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CN115644990B - Aspiration catheter for interventional procedures - Google Patents

Aspiration catheter for interventional procedures Download PDF

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Publication number
CN115644990B
CN115644990B CN202211576675.1A CN202211576675A CN115644990B CN 115644990 B CN115644990 B CN 115644990B CN 202211576675 A CN202211576675 A CN 202211576675A CN 115644990 B CN115644990 B CN 115644990B
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catheter
proximal
distal
outer sleeve
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CN115644990A (en
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陈志鹏
姜晓威
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Shanghai Hengchang Medical Technology Co ltd
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Priority to PCT/CN2023/120085 priority patent/WO2024119958A1/en
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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
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes

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

Abstract

The invention discloses a suction catheter for interventional operation, which comprises an outer sleeve and a reinforcing layer, wherein the outer sleeve extends along the axial direction, the outer sleeve is arranged on the outer layer of the reinforcing layer in the radial direction, the outer sleeve sequentially comprises a tail end, a far end section, a middle section and a near end section along the axial direction, and the material hardness of the far end section, the middle section and the near end section is sequentially improved; the material hardness of the middle section is sequentially increased along the axial direction from the distal section to the proximal section; the reinforcing layer in the distal section includes a spring structure, the reinforcing layer in the intermediate section includes a spring structure and a woven mesh tube structure, and the reinforcing layer in the proximal section includes a woven mesh tube structure. The suction catheter for interventional operation solves the problem that the inner diameter of the catheter cannot suck out emboli with larger volume; the problem of larger inner diameter catheters being difficult to traverse through tortuous vascular pathways; the catheter is easy to bend after passing through a smaller path; the catheter is easy to collapse under the condition of high suction negative pressure.

Description

用于介入手术的抽吸导管Aspiration catheters for interventional procedures

技术领域Technical Field

本发明涉及一种用于人类患者的血管内栓塞或血栓的血管内治疗系统,更具体地说,涉及一种用于介入手术的抽吸导管。The present invention relates to an intravascular treatment system for intravascular embolism or thrombosis of a human patient, and more particularly to an aspiration catheter for interventional surgery.

背景技术Background technique

凝血块可能存在于深静脉,或者随着血流流入肺动脉,它会导致肺动脉血流堵塞,从而影响血液的气体交换。The blood clot may be present in the deep veins, or it may flow into the pulmonary artery with the blood flow, causing blockage of blood flow in the pulmonary artery, thereby affecting the gas exchange of the blood.

目前存在的技术通过闭塞的血管重建血流包括:Currently available technologies to restore blood flow through occluded vessels include:

1.栓子切除术,通过球囊设置在闭塞的位置,通过回撤球囊移除栓塞物;1. Embolectomy, where a balloon is placed at the site of the occlusion and the embolus is removed by withdrawing the balloon;

2.球囊血管成形术,其中尖端有球囊的导管被引入血管(例如,通常通过导入导管),然后将尖端有球囊的导管推进到闭塞点并充气以扩张狭窄。球囊血管成形术适合于治疗血管狭窄,但对于治疗急性血栓栓塞大体上无效,因为没有任何闭塞物被移除并且在扩张之后经常发生再狭窄;2. Balloon angioplasty, in which a balloon-tipped catheter is introduced into the vessel (e.g., usually via an introducer catheter), then advanced to the site of the occlusion and inflated to dilate the stenosis. Balloon angioplasty is suitable for treating vascular stenosis but is generally ineffective for treating acute thromboembolism because none of the occlusion is removed and restenosis often occurs after dilation;

3.另一经皮技术涉及将导管设置在凝块附近并输注(infusing)链激酶,尿激酶,或其他血栓溶解剂以溶解凝块。血栓溶解通常花费数小时至数天才成功。另外,血栓溶解剂可能导致出血,并且在许多患者中根本不能使用血栓溶解剂;3. Another percutaneous technique involves placing a catheter near the clot and infusing streptokinase, urokinase, or other thrombolytic agents to dissolve the clot. Thrombolysis usually takes hours to days to be successful. In addition, thrombolytic agents may cause bleeding, and in many patients thrombolytic agents cannot be used at all;

4.导管经过血管介入,将导管远端靠近栓塞物,通过导管近端连接的注射器形成负压,从而达到抽吸出栓塞物的效果。4. The catheter is inserted through the blood vessel, and the distal end of the catheter is brought close to the embolus. Negative pressure is created through the syringe connected to the proximal end of the catheter to achieve the effect of aspirating the embolus.

现有导管存在以下问题:The existing catheter has the following problems:

1.导管类产品的内径较小,不足以吸出体积较大的栓塞物;1. The inner diameter of catheter products is small and is not enough to suck out large emboli;

2.较大的内径导管类产品,能够有效的抽吸,较大的尺寸导致其难以通过弯曲的血管路径;2. Larger inner diameter catheter products can effectively aspirate, but their larger size makes it difficult to pass through tortuous blood vessels;

3.导管在通过较小的路径后容易产生弯折,因此不能完成有效的抽吸;3. The catheter is prone to bending after passing through a smaller path, so effective suction cannot be completed;

4.抽吸负压较大的情况下导管(较软的部分,例如远端)容易出现先塌陷,导致该部分导管内径变小,从而影响抽吸的效率。4. When the negative pressure of suction is large, the catheter (the softer part, such as the distal end) tends to collapse first, causing the inner diameter of this part of the catheter to become smaller, thus affecting the efficiency of suction.

