WO2023065394A1 - Thrombectomy device - Google Patents

Thrombectomy device Download PDF

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Publication number
WO2023065394A1
WO2023065394A1 PCT/CN2021/127818 CN2021127818W WO2023065394A1 WO 2023065394 A1 WO2023065394 A1 WO 2023065394A1 CN 2021127818 W CN2021127818 W CN 2021127818W WO 2023065394 A1 WO2023065394 A1 WO 2023065394A1
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WO
WIPO (PCT)
Prior art keywords
net bag
net
assembly
units
unit
Prior art date
Application number
PCT/CN2021/127818
Other languages
French (fr)
Chinese (zh)
Inventor
夏顺
黄定国
Original Assignee
上海腾复医疗科技有限公司
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 CN202122515872.XU external-priority patent/CN218528839U/en
Priority claimed from CN202122513411.9U external-priority patent/CN216317840U/en
Priority claimed from CN202111215575.1A external-priority patent/CN113925568A/en
Application filed by 上海腾复医疗科技有限公司 filed Critical 上海腾复医疗科技有限公司
Publication of WO2023065394A1 publication Critical patent/WO2023065394A1/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
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions

Definitions

  • the present application relates to the technical field of medical devices, in particular to a thrombectomy device.
  • Intravascular thrombosis is a systemic disease with a very wide range of pathogenesis, which may affect the upper and lower extremities, visceral vessels and carotid arteries.
  • myocardial infarction can occur; if it occurs in the brain, it can cause cerebral infarction; if it occurs in the lungs, it can cause pulmonary embolism...
  • deaths caused by thrombotic diseases account for 51% of the global death toll , far exceeding the deaths caused by tumors, infectious diseases, and respiratory diseases.
  • the main treatment methods for thrombosis include: anticoagulant drug therapy, interventional operation treatment and surgical operation.
  • anticoagulant drugs can be used for conservative treatment; for patients who cannot be treated by drugs, necessary surgery must be taken.
  • interventional therapy has less trauma, faster recovery, and is more acceptable to patients. The effect of interventional therapy is more limited by interventional devices.
  • thrombosis disease sites due to the diversity of thrombosis disease sites and the complexity of thrombus morphology, existing thrombus removal devices, such as thrombus removal stents, suction catheters, etc., generally have difficulty in completely removing thrombus, low success rate of one-time thrombus removal, and Fragmented thrombus is easy to escape and block the distal branch.
  • the purpose of some embodiments of the present application is to provide a thrombus removal device to solve the problems of low success rate of one-time thrombus removal and easy omission of fragmented thrombus.
  • an embodiment of the present invention provides a thrombectomy device, including:
  • An expandable and contractable net bag assembly includes at least one net bag unit; when the net bag assembly includes a plurality of net bag units, the plurality of net bag units are arranged at intervals along the axial direction; each net bag unit includes: a net bag The main body and a plurality of pull rods; the main body of the net bag is a flat net structure with a closed distal end, and the distal ends of the plurality of pull rods are respectively connected to the proximal ends of the main body of the net bag; and
  • Conveying assembly the far-end of described net bag unit is connected with described conveying assembly, and the near-end of a plurality of pull rods of described net bag unit gathers and is connected with described conveying assembly, forms the described net bag unit between described multiple pull rods
  • the opening; the conveying assembly is used to accommodate the net bag assembly in a compressed state, and can release the net bag assembly to an expanded state and pull the net bag assembly in the expanded state back into the catheter.
  • the net bag assembly includes a plurality of net bag units, and the plurality of net bag units are integrally woven and formed by a plurality of braiding wires.
  • each tie rod of the net bag unit is a twisted rod structure formed by merging the plurality of braiding wires.
  • the net bag main body includes a circumferential closed-loop support section and a distal filter screen smoothly connected to the distal end of the support section; the mesh density of the support section is smaller than the mesh density of the distal filter screen; The plurality of pull rods of the net bag unit are evenly spaced along the circumferential direction and form a tapered structure.
  • the core tube includes an elastic telescopic section passing between the distal end and the proximal end of the net bag assembly and a rigid section connected to the proximal end of the elastic telescopic section.
  • the ratio of the axial length of the pull rod of the net bag unit to the axial length of the net bag body is greater than or equal to 0.5 and less than or equal to 5, and the ratio of the maximum diameter of the net bag body to the axial length of the net bag body Can be greater than or equal to 2 and less than or equal to 20.
  • the thrombus removing device includes a plurality of net pocket units, and each net pocket unit is formed by interlacing braiding with a plurality of braiding wires.
  • the conveying assembly includes a core tube;
  • the net bag assembly also includes a proximal development fixing ring;
  • the core tube is passed through the plurality of net pocket units, the distal ends of the plurality of net pocket units are connected to the core tube, and a plurality of braided wires between two adjacent net pocket units are braided to connect the net tubes.
  • the connecting network pipe is sleeved on the core tube, and the plurality of pull rods of the proximal net unit among the plurality of net pocket units are converged and connected with the proximal developing and fixing ring, and the proximal developing and fixing ring is fixedly sleeved on the said plurality of net pocket units.
  • the core tube is passed through the plurality of net pocket units, the distal ends of the plurality of net pocket units are connected to the core tube, and a plurality of braided wires between two adjacent net pocket units are braided to connect the net tubes.
  • the connecting network pipe is sleeved on the core tube, and the plurality of pull rods of the proximal net unit among the plurality of net pocket units
  • the delivery assembly also includes:
  • the operating handle is a hollow tubular structure and its peripheral wall is provided with a chute extending along its own axial direction;
  • a sheath tube the proximal end of which is movably passed through the operating handle and is used to accommodate the mesh bag assembly in a contracted state;
  • the sheath tube connector is a tubular structure and is arranged on the inner distal end side of the operating handle, the distal end of the sheath tube connector is connected to the proximal end of the sheath tube; the core tube is passed through the sheath tube and The sheath tube connector is in and sealed with the proximal end of the sheath tube connector, and can move axially relative to the sheath tube and the sheath tube connector; the proximal end of the core tube passes through and is fixed on the the proximal end of the operating handle; and
  • the driving part is arranged in the chute, the inner end of the driving part is connected with the sheath connecting part, and can drive the sheath connecting part to drive the sheath along the chute in the operation
  • the handle is moved proximally inwardly to release the net bag assembly.
  • the operating handle includes a first shell and a second shell that engage with each other;
  • Both the first shell and the second shell are provided with a positioning post and a positioning hole; the positioning post cooperates with the positioning hole so that the first shell and the second shell are aligned and clamped.
  • the present invention at least has the following advantages and positive effects:
  • the net bag assembly of the thrombus removing device in the embodiment of the present invention may include one or more net bag units, wherein the plurality of net bag units are arranged at intervals along the axial direction, and the net bag body of each net bag unit adopts a flat net bag structure with a distal end closed, and its The proximal end is equipped with a plurality of pull rods that are converging and connected to the delivery assembly, so that each net bag unit not only has a large opening to facilitate the thrombus entering the net bag body, but also can select a thrombus retrieval device with an appropriate number of net bag units according to the length of the thrombus , encircle the thrombus in sections and take it out completely.
  • the thrombus removal device in the embodiment of the present invention helps to improve the success rate of one-time thrombus removal, and at the same time, it can effectively prevent the thrombus from escaping and blocking the distal blood vessel after being broken, and has better removal efficiency. Throttle effect.
  • Fig. 1 is a schematic structural view of a thrombectomy device provided by an embodiment of the present invention
  • Fig. 2 is a three-dimensional structural schematic diagram of the net bag assembly of the thrombus removing device provided by an embodiment of the present invention
  • FIG. 3 is a schematic structural view of the net bag assembly of the thrombus removal device provided by an embodiment of the present invention.
  • Fig. 4 is the schematic diagram of the weaving structure of the pull bar of the net bag unit of the bolt removing device provided by an embodiment of the present invention
  • Figures 5a and 5b are schematic diagrams of the weaving structure of the net bag unit of the thrombus removing device provided by an embodiment of the present invention
  • Fig. 6 is a schematic structural diagram of a thrombectomy device provided by another embodiment of the present invention.
  • Fig. 7 is a schematic structural view of the delivery assembly of the thrombectomy device provided by the embodiment of the present invention.
  • Fig. 8 is a schematic diagram of an exploded structure of the delivery assembly of the thrombectomy device provided by the embodiment of the present invention.
  • Fig. 9 is a schematic diagram of the connecting structure of the sheath tube and the core tube of the delivery assembly of the thrombectomy device provided by the embodiment of the present invention.
  • Fig. 10 is a partial structural schematic diagram of the thrombus removal device in which the net bag assembly provided by the embodiment of the present invention is in a compressed state;
  • Fig. 11 is a schematic diagram of the structure of the net bag assembly provided by the embodiment of the present invention in a released state.
  • orientation or positional relationship indicated by various terms indicating orientation or positional relationship such as “center”, “upper”, “lower”, “inner” and “outer” are based on the Orientation or positional relationship is only for convenience of description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed or operate in a specific orientation, and thus should not be construed as limiting the application.
  • connection and “connected” should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, It can also be indirectly connected through an intermediary, and it can be the internal communication of two elements.
  • the near end and the far end mentioned in the present invention have the same meaning in terms of orientation, that is, in the state of use, the far end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the near end. Control the thrombectomy device.
  • an embodiment of the present invention provides a thrombus retrieval device, which is suitable for removing thrombus in a blood vessel, especially for rapid removal of thrombus with a large amount of thrombus.
  • the thrombus removal device of this embodiment mainly includes: an expandable and contractable net bag assembly and a delivery assembly connected with the net bag assembly.
  • the net bag assembly includes at least one net bag unit 1 .
  • the net bag unit 1 is an expandable and contractible thrombus retrieval structure, which can catch the thrombus from the distal end of the thrombus and pull it out of the body.
  • the expansion performance of the net bag unit 1 can be formed by using shape memory material.
  • the net bag assembly may include a net bag unit 1, which is suitable for removing a small amount of thrombus.
  • the net bag assembly can also include a plurality of net bag units 1.
  • the net bag assembly included a plurality of net bag units 1, the plurality of net bag units 1 were arranged at intervals along the axial direction. The number of 1 can be determined according to the length of the thrombus and the thrombus removal length of each net bag unit, so as to realize the rapid removal of a large number of thrombi.
