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CN118873816B - A catheter closure device - Google Patents

A catheter closure device Download PDF

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Publication number
CN118873816B
CN118873816B CN202411369019.3A CN202411369019A CN118873816B CN 118873816 B CN118873816 B CN 118873816B CN 202411369019 A CN202411369019 A CN 202411369019A CN 118873816 B CN118873816 B CN 118873816B
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CN
China
Prior art keywords
catheter
elastomer
plug
hemodialysis
joint
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CN202411369019.3A
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Chinese (zh)
Other versions
CN118873816A (en
Inventor
韩梁
万恒
梁坤
李虎
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Hope Medical Devices Co ltd
Original Assignee
Shanghai Hope Medical Devices Co ltd
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Publication date
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Priority to CN202411369019.3A priority Critical patent/CN118873816B/en
Publication of CN118873816A publication Critical patent/CN118873816A/en
Application granted granted Critical
Publication of CN118873816B publication Critical patent/CN118873816B/en
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Classifications

    • 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
    • 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1621Constructional aspects thereof
    • 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
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • 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
    • A61M39/20Closure caps or plugs for connectors or open ends of tubes
    • 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
    • A61M2025/0018Catheters; Hollow probes having a plug, e.g. an inflatable plug for closing catheter lumens
    • 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
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • External Artificial Organs (AREA)

Abstract

一种导管封闭装置,包括:封堵塞,封堵塞包括由发泡聚氨酯构成的弹性体和包裹在弹性体表面的ePTFE材质的覆膜,弹性体渗透在覆膜的微孔中以加固两者的连接强度,弹性体内部设置有起支撑作用的芯轴;导管,导管与封堵塞相连接,导管上设置有冲洗孔,用于冲洗血液透析导管;接头,接头与导管相连接,接头上设置有旋转阀,用于开合所述接头;输送轴,输送轴插在导管中,当输送完成后,抽出输送轴;止血阀,止血阀滑动套设于导管上,止血阀上设置有用于通过液体的侧支;封堵塞的远端为锥型结构,用于引导封堵塞,封堵塞侧面为波浪状,用于减小封堵塞与血液透析导管内壁的摩擦。

A catheter sealing device comprises: a sealing plug, which comprises an elastomer composed of foamed polyurethane and a coating made of ePTFE wrapped on the surface of the elastomer, wherein the elastomer penetrates into the micropores of the coating to strengthen the connection strength between the two, and a core shaft for supporting is arranged inside the elastomer; a catheter, which is connected to the sealing plug and is provided with a flushing hole for flushing a hemodialysis catheter; a joint, which is connected to the catheter and is provided with a rotary valve for opening and closing the joint; a delivery shaft, which is inserted into the catheter and is pulled out after the delivery is completed; a hemostatic valve, which is slidably sleeved on the catheter and is provided with a side branch for passing liquid; the distal end of the sealing plug is a conical structure for guiding the sealing plug, and the side surface of the sealing plug is wavy for reducing the friction between the sealing plug and the inner wall of the hemodialysis catheter.