发明内容Summary of the invention

针对现有技术存在的内径较小不足以吸出体积较大的栓塞物、较大尺寸的导管导致其难以通过弯曲的血管路径、通过较小的路径后容易产生弯折、抽吸负压较大的情况下导管容易出现塌陷等问题,本发明提供一种用于介入手术的抽吸导管,其至少解决了导管内径不能吸出体积较大的栓塞物,较大的内径导管难以通过弯曲的血管路径,导管在通过较小的路径后容易产生弯折,抽吸负压较大的情况下导管容易出现塌陷等问题。In view of the problems existing in the prior art, such as the inner diameter being too small to suck out larger embolic objects, the larger sized catheter making it difficult to pass through a curved blood vessel path, the catheter being easily bent after passing through a smaller path, and the catheter being easily collapsed under a large suction negative pressure, the present invention provides an aspiration catheter for interventional surgery, which at least solves the problems that the inner diameter of the catheter cannot suck out larger embolic objects, the larger inner diameter catheter is difficult to pass through a curved blood vessel path, the catheter is easily bent after passing through a smaller path, and the catheter is easily collapsed under a large suction negative pressure.

为实现上述目的,本发明采用如下技术方案:To achieve the above object, the present invention adopts the following technical solution:

一种用于介入手术的抽吸导管,包括沿轴向延伸的外套管和加固层,外套管在径向上设置于加固层外层,外套管沿轴向依次包括末端、远端段、中间段、近端段,其中远端段、中间段和近端段的材料硬度依次提升;中间段的材料硬度沿轴向从远端段至近端段方向依次提升;远端段内的加固层包括弹簧结构,中间段内的加固层包括弹簧结构和编织网管结构,近端段内的加固层包括编织网管结构。A suction catheter for interventional surgery comprises an outer sleeve and a reinforcement layer extending in the axial direction, wherein the outer sleeve is arranged on the outer layer of the reinforcement layer in the radial direction, and the outer sleeve comprises a terminal end, a distal section, a middle section, and a proximal section in the axial direction, wherein the material hardness of the distal section, the middle section, and the proximal section increases in sequence; the material hardness of the middle section increases in sequence from the distal section to the proximal section in the axial direction; the reinforcement layer in the distal section comprises a spring structure, the reinforcement layer in the middle section comprises a spring structure and a braided mesh tube structure, and the reinforcement layer in the proximal section comprises a braided mesh tube structure.

作为本发明的一种实施方式,末端沿轴向的长度为10mm,远端段沿轴向的长度为400mm,中间段沿轴向的长度为120mm,近端段沿轴向的长度为500mm。As an embodiment of the present invention, the axial length of the terminal end is 10 mm, the axial length of the distal end section is 400 mm, the axial length of the middle section is 120 mm, and the axial length of the proximal end section is 500 mm.

作为本发明的一种实施方式,末端的材料硬度大于等于35D,远端段的材料硬度小于等于35D,中间段的材料硬度为42D-63D,近端段的材料硬度大于等于63D。As an embodiment of the present invention, the material hardness of the end is greater than or equal to 35D, the material hardness of the distal segment is less than or equal to 35D, the material hardness of the middle segment is 42D-63D, and the material hardness of the proximal segment is greater than or equal to 63D.

作为本发明的一种实施方式,中间段的材料硬度沿轴向从远端段至近端段从42D提升至63D。As an embodiment of the present invention, the material hardness of the middle section increases from 42D to 63D along the axial direction from the distal section to the proximal section.

作为本发明的一种实施方式,中间段内的编织网管结构包括第一金属扁丝,第一金属扁丝的厚度为0.001-0.003英寸,宽度为0.003-0.005英寸。As an embodiment of the present invention, the braided mesh tube structure in the middle section includes a first metal flat wire, and the first metal flat wire has a thickness of 0.001-0.003 inches and a width of 0.003-0.005 inches.

作为本发明的一种实施方式,中间段内的弹簧结构包括第二金属扁丝,第二金属扁丝的厚度为0.002-0.005英寸,宽度为0.007-0.015英寸。As an embodiment of the present invention, the spring structure in the middle section includes a second metal flat wire, and the second metal flat wire has a thickness of 0.002-0.005 inches and a width of 0.007-0.015 inches.

作为本发明的一种实施方式,远端段内的弹簧结构的第二金属扁丝的厚度大于0.004英寸,宽度大于0.01英寸。As an embodiment of the present invention, the second flat metal wire of the spring structure in the distal section has a thickness greater than 0.004 inches and a width greater than 0.01 inches.

作为本发明的一种实施方式,抽吸导管的外径范围为16Fr-24Fr;当外径为16Fr时,抽吸导管的内径不小于4.2mm;当外径为24Fr时,抽吸导管的内径不小于7mm。As an embodiment of the present invention, the outer diameter of the suction catheter ranges from 16Fr to 24Fr; when the outer diameter is 16Fr, the inner diameter of the suction catheter is not less than 4.2mm; when the outer diameter is 24Fr, the inner diameter of the suction catheter is not less than 7mm.

作为本发明的一种实施方式,近端段的内径大于远端段的内径。As an embodiment of the present invention, the inner diameter of the proximal section is greater than the inner diameter of the distal section.

作为本发明的一种实施方式,当外径为16Fr时,近端段的内径大于5mm;当外径为24Fr时,近端段的内径大于8mm。As an embodiment of the present invention, when the outer diameter is 16 Fr, the inner diameter of the proximal section is greater than 5 mm; when the outer diameter is 24 Fr, the inner diameter of the proximal section is greater than 8 mm.

在上述技术方案中,本发明的导管内径较大可以吸出较大的栓塞物,在内径较大的情况下也可以通过弯曲的血管路径,也不会产生弯折和塌陷问题。In the above technical solution, the catheter of the present invention has a larger inner diameter and can suck out larger emboli. In the case of a larger inner diameter, the catheter can also pass through a curved blood vessel path without causing bending and collapse problems.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

图1是血栓治疗装置的结构示意图;FIG1 is a schematic diagram of the structure of a thrombus treatment device;

图2本发明导管的外部结构示意图;FIG2 is a schematic diagram of the external structure of the catheter of the present invention;

图3本发明导管的内部结构示意图;FIG3 is a schematic diagram of the internal structure of the catheter of the present invention;

图4是抗塌陷测试示意图;Fig. 4 is a schematic diagram of an anti-collapse test;

图5a是无塌陷的导管截面示意图;Fig. 5a is a schematic cross-sectional view of a catheter without collapse;

图5b是有塌陷的导管截面示意图。FIG. 5 b is a schematic diagram of a collapsed catheter cross section.

