WO2021136380A1 - Dispositif et système de récupération de caillot sanguin - Google Patents

Dispositif et système de récupération de caillot sanguin Download PDF

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Publication number
WO2021136380A1
WO2021136380A1 PCT/CN2020/141423 CN2020141423W WO2021136380A1 WO 2021136380 A1 WO2021136380 A1 WO 2021136380A1 CN 2020141423 W CN2020141423 W CN 2020141423W WO 2021136380 A1 WO2021136380 A1 WO 2021136380A1
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WO
WIPO (PCT)
Prior art keywords
thrombus
stent
distal end
umbrella
removal device
Prior art date
Application number
PCT/CN2020/141423
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English (en)
Chinese (zh)
Inventor
王永胜
高国庆
于鹏
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/zh
Priority claimed from CN201911424621.1A external-priority patent/CN113116462A/zh
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 WO2021136380A1 publication Critical patent/WO2021136380A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements 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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions

Definitions

  • the present invention relates to the technical field of medical equipment, in particular to a thrombus removal device 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 very 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 method fails to effectively capture the thrombus falling or overflowing from the thrombectomy stent, which easily causes the re-embolization of the blood vessel and the complications caused by thrombectomy treatment.
  • an embodiment of the present invention provides a bolt removal device, which includes a bolt removal bracket and a protective umbrella provided at the distal end of the bolt removal bracket.
  • the protective umbrella includes a main body structure and a connecting structure that are adjacent to each other.
  • the main structure is formed by interlacing ribs, at least two connecting bones are scattered and connected to the proximal end of the main structure, and the connecting structure is formed by joining the at least two connecting bones.
  • an embodiment of the present invention provides a thrombus retrieval system, including a push rod, a micro catheter, and the thrombus retrieval device described above.
  • the thrombus retrieval device includes a thrombus retrieval stent and a thrombus retrieval stent provided at the distal end of the thrombus retrieval stent.
  • Protective umbrella, the push rod is connected to the proximal end of the thrombus removal stent, the push rod, the thrombus removal stent and the protective umbrella are crimped into the micro catheter, the thrombus removal stent and the protective umbrella The push rod can be moved inside and outside the micro catheter through the push and pull of the push rod.
  • the thrombus removal stent and the protective umbrella are recovered into the micro catheter;
  • the push rod moves in a direction away from its proximal end, the thrombus removal stent and the protective umbrella are pushed out of the micro catheter.
  • the thrombus retrieval device and thrombus retrieval system are based on the provision of a protective umbrella at the distal end of the thrombus retrieval stent, thereby effectively preventing the thrombus falling off or overflowing from the thrombus retrieval stent from escaping.
  • the protective umbrella includes an adjacent main structure and a connecting structure.
  • the main structure is formed by interlacing umbrella ribs.
  • At least two connecting bones are scattered and connected to the proximal end of the main structure. Said at least two connecting bones are enclosed.
  • the thrombus falling off or overflowing from the thrombus removal stent can easily enter the main structure from the connecting structure, so that the protective umbrella can effectively recover the thrombus falling or overflowing from the thrombus removal stent, thereby avoiding blood vessels caused by the thrombus falling off or overflowing from the thrombus removal stent.
  • Fig. 1 is a schematic diagram of the structure of the bolt removal device provided by the first embodiment of the present invention.
  • Fig. 2 is a schematic structural diagram of the protective umbrella of the bolt removal device in Fig. 1.
  • Fig. 3 is a bottom view of the protective umbrella in Fig. 2.
  • Fig. 4 is a schematic structural view of the main structure of the protective umbrella in Fig. 2.
  • FIG. 5 is a three-dimensional plan view of a partial structure of the bolt removing bracket of the bolt removing device in FIG. 1.
  • FIG. 6 is a schematic diagram of the bolt removing process of the bolt removing device in FIG. 1.
  • Fig. 7 is a schematic structural diagram of a bolt removal device provided by a second embodiment of the present invention.
  • FIG. 8 is a schematic diagram of the structure of the bolt removing bracket and the connecting piece of the bolt removing device in FIG. 7.
  • Fig. 9 is a schematic structural diagram of a thrombus removal device provided by a third embodiment of the present invention.
