Thrombectomy catheter and clearing device

Abstract

The present application relates to the technical field of vascular intervention medical instruments, and discloses a thrombus removing catheter and a removing device, the catheter comprising a catheter body, a vibration structure arranged at the distal end of the catheter body and capable of stretching and contracting in the length direction to generate vibration, and a variable diameter structure connected to the distal end of the catheter body and capable of changing the size in the radial direction. The present application combines axial high-frequency vibration crushing with radial variable diameter adaptation, can be minimally invasively intervened and accurately arrived at the thrombus site under the guidance of a guide wire, can efficiently crush fresh thrombus, old thrombus and hardened plaque, and can adapt to the removing requirements of different diameter blood vessels and different size thrombus. The present application effectively solves the problems of poor adaptability and low crushing efficiency of the existing instruments, and significantly improves the completeness of thrombus removal and the success rate of operation.

Description

Technical Field

[0001] This invention relates to the field of vascular interventional medical device technology, specifically to a thrombus removal catheter and removal device. Background Technology

[0002] Thrombosis is a solid mass formed by the abnormal coagulation of blood within blood vessels. It can occur in various arteries and veins throughout the body and is a core risk factor for cardiovascular and cerebrovascular diseases, as well as peripheral vascular diseases. Conditions such as lower extremity venous thrombosis, pulmonary embolism, and cerebral thrombosis can directly cause limb swelling, tissue ischemia and necrosis, and organ failure due to thrombus obstruction of blood vessels, potentially endangering the patient's life in severe cases. Therefore, there is an urgent clinical need for efficient and safe thrombus removal. Currently, the mainstream methods for thrombus removal in clinical practice are mainly divided into two categories: thrombolytic therapy and mechanical thrombectomy. Both techniques have many insurmountable shortcomings in practical application and are difficult to adapt to the diverse clinical needs for thrombus treatment.

[0003] Thrombolytic therapy includes intravenous thrombolysis and intra-arterial thrombolysis, both of which rely on thrombolytic drugs to dissolve blood clots. However, this technique has significant limitations: firstly, the therapeutic window is extremely short, usually only effective within a few hours after thrombus formation, and it has almost no therapeutic effect on chronic or old thrombi; secondly, the applicable population is limited, and it is strictly prohibited for patients with bleeding tendencies or severe organ dysfunction. Furthermore, thrombolytic drugs can easily cause systemic coagulation abnormalities, leading to serious complications such as bleeding. In addition, thrombolytic therapy also has the problem of incomplete thrombolysis, which can easily lead to residual thrombi and secondary thrombus formation.

[0004] With the development of interventional vascular techniques, mechanical thrombectomy has become an important supplement to drug thrombolysis. Thrombectomy instruments rely on guidewires for intravascular guidance, with the guidewire connected to an external observation device. This guides the instrument through percutaneous puncture, allowing it to pass smoothly through vascular branches and stenotic segments, precisely reaching the site of thrombus obstruction. However, the thrombus fragmentation structures of existing mechanical thrombectomy instruments are mostly fixed-size rigid blades, burrs, or filter structures. The blade size cannot be adjusted, and it can only be adapted to vessels and thrombi of specific diameters. Its adaptability to thrombi of different sizes and shapes is extremely poor. It is ineffective in fragmenting large thrombi, and it is prone to scratching the vessel wall when dealing with small-diameter vessels, leading to complications such as vascular perforation and dissection. Furthermore, most mechanical thrombectomy instruments rely solely on physical scraping, burr grinding, or negative pressure aspiration to remove thrombi. For hard, old thrombi or thrombi combined with plaque, the fragmentation efficiency is extremely low, and incomplete thrombus fragmentation is common. Summary of the Invention

[0005] This invention provides a thrombus removal catheter and removal device to solve the problems of poor adaptability of existing thrombus removal instruments to thrombi of different sizes and hardness, and low fragmentation efficiency.

[0006] Firstly, a thrombus removal catheter includes: The catheter body is used to be fitted over the outside of the guidewire; A vibration structure is disposed at the distal end of the catheter body. The vibration structure has an extended state and a retracted state that can be switched along the extension length direction of the catheter body, and generates vibration when the state is switched to achieve thrombus fragmentation. A variable diameter structure is connected to the distal end of the catheter body. Along the direction intersecting the extension length direction of the catheter body, the variable diameter structure changes size to adapt to the fragmentation requirements of thrombi of different sizes.

[0007] Beneficial effects: By simultaneously setting an axial telescopic vibration structure and a radial diameter-changing structure at the distal end of the catheter body, a dual core function of vibration breakage and size adaptation is formed, which solves the key defects of existing thrombus removal devices from a structural level.

