Thrombectomy device and thrombectomy system

Abstract

The invention provides a thrombectomy device and a thrombectomy system.The thrombectomy device comprises an outer support and an inner support, and the inner support is rotationally sleeved with the outer support; the outer bracket comprises a plurality of fixed rods which are uniformly distributed around the rotating axis of the inner bracket, and each fixed rod is provided with a first outer convex part; the inner support comprises a plurality of movable rods evenly distributed around the rotating axis, the number of the movable rods is equal to that of the fixed rods, the movable rods are provided with second outwards-protruding parts, and the inner support has an unfolding position and a folding position. The second convex part is provided with a cutting part, and a film is arranged between the second convex part and the first convex part corresponding to the second convex part; when the inner stent is located at the unfolding position, the outer stent, the inner stent and the membrane seal the circumference of the thrombectomy device, the membrane further seals a far-end opening formed between the first outer convex part and the second outer convex part, and / or the thrombectomy device further comprises a far-end pocket body which is arranged at the far end of the thrombectomy device and covers part of the first outer convex part and part of the second outer convex part. The thrombectomy system is provided with the thrombectomy device, and the thrombectomy device is high in thrombectomy efficiency and good in thrombectomy leakage prevention effect and does not damage blood vessels.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a thrombus removal device and a thrombus removal system provided with the thrombus removal device. Background Art

[0002] Thrombosis refers to the abnormal blood clots in the circulating blood or the blood deposits on the inner wall of the heart or blood vessel walls caused by certain factors in the human body or animals during their survival. Thrombosis occurs throughout the body's tissues and organs, not only in myocardial infarction, deep vein thrombosis or cerebral vascular thrombosis, but also in blood vessels anywhere in the body. The incidence of venous thrombosis is higher than that of arterial thrombosis, with the ratio of the two reaching 4:1. Venous thrombosis accounts for 40% to 60% of the thrombotic mechanism; the incidence of obstructive coronary artery thrombosis is 15% to 95%, and 90% of thrombi are accompanied by atherosclerotic plaques. Thrombosis causes vascular occlusion and blood flow obstruction, leading to ischemia, hypoxia and even necrosis of the related vascular innervated tissues, resulting in symptoms of corresponding tissue and organ dysfunction.

[0003] In the early stage of thrombosis treatment, anticoagulants were mostly used for treatment, but the treatment effect was not obvious, the vascular recanalization rate was low, the recanalization time was long, and some patients were not suitable for thrombolytic therapy. Later, the thrombectomy device was developed, which provided a new and efficient vascular recanalization treatment method for patients with thrombosis. The mechanical thrombectomy operation time was short and the related complications were few. It is currently a research hotspot in the field of thrombus treatment. At present, the thrombectomy devices on the market have both single-layer and double-layer structures; however, the existing thrombectomy devices have the following shortcomings: since the stents of the thrombectomy devices are mostly laser-cut tubes or wire-woven into stents with large and small grids, there is a problem of leakage of thrombi during the thrombectomy process, which makes the thrombectomy unclean and there is a risk of scratching the inside of the blood vessel. Summary of the invention

[0004] In order to solve the above problems, the main purpose of the present invention is to provide a thrombus removal device with high thrombus removal efficiency, good thrombus leakage prevention effect and avoidance of damage to the inner wall of the blood vessel during the thrombus removal process.

[0005] Another object of the present invention is to provide a thrombus removal system provided with the above-mentioned thrombus removal device.

[0006] In order to achieve the main purpose of the present invention, the present invention provides a thrombus removal device, which includes an outer bracket and an inner bracket, wherein the outer bracket is rotatably sleeved on the outside of the inner bracket; the outer bracket includes a plurality of fixed rods evenly distributed around the rotation axis of the inner bracket, and a first outer protrusion is provided between the first proximal end and the first distal end of the fixed rod; the inner bracket includes a plurality of moving rods evenly distributed around the rotation axis, the number of the moving rods is equal to that of the fixed rods, and a second outer protrusion is provided between the second proximal end and the second distal end of the moving rod, and the inner bracket has an expanded position and a retracted position; along the expanded direction of the inner bracket, the inner bracket is In the direction, a cutting portion is provided on the downstream end side of the second outer protrusion, and a membrane is provided between the second outer protrusion and the first outer protrusion located at its upstream end and adjacent to the inner bracket; when the inner bracket is in the expanded position, the membrane is expanded, and along the expansion direction, the moving rod is attached to the fixed rod located at its downstream end and adjacent to the inner bracket, and the membrane also closes the distal opening formed between the first outer protrusion and the second outer protrusion connected to itself, and / or the thrombus removal device also includes a distal bag body, the first distal end and the second distal end are connected to the distal bag body, and the distal bag body covers part of the first outer protrusion and part of the second outer protrusion.

[0007] As can be seen from the above, before the thrombectomy device enters the blood vessel, its inner stent is in the retracted position; after the thrombectomy device enters the blood vessel and is placed at the thrombus, it expands and unfolds by itself, and the first outer protrusion of the outer stent will fit on the blood vessel wall, and then wait for the outer stent and inner stent of the thrombectomy device to embed into the thrombus; after the outer stent and the inner stent are embedded in the thrombus, the inner stent is controlled to rotate to the deployed position, and in the process of the inner stent moving to the deployed position, the cutting part on the inner stent will cut the thrombus, and cooperate with the gradually deployed membrane to gather the thrombus into the space surrounded by the outer stent, the inner stent and the membrane; when the inner stent is in the deployed position, the outer stent, the inner stent and the membrane or the outer stent, the inner stent, the membrane and the distal pocket form a space that is closed in the circumferential direction and distal end of the thrombectomy device, thereby collecting the thrombus in the space and avoiding thrombus leakage during the withdrawal of the thrombectomy device.

