的开口部伸入所述鞘管4的第二腔体内,扩张器1的远端从鞘管4的第二腔体内穿出并且将鞘管4的第二腔体封堵;The dilator 1 preferably has an outer diameter that matches the inner diameter of the second cavity of the sheath tube 4, and can be inserted into the second cavity of the sheath tube 4 from the opening of the handle 6, and the distal end of the dilator 1 passes through the second cavity of the sheath tube 4 and blocks the second cavity of the sheath tube 4;

取栓器,见图5所示,包括同轴套设的外管14和内管16,以及可膨胀的密网状取栓件13,且内管16的两端均外露于外管14的两端之外,且内管16可相对外管14沿轴向移动也可相互定位不动,密网状取栓件13一端与内管16的远端相连,密网状取栓件13另一端与外管16的远端相连,抽拉内管16可使网状取栓件13膨胀或松弛;取栓器可从所述手柄6的开口部伸入所述第二腔体内,且外管14的远端从所述第二腔体内穿出,见图7及图8所示,外管14的近端外露于所述手柄6的开口部的外侧。The thrombus remover, as shown in FIG5 , comprises an outer tube 14 and an inner tube 16 which are coaxially sleeved, and an expandable dense mesh thrombus remover 13, and both ends of the inner tube 16 are exposed outside the two ends of the outer tube 14, and the inner tube 16 can move axially relative to the outer tube 14 or can be positioned relative to each other, one end of the dense mesh thrombus remover 13 is connected to the distal end of the inner tube 16, and the other end of the dense mesh thrombus remover 13 is connected to the distal end of the outer tube 16, and pulling the inner tube 16 can expand or relax the mesh thrombus remover 13; the thrombus remover can be extended into the second cavity from the opening of the handle 6, and the distal end of the outer tube 14 passes through the second cavity, as shown in FIGS. 7 and 8, and the proximal end of the outer tube 14 is exposed outside the opening of the handle 6.

本发明的取栓导管具有三个组件,分别为上述阻断鞘、扩张器1以及上述取栓器,通过鞘管4远端的球囊3充盈来作为血栓近端的封堵塞,以此阻断血流,实现将血栓围在密网状取栓件13和球囊3之间,易于取栓,同时密网状取栓件13可使血液通过其上网孔,且密网状取栓件13由于其致密性,在进行取栓操作时,血栓易在密网状取栓件13的表面形成止挡膜,可以有效避免血栓栓子在取出过程中越过密网状取栓件向其他部位血管的外溢,密网状取栓件和阻断球囊取栓的同时配合负压抽吸,将失血量降至最低限度,特别适合用于吸取静脉中大容量的血栓。The thrombus removal catheter of the present invention has three components, namely the above-mentioned blocking sheath, dilator 1 and the above-mentioned thrombus removal device. The balloon 3 at the distal end of the sheath 4 is filled to serve as a sealing plug for the proximal end of the thrombus, thereby blocking the blood flow and enclosing the thrombus between the dense mesh thrombus removal member 13 and the balloon 3, which is easy to remove the thrombus. At the same time, the dense mesh thrombus removal member 13 allows blood to pass through the mesh holes on it, and the dense mesh thrombus removal member 13 has a density. When performing a thrombus removal operation, the thrombus is easy to form a stopper film on the surface of the dense mesh thrombus removal member 13, which can effectively prevent the thrombus from crossing the dense mesh thrombus removal member to overflow into other blood vessels during the removal process. The dense mesh thrombus removal member and the blocking balloon thrombus removal are combined with negative pressure suction to minimize blood loss, which is particularly suitable for absorbing large-volume thrombi in veins.