  • Fig. 10 is a schematic structural diagram of a thrombus removal device provided by a fourth embodiment of the present invention.
  • FIG. 11 is a schematic diagram of the structure of the bolt removal device provided by the fifth embodiment of the present invention.
  • Fig. 12 is a schematic structural diagram of a bolt removal system provided by an embodiment of the present invention.
  • the end of the instrument that is relatively close to the operator is usually called the proximal end, and the end of the instrument that is relatively 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.
  • axial direction refers to the direction in which the thrombus removal device of the present invention is advanced, that is, the longitudinal axis of the thrombus removal device is also coincident with the longitudinal axis of the blood vessel.
  • closed does not mean that a certain element structure is a completely sealed object, and its structure only represents a characteristic of the element structure, that is, the mesh body can form a storage space for thrombus, and the thrombus is not easy to escape from the place.
  • the sealing structure of the net body 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.
  • axial direction refers to the direction in which the thrombus removal device of the present invention is advanced, that is, the longitudinal axis of the thrombus removal device is also coincident with the longitudinal axis of the blood vessel.
  • closed does not mean that a certain element structure is a completely
  • FIG. 1 is a schematic structural diagram of a bolt removal device 2 provided by the first embodiment of the present invention.
  • the thrombus removal device 2 includes a thrombus removal bracket 4 and a protective umbrella 6 arranged at the distal end of the thrombus removal bracket 4.
  • the protective umbrella 6 includes an umbrella rib 61 and at least two connecting the umbrella rib 61 and the thrombus removal bracket 4. Connecting bones 63.
  • the protective umbrella 6 includes a main structure 601 and a connecting structure 603 that are adjacent to each other.
  • the main structure 601 is interlaced and woven by the ribs 61.
  • the proximal end of the main structure 601 is scattered and connected.
  • the connecting structure 603 is formed by enclosing the at least two connecting bones 63.
  • a protective umbrella 6 is provided at the distal end of the thrombus removal stent 6, thereby effectively preventing the thrombus falling off or overflowing from the thrombus removal stent 4 from escaping.
  • the thrombus falling off or overflowing from the thrombus removal stent 4 easily enters the main structure 601 from the connecting structure 603, so that the protective umbrella 6 can effectively recover the thrombus falling or overflowing from the thrombus removal stent 4, thereby avoiding falling off from the thrombus removal stent 4
  • overflow thrombosis can cause vascular re-embolization, and prevent complications caused by thrombus removal treatment, such as vasospasm, thereby increasing the recanalization rate of blood vessels.
  • Figure 2 shows a schematic diagram of the protective umbrella 6
  • Figure 3 shows a bottom view of the protective umbrella 6
  • Figure 4 shows the structure of the main structure 601 (net body 62) of the protective umbrella 6 Schematic.
  • the connecting structure 603 is gradually condensed from the distal end toward the proximal direction, and the proximal end of the connecting structure 603 extends in the direction parallel to the axis L of the thrombus removal stent 4 to form Connect the connecting part 631 of the fetching branch.
  • the number of connecting bones 63 forming the connecting structure 603 is 2-8, and the connecting bones 63 do not overlap each other, that is, the connecting structure 603 does not have a cross grid structure, so the connecting structure 603 has a larger space.
  • the thrombus falling off or overflowing from the thrombus removal stent 4 enters the main structure 601.
  • the protective umbrella 6 is fixed on the bolt-removing bracket 4.
  • the protective umbrella 6 further includes a fixing sleeve 8.
  • the connecting portion 631 of the connecting structure 603 is connected to the bolt-removing bracket 4 through the fixing sleeve 8, and the distal end of the connecting structure 603 is smoothly connected to the proximal end of the main structure 601.
  • the connecting portion 631 of the connecting structure 603 can be connected to the fixing sleeve 8 by means of adhesive or mechanical fixing.
  • the mechanical fixing method is, for example, but not limited to welding, crimping, hot melting or crimping, and other common technical means in the art to fix the connection together.
  • the connecting portion 631 of the connecting structure 603 can also be integrally formed with the bolt removing bracket 4 to improve the stability and reliability of the connection between the bolt removing bracket 4 and the protective umbrella 6.
  • the fixing sleeve 8 and the bolt removal bracket 4 are integrally formed.