[0008] Furthermore, when the inner support is in the expanded position, the membrane also closes the proximal opening formed between the first outer protrusion and the second outer protrusion connected to itself; and / or the thrombus removal device also includes a proximal pocket body, the first proximal end and the second proximal end are connected to the proximal pocket body, and the proximal pocket body covers part of the first outer protrusion and part of the second outer protrusion.

[0009] As can be seen from the above, the above design prevents the thrombus inside the thrombectomy device from leaking from the proximal side during the withdrawal process, especially in the process of withdrawing the thrombectomy device into the delivery sheath, which can effectively prevent the thrombus from being squeezed out from the proximal side due to the compression and deformation of the thrombectomy device.

[0010] Furthermore, the distal pocket body has a first dense mesh structure, or the distal pocket body is made of a microporous membrane material; the proximal pocket body has a second dense mesh structure, or the distal pocket body is made of a microporous membrane material.

[0011] As can be seen from the above, the above design allows blood to circulate in the blood vessels during thrombectomy to reduce intraoperative risks, while filtering and intercepting thrombus fragments to prevent thrombus fragments from flowing back into the blood vessels with the blood, thereby ensuring the thrombus removal rate.

[0012] Further, the first outer protrusion has a first arc segment, a second arc segment and a supporting segment, the first arc segment is connected between the first distal end and the supporting segment, the second arc segment is connected between the first proximal end and the supporting segment, the distal end bag body is covered on the first arc segment, and the proximal end bag body is covered on the second arc segment; the second outer protrusion has a third arc segment, a fourth arc segment and a cutting segment, the third arc segment is connected between the second distal end and the cutting segment, the fourth arc segment is connected between the second proximal end and the cutting segment, the distal end bag body is covered on the third arc segment, the proximal end bag body is covered on the fourth arc segment, and the cutting portion is arranged on the cutting segment.

[0013] As can be seen from the above, the above design is conducive to the withdrawal of the thrombectomy device into the delivery sheath, and avoids the presence of sharp parts on the external stent, thereby preventing the external stent from scratching the blood vessel.

[0014] Furthermore, the distal bag body has a first sleeve portion and a first cover portion, the first distal end and the second distal end are inserted in the first sleeve portion, and the first arc segment and the third arc segment are located in the first cover portion; the proximal bag body has a second sleeve portion and a second cover portion, the first proximal end and the second proximal end are inserted in the second sleeve portion, and the second arc segment and the fourth arc segment are located in the second cover portion.

[0015] As can be seen from the above, the sleeve part of the bag body cooperates with the ends of the fixed rod and the movable rod, which not only makes the bag body reliably fixed on the bracket, but also limits the fixed rod and the movable rod to ensure that the inner bracket can be reliably rotated relative to the outer bracket; the cover part can cover and close the openings between the arc segments of each fixed rod and the arc segments of the movable rod that are not closed by the membrane when the inner bracket is in the expanded position, and then cooperates with the outer bracket, the inner bracket and the membrane to seal the thrombus in the thrombus removal device, effectively preventing thrombus leakage.

[0016] Furthermore, a first membrane connecting portion is provided on the inner side of the supporting section, the first side of the membrane is connected to the first membrane connecting portion, and the second side of the membrane is connected to the cutting section; or a second membrane connecting portion is provided on the inner side of the first outer protrusion, and the first side of the membrane is connected to the second membrane connecting portion.

[0017] As can be seen from the above, the membrane connection portion facilitates the connection between the membrane and the fixed rod, and limits the membrane in the axial direction of the thrombus removal device; and the connection position between the membrane and the fixed rod and the moving rod can be set according to whether the thrombus removal device is provided with a distal pocket body, a proximal pocket body, and the anti-leakage requirements for thrombus.

[0018] Furthermore, a first developing portion is provided on the distal bag body, a second developing portion is provided on the proximal bag body; and / or a third developing portion is provided on the fixed rod, and / or a fourth developing portion is provided on the movable rod.

[0019] As can be seen from the above, the above design facilitates determination of the exact position of the thrombectomy device during surgery, ensuring that the thrombectomy device can cover the area where the thrombus is located, thereby ensuring the thrombectomy effect and thrombus removal rate.

[0020] Furthermore, the thrombus removal device further includes a fixing member, which is mounted on the first proximal end.

[0021] As can be seen from the above, the fixing member can further limit the fixed rods and the movable rods to ensure the reliability of the rotation of the inner bracket relative to the outer bracket, and at the same time, the bag body can be reliably fixed on the ends of the fixed rods and the movable rods. In addition, the fixing member can be used to connect the conveying device, thereby facilitating the control of the movement of the thrombectomy device and the rotation of the inner bracket relative to the outer bracket.

[0022] In order to achieve another purpose of the present invention, the present invention provides a thrombus removal system, including a delivery device and a delivery sheath, wherein the delivery device can be movably inserted into the delivery sheath, wherein the thrombus removal system also includes the above-mentioned thrombus removal device, and the proximal side of the thrombus removal device is connected to the delivery device; the delivery device can drive the thrombus removal device to pass through the third distal end of the delivery sheath to the outside of the delivery sheath to deploy the thrombus removal device, and control the inner bracket to rotate from the folded position to the deployed position; the delivery device can also drive the thrombus removal device to be compressed and recovered from the third distal end into the delivery sheath.

