Adaptive thrombectomy stent and manufacturing method thereof

Abstract

The present invention provides an adaptive thrombectomy stent and a manufacturing method thereof, which relates to the field of medical devices. The adaptive thrombectomy stent includes a fixed seat, a support frame, a thrombectomy net body, and an adjustment support. The proximal end of the support frame is fixedly connected to the fixed seat, and at least two wavy or mesh-shaped thrombus interception units extend from the distal end of the support frame; the thrombectomy net body is connected to the support frame; the adjustment support includes a plurality of adjustment rods passing through the through holes provided on the fixed seat, and the distal ends of the plurality of adjustment rods are fixedly connected to each thrombus interception unit one by one. The adjustment support can slide relative to the fixed seat along the axial direction of the adaptive thrombectomy stent to pull or push each thrombus interception unit, so that all thrombus interception units close or open the distal opening of the thrombectomy net body. The present invention alleviates the technical problems of insufficient radial support force of the existing thrombectomy stent, easy deformation and displacement during thrombectomy, easy escape of thrombus during removal, and short service life of the thrombectomy stent.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an adaptive thrombus removal bracket and a manufacturing method thereof. Background Art

[0002] In the medical field, thrombosis has always been one of the important factors threatening human health. When thrombosis forms and blocks blood vessels, it will seriously affect the normal circulation of blood, and then cause a series of serious diseases. At present, thrombus removal stents are one of the commonly used medical devices for dealing with thrombosis problems. However, existing thrombus removal stents have many shortcomings. Including:

[0003] (1) The thrombectomy mesh of the existing thrombectomy stent is a woven thrombectomy mesh, which is not stable enough in the blood vessel. In particular, it will deform when the amount of thrombus increases. It is also easy to shift in the blood vessel, causing leakage of thrombus and affecting the thrombectomy effect.

[0004] (2) When the thrombectomy net is withdrawn after a single thrombectomy, the thrombus is likely to escape from the thrombectomy port of the thrombectomy net, and repeated thrombectomy is required. Otherwise, the escaped thrombus may cause secondary embolism. The reciprocating operation increases the patient's pain and surgical risk.

[0005] (3) The thrombectomy net will be severely deformed after a single thrombectomy, and the stent structure has a short service life and cannot meet the needs of long-term clinical use. Summary of the invention

[0006] The object of the present invention is to provide an adaptive thrombus removal bracket and a manufacturing method thereof, so as to alleviate the above-mentioned technical problems existing in the prior art.

[0007] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions:

[0008] In a first aspect, an embodiment of the present invention provides an adaptive thrombus removal bracket, comprising a fixing seat, a supporting frame, a thrombus removal net body and an adjusting support member;

[0009] A through hole is provided in the middle of the fixing seat, and the central axis direction of the through hole is the axial direction of the adaptive thrombus removal bracket, and the radial direction of the through hole is the radial direction of the adaptive thrombus removal bracket:

[0010] The proximal end of the support frame is fixedly connected to the fixing seat, and at least two wavy or mesh-shaped thrombus interception units extend from the distal end of the support frame, and each two adjacent thrombus interception units are independent of each other; the support frame can shrink or self-expand along the radial direction of the adaptive thrombus removal stent;

[0011] The main body of the thrombus removal net is a cylindrical structure connected to the supporting frame and having a plurality of hollow areas on the peripheral surface. The proximal end of the supporting frame and the thrombus interception unit arranged at the distal end both extend out of the main body of the thrombus removal net;

[0012] The adjusting support member includes a plurality of adjusting rods passing through the through holes provided on the fixing seat, the number of the adjusting rods is the same as the number of the thrombus intercepting units, and the distal ends of the plurality of adjusting rods are fixedly connected to the respective thrombus intercepting units one by one;

[0013] The adjusting support member can slide relative to the fixing seat along the axial direction of the adaptive thrombus retriever stent, so as to pull each of the thrombus interception units in the proximal direction through the adjusting support member, so that all of the thrombus interception units are close to each other in the radial direction of the adaptive thrombus retriever stent, thereby closing the distal opening of the thrombus retriever net body; or, push each of the thrombus interception units in the distal direction through the adjusting support member, so that all of the thrombus interception units are away from each other in the radial direction of the adaptive thrombus retriever stent, thereby opening the distal opening of the thrombus retriever net body.

