WO2020114180A1 - 取栓装置及取栓方法 - Google Patents

取栓装置及取栓方法 Download PDF

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Publication number
WO2020114180A1
WO2020114180A1 PCT/CN2019/115807 CN2019115807W WO2020114180A1 WO 2020114180 A1 WO2020114180 A1 WO 2020114180A1 CN 2019115807 W CN2019115807 W CN 2019115807W WO 2020114180 A1 WO2020114180 A1 WO 2020114180A1
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WO
WIPO (PCT)
Prior art keywords
thrombus
suction
thrombectomy
head
balloon
Prior art date
Application number
PCT/CN2019/115807
Other languages
English (en)
French (fr)
Inventor
史增佐
韩建超
樊亚明
张琳琳
朱清
苗铮华
Original Assignee
上海蓝脉医疗科技有限公司
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
Application filed by 上海蓝脉医疗科技有限公司 filed Critical 上海蓝脉医疗科技有限公司
Priority to EP19893093.5A priority Critical patent/EP3892210B1/en
Priority to KR1020217017255A priority patent/KR102600886B1/ko
Priority to BR112021010894-7A priority patent/BR112021010894A2/pt
Publication of WO2020114180A1 publication Critical patent/WO2020114180A1/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
    • 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
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • 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
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • 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
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • 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
    • A61B2017/22038—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 a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • 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
    • 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
    • A61B2017/22079—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
    • A61B2017/22094—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 for crossing total occlusions, i.e. piercing
    • 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
    • A61B2017/320716—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material
    • 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
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320775—Morcellators, impeller or propeller like means
    • 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

  • This application relates to the technical field of medical devices, in particular to a thrombectomy device and a thrombectomy method.
  • Venous thrombosis is a disease caused by abnormal clotting of blood in a vein. Venous thrombosis can lead to increased venous pressure, blocked blood flow, swelling, pain and dysfunction of the limbs. In severe cases, post-thrombotic syndrome can also form, threatening life safety.
  • thrombectomy is performed by catheter thrombolysis or traditional surgical thrombectomy. However, it takes a long time for tube thrombolysis and is not suitable for patients with a high risk of bleeding. In traditional surgical procedures, thrombectomy is an invasive procedure, which can easily damage the vascular valve function and is prone to wound complications.
  • Various exemplary embodiments disclosed in the present application provide a thrombectomy device and a thrombectomy method.
  • this application provides a thrombectomy device for removing thrombus along the guide wire, including:
  • Suction plug assembly including an outer tube, a transmission tube, a driving member and a suction plug head, the outer tube is sleeved outside the transmission tube, and one end of the outer tube is connected to the suction plug head, the suction plug A thrombectomy knife is arranged in the head, the suction thrombosis head is used to suck and crush thrombus, and the two ends of the transmission tube are respectively connected to the thrombectomy knife and the driving member, and the driving member is used to drive the transmission tube to rotate ;as well as,
  • a thrombectomy assembly used to draw a thrombus to the suction head includes a multi-lumen tube and a balloon provided at one end of the multi-lumen tube.
  • the balloon has a contracted state and a liquid-filled inflation state.
  • the tube is provided with a liquid-filling cavity for filling the balloon and a guide-wire cavity for threading the guide wire, the multi-lumen tube passes through the transmission tube and the suction plug head in sequence, and makes The bolt taking assembly can move relatively with the sucking bolt assembly in the axial direction.
  • the suction plug assembly of the above-mentioned plug removal device is provided with a plug removal component, and the plug removal component can move axially relative to the suction plug component, so that in the area of small-diameter blood vessels that cannot be reached by the outer tube of the suction plug component, it can be moved by
  • the thrombus removal component passes through the thrombus, and then the balloon is inflated by filling the balloon with fluid, so that the thrombus removal component can draw the thrombus to the vicinity of the suction thrombosis component, and the suction thrombosis component can inhale and crush the thrombus, and then clear the thrombus.
  • the balloon after the balloon is inflated, it can closely adhere to the inner wall of the blood vessel. When pulled, the thrombus adhering to the wall of the blood vessel can be removed.
  • the plug removal assembly further includes a first connector, the first connector is sleeved on an end of the multi-lumen tube away from the balloon, and the first connector is disposed on the first connector There is a liquid filling interface communicating with the liquid filling cavity and a guide wire interface communicating with the guide wire cavity.
  • the plug removal assembly further includes a tapered head connected to an end of the multi-lumen tube away from the first connector, the tapered head has an internal cavity , And the internal cavity communicates with the guide wire cavity, so that the guide wire can pass through the tapered head.
  • the diameter of the tapered head gradually increases toward the first connector.
  • the balloon in the contracted state, is attached to the surface of the multi-lumen tube.
  • the volume of the balloon becomes large so that the surface of the balloon closely fits the inner wall of the blood vessel.
  • the balloon is sheathed outside the multi-lumen tube, and a side wall of the multi-lumen tube is provided with a balloon filling port connecting the liquid-filling cavity and the inside of the balloon .
  • the plug removal assembly further includes a developing wire, the developing wire is disposed outside the multi-lumen tube and located at both ends of the balloon.
  • the suction plug assembly further includes a second connector, the second connector is sleeved on an end of the outer tube away from the suction plug head, and the second connector is provided on the second connector There is a suction plug interface and a transmission tube interface, the suction plug interface communicates with the interior of the outer tube, and the transmission tube interface is used to pass through the transmission tube.
  • the suction plug assembly further includes a negative pressure suction device, the negative pressure suction device is provided with a suction port, and the suction port communicates with the suction plug interface.
  • the negative pressure suction device is further provided with a discharge port, the discharge port being connected to the collection bag.
  • the suction plug head has a hollow structure
  • the broken plug cutter is disposed in the suction plug head and sleeved outside the multi-lumen tube, and the end surface of the suction plug head is useful In order to pierce the pulling bolt hole of the multi-lumen tube.
  • the side of the embolic head is provided with at least one thrombectomy hole for inhaling thrombus
  • the side of the thrombectomy knife is provided with a blade
  • the thrombectomy hole faces the blade
  • the end face of the suction head is further provided with at least one thrombectomy hole for inhaling thrombus
  • the end face of the thrombectomy knife is provided with a blade edge
  • the thrombus extraction hole faces the blade edge
  • the pull bolt hole is provided at the center of the end surface of the suction plug head.
