WO2023240937A1 - 多功能血栓清除装置 - Google Patents

多功能血栓清除装置 Download PDF

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Publication number
WO2023240937A1
WO2023240937A1 PCT/CN2022/135669 CN2022135669W WO2023240937A1 WO 2023240937 A1 WO2023240937 A1 WO 2023240937A1 CN 2022135669 W CN2022135669 W CN 2022135669W WO 2023240937 A1 WO2023240937 A1 WO 2023240937A1
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Prior art keywords
suction
perfusion
tube
catheter
distal
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PCT/CN2022/135669
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English (en)
French (fr)
Inventor
刘载淳
黄定国
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上海腾复医疗科技有限公司
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Publication of WO2023240937A1 publication Critical patent/WO2023240937A1/zh

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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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/32075—Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • 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
    • A61B2017/22072—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 with an instrument channel, e.g. for replacing one instrument by the other
    • 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
    • A61B2017/22079—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 with suction of debris
    • 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
    • A61B2017/22082—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 after introduction of a substance
    • A61B2017/22084—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 after introduction of a substance stone- or thrombus-dissolving
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a multifunctional thrombus removal device.
  • vascular embolism has become the leading cause of death in my country, and vascular embolism has become the main factor in vascular disease.
  • the annual new incidence rate of patients with ischemic stroke, pulmonary embolism, and lower extremity venous embolism exceeds 5 million.
  • Interventional thrombectomy has gradually become a mainstream and recommended effective method for vascular embolization treatment in medicine. Interventional thrombectomy has many advantages such as less trauma, short postoperative recovery time, fewer complications after treatment, and good surgical results, and is more acceptable to patients.
  • systemic thrombolysis In the clinical practice of intravascular embolization treatment, the existing interventional technical solutions mainly include systemic thrombolysis, catheter contact thrombolysis, mechanical thrombectomy and other treatment methods. Different methods have different advantages and disadvantages: Systemic thrombolysis treatment plan There is a risk of causing cerebral hemorrhage or systemic hemorrhage; although catheter contact with thrombolysis reduces the dosage of thrombolytic drugs, there are still bleeding complications.
  • thrombectomy is economical, the blood loss during the operation is large, and the thrombectomy effect for thrombus in large lumen is often not very good; the rheological mechanical thrombectomy process requires attention to the monitoring of the use time, and postoperative hemoglobinuria is common. It has occurred, and it only has a certain effect on acute thrombus. It has very limited effect on thrombus in large lumen, especially subacute or even chronic thrombus. Therefore, there is an urgent clinical need for a thrombus removal device that can achieve better removal effects for different locations and types of thrombus.
  • the purpose of some embodiments of the present application is to provide a multifunctional thrombus removal device that is more economical and can achieve better removal effects for different locations and different types of thrombi.
  • the embodiment of the present application provides a multifunctional thrombus removal device, including: a thrombectomy stent, which is a self-expanding stent structure; a suction catheter, the proximal end of the thrombectomy stent is connected to the suction catheter, and the suction catheter is connected to the suction catheter.
  • the distal end of the suction catheter has a suction port, and the suction port is located in the thrombus retrieval stent.
  • the suction catheter is used to remove the thrombus collected by the thrombectomy stent in an expanded state through the suction port.
  • the distal end of the suction catheter is also formed with a perfusion pipe section, the perfusion pipe section is located at the proximal end of the thrombectomy stent; and a blocking component that can enter the perfusion pipe section and block the perfusion pipe section The distal end is used for the suction catheter to infuse thrombolytic drugs through the perfusion tube section.
  • the suction catheter includes a tube body and a tube interface connected to the proximal end of the tube body; the tube interface is used to connect a negative pressure source and provide suction negative pressure within the tube body, and the The pipe interface is also used to infuse thrombolytic drugs into the perfusion pipe section.
  • the tube interface includes: a handle part, an operating joint and a perfusion joint; the tube body, the handle part and the operating joint are coaxially connected in sequence from the distal end to the proximal end, and form a suction joint of the suction catheter.
  • Suction channel the operating joint includes a connecting pipe section and a joint part, the connecting pipe section is connected between the proximal end of the handle part and the distal end of the joint part; the inner end of the perfusion joint is connected to the peripheral wall of the connecting pipe section,
  • the perfusion joint has a perfusion channel, and the perfusion channel is connected to the connecting pipe section.
  • the tube body includes a distal tube portion, a suction mouth portion and a perfusion tube section connected in sequence from the distal end to the proximal end; the tube body has a distal tube section extending from the proximal end of the tube body to the suction tube section
  • the partition wall of the suction port is used to separate the tube body into a suction chamber and a guide wire chamber, and the guide wire chamber is arranged eccentrically relative to the tube body.
  • the distal tube part is tapered and extends in the axial direction.
  • the distal tube part is coaxially arranged with the tube body and has a guide wire hole for passing a guide wire.
  • the guide wire The hole is connected to the guide wire lumen.
  • the guide wire lumen includes a connected distal guide wire lumen and a proximal guide wire lumen, the distal guide wire lumen is a circumferentially closed closed-loop guide wire lumen, and the proximal guide wire lumen is Circumferentially open grooved guide wire cavity.
  • an axially extending reinforcing core is provided in the partition wall.
  • the suction port forms the suction port, and the suction port is a side bevel suction port that first gradually increases and then gradually decreases from the distal end to the proximal end.
  • the side beveled suction port extends from the proximal end of the distal tube part to the connection between the thrombectomy bracket and the tube body.
  • the perfusion tube section includes a blocking section and a perfusion section connected from the distal end to the proximal end; the perfusion section is provided with perfusion structures spaced along the axial and circumferential directions; the blocking component is a balloon catheter , the balloon catheter includes a balloon body and a catheter, the balloon body is connected to the catheter; the balloon body can enter the tube body through the tube interface and reach the blocking section, and the When the balloon body is inflated and inflated, it can block the blocking section; the tube interface can also inject thrombolytic drugs into the tube body, and the thrombolytic drugs can be ejected from the perfusion structure of the peripheral wall of the perfusion section. .
  • a development ring is provided at the distal end of the perfusion tube section, and a development mark is provided on the catheter; whether the balloon reaches the seal is determined by matching the positions of the development mark and the development ring. Blocked section.
  • the thrombectomy stent is spherical, ellipsoidal or spindle-shaped.
  • the thrombectomy stent includes: a fixed head, a collection part and a thrombectomy part connected in sequence from the distal end to the proximal end; the distal end of the collection part is connected to the proximal end of the fixed head; the fixed head It can move axially relative to the suction catheter to make the thrombectomy stent expand or contract;
  • the collection part includes a network structure formed by a plurality of connecting rods interlacedly connected, and the thrombectomy part includes A plurality of connecting rods arranged at intervals along the circumference, the distal end of the connecting rod is smoothly connected to the proximal end of the collection part, the proximal end of the connecting rod is connected to the suction catheter;
  • the tube body includes a The distal tube part, the suction mouth part and the perfusion tube section are connected in sequence; optionally, the fixed head is tapered and extends in the axial direction, and the fixed head is coaxially arranged with the thro
  • the device further includes: an ultrasonic catheter; ultrasonic transducers arranged at intervals along the axial direction are provided in the ultrasonic catheter; the ultrasonic catheter can enter the suction conduit and reach the perfusion pipe section within, and the ultrasonic transducer can radiate ultrasonic energy in the radial direction after being powered on.
