Extension aspiration catheter, catheter system, and method
By setting a guide wire tube in the extended catheter for small blood vessel intervention treatment, the guide wire can pass through the guide wire cavity of the guide wire tube without occupying the delivery channel of the catheter body, the problem of unsmooth suction pathway is solved and the aspiration effect of thrombus is improved.
Patent Information
- Application Number
- PCT/CN2024/117545
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-26
- Filing Date
- 2024-09-06
- Publication Date
- 2025-03-20
AI Technical Summary
During the small blood vessel intervention treatment, there are guidewires in the lumen of the extension catheter, resulting in unsmooth suction pathways and a small effective suction area, which affects the aspiration effect of the thrombus.
An extended suction catheter is designed, including a catheter body, a push rod, a sealed balloon and a guide tube. The guide tube is arranged on the catheter body so that the guide wire can pass through the guide wire cavity of the guide wire without occupying the area of the conveying channel of the catheter body.
By setting up a guide wire tube on the catheter body, the smoothness of the suction path is ensured, the effective suction area is increased, the suction effect of the thrombus is improved, and the guide wire is allowed to guide and anchor the catheter body to ensure that the catheter is accurately transported to the target area.
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Figure CN2024117545_20032025_PF_FP_ABST
Abstract
Description
Extended aspiration catheter, catheter system, and method
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to the Chinese patent application with application number 202322465547.6 filed on September 11, 2023, and with the invention name “Guide suction catheter and catheter system having the same”.
[0003] This application claims priority to Chinese patent application No. 202410667874.6 filed on May 27, 2024, entitled “Guide suction catheter and catheter system having the same”.
[0004] This application claims priority to the Chinese patent application with application number 202421176251.0 filed on May 27, 2024, and with the invention name “Distal Aspiration Catheter and Thrombus Aspiration Catheter System”.
[0005] This application claims priority to Chinese patent application No. 202410667865.7 filed on May 27, 2024, entitled “Extended Suction Catheter and Catheter System Having the Same”.
[0006] This application claims priority to the Chinese patent application with application number 202421477538.7 filed on June 26, 2024, and with the invention name “A kind of extension catheter and catheter system”.
[0007] This application claims priority to the Chinese patent application with application number 202421479506.0 filed on June 26, 2024, and with the invention name “A kind of extension catheter and its catheter system”. Technical Field
[0008] The present application relates to the field of medical devices, and in particular to an extended suction catheter, a catheter system, and a method. Background Art
[0009] Percutaneous transluminal coronary intervention (PCI) involves the use of percutaneous puncture to deliver a balloon catheter or other related device to relieve coronary artery stenosis or obstruction and restore coronary blood flow. With the continuous advancement of medicine, interventional procedures have also seen significant growth.
[0010] With the continuous development of medicine, medical interventional surgery has also been greatly developed. During the surgical interventional treatment of coronary TO lesions, the extension catheter is guided by the guide catheter, which can more deeply treat the side branches and lesions far away from the aorta. During the small blood vessel interventional treatment, under normal circumstances, the guide catheter will be delivered to the position of the larger blood vessel close to the small blood vessel, and then the guide wire will be passed through the guide catheter and delivered to the thrombus in the small blood vessel. The extension catheter is placed on the guide wire and follows the guide wire to the target area, and then suction is performed. However, this method has the following problems: for distal small blood vessels, an extension catheter needs to be used. Since there is a guide wire in the lumen of the extension catheter, the guide wire occupies the area of the lumen of the extension catheter, and the guide wire is not close to the catheter wall, resulting in an obstructed suction path and a small effective suction area, which affects the suction effect of the thrombus.
[0011] Therefore, it is necessary to provide an extended suction catheter, a catheter system having the extended suction catheter, and a method involving the catheter system to ensure a smooth suction path and avoid the guide wire affecting the effective suction area of the lumen.
[0012] Application Contents
[0013] The first object of the present application is to provide an extended suction catheter with a smooth suction passage and capable of preventing the guide wire from affecting the effective suction area of the lumen.
[0014] The second object of the present application is to provide a catheter system having an extended suction catheter with a smooth suction passage and capable of preventing the guide wire from affecting the effective suction area of the lumen.
[0015] A third object of the present application is to provide a method for performing thrombus aspiration using a catheter system to remove thrombus from a blood vessel.
[0016] A fourth object of the present application is to provide a method for performing a medical procedure in a body vessel using a catheter system to remove a thrombus from the vessel.
[0017] A fifth object of the present application is to provide a method for placing an extended aspiration catheter of a catheter system into a narrow and tortuous blood vessel of the body to remove a thrombus from the blood vessel.
[0018] To achieve the above-mentioned first purpose, the present application provides an extended suction catheter, comprising a catheter body, a push rod, a sealing balloon and a guide wire tube, 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 the interior of the push rod is provided with a filling channel; 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 guide wire tube is arranged on the catheter body, and a guide wire cavity for the guide wire to pass through is provided in the guide wire tube.
[0019] Preferably, the intermediate reinforcement layer is a woven mesh layer, a spring layer or a spirally cut tube layer.
[0020] Preferably, 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, and the hardness of the compliant zone, the transition zone and the push zone increases in sequence.
[0021] Preferably, 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 pushing zone is 5-50 cm.
[0022] Preferably, when 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; when 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.
[0023] Preferably, the spirally cut tube layer is divided into a soft 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 soft zone, the transition zone and the push zone meet at least one of the following characteristics; the slit length of the spirally cut tube layer in the soft zone > the slit length of the spiral cut tube layer in the transition zone > the slit length of the spiral cut tube layer in the push zone; or, the cutting spacing of the spiral cut tube layer in the soft zone < the cutting spacing of the spiral cut tube layer in the transition zone < the cutting spacing of the spiral cut tube layer in the push zone; or, the slit angle of the spiral cut tube layer in the soft zone < the slit angle of the spiral cut tube layer in the transition zone < the slit angle of the spiral cut tube layer in the push zone; or, the pitch of the spiral cut tube layer in the soft zone < the pitch of the spiral cut tube layer in the transition zone < the pitch of the spiral cut tube layer in the push zone.
[0024] Preferably, the hardness of the outer layer decreases from the proximal end to the distal end of the catheter body.
[0025] Preferably, 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 the other end of the metal connector is connected to the intermediate reinforcement layer.
[0026] Preferably, the metal connector is a metal ring arranged side by side along the axial direction of the catheter body, or the metal connector has 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 connecting strip are connected to the middle reinforcement layer, the push rod is connected to the connecting plate, and each connecting strip is wrapped and connected to the inner layer.
[0027] Preferably, 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.
[0028] Preferably, a first developing member is provided at the distal end of the pushing 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.
[0029] Preferably, the push rod is a metal tube or a plastic tube with a metal reinforcement layer.
[0030] Preferably, there is a first angle between the end face of the introduction port and the cross-section of the catheter body in the radial direction, and the size of the first angle is in the range of 0-150°, or / and there is a 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, and the size of the second angle is in the range of 0-150°.
[0031] Preferably, the distal end of the pushing rod is fixed in the tube wall of the catheter body, and a through hole is provided at a position of the pushing 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.
[0032] Preferably, the wire guide tube is arranged on the outer wall of the catheter body, and the wire guide tube is connected to the catheter body in parallel along the catheter direction of the catheter body.
