Embolus removal device

Abstract

The present invention relates to a thrombectomy device, which includes a thrombectomy stent, a thrombus fragmentation stent and a delivery assembly; the thrombectomy stent and the thrombus fragmentation stent are stent structures capable of contraction and expansion; the distal ends of the delivery assembly are respectively connected to the thrombectomy stent and the thrombus fragmentation stent, and are used for accommodating the thrombectomy stent and the thrombus fragmentation stent in a contracted state; and the delivery assembly can release the thrombectomy stent and the thrombus fragmentation stent to an expanded state, and can drive the thrombus fragmentation stent to move axially along the inner space of the thrombectomy stent in the expanded state of the thrombectomy stent. The present invention utilizes the cooperation of the thrombectomy stent and the thrombus fragmentation stent. When the thrombectomy stent accommodates the thrombus in the blood vessel within the thrombectomy stent, the delivery assembly is further used to control the thrombus fragmentation stent to extend into the inner space of the thrombectomy stent, and can axially move relative to the thrombectomy stent to cut the thrombus; thereby continuously cutting and crushing the thrombus therein; which is beneficial to crushing stubborn, large and hard thrombi and improving the thrombectomy effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a thrombus extraction device. Background Art

[0002] Venous thromboembolism (VTE) includes deep vein thrombosis (DVT) of the lower extremities and pulmonary embolism (PE).

[0003] Deep vein thrombosis (DVT) of the lower extremities is a high-incidence vascular surgery disease, mostly caused by abnormal coagulation of blood in the lower extremity veins, resulting in obstruction of blood return. Pulmonary embolism (PE) has become the third leading cause of death from cardiovascular diseases. The risk factors of pulmonary embolism include environmental factors and personal factors. Personal factors include age, previous history of VTE, history of cancer, cardiopulmonary failure, congenital or acquired coagulation disorders, hormone therapy, etc. Acute PE can lead to systemic hypotension and even heart failure, and then cause the death of patients.

[0004] Therefore, removing thrombus quickly and effectively as early as possible can relieve venous obstruction, effectively prevent PE, protect valve function, and reduce the recurrence rate of thrombus.

[0005] Some currently used thrombus extraction devices provide a new and efficient treatment method for vascular recanalization for patients with venous thrombus. The mechanical thrombus extraction surgery has a short operation time and few related complications, and is currently a research hotspot in the field of thrombus treatment; however, the existing thrombus extraction devices are difficult to crush and remove stubborn, large and hard thrombus, and the thrombus extraction effect is still not ideal. Summary of the Invention

[0006] The purpose of the present invention is to provide a thrombus extraction device to optimize the structure of the thrombus extraction device in the existing technology and improve the thrombus extraction effect.

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

[0008] According to one aspect of the present invention, the present invention provides a thrombus extraction device, which includes: a thrombus extraction stent, which is a stent structure that can be contracted and expanded, and its distal end is closed; a thrombus fragmentation stent, which is a stent structure that can be contracted and expanded; and a delivery assembly, the distal end of which is respectively connected to the thrombus extraction stent and the thrombus fragmentation stent, and is used to accommodate the thrombus extraction stent and the thrombus fragmentation stent in a contracted state; the delivery assembly can release the thrombus extraction stent and the thrombus fragmentation stent to an expanded state, and can drive the thrombus fragmentation stent to move axially along the inner space of the thrombus extraction stent in the expanded state.

[0009] According to some embodiments of the present application, the delivery assembly can also drive the thrombus fragmentation stent to rotate circumferentially along the inner space of the thrombus extraction stent in the expanded state.

[0010] According to some embodiments of the present application, the delivery assembly includes: an outer sheath for accommodating the thrombectomy stent in a contracted state; a traction sheath, the distal end of which is connected to the thrombectomy stent; the traction sheath is disposed within the outer sheath and is capable of moving axially relative to the outer sheath so that the thrombectomy stent extends out of or is accommodated in the outer sheath; the traction sheath can accommodate the fragmentation stent in a contracted state therein; and a drive sheath, the distal end of which is connected to the fragmentation stent; the drive sheath is disposed within the traction sheath and is capable of moving axially relative to the traction sheath to drive the fragmentation stent to extend out of the traction sheath and axially move within the internal space of the thrombectomy stent, or drive the fragmentation stent to be accommodated within the traction sheath.

[0011] According to some embodiments of the present application, the delivery assembly further includes a sheath connector, a drive handle, and a drive member; the sheath connector has a tubular structure and is connected to the proximal end of the outer sheath; the drive handle is disposed on the proximal side of the sheath connector; the drive handle has a tubular structure and is connected to the proximal end of the traction sheath; the drive handle can control the axial relative movement of the traction sheath within the sheath connector and the outer sheath; the drive member is connected to the drive sheath, and the drive member can control the axial relative movement of the drive sheath within the drive handle and the traction sheath.

[0012] According to some embodiments of the present application, a chute extending along its axial direction is provided on the peripheral wall of the drive handle; the drive member is disposed within the chute, the outer end portion of the drive member is exposed outside the outer wall of the drive handle, and its inner end portion extends into the drive handle and is connected to the drive sheath; the drive member can slide along the chute to control the axial relative movement of the drive sheath within the drive handle and the traction sheath.

[0013] According to some embodiments of the present application, the drive sheath can rotate circumferentially relative to the traction sheath to drive the fragmentation stent to rotate circumferentially within the internal space of the thrombectomy stent.

[0014] According to some embodiments of the present application, the delivery assembly further includes a snap ring fixedly sleeved on the drive sheath; an axial hole extending along the axial direction of the drive sheath is provided at the inner end portion of the drive member; the snap ring is rotatably disposed within the axial hole and is axially clamped with the inner end portion of the drive member; the drive sheath can axially move with the drive member through the snap ring and can rotate circumferentially within the axial hole of the inner end portion of the drive member together with the snap ring.

[0015] According to some embodiments of the present application, the conveying assembly further includes a rotating shaft, a rotating handle, a driving gear and a driven gear; the rotating shaft is rotatably disposed through the peripheral wall of the driving handle; the rotating handle is disposed outside the peripheral wall of the driving handle and is connected to the outer end of the rotating shaft; the driving gear is disposed inside the driving handle and is connected to the inner end of the rotating shaft; the driven gear is disposed inside the driving handle and meshes with the driving gear; the driven gear is disposed on the proximal side of the driving sheath tube and can drive the driving sheath tube to rotate synchronously; the driving sheath tube can move axially relative to the driven gear.

[0016] According to some embodiments of the present application, the distal end of the driven gear is provided with a shaft cylinder portion protruding axially; the shaft cylinder portion is sleeved on the proximal end of the driving sheath tube; among the inner wall of the shaft cylinder portion and the outer peripheral wall of the driving sheath tube, one of them is recessed with an axially extending limiting groove; the other is provided with a limiting protrusion, and the limiting protrusion is adapted to the limiting groove, so that the driving sheath tube can rotate circumferentially synchronously with the driven gear, and the driving sheath tube can drive the limiting protrusion to slide axially relative to the driven gear in the limiting groove.

[0017] According to some embodiments of the present application, the conveying assembly further includes an inner sheath core; the inner sheath core is tubular, and a guide wire can pass through the tube thereof; the inner sheath core is movably disposed through the driving sheath tube and the thrombus-breaking stent; the distal end of the inner sheath core is disposed through the thrombus-removing stent and is connected to the distal end of the thrombus-removing stent; the proximal end of the inner sheath core passes out of the proximal end of the driving handle and can move axially relative to the driving handle.

[0018] According to some embodiments of the present application, the conveying assembly further includes a fixing knob; the fixing knob is rotatably disposed at the proximal end of the driving handle; the proximal end of the inner sheath core movably passes out of the fixing knob; when the fixing knob rotates relative to the driving handle, it can clamp or loosen the inner sheath core.

[0019] According to some embodiments of the present application, the conveying assembly further includes a sheath core joint; the proximal end of the inner sheath core passes out of the fixing knob and is connected to the sheath core joint; when the fixing knob loosens the inner sheath core, the sheath core joint can control the axial movement of the inner sheath core in the driving handle.

[0020] According to some embodiments of the present application, the conveying assembly further includes a guiding head; the distal end of the guiding head is a tip, the proximal end of the guiding head is connected to the distal end of the inner sheath core, and an axially penetrating through hole is provided in the guiding head, and the through hole is communicated with the inner sheath core.