[0014] The adaptive thrombus removal stent provided by the embodiment of the present invention can at least achieve the following beneficial effects:

[0015] (1) Compared with ordinary braided stents, the adaptive thrombectomy stent provided in this embodiment optimizes the radial support force of the thrombectomy stent when it is released in the blood vessel by combining the support frame with the thrombectomy mesh body, so that the thrombectomy stent can provide strong radial support force after deployment, ensuring that it fits closely to the blood vessel wall, avoiding displacement or deformation as the thrombus volume increases, thereby avoiding leakage of thrombus and achieving better thrombectomy effect;

[0016] (2) After the thrombus removal is completed, the thrombus interception unit provided at the distal end of the support frame can be controlled by adjusting the support member to close the distal opening of the thrombus removal net body, thereby preventing the thrombus from escaping during withdrawal, thereby avoiding secondary embolism caused by thrombus fragments, and making thrombus removal safer;

[0017] (3) After a single thrombectomy, the structure of the supporting frame and the thrombectomy net is not easily deformed, thus extending the service life of the thrombectomy bracket.

[0018] In an optional implementation of this embodiment, the support frame includes at least two frame support units arranged circumferentially around the fixing seat; each frame support unit includes at least two frame support rods and one thrombus interception unit connected to the distal end of the at least two frame support rods. Each frame support rod is provided with a plurality of through holes arranged at intervals along the axial direction, the thrombus removal net body is wound around all the frame support rods in the form of a metal wire passing through each of the through holes, and each end of the metal wire is fixedly connected to any of the frame support rods; the wire diameter of the metal wire is smaller than the rod diameter of the frame support rod.

[0019] Furthermore: the main body of the thrombus retrieval net is formed by a metal wire spirally wrapped around all the skeleton support rods to form a cylindrical spiral hollow structure; or, the main body of the thrombus retrieval net is formed by a metal wire cross-wrapped around all the skeleton support rods from the proximal end to the distal end to form a cylindrical mesh structure with diamond-shaped meshes; or, the main body of the thrombus retrieval net is formed by a metal wire mixedly wrapped around all the skeleton support rods in the circumferential and radial directions of the adaptive thrombus retrieval bracket to form a cylindrical mesh structure.

[0020] Optionally, each of the skeleton support rods is provided with a plurality of connection parts spaced apart along the axial direction of the thrombus removal net body, the perforations are provided in the connection parts, and the radial cross-sectional area of ​​the connection parts is smaller than the radial cross-sectional area of ​​the remaining parts of the skeleton support rods except the connection parts.

[0021] Optionally, the distal end of each of the skeleton support rods is provided with a diameter reducing portion whose diameter gradually decreases and then increases from the proximal end to the distal end, and the proximal end of each of the thrombus interception units is fixed or integrally connected to the distal end of the diameter reducing portion on the corresponding skeleton support rod. Further optionally, each of the thrombus interception units includes a wavy main body and connecting rods connected to both ends of the wavy main body and extending toward the proximal end of the adaptive thrombus retriever stent; part of the thrombus retriever net body is also connected to the area between the two connecting rods of each of the thrombus interception units.

[0022] In an optional implementation of the present embodiment, each of the thrombus interception units is respectively provided with a connecting hole, and each of the adjusting rods passes through the connecting holes of each of the thrombus interception units one by one, and a blocking protrusion is provided at the distal end of each of the adjusting rods to limit the distal end of the adjusting rod to the distal side of the thrombus interception unit.

[0023] In an optional implementation manner of this embodiment, in the adjustment support, the proximal ends of all the adjustment rods are connected together to form a control rod segment, and the control rod segment is slidably inserted into a through hole provided on the fixing seat.

[0024] In a second aspect, an embodiment of the present invention provides a method for manufacturing an adaptive thrombectomy stent, which is used to manufacture the adaptive thrombectomy stent provided in the first aspect, wherein the support frame includes at least two frame support units arranged circumferentially around the fixing seat; each of the frame support units includes at least two frame support rods and a thrombus interception unit connected to the distal end of the at least two frame support rods. Each of the frame support rods is provided with a plurality of through holes arranged at intervals along the axial direction, and the thrombectomy net body is wound around all of the frame support rods in the manner of a metal wire passing through each of the through holes, and each end of the metal wire is fixedly connected to any of the frame support rods.

[0025] The production method comprises:

[0026] Step a: making a support skeleton, punching a plurality of holes on the skeleton material at preset intervals and positions; placing the punched skeleton material into a special mold, keeping it at a preset temperature for a preset time, so that the skeleton material is formed into a skeleton support unit; then, arranging at least two skeleton support units around the fixing seat in a circumferentially spaced manner, and connecting the proximal ends of the skeleton support rods to the fixing seat to form a support skeleton;

[0027] Step b: making a main body of the thrombus removal net on the support frame, passing a metal wire through each of the perforations and winding it around all of the support rods of the frame to form a cylindrical structure with a plurality of hollow areas on the circumference, and then fixing each end of the metal wire to any of the support rods of the frame to form the main body of the thrombus removal net;

[0028] Step c: connecting the adjustment support member inside the support frame; passing all the adjustment rods of the adjustment support member through the through holes provided on the fixing seat, and fixing the distal ends of the adjustment rods to the respective thrombus interception units one by one;

[0029] Wherein, step b is performed before or after step c.

