Thrombectomy system

Abstract

The present application relates to a thrombectomy system, comprising a suction catheter, a blocking device and a stirring device, the suction catheter has a suction channel and a guide wire channel, the blocking device comprises a blocking catheter and a blocking device arranged at the distal end of the blocking catheter and having an open state and a folded state; the stirring device comprises a first sheath tube, a second sheath tube slidingly sleeved outside the first sheath tube, and a stirring assembly arranged at the distal end of the first sheath tube. The present application can remove a large amount of thrombus in the inferior vena cava in a relatively safe manner, protect the venous valve and the venous vessel wall, control the amount of blood loss, simplify the operation steps, shorten the operation time and reduce the hospitalization cost of the patient.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a thrombus removal system. Background Technology

[0002] Thrombotic diseases include arterial thrombosis, venous thrombosis, and thromboembolism. Current treatment methods mainly include open thrombectomy, catheter-directed thrombolysis, and percutaneous mechanical thrombectomy. Open thrombectomy requires anatomical dissection and incision of blood vessels, such as the femoral artery, femoral vein, or brachial artery. With the development of endovascular interventional techniques and material innovations, this open surgical approach has been gradually replaced by minimally invasive endovascular treatments, namely catheter-directed thrombolysis and percutaneous mechanical thrombectomy. Catheter-directed thrombolysis carries a high risk of bleeding from thrombolytic drugs, and its indications are extremely strict. A large proportion of patients have contraindications to catheter-directed thrombolysis, therefore many patients cannot benefit from it.

[0003] Based on existing medical understanding, deep vein thrombosis often involves large thrombi, and in the acute phase, the thrombus feels soft and fragile; arterial thrombosis often involves small thrombi, and in the acute phase, the thrombus feels soft; old thrombi often adhere to the vessel wall. Currently, the main methods for treating old thrombi are mechanical scraping of the vessel wall or the use of thrombolytic drugs to dislodge them.

[0004] For example, thrombectomy catheter systems, such as the X-sizer thrombectomy catheter system, utilize a spiral cutter at the tip of the catheter to cut the thrombus and then aspirate the blood clot from the body. Chinese patent CN204092102U discloses a novel peripheral vascular thrombus aspiration connector, comprising: a tube body, a rotating rod, a spiral rotating plate, an arc-shaped connector, and a connecting tail seat. The tube body is hollow, with the arc-shaped connector threaded to the upper end. A rectangular groove is formed in the upper middle part of the tube body, and a rotating rod is inserted inside. A spiral rotating plate is fitted around the rotating rod. However, the aforementioned thrombectomy devices are complex in structure, costly to manufacture, and cumbersome to use. Furthermore, when the spiral cutter or spiral rotating plate is rotated within the blood vessel to peel off the thrombus from the vessel wall, it can easily damage the vascular endothelium, potentially leading to post-thrombectomy complications.

[0005] For example, the AngioJet thrombectomy device can inject a certain amount of thrombolytic agent under high pressure into the thrombus to break it up and increase the contact area with the thrombus, followed by thrombus aspiration (a process known as chemical-physical coupling thrombus reduction). It is suitable for acute thrombosis of the iliac, femoral, and popliteal veins. However, prolonged negative pressure often leads to excessive blood loss in patients, and rapid high-pressure agitation may cause red blood cell damage and hemolysis, which can easily lead to post-thrombectomy complications. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a thrombus removal system that can reduce the occurrence of sequelae after thrombectomy.

[0007] To solve the above technical problems, the present invention adopts the following technical solution:

[0008] From the product structure perspective, the thrombus removal system of the present invention includes an aspiration catheter, wherein the aspiration catheter has an aspiration channel for aspirating thrombi and a guidewire channel for inserting a guidewire, the aspiration channel extends along the axial direction of the aspiration catheter and passes through both ends of the aspiration catheter, and the guidewire channel is located at the distal end of the aspiration catheter.

[0009] The thrombus removal system also includes a blocking device and a stirring device;

[0010] The occlusion device includes an occlusion catheter and an occluder disposed at the distal end of the occlusion catheter, having an open state and a retracted state; when the occluder is in the open state, the outer diameter of the occluder is greater than or equal to the inner diameter of the blood vessel; when the occluder is in the retracted state, the occlusion device can pass through the aspiration channel.