[0021] According to some embodiments of the present application, the thrombectomy device further includes a constriction ring; the constriction ring is sleeved on the distal end of the inner sheath core and is connected to the proximal end of the guiding head; the distal ends of the thrombectomy stents converge and are connected to the constriction ring.

[0022] According to some embodiments of the present application, the thrombectomy stent includes a cutting section and a collection section that are sequentially connected from the proximal end to the distal end; an opening is provided at the proximal end of the cutting section; the distal end of the collection section is closed, the proximal end of the collection section is smoothly connected to the distal end of the cutting section, and a plurality of mesh holes are formed on the peripheral wall of the collection section.

[0023] According to some embodiments of the present application, the cutting section includes a support body whose distal end is connected to the collection section, a plurality of connecting rods connected to the proximal end of the support body, and a first fixing ring connected to the proximal ends of the plurality of connecting rods; the first fixing ring is connected to the distal end of the delivery assembly; the support body is a circumferentially closed cylinder; the plurality of connecting rods are circumferentially spaced around the center of the support body, the proximal ends of the plurality of connecting rods converge and are connected to the first fixing ring, and an opening is formed between adjacent connecting rods.

[0024] According to some embodiments of the present application, the support body includes a plurality of V-shaped rods that are circumferentially and axially connected; the distal end of the support body has a plurality of wave valleys formed by the ends of the V-shaped rods, and the wave valleys are connected to the proximal end of the collection section; the proximal end of the support body has a plurality of wave peaks formed by the ends of the V-shaped rods, and the wave peaks are connected to the distal ends of the connecting rods.

[0025] According to some embodiments of the present application, the collection section is a network tube structure formed by the intersection of multiple braided wires; the mesh holes are formed between the intersecting braided wires; the distal end of the collection section is formed by the distal ends of multiple braided wires being converged and connected to form a closed end; the proximal ends of the braided wires are connected to the distal end of the cutting section.

[0026] According to some embodiments of the present application, the collection section includes a circumferentially closed stent body and a film covering the peripheral wall of the stent body; the mesh holes are formed in the film; the distal ends of the film converge to form a closed end, and the proximal end of the film is connected to the distal end of the cutting section; the stent body includes a plurality of circumferentially closed corrugated rods that are axially spaced; the corrugated rods are fixed on the peripheral wall of the film, and the corrugated rods can be compressed and expanded in the radial direction.

[0027] According to some embodiments of the present application, the thrombus fragmentation stent includes a plurality of struts, a second fixing ring disposed at the proximal ends of the plurality of struts, and a third fixing ring disposed at the distal ends of the plurality of struts; the plurality of struts are circumferentially spaced apart; the proximal ends of the plurality of struts converge and are connected to the second fixing ring, and the distal ends of the plurality of struts converge and are connected to the third fixing ring; in the direction from the proximal end to the distal end of the thrombus fragmentation stent, the struts are in an arc shape or the struts are helically wound to form a spiral shape.

[0028] As can be seen from the above technical solutions, the embodiments of the present invention have at least the following advantages and positive effects:

[0029] In the thrombus extraction device of the embodiment of the present invention, by using the cooperation of the thrombus extraction stent and the thrombus fragmentation stent, when the thrombus extraction stent houses the thrombus in the blood vessel in the thrombus extraction stent, the thrombus fragmentation stent is controlled to extend into the internal space of the thrombus extraction stent through the delivery assembly, and the thrombus can be axially moved relative to the thrombus extraction stent to cut the thrombus; thus, the thrombus inside is continuously cut and crushed; it is beneficial to crush stubborn, relatively large and hard thrombi and improve the thrombus extraction effect. Description of the Drawings

[0030] Figure 1 is the overall structural schematic diagram of the thrombus extraction device according to the first embodiment of the present invention.

[0031] Figure 2 is Figure 1 the structural schematic diagram of the thrombus extraction stent after release in

[0032] Figure 3 is Figure 2 the structural schematic diagram of the thrombus extraction stent in

[0033] Figure 4 is Figure 3 the partial perspective view of

[0034] Figure 5 is Figure 4 the enlarged structural schematic diagram of area A in

[0035] Figure 6 is Figure 2 the structural schematic diagram of the thrombus extraction device after the thrombus extraction stent is retracted and the thrombus fragmentation stent is released in

[0036] Figure 7 is Figure 6 the partial enlarged schematic diagram of the distal end of the thrombus extraction device in

[0037] Figure 8 is Figure 7 the partial perspective view of

[0038] Figure 9 is Figure 8 the structural schematic diagram of the thrombus fragmentation stent in

[0039] Figure 10 is Figure 1 The structural schematic diagram of the driving handle and the sheath core joint in

[0040] Figure 11 is Figure 10 The sectional view of area B in

[0041] Figure 12 is Figure 10 The sectional view of area C in

[0042] Figure 13 is Figure 10 The sectional view of area D in

[0043] Figure 14 The structural schematic diagram of the inferior vena cava.

[0044] Figure 15 The schematic diagram of the thrombus removal device being transported to the lesion during the thrombus removal operation.

[0045] Figure 16 The schematic diagram of cutting and collecting thrombus after releasing the thrombus removal stent during the thrombus removal operation.

[0046] Figure 17 The schematic diagram of releasing the thrombus fragmentation stent after retracting the thrombus removal stent during the thrombus removal operation.

[0047] Figure 18 The schematic diagram of retracting the thrombus fragmentation stent after thrombus fragmentation during the thrombus removal operation.

[0048] Figure 19 The schematic diagram of retracting the thrombus removal stent during the thrombus removal operation.

[0049] Figure 20 The structural schematic diagram of the second embodiment of the cutting section of the thrombus removal stent of the present invention.

[0050] Figure 21 is Figure 20 The front view of

[0051] Figure 22 is Figure 21 The top view of

[0052] Figure 23 The structural schematic diagram of the third embodiment of the cutting section of the thrombus removal stent of the present invention.

[0053] Figure 24 is Figure 24 The front view of

[0054] Figure 25 The structural schematic diagram of the fourth embodiment of the cutting section of the thrombus removal stent of the present invention.

[0055] Figure 26 is Figure 25 the front view of

[0056] Figure 27 is a schematic structural view of the fifth embodiment of the cutting section of the thrombectomy stent of the present invention.

[0057] Figure 28 is Figure 27 the front view of

[0058] Figure 29 is a schematic structural view of the second embodiment of the collection section of the thrombectomy stent of the present invention.

[0059] Figure 30 is a schematic structural view of the second embodiment of the thrombus fragmentation stent of the present invention.

[0060] Figure 31 is Figure 30 the front view of

[0061] The description of the reference numerals is as follows:

[0062] 001, guide wire; 01, human heart; 02, superior vena cava; 03, inferior vena cava;

[0063] 1, thrombectomy stent; 11, cutting section; 12, collection section; 100, perforation; 101, guiding head; 102, constriction ring; 103, limiting ring; 111, support body; 112, connecting rod; 113, first fixing ring; 121, braided wire; 122, corrugated rod; 123, film; 1011, solder; 1111, V-shaped rod;

[0064] 2, thrombus fragmentation stent; 21, strut; 22, second fixing ring; 23, third fixing ring;

[0065] 3, outer sheath tube; 4, traction sheath tube; 5, drive sheath tube; 51, driven gear; 501, limiting projection; 511, shaft cylinder part; 512, limiting groove; 6, inner sheath core; 61, stainless steel tube; 7, sheath tube joint; 71, first hose; 8, drive handle; 81, second hose; 82, drive member; 83, snap ring; 84, rotating handle; 85, drive gear; 86, rotating shaft; 87, fixing knob; 801, sliding groove; 9, sheath core joint; 91, through hole; 92, steel sleeve. Detailed Description of the Invention

[0066] Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments, all of which do not depart from the scope of the present invention, and the descriptions and illustrations therein are for illustrative purposes in nature and not intended to limit the present invention.

[0067] In the description of the present application, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0068] In addition, the terms "first" and "second" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of the said features. In the description of the present application, the meaning of "a plurality" is two or more unless otherwise specifically defined.

[0069] In the description of the present application, it should be noted that unless otherwise clearly specified and defined, the terms "mounted", "connected" and "coupled" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0070] Please refer to Figure 1 、 Figure 2 and Figure 6 As shown in

[0071] The expandable thrombus extraction stent 1 can relatively completely peel and collect thrombus and can provide sufficient thrombus storage space.