  • the proximal end of the thrombectomy stent is connected to the distal end of the suction catheter, and the distal end of the suction catheter extends into the thrombectomy stent.
  • the thrombectomy stent can be withdrawn through the suction catheter.
  • the thrombectomy stent can peel off and collect thrombus, making the thrombus easier to aspirate.
  • the thrombus in the thrombectomy stent can be quickly aspirated out of the body through the suction catheter, which helps reduce the difficulty of thrombectomy and improves the efficiency of thrombectomy; and , because the distal end of the suction catheter has a perfusion tube section, and the distal end of the perfusion tube section can be blocked by the blocking component, and then thrombolytic drugs are perfused through the perfusion tube section, so that thrombolytic drugs can be injected accurately to further reduce the difficulty of stent removal. .
  • the multifunctional thrombus removal device of this embodiment cleverly combines stent thrombus removal, catheter thrombolysis, and negative pressure suction to learn from each other's strengths, reduce the difficulty of thrombus removal, and target thrombus of different lumen sizes and types. It can achieve better thrombectomy effect, help reduce complications, and have better therapeutic effect.
  • Figure 1 is a schematic structural diagram of a multifunctional thrombus removal device provided by an embodiment of the present application
  • Figure 2 is a partial structural schematic diagram of the suction catheter of the multifunctional thrombus removal device provided by an embodiment of the present application;
  • Figure 3 is a schematic cross-sectional structural diagram of Figure 2;
  • Figure 4 is a partial structural schematic diagram of the suction catheter of the multifunctional thrombus removal device provided by another embodiment of the present application.
  • Figure 5 is a partial structural schematic diagram of the thrombectomy stent of the multifunctional thrombus removal device provided by the embodiment of the present application;
  • Figure 6 is a partial cross-sectional structural diagram of the suction catheter of the multifunctional thrombus removal device provided by the embodiment of the present application;
  • Figure 7 is a schematic cross-sectional structural view of the distal end of the suction catheter of the multifunctional thrombus removal device provided by an embodiment of the present application;
  • Figure 8 is a schematic cross-sectional structural diagram of the proximal end of the suction catheter of the multifunctional thrombus removal device provided by the embodiment of the present application;
  • Figure 9 is a schematic diagram of the combined thrombectomy stent and suction catheter of the multifunctional thrombus removal device provided by the embodiment of the present application.
  • Figure 10 is a schematic diagram of the infusion of thrombolytic drugs in the multifunctional thrombus removal device provided by the embodiment of the present application;
  • Figure 11 is a schematic structural diagram of the ultrasonic catheter thrombolysis of the multifunctional thrombus removal device provided by the embodiment of the present 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 connected indirectly through an intermediary, which can be an internal connection between two components.
  • the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator;
  • the axial direction refers to the end parallel to the natural direction. The direction of the line connecting the distal center and the proximal center of the medical device in the state.
  • inventions of the present application provide a multifunctional thrombus removal device that can be used to effectively remove thrombus in different locations and types.
  • the multifunctional thrombus removal device of this embodiment mainly includes: a thrombectomy stent 12, a suction catheter, and a blocking component.
  • the thrombus retrieval stent 12 is a self-expanding stent structure, which can closely adhere to the inner wall of the blood vessel after expansion to peel off and collect the thrombus.
  • the proximal end of the thrombectomy stent 12 is connected to the suction catheter, that is, the thrombectomy stent 12 and the suction catheter form an integrated thrombectomy structure 1, and the thrombectomy stent 12 can be withdrawn through the suction catheter.
  • the distal end of the suction catheter has a suction port 1321, and the suction port 1321 is located in the thrombectomy stent 12.
  • the suction catheter is used to aspirate the thrombus collected by the thrombectomy stent 12 in the expanded state through the suction port 1321. After the thrombus is peeled off and collected by the thrombus removal stent 12, the difficulty of thrombus aspiration can be significantly reduced.
  • the suction catheter can directly aspirate the collected thrombus out of the body. At the same time, since the thrombus collected together is aspirated, the aspiration efficiency is improved. It is higher and also solves the problem of large lumen size making it difficult to aspirate.
  • a perfusion pipe section 133 is also formed at the distal end of the suction catheter, and the perfusion pipe section 133 is located on the proximal side of the thrombectomy stent 12 .
  • the blocking component can enter the perfusion tube section 133 and block the distal end of the perfusion tube section 133 so that the suction catheter can inject thrombolytic drugs through the perfusion tube section 133 .
  • the suction catheter can double as an infusion catheter for injecting thrombolysis.
  • thrombolysis can be performed first to reduce the binding force between the thrombus and the blood vessel wall, and then the thrombus can be removed with the thrombus retrieval stent 12 , thereby achieving better thrombus retrieval effects for different types of thrombi. .
  • the drug can be applied more accurately, saving drug dosage and reducing the risk of complications.
  • the thrombectomy bracket 12 may be spherical, ellipsoidal or spindle-shaped.
  • the main function of the thrombus retrieval stent 12 is to expand and adhere closely to the inner wall of the blood vessel after release, and to completely peel off the thrombus on the inner wall of the blood vessel when withdrawn. At the same time, it can collect and store an appropriate amount of thrombus without providing a large amount of thrombus storage space. Therefore, , the axial length of the thrombectomy stent 12 can be shorter, and the overall volume can be smaller. Compared with a thrombectomy stent that needs to directly take the thrombus out of the body, the manufacturing cost can be lower.
  • the thrombectomy stent 12 may include: a fixed head 11 , a collecting part 121 and a thrombectomy part 122 connected in sequence from the distal end to the proximal end.
  • the collection part 121 includes a mesh structure formed by a plurality of connecting rods 1211 interlacedly connected, and the distal end of the collection part 121 is connected to the proximal end of the fixed head 11 .
  • the thrombectomy part 122 may include a plurality of connecting rods 1221 arranged at circumferential intervals.
  • the distal end of the connecting rod 1221 is smoothly connected to the proximal end of the collection part 121, and the proximal end of the connecting rod 1221 is connected to the suction catheter.
  • the thrombectomy part 122 has a sparse mesh structure, and an opening for thrombus to enter is formed between adjacent connecting rods 1221, and the thrombus can be cut through the connecting rods 1221.
  • the collection part 121 has a dense mesh structure, which can filter and intercept thrombi and pass through the blood flow.
  • the fixed head 11 can move axially relative to the suction catheter to make the thrombectomy stent 12 expand or contract.
  • the thrombectomy stent 12 drives the fixed head 11 to move distally relative to the suction catheter under the action of external force, the thrombectomy stent 12 can be in a contracted state. After the thrombectomy stent 11 is released, the fixed head 11 can be driven to move relative to the suction catheter by its own elastic force. The suction catheter is moved proximally to expand the thrombectomy stent.
  • the thrombus retrieval bracket 12 may also include a distal connecting part 123, and may be fixedly connected to the proximal end of the fixed head 11 through the distal connecting part 123, such as by welding.
  • the distal connecting part 123 may include a plurality of distal fixing rods 1231 , and the distal fixing rods 1231 may be formed by extending from the connecting rods 1211 .