[0008] The catheter body is fitted over the guidewire, enabling minimally invasive intravascular intervention, precise advancement, and positioning, ensuring catheter accessibility and operational safety in tortuous and narrow vessels. The vibrating structure can reciprocate along the catheter's length, continuously generating high-frequency vibrations during this process. This impact and oscillation act on the thrombus, effectively breaking up fresh, old, and atherosclerotic thrombi, significantly improving thrombus fragmentation efficiency and applicability. The variable-diameter structure can change size radially along the catheter's length, flexibly adjusting the operating range according to vessel diameter and thrombus size. This ensures thorough fragmentation of large thrombi while avoiding over-dilation and vessel wall damage in small-diameter vessels, greatly enhancing the device's adaptability to different disease scenarios. The combined effect of these two components achieves precise intervention, efficient fragmentation, and flexible adaptation, effectively improving the safety and versatility of thrombus removal.

[0009] In one optional embodiment, the vibration structure is disposed on the distal inner side of the catheter body, the vibration structure is connected to a control line, the control line passes through the catheter body, and the control line is used to connect to a power source to provide a state switching drive voltage signal for the vibration structure.

[0010] Beneficial effects: Placing the vibration structure on the distal inner side of the catheter body, within a closed environment, prevents direct contact or compression between the vibration structure and the vessel wall or thrombus, reducing the risk of vascular injury and thrombus dislocation during intervention. The control line connected to the vibration structure is threaded inside the catheter body, without occupying external space or increasing the overall outer diameter, ensuring smooth passage and minimal invasiveness within the blood vessel. Simultaneously, the internal placement effectively protects the control line, preventing damage, short circuits, or signal interruption due to traction or friction during the procedure, thus improving structural reliability and lifespan. An external power supply and control system can be connected to the proximal end of the control line, enabling stable external transmission of state switching and vibration drive voltage signals to the vibration structure. This allows for precise control of the vibration structure's extension, retraction, start / stop, frequency, and amplitude. Physicians can adjust the fragmentation intensity in real time based on thrombus hardness and location, making the operation more intuitive and controllable.

[0011] In one alternative embodiment, the vibrating structure is a piezoelectric ceramic ring.

[0012] Beneficial effects: Using a piezoelectric ceramic ring as the vibration structure has the advantages of small size, fast response speed, stable vibration frequency and low energy consumption. It can generate high-frequency axial vibration in the narrow space at the distal end of the catheter, and has a good breaking effect on fresh thrombi, old thrombi and sclerotic plaques. At the same time, it generates little heat, has high safety and can work stably for a long time.

[0013] In one optional embodiment, the variable diameter structure is a variable diameter cutter head, which is connected to a heating structure located within the catheter body. The heating structure is used to heat the variable diameter cutter head to achieve dimensional changes in the variable diameter cutter head in the direction intersecting with the extension length direction of the catheter body.

[0014] Beneficial effects: The variable diameter structure is set as a heating-driven variable diameter cutter head, and the radial dimension can be adjusted through the heating structure. There are no complicated mechanical transmission parts, and the structure is simple and reliable. The heating structure is built into the catheter, which does not affect the overall outer diameter of the catheter and the smoothness of the intervention. The working range can be adjusted in real time according to the size of the thrombus, balancing the fragmentation efficiency and vascular protection.

[0015] In one optional embodiment, the variable diameter cutter head includes at least a deformation part, which is made of a shape memory deformable material. Under the heating of the heating structure, the deformation part can achieve dimensional changes in a direction intersecting the extension length direction of the catheter body.

[0016] Beneficial effects: The deformation section utilizes a shape memory deformable material, enabling stable and controllable radial deformation under the temperature-driven heating structure. Expansion and contraction are achieved solely through temperature changes, eliminating the need for additional mechanical transmissions, connecting rods, or elastic components. This results in a simpler and smaller distal catheter structure, facilitating minimally invasive interventions. The material exhibits rapid deformation response and high reset accuracy, maintaining stable deformation performance even after multiple heating and cooling cycles. It is less prone to fatigue failure, ensuring long-term, reliable switching of the variable diameter structure between operating states.

[0017] In one optional embodiment, the variable diameter structure includes a fixed part, the distal end of which is connected to the deformable part, and the deformable part is deformable relative to the fixed part; The thrombus removal catheter includes: A first support structure is disposed at the distal end of the catheter body, the fixing part is fixedly connected to the outside of the first support structure, and the proximal end of the first support structure is fixedly connected to the distal end of the vibration structure. The second support structure has its proximal end fixedly connected to the distal inner wall of the catheter body and the proximal end of the vibration structure, while the first support structure and the vibration structure are slidably connected to the second support structure.

[0018] Beneficial effects: The variable diameter structure, with its separate fixed and deformable parts, provides a reliable mounting base for the fixed part and allows the deformable part to achieve independent and undisturbed radial deformation, resulting in more precise movements and preventing abnormal deformation due to assembly stress. The first and second support structures form a coaxial guide and double support, ensuring smooth axial expansion and contraction and stable vibration of the vibrating structure, while also providing rigid support for the variable diameter structure, preventing swaying and displacement of the distal components during vibration and deformation.