[0023] As can be seen from the above, the thrombectomy system uses the above-mentioned thrombectomy device, so that when removing the thrombus, it will not scratch the blood vessel, reduce the risk during the operation, and prevent the leakage of thrombus fragments during the thrombus removal process and when the thrombus removal device is withdrawn, thereby ensuring the thrombus removal rate.

[0024] Further, the conveying device includes a first driving rod, the first driving rod is connected to the second proximal end, and the first driving rod can drive the inner bracket to rotate relative to the outer bracket; or the conveying device includes a second driving rod and a third driving rod, the second driving rod is connected to the first proximal end, the third driving rod is inserted into the second driving rod, the third driving rod is connected to the second proximal end, and the third driving rod can drive the inner bracket to rotate relative to the outer bracket.

[0025] As can be seen from the above, through the connection design between the delivery device and the thrombus removal device, the delivery device can reliably drive the inner stent to rotate relative to the outer stent to capture the thrombus and prevent the captured thrombus from leaking. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 1 is a structural diagram of an embodiment of the thrombus removal device of the present invention when the inner support is in a retracted position.

[0027] Figure 2 1 is a structural diagram of an embodiment of the thrombus removal device of the present invention when the inner support is in the expanded position.

[0028] Figure 34 is a structural diagram of an outer support of an embodiment of a thrombus removal device of the present invention.

[0029] Figure 4 4 is a structural diagram of a fixed rod of an embodiment of a thrombus removal device of the present invention.

[0030] Figure 5 1 is a structural diagram of an inner support of an embodiment of a thrombus removal device according to the present invention from a first viewing angle.

[0031] Figure 6 4 is a structural diagram of the inner support of the thrombus removal device embodiment of the present invention from a second viewing angle.

[0032] Figure 7 This is a structural diagram of the thrombus removal device according to an embodiment of the present invention when the inner support is in the folded position after omitting some components.

[0033] Figure 8 This is a first structural diagram after omitting some components when the inner support of the thrombus removal device embodiment of the present invention is in the expanded position.

[0034] Fig. 9 This is a second structural diagram after omitting some components when the inner support of the thrombus removal device embodiment of the present invention is in the expanded position.

[0035] Fig.10 1 is a structural diagram of the distal end housing of the thrombus removal device according to an embodiment of the present invention.

[0036] Fig.11 It is a third cross-sectional view of the thrombus removal device of the embodiment of the present invention when the thrombus removal device is placed in the delivery sheath tube with some components omitted.

[0037] The present invention is further described below in conjunction with the accompanying drawings and embodiments. DETAILED DESCRIPTION

[0038] Thrombectomy Device Embodiment

[0039] First of all, it is necessary to understand that in the following terms, "proximal" refers to the end of the instrument or component away from the operator, and "distal" refers to the end of the instrument or component away from the operator. The above orientation / position relationship is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0040] Reference Figure 1 and Figure 2The thrombus removal device 100 comprises an outer support 1, an inner support 2, a membrane 3, a distal pocket 4, a proximal pocket 5 and a fixing member 6. The outer support 1 is rotatably mounted on the outer portion of the inner support 2, that is, the overall outer contour of the outer support 1 is covered outside the overall outer contour of the inner support 2, and the inner support 2 can rotate relative to the outer support 1 around a rotation axis, and the rotation axis is parallel to the axial direction of the thrombus removal device 100.

[0041] Combination Figure 3 and Figure 4 The outer stent 1 includes a plurality of fixed rods 11, and the plurality of fixed rods 11 are evenly distributed around the rotation axis of the inner stent 2. The fixed rod 11 has a first proximal end 111, a first distal end 112, and a first convex portion 113, the first convex portion 113 is connected between the first proximal end 111 and the first distal end 112, the first convex portion 113 is arranged toward the outside of the outer stent 1, and the first convex portion 113 is used to contact the blood vessel wall. Among them, the first proximal ends 111 of the plurality of fixed rods 11 enclose a first limiting space, and the first limiting space plays a role similar to an axial hole; similarly, the first distal ends 112 of the plurality of fixed rods 11 enclose a second limiting space, and the second limiting space plays a role similar to an axial hole.

[0042] In this embodiment, the first outer protrusion 113 has a first arc segment 1131, a second arc segment 1132 and a support segment 1133; the first arc segment 1131 is connected between the first distal end 112 and the first end of the support segment 1133, the second arc segment 1132 is connected between the first proximal end 111 and the second end of the support segment 1133, and the support segment 1133 extends roughly along the axial direction of the thrombus removal device 100. The support section 1133 is used to contact the blood vessel wall to ensure that the thrombectomy device 100 can be fitted and fixed on the blood vessel wall; and an arc-shaped transition is made between the support section 1133 and the first proximal end 111, and an arc-shaped transition is made between the support section 1133 and the first distal end 112, to prevent the presence of sharp parts on the fixed rod 11, thereby avoiding the external stent 1 from scratching the blood vessel, reducing the risk during the operation, and at the same time, it is also beneficial for the thrombectomy device 100 to be withdrawn from the distal side of the delivery sheath 10 into the delivery sheath 10, and to be inserted from the proximal side of the delivery sheath 10 into the delivery sheath 10.

[0043] Combination Figure 5 and Figure 6The inner bracket 2 includes a plurality of movable rods 21, which are evenly distributed around the rotation axis of the inner bracket 2. The movable rod 21 has a second proximal end 211, a second distal end 212, and a second outer protrusion 213. The second outer protrusion 213 is connected between the second proximal end 211 and the second distal end 212. The profile of the second outer protrusion 213 is similar to the profile of the first outer protrusion 113 of the fixed rod 11, so that the movable rod 21 can be stored inside the fixed rod 11 and the movable rod 21 can be more closely attached to the fixed rod 11. Among them, a first rotating shaft portion is formed between the second proximal ends 211 of the plurality of movable rods 21, and the first rotating shaft portion is inserted into the above-mentioned first limiting space. The second distal ends 212 of the plurality of movable rods 21 form a second rotating shaft portion, and the second rotating shaft portion is inserted into the above-mentioned second limiting space, so that the inner bracket 2 can rotate relative to the outer bracket 1 through the cooperation between the first rotating shaft portion and the first limiting space and the cooperation between the second rotating shaft portion and the second limiting space.