  • the collecting part 121 can be reliably fixed to the fixing head 11 through the plurality of distal fixing rods 1231 .
  • connecting rods 1221 of the plug-removing part 122 can start from the intersection of the connecting rods 1211 of the collecting part 121 and extend toward the proximal end, or directly extend toward the proximal end from the connecting rods 1211 at the proximal end of the collecting part 121 and be bundled and fixed on the extraction part.
  • the number of connecting rods of the collecting part 121 is greater than the number of connecting rods 1221 of the plug removing part 122.
  • the thrombectomy part 122 may also include a proximal fixation part 124.
  • the proximal fixation part 124 may include a plurality of proximal fixation rods 1241 formed by extending the connecting rods 1221.
  • the proximal fixation rods 1241 may be fixedly connected to the suction catheter through welding.
  • the thrombus retrieval stent 12 can be made of nickel-titanium pipes that are laser cut and heat-set, or can be made of braided wires with shape memory capabilities, such as nickel-titanium alloy wires. It can be understood that this embodiment does not impose specific restrictions on the structure of the thrombectomy stent 12, as long as the required thrombectomy performance is achieved.
  • the fixing head 11 is tapered and extends along the axial direction.
  • the fixing head 11 is coaxially arranged with the thrombus retrieval bracket 12.
  • the fixing head 11 can improve the propulsion capability of the device in the blood vessel.
  • the fixed head 11 is provided with a through hole 113 for the guide wire (not shown) to pass through, and can cooperate with the guide wire to guide the device to reach the thrombus position during the operation.
  • the fixed head 11 may include a tapered portion 111 and a bracket connecting portion 112.
  • the distal fixing portion 1212 of the thrombectomy bracket 12 is fixedly connected to the bracket connecting portion 112.
  • the suction catheter may include a tube body 13 and a tube interface 15 connected to the proximal end of the tube body 13 .
  • the tube body 13 may include: a distal tube portion 131 , a suction port 132 , and a perfusion tube section 133 connected in sequence from the distal end to the proximal end.
  • the distal tube portion 131 extends in the axial direction.
  • the distal tube portion 131 is coaxially arranged with the tube body 13 and has a guide wire hole 1311 for passing a guide wire.
  • the distal tube portion 131 is tapered, and the distal end is a tip, which facilitates the distal end of the suction catheter to extend into the thrombectomy stent 12 .
  • the fixed head 11, the thrombus removal bracket 12 and the tube body 13 can all be arranged coaxially. When the fixed head 11 is a tapered head as shown in FIG. 3 , the fixed head 11 is disposed on the distal side of the distal tube portion 131 .
  • the fixed head 11 When the thrombectomy stent 12 is in a contracted state, the fixed head 11 is away from the distal tube portion 131 . When the thrombectomy stent 11 is in an expanded state, the fixed head is close to the distal tube portion 131 .
  • the fixed head 11 can be tubular.
  • the fixed head 11 and the distal end of the thrombus retrieval bracket 12 are fixed and coaxially arranged.
  • the fixed head 11 is slidably sleeved on the distal tube portion 131 , that is, the fixed head 11 can slide freely along the axial direction of the distal tube portion 131 to make the thrombectomy stent 12 expand or contract.
  • the distal end of the distal tube portion 131 is tapered to facilitate advancement of the device within the blood vessel.
  • the distal tube part also has a sliding section of equal diameter, and the length of the sliding section only needs to meet the axial sliding distance of the thrombectomy stent 12 when it expands and contracts.
  • the tube body 13 is provided with a partition wall 134 extending from the proximal end of the tube body 13 to the suction mouth 132.
  • the partition wall 134 is used to separate the tube body 13 into a suction chamber 1301 and a suction chamber 1301.
  • the guide wire cavity is arranged eccentrically relative to the tube body 13 .
  • an axially extending reinforcing core 135 may be provided within the partition wall 134 .
  • the reinforcing core 135 may be a reinforcing rod with a circular cross-section or a reinforcing rod with a rectangular cross-section.
  • the reinforcing core 135 may be made of stainless steel or nickel-titanium alloy. The strength of the tube body 13 can be increased by the reinforcing core 135 to prevent the tube body 13 from being deformed or buckled during operation.
  • the guide wire hole 1311 of the distal tube portion 131 is connected with the guide wire lumen to form a guide wire channel.
  • the guide wire lumen on the tube body 13 includes a connected distal guide wire lumen 1302 and a proximal guide wire lumen 1303.
  • the distal end of the distal guide wire lumen 1302 is connected to the guide wire hole 1311 of the distal tube portion 131, so that the suction catheter has a through guide wire channel.
  • the distal guidewire lumen 1302 is a circumferentially closed closed-loop guidewire lumen. Please refer to Figure 8.
  • the proximal guide wire lumen 1303 can be a circumferentially open groove-shaped guide wire lumen, that is, the tube body 13 is recessed inward to form a groove-shaped guide wire lumen, and the proximal end of the suction catheter adopts an open groove-shaped guide wire lumen.
  • the wire cavity not only facilitates the insertion of the guide wire, but also facilitates the advancement of the suction catheter within the blood vessel.
  • the suction lumen 1301 is a closed lumen that runs from the distal end to the proximal end and is used for the suction channel of the suction catheter.
  • the guidewire lumen is used to guide the thrombus removal device through the guidewire into the target thrombus location.
  • the guide wire cavity is eccentrically arranged on one side of the tube body 13, which is beneficial to enlarging the suction channel and improving thrombus suction performance.
  • the suction port 132 is formed with a suction port 1321.
  • the suction port 1321 is a side bevel suction port that first gradually increases and then gradually decreases from the distal end to the proximal end.
  • the thrombus can be aspirated in the axial direction of the thrombectomy stent 12 through the side beveled suction port, which has a larger suction port and good suction effect.
  • the side chamfered suction port 1321 extends from the proximal end of the distal tube portion 131 to the connection between the thrombectomy bracket 12 and the tube body 13 .
  • the suction port can directly aspirate thrombus within a wide range of the axial direction of the thrombectomy stent, with high suction efficiency.
  • the axial length of the suction port 1321 from the distal opening to the maximum incision is greater than the axial length from the maximum incision to the proximal incision.
  • the former can be 2 times or more than the latter. , so that the suction port can have better suction performance.
  • the suction catheter also includes a tube interface 15 connected to the proximal end of the tube body 13 .
  • the pipe interface 15 is used to connect a negative pressure source and provide suction negative pressure within the pipe body 13 .
  • the tube interface 15 is also used to inject thrombolytic drugs into the perfusion tube section 133 .
  • the pipe interface 15 may include: a handle portion 151, an operating joint 152 and a filling joint 153.
  • the tube body 13, the handle portion 151 and the operating joint 152 are coaxially connected in sequence from the distal end to the proximal end, and form a suction channel of the suction catheter.
  • the operating joint 152 may include a connecting pipe section 1522 and a joint part 1521.
  • the connecting pipe section 1522 is connected between the proximal end of the handle part 151 and the distal end of the joint part 1521.
  • the inner end of the perfusion joint 153 is connected to the peripheral wall of the connecting pipe 1522 section.
  • the perfusion joint 153 has a perfusion channel 1531, and the perfusion channel 1531 is connected to the connecting pipe 1522 section.
  • the perfusion connector 153 can be connected to the medication injection device to inject medication into the suction catheter.
