WO2021136350A1 - Thrombus retrieving stent and thrombus retrieving system - Google Patents

Thrombus retrieving stent and thrombus retrieving system Download PDF

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Publication number
WO2021136350A1
WO2021136350A1 PCT/CN2020/141281 CN2020141281W WO2021136350A1 WO 2021136350 A1 WO2021136350 A1 WO 2021136350A1 CN 2020141281 W CN2020141281 W CN 2020141281W WO 2021136350 A1 WO2021136350 A1 WO 2021136350A1
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WO
WIPO (PCT)
Prior art keywords
stent
closed
bracket
thrombus
bolt
Prior art date
Application number
PCT/CN2020/141281
Other languages
French (fr)
Chinese (zh)
Inventor
王永胜
尤岩
高国庆
舒素云
Original Assignee
杭州德诺脑神经医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201911423136.2A external-priority patent/CN113116461A/en
Priority claimed from CN201911424621.1A external-priority patent/CN113116462A/en
Application filed by 杭州德诺脑神经医疗科技有限公司 filed Critical 杭州德诺脑神经医疗科技有限公司
Publication of WO2021136350A1 publication Critical patent/WO2021136350A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions

Definitions

  • the invention relates to the technical field of medical devices, in particular to a thrombus removal stent and a thrombus removal system.
  • Thrombus is a small piece of blood that forms on the surface of the exfoliated or repaired part of the inner surface of the blood vessel of the cardiovascular system. Thrombosis spreads throughout the cardiovascular system and spreads to tissues and organs throughout the body. It is not limited to myocardial infarction, deep vein thrombosis or cerebrovascular thrombosis. Thrombosis can occur in blood vessels in any part of the body. Intracranial thrombosis is a special clinical type of cerebrovascular disease. It is easy to cause cerebral embolism. It has the characteristics of high morbidity, disability, mortality and recurrence. It is fatal and disabling for middle-aged and elderly people. The main disease.
  • the recanalization of blood vessels is the key to the treatment of acute ischemic stroke.
  • the conventional methods for the treatment of ischemic stroke include two categories: drug thrombolysis or mechanical thrombectomy.
  • Drug thrombolysis is a catheter injecting a thrombolytic agent into the attachment of the lesion in the blood vessel referred to by the lesion, and a high concentration of thrombolytic agent is formed in the local area of the lesion, thereby accelerating the speed of thrombolysis and increasing the chance of vascular recanalization.
  • intravenous thrombolysis should be performed within 3 hours of onset, and the arterial thrombolysis time window is within 6 hours. Therefore, drug thrombolytic therapy is only suitable for smaller blood clots. When the volume of the thrombus is too large, a very large dose is needed to dissolve the large blood clot, and it is easy to cause various complications and the risk is high.
  • Mechanical thrombectomy includes the following methods: thrombectomy, laser thrombectomy, thrombectomy with catcher, thrombectomy with thrombectomy net.
  • the thrombectomy is more thorough in removing the thrombus, but it damages the blood vessel wall too much, which can easily cause various concurrent inflammations.
  • the operation of laser thrombus breaking is difficult. If the laser energy is too low, it will be ineffective. If the energy is too high, the blood vessels will be damaged, and it is also easy to cause various complications.
  • the operation of the catcher to remove the thrombus is simple, and it does little damage to the blood vessel wall, but it often fails to catch the blood clot.
  • the operation of the thrombus-trapping net to remove the thrombus is simple, but it cannot be used in intracranial blood vessels because of the large volume of the thrombus-trapping net.
  • the existing mechanical thrombectomy methods fail to meet the characteristics of high thrombus capture efficiency and small mechanical damage at the same time.
  • an embodiment of the present invention provides a plug-removing stent, which includes a stent body having a tubular and/or cage-like structure.
  • the stent body includes a first stent body and a distal end of the first stent body.
  • a second stent body, the first stent body and the second stent body are smoothly transitionally connected, and the second stent body includes a large pipe diameter section and a small pipe diameter section that are alternately connected.
  • an embodiment of the present invention provides a thrombus removal system, including a microcatheter, a push rod, and the thrombus removal stent as described above, the push rod is connected to the proximal end of the thrombus removal stent, and the push rod The rod and the thrombus removal stent are crimped and introduced into the microcatheter. The thrombus removal stent can be pushed and pulled by the push rod to move inside and outside the microcatheter.
  • the bolt removal stent and bolt removal system are based on the smooth transition connection between the first stent body and the second stent body, and the second stent body includes alternately connected Large pipe diameter section and small pipe diameter section.
  • the thrombus removal stent has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent from collapsing when it completely passes through the blood vessel, thereby improving the efficiency of thrombus capture and the process of thrombus removal. It reduces the damage to the blood vessel caused by the embolization stent.
  • Fig. 1 is a schematic diagram of the structure of the bolt removal bracket provided by the first embodiment of the present invention.
  • Fig. 2 is a three-dimensional development view of the bolt removal bracket in Fig. 1 in a plane.
  • Fig. 3 is a schematic diagram of the structure of the bolt removal bracket provided by the second embodiment of the present invention.
  • Fig. 4 is a schematic diagram of the structure of the bolt removal bracket provided by the third embodiment of the present invention.
  • Fig. 5 is a schematic diagram of the structure of the bolt removal bracket provided by the fourth embodiment of the present invention.
  • Fig. 6 is a schematic structural diagram of a bolt removal bracket provided by a fifth embodiment of the present invention.
  • Fig. 7 is a schematic structural diagram of a bolt removal bracket provided by a sixth embodiment of the present invention.
  • Fig. 8 is a schematic structural diagram of a bolt removal system provided by an embodiment of the present invention.
  • the end of the instrument close to the operator is usually called the proximal end, and the end of the instrument far away from the operator is called the distal end.
  • the distal end refers to the end of the instrument that can be freely inserted into the animal or human body.
  • the near end refers to the end used for user or machine operation or the end used to connect to other devices.
  • FIG. 1 is a schematic structural diagram of a bolt removing bracket 100 provided by a first embodiment of the present invention
  • FIG. 2 is a planar three-dimensional expanded view of the bolt removing bracket 100.
  • the plug-removing stent 100 includes a stent body 101 having a tubular and/or cage-like structure.
  • the stent body 101 includes a first stent body 10 and a second stent body 30 provided at the distal end of the first stent body 10.
  • the first bracket body 10 and the second bracket body 30 are integrally formed and smoothly transitioned.
  • the second bracket body 30 includes a large pipe diameter section 31 and a small pipe diameter section 33 that are alternately connected.
  • the thrombus removal stent 100 has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent 100 from collapsing when it passes through the blood vessel completely, thereby improving the efficiency of thrombus capture, and During the embolization process, the damage to the blood vessel of the embolization stent is reduced.
  • first bracket body 10 and the second bracket body 30 are integrally formed so as to improve the stability and reliability of the connection between the first bracket body 10 and the second bracket body 30.
  • first bracket body 10 and the second bracket body 30 may also be fixedly connected together by technical means commonly used in the art, such as pressing, hot melting, bonding, welding, or pressure riveting.
  • both the proximal end and the distal end of the second stent body 30 are configured as large diameter sections 31.
  • the small pipe diameter section 33 is arranged between two adjacent large pipe diameter sections 31.
  • the second bracket body 30 includes a plurality of first closed loop units 311, a plurality of second closed loop units 312 and a plurality of third closed loop units 331.
  • the plurality of first closed loop units 311 and the plurality of second closed loop units 312 are connected to each other to form a large pipe diameter section 31.
  • the plurality of third closed-loop units 331 are connected to each other to form a small pipe diameter section 33.
  • the second stent body 30 includes two large diameter sections 31 and one small diameter section 33.
  • the two large diameter sections 31 are located at the proximal and distal ends of the second stent body 30.
  • the small pipe diameter section 33 is arranged in the middle of the second bracket body 30 and is located between two adjacent large pipe diameter sections 31.
  • the area of the first closed-loop unit 311 is smaller than the area of the second closed-loop unit 312 and larger than the area 331 of the third closed-loop unit, so that the thrombus removal stent 100 can provide a certain pulling force during the thrombus removal process, and effectively prevent thrombosis. Move, and then facilitate the removal of the thrombus.
  • the area of the second closed-loop unit 312 is relatively large, it is suitable for blood vessels of different sizes, that is, the second closed-loop unit 312 can be fully expanded for large blood vessels, and the second closed-loop unit 312 can be overlapped for small blood vessels. Thereby, the thrombus can be captured more firmly. Since the area of the area 331 of the first closed loop unit 311 and the third closed loop unit is relatively small, the contact area with the blood vessel wall is reduced, and the damage to the blood vessel wall is reduced.
  • the first closed-loop unit 311 surrounds the second closed-loop unit 312, and two adjacent second closed-loop units 312 are arranged at intervals along the circumferential direction of the second bracket body 30.
  • the second closed loop unit 312 is evenly distributed along the axial and circumferential directions of the second stent body 30 so that the thrombus can enter the thrombus removal stent 100.
  • a plurality of second closed-loop units 312 are located on the same layer in the radial direction of each large pipe diameter section 31.
  • the plurality of second closed-loop units 312 are located on different layers in the radial direction of each large pipe diameter section 31, and the plurality of second closed-loop units 312 of two adjacent layers are along the line of the second stent body 30. Circumferentially staggered settings in order to firmly capture the thrombus, thereby increasing the effective capture rate of the thrombus.
  • the shapes of the first closed-loop unit 311 and the third closed-loop unit 331 include, but are not limited to, one or more of a circle, an ellipse, a triangle, a diamond, a trapezoid, and a hexagon.
  • the second closed-loop unit 312 is approximately in the shape of an hourglass, so that when the second stent unit 30 is squeezed in the blood vessel, it can make a large deformation, so that the second stent unit 30 has better flexibility, thereby improving thrombus. Capture efficiency, and reduce the damage to the blood vessel of the embolization stent during the embolectomy process.
  • the second closed-loop unit 312 since the second closed-loop unit 312 is in the shape of an hourglass, the second closed-loop unit 312 can adapt to thrombus of different sizes, which improves the effective capture rate of thrombus.
  • both the first closed-loop unit 311 and the third closed-loop unit 331 are composed of a closed grid.
  • the second closed loop unit 312 is enclosed by two semi-closed grids.
  • a plurality of grids are arranged in a row in sequence, and the grids of two adjacent rows are arranged in a staggered manner.
  • Two adjacent grids are connected together by connecting ribs 103.
  • the grid of one row faces the gap between the two adjacent grids in the other row, so that the bolt removal stent 100 is more easily compressed and more adaptable Small blood vessels, and easy to introduce into the micro catheter 300 (refer to Figure 8).
  • the second closed loop unit 312 includes a first grid 3121, a second grid 3122, and a channel 3123 connecting the first grid 3121 and the second grid 3122.
  • the first grid 3121 and the first closed-loop unit 311 are sequentially arranged in a row
  • the second grid 3122 is also sequentially arranged in a row with the first closed-loop unit 311
  • the channel 3123 is also sequentially arranged in a row with the first closed-loop unit 311.
  • the multiple second closed-loop units 312 on the same layer are symmetrically distributed from the central axis of the second bracket body 30.
  • the extending direction of the channel 3123 is parallel to the central axis of the second bracket body 30. In the radial direction of the large pipe diameter section 31 of the same layer, the channel 3123 and the connecting rib 103 are directly opposite.
  • the first stent body 10 is configured in a funnel structure
  • the second stent body 30 is configured in a straight tube structure, so that the thrombus removal stent 100 avoids falling off of the thrombus when retracting toward the proximal end of the thrombus removal stent 100.
  • the first bracket body 10 includes a plurality of fourth closed-loop units 11. A plurality of fourth closed-loop units 11 are connected to each other to form the funnel structure.
