Thrombectomy system

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a thrombectomy system which comprises a handle module and a thrombectomy module, the thrombectomy module comprises a catheter assembly, a thrombectomy assembly and a positioning assembly, the catheter assembly comprises a tube body with the near end connected to the handle module and a suction opening formed in the tube body, and the thrombectomy assembly is arranged in the tube body in a penetrating mode; the suction port is formed in the far end of the catheter body and penetrates through the far end face of the catheter body, the positioning assembly comprises a positioning balloon arranged on the catheter body, and the positioning balloon is used for centering and positioning the catheter body after the catheter body extends into a blood vessel. According to the thrombus extraction system, thrombus pumped into the tube body can be broken through the thrombus breaking assembly, the broken thrombus is discharged through the negative pressure assembly, so that the tube body is not prone to being blocked, the positioning balloon is arranged, the tube body is centered in a blood vessel, the tube body is prevented from inclining, and the thrombus extraction efficiency is improved. And secondary injury to the blood vessel due to the fact that the suction port is adsorbed on the inner wall of the blood vessel is prevented.

Description

Technical Field

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

[0002] A thrombus is a small mass formed on the surface of the exfoliation or repair site of the vascular intima in the cardiovascular system by blood flow, and is composed of non-thrombolytic fibrin, deposited platelets, accumulated leukocytes, and trapped red blood cells.

[0003] Currently, the main methods for treating thrombus are drug antithrombotic therapy and artificial mechanical methods for physically restoring vascular patency. However, since the concentration of thrombolytic and anticoagulant drugs entering the blood vessels cannot be too high, otherwise it will cause side effects and toxicity to the human body, and at the same time, due to the metabolism and excretion of drugs in the human body, the concentration of antithrombotic drugs present in the blood vessels is relatively low. Antithrombosis by antithrombotic drugs has disadvantages such as slow action effect and cannot be used to rescue acute thromboembolic diseases such as acute myocardial infarction, cerebral infarction, and acute deep vein thrombosis of the lower extremities. For such diseases, only physical thrombectomy methods can be adopted.

[0004] Physical thrombectomy methods include stent thrombectomy type, thrombus aspiration type, and thrombus resection type. When aspirating thrombus through a negative pressure suction type thrombus aspiration catheter, for stable thrombus, after loosening, thrombus escape phenomenon will occur; for large-volume thrombus aspiration, large thrombus will block the aspiration port; for subacute thrombus or old thrombus, which adheres tightly to the blood vessel wall, ordinary aspiration may not be able to aspirate it, resulting in surgical failure.

[0005] Therefore, a new technical means is needed to improve the success rate of thrombus aspiration. Summary of the Invention

[0006] The purpose of the present invention is to at least solve the problem that the tube body of the traditional thrombectomy system is prone to blockage.

[0007] The present invention provides a thrombectomy system, including a handle module and a thrombectomy module. The thrombectomy module includes a catheter assembly, a thrombus fragmentation assembly, and a positioning assembly. The catheter assembly includes a tube body proximally connected to the handle module and a suction port provided on the tube body. The thrombus fragmentation assembly is disposed through the tube body; the suction port is provided at the distal end of the tube body and penetrates the distal end face of the tube body. The positioning assembly includes a positioning balloon provided on the tube body, and the positioning balloon is used to center and position the tube body after the tube body extends into the blood vessel.

[0008] The thrombectomy system in the present invention can break up the thrombus aspirated into the tube body through the thrombus fragmentation component, and discharge the broken-up thrombus through the negative pressure component, so that the tube body is not easily blocked. By setting the positioning balloon, the tube body can be centered in the blood vessel to avoid tilting, preventing secondary damage to the blood vessel caused by the suction port adhering to the inner wall of the blood vessel.

[0009] In addition, the thrombectomy system according to the present invention may further have the following additional technical features:

[0010] In some embodiments of the present invention, a positioning filling port is provided on the handle module, a positioning filling cavity is provided in the tube body, and the positioning filling cavity is used to communicate the positioning balloon and the positioning filling port.

[0011] In some embodiments of the present invention, the tube body includes a suction cavity and a guide wire cavity, the thrombus fragmentation component is disposed in the suction cavity, the catheter assembly further includes a guiding tube, the guiding tube is disposed in the guide wire cavity, and the positioning component further includes a blocking balloon disposed on the guiding tube, and the maximum outer diameter of the blocking balloon after inflation is greater than the outer diameter of the positioning balloon after inflation.

[0012] In some embodiments of the present invention, a blocking filling port is provided on the handle module, a blocking connection cavity is provided in the guiding tube, and the blocking connection cavity communicates the blocking balloon and the blocking filling port.

[0013] In some embodiments of the present invention, the outer diameter of the blocking balloon after inflation is greater than the inner diameter of the target blood vessel, and the outer diameter of the positioning balloon after inflation is less than the inner diameter of the target blood vessel.

[0014] In some embodiments of the present invention, a first imaging ring and a third imaging ring are provided on the tube body, the first imaging ring is located between the positioning balloon and the suction port, and the third imaging ring is located on the distal side of the suction port; a second imaging ring is provided on the guiding tube, and the second imaging ring is provided inside the blocking balloon.

[0015] In some embodiments of the present invention, the hardness of the blocking balloon after inflation is greater than or equal to the hardness of the positioning balloon.

[0016] In some embodiments of the present invention, the handle module includes a housing, a discharge member disposed in the housing, and a driving mechanism. The proximal end of the tube body is connected to the discharge member, the thrombus fragmentation component passes through the discharge member through the tube body, and is connected to the driving mechanism, and the driving mechanism is used to drive the thrombus fragmentation component.

[0017] In some embodiments of the present invention, the proximal end of the thrombus fragmentation assembly is connected to the handle module, and the distal end of the thrombus fragmentation assembly is located at the suction port; the thrombus fragmentation assembly includes a thrombus fragmentation connection part and a thrombus fragmentation head. The thrombus fragmentation connection part is disposed through the tube body, the proximal end of the thrombus fragmentation connection part is connected to the handle module, and the thrombus fragmentation head is disposed at the distal end of the thrombus fragmentation connection part and is located at the suction port.

[0018] In some embodiments of the present invention, the thrombus fragmentation head is spirally arranged, and the thrombus fragmentation connection part is spirally or rod-shaped. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a schematic diagram of the overall structure of the thrombectomy system in Embodiment 1 of the present invention;

[0020] Figure 2 is a schematic diagram of the internal structure of the thrombectomy system in Embodiment 1 of the present invention;

[0021] Figure 3 is a schematic diagram of the structure of the catheter assembly in Embodiment 1 of the present invention;

[0022] Figure 4 is a schematic diagram of the structure of another embodiment of the catheter assembly in Embodiment 1 of the present invention;

[0023] Figure 5 is a schematic diagram of the structure of the negative pressure assembly in Embodiment 1 of the present invention;

[0024] Figure 6 is a schematic diagram of the structure of the negative pressure assembly integrated in the handle module in Embodiment 1 of the present invention;

[0025] Figure 7 is a schematic diagram of the structure of the thrombus fragmentation assembly in Embodiment 1 of the present invention;

[0026] Figure 8 is a schematic diagram of the structure of another embodiment of the thrombus fragmentation assembly in Embodiment 1 of the present invention;

[0027] Figure 9 is a schematic diagram of the structure of the catheter assembly when it is a double lumen tube in Embodiment 1 of the present invention;

[0028] Figure 10 is a cross-sectional view of the catheter assembly when it is a double lumen tube in Embodiment 1 of the present invention;

[0029] Figure 11 is a schematic diagram of the structure of the discharge part in Embodiment 1 of the present invention;

[0030] Figure 12 is a schematic diagram of the structure of the driving mechanism in Embodiment 1 of the present invention;

[0031] Figure 13 Structural schematic diagram of the sealing component in Embodiment 1 of the present invention;

[0032] Figure 14 Structural schematic diagram of the connection of the rotary bearing in Embodiment 1 of the present invention;

[0033] Figure 15 Structural schematic diagram of the rotary bearing when welding windows are opened in Embodiment 1 of the present invention;

[0034] Figure 16 Another structural schematic diagram of the rotary bearing in Embodiment 1 of the present invention;

[0035] Figure 17 Structural schematic diagram of the rotary bearing when main body welding windows are opened in Embodiment 1 of the present invention;

[0036] Figure 18 Structural schematic diagram of the rotary bearing when both end and main body welding windows are present in Embodiment 1 of the present invention;

[0037] Figure 19 Structural schematic diagram of the main body welding window with a connection key embedded therein in Embodiment 1 of the present invention;

[0038] Figure 20 Of the present invention Figure 21 Cross-sectional view in the A-A direction;

[0039] Figure 21 Structural schematic diagram of the rotary bearing connecting to the sealed bearing in Embodiment 1 of the present invention;

[0040] Figure 22 Overall structural schematic diagram of the bolt extraction system in Embodiment 2 of the present invention;