  • the joint part 1521 can be connected to a negative pressure source such as a negative pressure pump to provide suction negative pressure in the su
  • the perfusion tube section 133 of the tube body 13 includes a blocking section 1331 and a perfusion section 1332 connected from the distal end to the proximal end.
  • the perfusion section 1332 is provided with perfusion structures 1333 spaced apart along the axial and circumferential directions.
  • the perfusion structure 1333 is used to establish a passage between the suction chamber 1301 and the outside world, thereby realizing drug injection.
  • the perfusion structure 1333 can be a tiny circular hole or a narrow rectangular hole, or other types of structures that can achieve drug perfusion under perfusion pressure, and are not specifically limited here.
  • the plurality of perfusion structures 1333 can be evenly distributed along the axial and circumferential directions of the perfusion section, so that the drug can be applied more evenly.
  • the blocking component may be a balloon catheter 2
  • the balloon catheter 2 may include a balloon body 21 and a catheter 23 .
  • the balloon body 21 is connected to the catheter 23 .
  • the balloon catheter 2 may be a compliant or semi-compliant balloon catheter.
  • the outer end of the catheter 23 can be equipped with a balloon catheter handle (not shown), and the balloon body 21 can be filled and pressurized through the catheter 23 to expand the balloon body 21, or the balloon catheter can be depressurized to expand the balloon body 21. Hug back and shrink.
  • the balloon body 21 can enter the tube body 13 through the tube interface and reach the blocking section 1331, and when the balloon body 21 is inflated, it can block the blocking section 1331.
  • the shape of the balloon body 21 can be a special-shaped balloon catheter that matches the shape of the suction chamber 1301 in the blocking section 1331, so that the blocking section 1331 can be better blocked and the medicine can be prevented from flowing far away from the suction catheter. This may result in over-injection or waste. It can be understood that the balloon body 21 can also be a round ordinary balloon catheter, as long as it can block the blocking section 1331 to a large extent.
  • Thrombolytic drugs can be perfused into the tube body 13 through the pipe interface, and the thrombolytic drugs can be ejected from the perfusion structure 1333 on the peripheral wall of the perfusion section 1332.
  • the balloon catheter 2 can enter the tube body 13 through the operating joint 152.
  • medicine is injected into the tube body 13 through the perfusion joint 153.
  • the length of the perfusion pipe section 133 can be set as needed, and is not specifically limited here.
  • the distal end of the perfusion tube section 133 of the tube body 13 can be provided with a developing ring 14, through which the position of the thrombus retrieval stent 12 can be positioned.
  • the developing ring 14 can be used to indicate the position of the suction catheter to facilitate the delivery of the thrombus retrieval stent 12 to the thrombus. the far end.
  • the developing ring 14 can be made of radiopaque alloy material and fixedly sleeved on the distal end of the perfusion tube section 133 .
  • the catheter 23 may also be provided with development marks 22 . Whether the balloon body 21 reaches the blocking section 1331 is determined by matching the position of the development mark 22 with the development ring 14 on the tube body 13 .
  • the positional relationship between the development ring 14 and the development mark 22 can be configured such that when the positions of the development ring 14 and the development mark 22 coincide, the balloon body 21 is exactly within the blocking section 1331.
  • the accurate positioning of 21 positions is sufficient.
  • the development mark 22 can be made of radiopaque alloy material and fixed on the catheter 23 to indicate the position of the balloon catheter 2 .
  • the multifunctional thrombus removal device may also include an ultrasonic catheter 3 .
  • the ultrasonic catheter is provided with ultrasonic transducers 31 arranged at intervals along the axial direction.
  • the ultrasonic catheter 3 can enter the suction catheter and reach the perfusion pipe section, and the ultrasonic transducer 31 can radiate ultrasonic sound in the radial direction after being powered on.
  • the ultrasonic transducer 31 is a device that converts electrical energy into ultrasonic energy.
  • the ultrasonic transducer 31 may be made of a suitable piezoelectric material, such as lead zirconate titanate.
  • Each ultrasonic transducer 31 can extend along the axial direction, and can radiate ultrasonic waves around it when energized.
  • the thrombectomy stent 12 When the device is in the thrombectomy and negative pressure suction working state, the thrombectomy stent 12 is close to the inner wall of the blood vessel due to its shape memory performance, and the thrombectomy part 122 can be withdrawn during the process of withdrawing the suction catheter. The thrombus 40 attached to the blood vessel wall is scraped off and collected in the collection part 121.
  • the external negative pressure source connected to the operating joint of the suction catheter can be opened for negative pressure suction, so that The suction chamber 1301 is in a negative pressure suction state, and the thrombus in the internal space of the collection part 121 is directly sucked out of the body (the thrombus suction direction is shown by the arrow in Figure 9), thereby achieving stent thrombectomy and negative pressure suction.
  • the thrombus suction direction is shown by the arrow in Figure 9
  • the balloon catheter 2 enters from the operating joint 152 and reaches the blocking section 1331.
  • the developing ring 14 of the tube body 13 and the balloon catheter 2 When the positions of the development marks 22 match, for example, when the two are radially aligned, the balloon body 21 is inflated through the catheter 23, and the balloon body 21 expands under the action of pressure and adheres to the suction cavity in the blocking section 1331 until Block the blocking section, and then inject thrombolytic drugs through the perfusion joint 153.
  • the thrombolytic drugs reach the inner cavity of the perfusion section 1332 through the suction channel, and are sprayed out from the perfusion structure 1333 (the direction of drug flow and perfusion is indicated by the arrow in Figure 10 As shown), the thrombolytic drugs can accurately act on the thrombus and achieve the dissolution of the thrombus.
  • physiological saline can be injected through the perfusion joint 153.
  • the physiological saline can flow through the ultrasonic transducer 31 to cool it down, and the physiological saline is finally discharged from the suction port.
  • the thrombus can be destroyed first through perfusion thrombolysis, ultrasonic accelerated thrombolysis and other means, and then combined thrombectomy with thrombectomy stent and suction catheter can be used to target different types and different tubes.
  • the thrombus with the cavity size can achieve better thrombectomy effect, which is helpful to reduce complications and better improve the therapeutic effect.
  • the multifunctional thrombus removal device in the embodiment of the present application cleverly combines stent thrombus removal, catheter thrombolysis, and negative pressure suction to learn from each other's strengths and reduce the difficulty of thrombus removal, and can target different lumen sizes and different types of thrombi. Achieve better thrombectomy effect, help reduce complications, and have better therapeutic effect.
  • the multifunctional thrombus removal device has a reasonable structure, economical production cost, and is suitable for popularization and application.