[0044] The inner support 2 has an expanded position (eg Figure 2 , Figure 8 , Fig. 9 as shown) and the stowed position (as shown Figure 1 , Figure 7 In the present embodiment, the second outer protrusion 213 has a third arc segment 2131, a fourth arc segment 2132 and a cutting segment 2133; the third arc segment 2131 is connected between the second distal end 212 and the first end of the cutting segment 2133, the fourth arc segment 2132 is connected between the second proximal end 211 and the second end of the cutting segment 2133, and the cutting segment 2133 extends along the axial direction of the thrombus removal device 100.

[0045] Along the deployment direction R of the inner stent 2, a cutting portion 21331 is provided at the downstream end side of the second outer protrusion 213, and the cutting portion 21331 extends along the axial direction of the thrombus removal device 100; in this embodiment, the cutting portion 21331 is provided on the cutting segment 2133, and the length of the cutting portion 21331 is substantially equal to the length of the cutting segment 2133. Since the area of ​​the movable rod 21 used for cutting thrombi is at the cutting segment 2133, the cutting portion 21331 is only provided on the cutting segment 2133 instead of the third arc segment 2131 and the fourth arc segment 2132, which can ensure that all blood vessels are effectively cut, and can simplify the structure of the movable rod 21, thereby reducing the difficulty of processing the movable rod 21.

[0046] In addition, since the outer support 1 is sleeved on the outer side of the inner support 2, the movable rod 21 almost fits the blood vessel wall but does not come into direct contact with it, thereby preventing the cutting portion 21331 on the movable rod 21 from scratching the inside of the blood vessel, thereby improving the safety of thrombus removal; and since the diameters of the fixed rod 11 and the movable rod 21 are very small, the thrombus removal rate can still be guaranteed. Furthermore, the surface of the fixed rod 11 is smoothly transitioned, and the other surfaces of the movable rod 21 except the cutting portion 21331 are also smoothly transitioned, thereby reducing the risk of the fixed rod 11 and the movable rod 21 scratching the blood vessel.

[0047] Both the fixed rod 11 and the movable rod 21 are made of shape memory material, so that they have elastic deformation ability, and when the thrombus removal device 100 detaches from the delivery sheath 10 and enters the blood vessel, the thrombus removal device 100 can present a set expansion state; in some embodiments, the fixed rod 11 and the movable rod 21 can be made of shape memory alloy (such as nickel-titanium alloy).

[0048] Combination Figure 7 and Figure 8 , along the deployment direction R of the inner stent 2, a membrane 3 is provided between the second outer protrusion 213 of the movable rod 21 and the second outer protrusion 213 of a fixed rod 11 located at the upstream end and adjacent to the movable rod 21. The connection method between the membrane 3 and the fixed rod 11 and the movable rod 21 includes but is not limited to at least one of winding, bonding, welding, etc.; the membrane 3 can be any elastic polymer material with good biocompatibility. Specifically, the membrane 3 can be a polymer membrane with good biocompatibility, with certain elasticity and not easy to tear. For example, the membrane 3 can be PET [the chemical name of PET membrane is polyethylene terephthalate (Polyethy l ene terephthalate), abbreviated as PET], PTFE [the chemical name of PTFE membrane is polytetrafluoroethylene (Polytetrafluoroethylene, abbreviated as PTFE)], etc.

[0049] When the inner support 2 is in the expanded position, the second side of the membrane 3 is driven by the passive rod 21, so that the membrane 3 is expanded, so that the membrane 3 closes the area formed by the cutting section 2133 of the second outer protrusion 213 and the corresponding supporting section 1133 of the first outer protrusion 113, and along the expansion direction R, the movable rod 21 fits tightly on the fixed rod 11 located at its downstream end and adjacent to it, thereby achieving a circumferential closure of the thrombus removal device 100, preventing the thrombus from leaking out of the thrombus removal device 100 from the circumference of the thrombus removal device 100 after the thrombus is removed and during the process of withdrawing the thrombus to the delivery sheath 10, so as to ensure the thrombus removal rate.