[0011] The stirring device includes a first sheath, a second sheath slidably sleeved outside the first sheath, and a stirring assembly disposed at the distal end of the first sheath. The stirring assembly includes a stirrer having an extended state and a retracted state. When the stirrer is in the extended state, the stirrer is detached from the second sheath, and the outer diameter of the stirrer is less than or equal to the inner diameter of the blood vessel. When the stirrer is in the retracted state, the stirring assembly is located inside the second sheath, and the stirring device can pass through the suction channel.

[0012] From the perspective of product usage, this thrombus removal system includes an aspiration catheter, which has an aspiration channel for aspirating thrombi and a guidewire channel for inserting a guidewire. The aspiration channel extends along the axial direction of the aspiration catheter and passes through both ends of the aspiration catheter, and the guidewire channel is located at the distal end of the aspiration catheter.

[0013] The thrombus removal system also includes a blocking device and a stirring device;

[0014] The occlusion device includes an occlusion catheter that passes through the aspiration channel and extends distally from the aspiration catheter, and an occluder disposed at the distal end of the occlusion catheter and having an open state and a closed state; when the occluder is in the open state, the occluder is attached to the inner wall of the blood vessel; when the occluder is in the closed state, the occlusion device can pass through the aspiration channel.

[0015] The stirring device includes a first sheath that passes through the aspiration channel and extends distally out of the aspiration catheter; a second sheath that is slidably sleeved outside the first sheath and passes through the aspiration channel; and a stirring assembly disposed at the distal end of the first sheath and located between the distal end of the aspiration catheter and the occluder. The stirring assembly includes a stirrer having an extended state and a retracted state. When the stirrer is in the extended state, it is detached from the second sheath and contacts the inner wall of the blood vessel. When the first sheath is dragged, the stirrer moves back and forth in the blood vessel. When the stirrer is in the retracted state, the stirring assembly is located inside the second sheath, and the stirring device can pass through the aspiration channel.

[0016] In use, this invention temporarily cuts off blood flow by blocking the upstream of the blood vessel using a blocking device. Then, by dragging the first sheath back and forth, the stirrer moves back and forth in the blood vessel, scraping the vessel wall and agitating the thrombus within the vessel. This causes the thrombus to detach from the vessel wall, break up the thrombus, and capture the thrombus. Combined with the aspiration catheter, the thrombus is aspirated, which can quickly remove a large number of deep vein thrombi and old thrombi without damaging the vessel wall and venous valves, reducing post-thrombectomy sequelae.

[0017] In this article, the proximal end is defined as the side closest to the medical staff when the thrombus removal system is in use; the distal end is defined as the side furthest from the medical staff when the thrombus removal system is in use.

[0018] The aspiration catheter of this invention, while having its own thrombectomy function, can also provide access to other thrombectomy devices, thereby facilitating doctors to choose surgical plans for different thrombi, thus making the indications for this thrombus removal system broad.

[0019] Of course, for some thrombotic diseases that can be treated simply by aspiration through the aspiration catheter, medical staff may use only the aspiration catheter of this invention without using the stirring device and the sealing device.

[0020] Preferably, the aspiration catheter further includes an inflation channel extending axially along the aspiration catheter and a balloon fixedly disposed at the distal end of the aspiration catheter and communicating with the inflation channel. The balloon has an open state and a closed state. When the balloon is in the open state, the outer diameter of the balloon is greater than or equal to the inner diameter of the blood vessel. By placing a balloon on the aspiration catheter, the downstream of the blood vessel can be blocked when the balloon is inflated, thereby temporarily cutting off blood flow and preventing thrombi from entering downstream blood vessels and causing thrombi in other parts of the body.

[0021] More preferably, the balloon is located between the two outlets of the guidewire channel.

