WO2023015653A1 - Introducer sheath sealing device - Google Patents

Introducer sheath sealing device Download PDF

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Publication number
WO2023015653A1
WO2023015653A1 PCT/CN2021/117587 CN2021117587W WO2023015653A1 WO 2023015653 A1 WO2023015653 A1 WO 2023015653A1 CN 2021117587 W CN2021117587 W CN 2021117587W WO 2023015653 A1 WO2023015653 A1 WO 2023015653A1
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WO
WIPO (PCT)
Prior art keywords
sealing
valve body
sealing valve
connector housing
outer end
Prior art date
Application number
PCT/CN2021/117587
Other languages
French (fr)
Chinese (zh)
Inventor
夏顺
黄定国
Original Assignee
上海腾复医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202110915943.7A external-priority patent/CN113577513A/en
Priority claimed from CN202121860627.6U external-priority patent/CN215741271U/en
Application filed by 上海腾复医疗科技有限公司 filed Critical 上海腾复医疗科技有限公司
Publication of WO2023015653A1 publication Critical patent/WO2023015653A1/en

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    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16LPIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L5/00Devices for use where pipes, cables or protective tubing pass through walls or partitions
    • F16L5/02Sealing
    • F16L5/10Sealing by using sealing rings or sleeves only

Definitions

  • the present application relates to the technical field of medical devices, in particular to a catheter sealing device.
  • Minimally invasive endovascular interventional surgery has gradually become the mainstream trend in the treatment of vascular diseases.
  • all interventional procedures require the introduction of surgical instruments through an introduction sheath.
  • Clinical application requires that the introduction sheath must have both tightness and low introduction resistance. Sealing requires that the introduction sheath can be well sealed to prevent blood from flowing out when used alone or in combination with other instruments.
  • Low introduction resistance requires that the introduction sheath has very little resistance when providing an introduction channel for other instruments, so as to avoid inability to introduce or damage the instrument during introduction.
  • the purpose of some embodiments of the present application is to provide a catheter sealing device, which solves the problem that the existing catheter sealing device cannot achieve both sealing performance and low introduction resistance.
  • An embodiment of the present application provides a catheter sealing device, including: a catheter body; a connector housing, in a tubular structure; a sealing assembly, the sealing assembly includes: an elastically twistable tubular sealing valve body, the catheter body and the inner end of the sealing valve body are all fixed in the connector housing, the conduit body communicates with the sealing valve body; and the adjustment knob is arranged on the connector housing and connected to the The outer end of the sealing valve body is connected to drive the outer end of the sealing valve body to rotate to adjust the sealing force of the sealing valve body; the adjusting knob has an instrument introduction channel communicated with the sealing valve body.
  • the adjusting knob is threadedly connected with the outer end of the connector housing, and the sealing force of the sealing valve body can be adjusted by the number of rotations and the screw pitch.
  • the inner end of the adjustment knob is provided with an internal thread
  • the outer end of the connector housing is provided with an external thread
  • the adjustment knob and the connector housing are threaded through the internal thread and the external thread. connect.
  • the sealing assembly also includes internal fixing parts arranged at both ends of the sealing valve body, and the sealing valve body is fixed on the inner wall of the connector housing through the internal fixing parts at the internal ends of the sealing valve body.
  • the valve body is fixedly connected with the adjusting knob through the inner fixing part at the outer end.
  • sealing valve body is dumbbell-shaped or straight-pipe-shaped.
  • the sealing valve body includes an elastic valve body body and a superslip film layer arranged on the inner wall of the elastic valve body body.
  • the super-slip film layer is made of polytetrafluoroethylene or expanded polytetrafluoroethylene.
  • sealing valve body is a straight tube balloon filled with liquid or gas.
  • the elasticity of the two ends of the straight tubular balloon is greater than that of the middle part of the balloon.
  • the catheter sealing device further includes a transfusion tube connected to the side wall of the connector body, and the transfusion tube communicates with the catheter tube body.
  • the sealing assembly is used as a sealing structure extending from the adjustment knob at the outer end to the introduction channel at the distal end of the catheter body.
  • the sealing valve body is an elastic and twistable tubular structure, and the inner end of the sealing valve body is sealed. It is fixed in the connector housing and communicated with the conduit body.
  • the outer end of the sealing valve body is connected with the adjustment knob.
  • the outer end of the sealing valve body can be driven to rotate by operating the adjustment knob, thereby driving the sealing valve body to twist.
  • the degree of torsion of the valve body adjusts the size of its sealing force.
  • the catheter sealing device of the embodiment of the present application can simultaneously take into account the sealing performance and low-resistance introduction performance, greatly improving the convenience of operation.
  • FIG. 1 is a schematic structural view of a catheter sealing device provided in an embodiment of the present application
  • Fig. 2 is a schematic cross-sectional structural view of the conduction state of the catheter sealing device provided by the embodiment of the present application;
  • FIG. 3 is a schematic cross-sectional structural view of the sealing state of the catheter sealing device provided by the embodiment of the present application.
  • Fig. 4 is a structural schematic diagram of a sealing component of the catheter sealing device provided in the embodiment of the present application.
  • Fig. 5 is a structural schematic diagram of another sealing assembly of the catheter sealing device provided in the embodiment of the present application.
  • Fig. 6 is a structural schematic diagram of another sealing component of the catheter sealing device provided in the embodiment of the present application.