[0050] In some embodiments, Figure 8As shown, when the inner support 2 is in the expanded position, the membrane 3 may not close the distal opening 102 formed between the first outer protrusion 113 and the second outer protrusion 213 connected to itself (the distal opening 102 is the opening formed between the first arc segment 1131 and the third arc segment 2131), and the membrane 3 may not close the proximal opening 101 formed between the first outer protrusion 113 and the second outer protrusion 213 connected to itself (the proximal opening 101 is the opening formed between the second arc segment 1132 and the fourth arc segment 2132); at this time, a distal pocket 4 needs to be provided at the distal end of the thrombus removal device 100 (i.e., the first distal end 112 and the second distal end 212), and in order to further reduce the risk of thrombus leakage after the thrombus removal device 100 is removed and withdrawn to the delivery sheath 10, a proximal pocket 5 may also be provided at the proximal end of the thrombus removal device 100 (i.e., the first proximal end 111 and the second proximal end 211). For specific settings, please refer to the following. In this embodiment, as an optional method, a first membrane connecting portion 1331 is provided on the inner side of the supporting section 1133 of the first outer protrusion 113, and the first side of the membrane 3 is connected to the first membrane connecting portion 1331. When connected, the first side of the membrane 3 is wound and fixed on the first membrane connecting portion 1331, and the membrane 3 can be further bonded and fixed to the first membrane connecting portion 1331 by an adhesive to ensure that the membrane 3 does not fall off from the first membrane connecting portion 11331. At the same time, the first membrane connecting portion 1331 can also limit the membrane 3 in the axial direction of the thrombus removal device 100; The second side of the membrane 3 is connected to the cutting segment 2133 of the second outer protrusion 213, and the second side of the membrane 3 is preferably connected to the side of the cutting segment 2133 opposite to the cutting portion 21331 (that is, the second side of the membrane 3 and the cutting portion 21331 are roughly located on both sides of the cutting segment 2133). When connected, the membrane 3 can be bonded and fixed to the cutting segment 2133 by an adhesive. Of course, the second side of the membrane 3 can be connected to other parts of the cutting segment 2133. In addition, the height of the membrane 3 in the circumferential direction of the thrombus removal device 100 is roughly consistent with the length of the supporting segment 1133 and the cutting segment 2133.

[0051] In some embodiments, Fig. 9As shown, when the inner stent 2 is in the deployed position, the membrane 3 also closes the distal opening 102 formed between the first outer protrusion 113 and the second outer protrusion 213 connected to the membrane 3; similarly, in order to further reduce the risk of thrombus leakage in the process of the thrombus removal device 100 after thrombus removal and withdrawal to the delivery sheath 10, the membrane 3 also closes the proximal opening 101 formed between the first outer protrusion 113 and the second outer protrusion 213 connected to the membrane 3; at this time, the tightness between the membrane 3 and the fixed rod 11 and the movable rod 21 can also prevent the thrombus from leaking in the process of the thrombus removal device 100 after thrombus removal and withdrawal to the delivery sheath 10. In order to further ensure that the thrombus does not leak, a distal pocket 4 can still be provided at the distal end of the thrombus removal device 100, and a proximal pocket 5 can be provided at the proximal end of the thrombus removal device 100. In this embodiment, as an optional method, a second membrane connecting portion is provided on the inner side of the first outer protrusion 113, and the inner side includes the inner sides of the first arc segment 1131, the second arc segment 1132 and the supporting segment 1133. The first side of the membrane 3 is connected to the second membrane connecting portion. When connected, the first side of the membrane 3 is wrapped and fixed on the second membrane connecting portion, and the membrane 3 can be further bonded and fixed to the second membrane connecting portion by an adhesive to ensure that the membrane 3 does not fall off from the second membrane connecting portion. At the same time, the second membrane connecting portion can also limit the membrane 3 in the axial direction of the thrombus removal device 100; the second side of the membrane 3 is connected to the second outer protrusion 213 (including the third arc segment 2131, the fourth arc segment 2132 and the cutting segment 2133). When connected, the membrane 3 can be bonded and fixed to the second outer protrusion 213 by an adhesive; in addition, the length of the membrane 3 in the extension direction of the fixed rod 11 is roughly consistent with the length of the first outer protrusion 113 and the second outer protrusion 213.

[0052] Combination Fig.10 The distal bag body 4 is connected to the first distal end 112 of the fixed rod 11 and the second distal end 212 of the movable rod 21, and the distal bag body 4 covers part of the first outer protrusion 113 of the fixed rod 11 and part of the second outer protrusion 213 of the movable rod 21; the connection method between the distal bag body 4 and the fixed rod 11 includes but is not limited to welding, bonding, etc.

[0053] As in the present embodiment, the distal bag body 4 has a first sleeve portion 41 and a first cover portion 42. When the distal bag body 4 is assembled with the outer bracket 1 and the inner bracket 2, the first distal end 112 of the fixed rod 11 and the second distal end 212 of the movable rod 21 are both inserted into the first sleeve portion 41, so that the distal bag body 4 and the outer bracket 1 are reliably fixed, and at the same time, the fixed rod 11 and the movable rod 21 are assisted in limiting the position, ensuring that the inner bracket 2 can be reliably rotated relative to the outer bracket 1. The first cover portion 42 is roughly trumpet-shaped, and the first arc segment 1131 of the fixed rod 11 and the third arc segment 2131 of the movable rod 21 are located in the first cover portion 42, so that the first cover portion 42 is covered on the end of the first arc segment of the outer bracket 1, and correspondingly, it is also covered on the end of the third arc segment of the inner bracket 2; preferably, the first cover portion 42 can also cover a small part of the end of the supporting segment 1133 of the fixed rod 11 and a small part of the end of the cutting segment 2133 of the movable rod 21; it can be seen that the first cover portion 42 can cover the above-mentioned distal opening 102 when the inner bracket 2 is in the expanded position, so as to prevent the thrombus from leaking from the distal opening 102 after the thrombus is removed and when it is withdrawn to the delivery sheath 10, and at the same time cooperate with the outer bracket 1, the inner bracket 2 and the membrane 3 to seal the thrombus in the thrombus removal device 100, so as to effectively prevent the leakage of thrombus. In addition, through the structural design of the distal bag body 4, when the distal bag body 4 serves as the flow-facing end, the flow resistance of the blood in the blood vessel can be appropriately reduced.