[0022] In this invention, the suction channel and the guidewire channel are separated from each other and not connected, thereby avoiding interference between the guidewire and other components. Furthermore, the filling channel, the suction channel, and the guidewire channel are each separated from each other and not connected, and the filling channel and the guidewire channel are located on opposite sides of the suction channel. Each channel has a clearly defined function and is easy to distinguish, while also maximizing the space available for the suction cavity, thus improving suction efficiency.

[0023] More preferably, the proximal end of the aspiration catheter is provided with a filling interface connected to the filling channel, an aspiration interface connected to the aspiration channel, and an interface for other devices connected to the aspiration channel, so that other devices can enter the blood vessel through the aspiration channel. Other devices include occlusion devices, stirring devices, and other necessary devices, such as thrombolytic catheters.

[0024] More preferably, the axis of the other device interface coincides with the axis of the suction channel, thereby facilitating the entry of other devices.

[0025] Preferably, the distal end of the aspiration catheter is beveled, which can expand the aspiration range and effect; the outlet of the guidewire channel is located at the distal end of the bevel, which facilitates the entire system to enter the lesion site along the guidewire.

[0026] Preferably, the occluder is a balloon, which can be inflated by inflating with air or liquid.

[0027] Preferably, the stirrer is a mesh basket made of memory fiber; when there is one stirrer, the degree of expansion of the stirrer can be controlled by the second sheath; when there are multiple stirrers, the multiple stirrers are arranged sequentially along the axial direction of the first sheath, and adjacent two stirrers are connected by an elastic element so that the adjacent two stirrers can move closer or further apart relative to each other along the axial direction of the first sheath.

[0028] The memory wire mentioned in this article can be a memory alloy such as nickel-titanium alloy.

[0029] In this invention, the mesh basket made of memory fiber can be formed by laser cutting and heat setting of a nickel-titanium alloy tube. The mesh basket design minimizes the contact area between the stirrer and the blood vessel wall when the stirrer is dragged back and forth, thus reducing damage to the blood vessel wall. Furthermore, the stirrer can partially break up and intercept thrombi in the blood vessel.

[0030] For a scheme with a single agitator, controlling the extent of agitator deployment by retracting the second sheath is a current technology.

[0031] The self-expansion of the stirrer is achieved by retracting the second sheath proximally, allowing the stirrer's adhesion to the wall and the dragging force to be adjusted as needed when dragging the thrombus.

[0032] For schemes with multiple agitators, the elastic element can be a thin-walled tube. According to one embodiment, the elastic element is a spring. The spring referred to herein includes any component with a spring-like helical shape that is elastic, thereby facilitating manufacturing. During use, the elastic element can be used to connect and pass through complex lesion sites, while improving the flexibility of the sheath and agitator diameter.

[0033] The elastic element and the first sheath can be welded or integrally formed. Preferably, the elastic element and the first sheath are integrally formed, that is, the elastic element is formed by spiral cutting a section of the first sheath to form a spring-like elastic element, which makes the preparation convenient and the strength good.

[0034] This invention provides a buffering effect between the stirrers and between the stirrers and the blood vessel when the first sheath is dragged back and forth.

[0035] Preferably, when the elastic element is in a stationary state, the distance between two adjacent agitators is 5-10 mm, thereby improving the agitator's smoothness during dragging.

[0036] More preferably, the projection of the stirrer on a plane perpendicular to the axis of the first sheath is petal-shaped, and the number of petals can be set according to actual needs, preferably 4 to 6 petals, so as to ensure that the vertical projection surfaces of the two stirrers can form an effective interception surface.

[0037] More preferably, the projections of the plurality of agitators on a plane perpendicular to the axis of the first sheath are staggered, thereby increasing the effective interception area for thrombus interception.

[0038] The "plane perpendicular to the axis of the first sheath" as defined here is... Figure 1 The first sheath shown in the image extends along an axis defined by a straight line, and this plane is perpendicular to the axis of the aforementioned straight line.

[0039] Preferably, the stirrer is spherical, which makes it less likely to scratch the blood vessel wall, has good adhesion to the wall, and easily removes old, adherent thrombi.

[0040] More preferably, the diameter of the stirrer is 9-14 mm, so that the stirrer can adapt to blood vessels with different inner diameters.