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Abstract

一种多功能血栓清除装置包括：取栓支架(12)、抽吸导管以及封堵组件；取栓支架(12)为自膨胀式支架结构；取栓支架(12)近端与抽吸导管相连，抽吸导管远端具有抽吸口(1321)，且抽吸口(1321)位于取栓支架(12)内，抽吸导管用于通过抽吸口(1321)对呈膨胀状态的取栓支架(12)收集的血栓进行抽吸；抽吸导管远端还形成有灌注管段(133)，灌注管段(133)位于取栓支架(12)近端侧；封堵组件能够进入灌注管段(133)内并封堵灌注管段(133)远端，以供抽吸导管通过灌注管段(133)灌注溶栓药物。

Description

多功能血栓清除装置
交叉引用
本申请引用于2022年05月07日递交的名称为“多功能血栓清除装置”的第2022106678997号中国专利申请，其通过引用被全部并入本申请。
技术领域
本申请涉及医疗器械技术领域，特别涉及一种多功能血栓清除装置。
背景技术
血管疾病已经成为我国第一大致死性疾病，而血管疾病中血管栓塞已成为主要因素。尤其缺血性脑卒中，肺栓塞，下肢静脉栓塞患者每年新发病率总和超过500万人。
目前医学上介入取栓已经逐渐成为一种血管栓塞治疗主流推荐的有效方式。介入取栓具有创伤小，术后恢复时间短，治疗后并发症少，手术效果好等诸多优点，也更能被病人接受。
在血管内栓塞治疗临床实践中，现有的介入技术方案主要包括系统性溶栓，导管接触溶栓，机械性取栓等治疗手段，不同手段有着不同的优势和缺点：系统性溶栓治疗方案具有引发脑出血或全身性出血的风险；导管接触溶栓虽然降低了溶栓药物使用剂量，但仍然有出血并发症，同时长时间置管溶栓还有感 染的风险；单纯负压抽吸式的取栓虽然经济，但手术过程失血量大，且对于大管腔内的血栓取栓效果往往无法达到很好的效果；流变型机械取栓过程需要注意使用时长的监控，术后血红蛋白尿常有发生，同时仅对于急性血栓有一定的效果，对于大管腔内的血栓，特别是亚急甚至是慢性的血栓，效果非常有限。因此，临床上亟需一种针对不同部位、不同类型的血栓均能达到较佳的清除效果的血栓清除装置。
需要说明的是，在上述背景技术部分公开的信息仅用于加强对本申请的背景的理解，因此可以包括不构成对本领域普通技术人员已知的现有技术的信息。
发明内容
本申请部分实施例的目的在于提供一种多功能血栓清除装置，以提供一种较为经济且针对不同部位、不同类型的血栓均能达到较佳的清除效果的血栓清除装置。
本申请实施例提供了一种多功能血栓清除装置，包括：取栓支架，其为自膨胀式支架结构；抽吸导管，所述取栓支架近端与所述抽吸导管相连，所述抽吸导管远端具有抽吸口，且所述抽吸口位于所述取栓支架内，所述抽吸导管用于通过所述抽吸口对呈膨胀状态的所述取栓支架收集的血栓进行抽吸；所述抽吸导管远端还形成有灌注管段，所述灌注管段位于所述取栓支架近端侧；以及封堵组件，其能够进入所述灌注管段内并封堵所述灌注管段远端，以供所述抽吸导管通过所述灌注管段灌注溶栓药物。
作为一个实施例，所述抽吸导管包括管体以及与所述管体近端相连的管 接口；所述管接口用于连接负压源并为所述管体内提供抽吸负压，所述管接口还用于向所述灌注管段内灌注溶栓药物。
作为一个实施例，所述管接口包括：手柄部、操作接头以及灌注接头；从远端至近端所述管体、手柄部以及操作接头依次同轴相连，并形成所述抽吸导管的抽吸通道；所述操作接头包括连接管段以及接头部，所述连接管段连接于所述手柄部近端和所述接头部远端之间；所述灌注接头内端与所述连接管段周壁相连，所述灌注接头具有灌注通道，所述灌注通道与连接管段相连。
作为一个实施例，所述管体包括从远端到近端依次相连的远端管部、抽吸口部以及灌注管段；所述管体内设有从所述管体近端延伸至所述抽吸口部的分隔壁，所述分隔壁用于将所述管体分隔成抽吸腔和导丝腔，且所述导丝腔相对所述管体偏心设置。
作为一个实施例，所述远端管部呈锥形且沿轴向延伸，所述远端管部与所述管体同轴设置且具有用于通过导丝的导丝孔，所述导丝孔与所述导丝腔相连。
作为一个实施例，所述导丝腔包括相连的远端导丝腔和近端导丝腔，所述远端导丝腔呈周向封闭的闭环导丝腔，所述近端导丝腔为周向开口的槽形导丝腔。
作为一个实施例，所述分隔壁内设有轴向延伸的加强芯。
作为一个实施例，所述抽吸口部形成所述抽吸口，所述抽吸口为从远端到近端先逐渐增大再逐渐减小的侧斜切抽吸口。
作为一个实施例，所述侧斜切抽吸口自所述远端管部近端延伸至所述取栓支架与所述管体的连接处。
作为一个实施例，所述灌注管段包括从远端到近端相连的封堵段和灌注段；所述灌注段沿轴向和周向间隔设有灌注结构；所述封堵组件为球囊导管，所述球囊导管包括球囊体以及导管，所述球囊体与所述导管相连；所述球囊体能够经所述管接口进入所述管体内并到达所述封堵段，且所述球囊体充盈膨胀时能够堵塞所述封堵段；通过所述管接口还能够向所述管体内灌注溶栓药物，所述溶栓药物能够从所述灌注段周壁的灌注结构中喷出。
作为一个实施例，所述灌注管段远端设有显影环，所述导管上设有显影标记；通过匹配所述显影标记与所述显影环的位置以确定所述球囊体是否到达所述封堵段内。
作为一个实施例，所述取栓支架呈球形、椭球形或者纺锤形。
作为一个实施例，所述取栓支架包括：从远端到近端依次相连的固定头、收集部以及取栓部；所述收集部远端与所述固定头近端相连；所述固定头能够相对所述抽吸导管轴向移动以使所述取栓支架呈膨胀或者收缩状态；可选的，所述收集部包括由若干连接杆交错相连形成的网状结构，所述取栓部包括若干沿周向间隔布置的连杆，所述连杆远端与所述收集部近端平滑相连，所述连杆近端与所述抽吸导管相连；所述管体包括从远端到近端依次相连的远端管部、抽吸口部以及灌注管段；可选的，所述固定头呈锥形并沿轴向延伸，所述固定头与所述取栓支架同轴设置且设置于所述远端管部远端侧，所述固定头内设有供导丝穿过的通孔，所述远端管部呈锥形；或者所述固定头呈管状并滑动套设于所述远端管部，且所述远端管部远端呈锥形。
作为一个实施例，所述装置还包括：超声导管；所述超声导管内设有沿轴向间隔布置的超声换能器；所述超声导管能够进入所述抽吸导管内并到达所 述灌注管段内，且所述超声换能器在通电后能够沿径向辐射超声能量。
由上述技术方案可知，本申请实施例至少具有如下优点和积极效果：
本申请实施例的多功能血栓清除装置中，取栓支架近端与抽吸导管远端相连，且抽吸导管远端伸入取栓支架内，通过抽吸导管可以回撤取栓支架，通过取栓支架可以剥离并收集血栓，使得血栓更易于抽吸，同时还可以通过抽吸导管将取栓支架内的血栓快速抽吸出体外，从而有利于降低取栓难度，提高取栓效率；并且，由于抽吸导管远端具有灌注管段，且通过封堵组件可以封堵住灌注管段远端，再通过灌注管段灌注溶栓药物，从而可以精准地注药溶栓，以进一步降低支架取栓难度。因此，本实施例的多功能血栓清除装置巧妙地将支架取栓、置管溶栓以及负压抽吸等手段结合起来，取长补短，降低取栓难度，针对不同管腔大小、不同类型的血栓均可达到更佳的取栓效果，且有利于降低并发症，具有更佳的治疗效果。