[0030] Optionally, in step a of the manufacturing method, the skeleton manufacturing material is an elastic metal, the punched skeleton manufacturing material is placed in a special mold, and maintained at a preset temperature for a preset time so that the skeleton manufacturing material is shaped into a skeleton support unit; or, the skeleton manufacturing material is a polymer material, and is maintained at a preset temperature and a preset pressure for a preset time so that the skeleton manufacturing material is shaped into a skeleton support unit. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0032] Figure 1 A schematic diagram of the overall structure of the adaptive thrombus retrieval bracket provided in an embodiment of the present invention when the distal end opening of the thrombus retrieval net body is open;

[0033] Figure 2 An enlarged view of the local structure of the adaptive thrombus retrieval bracket provided in an embodiment of the present invention when the distal end opening of the thrombus retrieval net body is open;

[0034] Figure 3 A schematic diagram of the overall structure of the adaptive thrombus retrieval stent provided in an embodiment of the present invention when the distal end opening of the thrombus retrieval net body is closed;

[0035] Figure 4 An enlarged view of the local structure of the adaptive thrombus retrieval stent provided in an embodiment of the present invention when the distal end opening of the thrombus retrieval net body is closed;

[0036] Figure 5 A schematic diagram of a delivery state of the adaptive thrombectomy stent provided in an embodiment of the present invention when it is retracted inside a delivery sheath;

[0037] Figure 6 A schematic diagram of the overall structure of a skeleton support unit in an adaptive thrombectomy stent provided in an embodiment of the present invention;

[0038] Figure 7 for Figure 6 A magnified view of the local structure;

[0039] Figure 8 A schematic diagram of the unfolded structure of the thrombus retrieval net main body in the adaptive thrombus retrieval stent provided in an embodiment of the present invention.

[0040] Icons: 1-fixing seat; 101-through hole; 2-support skeleton; 21-skeleton support unit; 211-thrombus intercepting unit; 2110-connecting hole; 2111-wavy main body; 2112-connecting rod; 212-skeleton support rod; 2120-perforation; 2121-connecting part; 2122-reducing part; 3-thrombus removal net main body; 4-adjusting support member; 41-adjusting rod; 411-blocking protrusion; 412-control rod segment; 5-conveyer outer sheath. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0042] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] It should be noted that like reference numerals and letters denote similar items in the drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0044] In the description of the present invention, it should be noted that:

[0045] Unless otherwise clearly specified and limited, the terms "disposed", "installed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0046] The orientation or position relationship indicated by the terms "proximal", "distal", "front end", "rear end", "axial", "radial", "inner", "outer", etc. is based on the orientation or position relationship shown in the drawings, or is the orientation or position relationship in which the product of the invention is usually placed when used. It is only for the convenience of describing the present invention 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 operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0047] The terms “first”, “second”, etc. are only used for distinguishing descriptions and do not indicate the total number or relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0048] Below, the end of the medical device close to the operator during surgery is referred to as the proximal end of the medical device, and the end of the medical device entering the patient's blood vessel is referred to as the distal end of the medical device (the front end of the medical device is the distal end, and the rear end of the medical device is the proximal end); in conjunction with the accompanying drawings, some embodiments of the present invention are described in detail.

[0049] In a first aspect, this embodiment provides an adaptive thrombus removal stent, referring to Figures 1 to 8 The adaptive thrombectomy stent comprises a fixing seat 1, a support frame 2, a thrombectomy net body 3 and an adjustment support member 4. Specifically, a through hole 101 is provided in the middle of the fixing seat 1, and the central axis direction of the through hole 101 is the axial direction of the adaptive thrombectomy stent of this embodiment, and the radial direction of the through hole 101 is the radial direction of the adaptive thrombectomy stent of this embodiment. Then: the proximal end of the above-mentioned support frame 2 is fixedly connected to the fixing seat 1, and at least two thrombus interception units 211 in a wave shape or a mesh shape are extended from the distal end of the support frame 2, and each two adjacent thrombus interception units 211 are independent of each other. The thrombectomy net body 3 is a cylindrical structure connected to the support frame 2 and having a plurality of hollow areas on the circumference. The proximal end of the support frame 2 and the thrombus interception unit 211 arranged at the distal end are both extended outside the thrombectomy net body 3; the support frame 2 can shrink or self-expand along the radial direction of the adaptive thrombectomy stent. The adjustment support member 4 includes a plurality of adjustment rods 41 passing through the through holes 101 provided on the fixing seat 1 . The number of the adjustment rods 41 is the same as the number of the thrombus interception units 211 , and the distal ends of the adjustment rods 41 are fixedly connected to each thrombus interception unit 211 one by one.