[0041] Preferably, the first sheath extends through the stirrer, and the axis of the first sheath coincides with the center line of the stirrer, thereby making the stirring device easy to prepare, easy to operate, and causing minimal damage to the blood vessel wall.

[0042] In this invention, the aspiration catheter, the occlusion device, and the stirring device are packaged separately. Each packaged component can be sold as a whole or individually, which facilitates selective use by medical personnel. Of course, the aspiration catheter, the occlusion device, and the stirring device can also be sold as a whole in one package.

[0043] According to one embodiment, the thrombus removal system further includes a guidewire. This product can be sold with the guidewire, or guidewires from other manufacturers can be used.

[0044] According to one embodiment, the thrombus removal system further includes a thrombolytic catheter. This product can be sold with the thrombolytic catheter, or thrombolytic catheters from other manufacturers can be used.

[0045] Due to the implementation of the above technical solutions, the present invention has the following advantages compared with the prior art:

[0046] This invention can remove a large number of thrombi in the inferior vena cava while ensuring relative safety, protecting the venous valves and venous walls, controlling blood loss, simplifying the operation, shortening the operation time, and reducing the patient's hospitalization costs. Attached Figure Description

[0047] Appendix Figure 1 This is a schematic diagram of the thrombus removal system according to a specific implementation method;

[0048] Appendix Figure 2 for Figure 1 AA cross-section view;

[0049] Appendix Figure 3 for Figure 1 BB cross-section;

[0050] Appendix Figure 4 for Figure 1 CC cross-section;

[0051] Appendix Figure 5 This is a schematic diagram showing the overlap of the BB cross-section and the CC cross-section;

[0052] Appendix Figure 6 for Figure 1 A magnified view of position D;

[0053] Appendix Figure 7 for Figure 1 A magnified view of position E;

[0054] Appendix Figure 8 This is a schematic diagram of the structure of the stirring device before it is deployed according to Embodiment 1 (the second sheath has been retracted, but the stirrer is not yet open).

[0055] Appendix Figure 9 This is a schematic diagram of the stirring device after it has been deployed according to Embodiment 1.

[0056] Appendix Figure 10 This is a schematic diagram of the unfolded structure of the stirring device according to Embodiment 2;

[0057] Appendix Figure 11 This is a schematic diagram of the stirring device before and after unfolding in Embodiment 2;

[0058] Among them, 1. Aspiration catheter; 2. Guide wire; 11. Aspiration channel; 12. Guide wire channel; 13. Filling channel; 14. Inclined surface; 15. Filling interface; 16. Aspiration interface; 17. Other equipment interface; 18. Balloon; 31. Occlusion catheter; 32. Occlusion device; 41. First sheath; 42. Second sheath; 43. Stirrer; 44. Memory wire; 45. Elastic element. Detailed Implementation

[0059] The present invention will be further described in detail below with reference to specific embodiments. It should be understood that these embodiments are used to illustrate the basic principles, main features and advantages of the present invention, and the present invention is not limited to the following embodiments.

[0060] like Figure 1 As shown, the thrombus removal system of the present invention includes an aspiration catheter 1, a guidewire 2, a stirring device, and a sealing device.

[0061] The aspiration catheter 1 has an aspiration channel 11 for aspirating thrombi, a guidewire channel 12 for inserting a guidewire 2, and a filling channel 13. The aspiration channel 11 extends along the axial direction of the aspiration catheter 1 and passes through both ends of the aspiration catheter 1. The guidewire channel 12 is located at the distal end of the aspiration catheter 1. The filling channel 13 extends along the axial direction of the aspiration catheter 1.

[0062] The filling channel 13, the suction channel 11, and the guidewire channel 12 are separated from each other and not connected. Furthermore, the filling channel 13 and the guidewire channel 12 are located on opposite sides of the suction channel 11. Figure 2 As shown.

[0063] The distal end of the suction catheter 1 is a bevel 14, as shown below. Figure 7 As shown, the outlets at the distal ends of the suction channel 11 and the guidewire channel 12 are both located on the inclined surface 14, and the outlet of the guidewire channel 12 is located at the distal end of the inclined surface 14, that is, at the tip of the suction catheter 1.