  • FIG. 7 is a structural schematic diagram of the sealing state of the sealing assembly of the conduit sealing device shown in FIG. 6 .
  • proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end. Control conduit seal.
  • orientation or positional relationship indicated by the terms “inner”, “outer”, “middle”, etc. are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating Or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the application.
  • a catheter sealing device provided by Embodiment 1 of the present application can be used for endovascular interventional surgery.
  • the catheter sealing device of the embodiment of the present application mainly includes: a catheter tube body 1 , a connector housing 2 , a sealing assembly 3 , an adjustment knob 4 and an infusion tube 5 .
  • the connector housing 2 has a tubular structure and is used for the sealed connection of the catheter body 1 , the infusion tube 5 and the sealing assembly 3 .
  • the infusion tube 5 is connected to the side wall of the connector housing 2 .
  • the transfusion tube 5 communicates with the catheter body 1, and thrombus suction and the like can be carried out by the transfusion tube 5.
  • the catheter sealing device may not include an infusion tube.
  • the connector housing 2 is mainly used for the sealed connection between the catheter body 1 and the sealing assembly 3 .
  • the sealing assembly 3 is disposed in the connector housing 2 .
  • the sealing assembly 3 includes: an elastically twistable tubular sealing valve body 30 , the inner ends of the conduit body 1 and the sealing valve body 30 are fixed in the connector housing 2 , and the conduit body 1 communicates with the sealing valve body 30 .
  • the adjustment knob 4 is arranged on the connector housing 2 and connected with the outer end of the sealing valve body 30 , for driving the outer end of the sealing valve body 30 to rotate to adjust the sealing force of the sealing valve body 30 .
  • the adjustment knob 4 has an instrument introduction channel communicated with the sealing valve body 30 .
  • An axial instrument introduction channel is formed in the catheter sealing device from the outer end of the adjustment knob 4 to the distal end of the catheter tube body 1 .
  • the sealing assembly 3 may further include: internal fixing parts arranged at both ends of the sealing valve body 30 .
  • the sealing valve body 30 is fixed on the inner wall of the connector housing 2 through the inner fixing part 31 at the inner end, and is fixedly connected with the adjusting knob 4 through the inner fixing part 32 at the outer end.
  • Both the inner fixing part 31 sealing the inner end of the valve body 30 and the inner fixing part 32 sealing the outer end of the valve body 30 are annular support parts.
  • the sealing valve body 30 is supported and fixed on the inner wall of the connector housing 2 by an inner fixing member 31 at its inner end.
  • the outer end of the adjusting knob 4 forms a fixing ring 40 extending axially inward, and the sealing valve body 30 is supported and fixed in the fixing ring 40 of the adjusting knob 4 through the inner fixing member 32 at the outer end.
  • the two ends of the sealing valve body 30 may not be provided with internal fixing parts, but the inner ends of the sealing valve body 30 are directly sleeved on the fixing ring formed in the connector housing 2, and the sealing valve body 30 The outer end is sheathed on the annular fixing structure of the adjusting knob 4 .
  • the adjusting knob 4 can be a cylindrical structure, and the adjusting knob 4 is threadedly connected with the outer end of the connector housing 2, and the sealing force of the sealing valve body 30 can be adjusted by the number of rotations and the screw pitch.
  • the inner end of the adjustment knob 4 is provided with an internal thread
  • the outer end of the connector housing 2 is provided with an external thread
  • the adjustment knob 4 and the connector housing 2 are threaded through the internal thread and the external thread.
  • the inner end of the adjustment knob 4 is provided with an external thread
  • the outer end of the connector housing 2 is provided with an internal thread
  • the adjustment knob 4 and the connector housing 2 are screwed together through the external thread and the internal thread.
  • the threaded connection method is not only convenient for the adjustment knob 4 to drive the sealing assembly 3 to rotate, but also can play a role of rotation locking, which is convenient for locking the sealing assembly 3 at any position. It can be understood that the adjustment knob 4 can also adopt other structures that are conveniently disposed on the connector housing 2 and can drive the sealing assembly 3 to rotate and lock, and no specific limitation is set here.
  • the sealing assembly 3 is the main part for opening and sealing the introduction passage, and its sealing valve body 30 is twisted and deformed under the driving of the adjustment knob 4, thereby reducing the passage in the sealing valve body 30 until it is completely closed.
  • the sealing valve body 30 is twisted more than two times, good sealing performance can be provided.
  • the sealing valve body 30 is not twisted, it can be in an open state as shown in FIG. Injury introduced instrument.
  • the narrowing degree of the introduction channel and the closing force after closing can be quantitatively controlled by adjusting the pitch and the rotation angle of the knob 4, so that the sealing performance is precisely and controllable.
  • the sealing valve body 30 may include an elastic valve body body 300 and a super-slip film layer 301 disposed on the inner wall of the elastic valve body body 300 .
  • the elastic valve body 300 is made of elastic material, which needs to have certain support and twistability.
  • the structure of the super-sliding film layer 301 can be made of polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (e-PTFE).
  • the sealing valve body 30 may be in the shape of a dumbbell.
  • the elasticity of the dumbbell-shaped sealing valve body 30 gradually increases from the middle to both ends. Therefore, when the sealing valve body 30 is subjected to torsion force, the central part is more likely to be torsionally deformed, making the sealing performance better and easier to control.
  • the sealing valve body 30 may also be in the shape of a straight pipe.
  • the straight pipe-shaped sealing valve body 30 can provide a larger introduction diameter in a natural state.