[0033] Preferably, the proximal end of the guide wire tube exceeds the sealing balloon, and the distal end of the guide wire tube extends to the distal end of the catheter body, or the proximal end of the guide wire tube is located on the distal end side of the sealing balloon, and the distal end of the guide wire tube extends to the distal end of the catheter body.
[0034] Preferably, the catheter body and the wire guide tube are separately provided, or the catheter body and the wire guide tube are integrally provided.
[0035] Preferably, the outer surface of the guide wire tube is provided with a hydrophilic layer; or / and the guide wire tube is provided with a hydrophobic layer on the inner wall of the guide wire cavity; or / and 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.
[0036] Preferably, the extended suction catheter further comprises a catheter seat, the distal end of the catheter seat is connected to the proximal end of the pushing rod, a through channel is provided in the catheter seat, and the through channel is communicated with the filling channel.
[0037] Preferably, the proximal end of the through channel forms a Luer connector on the catheter hub, 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.
[0038] Preferably, a third developing component is provided at the proximal end of the catheter body, and the third developing component is located inside the sealing balloon.
[0039] To achieve the above-mentioned second purpose, the present application provides a catheter system, including a guiding catheter and the above-mentioned extended suction catheter, wherein a guiding channel is provided in the guiding catheter, and when the sealing balloon is not inflated, the extended suction catheter slides in the guiding channel; when the sealing balloon is inflated, the sealing balloon expands and abuts against the inner wall of the guiding channel, and the delivery channel is connected to the guiding channel.
[0040] Preferably, the extended 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.
[0041] Preferably, when the sealing balloon is subjected to an inflation pressure of 0.1 bar to 5 bar, the sealing balloon abuts against the inner wall of the guiding channel, and by moving the pushing rod, the sealing balloon can slide in the guiding channel and maintain a sealing effect.
[0042] Preferably, a Y-shaped connecting valve is provided at the proximal end of the guiding 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 guiding channel, the guide wire and the extended suction catheter are both inserted into the first interface, and the proximal end of the push rod is located on the outside of the Y-shaped connecting valve.
[0043] Preferably, the catheter system further comprises a suction device for aspirating thrombus, wherein the suction device is connected to the second interface and communicates with the guiding channel.
[0044] To achieve the above-mentioned third purpose, the present application provides a method for performing thrombus aspiration using the above-mentioned catheter system, the method comprising: using the guide catheter that extends into the patient's blood vessel in a percutaneous structure to guide the extended aspiration catheter, expanding the sealing balloon to abut against the inner wall of the guide channel and maintain a sealing effect, applying suction through the guide channel and the delivery channel to aspirate the fluid out of the guide catheter, and thereby removing the thrombus from the blood vessel.
[0045] To achieve the above-mentioned fourth purpose, the present application provides a method for performing a medical procedure in a body blood vessel using the above-mentioned catheter system, wherein the proximal portion of the guide channel is connected to the delivery channel to form a suction lumen, and the method includes: sliding the extended suction catheter relative to the guide catheter, tracking the extended suction catheter to the desired position in the blood vessel, and applying suction through the suction lumen to remove the thrombus from the blood vessel.
[0046] To achieve the above-mentioned fifth purpose, the present application provides a method for placing the extended suction catheter of the above-mentioned catheter system into a narrow and curved blood vessel of the body, the method comprising: inserting a guidewire into the guidewire tube, advancing the extended suction catheter on the guidewire and pushing it out through the distal opening of the guide catheter, and after the extended suction catheter extends to a preset length, expanding the sealing balloon so that the sealing balloon abuts against the inner wall of the guide channel.
[0047] Preferably, the sealing balloon can slide in the guiding channel and maintain a sealing effect.
[0048] The beneficial effect of the extended suction catheter provided by the present application is that: compared with the prior art, the extended suction catheter of the present application is provided with a guidewire tube on the catheter body, so that the guidewire can pass through the guidewire lumen of the guidewire tube without occupying the area of the delivery channel of the catheter body, ensuring that the suction path for suction through the delivery channel of the catheter body is smooth, the effective suction area is relatively large, and the guidewire can be prevented from affecting the effective suction area of the lumen and improving the suction effect. At the same time, the guidewire passing through the guidewire lumen can also guide and anchor the catheter body, ensuring that the extended suction catheter can be accurately delivered to the target area. At the same time, the sealing balloon can be filled through the filling channel. After the sealing balloon is expanded, the outer wall of the sealing balloon abuts the inner wall of the inner cavity of the guide catheter, preventing the pressure from leaking through the gap between the extended suction catheter of the present application and the guide catheter during the thrombus suction process, so that the extended suction catheter of the present application is effectively connected to the guide catheter and forms a sealed suction lumen. The new suction lumen formed by the extended suction catheter of the present application and the guide catheter can provide a larger suction lumen and stronger suction force. After connection, in the absence of external force, the extended suction catheter of the present application is not easy to slip. During the operation of the operator, the proximal end of the extended suction catheter of the present application can be pushed to move it forward and backward.
[0049] The beneficial effect of the catheter system provided by the present application is that: compared with the prior art, the catheter system of the present application has an extended suction catheter, which is provided with a guidewire tube on the catheter body so that the guidewire can pass through the guidewire lumen of the guidewire tube without occupying the area of the delivery channel of the catheter body, thereby ensuring that the suction path for suction through the delivery channel of the catheter body is smooth, the effective suction area is relatively large, and the influence of the guidewire on the effective suction area of the lumen can be avoided, and the suction effect is improved. At the same time, the guidewire passing through the guidewire lumen can also guide and anchor the catheter body, ensuring that the extended suction catheter can be accurately delivered to the target area. At the same time, the sealing balloon can be filled through the filling channel. After the sealing balloon is expanded, the outer wall of the sealing balloon abuts against the inner wall of the inner cavity of the guiding catheter, preventing the pressure from leaking through the gap between the extended suction catheter of the present application and the guiding catheter during the thrombus suction process, so that the extended suction catheter of the present application is effectively connected to the guiding catheter and forms a sealed suction lumen. The new suction channel formed by connecting the extended suction catheter of the present application with the guiding catheter can provide a larger suction channel and stronger suction force. After connection, the extended suction catheter of the present application is not easy to slip without external force. During operation, the operator can push the proximal end of the extended suction catheter of the present application to move it forward and backward.
[0050] The beneficial effect of the method for thrombus aspiration using the above-mentioned catheter system provided in the present application is that: compared with the existing technology, by utilizing the guide catheter that extends into the patient's blood vessel in a percutaneous structure to guide the extended aspiration catheter, when the extended aspiration catheter is extended along the proximal end of the guide catheter, the proximal end of the push rod can be extended from the proximal end of the guide catheter, and the distal end of the catheter body can be extended 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. 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 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.
[0051] 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 catheter system is that, compared with the prior art, when the extended suction catheter is extended along the proximal end of the guide catheter, the proximal end of the push rod can be extended from the proximal end of the guide catheter, and the distal end of the catheter body can be extended 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. 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 extended suction catheter of the present application is effectively connected to the guide catheter and forms a sealed suction lumen. By sliding the extended suction catheter relative to the guide catheter, the extended suction catheter is tracked to the desired position in the blood vessel, and suction is applied through the suction lumen to effectively remove the thrombus from the blood vessel.
