A thrombus treatment platform

Abstract

The present invention relates to a thrombus treatment platform, comprising a suction catheter with a suction channel, a suction pump connected to the proximal end of the suction catheter, a stirring device and a filter assembly, wherein the filter assembly comprises a filter rod and a filter; the stirring device comprises a first catheter, a second catheter slidably sleeved outside the first catheter, an agitator arranged at the distal end of the first catheter and having an open state and a retracted state, an operating device arranged between the first catheter and the second catheter and capable of making the first catheter and the second catheter slide relative to each other so as to switch the agitator between the open state and the retracted state; the thrombus treatment platform also comprises a driving device connected to the first catheter or the second catheter and capable of driving the agitator to rotate. The present invention can remove thrombi while ensuring relative safety, is particularly suitable for removing a large amount of thrombi in the inferior vena cava, protects venous valves and venous blood vessel walls, has controllable blood loss, simple operating steps, shortens operation time, and reduces patient hospitalization costs.

Description

Technical Field

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

[0002] Thrombotic diseases include arterial thrombosis, venous thrombosis and thromboembolism. Existing treatment methods mainly include vascular embolectomy, catheter-directed thrombolysis and percutaneous mechanical embolectomy. The embolectomy requires anatomical separation and vascular incision, such as femoral artery, femoral vein or brachial artery incision. With the development of intracavitary interventional technology and the innovation of materials, this open surgical method has been gradually replaced by minimally invasive intracavitary treatment, namely catheter-directed thrombolysis and percutaneous mechanical embolectomy. Catheter-directed thrombolysis has a high risk of bleeding due to thrombolytic drugs and extremely strict surgical indications. A large proportion of patients have contraindications to catheter-directed thrombolysis, so many patients cannot benefit from it.

[0003] Based on existing medical knowledge, deep vein thrombosis is often large in volume, and the acute thrombus is soft and fragile; arterial thrombosis is often small in volume, and the acute thrombus is soft; old thrombus often adheres to the blood vessel wall. As for old thrombus, currently it is mainly removed by mechanically scraping the blood vessel wall or using thrombolytic drugs to make the old thrombus fall off.

[0004] For example, a thrombectomy catheter system that uses a spiral cutter at the front end of the catheter to cut the thrombus and extract the blood clot out of the body by suction, such as the X-sizer thrombectomy catheter system. Chinese patent CN204092102U discloses a new type of peripheral vascular disease thrombus suction connector, including: a tube body, a rotating rod, a spiral rotating piece, an arc joint, and a connecting tail seat. The tube body is hollow and tubular, and the upper end of the tube body is movably connected to the arc joint through a thread. A rectangular groove is opened in the upper middle part of the tube body, and a rotating rod is inserted into the tube body. The outer periphery of the rotating rod is provided with a spiral rotating piece. However, the above-mentioned thrombus removal device has a complex structure, high preparation cost, and cumbersome use. When the thrombus on the blood vessel wall is peeled off by the rotation of the spiral cutter or the spiral rotating piece in the blood vessel, the vascular endothelium is easily damaged, which can easily lead to the occurrence of thrombectomy sequelae.

[0005] For example, the AngioJet thrombus remover can spray a certain amount of thrombolytic agent into the thrombus at high pressure to break it up, increase the contact area with the thrombus, and then perform thrombus aspiration (which can be called chemical and physical coupling thrombus volume reduction), which is suitable for acute thrombus in the iliac, femoral, and popliteal veins. However, prolonged negative pressure often leads to excessive blood loss in patients, and high-pressure rapid stirring may cause red blood cell damage and hemolysis, which can easily lead to the occurrence of thrombectomy sequelae. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a thrombus treatment platform capable of reducing the occurrence of thrombus removal sequelae.

[0007] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0008] From the product structure point of view, the thrombus treatment platform of the present invention includes a suction catheter with a suction channel, and the thrombus treatment platform also includes a suction pump connected to the proximal end of the suction catheter, a stirring device and a filter assembly.

[0009] The filter assembly comprises a filter rod, and a filter fixedly mounted at the distal end of the filter rod and having an open state and a closed state;

[0010] The stirring device comprises a first conduit, a second conduit slidably sleeved outside the first conduit, a stirrer arranged at the distal end of the first conduit and having an open state and a retracted state, and an operating device arranged between the first conduit and the second conduit and capable of making the first conduit and the second conduit slide relative to each other so as to switch the stirrer between the open state and the retracted state;

[0011] The thrombus treatment platform also includes a driving device connected to the first catheter or the second catheter and capable of driving the agitator to rotate.

[0012] From the perspective of product usage, the thrombus treatment platform includes a suction catheter with a suction channel, and the thrombus treatment platform also includes a suction pump, a stirring device and a filter assembly connected to the proximal end of the suction catheter.

[0013] The filter assembly comprises a filter rod passing through the suction channel, and a filter fixedly mounted at the distal end of the filter rod and having an open state and a closed state; the filter is located at the distal end of the suction conduit;

[0014] The stirring device comprises a first catheter passing through the suction channel, a second catheter passing through the suction channel and slidably sleeved outside the first catheter, a stirrer arranged at the distal end of the first catheter and having an open state and a retracted state, and an operating device arranged between the first catheter and the second catheter and capable of making the first catheter and the second catheter slide relative to each other so as to switch the stirrer between the open state and the retracted state; when the stirrer is in the open state, the stirrer is located between the filter screen and the distal end of the suction catheter, and when the first catheter is dragged, the stirrer moves back and forth in the blood vessel;

[0015] The thrombus treatment platform also includes a driving device connected to the first catheter or the second catheter and capable of driving the agitator to rotate.

[0016] Preferably, when the agitator is in a retracted state, the outer diameter of the agitator is ≤6F, more preferably, the outer diameter of the agitator is ≤5.5F, more preferably ≤5F.

[0017] Preferably, the stirrer is a mesh basket formed of wire.

[0018] Preferably, the expansion degree of the agitator can be controlled by the second catheter, so that medical staff can control the distance and fit degree between the agitator and the blood vessel wall according to actual needs, which is more convenient for use; and the agitator of the present invention is woven with silk threads, and when it is in the retracted state, the outer diameter can be very small, thereby reducing the size of the second catheter, leaving more space for the suction channel, and improving the efficiency of thrombus extraction.

[0019] Further preferably, the agitator is woven from a plurality of the silk threads and the two ends of each silk thread are respectively located at the proximal end and the distal end of the first catheter, that is, the length direction of each silk thread is basically along the axial direction of the first catheter, rather than along a direction perpendicular to the axial direction of the first catheter.

[0020] More preferably, at least some of said threads intersect.

[0021] More preferably, at least part of the wire is rotated around the first conduit at a certain angle, wherein the angle may be determined according to the length of the wire and the maximum outer diameter required when the stirrer is in an open state.

[0022] According to a specific embodiment, the distal ends and proximal ends of the plurality of silk threads are fixedly arranged on the first catheter, and when the agitator is in a retracted state, the agitator is located in the second catheter; when the agitator is in an open state, at least part of the agitator is detached from the second catheter; this embodiment can control the diameter of the agitator after retracting by controlling the inner diameter of the second catheter.

[0023] According to another embodiment, the distal end of the first catheter extends out of the second catheter; the agitator includes a plurality of silk threads; the distal end of each of the silk threads is fixedly connected to the first catheter, and the proximal end is fixedly connected to the distal end of the second catheter; when the first catheter moves toward the proximal end relative to the second catheter, the agitator is turned on, and as the distance the first catheter moves increases, the degree of expansion of the agitator increases, and the outer diameter of the agitator increases; when the first catheter moves toward the distal end relative to the second catheter until the silk threads are straightened, the agitator is in a retracted state, at which time the outer diameter of the agitator is the smallest and basically fits on the first catheter.

[0024] Preferably, the material of the wire is one or more of nickel-titanium alloy, stainless steel wire, high molecular polymer, etc.

[0025] Preferably, the stirring device also includes a plurality of first ultrasonic generators fixedly arranged on the silk thread, a first power line connected to the first ultrasonic generator, and a first ultrasonic connector arranged on the operating device and capable of supplying power to the first power line.

[0026] Further preferably, the silk thread has an internal lumen, the first catheter or the second catheter also has an internal lumen, and the first power line is located in the internal lumen of the silk thread and the internal lumen of the first catheter or the second catheter.

[0027] More preferably, the diameter of the first ultrasonic generator is 0.2-0.4 mm, and the outer diameter of the silk thread is 0.2-0.3 mm.

[0028] More preferably, the inner diameter of the wire is 0.1-0.2 mm.

