WO2025055831A1 - Cathéter d'aspiration de type à extension de guide, et système et procédé de cathéter d'aspiration de caillot sanguin - Google Patents

Cathéter d'aspiration de type à extension de guide, et système et procédé de cathéter d'aspiration de caillot sanguin Download PDF

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Publication number
WO2025055831A1
WO2025055831A1 PCT/CN2024/117544 CN2024117544W WO2025055831A1 WO 2025055831 A1 WO2025055831 A1 WO 2025055831A1 CN 2024117544 W CN2024117544 W CN 2024117544W WO 2025055831 A1 WO2025055831 A1 WO 2025055831A1
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WO
WIPO (PCT)
Prior art keywords
catheter
guide
channel
catheter body
push rod
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.)
Pending
Application number
PCT/CN2024/117544
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English (en)
Chinese (zh)
Inventor
张志军
刘朝生
乔轩
谭睿哲
周威
黄琳
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.)
BROSMED MEDICAL Co Ltd
Brosmed Neurotec Co Ltd
Original Assignee
BROSMED MEDICAL Co Ltd
Brosmed Neurotec Co Ltd
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 CN202322465547.6U external-priority patent/CN221787839U/zh
Priority claimed from CN202410667874.6A external-priority patent/CN118477216A/zh
Priority claimed from CN202410667865.7A external-priority patent/CN118542982A/zh
Priority claimed from CN202421176251.0U external-priority patent/CN223287214U/zh
Priority claimed from CN202421479506.0U external-priority patent/CN223392755U/zh
Priority claimed from CN202421477538.7U external-priority patent/CN222930166U/zh
Application filed by BROSMED MEDICAL Co Ltd, Brosmed Neurotec Co Ltd filed Critical BROSMED MEDICAL Co Ltd
Publication of WO2025055831A1 publication Critical patent/WO2025055831A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • PCI Percutaneous transluminal coronary intervention
  • the guided extended aspiration catheter can be used as a guide to more deeply treat side branches and lesions far away from the aorta.
  • the guide catheter is generally delivered to the location of a larger blood vessel close to the small blood vessel, and the guided extended aspiration catheter used for distal aspiration of thrombus is inserted into the inner lumen of the guide catheter and reaches the target area, and then aspiration is performed.
  • the first purpose of the present application is to provide a guide extension type suction catheter to solve the technical problem in the prior art that the guide extension type suction catheter cannot be effectively sealed in the guide catheter or even slips off.
  • the second purpose of the present application is to provide a thrombus aspiration catheter system, which has a guide extension aspiration catheter to solve the technical problem in the prior art that the guide extension aspiration catheter cannot be effectively sealed in the guide catheter or even slips off.
  • the third object of the present application is to provide a method for performing thrombus aspiration using a thrombus aspiration catheter system to remove thrombus from a blood vessel.
  • a fourth object of the present application is to provide a method for performing a medical procedure in a body vessel using a thrombus aspiration catheter system to remove a thrombus from the vessel.
  • a fifth object of the present application is to provide a method for placing an extended guide aspiration catheter of a thrombus aspiration catheter system into a narrow and tortuous blood vessel of the body to remove the thrombus from the blood vessel.
  • the present application provides a guide extended suction catheter, including a catheter body, a push rod and a sealing balloon, wherein the catheter body is provided with a delivery channel for delivering medical devices, and the proximal end of the catheter body is provided with an introduction port connected to the delivery channel; the distal end of the push rod is connected to the proximal end of the catheter body, and a filling channel is provided inside the push rod; the sealing balloon is sleeved on the catheter body and located near the proximal end of the catheter body, and the inner cavity of the sealing balloon is connected to the filling channel.
  • the catheter body comprises an inner layer, an intermediate reinforcement layer and an outer layer which are sequentially arranged from the inside to the outside, and the delivery channel is located at the center of the inner layer.
  • the intermediate reinforcement layer is a woven mesh layer, a spring layer or a spiral cut tube layer.
  • the catheter body is divided into a compliant zone, a transition zone and a push zone in sequence from the distal end to the proximal end.
  • the hardness of the soft zone, the transition zone and the push zone increases successively.
  • the length of the compliant zone is 1-30 cm, or the length of the transition zone is 2-50 cm, or the length of the push zone is 5-50 cm.
  • the intermediate reinforcement layer is a woven mesh layer
  • the PPI of the proximal end of the woven mesh layer is greater than the PPI of the distal end
  • the intermediate reinforcement layer is a spring layer
  • the pitch of the proximal end of the spring layer is greater than the pitch of the distal end
  • the spirally cut tube layer is divided into a compliant zone, a transition zone and a push zone in sequence along the direction from the distal end to the proximal end of the catheter body, and the compliant zone, the transition zone and the push zone satisfy at least one of the following characteristics; the slit length of the spirally cut tube layer in the compliant zone > the slit length of the spirally cut tube layer in the transition zone > the slit length of the spirally cut tube layer in the push zone; or, the cutting spacing of the spirally cut tube layer in the compliant zone ⁇ the cutting spacing of the spirally cut tube layer in the transition zone ⁇ the cutting spacing of the spirally cut tube layer in the push zone; or, the slit angle of the spirally cut tube layer in the compliant zone ⁇ the slit angle of the spirally cut tube layer in the transition zone ⁇ the slit angle of the spirally cut tube layer in the push zone; or, the pitch of the spirally cut tube layer in the compliant zone ⁇ the pitch of the spirally cut tube layer in
  • the hardness of the outer layer decreases from the proximal end to the distal end of the catheter body.
  • the catheter body is provided with a metal connector at the proximal end of the intermediate reinforcement layer, the distal end of the push rod is connected to one end of the metal connector, and the other end of the metal connector is arranged in parallel with the intermediate reinforcement layer or connected to the intermediate reinforcement layer.
  • the metal connector is a metal ring arranged side by side along the axial direction of the catheter body, or the metal connector is in a spiral structure, or the metal connector includes a connecting plate and a plurality of connecting strips connected to opposite sides of the connecting plate, the connecting plate and each of the connecting strips are connected to the middle reinforcement layer, the push rod is connected to the connecting plate, and each of the connecting strips is wrapped and connected to the inner layer.
  • the metal connector is welded to the distal end of the push rod to form a welding area, and the diameter of the push rod is reduced at the welding connection between the metal connector and the push rod.
  • a first developing member is provided at the distal end of the push rod, and the first developing member is a filament made of a developing material that is opaque to X-rays, and the developing material is one or more of gold wire, tungsten wire, platinum wire, and platinum-iridium alloy wire.
  • the push rod is a metal tube or a plastic tube with a metal reinforcement layer.
  • first angle between the end face of the introduction port and the cross-section of the catheter body in the radial direction
  • size of the first angle is in the range of 0-150°
  • second angle between the end face of the distal suction port of the catheter body and the cross-section of the catheter body in the radial direction
  • size of the second angle is in the range of 0-150°
  • the distal end of the push rod is fixed in the tube wall of the catheter body, and a through hole is provided at a position of the push rod close to the proximal end of the catheter body, and the through hole is connected between the filling channel and the inner cavity of the sealing balloon.
  • the guide extension suction catheter further comprises a catheter seat, the distal end of the catheter seat is connected to the proximal end of the push rod, a through channel is provided in the catheter seat, and the through channel is communicated with the filling channel.
  • the proximal end of the through channel forms a Luer connector on the catheter seat, and the Luer connector is connected to a component with a one-way seal or a heparin cap; or, the proximal end of the through channel is connected to a component with a one-way seal or a heparin cap.