  • the number of the bolt taking holes is plural, and the plurality of bolt taking holes are evenly arranged along the circumferential direction of the bolt pulling hole.
  • the broken bolt cutter is provided with an intermediate through hole, and the intermediate through hole communicates with the pull bolt hole; the diameter of the multi-lumen tube is smaller than the diameter of the transmission tube, the pull bolt The diameter of the hole and the diameter of the intermediate through hole.
  • the number of the bolt removing assemblies is multiple groups, the multiple groups of bolt removing assemblies all pass through the transmission tube and the suction plug head, and each group of the bolt removing assemblies can be connected with The suction plug assembly moves relatively, and the multiple sets of plug removal assemblies are respectively sleeved on different guide wires.
  • this application also provides a method for removing a thrombus using any of the above-mentioned thrombus removal devices.
  • the method includes:
  • the suction head sucks the thrombus nearby, shatters the thrombus with the thrombectomy knife, and expels the shredded thrombus
  • FIG. 1 is a schematic structural diagram of a thrombectomy device according to an embodiment of the application
  • FIG. 2 is a cross-sectional view of the A-A cross section of the plug removing device shown in FIG. 1;
  • FIG. 3 is a schematic structural view of a bolt removing assembly of the bolt removing device shown in FIG. 1;
  • FIG. 4 is a schematic diagram of the deflated state of the balloon of the plug removal assembly shown in FIG. 3;
  • FIG. 5 is a schematic view of the balloon inflation state of the plug removal assembly shown in FIG. 3;
  • FIG. 6 is a schematic structural diagram of a suction plug head according to an embodiment of the application.
  • FIG. 7 is a schematic structural diagram of a suction plug head according to another embodiment of the present application.
  • FIG. 8 is a schematic view of the usage state of the thrombectomy device according to an embodiment of the application.
  • FIG. 9 is a schematic view of a use state of a thrombectomy device according to another embodiment of the present application.
  • FIG. 10 is a flowchart of a method for removing a thrombus according to an embodiment of the present application.
  • an element when referred to as being “fixed” to another element, it can be directly on the other element or there can also be a centered element. When an element is considered to be “connected” to another element, it may be directly connected to another element or there may be a center element at the same time.
  • an embodiment of the present application provides a thrombectomy device 100 for removing thrombus along a guide wire 200, particularly for removing thrombus in a region with a small blood vessel diameter.
  • the thrombectomy device 100 of an embodiment includes a thrombus assembly for inhaling, crushing, and expelling the thrombus, and a thrombus assembly for drawing the thrombus from the blood vessel along the guide wire 200 to the vicinity of the thrombus assembly.
  • the guide wire 200 here is a metal wire that is pre-implanted in the blood vessel and passes through the thrombus before the thrombectomy operation, and is used to guide the thrombectomy device 100.
  • the suction plug assembly includes an outer tube 111, a transmission tube 112, a suction plug head 113, and a driving member 114.
  • the outer tube 111 is sleeved outside the transmission tube 112, and there is a gap 1111 between the outer tube 111 and the transmission tube 112. After the thrombus is inhaled and crushed, it can be discharged through the gap 1111. Further, one end of the outer tube 111 is connected to the suction plug head 113, and the suction plug head 113 is used to suck and crush the thrombus.
  • a thrombectomy knife 115 for crushing thrombus is provided in the suction head 113.
  • the driving member 114 may be a rotary motor
  • the material of the suction plug 113 may be a metal material or a composite material of medical polymer and metal
  • the material of the outer tube 111 may be a medical polymer material or medical polymer
  • the metal composite material and the material of the transmission tube 112 may be a metal material or a medical polymer and metal composite material.
  • the plug removal assembly includes a balloon 122 and a multi-lumen tube 121 connected to the balloon 122.
  • the balloon 122 can be contracted or inflated with fluid, that is, the balloon 122 has a contracted state (as shown in FIG. 4) and an expanded state after being filled with liquid (as shown in FIG. 5).
  • the balloon 122 is attached to the surface of the multi-lumen tube 121.
  • the volume of the balloon 122 becomes so large that the surface of the balloon 122 closely adheres to the inner wall of the blood vessel. Referring specifically to FIG.
  • a multi-lumen tube 121 is provided with a liquid-filling cavity 1211 for filling the balloon 122 and a guide-wire cavity 1212 for threading the guide wire 200.
  • the diameter of the multi-lumen tube 121 is smaller than the diameter of the transmission tube 112 of the suction plug assembly, the diameter of the pull hole 1131 of the suction plug head 113 (see FIG. 6), and the middle through hole of the broken plug knife 115 in the suction plug head 113 (not shown) Diameter), so that the multi-lumen tube 121 can pass through the transmission tube 112 and the suction head 113 in sequence, so that in the area of small-diameter blood vessels that some suction plug components cannot reach.
  • the doctor can move the thrombus removal assembly relative to the suction thrombosis assembly by pushing the multi-lumen tube 121, so that the thrombus removal assembly can continue to advance along the guide wire 200 and pass through the thrombus.
  • the balloon is inflated, and then the multi-lumen tube 121 is pulled, and the thrombus removal component is pulled back, so that the thrombus in the small-diameter blood vessel area can be drawn to the vicinity of the suction head 113 for the suction head 113 to inhale , Smash.
  • the material of the balloon 122 is medical silica gel, latex, or elastomeric polymer material.
  • the material of the multi-lumen tube 121 is a medical polymer material or a composite material of a medical polymer and a metal. Further, the multi-lumen tube 121 may be a flexible tube, so that it can bend according to the blood vessel trend.
  • the suction plug assembly of the plug removal device 100 is provided with a plug removal component, and the plug removal component can move in the axial direction relative to the suction plug assembly.
  • the multi-lumen tube 121 can be moved to allow the thrombectomy assembly to enter the small-diameter blood vessel region and pass through the thrombus.
  • the balloon 122 is inflated, and the multi-lumen tube 121 is pulled so that the thrombus can be pulled near the suction plug assembly.
  • the thrombus assembly can suck and crush the thrombus, and then remove the thrombus.
  • the balloon 122 after the balloon 122 is inflated, it can closely adhere to the inner wall of the blood vessel, so that when the multi-lumen tube 121 is pulled, the balloon 122 can remove the thrombus adhering to the blood vessel wall.