图中:In the figure:

100-抽吸导管,200-止血阀,300-压力源,400-开关阀,500-快速拆装机构,11-外套管,12-加固层,13-内层,14-末端,15-远端段,16-中间段,17-近端段,21-弹簧结构,22-编织网管结构,31-塑料薄片。100-suction catheter, 200-hemostasis valve, 300-pressure source, 400-switch valve, 500-quick disassembly mechanism, 11-outer sleeve, 12-reinforcement layer, 13-inner layer, 14-end, 15-distal section, 16-middle section, 17-proximal section, 21-spring structure, 22-woven mesh tube structure, 31-plastic sheet.

具体实施方式Detailed ways

下面结合附图和实施例,对本发明实施例中的技术方案进一步作清楚、完整地描述。显然,所描述的实施例用来作为解释本发明技术方案之用,并非意味着已经穷举了本发明所有的实施方式。The following is a further clear and complete description of the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings and embodiments. Obviously, the described embodiments are used to explain the technical solutions of the present invention, and do not mean that all implementation methods of the present invention have been exhaustively listed.

所述实施例的示例在附图中示出,其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。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。Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the present invention, and should not be construed as limiting the present invention.

关于本说明书中的术语“远侧/远端”和“近侧/近端”,其中近端/近侧指的是靠近操作人员的一端,而远端/远侧指的是远离操作人员,或者进入人体血管的一端。每一个部件均可以具有近端和远端,近端/远端是对于相对方向/位置的描述,不直接代表距离的远近。Regarding the terms "distal side/distal end" and "proximal side/proximal end" in this specification, the proximal side/proximal end refers to the end close to the operator, and the distal side/distal end refers to the end away from the operator or entering the human blood vessel. Each component may have a proximal end and a distal end, and the proximal end/distal end is a description of the relative direction/position, and does not directly represent the distance.

如图1所示,本发明的抽吸导管100应用于血栓治疗装置中。血栓治疗装置主要包括抽吸导管100,止血阀200,压力源300,开关阀400以及快速拆装机构500。抽吸导管100是一根长管,如图1的画圈部分所示,具有近端和远端两个端部,并且抽吸导管100近端和远端之间的整体内部中空,形成一根长度较长的中空柔性管。抽吸导管100的远端进入人体血管,近端保持在人体之外和/或连接至止血阀200。抽吸导管100近端连接止血阀200,压力源300通过快速拆装机构500连接至止血阀200,并且快速拆装机构500和第二分叉之间可以设置开关阀400。As shown in FIG1 , the suction catheter 100 of the present invention is applied to a thrombus treatment device. The thrombus treatment device mainly includes a suction catheter 100, a hemostatic valve 200, a pressure source 300, a switch valve 400 and a quick disassembly mechanism 500. The suction catheter 100 is a long tube, as shown in the circled part of FIG1 , having two ends, a proximal end and a distal end, and the entire interior between the proximal end and the distal end of the suction catheter 100 is hollow, forming a long hollow flexible tube. The distal end of the suction catheter 100 enters the human blood vessel, and the proximal end remains outside the human body and/or is connected to the hemostatic valve 200. The proximal end of the suction catheter 100 is connected to the hemostatic valve 200, the pressure source 300 is connected to the hemostatic valve 200 through the quick disassembly mechanism 500, and the switch valve 400 can be set between the quick disassembly mechanism 500 and the second bifurcation.

参照图2和图3所示,抽吸导管100是一根长管,中间是中空的。抽吸导管100包括沿轴向延伸的外套管11,加固层12和内层13。外套管11在径向上设置于加固层12外层,内层13设置于加固层12内部,以此形成一个三层管结构。外套管11,加固层12和内层13是抽吸导管100在径向上的结构分层。作为本发明的一种实施方式,内层13的材料为聚四氟乙烯,加固层12的材料选择为金属,构成金属加固层。本发明的外套管11采用可变材料的结构,在轴向上形成材料上的变化,以此在轴向上形成外套管11硬度上的变化。As shown in Figures 2 and 3, the suction catheter 100 is a long tube that is hollow in the middle. The suction catheter 100 includes an outer sleeve 11 extending in the axial direction, a reinforcement layer 12 and an inner layer 13. The outer sleeve 11 is arranged on the outer layer of the reinforcement layer 12 in the radial direction, and the inner layer 13 is arranged inside the reinforcement layer 12, thereby forming a three-layer tube structure. The outer sleeve 11, the reinforcement layer 12 and the inner layer 13 are the structural layers of the suction catheter 100 in the radial direction. As an embodiment of the present invention, the material of the inner layer 13 is polytetrafluoroethylene, and the material of the reinforcement layer 12 is selected as metal to constitute a metal reinforcement layer. The outer sleeve 11 of the present invention adopts a variable material structure to form a change in material in the axial direction, thereby forming a change in the hardness of the outer sleeve 11 in the axial direction.