[0052] The beneficial effect of the method provided by the present application for placing the extended suction catheter of the above-mentioned catheter system into the narrow and curved blood vessels of the body is that: compared with the prior art, by inserting a guidewire into the guidewire tube, it is ensured that the extended suction catheter can be accurately delivered to the target area, and at the same time, the extended suction catheter can be advanced on the guidewire and accurately pushed out through the distal opening of the guiding catheter, so that the guidewire does not occupy the area of the delivery channel of the catheter body, ensuring that the suction path for suction through the delivery channel of the catheter body is smooth, the effective suction area is relatively large, avoiding the influence of the guidewire on the effective suction area of the lumen, and improving the suction effect. After the extended suction catheter is extended to a preset length, a sealing balloon can be filled through the filling channel. After the sealing balloon is expanded, the outer wall of the sealing balloon abuts against the inner wall of the inner cavity of the guiding catheter and maintains a sealing effect, ensuring that suction can be applied through the guide channel and the delivery channel to aspirate the fluid to the outside of the guiding catheter, thereby removing the thrombus from the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS
[0053] FIG1 is a structural diagram of the catheter system of the present application.
[0054] FIG2 is a structural diagram of the catheter system of the present application when aspirating thrombus.
[0055] FIG3 is a structural diagram of an extended suction catheter according to an embodiment of the present application.
[0056] FIG4 is a structural diagram of an extended suction catheter at the proximal end of the catheter body according to an embodiment of the present application.
[0057] FIG5 is a cross-sectional view of an extended aspiration catheter at the proximal end of the catheter body according to an embodiment of the present application.
[0058] FIG6 is an enlarged view of point A in FIG5.
[0059] FIG7 is a cross-sectional view of a catheter body of an extended suction catheter according to an embodiment of the present application.
[0060] FIG8 is a cross-sectional view of a push rod of an extended suction catheter according to an embodiment of the present application.
[0061] FIG9 is a three-dimensional structural diagram of a metal connector of an extended suction catheter according to an embodiment of the present application.
[0062] FIG10 is a cross-sectional view of an extended suction catheter inserted into a guiding catheter according to an embodiment of the present application.
[0063] FIG. 11 is a structural diagram of an extended suction catheter according to an embodiment of the present application.
[0064] FIG12 is a cross-sectional view along the BB direction in FIG11 .
[0065] FIG13 is an enlarged view of point D in FIG12 .
[0066] FIG14 is a cross-sectional view taken along the CC direction in FIG11 .
[0067] 15 is a cross-sectional view of the extended aspiration catheter shown in FIG11 after insertion of the guide catheter.
[0068] 16 is a cross-sectional view of the extended aspiration catheter shown in FIG. 11 at the distal end of the catheter body.
[0069] FIG. 17 is a structural diagram of an extended suction catheter according to an embodiment of the present application.
[0070] FIG18 is a cross-sectional view taken along the DD direction in FIG17 .
[0071] FIG19 is a cross-sectional view taken along the EE direction in FIG17.
[0072] FIG20 is a cross-sectional view of the second embodiment along the line EE in FIG17 .
[0073] FIG21 is a cross-sectional view of the third embodiment along the EE direction in FIG17.
[0074] FIG22 is a cross-sectional view of the fourth embodiment along the EE direction in FIG17.
[0075] 23 is a cross-sectional view of the extended aspiration catheter shown in FIG. 17 after insertion of the guide catheter.
[0076] FIG. 24 is a cross-sectional view of an extended suction catheter according to an embodiment of the present application.
[0077] FIG25 is a structural diagram of the connection between the metal connector and the push rod of the extended suction catheter according to an embodiment of the present application.
[0078] FIG26 is a cross-sectional view of a push rod of an extended suction catheter according to an embodiment of the present application.
[0079] FIG. 27 is a structural diagram of the middle reinforcement layer of the extended suction catheter according to an embodiment of the present application.
[0080] FIG28 is a cross-sectional view of a push rod of an extended suction catheter according to an embodiment of the present application.
[0081] FIG. 29 is a cross-sectional view of an extended suction catheter according to an embodiment of the present application.
[0082] FIG30 is a structural comparison diagram of the thrombus aspiration catheter system of the present application and a traditional aspiration system.
[0083] FIG31 is a cross-sectional structural comparison diagram of the thrombus aspiration catheter system shown in FIG30 at the proximal position and a conventional aspiration system at the proximal position. DETAILED DESCRIPTION
[0084] In order to explain the technical content and structural features of the present application in detail, the following further describes the embodiments in conjunction with the accompanying drawings.
[0085] 1 to 14 , the catheter system 200 of the present application includes a guiding catheter 201 and an extended suction catheter 100. The extended suction catheter 100 includes a catheter body 1, a push rod 2, a sealing balloon 3, and a guidewire tube. 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 is located near the proximal end of the catheter body 1. The inner cavity of the sealing balloon 3 is connected to the filling channel 21. The guidewire tube 7 is provided on the catheter body 1, and the guidewire tube 7 is provided with a guidewire cavity 71 for the guidewire 202 to pass through. The guiding catheter 201 is provided with a guiding channel 201a. When the sealing balloon 3 is not inflated, the extended suction catheter 100 slides within the guiding channel 201a. When the sealing balloon 3 is inflated, the expanded sealing balloon 3 abuts against the inner wall of the guiding channel 201a, and the delivery channel 11 is connected to the guiding channel 201a. The extended suction catheter 100 is inserted into the guiding channel 201a, and the distal end of the catheter body 1 extends out from the distal end of the guiding channel 201a. The proximal end of the catheter body 1 is located within the guiding channel 201a, and the proximal end of the push rod 2 is located outside the proximal end of the guiding channel 201a.
[0086] The present application sets a guidewire tube 7 on the catheter body 1, so that the guidewire 202 can pass through the guidewire cavity 71 of the guidewire tube 7 without occupying the area of the delivery channel 11 of the catheter body 1, thereby ensuring that the suction path for suction through the delivery channel 11 of the catheter body 1 is smooth and the effective suction area is relatively large, which can avoid the guidewire 202 from affecting the effective suction area of the lumen and improve the suction effect. At the same time, the guidewire 202 passing through the guidewire cavity 71 can also guide and anchor the catheter body 1, ensuring that the extended suction catheter 100 can be accurately delivered to the target area.
[0087] Please refer to Figure 5. In one embodiment, there is a first angle between the end face of the introduction port 12 and the cross section of the catheter body 1 in the radial direction. The size of the first angle is in the range of 0-150°, but is not limited thereto. Specifically, the introduction port 12 has an oblique structure, which can enable the extended suction catheter 100 of the present application to have better push transmission. Among them, 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. At the same time, during the suction process, the thrombus can smoothly pass through the introduction port 12 into the guiding catheter 201, and finally be sucked out of the body without being entangled by the extended suction catheter 100.
[0088] The sealing balloon 3 is inflated 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 guiding channel 201a of the guiding catheter 201, effectively connecting the extended aspiration catheter 100 to the guiding catheter 201 and forming a sealed aspiration lumen. As shown in Figures 30 and 31, the catheter system 200 of the present application has a larger average aspiration inner diameter than the conventional aspiration system 400.
[0089] According to the Hagen-Poiseuille equation (1):
[0090] The following rule can be derived: as the system's average inner diameter r increases, the flow resistance R decreases, thereby increasing the flow rate of catheter system 200. Therefore, catheter system 200 has a larger proximal aspiration lumen than traditional aspiration system 400, resulting in a greater average system flow resistance than traditional aspiration catheter 401. Ultimately, the flow rate during aspiration is greater than that of traditional aspiration catheter 401. During thrombus aspiration, as the extended aspiration catheter 100 is withdrawn, the system's aspiration length L shortens, similarly reducing the system's flow resistance and increasing the aspiration flow rate. However, the lumen of traditional aspiration catheter 401 remains unchanged.