  • the plug removal assembly further includes a first connector 123, and the first connector 123 is sleeved on the end of the multi-lumen tube 121 away from the balloon 122.
  • the first connector 123 is provided with a liquid filling interface 1231 and a guide wire interface 1232.
  • the liquid filling interface 1231 communicates with the liquid filling chamber 1211 of the multi-lumen tube 121 for injecting liquid into the liquid filling chamber 1211 to inflate the balloon 122.
  • a syringe 300 can also be connected to the liquid filling interface 1231 to facilitate the injection of liquid into the liquid filling chamber 1211.
  • the guide wire interface 1232 communicates with the guide wire cavity 1212, and the guide wire interface 1232 is used for the guide wire 200 to penetrate.
  • the first connector 123 is made of medical polymer material.
  • the plug removal assembly further includes a tapered head 124 connected to the end of the multi-lumen tube 121 away from the first connector 123.
  • the tapered head 124 has a hollow structure, and the inner cavity of the tapered head 124 communicates with the guide wire cavity 1212 so that the guide wire 200 can pass through the tapered head 124.
  • the diameter of the tapered head 124 gradually increases toward the first connector 123, so that it is easier to pass through the thrombus and prevent the inner wall of the blood vessel from being damaged.
  • the tapered head 124 is made of medical polymer material.
  • the balloon 122 is sheathed outside the multi-lumen tube 121, and a side wall of the multi-lumen tube 121 is provided with a balloon that connects the liquid-filling chamber 1211 and the inside of the balloon 122.
  • the liquid filling port 1213 is used for filling the balloon 122 with liquid.
  • the plug removal assembly further includes a developing wire 125, which is disposed outside the multi-lumen tube 121, and is located at both ends of the balloon 122 in the axial direction.
  • the developing wire 125 has developability, so that the medical imaging device can obtain the position of the balloon 122 during the removal of the plug.
  • the developing wire 125 is made of medical polymer material or metal material.
  • the suction plug assembly further includes a second connector 118, which is sleeved on the end of the outer tube 111 that is away from the suction plug head 113.
  • the second connector 118 is provided with a suction plug interface 1181 and a transmission tube interface 1182.
  • the suction plug interface 1181 communicates with the inside of the outer tube 111 so that the thrombus between the outer tube 111 and the transmission tube 112 is discharged from the suction plug interface 1181.
  • the transmission tube interface 1182 is used to pass through the transmission tube 112.
  • a negative pressure suction device 116 is connected to the suction plug interface 1181 for providing negative pressure to draw a bleeding plug. Specifically, the suction port of the negative pressure suction device 116 communicates with the suction plug interface 1181 through the hose 1161. The discharge port of the negative pressure suction device 116 is used to connect the collection bag 117 to collect thrombus. In one embodiment, the negative pressure suction device 116 may be a negative pressure pump.
  • the suction plug head 113 of one embodiment has a hollow structure.
  • the end surface of the suction plug head 113 is provided with a pull-bolt hole 1131 for penetrating the multi-lumen tube 121, and the multi-lumen tube 121 passes through the pull-bolt hole 1131.
  • the side of the suction plug head 113 is provided with at least one removal hole 1132, and the removal hole 1132 is used for inhaling thrombus.
  • the plug breaker 115 is disposed in the suction plug head 113 and sleeved outside the multi-lumen tube 121, and is connected to the transmission tube 112.
  • the broken bolt cutter 115 is provided with an intermediate through hole (not shown), and the intermediate through hole communicates with the pull bolt hole 1131, and the multi-lumen tube 121 sequentially passes through the middle through hole and the pull bolt hole 1131, and from the suction head 113 stretched out.
  • the side of the thrombectomy knife 115 is provided with a blade edge, and the thrombus taking hole 1132 faces the blade, so that after the thrombus enters the thrombus taking hole 1132, it can be crushed by the blade.
  • the suction head 113 has a hollow structure, and the end surface of the suction head 113 is provided with a pulling hole 1131 for penetrating the multi-lumen tube 121 and a taking hole 1132 for thrombus aspiration.
  • the thrombus cutter 115 is disposed in the suction head 113 and sleeved outside the multi-lumen tube 121.
  • the breaking bolt knife 115 is provided with an intermediate through hole (not shown), and the intermediate through hole communicates with the pulling bolt hole 1131.
  • the multi-lumen tube 121 sequentially passes through the middle through hole and the bolt pulling hole 1131, and extends from the suction plug head 113.
  • the end face of the bolt breaking knife 115 is provided with a blade edge, and the bolt hole 1132 is taken toward the blade edge.
  • the end surface of the suction plug head 113 may be directly integrally formed with the peripheral surface of the suction plug head 113 side, or a hollow baffle may be formed on the distal end cover of the suction plug head 113 in the shape of a hollow cylinder to form the above-mentioned
  • the end surfaces of the bolt pulling hole 1131 and the bolt taking hole 1132 are provided.
  • the pull-bolt hole 1131 is provided at the center of the end surface of the suction plug head 113, and the multi-lumen tube 121 passes through the pull-bolt hole 1131.
  • the number of the bolt taking holes 1132 is plural, and the plurality of bolt taking holes 1132 are evenly arranged along the circumferential direction of the bolt pulling hole 1131. Multiple thrombectomy holes 1132 can speed up the inhalation of thrombus.
  • first puncture the blood vessel 400 then pass one end of the guide wire 200 into the diseased blood vessel and pass through the thrombus 410, and at the same time pass the other end of the guide wire 200 into the thrombectomy device 100's guide wire lumen 1212. Send the front end of the thrombectomy device 100 into the blood vessel along the guide wire 200.
  • After reaching the stenosis of the blood vessel 400 keep the suction plug assembly immobile, and push the first connector 123 to continue moving the thrombus removal assembly along the guide wire 200 to wear Through pathological thrombosis 410.
  • the syringe 300 is connected to the liquid filling interface 1231, and the balloon 122 is inflated with iodine pure until the balloon 122 and the blood vessel wall conform to each other.
  • the driving member 114 of the suction plug assembly and the negative pressure suction device 116 are opened.
  • the thrombus is broken by the thrombus knife 115 in the suction head 113, and the negative pressure generated by the negative pressure suction device 116 is used to discharge the thrombus into the collection bag 117.