  • the sealing valve body 30 can also be a straight tubular balloon filled with liquid or gas.
  • the straight tubular balloon has a sealed structure, and a certain amount of liquid or gas is sealed inside.
  • the balloon structure sealing the valve body 30 can be made of elastic body and has good compliance.
  • Figure 7 when the adjustment knob 4 is rotated, the liquid or gas in the straight tube-shaped balloon-shaped sealing valve body 30 is squeezed to the middle by both ends, and the balloon is inflated in the middle, and finally reaches a tightness. combined state.
  • the elasticity of the two ends of the straight tubular balloon is greater than the elasticity of the middle portion of the balloon.
  • the length of its two ends can be made into a solid valve body, and the thickness of the solid valve body can also be made smaller, so that when the sealing valve body 30 is subjected to torsional force, Liquid or gas is squeezed towards the middle part.
  • the catheter sealing device In the interventional operation, the catheter sealing device according to the embodiment of the present application is inserted into the blood vessel according to the standard operation, and the adjustment knob is rotated to make the sealing valve body 30 to a tight state, which can play a role in hemostasis. Take the device to be introduced, loosen the adjustment knob 4 according to the size of the device, open the introduction channel to the required size, and quickly insert the device to be introduced, then observe the bleeding situation and rotate the adjustment knob until the bleeding is just stopped.
  • the catheter sealing device of the embodiment of the present application has adjustable inner diameter and adjustable sealing force.
  • the sealing force can be adjusted according to the demand, and can reduce the introduction and return as much as possible under the premise of achieving the hemostasis effect. Withdraw resistance.
  • the operation time can be saved, and the device can be prevented from being damaged by large resistance. Therefore, the catheter sealing device of the embodiment of the present application can simultaneously take into account the sealing performance and low-resistance introduction performance, greatly improving the convenience of operation.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

An introducer sheath sealing device. The introducer sheath sealing device comprises an introducer sheath body (1), a connector housing (2), a sealing assembly (3), and an adjustment knob (4); the sealing assembly (3) comprises a tubular sealing valve (30) that can be elastically twisted; the inner ends of the introducer sheath body (1) and the sealing valve (30) are fixedly provided in the connector housing (2); the introducer sheath body (1) is communicated with the sealing valve (30); the adjustment knob (4) is disposed on the connector housing (2), connected to the outer end of the sealing valve (30), and used for driving the outer end of the sealing valve (30) to rotate to adjust the sealing force of the sealing valve (30); the adjustment knob (4) has an instrument introduction channel communicated with the sealing valve (30). The introducer sheath sealing device enables an introducer sheath to have both a sealing property and low introduction resistance, thereby improving the convenience and efficiency in surgical operations.

Description

一种导管密封装置A conduit sealing device
交叉引用cross reference
本申请引用于2021年08月10日递交的名称为“一种导管密封装置”的第202110915943.7号中国专利申请,其通过引用被全部并入本申请This application refers to the Chinese patent application No. 202110915943.7 entitled "A Conduit Sealing Device" filed on August 10, 2021, which is incorporated by reference in its entirety into this application
技术领域technical field
本申请涉及医疗器械技术领域,特别涉及一种导管密封装置。The present application relates to the technical field of medical devices, in particular to a catheter sealing device.
背景技术Background technique
微创伤血管内介入手术已经逐渐成为血管疾病治疗的主流趋势。通常所有介入手术实施都需要通过导入鞘管导入手术器械。临床应用要求导入鞘管需同时具备密封性以及低导入阻力。密封性要求导入鞘管在单独使用以及配合其他器械导入时,都能密封良好,防止血液流出。低导入阻力要求导入鞘管在为其他器械提供导入通道时阻力很小,避免无法导入或导入过程中损伤器械。Minimally invasive endovascular interventional surgery has gradually become the mainstream trend in the treatment of vascular diseases. In general, all interventional procedures require the introduction of surgical instruments through an introduction sheath. Clinical application requires that the introduction sheath must have both tightness and low introduction resistance. Sealing requires that the introduction sheath can be well sealed to prevent blood from flowing out when used alone or in combination with other instruments. Low introduction resistance requires that the introduction sheath has very little resistance when providing an introduction channel for other instruments, so as to avoid inability to introduce or damage the instrument during introduction.
然而密封性和低导入阻力性能往往是无法兼得的,即要求密封性好,则导入阻力越大;若导入阻力小,则密封性能下降。However, it is often impossible to have both sealing performance and low introduction resistance performance. That is to say, if good sealing performance is required, the introduction resistance will be greater; if the introduction resistance is small, the sealing performance will decrease.
发明内容Contents of the invention
本申请部分实施例的目的在于提供一种导管密封装置,解决现有导管密 封装置密封性和低导入阻力性能无法兼得的问题。The purpose of some embodiments of the present application is to provide a catheter sealing device, which solves the problem that the existing catheter sealing device cannot achieve both sealing performance and low introduction resistance.
