A thrombus treatment system

Abstract

The present invention relates to a thrombus treatment system, comprising a first catheter, a second catheter, a blocking device and a stirring device. The first catheter has a first channel, the second catheter has a second channel, the blocking device includes a third catheter and a blocker disposed at the distal end of the third catheter and having an open state and a retracted state; 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 present invention can remove a large amount of thrombus in the inferior vena cava while ensuring relatively high safety, protect the venous valves and the venous vessel wall, control the blood loss, simplify the operation steps, make the operation more convenient, shorten the operation time, and reduce the hospitalization cost of patients.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to a thrombus treatment system. Background Art

[0002] Thrombotic diseases include arterial thrombosis, venous thrombosis, and thromboembolism. Existing treatment methods mainly include vascular thrombectomy, catheter-directed thrombolysis, and percutaneous mechanical thrombectomy. Vascular thrombectomy requires anatomical dissection and incision of blood vessels, such as femoral artery, femoral vein, or brachial artery incision. With the development of endovascular intervention techniques and the innovation of materials, this open surgical method has gradually been replaced by minimally invasive endovascular treatment, that is, catheter-directed thrombolysis and percutaneous mechanical thrombectomy. Due to the high bleeding risk of thrombolytic drugs in catheter-directed thrombolysis, the surgical indications are extremely strict, and a large proportion of patients have contraindications to catheter-directed thrombolysis. Therefore, many patients cannot benefit from it.

[0003] Based on existing medical knowledge, deep vein thrombosis often has a large volume, and the texture of acute-phase thrombus is soft and fragile; arterial thrombosis often has a small volume, and the texture of acute-phase thrombus is soft; old thrombus often adheres to the blood vessel wall. For old thrombus, currently, it is mainly removed by mechanically scraping the blood vessel wall or by using thrombolytic drugs to detach the old thrombus.

[0004] For example, a thrombus resection catheter system that uses a helical cutter at the front end of the catheter to rotate and cut the thrombus and aspirate the blood clot out of the body, such as the X-sizer thrombus resection catheter system. Chinese Patent CN204092102U discloses a novel thrombus aspiration connector for peripheral vascular diseases, including: a tube body, a rotating rod, a helical rotating piece, an arc-shaped connector, and a connecting tail seat. The tube body is a hollow tube, the upper end of the tube body is movably connected to the arc-shaped connector by a thread, a rectangular groove is opened in the middle and upper part of the tube body, a rotating rod is inserted into the tube body, and a helical rotating piece is sleeved outside the rotating rod. However, the above-mentioned thrombus removal device has a complex structure, high preparation cost, and cumbersome use. Moreover, when the thrombus on the blood vessel wall is peeled off by the rotation of the helical cutter or helical rotating piece in the blood vessel, it is easy to damage the vascular endothelium, thus easily leading to the occurrence of thrombus removal sequelae.

[0005] Another example is the AngioJet thrombus removal device, which can spray a certain amount of thrombolytic agent into the thrombus under high pressure to break up the thrombus and increase the contact area with the thrombus, and then aspirate the thrombus (which can be called chemical-physical coupled thrombus volume reduction), and is suitable for acute-phase thrombus in the iliac, femoral, and popliteal veins. However, too long negative pressure time often leads to excessive blood loss in patients, and at the same time, high-pressure rapid stirring may cause red blood cell damage and hemolysis, thus easily leading to the occurrence of thrombus removal sequelae. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a thrombus treatment system that can reduce the occurrence of thrombus removal sequelae and is more convenient to operate.

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

[0008] From the perspective of the product structure, the thrombus treatment system of the present invention includes a first catheter and a second catheter connected to the distal end of the first catheter; the first catheter has a first channel for aspirating thrombus, the first channel extends along the axial direction of the first catheter and penetrates both ends of the first catheter, the second catheter has a second channel, and the second channel extends along the axial direction of the second catheter and penetrates both ends of the second catheter;

[0009] The thrombus treatment system further includes a blocking device and a stirring device;

[0010] The blocking device includes a third catheter and a blocker provided at the distal end of the third catheter and having an open state and a retracted state; when the blocker is in the open state, the outer diameter of the blocker is greater than or equal to the inner diameter of the blood vessel; when the blocker is in the retracted state, the blocking device can pass through the second channel;

[0011] The stirring device includes a first sheath, a second sheath slidably sleeved outside the first sheath, and a stirring assembly provided at the distal end of the first sheath; the stirring assembly includes a stirrer having an unfolded state and a retracted state, when the stirrer is in the unfolded state, the stirrer is separated 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 first channel.