[0029] For the solution in which both ends of the wire are fixed to the first catheter, the structure of the operating device can be very simple, including only one handle.

[0030] Specifically, the operating device includes a handle sleeved on the first conduit and / or the second conduit, a locking component arranged between the first conduit and the second conduit and capable of locking the two relative to each other, and an operating component slidably connected to the handle and capable of cooperating with the first conduit or the second conduit to lock; when the locking component is in an unlocked state and the operating component is in a locked state, when the operating component slides relative to the handle, the first conduit and the second conduit slide relative to each other to switch the agitator between an open state and a retracted state; when the locking component is in a locked state, the relative positions of the first conduit and the second conduit are locked, and the driving device can drive the first conduit and the second conduit to rotate.

[0031] Further, the locking assembly includes a first locking piece fixedly connected to one of the first conduit and the second conduit, a second locking piece rotatably connected to the other of the first conduit and the second conduit, and a third locking piece arranged between the first locking piece and the second locking piece and capable of cooperating and locking with the other of the first conduit and the second conduit. When the locking assembly is in a locked state, the third locking piece cooperates and locks with the other of the first conduit and the second conduit, the first locking piece, and the second locking piece.

[0032] Furthermore, the material of the third locking piece is a material that can undergo elastic deformation. When the locking assembly is in a locked state, the third locking piece undergoes elastic deformation and closely cooperates with the other of the first conduit and the second conduit, the first locking piece, and the second locking piece.

[0033] Furthermore, a groove is formed on the second locking piece, an internal thread is formed on the groove wall of the groove, an external thread that can cooperate with the internal thread is formed on the outer surface of the first locking piece, the first locking piece is inserted into the groove of the second locking piece and is rotatably connected to the second locking piece through the internal thread and the external thread, and the third locking piece is located in the cavity formed by the first locking piece and the second locking piece.

[0034] Specifically, the operating component includes an operating member slidably connected to the handle, a matching portion formed on the operating member and capable of matching and locking with the first catheter or the second catheter, and an elastic member that allows the matching portion to have a tendency to move toward a state of matching and locking with the first catheter or the second catheter; when the operating component is in a locked state, the matching portion matches and locks with the first catheter or the second catheter; when the operating component is in an unlocked state, the matching portion is separated from the first catheter or the second catheter.

[0035] Furthermore, the operating component also includes a slide rail fixedly arranged on the inner wall of the handle, a slider connected to one end of the elastic member and capable of sliding in cooperation with the slide rail, and the other end of the elastic member is connected to the matching portion, so that when the operating member slides relative to the handle, the elastic member can slide smoothly along with the operating member.

[0036] According to a specific and preferred embodiment, the stirring device also includes a plurality of first ultrasonic generators fixedly arranged on the silk thread, a first power line connected to the first ultrasonic generator, and a first ultrasonic connector arranged on the operating device and capable of supplying power to the first power line; the silk thread has an internal cavity, the second catheter also has an internal cavity, and the first power line is located in the internal cavity of the silk thread and the internal cavity of the second catheter; the stirring device also includes a conductive ring fixedly arranged at the proximal end of the first power line; the first catheter includes a flexible tube section, a metal tube whose distal end is fixedly connected to the proximal end of the flexible tube section, and an insulating layer sleeved on a portion of the metal tube; the material of the matching part is an inductive material, the first ultrasonic connector is connected to the matching part, within the effective stroke of relative movement of the first catheter and the second catheter, the conductive ring is in contact with the metal tube of the first catheter, and the matching part can be in contact with the metal tube of the first catheter; when the matching part is in contact with the metal tube of the first catheter, the first ultrasonic connector can supply power to the first ultrasonic generator.

[0037] Specifically, the driving device includes a motor connected to the first conduit or the second conduit, and a power source capable of supplying power to the motor, wherein the power source may be a dry cell battery or a power cord capable of being connected to an external power source.

[0038] Preferably, the first catheter is sleeved on the filter rod, and the outer diameter of the filter rod is 0.1-1 mm, so that the filter rod can be used as a guide wire to facilitate guiding other components required for removing thrombus into the required part of the blood vessel.

[0039] Preferably, an injection hole for injecting thrombolytic drugs is formed at the proximal end of the first catheter, and a plurality of thrombolytic holes for the thrombolytic drugs to enter the blood vessels are formed at the distal end of the first catheter and / or the agitator.

[0040] Preferably, the filter screen is in the shape of a basket or a net bag with its opening facing the proximal end, or the filter screen is in the shape of a shuttle.

[0041] Preferably, the suction catheter includes a catheter portion having the suction channel, an operating portion movably connected to the proximal end of the catheter portion, a fixing member fixedly arranged on the catheter portion, and a connecting member respectively connected to the operating portion and the fixing member and capable of bending the distal end of the catheter portion by operating the operating portion.

[0042] In the present invention, the axis center line of the connecting member is parallel to the axis center line of the conduit portion and does not overlap.

[0043] The present invention enables medical personnel to operate the operating part so that the movement of the operating part drives the movement of the connecting part, and the connecting part further pulls the fixing part to bend the catheter part, thereby causing an angular offset between the distal end of the catheter part and the proximal end of the catheter part, thereby facilitating the adjustment of the angle of the suction catheter head according to clinical needs, for example, facilitating insertion into a bifurcated blood vessel, etc.

[0044] In the present invention, the fixing member and the conduit portion can be fixedly connected by means of heat melting or welding, and the connecting member and the fixing member can be fixedly connected by means of knotting, heat melting or welding.

[0045] In the present invention, the operating part and the catheter part can be connected by sliding or rotating. However, when the operating part is connected by sliding, it needs to move a certain distance in the axial direction of the suction catheter, which is not convenient for medical staff to operate and will also increase the volume of the suction catheter. Therefore, preferably, the operating part is rotationally connected to the catheter part, and the proximal end of the connecting piece is wrapped around the operating part, so that the length of the connecting piece between the operating part and the fixing piece can be extended or shortened by rotating the operating part in the forward or reverse direction, thereby achieving bending of the distal end of the catheter part.

[0046] According to one embodiment, the connecting member has a proximal end and a distal end, wherein the distal end is fixed on the fixing member and the proximal end is wrapped around the operating part. At this time, the connecting member and the fixing member have only one connection point. Therefore, when the operating part is rotated, the catheter part can only be bent in one direction.

[0047] According to another embodiment, the connecting piece has two distal end portions located at the distal end and a proximal end portion, the two distal end portions are respectively arranged on opposite sides of the catheter portion, and the proximal end is wrapped around the operating portion; when the operating portion rotates in one direction, the connecting piece on one side is extended, and the connecting piece on the other side is shortened accordingly, and the lengths of the extension and shortening are the same, and at this time the front end of the catheter portion is bent to one side; when the operating portion rotates in the other direction, the originally extended connecting piece is shortened, and the originally shortened connecting piece is extended, and at this time the front end of the catheter portion is bent to the other side. Under this scheme, the catheter portion can achieve bidirectional bending.

[0048] According to another embodiment, the operating part includes a first operating part movably connected to the proximal end of the catheter part, and a second operating part movably connected to the proximal end of the catheter part, and the connecting member includes a first connecting member wrapped around the first operating part and a second connecting member wrapped around the second operating part; the first connecting member and the second connecting member respectively have two distal end portions located at the distal end and a portion located at the proximal end, the two distal end portions of the first connecting member are respectively arranged on opposite sides of the catheter part, and the proximal end of the first connecting member is wrapped around the first operating part; the two distal end portions of the second connecting member are respectively arranged on opposite sides of the catheter part, and the proximal end of the second connecting member is wrapped around the second operating part; and the two distal ends of the first connecting member and the two distal ends of the second connecting member are evenly distributed along the circumference of the catheter part; when the first operating part and the second operating part are operated, the front end of the catheter part can be directionally rotated in three-dimensional space, that is, the head end of the catheter part can achieve 360° rotation.

[0049] Preferably, the suction catheter also includes a dilatation catheter connected to the distal end of the catheter portion and having an open state and a retracted state. When the dilatation catheter is in the retracted state, the dilatation catheter is located inside the catheter portion; when the dilatation catheter is in the open state, the diameter of the distal end of the dilatation catheter is greater than the diameter of the catheter portion.

[0050] Further preferably, the dilatation catheter comprises a soft membrane material whose proximal end is fixedly connected to the distal end of the catheter portion, and an expansion ring fixedly connected to the distal end of the soft membrane material.

[0051] More preferably, the expansion ring is a memory material or an air bag; when a memory material is used, it can be a self-expanding memory material or a memory material that needs to be expanded by an expander; when an air bag is used, the medical interventional catheter also includes a channel for inflating and deflating the air bag.