继续参照图2和图3,外套管11沿轴向依次包括末端14、远端段15、中间段16、近端段17,末端14、远端段15、中间段16、近端段17是抽吸导管100的外套管11在轴向上的结构划分。其中,末端14为最接近人体器官的一端,近端段17为最接近操作人员的一端。作为本发明的一种实施方式,外套管11是一根1030mm的圆柱形导管,末端14沿轴向的长度为10mm,远端段15沿轴向的长度为400mm,中间段16沿轴向的长度为120mm,近端段17沿轴向的长度为500mm。本领域的技术人员可以理解,上述长度上的选择只是本发明众多实施例之一,而并非本发明的限制。在本发明的其他实施例中,末端14、远端段15、中间段16、近端段17在轴向上可以具有其他的长度选择,均可以实现本发明的技术目的,达到本发明的技术效果。Continuing to refer to FIG. 2 and FIG. 3, the outer sleeve 11 includes a terminal 14, a distal section 15, an intermediate section 16, and a proximal section 17 in the axial direction. The terminal 14, the distal section 15, the intermediate section 16, and the proximal section 17 are the structural divisions of the outer sleeve 11 of the suction catheter 100 in the axial direction. Among them, the terminal 14 is the end closest to the human organ, and the proximal section 17 is the end closest to the operator. As an embodiment of the present invention, the outer sleeve 11 is a 1030mm cylindrical catheter, the terminal 14 has an axial length of 10mm, the distal section 15 has an axial length of 400mm, the intermediate section 16 has an axial length of 120mm, and the proximal section 17 has an axial length of 500mm. It can be understood by those skilled in the art that the above-mentioned length selection is only one of many embodiments of the present invention, and is not a limitation of the present invention. In other embodiments of the present invention, the terminal 14, the distal section 15, the intermediate section 16, and the proximal section 17 can have other length selections in the axial direction, which can all achieve the technical purpose of the present invention and achieve the technical effect of the present invention.

继续参照图2和图3,本发明的抽吸导管100是一种大口径的导管,因此其外径(周径)、内径的选择上具有特定的约束条件。在本发明中,抽吸导管100的外径范围为16Fr-24Fr,其中Fr为长度单位French的简称。2 and 3, the suction catheter 100 of the present invention is a large-caliber catheter, so the selection of its outer diameter (circumference) and inner diameter has specific constraints. In the present invention, the outer diameter of the suction catheter 100 ranges from 16Fr to 24Fr, where Fr is the abbreviation of the unit of length French.

当抽吸导管100的外径为16Fr时,其整体内径不小于4.2mm,而当抽吸导管100的外径为24Fr时,其整体内径不小于7mm。此外,由于抽吸导管100在轴向上分为末端14、远端段15、中间段16和近端段17,其内径在各个段上也可以存在变化。例如,近端段17的内径可以大于远端段15的内径。当外径为16Fr时,近端段17的内径大于5mm,而当外径为24Fr时,近端段17的内径大于8mm。此时,远端段15的外径相应地小于近端段17的外径。When the outer diameter of the suction catheter 100 is 16Fr, its overall inner diameter is not less than 4.2mm, and when the outer diameter of the suction catheter 100 is 24Fr, its overall inner diameter is not less than 7mm. In addition, since the suction catheter 100 is divided into the terminal end 14, the distal section 15, the middle section 16 and the proximal section 17 in the axial direction, its inner diameter may also vary in each section. For example, the inner diameter of the proximal section 17 may be larger than the inner diameter of the distal section 15. When the outer diameter is 16Fr, the inner diameter of the proximal section 17 is greater than 5mm, and when the outer diameter is 24Fr, the inner diameter of the proximal section 17 is greater than 8mm. At this time, the outer diameter of the distal section 15 is correspondingly smaller than the outer diameter of the proximal section 17.

根据Hagen–Poiseuille Law(哈根-泊肃叶公式),抽吸导管100的内径(内层13)的半径和流量成4次方正比关系,本发明选择将抽吸导管100制成大口径,使得抽吸导管100的抽吸效率(抽吸流量)能有显著提高,具体公式如下:According to the Hagen–Poiseuille Law, the radius of the inner diameter (inner layer 13) of the suction catheter 100 and the flow rate are in direct proportion to the fourth power. The present invention selects to make the suction catheter 100 with a large diameter, so that the suction efficiency (suction flow rate) of the suction catheter 100 can be significantly improved. The specific formula is as follows:

,

其中,Q=导管的抽吸效率,π=圆周率,r=内层13半径,ΔP=压差,ŋ=液体粘度,L=导管长度。Where Q = suction efficiency of the catheter, π = pi, r = inner radius, ΔP = pressure difference, ŋ = liquid viscosity, and L = catheter length.

16Fr-24Fr的外径范围以及上述的内径范围使得本发明的抽吸导管100的内径、外径大于普通的介入治疗导管。然而,随着抽吸导管100的内径、外径增大,其抗弯折性能和抗塌陷性能将受到挑战。普通的介入式抽吸导管无法做到该尺寸下的内径和外径,其原因在于大尺寸的导管在使用中会发生严重的弯折和塌陷问题。The outer diameter range of 16Fr-24Fr and the inner diameter range mentioned above make the inner diameter and outer diameter of the suction catheter 100 of the present invention larger than those of ordinary interventional treatment catheters. However, as the inner diameter and outer diameter of the suction catheter 100 increase, its anti-bending performance and anti-collapse performance will be challenged. Ordinary interventional suction catheters cannot achieve the inner diameter and outer diameter of this size, because large-sized catheters will have serious bending and collapse problems during use.

如图2和图3所示,为了配合上述大口径的抽吸导管100,使得抽吸导管100能在保持大口径的基础上,同时满足抗弯折性能和抗塌陷性能,因此在材料选择上,远端段15、中间段16和近端段17的材料硬度依次提升,中间段16的材料硬度沿轴向从远端段15至近端段17方向依次提升,但末端14的材料硬度是独立的,且末端14的材料硬度一般需要大于(至少等于)远端段15的材料硬度。作为本发明的一种实施方式,远端段15的材料为NEUSoft862(热塑性聚氨酯)和/或Pebax25D(聚醚嵌段酰胺)的组合。As shown in FIG. 2 and FIG. 3 , in order to match the above-mentioned large-caliber suction catheter 100, so that the suction catheter 100 can meet the anti-bending performance and anti-collapse performance while maintaining the large caliber, the material hardness of the distal segment 15, the middle segment 16 and the proximal segment 17 is increased in sequence in material selection, and the material hardness of the middle segment 16 is increased in sequence along the axial direction from the distal segment 15 to the proximal segment 17, but the material hardness of the terminal 14 is independent, and the material hardness of the terminal 14 generally needs to be greater than (at least equal to) the material hardness of the distal segment 15. As an embodiment of the present invention, the material of the distal segment 15 is a combination of NEUSoft862 (thermoplastic polyurethane) and/or Pebax25D (polyether block amide).