[0064] like Figure 1As shown, the proximal end of the suction catheter 1 is provided with a filling interface 15 communicating with the filling channel 13, a suction interface 16 communicating with the suction channel 11, and an other device interface 17 communicating with the suction channel 11. That is, the outlet of the proximal end of the filling channel 13 is connected to the filling interface 15, and the outlet of the proximal end of the suction channel 11 is connected to the suction interface 16 and the other device interface 17, respectively. Preferably, the axis of the other device interface 17 coincides with the axis of the suction channel 11, thereby facilitating the entry of other devices.

[0065] A balloon 18 is fixedly mounted at the distal end of the aspiration catheter 1. The balloon 18 is connected to the distal outlet of the inflation channel 13, allowing the balloon 18 to be inflated and released through the inflation port 15 and the inflation channel 13, thus enabling the balloon 18 to be in an open or closed state. During implantation and retrieval of the aspiration catheter 1, the balloon 18 is in the closed state, facilitating implantation and retrieval. In use, the balloon 18 is in the open state, with its outer diameter greater than or equal to the inner diameter of the blood vessel, preferably equal to or slightly greater than the inner diameter of the blood vessel. This allows for occlusion of the blood vessel, temporarily hindering blood flow and preventing loosened thrombi from drifting to other blood vessels during thrombectomy.

[0066] In this embodiment, the balloon 18 is located between the two outlets of the guidewire channel 12, such as Figure 1 As shown, the proximal outlet of the guidewire channel 12 is located on the wall of the aspiration catheter 1, and the outlet is located at the front end of the balloon 18.

[0067] In this embodiment, the aspiration catheter 1 is a three-lumen catheter; however, other multi-lumen catheters can also be used instead. The guidewire channel 12 of the aspiration catheter 1 allows for rapid guidewire exchange via OTW or central guidewire push, and is compatible with, but not limited to, 0.014" guidewires. This aspiration catheter 1, while ensuring its own ability to aspirate thrombi, also provides access to other devices, thus enabling it to handle various complex thrombi.

[0068] like Figure 1 As shown, the occlusion device includes an occlusion conduit 31 and an occluder 32 disposed at the distal end of the occlusion conduit 31 and having an open state and a closed state. The occluder 32 is a balloon that can be inflated by inflating with air or liquid.

[0069] When the occluder 32 is in the open state, its outer diameter is greater than or equal to the inner diameter of the blood vessel. Preferably, the outer diameter of the occluder 32 is equal to or slightly larger than the inner diameter of the blood vessel, allowing it to adhere to the inner wall of the blood vessel. In use, the occluder 32 is located at the distal end of the aspiration catheter 1, working simultaneously with the balloon 18 of the aspiration catheter 1 to create a closed space in the blood vessel within a short time. This allows the stirring device to effectively remove the thrombus or perform thrombolysis. When the occluder 32 is in the closed state, the occlusion device can pass through the aspiration channel 11.

[0070] The stirring device includes a first sheath 41, a second sheath 42 slidably sleeved outside the first sheath 41, and a stirring assembly disposed at the distal end of the first sheath 41. The stirring assembly includes a stirrer 43 having an extended state and a retracted state. When the stirrer 43 is in the open state, its outer diameter is less than or equal to the inner diameter of the blood vessel. In use, the stirring assembly and the first sheath 41 are retracted into the second sheath 42. The stirring device enters the aspiration channel 11 from the interface of other equipment and positions the stirrer 43 between the aspiration catheter 1 and the occluder 32. The second sheath 42 is retracted, opening the stirrer 43. The stirrer 43 is moved back and forth within the blood vessel by dragging the first sheath 41 back and forth.

[0071] Implementation Method 1:

[0072] like Figure 8 and Figure 9 As shown, there is only one stirrer 43, which is formed by several braided memory wires 44. It can self-expand by retracting the second sheath 42 to the proximal end. When dragging the first sheath 41, the degree of adhesion of the memory wires 44 to the wall and the dragging force can be controlled by adjusting the opening degree of the stirrer 43 by the length of retraction of the second sheath 42.