[0050] The above-mentioned adjustable support member 4 can slide relative to the fixed seat 1 along the axial direction of the adaptive thrombus retriever stent, so as to pull each thrombus interception unit 211 in the proximal direction by adjusting the support member 4, so that all the thrombus interception units 211 are close to each other in the radial direction of the adaptive thrombus retriever stent, and then close the distal opening of the thrombus retriever net body 3 (the way of closing the distal opening of the thrombus retriever net body 3 includes but is not limited to the overlapping or crossing of the thrombus interception units 211); or, by adjusting the support member 4 to push each thrombus interception unit 211 in the distal direction, all the thrombus interception units 211 are separated from each other in the radial direction of the adaptive thrombus retriever stent, and then open the distal opening of the thrombus retriever net body 3.

[0051] Reference Figure 5 The adaptive thrombectomy stent provided in this embodiment needs to be used in conjunction with the outer sheath tube 5 of the delivery device:

[0052] Before use, the adaptive thrombectomy stent is pre-loaded into the outer sheath tube 5 of the delivery device. The adaptive thrombectomy stent will appear as follows. Figure 5 The thrombus interception units 211 are in a radially contracted state as shown, and all of them are in a state of being separated from each other in the radial direction of the adaptive thrombus removal stent, and the distal opening of the thrombus removal net body 3 is in an open state; the proximal end (rear end) of the adjusting support member 4 and the proximal end (rear end) of the conveyor outer sheath 5 are connected to the conveyor operating handle (not shown);

[0053] Then, the artery is punctured with a puncture needle, and a guide wire is introduced after success, and the loaded delivery device outer sheath tube 5 is inserted through the guide wire. Under the guidance of an image (such as DSA), the delivery device outer sheath tube 5 is slowly pushed along the guide wire to the vicinity of the thrombus in the target blood vessel segment through the operating handle of the delivery device;

[0054] Next, the operating handle is used to push the adaptive thrombectomy stent in the distal direction (forward) relative to the outer sheath tube 5 of the conveyor (the pushing method can be to set up a push tube inside the outer sheath tube 5 of the conveyor, so that the proximal section of the adjusting support member 4 passes through the push tube, and the distal end of the push tube abuts against the fixing seat 1, and the adaptive thrombectomy stent is pushed out through the push tube, or it can be pushed out by directly pushing the adjusting support member 4 forward, or by withdrawing the outer sheath tube 5 of the conveyor relative to the adaptive thrombectomy stent). The adaptive thrombectomy stent is released in the blood vessel, and its support skeleton 2 and the thrombectomy net body 3 will radially self-expand and support on the inner wall of the blood vessel. This process is an adaptive deployment process. After deployment, the thrombus can be captured through the distal opening of the thrombectomy net body 3 in an open state, and the thrombus is collected by the thrombectomy net body 3. The support skeleton 2 provides sufficient radial support force to the thrombectomy net body 3 to avoid the problem of thrombus leakage caused by severe deformation of the thrombectomy net body 3 when the amount of thrombus in the thrombectomy net body 3 increases;

[0055] After a period of thrombus removal, the operating handle is used to pull the adjusting support member 4 in the proximal direction (backward) to pull each thrombus interception unit 211 in the proximal direction, so that all the thrombus interception units 211 are close to each other along the radial direction of the adaptive thrombus removal stent, and then the distal opening of the thrombus removal net body 3 is closed (in the process, the support frame 2 and the thrombus removal net body 3 are supported on the inner wall of the blood vessel by self-expansion without moving, and the manner of closing the distal opening of the thrombus removal net body 3 includes but is not limited to the overlapping or crossing of the thrombus interception units 211), so that the thrombus is safely wrapped inside the thrombus removal net body 3 to ensure that the thrombus will not escape;

[0056] Afterwards, the operating handle is used to withdraw the adaptive thrombectomy stent in the proximal direction (backward) relative to the outer sheath tube 5 of the conveyor (the withdrawal method can be achieved by directly pulling the adjustment support member 4 backward, or by pushing the outer sheath tube 5 of the conveyor forward relative to the adaptive thrombectomy stent), so that the adaptive thrombectomy stent is radially retracted in the outer tube of the conveyor again;

[0057] Finally, the entire delivery device is removed from the patient's body to complete the thrombectomy.