为了符合上述材料选择条件,以及满足抽吸导管100的抗弯折性能和抗塌陷性能,末端14的材料硬度大于等于35D(其中,D为邵氏硬度单位),远端段15的材料硬度小于等于35D,中间段16的材料硬度为42D-63D,中间段16的材料硬度沿轴向从远端段15至近端段17依次从42D提升至55D,最终提升至63D,近端段17的材料硬度大于等于63D。In order to meet the above-mentioned material selection conditions and satisfy the bending resistance and collapse resistance of the suction catheter 100, the material hardness of the terminal 14 is greater than or equal to 35D (where D is the Shore hardness unit), the material hardness of the distal segment 15 is less than or equal to 35D, and the material hardness of the middle segment 16 is 42D-63D. The material hardness of the middle segment 16 increases from 42D to 55D along the axial direction from the distal segment 15 to the proximal segment 17, and finally increases to 63D. The material hardness of the proximal segment 17 is greater than or equal to 63D.

作为上述实施方式的第一种具体选择,末端14的材料硬度为35D,远端段15的材料硬度为35D,中间段16的材料硬度沿轴向从远端段15至近端段17依次从42D连续渐变为55D,再连续渐变至63D,近端段17的材料硬度为63D。As a first specific option of the above embodiment, the material hardness of the end 14 is 35D, the material hardness of the distal segment 15 is 35D, the material hardness of the middle segment 16 changes continuously from 42D to 55D along the axial direction from the distal segment 15 to the proximal segment 17, and then continuously changes to 63D, and the material hardness of the proximal segment 17 is 63D.

作为上述实施方式的第二种具体选择,末端14的材料硬度为35D,远端段15的材料硬度为25D,中间段16的材料硬度沿轴向从远端段15至近端段17依次从42D连续渐变为55D,再连续渐变至63D,近端段17的材料硬度为70D。As a second specific option of the above embodiment, the material hardness of the end 14 is 35D, the material hardness of the distal segment 15 is 25D, the material hardness of the middle segment 16 changes continuously from 42D to 55D along the axial direction from the distal segment 15 to the proximal segment 17, and then continuously changes to 63D, and the material hardness of the proximal segment 17 is 70D.

上述外套管11材料硬度的变化有助于实现抽吸导管100的抗弯折性能和抗塌陷性能。除了外套管11的材料硬度变化之外,外套管11内层的加固层12的材料、结构选择同样对抽吸导管100的抗弯折性能和抗塌陷性能有影响。The change in the hardness of the outer sleeve 11 material helps to achieve the anti-bending and anti-collapse performance of the suction catheter 100. In addition to the change in the hardness of the outer sleeve 11 material, the material and structure selection of the inner reinforcement layer 12 of the outer sleeve 11 also affect the anti-bending and anti-collapse performance of the suction catheter 100.

继续参照图2和图3,为了配合外套管11的末端14、远端段15、中间段16、近端段17的材料选择,加固层12在结构上也产生变化,并且该变化对应外套管11的分段。如图2和图3所示,加固层12包括弹簧结构21和编织网管结构22,两者在轴向上具有相应的分布区域。远端段15所对应的加固层12部分包括弹簧结构21,中间段16所对应的加固层12部分包括弹簧结构21和编织网管结构22,近端段17所对应的加固层12部分包括编织网管结构22。Continuing to refer to FIG. 2 and FIG. 3, in order to match the material selection of the end 14, the distal segment 15, the middle segment 16, and the proximal segment 17 of the outer sleeve 11, the reinforcement layer 12 also changes in structure, and the change corresponds to the segmentation of the outer sleeve 11. As shown in FIG. 2 and FIG. 3, the reinforcement layer 12 includes a spring structure 21 and a braided mesh structure 22, and the two have corresponding distribution areas in the axial direction. The portion of the reinforcement layer 12 corresponding to the distal segment 15 includes the spring structure 21, the portion of the reinforcement layer 12 corresponding to the middle segment 16 includes the spring structure 21 and the braided mesh structure 22, and the portion of the reinforcement layer 12 corresponding to the proximal segment 17 includes the braided mesh structure 22.

作为本发明的一种实施方式,远端段15所对应的弹簧结构21部分的第二金属扁丝的厚度大于0.004英寸,宽度大于0.01英寸。中间段16所对应的编织网管结构22包括第一金属扁丝,第一金属扁丝的厚度为0.001-0.003英寸,宽度为0.003-0.005英寸;中间段16内弹簧结构21包括第二金属扁丝,第二金属扁丝的宽度为0.007-0.015英寸,厚度为0.002-0.005英寸。As an embodiment of the present invention, the thickness of the second metal flat wire of the spring structure 21 corresponding to the distal section 15 is greater than 0.004 inches and the width is greater than 0.01 inches. The braided mesh tube structure 22 corresponding to the middle section 16 includes a first metal flat wire, the thickness of the first metal flat wire is 0.001-0.003 inches, and the width is 0.003-0.005 inches; the spring structure 21 in the middle section 16 includes a second metal flat wire, the width of the second metal flat wire is 0.007-0.015 inches, and the thickness is 0.002-0.005 inches.