  • the fixing sleeve 8 is located inside the thrombus removal stent 4, so that the structure of the thrombus removal device 2 is compact, and the protective umbrella 6 is closer to the distal end of the thrombus removal stent 4, effectively preventing the thrombus falling off or overflowing from the thrombus removal stent from escaping.
  • the fixing sleeve 8 and the bolt removal bracket 4 can also be detachably connected together.
  • a positioning wire 41 connected to the fixing sleeve 8 is provided at the distal end of the bolt-removing bracket 4.
  • the positioning wire 41 extends along the periphery of the bolt removal bracket 4 toward its axis line, and is used to position the fixing sleeve 8 on the axis line L of the bolt removal bracket 4, so as to save the protective umbrella 6 occupying the space of the bolt removal device 2, and Ensure the smooth movement of the embolization stent 4 and the protective umbrella 6 in the blood vessel.
  • the positioning wires 41 are symmetrically distributed from the axis L of the bolt removal bracket 4.
  • the number of positioning wires is 2-8. It should be noted that the number of connecting bones 63 and positioning wires 41 can be set according to actual conditions, which is not limited in the present invention.
  • the axis line L of the bolt removing bracket 4 is collinear with the axis line P of the umbrella 6, that is, the axis line of the axis line connecting structure 603 of the bolt removing bracket 4 is collinear with the axis line of the main structure 601. In this way, the stability of the thrombus removal device is improved, and the smooth movement of the thrombus removal stent 4 and the protective umbrella 6 in the blood vessel is ensured.
  • the radial dimension of the rib 61 is greater than or equal to the radial dimension of the distal end of the thrombus removal stent 4, and the radial dimension of the rib 61 gradually decreases from the proximal end to the distal direction to ensure The thrombus falling off or overflowing from the embolization stent enters the protective umbrella.
  • the main structure 601 is configured as a semi-closed cone-shaped mesh body 62.
  • the proximal end of the net body 62 forms an opening structure 621
  • the distal end of the net body 62 forms a sealing structure 622.
  • the opening structure 621 covers the orthographic projection of the blocking structure 622 on the opening structure 621 in the axial direction, so that the protective umbrella 6 can capture more thrombi that fall off or overflow from the thrombus removal stent 4.
  • the radial size of the opening structure 621 is greater than or equal to the radial size of the distal end of the plug removal stent 4.
  • the blocking structure 622 is that the ribs 61 constituting the net body 62 are gradually condensed and closed from the proximal end to the distal direction. In other embodiments, the blocking structure 622 can also be closed by wrapping the distal end of the mesh body 62 tightly by the tightening structure. In this way, the space for the thrombus to enter the protective umbrella 6 is increased, and the thrombus in the protective umbrella 6 is prevented from escaping, thereby improving the thrombus capture performance of the thrombus removal device 2 so that the thrombus removal device 2 removes the thrombus cleanly and prevents vasospasm. And can quickly restore blood flow speed.
  • the mesh area of the mesh unit of the mesh body 62 gradually increases from the distal end to the proximal end, that is, the mesh design of the mesh body 62 is gradually dense from the proximal end to the distal end to prevent the thrombus entering the mesh body 62 from escaping .
  • the mesh body 62 is a mesh structure formed by a plurality of grid units connected to each other.
  • the mesh area of the mesh unit of the mesh body 62 gradually increases from the distal end to the proximal end. In this way, the thrombus falling off or overflowing from the thrombus removal stent easily enters the net 62 from the proximal end of the net 62, and is not easy to escape from the distal end of the net 62, so that it will fall off or overflow from the thrombus removal stent 4
  • the thrombus is recovered to increase the recanalization rate of blood vessels.
  • the net body 62 is configured in a tapered kaleidoscope pattern.
  • the mesh body 62 is composed of a multi-layer flower-shaped ring structure 6211 along the axial direction of the protective umbrella 6, and the multi-layer flower-shaped ring structures 6211 are seamlessly connected to each other, and each layer of the flower-shaped ring structure 6211 is composed of multiple mesh areas.
  • the same grid unit 6212 is connected.
  • one grid unit 6212 of one layer of flower-shaped ring structure 6211 faces the gap between two adjacent grid units 6212 of the other layer of flower-shaped ring structure 6211, so that the protective umbrella 6 is more easily compressed and more capable Adapt to small blood vessels.