[0041] Figure 23 Structural schematic diagram of the pipe body with multiple sub-ports in Embodiment 2 of the present invention;

[0042] Figure 24 Structural schematic diagram of another implementation manner of the pipe body with multiple sub-ports in Embodiment 2 of the present invention;

[0043] Figure 25 Structural schematic diagram of the connection of multiple sub-ports in Embodiment 2 of the present invention;

[0044] Figure 26 Structural schematic diagram of the bolt extraction system with an outer pipe in Embodiment 2 of the present invention;

[0045] Figure 27 Structural schematic diagram of the outer pipe in Embodiment 2 of the present invention;

[0046] Figure 28 Of the present inventionFigure 27 Enlarged view at location A

[0047] Figure 29 Structural schematic diagram when the mesh cover contracts in the second embodiment of the present invention

[0048] Figure 30 Structural schematic diagram when injection holes are provided on the outer tube in the second embodiment of the present invention

[0049] Figure 31 Overall structural schematic diagram of the thrombectomy system in the third embodiment of the present invention

[0050] Figure 32 Structural schematic diagram of the distal end of the tube body in the third embodiment of the present invention

[0051] Figure 33 Cross-sectional structural schematic diagram of the tube body in the third embodiment of the present invention

[0052] Figure 34 Structural diagram of the thrombectomy system with a guiding tube in the third embodiment of the present invention

[0053] Figure 35 Structural schematic diagram of the positioning component in the third embodiment of the present invention

[0054] Figure 36 Cross-sectional structural schematic diagram of the guiding tube in the third embodiment of the present invention

[0055] Figure 37 Overall structural schematic diagram of the thrombectomy system in the fourth embodiment of the present invention

[0056] Figure 38 Structural schematic diagram of the catheter assembly in the fourth embodiment of the present invention

[0057] Figure 39 Overall structural schematic diagram of the thrombectomy system in the fifth embodiment of the present invention

[0058] Figure 40 Structural schematic diagram of the catheter assembly in the fifth embodiment of the present invention

[0059] Figure 41 Structural schematic diagram when the balloon is oval in the fifth embodiment of the present invention

[0060] Figure 42 Structural schematic diagram of the balloon as a cylinder with tapered ends in the fifth embodiment of the present invention

[0061] The reference numerals in the drawings are represented as follows:

[0062] 10. Thrombectomy system; 100. Handle module; 110. Housing; 120. Discharge member; 121. Discharge seat; 122. Discharge pipe; 123. Discharge cavity; 130. Buffer seat; 200. Thrombectomy module; 210. Catheter assembly; 211. Tube body; 212. Suction port; 213. Sub-port; 214. Guide head; 215. Through hole; 216. Suction cavity; 217. Guide wire cavity; 218. Braided mesh; 219. Guide tube; 220. Thrombus fragmentation assembly; 221. Thrombus fragmentation connection part; 222. Thrombus fragmentation head; 230. Mesh pocket assembly; 231. Mesh cover; 232. Cover body connecting piece; 233. Traction wire; 234. Mesh hole; 240. Valve assembly; 241. Valve body; 242. Plug valve; 243. Three-way valve; 250. Outer tube; 251. Injection hole; 252. Injection channel; 253. Scale indicating structure; 260. Imaging member; 261. First imaging ring; 262. Second imaging ring; 263. Third imaging ring; 264. Fourth imaging ring; 265. Fifth imaging ring; 300. Negative pressure assembly; 310. Negative pressure source; 320. Negative pressure connecting pipe; 330. Negative pressure interface; 400. Driving mechanism; 410. Driving motor; 420. Transmission assembly; 421. Driving gear; 422. Driven gear; 423. Idler gear; 430. Driving switch; 500. Rotary bearing; 510. Bearing main body section; 511. Main body welding window; 512. Clamping part; 520. Proximal bearing section; 521. Proximal welding window; 522. Proximal sealed bearing; 523. Proximal sealing ring; 524. Proximal limiting bearing; 530. Distal bearing section; 531. Distal welding window; 532. Distal sealed bearing; 533. Distal sealing ring; 534. Distal limiting bearing; 540. Welding area; 550. Bearing extension part; 560. Welding window; 600. Sealing assembly; 610. Sealing seat; 611. Sealing cavity; 612. Connecting cavity; 620. Sealing gasket; 621. Annular groove; 630. Sealing hole; 640. Sealing fixing piece; 641. Extrusion piece; 700. Positioning assembly; 710. Positioning balloon; 711. Positioning filling port; 712. Positioning filling cavity; 720. Blocking balloon; 721. Blocking filling port; 722. Blocking filling cavity. Detailed implementation mode

[0063] The exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present application are shown in the drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present application can be more thoroughly understood and the scope of the present application can be completely conveyed to those skilled in the art.

[0064] It should be understood that the terms used herein are for the purpose of describing particular example embodiments only and are not intended to be limiting. Unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing", and "having" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless explicitly indicated as the order of performance. It should also be understood that additional or alternative steps may be used.

[0065] Although the terms first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly indicates otherwise, terms such as "first", "second", and other numerical terms when used herein do not imply an order or sequence.

[0066] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature shown in the figures to another element or feature, such as "inner", "outer", "inside", "outside", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation in addition to the orientations depicted in the figures.

[0067] For ease of description, the following description uses the terms "proximal" and "distal", where "proximal" refers to the end closer to the operator and "distal" refers to the end farther from the operator. The phrase "axial direction" should be understood herein to mean the direction in which the intervening element is advanced and withdrawn, and the direction perpendicular to the "axial direction" is defined as the "radial direction".

[0068] Example 1

[0069] Example 1 of the present invention provides a thrombectomy system 10, as Figures 1 to 3As shown, it includes a handle module 100, a thrombus extraction module 200, and a negative pressure assembly 300. The thrombus extraction module 200 includes a catheter assembly 210 and a thrombus fragmentation assembly 220. The catheter assembly 210 includes a tube body 211. The proximal end of the tube body 211 is connected to the handle module 100. A suction port 212 is provided on the tube body 211. The suction port 212 is used to communicate the inner cavity of the tube body 211 with the external space. The negative pressure assembly 300 provides negative pressure, and through the tube body 211 and the suction port 212, thrombus or plaque tissue in the blood vessel is extracted out of the body.

[0070] The handle module 100 includes a housing 110, a discharge member 120 provided in the housing 110, and a driving mechanism 400. A driving switch 430 is provided on the housing 110. The driving switch 430 is used to turn on or off the driving mechanism 400. The proximal end of the tube body 211 is connected to the discharge member 120. The thrombus fragmentation assembly 220 passes through the tube body 211 and the discharge member 120 in sequence and then is connected to the driving mechanism 400. The driving mechanism 400 is used to drive the thrombus fragmentation assembly 220 to work. The thrombus fragmentation assembly 220 is used to break up the inhaled thrombus or plaque tissue.

[0071] A buffer seat 130 is provided at the distal end of the housing 110. The tube body 211 passes through the buffer seat 130 and is connected to a discharge seat 121. The hardness of the buffer seat 130 is less than that of the tube body 211. By providing the buffer seat 130 for receiving the tube body 211 at the distal end of the housing 110, the stress on the connection between the tube body 211 and the housing 110 when the tube body 211 is bent is reduced, avoiding the tube body 211 from being folded at the connection with the housing 110 due to bending, and ensuring the smooth flow of the fluid inside the tube body 211. In this embodiment, the buffer seat 130 is snap-connected to the distal end of the housing 110. The buffer seat 130 is conically arranged. The tube body 211 penetrates into the buffer seat 130 and is fixedly connected to the buffer seat 130. Among them, the tube body 211 and the buffer seat 130 are fixedly connected by bonding.

[0072] As Figure 3 and Figure 4 shown, the suction port 212 is provided at the distal end of the tube body 211. The suction port 212 is a round-head opening or an inclined opening. When the suction port 212 is a round-head opening, it can better adapt to the lesion of the overall embolism of the blood vessel. When the suction port 212 is an inclined opening arranged obliquely, it can not only increase the opening area of the suction port 212, but also better adapt to the eccentric thrombus in the blood vessel, so that the opening of the suction port 212 can face the side of the eccentric thrombus, thereby improving the suction success rate of the eccentric thrombus in the blood vessel. When the suction port 212 is an inclined opening, if the inclination angle at the suction port 212 is too small, the suction ability for the eccentric thrombus is not prominent, and the opening area of the suction port 212 cannot be significantly increased; if the inclination angle at the opening is too large, it is difficult to take into account various scenarios of thrombus suction. Therefore, in this embodiment, when the suction port 212 is an inclined opening, the inclination angle is 15 degrees to 45 degrees.

[0073] In this embodiment, in combination with Figure 1 and Figure 5 as shown, the negative pressure assembly 300 is connected to the handle module 100 and adopts a split connection form. When the negative pressure assembly 300 adopts a split connection form, the negative pressure assembly 300 includes a negative pressure source 310 and a negative pressure connecting pipe 320 connected to the negative pressure source 310. A negative pressure interface 330 is provided on the negative pressure connecting pipe 320, and the negative pressure interface 330 is connected to the Luer interface on the handle module 100. Among them, the negative pressure source 310 is a negative pressure suction pump, and the negative pressure of the negative pressure suction pump can be adjusted by a switch.