  • the tube diameter of the first stent body 10 gradually increases from its proximal end to the distal direction, so as to prevent the proximal end of the first stent body 10 from being removed due to bolt removal during the process of retreating the bolt removal stent 100 toward its proximal direction.
  • the influence of the withdrawal force of the stent 100 causes the overall diameter of the stent 100 to be reduced or kinked, thereby improving the efficiency of capturing thrombus and reducing the damage to the blood vessel caused by the thrombus removal stent 100. In this way, a smooth transitional connection between the first stent body 10 and the second stent body 30 is ensured, thereby reducing the damage to the blood vessel caused by the thrombus removal stent during the thrombus removal process.
  • the area of the fourth closed-loop unit 11 is equal to the area of the first closed-loop unit 311, thereby reducing the contact area between the first stent body 10 and the second stent body 30 and the blood vessel wall, thereby reducing the impact on the blood vessel wall. damage.
  • FIG. 3 is a schematic structural diagram of a bolt-removing bracket 100 a provided by the second embodiment of the present invention.
  • the structure of the bolt removal bracket 100a is similar to the structure of the bolt removal bracket 100 of the first embodiment.
  • the proximal end of the first stent body 10a is configured as an oblique cone-shaped structure.
  • the proximal end of the first stent body 10a forms a sloped entrance 15a.
  • the shape of the inlet 15a is cone-shaped, like a drop shape. In this embodiment, the shape of the inlet 15a is a fusiform.
  • the bracket body 101 further includes a plurality of connecting ribs 103 connecting the first closed loop unit 311, the second closed loop unit 312, the third closed loop unit 331 and the fourth closed loop unit 11.
  • the plurality of connecting ribs 103 are parallel to the central axis of the bracket body 101.
  • the proximal end of the first stent body 10 is also provided with a connecting head 13.
  • the connector 13 extends in the direction of the central axis of the bracket body 101.
  • the traction force will be concentrated on the extension line where the connecting head 13 is located, ensuring that the diameter of the distal end of the stent body 101 remains unchanged, thereby improving the efficiency of thrombus capture.
  • the connecting head 13 is provided with a developing positioning element 102 so as to indicate the position of the plug-removing bracket 100 through the position of the developing positioning element 102 under the detection of the instrument.
  • the developing positioning member 102 is made of a radiopaque material.
  • the radiopaque material is preferably a precious metal material such as gold, platinum, or tantalum.
  • the developing positioning element 102 can take various forms such as ring shape, wire shape, ribbon shape, or dot shape, and is fixed to the bolt removal bracket 100 by pressing, hot melting, bonding, welding or pressure riveting and other common technical means in the art. on.
  • the developing positioning element 102 may be ring-shaped, and the developing positioning element 102 is sleeved outside the connecting head 13.
  • two visualization positioning elements 102 are respectively provided at the distal and proximal positions of the thrombus removal stent 100 to accurately locate the position of the thrombus, so that the thrombus can be detected during the thrombus removal process using the thrombus removal stent 100
  • the middle part of the thrombus removal stent 100 may also be provided with multiple visualization positioning elements to more accurately locate the position of the thrombus.
  • both the first stent body 10 and the second stent body 30 are made of a metal material with a memory effect or a polymer material with elasticity, so that the stent body 101 self-expands to form a tube and/or a cage. structure.
  • the metal material is, for example, but not limited to nickel-titanium alloy or cobalt-based alloy.
  • the first stent body 10 and the second stent body 30 can be formed by laser cutting a plate-shaped nickel-titanium alloy to form a tubular or cage-like structure with a hollow structure, and then be crimped, heat-treated and shaped.
  • first stent body 10 and the second stent body 30 can also form a tubular or cage-like structure with the hollow structure by weaving a wire-like Nitinol alloy.
  • first bracket body 10 and the second bracket body 30 may also be processed by using elastic plastic materials.
  • FIG. 4 is a schematic structural diagram of a bolt removal bracket 100b provided by the third embodiment of the present invention.
  • the structure of the bolt removal bracket 100b is similar to the structure of the bolt removal bracket 100 of the first embodiment.
  • the second bracket body 30b includes three large diameter sections 31b and two small diameter sections 33b.
  • the three large pipe diameter sections 31b and the two small pipe diameter sections 33b are integrally formed and smoothly transitioned.
  • the large pipe diameter section 31b, the small pipe diameter section 33b, the large pipe diameter section 31b, the small pipe diameter section 33b, and the large pipe diameter section 31b are sequentially connected to form the second stent body 30b.
  • two small pipe diameter sections 33b are arranged at intervals, and each small pipe diameter section 33b is arranged between two adjacent large pipe diameter sections 31b.
  • Both the proximal and distal ends of the second stent body 30b are configured as large diameter sections 31b.
  • the number of large diameter sections and small diameter sections can be designed according to actual environmental conditions such as thrombus size or blood vessel thickness, which is not limited in the present invention.
  • FIG. 5 is a schematic structural diagram of a bolt removal bracket 100c provided by the fourth embodiment of the present invention.
  • the structure of the bolt removal bracket 100c is similar to the structure of the bolt removal bracket 100b of the third embodiment. The difference is that the bolt removal bracket 100c further includes a plurality of capturing units 20c and a plurality of auxiliary capturing units 50c.
  • multiple capture units 20c are arranged at the junction of the large pipe diameter section 31c and the small pipe diameter section 33c, that is, the small pipe diameter section 33c is provided with multiple capture units at the proximal and distal ends. 20c to further improve the capture efficiency of the thrombus removal stent 100c.
  • the multiple catching units 20c are evenly distributed in the circumferential direction of the bolt removal bracket 100c.
  • a plurality of catching units 20c are enclosed in a circle from the circumference of the bolt-removing bracket 100c.
  • a circle can include 2-6 capture units.
  • the bolt-removing bracket 100c can be provided with 2-4 rounds of capture units in the axial direction.
  • each capture unit 20c is configured as a closed loop structure.
  • Each catching unit 20c includes a connecting part 21c and a catching part 22c opposed to each other.
  • the connecting portion 21c is substantially in an inverted V shape, and the capturing portion 22c is substantially in a V shape.
  • the connecting portion 21c is connected to the bracket body 101, and the capturing portion 22c can extend outward or inward relative to the bracket body 101c, so that a receiving space 201c is formed between the capturing portion 22c and the bracket body 101c.
  • the capturing portion 22c can move in a direction perpendicular to the axis of the bolt removal bracket 100c. In this way, it is avoided that when the thrombus removal stent 100c moves in the blood vessel, the capturing portion 22c does not directly contact the blood vessel wall, thereby avoiding damage to the blood vessel wall tissue.
  • the distal end of the capturing portion 22c is provided with an arc-shaped chamfer to further prevent the capturing portion 22c of the capturing unit 20 from damaging the blood vessel wall.
  • the capturing portion 22c of each capturing unit 20c is located outside the closed loop unit 32c of the bracket body 101c, that is, there is a gap between the capturing portion 22c and the bracket body 101c for capturing
  • the capturing part 22c of the unit 20c is inserted into the thrombus, or the thrombus is clamped in the accommodating space 201c, thereby improving the anchoring of the thrombus by the thrombus removal stent 100c.
  • each auxiliary catching unit 50c is fixed at the junction of the connecting part 21c and the catching part 22c of the catching unit 20c.
  • each auxiliary capture unit 50c is arranged between two adjacent capture units 20c.
  • the plurality of auxiliary catching units 50c are all configured in a barbed structure.
  • Each auxiliary catching unit 50c includes opposite connecting ends 51c and free ends 52c.
  • the proximal end of each auxiliary capturing unit 50c is a connecting end 51c
  • the distal end of each auxiliary capturing unit 50c is a free end 52c.
  • Each auxiliary catching unit 50c can also be directly connected to the connecting rib 103c of the bolt-removing bracket 100c.
  • Each auxiliary catching unit 50c and the connecting rib 103c are integrally formed.
  • the free end 52c of the auxiliary catching unit 50c can extend outward or inward relative to the bracket body 101c, and move in a direction perpendicular to the axis of the bolt removal bracket 100c.
  • the auxiliary catching unit 50c can be arranged in 2-6 circles along the axial direction of the stent body 101c, and each circle has 2-6 auxiliary catching units 50c, so as to further improve the thrombus catching efficiency of the thrombus removal stent 100c.
  • the auxiliary capture unit 50c has self-expandability.
  • the material contained in the auxiliary capture unit 50c can be the material contained in the bolt-removing bracket 100c, which will not be repeated here.
  • a receiving space 501c is formed between the free end of each auxiliary capture unit 50c and the bracket body 101c. In this way, when the thrombus removal stent 4c is in the released state, there is a gap between the free end of each auxiliary capture unit 50c and the stent body 101c, so that the auxiliary capture unit 50c can be inserted into the thrombus, or the thrombus can be held in the containing space. 501c, thereby further improving the anchoring of thrombus by the thrombus removal stent 100c.
  • each auxiliary capture unit 50c is provided with an arc-shaped chamfer to avoid damage to the blood vessel wall by the auxiliary capture unit 50c.
  • multiple auxiliary capturing units 50c are located at the junction of the large diameter section 31c and the small diameter section 33c, so as to reduce the risk of the auxiliary capturing unit 50c damaging the blood vessel wall.
  • the number of capture units 20c and auxiliary capture units 50c can be set according to the diameter of the plug-removing bracket 100c, and the arrangement positions, lengths, and inclination angles of the multiple auxiliary capture units 50c can be the same as each other. They may also be different from each other, and the present invention is not limited.
  • FIG. 6 is a schematic structural diagram of a bolt removal bracket 100 d according to a fifth embodiment of the present invention.
  • the structure of the bolt removing bracket 100d is similar to the structure of the bolt removing bracket 100c of the fourth embodiment.
  • the proximal end of the first stent body 10e is configured as an oblique cone-shaped structure.
  • the description of the second embodiment for the specific structure of the oblique cone cylindrical structure.
  • FIG. 7 is a schematic structural diagram of a bolt removal bracket 100 d according to a sixth embodiment of the present invention.
  • the structure of the bolt removal bracket 100e is similar to the structure of the bolt removal bracket 100c of the fourth embodiment. The difference is that the bolt removal bracket 100e further includes a plurality of connecting members 53e, and the plurality of auxiliary capturing units 50e are connected to the bracket body 101e through the corresponding connecting members 53e.
  • each connecting member 53e is configured as a curved structure, and each connecting member 53e is bent inwardly relative to the bracket body 101e to increase the receiving space 501e formed between the auxiliary catching unit 50e and the bracket body 101e. So as to provide more accommodation space for the thrombus. Specifically, a distance is formed between the inner side of each connecting piece 53e and the axis of the stent body 101e, and the outer side of each connecting piece 53e is connected to the periphery of the stent body 101e, so as to prevent the connecting piece 53e from intercepting the thrombus and preventing entry. Take the bolt inside the bracket 100e. The plurality of connecting members 53e are evenly distributed from the circumferential direction of the bracket body 101e.
  • Each connecting member 53e can be integrally formed with the bracket body 101e. In other embodiments, each connecting member 53e can also be fixed to the bracket body 101e by a mounting structure.
  • the mounting structure is, for example, but not limited to an adhesive, a crimping structure or a riveting structure.
  • each auxiliary capture unit 50e is connected to the bracket body 101e through a corresponding connecting member 53e.
  • Each auxiliary catching unit 50e is arranged at the connection between the connecting piece 53e and the catching unit 20e. Specifically, the connecting end 51e of the auxiliary capturing unit 50e is connected to the proximal end of the connecting piece 53e.
  • the plurality of connecting members 53e and the plurality of catching units 20e are alternately arranged and connected to each other to ensure the flexibility of the bolt removal stent 100e and a certain supporting force in the radial and axial directions of the bolt removal stent 100e.
  • the design of the connecting piece 53e can also increase the space between the capturing portion 22e and the stent body 101e, and provide more accommodating space for thrombus.