[0072] The thrombus fragmentation stent 2 can extend into the inside of the thrombus extraction stent 1 to cut and break the thrombus collected and stored inside the thrombus extraction stent 1, which is beneficial to break the stubborn, large and hard thrombus for convenient extraction.

[0073] The delivery assembly includes a multi-layer sheath tube and a plurality of control components. The multi-layer sheath tube can be used to sequentially accommodate the thrombus fragmentation stent 2 and the thrombus extraction stent 1 in a compressed state. The distal ends of the multi-layer sheath tube can be respectively connected to the thrombus extraction stent 1 and the thrombus fragmentation stent 2, and can cooperate with the plurality of control components through the multi-layer sheath tube to release the thrombus extraction stent 1 and the thrombus fragmentation stent 2 to an expanded state at the occlusive thrombus in the blood vessel, and can drive the thrombus fragmentation stent 2 to move axially along the inner space of the thrombus extraction stent 1 to cut the thrombus, or can further drive the thrombus fragmentation stent 2 to rotate circumferentially along the inner space of the thrombus extraction stent 1 to cut the thrombus, so as to continuously cut and break the thrombus therein.

[0074] Please refer to Figures 3 to 5 , the thrombus extraction stent 1 is a stent structure that can contract and expand. The distal end of the thrombus extraction stent 1 is closed and the proximal end has an opening.

[0075] Combined with Figures 14 to 17 As shown, when the thrombus extraction device passes through the thrombus in the blood vessel and the thrombus extraction stent 1 is released at the distal end of the thrombus, the thrombus extraction stent 1 can expand. It should be noted that the expansion performance of the thrombus extraction stent 1 can be the self-expansion performance formed by using a memory material, or the non-self-expansion performance that controls its contraction and expansion by artificially pulling the proximal and distal ends of the thrombus extraction stent 1.

[0076] At this time, the peripheral wall of the thrombus extraction stent 1 can adhere to the inner wall of the blood vessel, and the proximal opening of the thrombus extraction stent 1 is in an expanded state and faces the thrombus. Then, the thrombus extraction stent 1 is retracted proximally, and the thrombus enters the thrombus extraction stent 1 through the opening, and the thrombus in the blood vessel can be completely cut, peeled off and collected.

[0077] It can be understood that the proximal end of the thrombus extraction stent 1 can also not be provided with an opening, that is, the proximal end of the thrombus extraction stent 1 can also be a closed end, and its peripheral wall has a grid structure, and the grid structure can cut the thrombus when the thrombus extraction stent 1 expands. Specifically, the thrombus extraction stent 1 can be released at the location of the thrombus, and rely on the self-expansion force of the thrombus extraction stent 1 to expand and adhere to the inner wall of the blood vessel. During this process, the grid structure of the thrombus extraction stent 1 itself cuts the thrombus and accommodates the thrombus inside the thrombus extraction stent 1.

[0078] Still please refer to Figures 3 to 5 , the thrombus extraction stent 1 of this embodiment includes a cutting section 11 and a collection section 12 that are sequentially connected from the proximal end to the distal end.

[0079] The proximal end of the cutting section 11 is provided with an opening, which is the proximal opening structure of the thrombectomy stent 1. The distal end of the collection section 12 is closed, and the proximal end of the collection section 12 is smoothly connected to the distal end of the cutting section 11. There are a plurality of mesh holes on the peripheral wall of the collection section 12. Thrombus enters the inside of the cutting section 11 and the collection section 12 through the opening at the proximal end of the cutting section 11. The mesh holes on the peripheral wall of the collection section 12 allow blood flow to pass through and prevent thrombus from passing through. The fine mesh holes facilitate sheath withdrawal, and also facilitate complete collection of thrombus and prevent thrombus omission.

[0080] Please refer to Figure 3 and Figure 4 , the cutting section 11 of this embodiment includes a support body 111 whose distal end is connected to the collection section 12, a plurality of connecting rods 112 connected to the proximal end of the support body 111, and a first fixing ring 113 connected to the proximal ends of the plurality of connecting rods 112. The first fixing ring 113 is sleeved on the distal end of the sheath of the delivery assembly.

[0081] The support body 111 is a bare stent structure and is in a circumferentially closed cylindrical structure in the deployed state. The design of this structure makes the distal end of the cutting section 11 form a dense structure, which can provide better radial support force to better adhere to the inner wall of the blood vessel, so as to completely cut, separate and collect the thrombus between the thrombus and the inner wall of the blood vessel, and make the thrombus completely enter the collection section 12.

[0082] Specifically, the support body 111 may include a plurality of V-shaped rods 1111 that are circumferentially and axially connected.

[0083] A plurality of circumferentially connected V-shaped rods 1111 can form a corrugated ring. The corrugated ring has wave peaks and wave valleys that intersect with each other circumferentially. The wave peaks face the proximal end and the wave valleys face the distal end. According to the number of circumferentially connected V-shaped rods 1111, different numbers of wave valleys can be formed in the circumferential direction at the proximal end of the support body 111 to facilitate connection with the collection section 12.

[0084] A plurality of axially connected V-shaped rods 1111 can form a plurality of diamond grid units. When the support body 111 expands, the diamond grid units can also directly cut the thrombus to make the thrombus enter the cutting section 11. The proximal and distal ends of the diamond grid units can also form wave peaks and wave valleys respectively. According to the number of axially connected V-shaped rods 1111, the number of wave peaks at the proximal end of the support body 111 can be gradually adjusted to connect with different numbers of connecting rods 112 at the proximal end. Or gradually adjust the number of wave valleys at the distal end of the support body 111 to facilitate connection with the collection section 12 with different degrees of density. In this embodiment, the number of wave valleys at the distal end of the support body 111 is more than the number of wave peaks at the proximal end of the support body 111.

[0085] Thus, the distal end of the support body 111 can have a plurality of troughs formed by the ends of the V-shaped rods 1111, and these troughs are used to connect to the proximal end of the collection section 12. At the same time, the proximal end of the support body 111 can have a plurality of crests formed by the ends of the V-shaped rods 1111, and the crests are connected to the distal end of the connecting rod 112. The number of troughs at the distal end of the support body 111 can be adjusted according to the density of the proximal end of the collection section 12, and the number of crests at the proximal end of the support body 111 can be adjusted according to the number of connecting rods 112.

[0086] It should be noted that the collection section 12 can be integrally laser cut from a nickel-titanium pipe and made after heat setting.

[0087] Still refer to Figure 4 , a plurality of connecting rods 112 are circumferentially spaced around the center of the support body 111, and the proximal ends of the plurality of connecting rods 112 converge and are connected to the first fixing ring 113. The thrombectomy stent 1 can be connected to the traction sheath 4 through the first fixing ring 113. In addition, the structures of the connecting rod 112 and the first fixing ring 113 can make the distal end of the cutting section 11 form a sparse structure, so as to facilitate the collection and entry into the outer sheath 3.

[0088] An opening is formed at the proximal end of the cutting section 11 between adjacent connecting rods 112, and the number of openings can be adjusted according to the number of connecting rods 112. The plurality of openings are circumferentially arranged around the support body 111 at intervals of the connecting rods 112.

[0089] It should be noted that the first fixing ring 113 can be located on the axis of the support body 111. At this time, each opening can be evenly distributed around the axis of the support body 111, which is convenient for thrombus on all circumferential directions of the blood vessel inner wall to pass through each opening simultaneously. The first fixing ring 113 can also be arranged deviating from the axis of the support body 111. At this time, the opening on the deviating side is smaller, and the opening far from the deviating side is larger, which is convenient for relatively stubborn, larger and harder thrombus to pass through the larger opening. When the thrombus passes through the opening, the edge of the opening can be used to cut the thrombus to separate the thrombus from the inner wall of the blood vessel.

[0090] Please refer to Figures 3 to 5 , the collection section 12 is a network tube structure formed by the intersection of multiple braided wires 121, and mesh holes are formed between the intersecting braided wires 121. The distal end of the collection section 12 is formed by the distal ends of multiple braided wires 121 converging and connecting to form a closed end; the proximal ends of the braided wires 121 are connected to the distal end of the cutting section 11.