[0052] In the present invention, when the operating part is operated unidirectionally, the front end of the catheter part can be directional bent by 0 to 180°, preferably by 0 to 90°, and more preferably by 0 to 30°.

[0053] Preferably, the connecting piece is a metal wire, such as 304 stainless steel wire, nickel-titanium alloy wire, etc.

[0054] Preferably, the fixing member is a developing ring. By using the developing ring as the fixing member, a fixed connection between the connecting member and the conduit portion is achieved and the position of the suction conduit can be easily understood by the operator.

[0055] Preferably, the catheter portion includes a first tube portion located at the proximal end, a second tube portion located at the distal end, and a third tube portion located between the first tube portion and the second tube portion. The hardness of the third tube portion is less than that of the first tube portion and the second tube portion. The distal end of the connecting piece is located at the third tube portion, so that when the operating portion is operated, the connecting piece can well drive the second tube portion to bend.

[0056] Further preferably, the conduit portion includes a first wall layer located on the inner side, a second wall layer located on the outer side, and a support member arranged between the first wall layer and the second wall layer, and the support member includes a plurality of repeating bodies continuously arranged along the axial direction of the conduit portion, wherein the spacing between two adjacent repeating bodies of the first tube portion and the spacing between two adjacent repeating bodies of the second tube portion are smaller than the spacing between two adjacent repeating bodies of the third tube portion, so that the hardness of the third tube portion is smaller than the hardness of the first tube portion and the second tube portion.

[0057] Preferably, the suction catheter also includes a second ultrasonic generator arranged at the distal end of the suction catheter, a second power line and a signal transmission line connected to the second ultrasonic generator and arranged in the tube wall of the suction catheter, and a second ultrasonic connector arranged at the proximal end of the suction catheter and connected to the second power line and the signal transmission line.

[0058] Preferably, the thrombus treatment platform also includes a sheath that can pass through the suction channel and whose distal end extends to the proximal end of the filter, and the proximal end of the sheath is connected to a suction pump, wherein the suction pump and the suction pump connected to the suction catheter can be the same or two different ones.

[0059] Further preferably, the sheath comprises a first channel capable of allowing a guide wire to pass through, and a second channel capable of allowing a thrombus to pass through or capable of accommodating the filter.

[0060] When the present invention is in use, by arranging the filter assembly downstream of the blood flow, it is possible to prevent the thrombus from flowing into other parts along the blood flow; and by introducing thrombolytic drugs, the stirring device 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 stirs the thrombus in the blood vessel, or the stirrer is driven to rotate by a driving device to break up the thrombus, or ultrasonic turbulence is used to achieve the thrombus falling off the blood vessel wall, the thrombus breaking up and the thrombus capturing; and the thrombus is sucked out by the suction catheter, so a large amount of deep vein thrombosis and old thrombus can be quickly removed, and at the same time, the blood vessel wall and venous valves are not damaged, thereby reducing the sequelae of thrombectomy.

[0061] The proximal end in this article is defined as the side close to the medical staff when the thrombus management platform is in use; the distal end is defined as the side away from the medical staff when the thrombus management platform is in use.

[0062] The aspiration catheter of the present invention can not only have the thrombus removal function itself, but also provide a passage for other thrombus removal devices, thereby facilitating doctors to select surgical plans for different thrombi, thereby making the thrombus treatment platform of the present invention have a wide range of indications.

[0063] Of course, for some thrombotic diseases that can be treated only by suction through a suction catheter, medical personnel can only use the suction catheter of the present invention without using a stirring device and a filter assembly.

[0064] In the present invention, the suction catheter, the filter assembly, the stirring device, the sheath tube, the driving device, and the suction pump are separately packaged, and each independently packaged component can be sold as a whole or sold separately, so as to facilitate selective use by medical staff. Of course, the suction catheter, the filter assembly, the stirring device, the sheath tube, the driving device, and the suction pump can also be put in one package and sold as a whole.

[0065] According to one embodiment, the thrombus treatment platform further includes a guide wire. This product can be sold together with a guide wire, or a guide wire from another manufacturer can be used.

[0066] Due to the implementation of the above technical solution, the present invention has the following advantages compared with the prior art:

[0067] The present invention can remove blood clots while ensuring relative safety, and is particularly suitable for removing a large amount of blood clots in the inferior vena cava, protecting venous valves and venous vessel walls, and the amount of blood loss can be controlled. The operation steps are simple, the operation time is shortened, and the hospitalization expenses of patients are reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Attached Figure 1 It is a schematic diagram of the structure of the suction catheter of Example 1 and Example 2;

[0069] Attached Figure 2 is a partial cross-sectional schematic diagram of the suction catheter of Example 1;

[0070] Attached Figure 3 For attachment Figure 2 A partial enlarged view of

[0071] Attached Figure 4 Schematic diagram of the suction catheter of Example 1 at 0° and 30° bends;

[0072] Attached Figure 5 is a partial cross-sectional schematic diagram of the suction catheter of Example 2;

[0073] Attached Figure 6 For attachment Figure 5 A partial enlarged view of

[0074] Attached Figure 7 For attachment Figure 5 Schematic diagram of the transverse section;

[0075] Attached Figure 8 is a schematic diagram of the suction catheter of Example 2 under a ±30° bend;

[0076] Attached Fig. 9 is a schematic structural diagram of the suction catheter of Example 3;

[0077] Attached Fig.10 is a partial cross-sectional schematic diagram of the suction catheter of Example 3;

[0078] Attached Fig.11 For attachment Fig.10 A partial enlarged view of

[0079] Attached Fig.12 For attachment Fig.10 Schematic diagram of the transverse section;

[0080] Attached Fig.13 Schematic diagram of the suction catheter of Example 3 bent at ±30° in a plane;

[0081] Attached Fig.14 It is a schematic diagram of the structure of a filter assembly of a basket type filter;

[0082] Attached Fig.15 It is a schematic diagram of the structure of the filter assembly of the shuttle type filter;

[0083] Attached Fig.16 It is a schematic diagram of the structure of the filter assembly of the net bag type filter;

[0084] Attached Fig.17 is a schematic structural diagram of the stirring device of Example 5 when it is in a retracted state;

[0085] Attached Fig.18 is a schematic structural diagram of the stirring device of Example 5 when it is in an open state;

[0086] Attached Fig.19 For attachment Fig.18 A magnified image of point A;

[0087] Attached Fig. 20 is a schematic structural diagram of the stirring device of Example 6 when it is in a retracted state;

[0088] Attached Fig.21 This is a schematic diagram of the structure of the stirring device of Example 6 when it is in an open state;

[0089] Attached Fig. 22 for Fig.21 AA section view;

[0090] Attached Fig.23 for Fig.21 A magnified view of point B;

[0091] Attached Fig.24 for Fig.23 CC profile of ;

[0092] Attached Fig.25 A partial cross-sectional view of the stirring assembly with the operating assembly in a locked state and the stirrer in a retracted state (the stirring device does not include an ultrasonic function);

[0093] Attached Fig.26 A partial cross-sectional view of the stirring assembly with the operating assembly in a locked state and the stirrer in an open state (the stirring device does not include an ultrasonic function);

[0094] Attached Fig. 27 It is a structural schematic diagram in which the operating component is in an unlocked state and the locking component is in a locked state (the stirring device does not include an ultrasonic function);

[0095] Attached Fig.28 It is a schematic diagram of the structure of the suction catheter of Example 4 (the dilation catheter is in a retracted state);

[0096] Attached Fig.29 is a cross-sectional view of the dilatation catheter of Example 4 in a collapsed state;

[0097] Attached Fig.30 It is a schematic diagram of the structure of the suction in Example 4 (the dilatation catheter is in an open state);

[0098] Attached Fig.31 A cross-sectional view of the dilatation catheter of Example 4 in an open state;

[0099] Attached Fig.32 is a schematic diagram of the structure of the expander;

[0100] Attached Fig.33 is a schematic diagram of the structure of the sheath;

[0101] Attached Fig.34 For attachment Fig.33 AA section view;

[0102] Attached Fig.35 A state diagram of the sheath tube when delivering the filter assembly;

[0103] Attached Fig.36 For attachment Fig.35 AA section view;

[0104] Attached Fig.37This is a state diagram of the suction catheter (excluding the ultrasonic generator) and the filter assembly when they are in coordination;

[0105] Attached Fig.38 This is a state diagram of the suction catheter (including the ultrasonic generator) and the filter assembly when they are in coordination;

[0106] Attached Fig.39 The figure is a state diagram of the suction duct (including the ultrasonic generator), the stirring device (excluding the ultrasonic generator) and the filter assembly when they are in coordination;