  • the surface of the catheter body and the surface of the sealing balloon are both provided with a hydrophilic coating; or/and the surface of the push rod is provided with a hydrophobic coating.
  • the guide extension suction catheter also includes an expandable component
  • the distal end of the catheter body is provided with a distal opening of the catheter body connected to the delivery channel
  • the expandable component is expandably arranged on the distal end of the catheter body and extends at least to the farthest end of the catheter body, and the expandable component extends outwardly along the radial direction of the catheter body at the farthest end of the catheter body to limit the distal opening of the catheter body.
  • the expandable member when the expandable member is expanded, the expandable member forms a funnel structure.
  • the present application provides a thrombus aspiration catheter system, including a guide catheter and the above-mentioned guide extension aspiration catheter, wherein a guide channel is provided in the guide catheter, and when the sealing balloon is not inflated, the guide extension aspiration catheter slides in the guide channel; when the sealing balloon is inflated, the sealing balloon expands and abuts against the inner wall of the guide channel, and the delivery channel is connected to the guide channel.
  • the guide extension suction catheter is inserted into the guide channel, and the distal end of the catheter body passes through the distal end of the guide channel, the proximal end of the catheter body is located in the guide channel, and the proximal end of the push rod is located outside the proximal end of the guide channel.
  • a second developing member is disposed at the distal end of the catheter body, and a third developing member is disposed at the proximal end of the catheter body, and the third developing member is located inside the sealing balloon.
  • a fourth developing member is provided at the distal end of the guide catheter.
  • the length of the distal end of the catheter body extending out of the guide catheter is obtained by comparing and calculating the difference in developing position between the second developing member and the fourth developing member; or the length of the sealing balloon from the distal end of the catheter body and the length of the catheter body extending into the blood vessel is obtained by comparing and calculating the difference in developing position between the third developing member and the fourth developing member.
  • the sealing balloon when the sealing balloon is subjected to an inflation pressure of 0.1 bar to 5 bar, the sealing balloon abuts against an inner wall of the guide channel, and by moving the push rod, the sealing balloon can slide in the guide channel and maintain a sealing effect.
  • a Y-shaped connecting valve is provided at the proximal end of the guide catheter, and the Y-shaped connecting valve has a first interface and a second interface, the first interface and the second interface are respectively connected to the guide channel, the guide extension suction catheter is inserted into the first interface, and the proximal end of the push rod is located on the outside of the Y-shaped connecting valve.
  • the thrombus aspiration catheter system further comprises an aspirator for aspirating thrombus, wherein the aspirator is connected to the second interface and communicated with the guide channel.
  • the present application provides a method for performing thrombus aspiration using the above-mentioned thrombus aspiration catheter system, the method comprising: using the guide catheter that extends into the patient's blood vessel in a percutaneous structure to guide the guide extension aspiration catheter, and after the sealing balloon is expanded, it abuts against the inner wall of the guide channel and maintains the sealing effect, and suction is applied through the guide channel and the delivery channel to aspirate the fluid out of the guide catheter, thereby removing the thrombus from the blood vessel.
  • the present application provides a method for performing a medical procedure in a body blood vessel using the above-mentioned thrombus aspiration catheter system, wherein the proximal portion of the guide channel is connected to the delivery channel to form an aspiration cavity, and the method comprises: sliding the guide extension aspiration catheter relative to the guide catheter, tracking the guide extension aspiration catheter to the desired position in the blood vessel, and applying suction through the aspiration cavity to remove the thrombus from the blood vessel.
  • the present application provides a method for placing the guide extension type aspiration catheter of the thrombus aspiration catheter system into a narrow and curved blood vessel of the body, the method comprising: inserting a guide wire into the guide catheter, advancing the guide extension type aspiration catheter over the guide wire, and After the extended guide suction catheter is pushed out through the distal opening of the guide catheter and extends to a preset length, the sealing balloon is expanded so that the sealing balloon abuts against the inner wall of the guide channel.
  • moving the pushing rod can make the sealing balloon slide in the guiding channel and maintain the sealing effect.
  • the guide extension type suction catheter of the present application is provided with a sealing balloon at the proximal end of the catheter body, and a filling channel connected to the sealing balloon is provided in the push rod.
  • the proximal end of the push rod can extend from the proximal end of the guide catheter, and the distal end of the catheter body can extend from the distal end of the guide catheter.
  • the proximal end of the catheter body is located in the inner cavity of the guide catheter, and the sealing balloon can be filled through the filling channel.
  • the outer wall of the sealing balloon abuts against the inner wall of the inner cavity of the guide catheter, preventing the pressure from leaking through the gap between the guide extension type suction catheter of the present application and the guide catheter during the thrombus aspiration process, so that the guide extension type suction catheter of the present application is effectively connected to the guide catheter and forms a sealed suction cavity.
  • the new suction cavity formed by the guide extension type suction catheter of the present application and the guide catheter can provide a larger suction cavity and a stronger suction force. After connection, without external force, the guide extension type suction catheter of the present application is not easy to slip.
  • the proximal end of the guide extension type suction catheter of the present application can be pushed to make it move forward and backward.
  • the guide extension type suction catheter of the present application does not have the guidewire cavity of the traditional suction catheter, has a larger suction area, and fully utilizes the guide catheter cavity, and has a greater suction efficiency.
  • the beneficial effect of the thrombus aspiration catheter system provided by the present application is that: compared with the prior art, the thrombus aspiration catheter system of the present application has a guide extension aspiration catheter, and the guide extension aspiration catheter is provided with a sealing balloon at the proximal end of the catheter body, and a filling channel connected to the sealing balloon is provided in the push rod.
  • the guide extension aspiration catheter is extended along the proximal end of the guide catheter, the proximal end of the push rod can extend from the proximal end of the guide catheter, and the distal end of the catheter body can extend from the distal end of the guide catheter.
  • the proximal end of the catheter body is located in the inner cavity of the guide catheter, and the sealing balloon can be filled through the filling channel.
  • the sealing balloon After the sealing balloon is expanded, the outer wall of the sealing balloon abuts against the inner wall of the inner cavity of the guide catheter, so that the guide extension aspiration catheter of the present application is effectively connected with the guide catheter and forms a sealed aspiration cavity.
  • the new aspiration cavity formed by the guide extension aspiration catheter of the present application and the guide catheter can provide a larger aspiration cavity and a stronger aspiration force.
  • the proximal end of the guide catheter can be connected to an external aspirator, which can be used to connect the aspiration cavity to aspirate thrombi and plaques, thus avoiding the instability caused by frequent replacement of interventional catheters during surgery, shortening the operation time, reducing the difficulty of the operation, and reducing the risk of patients. Painful.
  • the guide extension type suction catheter of the present application is not easy to slip. During the operation of the operator, the proximal end of the guide extension type suction catheter of the present application can be pushed to make it move forward and backward.
  • the contrast agent/drug can also be input from the proximal end of the guide catheter.
  • the contrast agent/drug will flow along the guide channel of the guide catheter and the delivery channel of the catheter body in turn to perform super-selective angiography (by injecting contrast agents to display the lesions of the coronary arteries)/medication.
  • the guide extension type suction catheter of the present application does not have the guidewire cavity of the traditional suction catheter, has a larger suction area, and makes full use of the guide catheter cavity, with greater suction efficiency.
  • the guide extension aspiration catheter is guided by using the guide catheter that extends into the patient's blood vessel in a percutaneous structure.
  • the proximal end of the push rod can extend from the proximal end of the guide catheter, and the distal end of the catheter body can extend from the distal end of the guide catheter.