本实施例上述手柄6的开口部处设有连接卡扣11,所述扩张器1上设有与所述连接卡扣11配合固定的连接部12,通过连接部12和连接卡扣11的固定使扩张器1与阻断鞘固定,便于穿入血管内。本实施例中连接卡扣11上设有凸起部,连接部12上具有凹口121,扩张器1从手柄6的开口部穿入上述鞘管4的第二腔体内时,通过凸起部卡合在凹口121内,实现扩张器1与阻断鞘的定位相连,凸起部和凹口121的配合也便于两者的分离,易将扩张器1从阻断鞘内抽出。In this embodiment, a connection buckle 11 is provided at the opening of the handle 6, and a connection portion 12 that cooperates with the connection buckle 11 is provided on the dilator 1. The dilator 1 is fixed to the blocking sheath by the connection portion 12 and the connection buckle 11, so as to facilitate insertion into the blood vessel. In this embodiment, a protrusion is provided on the connection buckle 11, and a notch 121 is provided on the connection buckle 12. When the dilator 1 is inserted into the second cavity of the sheath tube 4 from the opening of the handle 6, the protrusion is engaged in the notch 121, so that the dilator 1 is positioned and connected to the blocking sheath. The cooperation of the protrusion and the notch 121 also facilitates the separation of the two, and the dilator 1 is easily withdrawn from the blocking sheath.

上述手柄6与扩张器1的定位相连不限于上述连接卡扣12和连接部11的配合,其也可以通过设置可旋转的定位部来实现,定位部旋紧后可锁定扩张器。上述手柄6同样可以通过旋转的定位部来锁定取栓器。The positioning connection between the handle 6 and the expander 1 is not limited to the cooperation between the connection buckle 12 and the connection part 11, and can also be achieved by providing a rotatable positioning part, which can lock the expander after being tightened. The handle 6 can also lock the thrombus remover by rotating the positioning part.

为便于穿插上述扩张器1,扩张器1的近端连设一手持部8,操作者可手握手持部8将扩张器1从上述手柄6的开口部插入鞘管4内。为便于医学影像,本实施例中扩张器1采用聚乙烯或聚氨酯等热塑性弹性体制成,且热塑性弹性体内填充有含显影剂材质硫酸钡、氧化铋或氯氧化铋。In order to facilitate the insertion of the dilator 1, a hand-held portion 8 is connected to the proximal end of the dilator 1, and the operator can hold the hand-held portion 8 and insert the dilator 1 into the sheath 4 from the opening of the handle 6. In order to facilitate medical imaging, the dilator 1 in this embodiment is made of thermoplastic elastomers such as polyethylene or polyurethane, and the thermoplastic elastomer is filled with barium sulfate, bismuth oxide or bismuth oxychloride containing developer materials.

本实施例中阻断鞘中的鞘管4为双腔结构或多腔结构,其中一个腔体即上述第一腔体用作充盈球囊3的通道,另一个腔体即上述第二腔体作为工作腔,用于穿设上述扩张器1或上述取栓器或其他医疗器械进出血管,鞘管4的材质为聚氨酯或聚酰胺类热塑性弹性体。本实施例中球囊3的材质为天然乳胶、合成橡胶、硅胶或聚氨酯等热塑性弹性体,通过手柄6上的球囊充盈腔接头7注入造影剂,使顺应性球囊充盈扩张,以形成阻断血液流通作用。为便于抽取血栓,本实施例中上述负压抽吸装置5通过连接管10与手柄6相连,且负压抽吸装置5还连设有二通9,便于与电动负压吸引器相连,形成抽吸负压,使血栓更高效地从阻断鞘内流入负压抽吸装置5的收集装置中。In this embodiment, the sheath tube 4 in the blocking sheath is a double-chamber structure or a multi-chamber structure, wherein one of the cavities, namely the first cavity, is used as a channel for filling the balloon 3, and the other cavity, namely the second cavity, is used as a working cavity for inserting the dilator 1 or the thrombus remover or other medical devices into and out of the blood vessel, and the sheath tube 4 is made of polyurethane or polyamide thermoplastic elastomer. In this embodiment, the material of the balloon 3 is a thermoplastic elastomer such as natural latex, synthetic rubber, silicone or polyurethane, and the contrast agent is injected through the balloon filling cavity joint 7 on the handle 6 to fill and expand the compliant balloon to form a blood circulation blocking effect. In order to facilitate the extraction of thrombus, in this embodiment, the negative pressure suction device 5 is connected to the handle 6 through a connecting tube 10, and the negative pressure suction device 5 is also connected with two passes 9, which are convenient for connecting with an electric negative pressure aspirator to form a suction negative pressure, so that the thrombus flows more efficiently from the blocking sheath into the collection device of the negative pressure suction device 5.