  • the proximal end of each connecting piece 53e is connected to the distal end of the connecting portion 21e of one of the catching units 20e (that is, the proximal end of the catching portion 22e), and the distal end of each connecting piece 53e is connected to the other catching unit.
  • each connecting member 53e can be integrally formed with the bracket body 101e. In some other embodiments, each connecting member 53e may also be fixed on the bracket body 101e by a mounting structure.
  • the mounting structure is, for example, but not limited to an adhesive, a crimping structure or a riveting structure.
  • the free end 52e of the auxiliary capturing unit 50e is configured as a curved structure, and the bending direction of the auxiliary capturing unit 50e is opposite to the bending direction of the connecting member 53e.
  • each auxiliary catching unit 50e is bent outward relative to the bolt-taking bracket 100e to further increase the accommodating space 201e formed between the auxiliary catching unit 20e and the bracket body 101e and to increase the auxiliary catching unit 50e and the bracket body 101e
  • the accommodating space 501e formed therebetween provides more accommodating space for further thrombosis.
  • the design of the curved structure of the auxiliary capture unit 50e can hold the thrombus more firmly, and improve the safety of the thrombus removal stent 100e, prevent the free end 52e from piercing the direction of the blood vessel wall, and increase the adhesion to the blood vessel wall. Avoid damaging the blood vessel wall tissue.
  • FIG. 8 is a schematic structural diagram of a bolt removal system 1000 according to an embodiment of the present invention.
  • the thrombus removal system 1000 includes the above-mentioned thrombus removal stent 100d, a push rod 200 and a micro catheter 300.
  • the push rod 200 is connected to the proximal end of the thrombus removal stent 100d, and the push rod 200 and the thrombus removal stent 100d are crimped and introduced into the microcatheter 300.
  • the plug-removing stent 100d can move inside and outside the microcatheter 300 by pushing and pulling the push rod 200.
  • the thrombus removal stent 100d When the push rod 200 moves toward its proximal end, the thrombus removal stent 100d is recovered into the micro catheter 300; when the push rod 200 moves away from its proximal end, the thrombus removal stent 100d is pushed out of the micro catheter 300 .
  • connection between the proximal end of the bolt-removing bracket 100d and the distal end of the push rod 200 includes welding, sleeve connection, or glue-fixed connection.
  • welding includes, but is not limited to silver welding or gold welding.
  • Adhesives include, but are not limited to UV glue or epoxy glue.
  • the micro catheter 300 is sleeved outside the pushing rod 200.
  • the bolt removal system 1000 further includes a loading tube 400. The loading tube 400 is used to fix the micro catheter 300.
  • the microcatheter 300 When in use, first connect the proximal end of the thrombus removal stent 100d and the distal end of the push rod 200, and then compress the installed thrombus removal stent 100d and the push rod 200 into the microcatheter 300 in advance.
  • the microcatheter 300 is delivered to the diseased part of the blood vessel, passes through the thrombus, and fixes the microcatheter 300.
  • the plug removal stent 100d is made of a shape memory material, the plug removal stent 100d has elasticity, so that the plug removal stent 100d can switch between a compressed state and a released state. By releasing the thrombus removal stent 100d, the thrombus removal stent 100d can be completely embedded inside the thrombus. After waiting for a certain period of time, the push rod 200 is pulled back, and the thrombus removal stent 100d is retracted to capture the thrombus, until the thrombus removal stent 100d together with the microcatheter 300 is retracted out of the body to complete the entire embolization process.
  • the thrombus removal device 1000 as a whole is crimped and introduced into the microcatheter 300, that is, the thrombus removal stent 100d is delivered to the diseased part of the blood vessel through the microcatheter 300.
  • bolt removal brackets 100, 100a, 100b, 100c, 100e in the first embodiment to the fourth embodiment and the sixth embodiment can all be applied to the bolt removal system, which will not be repeated here.
  • the bolt removal stent and bolt removal system provided by the embodiments of the present invention are based on the smooth transitional connection between the first stent body and the second stent body, and the second stent body includes alternately connected large pipe diameter sections and small pipe diameter sections.
  • the thrombus removal stent has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent from collapsing when it completely passes through the blood vessel, thereby improving the efficiency of thrombus capture and the process of thrombus removal. It reduces the damage to the blood vessel caused by the embolization stent.

Abstract

A thrombus retrieving stent (100, 100a, 100b, 100c, 100d, 100e) comprises a tubular and/or cage-shaped stent main body (101, 101a, 101b, 101c, 101d, 101e). The stent main body (101, 101a, 101b, 101c, 101d, 101e) comprises a first stent main body (10, 10a, 10b, 10c, 10d, 10e) and a second stent main body (30, 30a, 30b, 30c, 30d, 30e) provided at a distal end of the first stent main body (10, 10a, 10b, 10c, 10d, 10e) . The first stent main body (10, 10a, 10b, 10c, 10d, 10e) and the second stent main body (30, 30a, 30b, 30c, 30d, 30e) are in smooth transition connection. The second stent main body (30, 30a, 30b, 30c, 30d, 30e) comprises large-diameter sections (31, 31a, 31b, 31c, 31d, 31e) and small-diameter sections (33, 33a, 33b, 33c, 33d, 33e) arranged in an alternating manner and connected together.

Description

取栓支架及取栓系统Bolt removal bracket and bolt removal system
本申请要求于2019年12月30日提交中国专利局、申请号为CN 201911424621.1、发明名称为“取栓支架及取栓系统”的中国专利申请的优先权和于2019年12月30日提交中国专利局、申请号为CN 201911423136.2、发明名称为“取栓装置及取栓系统”的中国专利申请的优先权,其全部内容通过引用结合在本申请中。This application requires the priority of a Chinese patent application filed with the Chinese Patent Office on December 30, 2019, with the application number CN 201911424621.1, and the invention title is "Tbolt Removal Stent and Tether Removal System" and submitted to China on December 30, 2019 The Patent Office, the application number is CN 201911423136.2, and the title of the invention is the priority of the Chinese patent application "Tbolt removal device and bolt removal system", the entire content of which is incorporated into this application by reference.
技术领域Technical field
本发明涉及医疗器械技术领域,尤其涉及一种取栓支架及取栓系统。The invention relates to the technical field of medical devices, in particular to a thrombus removal stent and a thrombus removal system.
背景技术Background technique
血栓是血流在心血管系统血管内面剥落处或修补处的表面所形成的小块。血栓形成遍布整个心血管系统,波及全身组织器官,不止局限于心肌梗死,深部静脉血栓形成或脑血管血栓形成等病变,血栓可发生在体内任何部位的血管内。颅内血栓形成是脑血管病中的一种特殊临床类型,其容易造成脑栓塞,具有发病率高、致残率高、死亡率高和复发率高的特点,是中老年人致死和致残的主要疾病。Thrombus is a small piece of blood that forms on the surface of the exfoliated or repaired part of the inner surface of the blood vessel of the cardiovascular system. Thrombosis spreads throughout the cardiovascular system and spreads to tissues and organs throughout the body. It is not limited to myocardial infarction, deep vein thrombosis or cerebrovascular thrombosis. Thrombosis can occur in blood vessels in any part of the body. Intracranial thrombosis is a special clinical type of cerebrovascular disease. It is easy to cause cerebral embolism. It has the characteristics of high morbidity, disability, mortality and recurrence. It is fatal and disabling for middle-aged and elderly people. The main disease.
血管的再通是治疗急性缺血性脑卒中的关键。目前,治疗缺血性脑卒中的常规方法包括两大类:药物溶栓或机械取栓。The recanalization of blood vessels is the key to the treatment of acute ischemic stroke. At present, the conventional methods for the treatment of ischemic stroke include two categories: drug thrombolysis or mechanical thrombectomy.
药物溶栓是导管把溶栓剂注入病变所指的血管内的病灶附件,在病灶局部瞬间形成很高的溶栓剂浓度,从而加快血栓溶解速度,进而增加血管再通的机会。根据美国国立神经疾病与卒中研究院的研究结果,静脉溶栓应在发病3小时内进行,动脉溶栓时间窗为6小时之内,因此药物溶栓治疗只适用于体积较小的血栓。当血栓的体积过大时,需要非常大剂量才能够使大血凝块溶解,且容易引发各种并发症,风险较高。Drug thrombolysis is a catheter injecting a thrombolytic agent into the attachment of the lesion in the blood vessel referred to by the lesion, and a high concentration of thrombolytic agent is formed in the local area of the lesion, thereby accelerating the speed of thrombolysis and increasing the chance of vascular recanalization. According to the findings of the National Institute of Neurological Diseases and Stroke, intravenous thrombolysis should be performed within 3 hours of onset, and the arterial thrombolysis time window is within 6 hours. Therefore, drug thrombolytic therapy is only suitable for smaller blood clots. When the volume of the thrombus is too large, a very large dose is needed to dissolve the large blood clot, and it is easy to cause various complications and the risk is high.
为了解决上述药物溶栓的问题,采用机械方式消除血栓。机械取栓包括以下方法:血栓切除术、激光碎栓、抓捕器取栓、捕栓网取栓。血栓切除术的取栓较为彻底,但是对血管壁损伤过大,极易引起各种并发炎症。激光碎栓的操 作难度大,激光能量过低则无效,能量过高则损伤血管,而且同样易引起各种并发症。抓捕器取栓的操作简单,对血管壁损伤很小,但是经常不能套住血凝块。捕栓网取栓的操作简单,但因捕栓网体积较大而无法在颅内血管内使用。综上,现有的机械取栓方法未能同时满足血栓抓捕效率高且机械损伤小的特性。In order to solve the above-mentioned drug thrombolytic problem, mechanical methods are used to eliminate thrombosis. Mechanical thrombectomy includes the following methods: thrombectomy, laser thrombectomy, thrombectomy with catcher, thrombectomy with thrombectomy net. The thrombectomy is more thorough in removing the thrombus, but it damages the blood vessel wall too much, which can easily cause various concurrent inflammations. The operation of laser thrombus breaking is difficult. If the laser energy is too low, it will be ineffective. If the energy is too high, the blood vessels will be damaged, and it is also easy to cause various complications. The operation of the catcher to remove the thrombus is simple, and it does little damage to the blood vessel wall, but it often fails to catch the blood clot. The operation of the thrombus-trapping net to remove the thrombus is simple, but it cannot be used in intracranial blood vessels because of the large volume of the thrombus-trapping net. In summary, the existing mechanical thrombectomy methods fail to meet the characteristics of high thrombus capture efficiency and small mechanical damage at the same time.
发明内容Summary of the invention
有鉴于此,本发明有必要提供一种取栓支架及取栓系统,以解决上述技术问题。In view of this, it is necessary for the present invention to provide a bolt-removing bracket and a bolt-removing system to solve the above technical problems.
第一方面,本发明实施例提供了一种取栓支架,包括管状和/或笼状结构的支架本体,所述支架本体包括第一支架本体和设置在所述第一支架本体的远端的第二支架本体,所述第一支架本体与所述第二支架本体平滑过渡连接,所述第二支架本体包括交替相接的大管径段和小管径段。In the first aspect, an embodiment of the present invention provides a plug-removing stent, which includes a stent body having a tubular and/or cage-like structure. The stent body includes a first stent body and a distal end of the first stent body. A second stent body, the first stent body and the second stent body are smoothly transitionally connected, and the second stent body includes a large pipe diameter section and a small pipe diameter section that are alternately connected.