  • the proximal end of the catheter body is located in the inner cavity of the guide catheter, and a sealing balloon can be filled through the filling channel.
  • the outer wall of the sealing balloon abuts against the inner wall of the inner cavity of the guide catheter and maintains a sealing effect, ensuring that suction can be applied through the guide channel and the delivery channel to aspirate the fluid out of the guide catheter, thereby removing the thrombus from the blood vessel.
  • the beneficial effect of the method provided by the present application for performing a medical procedure in a body blood vessel using the above-mentioned thrombus aspiration catheter system is that, compared with the prior art, when the guide extension aspiration catheter is extended along the proximal end of the guide catheter, the proximal end of the push rod can extend from the proximal end of the guide catheter, and the distal end of the catheter body can extend from the distal end of the guide catheter.
  • the proximal end of the catheter body is located in the inner cavity of the guide catheter, and a sealing balloon can be filled through the filling channel.
  • the outer wall of the sealing balloon abuts against the inner wall of the inner cavity of the guide catheter, so that the guide extension aspiration catheter of the present application is effectively connected to the guide catheter and forms a sealed aspiration cavity.
  • the guide extension aspiration catheter By sliding the guide extension aspiration catheter relative to the guide catheter, the guide extension aspiration catheter is tracked to the desired position in the blood vessel, and suction is applied through the aspiration cavity to effectively remove the thrombus from the blood vessel.
  • the method provided by the present application for placing the guide extension type aspiration catheter of the above-mentioned thrombus aspiration catheter system into a narrow and curved blood vessel of the body has the following beneficial effects: compared with the prior art, by inserting a guide wire into the guide catheter, the guide extension type aspiration catheter is advanced on the guide wire and accurately pushed out through the distal end opening of the guide catheter; after the guide extension type aspiration catheter is extended to a preset length, The sealing balloon can be filled through the filling channel.
  • the outer wall of the sealing balloon abuts against the inner wall of the inner cavity of the guide catheter and maintains the sealing effect, ensuring that suction can be applied through the guide channel and the delivery channel to draw the fluid out of the guide catheter, thereby removing the thrombus from the blood vessel.
  • FIG. 1 is a structural diagram of a thrombus aspiration catheter system of the present application.
  • FIG. 2 is a structural diagram of the thrombus aspiration catheter system of the present application when aspirating thrombus.
  • FIG. 3 is a structural diagram of a guide extension type suction catheter according to an embodiment of the present application.
  • FIG. 4 is a structural diagram of a guide extension type suction catheter at the proximal end of the catheter body according to an embodiment of the present application.
  • FIG5 is a cross-sectional view of the guide extension suction catheter at the proximal end of the catheter body according to an embodiment of the present application.
  • FIG. 6 is an enlarged view of point A in FIG. 5 .
  • FIG. 7 is a cross-sectional view of the catheter body of the guide extension type aspiration catheter according to an embodiment of the present application.
  • FIG. 8 is a cross-sectional view of a push rod of a guide extension type aspiration catheter according to an embodiment of the present application.
  • FIG. 9 is a three-dimensional structural diagram of a metal connector of a guide extension type suction catheter according to an embodiment of the present application.
  • FIG. 10 is a cross-sectional view of an extended guide aspiration catheter inserted into the interior of a guide catheter according to an embodiment of the present application.
  • FIG. 11 is a structural diagram of a guide extension type suction catheter according to an embodiment of the present application.
  • Fig. 12 is a cross-sectional view along the B-B direction in Fig. 11 .
  • FIG. 13 is an enlarged view of point D in FIG. 12 .
  • Fig. 14 is a cross-sectional view along the C-C direction in Fig. 11 .
  • FIG. 15 is a structural diagram of a guide extension type suction catheter according to an embodiment of the present application.
  • FIG. 16 is a structural diagram of the distal end portion of the guide extension type suction catheter according to an embodiment of the present application.
  • FIG. 17 is a structural diagram of the expansion balloon of the guide extension suction catheter according to an embodiment of the present application when it is pressurized and expanded.
  • FIG. 18 is a structural diagram of the expansion balloon of the guide extension suction catheter according to an embodiment of the present application when not inflated.
  • FIG. 19 is a cross-sectional view of a guide extension type suction catheter according to an embodiment of the present application.
  • FIG. 20 is a diagram of a metal connector of a guide extension type suction catheter connected to a push rod according to an embodiment of the present application. Structure diagram of .
  • FIG. 21 is a cross-sectional view of a push rod of a guide extension type aspiration catheter according to an embodiment of the present application.
  • FIG. 22 is a structural diagram of the middle reinforcement layer of the guide extension suction catheter according to an embodiment of the present application.
  • FIG. 23 is a cross-sectional view of a push rod of a guide extension type aspiration catheter according to an embodiment of the present application.
  • FIG. 24 is a cross-sectional view of a guide extension type suction catheter according to an embodiment of the present application.
  • FIG. 25 is a structural comparison diagram of the thrombus aspiration catheter system of the present application and a traditional aspiration system.
  • FIG. 26 is a cross-sectional structural comparison diagram of the thrombus aspiration catheter system shown in FIG. 25 at a proximal position and a conventional aspiration system at a proximal position.
  • the thrombus aspiration catheter system 200 of the present application includes a guide catheter 201 and a guide extension aspiration catheter 100.
  • the guide extension aspiration catheter 100 includes a catheter body 1, a push rod 2 and a sealing balloon 3.
  • the catheter body 1 is provided with a delivery channel 11 for delivering medical devices, and the proximal end of the catheter body 1 is provided with an introduction port 12 connected to the delivery channel 11; the distal end of the push rod 2 is connected to the proximal end of the catheter body 1, and the interior of the push rod 2 is provided with a filling channel 21; the sealing balloon 3 is sleeved on the catheter body 1 and located near the proximal end of the catheter body 1, and the inner cavity of the sealing balloon 3 is connected to the filling channel 21.
  • a guide channel 201a is provided in the guide catheter 201. When the sealing balloon 3 is not inflated, the guide extended suction catheter 100 slides in the guide channel 201a. When the sealing balloon 3 is inflated, the sealing balloon 3 expands and abuts against the inner wall of the guide channel 201a, and the delivery channel 11 is connected to the guide channel 201a.
  • the guide extension suction catheter 100 is inserted into the guide channel 201a, and the distal end of the catheter body 1 comes out from the distal end of the guide channel 201a, the proximal end of the catheter body 1 is located in the guide channel 201a, and the proximal end of the push rod 2 is located outside the proximal end of the guide channel 201a.
  • the introduction port 12 is an oblique structure, which can enable the guide extension suction catheter 100 of the present application to have better push transmission.
  • the introduction port 12 forms a transition oblique structure between the catheter body 1 and the push rod 2, so that instruments such as balloon catheters or microcatheters can smoothly enter the inner cavity of the catheter body 1 without being damaged.
  • the thrombus can smoothly pass through the introduction port 12 into the guide catheter 201, Finally, it is sucked out of the body without being entangled by the guide extension type suction catheter 100 .
  • the sealing balloon 3 is filled through the filling channel 21. After the sealing balloon 3 is expanded, the outer wall of the sealing balloon 3 abuts against the inner wall of the guide channel 201a of the guide catheter 201, so that the extended guide aspiration catheter 100 is effectively connected to the guide catheter 201 and forms a sealed aspiration cavity. As shown in Figures 25 and 26, the thrombus aspiration catheter system 200 of the present application has a larger system average aspiration inner diameter than the traditional aspiration system 400.