[0058] The adaptive thrombus removal stent provided in this embodiment can at least achieve the following beneficial effects:

[0059] (1) Compared with ordinary braided stents, the adaptive thrombectomy stent provided in this embodiment optimizes the radial support force of the thrombectomy stent when it is released in the blood vessel by combining the support frame 2 with the thrombectomy mesh body 3, so that the thrombectomy stent can provide strong radial support force after deployment, ensuring that it fits closely to the blood vessel wall, avoiding displacement or deformation as the thrombus volume increases, thereby avoiding leakage of thrombus and achieving better thrombus removal effect;

[0060] (2) After the thrombus removal is completed, the thrombus interception unit 211 provided at the distal end of the support frame 2 can be controlled by adjusting the support member 4 to close the distal opening of the thrombus removal net body 3, thereby preventing the thrombus from escaping during withdrawal, thereby avoiding secondary embolism caused by thrombus fragments, and making thrombus removal safer;

[0061] (3) After a single thrombus removal is completed, the structure of the supporting frame 2 and the thrombus removal net is not easily deformed, thereby extending the service life of the thrombus removal bracket.

[0062] Continue to refer to Figures 1 to 8 In an optional implementation of this embodiment, the support frame 2 includes at least two frame support units 21 arranged circumferentially around the fixing seat 1; each frame support unit 21 includes at least two frame support rods 212 and a thrombus interception unit 211 connected to the distal ends of the at least two frame support rods 212. Each frame support rod 212 is provided with a plurality of through holes 2120 arranged at intervals along the axial direction, and the thrombus removal net body 3 is wound around all the frame support rods 212 in the form of a metal wire passing through each through hole 2120, and each end of the metal wire is fixedly connected to any frame support rod 212; wherein, the wire diameter of the metal wire is smaller than the rod diameter of the frame support rod 212.

[0063] In this optional embodiment, a plurality of skeleton support units 21 are arranged circumferentially around the fixing seat 1, which enhances the overall stability and strength of the thrombus removal stent. The perforations 2120 on the skeleton support rods 212 provide fixing points for the metal wire to be passed around, ensuring that the thrombus removal net body 3 is firmly connected to the support skeleton 2, while improving the flexibility. The wire diameter of the metal wire is smaller than the rod diameter of the skeleton support rods 212, ensuring the flexibility and adaptability of the thrombus removal net body 3, so that it can better fit the complex vascular morphology. In addition, in this optional embodiment, the support skeleton 2 is set as a plurality of skeleton support units 21 composed of a plurality of skeleton support rods 212. When the adjusting support member 4 pulls the thrombus interception unit 211 provided at the distal end of each skeleton support rod 212, the rod segments of the distal ends of each skeleton support rod 212 close to the thrombus interception unit 211 can also be made close to each other in the radial direction of the adaptive thrombus removal stent, thereby achieving a radial compression before the adaptive thrombus removal stent is withdrawn into the inner part of the conveyor outer tube, improving the smoothness of withdrawing the adaptive thrombus removal stent into the conveyor outer sheath 5, and further improving the surgical efficiency.

[0064] In this optional embodiment, the thrombus removal net body 3 is wound around all the skeleton support rods 212 in the form of a metal wire passing through each through hole 2120. There are many optional specific winding methods, such as:

[0065] Threading and winding method 1: The main body 3 of the thrombus removal net is formed by spirally winding metal wire around all the skeleton support rods 212 to form a cylindrical spiral hollow structure; the cylindrical spiral hollow structure formed by spiral winding has good flexibility and adaptability, and can evenly distribute stress when unfolded to avoid local deformation or rupture.

[0066] Alternatively, the second winding method: the thrombus removal net body 3 is made of metal wire that is cross-wound around all the skeleton support rods 212 from the proximal end to the distal end to form a cylindrical mesh structure with diamond-shaped meshes; the diamond mesh structure formed by cross-winding provides higher strength and stability, and is suitable for application scenarios that require stronger support.

[0067] Alternatively, winding method three: the thrombus removal net main body 3 is a cylindrical mesh structure formed by metal wires being wound around all the skeleton support rods 212 in a mixed manner in the circumferential and radial directions of the adaptive thrombus removal bracket; the cylindrical mesh structure formed by mixed winding in the circumferential and radial directions combines the advantages of the above-mentioned cylindrical spiral hollow structure and cylindrical mesh structure, and has both good flexibility and high strength.

