A device for removing a thrombus

Abstract

The application provides a device for removing embolus, which comprises an outer tube assembly and an inner tube assembly, the outer tube assembly comprises an outer tube body, the inner tube assembly is arranged in the outer tube body, the inner tube assembly comprises an inner sheath hose, an inner shaft and a device for removing embolus, the inner shaft is arranged in the inner sheath hose, the device for removing embolus is connected with the inner shaft, and the inner shaft is arranged non-coaxially with the outer tube body. The device for removing embolus can adapt to the bending of blood vessels in different degrees, is not prone to be stuck and damage the blood vessels and the vein wall when moving in the blood vessels, reduces the pain of patients in the treatment process, and reduces the skill requirement of medical staff in the treatment process.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to the field of interventional medical devices, and more particularly to a thrombectomy device. BACKGROUND

[0002] Venous thromboembolism refers to blood clots that form in the veins, causing complete or incomplete obstruction of the blood vessels, which is a venous return disorder. It includes deep vein thrombosis and pulmonary thromboembolism. The disease is often complicated by pulmonary embolism, post-thrombotic syndrome, chronic thromboembolic pulmonary hypertension, etc., which seriously affects the quality of life and work of patients.

[0003] Intravascular treatment of vessel occlusion and related devices, systems, and methods are a new thrombectomy technique, particularly systems and methods for extracting thrombus from the peripheral vasculature.

[0004] In the use of this method to extract thrombus, first, a catheter is used to open a corresponding part of the blood vessel, and a guide wire is inserted into the catheter and along the blood vessel to the back of the blood clot attached to the blood vessel wall. Then the outer shaft, middle shaft, and inner shaft of the thrombectomy device are inserted along the guide wire to the back of the thrombus, at which time the outer shaft, catheter, middle shaft, and inner shaft are coaxially arranged. By rotating the fixed block on the handle, the coring element and the mesh braid structure are released. The coring element and the mesh braid structure are made of a memory metal, such as nickel-titanium alloy, which expands to fill the inner diameter of the blood vessel when it comes into contact with normal temperature blood. At this time, the outer shaft, middle shaft, and inner shaft are simultaneously pulled towards the proximal end, and the sharp edge of the coring element can strip the blood clots and tissues attached to the blood vessel wall into the mesh structure until the coring element is pulled out to the position of the catheter. Then, a syringe is connected to the luer connector on the catheter assembly, the switch valve is opened, and the thrombus is extracted. The thrombus extraction device is designed to remove large clot volumes, and this method can effectively core and separate large volume thrombus while capturing the separated thrombus in the braided mesh. This reduces the need for drugs such as thrombolytic agents. This reduces the risk of bleeding, the recovery time of the human body after treatment, and the cost of health care procedures.

[0005] However, in order to facilitate the operation of the thrombus extraction, the intravascular treatment of the vessel occlusion and the related devices, systems and methods have high requirements for the coaxiality of the outer shaft and the catheter, the coaxiality of the intermediate shaft and the outer shaft and the coaxiality of the inner shaft and the intermediate shaft during the thrombus extraction. Due to the complex structure of the human body blood vessels, the coaxial outer shaft and the catheter, the coaxial intermediate shaft and the outer shaft and the coaxial inner shaft and the intermediate shaft are inserted into the curved blood vessels, which will inevitably cause the phenomenon of jamming of the shafts during the extraction, and the doctor is difficult to extract the thrombus during the thrombus extraction, and the device is damaged in severe cases; and the device will damage the blood vessel wall at the curved part of the blood vessel, causing inflammation of the blood vessel wall and forming a new thrombus; when passing through the venous valve, the venous valve is damaged, and the venous valve is damaged in severe cases. At the same time, the coaxiality of the outer shaft and the catheter, the coaxiality of the intermediate shaft and the outer shaft and the coaxiality of the inner shaft and the intermediate shaft make the manufacturing and processing technology of the whole device more difficult, the cost is higher, and it is not easy to popularize and use. SUMMARY

[0006] The present application provides a thrombus extraction device which can adapt to different degrees of bending of the blood vessels, is not easy to cause jamming during movement in the blood vessels, is not easy to damage the blood vessels and the venous wall, reduces the pain of the patient during treatment and reduces the skill requirement of the medical staff during treatment.