  • the thrombus aspiration catheter system 200 has a larger proximal aspiration cavity than the traditional aspiration system 400, so that the average flow resistance of the system is greater than that of the traditional aspiration catheter 401, and finally the flow rate of the system aspiration process will be greater than that of the traditional aspiration catheter 401.
  • the aspiration length L of the system becomes shorter, which also leads to a decrease in the system flow resistance and an increase in the aspiration flow rate, while the lumen of the traditional aspiration catheter 401 does not change.
  • ⁇ P is the pressure difference between the two ends of the catheter
  • L is the overall length of the catheter system
  • Q is the flow rate of the catheter in this case
  • r is the radius of the lumen
  • ⁇ is the viscosity of the liquid.
  • the thrombus aspiration catheter system 200 has a larger flow rate than the traditional aspiration system 400, thereby generating a higher aspiration efficiency.
  • the length of the thrombus aspiration catheter system 200 becomes shorter. According to equation (2), the flow rate of the aspiration system will continue to increase, thereby improving the aspiration efficiency.
  • the introduction port 12 can be used as a channel for the entry and exit of instruments, and can also be used as a channel for the aspiration of thrombus 300, for example
  • An external catheter or stent can enter the delivery channel 11 of the catheter body 1 from the introduction port 12 and move through it to the distal end of the catheter body 1.
  • the guided extended suction catheter 100 can be used as a rapid exchange catheter, thereby achieving rapid exchange of equipment; for example, the introduction port 12 can also be connected to a syringe through a guide catheter 201 to facilitate the suction of the thrombus 300 through the syringe.
  • a second angle is formed between the end face of the distal suction port of the catheter body 1 and the cross section of the catheter body 1 in the radial direction, and the size of the second angle is in the range of 0-150°.
  • the distal end of the catheter body 1 is a beveled suction port.
  • the catheter body 1 includes an inner layer 13, an intermediate reinforcement layer 14 and an outer layer 15 arranged in sequence from the inside to the outside, and the delivery channel 11 is located at the center of the inner layer 13.
  • the three-layer composite structure can provide strong support, pressure resistance and folding resistance.
  • the material of the inner layer 13 is polytetrafluoroethylene or linear low-density polyethylene.
  • Polytetrafluoroethylene has high lubricity and non-stickiness, which facilitates other devices to pass through the delivery channel 11 in the inner layer 13.
  • Linear low-density polyethylene has high softening temperature and melting temperature, and has the advantages of high strength, good toughness, high rigidity, good heat resistance and cold resistance, and also has good environmental stress cracking resistance, impact strength resistance, tear strength resistance and other properties.
  • the material of the outer layer 15 is a mixture of one or more polyether front-end polyamide, nylon, and polyurethane elastomer, which ensures that the outer surface of the catheter body 1 has a smoother appearance and feel, and fully protects the blood vessels from easily forming thrombi 300, dissection, etc.
  • the hardness of the outer layer 15 decreases from the proximal end to the distal end of the catheter body 1. This not only avoids deformation, but also makes it easier to pass through tortuous lesions.
  • the distal end uses a flexible material to avoid damage to the blood vessel wall during the pushing process, better meeting the needs of pushing the catheter in the human blood vessels, allowing doctors to operate more accurately and conveniently, and reducing the pain of patients during the operation.
  • the middle reinforcement layer 14 is a woven mesh layer, a spring layer or a spiral cut tube layer, which can improve the strong support, pressure resistance and folding resistance of the guided extension suction catheter 100.
  • the intermediate reinforcement layer 14 is a braided mesh layer, and the braided mesh layer is braided with metal wires, such as nickel-titanium alloy wires or stainless steel wires.
  • the braided mesh layer is braided in a one-on-one or one-on-two manner.
  • the braided mesh layer is braided with 8-16 strands of metal wire, and the PPI of the braided mesh layer is 20-120.
  • the braided mesh layer is made of round wire, and the wire diameter of the round wire is 0.001-0.01 inch.
  • the braided mesh layer adopts flat wire, the width of the flat wire is 0.001-0.01 inch, and the thickness is 0.001-0.005 inch.
  • the PPI of the proximal end of the braided mesh layer is greater than the PPI of the distal end, which can help the distal end of the manufactured catheter body 1 to have better flexibility and reachability, and the proximal end has better pushing performance.
  • the PPI of the distal end of the braided mesh layer is 20, and the PPI of the proximal end is 120.
  • PPI is "Pick Per Inch", which refers to the sum of the number of warps and wefts per inch. This is an important indicator to measure the density of the woven cloth. The higher the PPI value, the greater the density of the woven cloth.
  • the middle reinforcing layer 14 is a spring layer, and the spring layer is wound with a metal wire, and the metal wire can be a nickel-titanium alloy wire and/or a stainless steel wire, wherein the wire diameter of the metal wire is 0.01mm-0.3mm, and the pitch is 0.03mm-0.3mm.
  • the proximal end of the spring layer is wound with stainless steel wire, and the distal end is wound with a nickel-titanium alloy wire.
  • the pitch of the proximal end of the spring layer is greater than the pitch of the distal end, which can help the distal end of the manufactured catheter body 1 have better flexibility and reachability, and the proximal end has better pushing performance.
  • the distal end of the spring layer uses a nickel-titanium alloy wire with a wire diameter of 0.05mm and a pitch of 0.1mm
  • the proximal end uses a stainless steel wire with a wire diameter of 0.08mm and a pitch of 0.08mm.
  • the catheter body 1 is divided into a compliant zone, a transition zone and a push zone in the direction from the distal end to the proximal end, and the hardness of the compliant zone, the transition zone and the push zone increases in sequence.
  • the length of the compliant zone is 1-30cm, or the length of the transition zone is 2-50cm, or the length of the push zone is 5-50cm.
  • the schemes in which the length of the compliant zone is 1-30cm, the length of the transition zone is 2-50cm, and the length of the push zone is 5-50cm can also be set in the same scheme.
  • the middle reinforcement layer 14 is a spiral cut tube layer.
  • the spiral cut tube layer can ensure a certain strength while having better flexibility, can better adapt to complex vascular paths, and reduce stimulation and damage to blood vessels; it can also provide a more uniform distribution of support force, avoid local stress concentration, and help improve the stability of the catheter in the blood vessel.
  • the design of the spiral cut tube layer makes its outer diameter smaller and the structure more compact, thereby reducing the outer diameter of the entire guide extension suction catheter 100, reducing the difficulty of insertion and the impact on the blood vessel; and the weight is lighter, which helps to reduce the foreign body sensation in the patient's body.
  • the spirally cut tube layer is sequentially divided into a compliant zone 141 , a transition zone 142 and a push zone 143 along the direction from the distal end to the proximal end of the catheter body 1 , and the compliant zone 141 , the transition zone 142 and the push zone 143 meet at least one of the following characteristics;
  • the slit length L of the spiral cutting tube layer in the compliant zone 141 is greater than the slit length L of the spiral cutting tube layer in the transition zone 142 and greater than the slit length L of the spiral cutting tube layer in the pushing zone 143;
  • the cutting spacing d of the spiral cutting tube layer in the compliant zone 141 is less than the cutting spacing d of the spiral cutting tube layer in the transition zone 142 and less than the cutting spacing d of the spiral cutting tube layer in the pushing zone 143;
  • the slit angle ⁇ of the spirally cut tube layer in the compliant zone 141 is less than the slit angle ⁇ of the spirally cut tube layer in the transition zone 142 and less than the slit angle ⁇ of the spirally cut tube layer in the push zone 143;
  • the pitch p of the spirally cut tube layer in the compliant zone 141 is less than the pitch p of the spirally cut tube layer in the transition zone 142 and less than the pitch p of the spirally cut tube layer in the pushing zone 143 .