本实施例中上述取栓器中,密网状取栓件13由超弹记忆镍钛合金丝编织而成,并混编入一定数量的铂铱合金丝、黄金丝或不锈钢丝用于X光机下显影,其可允许取栓时血液流过密网状取栓件,在进行取栓操作时可以有效避免血栓栓子在取出过程中向其他部位血管的外溢;密网状取栓件取栓的同时配合负压抽吸,可有效减少失血量,可有效提升血栓抽吸效果。本实施例中的密网状取取栓件其所用的超弹记忆镍钛合金丝非常细,且编织成的网孔其孔径大约在0.3-1.0mm间,也就是说本实施例的密网状取栓件其为致密性的网状件,既能使血液通过,又能防止血栓块通过。外管14和内管16均采用聚酰胺类热塑性弹性体制成。整个取栓器材质柔软,在取栓过程中,降低血管内膜的损伤。In the above-mentioned thrombus remover in this embodiment, the dense mesh thrombus remover 13 is woven from superelastic memory nickel-titanium alloy wire, and a certain amount of platinum-iridium alloy wire, gold wire or stainless steel wire is mixed in for development under an X-ray machine, which allows blood to flow through the dense mesh thrombus remover during thrombus removal, and can effectively prevent the thrombus from overflowing to other blood vessels during the thrombus removal process; the dense mesh thrombus remover can effectively reduce blood loss and improve the thrombus suction effect while removing the thrombus. The superelastic memory nickel-titanium alloy wire used in the dense mesh thrombus remover in this embodiment is very fine, and the pore size of the woven mesh is approximately between 0.3-1.0mm, that is, the dense mesh thrombus remover in this embodiment is a dense mesh that can allow blood to pass through and prevent thrombus blocks from passing through. The outer tube 14 and the inner tube 16 are both made of polyamide thermoplastic elastomer. The entire thrombus remover is made of soft material, which reduces the damage to the vascular endothelium during the thrombus removal process.

为便于密网状取栓件的膨胀和松弛,本实施例中上述外管14的近端连设一个手持件15,见图5所示,手持件15的近端设有将内管16锁定的定位部。本实施例中手持件15可作手柄使用,便于操作者拿取取栓器。手持件15内的定位部可将内管16和外管14相定位,可使网状取栓件13保持呈膨胀状态,便于将血栓拉入阻断鞘内。该定位部可为旋转式或开关式的锁定件,通过旋转或开关实现内管和外管的锁定。In order to facilitate the expansion and relaxation of the dense mesh thrombus removal device, a handpiece 15 is connected to the proximal end of the outer tube 14 in this embodiment, as shown in FIG5 , and a positioning portion for locking the inner tube 16 is provided at the proximal end of the handpiece 15. In this embodiment, the handpiece 15 can be used as a handle to facilitate the operator to take the thrombus removal device. The positioning portion in the handpiece 15 can position the inner tube 16 and the outer tube 14, so that the mesh thrombus removal device 13 can be kept in an expanded state, which is convenient for pulling the thrombus into the blocking sheath. The positioning portion can be a rotating or switch-type locking member, and the inner tube and the outer tube are locked by rotation or switching.

见图5及图6所示,本实施例中内管16穿设在外管14内,且内管16的长度长于外管14的长度,内管16的两端均位于外管14的外面,密网状取栓件13的一端与内管16的远端相连,密网状取栓件13的另一端与外管14的远端相连,通过抽拉内管16改变内管16的远端和外管远端的相对距离,以此使密网状取栓件13膨胀和松弛,沿图5中的箭头方向抽拉内管,则密网状取栓件膨胀,反之则松弛。As shown in Figures 5 and 6, in this embodiment, the inner tube 16 is inserted into the outer tube 14, and the length of the inner tube 16 is longer than that of the outer tube 14. Both ends of the inner tube 16 are located outside the outer tube 14. One end of the dense mesh thrombus removal member 13 is connected to the distal end of the inner tube 16, and the other end of the dense mesh thrombus removal member 13 is connected to the distal end of the outer tube 14. The relative distance between the distal end of the inner tube 16 and the distal end of the outer tube is changed by pulling the inner tube 16, so that the dense mesh thrombus removal member 13 can be expanded and relaxed. When the inner tube is pulled in the direction of the arrow in Figure 5, the dense mesh thrombus removal member expands, and vice versa.