[0073] The first sheath 41 passes through the stirrer 43 and the axis of the first sheath 41 coincides with the center line of the stirrer 43. The stirrer 43 is fixed to the first sheath 41 by welding or other processes.

[0074] The shape of the basket can be a shape commonly used in existing technologies, such as spherical or spindle-shaped. The material of the memory wire 44 can be a memory alloy such as nickel-titanium alloy.

[0075] Implementation Method Two:

[0076] The stirrers 43 are arranged sequentially along the axial direction of the first sheath 41, such as... Figure 10 and Figure 11 As shown, there are two stirrers 43. The two adjacent stirrers 43 are connected by an elastic member 45, so that the two adjacent stirrers 43 can move closer or further apart relative to each other along the axial direction of the first sheath 41.

[0077] like Figure 6As shown, the elastic element 45 is integrally formed with the first sheath 41, and the elastic element 45 is formed by spiral cutting a section of the first sheath 41.

[0078] When the elastic element 45 is in a stationary state (i.e., the elastic element 45 is neither extended nor compressed), the distance between two adjacent stirrers 43 is 5~10mm.

[0079] The stirrer 43 is a basket made of memory wire 44, for example, formed by laser cutting and heat setting of a nickel-titanium alloy tube. The stirrer 43 is spherical and has a diameter of 9~14mm.

[0080] like Figure 3 and Figure 4 As shown, the projection of the stirrer 43 onto a plane perpendicular to the axis of the first sheath 41 is petal-shaped, and the number of petals can be set according to actual needs, preferably 4 to 6 petals, and in this embodiment, it is 5 petals.

[0081] like Figure 5 As shown, the projections of the multiple stirrers 43 on the plane perpendicular to the axis of the first sheath 41 are staggered, that is, the projections of the memory wires 44 of the multiple stirrers 43 on the plane do not coincide.

[0082] The first sheath 41 passes through the stirrer 43, and the axis of the first sheath 41 coincides with the center line of the stirrer 43. The stirrer 43 is fixed to the first sheath 41 by welding or other processes.

[0083] The thrombus removal system of the present invention also includes a guidewire 2 and a thrombolytic catheter. Improvements to the guidewire 2 and the thrombolytic catheter are not the focus of protection of the present invention; the guidewire 2 and the thrombolytic catheter in the prior art can be used.

[0084] The aspiration catheter 1, occlusion device, and stirring device are packaged separately. When sold, they can be equipped with separately packaged guide wire 2 and thrombolysis tube for the convenience of medical staff to use the whole set.

[0085] The steps for using this thrombus removal system are as follows:

[0086] 1. Insert guidewire 2 into the lesion site.

[0087] 2. Pass the guidewire 2 through the guidewire channel 12 to deliver the aspiration catheter 1 to the front end of the lesion site for angiography to observe the blockage.

[0088] 3. The occlusion device is introduced through the interface of other equipment, delivered through the suction channel 11 and the occluder 32 is passed through the lesion site. Then, the occluder 32 is inflated through the occlusion catheter 31 to block the distal end of the blood vessel. Then, the balloon 18 is inflated through the filling interface 15 and the filling channel 13 to block the proximal end of the blood vessel, so that a short-term closed space is formed between the occluder 32 and the balloon 18.

[0089] 4. Insert the thrombolysis tube through the interface of other equipment and deliver it to the lesion site in the closed space through the suction channel 11. The thrombolysis tube performs thrombolysis in the special space. After the thrombolysis is completed, remove the thrombolysis tube.

[0090] 5. Insert the stirring device through the interface of other equipment, and transport it to the lesion site in the closed space through the suction channel 11. Then, retract the second sheath 42 and open the stirrer 43.

[0091] 6. Grasp the first sheath 41 and drag it repeatedly, while simultaneously drawing negative pressure through the suction port 16 and suction channel 11.

[0092] 7. After the insoluble thrombus adheres to the stirrer 43, retract the first sheath 41 to remove the thrombus from the body.

[0093] 8. After completely removing the stirrer 43, repeatedly aspirate through the suction catheter 1 to remove any remaining thrombus.