[0068] In addition, in this optional embodiment, further optionally, each of the skeleton support rods 212 is provided with a plurality of connection parts 2121 arranged at intervals along the axial direction of the thrombus removal net body 3, and the perforations 2120 are provided in the connection parts 2121. The radial cross-sectional area of ​​the connection parts 2121 is smaller than the radial cross-sectional area of ​​the remaining parts of the skeleton support rod 212 except the connection parts 2121. The radial cross-sectional area of ​​the connection parts 2121 is smaller than that of other parts of the skeleton support rod 212. It has a smaller radial cross-sectional area, which helps to disperse stress, avoid material fatigue or fracture caused by local stress concentration, and extend the service life of the stent. The connection parts 2121 are preferably, but not limited to, designed as follows: Figure 7 The flat plate shape shown makes it easy for the metal wire to be threaded and wound in various forms.

[0069] Optionally, the distal end of each skeleton support rod 212 is provided with a diameter reducing portion 2122 whose diameter gradually decreases and then gradually increases from the proximal end to the distal end, and the proximal end of each thrombus interception unit 211 is fixed or integrally connected to the distal end of the diameter reducing portion 2122 on the corresponding skeleton support rod 212. The diameter reducing portion 2122 makes the distal end of the skeleton support rod 212 gradually decrease and then increase. As the main bending part of the thrombus interception unit 211, this design increases the flexibility of this part, which facilitates the thrombus interception unit 211 to bend smoothly to open or close the distal opening of the thrombus removal net body 3, so that the distal end of the thrombus removal stent can better adapt to the natural bending and changes of the blood vessel, reducing the potential risk of damage to the blood vessel wall; in addition, the design of the diameter reducing portion 2122 helps to reduce the resistance of the thrombus removal stent when it moves in the blood vessel, so that the thrombus removal stent can more easily pass through the narrow or tortuous blood vessel segment to reach the target position.

[0070] Further optionally, each thrombus interception unit 211 includes a wavy main body 2111 and a connecting rod 2112 connected to both ends of the wavy main body 2111 and extending toward the proximal direction of the adaptive thrombus removal bracket; part of the thrombus removal net body 3 is also connected to the area between the two connecting rods 2112 of each thrombus interception unit 211; the wavy main body 2111 increases the surface area of ​​the thrombus interception unit 211 and improves the efficiency of capturing thrombi, and the connecting rod 2112 extends toward the proximal end, ensuring a firm connection between the thrombus removal net body 3 and the thrombus interception unit 211 and enhancing the stability of the overall structure; the structural feature of "part of the thrombus removal net body 3 is also connected to the area between the two connecting rods 2112 of each thrombus interception unit 211" can further expand the effective area of ​​the thrombus capture by the thrombus removal net body 3, and can provide an additional barrier after the thrombus is captured to prevent thrombus fragments from escaping from the gap between adjacent thrombus interception units 211, further reducing the risk of secondary embolism.

[0071] In an optional implementation manner of the present embodiment, each thrombus intercepting unit 211 is respectively provided with a connecting hole 2110, and each adjusting rod 41 passes through the connecting hole 2110 of each thrombus intercepting unit 211 correspondingly, and a blocking protrusion 411 is provided at the distal end of each adjusting rod 41 to limit the distal end of the adjusting rod 41 to the distal side of the thrombus intercepting unit 211; in this optional implementation manner, the adjusting rod 41 is connected to the thrombus intercepting unit 211 through the connecting hole 2110 and is limited by the blocking protrusion 411, thereby ensuring the reliability of the connection and fully preventing the adjusting rod 41 from falling off.

[0072] In an optional implementation of this embodiment, in the adjustment support 4, the proximal ends of all the adjustment rods 41 are connected together to form a control rod segment 412, and the control rod segment 412 is slidably arranged in the through hole 101 arranged on the fixing seat 1. This simplifies the operation process, and the doctor can synchronously control the movements of all the adjustment rods 41 by controlling one control rod segment 412. The synchronous control improves the operation efficiency, reduces the operation steps, and shortens the operation time.

[0073] In the second aspect, an embodiment of the present invention provides a method for manufacturing an adaptive thrombectomy stent, which is used to manufacture the adaptive thrombectomy stent provided in the first aspect, wherein the support frame 2 includes at least two frame support units 21 arranged circumferentially around the fixing seat 1; each frame support unit 21 includes at least two frame support rods 212 and a thrombus interception unit 211 connected to the distal ends of the at least two frame support rods 212. Each frame support rod 212 is provided with a plurality of through holes 2120 arranged at intervals along the axial direction, and the thrombectomy net body 3 is passed through all the frame support rods 212 in the form of a metal wire passing through each through hole 2120, and each end of the metal wire is fixedly connected to any frame support rod 212.