[0019] In one optional implementation, the second support structure includes: The top bearing portion, on which the first support structure is slidably disposed; The vibration structure bearing part is connected at its far end to the near end of the top bearing part, and the vibration structure is slidably disposed on the vibration structure bearing part; The catheter connection is connected to the proximal end of the vibration structure bearing part. The catheter connection is fixedly connected to the inner side of the catheter body, and the proximal end of the vibration structure is fixedly connected to the distal end face of the catheter connection.

[0020] Beneficial effects: The second support structure adopts a three-section integrated design consisting of the top bearing section, the vibration structure bearing section, and the conduit connection section. This allows for precise positioning and constraint of the first support structure, the vibration structure, and the conduit body, ensuring high coaxiality and uniform stress distribution among all components. It effectively isolates vibration and diameter-changing actions, preventing mutual interference and enabling independent and stable operation of the vibration breakup and radial diameter-changing functions. Simultaneously, it improves assembly accuracy and reduces processing and assembly difficulty.

[0021] In one optional embodiment, the catheter body has a first channel on its wall and an inlet channel connected to it. One end of the inlet channel is connected to the first channel, and the other end is used to connect to an inlet medium source.

[0022] Beneficial effects: The catheter body has a first channel and an entry channel inside the wall, allowing for the simultaneous introduction of saline, thrombolytic drugs, contrast agents, or irrigation solutions via an external medium source while fragmenting the thrombus. This integrates multiple functions such as irrigation, cooling, drug administration, and contrast imaging, enabling multi-mode operations without the need for additional instrument replacements. The built-in channels do not occupy guidewire passage space or increase the catheter's outer diameter, ensuring smooth intervention and simplifying the surgical procedure.

[0023] In one optional embodiment, the first support structure is provided with a second channel, which is connected to the first channel when the vibrating structure is in a contracted state. And / or, the first support structure is provided with a third channel, one end of which is connected to the second channel and the other end is used to connect to the vascular environment; And / or, the catheter body is provided with a pull-back port on its outer periphery; The catheter body is provided with an outflow channel, one end of which is connected to the return port, and the other end is used to connect with the external environment.

[0024] Beneficial effects: The second and third channels, the return port, and the outflow channel form a complete process of fluid inlet, outlet, flushing, and aspiration. This allows for the timely and continuous aspiration and removal of thrombus fragments while simultaneously breaking them up through vibration, preventing residual fragments from causing distal vascular blockage. All channels remain smoothly connected during the contraction of the vibrating structure, ensuring stable fluid delivery and balanced pressure. This provides continuous flushing of the distal catheter and the local vascular area, while also rapidly removing thrombus fragments, significantly improving the thoroughness of thrombus removal.

[0025] Secondly, the present invention also provides a thrombus removal device, comprising: The aforementioned thrombus removal catheter.

[0026] Beneficial effects: Since the thrombus removal device includes a thrombus removal catheter, it has the same effect as a thrombus removal catheter, which will not be elaborated here. Attached Figure Description

[0027] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the structure of a thrombus removal device according to an embodiment of the present invention; Figure 2 for Figure 1 The diagram shown is a schematic of the thrombus removal catheter in the scalpel closed position. Figure 3 for Figure 1 The diagram shown is a structural schematic of the thrombus removal catheter in the scraper-spread state. Figure 4 This is a schematic diagram of the scraper in the closed state according to an embodiment of the present invention; Figure 5 This is a schematic diagram of the scraper in the deployed state according to an embodiment of the present invention; Figure 6 for Figure 2 Cross-sectional view of a thrombus removal catheter; Figure 7 for Figure 2 Right view of the thrombus removal catheter; Figure 8 for Figure 1 The exploded view of the thrombus removal catheter shown; Figure 9 for Figure 1 The diagram shows a cross-sectional view of the thrombus removal catheter as the piezoelectric ceramic coil expands. Figure 10 for Figure 2 The diagram shown illustrates the structure of a thrombus removal catheter during its operation within a blood vessel. Figure 11 for Figure 10 The diagram shows the structure of the scraper in its unfolded state during operation.

[0029] Explanation of reference numerals in the attached figures: 1. Catheter body; 101. First channel; 102. Inlet channel; 103. Aspiration port; 104. Outlet channel; 105. Fourth channel; 106. Control line channel; 2. Guidewire; 3. Vibration structure; 4. Variable diameter structure; 401. Deformation part; 402. Fixing part; 5. Signal line; 6. First support structure; 601. Second channel; 602. Third channel; 7. Second support structure; 701. Top bearing part; 702. Vibration structure bearing part; 703. Catheter connection part; 8. Main system; 801. First peristaltic pump; 802. Second peristaltic pump; 803. Inlet tube; 804. Outlet tube; 9. Saline bag; 10. Waste bag; 11. Infusion stand; 12. Sealing ring; 13. Blood vessel; 14. Thrombus; 15. Fragmented thrombus. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] The following is combined Figures 1 to 11 The following describes embodiments of the present invention.