  • Each net bag unit 1 includes: a net bag main body 11 and a plurality of pull rods 12 .
  • the net body 11 is a flat net structure with a closed distal end, and the distal ends of a plurality of pull rods 12 are respectively connected to the proximal ends of the net body 11 .
  • the far end of the net bag unit 1 is connected with the conveying assembly, and the proximal ends of the plurality of pull rods 12 of the net bag unit 1 converge and are connected with the conveying assembly, and the opening of the net bag unit 1 is formed between the plurality of pull rods 12 .
  • the delivery assembly is also configured to receive the net assembly in a compressed state, to release the net assembly to an expanded state, and to draw the expanded net assembly back into the catheter.
  • the net bag main body 11 of the net bag unit 1 can expand, the peripheral wall of the net bag main body 11 can attach to the inner wall of the blood vessel, and the thrombus can pass between multiple pull rods 12.
  • the opening of the net enters the main body 11 of the net bag and is caught by the main body 11 of the net bag, and then the net bag assembly and the thrombus are withdrawn into the catheter 100 through the delivery component, so that the thrombus can be taken out of the body.
  • a plurality of pull rods 12 of each net bag unit 1 are evenly spaced along the circumference and form a tapered structure, so that the net bag body 11 is evenly stressed, and it is convenient for the net bag body 11 to be retracted into the catheter 100 .
  • Each net bag unit 1 can take out the thrombus in a section of blood vessel length, and the blood vessel length can be the blood vessel length between the proximal side at the largest diameter of the net bag unit 1 and the distal end of the catheter, or the distal side of the adjacent net bag unit 1 The length of the blood vessel between the maximum diameter of the net bag unit 1 and the maximum diameter of the net bag unit 1 on the proximal side.
  • the net bag assembly can include two net bag units. It can be understood that the number of net bag units 1 can be more, such as four, to meet the demand for thrombus removal in a longer blood vessel length.
  • the net bag body 11 of the net bag unit 1 is used to pull out the thrombus in the length of the blood vessel it is responsible for along the inner wall of the blood vessel. With a larger opening, it is convenient for thrombus to enter the net bag main body 1 and be caught.
  • the multiple pull rods 12 of the net bag unit 1 are used to pull the net bag main body 11. At the same time, by adjusting the axial length of the pull rods 12, that is, the taper of the multiple pull rods, The retraction of the net bag body 11 into the catheter can be better controlled.
  • the ratio of the axial length of the pull rod 12 of the net bag unit 1 to the axial length of the net bag main body 11 can be greater than or equal to 0.5 and less than or equal to 5, and the maximum diameter of the net bag main body 11 and the axial length of the net bag main body 11
  • the ratio can be greater than or equal to 2 and less than or equal to 20, so that the net bag unit as a whole has a flat umbrella shape or an onion shape, so that the net bag unit has better thrombus removal performance.
  • a plurality of net bag units 1 can be integrally woven and formed by a plurality of braided wires.
  • a mesh is formed between the interlaced braided filaments, and the shape of the mesh can be a regular polygonal structure such as a rhombus or a rectangle.
  • the number of braiding filaments may be an even number.
  • the braided wire can be a shape-memory metal wire, such as a nickel-titanium alloy wire. Or use shape memory metal wire and polymer wire to weave together.
  • the mesh density of the walls around the main body 11 of the net bag can be the same.
  • the mesh density of the surrounding wall of the net bag body 11 can also vary in density.
  • the net bag body 11 includes a circumferential closed-loop support section 111 and a distal filter screen 112 smoothly connected to the distal end of the support section 111, the mesh density of the support section 111 may be smaller than the mesh density of the distal filter screen 112, Therefore, the main body of the net bag has better wall-attachment performance and better prevents thrombus from being missed.
  • proximal side of the support section 111 of the net bag main body 11 can continue to be woven into a net bag closing section, and the distal ends of a plurality of pull rods 12 are respectively connected to the proximal ends of the net bag closing section.
  • each pull rod 12 of the net bag unit 1 can be a twist rod structure that is combined with braiding through a plurality of braided wires, and the number of pull rods of the net bag unit can be determined according to the degree of difficulty of the weaving process and the retraction performance, for example, each The number of pull bars 12 of the net bag unit can be 3 or 4.
  • the The braiding filaments of the twist rod structure are dispersed, and then the next net bag unit is braided.
  • the delivery assembly may include: a core tube 2 , a guide head 3 , an operating handle 5 , a sheath tube 4 , a sheath tube connecting part 6 and a driving part 7 .
  • the net bag assembly can also include a proximal development fixing ring 13 . Please refer to Fig.
  • the core tube 2 is passed through the one net bag unit 1, and the distal end of the net bag unit 1 is connected to the core tube 2, and the proximal ends of a plurality of pull rods 12 are converged to connect the proximal ends A developing fixing ring 13 , the proximal developing fixing ring 13 is fixedly sleeved on the core tube 2 .
  • the net bag assembly includes a plurality of net bag units 1
  • the plurality of net bag units 2 are arranged at intervals along the axial direction and are integrally connected.
  • the core tube 2 is threaded through a plurality of net pocket units 1, and the distal ends of the plurality of net pocket units 1 are connected to the core tube 2, and a plurality of braided wires between two adjacent net pocket units 1 are braided into a connecting network tube 14, and there are 14 sets of connecting network tubes Located on the core tube 2 , the plurality of pull rods 12 of the proximal net bag unit 1 among the plurality of net bag units 1 are converged and connected to the developing fixing ring 13 , and the proximal developing fixing ring 13 is fixedly sleeved on the core tube 2 .
  • the net bag assembly can include two net bag units 1, the core tube 2 is sequentially passed through the two net bag units 1, and the distal end of the most distal net bag unit 1 is connected to the core tube 2, and the distance between the two net bag units 1 Connected through the connecting network pipe 14 , the plurality of pull rods 12 of the proximal net bag unit 1 converge to connect to the proximal developing and fixing ring 13 , and the proximal developing and fixing ring 13 is fixedly sleeved on the core tube 2 .
  • each net bag unit 1 in the plurality of net bag units can be formed by interlacing braiding with a plurality of braided wires, and then connected to the core tube 2 respectively.
  • the core tube 2 is connected.
  • the core tube 2 may include an elastic telescopic section passed through the net bag assembly and a rigid section connected to the proximal end of the elastic telescopic section.
  • the length of the elastic stretch section can be determined according to the stretchability of the material and the required stretch range.
  • the elastic expansion section of the core tube 2 can expand and contract with the net bag assembly in the axial direction, so that the net bag assembly can be accommodated and released by using the characteristics of the net bag assembly when it is axially extended, then radially compressed, and axially shortened, then radially expanded, which is not only easy to accommodate and release, and the expanded shape of the net bag assembly is not easily deformed.
  • the materials for the elastic stretch section of the core tube 2 include but are not limited to: pebax (nylon elastomer), TPU (ThermoPlastic Polyurethanes, thermoplastic polyurethane elastomer), TPE (Thermoplastic Elastomer, thermoplastic elastomer) or silica gel.
  • pebax nylon elastomer
  • TPU ThermoPlastic Polyurethanes, thermoplastic polyurethane elastomer
  • TPE Thermoplastic Elastomer, thermoplastic elastomer
  • silica gel silica gel.
  • the proximal end of the elastic telescopic section of the core tube 2 can be connected with the rigid section by heat welding or other physical connection methods. It can be understood that the core tube 2 as a whole can also adopt a rigid structure.
  • the guide head 3 is connected to the distal end of the core tube 2, and the distal end of the guide head 3 is a tip, which can adopt a tapered head structure, thereby improving the propulsion ability of the thrombectomy device in the blood vessel.
  • the operating handle 5 is a hollow tubular structure and its peripheral wall is provided with a sliding groove extending axially along itself.
  • the proximal end of the sheath tube 4 is movably threaded through the operating handle 5 .
  • the sheath tube connector 6 is a tubular structure and is disposed on the inner distal side of the operating handle 5 , and the distal end of the sheath tube connector 6 is connected to the proximal end of the sheath tube 4 .
  • the core tube 2 is passed through the sheath tube 4 and the sheath tube connector 6 and is in sealing connection with the proximal end of the sheath tube connector 6 , and can move axially relative to the sheath tube 4 and the sheath tube connector 6 .
  • the proximal end of the core tube 2 passes through and is fixed on the proximal end of the operating handle 5 .
  • the driver 7 is arranged in the chute, the inner end of the driver 7 is connected with the sheath connector 6, and the outer end of the driver 7 is exposed outside the chute, and the driver 7 can drive the sheath connector 6 to drive the sheath 4 along the slide.
  • the slot moves proximally within the operating handle 5 to release the net bag assembly. That is, the driving member 7 can drive the sheath tube 4 to slide axially relative to the core tube 2 in the operating handle 5 .
  • the operating handle 5 can be designed into a shape and size suitable for holding, and the driving part 7 can be designed into a shape and size suitable for finger operation.
  • the sheath tube 4 can be driven along the chute Move to the proximal end in the operating handle 5 to release the net bag assembly to the expanded state, so as to facilitate the thrombus removal operation.
  • the sheath tube connector 6 and the operating handle 5 can be locked by friction or other locking structures to prevent the sheath tube 4 from moving unintentionally.
  • the operating handle 5 may include a first shell 51 and a second shell 52 that are engaged with each other.
  • Both the first shell 51 and the second shell 52 are provided with a positioning post and a positioning hole, and the positioning post and the positioning hole cooperate to make the first shell 51 and the second shell 52 aligned and engaged.
  • the second housing 52 is provided with a positioning column 522 and a positioning hole 521, correspondingly, the first housing 51 is provided with a corresponding positioning hole and positioning column, the first housing 51 and the second housing 52 can be positioned through their respective The column and the positioning hole are aligned and clamped. It can be understood that the first shell 51 and the second shell 52 can also be aligned and snapped through other positioning structures, which is not specifically limited here.
  • the inner wall of the first shell 51 and/or the second shell 52 is provided with several criss-cross reinforcing ribs 523 to improve the overall strength of the operating handle 5 and better meet the operating requirements.
  • the delivery assembly may further include: an O-ring 61 disposed between the inner wall of the proximal end of the sheath connector 6 and the outer wall of the core tube 2 .