为了验证抽吸导管100能配合扩张器能够经股动脉推送至肺动脉主干,经左右肺段动脉时不发生弯折,本发明做了以下实验:将抽吸导管100缠绕在不同外径的圆柱上180度,缠绕后观察抽吸导管100是否发生弯折。本发明针对抽吸导管100的三层结构中的加固层12和外套管11不同组合进行实验,抗弯折的测试结果如下:In order to verify that the suction catheter 100 can be pushed to the pulmonary artery trunk through the femoral artery with the dilator, and does not bend when passing through the left and right pulmonary arteries, the present invention conducted the following experiment: the suction catheter 100 was wrapped 180 degrees on a cylinder with different outer diameters, and after wrapping, the suction catheter 100 was observed to see if it was bent. The present invention conducted experiments on different combinations of the reinforcement layer 12 and the outer sleeve 11 in the three-layer structure of the suction catheter 100, and the anti-bending test results are as follows:

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.002英寸、宽度为0.008英寸、与该部分对应的外套管11的硬度为35D时,最小弯曲直径为60mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.002 inches, the width is 0.008 inches, and the hardness of the outer sleeve 11 corresponding to this part is 35D, the minimum bending diameter is 60 mm.

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.003英寸、宽度为0.009英寸、与该部分对应的外套管11的硬度为35D时,最小弯曲直径为46mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.003 inches, the width is 0.009 inches, and the hardness of the outer sleeve 11 corresponding to this part is 35D, the minimum bending diameter is 46 mm.

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.003英寸、宽度为0.009英寸、与该部分对应的外套管11的硬度为63D时,最小弯曲直径为72mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.003 inches, the width is 0.009 inches, and the hardness of the outer sleeve 11 corresponding to this part is 63D, the minimum bending diameter is 72 mm.

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.004英寸、宽度为0.016英寸、与该部分对应的外套管11的硬度为35D时,最小弯曲直径为15mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.004 inches, the width is 0.016 inches, and the hardness of the outer sleeve 11 corresponding to this part is 35D, the minimum bending diameter is 15 mm.

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.004英寸、宽度为0.016英寸、与该部分对应的外套管11的硬度为55D时,最小弯曲直径为42mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.004 inches, the width is 0.016 inches, and the hardness of the outer sleeve 11 corresponding to this part is 55D, the minimum bending diameter is 42 mm.

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.004英寸、宽度为0.016英寸、与该部分对应的外套管11的硬度为63D时,最小弯曲直径为46mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.004 inches, the width is 0.016 inches, and the hardness of the outer sleeve 11 corresponding to this part is 63D, the minimum bending diameter is 46 mm.

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.005英寸、宽度为0.015英寸、与该部分对应的外套管11的硬度为25D时,最小弯曲直径为15mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.005 inches, the width is 0.015 inches, and the hardness of the outer sleeve 11 corresponding to this part is 25D, the minimum bending diameter is 15 mm.

当金属加固层采用弹簧结构,即第二金属扁丝的厚度为0.005英寸、宽度为0.015英寸、与该部分对应的外套管11的硬度为35D时,最小弯曲直径为6mm。When the metal reinforcement layer adopts a spring structure, that is, the thickness of the second metal flat wire is 0.005 inches, the width is 0.015 inches, and the hardness of the outer sleeve 11 corresponding to this part is 35D, the minimum bending diameter is 6 mm.

当金属加固层采用编织网管结构,即第一金属扁丝的厚度为0.002英寸、宽度为0.008英寸、与该部分对应的外套管11的硬度为35D时,最小弯曲直径为15mm。When the metal reinforcement layer adopts a braided mesh tube structure, that is, the thickness of the first metal flat wire is 0.002 inches, the width is 0.008 inches, and the hardness of the outer sleeve 11 corresponding to this part is 35D, the minimum bending diameter is 15 mm.

当金属加固层采用编织网管结构,即第一金属扁丝的厚度为0.002英寸、宽度为0.008英寸、与该部分对应的外套管11的硬度为63D时,最小弯曲直径为64mm。When the metal reinforcement layer adopts a braided mesh tube structure, that is, the thickness of the first metal flat wire is 0.002 inches, the width is 0.008 inches, and the hardness of the outer sleeve 11 corresponding to this part is 63D, the minimum bending diameter is 64mm.

当金属加固层采用编织网管结构,即第一金属扁丝的厚度为0.003英寸、宽度为0.007英寸、与该部分对应的外套管11的硬度为42A+25D(其中,A和D均为邵氏硬度单位)时,最小弯曲直径为15mm。When the metal reinforcement layer adopts a braided mesh tube structure, that is, the thickness of the first metal flat wire is 0.003 inches, the width is 0.007 inches, and the hardness of the outer sleeve 11 corresponding to this part is 42A+25D (where A and D are both Shore hardness units), the minimum bending diameter is 15mm.

当金属加固层采用圆丝,厚度为0.002英寸、与该部分对应的外套管11的硬度为35D时,最小弯曲直径为60mm。When the metal reinforcement layer is made of round wire with a thickness of 0.002 inches and the hardness of the outer sleeve 11 corresponding to this portion is 35D, the minimum bending diameter is 60 mm.

具体实验数据如下表所示:The specific experimental data are shown in the following table:

,

通过上表可见,当金属扁丝的厚度为0.002-0.005英寸,宽度在0.007-0.015英寸内,与硬度在42A-35D的材料组合能够抵抗15mm直径的弯折,有利于抗弯折能力。It can be seen from the above table that when the thickness of the metal flat wire is 0.002-0.005 inches and the width is within 0.007-0.015 inches, it is combined with a material with a hardness of 42A-35D to resist bending of 15mm diameter, which is beneficial to the bending resistance.