[0032] According to an embodiment of the present invention, in one aspect, a thrombus removal catheter is provided, comprising: The catheter body 1 is used to be sleeved on the outside of the guidewire 2; Vibration structure 3 is disposed at the distal end of catheter body 1. Vibration structure 3 has an extended state and a retracted state that can be switched along the extension length direction of catheter body 1, and generates vibration when switching states to achieve thrombus fragmentation. The variable diameter structure 4 is connected to the distal end of the catheter body 1. Along the direction intersecting the extension length direction of the catheter body 1, the variable diameter structure 4 changes size to adapt to the fragmentation requirements of thrombi of different sizes.

[0033] Specifically, the catheter body 1 has an inner lumen, and a guidewire 2 is provided inside the inner lumen.

[0034] It should be noted that, in one embodiment, the direction intersecting the extension length direction of the catheter body 1 refers to the direction perpendicular to the extension length direction of the catheter body 1. (Refer to...) Figure 2 The direction of the extension length of the catheter body 1 is... Figure 2 The left and right directions, the directions that intersect with the extension length direction of the catheter body 1, refer to... Figure 2The vertical direction. If the catheter body 1 is cylindrical, then the direction of its extension length is its axial direction, and the direction perpendicular to the extension length direction of the catheter body 1 is its radial direction. Of course, in other embodiments, the direction intersecting the extension length direction of the catheter body 1 is another direction that forms an angle with the extension length direction of the catheter body 1, such as... Figure 2 The left and right directions are at 45°, 30° or 60°.

[0035] By simultaneously setting an axial telescopic vibration structure 3 and a radial diameter-changing structure 4 at the distal end of the catheter body 1, a dual core function of vibration breakage and size adaptation is formed, which solves the key defects of existing thrombus removal devices from a structural level.

[0036] The catheter body 1 is fitted outside the guidewire 2, enabling minimally invasive intravascular intervention, precise advancement, and positioning, ensuring catheter accessibility and operational safety in tortuous and narrow blood vessels. The vibration structure 3 can reciprocate along the catheter's length, continuously generating high-frequency vibrations during this process. This vibration acts on the thrombus 14 through impact and oscillation, effectively breaking up fresh thrombi, old thrombi, and atherosclerotic plaques, significantly improving thrombus fragmentation efficiency and applicability. The variable diameter structure 4 can change its size radially along the catheter's length, flexibly adjusting the operating range according to vessel diameter and thrombus size. This ensures thorough fragmentation of large thrombi while avoiding excessive dilation and vessel wall damage in small-diameter vessels, greatly enhancing the device's adaptability to different disease scenarios. The synergistic effect of these two components achieves integrated precision intervention, efficient fragmentation, and flexible adaptation, effectively improving the safety and versatility of thrombus removal.

[0037] Specifically, the guidewire 2 is provided with a sealing ring 12 at the proximal connection position of the catheter body 1 to seal and prevent liquid from flowing out of the catheter body 1.

[0038] In one embodiment, the vibration structure 3 is disposed on the inner side of the distal end of the catheter body 1. The vibration structure 3 is connected to a control line, which passes through the catheter body 1. The control line is used to connect to a power source to provide a state switching drive voltage signal for the vibration structure 3.

[0039] The vibration structure 3 is positioned on the distal inner side of the catheter body 1, placing it within a closed environment inside the catheter. This prevents the vibration structure 3 from directly rubbing against or compressing the inner wall of the blood vessel 13 or the thrombus 14, reducing the risk of damage to the blood vessel 13 and displacement of the thrombus 14 during the intervention. The control line connected to the vibration structure 3 is threaded inside the catheter body 1, without occupying external space or increasing the overall outer diameter of the catheter, ensuring smooth passage and minimal invasiveness within the blood vessel 13. Simultaneously, the internal placement effectively protects the control line, preventing damage, short circuits, or signal interruptions caused by traction or friction during the procedure, thus improving structural reliability and lifespan. An external power supply and control system can be connected to the proximal end of the control line, enabling stable external transmission of state switching and vibration drive voltage signals to the vibration structure 3. This allows for precise control of the extension, retraction, start / stop, frequency, and amplitude of the vibration structure 3. Physicians can adjust the fragmentation intensity in real time based on the hardness and location of the thrombus, making the operation more intuitive and controllable.

[0040] As an alternative implementation method, the vibration structure 3 can also adopt an electromagnetic vibration type, a motor-driven type, or a pneumatic telescopic type structure, which can also achieve axial extension and vibration crushing.

[0041] like Figure 1 and Figure 7 As shown, a control line channel 106 is provided inside the tube wall of the catheter body 1. The control line is sealed and passed through the control line channel 106 in the form of a signal line 5, extending from the proximal end to the distal end along the length direction of the catheter body 1. The distal end of the signal line 5 is stably electrically connected to the electrode of the vibration structure 3, and the proximal end passes through the catheter body 1 and is connected to the external power supply and the host system 8 to form a complete electrical signal transmission circuit.