[0012] From the perspective of the product usage state, the thrombus treatment system includes a first catheter and a second catheter; the first catheter has a first channel for aspirating thrombus, the first channel extends along the axial direction of the first catheter and penetrates both ends of the first catheter, the second catheter is connected to the distal end of the first catheter, the second catheter has a second channel, and the second channel extends along the axial direction of the second catheter and penetrates both ends of the second catheter;

[0013] The thrombus treatment system further includes a blocking device and a stirring device;

[0014] The described occlusion device includes a third catheter passing through the second channel and having its distal end extending out of the second catheter, and an occluder provided at the distal end of the third catheter and having an open state and a retracted 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 retracted state, the occlusion device can pass through the second channel;

[0015] The described stirring device includes a first sheath tube passing through the first channel and having its distal end extending out of the first catheter, a second sheath tube slidably sleeved outside the first sheath tube and passing through the first channel, and a stirring assembly provided at the distal end of the first sheath tube and located between the distal end of the first catheter and the occluder; the stirring assembly includes a stirrer having an unfolded state and a retracted state, when the stirrer is in the unfolded state, the stirrer is separated from the second sheath tube, the stirrer is in contact with the inner wall of the blood vessel, and when the first sheath tube 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 tube, and the stirring device can pass through the first channel.

[0016] When the present invention is in use, the downstream of the blood vessel is occluded by the occlusion device to temporarily cut off the blood flow and prevent the thrombus from drifting towards the heart direction, and then the first sheath tube is dragged back and forth to make the stirrer move back and forth in the blood vessel, the stirrer scrapes the blood vessel wall back and forth and agitates the thrombus in the blood vessel, so as to realize the detachment of the thrombus from the blood vessel wall, the fragmentation of the thrombus and the capture of the thrombus; and cooperate with the first catheter to aspirate the thrombus, a large number of deep vein thrombi and old thrombi can be quickly removed, and at the same time, the blood vessel wall and venous valves are not damaged, reducing the sequelae of thrombus removal.

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

[0018] On the premise that the first catheter of the present invention has the function of thrombus removal itself, it can also provide a passage for other thrombus removal devices, so as to facilitate doctors to select surgical plans for different thrombi, so that the indication range of this thrombus treatment system is wide.

[0019] Of course, for some thrombus diseases that can be treated only by aspirating through the first catheter, medical staff can only use the first catheter in the present invention without using the stirring device and the occlusion device.

[0020] Preferably, the first catheter further includes a filling channel extending along the axial direction of the first catheter, and a balloon fixedly arranged at the distal end of the first catheter and communicating with the filling channel. The balloon has an open state and a collapsed 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 providing a balloon on the first catheter, when the balloon is filled, it can block the upstream of the blood vessel to temporarily cut off the blood flow, avoiding thrombus entering the downstream blood vessel and causing thrombus in other parts.

[0021] Further preferably, the balloon is located at the proximal end of the second catheter, and the diameter of the balloon in the open state is 10 - 12 mm.

[0022] In the present invention, the first channel and the second channel are separated from each other and not connected, so as to avoid interference between the guide wire, the occlusion device and other components. Further, the filling channel, the first channel, and the second channel are respectively separated from each other and not connected, and the filling channel and the second channel are respectively located on both sides of the first channel. Each channel has a clear function and is easy to distinguish. At the same time, the space can be maximally left for the suction channel to improve the suction efficiency.

[0023] Further preferably, the proximal end of the first catheter is provided with a filling interface communicating with the filling channel, a suction interface communicating with the first channel, and other device interfaces communicating with the first channel, so that other devices can enter the blood vessel through the first channel. Other devices include occlusion devices, stirring devices, and other devices in need, such as thrombolytic tubes, etc.

[0024] More preferably, the axis of the other device interface coincides with the axis of the first channel, so that other devices are convenient to enter.

[0025] Preferably, the distal end surface of the first catheter is a first inclined surface, so as to expand the suction range and effect; the distal end surface of the second catheter is a second inclined surface. The first inclined surface and the second inclined surface intersect and are in contact at the distal end, so that the distal ends of the first catheter and the second catheter form a tip, thereby reducing the resistance from the blood flow when the first catheter is inserted into the blood vessel and facilitating the entire system to quickly enter the lesion site along the guide wire.

[0026] In the present invention, the first catheter and the second catheter are an integral body formed by extrusion molding.

[0027] Preferably, the occluder is a balloon. In the open state, the diameter of the balloon is 12 - 14 mm, and the balloon can be filled by inflating or filling with liquid.