附图说明
一个或多个实施例通过与之对应的附图中的图片进行示例性说明，这些示例性说明并不构成对实施例的限定，附图中具有相同参考数字标号的元件表示为类似的元件，除非有特别申明，附图中的图不构成比例限制。
图1为本申请实施例提供的多功能血栓清除装置的结构示意图；
图2为本申请一实施例提供的多功能血栓清除装置的抽吸导管的局部结构示意图；
图3为图2的剖面结构示意图；
图4为本申请另一实施例提供的多功能血栓清除装置的抽吸导管的局部 结构示意图；
图5为本申请实施例提供的多功能血栓清除装置的取栓支架的局部结构示意图；
图6为本申请实施例提供的多功能血栓清除装置的抽吸导管的局部剖面结构示意图；
图7为本申请实施例提供的多功能血栓清除装置的抽吸导管远端的截面结构示意图；
图8为本申请实施例提供的多功能血栓清除装置的抽吸导管近端的截面结构示意图；
图9为本申请实施例提供的多功能血栓清除装置的取栓支架和抽吸导管联合取栓的示意图；
图10为本申请实施例提供的多功能血栓清除装置的灌注溶栓药物的示意图；
图11为本申请实施例提供的多功能血栓清除装置的超声导管溶栓结构示意图。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请部分实施例进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或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 本申请和简化描述，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、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”、“第三”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
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。
在本申请的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于自然状态下的医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便，并不能理解为对本申请的限制。
请参阅图1、图3及图9所示，本申请实施例提供一种多功能血栓清除装置，可用于不同位置、不同类型的血栓的有效清除。本实施例的多功能血栓清除装置主要包括：取栓支架12、抽吸导管以及封堵组件。
取栓支架12为自膨式支架结构，其能够在膨胀后紧贴血管内壁从而剥离和收集血栓。
取栓支架12近端与抽吸导管相连，即取栓支架12和抽吸导管形成一体式取栓结构1，通过抽吸导管可回撤取栓支架12。抽吸导管远端具有抽吸口1321，且抽吸口1321位于取栓支架12内，抽吸导管用于通过抽吸口1321对呈膨胀状态的取栓支架12收集的血栓进行抽吸。在取栓支架12将血栓剥离并收集后，可显著降低血栓抽吸难度，抽吸导管可直接将收集的血栓抽吸出体外，同时由于是对集中在一起的血栓进行抽吸，抽吸效率更高，并且还解决了大管腔尺寸 难以抽吸的难题。
抽吸导管远端还形成有灌注管段133，灌注管段133位于取栓支架12近端侧。封堵组件能够进入灌注管段133内并封堵灌注管段133远端，以供抽吸导管通过灌注管段133灌注溶栓药物。抽吸导管可以兼作灌注导管进行注药溶栓。对于一些慢性或取栓支架12难以剥离的血栓可以先适当进行溶栓，降低血栓与血管壁结合力后再通过取栓支架12取栓，从而可以针对不同类型的血栓达到较佳的取栓效果。通过封堵组件与抽吸导管配合封堵灌注管段133远端后再注药，可以更精准地施药，节省药物用量，降低并发症发生风险。
取栓支架12可以呈球形、椭球形或者纺锤形。取栓支架12的主要作用是释放后能够膨胀并紧贴于血管内壁，在回撤时能够将血管内壁血栓完整剥离掉，同时能够收集存储适量的血栓，而无需提供大量血栓的存储空间，因此，取栓支架12的轴向长度可以较短，整体的体积可以更小巧，相较于需要直接将血栓带出体外的取栓支架而言，制造成本可以更低。
请参阅图2、图5所示，取栓支架12可以包括：从远端到近端依次相连的固定头11、收集部121以及取栓部122。示例性地，收集部121包括由若干连接杆1211交错相连形成的网状结构，收集部121远端与固定头11近端相连。取栓部122可包括若干沿周向间隔布置的连杆1221，连杆1221远端与收集部121近端平滑相连，连杆1221近端与抽吸导管相连。取栓部122为疏网结构，相邻连杆1221之间形成血栓进入的开口，通过连杆1221可以切割血栓。收集部121为密网结构，可以过滤拦截血栓并能够通过血流。固定头11能够相对抽吸导管轴向移动以使取栓支架12呈膨胀或者收缩状态。当取栓支架12在外力作用下驱动固定头11相对抽吸导管向远端移动时可使取栓支架12呈收缩状态， 取栓支架11被释放后依靠自身弹性作用力可驱动固定头11相对抽吸导管向近端移动以使取栓支架呈膨胀状态。
收集部121的若干个连接杆1211分别沿正反两向螺旋延伸并相互交错连接形成网状结构，收集部121周壁可以形成菱形网孔。取栓支架12还可包括远端连接部123，并通过远端连接部123与固定头11近端固连，比如通过焊接相连。远端连接部123可包括若干远端固定杆1231，远端固定杆1231可以由连接杆1211延伸形成。通过多根远端固定杆1231能够将收集部121可靠地固定于固定头11。
取栓部122的若干个连杆1221可以由收集部121的连接杆1211的交叉点出发并向近端延伸或者由收集部121近端的连接杆1211直接向近端延伸并收束固定于抽吸鞘管远端。收集部121的连接杆数量大于取栓部122的连杆1221数量。取栓部122还可包括近端固定部124，近端固定部124可以包括若干由连杆1221延伸形成的近端固定杆1241，近端固定杆1241可通过焊接与抽吸导管固定连接。
取栓支架12可以采用镍钛管材经激光切割并经热定型制成，也可以采用具有形状记忆能力的编织丝编织而成，比如采用镍钛合金丝编织制成。可以理解的是，本实施例对于取栓支架12的结构不做具体限制，只要达到所需的取栓性能即可。
请参阅图3所示，固定头11呈锥形并沿轴向延伸，固定头11与取栓支架12同轴设置，固定头11可提高本装置在血管中的推进能力。固定头11内设有供导丝(图未示)穿过的通孔113，在术中可与导丝配合引导装置到达血栓位置。固定头11可包括锥形部111以及支架连接部112，取栓支架12的远端 固定部1212与支架连接部112固定相连。
抽吸导管可包括管体13以及与管体13近端相连的管接口15。