  • the four parameters of the spiral cutting tube layer's three partitions namely the slit length L, cutting spacing d, slit angle ⁇ , and pitch p, can be designed one or more of the four parameters according to the above-mentioned change rules, or all of them can be designed according to the above-mentioned change rules.
  • the slit angle ⁇ is the angle between the slit and the central axis of the catheter.
  • the flexibility of the catheter body 1 can be changed, and it can be divided into a flexible area 141, a transition area 142, and a push area 143. It is well known that the longer the slit length L, the smaller the cutting spacing d, the smaller the slit angle ⁇ , or the smaller the pitch p, the more flexible the tube body is and the stronger the passability is.
  • the compliant area 141 of the spirally cut tube layer has a longer slit length L, a smaller cutting spacing d, a smaller slit angle ⁇ and a smaller pitch p, making the area compliant and better adapted to the complex blood vessel path, thereby improving the ability of the catheter body 1 to pass through the blood vessel.
  • a smooth transition is achieved between the compliant area 141 and the push area 143 through the transition area 142, which not only maintains a certain degree of compliance to adapt to changes, but also gradually increases the convenience of pushing.
  • the push area 143 adopts a shorter slit length L, a larger cutting spacing d, a larger slit angle ⁇ and a larger pitch p, making the area more powerful when pushing, and facilitating accurate pushing of the catheter to the target position.
  • the reasonable setting of the characteristics of different regions allows the catheter body 1 to have both good soft adaptability and effective pushing ability as a whole, meeting the operation requirements at different stages and improving the success rate and safety of the operation.
  • the slit length of the spirally cut tube layer in the compliant zone 141 is 0.6 mm
  • the cutting spacing is 0.1 mm
  • the slit angle is 95°
  • the pitch is 0.09 mm
  • the slit width is 0.02 mm.
  • the slit length of the spiral cutting tube layer in the transition zone 142 is 0.4 mm, the cutting spacing is 0.3 mm, and the slit clamp The angle is 105°, the pitch is 0.12mm, and the slit width is 0.02mm.
  • the thread cutting tube layer in the push zone 143 has a slit length of 0.1 mm, a cutting pitch of 0.6 mm, a slit angle of 115°, a pitch of 0.30 mm, and a slit width of 0.02 mm.
  • the catheter body 1 is provided with a metal connector 4 at the proximal end of the intermediate reinforcement layer 14, and the distal end of the push rod 2 is connected to one end of the metal connector 4.
  • the other end of the metal connector 4 is arranged in parallel with the intermediate reinforcement layer 14, or the other end of the metal connector 4 is connected to the intermediate reinforcement layer 14.
  • the other end of the metal connector 4 is arranged in parallel with the intermediate reinforcement layer 14.
  • the other end of the metal connector 4 is connected to the intermediate reinforcement layer 14.
  • the metal connector 4 is a metal ring arranged side by side along the axial direction of the catheter body 1, and is arranged in the middle reinforcement layer 14 near one end of the push rod 2, and its cross-sectional shape is the same as the cross-sectional shape of the middle reinforcement layer 14.
  • the metal connector 4 is parallel to the middle reinforcement layer 14 on the side away from the push rod 2 but is not connected, and the metal connector 4 is connected to the push rod 2 on the side close to the push rod 2.
  • the metal connector 4 is superimposed and welded with the end of the push rod 2, and the design is hidden in the middle of the catheter body 1, so as not to cause damage to the blood vessel.
  • the metal connector 4 is a metal ring and is connected by welding, which can ensure the stability of the connection between the catheter body 1 and the push rod 2 and ensure the mechanical transmission during the operation.
  • the metal connector 4 is a spiral structure, which can effectively buffer the stress concentration at the connection between the push rod 2 and the catheter body 1. It can also provide effective bending resistance for the catheter body 1, and keep the lumen intact when the sealing balloon 3 is filled.
  • the spiral structure of the metal connector 4 can provide a certain degree of elasticity and adaptability, so that it can better adapt to different situations during the connection and force transmission process.
  • the metal connector 4 includes a connecting piece 41 and a plurality of connecting strips 42 connected to opposite sides of the connecting piece 41, the connecting piece 41 and each connecting strip 42 are connected to the middle reinforcing layer 14, the push rod 2 is connected to the connecting piece 41, and each connecting strip 42 is wrapped and connected to the inner layer 13.
  • the connecting strip 42 is wrapped and connected to the outer side of the inner layer 13 in a surrounding manner, which can ensure that the metal connector 4 is firmly connected to the catheter body 1.
  • the metal connector 4 and the push rod 2 may be connected by welding, gluing or the like.
  • the metal connector 4 is welded to the distal end of the push rod 2 to form Welding area 43.
  • welding areas 43 are respectively provided at both ends of the connection between the metal connector 4 and the push rod 2 to form a welded connection between the metal connector 4 and the push rod 2.
  • the diameter of the push rod 2 is reduced, so that the overall outer diameter does not increase, which is beneficial to the passability in the blood vessel and reduces damage to the blood vessel.
  • a first developing member 22 is provided at the distal end of the push rod 2.
  • the first developing member 22 is plugged at the distal end of the push rod 2 and is used to develop and display the position of the sealing balloon 3. Under X-rays, it can be accurately positioned in the patient's body to reduce the difficulty of operation.
  • the provision of the first developing member 22 facilitates accurate display of the position of the sealing balloon 3 through development during the operation, which helps to improve the accuracy and safety of the operation.
  • the first developing member 22 can be made of a filament made of a developing material that is opaque to X-rays, and the developing material is one or more of gold wire, tungsten wire, platinum wire, and platinum-iridium alloy wire.
  • the length of the first developing member 22 along the pushing rod 2 is 3-7 mm.
  • the push rod 2 is a metal tube or a plastic tube with a metal reinforcement layer, but not limited thereto.
  • the push rod 2 is a hypotube, which effectively improves the delivery performance and prevents the guide extension type suction catheter 100 of the present application from being folded during the pushing process. Furthermore, the hypotube has a double marking band to assist in determining whether the guide extension type suction catheter 100 of the present application has reached the coronary ostium. However, this is not limited thereto.
  • the distal end of the push rod 2 is fixed in the tube wall of the catheter body 1.
  • the push rod 2 is provided with a through hole 23 near the proximal end of the catheter body 1.
  • the through hole 23 is connected between the filling channel 21 and the inner cavity of the sealing balloon 3.
  • the push rod 2 can be hidden in the middle of the material of the catheter body 1, so that the push rod 2 does not cause damage to the blood vessel.
  • the push rod 2 is provided with a plurality of through holes 23, and the through holes 23 are distributed in the middle of the balloon.
  • the proximal end of the push rod 2 is a hollow structure
  • the filling channel 21 is formed in the hollow structure
  • the distal end of the push rod 2 is a solid structure.
  • the push rod 2 includes a push rod spring wire 24, a push rod braided layer 25 and a push rod outer layer 26.
  • the push rod spring wire 24 is sleeved on the push rod 2 to connect the metal connector.
  • the outer side of the connector 4 and close to the metal connector 4 reduce the stress concentration after welding, and at the same time improve the bending resistance of the end of the push rod 2 to prevent the end of the push rod 2 from bending during pushing.