[0074] In other embodiments, as Figure 6 shown, the negative pressure interface 330 can also be provided inside the handle module 100, so as to fix the negative pressure assembly 300 on the handle module 100; or the negative pressure assembly 300 is integrally arranged inside the handle module 100, so as to integrally arrange the negative pressure assembly 300 inside the handle module 100. By integrating the negative pressure assembly 300 on or inside the handle module 100, during the operation, the doctor does not need to separately assemble the negative pressure assembly 300 and the handle module 100, thus saving the operation time and improving the operation efficiency.

[0075] In this embodiment, in combination with Figure 3 and Figure 7 as shown, the thrombus fragmentation assembly 220 is disposed through the tube body 211. The proximal end of the thrombus fragmentation assembly 220 is connected to the handle module 100, and the distal end of the thrombus fragmentation assembly 220 is located at the suction port 212. The thrombus fragmentation assembly 220 includes a thrombus fragmentation connection portion 221 and a thrombus fragmentation head 222. Among them, the thrombus fragmentation connection portion 221 is disposed through the tube body 211, the proximal end of the thrombus fragmentation connection portion 221 is connected to the handle module 100, and the thrombus fragmentation head 222 is disposed at the distal end of the thrombus fragmentation connection portion 221 and is located at the suction port 212. The driving mechanism 400 in the handle module 100 drives the thrombus fragmentation connection portion 221 to drive the thrombus fragmentation head 222 to rotate, thereby breaking up the thrombus.

[0076] During operation, when the negative pressure assembly 300 sucks the thrombus in the blood vessel into the tube body 211 through negative pressure, the thrombus fragmentation head 222 of the thrombus fragmentation assembly 220 can break up the thrombus. The broken thrombus enters the inside of the handle module 100 through the tube body 211 and is discharged through the negative pressure connecting pipe 320 of the negative pressure assembly 300. Since the thrombus fragmentation assembly 220 can break up the thrombus sucked into the tube body 211 during rotation by the thrombus fragmentation head 222 during operation, the volume of the broken thrombus entering the tube body 211 is small, which can avoid blocking the suction port 212 or the tube body 211 due to the too large thrombus, so as to ensure the smooth flow of the fluid in the tube body 211, and further ensure the efficiency and success rate of thrombus aspiration.

[0077] like Figure 7 and Figure 8 As shown, the embolism breaking head 222 is arranged in a spiral shape, and the spiral embolism breaking head 222 can break the thrombus during the rotation process, and the spiral embolism breaking head 222 also has the function of conveying the thrombus, and can convey the broken thrombus in the direction of the handle module 100 during the thrombus breaking process. In addition, the embolism breaking head 222 is arranged inside the round head opening or the oblique opening to prevent the embolism breaking head 222 from accidentally damaging the inner wall of the blood vessel during the thrombus breaking process due to passing over the distal end of the tube body 211, thereby preventing unnecessary secondary damage.

[0078] The thrombus-breaking connection part 221 is in a spiral or rod shape. The thrombus-breaking connection part 221 in a spiral shape can further receive and transport the thrombus and has the function of further breaking up the thrombus, which can adapt to the situation where there are many thrombi or the thrombi are hard; the thrombus-breaking connection part 221 in a rod shape occupies less space in the tube body 211, thereby ensuring the suction area of ​​the suction cavity of the tube body 211, and can better adapt to the suction scene of small inner diameter blood vessels. Doctors can flexibly choose according to the specific use environment.

[0079] In other embodiments, the embolus breaking head 222 and the embolus breaking connecting portion 221 are in a continuous Archimedean screw shaft structure, and the negative pressure assembly 300 does not need to be connected to the handle module 100. The driving mechanism 400 drives the embolus breaking assembly 220 to rotate. Under the high-speed rotation of the Archimedean screw shaft structure, negative pressure can be generated, and the thrombus is sucked into the tube body 211 through the suction port 212, and is crushed and discharged at the same time, so as to achieve the purpose of thrombus removal without the need for the negative pressure assembly 300.

[0080] In this embodiment, the tube body 211 may be a single-lumen tube or a double-lumen tube.

[0081] like Figure 3 As shown, when the tube body 211 is a single-lumen tube, the embolism breaking assembly 220 and the guide wire both pass through the inner cavity of the tube body 211. The single-lumen tube setting can ensure the cross-sectional area of ​​the inner cavity of the tube body 211. When the tube body 211 is a single-lumen tube setting, the suction port 212 can be a round-headed opening or an oblique opening.

[0082] like Figure 9 and Figure 10As shown, when the tube body 211 is a double-lumen tube, the tube body 211 includes a suction cavity 216 and a guide wire cavity 217. The inner diameter of the guide wire cavity 217 is smaller than that of the suction cavity 216. The guide wire cavity 217 is arranged on one side of the inner wall of the suction cavity 216, and the guide wire cavity 217 and the suction cavity 216 are fixed by heat melting. The guide wire cavity 217 is used to penetrate the guide wire to ensure the smoothness inside the suction cavity 216. The thrombus fragmentation assembly 220 is arranged in the suction cavity 216 to separate the thrombus fragmentation assembly 220 and the guide wire, avoiding interference between the thrombus fragmentation assembly 220 and the guide wire during operation. When the tube body 211 adopts a double-lumen tube, the suction port 212 is arranged at the distal end of the suction cavity 216, and the suction port 212 is an inclined opening, so as to further increase the opening area of the suction cavity 216 and improve the suction rate.

[0083] Wherein, a first imaging ring 261 and a third imaging ring 263 are arranged on the tube body 211. The first imaging ring 261 is located on the proximal side of the suction port 212, and the third imaging ring 263 is located on the distal side of the suction port 212 and is arranged at the distal end of the guide wire cavity 217. Since the guide wire cavity 217 is offset relative to the tube body 211, doctors can judge the axial position and orientation of the suction port 212 by observing the first imaging ring 261 and the third imaging ring 263, which is convenient for doctors to adjust the orientation of the suction port 212, so as to facilitate the suction of eccentric thrombus.

[0084] The main body part of the tube body 211 is made of polymer materials, such as polyurethane, nylon, pebax materials, etc. A braided mesh 218 is embedded in the tube body 211, and the overall hardness of the tube body 211 is between 55D and 75D, so as to increase the overall flexibility and resilience of the tube body 211, ensure that the inside of the tube body 211 remains smooth when passing through curved blood vessels, and ensure the suction rate.

[0085] Figure 11 As shown, the discharge member 120 includes a discharge seat 121 arranged in the handle module 100 and a discharge pipe 122 connected to the side of the discharge seat 121. A through discharge cavity 123 is formed in the discharge seat 121, the discharge pipe 122 is communicated with the discharge cavity 123, and the discharge pipe 122 and the discharge seat 121 are arranged obliquely to facilitate the discharge of thrombus during movement.

[0086] Combined Figure 2 with Figure 12 As shown, the driving mechanism 400 includes a driving motor 410, a transmission component 420, a rotary bearing 500 and a sealing component 600 arranged in the housing 110. The proximal end of the thrombus fragmentation connecting part 221 is fixedly connected to the rotary bearing 500. When the driving motor 410 drives the rotary bearing 500 to rotate through the transmission component 420, the rotary bearing 500 drives the thrombus fragmentation connecting part 221 to rotate, and then drives the thrombus fragmentation head 222 to rotate.

[0087] The transmission assembly 420 includes a driving gear 421 connected to the driving motor 410, a driven gear 422 connected to the rotary bearing 500. The driven gear 422 is fixedly connected to the rotary bearing 500, and the driving gear 421 meshes with the driven gear 422.

[0088] In other embodiments, an idler gear 423 may be further disposed between the driving gear 421 and the driven gear 422. The idler gear 423 is used to connect the driving gear 421 and the driven gear 422. When the idler gear 423 is provided, not only can the internal space of the handle module 100 be saved, but also the rotation direction of the driven gear 422 can be reversed through the idler gear 423, so as to adjust the rotation direction of the bolt-breaking assembly 220.

[0089] In this embodiment, the sealing assembly 600 includes a sealing seat 610 disposed at the proximal end of the handle module 100. A sealing gasket 620 is disposed in the sealing seat 610. The guide wire can pass through the sealing gasket 620 to penetrate into or out of the handle module 100. The sealing assembly 600 seals the internal tube of the handle module 100 through the sealing gasket 620 to avoid blood leakage during the operation. The sealing gasket 620 is made of a soft material, such as silica gel, rubber, etc.