第二方面,本发明实施例提供了一种取栓系统,包括微导管、推送杆、以及如上所述的取栓支架,所述推送杆连接于所述取栓支架的近端,所述推送杆和所述取栓支架被压握导入所述微导管内,所述取栓支架可通过所述推送杆推拉在所述微导管内外活动,当所述推送杆朝靠近其近端的方向活动时,所述取栓支架被回收到所述微导管内;在所述推送杆朝远离其近端的方向活动时,所述取栓支架被推出所述微导管外。In the second aspect, an embodiment of the present invention provides a thrombus removal system, including a microcatheter, a push rod, and the thrombus removal stent as described above, the push rod is connected to the proximal end of the thrombus removal stent, and the push rod The rod and the thrombus removal stent are crimped and introduced into the microcatheter. The thrombus removal stent can be pushed and pulled by the push rod to move inside and outside the microcatheter. When the push rod moves toward the proximal end thereof When the time, the thrombus retrieval stent is recovered into the micro catheter; when the push rod moves in a direction away from its proximal end, the thrombus retrieval stent is pushed out of the micro catheter.
相较于现有技术,本发明实施例提供的取栓支架及取栓系统,基于所述第一支架本体与所述第二支架本体平滑过渡连接,所述第二支架本体包括交替相接的大管径段和小管径段。如此,取栓支架具有柔顺性的同时,还具有一定的径向和轴向的支撑力,且有效防止取栓支架完全通过血管时发生塌陷,从而提高了血栓抓捕效率,以及在取栓过程中减小了取栓支架对血管损伤。Compared with the prior art, the bolt removal stent and bolt removal system provided by the embodiments of the present invention are based on the smooth transition connection between the first stent body and the second stent body, and the second stent body includes alternately connected Large pipe diameter section and small pipe diameter section. In this way, while the thrombus removal stent has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent from collapsing when it completely passes through the blood vessel, thereby improving the efficiency of thrombus capture and the process of thrombus removal. It reduces the damage to the blood vessel caused by the embolization stent.
附图说明Description of the drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付 出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative labor.
图1是本发明第一实施例提供的取栓支架的结构示意图。Fig. 1 is a schematic diagram of the structure of the bolt removal bracket provided by the first embodiment of the present invention.
图2是图1中的取栓支架的平面立体展开图。Fig. 2 is a three-dimensional development view of the bolt removal bracket in Fig. 1 in a plane.
图3是本发明第二实施例提供的取栓支架的结构示意图。Fig. 3 is a schematic diagram of the structure of the bolt removal bracket provided by the second embodiment of the present invention.
图4是本发明第三实施例提供的取栓支架的结构示意图。Fig. 4 is a schematic diagram of the structure of the bolt removal bracket provided by the third embodiment of the present invention.
图5是本发明第四实施例提供的取栓支架的结构示意图。Fig. 5 is a schematic diagram of the structure of the bolt removal bracket provided by the fourth embodiment of the present invention.
图6是本发明第五实施例提供的取栓支架的结构示意图。Fig. 6 is a schematic structural diagram of a bolt removal bracket provided by a fifth embodiment of the present invention.
图7是本发明第六实施例提供的取栓支架的结构示意图。Fig. 7 is a schematic structural diagram of a bolt removal bracket provided by a sixth embodiment of the present invention.
图8本发明实施例提供的取栓系统的结构示意图。Fig. 8 is a schematic structural diagram of a bolt removal system provided by an embodiment of the present invention.
具体实施方式Detailed ways
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.
需要说明的是,在介入医疗领域,通常将器械靠近操作者的一端称作近端,将器械远离操作者的一端称作远端。具体的,远端是指器械可自由插入到动物或人体体内的一端。近端是指供用户或机器操作的一端或是用于连接其他器件的一端。It should be noted that in the field of interventional medicine, the end of the instrument close to the operator is usually called the proximal end, and the end of the instrument far away from the operator is called the distal end. Specifically, the distal end refers to the end of the instrument that can be freely inserted into the animal or human body. The near end refers to the end used for user or machine operation or the end used to connect to other devices.
可以理解,本发明的说明书和权利要求书及上述附图中的术语仅是为了描述特定实施例,并非要限制本发明。本发明的说明书和权利要求书及上述附图中的术语“第一”、“第二”、“第三”、“第四”等是用于区别不同对象,而非用于描述特定顺序。除非上下文另有明确表述,否则单数形式“一”和“所述”也旨在包括复数形式。术语“包括”以及它们任何变形,意图在于覆盖不排他的包含。此外,本发明可以以多种不同的形式来实现,并不限于本实施例所描述的实施例。提供以下具体实施例的目的是便于对本发明公开内容更清楚透彻的理解,其中上、下、左、右等指示方位的字词仅是针对所示结构在对应附图中位置而言。It can be understood that the terms in the specification and claims of the present invention and the above-mentioned drawings are only for describing specific embodiments, and are not intended to limit the present invention. The terms "first", "second", "third", "fourth", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish different objects, rather than to describe a specific sequence. Unless the context clearly states otherwise, the singular forms "a" and "the" are also intended to include the plural forms. The term "including" and any variations of them are intended to cover non-exclusive inclusion. In addition, the present invention can be implemented in a variety of different forms, and is not limited to the embodiment described in this embodiment. The purpose of providing the following specific embodiments is to facilitate a clearer and thorough understanding of the disclosure of the present invention, wherein the words indicating directions such as up, down, left, and right are only for the position of the structure shown in the corresponding drawings.
说明书后续描述为实施本发明的较佳实施例,然上述描述乃以说明本发明 的一般原则为目的,并非用以限定本发明的范围。本发明的保护范围当视所附权利要求所界定者为准。The following descriptions of the specification are preferred embodiments for implementing the present invention. However, the above description is for the purpose of explaining the general principles of the present invention and is not intended to limit the scope of the present invention. The protection scope of the present invention shall be subject to those defined by the appended claims.
请一并参阅图1和图2,图1所示为本发明第一实施例提供的一种取栓支架100的结构示意图,图2所示为取栓支架100的平面立体展开图。取栓支架100包括管状和/或笼状结构的支架本体101。支架本体101包括第一支架本体10和设置在第一支架本体10的远端的第二支架本体30。第一支架本体10与第二支架本体30一体式成型且平滑过渡连接。第二支架本体30包括交替相接的大管径段31和小管径段33。如此,取栓支架100具有柔顺性的同时,还具有一定的径向和轴向的支撑力,且有效防止取栓支架100完全通过血管时发生塌陷,从而提高了血栓抓捕效率,以及在取栓过程中减小了取栓支架对血管损伤。Please refer to FIG. 1 and FIG. 2 together. FIG. 1 is a schematic structural diagram of a bolt removing bracket 100 provided by a first embodiment of the present invention, and FIG. 2 is a planar three-dimensional expanded view of the bolt removing bracket 100. The plug-removing stent 100 includes a stent body 101 having a tubular and/or cage-like structure. The stent body 101 includes a first stent body 10 and a second stent body 30 provided at the distal end of the first stent body 10. The first bracket body 10 and the second bracket body 30 are integrally formed and smoothly transitioned. The second bracket body 30 includes a large pipe diameter section 31 and a small pipe diameter section 33 that are alternately connected. In this way, while the thrombus removal stent 100 has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent 100 from collapsing when it passes through the blood vessel completely, thereby improving the efficiency of thrombus capture, and During the embolization process, the damage to the blood vessel of the embolization stent is reduced.
具体的,在一些实施例中,第一支架本体10与第二支架本体30一体式成型,以便提高第一支架本体10与第二支架本体30连接的稳定性和可靠性。在其他一些实施例中,第一支架本体10与第二支架本体30也可以通过压握、热熔、粘接、焊接或者压铆等本领域常用的技术手段固定连接在一起。Specifically, in some embodiments, the first bracket body 10 and the second bracket body 30 are integrally formed so as to improve the stability and reliability of the connection between the first bracket body 10 and the second bracket body 30. In some other embodiments, the first bracket body 10 and the second bracket body 30 may also be fixedly connected together by technical means commonly used in the art, such as pressing, hot melting, bonding, welding, or pressure riveting.
其中,第二支架本体30的近端和远端均构造为大管径段31。小管径段33设置在相邻两大管径段31之间。第二支架本体30包括多个第一闭环单元311、多个第二闭环单元312及多个第三闭环单元331。多个第一闭环单元311和多个第二闭环单元312相互连接而形成大管径段31。多个第三闭环单元331相互连接而形成小管径段33。Wherein, both the proximal end and the distal end of the second stent body 30 are configured as large diameter sections 31. The small pipe diameter section 33 is arranged between two adjacent large pipe diameter sections 31. The second bracket body 30 includes a plurality of first closed loop units 311, a plurality of second closed loop units 312 and a plurality of third closed loop units 331. The plurality of first closed loop units 311 and the plurality of second closed loop units 312 are connected to each other to form a large pipe diameter section 31. The plurality of third closed-loop units 331 are connected to each other to form a small pipe diameter section 33.
在本实施例中,第二支架本体30包括2个大管径段31和1个小管径段33。2个大管径段31位于第二支架本体30的近端和远端。小管径段33设置在第二支架本体30的中部,且位于相邻两大管径段31之间。In this embodiment, the second stent body 30 includes two large diameter sections 31 and one small diameter section 33. The two large diameter sections 31 are located at the proximal and distal ends of the second stent body 30. The small pipe diameter section 33 is arranged in the middle of the second bracket body 30 and is located between two adjacent large pipe diameter sections 31.
可选的,第一闭环单元311的面积小于第二闭环单元312的面积,且大于第三闭环单元的面积331,从而在取栓过程中取栓支架100能够提供一定的拉力,有效防止血栓后移,进而方便血栓的取出。此外,由于第二闭环单元312的面积相对较大,因此适用不同尺寸大小的血管,也即,对于大血管第二闭环单元312可完全扩开,对于小血管第二闭环单元312可交叠,从而更牢固地捕获血栓。由于第一闭环单元311和第三闭环单元的面积331的面积相对较小, 因此减小了与血管壁的接触面积,以及降低了对血管壁的损伤。Optionally, the area of the first closed-loop unit 311 is smaller than the area of the second closed-loop unit 312 and larger than the area 331 of the third closed-loop unit, so that the thrombus removal stent 100 can provide a certain pulling force during the thrombus removal process, and effectively prevent thrombosis. Move, and then facilitate the removal of the thrombus. In addition, since the area of the second closed-loop unit 312 is relatively large, it is suitable for blood vessels of different sizes, that is, the second closed-loop unit 312 can be fully expanded for large blood vessels, and the second closed-loop unit 312 can be overlapped for small blood vessels. Thereby, the thrombus can be captured more firmly. Since the area of the area 331 of the first closed loop unit 311 and the third closed loop unit is relatively small, the contact area with the blood vessel wall is reduced, and the damage to the blood vessel wall is reduced.
如图2所示,在本实施例中,第一闭环单元311环绕第二闭环单元312,相邻两第二闭环单元312沿第二支架本体30的周向间隔设置。第二闭环单元312沿第二支架本体30的轴向和周向均匀分布,以便血栓进入取栓支架100。可选的,多个第二闭环单元312在每一大管径段31的径向上位于同一层上。在其他实施例中,多个第二闭环单元312在每一大管径段31的径向上位于不同的层上,且相邻两层的多个第二闭环单元312沿第二支架本体30的周向错开设置,以便牢固地抓捕血栓,从而提高了血栓的有效抓捕率。As shown in FIG. 2, in this embodiment, the first closed-loop unit 311 surrounds the second closed-loop unit 312, and two adjacent second closed-loop units 312 are arranged at intervals along the circumferential direction of the second bracket body 30. The second closed loop unit 312 is evenly distributed along the axial and circumferential directions of the second stent body 30 so that the thrombus can enter the thrombus removal stent 100. Optionally, a plurality of second closed-loop units 312 are located on the same layer in the radial direction of each large pipe diameter section 31. In other embodiments, the plurality of second closed-loop units 312 are located on different layers in the radial direction of each large pipe diameter section 31, and the plurality of second closed-loop units 312 of two adjacent layers are along the line of the second stent body 30. Circumferentially staggered settings in order to firmly capture the thrombus, thereby increasing the effective capture rate of the thrombus.