[0007] The present application provides a thrombus extraction device, which comprises an outer tube assembly and an inner tube assembly, the outer tube assembly comprises an outer tube body, the inner tube assembly is arranged in the outer tube body, the inner tube assembly comprises an inner sheath hose, an inner shaft and a thrombus extraction assembly, the inner shaft is arranged in the inner sheath hose, the thrombus extraction assembly is connected with the inner shaft, and the inner shaft and the outer tube body are arranged in a non-coaxial manner.

[0008] Further, the inner tube assembly further comprises a traction shaft and an inner tube adjusting handle, the inner shaft and the traction shaft are arranged in the inner sheath hose, and the inner tube assembly further comprises an inner tube adjusting handle, which is arranged on the inner sheath hose and connected with the traction shaft to drive the traction shaft to move relative to the inner shaft.

[0009] Further, the thrombus extraction assembly comprises a first end close to the adjusting handle and a second end away from the adjusting handle, the first end of the thrombus extraction assembly is connected with the inner shaft, and the second end of the thrombus extraction assembly is connected with the traction shaft.

[0010] Further, the thrombus extraction assembly is in a mesh structure, the thrombus extraction assembly comprises a connecting part and a mesh body, one end of the connecting part is connected with the mesh body, the other end of the connecting part is connected with the inner shaft, and the traction shaft is connected with one end of the mesh body away from the connecting part.

[0011] Further, the connecting parts are multiple, one end of the multiple connecting parts is connected with the inner shaft, the other end is arranged along the circumference of the net-shaped body and is connected with the net-shaped body.

[0012] Further, the lengths of the multiple connecting parts are not equal, so that the inner shaft connected with the connecting parts deviates from the axis of the net-shaped body.

[0013] Further, one of the inner tube assembly and the inner shaft is made of elastic material, and the other of the inner tube assembly and the inner shaft is made of non-elastic material.

[0014] Further, the elastic material includes memory alloy wire, spring tube, elastic plastic rope or elastic plastic tube; and the non-elastic material includes steel cable, solid wire, plastic tube with braided layer or spiral hollow tube.

[0015] Further, the traction shaft body is made of spiral hollow tube, the inner shaft is made of spring tube, or the traction shaft body is made of spring tube, and the inner shaft is made of spiral hollow tube.

[0016] Further, the thrombus extraction assembly is not provided with an inner tube.

[0017] Further, the thrombus extraction assembly further comprises a catheter assembly, the catheter assembly comprises a catheter body, an introduction sheath, a catheter fixing member, a catheter assembly evacuation pipe and a catheter assembly evacuation valve, one end of the catheter body is connected with the catheter fixing member, the other end is connected with the introduction sheath, the catheter assembly evacuation pipe is arranged on the catheter fixing member and is in communication with the inner pipe of the catheter body through the catheter fixing member, and the catheter assembly evacuation valve is arranged on the catheter assembly evacuation pipe.

[0018] In summary, in the present application, the non-coaxial arrangement of the inner shaft and the outer tube body can improve the adaptability of the thrombus extraction device to the curved blood vessel, reduce the damage to the blood vessel wall and the vein half mold, and can save more labor when moving the outer tube assembly, and reduce the requirement for operation precision.

[0019] Further, the traction shaft and the inner shaft are arranged in the inner sheath hose at the same time, and the traction shaft and the inner shaft are connected with two ends of the thrombus extraction assembly respectively, which can ensure the non-coaxiality of the inner shaft and the outer tube body.

[0020] Further, the arrangement of the inner shaft deviating from the axis of the net-shaped body can ensure the non-coaxiality of the inner shaft and the outer tube body, so that the thrombus extraction device is more suitable for shuttling in the curved blood vessel and is not easy to cause jamming and damage to the blood vessel and vein wall.

[0021] Further, by making one of the inner shaft and the traction shaft body from an elastic material and the other from a non-elastic material, the transmission of the pushing force and the pulling force can be ensured while the blood vessel is adapted. In the case that the inner shaft and the outer tube body are not coaxial, the special materials for the traction shaft and the inner shaft allow the shaft to be elongated when the operator makes a mistake, preventing the shaft from being broken, which can further reduce the damage to the blood vessel wall and the venous valve, reduce the pain of the patient during the treatment, and reduce the skill requirement of the medical staff during the treatment.