  • the sheath tube connector 6 and the core tube 2 are sealed and connected through an O-ring 61 . That is, the proximal end of the core tube 2 and the sheath tube connector 6 is in a sealed sliding connection, which can not only ensure the flexibility of the retraction operation of the sheath tube 4, but also prevent blood leakage during the operation.
  • the driving member 7 may include two operating buttons symmetrically arranged on the sheath tube connecting member 6 , and correspondingly, the sliding slots are symmetrically arranged on the peripheral wall of the operating handle 5 .
  • Each operation button may include a link 71 and an operation portion 72 .
  • the connecting rod 72 is located in the chute and can move along the chute. One end of the connecting rod 72 is connected with the sheath tube connector 61 , and the other end is connected with the operating part 71 .
  • the connecting rod 72 can move in the chute, and the operation part 71 is located outside the chute.
  • the operating portion 71 can be bent into a strip-shaped or sheet-shaped structure to form a roughly triangular cross-section, wherein the side wall of the operating portion 71 parallel to the chute is connected to the outer end of the connecting rod 72, and the operating portion 71
  • the other two side walls can be used as operating surfaces for finger operation to drive the sheath tube connector 6 to move axially within the operating handle 5 .
  • anti-slip lines 73 are also provided on the operating portion 71 to prevent fingers from slipping during operation.
  • the cross section of the operating handle 5 is substantially a chamfered rectangle.
  • the chute is symmetrically arranged on two mutually parallel side walls of the operating handle 5 .
  • the operating handle 5 is also provided with a scale line for indicating the distance that the sheath tube 4 moves axially along the operating handle 5 .
  • the scale line can be set on the two symmetrical long rectangular side wall surfaces on the operating handle 5, so that it is convenient to observe the distance of the sheath tube 4 retracting (that is, moving to the proximal end) from any side of the operating handle 5 during operation, so that the operator can control The release status of the net bag assembly. It can be understood that the scale line can also be provided only on one side surface of the operating handle 5, and no specific limitation is set here.
  • the length of the chute is the range within which the sheath tube 4 can move relative to the core tube 2 .
  • the delivery assembly may further include: a stress diffusion sheath 53 sheathed on the sheath tube 4 and fixed on the proximal end of the operating handle 5 .
  • the stress diffusion sleeve 13 is used to prevent the sheath tube 4 from buckling during the advancing process.
  • the distal end of the stress diffusion sleeve 13 is formed with an annular boss, and the inner wall of the proximal end of the operating handle 5 is provided with an annular groove.
  • the stress diffusion sleeve 13 can be made of silica gel.
  • the delivery device may also include an infusion tube, a first Luer connector 8 and a second Luer connector 9 .
  • One end of the infusion tube is connected to the peripheral wall of the sheath tube connector 6 and communicates with the gap between the sheath tube 4 and the core tube 2 .
  • the other end of the infusion tube is connected to the first Luer connector 8 .
  • the infusion tube can move in the chute, that is, the infusion tube and the driving member are located in the same chute.
  • the second Luer connector 9 is connected to the proximal end of the core tube 2 , and the distal end of the second Luer connector 9 is fixedly connected to the proximal end of the operating handle 5 , so that the proximal end of the core tube 2 is fixed on the sheath connector 6 .
  • Both the first Luer connector 8 and the second Luer connector 9 can be single-way or multi-way Luer connectors.
  • Physiological saline can be injected into the gap between the sheath tube 4 and the core tube 2 through the first Luer connector 8 and the infusion tube to discharge the air in the gap between the sheath tube 4 and the core tube 2 .
  • Physiological saline can be injected into the core tube 2 through the second Luer connector 9 to discharge the air in the core tube 2 .
  • thrombolytic agents or other functional liquids can be injected into the infusion tube and the core tube 2, and there is no specific limitation here.
  • the method of using the thrombectomy device in this embodiment is as follows:
  • the thrombectomy device of this embodiment can be used in conjunction with the catheter 100.
  • the sheath tube 4 equipped with the net bag assembly is inserted into the catheter 100 along the guide wire and pushed to the position of thrombus removal, and then the driving member is operated to pull back the sheath tube 4
  • the net bag assembly is released, and the degree of release of the net bag assembly can be judged by the scale line on the operating handle 5.
  • the operating handle 5 is retracted as a whole to withdraw the net bag assembly and thrombus into the catheter 100 and take them out of the body. .
  • the present invention has at least the following advantages and positive effects:
  • the net bag assembly of the thrombus removing device in the embodiment of the present invention may include one or more net bag units, wherein the plurality of net bag units are arranged at intervals along the axial direction, and the net bag body of each net bag unit adopts a flat net bag structure with a distal end closed, and its The proximal end is equipped with a plurality of pull rods that are converging and connected to the delivery assembly, so that each net bag unit not only has a large opening to facilitate the thrombus entering the net bag body, but also can select a thrombus retrieval device with an appropriate number of net bag units according to the length of the thrombus , encircle the thrombus in sections and take it out completely.
  • the thrombus removal device in the embodiment of the present invention helps to improve the success rate of one-time thrombus removal, and at the same time, it can effectively prevent the thrombus from escaping and blocking the distal blood vessel after being broken, and has better removal efficiency. Throttle effect.

Abstract

A thrombectomy device, comprising a net bag assembly capable of expanding and contracting and a conveying assembly; the net bag assembly comprises at least one net bag unit (1); when the net bag assembly comprises a plurality of net bag units (1), the plurality of net bag units (1) are arranged at intervals in the axial direction; each net bag unit (1) comprises a net bag body (11) and a plurality of pull rods (12); the net bag body (11) is of a flat net bag structure having a closed distal end, and the distal ends of the plurality of pull rods (12) are respectively connected to the proximal end of the net bag body (11); the distal end of the net bag unit (1) is connected to the conveying assembly, and the proximal ends of the plurality of pull rods (12) of the net bag unit (1) are converged and connected to the conveying assembly; an opening of the net bag unit (1) is formed between the plurality of pull rods (12); the conveying assembly is used for accommodating the net bag assembly in a compressed state, and can release the net bag assembly to an expanded state and pull the net bag assembly in the expanded state back into a guide tube (100). Therefore, the one-time thrombectomy success rate can be increased, and thrombus escape can be effectively avoided.

Description

取栓装置Thrombectomy device
交叉引用cross reference
本申请引用于2021年10月19日递交的名称为“取栓装置”的第202111215575.1号中国专利申请,其通过引用被全部并入本申请This application refers to the Chinese patent application No. 202111215575.1 entitled "Thrombectomy Device" submitted on October 19, 2021, which is incorporated by reference in its entirety into this application
技术领域technical field
本申请涉及医疗器械技术领域,特别涉及一种取栓装置。The present application relates to the technical field of medical devices, in particular to a thrombectomy device.
背景技术Background technique
血管内血栓是一种发病范围非常广泛的全身性疾病,它可能影响上肢、下肢、内脏血管和颈动脉。当血栓发生于心脏部位,可出现心肌梗塞;发生在脑部,可造成脑梗塞;发生在肺部,可造成肺栓塞……据统计,因血栓性疾病导致的死亡占全球死亡人数的51%,远超过肿瘤、传染性疾病、呼吸***疾病等造成的死亡。Intravascular thrombosis is a systemic disease with a very wide range of pathogenesis, which may affect the upper and lower extremities, visceral vessels and carotid arteries. When thrombus occurs in the heart, myocardial infarction can occur; if it occurs in the brain, it can cause cerebral infarction; if it occurs in the lungs, it can cause pulmonary embolism... According to statistics, deaths caused by thrombotic diseases account for 51% of the global death toll , far exceeding the deaths caused by tumors, infectious diseases, and respiratory diseases.
目前血栓的主要治疗方法包括:抗凝药物治疗、介入手术治疗和外科手术。对于症状轻的患者,可使用抗凝药物做保守治疗;而对于药物无法治疗的患者,必须采取必要的手术。相比外科手术,介入治疗创伤小、恢复快,更易被患者接受。介入治疗效果更多受到介入器械的限制。At present, the main treatment methods for thrombosis include: anticoagulant drug therapy, interventional operation treatment and surgical operation. For patients with mild symptoms, anticoagulant drugs can be used for conservative treatment; for patients who cannot be treated by drugs, necessary surgery must be taken. Compared with surgery, interventional therapy has less trauma, faster recovery, and is more acceptable to patients. The effect of interventional therapy is more limited by interventional devices.
发明人发现:由于血栓疾病发病部位多样性以及血栓形态的复杂性,现 有的取栓器械,如取栓支架、抽吸导管等,普遍存在难以完全清除血栓、一次取栓成功率低,且碎化血栓易逃逸堵塞远端分支的问题。The inventors found that: due to the diversity of thrombosis disease sites and the complexity of thrombus morphology, existing thrombus removal devices, such as thrombus removal stents, suction catheters, etc., generally have difficulty in completely removing thrombus, low success rate of one-time thrombus removal, and Fragmented thrombus is easy to escape and block the distal branch.
发明内容Contents of the invention
本申请部分实施例的目的在于提供一种取栓装置,解决一次取栓成功率低、碎化血栓易遗漏的问题。The purpose of some embodiments of the present application is to provide a thrombus removal device to solve the problems of low success rate of one-time thrombus removal and easy omission of fragmented thrombus.
为解决上述技术问题,本发明实施例提供了一种取栓装置,包括:In order to solve the above technical problems, an embodiment of the present invention provides a thrombectomy device, including:
可膨胀和收缩的网兜组件,所述网兜组件包括至少一网兜单元;当所述网兜组件包括多个网兜单元时,所述多个网兜单元沿轴向间隔布置;每个网兜单元分别包括:网兜主体以及多个拉杆;所述网兜主体呈远端封闭的扁平网兜结构,所述多个拉杆的远端分别与所述网兜主体近端相连;及An expandable and contractable net bag assembly, the net bag assembly includes at least one net bag unit; when the net bag assembly includes a plurality of net bag units, the plurality of net bag units are arranged at intervals along the axial direction; each net bag unit includes: a net bag The main body and a plurality of pull rods; the main body of the net bag is a flat net structure with a closed distal end, and the distal ends of the plurality of pull rods are respectively connected to the proximal ends of the main body of the net bag; and
输送组件,所述网兜单元的远端与所述输送组件相连,且所述网兜单元的多个拉杆近端汇聚并与所述输送组件相连,所述多个拉杆之间形成所述网兜单元的开口;所述输送组件用于收容呈压缩状态的所述网兜组件,并能够将所述网兜组件释放至膨胀状态以及将膨胀状态的网兜组件回拉至导管内。Conveying assembly, the far-end of described net bag unit is connected with described conveying assembly, and the near-end of a plurality of pull rods of described net bag unit gathers and is connected with described conveying assembly, forms the described net bag unit between described multiple pull rods The opening; the conveying assembly is used to accommodate the net bag assembly in a compressed state, and can release the net bag assembly to an expanded state and pull the net bag assembly in the expanded state back into the catheter.