除了抗弯折性能,本发明的材料选择还体现在抽吸导管100末端14的抗塌陷性能。参照图4,作为本发明的一种实施方式,抽吸导管100末端14的长度约为10mm、材料硬度大于等于35D,这样末端14在97kpa的负压抽吸下不会出现塌陷的现象。In addition to the anti-bending performance, the material selection of the present invention is also reflected in the anti-collapse performance of the end 14 of the suction catheter 100. Referring to Figure 4, as an embodiment of the present invention, the length of the end 14 of the suction catheter 100 is about 10 mm, and the material hardness is greater than or equal to 35D, so that the end 14 will not collapse under the negative pressure suction of 97kpa.

如图4所示,为了验证导管抽吸的有效性,本发明做了以下实验:As shown in FIG4 , in order to verify the effectiveness of catheter aspiration, the present invention conducted the following experiments:

在抽吸导管100近端段17施加一个大气压的负压,末端14用一种透明的塑料薄片31堵住,观察抽吸导管100整体是否有塌陷的现象。本发明测试了不同硬度的24Fr抽吸导管100末端14,测试结果如下:A negative pressure of atmospheric pressure is applied to the proximal section 17 of the suction catheter 100, and the end 14 is blocked with a transparent plastic sheet 31 to observe whether the suction catheter 100 as a whole collapses. The present invention tests the end 14 of the 24Fr suction catheter 100 of different hardnesses, and the test results are as follows:

末端14硬度为42A时,抽吸导管100有塌陷,且严重塌陷,如图5b所示。When the hardness of the tip 14 is 42A, the suction catheter 100 collapses and collapses severely, as shown in FIG. 5 b .

末端14硬度为62A时,抽吸导管100有塌陷,且严重塌陷,如图5b所示。When the hardness of the tip 14 is 62A, the suction catheter 100 collapses and collapses severely, as shown in FIG. 5 b .

末端14硬度为35D时,抽吸导管100有塌陷,但是稍有塌陷,如图5b所示。When the hardness of the tip 14 is 35D, the aspiration catheter 100 collapses, but only slightly, as shown in FIG. 5b.

末端14硬度为45D时,抽吸导管100无塌陷,如图5a所示。When the hardness of the tip 14 is 45D, the aspiration catheter 100 does not collapse, as shown in FIG. 5 a .

末端14硬度为63D时,抽吸导管100无塌陷,如图5a所示。When the hardness of the tip 14 is 63D, the aspiration catheter 100 does not collapse, as shown in FIG. 5 a .

具体实验数据如下表所示:The specific experimental data are shown in the following table:

,

通过上表可见,当末端14的材料硬度大于等于35D时,可以保证导管抽吸的有效性。It can be seen from the above table that when the material hardness of the end 14 is greater than or equal to 35D, the effectiveness of catheter suction can be guaranteed.

由上述一系列测试可见,为了制成一种大口径(16Fr-24Fr)的导管,本发明同时对抽吸导管100的外套管11和加固层12的结构/材料进行改进。一方面,外套管11的硬度在轴向上产生变化,使得外套管11的硬度由远端段15到近端段17逐渐增加,并且抽吸导管100的最远端(即末端14)采用硬度较高的材料,以此保持大口径下的抗弯折性能和抗塌陷性能。It can be seen from the above series of tests that in order to manufacture a large-caliber (16Fr-24Fr) catheter, the present invention simultaneously improves the structure/material of the outer sleeve 11 and the reinforcement layer 12 of the suction catheter 100. On the one hand, the hardness of the outer sleeve 11 changes in the axial direction, so that the hardness of the outer sleeve 11 gradually increases from the distal section 15 to the proximal section 17, and the farthest end (i.e., the end 14) of the suction catheter 100 is made of a material with a higher hardness, so as to maintain the anti-bending performance and anti-collapse performance under large caliber.

另一方面,加固层12在轴向上的材料和硬度配合外套管11同样发生变化,利用金属扁丝代替的传统的圆丝,并且金属扁丝的编织方式从弹簧结构渐变为编织网管结构,且金属扁丝的厚度和宽度也能相应改变。On the other hand, the material and hardness of the reinforcement layer 12 in the axial direction also change with the outer sleeve 11, using metal flat wire instead of traditional round wire, and the weaving method of the metal flat wire gradually changes from a spring structure to a woven mesh structure, and the thickness and width of the metal flat wire can also be changed accordingly.

通过上述实施方式可见,本发明测试了多种外套管11和加固层12在材料上的选择,最终确定了适合大口径抽吸导管100的外套管11和加固层12的材料/结构取值范围。通过外套管11和加固层12的配合与改进,本发明的用于介入手术的抽吸导管至少具有以下的有益效果:It can be seen from the above embodiments that the present invention has tested various choices of materials for the outer sleeve 11 and the reinforcement layer 12, and finally determined the material/structure value range of the outer sleeve 11 and the reinforcement layer 12 suitable for the large-caliber suction catheter 100. Through the coordination and improvement of the outer sleeve 11 and the reinforcement layer 12, the suction catheter for interventional surgery of the present invention has at least the following beneficial effects:

1.导管的内径较大,足以吸出体积较大的栓塞物;1. The inner diameter of the catheter is large enough to aspirate larger emboli;

2.较大内径的导管可以通过弯曲的血管路径;2. Catheters with larger inner diameters can pass through tortuous blood vessels;

3.导管在通过较小的路径后不会产生弯折,因此不会影响有效的抽吸;3. The catheter will not bend after passing through a smaller path, so it will not affect effective suction;

4.抽吸负压较大的情况下导管不会出现塌陷,因此不会影响抽吸的效率。4. The catheter will not collapse when the negative pressure of suction is large, so it will not affect the efficiency of suction.