  • the balloon 122 can be decompressed , To return to the contracted configuration, turn off the drive member 114 and the negative pressure suction device 116. After the removal of the plug, the plug removal device 100 is withdrawn from the body.
  • a set of suction thrombosis assemblies may also be equipped with multiple sets of thrombectomy assemblies, so that the thrombus in the lumen of the multi-branch blood vessels can be cleaned at the same time.
  • the thrombectomy device 500 of an embodiment is used to remove thrombus in different blood vessels along multiple guide wires 200, respectively.
  • the thrombectomy device 500 includes a suction plug assembly 510 and multiple sets of suction plug assemblies 520.
  • the suction plug assembly 510 is similar to the structure of the plug removal assembly described in the previous embodiment, including an outer tube, a transmission tube, a suction plug head and a driving member, the outer tube is sleeved outside the transmission tube, and between the outer tube and the transmission tube There is a gap, and the thrombus can be expelled through the gap after being inhaled and crushed.
  • the outer tube is connected with a suction plug head, the suction plug head is used for sucking and crushing thrombus, the suction plug head is provided with a broken thrombus knife for crushing thrombus, and both ends of the transmission tube are respectively connected with the broken thrombus knife and the driving part , So that the torque of the driving part is transmitted to the broken bolt cutter to drive the broken bolt cutter to rotate.
  • the driving member may be a rotary motor
  • the suction plug head may be a metal or medical polymer and metal composite material
  • the outer tube is a medical polymer material or a medical polymer and metal composite material
  • the transmission tube is Metal materials or composite materials of medical polymers and metals.
  • each plug removal assembly 520 includes a balloon and a multi-lumen tube connected to the balloon, wherein the balloon can be deflated or inflated by fluid filling, that is, the balloon has a deflated state and an inflated state after fluid filling.
  • the balloon In the contracted state, the balloon can be attached to the surface of the multi-lumen tube.
  • the volume of the balloon can become so large that the surface of the balloon closely fits the inner wall of the blood vessel.
  • the multi-lumen tube is provided with a liquid-filling cavity for filling the balloon and a guide-wire cavity for threading the guide wire.
  • the guide wire lumen of each multi-lumen tube is used to pierce different guide wires, so that multiple sets of plug removal assemblies 520 can be moved along different guide wires to different blood vessel branches, respectively, so that different blood vessels The thrombus in the branch is drawn near the suction head.
  • suction plug assembly 510 and each set of plug removal assemblies 520 can be set in the same manner as in the previous embodiment if there is no contradiction, and details are not described here.
  • the suction plug assembly 510 of the plug removal device 500 is provided with multiple sets of plug removal assemblies 520, and each set of the plug removal assembly 520 can move relative to the suction plug assembly 510 in the axial direction of the suction plug assembly 510.
  • multiple sets of plug removal assemblies 520 can be moved to different branch blood vessels along different guide wires, respectively.
  • the thrombus in different branch blood vessels is pulled to the vicinity of the suction head, which improves the efficiency of taking the thrombus.
  • the suction head can inhale and crush the thrombus, and then remove the thrombus. After the balloon is inflated, it can closely adhere to the inner wall of the blood vessel, so that when pulled, the thrombus adhering to the wall of the blood vessel can be removed.
  • an exemplary embodiment of the present application further provides a method for removing a thrombus, which is used for the thrombus removal device in the foregoing embodiments.
  • the thrombectomy method includes the following steps.
  • S200 Send the thrombectomy device into the blood vessel along the guide wire, and after reaching the narrowed part of the blood vessel, keep the suction thrombus assembly still.
  • the balloon is filled with fluid through the multi-lumen tube, so that the balloon enters the state of inflation and inflation from the contracted state.
  • the suction head sucks the nearby thrombus, shatters the thrombus with a thrombus knife, and expels the shredded thrombus.
  • steps in the above method have been described in detail in the embodiment of the thrombectomy device, and will not be repeated here. It should be understood that although the steps in the flowchart of FIG. 10 are displayed in order according to the arrows, the steps are not necessarily executed in the order indicated by the arrows. Unless clearly stated in this article, the execution of these steps is not strictly limited in order, and these steps can be executed in other orders. Moreover, at least a part of the steps in FIG. 10 may include multiple sub-steps or multiple stages. These sub-steps or stages are not necessarily executed and completed at the same time, but may be executed at different times. The order is not necessarily sequential, but may be executed in turn or alternately with at least a part of other steps or sub-steps or stages of other steps.