本申请实施例提供了一种导管密封装置,包括:导管管体;连接件壳体,呈管状结构;密封组件,所述密封组件包括:可弹性扭转的管状密封阀体,所述导管管体及所述密封阀体的内端均固设于所述连接件壳体内,所述导管管体与所述密封阀体连通;以及调节旋钮,设置于所述连接件壳体上,且与所述密封阀体的外端相连,用于带动所述密封阀体外端旋转,以调节所述密封阀体的密封力;所述调节旋钮具有与所述密封阀体连通的器械导入通道。An embodiment of the present application provides a catheter sealing device, including: a catheter body; a connector housing, in a tubular structure; a sealing assembly, the sealing assembly includes: an elastically twistable tubular sealing valve body, the catheter body and the inner end of the sealing valve body are all fixed in the connector housing, the conduit body communicates with the sealing valve body; and the adjustment knob is arranged on the connector housing and connected to the The outer end of the sealing valve body is connected to drive the outer end of the sealing valve body to rotate to adjust the sealing force of the sealing valve body; the adjusting knob has an instrument introduction channel communicated with the sealing valve body.
另外,所述调节旋钮与所述连接件壳体的外端螺纹连接,并通过旋转圈数以及螺距调节所述密封阀体的密封力。In addition, the adjusting knob is threadedly connected with the outer end of the connector housing, and the sealing force of the sealing valve body can be adjusted by the number of rotations and the screw pitch.
另外,所述调节旋钮的内端设有内螺纹,所述连接件壳体的外端设有外螺纹,所述调节旋钮与所述连接件壳体通过所述内螺纹以及所述外螺纹螺纹连接。In addition, the inner end of the adjustment knob is provided with an internal thread, the outer end of the connector housing is provided with an external thread, and the adjustment knob and the connector housing are threaded through the internal thread and the external thread. connect.
另外,所述密封组件还包括设置于所述密封阀体两端的内固定件,所述密封阀体通过所述密封阀体内端的内固定件固设于所述连接件壳体内壁,所述密封阀体通过其外端的内固定件与所述调节旋钮固定连接。In addition, the sealing assembly also includes internal fixing parts arranged at both ends of the sealing valve body, and the sealing valve body is fixed on the inner wall of the connector housing through the internal fixing parts at the internal ends of the sealing valve body. The valve body is fixedly connected with the adjusting knob through the inner fixing part at the outer end.
另外,述密封阀体为哑铃形或者直管形。In addition, the sealing valve body is dumbbell-shaped or straight-pipe-shaped.
另外,所述密封阀体包括弹性阀体本体以及设置于所述弹性阀体本体内壁的超滑膜层。In addition, the sealing valve body includes an elastic valve body body and a superslip film layer arranged on the inner wall of the elastic valve body body.
另外,所述超滑膜层采用聚四氟乙烯或者膨体聚四氟乙烯制成。In addition, the super-slip film layer is made of polytetrafluoroethylene or expanded polytetrafluoroethylene.
另外,所述密封阀体为直管形球囊,所述直管形球囊内充设有液体或者气体。In addition, the sealing valve body is a straight tube balloon filled with liquid or gas.
另外,所述直管形球囊的两端的弹性大于所述球囊中间部分的弹性。In addition, the elasticity of the two ends of the straight tubular balloon is greater than that of the middle part of the balloon.
另外,所述导管密封装置还包括与所述连接件本体的侧壁相连的输液管,所述输液管与所述导管管体连通。In addition, the catheter sealing device further includes a transfusion tube connected to the side wall of the connector body, and the transfusion tube communicates with the catheter tube body.
由上述技术方案可知,本申请实施例至少具有如下优点和有益效果:It can be seen from the above technical solutions that the embodiments of the present application have at least the following advantages and beneficial effects:
本申请实施例的导管密封装置中,密封组件作为从外端的调节旋钮延伸到导管管体远端的导入通道的密封结构,其密封阀体为弹性可扭转的管状结构,密封阀体的内端固设于连接件壳体内,并与导管管体连通,密封阀体的外端与调节旋钮相连,通过操作调节旋钮可带动密封阀体的外端旋转,从而带动密封阀体扭转,通过控制密封阀体扭转的程度调节其密封力的大小,在需要密封导入通道时,使其能够提供较大的密封力,而在需要导入器械时,可使其具有很小的导入阻力,便于迅速导入器械。因此,本申请实施例的导管密封装置可同时兼顾密封性以及低阻力导入性能,大大提高手术操作便利性。In the catheter sealing device of the embodiment of the present application, the sealing assembly is used as a sealing structure extending from the adjustment knob at the outer end to the introduction channel at the distal end of the catheter body. The sealing valve body is an elastic and twistable tubular structure, and the inner end of the sealing valve body is sealed. It is fixed in the connector housing and communicated with the conduit body. The outer end of the sealing valve body is connected with the adjustment knob. The outer end of the sealing valve body can be driven to rotate by operating the adjustment knob, thereby driving the sealing valve body to twist. By controlling the sealing The degree of torsion of the valve body adjusts the size of its sealing force. When it is necessary to seal the introduction channel, it can provide a large sealing force, and when it is necessary to introduce the device, it can make it have a small introduction resistance, which is convenient for the rapid introduction of the device. . Therefore, the catheter sealing device of the embodiment of the present application can simultaneously take into account the sealing performance and low-resistance introduction performance, greatly improving the convenience of operation.
附图说明Description of drawings
为了更清楚地说明本申请实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,可以理解地,下面描述中的附图仅仅是本申请的实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据提供的附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. It can be understood that the accompanying drawings in the following description It is only an embodiment of the present application, and those skilled in the art can also obtain other drawings according to the provided drawings without creative work.