请参阅图2和图3所示，管体13可包括：从远端至近端依次相连的远端管部131、抽吸口部132以及灌注管段133。
远端管部131沿轴向延伸，远端管部131与管体13同轴设置且具有用于通过导丝的导丝孔1311。远端管部131呈锥形，远端为尖端，便于抽吸导管远端伸入取栓支架12内。固定头11、取栓支架12以及管体13均可同轴设置。当固定头11为如图3所示的锥形头时，固定头11设置于远端管部131远端侧。取栓支架12呈收缩状态时，固定头11远离远端管部131，取栓支架11呈膨胀状态时，固定头靠近远端管部131。
请参阅图4所示，作为一种替换例，固定头11可呈管状，固定头11与取栓支架12的远端固结并同轴设置，固定头11滑动套设于远端管部131，即固定头11能够沿远端管部131轴向自由滑动以使取栓支架12呈膨胀或者收缩状态。远端管部131远端呈锥形，便于装置在血管内推进。远端管部还具有等径的滑动段，滑动段的长度满足取栓支架12膨胀和收缩时轴向滑动的距离即可。
请参阅图7和图8所示，管体13内设有从管体13近端延伸至抽吸口部132的分隔壁134，分隔壁134用于将管体13分隔成抽吸腔1301和导丝腔，且导丝腔相对管体13偏心设置。
可选地，分隔壁134内可设有轴向延伸的加强芯135。加强芯135可以为截面呈圆形的加强杆或者截面呈矩形的加强杆。示例性地，加强芯135可采用不锈钢或者镍钛合金制成。通过加强芯135可提高管体13的强度，避免管体13在操作过程中变形或者打折。
远端管部131的导丝孔1311与导丝腔相连，形成导丝通道。可选地，管体13上的导丝腔包括相连的远端导丝腔1302和近端导丝腔1303。远端导丝腔1302远端与远端管部131的导丝孔1311相连，使得抽吸导管具有贯通的导丝通道。请继续参阅图7所示，远端导丝腔1302呈周向封闭的闭环导丝腔。请参阅图8所示，近端导丝腔1303可以为周向开口的槽形导丝腔，即管体13向内凹陷形成槽形导丝腔，抽吸导管近端采用开口的槽形导丝腔，既便于穿入导丝，且有利于抽吸导管在血管内推进。
抽吸腔1301为从远端到近端贯通的密闭管腔，用于抽吸导管的抽吸通道。导丝腔用于通过导丝以引导血栓清除装置进入目标血栓位置。导丝腔偏心地设置于管体13一侧，有利于增大抽吸通道，提高血栓抽吸性能。
抽吸口部132形成有抽吸口1321，抽吸口1321为从远端到近端先逐渐增大再逐渐减小的侧斜切抽吸口。通过侧斜切抽吸口可以在取栓支架12轴向对血栓进行抽吸，具有更大的抽吸口，抽吸效果佳。进一步地，侧斜切抽吸口1321自远端管部131近端延伸至取栓支架12与管体13的连接处。从而使得抽吸口能够对取栓支架轴向大范围内的血栓直接进行抽吸，具有很高的抽吸效率。且抽吸口1321从远端开口处到最大切口处之间的轴向长度大于从最大切口处到近端切口处之间的轴向长度，比如前者可以为后者的2倍或2倍以上，从而可使抽吸口具有较佳的抽吸性能。
抽吸导管还包括与管体13近端相连的管接口15。管接口15用于连接负压源并为管体13内提供抽吸负压。管接口15还用于向灌注管段133内灌注溶栓药物。
请参阅图6所示，管接口15可包括：手柄部151、操作接头152以及灌 注接头153。从远端至近端管体13、手柄部151以及操作接头152依次同轴相连，并形成抽吸导管的抽吸通道。操作接头152可包括连接管段1522以及接头部1521，连接管段1522连接于手柄部151近端和接头部1521远端之间。灌注接头153内端与连接管1522段的周壁相连，灌注接头153具有灌注通道1531，灌注通道1531与连接管1522段相连。灌注接头153可以与注药装置连接，从而向抽吸导管内灌注药物。接头部1521可以与负压泵等负压源相连，从而为抽吸导管内提供抽吸负压。
请继续参阅图3和图10所示，管体13的灌注管段133包括从远端到近端相连的封堵段1331和灌注段1332。灌注段1332沿轴向和周向间隔设有灌注结构1333。灌注结构1333用于建立抽吸腔1301与与外界的通路，从而实现药物喷注。灌注结构1333可以为微小的圆形孔或者窄缝型的矩形孔，或者其他类型的能够在灌注压力下实现药物灌注的结构，在此不做具体限制。多个灌注结构1333可沿灌注段轴向和周向均匀分布，从而可以将药物更均匀地施加药物。
举例而言，封堵组件可以为球囊导管2，球囊导管2可包括球囊体21以及导管23。球囊体21与导管23相连。球囊导管2可以为顺应性或半顺应性球囊导管。导管23外端可以带有球囊导管手柄(图未示)，通过导管23可以对球囊体21进行充盈增压使球囊体21膨胀，或者对球囊导管进行减压使球囊体21回抱收缩。
球囊体21能够经管接口进入管体13内并到达封堵段1331，且球囊体21充盈膨胀时能够堵塞封堵段1331。球囊体21的形状可以为与封堵段1331内的抽吸腔1301的形状相匹配的异形球囊导管，从而可以更好地将封堵段1331封堵住，避免药物流向抽吸导管远端造成过量注药或者浪费。可以理解的是，球 囊体21也可以为圆形的普通球囊导管，只要能够较大限度地封堵住封堵段1331即可。
通过管接口能够向管体13内灌注溶栓药物，溶栓药物能够从灌注段1332周壁的灌注结构1333中喷出。其中，球囊导管2可以通过操作接头152进入管体13内，当球囊体21充盈膨胀后，通过灌注接头153向管体13内灌注药物。灌注管段133的长度可以根据需要设置，在此不做具体限制。
管体13的灌注管段133远端可设有显影环14，通过显影环14可以定位取栓支架12的位置，显影环14可用于指示抽吸导管的位置，便于将取栓支架12输送至血栓的远端。显影环14可以采用不透射线的合金材料制作并固定套设于灌注管段133远端。导管23上也可设有显影标记22。通过匹配显影标记22与管体13上显影环14的位置以确定球囊体21是否到达封堵段1331内。比如，显影环14和显影标记22的位置关系可以配置为当显影环14和显影标记22的位置重合时，球囊体21恰好在封堵段1331内，然不限于此，只要方便球囊体21位置的准确定位即可。显影标记22可以采用不透射线的合金材料制成，并固设于导管上23，以便指示球囊导管2的位置。
请参阅图11所示，在一些例子中，多功能血栓清除装置还可包括：超声导管3。超声导管内设有沿轴向间隔布置的超声换能器31。超声导管3能够进入抽吸导管内并到达灌注管段内，且超声换能器31在通电后能够沿径向辐射超声声量。超声换能器31是将电能转换成超声波能量的器件。超声换能器31可由适合的压电材料，比如锆钛酸铅制成。每个超声换能器31可沿轴向延伸，通电时可以向其周围辐射超声波。超声换能器31可以为多个，多个超声换能器31之间可以通过导线串联连接形成换能器组，从而能够在更大长度的血栓段内 辐射超声波。
本实施例的多功能血栓清除装置的使用方法如下：