另外,所述网兜组件包括多个网兜单元,且所述多个网兜单元由多根编织丝一体交错编织成型。In addition, the net bag assembly includes a plurality of net bag units, and the plurality of net bag units are integrally woven and formed by a plurality of braiding wires.
另外,所述网兜单元的各拉杆为经所述多根编织丝合并以编织成的麻花杆结构。In addition, each tie rod of the net bag unit is a twisted rod structure formed by merging the plurality of braiding wires.
另外,所述网兜主体包括周向闭环的支撑段和与所述支撑段远端平滑相接的远端过滤网;所述支撑段的网孔密度小于所述远端过滤网的网孔密度;所述网兜单元的多个拉杆沿周向均匀间隔布置并形成锥形结构。In addition, the net bag main body includes a circumferential closed-loop support section and a distal filter screen smoothly connected to the distal end of the support section; the mesh density of the support section is smaller than the mesh density of the distal filter screen; The plurality of pull rods of the net bag unit are evenly spaced along the circumferential direction and form a tapered structure.
另外,所述芯管包括穿设于所述网兜组件远端和近端之间的弹性伸缩段以及与所述弹性伸缩段近端相连的刚性段。In addition, the core tube includes an elastic telescopic section passing between the distal end and the proximal end of the net bag assembly and a rigid section connected to the proximal end of the elastic telescopic section.
另外,所述网兜单元的拉杆的轴向长度与网兜主体的轴向长度之比大于或者等于0.5且小于或者等于5,且所述网兜主体的最大直径与所述网兜主体的轴向长度之比可以大于或者等于2且小于或者等于20。In addition, the ratio of the axial length of the pull rod of the net bag unit to the axial length of the net bag body is greater than or equal to 0.5 and less than or equal to 5, and the ratio of the maximum diameter of the net bag body to the axial length of the net bag body Can be greater than or equal to 2 and less than or equal to 20.
另外,所述取栓装置包括多个网兜单元,每个网兜单元分别采用多根编织丝交错编织成型。In addition, the thrombus removing device includes a plurality of net pocket units, and each net pocket unit is formed by interlacing braiding with a plurality of braiding wires.
另外,所述输送组件包括芯管;所述网兜组件还包括近端显影固定环;In addition, the conveying assembly includes a core tube; the net bag assembly also includes a proximal development fixing ring;
所述芯管穿设于所述多个网兜单元,所述多个网兜单元的远端与所述芯管相连,相邻两个网兜单元之间的多根编织丝编织成连接网管,所述连接网管套设于所述芯管,所述多个网兜单元中近端的网兜单元的多个拉杆汇聚并与所述近端显影固定环相连,所述近端显影固定环固定套设于所述芯管。The core tube is passed through the plurality of net pocket units, the distal ends of the plurality of net pocket units are connected to the core tube, and a plurality of braided wires between two adjacent net pocket units are braided to connect the net tubes. The connecting network pipe is sleeved on the core tube, and the plurality of pull rods of the proximal net unit among the plurality of net pocket units are converged and connected with the proximal developing and fixing ring, and the proximal developing and fixing ring is fixedly sleeved on the said plurality of net pocket units. The core tube.
另外,所述输送组件还包括:In addition, the delivery assembly also includes:
操作手柄,其为中空管状结构且其周壁设有沿其自身轴向延伸的滑槽;The operating handle is a hollow tubular structure and its peripheral wall is provided with a chute extending along its own axial direction;
鞘管,其近端活动地穿设于所述操作手柄并用于收容呈收缩状态的所述网兜组件;a sheath tube, the proximal end of which is movably passed through the operating handle and is used to accommodate the mesh bag assembly in a contracted state;
鞘管连接件,其为管状结构且设置于所述操作手柄内部远端侧,所述鞘管连接件远端与所述鞘管近端相连;所述芯管穿设于所述鞘管以及所述鞘管连接件内且与所述鞘管连接件近端密封连接,并可相对所述鞘管和所述鞘管连接件轴向移动;所述芯管近端穿出并固设于所述操作手柄近端;以及The sheath tube connector is a tubular structure and is arranged on the inner distal end side of the operating handle, the distal end of the sheath tube connector is connected to the proximal end of the sheath tube; the core tube is passed through the sheath tube and The sheath tube connector is in and sealed with the proximal end of the sheath tube connector, and can move axially relative to the sheath tube and the sheath tube connector; the proximal end of the core tube passes through and is fixed on the the proximal end of the operating handle; and
驱动件,设置于所述滑槽内,所述驱动件内端部与所述鞘管连接件相连,并能够驱动所述鞘管连接件带动所述鞘管沿所述滑槽在所述操作手柄内向近端 移动,以释放所述网兜组件。The driving part is arranged in the chute, the inner end of the driving part is connected with the sheath connecting part, and can drive the sheath connecting part to drive the sheath along the chute in the operation The handle is moved proximally inwardly to release the net bag assembly.
另外,所述操作手柄包括相卡接的第一外壳以及第二外壳;In addition, the operating handle includes a first shell and a second shell that engage with each other;
所述第一外壳和所述第二外壳均设有定位柱和定位孔;所述定位柱和所述定位孔相配合,以使所述第一外壳和所述第二外壳对准卡接。Both the first shell and the second shell are provided with a positioning post and a positioning hole; the positioning post cooperates with the positioning hole so that the first shell and the second shell are aligned and clamped.
由上述技术方案可知,本发明至少具有如下优点和积极效果:As can be seen from the foregoing technical solutions, the present invention at least has the following advantages and positive effects:
本发明实施例的取栓装置的网兜组件可以包括一个或者多个网兜单元,其中,多个网兜单元沿轴向间隔布置,每个网兜单元的网兜主体采用远端封闭的扁平网兜结构,且其近端设有多个汇聚连接于输送组件的拉杆,从而使得每个网兜单元不仅具有很大的开口便于血栓进入网兜主体,而且还可以根据血栓的长度选取具有合适数量的网兜单元的取栓装置,分段地将血栓兜住并完整取出,因此,本发明实施例的取栓装置有助于提高一次取栓成功率,同时可有效防止血栓破碎后逃逸堵塞远端血管,具有较佳的取栓效果。The net bag assembly of the thrombus removing device in the embodiment of the present invention may include one or more net bag units, wherein the plurality of net bag units are arranged at intervals along the axial direction, and the net bag body of each net bag unit adopts a flat net bag structure with a distal end closed, and its The proximal end is equipped with a plurality of pull rods that are converging and connected to the delivery assembly, so that each net bag unit not only has a large opening to facilitate the thrombus entering the net bag body, but also can select a thrombus retrieval device with an appropriate number of net bag units according to the length of the thrombus , encircle the thrombus in sections and take it out completely. Therefore, the thrombus removal device in the embodiment of the present invention helps to improve the success rate of one-time thrombus removal, and at the same time, it can effectively prevent the thrombus from escaping and blocking the distal blood vessel after being broken, and has better removal efficiency. Throttle effect.
附图说明Description of 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,可以理解地,下面描述中的附图仅仅是本发明的实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据提供的附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. It can be understood that the accompanying drawings in the following description It is only an embodiment of the present invention, and those skilled in the art can also obtain other drawings according to the provided drawings without creative work.
图1为本发明一实施例提供的取栓装置的结构示意图;Fig. 1 is a schematic structural view of a thrombectomy device provided by an embodiment of the present invention;
图2为本发明一实施例提供的取栓装置的网兜组件的立体结构示意图;Fig. 2 is a three-dimensional structural schematic diagram of the net bag assembly of the thrombus removing device provided by an embodiment of the present invention;
图3为本发明一实施例提供的取栓装置的网兜组件的结构示意图;3 is a schematic structural view of the net bag assembly of the thrombus removal device provided by an embodiment of the present invention;
图4为本发明一实施例提供的取栓装置的网兜单元的拉杆的编织结构示 意图;Fig. 4 is the schematic diagram of the weaving structure of the pull bar of the net bag unit of the bolt removing device provided by an embodiment of the present invention;
图5a、5b分别为本发明一实施例提供的取栓装置的网兜单元的编织结构示意图;Figures 5a and 5b are schematic diagrams of the weaving structure of the net bag unit of the thrombus removing device provided by an embodiment of the present invention;
图6为本发明又一实施例提供的取栓装置的结构示意图;Fig. 6 is a schematic structural diagram of a thrombectomy device provided by another embodiment of the present invention;
图7为本发明实施例提供的取栓装置的输送组件的结构示意图;Fig. 7 is a schematic structural view of the delivery assembly of the thrombectomy device provided by the embodiment of the present invention;
图8为本发明实施例提供的取栓装置的输送组件的分解结构示意图;Fig. 8 is a schematic diagram of an exploded structure of the delivery assembly of the thrombectomy device provided by the embodiment of the present invention;
图9为本发明实施例提供的取栓装置的输送组件的鞘管和芯管的连接结构示意图;Fig. 9 is a schematic diagram of the connecting structure of the sheath tube and the core tube of the delivery assembly of the thrombectomy device provided by the embodiment of the present invention;
图10为本发明实施例提供的网兜组件呈压缩状态的取栓装置的局部结构示意图;Fig. 10 is a partial structural schematic diagram of the thrombus removal device in which the net bag assembly provided by the embodiment of the present invention is in a compressed state;
图11为本发明实施例提供的网兜组件呈释放状态的结构示意图。Fig. 11 is a schematic diagram of the structure of the net bag assembly provided by the embodiment of the present invention in a released state.