其中,第一闭环单元311和第三闭环单元331的形状包括,但不局限于,圆形、椭圆形、三角形、菱形、梯形和六边形中的一种或多种。第二闭环单元312大致呈沙漏状,从而第二支架单元30在血管内受到挤压时,能够做出较大的形变,以使第二支架单元30具有较好的柔顺性,进而提高了血栓抓捕效率,且在取栓过程中减小了取栓支架对血管损伤。此外,由于第二闭环单元312呈沙漏状,因此第二闭环单元312能够适应不同大小尺寸的血栓,提高了血栓的有效抓捕率。The shapes of the first closed-loop unit 311 and the third closed-loop unit 331 include, but are not limited to, one or more of a circle, an ellipse, a triangle, a diamond, a trapezoid, and a hexagon. The second closed-loop unit 312 is approximately in the shape of an hourglass, so that when the second stent unit 30 is squeezed in the blood vessel, it can make a large deformation, so that the second stent unit 30 has better flexibility, thereby improving thrombus. Capture efficiency, and reduce the damage to the blood vessel of the embolization stent during the embolectomy process. In addition, since the second closed-loop unit 312 is in the shape of an hourglass, the second closed-loop unit 312 can adapt to thrombus of different sizes, which improves the effective capture rate of thrombus.
在本实施例中,第一闭环单元311和第三闭环单元331均由一个封闭的网格构成。第二闭环单元312由两个半封闭的网格围合而成。多个网格依次排列成行,且相邻两行的网格错位排列。相邻的两网格通过连接筋103连接在一起。在平行于取栓支架100的轴向上,相邻两行中,其中一行的网格对着其中另一行相邻两个网格的空隙,以使得取栓支架100更容易压缩,更能适应细小血管,且容易导入微导管300(参图8)内。In this embodiment, both the first closed-loop unit 311 and the third closed-loop unit 331 are composed of a closed grid. The second closed loop unit 312 is enclosed by two semi-closed grids. A plurality of grids are arranged in a row in sequence, and the grids of two adjacent rows are arranged in a staggered manner. Two adjacent grids are connected together by connecting ribs 103. In the axial direction parallel to the bolt removal stent 100, in two adjacent rows, the grid of one row faces the gap between the two adjacent grids in the other row, so that the bolt removal stent 100 is more easily compressed and more adaptable Small blood vessels, and easy to introduce into the micro catheter 300 (refer to Figure 8).
具体的,第二闭环单元312包括第一网格3121、第二网格3122及连通第一网格3121和第二网格3122的通道3123。第一网格3121与第一闭环单元311依次排列成行,第二网格3122也与第一闭环单元311依次排列成行,通道3123也与第一闭环单元311依次排列成行。同一层的多个第二闭环单元312自第二支架本体30的中心轴线对称分布。通道3123的延伸方向与第二支架本体30的中心轴线相平行。在同一层大管径段31的径向上通道3123与连接筋103正相对。Specifically, the second closed loop unit 312 includes a first grid 3121, a second grid 3122, and a channel 3123 connecting the first grid 3121 and the second grid 3122. The first grid 3121 and the first closed-loop unit 311 are sequentially arranged in a row, the second grid 3122 is also sequentially arranged in a row with the first closed-loop unit 311, and the channel 3123 is also sequentially arranged in a row with the first closed-loop unit 311. The multiple second closed-loop units 312 on the same layer are symmetrically distributed from the central axis of the second bracket body 30. The extending direction of the channel 3123 is parallel to the central axis of the second bracket body 30. In the radial direction of the large pipe diameter section 31 of the same layer, the channel 3123 and the connecting rib 103 are directly opposite.
在一些实施例中,第一支架本体10构造成漏斗结构,第二支架本体30 构造成直管结构,从而取栓支架100在朝靠近其近端的方向回撤的过程中避免血栓的脱落。具体的,第一支架本体10包括多个第四闭环单元11。多个第四闭环单元11相互连接而形成所述漏斗结构。其中,第一支架本体10的管径由其近端朝远端方向逐渐增大,从而防止第一支架本体10的近端在取栓支架100朝其近端方向回撤的过程中因取栓支架100的回撤力的影响而导致其整体的管径变小或扭结,进而提高了血栓抓捕效率,以及减小了取栓支架100对血管损伤。如此,确保第一支架本体10与第二支架本体30之间的平滑过渡连接,进而在取栓过程中减小了取栓支架对血管损伤。In some embodiments, the first stent body 10 is configured in a funnel structure, and the second stent body 30 is configured in a straight tube structure, so that the thrombus removal stent 100 avoids falling off of the thrombus when retracting toward the proximal end of the thrombus removal stent 100. Specifically, the first bracket body 10 includes a plurality of fourth closed-loop units 11. A plurality of fourth closed-loop units 11 are connected to each other to form the funnel structure. Wherein, the tube diameter of the first stent body 10 gradually increases from its proximal end to the distal direction, so as to prevent the proximal end of the first stent body 10 from being removed due to bolt removal during the process of retreating the bolt removal stent 100 toward its proximal direction. The influence of the withdrawal force of the stent 100 causes the overall diameter of the stent 100 to be reduced or kinked, thereby improving the efficiency of capturing thrombus and reducing the damage to the blood vessel caused by the thrombus removal stent 100. In this way, a smooth transitional connection between the first stent body 10 and the second stent body 30 is ensured, thereby reducing the damage to the blood vessel caused by the thrombus removal stent during the thrombus removal process.
在一些实施例中,第四闭环单元11的面积等于第一闭环单元311的面积,从而缩小了第一支架本体10及第二支架本体30与血管壁的接触面积,进而降低了对血管壁的损伤。In some embodiments, the area of the fourth closed-loop unit 11 is equal to the area of the first closed-loop unit 311, thereby reducing the contact area between the first stent body 10 and the second stent body 30 and the blood vessel wall, thereby reducing the impact on the blood vessel wall. damage.
请参阅图3,图3所示为本发明第二实施例提供的一种取栓支架100a的结构示意图。在第二实施方式中,取栓支架100a的结构与第一实施方式的取栓支架100的结构相似。不同的是,第一支架本体10a的近端构造为斜圆锥筒型结构。第一支架本体10a的近端形成具有坡度的入口15a。入口15a的形状是锥形,像水滴状。在本实施例中,入口15a的形状是梭形。如此,基于第一支架本体10a的入口15a的坡度设计,不仅能够有效阻隔回撤取栓支架100a的回撤力传递至整个取栓支架100a的周向上,且避免第一支架本体10a的管径在回撤取栓支架100a的过程中变小,从而确保血栓在取栓支架100a被回撤过程中不易出现脱落的现象。Please refer to FIG. 3, which is a schematic structural diagram of a bolt-removing bracket 100 a provided by the second embodiment of the present invention. In the second embodiment, the structure of the bolt removal bracket 100a is similar to the structure of the bolt removal bracket 100 of the first embodiment. The difference is that the proximal end of the first stent body 10a is configured as an oblique cone-shaped structure. The proximal end of the first stent body 10a forms a sloped entrance 15a. The shape of the inlet 15a is cone-shaped, like a drop shape. In this embodiment, the shape of the inlet 15a is a fusiform. In this way, based on the gradient design of the entrance 15a of the first stent body 10a, not only can the withdrawal force of the withdrawal bolt removal stent 100a be effectively prevented from being transmitted to the entire circumference of the bolt removal stent 100a, but also the pipe diameter of the first stent body 10a can be avoided. It becomes smaller during the withdrawal of the thrombus removal stent 100a, so as to ensure that the thrombus is not easy to fall off when the thrombus removal stent 100a is withdrawn.
请再次参阅图1和图2,可选的,支架本体101还包括连接第一闭环单元311、第二闭环单元312、第三闭环单元331及第四闭环单元11的多个连接筋103。多个连接筋103与支架本体101的中心轴线相平行。第一支架本体10的近端还设置有连接头13。连接头13沿支架本体101的中心轴线的方向延伸。在取栓支架100a被回撤过程中,牵引力将集中于连接头13所在的延长线上,保证了支架本体101的远端的管径不变,从而提高了血栓抓捕效率。Please refer to FIGS. 1 and 2 again. Optionally, the bracket body 101 further includes a plurality of connecting ribs 103 connecting the first closed loop unit 311, the second closed loop unit 312, the third closed loop unit 331 and the fourth closed loop unit 11. The plurality of connecting ribs 103 are parallel to the central axis of the bracket body 101. The proximal end of the first stent body 10 is also provided with a connecting head 13. The connector 13 extends in the direction of the central axis of the bracket body 101. When the thrombus removal stent 100a is withdrawn, the traction force will be concentrated on the extension line where the connecting head 13 is located, ensuring that the diameter of the distal end of the stent body 101 remains unchanged, thereby improving the efficiency of thrombus capture.
在一些实施例中,连接头13上设置有显影定位元件102,以便于在仪器检测下通过显影定位元件102的位置指示取栓支架100位置。显影定位元件102由不透射线的材料制成。不透射线的材料优选为金、铂或钽等贵金属材料。 显影定位元件102可以采用环状、丝状、带状或者点状等多种形式,并且通过压握、热熔、粘接、焊接或者压铆等本领域常用的技术手段固定在取栓支架100上。在一些实施例中,显影定位元件102可以呈环状,显影定位元件102套设在连接头13外。In some embodiments, the connecting head 13 is provided with a developing positioning element 102 so as to indicate the position of the plug-removing bracket 100 through the position of the developing positioning element 102 under the detection of the instrument. The developing positioning member 102 is made of a radiopaque material. The radiopaque material is preferably a precious metal material such as gold, platinum, or tantalum. The developing positioning element 102 can take various forms such as ring shape, wire shape, ribbon shape, or dot shape, and is fixed to the bolt removal bracket 100 by pressing, hot melting, bonding, welding or pressure riveting and other common technical means in the art. on. In some embodiments, the developing positioning element 102 may be ring-shaped, and the developing positioning element 102 is sleeved outside the connecting head 13.
本实施方式中,取栓支架100的远端和近端的位置处分别设置有两个显影定位元件102,以精准定位血栓的位置,从而在采用取栓支架100取栓的过程中可以对血栓的抓捕以及在取栓支架100回撤过程中判断血栓是否脱离取栓支架100进行实时观察,进而指导具体的取栓微观操作,也即指导取栓支架100在压缩状态和释放状态之间转换,使得取栓更为精准。在其他一些实施例中,取栓支架100的中部也可以设置多个显影定位元件,以更精准定位血栓的位置。In this embodiment, two visualization positioning elements 102 are respectively provided at the distal and proximal positions of the thrombus removal stent 100 to accurately locate the position of the thrombus, so that the thrombus can be detected during the thrombus removal process using the thrombus removal stent 100 To capture the thrombus and determine whether the thrombus is separated from the thrombus retrieval stent 100 during the withdrawal process of the thrombus retrieval stent 100 for real-time observation, and then guide the specific microscopic operation of thrombus retrieval, that is, to guide the thrombus retrieval stent 100 to switch between the compressed state and the released state , Which makes the bolt removal more accurate. In some other embodiments, the middle part of the thrombus removal stent 100 may also be provided with multiple visualization positioning elements to more accurately locate the position of the thrombus.
在本实施例中,第一支架本体10和第二支架本体30均是由具有记忆效应的金属材料或具有弹性的高分子材料制成,以便支架本体101自膨胀而形成管状和/或笼状结构。所述金属材料例如是,但不局限于镍钛合金或者钴基合金。具体的,第一支架本体10和第二支架本体30可以通过激光切割板状的镍钛合金而形成具有镂空结构的管状或笼状结构,再经过卷曲、热处理定型。在另一实施例中,第一支架本体10和第二支架本体30还可以通过编织丝状的镍钛合金而形成具有所述镂空结构的管状或笼状结构。在其他实施例中,第一支架本体10和第二支架本体30还可以通过使用具有弹性的塑料材料加工而成。In this embodiment, both the first stent body 10 and the second stent body 30 are made of a metal material with a memory effect or a polymer material with elasticity, so that the stent body 101 self-expands to form a tube and/or a cage. structure. The metal material is, for example, but not limited to nickel-titanium alloy or cobalt-based alloy. Specifically, the first stent body 10 and the second stent body 30 can be formed by laser cutting a plate-shaped nickel-titanium alloy to form a tubular or cage-like structure with a hollow structure, and then be crimped, heat-treated and shaped. In another embodiment, the first stent body 10 and the second stent body 30 can also form a tubular or cage-like structure with the hollow structure by weaving a wire-like Nitinol alloy. In other embodiments, the first bracket body 10 and the second bracket body 30 may also be processed by using elastic plastic materials.