[0022] Further, by canceling the intermediate shaft, the gap between the inner tube assembly and the outer tube assembly can be increased, so that the inner shaft and the outer tube body are kept non-coaxial. Further, by omitting the intermediate shaft and arranging the inner shaft and the outer tube body non-coaxially, the process requirement for manufacturing the thrombectomy device is lower, the requirement for the operator is lower, the cost is reduced, and the thrombectomy device is easy to popularize and use.

[0023] The above description is only a summary of the technical solutions of the present application. In order to enable the technical means of the present application to be more clearly understood, and to be implemented according to the content of the specification, and in order to enable the above and other purposes, characteristics and advantages of the present application to be more apparent and easy to understand, the following preferred embodiments are described in detail, and the accompanying drawings are described as follows. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 Fig. 1 shows a schematic view of the shaft side structure of the catheter assembly of the thrombectomy device provided by the first embodiment of the present application.

[0025] Figure 2 Fig. 2 shows a schematic view of the side structure of the catheter assembly. Figure 1

[0026] Figure 3 Fig. 3 shows a schematic view of the shaft side structure of the plugger of the thrombectomy device provided by the first embodiment of the present application.

[0027] Figure 4 Fig. 4 shows a schematic view of the side structure of the plugger. Figure 3

[0028] Figure 5 Fig. 5 shows a schematic view of the shaft side structure of the outer tube assembly provided by the first embodiment of the present application.

[0029] Figure 6 Fig. 6 shows a schematic view of the side structure of the outer tube assembly. Figure 5

[0030] Figure 7 Fig. 7 shows a schematic view of the shaft side structure of the inner tube assembly provided by the first embodiment of the present application.

[0031] Figure 8 Fig. 8 shows a schematic view of the side structure of the inner tube assembly.​​​Figure 7 A side view of the inner tube assembly.

[0032] Figure 9 A structure diagram of the end of the inner tube assembly is shown.

[0033] Figure 10 A structure diagram of the end of the inner tube assembly is shown. Figure 9

[0034] Figure 11 A structure diagram of the end of the inner tube assembly is shown. Figure 9

[0035] Figure 12 A structure diagram of the end of the inner tube assembly is shown.

[0036] Figure 13 A structure diagram of the end of the inner tube assembly is shown.

[0037] Figure 14 A structure diagram of the end of the inner tube assembly is shown. Figure 13

[0038] Figure 15 A structure diagram of the end of the inner tube assembly is shown. Figure 13 DETAILED DESCRIPTION

[0039] To further illustrate the technical means and effects taken by the present application to achieve the predetermined purposes, the following detailed description is provided in conjunction with the accompanying drawings and preferred embodiments.

[0040] The present application provides a thrombus removal device which can adapt to different degrees of bending of blood vessels, is not easy to cause jamming and damage to blood vessels and vein walls when moving in the blood vessels, reduces the pain of patients during treatment, and reduces the skill requirements of medical personnel during treatment.

[0041] As shown in Figure 1 and Figure 2 The thrombus removal device provided by the present application comprises a catheter assembly 10, which comprises a catheter body 11, an introduction sheath 12, a catheter fixing member 13, a catheter assembly evacuation pipe 14 and a catheter assembly evacuation valve 15.

[0042] One end of the catheter body 11 is connected to the catheter fixing member 13, and the other end is connected to the introduction sheath 12. The catheter assembly evacuation pipe 14 is arranged on the catheter fixing member 13 and communicates with the internal pipeline of the catheter body 11 through the catheter fixing member 13. The catheter assembly evacuation valve 15 is arranged on the catheter assembly evacuation pipe 14 to control the catheter assembly evacuation pipe 14.​​​​

[0043] The introduction sheath 12 gradually increases in cross-sectional area perpendicular to its axis from the side closer to the catheter body 11 to the side further from the catheter body 11, in other words, it is generally funnel-shaped. The introduction sheath 12 can be a nitinol woven mesh structure. The mesh structure can be automated woven or hand woven to guide the subsequent inserted components when retrieving the thrombus, reducing the escape of the thrombus.

[0044] In use, the catheter body 11 on the catheter assembly 10 can be inserted into the blood vessel at the opening of the popliteal access site, the femoral access site or the internal jugular access site close to the thrombus to guide the subsequent assembly.