图1为本申请实施例提供的导管密封装置的结构示意图;FIG. 1 is a schematic structural view of a catheter sealing device provided in an embodiment of the present application;
图2为本申请实施例提供的导管密封装置的导通状态的剖面结构示意图;Fig. 2 is a schematic cross-sectional structural view of the conduction state of the catheter sealing device provided by the embodiment of the present application;
图3为本申请实施例提供的导管密封装置的密封状态的剖面结构示意图;3 is a schematic cross-sectional structural view of the sealing state of the catheter sealing device provided by the embodiment of the present application;
图4为本申请实施例提供的导管密封装置的一种密封组件的结构示意图;Fig. 4 is a structural schematic diagram of a sealing component of the catheter sealing device provided in the embodiment of the present application;
图5为本申请实施例提供的导管密封装置的又一种密封组件的结构示意 图;Fig. 5 is a structural schematic diagram of another sealing assembly of the catheter sealing device provided in the embodiment of the present application;
图6为本申请实施例提供的导管密封装置的再一种密封组件的结构示意图;Fig. 6 is a structural schematic diagram of another sealing component of the catheter sealing device provided in the embodiment of the present application;
图7为图6所示的导管密封装置的密封组件的密封状态结构示意图。FIG. 7 is a structural schematic diagram of the sealing state of the sealing assembly of the conduit sealing device shown in FIG. 6 .
具体实施方式Detailed ways
为使本申请实施例的目的、技术方案和优点更加清楚,下面将结合附图对本申请的各实施方式进行详细的阐述。然而,本领域的普通技术人员可以理解,在本申请各实施方式中,为了使读者更好地理解本申请而提出了许多技术细节。但是,即使没有这些技术细节和基于以下各实施方式的种种变化和修改,也可以实现本申请所要求保护的技术方案。In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, various implementations of the present application will be described in detail below in conjunction with the accompanying drawings. However, those of ordinary skill in the art can understand that, in each implementation manner of the present application, many technical details are provided for readers to better understand the present application. However, even without these technical details and various changes and modifications based on the following implementation modes, the technical solution claimed in this application can also be realized.
除非特别说明,本申请中提及的近端、远端在朝向上具有相同含义,即使用状态下,远端为远离操作者的一端,近端为靠近操作者的一端,操作者在近端控制导管密封装置。需要理解的是,术语“内”、“外”、“中间”等指示的方位或位置关系为基于附图所示的方位或者位置关系,仅是为了便于描述本申请和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本申请的限制。Unless otherwise specified, the proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end. Control conduit seal. It should be understood that the orientation or positional relationship indicated by the terms "inner", "outer", "middle", etc. are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating Or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the application.
请参阅图1~图5所示,本申请实施例1提供的一种导管密封装置,可用于血管内介入手术治疗。本申请实施例的导管密封装置主要包括:导管管体1、连接件壳体2、密封组件3、调节旋钮4以及输液管5。Please refer to FIG. 1 to FIG. 5 , a catheter sealing device provided by Embodiment 1 of the present application can be used for endovascular interventional surgery. The catheter sealing device of the embodiment of the present application mainly includes: a catheter tube body 1 , a connector housing 2 , a sealing assembly 3 , an adjustment knob 4 and an infusion tube 5 .
连接件壳体2呈管状结构,用于导管管体1、输液管5以及密封组件3的密封连接。输液管5与连接件壳体2的侧壁相连。输液管5与导管管体1连 通,通过输液管5可以进行血栓抽吸等。在一些例子中,导管密封装置也可以不包含输液管,此时,连接件壳体2主要用于导管管体1以及密封组件3的密封连接。密封组件3设置于连接件壳体2内。密封组件3包括:可弹性扭转的管状密封阀体30,导管管体1及密封阀体30的内端均固设于连接件壳体2内,导管管体1与密封阀体30连通。The connector housing 2 has a tubular structure and is used for the sealed connection of the catheter body 1 , the infusion tube 5 and the sealing assembly 3 . The infusion tube 5 is connected to the side wall of the connector housing 2 . The transfusion tube 5 communicates with the catheter body 1, and thrombus suction and the like can be carried out by the transfusion tube 5. In some examples, the catheter sealing device may not include an infusion tube. In this case, the connector housing 2 is mainly used for the sealed connection between the catheter body 1 and the sealing assembly 3 . The sealing assembly 3 is disposed in the connector housing 2 . The sealing assembly 3 includes: an elastically twistable tubular sealing valve body 30 , the inner ends of the conduit body 1 and the sealing valve body 30 are fixed in the connector housing 2 , and the conduit body 1 communicates with the sealing valve body 30 .
调节旋钮4设置于连接件壳体2上,且与密封阀体30的外端相连,用于带动密封阀体30外端旋转,以调节密封阀体30的密封力。调节旋钮4具有与密封阀体30连通的器械导入通道。导管密封装置中从调节旋钮4外端到导管管体1远端形成轴向器械导入通道。The adjustment knob 4 is arranged on the connector housing 2 and connected with the outer end of the sealing valve body 30 , for driving the outer end of the sealing valve body 30 to rotate to adjust the sealing force of the sealing valve body 30 . The adjustment knob 4 has an instrument introduction channel communicated with the sealing valve body 30 . An axial instrument introduction channel is formed in the catheter sealing device from the outer end of the adjustment knob 4 to the distal end of the catheter tube body 1 .