[0042] This arrangement ensures that the control line is not exposed and does not come into contact with the inner wall of blood vessel 13, providing effective protection throughout the entire process of catheter intervention, advancement, and retraction, avoiding risks such as bending, abrasion, and breakage, and guaranteeing continuous and stable transmission of the drive voltage signal.

[0043] As an alternative implementation, the control line channel 106 may also be located on the inner wall of the central cavity of the catheter body 1, or share the same cavity with the medium channel and be separated by an isolation layer.

[0044] like Figure 6 and Figure 9 As shown, the vibration structure 3 is a piezoelectric ceramic ring.

[0045] Using a piezoelectric ceramic ring as the vibration structure 3 has the advantages of small size, fast response speed, stable vibration frequency and low energy consumption. It can generate high-frequency axial vibration in the narrow space at the distal end of the catheter, and has a good breaking effect on fresh thrombi, old thrombi and sclerotic plaques. At the same time, it generates little heat, has high safety and can work stably for a long time.

[0046] like Figure 2 and Figure 3 As shown, the variable diameter structure 4 is a variable diameter cutter head, which is connected to a heating structure. The heating structure is located inside the catheter body 1 and is used to heat the variable diameter cutter head to achieve dimensional changes of the variable diameter cutter head in the direction intersecting with the extension length direction of the catheter body 1.

[0047] The variable diameter structure 4 is set as a heating-driven variable diameter cutter head. The radial dimension can be adjusted through the heating structure. There are no complicated mechanical transmission parts, and the structure is simple and reliable. The heating structure is built into the catheter and does not affect the overall outer diameter of the catheter or the smoothness of the intervention. The working range can be adjusted in real time according to the size of the thrombus, taking into account both fragmentation efficiency and vascular protection.

[0048] Specifically, the heating structure is a resistance wire, which, along with the control wire controlling its operation, is threaded within the control wire channel 106 of the catheter body 1. This does not occupy the space for the guide wire 2 or the medium flow channel inside the catheter, maintaining a neat internal layout. The heating end of the resistance wire is tightly fitted to the inner surface of the variable-diameter blade, ensuring that heat is quickly and evenly transferred to the entire variable-diameter blade, allowing its temperature to reach the deformation threshold in a short time. By adjusting the energizing duration and output power of the heating structure through an external control system, the radial expansion amplitude and deformation speed of the variable-diameter blade can be controlled. This allows for real-time matching of thrombus fragmentation requirements with different vessel diameters and thrombus volumes, improving the fragmentation coverage while avoiding damage to the inner wall of the vessel 13 due to excessive size, further enhancing the safety and adaptability of the surgical procedure.

[0049] As an alternative implementation method, the variable diameter cutter head can also be radially expanded and contracted using a micro motor in conjunction with a linkage mechanism.

[0050] like Figure 4 and Figure 5 As shown, the variable diameter cutter head includes at least a deformation part 401. The deformation part 401 is made of a shape memory deformable material. Under the heating of the heating structure, it deforms to achieve a change in size along the direction intersecting the extension length direction of the guide tube body 1.

[0051] The deformation section 401 uses a shape memory deformable material, which can achieve stable and controllable radial deformation under the temperature drive of the heating structure. It can complete the expansion and contraction simply by changing the temperature, without the need for additional mechanical transmission, connecting rods or elastic components, making the distal end structure of the catheter simpler and smaller, which is conducive to minimally invasive intervention. This material has fast deformation response and high reset accuracy, and can maintain stable deformation performance after multiple heating and cooling cycles. It is not prone to fatigue failure, which can ensure that the variable diameter structure 4 can switch working states reliably for a long time.

[0052] Specifically, the deformation part 401 is made of nickel-titanium shape memory alloy, and its phase transition end temperature is set between 37°C and 45°C, slightly higher than the human body temperature, so that the deformation part 401 remains in a contracted state at room temperature and under normal human body conditions. When the resistance wire of the heating structure is heated to above the phase transition temperature, it produces radial outward directional deformation. After heating is stopped and the temperature is lowered, it can automatically return to the initial contracted state. The deformation response is rapid, the reset accuracy is high, the cycle service life is long, and it has good biocompatibility and structural strength, which can meet the safety requirements of vascular interventional devices.

[0053] In actual setup, the entire structure of the variable diameter cutter head can be the deformation part 401, or only a portion of it can be the deformation part 401; no further restrictions are imposed here.

[0054] In one embodiment, a portion of the variable diameter cutter head's structure is a deformation section 401, such as... Figure 8 As shown, the variable diameter structure 4 includes a fixed part 402, and a deformable part 401 is connected to the far end of the fixed part 402. The deformable part 401 can deform relative to the fixed part 402. Thrombosis removal catheters include: The first support structure 6 is disposed at the distal end of the catheter body 1, the fixing part 402 is fixedly connected to the outside of the first support structure 6, and the proximal end of the first support structure 6 is fixedly connected to the distal end of the vibration structure 3. The second support structure 7 is fixedly connected at its proximal end to the distal inner wall of the catheter body 1 and the proximal end of the vibration structure 3. The first support structure 6 and the vibration structure 3 are slidably connected to the second support structure 7.