[0054] In some embodiments, the distal pocket 4 has a first dense mesh structure 421, which can be spread throughout the distal pocket 4 (i.e., the entire distal pocket 4 is regarded as a dense mesh pocket); or, the first dense mesh structure 421 is a local structure on the distal pocket 4. This design allows blood in the blood vessel to circulate and flow normally during thrombus removal, thereby reducing intraoperative risks; at the same time, the distal pocket 4 also plays a role in filtering and intercepting thrombus fragments, preventing thrombus fragments from flowing back into the blood vessel with the blood, thereby ensuring the thrombus removal rate.

[0055] In some embodiments, the distal pocket 4 can be formed of a microporous membrane material, wherein the microporous membrane material can be an ePTFE membrane (expanded polytetrafluoroethylene membrane) or other microporous membrane materials with the same function and effect. The tiny mesh holes on the microporous membrane material allow blood to pass through, while filtering and intercepting thrombus fragments.

[0056] The proximal pocket 5 is connected to the first proximal end 111 of the fixed rod 11 and the second proximal end 211 of the movable rod 21, and the proximal pocket 5 covers a part of the first outer protrusion 113 of the fixed rod 11 and a part of the second outer protrusion 213 of the movable rod 21. The connection method between the proximal pocket 5 and the fixed rod 11 includes but is not limited to welding, bonding, etc.

[0057] As in the present embodiment, the proximal pocket 5 has a second sleeve portion 51 and a second cover portion 52. When the proximal pocket 5 is assembled with the outer support 1 and the inner support 2, the first proximal end 111 of the fixed rod 11 and the second proximal end 211 of the movable rod 21 are both inserted into the second sleeve portion 51, so that the proximal pocket 5 and the outer support 1 are reliably fixed, and at the same time, the fixed rod 11 and the movable rod 21 are assisted in limiting the position, ensuring that the inner support 2 can be reliably rotated relative to the outer support 1. The second cover portion 52 is roughly trumpet-shaped, and the second arc segment 1132 of the fixed rod 11 and the fourth arc segment 2132 of the movable rod 21 are located in the second cover portion 52, so that the second cover portion 52 is covered on the end of the second arc segment of the outer support 1, and correspondingly, it is also covered on the end of the fourth arc segment of the inner support 2. Preferably, the second cover portion 52 can also cover the end of a small part of the support segment 1133 of the fixed rod 11 and the end of a small part of the cutting segment 2133 of the movable rod 21.

[0058] It can be seen that the proximal pocket body 5 cooperates with the outer support 1, the inner support 2, the membrane 3, and the distal pocket body 4 to form a closed space in the thrombus removal device 100 when the inner support 2 is in the expanded position, so as to confine the thrombus in the closed space and effectively prevent the leakage of the thrombus; wherein, the second cover portion 52 can cover and cover the above-mentioned proximal opening 101 when the inner support 2 is in the expanded position, so as to prevent the thrombus from leaking from the proximal opening 101 after the thrombus removal device 100 is removed, especially when the thrombus removal device 100 is withdrawn to the delivery sheath 10, it can effectively prevent the thrombus from being squeezed out from the proximal side due to the compression and deformation of the thrombus removal device 100, thereby improving the efficiency and success rate of the thrombus removal operation. In addition, through the structural design of the proximal pocket body 5, when the proximal pocket body 5 is used as the inflow end, the flow resistance to the blood in the blood vessel can be appropriately reduced.

[0059] In some embodiments, the proximal pocket 5 has a second dense mesh structure 521, which can be spread over the distal and proximal pockets (i.e., the entire proximal pocket 5 is regarded as a dense mesh pocket); or, the second dense mesh structure 521 is a local structure on the proximal pocket 5. This design allows blood in the blood vessels to circulate and flow normally during thrombus removal, thereby reducing intraoperative risks; at the same time, the proximal pocket 5 also plays a role in filtering and intercepting thrombus fragments, preventing thrombus fragments from flowing back into the blood vessels with the blood, thereby ensuring the thrombus removal rate.

[0060] In some embodiments, the proximal pocket 5 may be formed of a microporous membrane material, so that the tiny mesh holes on the microporous membrane material can allow blood to pass through and filter and intercept thrombus fragments.

[0061] The fixing member 6 is installed on the first proximal end 111 of the fixed rod 11. Specifically, the fixing member 6 is arranged around the first proximal end 111 of each fixed rod 11; when the thrombus removal device 100 is provided with a proximal pocket body 5, the fixing member 6 is arranged around the second sleeve portion 51 of the proximal pocket body 5. The fixing member 6 can further limit each fixed rod 11 and each movable rod 21 to ensure the reliability of the rotation of the inner bracket 2 relative to the outer bracket 1, and at the same time, the proximal pocket body 5 can be reliably fixed to the first proximal end 111 of the fixed rod 11 and the second proximal end 211 of the movable rod 21, and the fixing member 6 can be used for connection with the conveying device, thereby facilitating the control of the movement of the thrombus removal device 100 and the control of the rotation of the inner bracket 2 relative to the outer bracket 1. Preferably, a fixing member 6 may also be provided on the first distal end 112 of the fixed rod 11, that is, the fixing member 6 is arranged around the first distal end 112 of each fixed rod 11; when the thrombus removal device 100 is provided with a distal bag body 4, the fixing member 6 is arranged around the first sleeve portion 41 of the distal bag body 4, so that the distal bag body 4 can be reliably fixed to the first proximal end 111 of the fixed rod 11 and the second proximal end 211 of the movable rod 21, so as to further limit the position of each fixed rod 11 and each movable rod 21, and further ensure the reliability of the rotation of the inner bracket 2 relative to the outer bracket 1.