密封组件3还可以包括:设置于密封阀体30两端的内固定件。密封阀体30通过其内端的内固定件31固设于连接件壳体2内壁,并通过其外端的内固定件32与调节旋钮4固定连接。密封阀体30内端的内固定件31和密封阀体30外端的内固定件32均为环形支撑件。密封阀体30通过其内端的内固定件31支撑固定于连接件壳体2内壁。调节旋钮4外端形成沿轴向向内延伸的固定环40,密封阀体30通过其外端的内固定件32支撑固定于调节旋钮4的固定环40内。通过在密封阀体30两端设置内固定件,可防止密封阀体30两端变形,并可便于将密封阀体30固定于连接件壳体2以及调节旋钮4上。The sealing assembly 3 may further include: internal fixing parts arranged at both ends of the sealing valve body 30 . The sealing valve body 30 is fixed on the inner wall of the connector housing 2 through the inner fixing part 31 at the inner end, and is fixedly connected with the adjusting knob 4 through the inner fixing part 32 at the outer end. Both the inner fixing part 31 sealing the inner end of the valve body 30 and the inner fixing part 32 sealing the outer end of the valve body 30 are annular support parts. The sealing valve body 30 is supported and fixed on the inner wall of the connector housing 2 by an inner fixing member 31 at its inner end. The outer end of the adjusting knob 4 forms a fixing ring 40 extending axially inward, and the sealing valve body 30 is supported and fixed in the fixing ring 40 of the adjusting knob 4 through the inner fixing member 32 at the outer end. By arranging internal fixing parts at both ends of the sealing valve body 30 , deformation of both ends of the sealing valve body 30 can be prevented, and the sealing valve body 30 can be easily fixed on the connector housing 2 and the adjusting knob 4 .
在一些例子中,密封阀体30的两端也可以不设置内固定件,而直接将密封阀体30的内端套设于连接件壳体2内形成的固定环上,将密封阀体30的外端套设于调节旋钮4的环形固定结构上。In some examples, the two ends of the sealing valve body 30 may not be provided with internal fixing parts, but the inner ends of the sealing valve body 30 are directly sleeved on the fixing ring formed in the connector housing 2, and the sealing valve body 30 The outer end is sheathed on the annular fixing structure of the adjusting knob 4 .
调节旋钮4可为圆筒状结构,调节旋钮4与连接件壳体2的外端螺纹连接,并通过旋转圈数以及螺距调节密封阀体30的密封力。如图2、3所示,调 节旋钮4的内端设有内螺纹,连接件壳体2的外端设有外螺纹,调节旋钮4与连接件壳体2通过内螺纹以及外螺纹螺纹连接。在一些例子中,调节旋钮4的内端设有外螺纹,连接件壳体2的外端设有内螺纹,调节旋钮4与连接件壳体2通过外螺纹以及内螺纹螺纹连接。螺纹连接方式不仅便于调节旋钮4带动密封组件3旋转,而且可起到旋转锁定作用,便于将密封组件3锁定在任意位置。可以理解的是,调节旋钮4也可以采用其他便于设置于连接件壳体2上且能够带动密封组件3旋转及锁定的结构,在此不做具体限制。The adjusting knob 4 can be a cylindrical structure, and the adjusting knob 4 is threadedly connected with the outer end of the connector housing 2, and the sealing force of the sealing valve body 30 can be adjusted by the number of rotations and the screw pitch. As shown in Figures 2 and 3, the inner end of the adjustment knob 4 is provided with an internal thread, and the outer end of the connector housing 2 is provided with an external thread, and the adjustment knob 4 and the connector housing 2 are threaded through the internal thread and the external thread. In some examples, the inner end of the adjustment knob 4 is provided with an external thread, the outer end of the connector housing 2 is provided with an internal thread, and the adjustment knob 4 and the connector housing 2 are screwed together through the external thread and the internal thread. The threaded connection method is not only convenient for the adjustment knob 4 to drive the sealing assembly 3 to rotate, but also can play a role of rotation locking, which is convenient for locking the sealing assembly 3 at any position. It can be understood that the adjustment knob 4 can also adopt other structures that are conveniently disposed on the connector housing 2 and can drive the sealing assembly 3 to rotate and lock, and no specific limitation is set here.
密封组件3作为导入通道开启和密合的主要部件,其密封阀体30在调节旋钮4的带动下发生扭转形变,从而缩小密封阀体30内的通道,直到完全关闭。比如,当密封阀体30扭转两圈以上时,可提供良好的密封性能,当密封阀体30不扭转时,可呈如图2所示的开启状态,此时导入阻力很小,从而不会损伤导入的器械。并且导入通道的缩小程度以及关闭后的闭紧力可通过调节旋钮4的螺距和旋转角度进行定量控制,从而使得密封性能精确可控。The sealing assembly 3 is the main part for opening and sealing the introduction passage, and its sealing valve body 30 is twisted and deformed under the driving of the adjustment knob 4, thereby reducing the passage in the sealing valve body 30 until it is completely closed. For example, when the sealing valve body 30 is twisted more than two times, good sealing performance can be provided. When the sealing valve body 30 is not twisted, it can be in an open state as shown in FIG. Injury introduced instrument. Moreover, the narrowing degree of the introduction channel and the closing force after closing can be quantitatively controlled by adjusting the pitch and the rotation angle of the knob 4, so that the sealing performance is precisely and controllable.