为便于抽拉内管,见图5所示,本实施例中内管16的近端连设有抽拉手柄17。为便于取栓器穿过血栓,运行至血栓的远端,本实施例中内管16的远端圆润且有一定锥度,即其端部为锥形。To facilitate the pulling of the inner tube, as shown in Fig. 5, a pulling handle 17 is connected to the proximal end of the inner tube 16 in this embodiment. To facilitate the thrombus remover to pass through the thrombus and move to the distal end of the thrombus, the distal end of the inner tube 16 in this embodiment is rounded and has a certain taper, that is, its end is tapered.

采用上述取栓导管对血管中血栓进行抽取的具体过程如下:The specific process of extracting thrombus from blood vessel by using the above-mentioned thrombectomy catheter is as follows:

对血管进行穿刺插管,通过动脉或静脉造影,了解血栓位置及周围血管情况后,首先将上述扩张器1穿设在鞘管4的第二腔体内,见图1及图2所示为扩张器1穿设在阻断鞘内的状态,然后在导丝引导下,将上述鞘管4引导至血栓近端;用生理盐水或其他合适药液,连接球囊腔接头7充盈球囊3至血管内径大小,使球囊将血栓近端的血管堵塞,阻断血流;从阻断鞘中撤出扩张器1,沿着导丝放入取栓器,见图7所示,取栓器中的密网状取栓件13穿过血栓,放置到血栓的远端;向外拉动取栓器的内管16,见图8所示,密网状取栓件13膨胀,将内管16与外管14锁定,保持密网状取栓件13为膨胀状态;向外拉动外管14,将血栓收入阻断鞘的鞘管4内,同步的,通过负压抽吸将血栓排入负压抽吸装置5中,且在拉血栓时,血液可通过密网状取栓件13,降低失血量,但是块状血栓会随吸力被吸出;某段血管取栓完毕后,通过充、放阻断鞘上的球囊,移动到下一段血栓处进行取栓操作。本实施例取栓器较细的尖端和管身,可以到达血栓更深的位置。After puncturing and cannulating the blood vessel and understanding the location of the thrombus and the surrounding blood vessels through arterial or venography, the dilator 1 is first inserted into the second cavity of the sheath 4, as shown in Figures 1 and 2, which show the state of the dilator 1 inserted into the blocking sheath. Then, under the guidance of the guide wire, the sheath 4 is guided to the proximal end of the thrombus; physiological saline or other suitable liquid medicine is connected to the balloon cavity connector 7 to fill the balloon 3 to the size of the inner diameter of the blood vessel, so that the balloon blocks the blood vessel proximal to the thrombus and blocks the blood flow; the dilator 1 is withdrawn from the blocking sheath, and the thrombus remover is placed along the guide wire, as shown in Figure 7, and the dense mesh thrombus remover 13 in the thrombus remover is inserted. The thrombus is passed through the thrombus and placed at the far end of the thrombus; the inner tube 16 of the thrombus remover is pulled outward, as shown in FIG8 , the dense mesh thrombus remover 13 expands, the inner tube 16 and the outer tube 14 are locked, and the dense mesh thrombus remover 13 is kept in an expanded state; the outer tube 14 is pulled outward to collect the thrombus into the sheath tube 4 of the blocking sheath, and the thrombus is discharged into the negative pressure suction device 5 by negative pressure suction at the same time, and when the thrombus is pulled, blood can pass through the dense mesh thrombus remover 13 to reduce the amount of blood loss, but the block thrombus will be sucked out with the suction; after the thrombus is removed from a certain section of the blood vessel, the balloon on the blocking sheath is filled and released to move to the next section of the thrombus for thrombus removal. The thinner tip and tube body of the thrombus remover in this embodiment can reach a deeper position of the thrombus.