[0091] Specifically, the collection section 12 can be formed by interweaving multiple strands of nitinol wire. When weaving, nodes can be formed at the troughs at the distal end of the cutting section 11 through which the nitinol wire passes. Each node can pass through two nitinol wires, and after folding in half, two strands of wire are formed. The two strands of wire are respectively woven step by step in a positive and negative helical structure to form a network tube structure. The network tube structure formed by this material structure is both soft and elastic, has good wall attachment performance, and can form mesh holes with different densities according to the number of different weaving wires 121, changing the density of the pores on the collection section 12, and effectively preventing the cut and collected thrombus from detaching from the thrombus extraction stent 1.

[0092] After the distal ends of the multiple strands of nitinol wire are bundled, they can be clamped and fixed using a bundling ring 102, or further welded and fixed using a laser spot welder to improve the firmness of the distal end of the collection section 12.

[0093] Please refer to Figures 6 to 9 , the thrombus fragmentation stent 2 is a stent structure that can contract and expand. The thrombus fragmentation stent 2 can extend into the thrombus extraction stent 1 in the expanded state, and the thrombus fragmentation stent 2 can expand in the internal space of the thrombus extraction stent 1. It can be understood that the thrombus fragmentation stent 2 can adopt a stent structure with self-expansion performance, or it can be a non-self-expanding stent structure that is manually controlled to contract and expand.

[0094] In this embodiment, the thrombus fragmentation stent 2 includes a plurality of struts 21 arranged at circumferential intervals and a second fixing ring 22 provided at the proximal ends of the plurality of struts 21.

[0095] The struts 21 have the performance of contracting and expanding along the radial direction. When naturally expanding, the struts 21 protrude radially in the internal space of the thrombus extraction stent 1 along the radial direction of the thrombus extraction stent 1 to facilitate cutting the thrombus in the internal space of the thrombus extraction stent 1.

[0096] The struts 21 can adopt an arc-shaped rod structure. It can be understood that the struts 21 can also adopt other shapes.

[0097] The proximal ends of the plurality of struts 21 converge and are connected to the second fixing ring 22, and the second fixing ring 22 is used to connect to the drive sheath 5.

[0098] Furthermore, in this embodiment, the thrombus fragmentation stent 2 further includes a third fixing ring 23 provided at the distal ends of the plurality of struts 21. The distal ends of the plurality of struts 21 converge and are connected to the third fixing ring 23 to make the overall structure of the thrombus fragmentation stent 2 more stable.

[0099] It should be noted that the thrombus fragmentation stent 2 can also be integrally laser cut from nitinol tubing and made after heat setting.

[0100] Please refer to Figures 3 to 5, the thrombectomy device of this embodiment further includes a guiding head 101. The guiding head 101 is provided at the distal end of the thrombectomy stent 1 and extends along the axial direction of the thrombectomy stent 1. The distal end of the guiding head 101 is a tip to improve the guiding and advancing capabilities of the thrombectomy device.

[0101] An axially penetrating perforation 100 is provided in the guiding head 101, and the guide wire 001 can pass through the perforation 100.

[0102] Combined Figure 14 and Figure 15 As shown, when the guide wire 001 punctures into the thrombus in the blood vessel and establishes a thrombectomy channel, the thrombectomy device can be delivered along the guide wire 001 to the thrombus, and the structure of the guiding head 101 is conducive to the distal end of the thrombectomy device puncturing through the thrombus.

[0103] Please refer to Figure 4 and Figure 5 , further, the thrombectomy device of this embodiment further includes a constriction ring 102 provided at the proximal end of the guiding head 101. The constriction ring 102 is opposite to the perforation 100 in the guiding head 101. The distal end of the thrombectomy stent 1 is constricted and clamped within the constriction ring 102. In addition, the distal end of the nitinol wire in the constriction ring 102 and the thrombectomy stent 1 can be fixed by laser spot welding, and the constriction ring 102 and the guiding head 101 can be fixed by hot melt welding with a soldering agent 1011.

[0104] Please refer to Figures 1 to 8 , in this embodiment, the multi-layer sheath of the delivery assembly includes an outer sheath 3, a traction sheath 4, a drive sheath 5, and an inner sheath core 6.

[0105] The outer sheath 3 is used to accommodate the thrombectomy stent 1 in a contracted state.

[0106] The distal end of the traction sheath 4 is connected to the proximal end of the thrombectomy stent 1, and the thrombectomy stent 1 is sleeved on the traction sheath 4 through the first fixing ring 113 at its distal end. The traction sheath 4 is movably disposed within the outer sheath 3 and can move axially relative to the outer sheath 3 to cause the thrombectomy stent 1 to extend out of the outer sheath 3 and be released to an expanded state, or to cause the thrombectomy stent 1 to be accommodated within the outer sheath 3 to make the thrombectomy stent 1 in a contracted state. At the same time, the traction sheath 4 can accommodate the fragmentation stent 2 in a contracted state.

[0107] The distal end of the driving sheath tube 5 is connected to the proximal end of the thrombus-breaking stent 2. The driving sheath tube 5 is movably disposed within the traction sheath tube 4 and can move axially relative to the traction sheath tube 4 to drive the thrombus-breaking stent 2 to move axially out of the traction sheath tube 4 along the axis of the traction sheath tube 4, so that the thrombus-breaking stent 2 is released to an expanded state, and the thrombus-breaking stent 2 axially moves within the internal space of the thrombus-removing stent 1 to cut the thrombus collected within the thrombus-removing stent 1, or drive the thrombus-breaking stent 2 to be received within the traction sheath tube 4 so that the thrombus-breaking stent 2 is in a contracted state. In addition, the driving sheath tube 5 can also rotate circumferentially along the traction sheath tube 4 to drive the thrombus-breaking stent 2 to rotate circumferentially within the internal space of the thrombus-removing stent 1, and further circumferentially rotate to cut the thrombus collected within the thrombus-removing stent 1.

[0108] The inner sheath core 6 is tubular, and a guide wire 001 can pass through the inside of its tube. The inner sheath core 6 is disposed within the driving sheath tube 5. At the same time, the inner sheath core 6 is made of PEEK material. The inner sheath core 6 is disposed within the thrombus-breaking stent 2 and the thrombus-removing stent 1, and the distal end of the inner sheath core 6 is connected to the distal end of the thrombus-removing stent 1.

[0109] Please refer to Figure 5 , in this embodiment, the distal end of the inner sheath core 6 passes through the constriction ring 102 and is connected to the proximal end of the guiding head 101. The constriction ring 102 is sleeved on the distal end of the inner sheath core 6. The inner sheath core 6 is in communication with the perforation 100 within the guiding head 101 for the guide wire 001 to pass through, that is, the guide wire 001 can sequentially pass through the inner sheath core 6 and the guiding head 101.

[0110] Please refer to Figure 8 , in this embodiment, both the driving sheath tube 5 and the thrombus-breaking stent 2 are movably sleeved on the inner sheath core 6. Among them, the second fixing ring 22 and the third fixing ring 23 of the thrombus-breaking stent 2 are both movably sleeved on the inner sheath core 6, and a plurality of struts 21 are arranged circumferentially around the inner sheath core 6. Thus, the driving sheath tube 5 can drive the thrombus-breaking stent 2 to move axially or rotate circumferentially along the axis of the inner sheath core 6, and further make the movement of the thrombus-breaking stent 2 smoother.

[0111] Still please refer to Figure 5 , in this embodiment, the distal end of the inner sheath core 6 is connected to the constriction ring 102. A limiting ring 103 is sleeved on the distal end of the inner sheath core 6, and the limiting ring 103 is spaced on the proximal side of the constriction ring 102. The limiting ring 103 can be used to abut against the constriction ring 102 when the constriction ring 102 is separated from the inner sheath core 6 and prevent the distal end of the thrombus-removing stent 1 from being retracted by the constriction ring 102, resulting in the collapse of the thrombus-removing stent 1.

[0112] Please refer to Figure 1 , Figure 2 and Figure 6 As shown in

[0113] The sheath connector 7 has a tubular structure. The distal end of the sheath connector 7 is connected to the proximal end of the outer sheath 3. The traction sheath 4 is sequentially disposed within the sheath connector 7 and the outer sheath 3. The sheath connector 7 can drive the outer sheath 3 to move axially relative to the traction sheath 4.