[0091] Where ΔP is the pressure difference across the catheter, L is the total length of the catheter system, Q is the flow rate of the catheter in this case, r is the radius of the lumen, and μ is the viscosity of the liquid.
[0092] The above Hagen-Poiseuille equation can be converted to the flow rate of the catheter system 200 as equation (2):
[0093] 30 and 31 , under the same pressure difference at both ends (for example, the negative pressure generated by a 30 ml syringe), the flow rate Q of the catheter system 200 of the present application is B and the flow rate Q of the traditional suction system 400 A The relationship can be derived, equation (3) is:
[0094] From the above formula, we can know that Q A <Q B Therefore, under the same negative pressure, catheter system 200 has a greater flow rate than conventional suction system 400, thereby generating higher suction efficiency. At the same time, as suction catheter 100 is extended and guiding catheter 201 is withdrawn, the length of catheter system 200 becomes shorter. According to equation (2), the flow rate of the suction system will continue to increase, improving suction efficiency.
[0095] 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 aspirating the 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. In this way, the extended aspiration catheter 100 can be used as a quick-exchange catheter, thereby realizing rapid exchange of instruments; for example, the introduction port 12 can also be connected to a syringe through the guiding catheter 201 to facilitate aspiration of the thrombus 300 through the syringe.
[0096] Referring to Figure 2 , in one embodiment, a second angle is formed between the end surface of the distal suction port of the catheter body 1 and the radial cross-section of the catheter body 1. The second angle is within a range of 0-150°. Specifically, the distal end of the catheter body 1 is configured as a beveled suction port. By configuring the distal end of the catheter body 1 as the beveled suction port, the contact area between the distal end of the catheter body 1 and the thrombus 300 is increased, thereby enhancing the ability to capture the thrombus 300 and improving suction efficiency, but the present invention is not limited thereto.
[0097] 7 , in one embodiment, the catheter body 1 includes an inner layer 13, an intermediate reinforcement layer 14, and an outer layer 15, arranged sequentially from the inside out. The delivery channel 11 is located at the center of the inner layer 13. The three-layer composite structure provides strong support, pressure resistance, and flexural resistance.
[0098] Inner layer 13 is made of polytetrafluoroethylene (PTFE) or linear low-density polyethylene (LLDPE). PTFE is highly lubricating and non-sticky, facilitating the passage of other devices through delivery channel 11 within inner layer 13. LLDPE has high softening and melting temperatures, and offers advantages such as high strength, toughness, rigidity, and excellent heat and cold resistance. It also exhibits excellent resistance to environmental stress cracking, impact strength, and tear resistance.
[0099] 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.
[0100] The outer layer 15 has a decreasing hardness from the proximal end to the distal end of the catheter body 1. This not only prevents deformation but also makes it easier to navigate tortuous lesions. The flexible material at the distal end prevents damage to the vessel wall during insertion, better meeting the requirements for catheter insertion within human blood vessels. This allows doctors to operate more accurately and conveniently while reducing pain for patients during surgery.
[0101] 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 extended suction catheter 100.
[0102] In one embodiment, the intermediate reinforcement layer 14 is a braided mesh layer, which is woven from metal wires, such as nickel-titanium alloy wires or stainless steel wires. In one embodiment, the braided mesh layer is woven using a one-on-one or one-on-two method. In one embodiment, the braided mesh layer is woven from 8-16 strands of metal wire, and the PPI of the braided mesh layer is 20-120. In one embodiment, the braided mesh layer is made of round wire with a wire diameter of 0.001-0.01 inches. In another embodiment, the braided mesh layer is made of flat wire with a width of 0.001-0.01 inches and a thickness of 0.001-0.005 inches. In one embodiment, 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 have better flexibility and reachability, and the proximal end has better pushing performance. For example, using 0.01-inch round wire, the PPI of the distal end of the braided mesh layer is 20, and the PPI of the proximal end is 120. PPI stands for "Pick Per Inch," which refers to the sum of the number of warp and weft threads per inch. It is an important indicator for measuring the density of woven fabrics. A higher PPI value generally means a denser fabric.
[0103] In one embodiment, the middle reinforcing layer 14 is a spring layer, which is wound with a metal wire. 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. In one embodiment, the proximal end of the spring layer is wound with a stainless steel wire, and the distal end is wound with a nickel-titanium alloy wire. In one embodiment, 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. For example, 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, and the proximal end uses a stainless steel wire with a wire diameter of 0.08mm and a pitch of 0.08mm.
[0104] In one embodiment, 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. Further, in an optional solution, 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. Of course, in other optional solutions, the solution in which the length of the compliant zone is 1-30 cm, the length of the transition zone is 2-50 cm, and the length of the push zone is 5-50 cm can also be set in the same solution.
[0105] In one embodiment, the intermediate reinforcement layer 14 is a spirally cut tubing layer. This ensures a certain level of strength while maintaining superior flexibility, making it more adaptable to complex vascular pathways and reducing irritation and damage to blood vessels. It also provides a more even distribution of support force, avoiding localized stress concentration and helping to improve the stability of the catheter within the vessel. Furthermore, the spirally cut tubing design results in a smaller outer diameter and a more compact structure, thereby reducing the outer diameter of the entire extended aspiration catheter 100, reducing the difficulty of insertion and the impact on the blood vessels. Furthermore, the lighter weight helps alleviate the foreign body sensation in the patient's body.
[0106] Furthermore, as shown in FIG27 , the spirally cut tube layer is sequentially divided into a compliant zone 141 , a transition zone 142 and a push zone 143 along the distal to proximal direction 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;
[0107] The slit length L of the spirally cut tube layer in the compliant zone 141 is greater than the slit length L of the spirally cut tube layer in the transition zone 142 and greater than the slit length L of the spirally cut tube layer in the pushing zone 143;
[0108] Or, the cutting spacing d of the spirally cut tube layer in the compliant zone 141 is less than the cutting spacing d of the spirally cut tube layer in the transition zone 142 and less than the cutting spacing d of the spirally cut tube layer in the pushing zone 143;
[0109] Or, the slit angle θ of the spirally cut tube layer in the compliant zone 141 is less than the slit angle θ of the spirally cut tube layer in the transition zone 142 and less than the slit angle θ of the spirally cut tube layer in the pushing zone 143;
[0110] Alternatively, 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 .
[0111] It should be noted that the four parameters of the spiral cutting tube layer, namely the slit length L, cutting spacing d, slit angle θ, and pitch p of the three partitions of the soft zone 141, transition zone 142 and push zone 143, can be designed according to the above-mentioned change rules. One or more of the four parameters can also be designed according to the above-mentioned change rules.
[0112] It should also be noted that, in the present application, the slit angle θ is the angle between the slit and the central axis of the catheter.
[0113] By controlling the slit length L, cutting spacing d, slit angle θ, and pitch p of the spiral cutting tube layer, the flexibility of the catheter body 1 can be changed, dividing it into a compliant zone 141, a transition zone 142, and a push zone 143. As is well known, the longer the slit length L, the smaller the cutting spacing d, the smaller the slit angle θ, or the smaller the pitch p, the more compliant the tube body is and the better its passability.