综上所述,本发明的取栓导管以及用于取栓导管的取栓器,其通过阻断鞘远端的球囊充盈阻断血流,在取栓过程中,柔软的取栓器,降低血管内膜的损伤;密网状取栓件可以使血液通过其上网孔,在进行取栓操作时可以有效避免血栓栓子在取出过程中向其他部位血管的外溢,密网状取栓件取栓的同时配合负压抽吸,利于血栓去除,将失血量降至最低限度;取栓器的内管具有较细的尖端和管身,可以到达血栓更深的位置;适合大中型血管的取栓,包括相对陈旧性病变;本发明为无源取栓器械,成本低,操作简单,可大幅降低取栓手术费用;可高效率取出大容量血栓,减少瓣膜损伤,更少量溶栓药物应用,更少量失血,更小创伤,更快恢复期。所以,本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。In summary, the thrombus removal catheter and the thrombus removal device used for the thrombus removal catheter of the present invention block the blood flow by filling the balloon at the distal end of the blocking sheath. During the thrombus removal process, the soft thrombus removal device reduces the damage to the vascular endothelium; the dense mesh thrombus removal device allows blood to pass through the mesh holes on it, and can effectively prevent the thrombus embolus from overflowing to other parts of the blood vessels during the thrombus removal process. The dense mesh thrombus removal device cooperates with negative pressure suction while removing the thrombus, which is conducive to the removal of the thrombus and reduces the blood loss to a minimum; the inner tube of the thrombus removal device has a thinner tip and tube body, which can reach a deeper position of the thrombus; it is suitable for thrombus removal of large and medium-sized blood vessels, including relatively old lesions; the present invention is a passive thrombus removal device with low cost and simple operation, which can greatly reduce the cost of thrombus removal surgery; it can efficiently remove large-volume thrombi, reduce valve damage, use less thrombolytic drugs, less blood loss, less trauma, and faster recovery period. Therefore, the present invention effectively overcomes various shortcomings in the prior art and has a high industrial utilization value.

上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Anyone familiar with the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by a person of ordinary skill in the art without departing from the spirit and technical ideas disclosed by the present invention shall still be covered by the claims of the present invention.

Claims (7)