具体实施方式Detailed ways
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合附图对本发明的各实施方式进行详细的阐述。然而,本领域的普通技术人员可以理解,在本发明各实施方式中,为了使读者更好地理解本发明而提出了许多技术细节。但是,即使没有这些技术细节和基于以下各实施方式的种种变化和修改,也可以实现本发明所要求保护的技术方案。In order to make the purpose, technical solutions and advantages of the embodiments of the present invention more clear, various implementation modes of the present invention will be described in detail below in conjunction with the accompanying drawings. However, those of ordinary skill in the art can understand that in each implementation manner of the present invention, many technical details are proposed in order to enable readers to better understand the present invention. However, even without these technical details and various changes and modifications based on the following implementation modes, the technical solution claimed in the present invention can also be realized.
在本申请的描述中,“中心”、“上”、“下”、“内”、“外”等各种指示方位或位置关系的术语所指示的方位或者位置关系为基于附图所示的方位或位置关系,仅是为了便于描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造或操作,因此不能理解为对本申请的限制。In the description of this application, the orientation or positional relationship indicated by various terms indicating orientation or positional relationship such as "center", "upper", "lower", "inner" and "outer" are based on the Orientation or positional relationship is only for convenience of description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed or operate in a specific orientation, and thus should not be construed as limiting the application.
需要说明的是,除非另有明确的规定,术语“相连”、“连接”等应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。It should be noted that, unless otherwise specified, the terms "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, It can also be indirectly connected through an intermediary, and it can be the internal communication of two elements.
除非特别说明,本发明中提及的近端、远端在朝向上具有相同含义,即使用状态下,远端为远离操作者的一端,近端为靠近操作者的一端,操作者在近端控制取栓装置。Unless otherwise specified, the near end and the far end mentioned in the present invention have the same meaning in terms of orientation, that is, in the state of use, the far end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the near end. Control the thrombectomy device.
请参阅图1~图3所示,本发明实施例提供了一种取栓装置,适用于血管内血栓的清除,尤其适用于血栓量大的血栓的快速清除。如图1至图3所示,本实施例的取栓装置主要包括:可膨胀和收缩的网兜组件以及与网兜组件相连的输送组件。Referring to FIGS. 1 to 3 , an embodiment of the present invention provides a thrombus retrieval device, which is suitable for removing thrombus in a blood vessel, especially for rapid removal of thrombus with a large amount of thrombus. As shown in FIGS. 1 to 3 , the thrombus removal device of this embodiment mainly includes: an expandable and contractable net bag assembly and a delivery assembly connected with the net bag assembly.
网兜组件包括至少一网兜单元1。网兜单元1为可膨胀和收缩的取栓结构,能够从血栓远端将血栓兜住并被拉出体外。网兜单元1的膨胀性能可以采用形状记忆材料制作而形成。The net bag assembly includes at least one net bag unit 1 . The net bag unit 1 is an expandable and contractible thrombus retrieval structure, which can catch the thrombus from the distal end of the thrombus and pull it out of the body. The expansion performance of the net bag unit 1 can be formed by using shape memory material.
网兜组件可以包括一个网兜单元1,适用于少量血栓的清除。网兜组件还可以包括多个网兜单元1,当网兜组件包括多个网兜单元1时,多个网兜单元1沿轴向间隔布置,此时各个网兜单元1能够分段将血栓带出体外,网兜单元1的数量可以根据血栓长度以及各个网兜单元的取栓长度等确定,以实现大量血栓的快速清除。The net bag assembly may include a net bag unit 1, which is suitable for removing a small amount of thrombus. The net bag assembly can also include a plurality of net bag units 1. When the net bag assembly included a plurality of net bag units 1, the plurality of net bag units 1 were arranged at intervals along the axial direction. The number of 1 can be determined according to the length of the thrombus and the thrombus removal length of each net bag unit, so as to realize the rapid removal of a large number of thrombi.
每个网兜单元1分别包括:网兜主体11以及多个拉杆12。网兜主体11呈远端封闭的扁平网兜结构,多个拉杆12的远端分别与网兜主体11近端相连。网兜单元1的远端与输送组件相连,且网兜单元1的多个拉杆12近端汇聚并与输送组件相连,多个拉杆12之间形成网兜单元1的开口。输送组件还用于收容 呈压缩状态的网兜组件,并用于将网兜组件释放至膨胀状态以及将膨胀状态的网兜组件回拉至导管内。Each net bag unit 1 includes: a net bag main body 11 and a plurality of pull rods 12 . The net body 11 is a flat net structure with a closed distal end, and the distal ends of a plurality of pull rods 12 are respectively connected to the proximal ends of the net body 11 . The far end of the net bag unit 1 is connected with the conveying assembly, and the proximal ends of the plurality of pull rods 12 of the net bag unit 1 converge and are connected with the conveying assembly, and the opening of the net bag unit 1 is formed between the plurality of pull rods 12 . The delivery assembly is also configured to receive the net assembly in a compressed state, to release the net assembly to an expanded state, and to draw the expanded net assembly back into the catheter.
如图11所示,当网兜组件被释放至血管内的取栓位置时,网兜单元1的网兜主体11能够膨胀,网兜主体11的周壁能够贴附血管内壁,血栓可经多个拉杆12之间的开口进入网兜主体11并被网兜主体11兜住,再通过输送组件将网兜组件以及血栓回撤入导管100内,即可将血栓带出体外。As shown in Figure 11, when the net bag assembly is released to the thrombus removal position in the blood vessel, the net bag main body 11 of the net bag unit 1 can expand, the peripheral wall of the net bag main body 11 can attach to the inner wall of the blood vessel, and the thrombus can pass between multiple pull rods 12. The opening of the net enters the main body 11 of the net bag and is caught by the main body 11 of the net bag, and then the net bag assembly and the thrombus are withdrawn into the catheter 100 through the delivery component, so that the thrombus can be taken out of the body.
可选地,每个网兜单元1的多个拉杆12沿周向均匀间隔布置并形成锥形结构,从而使得网兜主体11受力均匀,便于网兜主体11收入导管100内。Optionally, a plurality of pull rods 12 of each net bag unit 1 are evenly spaced along the circumference and form a tapered structure, so that the net bag body 11 is evenly stressed, and it is convenient for the net bag body 11 to be retracted into the catheter 100 .
每个网兜单元1可将一段血管长度内的血栓取出,该血管长度可以是网兜单元1最大直径处近端侧与导管远端之间的血管长度,或者是相邻网兜单元1中远端侧的网兜单元1的最大直径处与近端侧的网兜单元1的最大直径处之间的血管长度。本实施例中,网兜组件可以包含2个网兜单元,可以理解的是,网兜单元1的数量还可以为更多个,比如4个,以满足较长的血管长度内的取栓需求。Each net bag unit 1 can take out the thrombus in a section of blood vessel length, and the blood vessel length can be the blood vessel length between the proximal side at the largest diameter of the net bag unit 1 and the distal end of the catheter, or the distal side of the adjacent net bag unit 1 The length of the blood vessel between the maximum diameter of the net bag unit 1 and the maximum diameter of the net bag unit 1 on the proximal side. In this embodiment, the net bag assembly can include two net bag units. It can be understood that the number of net bag units 1 can be more, such as four, to meet the demand for thrombus removal in a longer blood vessel length.
网兜单元1的网兜主体11用于沿血管内壁将其负责的血管长度内的血栓拉出,当网兜主体11呈椭球形的扁平结构时,不仅可以提供良好的支撑性能,而且可使网兜主体11具有较大的开口,便于血栓进入网兜主体1内并被兜住,网兜单元1的多个拉杆12用于拉动网兜主体11,同时通过调整拉杆12的轴向长度,即多个拉杆的锥度,可以更好地控制网兜主体11回撤入导管内。可选地,网兜单元1的拉杆12的轴向长度与网兜主体11的轴向长度之比可以大于或者等于0.5且小于或者等于5,且网兜主体11的最大直径与网兜主体11的轴向长度之比可以大于或者等于2且小于或者等于20,从而使网兜单元整体呈扁平的 伞形或者洋葱形,进而使得网兜单元具有更佳的取栓性能。The net bag body 11 of the net bag unit 1 is used to pull out the thrombus in the length of the blood vessel it is responsible for along the inner wall of the blood vessel. With a larger opening, it is convenient for thrombus to enter the net bag main body 1 and be caught. The multiple pull rods 12 of the net bag unit 1 are used to pull the net bag main body 11. At the same time, by adjusting the axial length of the pull rods 12, that is, the taper of the multiple pull rods, The retraction of the net bag body 11 into the catheter can be better controlled. Optionally, the ratio of the axial length of the pull rod 12 of the net bag unit 1 to the axial length of the net bag main body 11 can be greater than or equal to 0.5 and less than or equal to 5, and the maximum diameter of the net bag main body 11 and the axial length of the net bag main body 11 The ratio can be greater than or equal to 2 and less than or equal to 20, so that the net bag unit as a whole has a flat umbrella shape or an onion shape, so that the net bag unit has better thrombus removal performance.
多个网兜单元1可由多根编织丝一体交错编织成型。交错的编织丝之间形成网孔,网孔形状可以为菱形、矩形等规则的多边形结构。编织丝的数量可以为偶数根。编织丝可以采用形状记忆金属丝,比如镍钛合金丝。或者采用形状记忆金属丝与聚合丝共同编织。A plurality of net bag units 1 can be integrally woven and formed by a plurality of braided wires. A mesh is formed between the interlaced braided filaments, and the shape of the mesh can be a regular polygonal structure such as a rhombus or a rectangle. The number of braiding filaments may be an even number. The braided wire can be a shape-memory metal wire, such as a nickel-titanium alloy wire. Or use shape memory metal wire and polymer wire to weave together.
请参阅图5a,网兜主体11周壁的网孔密度可以相同。作为一种替换例,网兜主体11周壁的网孔密度也可以有疏密变化,请参阅图5b,网兜主体11远端侧的网孔密度小于网兜主体11近端侧的网孔密度。进一步地,网兜主体11包括周向闭环的支撑段111和与支撑段111远端平滑相接的远端过滤网112,支撑段111的网孔密度可以小于远端过滤网112的网孔密度,从而使得网兜主体具有更佳的贴壁性能以及更好地防止血栓遗漏。需要说明的是,网兜主体11的支撑段111的近端侧可以继续编织成网兜收口段,多个拉杆12远端分别与网兜收口段近端相连。Please refer to Fig. 5a, the mesh density of the walls around the main body 11 of the net bag can be the same. As an alternative, the mesh density of the surrounding wall of the net bag body 11 can also vary in density. Please refer to FIG. Further, the net bag body 11 includes a circumferential closed-loop support section 111 and a distal filter screen 112 smoothly connected to the distal end of the support section 111, the mesh density of the support section 111 may be smaller than the mesh density of the distal filter screen 112, Therefore, the main body of the net bag has better wall-attachment performance and better prevents thrombus from being missed. It should be noted that the proximal side of the support section 111 of the net bag main body 11 can continue to be woven into a net bag closing section, and the distal ends of a plurality of pull rods 12 are respectively connected to the proximal ends of the net bag closing section.