[0114] Correspondingly, the compliant zone 141 of the spirally cut tube layer has a longer slit length L, a smaller slit spacing d, a smaller slit angle θ, and a smaller pitch p, making this area compliant and better able to adapt to complex vascular pathways, thereby improving the ability of the catheter body 1 to pass through the blood vessel. The transition zone 142 achieves a smooth transition between the compliant zone 141 and the push zone 143, maintaining a certain degree of flexibility to adapt to changes while gradually increasing the convenience of pushing. The push zone 143 adopts a shorter slit length L, a larger slit spacing d, a larger slit angle θ, and a larger pitch p, making this area more powerful during pushing, facilitating accurate pushing of the catheter to the target location.
[0115] The reasonable setting of the characteristics of different areas 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.
[0116] Specifically, in this embodiment, the spiral cutting tube layer of the compliant zone 141 has a slit length of 0.6 mm, a cutting pitch of 0.1 mm, a slit angle of 95°, a pitch of 0.09 mm, and a slit width of 0.02 mm.
[0117] The slit length of the spirally cut tube layer in the transition zone 142 is 0.4 mm, the cutting spacing is 0.3 mm, the slit angle is 105°, the pitch is 0.12 mm, and the slit width is 0.02 mm.
[0118] The thread cutting tube layer in the pushing area 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.
[0119] Referring to Figures 3 and 4 , the catheter body 1 is provided with a metal connector 4 at the proximal end of the intermediate reinforcement layer 14. 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 positioned juxtaposed with the intermediate reinforcement layer 14, or alternatively, is connected to the intermediate reinforcement layer 14. As shown in Figure 24 , the other end of the metal connector 4 is positioned juxtaposed with the intermediate reinforcement layer 14. As shown in Figure 29 , the other end of the metal connector 4 is connected to the intermediate reinforcement layer 14.
[0120] As shown in FIG24 , in one embodiment, 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 intermediate reinforcement layer 14 near one end of the push rod 2. Its cross-sectional shape is the same as the cross-sectional shape of the intermediate reinforcement layer 14. In the axial direction of the guiding catheter 201, the metal connector 4 is parallel to the intermediate reinforcement layer 14 on the side away from the push rod 2 but is not connected. The metal connector 4 is connected to the push rod 2 on the side close to the push rod 2. As shown in FIG29 , the metal connector 4 is superimposed and welded to 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 vessels. 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 guarantee the mechanical transmission during operation.
[0121] As shown in Figures 24 and 25 , in one embodiment, the metal connector 4 has a helical structure, which effectively mitigates stress concentration at the connection between the push rod 2 and the catheter body 1. It also provides effective bending resistance for the catheter body 1, maintaining the integrity of the lumen when the sealing balloon 3 is inflated. Furthermore, the helical structure of the metal connector 4 provides a certain degree of flexibility and adaptability, making it more adaptable to various conditions during connection and force transmission.
[0122] As shown in Figures 4 and 9, in one embodiment, 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 intermediate reinforcement layer 14. The push rod 2 is connected to the connecting piece 41. Each connecting strip 42 is wrapped around and connected to the inner layer 13. The connecting strips 42 are wrapped around and connected to the outside of the inner layer 13 to ensure that the metal connector 4 is firmly connected to the catheter body 1.
[0123] In one embodiment, the metal connector 4 and the push rod 2 can be connected by welding, gluing, or the like.
[0124] As shown in Figure 25, in one embodiment, the metal connector 4 is welded to the distal end of the push rod 2 to form a weld region 43. Specifically, weld regions 43 are provided at both ends of the connection between the metal connector 4 and the push rod 2, forming a welded connection between the metal connector 4 and the push rod 2. Furthermore, at the 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 facilitates passage through the blood vessel and reduces damage to the blood vessel.
[0125] Please refer to Figures 24 and 26. In one embodiment, a first developing member 22 is provided at the distal end of the push rod 2. The first developing member 22 is inserted at the distal end of the push rod 2 and is used to develop and display the position of the sealing balloon 3, allowing precise positioning within the patient's body under X-rays 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 surgery, helping to improve the accuracy and safety of the operation. The first developing member 22 can be a filament made of an X-ray-opaque developing material, and the developing material can be one or more of gold wire, tungsten wire, platinum wire, and platinum-iridium alloy wire.
[0126] In this embodiment, the length of the first developing member 22 along the pushing rod 2 is 3-7 mm.
[0127] In one embodiment, the push rod 2 is a metal tube or a plastic tube with a metal reinforcement layer, but is not limited thereto.
[0128] In one embodiment, the push rod 2 is a hypotube, which effectively improves delivery and prevents the extendable aspiration catheter 100 of the present application from buckling during the push process. Furthermore, the hypotube has dual marking bands to assist in determining whether the extendable aspiration catheter 100 of the present application has reached the coronary ostium. However, this is not a limitation.
[0129] Referring to Figures 12, 13, and 26, in one embodiment, the distal end of the push rod 2 is fixed within the wall of the catheter body 1. A through hole 23 is provided near the proximal end of the push rod 2, connecting the filling channel 21 with the inner lumen of the sealing balloon 3. Furthermore, because the distal end of the push rod 2 is fixed within the wall of the catheter body 1, the push rod 2 can be concealed within the material of the catheter body 1, preventing the push rod 2 from damaging the blood vessels. Specifically, as shown in Figures 5 and 6, the push rod 2 is provided with a plurality of through holes 23, which are distributed in the center of the sealing balloon 3.
[0130] Referring to Figures 11 to 14 , in one embodiment, the proximal end of the push rod 2 is hollow, with the filling channel 21 formed within the hollow structure. The distal end of the push rod 2 is solid. This solid structure of the distal end of the push rod 2 allows for better transmission of the pushing force. Furthermore, the outer diameter of the hollow structure is larger than that of the solid structure, thereby ensuring the strength of the push rod 2 at the location of the hollow structure.
[0131] Please refer to Figure 28. In one embodiment, 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 outside of a section of the push rod 2 connected to the metal connector 4 and is close to the metal connector 4 to reduce stress concentration after welding, while improving the bending resistance of the end of the push rod 2 to prevent this 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. 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 entire outer layer of the push rod 2. The push rod spring wire 24 and the push rod braided layer 25 are both located inside the push rod 2.
[0132] In this embodiment, the middle section of the push rod 2 utilizes a push rod braid 25 with a needle count per inch, providing good lumen retention, torque transmission, and a certain degree of pushing performance. The proximal end of the push rod 2 utilizes a push rod braid 25 with a needle count per inch, providing excellent pushing capability. The push rod braid 25 can be woven from stainless steel wire. The push rod outer layer 26 is a polytetrafluoroethylene layer, which provides low surface friction and reduces the probability of thrombus attachment in the body. The polytetrafluoroethylene layer can be prepared using a polytetrafluoroethylene coating.
[0133] In one embodiment, a marking band is provided at the distal end of the sealing balloon 3 for indicating its position.
[0134] Please refer to FIG. 11 to FIG. 23 . In one embodiment, the wire guide tube 7 is disposed on the outer wall of the catheter body 1 , and the wire guide tube 7 is connected in parallel with the catheter body 1 along the catheter direction of the catheter body 1 .
[0135] Referring to Figures 11 to 16 , in one embodiment, the proximal end of the guidewire tube 7 extends beyond the sealing balloon 3 , and the distal end of the guidewire tube 7 extends to the distal end of the catheter body 1 , thereby ensuring that the guidewire 202 is located within the guidewire tube 7 from the position corresponding to the sealing balloon 3 to the position corresponding to the distal end of the catheter body 1 , thereby preventing the guidewire 202 from forming an angle with the outer side of the catheter body 1 , thereby ensuring smooth pushing of the catheter body 1 . Furthermore, the guidewire tube 7 is located near the pushing rod 2 .