[0055] The variable diameter structure 4 is separately configured with a fixing part 402 and a deformation part 401. This allows the fixing part 402 to provide a reliable installation base, while the deformation part 401 achieves independent and interference-free radial deformation, resulting in more precise movements and preventing abnormal deformation due to assembly stress. The first support structure 6 and the second support structure 7 form a coaxial guide and double support, ensuring that the vibration structure 3 can smoothly extend and retract axially and vibrate stably, while also providing rigid support for the variable diameter structure 4 to prevent the distal components from swaying or shifting during vibration and deformation.

[0056] Specifically, the fixing part 402 is welded and bonded to the outer side wall of the first support structure 6 to ensure that it does not loosen or shift during vibration and deformation, and to provide a stable mounting base for the deformable part 401. The deformable part 401 extends outward from the far edge of the fixing part 402, and a flexible transition area is formed between the two, so that the deformable part 401 can be independently and smoothly expanded or contracted radially from the fixing part 402 under heating drive, without being disturbed by assembly stress and vibration impact.

[0057] The first support structure 6 is the top end, with its proximal end face fixedly connected to the distal end face of the vibration structure 3. It can synchronously extend and retract along the axial direction and vibrate at high frequency with the vibration structure 3 to achieve impact and breakup of the thrombus 14. The second support structure 7 is fixed axially to the inner side of the distal end of the catheter body 1. The first support structure 6 and the vibration structure 3 are coaxially sleeved on the outer wall of the second support structure 7 and slide with it to form a coaxial guiding mechanism. This ensures that the extension and retraction of the vibration structure 3 and the reciprocating motion of the first support structure 6 remain coaxial and smooth, effectively avoiding eccentricity, jamming, or shaking during the movement, and further improving the movement accuracy and working stability of the distal structure.

[0058] As an alternative implementation, the first support structure 6 and the vibration structure 3 can also be connected by a threaded connection, a snap-fit ​​connection, or an integrally formed structure.

[0059] Specifically, the second support structure 7 includes: The top bearing part 701 has a first support structure 6 slidably disposed on the top bearing part 701; The vibrating structure bearing part 702 is connected at its far end to the near end of the top bearing part 701, and the vibrating structure 3 is slidably disposed on the vibrating structure bearing part 702; The catheter connection part 703 is connected to the proximal end of the vibration structure bearing part 702. The catheter connection part 703 is fixedly connected to the inner side of the catheter body 1. The proximal end of the vibration structure 3 is fixedly connected to the distal end face of the catheter connection part 703.

[0060] The second support structure 7 adopts a three-section integrated design consisting of a top bearing section 701, a vibration structure bearing section 702, and a conduit connection section 703. This design allows for precise positioning and constraint of the first support structure 6, the vibration structure 3, and the conduit body 1, ensuring high coaxiality and uniform stress distribution among the components. It effectively isolates vibration and diameter-changing actions, preventing mutual interference and enabling independent and stable operation of the vibration breakup and radial diameter-changing functions. Simultaneously, it improves assembly accuracy and reduces processing and assembly difficulty.

[0061] As an alternative implementation, the second support structure 7 can also be a two-section or integral structure, as long as it can achieve coaxial guidance and fixed connection.

[0062] In one embodiment, the conduit body 1 has a first channel 101 on its wall and an inlet channel 102 connected to the conduit body 1. One end of the inlet channel 102 is connected to the first channel 101, and the other end is used to connect to the inlet medium source.

[0063] The catheter body 1 has a first channel 101 and an inlet channel 102 inside its wall. This allows for the simultaneous introduction of saline, thrombolytic drugs, contrast agents, or irrigation fluid via an external medium source while the thrombus is fragmented. This integrates multiple functions such as irrigation, cooling, drug administration, and imaging, enabling multi-mode operations without the need for additional instrument replacements. The built-in channels do not occupy the space for the guidewire 2, do not increase the catheter's outer diameter, ensure smooth intervention, and simplify the surgical procedure.

[0064] As an alternative implementation, the access channel 102 can also be directly opened at the proximal connector of the catheter body 1 and directly communicate with the first channel 101.

[0065] Specifically, the first support structure 6 is provided with a second channel 601, which is connected to the first channel 101 when the vibration structure 3 is in a contracted state. The second channel 601 is an axially continuous medium flow channel. When the vibrating structure 3 is in a contracted state, the proximal opening of the second channel 601 is precisely aligned with the distal opening of the first channel 101 inside the tube wall of the catheter body 1 and they are interconnected. This ensures that media such as saline can flow smoothly from the first channel 101 into the second channel 601, achieving continuous flow and further improving cooling efficiency.