  • the diameter of the push rod spring wire 24 is 0.05mm, the spacing is 0.07mm, and the material is nickel-titanium alloy or stainless steel.
  • the middle section and the proximal section of the push rod 22 are both provided with a push rod braided layer 25, and the braiding density of the push rod braided layer 25 of the middle section of the push rod 2 is greater than the braiding density of the push rod braided layer 25 of the proximal section of the push rod 2.
  • the push rod outer layer 26 is sleeved on the overall outer layer of the push rod 2, and the push rod spring wire 24 and the push rod braided layer 25 are both located inside the push rod 2.
  • the middle section of the push rod 2 adopts a push rod braided layer 25 with a needle number per inch, which provides good lumen retention, torque transmission and certain pushing performance, while the proximal end of the push rod 2 adopts a push rod braided layer 25 with a needle number per inch, which provides good pushing ability.
  • the push rod braided layer 25 can be woven with stainless steel wire.
  • the outer layer 26 of the push rod is a polytetrafluoroethylene layer, which provides lower friction on the surface and reduces the probability of catching thrombus in the body.
  • the polytetrafluoroethylene layer can be prepared using a polytetrafluoroethylene coating.
  • a marking band is provided at the distal end of the sealing balloon 3 for indicating its position.
  • the guide extension type suction catheter 100 also includes a catheter seat 5, the distal end of the catheter seat 5 is connected to the proximal end of the push rod 2, and a through channel is provided in the catheter seat 5, and the through channel is connected to the filling channel 21.
  • the catheter seat 5, the push rod 2 and the sealing balloon 3 are interconnected to form a single-lumen channel.
  • the doctor can connect the injection fluid and other media at the catheter seat 5, fill the sealing balloon 3 through the fluid channel in the push rod 2, so that the sealing balloon 3 is quickly anchored in the inner cavity of the guide catheter 201 and blocked.
  • the distal end of the catheter seat 5 is connected to the proximal end of the push rod 2.
  • the connection between the two is a welding connection.
  • the catheter seat 5 is flat, which is convenient for finger gripping and turning.
  • the proximal end of the through channel forms a Luer connector on the catheter seat 5, and the Luer connector is connected to a component with a one-way seal or a heparin cap to prevent the filling medium from flowing out of the catheter seat 5, thereby preventing backflow.
  • the proximal end of the through channel may also be connected to a component with a one-way seal or a heparin cap, which may also prevent the filling medium from flowing out of the catheter seat 5, thereby preventing backflow.
  • the catheter seat 5 and the one-way sealed component or the heparin cap may be connected in an integrated structure or in a split arrangement.
  • the one-way sealed component may adopt a one-way valve, but is not limited thereto.
  • an hour needle syringe may be used to insert the heparin cap to inject the filling medium, so that the sealing balloon 3 expands.
  • the one-way valve is set up so that a syringe with a Luer connector can be connected to the one-way valve to inject a filling medium to expand the sealing balloon 3.
  • a stress sleeve is provided between the distal end of the catheter seat 5 and the proximal end of the push rod 2 , and the stress sleeve plays a role of stress buffering.
  • the surface of the catheter body 1 and the surface of the sealing balloon 3 are both provided with a hydrophilic coating, so that the guide extension suction catheter 100 can smoothly reach the rugged distal end of the blood vessel; in one embodiment, the hydrophilic coating is added to the surface of the catheter body 1 and the sealing balloon 3 by leaching, spraying, etc.
  • the surface of the push rod 2 is provided with a hydrophobic coating; in one embodiment, the hydrophobic coating is added to the surface of the push rod 2 by leaching, spraying, etc.
  • the hydrophobic coating can be made of existing PTFE material, but is not limited thereto.
  • a scale or marking band is provided on the surface of the push rod 2 .
  • the operator can directly hold the catheter seat 5 to steadily push the catheter body 1 into the human body, and the push rod 2 provides good support and pushing force for the guided extended suction catheter 100 to ensure the smooth progress of the operation.
  • the push rod 2 can be made of stainless steel, and the outer surface is polished to improve the safety of the interventional treatment.
  • the guide extension suction catheter 100 also includes an expandable member 6.
  • the distal end of the catheter body 1 is provided with a catheter body distal opening 16 connected to the delivery channel 11.
  • the expandable member 6 is expandably disposed on the distal end of the catheter body 1 and extends at least to the farthest end of the catheter body 1.
  • the expandable member 6 extends outward along the radial direction of the catheter body 1 at the farthest end of the catheter body 1 to limit the catheter body distal opening 16.
  • the expandable member 6 when the expandable member 6 is expanded, the expandable member 6 forms a funnel structure. Further, the funnel structure has a distal inlet 61 located at the distal end and expanded, and a proximal outlet 62 located at the proximal end and narrower than the distal inlet 61, and the proximal outlet 62 is connected to the distal opening 16 of the catheter body.
  • the funnel structure helps the thrombus 300 in the blood vessel to pass through and enter the distal opening 16 of the catheter body, and does not require a pull wire or other such rigid and bulky mechanical actuators.
  • the expandable member 6 includes an expandable balloon 63.
  • the distal end of the push rod 2 extends to the distal end of the catheter body 1.
  • the filling channel 21 is connected to the inner cavity of the expandable balloon 63.
  • the expansion balloon 63 extends outward in the radial direction and axial direction of the catheter body 1 under the action of inflation and inflation, so as to form a funnel structure at the farthest end of the catheter body 1, and the funnel structure is connected with the distal opening 16 of the catheter body.
  • the distal end of the push rod 2 is fixed in the tube wall of the catheter body 1, and the push rod 2 is provided with an opening (not shown, similar to the through hole 23) at a position close to the distal end of the catheter body 1, and the opening is connected between the filling channel 21 and the inner cavity of the expansion balloon 63.
  • the inner cavity of the catheter seat 5, the filling channel 21 of the push rod 2 and the inner cavity of the expansion balloon 63 are interconnected and form a single-cavity channel.
  • the doctor can connect the injection fluid and other media at the catheter seat 5, and the fluid and other media can enter the expansion balloon 63 through the inner cavity of the catheter seat 5, the filling channel 21 of the push rod 2 and the opening, so as to pressurize the expansion balloon 63, so that the expansion balloon 63 forms a funnel structure.
  • the push rod 2 is not provided with an opening, and the end of the push rod 2 has an opening, and the medium enters the expansion balloon 63 through the inner cavity of the catheter seat 5, the filling channel 21 of the push rod 2 and the end opening of the push rod 2.
  • a fluid or other medium can be connected to the catheter seat 5, and the fluid or other medium can pass through the inner cavity of the catheter seat 5 and the filling channel 21 of the push rod 2, thereby entering the sealing balloon 3 and the expansion balloon 63 respectively, so that the sealing balloon 3 and the expansion balloon 63 are pressurized and expanded at the same time. Furthermore, the number and total area of the through holes 23 and the openings can be set to achieve the sealing balloon 3 and the expansion balloon 63 reaching the set target diameter at the same time.
  • the expansion balloon 63 can apply tension to the farthest end of the catheter body 1 under the effect of inflation, thereby forming a funnel structure at the farthest end of the catheter body 1.
  • the funnel structure has a distal inlet 61 that is located at the far end and is enlarged, and a proximal outlet 62 that is located at the near end and narrower than the distal inlet 61, and the proximal outlet 62 is communicated with the distal opening 16 of the catheter body.
  • the diameter of the distal inlet 61 of the funnel structure is greater than or significantly greater than the diameter of the proximal outlet 62, the diameter of the distal inlet 61 of the funnel structure is greater than or significantly greater than the diameter of the opening at the distal end of the catheter body 1, and at the same time, a real funnel structure is formed without the need for a pull line or other such rigid and bulky mechanical actuation.