  • the net body 62 is formed by interlacing a plurality of umbrella ribs 61.
  • the plurality of umbrella ribs 61 are structured in a petal structure and distributed radially.
  • the proximal end of each rib 61 protrudes outward relative to the net body 62 to form an arc-shaped end 611 to increase the overall area of the net body 62 and prevent the thrombus falling off or overflowing from the thrombus removal stent 4 from escaping.
  • the connecting bone 63 can be woven and formed by converging a plurality of umbrella bones 61.
  • the connecting bone 63 and the umbrella bone 61 are an integral structure, which can improve the stability and reliability of the main structure 601 and the connecting structure 603 of the protective umbrella.
  • the umbrella ribs 61 converge into a connecting bone 63.
  • a convex rib 6111 is provided in the middle of the edge of the arc-shaped end 611.
  • the distal end of each connecting bone 63 is smoothly connected to the corresponding rib 6111, and the proximal end of each connecting bone 63 is connected to the fixing sleeve 8 to improve the stability of the connecting bone 63 to the umbrella body 62.
  • the center of the edge of the arc-shaped end 6111 coincides with the flower axis C of the petal structure.
  • the flower axis C of the petal structure and the axis P of the umbrella 6 form an acute angle.
  • At least two connecting bones 63 are symmetrically distributed from the axis P of the umbrella 6.
  • the protective umbrella 6 further includes a protective sleeve 65.
  • the protective sleeve 65 is fixedly sleeved on the distal end of the umbrella rib 61 to wrap and tighten the distal end of the umbrella rib 61.
  • the protective sleeve 65 can be used as the blocking structure 622 of the net body 62. In this way, contact between the distal end of the rib 61 and the blood vessel wall is avoided, thereby reducing damage to the blood vessel wall, and ensuring that the thrombus falling off or overflowing from the thrombus removal stent 4 is always contained in the protective umbrella 6.
  • FIG. 5 is a three-dimensional plan view of a partial structure of the bolt removal support 4 of the bolt removal device 2.
  • the bolt removal stent 4 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 transitionally connected.
  • 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 4 has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent 4 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.
  • the existing thrombectomy stent requires a large radial size in the catheter and cannot pass through tortuous intracranial blood vessels, while the thrombus removal device 2 of the present application requires a small radial size inside the catheter, so it is suitable for smaller intracranial and other smaller diameters. Blood vessels.
  • 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 stent body 30 includes three large diameter sections 31 and two small diameter sections 33.
  • the three large diameter sections 31 are respectively located at the proximal, middle and distal ends of the second stent body 30 .
  • the small pipe diameter section 33 is located between two adjacent large pipe diameter sections 31. It should be noted that the number of the large pipe diameter section 31 and the small pipe diameter section 33 can be set according to actual requirements, which is not limited in the present invention.
  • Both the large pipe diameter section 31 and the small pipe diameter section 33 are formed by connecting a plurality of closed loop units 32 to each other.
  • the shape of the closed-loop unit 32 includes, but is not limited to, one or more of a circle, an ellipse, a triangle, a diamond, a trapezoid, and a hexagon.
  • the same bracket body 30 may include one, two or more at the same time.
  • kind of closed-loop unit 32 Two adjacent closed-loop units 32 are connected together by connecting ribs 103.
  • the connecting rib 103 is parallel to the axis L of the bolt removal bracket 4.
  • the closed-loop unit 32 of one row faces the gap between two adjacent closed-loop units 32 in the other row, so that the bolt removal bracket 4 is more easily compressed. It is more suitable for small blood vessels and is easy to introduce into the micro catheter 300 (refer to FIG. 12).
  • the proximal end of the first stent body 10 is configured as an oblique cone cylindrical structure.
  • the first bracket body 10 also includes a plurality of closed loop units 11.
  • a plurality of closed loop units 11 are connected to each other to form the oblique cone cylindrical structure.
  • the proximal end of the first stent body 10 forms an entrance 15 with a slope.
  • the shape of the inlet 15 is tapered, such as a drop shape. In this embodiment, the shape of the inlet 15 is a fusiform.
  • the proximal end of the first stent body 10 is also provided with a connecting head 13.
  • the connecting head 13 extends in a direction parallel to the axis L of the bolt-removing bracket 4.