[0074] The production method includes:

[0075] Step a: making a support skeleton 2, punching a plurality of perforations 2120 on the skeleton material at preset intervals and positions; placing the punched skeleton material into a special mold, keeping it at a preset temperature for a preset time, so that the skeleton material is formed into a skeleton support unit 21; then, arranging at least two skeleton support units 21 around the fixing seat 1 in a circumferentially spaced manner, and connecting the proximal ends of the skeleton support rods 212 to the fixing seat 1 to form the support skeleton 2;

[0076] Step b: Making the thrombus removal net body 3 on the support frame 2, passing the metal wire through each through hole 2120 and winding around all the frame support rods 212 to form a cylindrical structure with a plurality of hollow areas on the circumference, and then fixing each end of the metal wire to any frame support rod 212 to form the thrombus removal net body 3;

[0077] Step c: Connect the adjustment support member 4 inside the support frame 2; pass all the adjustment rods 41 of the adjustment support member 4 through the through holes 101 provided on the fixing seat 1, and fix the distal ends of the adjustment rods 41 to the respective thrombus interception units 211 one by one;

[0078] Wherein, step b is performed before or after step c.

[0079] In step a of the manufacturing method provided in this embodiment, optionally, the skeleton material is nickel-titanium memory alloy or other elastic metal, the punched skeleton material is placed in a special mold, and maintained at a preset temperature (for example but not limited to 400-600° C., the specific temperature is determined according to the metal material) for a preset time, so that the skeleton material is formed into a skeleton support unit 21;

[0080] Alternatively, optionally, the skeleton manufacturing material is polyurethane, silicone or other polymer materials, which are maintained at a preset temperature (for example but not limited to 80-150°C, the specific temperature is determined according to the polymer material) and a preset pressure (for example but not limited to 5-20MPa) for a preset time (for example but not limited to 10-60s) to shape the skeleton manufacturing material into a skeleton support unit 21.

[0081] Finally, it should be noted that the above embodiments and their optional implementation modes in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned optional implementation modes, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that the features of the embodiments in this specification and the optional implementation modes in the embodiments can be combined with each other without conflict.

Claims

1. An adaptive thrombectomy stent, characterized in that: It comprises a fixing seat (1), a supporting frame (2), a main body of the thrombus removal net (3) and an adjusting support member (4); A through hole (101) is provided in the middle of the fixing seat (1), with the central axis direction of the through hole (101) being the axial direction of the adaptive thrombectomy bracket, and the radial direction of the through hole (101) being the radial direction of the adaptive thrombectomy bracket: The proximal end of the support frame (2) is fixedly connected to the fixing seat (1), and at least two wavy or mesh-shaped thrombus interception units (211) extend from the distal end of the support frame (2), and each two adjacent thrombus interception units (211) are independent of each other; the support frame (2) is capable of contracting or self-expanding along the radial direction of the adaptive thrombus removal stent; The thrombus removal net body (3) is a cylindrical structure connected to the support frame (2) and having a plurality of hollow areas on its circumference, and the proximal end of the support frame (2) and the thrombus interception unit (211) disposed at the distal end both extend outside the thrombus removal net body (3); The adjusting support member (4) comprises a plurality of adjusting rods (41) passing through the through holes (101) provided on the fixing seat (1), the number of the adjusting rods (41) being the same as the number of the thrombus intercepting units (211), and the distal ends of the plurality of adjusting rods (41) are fixedly connected to the respective thrombus intercepting units (211) in a one-to-one correspondence; The adjusting support member (4) can slide relative to the fixing seat (1) along the axial direction of the adaptive thrombus removal stent, so as to pull each of the thrombus interception units (211) in the proximal direction through the adjusting support member (4), so that all of the thrombus interception units (211) are close to each other in the radial direction of the adaptive thrombus removal stent, thereby closing the distal opening of the thrombus removal net body (3); or, push each of the thrombus interception units (211) in the distal direction through the adjusting support member (4), so that all of the thrombus interception units (211) are separated from each other in the radial direction of the adaptive thrombus removal stent, thereby opening the distal opening of the thrombus removal net body (3).

2. The adaptive thrombus removal stent according to claim 1, characterized in that: The support frame (2) comprises at least two frame support units (21) arranged circumferentially around the fixing seat (1); each of the frame support units (21) comprises at least two frame support rods (212) and one of the thrombus interception units (211) connected to the distal ends of the at least two frame support rods (212); Each of the skeleton support rods (212) is provided with a plurality of through holes (2120) arranged at intervals along the axial direction, and the thrombus removal net body (3) is wound around all the skeleton support rods (212) in the form of a metal wire passing through each of the through holes (2120), and each end of the metal wire is fixedly connected to any of the skeleton support rods (212); the wire diameter of the metal wire is smaller than the rod diameter of the skeleton support rod (212).