[0094] 9. After thrombectomy, depressurize the occluder 32 and balloon 18, and perform angiography again to observe the treatment effect. If the thrombus is not completely removed, repeat the above steps until the thrombus is completely aspirated.

[0095] 10. After completing the treatment, withdraw the aspiration catheter 1 along the guidewire 2, and then withdraw the occluder 32.

[0096] The above steps are for treating old thrombi that are difficult to treat. For some thrombi that are easier to treat, steps such as thrombolysis with a thrombolytic catheter can be omitted.

[0097] This invention utilizes guidewire 2 for intervention. When the aspiration catheter 1, balloon 18, and occluder 32 are inflated, the blood vessel is sealed. This facilitates surgical procedures, enhances the effectiveness of thrombolysis, and prevents emboli from dislodging and drifting to the heart during thrombectomy. Using a large-diameter aspiration catheter 1 in conjunction with a stirrer 43 in a vein can effectively remove large areas of acute and subacute thrombi in the inferior vena cava. When dealing with old thrombi in the inferior vena cava, thrombolysis can be performed first, followed by dragging the thrombus into the aspiration catheter 1 using the stirrer 43. Using this device allows for the removal of large amounts of thrombi in the inferior vena cava with relative safety, protecting venous valves and the venous wall, controlling blood loss, simplifying the procedure, shortening surgical time, and reducing hospitalization costs for patients.

[0098] As described above, we have explained the invention entirely in accordance with its spirit; however, the invention is not limited to the embodiments and implementation methods described above. Those skilled in the art can make different variations and implementations within the scope permitted by the technical concept of this invention.

Claims

1. A thrombus removal system, comprising an aspiration catheter (1), characterized in that: The aspiration catheter (1) has an aspiration channel (11) for aspirating thrombi and a guidewire channel (12) for inserting a guidewire (2). The aspiration channel (11) extends along the axial direction of the aspiration catheter (1) and passes through both ends of the aspiration catheter (1). The guidewire channel (12) is located at the distal end of the aspiration catheter (1). The thrombus removal system also includes a blocking device and a stirring device; The occlusion device includes an occlusion catheter (31) and an occluder (32) disposed at the distal end of the occlusion catheter (31) and having an open state and a closed state; when the occluder (32) is in the open state, the outer diameter of the occluder (32) is greater than or equal to the inner diameter of the blood vessel; when the occluder (32) is in the closed state, the occlusion device can pass through the aspiration channel (11); The stirring device includes a first sheath (41), a second sheath (42) slidably sleeved outside the first sheath (41), and a stirring assembly disposed at the distal end of the first sheath (41). The stirring assembly includes a stirrer (43) having an extended state and a retracted state. When the stirrer (43) is in the extended state, the stirrer (43) is disengaged from the second sheath (42), and the outer diameter of the stirrer (43) is less than or equal to the inner diameter of the blood vessel. When the stirrer (43) is in the retracted state, the stirring assembly is located inside the second sheath (42), and the stirring device can pass through the suction channel (11). The stirrer (43) is a mesh basket made of memory wire (44); there are multiple stirrers (43), and the multiple stirrers (43) are arranged sequentially along the axial direction of the first sheath (41). Adjacent stirrers (43) are connected by elastic members (45) so that adjacent stirrers (43) can move closer or further away from each other along the axial direction of the first sheath (41); the elastic member (45) is a spring, and the elastic member (45) is formed by spiral cutting a section of the first sheath (41).