[0028] Preferably, the stirrer is a wire basket made of shape memory wire; when there is one stirrer, the degree of deployment of the stirrer can be controlled by the second sheath; when there are multiple stirrers, the multiple stirrers are arranged in sequence along the axial direction of the first sheath, and adjacent two stirrers are connected by an elastic member so that adjacent two stirrers can approach or move away from each other relatively along the axial direction of the first sheath.

[0029] The shape memory wire in this article can be a shape memory alloy such as nickel-titanium alloy.

[0030] In the present invention, the wire basket made of shape memory wire can be formed by laser cutting and heat setting of a nickel-titanium alloy whole tube. The setting of the wire basket makes the contact area between the stirrer and the blood vessel wall small when dragging the stirrer back and forth, so the damage to the blood vessel wall is small, and the stirrer can partially break and intercept the thrombus in the blood vessel.

[0031] For the solution with one stirrer, controlling the degree of deployment of the stirrer by retracting the second sheath is an existing technology.

[0032] The self-expansion degree of the stirrer is achieved by retracting the second sheath proximally, so that the degree of wall attachment of the stirrer and the dragging force can be adjusted as needed when dragging the thrombus.

[0033] For the solution with multiple stirrers, the elastic member can be a thin-walled pipe. According to one embodiment, the elastic member is a spring. The spring referred to in this article includes all components with a similar spring-like spiral shape and thus elasticity, which is convenient for processing in terms of technology, and can connect and pass through complex lesion sites through the elastic member during use, while improving the flexibility of the diameters of the sheath and the stirrer.

[0034] Among them, the elastic member and the first sheath can be welded or integrally provided. Preferably, the elastic member and the first sheath are integrally provided, that is, a spring-like elastic member is formed by helically cutting a section of the first sheath, so that the preparation is convenient and the firmness is good.

[0035] In the present invention, by arranging the stirrers to be elastically connected by an elastic member, when dragging the first sheath back and forth, there is a certain buffering effect between the stirrers and between the stirrer and the blood vessel.

[0036] Preferably, when the elastic member is in a static state, the distance between adjacent two stirrers is 5-10 mm, so as to improve the flexibility of the stirrer during dragging.

[0037] Further preferably, the projection of the stirrer on a plane perpendicular to the axis of the first sheath tube is petal-shaped, and the number of petals can be set according to actual needs, preferably set to 4 to 6 petals, so as to ensure that the vertical projection surfaces of the two stirrers can form an effective interception cross-section.

[0038] Further preferably, the projections of multiple stirrers on a plane perpendicular to the axis of the first sheath tube are staggered, so as to increase the effective interception area for intercepting thrombus.

[0039] The "plane perpendicular to the axis of the first sheath tube" defined herein is based on Figure 8 the axis defined by the straight extension of the first sheath tube shown in, and this plane is perpendicular to the above-mentioned straight axis.

[0040] Preferably, the stirrer is spherical. The spherical shape is not easy to scratch the blood vessel wall, has good wall attachment property, and is easy to remove old adherent thrombus.

[0041] Further preferably, the diameter of the stirrer is 9 to 14 mm, so that the stirrer can adapt to blood vessels with different inner diameters.

[0042] Preferably, the first sheath tube penetrates through the stirrer, and the axis of the first sheath tube coincides with the center line of the stirrer, so that the preparation of the stirring device is convenient, the operation is convenient, and the damage to the blood vessel wall is small.

[0043] In the present invention, the first catheter, the occlusion device, and the stirring device are independently packaged. The independently packaged components can be sold as a whole or separately, so as to facilitate the selective use by medical staff. Of course, the first catheter, the occlusion device, and the stirring device can also be sold as a whole in one package.

[0044] According to one embodiment, the thrombus treatment system further includes a guide wire. This product can be sold together with a guide wire, or a guide wire from other manufacturers can be used.

[0045] Further preferably, the outer diameter of the third catheter is 3.5 to 4.5F, and the outer diameter of the first catheter is

[0046] 12 to 14F, and the diameter of the first channel is 8 to 10F.

[0047] In the present invention, the inner diameter of the second catheter is slightly larger than the outer diameter of the third catheter. The inner diameter of the second catheter only needs to allow the guide wire and the occlusion device to pass through; if the size of the second catheter is too large, the size of the whole system will be too large, which is not conducive to use.

[0048] In the present invention, the thrombus treatment system further includes a guide wire and / or a thrombolytic tube. This product can be sold with a guide wire and a thrombolytic tube, or the guide wire and thrombolytic tube of other manufacturers can be used.