[0114] Please refer to Figure 2 , in this embodiment, the delivery assembly further includes a first flexible tube 71 connected to the peripheral wall of the sheath connector 7 at one end.

[0115] There are gaps formed between the inner wall of the sheath connector 7 and the inner wall of the outer sheath 3 and the outer wall of the traction sheath 4, and these gaps form a first liquid passage; the first flexible tube 71 is in communication with the first liquid passage.

[0116] The other end of the first flexible tube 71 is connected to a three-way Luer connector. It can be understood that the Luer connector can also be a single-pass Luer connector, or a multi-pass Luer connector such as a two-way or four-way Luer connector.

[0117] Saline can be injected into the first liquid passage through the first flexible tube 71 to discharge the air in the gap between the outer sheath 3 and the traction sheath 4. Liquid medicine can also be injected into the thrombus in the blood vessel through the first flexible tube 71 and the first liquid passage to ablate the thrombus in the blood vessel; or a contrast agent can be injected to facilitate marking the position where the thrombectomy device enters the human blood vessel.

[0118] Please refer to Figure 1 , Figure 2 and Figure 6 , the drive handle 8 is disposed on the proximal side of the sheath connector 7. The drive handle 8 has a tubular structure, and the distal end of the drive handle 8 is connected to the proximal end of the traction sheath 4; the drive sheath 5 is sequentially disposed within the drive handle 8 and the traction sheath 4.

[0119] The drive handle 8 can drive the traction sheath 4 to move axially relative within the sheath connector 7 and the outer sheath 3, so that the traction sheath 4 drives the thrombectomy stent 1 to extend or retract into the outer sheath 3. At the same time, it can also drive the traction sheath 4 to move axially relative to the drive sheath 5, so that the drive sheath 5 and the thrombus fragmentation stent 2 extend or retract into the traction sheath 4.

[0120] Please refer to Figure 6 , in this embodiment, the delivery assembly further includes a second flexible tube 81 connected to the peripheral wall of the drive handle 8 at one end.

[0121] There are gaps formed between the inner wall of the drive handle 8 and the inner wall of the traction sheath 4 and the outer wall of the drive sheath 5, and these gaps form a second liquid passage. The second flexible tube 81 is in communication with the second liquid passage.

[0122] The other end of the second flexible tube 81 is connected to a three-way Luer connector. It can be understood that the Luer connector can also be a single-pass Luer connector, or a multi-pass Luer connector such as a two-way or four-way Luer connector.

[0123] Saline can also be injected into the second liquid passage through the second hose 81 to discharge the air in the gap between the traction sheath 4 and the drive sheath 5. Liquid medicine can also be injected into the thrombus in the blood vessel through the second hose 81 and the second liquid passage to ablate the thrombus in the blood vessel; or a contrast agent can be injected to facilitate marking the position where the thrombectomy device enters the human blood vessel.

[0124] Please refer to Figure 10 and Figure 11 and in combination with Figure 2 and Figure 6 The driving member 82 is connected to the drive sheath 5. The driving member 82 can control the drive sheath 5 to move axially relative to the traction sheath 4 within the drive handle 8 and the traction sheath 4, so that the drive sheath 5 and the thrombus-breaking stent 2 extend or retract into the traction sheath 4.

[0125] In this embodiment, a chute 801 extending along its axial direction is provided on the peripheral wall of the drive handle 8; the driving member 82 is arranged in the chute 801 and can slide along the chute 801.

[0126] The outer end of the driving member 82 is exposed on the outer wall of the drive handle 8 to facilitate the operator to contact and control the driving member 82 to slide along the chute 801.

[0127] The inner end of the driving member 82 extends into the drive handle 8 and is connected to the drive sheath 5. The driving member 82 can slide along the chute 801 and drive the drive sheath 5 to move axially relative to the traction sheath 4 within the drive handle 8 and the traction sheath 4. It can be understood that the length of the chute 801 is the range of the axial movement of the drive sheath 5 relative to the traction sheath 4.

[0128] Please refer to Figure 11 Furthermore, a snap ring 83 is fixedly sleeved on the drive sheath 5 of this embodiment; an axial hole extending along the axial direction of the drive sheath 5 is provided at the inner end of the driving member 82; the snap ring 83 is rotatably inserted into the axial hole at the inner end of the driving member 82 and is axially clamped with the inner end of the driving member 82.

[0129] Specifically, as Figure 11As shown, circumferentially distributed card slots are recessed in the outer peripheral wall of the snap ring 83. The inner end of the driving member 82 is sleeved on the card slot of the snap ring 83 through a shaft hole. The side walls on both sides of the card slot can axially limit the driving member 82, so that the driving member 82 is axially clamped with the snap ring 83, and the axial synchronous movement of the driving member 82 and the driving sheath 5 is realized. When the driving member 82 slides on the outer wall of the driving handle 8, the driving member 82 can drive the driving sheath 5 to axially move relative to the driving handle 8 and the traction sheath 4 through the snap ring 83; at the same time, the driving sheath 5 can rotate circumferentially in the shaft hole of the driving member 82 and within the driving handle 8 together with the snap ring 83. Therefore, it is beneficial to simultaneously realize the axial linear movement and circumferential rotational movement of the driving sheath 5.

[0130] It can be understood that the driving member 82 and the snap ring 83 can adopt the following structure. A circumferentially extending annular groove is recessed on the inner wall of the shaft hole of the driving member 82. The driving sheath 5 is inserted into the shaft hole of the driving member 82, and the snap ring 83 is clamped in the annular groove in the shaft hole. The side walls on both sides of the annular groove can axially limit the snap ring 83, and at the same time, the snap ring 83 can rotate circumferentially in the annular groove of the shaft hole.

[0131] Please refer to Figure 10 and Figure 12 , the conveying assembly of this embodiment further includes a rotating handle 84 provided on the outer side of the peripheral wall of the driving handle 8, a driving gear 85 provided inside the driving handle 8, and a rotating shaft 86 connecting the rotating handle 84 and the driving gear 85.

[0132] The rotating shaft 86 is rotatably inserted through the peripheral wall of the driving handle 8. The rotating handle 84 and the driving gear 85 can rotate coaxially with the rotating shaft 86 as the axis.

[0133] A driven gear 51 is provided on the proximal side of the driving sheath 5. The driven gear 51 can rotate synchronously with the driving sheath 5, and the driving sheath 5 can move axially relative to the driven gear 51. The driven gear 51 meshes with the driving gear 85.

[0134] When the rotating handle 84 rotates, the rotation of the driving gear 85 can be synchronously controlled, and then the driven gear 51 meshing with the driving gear 85 can be controlled to rotate synchronously, thereby driving the driving sheath 5 to perform circumferential rotational movement within the traction sheath 4 without affecting the axial movement of the driving sheath 5 within the traction sheath 4.

[0135] Please refer to Figure 10 and Figure 12 , further, a shaft cylinder portion 511 extending axially and protruding is provided at the distal end of the driven gear 51 of this embodiment. The shaft cylinder portion 511 is sleeved on the proximal end of the driving sheath 5, and a limiting groove 512 extending along the axial direction of the driving sheath 5 is provided on the inner wall of the shaft cylinder portion 511.

[0136] On the outer peripheral wall of the proximal end of the drive sheath tube 5, a limit projection 501 adapted to the limit groove 512 is convexly provided, and the limit projection 501 is slidably disposed in the limit groove 512.

[0137] When the driven gear 51 rotates driven by the drive gear 85, the cooperation between the limit groove 512 on the inner wall of the shaft cylinder part 511 and the limit projection 501 on the outer peripheral wall of the drive sheath tube 5 can be utilized to drive the drive sheath tube 5 to perform a circumferential rotational movement. At the same time, by using the sliding fit structure between the limit projection 501 and the limit groove 512, the drive sheath tube 5 can perform an axial linear movement within the shaft cylinder part 511 of the driven gear 51. Therefore, this structural design is beneficial to realizing the axial linear movement and circumferential rotational movement of the drive sheath tube 5.

[0138] It can be understood that the limit groove 512 can be recessed on the outer peripheral wall of the drive sheath tube 5, and at the same time, the limit projection 501 is provided on the inner wall of the shaft cylinder part 511. With this structural design, it is also possible to realize the sliding of the drive sheath tube 5 relative to the driven gear 51 along the axis, and at the same time realize the synchronous circumferential rotation of the drive sheath tube 5 with the driven gear 51.