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Abstract

一种取栓装置（100）和取栓方法。取栓装置（100）用于沿着导丝（200）清除血栓，包括吸栓组件以及取栓组件。其中，吸栓组件包括外管（111）、传动管（112）、驱动件（114）以及吸栓头（113）。外管（111）套设在传动管（112）外，并且外管（111）的一端与吸栓头（113）连接。吸栓头（113）用于吸入并粉碎血栓，吸栓头（113）内设置有碎栓刀（115）。传动管（112）的两端分别连接碎栓刀（115）以及驱动件（114）。取栓组件，用于将血栓牵引至吸栓头（113），包括球囊（122）以及与球囊（122）连接的多腔管（121）。球囊（122）能收缩或充液膨胀，多腔管（121）内设置有用于对球囊（122）充液的充液腔（1211）以及用于穿设导丝（200）的导丝腔（1212），多腔管（121）依次穿过传动管（112）以及吸栓头（113），并使取栓组件能与吸栓组件在轴向上相对移动。

Description

取栓装置及取栓方法
援引加入
本申请要求于2018年12月05日提交中国专利局、申请号为201811481427.2、发明名称为“取栓装置”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，特别是涉及一种取栓装置及取栓方法。
背景技术
静脉血栓是血液在静脉内不正常凝结引起的疾病。静脉血栓会导致静脉压力增高，血液回流受阻，出现肢体肿胀、疼痛及功能障碍。严重时还会形成血栓后综合征，危及生命安全。传统地，有通过置管溶栓或传统外科手术取栓的方式进行血栓清除。然而，置管溶栓所需时间长并且不适于出血风险高的患者，而传统外科手术取栓为有创操作，容易伤及血管瓣膜功能，并且易出现伤口并发症。
近年来出现了机械血栓清除装置，该装置采用溶解、粉碎、抽吸方式清除血管内血栓，以恢复血运循环和瓣膜功能。但一般的机械血栓清除装置只能到达血管内与导管直径相同的区域，血管直径小于导管直径的区域无法到达，导致小直径血管内的血栓无法清除。此外，当血栓粘附血壁时一般的机械血栓清除装置无法也将其全部吸除，导致血管壁上仍然有血栓残留。
发明内容
本申请公开的各种示例性实施例提供一种取栓装置及取栓方法。
本申请一方面提供一种取栓装置，用于沿着导丝清除血栓，包括：
吸栓组件，包括外管、传动管、驱动件以及吸栓头，所述外管套设在所述 传动管外，并且所述外管的一端与所述吸栓头连接，所述吸栓头内设置有碎栓刀，所述吸栓头用于吸入并粉碎血栓，所述传动管的两端分别连接所述碎栓刀以及所述驱动件，所述驱动件用于驱动传动管旋转；以及，
取栓组件，用于将血栓牵引至所述吸栓头，包括多腔管以及设置于所述多腔管一端的球囊，所述球囊具有收缩状态和充液膨胀状态，所述多腔管内设置有用于对所述球囊充液的充液腔以及用于穿设所述导丝的导丝腔，所述多腔管依次穿过所述传动管以及所述吸栓头，并使所述取栓组件能与所述吸栓组件在轴向上相对移动。
上述取栓装置的吸栓组件中穿设有取栓组件，并且取栓组件能相对吸栓组件的轴向移动，从而在一些吸栓组件的外管无法到达的小直径血管区域，可以通过移动取栓组件穿过血栓，再通过对球囊充液使球囊膨胀，从而拉动取栓组件能将血栓牵引至吸栓组件附近，吸栓组件能吸入并粉碎血栓，进而将血栓清除。并且，球囊膨胀后能与血管内壁紧密贴合，拉动时，可以将粘附在血管壁的血栓清除干净。
在其中一个实施例中，所述取栓组件还包括第一连接件，所述第一连接件套设在所述多腔管的远离所述球囊的一端，所述第一连接件上设置有与所述充液腔连通的充液接口以及与所述导丝腔连通的导丝接口。
在其中一个实施例中，所述取栓组件还包括锥形头，所述锥形头与所述多腔管的远离所述第一连接件的一端连接，所述锥形头具有内部空腔，并且所述内部空腔与所述导丝腔连通，使得所述导丝能穿出锥形头。
在其中一个实施例中，所述锥形头的直径沿朝向所述第一连接件方向逐渐增大。
在其中一个实施例中，在所述收缩状态时，所述球囊贴合在所述多腔管的表面。
在其中一个实施例中，在所述充液膨胀状态时，所述球囊体积变大至所述球囊表面与血管内壁紧密贴合。
在其中一个实施例中，所述球囊套设在所述多腔管外，所述多腔管的侧壁 上开设有连通所述充液腔与所述球囊内部的球囊充液口。
在其中一个实施例中，所述外管与所述传动管之间具有间隙，所述间隙用于将被所述吸栓组件吸入并粉碎的血栓排出。
在其中一个实施例中，所述取栓组件还包括显影丝，所述显影丝设置在所述多腔管外，并位于所述球囊的两端。
在其中一个实施例中，所述吸栓组件还包括第二连接件，所述第二连接件套设在所述外管的远离所述吸栓头的一端，所述第二连接件上设置有吸栓接口和传动管接口，所述吸栓接口与所述外管的内部连通，以及所述传动管接口用于穿设所述传动管。
在其中一个实施例中，所述吸栓组件还包括负压抽吸装置，所述负压抽吸装置设有吸入口，所述吸入口与所述吸栓接口连通。
在其中一个实施例中，所述负压抽吸装置还设有排出口，所述排出口连接至收集袋。
在其中一个实施例中，所述吸栓头为中空结构，所述碎栓刀设置于所述吸栓头内并套设于所述多腔管外，并且所述吸栓头的端面开设有用以穿设所述多腔管的拉栓孔。
在其中一个实施例中，所述吸栓头的侧面设置有用于吸入血栓的至少一个取栓孔，所述碎栓刀的侧面设有刀锋，并且所述取栓孔朝向所述刀锋。
在其中一个实施例中，所述吸栓头的端面还开设有用于吸入血栓的至少一个取栓孔，所述碎栓刀的端面设有刀锋，并且所述取栓孔朝向所述刀锋。
在其中一个实施例中，所述拉栓孔设置于所述吸栓头的端面中心。
在其中一个实施例中，所述取栓孔的数量为多个，所述多个取栓孔沿所述拉栓孔的周向均匀设置。
在其中一个实施例中，所述碎栓刀设置有中间通孔，并且所述中间通孔与所述拉栓孔连通；所述多腔管直径小于所述传动管的直径、所述拉栓孔的直径，以及所述中间通孔的直径。
在其中一个实施例中，所述取栓组件的数量为多组，所述多组取栓组件均 穿过所述传动管以及所述吸栓头，并且每组所述取栓组件均能与所述吸栓组件相对移动，所述多组取栓组件分别套设在不同的导丝外。