[0049] Due to the implementation of the above technical solutions, the present invention has the following advantages compared with the prior art:

[0050] The present invention can remove a large amount of thrombus in the inferior vena cava while ensuring relative safety, protect the venous valves and the venous vessel wall, the blood loss is controllable, the operation steps are simple, it is more convenient during operation, the operation time can be shortened, and the hospitalization cost of patients can be reduced. Description of the Drawings

[0051] Attached Figure 1 is a schematic structural diagram of the thrombus treatment system for the specific embodiment;

[0052] Attached Figure 2 is Figure 1 a partial enlarged view of position A of ;

[0053] Attached Figure 3 is Figure 1 a partial enlarged view of position B of ;

[0054] Attached Figure 4 is Figure 1 a C-C sectional view of ;

[0055] Attached Figure 5 is a schematic structural diagram of the stirring device before deployment in Embodiment 1 (the second sheath has been retracted, but before the stirrer is opened);

[0056] Attached Figure 6 is a schematic structural diagram of the stirring device after deployment in Embodiment 1;

[0057] Attached Figure 7 is a schematic structural diagram of the stirring device before deployment in Embodiment 2;

[0058] Attached Figure 8 is a schematic structural diagram of the stirring device after deployment in Embodiment 2;

[0059] Attached Figure 9 is a partial structural schematic diagram of the stirring device after deployment in Embodiment 2;

[0060] Attached Figure 10 is a top view of the stirring device after deployment in Embodiment 2;

[0061] Attached Figure 11 is a top view of the first stirrer of the stirring device after deployment in Embodiment 2;

[0062] Attached Figure 12Top view of the second stirrer of the stirring device according to Embodiment 2 after unfolding;

[0063] Wherein, 1, the first catheter; 2, the guide wire; 11, the first channel; 12, the second channel; 13, the filling channel; 14, the first inclined surface; 15, the filling interface; 16, the suction interface; 17, the interface for other devices; 18, the balloon; 19, the second inclined surface; 20, the second catheter; 31, the third catheter; 32, the occluder; 41, the first sheath; 42, the second sheath; 43, the stirrer; 44, the memory wire; 45, the elastic member. Specific embodiments

[0064] The present invention will be further described in detail below in conjunction with 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 by the following embodiments.

[0065] As Figure 1 shown, the thrombus treatment system of the present invention includes a first catheter 1, a second catheter 20, a guide wire 2, a stirring device and an occluding device.

[0066] The first catheter 1 has a first channel 11 for aspirating thrombus and a filling channel 13. The first channel 11 extends along the axial direction of the first catheter 1 and penetrates both ends of the first catheter 1, and the filling channel 13 extends along the axial direction of the first catheter 1.

[0067] The second catheter 20 is integrally formed with the distal end of the first catheter 1. The second catheter 20 has a second channel 12 for threading the guide wire and the occluding device. The second channel 12 extends along the axial direction of the second catheter 20 and penetrates both ends of the second catheter 20.

[0068] The distal end surface of the first catheter 1 is a first inclined surface 14, and the distal end surface of the second catheter 20 is a second inclined surface 19. As Figure 3 shown, the outlet at the distal end of the first channel 11 is opened on the first inclined surface 14, and the outlet at the distal end of the second channel 12 is opened on the second inclined surface 19. Moreover, the first inclined surface 14 and the second inclined surface 19 intersect and the distal ends are in contact to form a tip.

[0069] The filling channel 13, the first channel 11, and the second channel 12 are separated from each other and not connected, and the filling channel 13 and the second channel 12 are respectively located on both sides of the first channel 11, as Figures 2 to 4 shown.

[0070] As Figure 1As shown in the figure, the proximal end of the first catheter 1 is provided with a filling interface 15 communicating with the filling channel 13, a suction interface 16 communicating with the first channel 11, and other device interfaces 17 communicating with the first channel 11. That is, the outlet at the proximal end of the filling channel 13 communicates with the filling interface 15, and the outlets at the proximal end of the first channel 11 communicate with the suction interface 16 and the other device interfaces 17 respectively. Preferably, the axis of the other device interface 17 coincides with the axis of the first channel 11, so that other devices can enter conveniently.