[0045] A reverse flow valve (not shown in the figure) such as a silicone reverse flow valve is also provided inside the catheter assembly 10 fixing member to prevent blood backflow.

[0046] As shown in Figure 3 and Figure 4 The thrombus retrieval device provided by the present application further comprises an obturator assembly 20, which comprises an obturator guide head 21, an obturator obturator tube 22, an obturator catheter 23, an obturator handle 24, an obturator evacuation tube 25 and an obturator on-off valve 26.

[0047] The obturator guide head 21 is provided at the end of the obturator assembly 20, and the obturator obturator tube 22 is connected between the obturator guide head 21 and the obturator catheter 23. The obturator handle 24 and the obturator evacuation tube 25 are provided on the end of the obturator catheter 23 away from the obturator guide head 21, and the obturator evacuation tube 25 communicates with the obturator obturator tube 22 through the obturator catheter 23. The obturator on-off valve 26 is provided on the obturator evacuation tube 25.

[0048] The obturator assembly 20 is used for the expansion of the introduction sheath 12 in the catheter assembly 10. In use, the obturator assembly 20 is inserted from the tail of the catheter fixing member 13 of the catheter assembly 10 and fixed. The button of the obturator handle 24 on the obturator assembly 20 is moved away from the operator until the funnel-shaped mesh structure of the introduction sheath 12 is fully expanded. Then the obturator assembly 20 is removed.

[0049] Please continue to refer to Figure 5 and Figure 6 In this embodiment, the thrombus retrieval device further comprises an outer tube assembly 30, which comprises an outer tube visualization ring 31, an outer tube body 32, an outer tube handle 33, an outer tube evacuation tube 34 and an outer tube on-off valve 35.

[0050] The outer tube body 32 is connected with the outer tube handle 33, and the outer tube developing ring 31 is arranged at one end of the outer tube body 32 away from the outer tube handle 33. The outer tube evacuation tube 34 is arranged on the outer tube handle 33 and communicates with the outer tube body 32 through the outer tube handle 33. The outer tube switch valve 35 is arranged on the outer tube evacuation tube 34.

[0051] After the introducer sheath 12 is unfolded by the filler assembly 20, the outer tube assembly 30 can be inserted into the catheter assembly 10. The outer tube developing ring 31 can display the position of the outer tube assembly 30 inserted into the body, and the outer tube handle 33 can control the length of the outer tube body 32 inserted into the body through the threaded connection. The outer tube assembly 30 can bind other assemblies inserted into the outer tube body 32, so that other assemblies can smoothly reach the rear of the thrombus in the blood vessel.

[0052] As shown in Figures 7 to 12 , the present application also includes an inner tube assembly 40, which is used for threading in the outer tube assembly 30 during thrombus removal.

[0053] The inner tube assembly 40 includes an inner sheath hose 41, an inner shaft 42, a traction shaft 43, a thrombus removal assembly 44, a guide head 45, an inner tube distal end developing ring 46, an inner tube adjusting handle 47 and a luer joint 48.

[0054] The luer joint 48 is connected with the inner sheath hose 41. The inner shaft 42 and the traction shaft 43 are both threaded in the inner sheath hose 41. The inner tube adjusting handle 47 is arranged on the inner sheath hose 41 and connected with the traction shaft 43 to drive the traction shaft 43 to move relative to the inner shaft 42.

[0055] The thrombus removal assembly 44 includes a first end close to the inner tube adjusting handle 47 and a second end away from the inner tube adjusting handle 47. The first end of the thrombus removal assembly 44 is connected with the inner shaft 42, and the second end is connected with the traction shaft 43.

[0056] In this embodiment, the thrombus removal assembly 44 is a mesh structure, such as a nitinol metal woven mesh. The thrombus removal assembly 44 includes an unfolded state and a contracted state. In the contracted state, the thrombus removal assembly 44 is accommodated in the inner sheath hose 41, and in the unfolded state, the thrombus removal assembly 44 extends out of the inner sheath hose 41.

[0057] The guide head 45 is arranged at one end of the thrombus removal assembly 44 away from the inner tube adjusting handle 47 to guide the movement of the entire outer tube assembly 30. The inner tube distal end developing ring 46 is arranged between the guide head 45 and the thrombus removal assembly 44 to display the position of the thrombus removal assembly 44 in the blood vessel.