[0062] In some embodiments, a first developing portion may be provided on the distal housing 4, and a second developing portion may be provided on the proximal housing 5; and / or a third developing portion may be provided on the fixed rod 11, and / or a fourth developing portion may be provided on the movable rod 21, wherein the third developing portion may be the entire fixed rod 11, or the first proximal end 111 and the first distal end 112 of the fixed rod 11, and the fourth developing portion may be the entire movable rod 21, or the second proximal end 211 and the second distal end 212 of the movable rod 21. The above design allows doctors to clearly observe the relative position of the thrombus removal device 100 and the thrombus through medical imaging equipment, ensuring that the thrombus removal device 100 can cover the area where the thrombus is located, ensuring the thrombus removal effect and the thrombus removal rate, and improving the accuracy and safety of the operation.

[0063] Combination Fig.11Before the thrombus removal device 100 enters the blood vessel, its inner support 2 is in the retracted position, and the thrombus removal device 100 is compressed and arranged in the delivery sheath 10. After the thrombus removal device 100 is released from the distal end of the delivery sheath 10 into the blood vessel and placed at the thrombus, the thrombus removal device 100 expands and unfolds itself, so that the first outer protrusion 113 of the outer support 1 is attached to the blood vessel wall, and then waits for the outer support 1 and the inner support 2 of the thrombus removal device 100 to be embedded in the thrombus; and because the inner support 2 is in the retracted position, the movable rod 21 is basically folded on the inner side of the fixed rod 11, at this time, it is equivalent to only the outer support 1, and a super large grid is formed between the fixed rods 11, which is more conducive to the thrombus removal device 100 to be embedded in the thrombus, and when the movable rod 21 cuts the thrombus and cooperates with the membrane 3 to collect the thrombus into the thrombus removal device 100, the integrity of the thrombus is better, thereby avoiding excessive fragmentation of the thrombus during the thrombus removal process, effectively reducing or even eliminating the leakage and overflow of the thrombus, and improving the thrombus removal rate.

[0064] After the outer support 1 and the inner support 2 are embedded in the thrombus, the inner support 2 is controlled to rotate to the deployed position; during the movement of the inner support 2 to the deployed position, the cutting portion 21331 on the inner support 2 will cut the thrombus, and at the same time, cooperate with the gradually deployed membrane 3 to gather the thrombus into the space surrounded by the outer support 1, the inner support 2 and the membrane 3; when the inner support 2 is in the deployed position, the outer support 1, the inner support 2 and the membrane 3 or the outer support 1, the inner support 2, the membrane 3, the distal pocket 4, and the proximal pocket 5 form a space that is closed in the circumferential, distal and proximal directions of the thrombus removal device 100, thereby collecting the thrombus into the space and avoiding thrombus leakage during the withdrawal of the thrombus removal device 100.

[0065] In summary, the design of the thrombus removal device 100 can achieve high thrombus removal efficiency, good thrombus leakage prevention effect, and avoidance of damage to the inner wall of the blood vessel during the thrombus removal process.

[0066] Thrombectomy System Embodiments

[0067] The thrombus removal system includes a delivery device, a delivery sheath 10, and the thrombus removal device 100 described in the above-mentioned thrombus removal device embodiment. The delivery device can be movably arranged in the delivery sheath 10, and the proximal side of the thrombus removal device 100 is connected to the delivery device; the delivery device can drive the thrombus removal device 100 to pass through the third distal end of the delivery sheath 10 to the outside of the delivery sheath 10 to expand the thrombus removal device 100, and control the inner support 2 to rotate from the retracted position to the expanded position, and the delivery device can also drive the thrombus removal device 100 to be compressed and recovered from the third distal end into the delivery sheath 10.

[0068] In some embodiments, the delivery device includes a first drive rod 21, which is connected to the second proximal end 211, and the first drive rod 21 can drive the inner support 2 to rotate relative to the outer support 1. The connection design of the delivery device and the thrombus removal device 100 enables the delivery device to reliably drive the inner support 2 to rotate relative to the outer support 1 to capture the thrombus and prevent the captured thrombus from leaking.

[0069] In some embodiments, the delivery device includes a second driving rod 21 and a third driving rod 21, wherein the second driving rod 21 is connected to the first proximal end 111 of the fixed rod 11, the third driving rod 21 is inserted into the second driving rod 21, and the third driving rod 21 is connected to the second proximal end 211 of the moving rod 21. Through the cooperation between the second driving rod 21 and the third driving rod 21, the second driving rod 21 can control the outer stent 1 to remain different relative to the blood vessel, so as to reduce the risk of damage to the blood vessel wall due to friction with the outer stent 1, and better protect the blood vessel; the third driving rod 21 controls the inner stent 2 to rotate relative to the outer stent 1, and can more reliably ensure that the moving rod 21 is tightly fitted with the fixed rod 11 located at the downstream end of the deployment direction R and adjacent to itself (i.e., the aforementioned moving rod 21), ensuring that the thrombus will not leak from between the fixed rod 11 and the moving rod 21.

[0070] During thrombectomy, the best puncture point is determined based on the location of the thrombus at the lesion site, and then the patient is punctured using the puncture needle.

[0071] Next, a guide wire is placed along the puncture needle and passed through the thrombus, and then the puncture needle is withdrawn.

[0072] Next, the outer sheath will be pushed to the appropriate position at the end of the thrombus with the help of the guide wire, and then the guide wire will be withdrawn.

[0073] Next, the thrombectomy system is pushed into the outer sheath to place the thrombectomy device 100 at a suitable position, and then the outer sheath is withdrawn; subsequently, the thrombectomy device 100 is pushed out of the delivery sheath 10 by the delivery device and the delivery sheath 10 is withdrawn.

[0074] Next, after waiting for the thrombus removal device 100 to be embedded in the thrombus, the inner support 2 is controlled by the conveying device to rotate to the deployed position to complete the thrombus removal.