[0071] The distal end of the first catheter 1 is fixedly provided with a balloon 18, which communicates with the distal outlet of the filling channel 13. Thus, the balloon 18 can be filled and released through the filling interface 15 and the filling channel 13, so that the balloon 18 has an open state and a collapsed state. When implanting and retrieving the first catheter 1, the balloon 18 is in the collapsed state, which is convenient for the implantation and retrieval of the first catheter 1. When in use, the balloon 18 is in the open state, and the outer diameter of the balloon 18 is greater than or equal to the inner diameter of the blood vessel. Preferably, the outer diameter of the balloon 18 is equal to or slightly greater than the inner diameter of the blood vessel. In this embodiment, the diameter of the balloon 18 in the open state is preferably 10 - 12 mm, so as to form a blockage of the blood vessel, temporarily prevent blood flow, and prevent the loose free thrombus from drifting to other blood vessels during the thrombus removal process. In this embodiment, the balloon 18 is located at the proximal end of the second catheter 20, as Figure 1 shown in the figure, that is, the outlet at the proximal end of the second channel 12 is located at the distal end of the balloon 18.

[0072] In this embodiment, the first catheter 1 is a two - lumen catheter. Of course, other multi - lumen catheters can also be used instead. The second channel 12 of the second catheter 20 can allow an OTW rapid exchange wire or a central push wire to pass through, and is adapted to but not limited to a 0.014″ wire. While ensuring its own ability to aspirate thrombus, the first catheter 1 reserves other device access paths, so as to deal with various complex thrombi.

[0073] As Figure 1 shown in the figure, the occlusion device includes a third catheter 31 and an occluder 32 provided at the distal end of the third catheter 31, which has an open state and a collapsed state. The occluder 32 is a balloon, and the balloon can be filled by inflating or filling with liquid.

[0074] 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. Preferably, the outer diameter of the occluder 32 is equal to or slightly larger than the inner diameter of the blood vessel, so that the occluder 32 is attached to the inner wall of the blood vessel. During use, the occluder 32 is located at the distal end of the first catheter 1 and acts simultaneously with the balloon 18 of the first catheter 1 to form a closed space in the blood vessel in a short time, so that good curative effects can be achieved whether the stirring device is used to drag thrombus or dissolve thrombus. When the occluder 32 is in the retracted state, the occluding device can pass through the second channel 12.

[0075] The stirring device includes a first sheath 41, a second sheath 42 slidably sleeved outside the first sheath 41, and a stirring assembly provided at the distal end of the first sheath 41; the stirring assembly includes a stirrer 43 having an expanded state and a retracted state, and the outer diameter of the stirrer 43 in the open state is less than or equal to the inner diameter of the blood vessel. During use, the stirring assembly and the first sheath 41 are retracted into the second sheath 42. The stirring device enters the first channel 11 from other device interfaces and positions the stirrer 43 between the first catheter 1 and the occluder 32. The second sheath 42 is retracted to open the stirrer 43, and the stirrer 43 is moved back and forth in the blood vessel by dragging the first sheath 41 back and forth.

[0076] Embodiment 1:

[0077] As Figure 5 and Figure 6 shown, there is only one stirrer 43, which is formed by shaping several braided memory wires. It can be self-expanded by retracting proximally through the second sheath 42. When dragging the first sheath 41, the degree of wall attachment of the memory wire 44 and the dragging force can be controlled by adjusting the opening degree of the stirrer 43 by the length of the retraction of the second sheath 42.

[0078] 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, and the stirrer 43 is fixed on the first sheath 41 by welding or other processes.

[0079] The shape of the wire basket can be a commonly used shape in the prior art, such as spherical, fusiform, etc. The material of the memory wire can be a memory alloy such as nitinol.

[0080] Embodiment 2:

[0081] The stirrer 43 is a plurality of axially arranged along the first sheath 41 in sequence. As Figure 7 , Figure 8 shown, there are two stirrers 43. Adjacent stirrers 43 are connected by an elastic member 45 so that adjacent stirrers 43 can approach or move away from each other axially along the first sheath 41.

[0082] As Figures 7 to 9As shown, the elastic member 45 is integrally provided with the first sheath tube 41, and an elastic member 45 similar to a spring is formed by helically cutting a section of the first sheath tube 41.

[0083] When the elastic member 45 is in a static state (i.e., the elastic member 45 is neither extended nor compressed), the distance between two adjacent agitators 43 is 5 - 10 mm.

[0084] The agitator 43 is a wire basket made of a shape memory wire 44, for example, it is formed by laser cutting and heat setting a whole tube of nickel-titanium alloy. The agitator 43 is spherical, and the diameter of the agitator 43 is 9 - 14 mm.

[0085] As Figure 11 and Figure 12 shown, the projection of the agitator 43 on a plane perpendicular to the axis of the first sheath tube 41 is in the shape of a petal, and the number of petals can be set according to actual needs, preferably set to 4 - 6 petals, and in this embodiment, it is 5 petals.