[0136] Referring to Figures 17 to 19 and Figure 23, in one embodiment, the proximal end of the guidewire tube 7 is located on the distal side of the sealing balloon 3, and the distal end of the guidewire tube 7 extends to the distal end of the catheter body 1. When the sealing balloon 3 is not inflated, the extended suction catheter 100 slides within the guiding channel 201a, and the guidewire 202 can movably pass through the guiding channel 201a and the guidewire cavity 71. When the sealing balloon 3 is inflated, the sealing balloon 3 expands and abuts against the inner wall of the guiding channel 201a and the guidewire 202, and the delivery channel 11 is connected to the guiding channel 201a.
[0137] 14 and 19 , in one embodiment, the catheter body 1 and the guidewire tube 7 are separately provided, and the catheter body 1 and the guidewire tube 7 are bonded, welded, or connected together via a connector. It is understood that any configuration that separates the guidewire lumen 71 and the delivery channel 11 falls within the scope of this application.
[0138] Please refer to Figures 20 to 22. In one embodiment, the catheter body 1 and the guidewire tube 7 are integrally arranged, so that the guidewire cavity 71 and the delivery channel 11 are separated and arranged. The guidewire cavity 71 is preferably arranged in the catheter body 1, and the cross-sectional shape of the delivery channel 11 can be variously deformed, but is not limited to this.
[0139] Please refer to Figures 3, 11 and 15. In one embodiment, the extended 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. 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. During operation, the doctor can connect a medium such as an injection fluid to the catheter seat 5, fill the sealing balloon 3 through the fluid channel in the push rod 2, and quickly anchor the sealing balloon 3 in the inner cavity of the guiding catheter 201 and seal it. The distal end of the catheter seat 5 is connected to the proximal end of the push rod 2. In this embodiment, the connection between the two is a welding connection. Preferably, the catheter seat 5 is flat, which is convenient for finger gripping and turning.
[0140] Furthermore, in one embodiment, the proximal end of the through-channel forms a Luer connector on the catheter adapter 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 adapter 5, thereby preventing backflow. In other embodiments, the proximal end of the through-channel can also be connected to a component with a one-way seal or a heparin cap, which can also prevent the filling medium from flowing out of the catheter adapter 5, thereby preventing backflow. The catheter adapter 5 and the one-way seal component or heparin cap can be connected in an integrated structure or a separate structure. Among them, the one-way seal component can be a one-way valve, but is not limited to this. Corresponding to the heparin cap setting, a needle-type syringe can be inserted into the heparin cap to inject the filling medium, so that the sealing balloon 3 expands. Corresponding to the one-way valve setting, a syringe with a Luer connector can be connected to the one-way valve to inject the filling medium, so that the sealing balloon 3 expands.
[0141] In one embodiment, 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 acts as a stress buffer.
[0142] In one embodiment, to reduce friction between the guide extension aspiration catheter 100 and the guide catheter 201, a hydrophilic coating is provided on the surface of the catheter body 1 and the surface of the sealing balloon 3, allowing the guide extension aspiration catheter 100 to smoothly reach the distal end of the rugged 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, or other methods. To reduce the adhesion of blood clots to the push rod 2, a hydrophobic coating is provided on the surface of the push rod 2. In one embodiment, the hydrophobic coating is added to the surface of the push rod 2 by leaching, spraying, or other methods. The hydrophobic coating can be made of existing PTFE material, but is not limited to this.
[0143] Furthermore, in order to facilitate medical personnel to know the depth of the catheter body 1 and the sealing balloon 3 inserted into the human body, a scale or marking band is provided on the surface of the pushing rod 2 .
[0144] During interventional therapy, the operator can directly grasp the catheter adapter 5 to smoothly advance the catheter body 1 into the human body. The push rod 2 provides good support and pushing force for extending the suction catheter 100, ensuring a smooth operation. The push rod 2 can be made of stainless steel with a polished outer surface to enhance the safety of the interventional therapy.
[0145] In one embodiment, a fluid or other medium can be injected into the catheter adapter 5. The fluid or other medium can pass through the inner cavity of the catheter adapter 5 and the filling channel 21 of the push rod 2, thereby entering the sealing balloon 3, causing the sealing balloon 3 to be pressurized and expanded. Furthermore, the number and total area of the through holes 23 and the openings can be adjusted to achieve a set target diameter for the sealing balloon 3.
[0146] Please refer to Figures 3 and 4. In one embodiment, the sealing balloon 3 is vacuum-fitted flatly 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, thereby forming 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 bumps and bumps, making it easier to enter other channel instruments with low resistance. Specifically, the sealing balloon 3 can be a compliant balloon. The compliant balloon here means that after the sealing balloon 3 expands to a predetermined diameter, its diameter and volume can continue to increase as the filling pressure increases. The sealing balloon 3 can be made of nylon, polyethylene, polyurethane or polyethylene terephthalate.
[0147] Referring to Figures 3, 11, and 24, in one embodiment, a second developing member 17 is provided at the distal end of the catheter body 1. The second developing member 17 is used to develop and display the position of the distal end of the catheter body 1, allowing for precise positioning within the patient's body under X-rays, thereby reducing operational difficulty.
[0148] Referring to Figures 3 and 11 , in one embodiment, a third developing element 18 is provided at the proximal end of the catheter body 1 and is located within the sealing balloon 3. The third developing element 18 is used to visualize and display the position of the sealing balloon 3, enabling precise positioning within the patient's body under X-rays and reducing operational difficulty. The provision of the third developing element 18 facilitates accurate visualization of the position of the sealing balloon 3 during surgery, helping to improve the accuracy and safety of the procedure. The function of the third developing element 18 is similar to that of the first developing element 22.
[0149] 10 , in one embodiment, a fourth developing member 201 b is provided at the distal end of the guiding catheter 201 . A fourth developing member 201 b is provided at the distal end of the guiding catheter 201 .
[0150] 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 guiding catheter 201 .
[0151] By comparing and calculating the difference in imaging position between the third imaging member 18 and the fourth imaging member 201b, 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 determined. Alternatively, by comparing and calculating the difference in imaging position between the first imaging member 22 and the fourth imaging member 201b, 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 determined.
[0152] During the imaging procedure, the second developing element 17, the third developing element 18, and the fourth developing element 201b can display a black shadow, providing the operator with position information. The developing element can be made of an X-ray-opaque developing material, such as one or more of gold, tungsten, platinum, or a platinum-iridium alloy. The developing element can be a developing ring, a cylindrical spiral developing coil, or a developing coating. Specifically, the developing element is preferably a developing ring, which helps the operator quickly determine the position of the catheter body 1 and the sealing balloon 3.
[0153] Please refer to Figure 10. In one embodiment, when the sealing balloon 3 is subjected to an inflation pressure of 0.1 bar to 5 bar, the sealing balloon 3 abuts against the inner wall of the guiding channel 201a, and by moving the push rod 2, the sealing balloon 3 can slide in the guiding channel 201a and maintain the sealing effect.
[0154] Referring to FIG. 2 , in one embodiment, the catheter system 200 further includes a guide wire 202 , which can movably pass through the guiding channel 201 a and the delivery channel 11 .