请参阅图4,图4所示为本发明第三实施例提供的一种取栓支架100b的结构示意图。在第三实施方式中,取栓支架100b的结构与第一实施方式的取栓支架100的结构相似。不同的是,第二支架本体30b包括3个大管径段31b和2个小管径段33b。Please refer to FIG. 4, which is a schematic structural diagram of a bolt removal bracket 100b provided by the third embodiment of the present invention. In the third embodiment, the structure of the bolt removal bracket 100b is similar to the structure of the bolt removal bracket 100 of the first embodiment. The difference is that the second bracket body 30b includes three large diameter sections 31b and two small diameter sections 33b.
在本实施例中,3个大管径段31b和2个小管径段33b一体式成型且平滑过渡连接。大管径段31b、小管径段33b、大管径段31b、小管径段33b及大管径段31b依次连接而形成第二支架本体30b。具体的,2个小管径段33b间隔设置,每一小管径段33b设置在相邻两大管径段31b之间。第二支架本体30b的近端和远端均构造成大管径段31b。如此,取栓支架100b能够更有效避免血栓的脱离,且适用于不同尺寸大小的血管取栓。In this embodiment, the three large pipe diameter sections 31b and the two small pipe diameter sections 33b are integrally formed and smoothly transitioned. The large pipe diameter section 31b, the small pipe diameter section 33b, the large pipe diameter section 31b, the small pipe diameter section 33b, and the large pipe diameter section 31b are sequentially connected to form the second stent body 30b. Specifically, two small pipe diameter sections 33b are arranged at intervals, and each small pipe diameter section 33b is arranged between two adjacent large pipe diameter sections 31b. Both the proximal and distal ends of the second stent body 30b are configured as large diameter sections 31b. In this way, the thrombus removal stent 100b can more effectively avoid the detachment of the thrombus, and is suitable for thrombus removal from blood vessels of different sizes.
需要说明的是,在其他一些实施例中,大管径段和小管径段的数量可以根据血栓大小或血管粗细等实际环境条件来设计,本发明不做限定。It should be noted that in some other embodiments, the number of large diameter sections and small diameter sections can be designed according to actual environmental conditions such as thrombus size or blood vessel thickness, which is not limited in the present invention.
请参阅图5,图5所示为本发明第四实施例提供的一种取栓支架100c的结构示意图。在第四实施方式中,取栓支架100c的结构与第三实施方式的取栓支架100b的结构相似。不同的是,取栓支架100c还包括多个抓捕单元20c和多个辅助抓捕单元50c。Please refer to FIG. 5. FIG. 5 is a schematic structural diagram of a bolt removal bracket 100c provided by the fourth embodiment of the present invention. In the fourth embodiment, the structure of the bolt removal bracket 100c is similar to the structure of the bolt removal bracket 100b of the third embodiment. The difference is that the bolt removal bracket 100c further includes a plurality of capturing units 20c and a plurality of auxiliary capturing units 50c.
在本实施例中,多个抓捕单元20c设置在大管径段31c和小管径段33c的交界处,也即小管径段33c的近端和远端均设置有多个抓捕单元20c,以进一步提高取栓支架100c对血栓的抓捕效率。多个抓捕单元20c均匀地分布在取栓支架100c的周向。多个抓捕单元20c自取栓支架100c的周向围成一圈。一圈可包括2-6个抓捕单元。取栓支架100c可以在轴向设置2-4圈抓捕单元。In this embodiment, multiple capture units 20c are arranged at the junction of the large pipe diameter section 31c and the small pipe diameter section 33c, that is, the small pipe diameter section 33c is provided with multiple capture units at the proximal and distal ends. 20c to further improve the capture efficiency of the thrombus removal stent 100c. The multiple catching units 20c are evenly distributed in the circumferential direction of the bolt removal bracket 100c. A plurality of catching units 20c are enclosed in a circle from the circumference of the bolt-removing bracket 100c. A circle can include 2-6 capture units. The bolt-removing bracket 100c can be provided with 2-4 rounds of capture units in the axial direction.
其中,每一抓捕单元20c构造成闭环结构。每一抓捕单元20c包括相对的连接部21c和捕捉部22c。连接部21c大致呈倒V型,捕捉部22c大致呈V型。连接部21c连接于支架本体101上,捕捉部22c可相对于支架本体101c向外或者向内延伸,以使捕捉部22c与支架本体101c之间形成收容空间201c。捕捉部22c可朝垂直于取栓支架100c的轴心线的方向移动。如此,避免取栓支架100c在血管内移动时,捕捉部22c不与血管壁直接接触,从而避免损伤血管壁组织。Among them, each capture unit 20c is configured as a closed loop structure. Each catching unit 20c includes a connecting part 21c and a catching part 22c opposed to each other. The connecting portion 21c is substantially in an inverted V shape, and the capturing portion 22c is substantially in a V shape. The connecting portion 21c is connected to the bracket body 101, and the capturing portion 22c can extend outward or inward relative to the bracket body 101c, so that a receiving space 201c is formed between the capturing portion 22c and the bracket body 101c. The capturing portion 22c can move in a direction perpendicular to the axis of the bolt removal bracket 100c. In this way, it is avoided that when the thrombus removal stent 100c moves in the blood vessel, the capturing portion 22c does not directly contact the blood vessel wall, thereby avoiding damage to the blood vessel wall tissue.
捕捉部22c的远端设置有圆弧形的倒角,以进一步避免抓捕单元20的捕捉部22c对血管壁造成损伤。此外,当取栓支架100c处于膨胀状态时,每一抓捕单元20c的捕捉部22c位于支架本体101c的闭环单元32c的外部,也即捕捉部22c与支架本体101c之间存在间隙,以便抓捕单元20c的捕捉部22c插入至血栓中,或将血栓夹持在收容空间201c内,从而提高了取栓支架100c对血栓的锚固。The distal end of the capturing portion 22c is provided with an arc-shaped chamfer to further prevent the capturing portion 22c of the capturing unit 20 from damaging the blood vessel wall. In addition, when the bolt-removing bracket 100c is in an expanded state, the capturing portion 22c of each capturing unit 20c is located outside the closed loop unit 32c of the bracket body 101c, that is, there is a gap between the capturing portion 22c and the bracket body 101c for capturing The capturing part 22c of the unit 20c is inserted into the thrombus, or the thrombus is clamped in the accommodating space 201c, thereby improving the anchoring of the thrombus by the thrombus removal stent 100c.
具体的,每一辅助抓捕单元50c固定在抓捕单元20c的连接部21c和捕捉部22c的交界处。在本实施例中,每一辅助抓捕单元50c设置在相邻两抓捕单元20c之间。Specifically, each auxiliary catching unit 50c is fixed at the junction of the connecting part 21c and the catching part 22c of the catching unit 20c. In this embodiment, each auxiliary capture unit 50c is arranged between two adjacent capture units 20c.
多个辅助抓捕单元50c均构造成倒刺结构。每一辅助抓捕单元50c包括相对的连接端51c和自由端52c。其中,每一辅助抓捕单元50c的近端为连接端 51c,每一辅助抓捕单元50c的远端为自由端52c。每一辅助抓捕单元50c还可以直接连接取栓支架100c的连接筋103c。每一辅助抓捕单元50c与连接筋103c一体成型。The plurality of auxiliary catching units 50c are all configured in a barbed structure. Each auxiliary catching unit 50c includes opposite connecting ends 51c and free ends 52c. The proximal end of each auxiliary capturing unit 50c is a connecting end 51c, and the distal end of each auxiliary capturing unit 50c is a free end 52c. Each auxiliary catching unit 50c can also be directly connected to the connecting rib 103c of the bolt-removing bracket 100c. Each auxiliary catching unit 50c and the connecting rib 103c are integrally formed.
辅助抓捕单元50c的自由端52c可相对于支架本体101c向外或者向内延伸,且朝垂直于取栓支架100c的轴心线的方向移动。其中,辅助抓捕单元50c可以沿支架本体101c的轴向设置2~6圈,每一圈具有2-6个辅助抓捕单元50c,以进一步提高取栓支架100c对血栓的抓捕效率。The free end 52c of the auxiliary catching unit 50c can extend outward or inward relative to the bracket body 101c, and move in a direction perpendicular to the axis of the bolt removal bracket 100c. Wherein, the auxiliary catching unit 50c can be arranged in 2-6 circles along the axial direction of the stent body 101c, and each circle has 2-6 auxiliary catching units 50c, so as to further improve the thrombus catching efficiency of the thrombus removal stent 100c.
其中,辅助抓捕单元50c具有自膨性。辅助抓捕单元50c包含的材料可以采用取栓支架100c包含的材料,此处不再赘述。Among them, the auxiliary capture unit 50c has self-expandability. The material contained in the auxiliary capture unit 50c can be the material contained in the bolt-removing bracket 100c, which will not be repeated here.
在一些实施例中,每一辅助抓捕单元50c的自由端与支架本体101c之间形成收容空间501c。如此,当取栓支架4c处于释放状态时,每一辅助抓捕单元50c的自由端与支架本体101c之间存在间隙,以便辅助抓捕单元50c插入至血栓中,或将血栓夹持在收容空间501c内,从而进一步提高了取栓支架100c对血栓的锚固。In some embodiments, a receiving space 501c is formed between the free end of each auxiliary capture unit 50c and the bracket body 101c. In this way, when the thrombus removal stent 4c is in the released state, there is a gap between the free end of each auxiliary capture unit 50c and the stent body 101c, so that the auxiliary capture unit 50c can be inserted into the thrombus, or the thrombus can be held in the containing space. 501c, thereby further improving the anchoring of thrombus by the thrombus removal stent 100c.
每一辅助抓捕单元50c的远端52c设置有圆弧形的倒角,以避免辅助抓捕单元50c对血管壁的损伤。在本实施例中,多个辅助抓捕单元50c位于大管径段31c和小管径段33c的交界处,以降低辅助抓捕单元50c损伤血管壁的风险。The distal end 52c of each auxiliary capture unit 50c is provided with an arc-shaped chamfer to avoid damage to the blood vessel wall by the auxiliary capture unit 50c. In this embodiment, multiple auxiliary capturing units 50c are located at the junction of the large diameter section 31c and the small diameter section 33c, so as to reduce the risk of the auxiliary capturing unit 50c damaging the blood vessel wall.
需要说明的是,抓捕单元20c及辅助抓捕单元50c的数量可以根据取栓支架100c的直径大小来设定,且多个辅助抓捕单元50c的排列位置、长度、倾斜角度可以彼此相同,也可以彼此不同,本发明不做限定。It should be noted that the number of capture units 20c and auxiliary capture units 50c can be set according to the diameter of the plug-removing bracket 100c, and the arrangement positions, lengths, and inclination angles of the multiple auxiliary capture units 50c can be the same as each other. They may also be different from each other, and the present invention is not limited.
请参阅图6,图6所示为本发明第五实施例提供的一种取栓支架100d的结构示意图。在第五实施方式中,取栓支架100d的结构与第四实施方式的取栓支架100c的结构相似。不同的是,第一支架本体10e的近端构造为斜圆锥筒型结构。斜圆锥筒型结构的具体结构请参阅第二实施例的描述。Please refer to FIG. 6. FIG. 6 is a schematic structural diagram of a bolt removal bracket 100 d according to a fifth embodiment of the present invention. In the fifth embodiment, the structure of the bolt removing bracket 100d is similar to the structure of the bolt removing bracket 100c of the fourth embodiment. The difference is that the proximal end of the first stent body 10e is configured as an oblique cone-shaped structure. Please refer to the description of the second embodiment for the specific structure of the oblique cone cylindrical structure.