[0107] Attached Fig.40 The figure is a state diagram of the suction duct (excluding the ultrasonic generator), the stirring device (excluding the ultrasonic generator) and the filter assembly when they are in coordination;

[0108] Attached Fig.41 This is a state diagram of the suction conduit (without the ultrasonic generator), the stirring device (including the ultrasonic generator) and the filter assembly when they are in coordination (the driving device is omitted and not shown);

[0109] Attached Fig.42 It is a state diagram of the suction catheter (including the dilation catheter), the stirring device (including the ultrasonic generator) and the filter assembly when they are in coordination (the driving device is omitted and not shown);

[0110] Attached Fig.43 This is a state diagram of the suction conduit (including the ultrasonic generator), the stirring device (including the ultrasonic generator) and the filter assembly when they are in coordination (the driving device is omitted and not shown);

[0111] Attached Fig.44 This is a state diagram of the suction catheter (excluding the ultrasonic generator), the sheath tube and the filter assembly when they are in coordination;

[0112] Attached Fig.45 This is a state diagram of the suction catheter (including the dilation catheter), the sheath tube and the filter assembly when they are in coordination;

[0113] Attached Fig.46 This is a state diagram of the suction catheter (including ultrasonic generator), sheath tube and filter assembly when they are in coordination;

[0114] Attached Fig.47 It is a partial cross-sectional view of the stirring component (the stirring device includes ultrasonic function) with the operating component in a locked state;

[0115] Attached Fig.48 It is a partial cross-sectional view of the stirring component (the stirring device includes ultrasonic function) with the operating component in a locked state;

[0116] Attached Fig.49 for Fig.47 and 48 Enlarged view of point A. DETAILED DESCRIPTION

[0117] The present invention is further described in detail below in conjunction with specific examples. It should be understood that these examples 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 examples.

[0118] The thrombus treatment platform of the present invention comprises a suction catheter 10 having a suction channel, a suction pump 19, a stirring device, a filter assembly, and the like.

[0119] Attached Figures 1 to 13 Schematic diagram of the structure of the suction catheter 10 of embodiments 1 to 3, Figures 28 to 31 Schematic diagram of the structure of the suction catheter 10 of Example 4. The suction catheter 10 comprises a catheter portion having a suction channel, the suction channel extending along the axial direction of the catheter portion and penetrating the catheter portion, and the outer diameter of the catheter portion is 12 to 14 French.

[0120] The catheter portion includes a first wall layer 11 located on the inner side, a second wall layer 12 located on the outer side, and a support member 13 arranged between the first wall layer 11 and the second wall layer 12. The support member 13 includes a plurality of repeating bodies continuously arranged along the axial direction of the catheter portion, wherein the spacing between the repeating bodies of the support member 13 changes from the proximal end to the distal end, so that the catheter portion is composed of a first tube portion 1 located at the proximal end, a second tube portion 2 located at the distal end, and a third tube portion 3 located between the first tube portion 1 and the second tube portion 2, and the spacing between two adjacent repeating bodies at the position of the first tube portion 1 and the spacing between two adjacent repeating bodies at the position of the second tube portion 2 is smaller than the spacing between two adjacent repeating bodies at the position of the third tube portion 3, so that the hardness of the third tube portion 3 is smaller than the hardness of the first tube portion 1 and the second tube portion 2, thereby better realizing the bending of the second tube portion 2 relative to the first tube portion 1.

[0121] The support member 13 composed of multiple repeating bodies can be a spiral shape similar to a spring, or can be a structure similar to an accordion. When the support member 13 is a spiral shape, the spacing between the repeating bodies is the pitch. When the support member 13 is an accordion structure, the spacing between the repeating bodies is the distance between two adjacent wave peaks. In this embodiment, the support member 13 is preferably a spiral shape.

[0122] As for the bending angle of the second tube portion 2 relative to the first tube portion 1, it can be achieved by adjusting the spacing between the repeating bodies and the material of the conduit portion. In this embodiment, the material of the support member 13 is metal, such as 304 stainless steel, nickel-titanium alloy wire, etc.; the material of the first wall layer 11 and the second wall layer 12 is polytetrafluoroethylene (PTFE), segmented polyetheramide (Pcbax), polyimide (PI), polyamide (PA), polyethylene (PE), metal film, etc. Preferably, the first wall layer 11 adopts polytetrafluoroethylene (PTFE) with better lubricity, and the second wall layer 12 adopts segmented polyetheramide (Pcbax) metal film, etc., and the second wall layer 12 of the first tube portion 1, the second tube portion 2, and the third tube portion 3 can be spliced ​​with different materials.

[0123] The suction catheter 10 also includes a fixing member 15 fixedly arranged at the distal end of the third tube portion 3 of the catheter portion. The fixing member 15 of this embodiment is a developing ring. For the solutions of embodiments 1 to 3, the developing ring is fixed between the first wall layer 11 and the second wall layer 12 by heat melting or welding.

[0124] The suction catheter 10 further includes a connector 14 fixedly connected to the fixing member 15 at the distal end, and an operating portion 4 rotatably connected to the proximal end of the catheter portion. The connector 14 is located between the first wall layer 11 and the second wall layer 12 and extends along the axial direction of the catheter portion, so that the axis of the connector 14 is parallel to and does not overlap with the axis of the catheter portion, thereby enabling the connector 14 to drive the second tube portion 2 to bend.

[0125] The suction catheter 10 also includes a second ultrasonic generator 5 arranged at the distal end of the catheter portion (i.e., the distal end of the second tube portion 2), a second power line 16 and a second signal transmission line 17 connected to the second ultrasonic generator 5 and arranged in the tube wall of the catheter portion (i.e., between the first wall layer 11 and the second wall layer 12), and a second ultrasonic connector 6 arranged at the proximal end of the catheter portion and connected to the second power line 16 and the second signal transmission line 17, and the second ultrasonic connector 6 can be connected to other equipment.

[0126] like Figures 1 to 4 The embodiment 1 is shown, in which the connecting member 14 is only a steel wire, and the distal end of the connecting member 14 is fixedly connected to the developing ring, and the proximal end is wound around the operating part 4. At this time, the connecting member 14 and the developing ring have only one connection point. Therefore, when the operating part 4 is rotated, the catheter part can only be bent in one direction, and the bending angle range is 0 to 90 degrees. Figure 4 The angle ranges shown in are 0° and 30°.

[0127] like Figure 1 , 58 show Example 2, in which the connecting member 14 is also a steel wire, but the two ends of the connecting member 14 (i.e., the distal end of the connecting member 14) are fixedly connected to the opposite sides of the fixing member 15, respectively, and the middle position of the connecting member 14 is wound around the operating part 4, so that the connecting member 14 is divided into two parts by the operating part 4, which are described here as the upper part and the lower part. For example, when the operating part 4 rotates clockwise, the upper connecting member 14 is elongated, and the lower connecting member 14 is shortened accordingly, and the second tube part 2 of the catheter part is rotated downward by a certain angle; when the operating part 4 rotates counterclockwise, the upper connecting member 14 is shortened, and the lower connecting member 14 is elongated accordingly, and the second tube part 2 of the catheter part is rotated upward by a certain angle. The description here is based on the second tube part 2 being located on the same straight line as the first tube part 1 and the third tube part 3, that is, the bending angle of the second tube part 2 is 0° as the starting position. Therefore, the catheter part of Example 2 can achieve bidirectional bending, and both directions can be bent within the range of 0 to 90°. Figure 8 The angle range shown in is 0° and ±30°.

[0128] like Figures 9 to 13 The third embodiment is shown, wherein the operating part includes a first operating part 41 movably connected to the proximal end of the catheter part, and a second operating part 42 movably connected to the proximal end of the catheter part, and the connecting member includes a first connecting member 21 wound around the first operating part 41, and a second connecting member 22 wound around the second operating part 42, and the two distal ends of the first connecting member 21 are respectively arranged on opposite sides of the fixing member 15, and the two distal ends of the second connecting member 22 are respectively arranged on opposite sides of the fixing member 15, and the two distal ends of the first connecting member 21 and the two distal ends of the second connecting member 22 are evenly distributed along the circumference of the fixing member 15, so that the head end of the catheter part can achieve 360° rotation by simultaneously operating the first operating part 41 and the second operating part 42. That is, the scheme of the third embodiment is equivalent to adding a set of operating parts and connecting members on the basis of the scheme of the second embodiment.