[0155] Referring to Figures 1 and 2 , in one embodiment, a Y-shaped connecting valve 203 is provided at the proximal end of the guiding catheter 201. The Y-shaped connecting valve 203 has a first port 203a and a second port 203b, each of which is in communication with the guiding channel 201a. The guidewire 202 and the extended suction catheter 100 are both inserted into the first port 203a, and the proximal end of the push rod 2 is located outside the Y-shaped connecting valve 203. The guidewire 202 is inserted into the first port 203a and then passes through the guidewire lumen 71 via the guiding channel 201a.
[0156] In one embodiment, after the extended suction catheter 100 of the present application completes the anchoring operation, contrast agent or other fluid medium can be injected through the Y-type connecting valve on the guiding catheter 201. The medium can flow along the guiding channel 201a of the guiding catheter 201 into the delivery channel 11 of the catheter body 1 of the extended suction catheter 100 for super-selective angiography or other targeted treatments.
[0157] In one embodiment, catheter system 200 further includes a suction device for aspirating thrombus 300. The suction device is connected to second interface 203b and communicates with guiding channel 201a. After the extended aspiration catheter 100 of the present application completes the anchoring operation, the associated suction device can be used to aspirate thrombus 300, calcified plaque, etc., from the blood vessel through the Y-shaped connecting valve on guiding catheter 201. Under the action of negative pressure, thrombus 300, calcified plaque, etc., can flow back along delivery channel 11 of catheter body 1 of extended aspiration catheter 100 to guiding channel 201a of guiding catheter 201, and ultimately be aspirated out of the body.
[0158] 1 to 31 , taking the example of entering a small blood vessel to aspirate a thrombus 300 , the specific working principle of the catheter system 200 of the present application is as follows:
[0159] Entering the target area: If thrombus 300 is located in a small blood vessel, guide catheter 201 is transported to a larger vessel near the small vessel. Guidewire 202 is then transported along first port 203a of Y-shaped connecting valve 203 at the proximal end of guiding catheter 201 to the location of thrombus 300 in the small vessel. Guidewire tube 7 is then transported along guidewire 202 to extend aspiration catheter 100. Extended aspiration catheter 100 extends into guiding catheter 201 through first port 203a of Y-shaped connecting valve 203 at the proximal end of guiding catheter 201. The distal end of catheter body 1 of extended aspiration catheter 100 extends from the distal end of guiding catheter 201, with the proximal end of catheter body 1 positioned within guiding channel 201a. One end of push rod 2 is positioned within guiding channel 201a, while the other end of push rod 2 extends from first port 203a of Y-shaped connecting valve 203. Catheter hub 5 is positioned outside Y-shaped connecting valve 203. 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, making it easy for the guiding catheter 201 to enter the branch blood vessels and narrow blood vessels.
[0160] 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. After the sealing balloon 3 is expanded, it is anchored in the guiding channel 201a. The sealing balloon 3 blocks the gap between the guiding catheter 201 and the catheter body 1, and the guiding channel 201a is connected to the catheter cavity.
[0161] Delivery of contrast agent / drug: The first interface 203a of the push rod 2 extending from the Y-shaped connecting valve 203 of the guiding 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 guiding 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.
[0162] Connect an external suction device to aspirate thrombus 300 or plaque: Seal first port 203a, extending from push rod 2, at Y-shaped connecting valve 203 of guiding catheter 201. Connect a suction device to second port 203b of Y-shaped connecting valve 203 to aspirate thrombus 300 or plaque at the distal end of catheter body 1. Under negative pressure, thrombus 300 or calcified plaque flows back through delivery channel 11 of catheter body 1 into guiding channel 201a until it is removed from the body.
[0163] Withdrawing the guidewire 202 (or extended aspiration catheter 100): Use a pressure pump under negative pressure to withdraw the medium within the sealing balloon 3. Under X-ray fluoroscopy, confirm that the sealing balloon 3 is deflated and no medium remains. Then withdraw the guidewire 202 (or extended aspiration catheter 100) until it is out of the body.
[0164] The present application also provides a method for performing thrombus aspiration using the above-mentioned catheter system 200, the method comprising: using a guide catheter 201 that extends into the patient's blood vessel in a percutaneous structure to guide the extended aspiration catheter 100, expanding the sealing balloon 3 to abut against the inner wall of the guide channel 201a and maintain the sealing effect, applying suction through the guide channel 201a and the delivery channel 11 to aspirate the fluid out of the guide catheter 201, and thereby removing the thrombus 300 from the blood vessel.
[0165] The present application also provides a method for performing a medical procedure in a body blood vessel using the above-mentioned catheter system 200, wherein the proximal portion of the guide channel 201a is connected to the delivery channel 11 and forms a suction lumen, and the method includes: extending the suction catheter 100 by sliding relative to the guide catheter 201, tracking the extended suction catheter 100 to a desired position in the blood vessel, and applying suction through the suction lumen to remove the thrombus 300 from the blood vessel.
[0166] The present application also provides a method for placing the extended aspiration catheter 100 of the catheter system 200 into a narrow and tortuous blood vessel in the body, the method comprising: inserting a guidewire 202 into a guidewire tube 7, advancing the extended aspiration catheter 100 over the guidewire 202 and pushing it out through the distal opening of the guiding catheter 201, and after the extended aspiration catheter 100 has been extended to a predetermined length, expanding the sealing balloon 3 so that the sealing balloon 3 abuts against the inner wall of the guiding channel 201a. Furthermore, moving the push rod 2 can cause the sealing balloon 3 to slide within the guiding channel 201a and maintain a sealing effect.
[0167] In summary, the catheter system 200 of the present application has an extended suction catheter 100, which is provided with a sealing balloon 3 at the proximal end of the catheter body 1, and a filling channel 21 connected to the sealing balloon 3 is provided in the push rod 2. When the extended suction catheter 100 is extended along the proximal end of the guiding catheter 201, one end of the push rod 2 extends out of the proximal end of the guiding catheter 201, and the distal end of the catheter body 1 extends from the distal end of the guiding catheter 201. The proximal end of the catheter body 1 is located in the guiding channel 201a of the guiding catheter 201, and the sealing balloon 3 can be 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 guiding channel 201a of the guiding catheter 201, so as to prevent the pressure from leaking through the gap between the guiding extended suction catheter 100 and the guiding catheter 201 during the thrombus aspiration process, so that the extended suction catheter 100 is effectively connected to the guiding catheter 201 and forms a sealed suction cavity. The new suction channel formed by connecting the extended suction catheter 100 of the present application with the guiding catheter 201 provides a larger suction channel and stronger suction force. Once connected, in the absence of external forces, the extended suction catheter 100 of the present application is unlikely to slip or fall out of the guiding channel 201a, thereby enhancing the axial stability of the extended suction catheter 100 within the guiding catheter 201. During operation, the operator can push the proximal end of the extended suction catheter 100 of the present application forward and backward. Secondly, the extended suction catheter 100 of the present application is provided with a guidewire tube 7 on the catheter body 1, so that the guidewire 202 can pass through the guidewire cavity 71 of the guidewire tube 7 without occupying the area of the delivery channel 11 of the catheter body 1, ensuring that the suction path for suction through the guide channel 201a and the delivery channel 11 is smooth, and the effective suction area is relatively large, which can avoid the guidewire 202 from affecting the effective suction area of the lumen and improve the suction effect. At the same time, the guidewire 202 passing through the guidewire cavity 71 can also guide and anchor the catheter body 1, ensuring that the extended suction catheter 100 can be accurately delivered to the target area. In addition, since the guidewire 202 does not occupy the area of the delivery channel 11 of the catheter body 1, the effective suction area is relatively large, which has better suction ability for large thrombi and reduces complications. In addition, the extended aspiration catheter 100 of the present application can be used as a guide instrument to be inserted deeper into the blood vessel, and can also realize the function of aspirating thrombus and plaque, thereby reducing thrombotic events caused by thrombus aspiration, reducing the exchange between instruments, and improving surgical efficiency.