Description

Catheter sealing device
Technical Field
The invention relates to the field of medical instruments, in particular to a catheter sealing device.
Background
The life line of the hemodialysis patient is a vascular access, the stable and reliable vascular access is the basic guarantee of the maintenance hemodialysis patient to carry out hemodialysis, and the establishment of the internal fistula is more and more difficult along with the aging of population, the continuous increase of the dialysis age of the maintenance hemodialysis patient, the increase of the incidence rate of crowds such as hypertension, diabetes, obesity, autoimmune diseases and the like. Temporary dialysis catheters and semi-permanent dialysis catheters have long been used clinically as one type of long term hemodialysis access. It is counted that 40% of catheter failure during clinical use is due to venous thrombosis and fibrin sheath formation, about 17% -33% of catheters are forced to be removed due to thrombosis, complications of thrombosis lead to insufficient flow rates, prolonged dialysis time and increased costs, severely affecting patient quality of life.
The dialysis catheter is sealed by using the sealing liquid after the dialysis is finished clinically so as to prevent coagulation thrombosis generated in the dialysis catheter or external bacteria from entering the dialysis catheter, but because the catheter is positioned in a blood vessel and soaked in blood, the sealing liquid can gradually diffuse and flow into a circulatory system in the blood circulation process, so that the concentration of the sealing liquid is reduced, and the risk of thrombosis still exists in the catheter. There is a need for a device that isolates the catheter from blood to prevent thrombus formation within the catheter.
Disclosure of Invention
The invention aims to overcome the defects and provide a catheter sealing device.
The technical scheme adopted by the invention is as follows:
A catheter sealing device is characterized by comprising a sealing plug, a catheter, a connector and a conveying shaft, wherein the sealing plug comprises an elastomer made of expanded polyurethane and an ePTFE material covering film wrapping the surface of the elastomer, the elastomer permeates into micropores of the covering film to strengthen the connection strength of the elastomer and the ePTFE material covering film, a mandrel with a supporting function is arranged in the elastomer, the elastomer can be compressed to at least one third of the original volume, the catheter is connected with the sealing plug, a flushing hole is formed in the catheter and used for flushing a hemodialysis catheter, the connector is connected with the catheter, a rotary valve is arranged on the connector and used for opening and closing the connector, the conveying shaft is inserted into the catheter, and after conveying is completed, the conveying shaft is pulled out, the hemostatic valve is sleeved on the catheter in a sliding mode and is provided with a side branch used for passing through liquid.
The distal end of the plugging plug is of a conical structure and is used for guiding the plugging plug, and the side surface of the plugging plug is wavy and is used for reducing friction between the plugging plug and the inner wall of the hemodialysis catheter.
Preferably, the flushing port is provided at an end of the conduit adjacent the plug.
Preferably, the catheter and the plug are connected together by the mandrel.
Preferably, the surface of the coating film is coated with heparin.
Preferably, the length of the closure plug is 1cm-3cm.
Preferably, the elastomer is a hydrogel or a silica gel.
Drawings
FIG. 1 is a catheter lock device of the present invention;
FIG. 2 is a closure plug;
fig. 3 shows a state in which a catheter sealing device according to the present invention is inserted into a hemodialysis catheter.
Detailed Description
Embodiments of the present invention are described in further detail below with reference to the accompanying drawings and examples. The following examples are illustrative of the invention but are not intended to limit the scope of the invention.
The catheter sealing device is characterized by comprising a sealing plug 100, wherein the sealing plug 100 comprises an elastomer 120 formed by foaming polyurethane and an ePTFE (ePTFE) coating film 110 wrapped on the surface of the elastomer 120, the elastomer 120 permeates into micropores of the coating film to strengthen the connection strength of the elastomer and the coating film, a mandrel 130 for supporting is arranged inside the elastomer 120, and the elastomer 120 can be compressed to at least one third of the original volume. The elasticity of the plug 100 is mainly provided by the foaming polyurethane, so that the shape of the plug 100 can be changed arbitrarily when the plug enters the hemodialysis catheter, thereby adapting to the channel of the hemodialysis catheter and improving the sealing performance. The elastomer 120 generally has a larger friction coefficient, when the elastomer 120 enters the hemodialysis catheter, the elastomer 120 generates strong pressure on the inner wall of the tube due to compression, and the friction force of the elastomer 120 on the inner wall of the tube is large, so that the catheter sealing device is difficult to push and even damages a product, and the friction force between the sealing plug 100 and the inner wall of the tube needs to be reduced. The expanded polytetrafluoroethylene is prepared from polytetrafluoroethylene resin through special processing methods such as stretching and the like, and has a network structure formed by connecting microfibers, wherein the microfibers form countless pores, when the plugging plug 100 is prepared, the ePTFE film 110 is used for wrapping a liquid polyurethane foaming agent, after the foaming polyurethane is molded, part of polyurethane can permeate into the pores of the ePTFE film 110, so that the connection strength between the ePTFE film 110 and the foaming polyurethane is enhanced, and the ePTFE film 110 and the foaming polyurethane bracket are not easy to separate in the pushing process of the plugging plug 100.