本申请一方面还提供一种使用上述任意一种取栓装置的取栓方法，所述方法包括：
将所述导丝的一端穿入所述血管并穿过所述血栓，并将所述导丝的另一端穿入所述取栓装置的导丝腔；
将所述取栓装置沿所述导丝送入所述血管，并在到达所述血管的收窄处后，保持所述吸栓组件静止；
推动所述取栓组件继续沿所述导丝向前移动以穿过所述血栓；
通过所述多腔管向所述球囊充液，使所述球囊从所述收缩状态进入所述充液膨胀状态；
将所述取栓组件向所述吸栓头方向拉动，将所述血栓牵引至所述吸栓头附近；以及
所述吸栓头将附近的所述血栓吸入，通过所述碎栓刀将所述血栓切碎，并将切碎后的所述血栓排出
附图说明
为了更清楚地说明本实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他实施例的附图。
图1为本申请一实施例的取栓装置的结构示意图；
图2为图1中所示的取栓装置的A-A截面的截面图；
图3为图1中所示的取栓装置的取栓组件结构示意图；
图4为图3中所示的取栓组件的球囊收缩状态的示意图；
图5为图3中所示的取栓组件的球囊膨胀状态的示意图；
图6为本申请一实施例的吸栓头的结构示意图；
图7为本申请另一实施例的吸栓头的结构示意图；
图8为本申请一实施例的取栓装置使用状态示意图；
图9为本申请另一实施例的取栓装置的使用状态示意图；
图10为本申请一实施例的取栓方法的流程图。
具体实施方式
为使本申请的上述目的、特征和优点能够更加明显易懂，下面结合附图对本申请的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本申请。但是本申请能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本申请内涵的情况下做类似改进，因此本申请不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
参见图1-8，本申请的一个实施例提供一种取栓装置100，用于沿着导丝200清除血栓，特别是用于清除血管直径较小区域的血栓。具体地，一实施例的取栓装置100包括用于对血栓吸入、粉碎并排出的吸栓组件以及用于沿着导丝200将血栓从血管牵引至吸栓组件附近的取栓组件。此处的导丝200是在取栓手术前，预先植入血管中并穿过血栓的金属丝线，用于对取栓装置100起导向作用。
具体地，吸栓组件包括外管111、传动管112、吸栓头113以及驱动件114，外管111套设在传动管112外，并且外管111与传动管112之间具有间隙1111。血栓被吸入、粉碎后可经由该间隙1111排出。进一步地，外管111的一端与吸栓头113连接，吸栓头113用于吸入并粉碎血栓。吸栓头113内设置有用于粉碎 血栓的碎栓刀115。传动管112的两端分别连接碎栓刀115以及驱动件114，从而将驱动件114的扭矩传递至碎栓刀115，以驱动碎栓刀115转动。在一个实施例中，驱动件114可以为旋转马达，吸栓头113的材料可以为金属材料或医用高分子与金属的复合材料，外管111的材料可以为医用高分子材料或医用高分子与金属的复合材料，以及传动管112的材料可以为金属材料或医用高分子与金属的复合材料。
进一步地，取栓组件沿吸栓组件的轴向穿设通过吸栓组件，并能与吸栓组件在轴向上相对移动。具体地，取栓组件包括球囊122以及与球囊122连接的多腔管121。球囊122能收缩或充液膨胀，即球囊122具有收缩状态(如图4所示)以及在充液后的膨胀状态(如图5所示)。在收缩状态时，球囊122贴合在多腔管121的表面。在膨胀状态时，球囊122体积变大至球囊122表面与血管内壁紧密贴合。具体参照图2，多腔管121内设置有用于对球囊122充液的充液腔1211以及用于穿设导丝200的导丝腔1212。多腔管121直径小于吸栓组件的传动管112的直径、吸栓头113的拉栓孔1131的直径(参图6)，以及吸栓头113中碎栓刀115的中间通孔(未图示)的直径，以此使得多腔管121可以依次穿过传动管112以及吸栓头113，从而在一些吸栓组件无法到达的小直径血管区域。医生可通过推动多腔管121使取栓组件相对于吸栓组件移动，进而使得取栓组件能沿着导丝200继续前进并穿过血栓。通过对球囊充液使球囊膨胀，再拉动多腔管121，将取栓组件拉回，即可将小直径血管区域内的血栓牵引至吸栓头113附近，以供吸栓头113吸入、粉碎。在一个实施例中，球囊122的材料为医用硅胶、乳胶或弹性体高分子材料。多腔管121的材料为医用高分子材料或医用高分子与金属的复合材料。进一步地，多腔管121可以为柔性管，从而能跟随血管走势弯曲。
上述取栓装置100的吸栓组件中穿设有取栓组件，并且取栓组件能相对吸栓组件在轴向上移动。在一些吸栓组件的外管111无法到达的小直径血管区域，通过移动多腔管121可以使取栓组件进入小直径血管区域并穿过血栓。然后，通过对球囊122充液使球囊122膨胀，拉动多腔管121使得能将血栓牵引至吸 栓组件附近。吸栓组件能吸入并粉碎血栓，进而将血栓清除。此外，球囊122膨胀后可以与血管内壁紧密贴合，从而在拉动多腔管121时，球囊122可以将粘附在血管壁的血栓清除干净。
参见图1和图2，在其中一个实施例中，取栓组件还包括第一连接件123，第一连接件123套设在多腔管121的远离所述球囊122的一端。进一步地，第一连接件123上设置有充液接口1231以及导丝接口1232。具体地，充液接口1231与多腔管121的充液腔1211连通，用于向充液腔1211内注入液体，以使得球囊122膨胀。进一步地，充液接口1231上还可以连接注射器300，便于向充液腔1211内注入液体。导丝接口1232与导丝腔1212连通，导丝接口1232用于导丝200穿入。在一个实施例中，第一连接件123由医用高分子材料制成。
参见图2和图3，在其中一个实施例中，所述取栓组件还包括锥形头124，锥形头124与多腔管121的远离第一连接件123的一端连接。具体地，锥形头124为中空结构，并且锥形头124内部空腔与导丝腔1212连通，使得导丝200能穿出锥形头124。进一步地，锥形头124的直径沿朝向第一连接件123方向逐渐增大，从而更易于穿过血栓，并且防止血管内壁受损。优选地，锥形头124由医用高分子材料制成。