[0168] The above disclosure is only a preferred example of the present application and cannot be used to limit the scope of rights of the present application. Therefore, equivalent changes made according to the claims of the present application are all within the scope covered by the present application.
Claims
1. An extended suction catheter, characterized in that: include: A catheter body, wherein a delivery channel for delivering medical devices is provided in the catheter body, and a proximal end of the catheter body is provided with an introduction port communicating with the delivery channel; A push rod, the distal end of which is connected to the proximal end of the catheter body, and a filling channel is provided inside the push rod; A sealing balloon, which is sleeved on the catheter body and located near the proximal end of the catheter body, and whose inner cavity is communicated with the filling channel; A guide wire tube is arranged on the catheter body, and a guide wire cavity is provided in the guide wire tube for the guide wire to pass through.
2. The extended suction catheter according to claim 1, characterized in that 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.
3. The extended suction catheter according to claim 2, characterized in that The middle reinforcement layer is a woven mesh layer, a spring layer or a spiral cut tube layer.
4. The extended suction catheter according to claim 3, characterized in that 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, and the hardness of the compliant zone, the transition zone and the push zone increases in sequence.
5. The extended suction catheter according to claim 4, characterized in that The length of the compliant zone is 1-30 cm, the length of the transition zone is 2-50 cm, or the length of the push zone is 5-50 cm.
6. The extended suction catheter according to claim 4, characterized in that When the intermediate reinforcement layer is a braided mesh layer, the PPI of the proximal end of the braided mesh layer is greater than the PPI of the distal end; when 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.
7. The extended suction catheter according to claim 4, characterized in that The spirally cut tube layer is divided into a compliant zone, a transition zone and a push zone in sequence from the distal end to the proximal end of the catheter body, and the compliant zone, the transition zone and the push zone meet at least one of the following characteristics; The slit length of the spiral cutting tube layer in the compliant zone is greater than the slit length of the spiral cutting tube layer in the transition zone and greater than the slit length of the spiral cutting tube layer in the push zone; Or, the cutting pitch of the spiral cutting tube layer in the compliant zone is less than the cutting pitch of the spiral cutting tube layer in the transition zone and less than the cutting pitch of the spiral cutting tube layer in the pushing zone; Or, the slit angle of the spirally cut tube layer in the compliant zone is less than the slit angle of the spirally cut tube layer in the transition zone and less than 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 is less than the pitch of the spirally cut tube layer in the transition zone and less than the pitch of the spirally cut tube layer in the pushing zone.
8. The extended suction catheter according to claim 2, characterized in that The hardness of the outer layer decreases from the proximal end to the distal end of the catheter body.
9. The extended suction catheter according to claim 2, characterized in that 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.
10. The extended suction catheter according to claim 9, characterized in that 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.
11. The extended suction catheter according to claim 9, characterized in that 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.
12. The extended suction catheter according to claim 1, characterized in that A first developing member is provided at the distal end of the push rod. The first developing member is a filament made of a developing material that is opaque to X-rays. The developing material is one or more of gold wire, tungsten wire, platinum wire, and platinum-iridium alloy wire.
13. The extended suction catheter according to claim 1, characterized in that The push rod is a metal tube or a plastic tube with a metal reinforcement layer.
14. The extended suction catheter according to claim 1, characterized in that There is a first angle between the end face of the introduction port and the cross-section of the catheter body in the radial direction, and the size of the first angle is in the range of 0-150°, or / and there is a 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, and the size of the second angle is in the range of 0-150°.
15. The extended suction catheter according to claim 1, characterized in that The distal end of the push rod is fixed in the tube wall of the catheter body. A through hole is provided at a position of the push rod close to the proximal end of the catheter body. The through hole is connected between the filling channel and the inner cavity of the sealing balloon.
16. The extended suction catheter according to claim 1, characterized in that The wire guide tube is arranged on the outer wall of the catheter body, and the wire guide tube is connected in parallel with the catheter body along the catheter direction of the catheter body.
17. The extended suction catheter according to claim 1, characterized in that The proximal end of the guide wire tube exceeds the sealing balloon, and the distal end of the guide wire tube extends to the distal end of the catheter body, or the proximal end of the guide wire tube is located on one side of the distal end of the sealing balloon, and the distal end of the guide wire tube extends to the distal end of the catheter body.
18. The extended suction catheter according to claim 1, characterized in that The catheter body and the wire guide tube are arranged separately, or the catheter body and the wire guide tube are arranged in one piece.
19. The extended suction catheter according to claim 1, characterized in that The outer surface of the guide wire tube is provided with a hydrophilic layer; or / and the guide wire tube is provided with a hydrophobic layer on the inner wall of the guide wire cavity; or / and 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.
20. The elongated suction catheter of claim 1, wherein: It also includes a catheter seat, the distal end of which is connected to the proximal end of the pushing rod, and a through channel is provided in the catheter seat, which is communicated with the filling channel.
21. The elongated suction catheter according to claim 20, characterized in that 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.
22. The elongated suction catheter of claim 1, wherein: A third developing component is disposed at the proximal end of the catheter body, and the third developing component is located in the sealing balloon.
23. A catheter system, characterized in that: It comprises a guiding catheter and the extended suction catheter as described in any one of claims 1-22, wherein a guiding channel is provided in the guiding catheter, and when the sealing balloon is not inflated, the extended suction catheter slides in the guiding channel; when the sealing balloon is inflated, the sealing balloon abuts against the inner wall of the guiding channel after expansion, and the delivery channel is connected with the guiding channel.
24. The catheter system according to claim 23, characterized in that The extended suction catheter is inserted into the guiding channel, and the distal end of the catheter body passes through the distal end of the guiding channel, the proximal end of the catheter body is located in the guiding channel, and the proximal end of the push rod is located outside the proximal end of the guiding channel.
25. The catheter system of claim 23, wherein: When the sealing balloon is subjected to a filling pressure of 0.1 bar to 5 bar, the sealing balloon abuts against the inner wall of the guiding channel, and by moving the pushing rod, the sealing balloon can slide in the guiding channel and maintain a sealing effect.
26. The catheter system of claim 23, wherein: A Y-shaped connecting valve is provided at the proximal end of the guiding 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 guiding channel, the extended 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.
27. The catheter system of claim 26, wherein: It also includes a suction device for aspirating thrombus, wherein the suction device is connected to the second interface and communicated with the guiding channel.
28. A method for performing thrombus aspiration using the catheter system according to any one of claims 23 to 27, characterized in that: The method comprises: The extended suction catheter is guided by the guide catheter that is extended into the patient's blood vessel in a percutaneous structure. After the sealing balloon is expanded, it abuts against the inner wall of the guide channel and maintains a sealing effect. Suction is applied through the guide channel and the delivery channel to draw fluid out of the guide catheter, thereby removing the thrombus from the blood vessel.
Citation Information
Patent Citations
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