2. A thrombus removal system, comprising an aspiration catheter (1), characterized in that: The aspiration catheter (1) has an aspiration channel (11) for aspirating thrombi and a guidewire channel (12) for inserting a guidewire (2). The aspiration channel (11) extends along the axial direction of the aspiration catheter (1) and passes through both ends of the aspiration catheter (1). The guidewire channel (12) is located at the distal end of the aspiration catheter (1). The thrombus removal system also includes a blocking device and a stirring device; The occlusion device includes an occlusion catheter (31) that passes through the aspiration channel (11) and extends distally out of the aspiration catheter (1), and an occluder (32) disposed at the distal end of the occlusion catheter (31) and having an open state and a closed state; when the occluder (32) is in the open state, the occluder (32) is attached to the inner wall of the blood vessel; when the occluder (32) is in the closed state, the occlusion device can pass through the aspiration channel (11); The stirring device includes a first sheath (41) that passes through the suction channel (11) and extends distally out of the suction conduit (1); a second sheath (42) that is slidably sleeved outside the first sheath (41) and passes through the suction channel (11); and a stirring assembly disposed at the distal end of the first sheath (41) and located between the distal end of the suction conduit (1) and the plug (32); the stirring assembly includes a stirrer (43) having an extended state and a retracted state. When the stirrer (43) is in the extended state, the stirrer (43) is detached from the second sheath (42), the stirrer (43) is in contact with the inner wall of the blood vessel, and when the first sheath (41) is dragged, the stirrer (43) moves back and forth in the blood vessel; when the stirrer (43) is in the retracted state, the stirring assembly is located inside the second sheath (42), and the stirring device can pass through the suction channel (11); The stirrer (43) is a mesh basket made of memory wire (44); there are multiple stirrers (43), and the multiple stirrers (43) are arranged sequentially along the axial direction of the first sheath (41). Adjacent stirrers (43) are connected by elastic members (45) so that adjacent stirrers (43) can move closer or further away from each other along the axial direction of the first sheath (41); the elastic member (45) is a spring, and the elastic member (45) is formed by spiral cutting a section of the first sheath (41).

3. The thrombus removal system according to claim 1 or 2, characterized in that: The aspiration catheter (1) further includes an filling channel (13) extending along the axial direction of the aspiration catheter (1) and a balloon (18) fixedly disposed at the distal end of the aspiration catheter (1) and connected to the filling channel (13). The balloon (18) has an open state and a closed state. When the balloon (18) is in the open state, the outer diameter of the balloon (18) is greater than or equal to the inner diameter of the blood vessel.

4. The thrombus removal system according to claim 3, characterized in that: The balloon (18) is located between the two outlets of the guidewire channel (12).

5. The thrombus removal system according to claim 3, characterized in that: The filling channel (13), the suction channel (11), and the guide wire channel (12) are separated from each other, and the filling channel (13) and the guide wire channel (12) are located on both sides of the suction channel (11).

6. The thrombus removal system according to claim 3, characterized in that: The proximal end of the suction catheter (1) is provided with a filling interface (15) connected to the filling channel (13), a suction interface (16) connected to the suction channel (11), and other device interfaces (17) connected to the suction channel (11).

7. The thrombus removal system according to claim 6, characterized in that: The axis of the other device interface (17) coincides with the axis of the suction channel (11).

8. The thrombus removal system according to claim 1 or 2, characterized in that: The distal end of the suction catheter (1) is a slope (14), and the outlet of the guidewire channel (12) is located at the distal end of the slope (14).

9. The thrombus removal system according to claim 1 or 2, characterized in that: The occluder (32) is a balloon.

10. The thrombus removal system according to claim 1 or 2, characterized in that: When the elastic element (45) is in a stationary state, the distance between two adjacent stirrers (43) is 5 to 10 mm.

11. The thrombus removal system according to claim 1 or 2, characterized in that: The projection of the stirrer (43) on a plane perpendicular to the axis of the first sheath (41) is petal-shaped, and the projections of multiple stirrers (43) on a plane perpendicular to the axis of the first sheath (41) are staggered.

12. The thrombus removal system according to claim 1 or 2, characterized in that: The stirrer (43) is spherical and has a diameter of 9-14 mm.

13. The thrombus removal system according to claim 1 or 2, characterized in that: The first sheath (41) penetrates the stirrer (43), and the axis of the first sheath (41) coincides with the center line of the stirrer (43).

14. The thrombus removal system according to claim 1 or 2, characterized in that: The suction tube (1), the sealing device, and the stirring device are each packaged separately.

15. The thrombus removal system according to claim 1 or 2, characterized in that: The thrombus removal system also includes a guidewire (2).

16. The thrombus removal system according to claim 1 or 2, characterized in that: The thrombus removal system also includes a thrombolytic tube.

Images