  • the connecting head 13 is provided with a developing positioning element 102, so that the position of the developing positioning element 102 can be used to indicate the position of the plug-removing device 2 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, filament shape, ribbon shape, or dot shape, and is fixed to the bolt removal bracket 4 by pressing, hot melting, bonding, welding, or riveting and other technical means commonly used 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.
  • the proximal end of the thrombus retrieval stent 4 is provided with a visualization positioning element 102 to accurately locate the position of the thrombus, so that the thrombus can be captured during the thrombus retrieval by using the thrombus retrieval stent 4, as well as in the thrombus retrieval stent. 4
  • the thrombus removal stent 4 is instructed to switch between the compressed state and the released state, so that the thrombus removal is more accurate.
  • the middle part of the thrombus removal stent 4 may also be provided with multiple visualization positioning elements to more accurately locate the position of the thrombus.
  • the first stent body 10, the second stent body 30, and the protective umbrella 6 are all made of a metal material with a memory effect or an elastic polymer material, so that the stent body 101 and the protective umbrella 6 are formed by self-expanding.
  • Tubular and/or cage-like structure The metal material is, for example, but not limited to nickel-titanium alloy or cobalt-based alloy.
  • the first stent body 10, the second stent body 30, and the protective umbrella 6 can be formed by laser cutting a plate-shaped nickel-titanium alloy into a tubular or cage-like structure with a hollow structure, and then crimping, heat treatment and shaping.
  • first stent body 10, the second stent body 30 and the protective umbrella 6 can also be formed into a tubular or cage-like structure with the hollow structure by weaving a wire-like Nitinol alloy.
  • first bracket body 10, the second bracket body 30 and the protective umbrella 6 may also be processed by using elastic plastic materials.
  • the bolt-removing bracket 4 further includes a plurality of capturing units 20.
  • multiple capture units 20 are arranged at the junction of the large pipe diameter section 31 and the small pipe diameter section 33, that is, the proximal end and the distal end of the small pipe diameter section 33 are both provided with multiple capture units. 20, in order to further improve the thrombus capture efficiency of the thrombus removal stent 4.
  • the multiple catching units 20 are evenly distributed in the circumferential direction of the bolt-removing bracket 4.
  • a plurality of catching units 20 form a circle from the circumference of the bolt-removing bracket 4.
  • a circle can include 2-6 capture units.
  • the bolt-removing bracket 4 can be provided with 2-4 rounds of capture units in the axial direction.
  • each capture unit 20 is configured in a closed loop structure.
  • Each catching unit 20 includes a connecting part 21 and a catching part 22 opposite to each other.
  • the connecting portion 21 is substantially in an inverted V shape, and the capturing portion 22 is substantially in a V shape.
  • the connecting portion 21 is connected to the bracket body 101, and the capturing portion 22 can extend outward or inward relative to the bracket body 101, so that a receiving space 201 is formed between the capturing portion 22 and the bracket body 101.
  • the catching portion 22 can move in a direction perpendicular to the axis L of the bolt removal bracket 4. In this way, it is avoided that when the thrombus removal stent 4 moves in the blood vessel, the capturing portion 22 does not directly contact the blood vessel wall, thereby avoiding damage to the blood vessel wall tissue.
  • the distal end of the capturing portion 22 is provided with a circular arc chamfer to further prevent the capturing portion 22 of the capturing unit 20 from damaging the blood vessel wall.
  • the capturing portion 22 of each capturing unit 20 is located outside the closed loop unit 32 of the bracket body 101, that is, there is a gap between the capturing portion 22 and the bracket body 101 for capturing
  • the capturing part 22 of the unit 20 is inserted into the thrombus or clamps the thrombus in the accommodating space 201, thereby improving the anchoring of the thrombus by the thrombus removal stent 4.
  • the bolt removal bracket 4 further includes a plurality of connecting members 53.
  • the plurality of connecting members 53 and the plurality of capturing units 20 are alternately arranged and connected to each other to ensure the flexibility of the bolt removal stent 4 and a certain supporting force in the radial and axial directions of the bolt removal stent 4.
  • the design of the connecting piece 53 can also increase the space between the capturing portion 22 and the stent body 101, and provide more accommodating space for thrombus.