[0058] In the present embodiment, after the introducer sheath 12 on the catheter assembly 10 is deployed by the obturator assembly 20, the obturator is removed, and then the inner tube assembly 40 is extended into the outer tube assembly 30, and the inner tube assembly 40 is extended into the catheter assembly 10 together with the outer tube assembly 30. The inner tube assembly 40 and the outer tube assembly 30 are extended until the inner tube distal end visualization ring 46 is seen at a predetermined distance, such as 50 mm, distal to the thrombus, which indicates that the outer tube assembly 30 and the inner tube assembly 40 are located 50 mm distal to the thrombus, and the thrombus is located between the introducer sheath 12 and the thrombus extraction assembly 44. At this time, the outer tube handle 33 on the outer tube assembly 30 is moved, and the inner tube assembly 40 is relatively slid with the outer tube assembly 30, and the thrombus extraction assembly 44 is pushed distally (i.e., away from the operator). The inner tube adjustment handle 47 is adjusted, and the pull shaft 43 is moved proximally (i.e., towards the operator), and the braided mesh of the thrombus extraction assembly 44 is expanded, and the thrombus is cleaned.

[0059] In the present embodiment, when the inner tube assembly 40 is extended into the outer tube assembly 30, the inner shaft 42 in the inner tube assembly 40 is non-coaxially arranged with the outer tube body 32. Through the non-coaxial arrangement of the inner shaft 42 and the outer tube body 32, when the outer tube assembly 30 and the inner tube assembly 40 are extended into the blood vessel, in the curved blood vessel, the inner shaft 42 can swing relative to the outer tube body 32, which reduces the damage to the blood vessel wall and the venous half mold, and when the outer tube assembly 30 is moved, it can be more labor-saving, and the requirement for operation precision is reduced.

[0060] Further, in the present embodiment, the inner shaft 42 is composed of an elastic material, such as a memory alloy wire, a spring tube, an elastic plastic rope, an elastic plastic tube, etc.; and the pull shaft 43 is composed of a non-elastic material, such as a plastic tube with a braided layer, a helical hollow (HHS) tube, etc.

[0061] In the embodiment, the inner shaft 42 is made of a spring tube, and the traction shaft 43 is made of an HHS tube. In the embodiment, since the traction shaft 43 is made of the HHS tube which is a non-elastic material, the HHS tube has a good torque and thrust transmission effect, and can transmit the required thrust and tension of the entire assembly into the blood vessel. Since the inner shaft 42 is made of the spring tube which is an elastic material, the spring tube has good flexibility and elasticity. When the outer tube assembly 30 and the inner tube assembly 40 are pulled outwards, the thrombectomy assembly 44 has a certain buffering effect when the traction force increases, which can avoid damage to the blood vessel wall and reduce the pain of the patient. Further, the above-mentioned arrangement can further maintain the non-coaxial arrangement of the outer tube body 32 and the inner shaft 42. At the same time, due to the non-coaxial arrangement of the inner shaft 42 and the outer tube body 32, the thrombectomy assembly 44 can swing along with the curved blood vessel when subjected to external traction in the curved blood vessel, further reducing the possibility of damaging the blood vessel wall and the venous valve. When the outer tube assembly 30 and the inner tube assembly 40 are pulled out, it is more labor-saving.

[0062] In some embodiments, the traction shaft 43 is made of a woven hollow cable or an HHS tube (the traction shaft 43 cannot be a solid shaft), and the inner shaft 42 is made of a hollow tube or a spring tube or a solid wire. Due to the special structure of the thrombectomy assembly 44, the inner shaft 42 and the traction shaft 43 are non-coaxial in the cavity of the outer tube assembly 30.

[0063] In some embodiments, the traction shaft 43 is made of an HHS tube, and the inner shaft 42 is made of a spring tube. After the traction shaft 43 is made of the HHS tube, the HHS tube has good torque and thrust transmission performance, which is suitable for transmitting the thrust and tension of the entire assembly into the human body. In addition, the HHS tube has excellent non-whipping and high anti-kinking, so that the traction shaft 43 and the inner shaft 42 are not easy to be stuck.