[0086] As Figure 10 shown, the projections of multiple agitators 43 on a plane perpendicular to the axis of the first sheath tube 41 are staggered, that is, the projections of the shape memory wires 44 of multiple agitators 43 on the plane do not coincide.

[0087] The first sheath tube 41 passes through the agitator 43, and the axis of the first sheath tube 41 coincides with the center line of the agitator 43, and the agitator 43 is fixed on the first sheath tube 41 by welding or other processes.

[0088] The thrombus treatment system of the present invention further includes a guide wire 2 and a thrombolytic tube. The improvement of the guide wire 2 and the thrombolytic tube is not the focus of the protection of the present invention, and the guide wire 2 and the thrombolytic tube in the prior art can be used.

[0089] The first catheter 1, the occlusion device, and the agitation device are separately packaged. When sold, an independently packaged guide wire 2 and thrombolytic tube can be equipped, which is convenient for medical staff to use the whole set.

[0090] The use steps of this thrombus treatment system are as follows:

[0091] 1. Thread the guide wire 2 to the lesion site.

[0092] 2. Thread the guide wire 2 through the second channel 12 so as to send the distal ends of the first catheter 1 and the second catheter 20 to the front end of the lesion site, and perform angiography to observe the occlusion condition.

[0093] 3. Insert the occlusion device into the second catheter 20, deliver it through the second catheter 20, and enable the occluder 32 to pass through the lesion site. Then, through the third catheter 31, inflate the occluder 32 to occlude the distal end of the blood vessel. Subsequently, inflate the balloon 18 through the inflation interface 15 and the inflation channel 13 to occlude the proximal end of the blood vessel, so as to form a short-term closed space between the occluder 32 and the balloon 18.

[0094] 4. Insert the thrombolytic tube into the other device interface 17, deliver it through the first channel 11 to the lesion site within the closed space, and perform thrombolysis with the thrombolytic tube within the specific space. After thrombolysis is completed, remove the thrombolytic tube.

[0095] 5. Insert the stirring device into the other device interface 17, deliver it through the first channel 11 to the lesion site within the closed space, and then withdraw the second sheath 42 to open the stirrer 43.

[0096] 6. Grasp the first sheath 41 and repeatedly drag it, while simultaneously applying negative pressure through the aspiration interface 16 via the first channel 11.

[0097] 7. After the insoluble thrombus adheres to the stirrer 43, withdraw the first sheath 41 to aspirate the thrombus out of the body.

[0098] 8. After completely removing the stirrer 43, repeatedly aspirate the first catheter 1 to aspirate the remaining thrombus.

[0099] 9. After thrombus extraction is completed, release the pressure on the occluder 32 and the 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.

[0100] 10. After the treatment is completed, withdraw the first catheter 1 and the second catheter 20 along the guide wire 2, and then withdraw the occluder 32.

[0101] The above steps are for the treatment of difficult-to-treat old thrombi. For some relatively easy-to-treat thrombi, steps such as thrombolysis with the thrombolytic tube can be omitted accordingly.

[0102] The present invention intervenes through the guide wire 2. When the balloon 18 and the occluder 32 are inflated, they occlude the blood vessel, which is convenient for doctors' surgical operations, and at the same time can enhance the effect of catheter-directed thrombolysis and prevent emboli from detaching and floating to the heart during thrombus extraction. The combined use of the large-sized first catheter 1 and the stirrer 43 in the 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, and then dragged into the first catheter 1 through the stirrer 43. Using this instrument can remove a large amount of thrombi in the inferior vena cava while ensuring relative safety, protect the venous valves and the venous vessel wall, with controllable blood loss, simple operation steps, shortened operation time, and reduced hospitalization costs for patients.

[0103] By delivering the occlusion device into the lesion site through the second catheter 20, the present invention reduces the travel distance of the occlusion device, facilitating the operation of medical staff. At the same time, it also avoids occupying the aspiration channel, thus providing sufficient thrombus channels and thrombolysis catheter channels, further shortening the operation time and improving the operation effect.

[0104] As described above, we have fully explained in accordance with the purpose of the present invention, but the present invention is not limited to the above embodiments and implementation methods. Practitioners in the relevant technical fields can make different changes and implementations within the scope permitted by the technical idea of the present invention.