[0129] The operating part 4 of embodiments 1 to 3 can be arranged at the proximal end of the catheter part, or at the proximal side of the catheter part, preferably at the proximal side of the catheter part, so that the hemostatic valve 7 can be easily arranged at the proximal end of the catheter part. For embodiment 3, the first operating part 41 and the second operating part 42 are located on both sides of the catheter part, so that the layout of the handle 54 of the suction catheter 10 is more reasonable.

[0130] Attached Figures 28 to 31 The schematic diagram of the structure of the suction catheter 10 of Example 4 is shown. Its structure is that a dilation catheter is added on the basis of Examples 1 to 3. The specific structure is as follows:

[0131] The suction catheter 10 also includes a dilatation catheter connected to the distal end of the catheter portion and having an open state and a retracted state. When the dilatation catheter is in the retracted state, the dilatation catheter is located in the catheter portion; when the dilatation catheter is in the open state, the diameter of the distal end of the dilatation catheter is greater than the diameter of the catheter portion. The dilatation catheter includes a soft membrane material 71 whose proximal end is fixedly connected to the distal end of the catheter portion, and an expansion ring 72 fixedly connected to the distal end of the soft membrane material 71. The expansion ring 72 can be a memory material or a balloon that can keep the distal end of the dilatation catheter open; when a memory material is used, it can be a self-expanding memory material or a memory material that needs to be expanded by a dilator. The memory material can be a nickel-titanium material, etc. At this time, the material of the soft membrane material 71 is PTFE or ePTFE; when an airbag is used, the suction catheter 10 also includes a channel for inflating and deflating the airbag, and at this time, the soft membrane material 71 can be a latex elastic polymer material with biocompatibility. When using the aspiration catheter 10 with a dilation catheter at the distal end, the outer diameter of the catheter portion can be 12F; and the outer diameter of the dilation catheter after expansion can reach 14F, which makes the aspiration catheter 10 more convenient to insert and withdraw from the human body and can adapt to more blood vessels.

[0132] The structure of the catheter part of the suction catheter 10 can refer to the structure of the catheter part of Example 1, wherein the first wall layer 11 and the second wall layer 12 can slide relative to each other, and the proximal end of the soft membrane material 71 of the dilatation catheter is fixedly connected to the distal end of the first wall layer 11 and the distal end of the second wall layer 12, respectively, so that when the dilatation catheter needs to be opened, the dilatation catheter can be pushed out of the catheter part by moving the first wall layer 11 toward the distal end, and when the dilatation catheter needs to be retracted, the dilatation catheter can be retracted into the catheter part by moving the first wall layer 11 toward the proximal end. Among them, the first wall layer 11 and the second wall layer 12 need to have good flexibility and anti-folding ability, and the material of the first wall layer 11 and the second wall layer 12 is preferably a soft material membrane such as ePTFE, PTFE, etc. The structure of the support member 13 and the like is the same as that of Examples 1 to 3.

[0133] Since the first wall layer 11 and the second wall layer 12 of this embodiment can slide relative to each other, the fixing member 15 is preferably fixed on the second wall layer 12 .

[0134] In this embodiment, the suction catheter 10 also includes a handle 73 fixedly connected to the first wall layer 11, and the handle 73 is rotatably connected to the second wall layer 12, so that the first wall layer 11 can be driven to rotate relative to the second wall layer 12 and move in the axial direction by rotating the handle 73, so that the expansion catheter can be pushed out and retracted. The hemostatic valve 7, the first operating part 41, and the second operating part 41 are installed on the handle 73, and the three-way valve 8 is installed on the handle 73 and is connected to the internal volume of the first wall layer 11.

[0135] The present invention can accurately control the bending direction and bending angle of the front end of the catheter portion by rotating the operating portion 4. For example, the diameter of the operating portion 4 can be adjusted by calculation, so that the front end of the catheter portion can be bent at a certain angle, such as 1°, 2°, 3°, etc., every time the operating portion 4 is rotated one circle. Of course, in order to avoid excessive workload for medical staff, the bending angle of the catheter portion caused by each rotation of the operating portion 4 can be set to 5°, etc.

[0136] The suction catheter 10 of the present invention also includes a three-way valve 8 connected to the proximal end of the catheter part. Medical staff can introduce physiological saline, thrombolytic agents, etc. into the catheter part through the three-way valve 8, and can also connect the suction pump 19 through the three-way valve 8 to suction thrombus.

[0137] In the present invention, the operator operates the operating part 4 so that the operating part 4 moves to drive the connecting piece 14 to move. The connecting piece 14 further pulls the catheter wall to bend the catheter portion, thereby causing an angular offset between the distal end of the catheter portion and the proximal end of the catheter portion. This makes it easier to adjust the angle of the head of the suction catheter 10 according to clinical needs. For example, the suction catheter 10 can be used to enter a blood vessel. By adjusting the angle of the head end, it can be more convenient to insert into a bifurcated blood vessel, etc.

[0138] like Figures 14 to 16 There are three filter screen assemblies with different structures, and the three filter screen assemblies can be used in conjunction with the suction catheters 10 of the above four embodiments.

[0139] The filter assembly includes a filter rod 31 and a filter 32 fixedly mounted at the distal end of the filter rod 31 and having an open state and a closed state. Fig.14 The filter screen 32 shown is in the shape of a basket with its opening facing the proximal end. Fig.15 The filter screen 32 shown is in the shape of a shuttle. Fig.16 The filter screen 32 shown is in the shape of a net bag with its opening facing the proximal end.

[0140] The outer diameter of the filter rod 31 is 0.1-1 mm, preferably 0.035 in, so that the filter rod 31 can be used as a guide wire to facilitate other components to enter the desired position along the filter rod 31.

[0141] like Fig.33 and 34 3 is a schematic diagram of the structure of the sheath 18 , wherein the sheath 18 includes a first channel 181 for allowing the guide wire to pass through and a second channel 182 that can allow thrombus to pass through or can accommodate the filter 32 .

[0142] The filter assembly can enter the blood vessel and extend to the distal end of the thrombus by conventional methods of the prior art, for example, by loading the filter assembly in the sheath 18, and then advancing the sheath 18 along the guide wire into the desired position. The filter 32 can be loaded in the sheath 18 when in the retracted state, and in the open state, the outer diameter of the filter 32 (i.e., the maximum spacing of the cross section of the filter 32 after the filter 32 is expanded) is greater than or equal to the inner diameter of the blood vessel, so that the filter 32 can well filter the thrombus passing through the filter 32 and prevent the thrombus from flowing to other parts.

[0143] like Figures 17 to 24 Schematic diagram of the structure of the stirring device of Example 5 and Example 6.

[0144] The stirring device includes a first catheter 51, a second catheter 52 slidably sleeved outside the first catheter 51, a stirrer 53 disposed at the distal end of the first catheter 51 and having an open state and a retracted state, and an operating device disposed between the first catheter 51 and the second catheter 52 and capable of making the first catheter 51 and the second catheter 52 slide relative to each other so as to switch the stirrer 53 between the open state and the retracted state. The thrombus treatment platform also includes a driving device connected to the first catheter 51 or the second catheter 52 and capable of driving the stirrer 53 to rotate.

[0145] The driving device includes a motor 20 connected to the first conduit 51 or the second conduit 52 and a power source capable of supplying power to the motor 20 , wherein the power source may be a dry cell or a power cord capable of being connected to an external power source.

[0146] The agitator 53 is a mesh basket woven from a plurality of wires 56, and the two ends of each wire 56 are respectively located at the proximal end and the distal end of the first catheter 51, that is, the axial direction of each wire 56 is roughly extended along the axial direction of the first catheter 51, but at least part of the wires 56 rotate around the first catheter 51 at a certain angle and at least part of the wires 56 intersect, wherein the specific angle can be set according to the density and size of the mesh basket to be woven. The wire 56 is made of nickel-titanium alloy, stainless steel wire, high molecular polymer, etc. When the agitator 53 is in a retracted state, the outer diameter of the agitator 53 is ≤6F, and further preferably, the outer diameter of the agitator 53 is ≤5.5F, and more preferably ≤5F.

[0147] The expansion degree of the agitator 53 can be controlled by the second catheter 52, so that medical staff can control the distance and fit degree between the agitator 53 and the blood vessel wall according to actual needs, which is more convenient for use; and the agitator 53 of the present invention is woven with silk thread 56, and when it is in the retracted state, the outer diameter is very small, so that the size of the second catheter 52 can be reduced, leaving more space for the suction channel, and improving the efficiency of thrombus extraction.