  • the proximal end of each connecting piece 53 is connected to the distal end of the connecting portion 21 of one of the catching units 20 (that is, the proximal end of the catching portion 22), and the distal end of each connecting piece 53 is connected to the other catching unit.
  • each connecting member 53 can be integrally formed with the bracket body 101. In some other embodiments, each connecting member 53 may also be fixed on the bracket body 101 by a mounting structure.
  • the mounting structure is, for example, but not limited to an adhesive, a crimping structure or a riveting structure.
  • the bolt removal bracket 4 further includes a plurality of auxiliary capturing units 50.
  • Each auxiliary catching unit 50 is arranged at the connection between the connecting member 53 and the catching unit 20. Specifically, each auxiliary catching unit 50 is fixed at the junction of the connecting part 21 and the catching part 22 of the catching unit 20. In this embodiment, each auxiliary capture unit 50 is arranged between two adjacent capture units 20.
  • the plurality of auxiliary capture units 50 are all configured in a barbed structure.
  • Each auxiliary catching unit 50 includes opposite connecting ends 51 and free ends 52.
  • the proximal end of each auxiliary capturing unit 50 is a connecting end 51
  • the distal end of each auxiliary capturing unit 50 is a free end 52.
  • each auxiliary capture unit 50 is connected to the bracket body 101 through a corresponding connecting member 53.
  • the connecting end 51 of the auxiliary capturing unit 50 is connected to the proximal end of the connecting piece 53.
  • each auxiliary capture unit 50 can also be directly connected to the connecting rib 103 of the bolt-removing bracket 4.
  • Each auxiliary catching unit 50 and the connecting rib 103 are integrally formed.
  • the free end 52 of the auxiliary catching unit 50 can extend outward or inward relative to the bracket body 101 and move in a direction perpendicular to the axis L of the bolt removal bracket 4.
  • the auxiliary catching unit 50 can be arranged in 2-6 circles along the axial direction of the stent body 101, and each circle has 2-6 auxiliary catching units 50, so as to further improve the thrombus catching efficiency of the thrombus removal stent 4.
  • the auxiliary capture unit 50 has self-expandability.
  • the material contained in the auxiliary capture unit 50 can be the material contained in the bolt-removing bracket 4, which will not be repeated here.
  • a receiving space 501 is formed between the free end of each auxiliary capture unit 50 and the bracket body 101.
  • a gap between the free end of each auxiliary catching unit 50 and the stent body 101, so that the auxiliary catching unit 50 can be inserted into the thrombus, or the thrombus can be held in the containing space.
  • the anchorage of thrombus by the thrombus removal stent 4 is further improved.
  • each auxiliary capture unit 50 is provided with an arc-shaped chamfer to avoid damage to the blood vessel wall by the auxiliary capture unit 50.
  • a plurality of auxiliary capturing units 50 are located at the junction of the large diameter section 31 and the small diameter section 33 to reduce the risk of the auxiliary capturing unit 50 damaging the blood vessel wall.
  • the number of capture units 20 and auxiliary capture units 50 can be set according to the diameter of the bolt-removing bracket 4, and the arrangement positions, lengths, and inclination angles of multiple auxiliary capture units 50 can be the same as each other. They may also be different from each other, and the present invention is not limited.
  • FIG. 6 shows a schematic diagram of the bolt removal process of the bolt removal bracket 4.
  • the distal end of the thrombus removal stent 4 is attached to the blood vessel wall 104, and the proximal end of the thrombus removal stent 4 is deployed in the thrombus so that the large thrombus 105 enters the stent body 101, and the thrombus removal stent 4 drives the grasping
  • the proximal end of the thrombus removal stent 4 falls off or the smaller volume thrombus 106 that overflows from the embolism removal stent 4 is removed.
  • the protective umbrella 6 intercepts, that is, the smaller-volume thrombus 106 enters the main structure 603 from the connecting structure 601 of the protective umbrella 6, so the protective umbrella 6 can effectively recover the smaller-volume thrombus 106 that falls off in the embolization stent 4, thereby reducing the loss of thrombus.
  • the problem of re-embolization of blood vessels thus increasing the recanalization rate of blood vessels, and preventing vasospasm.
  • FIG. 7 is a schematic structural diagram of a plug-removing device 2a provided by a second embodiment of the present invention
  • FIG. 8 is a connecting piece of the plug-removing bracket 4a of the plug-removing device 2a.