[0066] Specifically, the first support structure 6 is provided with a third channel 602, one end of which is connected to the second channel 601, and the other end is used to connect with the vascular environment; The third channel 602 extends radially or obliquely, with one end connected to the second channel 601 and the other end passing through the outer wall of the first support structure 6 and directly connected to the internal environment of the blood vessel. This allows the flushing fluid and drugs delivered through the second channel 601 to act directly on the thrombus site through the third channel 602, achieving local flushing, cooling and drug infiltration, and improving the thrombus fragmentation effect and safety.

[0067] As an alternative implementation, the third channel 602 can also be configured as a plurality of small holes evenly distributed circumferentially to improve the uniformity of rinsing and drug diffusion.

[0068] Specifically, the catheter body 1 has a pull-back port 103 on its outer periphery, and the pull-back port 103 is connected to the inner lumen of the catheter body 1. The catheter body 1 is provided with an outflow channel 104, and a fourth channel 105 is provided inside the outflow channel 104. One end of the fourth channel 105 is connected to the inner lumen of the catheter body 1, and the other end is used to connect with the external environment.

[0069] The aspiration port 103 is located at the distal end of the catheter near the fragmented area, and is used to draw the mixed fluid of fragmented thrombus fragments and flushing fluid into the catheter. One end of the outflow channel 104 is sealed and connected to the aspiration port 103, and the other end extends to the proximal end of the catheter and is connected to an external negative pressure suction device, which continuously draws out the fragmented thrombus 15 and waste fluid under negative pressure.

[0070] like Figure 10 and Figure 11 As shown, the overall structure of the thrombus removal catheter forms a complete process of fluid inlet, outlet, flushing, and aspiration through the second channel 601, the third channel 602, the aspiration port 103, and the outflow channel 104. This allows for the timely and continuous aspiration and removal of thrombus fragments 14 while simultaneously vibrating and breaking them up, preventing residual fragments from causing blockage of the distal blood vessel 13. All channels remain smoothly connected when the vibrating structure 3 is contracted, ensuring stable fluid delivery and balanced pressure. This allows for continuous flushing of the distal end of the catheter and the local area of ​​the blood vessel 13, while also rapidly removing thrombus fragments 15, significantly improving the thoroughness of thrombus removal.

[0071] According to an embodiment of the present invention, in another aspect, a thrombus removal device is also provided, comprising: The aforementioned thrombus removal catheter.

[0072] Specifically, the thrombus removal device also includes a main system 8, which includes a first peristaltic pump 801, a second peristaltic pump 802, an inlet pipe 803, and an outlet pipe 804. The first peristaltic pump 801 is connected to the inlet channel 102 of the catheter body 1 through the inlet pipe 803, and is used to stably pump the flushing fluid, medication, and other media in the saline bag 9 into the catheter, providing continuous flushing and cooling support for the thrombus removal operation. The second peristaltic pump 802 is connected to the outlet channel 104 of the catheter body 1 through the outlet pipe 804, and is used to create a stable negative pressure at the distal end of the catheter, drawing the broken thrombus fragments 14 and waste fluid through the return port 103 into the waste fluid bag 10, so as to achieve timely discharge of fragments.

[0073] Vibration structure 3 and variable diameter structure 4 are respectively connected to the host system 8 through corresponding signal lines 5. The host system 8 outputs drive voltage signals and heating control signals in a unified manner to realize the automatic and precise control of vibration frequency, extension and contraction amplitude of vibration structure 3 and deformation state of variable diameter structure 4.

[0074] The entire device uses an infusion stand 11 to fix the tubing and equipment, which has a high degree of structural integration and is easy to operate. It can realize fully automatic operation of intervention, thrombus fragmentation, diameter change, flushing and aspiration, significantly improving the efficiency, integrity and safety of thrombus removal 14. It is suitable for clinical thrombus removal treatment in various vascular 13 sites.

[0075] When using this thrombus removal device, the saline bag 9 is suspended above the infusion stand 11, and the waste bag 10 is placed in a low position. One end of the inlet tube 803 is connected to the saline bag 9, and the other end is connected to the first peristaltic pump 801 of the main system 8, and connected to the inlet channel 102 of the catheter. One end of the outlet tube 804 is connected to the waste bag 10, and the other end is connected to the second peristaltic pump 802 of the main system 8, and connected to the outlet channel 104 of the catheter. The proximal end of the signal line 5 is connected to the main system 8, and the distal end is laid along the catheter channel and reliably connected to the vibration structure 3 and the variable diameter structure 4.

[0076] Start the main system 8 and turn on the first peristaltic pump 801 to vent air from the tubing, filling the first channel 101, the second channel 601, and the third channel 602 with saline solution to remove air bubbles from the tubing. Under medical imaging guidance, first push the guidewire 2 to the proximal position of the thrombus 14; then slowly push the catheter body 1 along the guidewire 2 so that the distal tip of the catheter reaches the thrombus 14.