[0090] Combined Figure 12 with Figure 13 As shown, a tapered sealing hole 630 is formed in the middle of the sealing gasket 620. The porosity of the sealing hole 630 on the side facing the distal end is larger, and the porosity of the sealing hole 630 on the side facing the proximal end is smaller. Since when the guide wire establishes the access path for inserting the thrombectomy system 10 into the blood vessel, it is inserted through the distal end of the tube body 211 and passes out through the sealing assembly 600 of the handle module 100, the guide wire first contacts the distal side of the sealing gasket 620. The porosity of the sealing hole 630 on the side facing the distal end is larger, which is convenient for guiding the guide wire to pass out along the tapered sealing hole 630.

[0091] The sealing seat 610 includes a sealing cavity 611 and a connecting cavity 612. The sealing cavity 611 and the connecting cavity 612 are coaxially arranged. The inner diameter of the sealing cavity 611 is larger than the inner diameter of the connecting cavity 612. The sealing cavity 611 is used to assemble the sealing gasket 620, and the connecting cavity 612 is used to connect the rotary bearing 500. The sealing gasket 620 is disposed in the sealing cavity 611 during assembly, and the distal end of the sealing gasket 620 fits against the bottom of the sealing cavity 611. A sealing fixing member 640 is further provided on the sealing seat 610, and the sealing fixing member 640 is used to fix the sealing gasket 620 in the sealing cavity 611.

[0092] The sealing and fixing member 640 includes an extrusion member 641 disposed on the inner wall of the sealing cavity 611. The extrusion member 641 abuts against the proximal end of the sealing gasket 620, and the cross-section of the extrusion member 641 is in a shape such as an arc or a triangle. When the guide wire is not inserted into the sealing hole 630, the extrusion member 641 provides a force pressing the sealing hole 630 towards the axis by abutting against the sealing gasket 620, thereby prompting the sealing hole 630 to close and maintaining the sealing performance of the sealing gasket 620. When a guide wire is inserted into the sealing hole 630, the guide wire provides an outward expanding force relative to the sealing gasket 620. While expanding the sealing hole 630, the guide wire passes through the sealing hole 630, and under the combined action of the extrusion member 641 and the sealing gasket 620, the sealing effect of the sealing gasket 620 on the guide wire is ensured.

[0093] Combined Figures 13 to 15 As shown, the rotary bearing 500 includes a bearing main body section 510 and bearing extension parts 550 disposed at both ends of the bearing main body section 510. A welding window 560 is provided on the bearing extension parts 550. The bolt-breaking assembly 220 passes through the rotary bearing 500 and is fixedly connected to the rotary bearing 500. The bearing extension parts 550 include a proximal bearing section 520 disposed on the proximal side of the bearing main body section 510 and a distal bearing section 530 disposed on the distal side of the bearing main body section. The outer diameters of the proximal bearing section 520 and the distal bearing section 530 are smaller than that of the bearing main body section 510. The proximal bearing section 520, the distal bearing section 530, and the bearing main body section 510 are all in a hollow tubular shape, and the three are coaxially arranged and fixed as a whole. The bearing main body section 510 is used to connect the driven gear 422. The proximal bearing section 520 is connected to the sealing seat 610, and the proximal bearing section 520 and the sealing seat 610 are rotatably connected through a proximal sealing bearing 522. The distal bearing section 530 is connected to the discharge seat 121, and the distal bearing section 530 and the discharge seat 121 are connected through a distal sealing bearing 532. Among them, a clamping portion 512 is provided on the bearing main body section 510, and the clamping portion 512 is used to fix the driven gear 422.

[0094] The bolt-breaking assembly 220 passes through the rotary bearing 500 and is fixedly connected to the rotary bearing 500, and rotates together with the rotary bearing 500. Among them, the bolt-breaking mechanism and the rotary bearing 500 are fixed as a whole by welding.

[0095] Due to the fact that the welding head cannot extend into the interior of the rotary bearing 500 in common welding methods, welding and fixing can only be performed at the two side ports. Since the bolt-breaking mechanism adopts a spiral structure, welding and fixing can only be performed at the ports of the rotary bearing 500, and the firmness of the fixation between the bolt-breaking assembly 220 and the rotary bearing 500 is questionable. During the process of the rotary bearing 500 driving the bolt-breaking assembly 220 to rotate at a high speed, if the welding is not firm, it will cause the bolt-breaking assembly 220 to separate from the rotary bearing 500, and the bolt-breaking assembly 220 cannot rotate together with the rotary bearing 500, thereby causing the bolt-breaking assembly 220 to fail.

[0096] In this embodiment, a welding window 560 is provided on the bearing extension 550, and a welding area 540 is provided within the welding window 560, so that the broken bolt assembly 220 can be fixedly welded to the rotary bearing 500 through the welding area 540, increasing the welding area and improving the fixing strength between the two.

[0097] As Figure 15 shown in Figure 16 FIG. 8, the welding window 560 includes a proximal welding window 521 and a distal welding window 531, that is, a proximal welding window 521 and a distal welding window 531 are respectively formed on the proximal bearing section 520 and / or the distal bearing section 530, and welding areas 540 are provided within both the proximal welding window 521 and the distal welding window 531. Through the proximal welding window 521 and / or the distal welding window 531 at both ends, the broken bolt assembly 220 inserted into the rotary bearing 500 is exposed, so that the welding machine can reach the welding area 540 inside the rotary bearing 500 through the welding windows 560 at both ends for welding. That is, by adding welding areas 540 at at least one end of the rotary bearing 500, the number of welding points is increased to firmly weld the broken bolt assembly 220 to the rotary bearing 500. Among them, the surface of the welding area 540 is provided with pattern protrusions to increase the welding strength between the welding area 540 and the broken bolt assembly 220.

[0098] Among them, if the welding window is too large, it will affect the overall strength of the bearing section; if the welding window is too small, it will reduce the area of the welding area 540. Therefore, the ratio of the axial length of each welding window to the total length of its bearing section is 0.4 to 0.8, so as to balance the structural strength of the rotary bearing 500 and the welding strength of the broken bolt assembly 220. In addition, to ensure the overall welding strength between the rotary bearing 500 and the broken bolt assembly 220, there are at least three welding points between the welding area 540 of the rotary bearing 500 and the broken bolt connection part 221.

[0099] In addition, as Figure 17 shown in Figure 18 FIG. 9, the welding window 560 further includes a main body welding window 511. A main body welding window 511 can also be formed on the bearing main body section 510, or corresponding welding windows 560 can be provided on the bearing main body section 510, the proximal bearing section 520, and the distal bearing section 530 at the same time to increase the welding area 540 between the broken bolt assembly 220 and the rotary bearing 500, thereby increasing the connection strength.

[0100] Through the above technical solution, the sizes of the respective welding windows 560 can be adjusted and the number of welding points can be controlled. That is, for the broken bolt assemblies 220 of different sizes, by selecting the appropriate size of the welding window, the welding strength between the rotary bearing 500 and the broken bolt assembly 220 and the strength of the rotary bearing 500 itself can be balanced, so as to meet the fixing requirements for the broken bolt assemblies 220 of different sizes.

[0101] As shown in combination with Figures 19 to 21 , a connecting key 513 is embedded in the main body welding window 511 of this embodiment. A key groove 4221 is provided on the inner side of the driven gear 422. The connecting key 513 is snap-fitted with the key groove 4221 to fix the driven gear 422. A support step 514 is provided on the inner edge of the main body welding window 511 opened on the bearing main body section 510. The support step 514 is used to support the connecting key 513. The connecting key 513 and the main body welding window 511 are connected by an interference fit. On the one hand, it can connect the driven gear 422, on the other hand, it can seal the main body welding window 511, and at the same time increase the strength of the bearing main body section 510 at the main body welding window 511, avoiding plastic deformation of the bearing main body section 510 during high-speed rotation.

[0102] After the connecting key 513 is assembled, its radial height from the rotation center of the rotary bearing 500 is greater than the outer diameter of the bearing main body section 510 and less than the outer diameter of the snap-fitting portion 512. After the driven gear 422 is snap-fitted and fixed with the connecting key 513 through the key groove 4221, it abuts against the snap-fitting portion 512, thereby realizing axial positioning.

[0103] In this embodiment, as shown in Figure 14 , the proximal sealing bearing 522 is hermetically connected to the sealing seat 610 through the proximal sealing ring 523. The proximal sealing ring 523 is sleeved on the outside of the proximal sealing bearing 522. The distal sealing bearing 532 is hermetically connected to the discharge seat 121 through the distal sealing ring 533. The distal sealing ring 533 is sleeved on the outside of the distal sealing bearing 532.

[0104] Since the broken bolt assembly 220 needs to rotate under the drive of the drive mechanism 400, a seal needs to be provided between the transmission assembly 420 and the broken bolt assembly 220 to ensure that the rotary bearing 500 remains sealed during continuous rotation. This embodiment uses the method of setting sealing rings outside each sealing bearing for dynamic sealing to achieve the sealing of the proximal and distal ends of the rotary bearing 500, provide a sealed environment for the negative pressure assembly 300, and ensure that the negative pressure provided by the negative pressure assembly 300 can maintain the function of thrombus aspiration.