  • the structure of the bolt removing device 2a is similar to the structure of the bolt removing device 2 of the first embodiment.
  • each connecting piece 53a is configured as a curved structure, thereby improving the flexibility of the connecting position, while reserving more thrombus accommodating space, and improving the thrombus capture rate.
  • each connecting piece 53a is bent inwardly relative to the bracket body 101a to increase the receiving space 201a formed between the catching unit 20a and the bracket body 101a and to increase the gap between the auxiliary catching unit 50a and the bracket body 101a.
  • the accommodating space 501a is formed between, thereby providing more accommodating space for thrombus.
  • a distance is formed between the inner side of each connecting piece 53a and the axis L of the stent body 101a, and the outer side of each connecting piece 53a is connected to the periphery of the stent body 101a, so as to prevent the connecting piece 53a from intercepting the thrombus. Enter the bolt-removing bracket 4a.
  • the plurality of connecting members 53a are evenly distributed from the circumferential direction of the bracket body 101a.
  • FIG. 9 is a schematic structural diagram of a bolt removal device 2 b according to a third embodiment of the present invention.
  • the structure of the bolt removing device 2b is similar to the structure of the bolt removing device 2a of the second embodiment.
  • the difference is that the free end 52b of the auxiliary catching unit 50b is configured as a curved structure, and the bending direction of the auxiliary catching unit 50b is opposite to the bending direction of the connecting member 53b.
  • each auxiliary catching unit 50b is bent outwards relative to the bolt-taking bracket 4b to further increase the receiving space 201b formed between the catching unit 20b and the bracket body 101b, and to increase the size of the auxiliary catching unit 50b and
  • the accommodating space 501b formed between the stent bodies 101b provides more accommodating space for further thrombosis.
  • the design of the curved structure of the auxiliary capture unit 50b can hold the thrombus more firmly, and improve the safety of the thrombus removal device 2b, prevent the free end 52b 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. 10 is a schematic structural diagram of a bolt removing device 2c according to a fourth embodiment of the present invention.
  • the structure of the plug removal device 2c is similar to the structure of the plug removal device 2b of the third embodiment.
  • the first stent body 10c is configured as a funnel structure
  • the second stent body 30c is configured as a straight tube structure, so that the thrombus is prevented from falling off when the thrombus removal stent 4c is retracted toward the proximal end thereof.
  • the first bracket body 10c also includes a plurality of closed loop units 11c. A plurality of closed loop units 11c are connected to each other to form the funnel structure.
  • the tube diameter of the first stent body 10c gradually increases from its proximal end to the distal direction, thereby preventing the proximal end of the first stent body 10c from being removed due to bolt removal during the withdrawal of the bolt removal stent 4c in the proximal direction.
  • the effect of the withdrawal force of the stent 4c causes its overall tube diameter to be reduced or kinked, thereby improving the efficiency of thrombus capture and reducing the damage to the blood vessel of the thrombus removal stent 4c. In this way, a smooth transitional connection between the first stent body 10c and the second stent body 30c is ensured, thereby reducing the damage to the blood vessel caused by the embolization stent during the embolectomy process.
  • first bracket body 10c of the bolt removal device 2c of the fourth embodiment is applicable to the bolt removal brackets 2, 2a, 2b in the first to third embodiments, and details are not described herein again.
  • FIG. 11 is a schematic structural diagram of a bolt removing device 2d according to a fifth embodiment of the present invention.
  • the structure of the plug removing device 2d is similar to the structure of the plug removing device 2b of the third embodiment.
  • the protective umbrella 6d also includes a developing positioning element 65d.
  • the bolt removal device 2d may not include a protective cover.
  • the imaging positioning element 65d is fixedly sleeved on the distal end of the umbrella rib 61d to wrap and tighten the distal end of the umbrella rib 61d.
  • the developing positioning member 65d is, for example, but not limited to a developing ring or a developing wire.
  • the developing wire is spirally wound at the distal end of the protective umbrella 6d.
  • the imaging ring is sleeved on the distal end of the protective umbrella 6d.
  • the imaging positioning element 65d is fixed on the distal end of the umbrella rib 61d as a distal end marker of the entire thrombus removal device 2d, so as to more accurately locate the position of the thrombus.