[0064] In some embodiments, the traction shaft 43 is made of a hollow tube or a spring, and the inner shaft 42 is made of a solid wire or a woven cable or an HHS tube. Due to the special structure of the thrombectomy assembly 44, the inner shaft 42 and the traction shaft 43 are non-coaxial in the outer tube assembly 30.

[0065] In some embodiments, the traction shaft 43 is made into a spring tube, and the inner shaft 42 is made into HHS tube material. After the traction shaft 43 is made into a spring tube, because the spring has good flexibility and elasticity due to the spring tube, the complex structure of the blood vessel is bent, so that the assembly has good adaptability, elasticity and compliance when entering the human body, so that the blood vessel wall is not easily damaged. After the inner shaft 42 is made into an HHS tube, because the HHS tube has good torque and thrust transmission performance, it is more suitable for the core assembly to transmit thrust and tension, and the HHS tube has excellent non-whipping and high resistance to kinking, so as to more adapt to the complex structure of the bent blood vessel during the thrombectomy traction, thereby reducing the damage to the blood vessel wall; the traction shaft and the inner shaft are different shafts, which reduces the use requirements of the operator, and because the processing and manufacturing requirements are relatively low, the cost and labor cost of the manufacturing process of the instrument are less; the traction shaft 43 or the inner shaft 42 can include the following materials: steel cable, solid metal wire, memory alloy wire, spring, elastic plastic rope, elastic plastic tube, plastic tube with braided layer, HHS tube (here, the traction shaft 43 cannot be selected as a solid shaft).

[0066] Further, in the present embodiment, the thrombectomy device does not set an intermediate shaft. In the prior art, the main function of the intermediate shaft is to replace the small inner shaft 42 as a structure for bearing traction. In the present embodiment, because the outer tube body 32 is made of a non-elastic material, the inner shaft 42 is made of an elastic material, and the inner shaft 42 is arranged non-coaxially with the outer tube body 32. This enables the inner shaft 42 itself to serve as a structure for bearing traction, so as to omit the intermediate shaft; further, by omitting the intermediate shaft, the gap between the inner tube assembly 40 and the outer tube assembly 30 can be increased, so as to maintain the non-coaxial arrangement between the inner shaft 42 and the outer tube body 32. Further, by omitting the intermediate shaft and arranging the inner shaft 42 non-coaxially with the outer tube body 32, the thrombectomy device can have lower process requirements and lower requirements for operators during manufacturing and processing, thereby reducing costs and facilitating popular use. Further, by arranging the inner shaft 42 and the traction shaft 43 as double shafts and connecting the double shafts to the two ends of the thrombectomy assembly 44 respectively, the inner shaft 42 and the traction shaft 43 can replace the intermediate shaft to bear traction.

[0067] Further, please continue to refer to Figures 9 to 11 In the present embodiment, the thrombectomy assembly 44 includes a connecting portion 441 and a mesh body 442, one end of the connecting portion 441 is connected to the mesh body 442, and the other end is connected to the inner shaft 42. The traction shaft 43 is connected to the end of the mesh body 442 away from the connecting portion.

[0068] More specifically, the connecting portions 441 are multiple. One end of each connecting portion 441 is arranged along the circumference of the mesh body 442 at intervals and connected to the mesh body 442, and the other end is connected to the inner shaft 42. The lengths of the connecting portions 441 are not equal, so that the inner shaft 42 connected to the connecting portions 441 deviates from the axis of the mesh body 442. The design of the thrombus extraction assembly 44 is not limited to the connecting portions 441 and the mesh body 442 described above, and it is only required that the inner shaft 42 is arranged non-coaxially with the inner sheath hose 41 to ensure that the inner shaft 42 is arranged non-coaxially with the outer pipe body 32.

[0069] In the present embodiment, the connecting portions 441 are used to connect the mesh body 442 to the inner shaft 42, and on the other hand, the thrombus can be cut and broken when the thrombus is extracted. The mesh body 442 can accommodate the thrombus when it is deployed.

[0070] Please continue to refer to Figure 12 As shown in FIG. 5, the thrombus extraction device provided by the present application further comprises a syringe 50. A pull ring 51 is arranged at the tail of the pull rod of the syringe 50 to facilitate the operation of the user.