  • the diameter of the distal inlet 61 of the formed funnel structure is ideally greater than the diameter of the proximal outlet 62 by at least 20%, and preferably greater than the diameter of the proximal outlet 62 by 50% or 100%.
  • the expansion balloon 63 includes a plurality of components, wherein the wall thickness of one component is different from the wall thickness of at least one other component.
  • different components have different wall thicknesses to produce a desired shape and effect when pressurized.
  • the expansion balloon 63 includes a low-wall-thickness component 631, a high-wall-thickness component 632, a thin-wall-thickness component 633, and an end portion 634 connected in sequence.
  • the low wall thickness component 631 is subjected to the highest strain, so it expands the most when pressurized, forming a sac shape that can be used to limit or prevent blood flow through the catheter body 1.
  • the high wall thickness component 632 is subjected to much lower strain under the same stress (and pressure) level, so it cannot expand to the same diameter as the lower wall thickness component 631, but it is under axial tension due to the pressure in the expansion balloon 63, and this tension continues to pull and help the end segment component 634 to open and form an opening angle.
  • the opening angle is preferably between degrees and degrees, and most preferably between degrees and degrees.
  • the thin wall thickness component 633 plays the role of a hinge, so that the resistance of the end segment component 634 to open is minimized. Other feature parts such as bends or undulations can also be provided to the component to help the end to open.
  • a visualization element may also be provided, shown inside the expandable member 6, which serves a dual purpose: to provide visibility of the distal-most tip of the catheter body 1 under fluoroscopy, and to provide circumferential strength to the catheter body 1 to prevent deformation under inflation pressure.
  • the sealing balloon 3 is vacuum-flattened and attached to the outer layer 15 of the catheter body 1.
  • the distal end of the sealing balloon 3 is tightly welded or bonded to the outer layer 15 of the catheter body 1 to form a sealed end.
  • the proximal end of the sealing balloon 3 is tightly welded to the outer layer 15 of the catheter and the distal end of the push rod 2.
  • the welding or bonding at both ends of the entire sealing balloon 3 has a smooth transition without obvious uneven feel, and it is smoother to enter other channel instruments with low resistance.
  • the sealing balloon 3 can be a compliant balloon, and the compliant balloon here means that after the sealing balloon 3 is expanded to a predetermined diameter, its diameter and volume can continue to increase with the increase of filling pressure.
  • the sealing balloon 3 can be made of nylon, polyethylene, polyurethane or polyethylene terephthalate.
  • the distal end of the catheter body 1 is provided with a second developing member 17.
  • the second developing member 17 is provided to develop and display the position of the distal end of the catheter body 1, and accurately locate it in the patient's body under X-ray, thereby reducing the difficulty of operation.
  • a third developing member 18 is provided at the proximal end of the catheter body 1.
  • the third developing member 18 is located inside the sealing balloon 3.
  • the third developing member 18 is provided to develop and display the position of the sealing balloon 3, and accurately locate the sealing balloon 3 in the patient's body under X-ray, thereby reducing the difficulty of operation.
  • the provision of the third developing member 18 facilitates accurate display of the position of the sealing balloon 3 by development during the operation, which helps to improve the accuracy and safety of the operation.
  • the role played by the third developing member 18 is the same as that played by the first developing member 22.
  • a fourth developing member 201 b is disposed at the distal end of the guide catheter 201 .
  • the difference in developing position between the second developing member 17 and the fourth developing member 201 b is calculated by comparison to obtain the length of the distal end of the catheter body 1 extending out of the guide catheter 201 .
  • the length of the sealing balloon 3 from the distal end of the catheter body 1 and the length of the catheter body 1 extending into the blood vessel can be obtained.
  • the length of the sealing balloon 3 from the distal end of the catheter body 1 and the length of the catheter body 1 extending into the blood vessel can be obtained.
  • the developing elements used by the second developing element 17, the third developing element 18, and the fourth developing element 201b can display a black shadow to provide position information for the operator.
  • the developing element can be made of a developing material that is opaque to X-rays, and the developing material is one or more of gold, tungsten, platinum, and platinum-iridium alloy.
  • the developing element can be a developing ring, a cylindrical spiral developing coil, or a developing coating.
  • the developing element is preferably a developing ring, which can help the operator quickly capture the position of the catheter body 1 and the balloon.
  • the sealing balloon 3 when the sealing balloon 3 is filled with a pressure of 0.1 bar to 5 bar, the sealing balloon 3 abuts against the inner wall of the guide channel 201a, and by moving the push rod 2, the sealing balloon 3 can slide in the guide channel 201a and maintain the sealing effect.
  • the guide wire 202 can movably pass through the guide channel 201 a and the delivery channel 11 .
  • a Y-shaped connection valve 203 is provided at the proximal end of the guide catheter 201, and the Y-shaped connection valve 203 has a first interface 203a and a second interface 203b, the first interface 203a and the second interface 203b are respectively connected to the guide channel 201a, the guide extension suction catheter 100 is inserted into the first interface 203a, and the proximal end of the push rod 2 is located outside the Y-shaped connection valve 203.
  • the guide wire 202 passes through the first interface 203a.
  • contrast agent or other fluid medium can be injected through the Y-type connecting valve on the guide catheter 201.
  • the medium can flow along the guide channel 201a of the guide catheter 201 to the delivery channel 11 of the catheter body 1 of the guide extended aspiration catheter 100 for super-selective angiography or other targeted treatments.
  • the thrombus aspiration catheter system 200 further includes an aspirator for aspirating the thrombus 300, the aspirator being connected to the second interface 203b and communicating with the guide channel 201a.
  • the relevant suction device can be used to suction the thrombus 300, calcified plaque, etc. from the blood vessel through the Y-type connecting valve on the guide catheter 201. Under the action of negative pressure, the thrombus 300 or calcified plaque can flow back to the guide channel 201a of the guide catheter 201 along the delivery channel 11 of the catheter body 1 of the guide extension suction catheter 100, and finally be sucked out of the body.
  • the specific working principle of the thrombus aspiration catheter system 200 of the present application is as follows:
  • the guide catheter 201 When the thrombus 300 is in a small blood vessel, the guide catheter 201 is transported to a larger blood vessel near the small blood vessel, and the guide wire 202 is transported along the first interface 203a of the Y-shaped connection valve 203 at the proximal end of the guide catheter 201 to the location of the thrombus 300 in the small blood vessel.
  • the guide extension type suction catheter 100 is transported along the guide wire 202, and the guide extension type suction catheter 100 extends into the guide catheter 201 from the first interface 203a of the Y-shaped connection valve 203 at the proximal end of the guide catheter 201.
  • the distal end of the catheter body 1 of the guide extension type suction catheter 100 extends from the distal end of the guide catheter 201, the proximal end of the catheter body 1 is located in the guide channel 201a, one end of the push rod 2 is located in the guide channel 201a, the other end of the push rod 2 extends from the first interface 203a of the Y-shaped connection valve 203, and the catheter seat 5 is located outside the Y-shaped connection valve 203.
  • the catheter body 1 Under the guidance of the guide wire 202, the catheter body 1 reaches the desired position. Since the catheter body 1 contains a push rod 2, the push rod 2 can exert force, so that the guide catheter 201 can easily enter the branch blood vessels and narrow blood vessels.