请参阅图4,网兜单元1的各拉杆12可以为经多根编织丝合并以编织成的麻花杆结构,网兜单元的拉杆数量可以根据编织工艺难易度以及回撤性能确定,比如,每个网兜单元的拉杆12数量可以为3根或者4根。在编织时,可以先使用偶数根编织丝编织出网兜单元的网兜主体结构,再将网兜主体的偶数根编织丝均匀合并缠绕成麻花杆结构,在需要继续编织出下一个网兜单元时,再将麻花杆结构的编织丝分散开,继而进行下一个网兜单元的编织。Referring to Fig. 4, each pull rod 12 of the net bag unit 1 can be a twist rod structure that is combined with braiding through a plurality of braided wires, and the number of pull rods of the net bag unit can be determined according to the degree of difficulty of the weaving process and the retraction performance, for example, each The number of pull bars 12 of the net bag unit can be 3 or 4. When weaving, you can use an even number of braided wires to weave the net bag main structure of the net bag unit, and then evenly combine and wind the even number of braided wires of the net bag body to form a twist rod structure. When it is necessary to continue weaving the next net bag unit, the The braiding filaments of the twist rod structure are dispersed, and then the next net bag unit is braided.
请参阅图7~图9,输送组件可以包括:芯管2、导向头3、操作手柄5、鞘管4、鞘管连接件6以及驱动件7。网兜组件还可以包括近端显影固定环13。请参阅图6,当网兜组件包括1个网兜单元时,芯管2穿设于该一个网兜单元1, 且该网兜单元1远端与芯管2相连,多个拉杆12近端汇聚连接近端显影固定环13,近端显影固定环13固定套设于芯管2。请继续参阅图1,当网兜组件包括多个网兜单元1时,多个网兜单元2沿轴向间隔布置,且一体连接。芯管2穿设于多个网兜单元1,多个网兜单元1的远端与芯管2相连,相邻两个网兜单元1之间的多根编织丝编织成连接网管14,连接网管14套设于芯管2,多个网兜单元1中近端的网兜单元1的多个拉杆12汇聚并与显影固定环13相连,近端显影固定环13固定套设于芯管2。示例性地,网兜组件可以包括2个网兜单元1,芯管2依次穿设于2个网兜单元1,且最远端的网兜单元1远端与芯管2相连,2个网兜单元1之间通过连接网管14相连,近端的网兜单元1的多个拉杆12近端汇聚连接近端显影固定环13,近端显影固定环13固定套设于芯管2。Please refer to FIGS. 7 to 9 , the delivery assembly may include: a core tube 2 , a guide head 3 , an operating handle 5 , a sheath tube 4 , a sheath tube connecting part 6 and a driving part 7 . The net bag assembly can also include a proximal development fixing ring 13 . Please refer to Fig. 6, when the net bag assembly includes a net bag unit, the core tube 2 is passed through the one net bag unit 1, and the distal end of the net bag unit 1 is connected to the core tube 2, and the proximal ends of a plurality of pull rods 12 are converged to connect the proximal ends A developing fixing ring 13 , the proximal developing fixing ring 13 is fixedly sleeved on the core tube 2 . Please continue to refer to FIG. 1 , when the net bag assembly includes a plurality of net bag units 1 , the plurality of net bag units 2 are arranged at intervals along the axial direction and are integrally connected. The core tube 2 is threaded through a plurality of net pocket units 1, and the distal ends of the plurality of net pocket units 1 are connected to the core tube 2, and a plurality of braided wires between two adjacent net pocket units 1 are braided into a connecting network tube 14, and there are 14 sets of connecting network tubes Located on the core tube 2 , the plurality of pull rods 12 of the proximal net bag unit 1 among the plurality of net bag units 1 are converged and connected to the developing fixing ring 13 , and the proximal developing fixing ring 13 is fixedly sleeved on the core tube 2 . Exemplarily, the net bag assembly can include two net bag units 1, the core tube 2 is sequentially passed through the two net bag units 1, and the distal end of the most distal net bag unit 1 is connected to the core tube 2, and the distance between the two net bag units 1 Connected through the connecting network pipe 14 , the plurality of pull rods 12 of the proximal net bag unit 1 converge to connect to the proximal developing and fixing ring 13 , and the proximal developing and fixing ring 13 is fixedly sleeved on the core tube 2 .
需要说明的是,多个网兜单元中每个网兜单元1可以分别采用多根编织丝交错编织成型,然后分别与芯管2相连,相邻的网兜单元之间的编织丝可以通过显影固定环与芯管2相连。It should be noted that each net bag unit 1 in the plurality of net bag units can be formed by interlacing braiding with a plurality of braided wires, and then connected to the core tube 2 respectively. The core tube 2 is connected.
值得一提的是,芯管2可以包括穿设于网兜组件的弹性伸缩段以及与弹性伸缩段近端相连的刚性段。弹性伸缩段的长度可以根据材料的伸缩性以及需要的伸缩范围确定。芯管2的弹性伸缩段能够随网兜组件轴向伸缩,从而可利用网兜组件轴向伸长则径向压缩、轴向缩短则径向膨胀的特性对网兜组件进行收容和释放,不仅易于收纳和释放,而且网兜组件的扩张形态不易变形。芯管2的弹性伸缩段的制作材料包括但不限于:pebax(尼龙弹性体)、TPU(ThermoPlastic Polyurethanes,热塑性聚氨酯弹性体)、TPE(Thermoplastic Elastomer,热塑性弹性体)或者硅胶。芯管2弹性伸缩段近端可以通过热焊接或者其他物理连接方式与刚性段相连。可以理解的是,芯管2整体也可以均采用 刚性结构。It is worth mentioning that the core tube 2 may include an elastic telescopic section passed through the net bag assembly and a rigid section connected to the proximal end of the elastic telescopic section. The length of the elastic stretch section can be determined according to the stretchability of the material and the required stretch range. The elastic expansion section of the core tube 2 can expand and contract with the net bag assembly in the axial direction, so that the net bag assembly can be accommodated and released by using the characteristics of the net bag assembly when it is axially extended, then radially compressed, and axially shortened, then radially expanded, which is not only easy to accommodate and release, and the expanded shape of the net bag assembly is not easily deformed. The materials for the elastic stretch section of the core tube 2 include but are not limited to: pebax (nylon elastomer), TPU (ThermoPlastic Polyurethanes, thermoplastic polyurethane elastomer), TPE (Thermoplastic Elastomer, thermoplastic elastomer) or silica gel. The proximal end of the elastic telescopic section of the core tube 2 can be connected with the rigid section by heat welding or other physical connection methods. It can be understood that the core tube 2 as a whole can also adopt a rigid structure.
导向头3与芯管2远端相连,导向头3远端为尖端,可以采用锥形头结构,从而提高取栓装置在血管中的推进能力。The guide head 3 is connected to the distal end of the core tube 2, and the distal end of the guide head 3 is a tip, which can adopt a tapered head structure, thereby improving the propulsion ability of the thrombectomy device in the blood vessel.
操作手柄5为中空管状结构且其周壁设有沿其自身轴向延伸的滑槽。鞘管4近端活动地穿设于操作手柄5。鞘管连接件6为管状结构且设置于操作手柄5内部远端侧,鞘管连接件6远端与鞘管4近端相连。芯管2穿设于鞘管4以及鞘管连接件6内且与鞘管连接件6近端密封连接,并可相对鞘管4和鞘管连接件6轴向移动。芯管2近端穿出并固设于操作手柄5近端。驱动件7设置于滑槽内,驱动件7内端部与鞘管连接件6相连,驱动件7外端外露出滑槽外,驱动件7能够驱动鞘管连接件6带动鞘管4沿滑槽在操作手柄5内向近端移动,以释放网兜组件。即通过驱动件7可带动鞘管4在操作手柄5内相对芯管2轴向滑动。The operating handle 5 is a hollow tubular structure and its peripheral wall is provided with a sliding groove extending axially along itself. The proximal end of the sheath tube 4 is movably threaded through the operating handle 5 . The sheath tube connector 6 is a tubular structure and is disposed on the inner distal side of the operating handle 5 , and the distal end of the sheath tube connector 6 is connected to the proximal end of the sheath tube 4 . The core tube 2 is passed through the sheath tube 4 and the sheath tube connector 6 and is in sealing connection with the proximal end of the sheath tube connector 6 , and can move axially relative to the sheath tube 4 and the sheath tube connector 6 . The proximal end of the core tube 2 passes through and is fixed on the proximal end of the operating handle 5 . The driver 7 is arranged in the chute, the inner end of the driver 7 is connected with the sheath connector 6, and the outer end of the driver 7 is exposed outside the chute, and the driver 7 can drive the sheath connector 6 to drive the sheath 4 along the slide. The slot moves proximally within the operating handle 5 to release the net bag assembly. That is, the driving member 7 can drive the sheath tube 4 to slide axially relative to the core tube 2 in the operating handle 5 .
操作手柄5可设计成适于握持的形状及大小,驱动件7可设计成适合手指操作的形状及大小,通过握持操作手柄5,回拉驱动件7即可驱动鞘管4沿滑槽在操作手柄5内向近端移动,以将网兜组件释放至膨胀状态,便于进行取栓操作。可以理解的是,鞘管连接件6与操作手柄5之间可以通过摩擦力锁定或者通过其他锁定结构相锁定,防止鞘管4非人为的移动。The operating handle 5 can be designed into a shape and size suitable for holding, and the driving part 7 can be designed into a shape and size suitable for finger operation. By holding the operating handle 5 and pulling back the driving part 7, the sheath tube 4 can be driven along the chute Move to the proximal end in the operating handle 5 to release the net bag assembly to the expanded state, so as to facilitate the thrombus removal operation. It can be understood that the sheath tube connector 6 and the operating handle 5 can be locked by friction or other locking structures to prevent the sheath tube 4 from moving unintentionally.