参见图3和图4，在其中一个实施例中，球囊122套设在多腔管121外，并且多腔管121的侧壁上开设有连通充液腔1211与球囊122内部的球囊充液口1213，用于对球囊122充液。进一步地，取栓组件还包括显影丝125，显影丝125设置在多腔管121外，并在轴向上位于球囊122的两端。显影丝125具有显影性，从而在取栓过程中，能让医疗影像设备获取到所述球囊122的位置。在一个实施例中，显影丝125由医用高分子材料或金属材料制成。
参见图1，具体地，吸栓组件还包括第二连接件118，第二连接件118套设在外管111的远离吸栓头113的一端。第二连接件118上设置有吸栓接口1181以及传动管接口1182，吸栓接口1181与外管111的内部连通，以便外管111与传动管112之间的血栓从吸栓接口1181排出。传动管接口1182用于穿设传动管112。
进一步地，吸栓接口1181上连接有负压抽吸装置116，用于提供负压，以抽出血栓。具体地，负压抽吸装置116的吸入口通过软管1161与吸栓接口1181连通。负压抽吸装置116的排出口用以连接收集袋117，以收集血栓。在一个实施例中，负压抽吸装置116可以为负压泵。
参见图6，一实施例的吸栓头113为中空结构，吸栓头113的端面开设用以穿设多腔管121的拉栓孔1131，并且多腔管121从拉栓孔1131穿出。进一步地，吸栓头113的侧面设置有至少一个取栓孔1132，取栓孔1132用于吸入血栓。碎栓刀115设置于吸栓头113内并套设于多腔管121外，并连接于传动管112。具体地，碎栓刀115设置有中间通孔(未示出)，并且中间通孔与拉栓孔1131连通，多腔管121依次穿过中间通孔与拉栓孔1131，并从吸栓头113伸出。碎栓刀115的侧面设有刀锋，取栓孔1132朝向刀锋，以便血栓从取栓孔1132进入后，能被刀锋粉碎。
参见图7，在另一个实施例中，吸栓头113为中空结构，吸栓头113的端面开设有用以穿设多腔管121的拉栓孔1131以及用于血栓吸入的取栓孔1132。碎栓刀115设置于吸栓头113内并套设于多腔管121外。具体地，碎栓刀115设置有中间通孔(未示出)，并且中间通孔与拉栓孔1131连通。多腔管121依次穿过中间通孔与拉栓孔1131，并从吸栓头113伸出。碎栓刀115的端面设有刀锋，取栓孔1132朝向刀锋。进一步地，吸栓头113的端面可以与吸栓头113侧周面直接一体成形，或者可以通过在形状为空心圆柱体的吸栓头113的远端罩上一个镂空挡板，以形成上述的设置有拉栓孔1131以及取栓孔1132的端面。
进一步地，请继续参见图7，在该实施例中，拉栓孔1131设置于吸栓头113的端面中心，多腔管121从拉栓孔1131穿出。取栓孔1132的数量为多个，并且多个取栓孔1132沿拉栓孔1131的周向均匀设置。多个取栓孔1132能加快血栓吸入。
请继续参见图1-8，在手术过程中，先对血管400进行穿刺，然后将导丝200的一端穿入病变血管并穿过血栓410，同时将导丝200的另一端穿入取栓装置100的导丝腔1212。将取栓装置100的前端沿导丝200送入血管，在送达到血 管400狭窄处后，保持吸栓组件不动，通过推动第一连接件123将取栓组件继续沿导丝200移动至穿过病变血栓410。然后将注射器300与充液接口1231连接，用碘帕淳将球囊122充压至球囊122与血管壁贴合。通过拉动第一连接件123将取栓组件往吸栓头113方向移动，同时将吸栓组件的驱动件114和负压抽吸装置116开启。通过吸栓头113中的碎栓刀115将血栓切碎，同时通过负压抽吸装置116产生的负压将血栓排到收集袋117中，当血栓清除完毕，即可将球囊122泄压，恢复到收缩形态，关掉驱动件114和负压抽吸装置116。取栓结束，将取栓装置100撤出体外。
参见图9，在另一实施例中，一组吸栓组件也可以配备多组取栓组件，从而可以同时清理多分支血管腔内的血栓。具体地，一实施例的取栓装置500，用于沿着多根导丝200分别清除不同血管里的血栓。取栓装置500包括吸栓组件510以及多组吸栓组件520。其中，吸栓组件510与前述实施例中描述的取栓组件结构相似，包括外管、传动管、吸栓头以及驱动件，外管套设在传动管外，并且外管与传动管之间具有间隙，血栓被吸入、粉碎后可经由该间隙排出。进一步地，外管的一端与吸栓头连接，吸栓头用于吸入并粉碎血栓，吸栓头内设置有用于粉碎血栓的碎栓刀，传动管的两端分别连接碎栓刀以及驱动件，从而将驱动件的扭矩传递至碎栓刀，以驱动碎栓刀转动。在一个实施例中，驱动件可以为旋转马达，吸栓头可以为金属或医用高分子与金属的复合材料，外管为医用高分子材料或医用高分子与金属的复合材料，以及传动管为金属材料或医用高分子与金属的复合材料。
进一步地，多组取栓组件520均穿过传动管以及驱动件，并且每个取栓组件520都能与吸栓组件510相对移动。具体地，每个取栓组件520包括球囊以及与球囊连接的多腔管，其中，球囊能收缩或充液膨胀，即球囊具有收缩状态以及在充液后的膨胀状态。在收缩状态时，球囊可以贴合在多腔管的表面。在膨胀状态时，球囊体积可以变大至球囊表面与血管内壁紧密贴合。多腔管内设置有用于对球囊充液的充液腔以及用于穿设导丝的导丝腔。具体地，每根多腔管的导丝腔分别用于穿设不同的导丝，从而多组取栓组件520能分别沿着不同 的导丝移动到不同的血管分支中，从而将不同的血管分支中的血栓牵引到吸栓头附近。
需要说明的是，吸栓组件510以及每套取栓组件520的其他特征在不矛盾的情况下均可以与上一实施例相同设置，在此不做赘述。
上述取栓装置500的吸栓组件510中穿设有多组取栓组件520，并且每套取栓组件520均能在吸栓组件510的轴向上相对吸栓组件510移动。在吸栓组件510的外管无法到达的一些多分支的小直径血管区域，多组取栓组件520可以分别沿着不同的导丝移动至不同的分支血管中。然后，通过可充液膨胀的球囊，将不同的分支血管中的血栓牵引到吸栓头附近，提高了取栓效率。此外，吸栓头能吸入并粉碎血栓，进而将血栓清除。球囊膨胀后能与血管内壁紧密贴合，从而在拉动时，可以将粘附在血管壁的血栓清除干净。