  • Establish a transmission channel fill the sealing balloon 3 through the inner cavity of the catheter seat 5 and the filling channel 21 in the push rod 2, and after the sealing balloon 3 is expanded, it is anchored in the guide channel 201a.
  • the sealing balloon 3 blocks the gap between the guide catheter 201 and the catheter body 1, and the guide channel 201a is connected to the catheter cavity.
  • the first interface 203a of the push rod 2 extending from the Y-shaped connecting valve 203 of the guide catheter 201 is blocked, and the contrast agent/drug is delivered at the second interface 203b of the Y-shaped connecting valve 203.
  • the contrast agent/drug flows along the guide channel 201a into the delivery channel 11 of the catheter body 1, and then flows out at the distal end of the catheter body 1.
  • the contrast agent/drug flows to the distal end of the small blood vessels, thereby performing super-selective angiography/targeted drug administration.
  • An external suction device is used to suck out the thrombus 300 and plaque: the first interface 203a of the push rod 2 extending from the Y-shaped connection valve 203 of the guide catheter 201 is blocked, and the suction device is connected to the second interface 203b of the Y-shaped connection valve 203 to suck out the thrombus 300 and plaque at the distal end of the catheter body 1. Under the action of negative pressure, the thrombus 300 or calcified plaque flows back to the guide channel 201a along the delivery channel 11 of the catheter body 1 until it is sucked out of the body.
  • Withdrawal of the guide wire 202 (or the extended guide suction catheter 100): Use a pressure pump to withdraw the medium in the sealing balloon 3 under negative pressure. Under X-ray fluoroscopy, confirm that the sealing balloon 3 is deflated and no medium remains. The guide wire 202 (or the guide extension type suction catheter 100) is withdrawn as a whole until it exits the body.
  • the outer wall of the sealing balloon 3 abuts against the inner wall of the guide channel 201a of the guide catheter 201, preventing the pressure from leaking through the gap between the guide extension type suction catheter 100 and the guide catheter 201 during the thrombus aspiration process, so that the guide extension type suction catheter 100 is effectively connected to the guide catheter 201 and forms a sealed suction cavity.
  • the new suction cavity formed by the connection between the guide extension type suction catheter 100 and the guide catheter 201 of the present application can provide a larger suction cavity and a stronger suction force.
  • the guide extension type suction catheter 100 of the present application is not easy to slip or slip off in the guide channel 201a, thereby enhancing the guide extension type suction catheter.
  • the axial stability of the guide catheter 201 is improved.
  • the proximal end of the guide extension type suction catheter 100 of the present application can be pushed forward and backward.
  • the guide extension type suction catheter 100 of the present application does not have the guidewire cavity of the traditional suction catheter, has a larger suction area, and fully utilizes the lumen of the guide catheter 201, and has a greater suction efficiency.
  • the thrombus aspiration catheter system 200 of the present application uses the above-mentioned guide extension aspiration catheter 100.
  • the sealing balloon 3 After the sealing balloon 3 is expanded, the outer wall of the sealing balloon 3 is close to the inner cavity of the guide catheter 201, and the inner cavity of the guide catheter 201 is completely closed.
  • the contrast agent/drug is input from the proximal end of the guide catheter 201, and the contrast agent/drug will flow along the guide channel 201a and enter the delivery channel 11 through the introduction port 12 for super-selective angiography (by injecting contrast agent, thereby displaying the lesions of the coronary artery)/drug administration.
  • the delivery channel 11 is connected to the guide channel 201a, and the proximal end of the guide catheter 201 can be externally connected to an aspirator.
  • the aspirator is used to connect the delivery channel 11 and the guide channel 201a to aspirate the thrombus 300 and plaque, which can avoid the instability caused by frequent replacement of interventional catheters during surgery, shorten the operation time, reduce the difficulty of surgery, and reduce the pain of patients.
  • the guide extension suction catheter 100 of the present application is provided with an expandable component 6 at the distal end of the catheter body 1. When the guide extension suction catheter 100 enters the blood vessel, the expandable component 6 can be in an initial unexpanded state, and the expandable component 6 may not contact the blood vessel wall to avoid damage to the blood vessel.
  • the expandable component 6 When the guide extension suction catheter 100 reaches the target area, the expandable component 6 is expanded to a diameter that makes it contact the blood vessel wall, thereby partially or completely blocking blood flow through the expandable component 6, thereby helping to increase the possibility of aspirating all thrombi 300 in the target area, while reducing the amount of blood drawn.

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Abstract

L'invention concerne un cathéter d'aspiration de type à extension de guide, et un système et un procédé de cathéter d'aspiration de caillot sanguin. Le cathéter d'aspiration de type à extension de guide comprend un corps de cathéter, une tige de poussée et un ballonnet d'étanchéité, un canal de transport étant disposé dans le corps de cathéter. La tige de poussée est reliée au corps de cathéter, et un canal de remplissage est disposé à l'intérieur de la tige de poussée. Le ballonnet d'étanchéité est emmanché sur le corps de cathéter et une cavité interne du ballonnet d'étanchéité est en communication avec le canal de remplissage. Une extrémité distale du corps de cathéter de la présente invention peut s'étendre hors d'une extrémité distale d'un cathéter de guidage, une extrémité proximale du corps de cathéter est située dans le cathéter de guidage, le ballonnet d'étanchéité peut être rempli au moyen du canal de remplissage et une paroi externe du ballonnet d'étanchéité vient en butée contre une paroi interne de la cavité interne du cathéter de guidage, de sorte que le cathéter d'aspiration de type à extension de guide est efficacement couplé au cathéter de guidage pour former un canal de cavité d'aspiration étanche, et le canal de cavité d'aspiration peut fournir un grand canal de cavité d'aspiration et une force d'aspiration élevée. Après avoir été accouplé, le cathéter d'aspiration de type à extension de guide est moins susceptible de glisser sous l'action d'aucune force externe, pendant le processus d'actionnement par un opérateur, une extrémité proximale du cathéter d'aspiration de type à extension de guide peut être poussée, de sorte que le cathéter d'aspiration de type à extension de guide peut se déplacer vers l'avant et vers l'arrière.
PCT/CN2024/117544 2023-09-11 2024-09-06 Cathéter d'aspiration de type à extension de guide, et système et procédé de cathéter d'aspiration de caillot sanguin Pending WO2025055831A1 (fr)

Applications Claiming Priority (12)

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CN202322465547.6 2023-09-11
CN202322465547.6U CN221787839U (zh) 2023-09-11 2023-09-11 导引抽吸导管及具有该导管的导管系统
CN202410667865.7 2024-05-27
CN202410667874.6A CN118477216A (zh) 2024-05-27 2024-05-27 导引抽吸导管及具有该导管的导管系统
CN202421176251.0 2024-05-27
CN202410667865.7A CN118542982A (zh) 2024-05-27 2024-05-27 延长抽吸导管及具有该导管的导管系统
CN202421176251.0U CN223287214U (zh) 2024-05-27 2024-05-27 远端抽吸导管及血栓抽吸导管系统
CN202410667874.6 2024-05-27
CN202421477538.7 2024-06-26
CN202421479506.0U CN223392755U (zh) 2024-06-26 2024-06-26 一种延长导管及其导管系统
CN202421479506.0 2024-06-26
CN202421477538.7U CN222930166U (zh) 2024-06-26 2024-06-26 一种延长导管及导管系统

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PCT/CN2024/117544 Pending WO2025055831A1 (fr) 2023-09-11 2024-09-06 Cathéter d'aspiration de type à extension de guide, et système et procédé de cathéter d'aspiration de caillot sanguin

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