In another embodiment, the elastomer 120 is made of hydrogel or silica gel. When the elastomer 120 is a hydrogel, the hydrogel is encapsulated in the ePTFE membrane 110, and has a small volume prior to encountering the liquid, and may pass through the hemodialysis catheter smoothly, and when the stopper 100 is placed in the desired position, the hydrogel expands due to the action of blood, thereby blocking the orifice of the catheter. When the elastomer 120 is silicone, the silicone is wrapped in the ePTFE membrane 110, and because of the elasticity of the silicone, the plug 100 can adapt to the lumen of the dialysis catheter when it enters the hemodialysis catheter, thereby plugging the catheter orifice.
The elastic body 120 is also provided with a core shaft 130 for supporting. Because the elastomer 120 is not sufficiently stiff to provide sufficient force in the axial direction, a mandrel 130 is required to be positioned within the elastomer 120 to push the elastomer 120. The mandrel 130 is provided with a plurality of small holes, so that the elastic body 120 can permeate into the small holes, thereby improving the connection strength between the mandrel 130 and the elastic body 120.
The distal end of the stopper 100 has a tapered structure for guiding the stopper 100, preventing the stopper 100 from being damaged when it is inserted into a hemodialysis catheter, and facilitating the insertion of the stopper 100. The proximal end of the blocking plug 100 is provided with an arc chamfer, which is convenient for withdrawing the blocking plug 100 from the dialysis catheter. The side of the plugging plug is of a wavy structure, and the contact area between the side of the plugging plug and the inner wall of the hemodialysis catheter can be reduced by the wavy structure, so that the friction force between the side of the plugging plug and the inner wall of the hemodialysis catheter is reduced, and the pushing is smoother. The length of the plugging plug 100 is 1-3cm.
The stopper 100 is coated with a heparin coating having an anticoagulant function on the surface of the ePTFE membrane 110 because the distal end is exposed to blood and there is a risk of thrombus formation when the stopper is closed.
One end of a catheter 200 is connected to the stopper 100, and a flushing hole 210 is provided in the catheter 200 for flushing the hemodialysis catheter. The flushing port 210 is disposed near one end of the plug 100, and the flushing port 210 is square, circular, or a combination thereof. The catheter 200 and the plugging plug 100 are connected together through the mandrel 130, one end of the mandrel 130 is inserted into the elastomer 120, the other end is inserted into the catheter 200, the length of the mandrel 130 inserted into the catheter 200 does not block the flushing hole 210, and the mandrel 130 and the catheter 200 are bonded together through glue.
The other end of the guide pipe 200 is connected with a joint 300 through glue, flushing liquid and a mandrel 130 enter the guide pipe 200 through the joint, and a rotary valve 310 is further arranged on the joint 300 and used for opening and closing the joint. The conveying shaft 400 is inserted into the catheter 200, and the catheter 200 is softer and has insufficient strength, so that the catheter is easy to fold when conveyed into the dialysis catheter, and the folding resistance of the catheter can be improved after the catheter is inserted into the conveying shaft 400, so that the conveying of products in the dialysis catheter is smoother, and the conveying shaft is withdrawn after the products are conveyed in place.
The catheter 200 is also slidably fitted with a hemostatic valve 500, the hemostatic valve 500 being adapted to prevent backflow of blood from the dialysis catheter when the plug 100 is inserted. The hemostatic valve 500 is provided with a side branch 510 for passing a liquid.
The application steps of the invention are as follows:
in using the present invention, the plug 100 is first inserted into the connector of the hemodialysis catheter 600, then the connector of the hemostatic valve and the dialysis catheter is screwed down, then the hemostatic buckle of the dialysis catheter is opened, and then the plug 100 is inserted continuously until the desired position is reached. Flushing fluid, such as heparin, is then introduced from the connector of the present invention, and then flows out of the flushing port 210, flushing all of the blood in the dialysis catheter, and the flushed blood flows out of the side branch of the hemostatic valve.
The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. The invention is not limited to the embodiments described above, i.e. it is not meant that the invention has to be carried out in dependence on the embodiments described above. It should be apparent to those skilled in the art that any modification of the present invention, equivalent substitution of selected raw materials, addition of auxiliary components, selection of specific modes, etc. fall within the scope of the present invention and the scope of disclosure.