[0105] Among them, as shown in Figure 21As shown, a proximal limiting bearing 524 is provided on the outer side of the proximal sealing bearing 522. The proximal limiting bearing 524 is connected to the proximal bearing section 520 and is disposed closely against the sealing seat 610. A distal limiting bearing 534 is provided on the outer side of the distal sealing bearing 532. The distal limiting bearing 534 is connected to the distal bearing section 530 and is disposed closely against the discharge seat 121. In this embodiment, by adding a limiting bearing between the rotating bearing 500 and each sealing bearing, the functions of limiting and stabilizing are achieved, preventing each sealing bearing and sealing ring at both ends from falling off when the rotating bearing 500 rotates at a high speed, thereby ensuring the structural stability.

[0106] In specific implementation, the negative pressure interface 330 of the negative pressure assembly 300 is connected to the Luer interface on the discharge seat 121. The guide wire already placed in the blood vessel penetrates from the distal end of the thrombectomy system 10 and exits from the guide wire outlet of the handle module 100. The guide wire outlet is the sealing hole 630 of the gasket 620. After establishing the path for the thrombectomy system 10 to enter the blood vessel lesion location through the guide wire, the thrombectomy system 10 is inserted into the blood vessel along the guide wire and reaches the designated position. At this time, the negative pressure assembly 300 is turned on, and the driving mechanism 400 is started to drive the thrombus fragmentation assembly 220 to rotate. At this time, the handle module 100 drives the tube body 211 to slowly retreat along the guide wire. The thrombus will be aspirated into the tube body 211 by the negative pressure assembly 300 through the suction port 212 and will be broken by the thrombus fragmentation assembly 220 in the tube body 211. The broken thrombus enters the handle body through the inner tube and is discharged through the discharge member 120 and the negative pressure connecting tube 320 of the negative pressure assembly 300.

[0107] The above technical solution of this embodiment, compared with traditional thrombus aspiration instruments, integrates the aspiration and thrombus fragmentation structures. While ensuring the thrombus aspiration force, it prevents the thrombus from getting stuck in the suction port 212 or the tube body 211, improving the surgical success rate and efficiency.

[0108] Embodiment Two

[0109] Embodiment Two of the present invention proposes a thrombectomy system 10. The same parts as those in Embodiment One will not be described in detail. The differences between Embodiment Two and Embodiment One are as follows. Figure 22 As shown, a guiding head 214 is provided at the distal end of the tube body 211, and the suction port 212 is opened on the side wall of the tube body 211; one or more suction ports 212 are provided on the tube body 211. When there are multiple suction ports 212, the multiple suction ports 212 are arranged at intervals along the circumferential direction of the tube body 211.

[0110] Specifically, a single suction port 212 may be provided on the tube body 211, or the tube body 211 may include two suction ports 212 disposed opposite to each other, or multiple suction ports 212 disposed at intervals along the circumferential direction, so as to adapt to different forms of vascular embolism. When the vascular embolism is an eccentric thrombus in the blood vessel, a single suction port 212 structure may be adopted to concentrate the suction force and ensure the suction effect of the thrombus. When the entire blood vessel is embolic, a structure of two or more suction ports 212 may be adopted to increase the suction area and improve the surgical efficiency.

[0111] In other embodiments, Figures 23 to 25 As shown, the suction port 212 may also include a plurality of sub-ports 213. When the suction port 212 is formed by combining a plurality of sub-ports 213, the negative pressure suction force of a single sub-port 213 can be improved while ensuring the coverage of the suction port 212, thereby improving the suction effect of the mural thrombus, and effectively increasing the suction force on the broken thrombus, thereby avoiding the residual broken thrombus in the blood vessel due to insufficient suction force of the thrombus removal system 10, thereby avoiding secondary embolism of the downstream branch blood vessels. The shape of the sub-port 213 may be circular, elliptical, etc., and a plurality of sub-ports 213 may be interconnected or spaced apart.

[0112] The guide head 214 is arranged in a conical shape, and a through hole 215 is arranged in the axial direction of the guide head 214, and the through hole 215 is connected with the tube body 211, and is used as a passage for the guide wire to pass through. The guide head 214 and the plug-breaking assembly 220 are arranged at intervals, so as to reserve a deformation margin generated by the plug-breaking assembly 220 during the rotation process, ensure that the plug-breaking assembly 220 moves smoothly during the working process, and ensure the plug-breaking effect of the plug-breaking assembly 220.

[0113] Before the thrombus removal system 10 enters the blood vessel, a guide wire is first inserted to establish a path for the thrombus removal system 10 to enter the vascular lesion position. The hardness of the guide head 214 is less than that of the tube body 211, and the hardness of the guide head 214 is between 40D and 55D, so that the tube body 211 can enter the body easily and the guide head 214 of the tube body 211 will not cause damage to the blood vessel. The material of the guide head 214 can be the same as that of the tube body 211, or different.

[0114] Among them, Figures 26 to 28 As shown, the catheter assembly 210 also includes an outer tube 250 that is sleeved on the outside of the tube body 211, the distal end of the tube body 211 is arranged to pass through the outer tube 250, and the suction port 212 is arranged on the tube body 211 and located on the distal side of the outer tube 250; a net bag assembly 230 with shape memory performance is arranged between the tube body 211 and the outer tube 250, and the net bag assembly 230 is covered on the outside of the suction port 212.

[0115] In this embodiment, by adding a mesh bag assembly 230 outside the catheter assembly 210, during the aspiration process, the mesh bag assembly 230 can converge the thrombus near the aspiration port 212, to a greater extent avoid the phenomenon of thrombus escape during thrombus aspiration, and can improve the efficiency of thrombus aspiration, reduce the operation time, and increase the success rate of the operation.

[0116] The mesh bag assembly 230 includes a mesh cover 231 and a cover body connecting member 232. The distal end of the mesh cover 231 is connected to the tube body 211. The distal end of the mesh cover 231 is closed and located on the distal side of the aspiration port 212. The proximal end of the mesh cover 231 is open. The distal end of the cover body connecting member 232 is connected to the mesh cover 231, and the proximal end of the cover body connecting member 232 is connected to the outer tube 250. The outer tube 250 and the tube body 211 can slide relative to each other to control the opening size of the proximal end of the mesh cover 231 through the cover body connecting member 232.

[0117] The mesh cover 231 is in a spindle-shaped self-expanding type. The mesh cover 231 is formed by weaving a memory material, including nitinol, stainless steel, polymer materials, etc. In this embodiment, the mesh cover 231 is formed by weaving nickel-titanium wires. After the mesh cover 231 is woven and formed, it has mesh holes 234. The density of the mesh holes 234 of the mesh cover 231 gradually increases from the proximal end to the distal end or the density of the mesh holes 234 of the mesh cover 231 is evenly distributed, so as to facilitate the aggregation of thrombus, and the aggregated thrombus is not easy to escape from the mesh holes 234.

[0118] Among them, the cover body connecting member 232 is at least two traction wires 233 arranged at the proximal end of the mesh cover 231. The distal end of the mesh cover 231 is connected to the tube body 211, and the traction wires 233 are connected to the outer tube 250. When there are multiple traction wires 233, the multiple traction wires 233 are circumferentially spaced apart, so that the mesh cover 231 is evenly stressed.

[0119] A valve assembly 240 is provided at the proximal end of the outer tube 250. The tube body 211 passes through the outer tube 250 through the valve assembly 240. The outer tube 250 can be advanced or retracted along the tube body 211, and the release size of the mesh cover 231 is controlled by controlling the relative position of the tube body 211 and the outer tube 250.

[0120] The valve assembly 240 includes a valve body 241, a plug valve 242 provided on the valve body 241, and a three-way valve 243 connected to the side of the valve body 241 through a hose. The plug valve 242 is used to control the locking or separation between the outer tube 250 and the tube body 211. Specifically, when the plug valve 242 is loosened, the outer tube 250 can be advanced or retracted along the inner tube. When the plug valve 242 is locked, the outer tube 250 is fixed on the inner tube, so that the size of the mesh cover 231 is fixed, and the proximal end of the outer tube 250 is sealed with the tube body 211.

[0121] Combined Figures 27 to 29As shown, when inserting or removing the catheter assembly 210, the outer tube 250 is moved proximally relative to the tube body 211 until the mesh cover 231 is straightened and abuts against the outer wall of the tube body 211, causing the mesh cover 231 to be in a contracted state. At this time, the locking stopcock valve 242 is tightened so that the doctor can quickly move the catheter assembly 210. When it is necessary to release the mesh cover 231, the outer tube 250 is moved distally relative to the tube body 211 until the mesh cover 231 is released to a predetermined size. At this time, the locking stopcock valve 242 is tightened to fix the size of the mesh cover 231.

[0122] In other embodiments, a scale indicating structure 253 may also be provided on the tube body 211 for identifying the locking position of the stopcock valve 242, thereby indicating the release size of the mesh cover 231, facilitating the doctor's recognizable operation during the surgery.