请继续参阅图8,操作手柄5可以包括相卡接的第一外壳51以及第二外壳52。Please continue to refer to FIG. 8 , the operating handle 5 may include a first shell 51 and a second shell 52 that are engaged with each other.
第一外壳51和第二外壳52均设有定位柱和定位孔,定位柱和定位孔相配合,以使第一外壳51和第二外壳52对准卡接。比如,第二外壳52上设有定位柱522以及定位孔521,相应地,第一外壳51上设有对应的定位孔和定位柱, 第一外壳51和第二外壳52可通过其各自的定位柱和定位孔对齐卡接。可以理解的是,第一外壳51和第二外壳52也可以通过其他定位结构实现对齐卡接,在此不做具体限制。Both the first shell 51 and the second shell 52 are provided with a positioning post and a positioning hole, and the positioning post and the positioning hole cooperate to make the first shell 51 and the second shell 52 aligned and engaged. For example, the second housing 52 is provided with a positioning column 522 and a positioning hole 521, correspondingly, the first housing 51 is provided with a corresponding positioning hole and positioning column, the first housing 51 and the second housing 52 can be positioned through their respective The column and the positioning hole are aligned and clamped. It can be understood that the first shell 51 and the second shell 52 can also be aligned and snapped through other positioning structures, which is not specifically limited here.
可选地,第一外壳51和/或第二外壳52内壁设有若干纵横交错的加强筋523,以提高操作手柄5整体的强度,更好地满足操作要求。Optionally, the inner wall of the first shell 51 and/or the second shell 52 is provided with several criss-cross reinforcing ribs 523 to improve the overall strength of the operating handle 5 and better meet the operating requirements.
请参阅图8,输送组件还可包括:设置于鞘管连接件6近端内壁和芯管2外壁之间的O型密封圈61。鞘管连接件6和芯管2通过O型密封圈61密封连接。即芯管2与鞘管连接件6近端为密封滑动连接,既可保证鞘管4回撤操作灵活性,又可防止术中血液漏出。Referring to FIG. 8 , the delivery assembly may further include: an O-ring 61 disposed between the inner wall of the proximal end of the sheath connector 6 and the outer wall of the core tube 2 . The sheath tube connector 6 and the core tube 2 are sealed and connected through an O-ring 61 . That is, the proximal end of the core tube 2 and the sheath tube connector 6 is in a sealed sliding connection, which can not only ensure the flexibility of the retraction operation of the sheath tube 4, but also prevent blood leakage during the operation.
示例性地,驱动件7可以包括两个对称设置于鞘管连接件6上的操作钮,相应地,滑槽对称设置于操作手柄5周壁。每个操作钮可以包括连杆71以及操作部72。连杆72位于滑槽内,可沿滑槽移动,连杆72一端与鞘管连接件61相连,另一端与操作部71相连。连杆72可在滑槽内移动,操作部71位于滑槽外。具体地,操作部71可采用带状或者片状结构弯折形成为截面大致呈三角形的结构,其中,操作部71的平行于滑槽的侧壁与连杆72外端连接,操作部71的另外两个侧壁可用于手指操作的操作面,以带动鞘管连接件6在操作手柄5内沿轴向移动。Exemplarily, the driving member 7 may include two operating buttons symmetrically arranged on the sheath tube connecting member 6 , and correspondingly, the sliding slots are symmetrically arranged on the peripheral wall of the operating handle 5 . Each operation button may include a link 71 and an operation portion 72 . The connecting rod 72 is located in the chute and can move along the chute. One end of the connecting rod 72 is connected with the sheath tube connector 61 , and the other end is connected with the operating part 71 . The connecting rod 72 can move in the chute, and the operation part 71 is located outside the chute. Specifically, the operating portion 71 can be bent into a strip-shaped or sheet-shaped structure to form a roughly triangular cross-section, wherein the side wall of the operating portion 71 parallel to the chute is connected to the outer end of the connecting rod 72, and the operating portion 71 The other two side walls can be used as operating surfaces for finger operation to drive the sheath tube connector 6 to move axially within the operating handle 5 .
可选地,操作部71上还设有防滑纹73,可避免操作过程中手指打滑。Optionally, anti-slip lines 73 are also provided on the operating portion 71 to prevent fingers from slipping during operation.
示例性地,操作手柄5截面大致呈倒角矩形。其中,滑槽对称设置于操作手柄5的两个相互平行的侧壁。操作手柄5上还设有用于指示鞘管4沿操作手柄5轴向移动的距离的刻度线。刻度线可设置于操作手柄5上两个对称的长矩形侧壁表面,便于在操作中从操作手柄5任意一侧观察鞘管4回退(即向近 端移动)的距离,以便操作者掌控网兜组件释放的状况。可以理解的是,也可仅在操作手柄5的一侧表面设置刻度线,在此不做具体限制。滑槽的长度即为鞘管4可相对芯管2移动的范围。Exemplarily, the cross section of the operating handle 5 is substantially a chamfered rectangle. Wherein, the chute is symmetrically arranged on two mutually parallel side walls of the operating handle 5 . The operating handle 5 is also provided with a scale line for indicating the distance that the sheath tube 4 moves axially along the operating handle 5 . The scale line can be set on the two symmetrical long rectangular side wall surfaces on the operating handle 5, so that it is convenient to observe the distance of the sheath tube 4 retracting (that is, moving to the proximal end) from any side of the operating handle 5 during operation, so that the operator can control The release status of the net bag assembly. It can be understood that the scale line can also be provided only on one side surface of the operating handle 5, and no specific limitation is set here. The length of the chute is the range within which the sheath tube 4 can move relative to the core tube 2 .
输送组件还可以包括:套设于鞘管4并固设于操作手柄5近端的应力扩散套53。应力扩散套13用于防止鞘管4在推进过程中打折。具体地,应力扩散套13远端形成有环形凸台,操作手柄5近端内壁设有环形凹槽,环形凸台与环形凹槽相配合,以使应力扩散套13固设于操作手柄5。应力扩散套13可以采用硅胶材质制作。The delivery assembly may further include: a stress diffusion sheath 53 sheathed on the sheath tube 4 and fixed on the proximal end of the operating handle 5 . The stress diffusion sleeve 13 is used to prevent the sheath tube 4 from buckling during the advancing process. Specifically, the distal end of the stress diffusion sleeve 13 is formed with an annular boss, and the inner wall of the proximal end of the operating handle 5 is provided with an annular groove. The stress diffusion sleeve 13 can be made of silica gel.
可选地,输送装置还可以包括输液管、第一鲁尔接头8和第二鲁尔接头9。输液管的一端与鞘管连接件6的周壁相连,且与鞘管4和芯管2之间的间隙连通。输液管的另一端连接第一鲁尔接头8。作为示例而非限制,输液管可在滑槽内移动,即输液管与驱动件位于相同滑槽内。第二鲁尔接头9与芯管2的近端相连,第二鲁尔接头9远端与操作手柄5近端固定连接,从而将芯管2近端固定于鞘管连接件6上。第一鲁尔接头8和第二鲁尔接头9均可为单通或者多通鲁尔接头。通过第一鲁尔接头8和输液管可以向鞘管4和芯管2之间的间隙内注入生理盐水,以排出鞘管4和芯管2之间的间隙内的空气。通过第二鲁尔接头9可以向芯管2内注入生理盐水,以排出芯管2内的空气。当然,也可以向输液管和芯管2内注入溶栓药剂或者其他功能性液体,在此不做具体限制。Optionally, the delivery device may also include an infusion tube, a first Luer connector 8 and a second Luer connector 9 . One end of the infusion tube is connected to the peripheral wall of the sheath tube connector 6 and communicates with the gap between the sheath tube 4 and the core tube 2 . The other end of the infusion tube is connected to the first Luer connector 8 . As an example and not limitation, the infusion tube can move in the chute, that is, the infusion tube and the driving member are located in the same chute. The second Luer connector 9 is connected to the proximal end of the core tube 2 , and the distal end of the second Luer connector 9 is fixedly connected to the proximal end of the operating handle 5 , so that the proximal end of the core tube 2 is fixed on the sheath connector 6 . Both the first Luer connector 8 and the second Luer connector 9 can be single-way or multi-way Luer connectors. Physiological saline can be injected into the gap between the sheath tube 4 and the core tube 2 through the first Luer connector 8 and the infusion tube to discharge the air in the gap between the sheath tube 4 and the core tube 2 . Physiological saline can be injected into the core tube 2 through the second Luer connector 9 to discharge the air in the core tube 2 . Of course, it is also possible to inject thrombolytic agents or other functional liquids into the infusion tube and the core tube 2, and there is no specific limitation here.
结合图1、图10以及图11本实施例的取栓装置的使用方法如下:Combined with Fig. 1, Fig. 10 and Fig. 11, the method of using the thrombectomy device in this embodiment is as follows:
本实施例的取栓装置可与导管100配合使用,在手术操作前,通过注射器分别向第一鲁尔接头8和第二鲁尔接头9内注入生理盐水,排空鞘管4以及芯管2内的空气。先将导管100沿预先植入的导丝推进到位后,再将装有网兜 组件的鞘管4整体沿导丝穿入导管100内并推进到取栓位置,然后操作驱动件回拉鞘管4,此时网兜组件被释放,通过操作手柄5上的刻度线可判断网兜组件的释放程度,待网兜组件完全释放后再整体回撤操作手柄5将网兜组件以及血栓撤回导管100内并带出体外。The thrombectomy device of this embodiment can be used in conjunction with the catheter 100. Before the operation, inject physiological saline into the first Luer connector 8 and the second Luer connector 9 respectively, and empty the sheath tube 4 and the core tube 2. the air inside. After the catheter 100 is pushed into place along the pre-implanted guide wire, the sheath tube 4 equipped with the net bag assembly is inserted into the catheter 100 along the guide wire and pushed to the position of thrombus removal, and then the driving member is operated to pull back the sheath tube 4 At this time, the net bag assembly is released, and the degree of release of the net bag assembly can be judged by the scale line on the operating handle 5. After the net bag assembly is completely released, the operating handle 5 is retracted as a whole to withdraw the net bag assembly and thrombus into the catheter 100 and take them out of the body. .