[0139] Please refer to Figures 10 to 13 , the stainless steel tube 61 passes through the proximal end of the drive handle 8 and extends into the traction sheath tube 4. The proximal end of the inner sheath core 6 is inserted into the stainless steel tube 61 and fixedly connected to the proximal end of the stainless steel tube 61. The stainless steel tube 61 can cover the inner sheath core 6 to prevent the inner sheath core 6 from being exposed to the air. Combining Figure 8 , Figure 16 and Figure 17 As shown, when the outer sheath tube 3, the traction sheath tube 4 and the drive handle 8 do not move, the inner sheath core 6 and the guide head 101 can be separately pulled through the stainless steel tube 61, so that the inner sheath core 6 and the guide head 101 move axially, and further the position of the front end of the thrombectomy stent 1 and the expansion form of the thrombectomy stent 1 can be adjusted, so that the thrombectomy stent 1 can better adhere to the inner wall of the blood vessel.

[0140] Please refer to Figures 10 to 13 , the sheath core joint 9 is fixedly sleeved on the proximal end of the stainless steel tube 61.

[0141] Axially distributed through holes 91 are provided at the proximal end of the sheath core joint 9; the proximal end of the inner sheath core 6 is communicated with the through holes 91. The sheath core joint 9 can facilitate the control of the axial movement of the stainless steel tube 61 and the inner sheath core 6. The through holes 91 on the sheath core joint 9 can facilitate the passing of the guide wire 001, so that the whole thrombectomy device can be conveyed along the guide wire 001.

[0142] Still please refer to Figures 10 to 13 , further, a steel sleeve 92 extending axially is embedded at the distal end of the through hole 91 in the sheath core joint 9 of this embodiment. Internal threads are provided on the inner wall of the steel sleeve 92. The proximal end of the stainless steel tube 61 extends into the sheath core joint 9 and is threadedly connected to the steel sleeve 92.

[0143] Please refer to Figure 10 and Figure 12 Furthermore, the delivery assembly of this embodiment further includes a fixing knob 87. The fixing knob 87 is rotatably provided at the proximal end of the driving handle 8. The inner sheath core 6 and the stainless steel tube 61 are movably inserted into the fixing knob 87; the fixing knob 87 can clamp or loosen the stainless steel tube 61, and further clamp or loosen the inner sheath core 6 inside the stainless steel tube 61. Among them, the specific implementation manner of the fixing knob 87 to clamp or loosen the stainless steel tube 61 can, but is not limited to, adopt a structure such as using a knob rotation to clamp the core wire in Chinese Patent Application Publication No. CN209751157U.

[0144] When the fixing knob 87 rotates to loosen the inner sheath core 6 and the stainless steel tube 61, the sheath core joint 9 can control the axial movement of the inner sheath core 6 in the driving handle 8, the traction sheath tube 4 and the driving sheath tube 5, so that the distal end of the inner sheath core 6 drives the distal end of the thrombectomy stent 1 to move axially. At this time, when the proximal position of the thrombectomy stent 1 remains unchanged, the expansion degree of the thrombectomy stent 1 can be finely adjusted to change the expansion degree of the thrombectomy stent 1, so that the thrombectomy stent 1 can better fit the inner wall of the blood vessel, and then completely cut, strip and collect the thrombus in the blood vessel.

[0145] When driving the inner sheath core 6 and the guide head 101 to move axially through the sheath core joint 9 and the stainless steel tube 61, and after adjusting the position and shape of the thrombectomy stent 1, the fixing knob 87 can be rotated to clamp the stainless steel tube 61 and the inner sheath core 6, so that the inner sheath core 6 maintains a fixed relative position with the driving handle 8, the traction sheath tube 4 and the thrombectomy stent 1, and further the position and shape of the thrombectomy stent 1 can be maintained, so as to facilitate the independent control of the driving sheath tube 5 and the thrombus fragmentation stent 2, so that the thrombus fragmentation stent 2 can cut the thrombus inside it in the inner space of the thrombectomy stent 1 in a fixed shape.

[0146] Please refer to in combination Figures 14 to 19 The working principle of the thrombectomy device of this embodiment will be illustrated by way of example below.

[0147] Please refer to Figure 14 as shown Figure 14 The structure of the human heart 01, the superior vena cava 02 and the inferior vena cava 03 blood vessels is shown. Among them, the superior vena cava 02 and the inferior vena cava 03 communicate with the right atrium, and there is a thrombus in the inferior vena cava 03. During the thrombectomy process, the guide wire 001 first punctures from the right femoral vein into the common iliac vein, and then enters the inferior vena cava 03 and the superior vena cava 02 in sequence to establish a thrombectomy channel.

[0148] Please refer to Figure 15 as shown Figure 1The thrombus removal device in this state enters the venous blood vessel channel along the guide wire 001 to reach the thrombus position until the guide head 101 and the distal end of the outer sheath tube 3 completely pass through the distal end of the thrombus.

[0149] See also Figure 16 As shown, the sheath tube connector 7 is fixed to fix the outer sheath tube 3, and the driving handle 8 is pushed to the distal end as a whole, so as to gradually release the thrombus removal stent 1 from the distal end of the outer sheath tube 3 by pulling the sheath tube 4. When the pulling sheath tube 4 and the first fixing ring 113 of the thrombus removal stent 1 are completely exposed from the distal end of the outer sheath tube 3 and pass through the distal end of the thrombus, the release of the thrombus removal stent 1 is completed.

[0150] During the release of the thrombus removal stent 1, the stainless steel tube 61 can be clamped and fixed by the fixing knob 87, so that the guide head 101, the inner sheath core 6 and the thrombus removal stent 1 are pushed forward as a whole, which can improve its pushing ability. In fact, if the fixing knob 87 does not clamp and fix the stainless steel tube 61, after the driving handle 8 is pushed to partially release the thrombus removal stent 1, the thrombus removal stent 1 will contact the inner wall of the blood vessel, so that the subsequent push of the driving handle 8 to completely release the thrombus removal stent 1 will encounter greater resistance and may also damage the blood vessel wall.

[0151] It should be noted that the driving handle 8 may also be fixed, and the sheath connector 7 may be pulled back to release the thrombus removal stent 1 by withdrawing the outer sheath 3 , which may also achieve the same effect.

[0152] When the thrombus removal stent 1 is completely released at the distal end of the thrombus, the clamping of the stainless steel tube 61 can be loosened by rotating the fixing knob 87, so that the thrombus removal stent 1 can restore its original shape, complete expansion and cling to the inner wall of the blood vessel. Then, the sheath tube 4 connector and the driving handle 8 are pulled toward the proximal end at the same time, and the thrombus can be completely cut, separated and collected into the thrombus removal stent 1 by the proximal edge of the cutting section 11 of the thrombus removal stent 1 from the inner wall of the blood vessel.

[0153] See also Figure 17 As shown, after the thrombus is cut, separated and collected, the sheath connector 7 is fixed, and the driving handle 8 is pulled to pull the proximal opening of the cutting section 11 of the thrombus removal stent 1 by pulling the sheath 4 to close and compress it into the distal end of the outer sheath 3. At this time, the proximal end of the collection section 12 of the thrombus removal stent 1 and the distal connection point of the cutting section 11 will also shrink, so that the collection section 12 forms a closed rugby ball structure to wrap the internal thrombus. Figure 6 and Figure 11 , and then push the driving member 82 on the driving handle 8, drive the broken bolt bracket 2 to extend out of the traction sheath 4 through the driving sheath 5, and enter the interior of the collection section 12 ( Figure 17In the state shown). By moving the driving member 82 back and forth, the thrombus-breaking stent 2 is axially reciprocated to cut the thrombus, or by shaking the rotating handle 84, the driving sheath 5 is rotated to drive the thrombus-breaking stent 2 to rotate circumferentially, and the large-particle thrombus and hard thrombus inside the thrombus extraction stent 1 are broken up. It can be understood that the axial movement and circumferential rotation of the thrombus-breaking stent 2 can be carried out synchronously or step by step, and the two cooperate to finally achieve the complete fragmentation of the thrombus inside the thrombus extraction stent 1.

[0154] Please refer to Figure 18 As shown, after completing the thrombus-breaking work, the driving member 82 is pushed proximally to retract the thrombus-breaking stent 2, the sheath tube connector 7 is fixed, and the driving handle 8 and the traction sheath tube 4 are continuously pulled to make the thrombus extraction stent 1 and the fine thrombus inside it enter the outer sheath tube 3 together.