[0071] In the present embodiment, the thrombus extraction operation can be performed in the following manner:

[0072] First, the catheter body 11 of the catheter assembly 10 is inserted into the blood vessel at the opening of the popliteal access site, the femoral access site or the internal carotid access site near the thrombus, the guide wire is inserted into the blood vessel along the inner cavity of the catheter assembly 10 until it extends to the distal end of the thrombus (i.e. the end away from the operator), and the plugger assembly 20 is inserted into the catheter fixing member 13 of the catheter assembly 10 and fixed. The plugger handle 24 button of the plugger assembly 20 is moved to the end away from the operator until the funnel-shaped mesh structure of the introduction sheath 12 is fully expanded, and the plugger is removed. Then, the outer tube assembly 30 and the inner tube assembly 40 are installed together and loaded into the catheter assembly 10, and the outer tube assembly 30 and the inner tube assembly 40 are extended until the outer tube assembly 30 distal end development ring appears at the distal end of the thrombus 50 mm, which indicates that the outer tube assembly 30 and the inner tube assembly 40 are located 50 mm behind the thrombus. At this time, the outer tube handle 33 button of the outer tube assembly 30 is moved to the end away from the operator, the inner tube assembly 40 and the outer tube assembly 30 are relatively slid, the thrombus extraction assembly 44 is pushed to the distal end, the inner tube adjustment handle 47 of the inner shaft 42 assembly is adjusted, the traction shaft 43 is moved to the end close to the user, the thrombus extraction assembly 44 is expanded until it extends to the blood vessel wall, the outer tube assembly 30 and the inner tube assembly 40 are pulled to the end close to the user at the same time, the thrombus extraction assembly 44 is pulled to 1 / 3 of the funnel-shaped mesh basket structure of the introduction sheath 12, the syringe 50 is connected to the catheter assembly emptying valve 15 of the catheter assembly 10, the catheter assembly emptying valve 15 is opened, the fine thrombus is extracted, the catheter assembly emptying valve 15 is closed, the outer tube assembly 30 and the inner tube assembly 40 are removed, and the thrombus in the mesh basket is cleaned.

[0073] As shown in Figures 13 to 15 The second embodiment of the present application is basically the same as the first embodiment, and the difference is that in the present embodiment, the outer tube body 32 is made of elastic material, such as spring tube; and the inner shaft 42 is made of non-elastic material, such as HHS tube.

[0074] Due to the good flexibility and elasticity of the spring tube, the complex structure of the blood vessel makes the assembly have good adaptability and compliance when entering the human body, so that the blood vessel wall is not easy to be damaged. After the inner shaft 42 is made of HHS tube, the HHS tube has good torque transmission and thrust transmission performance, which is suitable for transmitting thrust and tension to the thrombus extraction assembly 44, and the HHS tube has excellent non-whipping property and high resistance to kinking, so that it is more compliant to the complex blood vessel structure during thrombus extraction, thereby reducing the damage to the blood vessel wall; the outer tube body 32 and the inner shaft 42 are different shafts, and the intermediate shaft is reduced, so that the use requirement of the operator is reduced, and the manufacturing requirement is relatively low, so that the cost and labor cost of the manufacturing process of the instrument are less.

[0075] That is, in the present embodiment, one of the inner shaft 42 and the outer tube body 32 is made of elastic material, and the other of the inner shaft 42 and the outer tube body 32 is made of non-elastic material.

[0076] In summary, in the present application, by the non-coaxial arrangement of the inner shaft 42 and the outer tube body 32, the adaptability of the thrombectomy device to the curvature of the blood vessel is improved, the damage to the blood vessel wall and the venous valve is reduced, and the force required to move the outer tube assembly 30 is reduced, and the requirement for operation precision is reduced.

[0077] Further, by arranging the inner shaft 42 and the traction shaft 43 in the inner sheath hose 41, and connecting the inner shaft 42 and the traction shaft 43 to the two ends of the thrombectomy assembly 44 respectively, the non-coaxiality of the inner shaft 42 and the outer tube body 32 is ensured.

[0078] Further, by arranging the inner shaft 42 to be offset from the axis of the mesh body 442, the non-coaxiality of the inner shaft 42 and the outer tube body 32 is ensured, so that the thrombectomy device is more suitable for moving in a curved blood vessel, and is less likely to cause jamming and damage to the blood vessel and the venous wall.