  • the fixing method of the developing positioning element 65d is, for example, but not limited to welding, crimping, hot melting, or pressure riveting, etc., to be fixedly connected together by technical means commonly used in the art.
  • FIG. 12 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 device 2, a push rod 200 and a micro catheter 300.
  • the bolt removal device 2 includes a bolt removal bracket 4 and a protective umbrella 6 arranged at the distal end of the bolt removal bracket 4.
  • the push rod 200 is connected to the proximal end of the bolt removal bracket 4, and the push rod 200, the bolt removal bracket 4 and the protective umbrella 6 are It is crimped and introduced into the microcatheter 300.
  • the plug-removing bracket 4 and the protective umbrella 6 can move inside and outside the microcatheter 300 by pushing and pulling the push rod 200.
  • connection between the proximal end of the plug-removing device 2 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 bracket 4 and the distal end of the push rod 200, and then compress the installed thrombus removal device 2 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.
  • the thrombus retrieval device 2 Since the thrombus retrieval device 2 is made of a shape memory material, the thrombus retrieval device 2 has elasticity, so that the thrombus retrieval device 2 can be switched between a compressed state and a released state. By releasing the thrombus retrieval device 2, the thrombus retrieval device 2 can be completely embedded in the thrombus. After waiting for a certain period of time, the push rod 200 is pulled back, and the thrombus removal device 2 is retracted to capture the thrombus, until the thrombus removal device 2 and the microcatheter 300 are retracted and withdrawn from the body, and the entire thrombus removal process is completed.
  • the thrombus removal device 1000 as a whole is crimped and introduced into the microcatheter 300, that is, the thrombus removal device 2 is delivered to the diseased part of the blood vessel through the microcatheter 300.
  • thrombus removal devices 2a, 2b, 2c, and 2d in the second embodiment to the fifth embodiment can all be applied to the thrombus removal system, which will not be repeated here.
  • the thrombus removal stent and thrombus removal system provided by the embodiments of the present invention are based on the provision of a protective umbrella at the distal end of the thrombus removal stent, thereby effectively preventing thrombus falling or overflowing from the thrombus removal stent from escaping.
  • the protective umbrella includes an adjacent main structure and a connecting structure.
  • the main structure is formed by interlacing umbrella ribs.
  • At least two connecting bones are scattered and connected to the proximal end of the main structure. Said at least two connecting bones are enclosed.
  • the thrombus falling off or overflowing from the thrombus removal stent can easily enter the main structure from the connecting structure, so that the protective umbrella can effectively recover the thrombus falling or overflowing from the thrombus removal stent, thereby avoiding blood vessels caused by the thrombus falling off or overflowing from the thrombus removal stent.
  • Re-embolization problems, and prevent complications caused by thrombectomy therapy, such as vasospasm thereby increasing the recanalization rate of blood vessels, and suitable for smaller blood vessels such as intracranial.

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Abstract

Dispositif de récupération de caillot sanguin (2, 2a, 2b, 2c, 2d) comprenant une endoprothèse de récupération de caillot sanguin (4, 4a, 4b, 4c, 4d) et un parapluie de protection (6, 6a, 6b, 6c, 6d) disposé au niveau d'une extrémité distale de l'endoprothèse de récupération de caillot sanguin (4, 4a, 4b, 4d). Le parapluie de protection (6, 6a, 6b, 6c, 6d) comprend une structure de corps principal (601) et une structure de liaison (603) adjacentes l'une à l'autre. La structure de corps principal est formée par entrelacement d'éléments de nervure (61). Au moins deux éléments de liaison (63) sont reliés séparément à une extrémité proximale de la structure de corps principal (601). La structure de liaison (603) est délimitée par les au moins deux éléments de liaison (63) qui sont reliés.
PCT/CN2020/141423 2019-12-30 2020-12-30 Dispositif et système de récupération de caillot sanguin WO2021136380A1 (fr)

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CN201911423136.2A CN113116461A (zh) 2019-12-30 2019-12-30 取栓装置及取栓系统
CN201911424621.1 2019-12-30
CN201911423136.2 2019-12-30
CN201911424621.1A CN113116462A (zh) 2019-12-30 2019-12-30 取栓支架及取栓系统

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