为了使得密封阀体30具有较佳的密封性能,密封阀体30可包括弹性阀体本体300以及设置于弹性阀体本体300内壁的超滑膜层301。弹性阀体本体300采用弹性材料制成,需具备一定的支撑性和可扭转性。超滑膜层301结构可采用聚四氟乙烯(PTFE)或者膨体聚四氟乙烯(e-PTFE)制成。In order to make the sealing valve body 30 have better sealing performance, the sealing valve body 30 may include an elastic valve body body 300 and a super-slip film layer 301 disposed on the inner wall of the elastic valve body body 300 . The elastic valve body 300 is made of elastic material, which needs to have certain support and twistability. The structure of the super-sliding film layer 301 can be made of polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (e-PTFE).
如图4所示,密封阀体30可以为哑铃形。哑铃形的密封阀体30的弹性从中间到两端逐渐增大,因此,在密封阀体30受到扭转力时,中间部分更易集中发生扭转变形,使得密封性更佳且更易控制。As shown in FIG. 4 , the sealing valve body 30 may be in the shape of a dumbbell. The elasticity of the dumbbell-shaped sealing valve body 30 gradually increases from the middle to both ends. Therefore, when the sealing valve body 30 is subjected to torsion force, the central part is more likely to be torsionally deformed, making the sealing performance better and easier to control.
如图5所示,密封阀体30也可以为直管形。直管形的密封阀体30在自然状态下,可提供较大的导入直径。As shown in FIG. 5 , the sealing valve body 30 may also be in the shape of a straight pipe. The straight pipe-shaped sealing valve body 30 can provide a larger introduction diameter in a natural state.
作为上述实施例中密封阀体的替换方式,如图6所示,密封阀体30还可以为直管形球囊,直管形球囊内充设有液体或者气体。直管形球囊为密封结构,内部密封有一定量的液体或者气体。密封阀体30的球囊结构可以采用弹性体制成,并具有良好的顺应性。如图7所示,当旋转调节旋钮4时,直管形球囊状的密封阀体30内的液体或者气体被两端挤压至中间,并使得球囊在中间部位发生膨胀,最终达到密合状态。在一些例子中,直管形球囊的两端的弹性大于球囊中间部分的弹性。比如,在制作球囊密封阀体30时,可以将其两端部分长度制作成实心阀体,实心阀体的厚度也可以制作得更小些,从而使得密封阀体30在受到扭转力时,液体或者气体朝中间部分挤压。As an alternative to the sealing valve body in the above embodiment, as shown in FIG. 6 , the sealing valve body 30 can also be a straight tubular balloon filled with liquid or gas. The straight tubular balloon has a sealed structure, and a certain amount of liquid or gas is sealed inside. The balloon structure sealing the valve body 30 can be made of elastic body and has good compliance. As shown in Figure 7, when the adjustment knob 4 is rotated, the liquid or gas in the straight tube-shaped balloon-shaped sealing valve body 30 is squeezed to the middle by both ends, and the balloon is inflated in the middle, and finally reaches a tightness. combined state. In some examples, the elasticity of the two ends of the straight tubular balloon is greater than the elasticity of the middle portion of the balloon. For example, when making the balloon sealing valve body 30, the length of its two ends can be made into a solid valve body, and the thickness of the solid valve body can also be made smaller, so that when the sealing valve body 30 is subjected to torsional force, Liquid or gas is squeezed towards the middle part.
在介入手术治疗中,将本申请实施例的导管密封装置按照标准手术操作插入到血管中,旋转调节旋钮使密封阀体30至密合状态,此时可起到止血作用。取需要导入的器械,根据器械尺寸旋松调节旋钮4,使导入通道开启至需要的大小,并快速插入需导入的器械,再观察漏血情况并旋转调节旋钮至刚好止血即可。In the interventional operation, the catheter sealing device according to the embodiment of the present application is inserted into the blood vessel according to the standard operation, and the adjustment knob is rotated to make the sealing valve body 30 to a tight state, which can play a role in hemostasis. Take the device to be introduced, loosen the adjustment knob 4 according to the size of the device, open the introduction channel to the required size, and quickly insert the device to be introduced, then observe the bleeding situation and rotate the adjustment knob until the bleeding is just stopped.
由上述技术方案可知,本申请实施例具有如下优点和有益效果:It can be seen from the above technical solutions that the embodiments of the present application have the following advantages and beneficial effects:
本申请实施例的导管密封装置具有内径可调节性以及密封力可调节性,用于导入其他介入手术器械时可根据需求调节密封力,能够在达到止血效果的前提下尽可能地降低导入和回撤阻力。在手术过程中可以节省手术时间,避免阻力大损伤器械。因此,本申请实施例的导管密封装置可同时兼顾密封性以及低阻力导入性能,大大提高手术操作便利性。The catheter sealing device of the embodiment of the present application has adjustable inner diameter and adjustable sealing force. When used to introduce other interventional surgical instruments, the sealing force can be adjusted according to the demand, and can reduce the introduction and return as much as possible under the premise of achieving the hemostasis effect. Withdraw resistance. During the operation, the operation time can be saved, and the device can be prevented from being damaged by large resistance. Therefore, the catheter sealing device of the embodiment of the present application can simultaneously take into account the sealing performance and low-resistance introduction performance, greatly improving the convenience of operation.
本领域的普通技术人员可以理解,上述各实施方式是实现本申请的具体实施例,而在实际应用中,可以在形式上和细节上对其作各种改变,而不偏离 本申请的精神和范围。Those of ordinary skill in the art can understand that the above-mentioned implementation modes are specific examples for realizing the present application, and in practical applications, various changes can be made to it in form and details without departing from the spirit and spirit of the present application. scope.