[0079] Further, by making one of the inner shaft 42 and the traction shaft 43 of elastic material, and the other of the inner shaft 42 and the traction shaft 43 of non-elastic material, the transmission of thrust and tension can be ensured while adapting to the curvature of the blood vessel. Under the premise of the non-coaxial arrangement of the inner shaft 42 and the outer tube body 32, the damage to the blood vessel wall and the venous valve is further reduced, the pain of the patient during treatment is reduced, and the skill requirement of the medical staff during treatment is reduced.

[0080] Further, by canceling the intermediate shaft, the gap between the inner tube assembly 40 and the outer tube assembly 30 can be increased, so that the inner shaft 42 and the outer tube body 32 remain non-coaxial. Further, by omitting the intermediate shaft and arranging the inner shaft 42 and the outer tube body 32 non-coaxially, the thrombectomy device can be manufactured with lower process requirements and lower requirements for operators, reducing costs and facilitating popularization and use.

[0081] The above is only a preferred embodiment of the present application, and does not limit the present application in any form. Although the present application has been disclosed as above with a preferred embodiment, it is not intended to limit the present application. Any person skilled in the art can make some changes or modifications to the above disclosed technical content to obtain equivalent embodiments with equivalent changes, without departing from the technical solution of the present application. Any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the present application, all fall within the scope of the technical solution of the present application.

Claims

1. A thrombectomy device, characterized by: The application relates to a catheter assembly, which comprises an outer tube assembly and an inner tube assembly, the outer tube assembly comprises an outer tube body, the inner tube assembly is arranged in the outer tube body, the inner tube assembly comprises an inner sheath hose, an inner shaft and a thrombus extraction assembly, the inner shaft is arranged in the inner sheath hose, the thrombus extraction assembly is connected with the inner shaft, the inner shaft is arranged non-coaxially with the outer tube body, the inner tube assembly further comprises a traction shaft, the traction shaft is arranged in the inner sheath hose, the inner tube assembly further comprises an inner tube adjusting handle, the inner tube adjusting handle is arranged on the inner sheath hose and connected with the traction shaft to drive the traction shaft to move relative to the inner shaft, the thrombus extraction assembly comprises a first end close to the adjusting handle and a second end away from the adjusting handle, the first end of the thrombus extraction assembly is connected with the inner shaft, the second end of the thrombus extraction assembly is connected with the traction shaft, the thrombus extraction assembly is in a net structure, the thrombus extraction assembly comprises a connecting part and a net body, one end of the connecting part is connected with the net body, and the other end of the connecting part is connected with the inner shaft, and the traction shaft is connected with one end of the net body away from the connecting part.

2. The thrombectomy device of claim 1, wherein: The connecting part is a plurality of connecting parts, one end of the plurality of connecting parts is connected with the inner shaft, and the other end of the plurality of connecting parts is arranged at intervals along the circumference of the net body and connected with the net body.

3. The thrombectomy device of claim 2, wherein: The lengths of the plurality of connecting parts are not equal, so that the inner shaft connected with the connecting part deviates from the axis of the net body.

4. The thrombectomy device of claim 1, wherein: One of the inner tube assembly and the inner shaft is made of an elastic material, and the other of the inner tube assembly and the inner shaft is made of a non-elastic material.

5. The thrombectomy device of claim 4, wherein: The elastic material comprises a memory alloy wire, a spring tube, an elastic plastic rope or an elastic plastic tube; and the non-elastic material comprises a steel cable, a solid wire, a plastic tube with a braided layer or a spiral hollow tube.

6. The thrombectomy device of claim 5, wherein: The thrombus extraction assembly is not provided with an inner tube.

7. The thrombectomy device of any of claims 1-6, wherein: The application further relates to a catheter assembly, which comprises a catheter body, an introduction sheath, a catheter fixing part, a catheter assembly emptying pipe and a catheter assembly emptying valve, one end of the catheter body is connected with the catheter fixing part, the other end of the catheter body is connected with the introduction sheath, the catheter assembly emptying pipe is arranged on the catheter fixing part and communicates with the inner pipeline of the catheter body through the catheter fixing part, and the catheter assembly emptying valve is arranged on the catheter assembly emptying pipe; and the outer tube assembly and the inner tube assembly are arranged in the catheter body.

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