请继续参阅图9所示，当该装置处于取栓和负压抽吸工作状态时，取栓支架12由于具有形状记忆性能紧贴于血管内壁，回撤抽吸导管过程中取栓部122能够将贴附于血管壁的血栓40进行刮除剥离，并收集于收集部121内，回撤一段距离后，可打开连接于抽吸导管的操作接头的外界负压源进行负压抽吸，使得抽吸腔1301处于负压抽吸的状态，将收集部121内部空间中的血栓直接抽吸至体外(血栓抽吸方向如图9中的箭头所示)，实现支架取栓和负压抽吸的一体化操作，当血栓段较长时，可以分段取栓分段抽吸，操作灵活。且先将血栓收集到取栓支架12内，再通过抽吸导管对取栓支架12内的血栓进行抽吸，可显著减少失血量，提高抽吸效果。
请继续参阅图10所示，当该装置处于注药溶栓工作状态时，球囊导管2从操作接头152进入并到达封堵段1331，当管体13的显影环14与球囊导管2的显影标记22位置匹配时，比如两者径向对齐时，通过导管23对球囊体21进行充盈，球囊体21在压力的作用下膨胀贴附至封堵段1331内的抽吸腔，直至堵塞住封堵段，然后通过灌注接头153注入溶栓药物，溶栓药物经抽吸通道到达灌注段1332的内腔，并从灌注结构1333处喷洒出来(药物流动灌注方向如图10中的箭头所示)，使溶栓药物精准地作用于血栓，实现血栓的溶解。
请继续参阅图11所示，当该装置处于超声工作状态时，在溶栓药物注入之后，通过导管23进行负压抽吸，使球囊体21回缩后将球囊导管2整体撤出抽吸导管，然后将超声导管3从操作接头152输送至灌注管段133的内腔中，通电后超声导管3中的多个超声换能器31分别向周向辐射超声波，从而通过超 声波机械能量加速溶栓药物与血栓的结合作用，加速血栓的溶解。同时为了降低超声换能器31工作过程中的产生的温度，可以通过灌注接头153注入生理盐水，生理盐水可流经超声换能器31从而使其降温，生理盐水最后从抽吸口排出。
在实际应用中，针对慢性血栓，可先通过灌注溶栓、超声加速溶栓等手段对血栓进行破坏，然后再通过取栓支架和抽吸导管进行联合取栓，从而可以针对不同类型，不同管腔尺寸的血栓达到更佳的取栓效果，且有利于减少并发症，更好地提高治疗效果。
基于上述技术方案本申请至少具有如下优点和积极效果：
本申请实施例的多功能血栓清除装置巧妙地将支架取栓、置管溶栓以及负压抽吸等手段结合起来，取长补短，降低取栓难度，针对不同管腔大小、不同类型的血栓均可达到更佳的取栓效果，且有利于降低并发症，具有更佳的治疗效果。并且该多功能血栓清除装置结构合理、制作成本经济，适于推广应用。
本领域的普通技术人员可以理解，上述各实施例是实现本申请的具体实施例，而在实际应用中，可以在形式上和细节上对其作各种改变，而不偏离本申请的精神和范围。

Claims (15)

  1. 一种多功能血栓清除装置，其特征在于，包括：
    取栓支架，其为自膨胀式支架结构；
    抽吸导管，所述取栓支架近端与所述抽吸导管相连，所述抽吸导管远端具有抽吸口，且所述抽吸口位于所述取栓支架内，所述抽吸导管用于通过所述抽吸口对呈膨胀状态的所述取栓支架收集的血栓进行抽吸；所述抽吸导管远端还形成有灌注管段，所述灌注管段位于所述取栓支架近端侧；以及
    封堵组件，其能够进入所述灌注管段内并封堵所述灌注管段远端，以供所述抽吸导管通过所述灌注管段灌注溶栓药物。
  2. 如权利要求1所述的装置，其中，所述抽吸导管包括管体以及与所述管体近端相连的管接口；
    所述管接口用于连接负压源并为所述管体内提供抽吸负压，所述管接口还用于向所述灌注管段内灌注溶栓药物。
  3. 如权利要求2所述的装置，其中，所述管接口包括：手柄部、操作接头以及灌注接头；
    从远端至近端所述管体、手柄部以及操作接头依次同轴相连，并形成所述抽吸导管的抽吸通道；
    所述操作接头包括连接管段以及接头部，所述连接管段连接于所述手柄部近端和所述接头部远端之间；所述灌注接头内端与所述连接管段周壁相连，所述灌注接头具有灌注通道，所述灌注通道与连接管段相连。
  4. 如权利要求2所述的装置，其中，所述管体包括从远端到近端依次相连的远端管部、抽吸口部以及灌注管段；所述管体内设有从所述管体近端延伸至 所述抽吸口部的分隔壁，所述分隔壁用于将所述管体分隔成抽吸腔和导丝腔，且所述导丝腔相对所述管体偏心设置。
  5. 如权利要求4所述的装置，其中，所述远端管部呈锥形且沿轴向延伸，所述远端管部与所述管体同轴设置且具有用于通过导丝的导丝孔，所述导丝孔与所述导丝腔相连。
  6. 如权利要求4所述的装置，其中，所述导丝腔包括相连的远端导丝腔和近端导丝腔，所述远端导丝腔呈周向封闭的闭环导丝腔，所述近端导丝腔为周向开口的槽形导丝腔。
  7. 如权利要求4所述的装置，其中，所述分隔壁内设有轴向延伸的加强芯。
  8. 如权利要求4所述的装置，其中，所述抽吸口部形成所述抽吸口，所述抽吸口为从远端到近端先逐渐增大再逐渐减小的侧斜切抽吸口。
  9. 如权利要求8所述的装置，其中，所述侧斜切抽吸口自所述远端管部近端延伸至所述取栓支架与所述管体的连接处。
  10. 如权利要求2所述的装置，其中，所述灌注管段包括从远端到近端相连的封堵段和灌注段；所述灌注段沿轴向和周向间隔设有灌注结构；
    所述封堵组件为球囊导管，所述球囊导管包括球囊体以及导管，所述球囊体与所述导管相连；
    所述球囊体能够经所述管接口进入所述管体内并到达所述封堵段，且所述球囊体充盈膨胀时能够堵塞所述封堵段；通过所述管接口还能够向所述管体内灌注溶栓药物，所述溶栓药物能够从所述灌注段周壁的灌注结构中喷出。
  11. 如权利要求10所述的装置，其中，所述灌注管段远端设有显影环，所述导管上设有显影标记；通过匹配所述显影标记与所述显影环的位置以确定所 述球囊体是否到达所述封堵段内。
  12. 如权利要求1所述的装置，其中，所述取栓支架呈球形、椭球形或者纺锤形。
  13. 如权利要求2所述的装置，其中，所述取栓支架包括：从远端到近端依次相连的固定头、收集部以及取栓部；
    所述收集部远端与所述固定头近端相连，所述固定头能够相对所述抽吸导管轴向移动以使所述取栓支架呈膨胀或者收缩状态。
  14. 如权利要求13所述的装置，其中，所述收集部包括由若干连接杆交错相连形成的网状结构；所述取栓部包括若干沿周向间隔布置的连杆，所述连杆远端与所述收集部近端平滑相连，所述连杆近端与所述抽吸导管相连；
    所述管体包括从远端到近端依次相连的远端管部、抽吸口部以及灌注管段；可选的，所述固定头呈锥形并沿轴向延伸，所述固定头与所述取栓支架同轴设置且设置于所述远端管部远端侧，所述固定头内设有供导丝穿过的通孔，所述远端管部呈锥形；或者
    所述固定头呈管状并滑动套设于所述远端管部，且所述远端管部远端呈锥形。
  15. 如权利要求2至14中任一项所述的装置，其中，所述装置还包括：超声导管；所述超声导管内设有沿轴向间隔布置的超声换能器；
    所述超声导管能够进入所述抽吸导管内并到达所述灌注管段内，且所述超声换能器在通电后能够沿径向辐射超声能量。
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