Claims (6)

1. A catheter lock device, comprising:
The plugging plug comprises an elastomer formed by expanded polyurethane and a covering film made of ePTFE material and wrapped on the surface of the elastomer, wherein the elastomer permeates into micropores of the covering film to strengthen the connection strength of the elastomer and the covering film, a mandrel with supporting function is arranged in the elastomer, and the elastomer can be compressed to at least one third of the original volume;
the catheter is connected with the plugging plug, and a flushing hole is formed in the catheter and used for flushing the hemodialysis catheter;
The joint is connected with the guide pipe, and a rotary valve is arranged on the joint and used for opening and closing the joint;
A delivery shaft inserted in the catheter, the delivery shaft being withdrawn when delivery is complete;
The hemostatic valve is sleeved on the catheter in a sliding way, and a side branch for passing liquid is arranged on the hemostatic valve;
The distal end of the plugging plug is of a conical structure and is used for guiding the plugging plug, and the side surface of the plugging plug is wavy and is used for reducing friction between the plugging plug and the inner wall of the hemodialysis catheter.
2. A catheter lock device as set forth in claim 1 wherein said flush hole is disposed at an end of said catheter adjacent said occlusion.
3. A catheter closure device as in claim 1 wherein said catheter and said occlusion plug are connected together by said mandrel.
4. A catheter sealing device according to claim 1, wherein the surface of the cover is coated with heparin.
5. A catheter sealing device according to claim 1, wherein the length of the plug is 1cm-3cm.
6. A catheter closure device according to claim 1, wherein said elastomer is a hydrogel or a silicone gel.
CN202411369019.3A 2024-09-29 2024-09-29 A catheter closure device Active CN118873816B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202411369019.3A CN118873816B (en) 2024-09-29 2024-09-29 A catheter closure device

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202411369019.3A CN118873816B (en) 2024-09-29 2024-09-29 A catheter closure device

Publications (2)

Publication Number Publication Date
CN118873816A CN118873816A (en) 2024-11-01
CN118873816B true CN118873816B (en) 2025-03-21

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Family Applications (1)

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CN202411369019.3A Active CN118873816B (en) 2024-09-29 2024-09-29 A catheter closure device

Country Status (1)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09173461A (en) * 1995-12-27 1997-07-08 Unitika Ltd Obturator for blood vessel indwelling catheter
JP2005287670A (en) * 2004-03-31 2005-10-20 Nipro Corp Intravascular catheter

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WO1998012990A1 (en) * 1996-09-26 1998-04-02 Scimed Life Systems, Inc. Support structure/membrane composite medical device
WO2006026725A2 (en) * 2004-08-31 2006-03-09 C.R. Bard, Inc. Self-sealing ptfe graft with kink resistance
US20080312577A1 (en) * 2007-02-05 2008-12-18 Boston Scientific Scimed, Inc. Expandable dialysis apparatus and method
US8366658B2 (en) * 2010-05-06 2013-02-05 Becton, Dickinson And Company Systems and methods for providing a closed venting hazardous drug IV set
JP2013048650A (en) * 2011-08-30 2013-03-14 Nihon Covidien Kk Dialysis catheter
US11399842B2 (en) * 2013-03-13 2022-08-02 Conformal Medical, Inc. Devices and methods for excluding the left atrial appendage
CA2940164C (en) * 2014-02-20 2018-10-16 Repro-Med Systems, Inc. Connector with filter
CN106955135A (en) * 2017-04-07 2017-07-18 上海申淇医疗科技有限公司 A kind of plugging device choked flow film and its manufacture method
WO2020056120A1 (en) * 2018-09-14 2020-03-19 Becton, Dickinson And Company Universal disinfecting cap

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09173461A (en) * 1995-12-27 1997-07-08 Unitika Ltd Obturator for blood vessel indwelling catheter
JP2005287670A (en) * 2004-03-31 2005-10-20 Nipro Corp Intravascular catheter

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