基于上述技术方案本发明至少具有如下优点和积极效果:Based on the above-mentioned technical scheme, the present invention has at least the following advantages and positive effects:
本发明实施例的取栓装置的网兜组件可以包括一个或者多个网兜单元,其中,多个网兜单元沿轴向间隔布置,每个网兜单元的网兜主体采用远端封闭的扁平网兜结构,且其近端设有多个汇聚连接于输送组件的拉杆,从而使得每个网兜单元不仅具有很大的开口便于血栓进入网兜主体,而且还可以根据血栓的长度选取具有合适数量的网兜单元的取栓装置,分段地将血栓兜住并完整取出,因此,本发明实施例的取栓装置有助于提高一次取栓成功率,同时可有效防止血栓破碎后逃逸堵塞远端血管,具有较佳的取栓效果。The net bag assembly of the thrombus removing device in the embodiment of the present invention may include one or more net bag units, wherein the plurality of net bag units are arranged at intervals along the axial direction, and the net bag body of each net bag unit adopts a flat net bag structure with a distal end closed, and its The proximal end is equipped with a plurality of pull rods that are converging and connected to the delivery assembly, so that each net bag unit not only has a large opening to facilitate the thrombus entering the net bag body, but also can select a thrombus retrieval device with an appropriate number of net bag units according to the length of the thrombus , encircle the thrombus in sections and take it out completely. Therefore, the thrombus removal device in the embodiment of the present invention helps to improve the success rate of one-time thrombus removal, and at the same time, it can effectively prevent the thrombus from escaping and blocking the distal blood vessel after being broken, and has better removal efficiency. Throttle effect.
本领域的普通技术人员可以理解,上述各实施方式是实现本发明的具体实施例,而在实际应用中,可以在形式上和细节上对其作各种改变,而不偏离本发明的精神和范围。Those of ordinary skill in the art can understand that the above-mentioned embodiments are specific examples for realizing the present invention, and in practical applications, various changes can be made to it in form and details without departing from the spirit and spirit of the present invention. scope.

Claims (10)

  1. 一种取栓装置,其特征在于,包括:A thrombectomy device, characterized in that it comprises:
    可膨胀和收缩的网兜组件,所述网兜组件包括至少一网兜单元;当所述网兜组件包括多个网兜单元时,所述多个网兜单元沿轴向间隔布置;每个网兜单元分别包括:网兜主体以及多个拉杆;所述网兜主体呈远端封闭的扁平网兜结构,所述多个拉杆的远端分别与所述网兜主体近端相连;及An expandable and contractable net bag assembly, the net bag assembly includes at least one net bag unit; when the net bag assembly includes a plurality of net bag units, the plurality of net bag units are arranged at intervals along the axial direction; each net bag unit includes: a net bag The main body and a plurality of pull rods; the main body of the net bag is a flat net structure with a closed distal end, and the distal ends of the plurality of pull rods are respectively connected to the proximal ends of the main body of the net bag; and
    输送组件,所述网兜单元的远端与所述输送组件相连,且所述网兜单元的多个拉杆近端汇聚并与所述输送组件相连,所述多个拉杆之间形成所述网兜单元的开口;所述输送组件用于收容呈压缩状态的所述网兜组件,并能够将所述网兜组件释放至膨胀状态以及将膨胀状态的网兜组件回拉至导管内。Conveying assembly, the far-end of described net bag unit is connected with described conveying assembly, and the near-end of a plurality of pull rods of described net bag unit gathers and is connected with described conveying assembly, forms the described net bag unit between described multiple pull rods The opening; the conveying assembly is used to accommodate the net bag assembly in a compressed state, and can release the net bag assembly to an expanded state and pull the net bag assembly in the expanded state back into the catheter.
  2. 如权利要求1所述的取栓装置,其中,所述网兜组件包括多个网兜单元,且所述多个网兜单元由多根编织丝一体交错编织成型。The thrombectomy device according to claim 1, wherein the net bag assembly comprises a plurality of net bag units, and the plurality of net bag units are integrally woven and formed by a plurality of braiding wires.
  3. 如权利要求2所述的取栓装置,其中,所述网兜单元的各拉杆为经所述多根编织丝合并以编织成的麻花杆结构。The thrombus removing device according to claim 2, wherein each pull rod of the net bag unit is a twisted rod structure formed by combining the plurality of braided wires.
  4. 如权利要求1所述的取栓装置,其中,所述网兜主体包括周向闭环的支撑段和与所述支撑段远端平滑相接的远端过滤网;所述支撑段的网孔密度小于所述远端过滤网的网孔密度;所述网兜单元的多个拉杆沿周向均匀间隔布置并形成锥形结构。The thrombectomy device according to claim 1, wherein the net bag body comprises a circumferential closed-loop support section and a distal filter screen smoothly connected to the distal end of the support section; the mesh density of the support section is less than The mesh density of the filter at the far end; the plurality of pull rods of the mesh bag unit are evenly spaced along the circumference and form a tapered structure.
  5. 如权利要求1所述的取栓装置,其中,所述芯管包括穿设于所述网兜组件的弹性伸缩段以及与所述弹性伸缩段近端相连的刚性段。The thrombus retrieval device according to claim 1, wherein the core tube comprises an elastic telescopic section passed through the net bag assembly and a rigid section connected to a proximal end of the elastic telescopic section.
  6. 如权利要求1所述的取栓装置,其中,所述网兜单元的拉杆的轴向长度与网兜主体的轴向长度之比大于或者等于0.5且小于或者等于5,且所述网兜主 体的最大直径与所述网兜主体的轴向长度之比可以大于或者等于2且小于或者等于20。The bolt removing device according to claim 1, wherein the ratio of the axial length of the pull rod of the net unit to the axial length of the net body is greater than or equal to 0.5 and less than or equal to 5, and the maximum diameter of the net body is The ratio to the axial length of the main body of the net bag may be greater than or equal to 2 and less than or equal to 20.
  7. 如权利要求1所述的取栓装置,其中,所述取栓装置包括多个网兜单元,每个网兜单元分别采用多根编织丝交错编织成型。The thrombus removing device according to claim 1, wherein the thrombus removing device comprises a plurality of net pocket units, and each net pocket unit is formed by interlacing braiding of a plurality of braiding wires.
  8. 如权利要求2所述的取栓装置,其中,所述输送组件包括芯管;所述网兜组件还包括近端显影固定环;The thrombectomy device according to claim 2, wherein the conveying assembly includes a core tube; the net bag assembly also includes a proximal development fixing ring;
    所述芯管穿设于所述多个网兜单元,所述多个网兜单元的远端与所述芯管相连,相邻两个网兜单元之间的多根编织丝编织成连接网管,所述连接网管套设于所述芯管,所述多个网兜单元中近端的网兜单元的多个拉杆汇聚并与所述近端显影固定环相连,所述近端显影固定环固定套设于所述芯管。The core tube is passed through the plurality of net pocket units, the distal ends of the plurality of net pocket units are connected to the core tube, and a plurality of braided wires between two adjacent net pocket units are braided to connect the net tubes. The connecting network pipe is sleeved on the core tube, and the plurality of pull rods of the proximal net unit among the plurality of net pocket units are converged and connected with the proximal developing and fixing ring, and the proximal developing and fixing ring is fixedly sleeved on the said plurality of net pocket units. The core tube.
  9. 如权利要求2所述的取栓装置,其中,所述输送组件还包括:The thrombectomy device according to claim 2, wherein the delivery assembly further comprises:
    操作手柄,其为中空管状结构且其周壁设有沿其自身轴向延伸的滑槽;The operating handle is a hollow tubular structure and its peripheral wall is provided with a chute extending along its own axial direction;
    鞘管,其近端活动地穿设于所述操作手柄并用于收容呈收缩状态的所述网兜组件;a sheath tube, the proximal end of which is movably passed through the operating handle and is used to accommodate the mesh bag assembly in a contracted state;
    鞘管连接件,其为管状结构且设置于所述操作手柄内部远端侧,所述鞘管连接件远端与所述鞘管近端相连;所述芯管穿设于所述鞘管以及所述鞘管连接件内且与所述鞘管连接件近端密封连接,并可相对所述鞘管和所述鞘管连接件轴向移动;所述芯管近端穿出并固设于所述操作手柄近端;以及The sheath tube connector is a tubular structure and is arranged on the inner distal end side of the operating handle, the distal end of the sheath tube connector is connected to the proximal end of the sheath tube; the core tube is passed through the sheath tube and The sheath tube connector is in and sealed with the proximal end of the sheath tube connector, and can move axially relative to the sheath tube and the sheath tube connector; the proximal end of the core tube passes through and is fixed on the the proximal end of the operating handle; and
    驱动件,设置于所述滑槽内,所述驱动件内端部与所述鞘管连接件相连,并能够驱动所述鞘管连接件带动所述鞘管沿所述滑槽在所述操作手柄内向近端移动,以释放所述网兜组件。The driving part is arranged in the chute, the inner end of the driving part is connected with the sheath connecting part, and can drive the sheath connecting part to drive the sheath along the chute in the operation The handle is moved proximally inwardly to release the net bag assembly.
  10. 如权利要求2所述的取栓装置,其中,所述操作手柄包括相卡接的第一外壳以及第二外壳;The thrombectomy device according to claim 2, wherein the operating handle includes a first shell and a second shell that engage with each other;
    所述第一外壳和所述第二外壳均设有定位柱和定位孔;所述定位柱和所述定位孔相配合,以使所述第一外壳和所述第二外壳对准卡接。Both the first shell and the second shell are provided with a positioning post and a positioning hole; the positioning post cooperates with the positioning hole so that the first shell and the second shell are aligned and clamped.
PCT/CN2021/127818 2021-10-19 2021-11-01 Thrombectomy device WO2023065394A1 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
CN202122515872.XU CN218528839U (en) 2021-10-19 2021-10-19 Thrombus taking device
CN202122513411.9U CN216317840U (en) 2021-10-19 2021-10-19 Thrombectomy support conveying device
CN202122513411.9 2021-10-19
CN202111215575.1A CN113925568A (en) 2021-10-19 2021-10-19 Thrombus taking device
CN202111215575.1 2021-10-19
CN202122515872.X 2021-10-19

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CN104768479A (en) * 2012-11-06 2015-07-08 柯惠有限合伙公司 Multi-pivot thrombectomy device
CN107374700A (en) * 2017-08-28 2017-11-24 北京赛铂医药科技有限公司 A kind of segmented thrombus is broken to take device
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