[0075] Next, the delivery device withdraws the thrombectomy device 100 into the delivery sheath 10, withdraws the delivery sheath 10, and then withdraws the outer sheath; finally, the thrombectomy operation is completed.

[0076] In summary, the thrombus removal system uses the above-mentioned thrombus removal device 100 to avoid scratching the blood vessels when removing the thrombus, thereby reducing the risk during the operation. At the same time, it prevents the leakage of thrombus fragments during the thrombus removal process and when the thrombus removal device 100 is withdrawn, thereby ensuring the thrombus removal rate.

[0077] Finally, it should be emphasized that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various changes and modifications. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A thrombus removal device, characterized in that: It comprises an outer bracket and an inner bracket, wherein the outer bracket is rotatably sleeved on the outside of the inner bracket; The outer support comprises a plurality of fixed rods evenly distributed around the rotation axis of the inner support, and a first outer protrusion is provided between a first proximal end and a first distal end of the fixed rod; The inner support comprises a plurality of movable rods evenly distributed around the rotation axis, the number of the movable rods is equal to the number of the fixed rods, a second outer protrusion is provided between the second proximal end and the second distal end of the movable rod, and the inner support has an extended position and a retracted position; Along the deployment direction of the inner bracket, a cutting portion is provided at the downstream end side of the second outer protrusion, and a membrane is provided between the second outer protrusion and the first outer protrusion located at the upstream end and adjacent to the second outer protrusion; When the inner support is in the unfolded position, the membrane is unfolded, and along the unfolding direction, the moving rod is attached to the fixed rod located at its downstream end and adjacent to the fixed rod. The membrane further closes the distal opening formed between the first outer protrusion and the second outer protrusion connected to the membrane, and / or The thrombus removal device further includes a distal bag body, the first distal end and the second distal end are connected to the distal bag body, and the distal bag body covers a portion of the first outer protrusion and a portion of the second outer protrusion.

2. The thrombus removal device according to claim 1, characterized in that: When the inner stent is in the deployed position, the membrane further closes the proximal opening formed between the first outer protrusion and the second outer protrusion connected to the membrane; and / or The thrombus removal device further includes a proximal bag body, the first proximal end and the second proximal end are connected to the proximal bag body, and the proximal bag body covers a portion of the first outer protrusion and a portion of the second outer protrusion.

3. The thrombus removal device according to claim 2, characterized in that: The distal end pocket body has a first dense mesh structure, or the distal end pocket body is made of a microporous membrane material; The proximal bag body has a second dense mesh structure, or the distal bag body is made of a microporous membrane material.

4. The thrombus removal device according to claim 2, characterized in that: The first outer convex portion has a first arc segment, a second arc segment and a support segment, the first arc segment is connected between the first distal end and the support segment, the second arc segment is connected between the first proximal end and the support segment, the distal end pocket body is covered on the first arc segment, and the proximal end pocket body is covered on the second arc segment; The second outer protrusion has a third arc segment, a fourth arc segment and a cutting segment, the third arc segment is connected between the second distal end and the cutting segment, the fourth arc segment is connected between the second proximal end and the cutting segment, the distal end bag body is covered on the third arc segment, the proximal end bag body is covered on the fourth arc segment, and the cutting portion is arranged on the cutting segment.

5. The thrombus removal device according to claim 4, characterized in that: The distal end pocket body comprises a first sleeve portion and a first cover portion, the first distal end and the second distal end are inserted into the first sleeve portion, and the first arc segment and the third arc segment are located in the first cover portion; The proximal bag body has a second sleeve portion and a second cover portion, the first proximal end and the second proximal end are inserted into the second sleeve portion, and the second arc segment and the fourth arc segment are located in the second cover portion.

6. The thrombus removal device according to claim 4, characterized in that: A first membrane connecting portion is provided on the inner side of the supporting section, a first side of the membrane is connected to the first membrane connecting portion, and a second side of the membrane is connected to the cutting section; or A second membrane connecting portion is provided on the inner side of the first outer protrusion, and the first side of the membrane is connected to the second membrane connecting portion.

7. The thrombus removal device according to claim 2, characterized in that: The distal end pocket body is provided with a first developing portion, and the proximal end pocket body is provided with a second developing portion; and / or The fixed rod is provided with a third developing portion, and / or the movable rod is provided with a fourth developing portion.

8. The thrombus removal device according to any one of claims 1 to 7, characterized in that: The thrombus removal device further includes a fixing member, which is mounted on the first proximal end.

9. Thrombectomy system, including: Conveying device; A delivery sheath tube, wherein the delivery device can be movably arranged in the delivery sheath tube; Features: The thrombus removal system further comprises a thrombus removal device according to any one of claims 1 to 8, wherein the proximal end side of the thrombus removal device is connected to the delivery device; The delivery device can drive the thrombus removal device to pass through the third distal end of the delivery sheath tube to the outside of the delivery sheath tube to deploy the thrombus removal device, and control the inner support to rotate from the folded position to the deployed position; The delivery device can also drive the thrombus removal device to be compressed and recovered from the third distal end into the delivery sheath.

10. The thrombus removal system according to claim 9, characterized in that: The conveying device comprises a first driving rod, the first driving rod is connected to the second proximal end, and the first driving rod can drive the inner support to rotate relative to the outer support; or The conveying device includes a second driving rod and a third driving rod, the second driving rod is connected to the first proximal end, the third driving rod is inserted into the second driving rod, the third driving rod is connected to the second proximal end, and the third driving rod can drive the inner bracket to rotate relative to the outer bracket.

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