3. The adaptive thrombus removal stent according to claim 2, characterized in that: The thrombus removal net body (3) is formed by spirally passing metal wires through all the skeleton support rods (212) to form a cylindrical spiral hollow structure; Alternatively, the thrombus removal net body (3) is formed by metal wires that are sequentially and cross-threaded around all the skeleton support rods (212) from the proximal end to the distal end to form a cylindrical mesh structure with diamond-shaped meshes; Alternatively, the thrombus retrieval net body (3) is a cylindrical mesh structure formed by metal wires mixedly passing through all the skeleton support rods (212) in the circumferential and radial directions of the adaptive thrombus retrieval stent.

4. The adaptive thrombus removal stent according to claim 2, characterized in that: Each of the skeleton support rods (212) is provided with a plurality of connection parts (2121) arranged at intervals along the axial direction of the thrombus removal net body (3), the through holes (2120) are provided in the connection parts (2121), and the radial cross-sectional area of ​​the connection parts (2121) is smaller than the radial cross-sectional area of ​​the remaining parts of the skeleton support rod (212) except the connection parts (2121).

5. The adaptive thrombus removal stent according to claim 2, characterized in that: The distal end of each of the skeleton support rods (212) is provided with a diameter reducing portion (2122) whose diameter gradually decreases and then gradually increases from the proximal end to the distal end, and the proximal end of each of the thrombus interception units (211) is fixed or integrally connected to the distal end of the diameter reducing portion (2122) on the corresponding skeleton support rod (212).

6. The adaptive thrombus removal stent according to claim 5, characterized in that: Each of the thrombus interception units (211) comprises a wavy main body (2111) and a connecting rod (2112) connected to both ends of the wavy main body (2111) and extending toward the proximal end of the adaptive thrombus removal stent; part of the thrombus removal net body (3) is also connected to the area between the two connecting rods (2112) of each of the thrombus interception units (211).

7. The adaptive thrombectomy stent according to any one of claims 1 to 6, characterized in that: Each of the thrombus interception units (211) is provided with a connection hole (2110), and each of the adjustment rods (41) passes through the connection hole (2110) of each of the thrombus interception units (211) in a one-to-one correspondence. A blocking protrusion (411) is provided at the distal end of each of the adjustment rods (41) for limiting the distal end of the adjustment rod (41) to the distal side of the thrombus interception unit (211).

8. The adaptive thrombectomy stent according to any one of claims 1 to 6, characterized in that: In the adjustment support member (4), the proximal ends of all the adjustment rods (41) are connected together to form a control rod segment (412), and the control rod segment (412) is slidably inserted into a through hole (101) provided on the fixing seat (1).

9. A method for manufacturing an adaptive thrombus removal stent, characterized in that: Used to manufacture the adaptive thrombectomy stent according to any one of claims 2 to 6; the manufacturing method comprises: Step a: manufacturing a support skeleton (2), punching a plurality of holes (2120) on a skeleton manufacturing material at preset intervals and positions; placing the punched skeleton manufacturing material into a special mold, maintaining it at a preset temperature for a preset time, so that the skeleton manufacturing material is formed into a skeleton support unit (21); then, arranging at least two skeleton support units (21) circumferentially around the fixing seat (1) at intervals, and connecting the proximal ends of the skeleton support rods (212) to the fixing seat (1) to form a support skeleton (2); Step b: manufacturing a main body (3) of the thrombus removal net on the support frame (2), passing a metal wire through each of the through holes (2120) and winding it around all of the frame support rods (212) to form a cylindrical structure having a plurality of hollow areas on the circumference, and then fixing each end of the metal wire to any of the frame support rods (212) to form the main body (3) of the thrombus removal net; Step c: connecting the adjustment support member (4) inside the support frame (2); passing all the adjustment rods (41) of the adjustment support member (4) through the through holes (101) provided on the fixing seat (1), and fixing the distal ends of the adjustment rods (41) to the respective thrombus interception units (211) in a one-to-one correspondence; Wherein, step b is performed before or after step c.

10. The method for manufacturing the adaptive thrombus removal stent according to claim 9, characterized in that: In step a, the skeleton making material is an elastic metal, the punched skeleton making material is placed in a special mold, and maintained at a preset temperature for a preset time, so that the skeleton making material is shaped into a skeleton support unit (21); or, the skeleton making material is a polymer material, and is maintained at a preset temperature and a preset pressure for a preset time, so that the skeleton making material is shaped into a skeleton support unit (21).

Images