[0123] In this embodiment, the distal end of the thrombus fragmentation assembly 220 terminates at the end of the tube body 211, and the thrombus fragmentation assembly 220 is spaced apart from the guide head 214. The proximal end of the thrombus fragmentation assembly 220 is connected to the drive mechanism 400 in the handle module 100. The drive mechanism 400 controls the thrombus fragmentation assembly 220 to reciprocate axially or rotate radially at the suction port 212 of the tube body 211, thereby breaking up the thrombus at the suction port 212.

[0124] In other embodiments, as Figure 30 shown, an injection hole 251 is further provided at the distal end of the outer tube 250. The injection hole 251 may be one or more. An injection channel 252 is provided on the tube body of the outer tube 250. The injection channel 252 connects the injection hole 251 and the three-way valve 243 on the valve body 241. During use, the thrombus extraction system 10 is delivered to a predetermined position along the guide wire. For a relatively hard thrombus, a thrombolytic agent or a softening agent and other medicaments can be injected through the three-way valve 243 on the outer tube 250. The medicaments are sprayed onto the thrombus through the injection hole 251, and the softened thrombus can be removed after waiting for a while.

[0125] During specific operation, connect the negative pressure interface 330 of the negative pressure component 300 to the Luer interface of the handle module 100. The guide wire already placed in the blood vessel penetrates into the guiding head 214 of the thrombectomy system 10 and exits from the guide wire outlet of the sealing component 600. After the mesh cover 231 of the thrombectomy system 10 reaches the designated position along the guide wire, the doctor can push the stopcock valve 242 to the required position and then tighten it according to the size of the blood vessel diameter, so that the mesh cover 231 expands by itself to a size adapted to the blood vessel. Then turn on the switches of the negative pressure component 300 and the driving mechanism 400, and slowly withdraw the thrombectomy system 10 along the guide wire by controlling the handle module 100. Pull the thrombus into the mesh pocket through the mesh cover 231. The thrombus will be aspirated into the tube body 211 by the negative pressure component 300 through the suction port 212 and be broken by the thrombus-breaking component 220 in the tube body 211. Finally, the broken thrombus is discharged in sequence through the tube body 211, the discharge component 120 and the negative pressure connecting tube 320 of the negative pressure component 300.

[0126] In this embodiment, the catheter assembly 210 with the mesh cover 231 is adopted, which can avoid the phenomenon of thrombus escape to a greater extent during the thrombus aspiration process, and can improve the efficiency of thrombus aspiration, reduce the operation time, and improve the success rate of the operation.

[0127] Embodiment III

[0128] Embodiment III of the present invention provides a thrombectomy system 10. The same parts as those in Embodiment I will not be described in detail. The differences between Embodiment III and Embodiment I are as follows Figures 31 to 33 As shown, the suction port 212 is arranged at the distal end of the tube body 211, and a positioning component 700 is arranged on the catheter assembly 210. The positioning component 700 is used to center the catheter assembly 210, so as to prevent the catheter assembly 210 from skewing during the thrombus aspiration process and avoid secondary damage to the blood vessel caused by the suction port 212. The positioning component 700 includes a positioning balloon 710, and the positioning balloon 710 is located on the proximal side of the suction port 212. Among them, the positioning balloon 710 is arranged at one end of the suction port 212 close to the tube body 211. The positioning balloon 710 is coaxially arranged with the tube body 211. The outer diameter of the positioning balloon 710 is larger than that of the tube body 211. The positioning balloon 710 is used to center and position the tube body 211 after the tube body 211 extends into the blood vessel.

[0129] During the thrombectomy process of the thrombectomy system 10, negative pressure needs to be provided by the negative pressure component 300, and the thrombus is aspirated by the negative pressure formed at the aspiration port 212. There is a situation where the aspiration port 212 is adsorbed on the inner wall of the blood vessel due to negative pressure, especially when the aspiration port 212 is an inclined opening. If the aspiration port 212 is adsorbed on the inner wall of the blood vessel due to negative pressure, it will cause damage to the blood vessel wall. In this embodiment, a positioning balloon 710 with an outer diameter larger than that of the tube body 211 is arranged at one end of the tube body 211 close to the aspiration port 212, so that the tube body 211 is not prone to tilt during the thrombectomy process of the thrombectomy system 10, ensuring that the blood vessel will not be damaged secondary during the thrombus aspiration process.

[0130] Among them, a positioning filling port 711 is arranged on the housing 110 of the handle module 100, and a positioning filling cavity 712 is arranged on the tube body 211. The positioning filling cavity 712 is connected to the positioning balloon 710 and the positioning filling port 711. When the tube body 211 is inserted into the blood vessel, the filling medium in the positioning balloon 710 is evacuated through the positioning filling port 711, so that the positioning balloon 710 is in a contracted state. The balloon in the contracted state fits against the outer wall of the tube body 211, so that the tube body 211 can be smoothly inserted into the blood vessel. When the tube body 211 moves to a preset position, the filling medium is filled into the positioning balloon 710 through the positioning filling port 711, so that the positioning balloon 710 expands. The outer diameter of the expanded positioning balloon 710 is larger than the outer diameter of the tube body 211, so as to achieve the effect of centering the tube body 211 in the blood vessel, and achieve the purpose of avoiding damage to the inner wall of the blood vessel caused by the inclination of the tube body 211 during the thrombectomy process.

[0131] In this embodiment, the outer diameter of the positioning balloon 710 is larger than the outer diameter of the tube body 211 and smaller than the inner diameter of the target blood vessel, so that the positioning balloon 710 can not only achieve the effect of roughly centering the tube body 211 in the blood vessel, but also the tube body 211 can move along the blood vessel to perform thrombectomy work on thrombi in different parts.

[0132] As Figures 34 to 36 shown, the catheter assembly 210 further includes a guiding tube 219, and the positioning assembly 700 further includes a blocking balloon 720 arranged on the guiding tube 219. The blocking balloon 720 is located on the distal side of the aspiration port 212, and the outer diameter of the blocking balloon is larger than the inner diameter of the target blood vessel, so as to block the blood flow. The tube body 211 is a double-lumen tube, and the tube body 211 includes an aspiration cavity 216 and a guide wire cavity 217. The guide wire cavity 217 is arranged on one side of the aspiration cavity 216. The thrombus fragmentation assembly 220 is inserted into the aspiration cavity 216, and the guiding tube 219 passes through the guide wire cavity 217 and out of the tube body 211, so as to establish a passage for the tube body 211 to enter the blood vessel. Since the aspiration cavity 216 and the guide wire cavity 217 are respectively arranged, the internal smoothness of the aspiration cavity 216 is ensured.

[0133] The occlusion balloon 720 is disposed at the distal end of the guiding catheter 219. An occlusion filling cavity 722 communicating with the occlusion balloon 720 is provided inside the guiding catheter 219. An occlusion filling port 721 is provided on the housing 110. The occlusion filling cavity 722 communicates with the occlusion balloon 720 and the occlusion filling port 721. After the occlusion balloon 720 passes through the guide wire lumen 217 following the guiding catheter 219, it is located on the distal side of the tube body 211. The outer diameter of the occlusion balloon 720 is larger than that of the positioning balloon 710. The occlusion balloon 720 is used to be anchored in the blood vessel after inflation. When retrieving a thrombus, the occlusion balloon 720 can occlude the distal end of the blood vessel and play a role in blocking blood flow. Since the occlusion balloon 720 blocks the blood flow at the distal end of the aspiration port 212 after inflation, it can prevent thrombus from falling off to the distal end of the blood vessel during aspiration and avoid fragmented thrombus remaining in the blood vessel after aspiration, ensuring the effect of thrombus aspiration.

[0134] Among them, the hardness of the occlusion balloon 720 is greater than or equal to that of the positioning balloon 710. The positioning balloon 710 is preferably a semi-compliant balloon with a certain hardness. The material can be selected as nylon, and the hardness is between 35D and 45D, so as to play a good central positioning role. The occlusion balloon 720 is preferably a compliant balloon that can deform to a large extent. The material can be selected as polyurethane, and the hardness is between 30D and 42D, so as to play a good supporting and occluding role.

[0135] A radiopaque member 260 can also be provided on the tube body 211 and / or the guiding catheter 219. The radiopaque member 260 is disposed inside or outside the positioning balloon 710 and / or the occlusion balloon 720. The radiopaque member 260 is made of a metal material with radiopaque properties, such as tantalum or gold. By providing the radiopaque member 260 on the catheter assembly 210, the position of the catheter assembly 210 can be known in real time during the operation to assist the doctor in operation.

[0136] In this embodiment, the radiopaque member 260 includes two radiopaque rings provided on the catheter assembly 210. Among them, the first radiopaque ring 261 is provided on the tube body 211. The first radiopaque ring 261 is located on the proximal side of the aspiration port 212 and on the distal side of the positioning balloon 710, and is used to show the positions of the aspiration port 212 and the positioning balloon 710; the second radiopaque ring 262 is provided on the guiding catheter 219. The second radiopaque ring 262 is disposed inside the occlusion balloon 720 and at the middle position of the occlusion balloon 720, and is used to show the position of the occlusion balloon 720.