1.一种取栓导管,其特征在于,包括:1. A thrombectomy catheter, comprising: 阻断鞘,包括鞘管,所述鞘管的远端设有球囊,所述鞘管的近端设有开口部;所述鞘管内设有至少两个轴向延伸的腔体,第一腔体的远端与所述球囊的内腔相连通,第二腔体与所述开口部轴向相通;The blocking sheath comprises a sheath tube, wherein a balloon is arranged at the distal end of the sheath tube, and an opening is arranged at the proximal end of the sheath tube; at least two axially extending cavities are arranged in the sheath tube, wherein the distal end of the first cavity is connected to the inner cavity of the balloon, and the second cavity is axially connected to the opening; 扩张器,所述扩张器可从所述开口部伸入所述第二腔体内,所述扩张器的外径与所述第二腔体的内径相匹配,所述扩张器的远端从所述第二腔体内穿出并且将其封堵;a dilator, the dilator being extendable from the opening into the second cavity, the outer diameter of the dilator matching the inner diameter of the second cavity, the distal end of the dilator passing through the second cavity and blocking it; 取栓器,包括同轴套设的外管和内管,以及可膨胀的密网状取栓件,所述密网状取栓件由超弹记忆镍钛合金丝混合铂铱合金丝、黄金丝或不锈钢丝编织而成,所述内管可相对外管沿轴向移动,所述密网状取栓件一端与所述内管的远端相连,所述密网状取栓件另一端与所述外管的远端相连,抽拉所述内管可使所述密网状取栓件膨胀或松弛,所述外管的近端连设一个手持件,所述手持件的近端设有将所述内管锁定的定位部,所述定位部包括旋转式或开关式的锁定件,通过旋转或开关实现所述内管和所述外管的锁定;所述密网状取栓件可使血液通过其上网孔,并使得血栓在所述密网状取栓件的表面形成止挡膜;从所述阻断鞘中撤出所述扩张器后,所述取栓器可从所述开口部伸入所述第二腔体内,所述外管的远端从所述第二腔体内穿出,所述外管的近端外露于所述开口部的外侧;The thrombus remover comprises an outer tube and an inner tube which are coaxially sleeved, and an expandable dense mesh thrombus remover, wherein the dense mesh thrombus remover is woven from superelastic memory nickel-titanium alloy wire mixed with platinum-iridium alloy wire, gold wire or stainless steel wire, the inner tube can move axially relative to the outer tube, one end of the dense mesh thrombus remover is connected to the distal end of the inner tube, and the other end of the dense mesh thrombus remover is connected to the distal end of the outer tube, and pulling the inner tube can expand or relax the dense mesh thrombus remover, and a handpiece is connected to the proximal end of the outer tube, and the proximal end of the handpiece A positioning part is provided for locking the inner tube, and the positioning part includes a rotating or switch-type locking part, and the inner tube and the outer tube are locked by rotation or switch; the dense mesh thrombus removal part allows blood to pass through the mesh holes on it, and the thrombus forms a stopper film on the surface of the dense mesh thrombus removal part; after the dilator is withdrawn from the blocking sheath, the thrombus removal part can be extended into the second cavity from the opening, the distal end of the outer tube passes through the second cavity, and the proximal end of the outer tube is exposed outside the opening; 在取栓过程中,所述密网状取栓件用于穿过血栓并放置到血栓的远端后膨胀,所述密网状取栓件和所述球囊能够将中大型静脉中大容量的血栓围在两者之间,所述密网状取栓件和所述球囊在取栓的同时配合负压抽吸,将失血量降至最低限度,适合用于吸取静脉中大容量的血栓。During the thrombus removal process, the dense mesh thrombus removal device is used to pass through the thrombus and is placed at the distal end of the thrombus and then expands. The dense mesh thrombus removal device and the balloon can surround large-capacity thrombi in medium and large veins between the two. The dense mesh thrombus removal device and the balloon cooperate with negative pressure suction while removing the thrombus to minimize blood loss, and are suitable for absorbing large-capacity thrombi in veins. 2.根据权利要求1所述的取栓导管,其特征在于,所述鞘管的近端连设手柄,所述开口部设置于所述手柄上;所述第一腔体将所述球囊的内腔和连设在所述手柄上的球囊充盈接头相连通,所述第二腔体的近端与连设在手柄上的负压抽吸装置相连通。2. The thrombectomy catheter according to claim 1 is characterized in that a handle is connected to the proximal end of the sheath, and the opening is arranged on the handle; the first cavity connects the inner cavity of the balloon and the balloon filling connector connected to the handle, and the proximal end of the second cavity is connected to the negative pressure suction device connected to the handle. 3.根据权利要求2所述的取栓导管,其特征在于,所述手柄上设有连接卡扣,所述扩张器的近端连设一手持部,手持部上设有与所述连接卡扣配合固定的连接部。3. The thrombectomy catheter according to claim 2 is characterized in that a connecting buckle is provided on the handle, a hand-held portion is connected to the proximal end of the dilator, and a connecting portion that cooperates and is fixed with the connecting buckle is provided on the hand-held portion. 4.根据权利要求1所述的取栓导管,其特征在于,所述扩张器采用热塑性弹性体制成,且热塑性弹性体内填充有含显影剂材质硫酸钡、氧化铋或氯氧化铋。4. The thrombectomy catheter according to claim 1 is characterized in that the dilator is made of a thermoplastic elastomer, and the thermoplastic elastomer is filled with a developer-containing material such as barium sulfate, bismuth oxide or bismuth oxychloride. 5.根据权利要求1所述的取栓导管,其特征在于,所述内管的两端均外露于所述外管的两端之外,所述内管的近端连设有抽拉手柄。5. The thrombus removal catheter according to claim 1 is characterized in that both ends of the inner tube are exposed outside the two ends of the outer tube, and the proximal end of the inner tube is connected to a pulling handle. 6.根据权利要求1所述的取栓导管,其特征在于,所述鞘管、所述内管和所述外管均采用聚氨酯或聚酰胺类热塑性弹性体制成。6. The thrombectomy catheter according to claim 1 is characterized in that the sheath tube, the inner tube and the outer tube are all made of polyurethane or polyamide thermoplastic elastomer. 7.根据权利要求1所述的取栓导管,其特征在于,所述鞘管和所述内管的远端为锥形。7. The thrombectomy catheter according to claim 1 is characterized in that the distal ends of the sheath tube and the inner tube are tapered.
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