Claims

1. A thrombus treatment system, comprising a first catheter (1) having a first channel (11), characterized in that: The described thrombus treatment system further includes a second catheter (20) connected to the distal end of the first catheter (1) and having a second channel (12). The first channel (11) extends along the axial direction of the first catheter (1) and penetrates both ends of the first catheter (1). The second channel (12) extends along the axial direction of the second catheter (20) and penetrates both ends of the second catheter (20). The described thrombus treatment system further includes a blocking device and a stirring device. The blocking device includes a third catheter (31) and a blocker (32) provided at the distal end of the third catheter (31) and having an open state and a collapsed state. When the blocker (32) is in the open state, the outer diameter of the blocker (32) is greater than or equal to the inner diameter of the blood vessel. When the blocker (32) is in the collapsed state, the blocking device can pass through the second channel (12). The stirring device includes a first sheath (41), a second sheath (42) slidably sleeved outside the first sheath (41), and a stirring assembly provided at the distal end of the first sheath (41). The stirring assembly includes a stirrer (43) having an expanded state and a collapsed state. When the stirrer (43) is in the expanded 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 collapsed state, the stirring assembly is located inside the second sheath (42), and the stirring device can pass through the first channel (11). The stirrer (43) is a wire basket made of shape memory wire (44). There are multiple stirrers (43), and the multiple stirrers (43) are arranged in sequence along the axial direction of the first sheath (41). Adjacent two stirrers (43) are connected by an elastic member (45) so that adjacent two stirrers (43) can relatively approach or move away from each other along the axial direction of the first sheath (41). The elastic member (45) is a spring. 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 the multiple stirrers (43) on a plane perpendicular to the axis of the first sheath (41) are staggered from each other. The elastic member (45) is formed by helical cutting on a section of the first sheath (41).

2. The thrombus treatment system according to claim 1, characterized in that: The first catheter (1) further includes a filling channel (13) extending along the axial direction of the first catheter (1), and a balloon (18) fixedly provided at the distal end of the first catheter (1) and communicating with the filling channel (13). The balloon (18) has an open state and a collapsed 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.

3. The thrombus treatment system according to claim 2, wherein: The balloon (18) is located at the proximal end of the second catheter (20), and the diameter of the balloon (18) in the open state is 10-12 mm.

4. The thrombus treatment system according to claim 2, wherein: The filling channel (13) and the first channel (11) are separated from each other, the first channel (11) and the second channel (12) are separated from each other, and the filling channel (13) and the second channel (12) are respectively located on both sides of the first channel (11).

5. The thrombus treatment system according to claim 2, characterized in that: At the proximal end of the first catheter (1), there are provided a filling interface (15) communicating with the filling channel (13), a suction interface (16) communicating with the first channel (11), and other device interfaces (17) communicating with the first channel (11).

6. The thrombus treatment system according to claim 5, wherein: The axis of the other device interface (17) coincides with the axis of the first channel (11).

7. The thrombus treatment system according to claim 1, wherein: The distal end face of the first catheter (1) is a first inclined surface (14), and the distal end face of the second catheter (20) is a second inclined surface (19); the first inclined surface (14) and the second inclined surface (19) intersect and are in contact at the distal end.

8. The thrombus treatment system according to claim 1, wherein: The occluder (32) is a balloon, and in the open state, the diameter of the balloon is 12-14 mm.

9. The thrombus treatment system according to claim 1, wherein: The elastic member (45) is integrally provided with the first sheath (41).

10. The thrombus treatment system according to claim 1, wherein: When the elastic member (45) is in a static state, the distance between two adjacent agitators (43) is 5-10 mm.

11. The thrombus treatment system according to claim 1, wherein: In the deployed state, the agitator (43) is spherical, and the diameter of the agitator (43) is 9-14 mm.

12. The thrombus treatment system according to claim 1, wherein: The first sheath (41) penetrates through the agitator (43), and the axis of the first sheath (41) coincides with the center line of the agitator (43).

13. The thrombus treatment system according to claim 1, wherein: The first catheter (1) and the second catheter (20) are integrally formed; the first catheter (1), the occluding device, and the agitating device are separately packaged.

14. The thrombus treatment system according to claim 1, wherein: The thrombus treatment system further includes a guide wire (2) and / or a thrombolytic tube.

15. The thrombus treatment system according to claim 1, characterized in that: The outer diameter of the third catheter (31) is 3.5-4.5F, the outer diameter of the first catheter (1) is 12-14F, and the diameter of the first channel (11) is 8-10F.