Claims (10)

  1. 一种导管密封装置,其特征在于,包括:A conduit sealing device, characterized in that it comprises:
    导管管体;Catheter body;
    连接件壳体,呈管状结构;The connector housing has a tubular structure;
    密封组件,所述密封组件包括:可弹性扭转的管状密封阀体,所述导管管体及所述密封阀体的内端均固设于所述连接件壳体内,所述导管管体与所述密封阀体连通;以及A sealing assembly, the sealing assembly includes: an elastically twistable tubular sealing valve body, the conduit body and the inner end of the sealing valve body are fixed in the connector housing, the conduit body and the seal valve body communication as described above; and
    调节旋钮,设置于所述连接件壳体上,且与所述密封阀体的外端相连,用于带动所述密封阀体外端旋转,以调节所述密封阀体的密封力;所述调节旋钮具有与所述密封阀体连通的器械导入通道。The adjustment knob is arranged on the connector housing and is connected with the outer end of the sealing valve body, and is used to drive the outer end of the sealing valve body to rotate to adjust the sealing force of the sealing valve body; the adjustment The knob has an instrument introduction channel communicated with the sealing valve body.
  2. 如权利要求1所述的装置,其中,所述调节旋钮与所述连接件壳体的外端螺纹连接,并通过旋转圈数以及螺距调节所述密封阀体的密封力。The device according to claim 1, wherein the adjusting knob is threadedly connected to the outer end of the connector housing, and the sealing force of the sealing valve body can be adjusted by the number of rotations and the screw pitch.
  3. 如权利要求2所述的装置,其中,所述调节旋钮的内端设有内螺纹,所述连接件壳体的外端设有外螺纹,所述调节旋钮与所述连接件壳体通过所述内螺纹以及所述外螺纹螺纹连接。The device according to claim 2, wherein the inner end of the adjustment knob is provided with internal threads, the outer end of the connector housing is provided with external threads, and the adjustment knob and the connector housing pass through the The internal thread and the external thread are threaded.
  4. 如权利要求1所述的装置,其中,所述密封组件还包括设置于所述密封阀体两端的内固定件,所述密封阀体通过所述密封阀体内端的内固定件固设于所述连接件壳体内壁,所述密封阀体通过其外端的内固定件与所述调节旋钮固定连接。The device according to claim 1, wherein the sealing assembly further includes internal fixings arranged at both ends of the sealing valve body, and the sealing valve body is fixed on the The inner wall of the connector housing, the sealing valve body is fixedly connected with the adjusting knob through the inner fixing member at the outer end.
  5. 如权利要求1所述的装置,其中,所述密封阀体为哑铃形或者直管形。The device according to claim 1, wherein the sealing valve body is dumbbell-shaped or straight-pipe-shaped.
  6. 如权利要求1所述的装置,其中,所述密封阀体包括弹性阀体本体以及设置于所述弹性阀体本体内壁的超滑膜层。The device according to claim 1, wherein the sealing valve body comprises an elastic valve body body and a super-slip film layer arranged on the inner wall of the elastic valve body body.
  7. 如权利要求6所述的装置,其中,所述超滑膜层采用聚四氟乙烯或者膨体聚四氟乙烯制成。The device according to claim 6, wherein the super-slip film layer is made of polytetrafluoroethylene or expanded polytetrafluoroethylene.
  8. 如权利要求1所述的装置,其中,所述密封阀体为直管形球囊,所述直管形球囊内充设有液体或者气体。The device according to claim 1, wherein the sealing valve body is a straight tubular balloon filled with liquid or gas.
  9. 如权利要求8所述的装置,其中,所述直管形球囊的两端的弹性大于所述球囊中间部分的弹性。The device according to claim 8, wherein the elasticity of the two ends of the straight tubular balloon is greater than the elasticity of the middle part of the balloon.
  10. 如权利要求1所述的装置,其中,所述导管密封装置还包括与所述连接件本体的侧壁相连的输液管,所述输液管与所述导管管体连通。The device according to claim 1, wherein the catheter sealing device further comprises a fluid delivery tube connected to the side wall of the connector body, and the fluid delivery tube communicates with the catheter body.
PCT/CN2021/117587 2021-08-10 2021-09-10 Introducer sheath sealing device WO2023015653A1 (en)

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CN202110915943.7A CN113577513A (en) 2021-08-10 2021-08-10 Conduit sealing device
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CN211835810U (en) * 2019-12-31 2020-11-03 杭州启明医疗器械股份有限公司 Internal balance type hemostatic valve and catheter sheath
CN113117227A (en) * 2019-12-31 2021-07-16 杭州启明医疗器械股份有限公司 Self-adaptive hemostatic valve, catheter sheath and interventional instrument sealing method
CN113694367A (en) * 2021-07-09 2021-11-26 江苏朴芃医疗科技有限公司 Adjustable hemostasis valve device

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116898389A (en) * 2023-09-12 2023-10-20 湖南英术生命科技有限公司 Arthroscope assembly
CN116898389B (en) * 2023-09-12 2023-11-28 湖南英术生命科技有限公司 Arthroscope assembly
CN117282013A (en) * 2023-10-10 2023-12-26 晨兴(南通)医疗器械有限公司 Catheter sealing assembly for medical delivery device and delivery system for pulmonary artery thrombus removal device
CN117282013B (en) * 2023-10-10 2024-05-24 晨兴(南通)医疗器械有限公司 Catheter sealing assembly for medical delivery device and delivery system for pulmonary artery thrombus removal device

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