如本说明和权利要求书所示,“一”、“一个”、“一种”和/或“该”等词语并不具体指单数,而可包括复数,除非上下文明确暗示例外。一般而言,术语“包含”和“包括”仅表示包含明确标识的步骤和要素,这些步骤和要素不构成排他性清单,并且方法或装置可能包含其他步骤或要素。As shown in this specification and claims, the words "a", "an", "an" and/or "the" do not specifically refer to the singular, but may include the plural, unless the context clearly implies an exception. In general, the terms "comprises" and "including" only mean that the steps and elements specifically identified are included, which do not constitute an exclusive list, and the method or apparatus may include other steps or elements.

本技术领域中的普通技术人员应当认识到,以上的实施例仅是用来说明本发明,而并非用作为对本发明的限定,只要在本发明的实质精神范围内,对以上所述实施例的变化、变型都将落在本发明的权利要求书范围内。Those skilled in the art should recognize that the above embodiments are only used to illustrate the present invention, and are not intended to limit the present invention. As long as they are within the spirit of the present invention, any changes or modifications to the above embodiments will fall within the scope of the claims of the present invention.

Claims (6)

1.一种用于介入手术的抽吸导管,包括沿轴向延伸的外套管和加固层,所述外套管在径向上设置于加固层外层,其特征在于:1. A suction catheter for interventional surgery, comprising an outer sleeve extending axially and a reinforcement layer, wherein the outer sleeve is arranged radially outside the reinforcement layer, characterized in that: 所述外套管沿轴向依次包括末端、远端段、中间段、近端段,其中所述远端段、中间段和近端段的材料硬度依次提升;The outer sleeve comprises a terminal end, a distal end section, a middle section, and a proximal end section in sequence along the axial direction, wherein the material hardness of the distal end section, the middle section, and the proximal end section increases in sequence; 所述末端的材料硬度大于等于35D,所述近端段的材料硬度大于等于63D;The material hardness of the terminal end is greater than or equal to 35D, and the material hardness of the proximal end section is greater than or equal to 63D; 所述中间段的材料硬度沿轴向从远端段至近端段方向依次提升;The material hardness of the middle section increases in sequence from the distal section to the proximal section along the axial direction; 所述加固层包括弹簧结构和编织网管结构,两者在轴向上具有相应的分布区域,其中,所述远端段内的加固层为弹簧结构,所述中间段内的加固层为弹簧结构和编织网管结构,所述近端段内的加固层为编织网管结构;The reinforcement layer includes a spring structure and a braided mesh tube structure, and the two have corresponding distribution areas in the axial direction, wherein the reinforcement layer in the distal segment is a spring structure, the reinforcement layer in the middle segment is a spring structure and a braided mesh tube structure, and the reinforcement layer in the proximal segment is a braided mesh tube structure; 所述中间段的材料硬度为42D-63D;所述中间段内的编织网管结构包括第一金属扁丝,所述第一金属扁丝的厚度为0.001-0.003英寸,宽度为0.003-0.005英寸;所述中间段内的所述弹簧结构包括第二金属扁丝,所述第二金属扁丝的厚度为0.002-0.005英寸,宽度为0.007-0.015英寸;The material hardness of the middle section is 42D-63D; the braided mesh tube structure in the middle section includes a first metal flat wire, the thickness of the first metal flat wire is 0.001-0.003 inches, and the width is 0.003-0.005 inches; the spring structure in the middle section includes a second metal flat wire, the thickness of the second metal flat wire is 0.002-0.005 inches, and the width is 0.007-0.015 inches; 所述远端段的材料硬度小于等于35D;所述远端段内的弹簧结构的第二金属扁丝的厚度大于0.004英寸,宽度大于0.01英寸;The material hardness of the distal segment is less than or equal to 35D; the thickness of the second metal flat wire of the spring structure in the distal segment is greater than 0.004 inches and the width is greater than 0.01 inches; 所述抽吸导管的外径范围为16Fr-24Fr。The outer diameter of the suction catheter ranges from 16Fr to 24Fr. 2.如权利要求1所述的用于介入手术的抽吸导管,其特征在于:2. The aspiration catheter for interventional surgery according to claim 1, characterized in that: 所述末端沿轴向的长度为10mm,所述远端段沿轴向的长度为400mm,所述中间段沿轴向的长度为120mm,所述近端段沿轴向的长度为500mm。The axial length of the terminal end is 10 mm, the axial length of the distal end section is 400 mm, the axial length of the middle section is 120 mm, and the axial length of the proximal end section is 500 mm. 3.如权利要求1所述的用于介入手术的抽吸导管,其特征在于:3. The aspiration catheter for interventional surgery according to claim 1, characterized in that: 所述中间段的材料硬度沿轴向从远端段至近端段的方向从42D提升至63D。The material hardness of the middle section increases from 42D to 63D along the axial direction from the distal section to the proximal section. 4.如权利要求1-3中任意一项所述的用于介入手术的抽吸导管,其特征在于:4. The aspiration catheter for interventional surgery according to any one of claims 1 to 3, characterized in that: 当外径为16Fr时,所述抽吸导管的内径不小于4.2mm;When the outer diameter is 16Fr, the inner diameter of the suction catheter is not less than 4.2mm; 当外径为24Fr时,所述抽吸导管的内径不小于7mm。When the outer diameter is 24 Fr, the inner diameter of the suction catheter is not less than 7 mm. 5.如权利要求4所述的用于介入手术的抽吸导管,其特征在于:5. The aspiration catheter for interventional surgery according to claim 4, characterized in that: 所述近端段的内径大于所述远端段的内径。The inner diameter of the proximal section is greater than the inner diameter of the distal section. 6.如权利要求5所述的用于介入手术的抽吸导管,其特征在于:6. The aspiration catheter for interventional surgery according to claim 5, characterized in that: 当外径为16Fr时,所述近端段的内径大于5mm;When the outer diameter is 16Fr, the inner diameter of the proximal section is greater than 5mm; 当外径为24Fr时,所述近端段的内径大于8mm。When the outer diameter is 24 Fr, the inner diameter of the proximal section is greater than 8 mm.
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