[0137] In other embodiments, such as Figure 32As shown, a third developing ring 263 may also be provided on the tube body 211. The third developing ring 263 is located at the distal side of the suction port 212 and is provided at the end of the guide wire cavity 217. Since the guide wire cavity 217 is offset relative to the tube body 211, the doctor can determine the axial position and direction of the suction port 212 by observing the first developing ring 261 and the third developing ring 263, which can facilitate the doctor to adjust the direction of the suction port 212, thereby facilitating the suction of eccentric thrombus.

[0138] Through the above technical solution of this embodiment, when thrombus aspiration is performed, since the thrombus-breaking assembly 220 is provided in the aspiration chamber 216, the thrombus will not accumulate at the aspiration port 212, and the aspiration port 212 can be prevented from being blocked, thereby ensuring the success rate of thrombus aspiration. By providing a positioning balloon 710 having an outer diameter greater than that of the tube body 211 at one end of the tube body 211 close to the aspiration port 212, the tube body 211 of the thrombus removal system 10 is not easy to tilt during the thrombus removal process, thereby ensuring that no secondary damage is caused to the blood vessel during the thrombus aspiration process. In addition, a guide tube 219 is provided, and a blocking balloon 720 is provided at the distal end of the guide tube 219. The blocking balloon 720 can block the thrombus broken by the thrombus-breaking assembly 220, thereby ensuring that all thrombi can be extracted from the aspiration port 212, thereby avoiding the thrombus residue after aspiration, which causes the postoperative thrombus-breaking thrombus to block the downstream branch thrombus.

[0139] Embodiment 4

[0140] The fourth embodiment of the present invention provides a thrombus removal system 10. The similarities between the fourth embodiment and the third embodiment are not repeated here. The difference between the fourth embodiment and the third embodiment is that: Figures 37 to 38 As shown, the suction port 212 is arranged at the distal end of the tube body 211. The tube body 211 is a double-lumen tube. The tube body 211 includes a suction cavity 216 and a guidewire cavity 217. The guidewire cavity 217 is arranged on one side of the suction cavity 216. The thrombus-breaking assembly 220 is penetrated in the suction cavity 216. The catheter assembly 210 also includes a guide tube 219. The guide tube 219 passes through the tube body 211 through the guidewire cavity 217 and is used to establish a path for the tube body 211 to enter the blood vessel. A positioning assembly 700 is arranged on the catheter assembly 210. The positioning assembly 700 is used to center the catheter assembly 210, thereby preventing the catheter assembly 210 from tilting during the process of thrombus aspiration and avoiding secondary damage to the blood vessel caused by the suction port 212. The positioning assembly 700 includes a positioning balloon 710.

[0141] In this embodiment, the positioning balloon 710 is disposed on the guiding catheter 219. The positioning balloon 710 is located on the distal side of the aspiration port 212. A positioning filling port 711 is provided on the housing 110 of the handle module 100. A filling medium is injected into or evacuated from the positioning balloon 710 through the positioning filling port 711. The inflated positioning balloon 710 can keep the tube body 211 approximately centered during movement, thereby preventing the tube body 211 from tilting and avoiding secondary damage to blood vessels caused by the aspiration port 212 during thrombus aspiration.

[0142] In this embodiment, the catheter assembly 210 further includes an outer tube 250 sleeved outside the tube body 211. The distal end of the tube body 211 passes through the outer tube 250. The aspiration port 212 is provided on the tube body 211 and is located on the distal side of the outer tube 250. A valve assembly 240 is provided at the proximal end of the outer tube 250. The tube body 211 passes through the valve assembly 240 and penetrates into the outer tube 250. The outer tube 250 can be advanced or retracted along the tube body 211. The valve assembly 240 includes a valve body 241, a plug valve 242 provided on the valve body 241, and a three-way valve 243 connected to the side of the valve body 241 through a hose. The plug valve 242 is used to control the locking or separation between the outer tube 250 and the tube body 211.

[0143] The positioning assembly 700 further includes a blocking balloon 720. The blocking balloon 720 is disposed on the outer tube 250. The outer tube 250 and the blocking balloon 720 are located on the proximal side of the aspiration port 212. A blocking filling port 721 is provided on the valve assembly 240. The blocking filling port 721 communicates with the blocking balloon 720 through the outer tube 250. The outer diameter of the blocking balloon 720 is larger than that of the positioning balloon 710. The blocking balloon 720 is used to be anchored in the blood vessel after inflation. When retrieving a thrombus, the blocking balloon 720 can block the proximal end of the blood vessel and play a role in blocking blood flow. Since the blocking balloon 720 blocks the blood flow at the proximal end of the aspiration port 212 after inflation, thrombus detachment to the proximal end of the blood vessel during aspiration can be avoided, and fragmented thrombus remaining in the blood vessel after aspiration can be avoided, ensuring the effect of thrombus aspiration.

[0144] When the catheter assembly 210 is inserted into a blood vessel, the axial position of the outer tube 250 relative to the tube body 211 is fixed by tightening the stopcock valve 242. At the same time, during the process of inserting the tube body 211 into the blood vessel, the positioning balloon 710 is evacuated through the positioning filling port 711, and the guide tube 219 and the positioning balloon 710 are placed in the guide wire lumen 217 of the tube body 211. When the tube body 211 reaches the designated position, the guide tube 219 is passed out of the guide wire lumen 217. When the guide tube 219 reaches the designated position, a filling medium is injected into the positioning balloon 710 through the positioning filling port 711 to inflate the positioning balloon 710. The inflated positioning balloon 710 can prevent the tube body 211 from tilting, and a filling medium is injected into the occlusion balloon 720 through the occlusion filling port 721 to inflate the occlusion balloon 720. The inflated occlusion balloon 720 is anchored in the blood vessel and blocks the blood flow. Then, the stopcock valve 242 is rotated and loosened to disengage the tube body 211 and the outer tube 250 from the fixed state. At this time, the tube body 211 can move axially along the outer tube 250, and thrombus aspiration work can be performed.

[0145] A visualization member 260 is provided on the catheter assembly 210. The visualization member 260 includes a fourth visualization ring 264 provided on the outer tube 250, and the fourth visualization ring 264 is provided within the occlusion balloon 720; a fifth visualization ring 265 provided on the guide tube 219, and the fifth visualization ring 265 is provided within the positioning balloon 710. The fourth visualization ring 264 and the fifth visualization ring 265 are used to respectively display the positions of the occlusion balloon 720 and the positioning balloon 710 to assist the doctor in the operation.

[0146] The visualization member 260 further includes a first visualization ring 261 provided on the tube body 211, the first visualization ring 261 is located on the proximal side of the aspiration port 212, and a third visualization ring 263 located on the distal side of the aspiration port 212 and provided at the distal end of the guide wire lumen 217. Since the guide wire lumen 217 is offset relative to the tube body 211, the doctor can judge the axial position and the orientation of the aspiration port 212 by observing the first visualization ring 261 and the third visualization ring 263, which can facilitate the doctor to adjust the orientation of the aspiration port 212, thereby facilitating the aspiration of eccentric thrombi.

[0147] Among them, before thrombus aspiration, angiography is first performed to show the thrombus or plaque to be aspirated, and then by observing the visualization member 260, the occlusion balloon 720 and the positioning balloon 710 are respectively located on both sides of the thrombus or plaque to be aspirated, so that the thrombus aspiration work can be completed by one thrombus removal action, saving the operation time.

[0148] Through the above technical solution of this embodiment, when thrombus aspiration is performed, since the thrombus-breaking assembly 220 is provided in the aspiration chamber 216, the thrombus will not accumulate at the aspiration port 212, and the aspiration port 212 can be prevented from being blocked, thereby ensuring the success rate of thrombus aspiration. A positioning balloon 710 is provided at the distal end of the guide tube 219, and the outer diameter of the positioning balloon 710 is larger than the outer diameter of the tube body 211 and smaller than the inner diameter of the blood vessel, so that the tube body 211 of the thrombus removal system 10 is not easy to tilt during the thrombus removal process, ensuring that no secondary damage is caused to the blood vessel during the thrombus aspiration process. In addition, a blocking balloon 720 is provided on the outer tube 250, and the blocking balloon 720 is located at the proximal side of the aspiration port 212. The blocking balloon 720 can block the thrombus broken by the thrombus-breaking assembly 220, ensuring that the thrombus can be extracted from the aspiration port 212, and avoiding the thrombus residue after aspiration, resulting in the postoperative thrombus-breaking thrombus blocking the downstream branch thrombus.