[0148] As attached Figures 17 to 19is an implementation of the stirring device of Example 5, wherein the distal end of the first conduit 51 extends out of the second conduit 52; the distal end of each wire 56 is fixedly connected to the first conduit 51, and the proximal end is fixedly connected to the second conduit 52; when the first conduit 51 moves toward the proximal end relative to the second conduit 52, the stirrer 53 is turned on, and as the moving distance of the first conduit 51 increases, the degree of expansion of the stirrer 53 increases, and the outer diameter of the stirrer 53 increases, such as Fig.18 When the first catheter 51 moves toward the distal end relative to the second catheter 52 until the wire 56 is straightened, the agitator 53 is in a retracted state, at which time the outer diameter of the agitator 53 is the smallest and is substantially attached to the first catheter 51, as shown in FIG. Fig.17 In the above-mentioned embodiment 5, the structure of the operating device is as follows Figures 25 to 27 As shown, the operating device includes a handle 54 sleeved on the first catheter 51 and the second catheter 52, a locking component disposed between the first catheter 51 and the second catheter 52 and capable of locking the two relative to each other, and an operating component slidably connected to the handle 54 and capable of locking in cooperation with the first catheter 51. The first catheter 51 passes through the handle 54 and extends from the front end of the handle 54.

[0149] The locking assembly includes a first locking member 60, a second locking member 61, a third locking member 62, and the like.

[0150] The first locking member 60 is fixedly connected to the distal end of the second conduit 52, wherein the first locking member 60 and the second conduit 52 can be fixedly connected by heat melting, welding, etc., or can be integrally formed by extrusion or injection molding. An external thread is formed on the outer surface of the first locking member 60.

[0151] The distal end of the handle 54 is provided with a receiving groove capable of accommodating the second locking member 61. The second locking member 61 can rotate in the receiving groove. A plurality of ridges are formed on the outer surface of the second locking member 61. The ridges can increase the friction force of the outer surface of the second locking member 61, thereby facilitating the rotation of the second locking member 61 to achieve locking and unlocking of the locking assembly. The second locking member 61 is sleeved on the first conduit 51 and can rotate around the first conduit 51. A groove is formed on the second locking member 61, and an internal thread is formed on the groove wall of the groove.

[0152] The first locking piece 60 is inserted into the groove of the second locking piece 61, and the first locking piece 60 and the second locking piece 61 are rotatably connected through internal threads and external threads so that the distance between the proximal end of the first locking piece 60 and the bottom of the groove can be adjusted, and a cavity is formed between the proximal end of the first locking piece 60 and the bottom of the groove, and the third locking piece 62 is located in the cavity.

[0153] The third locking member 62 is made of a material that can undergo elastic deformation, such as silicone.

[0154] When the locking assembly is in the unlocked state, the third locking piece 62 is in a natural state. At this time, although the third locking piece 62 is still in contact with the first locking piece 60, the second locking piece 61 and the first conduit 51, the degree of fit is not high. At this time, when an external force greater than the friction force between the third locking piece 62 and the first conduit 51 is applied to the first conduit 51, the first conduit 51 and the second conduit 52 can slide relative to each other.

[0155] When the locking assembly needs to be locked, the second locking piece 61 is rotated to move the second locking piece 61 toward the distal end, thereby reducing the size of the cavity between the first locking piece 60 and the second locking piece 61. At this time, the third locking piece 62 is squeezed and elastically deformed, thereby making the third locking piece 62 and the first locking piece 60, the second locking piece 61 and the first catheter 51 fit more closely. At this time, the friction between the third locking piece 62 and the first catheter 51 is greatly increased, and the relative positions of the first catheter 51 and the second catheter 52 are locked. When the motor 20 drives the first catheter 51 to rotate around its own axis, the second catheter 52 will rotate with the first catheter 51, thereby realizing the rotation of the agitator 53 around its own axis to break up the blood clot.

[0156] In order to ensure that the locking assembly has a good sealing effect and can function as a hemostatic valve while having the function of relatively locking the first catheter 51 and the second catheter 52, the locking assembly also includes a gasket 63 arranged between the third locking piece 62 and the first locking piece 60.

[0157] The operating assembly includes a slide groove 57 provided on the handle 54 and extending in the proximal-distal direction, an operating member 55 inserted in the slide groove 57 and slidably connected to the handle 54, a matching portion 64 formed on the operating member 55 and capable of matching and locking with the first catheter 51, a slide rail 65 fixedly provided on the inner wall of the handle 54, a slider 66 capable of sliding in cooperation with the slide rail 65, and an elastic member 67 whose two ends are respectively provided at the bottom of the matching portion 64 and the upper surface of the slider 66. The elastic member 67 is a spring, and the number of the elastic members 67 is two provided along the axial direction of the handle 54.

[0158] When the operating component is in a locked state, the upper surface of the matching portion 64 and the lower surface of the first conduit 51 are tightly matched and relatively locked under the elastic force of the elastic member 67, and when the locking component is in an unlocked state, by sliding the operating member 55 toward the proximal end, the first conduit 51 can be driven to slide toward the proximal end to open the agitator 53; otherwise, the agitator 53 can be retracted.

[0159] When the motor 20 is required to drive the agitator 53 to rotate, the second locking member 61 is rotated to lock the locking assembly, and the operating member 55 is pressed downward to overcome the elastic force of the elastic member 67, so that the matching portion 64 is disengaged from the first conduit 51 and the operating assembly is in an unlocked state. At this time, the motor 20 is started to drive the first conduit 51 to rotate, so that the agitator 53 can be rotated.

[0160] like Figures 20 to 24 The stirring device of Example 6 has the function of emitting ultrasonic waves to break up blood clots, wherein the stirring device further comprises a plurality of first ultrasonic generators 81 fixedly arranged on the thread 56, a first power line 82 connected to the first ultrasonic generator 81, and a first ultrasonic connector 84 arranged on the operating device and capable of supplying power to the first power line 82. In this embodiment, the thread 56 has an internal cavity, and the first catheter 51 or the second catheter 52 also has an internal cavity. The first power line 82 passes through the internal cavity of the thread 56 and the internal cavity of the first catheter 51 or the second catheter 52 to connect the first ultrasonic generator 81 and the first ultrasonic connector 84. For the scheme in which both ends of the thread 56 are fixed on the first catheter 51, the first power line 82 is passed through the tube wall of the first catheter 51; for the scheme in which the distal end of the thread 56 is fixed on the first catheter 51 and the proximal end is fixed on the second catheter 52, the first power line 82 is passed through the tube wall of the second catheter 52.

[0161] In this embodiment, the diameter of the first ultrasonic generator 81 is 0.2-0.4 mm, preferably 0.3 mm, the outer diameter of the wire 56 is 0.2-0.3 mm, preferably 0.25 mm, and the inner diameter of the wire 56 is 0.1-0.2 mm, preferably 0.15 mm.

[0162] The first ultrasonic generator 81 is fixed to the wire 56 by welding.

[0163] The structure of the operating device of this embodiment is basically the same as the operating device used in the agitator of Example 5, except that: the first power line 82 is connected to the first ultrasonic connector 84.

[0164] In this scheme, the first power line 82 is located in the internal cavity of the wire 56 and the internal cavity (i.e., the tube wall) of the second catheter 52; the stirring device also includes a conductive ring 91 fixedly arranged at the proximal end of the first power line 82; the conductive ring 91 is fixedly connected to the second catheter 52, and is slidably sleeved on the first catheter 51 and contacts the first catheter 51; the first catheter 51 includes a flexible tube section, a metal tube whose distal end is fixedly connected to the proximal end of the flexible tube section, and an insulating layer sleeved on a portion of the metal tube, and the material of the metal tube is stainless steel, etc.; the material of the matching part 64 is an inductive material, and the first ultrasonic connector 84 is connected to the matching part 64. Within the effective stroke of relative movement between the first catheter 51 and the second catheter 52, the conductive ring 91 contacts the metal tube of the first catheter 51, and the matching part 64 can contact the metal tube of the first catheter 51; when the matching part 64 contacts the metal tube of the first catheter 51, the first ultrasonic connector 84 can supply power to the first ultrasonic generator 81.

[0165] In another embodiment (not shown), the distal ends and proximal ends of the plurality of wires are fixedly arranged on the first conduit, and the opening and closing of the agitator and the degree of expansion of the agitator are determined by how much the agitator is closed in the second conduit. When the agitator is in the closed state, the agitator is completely located in the second conduit; when the agitator is in the open state, at least part of the agitator is separated from the second conduit; when the agitator is completely separated from the second conduit, the agitator is opened to the maximum state. This embodiment can control the diameter of the agitator after closing by controlling the inner diameter of the second conduit.