请参阅图7,图7所示为本发明第六实施例提供的一种取栓支架100d的结构示意图。在第六实施方式中,取栓支架100e的结构与第四实施方式的取栓支架100c的结构相似。不同的是,取栓支架100e还包括多个连接件53e,多个辅助抓捕单元50e通过相应的连接件53e与支架本体101e连接。Please refer to FIG. 7. FIG. 7 is a schematic structural diagram of a bolt removal bracket 100 d according to a sixth embodiment of the present invention. In the sixth embodiment, the structure of the bolt removal bracket 100e is similar to the structure of the bolt removal bracket 100c of the fourth embodiment. The difference is that the bolt removal bracket 100e further includes a plurality of connecting members 53e, and the plurality of auxiliary capturing units 50e are connected to the bracket body 101e through the corresponding connecting members 53e.
在本实施例中,每一连接件53e构造为弯曲结构,且每一连接件53e相对 支架本体101e向内弯曲,以增大辅助抓捕单元50e与支架本体101e之间形成的收容空间501e,从而为血栓提供更多的容纳空间。具体的,每一连接件53e的内侧与支架本体101e的轴心线之间形成有一间距,每一连接件53e的外侧与支架本体101e的周缘相接,从而避免连接件53e拦截血栓而无法进入取栓支架100e内。多个连接件53e自支架本体101e的周向均匀分布。每一连接件构53e可以与支架本体101e一体成型。在其他实施例中,每一连接件构53e还可以通过安装结构固定于支架本体101e上。所述安装结构例如是,但不局限于胶粘剂、压握结构或铆接结构。In this embodiment, each connecting member 53e is configured as a curved structure, and each connecting member 53e is bent inwardly relative to the bracket body 101e to increase the receiving space 501e formed between the auxiliary catching unit 50e and the bracket body 101e. So as to provide more accommodation space for the thrombus. Specifically, a distance is formed between the inner side of each connecting piece 53e and the axis of the stent body 101e, and the outer side of each connecting piece 53e is connected to the periphery of the stent body 101e, so as to prevent the connecting piece 53e from intercepting the thrombus and preventing entry. Take the bolt inside the bracket 100e. The plurality of connecting members 53e are evenly distributed from the circumferential direction of the bracket body 101e. Each connecting member 53e can be integrally formed with the bracket body 101e. In other embodiments, each connecting member 53e can also be fixed to the bracket body 101e by a mounting structure. The mounting structure is, for example, but not limited to an adhesive, a crimping structure or a riveting structure.
在一些实施例中,每一辅助抓捕单元50e通过相应的连接件53e与支架本体101e连接。每一辅助抓捕单元50e设置在连接件53e与抓捕单元20e的连接处。具体的,辅助抓捕单元50e的连接端51e与连接件53e的近端相连接。In some embodiments, each auxiliary capture unit 50e is connected to the bracket body 101e through a corresponding connecting member 53e. Each auxiliary catching unit 50e is arranged at the connection between the connecting piece 53e and the catching unit 20e. Specifically, the connecting end 51e of the auxiliary capturing unit 50e is connected to the proximal end of the connecting piece 53e.
其中,多个连接件53e与多个抓捕单元20e交替设置并彼此连接,以确保取栓支架100e具有柔顺性,且使取栓支架100e的径向和轴向具有一定的支撑力。此外,连接件53e的设计还可以增大捕捉部22e与支架本体101e之间的空间,为血栓提供更多的容纳空间。具体的,每一连接件53e的近端连接其中一个抓捕单元20e的连接部21e的远端(即捕捉部22e的近端),每一连接件53e的远端连接其中另一个抓捕单元20e的连接部21e的近端。在本实施例中,每一连接件53e可以与支架本体101e一体成型。在其它一些实施例中,每一连接件53e还可以通过安装结构固定在支架本体101e上。所述安装结构例如是,但不局限于胶粘剂、压握结构或铆接结构。Wherein, the plurality of connecting members 53e and the plurality of catching units 20e are alternately arranged and connected to each other to ensure the flexibility of the bolt removal stent 100e and a certain supporting force in the radial and axial directions of the bolt removal stent 100e. In addition, the design of the connecting piece 53e can also increase the space between the capturing portion 22e and the stent body 101e, and provide more accommodating space for thrombus. Specifically, the proximal end of each connecting piece 53e is connected to the distal end of the connecting portion 21e of one of the catching units 20e (that is, the proximal end of the catching portion 22e), and the distal end of each connecting piece 53e is connected to the other catching unit. The proximal end of the connecting portion 21e of 20e. In this embodiment, each connecting member 53e can be integrally formed with the bracket body 101e. In some other embodiments, each connecting member 53e may also be fixed on the bracket body 101e by a mounting structure. The mounting structure is, for example, but not limited to an adhesive, a crimping structure or a riveting structure.
在一些实施例中,辅助抓捕单元50e的自由端52e构造为弯曲结构,且辅助抓捕单元50e弯曲方向与连接件53e弯曲方向相反。其中,每一辅助抓捕单元50e相对取栓支架100e向外弯曲,以进一步增大辅助抓捕单元20e与支架本体101e之间形成的收容空间201e及增大辅助抓捕单元50e与支架本体101e之间形成的收容空间501e,从而为进一步血栓提供更多的容纳空间。此外,辅助抓捕单元50e的弯曲结构的设计可以更加牢固地夹持血栓,并且提高取栓支架100e的安全性,防止自由端52e刺向血管壁方向,以及增加与血管壁贴合性,进而避免损伤血管壁组织。In some embodiments, the free end 52e of the auxiliary capturing unit 50e is configured as a curved structure, and the bending direction of the auxiliary capturing unit 50e is opposite to the bending direction of the connecting member 53e. Wherein, each auxiliary catching unit 50e is bent outward relative to the bolt-taking bracket 100e to further increase the accommodating space 201e formed between the auxiliary catching unit 20e and the bracket body 101e and to increase the auxiliary catching unit 50e and the bracket body 101e The accommodating space 501e formed therebetween provides more accommodating space for further thrombosis. In addition, the design of the curved structure of the auxiliary capture unit 50e can hold the thrombus more firmly, and improve the safety of the thrombus removal stent 100e, prevent the free end 52e from piercing the direction of the blood vessel wall, and increase the adhesion to the blood vessel wall. Avoid damaging the blood vessel wall tissue.
需要说明的是,第二实施例的取栓支架100a的结构设计适用于第三和第 六实施例中的取栓支架100b,100e,此处不再赘述。It should be noted that the structural design of the bolt removal bracket 100a of the second embodiment is applicable to the bolt removal brackets 100b, 100e in the third and sixth embodiments, and will not be repeated here.
请参阅图8,图8所示为本发明实施例提供的一种取栓系统1000的结构示意图。取栓系统1000包括上述取栓支架100d以及推送杆200和微导管300。推送杆200连接于取栓支架100d的近端,推送杆200和取栓支架100d被压握导入微导管300内。取栓支架100d可通过推送杆200的推拉而在微导管300内外活动。当推送杆200朝靠近其近端的方向活动时,取栓支架100d被回收到微导管300内;当推送杆200朝远离其近端的方向活动时,取栓支架100d被推出微导管300外。Please refer to FIG. 8, which is a schematic structural diagram of a bolt removal system 1000 according to an embodiment of the present invention. The thrombus removal system 1000 includes the above-mentioned thrombus removal stent 100d, a push rod 200 and a micro catheter 300. The push rod 200 is connected to the proximal end of the thrombus removal stent 100d, and the push rod 200 and the thrombus removal stent 100d are crimped and introduced into the microcatheter 300. The plug-removing stent 100d can move inside and outside the microcatheter 300 by pushing and pulling the push rod 200. When the push rod 200 moves toward its proximal end, the thrombus removal stent 100d is recovered into the micro catheter 300; when the push rod 200 moves away from its proximal end, the thrombus removal stent 100d is pushed out of the micro catheter 300 .
在本实施例中,取栓支架100d的近端与推送杆200的远端的连接方式包括焊接、套接或粘胶固定连接。可选的,焊接包括,但不局限于银焊或金焊。粘胶包括,但不局限于UV胶或环氧树脂胶。微导管300套设在推送杆200外。取栓系统1000还包括装载管400。装载管400用于固定微导管300。In this embodiment, the connection between the proximal end of the bolt-removing bracket 100d and the distal end of the push rod 200 includes welding, sleeve connection, or glue-fixed connection. Optionally, welding includes, but is not limited to silver welding or gold welding. Adhesives include, but are not limited to UV glue or epoxy glue. The micro catheter 300 is sleeved outside the pushing rod 200. The bolt removal system 1000 further includes a loading tube 400. The loading tube 400 is used to fix the micro catheter 300.
使用时,先将取栓支架100d的近端与推送杆200的远端连接,再将安装好的取栓支架100d和推送杆200预先压缩至微导管300内。在介入治疗时,将微导管300输送至血管的病变部位,并穿越血栓,固定微导管300。通过推送杆200将取栓支架100d推至根据显影定位元件102确定的血栓所在位置,回撤微导管300使取栓支架100d在其远端释放,取栓支架100d在远端弹开锚定住血管壁,随后缓慢前推推送杆200,同时在反作用力下回撤微导管300,释放微导管300的张力,重复多次直至取栓支架100d全部释放。When in use, first connect the proximal end of the thrombus removal stent 100d and the distal end of the push rod 200, and then compress the installed thrombus removal stent 100d and the push rod 200 into the microcatheter 300 in advance. During the interventional treatment, the microcatheter 300 is delivered to the diseased part of the blood vessel, passes through the thrombus, and fixes the microcatheter 300. Push the thrombus removal stent 100d through the push rod 200 to the position of the thrombus determined according to the imaging positioning element 102, retract the microcatheter 300 to release the thrombus removal stent 100d at its distal end, and the thrombus removal stent 100d bounces at the distal end to anchor the blood vessel Then, push the push rod 200 forward slowly, and at the same time withdraw the micro-catheter 300 under the reaction force to release the tension of the micro-catheter 300, and repeat it many times until the embolization stent 100d is fully released.
由于取栓支架100d由形状记忆材料制成,因此取栓支架100d具有弹性,从而取栓支架100d可以在压缩状态和释放状态之间转换。通过对取栓支架100d的释放,取栓支架100d能够完全嵌入血栓内部。等待一定时间后,回拉推送杆200,回撤取栓支架100d捕获血栓,直至将取栓支架100d连同微导管300一并收回撤出体外,完成整个取栓过程。作为整体的取栓装置1000被压握导入微导管300内,也就是取栓支架100d通过微导管300输送至血管的病变部位。Since the plug removal stent 100d is made of a shape memory material, the plug removal stent 100d has elasticity, so that the plug removal stent 100d can switch between a compressed state and a released state. By releasing the thrombus removal stent 100d, the thrombus removal stent 100d can be completely embedded inside the thrombus. After waiting for a certain period of time, the push rod 200 is pulled back, and the thrombus removal stent 100d is retracted to capture the thrombus, until the thrombus removal stent 100d together with the microcatheter 300 is retracted out of the body to complete the entire embolization process. The thrombus removal device 1000 as a whole is crimped and introduced into the microcatheter 300, that is, the thrombus removal stent 100d is delivered to the diseased part of the blood vessel through the microcatheter 300.
需要说明的是,第一实施例至第四实施例及第六实施例中的取栓支架100,100a,100b,100c,100e均可以应用于取栓系统,此处不再赘述。It should be noted that the bolt removal brackets 100, 100a, 100b, 100c, 100e in the first embodiment to the fourth embodiment and the sixth embodiment can all be applied to the bolt removal system, which will not be repeated here.