16. A thrombus treatment system, comprising a first catheter (1) having a first channel (11), characterized in that: The thrombus treatment system further includes a second catheter (20) connected to the distal end of the first catheter (1) and having a second channel (12). The first channel (11) extends along the axial direction of the first catheter (1) and penetrates both ends of the first catheter (1), and the second channel (12) extends along the axial direction of the second catheter (20) and penetrates both ends of the second catheter (20); The thrombus treatment system further includes an occluding device and an agitating device; The described occlusion device includes a third catheter (31) passing through the second channel (12) and having its distal end extending out of the second catheter (20), and an occluder (32) provided at the distal end of the third catheter (31) and having an open state and a collapsed 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 collapsed state, the occlusion device can pass through the second channel (12). The described stirring device includes a first sheath (41) passing through the first channel (11) and having its distal end extending out of the first catheter (1), a second sheath (42) slidably sleeved outside the first sheath (41) and passing through the first channel (11), and a stirring assembly provided at the distal end of the first sheath (41) and located between the distal end of the first catheter (1) and the occluder (32); the stirring assembly includes a stirrer (43) having an expanded state and a collapsed state, when the stirrer (43) is in the expanded state, the stirrer (43) is disengaged 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 collapsed state, the stirring assembly is located inside the second sheath (42), and the stirring device can pass through the first channel (11). The stirrer (43) is a wire basket made of a shape memory wire (44); there are multiple stirrers (43), and the multiple stirrers (43) are arranged in sequence along the axial direction of the first sheath (41), and adjacent two stirrers (43) are connected by an elastic member (45) so that adjacent two stirrers (43) can relatively approach or move away from each other along the axial direction of the first sheath (41); the elastic member (45) is a spring; the projection of the stirrer (43) on a plane perpendicular to the axis of the first sheath (41) is in a petal shape, and the projections of the multiple stirrers (43) on a plane perpendicular to the axis of the first sheath (41) are staggered from each other; the elastic member (45) is formed by helical cutting on a section of the first sheath (41).

17. The thrombus treatment system according to claim 16, wherein: The first catheter (1) further includes a filling channel (13) extending along the axial direction of the first catheter (1), and a balloon (18) fixedly provided at the distal end of the first catheter (1) and communicating with the filling channel (13), the balloon (18) having an open state and a collapsed 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.

18. The thrombus treatment system according to claim 17, wherein: The balloon (18) is located at the proximal end of the second catheter (20), and the diameter of the balloon (18) in the open state is 10 - 12 mm.

19. The thrombus treatment system according to claim 17, wherein: The described filling channel (13) and the described first channel (11) are separated from each other, the described first channel (11) and the described second channel (12) are separated from each other, and the described filling channel (13) and the described second channel (12) are respectively located on both sides of the described first channel (11).

20. The thrombus treatment system according to claim 17, wherein: At the proximal end of the described first catheter (1), there is provided a filling interface (15) communicating with the described filling channel (13), a suction interface (16) communicating with the described first channel (11), and another device interface (17) communicating with the described first channel (11).

21. The thrombus treatment system according to claim 20, wherein: The axis of the described another device interface (17) coincides with the axis of the described first channel (11).

22. The thrombus treatment system according to claim 16, wherein: The distal end surface of the described first catheter (1) is a first inclined surface (14), and the distal end surface of the described second catheter (20) is a second inclined surface (19); the described first inclined surface (14) and the described second inclined surface (19) intersect and are in contact at the distal end.

23. The thrombus treatment system according to claim 16, wherein: The occluder (32) is a balloon, and in the open state, the diameter of the balloon is 12 - 14 mm.

24. The thrombus treatment system according to claim 16, wherein: The elastic member (45) is integrally provided with the first sheath tube (41).

25. The thrombus treatment system according to claim 16, characterized in that: When the elastic member (45) is in a static state, the distance between two adjacent stirrers (43) is 5 - 10 mm.

26. The thrombus treatment system according to claim 16, wherein: In the deployed state, the stirrer (43) is spherical, and the diameter of the stirrer (43) is 9 - 14 mm.

27. The thrombus treatment system according to claim 16, wherein: The first sheath tube (41) penetrates through the stirrer (43), and the axis of the first sheath tube (41) coincides with the center line of the stirrer (43).

28. The thrombus treatment system according to claim 16, wherein: The described first catheter (1) and the described second catheter (20) are integrally formed; the described first catheter (1), the occluding device, and the stirring device are respectively independently packaged.

29. The thrombus treatment system according to claim 16, characterized in that: The described thrombus treatment system further includes a guide wire (2) and / or a thrombolytic tube.

30. The thrombus treatment system according to claim 16, wherein: The outer diameter of the described third catheter (31) is 3.5 - 4.5F, the outer diameter of the described first catheter (1) is 12 - 14F, and the diameter of the described first channel (11) is 8 - 10F.

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