[0166] In this embodiment, the structure of the operating device can be the same as that of the above-mentioned embodiment. However, since the threads of the agitator are all arranged on the first conduit, when the driving device drives the first conduit to rotate, the second conduit does not need to rotate together. Therefore, the operating device in this embodiment can omit the locking component, while the structure of the operating component can still be retained, and the structure of the operating component will not be repeated here.

[0167] The agitators 53 of the above two embodiments can also be used in conjunction with the suction catheter 10 shown in the above embodiments 1 to 3.

[0168] In the present invention, the stirring component also has the function of introducing thrombolytic drugs, and the specific structure can be as follows: Figures 17 to 19 As shown, the first catheter 51 has a thrombolytic channel extending in the axial direction, the proximal end of the first catheter 51 is provided with an injection hole 58 connected to the thrombolytic channel and used to inject thrombolytic drugs, and the distal end of the first catheter 51 and / or the agitator 53 are formed with a plurality of thrombolytic holes 59 for the thrombolytic drugs to enter the blood vessel, wherein: Fig.19The structure in which the thrombolytic holes 59 are located on the first catheter 51 is shown. The plurality of thrombolytic holes 59 are evenly distributed along the axial direction of the first catheter 51 , and the plurality of thrombolytic holes 59 are located between the proximal end and the distal end of the agitator 53 .

[0169] The steps of performing surgery using this thrombus management platform are as follows:

[0170] 1. First, send the 0.035in guide wire into the designated position;

[0171] 2. Push the 6F sheath 18 loaded with the filter assembly through the 0.035in guide wire to the site where the thrombus has passed, and then withdraw the 6F sheath 18 to open the filter 32. Fig.35 As shown, the 6F sheath 18 is withdrawn;

[0172] 3. Place the expander 9 (structured as Fig.32 As shown in FIG. 1 ), the filter is inserted into the suction catheter 10 and then pushed along the filter rod 31 to a designated position of the human body. Fig.37 or Fig.38 As shown, the dilator is withdrawn;

[0173] 4. Insert the stirring device into the suction catheter 10 along the filter rod 31 and push it to the thrombus site. At this time, the stirrer 53 is located between the distal end of the suction catheter 10 and the filter screen 32. The thrombolysis or the stirrer 53 can be dragged or rotated back and forth according to actual needs. For example, the thrombolytic drug is first injected into the thrombolytic channel of the first catheter 51 from the injection hole 58, and then enters the thrombus from the thrombolytic hole 59 to dissolve the thrombus. After waiting for the thrombolysis to be completed, the operating member 55 is operated to slide toward the proximal end to drive the first catheter 51 to slide toward the proximal end, so that the agitator 53 is opened, and the handle 54 is repeatedly dragged back and forth to break and collect the insoluble thrombus. Then, the operating member 55 is pressed to unlock the operating component and lock the locking component, and the motor 20 is started to drive the first catheter 51, the second catheter 52 and the agitator 53 to rotate together; or the first ultrasonic generator 81 is turned on to generate ultrasonic waves to vibrate the thrombus; at the same time, the suction pump 19 is installed on the three-way valve 8 at the proximal end of the suction catheter 10, and negative pressure is applied to the suction catheter 10 for suction. The suction pump 19 is connected to a recovery bag 23 for collecting thrombus, which can prevent large thrombus from drifting during the dragging process. Figures 39 to 43 As shown;

[0174] 5. After the operation is completed, the stirring device is withdrawn from the body, and the 0.035in guide wire is pushed to the front end of the filter assembly through the suction catheter 10 again. The 6F sheath 18 is inserted into the suction catheter 10 along the 0.035in guide wire and pushed to the front end of the filter assembly. The suction pump 19 is connected to the three-way valve 8 of the 6F sheath 18, and negative pressure is applied to the 6F sheath 18 to suck the broken small thrombi intercepted in the filter 32. The suction pump 19 is connected to a recovery bag 23 for collecting thrombi. The suction negative pressure should not exceed 0.02Mpa to minimize the impact on red blood cell deformability and reduce the occurrence of hemolysis. Fig.45 or as shown in 46;

[0175] 6. After the suction is completed, the 6F sheath 18 and the 0.035in guide wire are withdrawn from the body, and then the suction pump 19 is connected to the suction catheter 10 to perform suction again to remove the remaining thrombus. Then the suction catheter 10 is pushed to the distal end along the filter rod 31 until the filter 32 is completely withdrawn into the suction catheter 10, the hemostatic valve 7 is locked, and the entire system is withdrawn to complete the surgical operation.

[0176] The present invention will not block the blood flow in the blood vessels during the operation, and can prevent the thrombus from drifting downstream in the blood flow during the process of dragging, thrombolysis and suction. The present invention can be used in conjunction with veins to 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 dragging can be performed through the agitator 53, and combined with suction and filter protection. The use of this instrument can remove a large amount of thrombi in the inferior vena cava while ensuring relative safety, protect the venous valves and venous blood vessel walls, controllable blood loss, simple operating steps, shortened operation time, and reduced patient hospitalization costs.

[0177] As mentioned above, we have described the invention in full accordance with the purpose of the invention, but the invention is not limited to the above embodiments and implementation methods. Practitioners in the relevant technical field can make different changes and implementations within the scope permitted by the technical concept of the invention.

Claims

1. A thrombus treatment platform, comprising an aspiration catheter having an aspiration channel, characterized in that: The thrombus treatment platform also includes a suction pump, a stirring device and a filter assembly connected to the proximal end of the suction catheter. The filter assembly comprises a filter rod, and a filter fixedly mounted at the distal end of the filter rod and having an open state and a closed state; The stirring device comprises a first conduit, a second conduit slidably sleeved outside the first conduit, a stirrer arranged at the distal end of the first conduit and having an open state and a retracted state, and an operating device arranged between the first conduit and the second conduit and capable of making the first conduit and the second conduit slide relative to each other so as to switch the stirrer between the open state and the retracted state; The thrombus treatment platform further includes a driving device connected to the first catheter or the second catheter and capable of driving the agitator to rotate; The operating device comprises a handle sleeved on the first catheter and / or the second catheter, and an operating component slidably connected to the handle and capable of being matched and locked with the first catheter or the second catheter; The operating assembly includes an operating member slidably connected to the handle, a matching portion formed on the operating member and capable of matching and locking with the first catheter or the second catheter, and an elastic member that allows the matching portion to have a tendency to move toward a state of matching and locking with the first catheter or the second catheter; when the operating assembly is in a locked state, the matching portion matches and locks with the first catheter or the second catheter; when the operating assembly is in an unlocked state, the matching portion is separated from the first catheter or the second catheter; The driving device includes a motor connected to the first conduit or the second conduit, and a power source capable of supplying power to the motor.

2. A thrombus treatment platform, comprising an aspiration catheter having an aspiration channel, characterized in that: The thrombus treatment platform also includes a suction pump, a stirring device and a filter assembly connected to the proximal end of the suction catheter. The filter assembly comprises a filter rod passing through the suction channel, and a filter fixedly mounted at the distal end of the filter rod and having an open state and a closed state; the filter is located at the distal end of the suction conduit; The stirring device comprises a first conduit passing through the suction channel, a second conduit passing through the suction channel and slidably sleeved outside the first conduit, a stirrer arranged at the distal end of the first conduit and having an open state and a retracted state, and an operating device arranged between the first conduit and the second conduit and capable of making the first conduit and the second conduit slide relative to each other so as to switch the stirrer between the open state and the retracted state; When the agitator is in an on state, the agitator is located between the filter screen and the distal end of the suction catheter, and when the first catheter is dragged, the agitator moves back and forth in the blood vessel; The thrombus treatment platform further includes a driving device connected to the first catheter or the second catheter and capable of driving the agitator to rotate; The operating device comprises a handle sleeved on the first catheter and / or the second catheter, and an operating component slidably connected to the handle and capable of being matched and locked with the first catheter or the second catheter; The operating assembly includes an operating member slidably connected to the handle, a matching portion formed on the operating member and capable of matching and locking with the first catheter or the second catheter, and an elastic member that allows the matching portion to have a tendency to move toward a state of matching and locking with the first catheter or the second catheter; when the operating assembly is in a locked state, the matching portion matches and locks with the first catheter or the second catheter; when the operating assembly is in an unlocked state, the matching portion is separated from the first catheter or the second catheter; The driving device includes a motor connected to the first conduit or the second conduit, and a power source capable of supplying power to the motor.

3. The thrombus treatment platform according to claim 1 or 2, characterized in that: When the stirrer is in a retracted state, the outer diameter of the stirrer is ≤6F.

4. The thrombus treatment platform according to claim 1 or 2, characterized in that: The agitator can be deployed to a controlled degree by the second conduit.