[0077] The main system 8 is started, and the vibration mode is activated, causing the piezoelectric ceramic ring of the vibration structure 3 to drive the first support structure 6 to reciprocate at high frequency to impact the thrombus 14. Based on the size of the thrombus 14, the heating structure is controlled to heat the variable-diameter structure 4, causing the deformed part 401 to expand and increase the fragmentation range. Simultaneously, the first peristaltic pump 801 is activated to continuously infuse physiological saline flushing fluid. The physiological saline can flush the fragmented thrombus 15 and also cool the entire pipeline. At the same time, the second peristaltic pump 802 is activated to continuously suction under negative pressure, promptly discharging the fragmented thrombus 15 and waste fluid into the waste fluid bag 10.

[0078] After completion, stop heating and vibration, and continue suction for a period of time to clear any remaining debris; slowly retract the catheter and guidewire 2 together, remove the tubing and shut down the main system 8 to complete the thrombus removal operation.

[0079] Although embodiments of the invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A thrombus removal catheter, characterized in that, include: The catheter body (1) is used to be sleeved on the outside of the guidewire (2); Vibration structure (3), the vibration structure (3) is disposed at the distal end of the catheter body (1), the vibration structure (3) has an extended state and a retracted state that switch along the extension length direction of the catheter body (1), and generates vibration when switching states to achieve thrombus fragmentation; A variable diameter structure (4) is connected to the distal end of the catheter body (1). Along the direction intersecting the extension length direction of the catheter body (1), the variable diameter structure (4) changes size to adapt to the fragmentation requirements of thrombi of different sizes.

2. The thrombus removal catheter according to claim 1, characterized in that, The vibration structure (3) is disposed on the inner side of the distal end of the catheter body (1). The vibration structure (3) is connected to a control line, which passes through the catheter body (1). The control line is used to connect to a power source to provide a state switching drive voltage signal for the vibration structure (3).

3. The thrombus removal catheter according to claim 2, characterized in that, The vibration structure (3) is a piezoelectric ceramic ring.

4. The thrombus removal catheter according to claim 1, characterized in that, The variable diameter structure (4) is a variable diameter cutter head. The variable diameter cutter head is connected to a heating structure. The heating structure is located inside the catheter body (1). The heating structure is used to heat the variable diameter cutter head so as to realize the size change of the variable diameter cutter head in the direction intersecting with the extension length direction of the catheter body (1).

5. The thrombus removal catheter according to claim 4, characterized in that, The variable diameter cutter head includes at least a deformation part (401), which is made of shape memory deformable material. Under the heating of the heating structure, the deformation part achieves dimensional change in the direction intersecting the extension length direction of the catheter body (1).

6. The thrombus removal catheter according to claim 5, characterized in that, The variable diameter structure (4) includes a fixed part (402), the distal end of which is connected to the deformable part (401), and the deformable part (401) can deform relative to the fixed part (402); The thrombus removal catheter includes: The first support structure (6) is disposed at the distal end of the catheter body (1), the fixing part (402) is fixedly connected to the outside of the first support structure (6), and the proximal end of the first support structure (6) is fixedly connected to the distal end of the vibration structure (3). The second support structure (7) has its proximal end fixedly connected to the distal inner wall of the catheter body (1) and the proximal end of the vibration structure (3), and the first support structure (6) and the vibration structure (3) are slidably connected to the second support structure (7).

7. The thrombus removal catheter according to claim 6, characterized in that, The second support structure (7) includes: Top bearing part (701), on which the first support structure (6) is slidably disposed; The vibration structure bearing part (702) is connected at its far end to the near end of the top bearing part (701), and the vibration structure (3) is slidably disposed on the vibration structure bearing part (702). The catheter connection part (703) is connected to the proximal end of the vibration structure bearing part (702), the catheter connection part (703) is fixedly connected to the inner side of the catheter body (1), and the proximal end of the vibration structure (3) is fixedly connected to the distal end face of the catheter connection part (703).

8. The thrombus removal catheter according to any one of claims 1-7, characterized in that, The catheter body (1) has a first channel (101) on its wall and an inlet channel (102) connected to it. One end of the inlet channel (102) is connected to the first channel (101), and the other end is used to connect to the inlet medium source.

9. The thrombus removal catheter according to claim 8, characterized in that, The first support structure (6) is provided with a second channel (601), which is connected to the first channel (101) when the vibration structure (3) is in a contracted state; And / or, the first support structure (6) is provided with a third channel (602), one end of the third channel (602) is connected to the second channel (601), and the other end is used to connect to the blood vessel (13) environment; And / or, the outer periphery of the catheter body (1) is provided with a pull-back port (103). The catheter body (1) is provided with an outflow channel (104), one end of which is connected to the return port (103), and the other end is used to connect with the external environment.

10. A thrombus removal device, characterized in that, include: The thrombus removal catheter according to any one of claims 1-9.

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