本发明实施例提供的取栓支架及取栓系统,基于第一支架本体与第二支架 本体平滑过渡连接,第二支架本体包括交替相接的大管径段和小管径段。如此,取栓支架具有柔顺性的同时,还具有一定的径向和轴向的支撑力,且有效防止取栓支架完全通过血管时发生塌陷,从而提高了血栓抓捕效率,以及在取栓过程中减小了取栓支架对血管损伤。The bolt removal stent and bolt removal system provided by the embodiments of the present invention are based on the smooth transitional connection between the first stent body and the second stent body, and the second stent body includes alternately connected large pipe diameter sections and small pipe diameter sections. In this way, while the thrombus removal stent has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent from collapsing when it completely passes through the blood vessel, thereby improving the efficiency of thrombus capture and the process of thrombus removal. It reduces the damage to the blood vessel caused by the embolization stent.
以上对本发明实施例进行了详细介绍,本文中应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的方法及其核心思想;同时,对于本领域的一般技术人员,依据本发明的思想,在具体实施方式及应用范围上均会有改变之处,综上上述,本说明书内容不应理解为对本发明的限制。The embodiments of the present invention are described in detail above, and specific examples are used in this article to illustrate the principles and implementation of the present invention. The descriptions of the above embodiments are only used to help understand the methods and core ideas of the present invention; at the same time, for Those of ordinary skill in the art, based on the idea of the present invention, will have changes in the specific implementation and the scope of application. In summary, the content of this specification should not be construed as limiting the present invention.

Claims (21)

  1. 一种取栓支架,包括管状和/或笼状结构的支架本体,所述支架本体包括第一支架本体和设置在所述第一支架本体的远端的第二支架本体,所述第一支架本体与所述第二支架本体平滑过渡连接,所述第二支架本体包括交替相接的大管径段和小管径段。A plug-removing stent includes a stent body with a tubular and/or cage-like structure. The stent body includes a first stent body and a second stent body arranged at the distal end of the first stent body. The first stent The body is smoothly transitionally connected with the second bracket body, and the second bracket body includes a large pipe diameter section and a small pipe diameter section that are alternately connected.
  2. 如权利要求1所述的取栓支架,其特征在于,所述第二支架本体的近端和远端均构造为所述大管径段,所述小管径段设置在相邻两所述大管径段之间。The thrombus removal stent according to claim 1, wherein the proximal end and the distal end of the second stent body are both configured as the large tube diameter section, and the small tube diameter section is arranged at two adjacent Between large pipe diameter sections.
  3. 如权利要求1所述的取栓支架,其特征在于,所述第二支架本体包括多个第一闭环单元、多个第二闭环单元及多个第三闭环单元,多个所述第一闭环单元和多个所述第二闭环单元相互连接而形成所述大管径段,多个第三闭环单元相互连接而形成所述小管径段。The bolt removal stent according to claim 1, wherein the second stent body includes a plurality of first closed loop units, a plurality of second closed loop units, and a plurality of third closed loop units, and a plurality of the first closed loops The unit and the plurality of second closed-loop units are connected to each other to form the large pipe diameter section, and a plurality of third closed-loop units are connected to each other to form the small pipe diameter section.
  4. 如权利要求3所述的取栓支架,其特征在于,所述第一闭环单元的面积小于所述第二闭环单元的面积,且大于所述第三闭环单元的面积。3. The bolt removal bracket of claim 3, wherein the area of the first closed-loop unit is smaller than the area of the second closed-loop unit and larger than the area of the third closed-loop unit.
  5. 如权利要求3所述的取栓支架,其特征在于,所述第一闭环单元环绕所述第二闭环单元,相邻两所述第二闭环单元沿所述第二支架本体的周向间隔设置。The bolt removal stent according to claim 3, wherein the first closed-loop unit surrounds the second closed-loop unit, and two adjacent second closed-loop units are arranged at intervals along the circumferential direction of the second stent body .
  6. 如权利要求3所述的取栓支架,其特征在于,所述第二闭环单元沿所述第二支架本体的轴向和周向均匀分布。3. The bolt removal stent according to claim 3, wherein the second closed loop unit is evenly distributed along the axial and circumferential directions of the second stent body.
  7. 如权利要求6所述的取栓支架,其特征在于,多个所述第二闭环单元在每一所述大管径段的径向上位于同一层上;或者多个所述第二闭环单元在每一所述大管径段的径向上位于不同的层上,且相邻两层的多个所述第二闭环单元沿所述第二支架本体的周向错开设置。The bolt removal stent according to claim 6, wherein a plurality of the second closed-loop units are located on the same layer in the radial direction of each of the large pipe diameter sections; or a plurality of the second closed-loop units are located on the same layer. Each of the large pipe diameter sections is located on a different layer in the radial direction, and a plurality of the second closed-loop units of two adjacent layers are staggered along the circumferential direction of the second stent body.
  8. 如权利要求3所述的取栓支架,其特征在于,所述第二闭环单元呈沙漏状,所述第一闭环单元和所述第三闭环单元的形状包括圆形、椭圆形、三角形、菱形、梯形和六边形中的一种或多种。The bolt removal stent according to claim 3, wherein the second closed-loop unit is in the shape of an hourglass, and the shapes of the first closed-loop unit and the third closed-loop unit include a circle, an ellipse, a triangle, and a diamond. One or more of, trapezoid and hexagon.
  9. 如权利要求1所述的取栓支架,其特征在于,所述第二支架本体包括至少两个大管径段和至少两个所述小管径段,所述大管径段和所述小管径段依次间隔连接形成所述第二支架本体。The thrombus removal stent according to claim 1, wherein the second stent body includes at least two large pipe diameter sections and at least two small pipe diameter sections, and the large pipe diameter section and the small pipe diameter section The pipe diameter sections are sequentially connected at intervals to form the second bracket body.
  10. 如权利要求3所述的取栓支架,所述第一支架本体包括多个第四闭环单 元,多个所述第四闭环单元相互连接而形成漏斗结构,所述第一支架本体的管径由其近端朝远端方向逐渐增大。The thrombus removal stent according to claim 3, the first stent body includes a plurality of fourth closed-loop units, the plurality of fourth closed-loop units are connected to each other to form a funnel structure, and the pipe diameter of the first stent body is determined by The proximal end gradually increases toward the distal end.
  11. 如权利要求10所述的取栓支架,其特征在于,所述支架本体还包括连接所述第一闭环单元、所述第二闭环单元、所述第三闭环单元及所述第四闭环单元的多个连接筋,所述多个连接筋与所述支架本体的中心轴线相平行。The bolt removal stent according to claim 10, wherein the stent body further comprises a connection connecting the first closed-loop unit, the second closed-loop unit, the third closed-loop unit, and the fourth closed-loop unit A plurality of connecting ribs, the plurality of connecting ribs are parallel to the central axis of the bracket body.
  12. 如权利要求1所述的取栓支架,其特征在于,还包括多个抓捕单元,所述多个抓捕单元设置在所述大管径段和所述小管径段的交界处。5. The bolt removal stent according to claim 1, further comprising a plurality of catching units, the plurality of catching units are arranged at the junction of the large pipe diameter section and the small pipe diameter section.
  13. 如权利要求12所述的取栓支架,其特征在于,还包括多个连接件,多个所述连接件与多个所述抓捕单元交替设置并彼此连接。The bolt removal bracket according to claim 12, further comprising a plurality of connecting members, and the plurality of connecting members and the plurality of capturing units are alternately arranged and connected to each other.
  14. 如权利要求13所述的取栓支架,其特征在于,每一所述连接件构造为弯曲结构,且每一所述连接件相对所述支架本体向内弯曲。The bolt removal bracket of claim 13, wherein each of the connecting members is configured as a curved structure, and each of the connecting members is bent inwardly with respect to the bracket body.
  15. 如权利要求12所述的取栓支架,其特征在于,每一所述抓捕单元包括V型的捕捉部,所述捕捉部可相对于所述支架本体向外或者向内延伸,且与所述支架本体之间形成第一收容空间。The bolt-removing bracket according to claim 12, wherein each of the catching units includes a V-shaped catching portion, and the catching portion can extend outward or inward relative to the stent body, and is in line with the A first accommodating space is formed between the bracket bodies.
  16. 如权利要求13所述的取栓支架,其特征在于,所述支架本体还包括至少一个辅助抓捕单元,每一所述辅助抓捕单元设置在所述连接件与所述抓捕单元的连接处。The bolt-removing bracket according to claim 13, wherein the bracket body further comprises at least one auxiliary catching unit, and each auxiliary catching unit is provided in the connection between the connecting piece and the catching unit. Place.
  17. 如权利要求16所述的取栓支架,其特征在于,每一所述辅助抓捕单元的远端为自由端,所述辅助抓捕单元的自由端设置有圆弧形的倒角,所述辅助抓捕单元的自由端可相对于所述支架本体向外或者向内延伸,且朝垂直于所述取栓支架的轴心线的方向移动。The plug-removing bracket according to claim 16, wherein the distal end of each auxiliary catching unit is a free end, and the free end of the auxiliary catching unit is provided with an arc-shaped chamfer, and the The free end of the auxiliary catching unit can extend outward or inward relative to the bracket body and move in a direction perpendicular to the axis of the bolt-removing bracket.
  18. 如权利要求16所述的取栓支架,其特征在于,每一所述辅助抓捕单元的自由端与所述支架本体之间形成第二收容空间。The bolt-removing bracket according to claim 16, wherein a second receiving space is formed between the free end of each auxiliary capturing unit and the bracket body.
  19. 如权利要求16所述的取栓支架,其特征在于,每一所述辅助抓捕单元构造为弯曲结构,且每一所述辅助抓捕单元相对所述支架本体向外弯曲。16. The bolt-removing bracket of claim 16, wherein each of the auxiliary catching units is configured as a curved structure, and each of the auxiliary catching units is bent outward relative to the bracket body.
  20. 如权利要求16所述的取栓支架,其特征在于,所述辅助抓捕单元沿所述支架本体的轴向设置2~6圈,每一圈具有2-6个所述辅助抓捕单元。16. The bolt removal stent according to claim 16, wherein the auxiliary catching unit is arranged in 2-6 circles along the axial direction of the stent body, and each circle has 2-6 auxiliary catching units.
  21. 一种取栓系统,包括推送杆、微导管、以及如权利要求1-20任意一项所述的取栓支架,所述推送杆连接于所述取栓支架的近端,所述推送杆和所述取栓 支架被压握导入所述微导管内,所述取栓支架可通过所述推送杆的推拉而在所述微导管内外活动,当所述推送杆朝靠近其近端的方向活动时,所述取栓支架被回收到所述微导管内;当所述推送杆朝远离其近端的方向活动时,所述取栓支架被推出所述微导管外。A thrombus removal system, comprising a push rod, a micro catheter, and the thrombus removal stent according to any one of claims 1-20, the push rod is connected to the proximal end of the thrombus removal stent, and the push rod and The thrombus removal stent is crimped and introduced into the microcatheter. The thrombus removal stent can move inside and outside the microcatheter through the push and pull of the push rod. When the push rod moves toward the proximal end thereof When the time, the thrombus removal stent is recovered into the micro catheter; when the push rod moves in a direction away from its proximal end, the thrombus removal stent is pushed out of the micro catheter.
PCT/CN2020/141281 2019-12-30 2020-12-30 Thrombus retrieving stent and thrombus retrieving system WO2021136350A1 (en)

Applications Claiming Priority (4)

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CN201911423136.2A CN113116461A (en) 2019-12-30 2019-12-30 Thrombus taking device and thrombus taking system
CN201911424621.1 2019-12-30
CN201911424621.1A CN113116462A (en) 2019-12-30 2019-12-30 Thrombectomy support and thrombectomy system
CN201911423136.2 2019-12-30

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