[0149] Embodiment 5

[0150] The fifth embodiment of the present invention provides a thrombus removal system 10. The similarities between the fifth embodiment and the second embodiment are not repeated here. The difference between the fifth embodiment and the second embodiment is that: Figures 39 to 40 As shown, the suction port 212 is located on the side wall of the tube body 211, and a guide head 214 is provided at the distal end of the tube body 211. The guide head 214 is arranged in a conical shape, and a through hole 215 is arranged in the axial direction of the guide head 214. The through hole 215 is connected to the tube body 211 and is used as a channel for the guide wire to pass through. The catheter assembly 210 also includes an outer tube 250 sleeved on the outside of the tube body 211, and the distal end of the tube body 211 passes through the outer tube 250. The suction port 212 is arranged on the tube body 211 and is located on the distal side of the outer tube 250.

[0151] The positioning assembly 700 includes a positioning balloon 710 disposed on the tube body 211, and the outer diameter of the positioning balloon 710 is larger than the outer diameter of the tube body 211 and smaller than the inner diameter of the blood vessel. A positioning filling port 711 is disposed on the housing 110 of the handle module 100, and the positioning filling port 711 is connected to the positioning balloon 710. When the tube body 211 is placed in the blood vessel, the filling medium in the positioning balloon 710 is evacuated through the positioning filling port 711, so that the positioning balloon 710 is in a contracted state, and the balloon in the contracted state is attached to the outer wall of the tube body 211, so that the tube body 211 can be smoothly placed in the blood vessel. When the tube body 211 moves to the preset position, the filling medium is filled into the positioning balloon 710 through the positioning filling port 711 to expand the positioning balloon 710. The outer diameter of the expanded positioning balloon 710 is larger than the outer diameter of the tube body 211 and smaller than the inner diameter of the blood vessel. Therefore, the positioning balloon 710 can be used to center the tube body 211 in the blood vessel, and the tube body 211 can also move along the blood vessel to remove the thrombus, thereby avoiding the suction port 212 from damaging the inner wall of the blood vessel due to the tilt of the tube body 211 during the thrombus removal process.

[0152] A valve assembly 240 is provided at the proximal end of the outer tube 250. The tube body 211 penetrates into the outer tube 250 through the valve assembly 240, and the outer tube 250 can be advanced or retracted along the tube body 211. The valve assembly 240 includes a valve body 241, a plug valve 242 provided on the valve body 241, and a three-way valve 243 connected to the side of the valve body 241 through a hose. The plug valve 242 is used to control the locking or separation between the outer tube 250 and the tube body 211.

[0153] The positioning assembly 700 further includes a blocking balloon 720. The blocking balloon 720 is provided on the outer tube 250, and the outer tube 250 and the blocking balloon 720 are located on the proximal side of the suction port 212. A blocking inflation port 721 is provided on the valve assembly 240, and the blocking inflation port 721 communicates with the blocking balloon 720 through the outer tube 250. The outer diameter of the blocking balloon 720 is larger than the outer diameter of the positioning balloon 710. The blocking balloon 720 is used to be anchored in the blood vessel after inflation. When removing the thrombus, the blocking balloon 720 can block the proximal end of the blood vessel and play a role in blocking blood flow. Since the blocking balloon 720 blocks the blood flow at the proximal end of the suction port 212 after inflation, it can avoid the thrombus falling off to the proximal end of the blood vessel during suction, avoid the fragmented thrombus remaining in the blood vessel after suction, and ensure the effect of thrombus aspiration.

[0154] When the catheter assembly 210 penetrates into the blood vessel, the axial positions of the outer tube 250 and the tube body 211 are relatively fixed by tightening the plug valve 242. At the same time, during the process of the tube body 211 penetrating into the blood vessel, the positioning balloon 710 is evacuated through the positioning inflation port 711. When the tube body 211 reaches the designated position, a filling medium is injected into the positioning balloon 710 through the positioning inflation port 711 to inflate the positioning balloon 710. The inflated positioning balloon 710 can prevent the tube body 211 from tilting, and a filling medium is injected into the blocking balloon 720 through the blocking inflation port 721 to inflate the blocking balloon 720. The inflated blocking balloon 720 is anchored in the blood vessel and blocks the blood flow. Then, the plug valve 242 is rotated and loosened to disengage the tube body 211 and the outer tube 250 from the fixed state. At this time, the tube body 211 can move axially along the outer tube 250, and thrombus aspiration work can be carried out.

[0155] In other embodiments, such as Figure 41 as Figure 42 shown, the above-mentioned balloon can also adopt an oval shape, or a cylindrical structure with tapered ends. For example, the blocking balloon 720 adopts a cylindrical structure with tapered ends, so as to increase the contact area between the blocking balloon 720 and the inner wall of the blood vessel, improve the blocking effect, and reduce the pressure of the blocking balloon 720 on the inner wall of the blood vessel.

[0156] Through the above technical solution of this embodiment, when thrombus aspiration is performed, since the thrombus crushing assembly 220 is provided in the aspiration chamber 216, the thrombus will not accumulate at the aspiration port 212, and the aspiration port 212 can be prevented from being blocked, thereby ensuring the success rate of thrombus aspiration. By providing a positioning balloon 710 having an outer diameter larger than that of the tube 211 on the tube 211, and the positioning balloon 710 is located at the distal end of the aspiration port 212, the tube 211 of the thrombus removal system 10 is not prone to tilting during the thrombus removal process, thereby ensuring that the blood vessel will not be damaged secondary during the thrombus aspiration process. In addition, an outer tube 250 is provided which is sleeved on the outside of the tube body 211. A blocking balloon 720 is provided on the outer tube 250. The blocking balloon 720 is located on the proximal side of the suction port 212. The blocking balloon 720 can block the thrombus broken by the thrombus-breaking assembly 220, ensuring that the thrombus can be extracted from the suction port 212, thereby avoiding residual thrombus after suction, which would cause the postoperative thrombus-breaking thrombus to block the downstream branch thrombus.

[0157] The above is only a preferred specific implementation of the present invention, but the protection scope of this application is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed in this application should be included in the protection scope of this application. Therefore, the protection scope of this application should be based on the protection scope of the claims.

Claims

1. A thrombectomy system, characterized in that, It includes a handle module and an embolus extraction module. The embolus extraction module includes a catheter assembly, an embolus fragmentation assembly, and a positioning assembly. The catheter assembly includes a tube body with its proximal end connected to the handle module and a suction port provided on the tube body. The embolus fragmentation assembly is inserted through the tube body; the suction port is arranged at the distal end of the tube body and penetrates through the distal end face of the tube body. The positioning assembly includes a positioning balloon provided on the tube body, and the positioning balloon is used to center and position the tube body after the tube body extends into a blood vessel.

2. The thrombectomy system according to claim 1, wherein A positioning filling port is provided on the handle module, and a positioning filling cavity is arranged in the tube body. The positioning filling cavity is used to connect the positioning balloon and the positioning filling port.

3. The thrombectomy system according to claim 1, characterized in that, The tube body includes a suction cavity and a guide wire cavity. The embolus fragmentation assembly is inserted in the suction cavity. The catheter assembly further includes a guiding tube which is inserted in the guide wire cavity. The positioning assembly further includes a blocking balloon provided on the guiding tube, and the maximum outer diameter of the blocking balloon after inflation is larger than the outer diameter of the positioning balloon after inflation.

4. The thrombectomy system according to claim 3, wherein A blocking filling port is provided on the handle module, and a blocking connection cavity is arranged in the guiding tube. The blocking connection cavity connects the blocking balloon and the blocking filling port.

5. The thrombectomy system according to claim 3, wherein The outer diameter of the blocking balloon after inflation is larger than the inner diameter of the target blood vessel, and the outer diameter of the positioning balloon after inflation is smaller than the inner diameter of the target blood vessel.

6. The thrombectomy system according to claim 3, wherein, A first imaging ring and a third imaging ring are provided on the tube body. The first imaging ring is located between the positioning balloon and the suction port, and the third imaging ring is located on the distal side of the suction port; a second imaging ring is provided on the guiding tube, and the second imaging ring is arranged inside the blocking balloon.

7. The thrombectomy system according to claim 3, wherein The hardness of the blocking balloon after inflation is greater than or equal to the hardness of the positioning balloon.

8. The thrombectomy system according to claim 1, wherein The handle module includes a housing, a discharging member arranged in the housing, and a driving mechanism. The proximal end of the tube body is connected to the discharging member. The embolus fragmentation assembly passes through the discharging member through the tube body and is connected to the driving mechanism. The driving mechanism is used to drive the embolus fragmentation assembly.

9. The thrombectomy system according to claim 8, wherein The proximal end of the embolus fragmentation assembly is connected to the handle module, and the distal end of the embolus fragmentation assembly is located at the suction port; the embolus fragmentation assembly includes an embolus fragmentation connecting portion and an embolus fragmentation head. The embolus fragmentation connecting portion is inserted through the tube body, the proximal end of the embolus fragmentation connecting portion is connected to the handle module, and the embolus fragmentation head is arranged at the distal end of the embolus fragmentation connecting portion and is located at the suction port.

10. The thrombectomy system according to claim 9, characterized in that, The embolus fragmentation head is arranged in a spiral shape, and the embolus fragmentation connecting portion is arranged in a spiral shape or a rod shape.

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