5. The thrombus treatment platform according to claim 1 or 2, characterized in that: The stirrer is woven from a plurality of silk threads, and two ends of each of the silk threads are respectively fixed at the proximal end and the distal end of the first catheter.

6. The thrombus treatment platform according to claim 4, characterized in that: The distal end of the first conduit extends out of the second conduit; the agitator comprises a plurality of silk threads; the distal end of each of the silk threads is fixedly connected to the first conduit, and the proximal end of each of the silk threads is fixedly connected to the second conduit.

7. The thrombus treatment platform according to claim 5 or 6, characterized in that: At least part of the wires intersect; at least part of the wires rotate around the first catheter at a certain angle; the wires are made of one or more of nickel-titanium alloy, stainless steel wire, and high molecular polymer.

8. The thrombus treatment platform according to claim 5 or 6, characterized in that: The stirring device also includes a plurality of first ultrasonic generators fixedly arranged on the silk thread, a first power line connected to the first ultrasonic generator, and a first ultrasonic connector arranged on the operating device and capable of supplying power to the first power line.

9. The thrombus treatment platform according to claim 8, characterized in that: The wire has an internal lumen, the first catheter or the second catheter also has an internal lumen, and the first power line is located in the internal lumen of the wire and the internal lumen of the first catheter or the second catheter.

10. The thrombus treatment platform according to claim 9, characterized in that: The diameter of the first ultrasonic generator is 0.2-0.4 mm, the outer diameter of the wire is 0.2-0.3 mm, and the inner diameter of the wire is 0.1-0.2 mm.

11. The thrombus treatment platform according to claim 1 or 2, characterized in that: The operating device comprises a locking assembly disposed between the first conduit and the second conduit and capable of locking the two relative to each other; when the locking assembly is in an unlocked state and the operating assembly is in a locked state, when the operating assembly slides relative to the handle, the first conduit and the second conduit slide relative to each other so that the agitator switches between an open state and a retracted state; When the locking assembly is in a locked state, the relative positions of the first conduit and the second conduit are locked, and the driving device can drive the first conduit and the second conduit to rotate.

12. The thrombus treatment platform according to claim 11, characterized in that: The locking assembly includes a first locking piece fixedly connected to one of the first conduit and the second conduit, a second locking piece rotatably connected to the other of the first conduit and the second conduit, and a third locking piece disposed between the first locking piece and the second locking piece and capable of cooperating and locking with the other of the first conduit and the second conduit. When the locking assembly is in a locked state, the third locking piece cooperates and locks with the other of the first conduit and the second conduit, the first locking piece, and the second locking piece.

13. The thrombus treatment platform according to claim 12, characterized in that: The third locking piece is made of a material that can undergo elastic deformation. When the locking assembly is in a locked state, the third locking piece undergoes elastic deformation and closely cooperates with the other of the first conduit and the second conduit, the first locking piece, and the second locking piece.

14. The thrombus treatment platform according to claim 12 or 13, characterized in that: A groove is formed on the second locking piece, an internal thread is formed on the groove wall of the groove, an external thread that can cooperate with the internal thread is formed on the outer surface of the first locking piece, the first locking piece is inserted into the groove of the second locking piece and is rotatably connected to the second locking piece through the internal thread and the external thread, and the third locking piece is located in the cavity formed by the first locking piece and the second locking piece.

15. The thrombus treatment platform according to claim 1 or 2, characterized in that: The operating assembly also includes a slide rail fixedly arranged on the inner wall of the handle, a slider connected to one end of the elastic member and capable of sliding in cooperation with the slide rail, and the other end of the elastic member is connected to the matching portion.

16. The thrombus treatment platform according to claim 1 or 2, characterized in that: The stirrer includes a plurality of silk threads, and the stirring device also includes a plurality of first ultrasonic generators fixedly arranged on the silk threads, a first power line connected to the first ultrasonic generator, and a first ultrasonic connector arranged on the operating device and capable of supplying power to the first power line; the silk thread has an internal cavity, and the second catheter also has an internal cavity, and the first power line is located in the internal cavity of the silk thread and the internal cavity of the second catheter; the stirring device also includes a conductive ring fixedly arranged at the proximal end of the first power line; the first catheter includes a flexible tube section, a metal tube whose distal end is fixedly connected to the proximal end of the flexible tube section, and an insulating layer sleeved on a portion of the metal tube; the matching part is made of an inductive material, the first ultrasonic connector is connected to the matching part, and within the effective stroke of relative movement of the first catheter and the second catheter, the conductive ring is in contact with the metal tube of the first catheter, and the matching part can be in contact with the metal tube of the first catheter; when the matching part is in contact with the metal tube of the first catheter, the first ultrasonic connector can supply power to the first ultrasonic generator.

17. The thrombus treatment platform according to claim 1 or 2, characterized in that: The first catheter is sleeved on the filter rod, and the outer diameter of the filter rod is 0.1-1 mm.

18. The thrombus treatment platform according to claim 1 or 2, characterized in that: The proximal end of the first catheter is provided with an injection hole for injecting thrombolytic drugs, and the distal end of the first catheter and / or the agitator are formed with a plurality of thrombolytic holes for the thrombolytic drugs to enter the blood vessels.

19. The thrombus treatment platform according to claim 1 or 2, characterized in that: The suction catheter includes a catheter portion having the suction channel, an operating portion movably connected to the proximal end of the catheter portion, a fixing member fixedly arranged on the catheter portion, and a connecting member respectively connected to the operating portion and the fixing member and capable of bending the distal end of the catheter portion by operating the operating portion.

20. The thrombus treatment platform according to claim 19, characterized in that: The operating part is rotatably connected to the catheter part, and the connecting piece has a proximal end and a distal end, the proximal end of the connecting piece is wrapped around the operating part, and the distal end of the connecting piece is arranged at the distal end of the catheter part; or, the connecting piece has two distal end portions located at the distal end and a proximal end portion located at the proximal end, the two distal end portions are respectively arranged on opposite sides of the catheter part, and the proximal end is wrapped around the operating part.

21. The thrombus treatment platform according to claim 19, characterized in that: The operating part includes a first operating part movably connected to the proximal end of the catheter part, and a second operating part movably connected to the proximal end of the catheter part, and the connecting member includes a first connecting member and a second connecting member; the first connecting member and the second connecting member respectively have two distal end portions located at the distal end and a portion located at the proximal end, the two distal end portions of the first connecting member are respectively arranged on opposite sides of the catheter part, and the proximal end of the first connecting member is wound around the first operating part; the two distal end portions of the second connecting member are respectively arranged on opposite sides of the catheter part, and the proximal end of the second connecting member is wound around the second operating part; and the two distal ends of the first connecting member and the two distal ends of the second connecting member are evenly distributed along the circumference of the catheter part; when the first operating member and the second operating member are operated, the front end of the catheter part can be directional and rotated in three-dimensional space.

22. The thrombus treatment platform according to claim 19, characterized in that: The suction catheter also includes a dilatation catheter connected to the distal end of the catheter portion and having an open state and a retracted state. When the dilatation catheter is in the retracted state, the dilatation catheter is located inside the catheter portion; when the dilatation catheter is in the open state, the diameter of the distal end of the dilatation catheter is greater than the diameter of the catheter portion.

23. The thrombus treatment platform according to claim 22, characterized in that: The dilatation catheter comprises a soft membrane material whose proximal end is fixedly connected to the distal end of the catheter part, and an expansion ring fixedly connected to the distal end of the soft membrane material.

24. The thrombus treatment platform according to claim 23, characterized in that: The expansion ring is a memory material or an air bag.

25. The thrombus treatment platform according to claim 1 or 2, characterized in that: The thrombus treatment platform also includes a second ultrasonic generator arranged at the distal end of the suction catheter, a second power line and a signal transmission line connected to the second ultrasonic generator and arranged in the tube wall of the suction catheter, and a second ultrasonic connector arranged at the proximal end of the suction catheter and connected to the second power line and the signal transmission line.

26. The thrombus treatment platform according to claim 1 or 2, characterized in that: The thrombus treatment platform further comprises a sheath tube which can pass through the suction channel and whose distal end extends to the proximal end of the filter screen, and the proximal end of the sheath tube is connected to a suction pump.

27. The thrombus treatment platform according to claim 26, characterized in that: The sheath tube includes a first channel capable of allowing a guide wire to pass through, and a second channel capable of allowing a thrombus to pass through or capable of accommodating the filter.

28. The thrombus treatment platform according to claim 1 or 2, characterized in that: The filter screen is in the shape of a basket or a net bag with an opening toward the proximal end, or the filter screen is in the shape of a shuttle.

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