[0155] Please refer to Figure 19 As shown, when the guiding head 101 and the distal end of the outer sheath tube 3 are completely closed, the thrombus extraction device is withdrawn from the human blood vessel channel together with the guide wire 001 to complete the thrombus extraction operation.

[0156] Figures 20 to 22 The structure shown is the second embodiment of the cutting section 11 of the thrombus extraction stent 1.

[0157] Please refer to Figures 20 to 22 , the basic structure of the cutting section 11 of this embodiment is the same as that of the cutting section 11 of the first embodiment, and both include a support body 111, a connecting rod 112 and a first fixing ring 113. The difference lies in the different structures of the support body 111 and the number of connecting rods 112.

[0158] In the proximal end of the cutting section 11 of this embodiment, there are two connecting rods 112 connected to the first fixing ring 113, and the two connecting rods 112 are symmetrically arranged at 180°. The first fixing ring 113 is disposed in the middle and is located at the axis of the support body 111.

[0159] In the proximal end of the support body 111 of this embodiment, there are two wave crests of V-shaped structures, which are respectively connected to the two connecting rods 112 in one-to-one correspondence.

[0160] In the distal end of the support body 111 of this embodiment, there are two wave troughs of V-shaped structures. A plurality of nodes are formed on the wave troughs of the V-shaped structures for the braided wires 121 to be respectively connected.

[0161] The double V-shaped structures at the proximal and distal ends of the support body 111 of this embodiment can provide radial support force and can be more conveniently received into the outer sheath tube 3.

[0162] Figure 23 and Figure 24 The structure shown is the third embodiment of the cutting section 11 of the thrombus extraction stent 1.

[0163] Please refer to Figures 20 to 22, the cutting section 11 of this embodiment has the same basic structure as that of the cutting section 11 of the second embodiment, and both include a support body 111, a connecting rod 112, and a first fixing ring 113. The difference lies in the structure of the support body 111 and the number of connecting rods 112.

[0164] At the proximal end of the cutting section 11 of this embodiment, there are three connecting rods 112 connected to the first fixing ring 113. The three connecting rods 112 are arranged at circumferential intervals of 120°.

[0165] At the proximal end of the support body 111 of this embodiment, there are three wave crests with a V-shaped structure, which are respectively connected to the three connecting rods 112 in one-to-one correspondence.

[0166] At the distal end of the support body 111 of this embodiment, there are 6 wave troughs, which can form 6 nodes. Each node corresponds to two braided wires 121. Each braided wire 121 is folded in half at the node, and 24 strands of silk threads can be formed.

[0167] Figure 25 and Figure 26 The structure shown is the fourth embodiment of the cutting section 11 of the thrombectomy stent 1.

[0168] Please refer to Figures 20 to 22 , the cutting section 11 of this embodiment has the same basic structure as that of the cutting section 11 of the third embodiment, and both include a support body 111, a connecting rod 112, and a first fixing ring 113. The difference lies in the structure of the support body 111.

[0169] At the distal end of the support body 111 of this embodiment, there are 12 wave troughs, which can form 12 nodes. Each node corresponds to two braided wires 121. Each braided wire 121 is folded in half at the node, and 48 strands of silk threads can be formed.

[0170] Figure 27 and Figure 28 The structure shown is the fifth embodiment of the cutting section 11 of the thrombectomy stent 1.

[0171] Please refer to Figures 20 to 22 , the cutting section 11 of this embodiment has the same basic structure as that of the cutting section 11 of the third embodiment, and both include a support body 111, a connecting rod 112, and a first fixing ring 113. The difference lies in the different structure of the support body 111.

[0172] At the distal end of the support body 111 of this embodiment, there are 18 wave troughs, which can form 18 nodes. Each node corresponds to two braided wires 121. Each braided wire 121 is folded in half at the node, and 72 strands of silk threads can be formed.

[0173] Combined with Figures 20 to 28As shown, the proximal end of the support body 111 can be connected to the first fixing ring 113 by different numbers of connecting rods 112, such as two or three, thus forming openings of different numbers. At the same time, the position of the first fixing ring 113 can be adjusted and changed. The first fixing ring 113 can be located at the axis of the support body 111 or deviate from the axis of the support body 111. The distal end of the support body 111 has different numbers of wave valleys, and can be connected to different numbers of braided wires of the collection section 12, thereby changing the density of the pores on the circumferential wall of the collection section 12 of the thrombectomy stent 1.

[0174] Figure 29 The structure shown is the second embodiment of the collection section 12 of the thrombectomy stent 1.

[0175] Please refer to Figure 29 , the difference between the collection section 12 of this embodiment and the collection section 12 in the first embodiment is that the braided wire 121 is not used. The collection section 12 of this embodiment includes a circumferentially closed stent body and a film 123 coated on the circumferential wall of the stent body.

[0176] A plurality of holes are formed in the film 123, and the distal ends of the film 123 converge to form a closed end. The size and density of the holes represent the size and density of the pores of the collection section 12. The size of the holes is easy to adjust, and the pore diameter can be finer, so that thrombus particles are not easy to leak and escape.

[0177] The stent body includes a plurality of circumferentially closed corrugated rods 122 arranged at axial intervals. The corrugated rods 122 are fixed on the circumferential wall of the film 123, and the corrugated rings can be compressed and self-expanded in the radial direction. The radial dimension of the corrugated rod 122 at the distal end gradually becomes smaller to adapt to the converging structure at the distal end of the film 123. The corrugated rod 122 can provide radial support force, and the shape can be diversified. The sheath retraction occupies less space and is convenient for use in blood vessels with smaller sizes.

[0178] Figure 30 and Figure 31 The structure shown is the second embodiment of the thrombus fragmentation stent 2.

[0179] Please refer to Figure 30 and Figure 31 , the difference between the thrombus fragmentation stent 2 of this embodiment and the thrombus fragmentation stent 2 in the first embodiment is the different structure of the strut 21.

[0180] The strut 21 of this embodiment is helical. That is, in the direction from the proximal end to the distal end of the thrombus fragmentation stent 2, the strut 21 is helically wound to be helical. The winding angle of the helical strut 21 from the proximal end to the distal end is in the range of 0 to 360°. When the helical strut 21 rotates circumferentially on the thrombus fragmentation stent 2, a helical stirring blade can be formed, thereby changing the angle of cutting the thrombus, reducing the resistance of cutting the thrombus, and also being convenient for retracting into the traction sheath tube 4.

[0181] Based on the above technical solutions, the embodiments of the present invention have at least the following advantages and positive effects:

[0182] In the thrombus extraction device of the embodiment of the present invention, the thrombus extraction stent 1 and the thrombus fragmentation stent 2 are cooperated. When the thrombus extraction stent 1 receives the thrombus in the blood vessel into the thrombus extraction stent 1, the delivery component is used to control the thrombus fragmentation stent 2 to extend into the internal space of the thrombus extraction stent 1, and the thrombus can be axially moved relative to the thrombus extraction stent 1 to cut the thrombus, so as to continuously cut and crush the thrombus therein; it is beneficial to crush stubborn, large and hard thrombi and improve the thrombus extraction effect.

[0183] Although the present invention has been described with reference to several exemplary embodiments, it should be understood that the terms used are illustrative and exemplary rather than restrictive. Since the present invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above-described embodiments are not limited to any of the foregoing details, but should be broadly construed within the spirit and scope defined by the appended claims. Therefore, all changes and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.

Claims

1. A thrombectomy device, characterized in that, Comprising: A thrombectomy stent, which is a stent structure capable of contraction and expansion, and its distal end is closed and its proximal end has an opening; the thrombectomy stent includes a cutting section and a collection section sequentially connected from the proximal end to the distal end; an opening is provided at the proximal end of the cutting section; the distal end of the collection section is closed, the proximal end of the collection section is smoothly connected to the distal end of the cutting section, and a plurality of mesh holes are provided on the peripheral wall of the collection section; A thrombus fragmentation stent, which is a stent structure capable of contraction and expansion, the thrombus fragmentation stent includes a plurality of struts, a second fixing ring provided at the proximal ends of the plurality of struts, and a third fixing ring provided at the distal ends of the plurality of struts; the plurality of struts are circumferentially spaced apart; the proximal ends of the plurality of struts converge and are connected to the second fixing ring, and the distal ends of the plurality of struts converge and are connected to the third fixing ring; the thrombus fragmentation stent can extend into the thrombectomy stent to cut and break the thrombus collected and stored inside the thrombectomy stent; and A delivery assembly, the distal ends of which are respectively connected to the thrombectomy stent and the thrombus fragmentation stent, and are used for accommodating the thrombectomy stent and the thrombus fragmentation stent in a contracted state; the delivery assembly can release the thrombectomy stent and the thrombus fragmentation stent to an expanded state, and can drive the thrombus fragmentation stent to move axially in the internal space of the thrombectomy stent in the expanded state along the thrombectomy stent.

2. The thrombectomy device according to claim 1, characterized in that, The delivery assembly can also drive the thrombus fragmentation stent to rotate circumferentially in the internal space of the thrombectomy stent in the expanded state along the thrombectomy stent.

3. The thrombectomy device according to claim 1, characterized in that, The delivery assembly includes: An outer sheath tube, which is used for accommodating the thrombectomy stent in a contracted state; A traction sheath tube, the distal end of which is connected to the thrombectomy stent; the traction sheath tube is inserted into the outer sheath tube and can move axially relative to the outer sheath tube so that the thrombectomy stent extends out of or is accommodated in the outer sheath tube; the traction sheath tube can accommodate the thrombus fragmentation stent in a contracted state; and A driving sheath tube, the distal end of which is connected to the thrombus fragmentation stent; the driving sheath tube is inserted into the traction sheath tube and can move axially relative to the traction sheath tube to drive the thrombus fragmentation stent to extend out of the traction sheath tube and move axially in the internal space of the thrombectomy stent, or drive the thrombus fragmentation stent to be accommodated in the traction sheath tube.

4. The thrombectomy device according to claim 3, characterized in that, The delivery assembly further includes a sheath tube joint, a driving handle and a driving member; The sheath tube joint is in a tubular structure and is connected to the proximal end of the outer sheath tube; The driving handle is arranged on the proximal side of the sheath tube joint; the driving handle is in a tubular structure and is connected to the proximal end of the traction sheath tube; the driving handle can control the axial relative movement of the traction sheath tube in the sheath tube joint and the outer sheath tube; The driving member is connected to the driving sheath tube, and the driving member can control the axial relative movement of the driving sheath tube in the driving handle and the traction sheath tube.

5. The thrombectomy device according to claim 4, characterized in that, A chute extending along the axial direction is provided on the peripheral wall of the driving handle; The driving member is arranged in the chute. The outer end of the driving member is exposed outside the outer wall of the driving handle, and its inner end extends into the driving handle and is connected to the driving sheath tube. The driving member can slide along the chute to control the relative axial movement of the driving sheath tube in the driving handle and the traction sheath tube.

6. The thrombus extraction device according to claim 5, wherein The driving sheath tube can rotate circumferentially relative to the traction sheath tube to drive the thrombus fragmentation stent to rotate circumferentially in the inner space of the thrombus extraction stent.

7. The thrombus extraction device according to claim 6, wherein The conveying assembly further includes a snap ring fixedly sleeved on the driving sheath tube; An axial hole extending along the axial direction of the driving sheath tube is provided at the inner end of the driving member; The snap ring is rotatably inserted into the axial hole and is axially clamped with the inner end of the driving member; The driving sheath tube can axially move with the driving member through the snap ring and can rotate circumferentially in the axial hole at the inner end of the driving member together with the snap ring.

8. The thrombus extraction device according to claim 6, wherein The conveying assembly further includes a rotating shaft, a rotating handle, a driving gear and a driven gear; The rotating shaft is rotatably inserted through the peripheral wall of the driving handle; The rotating handle is arranged outside the peripheral wall of the driving handle and is connected to the outer end of the rotating shaft; The driving gear is arranged inside the driving handle and is connected to the inner end of the rotating shaft; The driven gear is arranged inside the driving handle and meshes with the driving gear; The driven gear is arranged on the proximal side of the driving sheath tube and can drive the driving sheath tube to rotate synchronously; The driving sheath tube can move axially relative to the driven gear.

9. The thrombus extraction device according to claim 8, wherein An axially protruding shaft cylinder part is provided at the distal end of the driven gear. The shaft cylinder part is sleeved on the proximal end of the driving sheath tube; One of the inner wall of the shaft cylinder part and the outer peripheral wall of the driving sheath tube is recessed with an axially extending limiting groove, and the other is provided with a limiting protrusion adapted to the limiting groove, so that the driving sheath tube can rotate circumferentially synchronously with the driven gear, and the driving sheath tube can drive the limiting protrusion to slide axially relative to the driven gear in the limiting groove.

10. The thrombus extraction device according to claim 5, wherein The conveying assembly further includes an inner sheath core; The inner sheath core is tubular, and a guide wire can pass through its tube; The inner sheath core is movably inserted through the driving sheath tube and the thrombus fragmentation stent; The distal end of the inner sheath core is inserted through the thrombus extraction stent and is connected to the distal end of the thrombus extraction stent. The proximal end of the inner sheath core passes out of the proximal end of the driving handle and can move axially relative to the driving handle.

11. The thrombus extraction device according to claim 10, wherein The conveying assembly further includes a fixing knob. The fixing knob is rotatably arranged at the proximal end of the driving handle; The proximal end of the inner sheath core is movably inserted out of the fixing knob; When the fixed knob rotates relative to the driving handle, it can clamp or loosen the inner sheath core.

12. The thrombus extraction device according to claim 11, wherein the conveying assembly further includes a sheath core joint; the proximal end of the inner sheath core passes through the fixed knob and is connected to the sheath core joint; when the fixed knob loosens the inner sheath core, the sheath core joint can control the axial movement of the inner sheath core within the driving handle.

13. The thrombus extraction device according to claim 10, wherein the conveying assembly further includes a guiding head; the distal end of the guiding head is a tip, the proximal end of the guiding head is connected to the distal end of the inner sheath core, and an axially penetrating perforation is provided in the guiding head and is connected to the inner sheath core.

14. The thrombus extraction device according to claim 13, wherein the thrombus extraction device further includes a constricting ring; the constricting ring is sleeved on the distal end of the inner sheath core and is connected to the proximal end of the guiding head; the distal ends of the thrombus extraction brackets converge and are connected to the constricting ring.

15. The thrombus extraction device according to claim 1, wherein the cutting section includes a support body with a distal end connected to the collection section, a plurality of connecting rods connected to the proximal end of the support body, and a first fixing ring connected to the proximal ends of the plurality of connecting rods; the first fixing ring is connected to the distal end of the conveying assembly; the support body is a circumferentially closed cylinder; the plurality of connecting rods are circumferentially spaced around the center of the support body, the proximal ends of the plurality of connecting rods converge and are connected to the first fixing ring, and an opening is formed between adjacent connecting rods.

16. The thrombus extraction device according to claim 15, wherein the support body includes a plurality of V-shaped rods that are circumferentially and axially connected; the distal end of the support body has a plurality of valleys formed by the ends of the V-shaped rods, and the valleys are connected to the proximal end of the collection section; the proximal end of the support body has a plurality of peaks formed by the ends of the V-shaped rods, and the peaks are connected to the distal ends of the connecting rods.

17. The thrombus extraction device according to claim 1, wherein the collection section is a net tube structure formed by the intersection of multiple braided wires, and mesh holes are formed between the intersecting braided wires; the distal end of the collection section is formed by the distal ends of multiple braided wires converging and connecting to form a closed end; the proximal ends of the braided wires are connected to the distal end of the cutting section.

18. The thrombus extraction device according to claim 1, wherein the collection section includes a circumferentially closed support body and a film covering the peripheral wall of the support body; the mesh holes are formed in the film; the distal ends of the film converge to form a closed end, and the proximal end of the film is connected to the distal end of the cutting section; the support body includes a plurality of circumferentially closed corrugated rods arranged at axial intervals; the corrugated rods are fixed on the peripheral wall of the film, and the corrugated rods can be compressed and expanded in the radial direction.

19. The thrombus extraction device according to claim 1, wherein in the direction from the proximal end to the distal end of the thrombus fragmentation bracket, the support rods are in an arc shape or the support rods are helically wound to form a spiral shape.

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