参见图10，本申请示例性实施例还提供了一种取栓方法，该取栓方法用于上述各实施例中的取栓装置。该取栓方法包括以下步骤。
S100，将导丝的一端穿入血管并穿过血栓，并将导丝的另一端穿入取栓装置的导丝腔。
S200，将取栓装置沿导丝送入血管，并在到达所述血管的收窄处后，保持吸栓组件静止。
S300，推动取栓组件继续沿导丝向前移动以穿过血栓。
S400，通过多腔管向球囊充液，使球囊从收缩状态进入充液膨胀状态。
S500，将取栓组件向吸栓头方向拉动，将血栓牵引至吸栓头附近。
S600，吸栓头将附近的血栓吸入，通过碎栓刀将血栓切碎，并将切碎后的血栓排出。
上述方法中的各步骤在取栓装置的实施例中已经进行了详细描述，这里不再赘述。应该理解的是，虽然图10的流程图中的各个步骤按照箭头的指示依次显示，但是这些步骤并不是必然按照箭头指示的顺序依次执行。除非本文中有明确的说明，这些步骤的执行并没有严格的顺序限制，这些步骤可以以其它的顺序执行。而且，图10中的至少一部分步骤可以包括多个子步骤或者多个阶段， 这些子步骤或者阶段并不必然是在同一时刻执行完成，而是可以在不同的时刻执行，这些子步骤或者阶段的执行顺序也不必然是依次进行，而是可以与其它步骤或者其它步骤的子步骤或者阶段的至少一部分轮流或者交替地执行。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请的保护范围应以所附权利要求为准。

Claims (20)

  1. 一种取栓装置，用于沿着导丝清除血栓，其特征在于，所述取栓装置包括：
    吸栓组件，包括外管、传动管、驱动件以及吸栓头，所述外管套设在所述传动管外，并且所述外管的一端与所述吸栓头连接，所述吸栓头内设置有碎栓刀，所述吸栓头用于吸入并粉碎血栓，所述传动管的两端分别连接所述碎栓刀以及所述驱动件，所述驱动件用于驱动传动管旋转；以及，
    取栓组件，用于将血栓牵引至所述吸栓头，包括多腔管以及设置于所述多腔管一端的球囊，所述球囊具有收缩状态和充液膨胀状态，所述多腔管内设置有用于对所述球囊充液的充液腔以及用于穿设所述导丝的导丝腔，所述多腔管依次穿过所述传动管以及所述吸栓头，并使所述取栓组件能与所述吸栓组件在轴向上相对移动。
  2. 根据权利要求1所述的取栓装置，其中，所述取栓组件还包括第一连接件，所述第一连接件套设在所述多腔管的远离所述球囊的一端，所述第一连接件上设置有与所述充液腔连通的充液接口以及与所述导丝腔连通的导丝接口。
  3. 根据权利要求2所述的取栓装置，其中，所述取栓组件还包括锥形头，所述锥形头与所述多腔管的远离所述第一连接件的一端连接，所述锥形头具有内部空腔，并且所述内部空腔与所述导丝腔连通，使得所述导丝能穿出锥形头。
  4. 根据权利要求3所述的取栓装置，其中，所述锥形头的直径沿朝向所述第一连接件方向逐渐增大。
  5. 根据权利要求1所述的取栓装置，其中，在所述收缩状态时，所述球囊贴合在所述多腔管的表面。
  6. 根据权利要求1所述的取栓装置，其中，在所述充液膨胀状态时，所述球囊体积变大至所述球囊表面与血管内壁紧密贴合。
  7. 根据权利要求1所述的取栓装置，其中，所述球囊套设在所述多腔管外，所述多腔管的侧壁上开设有连通所述充液腔与所述球囊内部的球囊充液口。
  8. 根据权利要求1所述的取栓装置，其中，所述外管与所述传动管之间具有间隙，所述间隙用于将被所述吸栓组件吸入并粉碎的血栓排出。
  9. 根据权利要求1所述的取栓装置，其中，所述取栓组件还包括显影丝，所述显影丝设置在所述多腔管外，并位于所述球囊的两端。
  10. 根据权利要求1所述的取栓装置，其中，所述吸栓组件还包括第二连接件，所述第二连接件套设在所述外管的远离所述吸栓头的一端，所述第二连接件上设置有吸栓接口和传动管接口，所述吸栓接口与所述外管的内部连通，以及所述传动管接口用于穿设所述传动管。
  11. 根据权利要求10所述的取栓装置，其中，所述吸栓组件还包括负压抽吸装置，所述负压抽吸装置设有吸入口，所述吸入口与所述吸栓接口连通。
  12. 根据权利要求11所述的取栓装置，其中，所述负压抽吸装置还设有排出口，所述排出口连接至收集袋。
  13. 根据权利要求1所述的取栓装置，其中，所述吸栓头为中空结构，所述碎栓刀设置于所述吸栓头内并套设于所述多腔管外，并且所述吸栓头的端面开设有用以穿设所述多腔管的拉栓孔。
  14. 根据权利要求13所述的取栓装置，其中，所述吸栓头的侧面设置有用于吸入血栓的至少一个取栓孔，所述碎栓刀的侧面设有刀锋，并且所述取栓孔朝向所述刀锋。
  15. 根据权利要求13所述的取栓装置，其中，所述吸栓头的端面还开设有用于吸入血栓的至少一个取栓孔，所述碎栓刀的端面设有刀锋，并且所述取栓孔朝向所述刀锋。
  16. 根据权利要求15所述的取栓装置，其中，所述拉栓孔设置于所述吸栓头的端面中心。
  17. 根据权利要求16所述的取栓装置，其中，所述取栓孔的数量为多个，所述多个取栓孔沿所述拉栓孔的周向均匀设置。
  18. 根据权利要求13所述的取栓装置，其中，所述碎栓刀设置有中间通孔，并且所述中间通孔与所述拉栓孔连通；所述多腔管直径小于所述传动管的直径、 所述拉栓孔的直径，以及所述中间通孔的直径。
  19. 根据权利要求1所述的取栓装置，其中，所述取栓组件的数量为多组，所述多组取栓组件均穿过所述传动管以及所述吸栓头，并且每组所述取栓组件均能与所述吸栓组件相对移动，所述多组取栓组件分别套设在不同的导丝外。
  20. 一种使用如权利要求1～19中任意一项所述的取栓装置的取栓方法，所述方法包括：
    将所述导丝的一端穿入所述血管并穿过所述血栓，并将所述导丝的另一端穿入所述取栓装置的导丝腔；
    将所述取栓装置沿所述导丝送入所述血管，并在到达所述血管的收窄处后，保持所述吸栓组件静止；
    推动所述取栓组件继续沿所述导丝向前移动以穿过所述血栓；
    通过所述多腔管向所述球囊充液，使所述球囊从所述收缩状态进入所述充液膨胀状态；
    将所述取栓组件向所述吸栓头方向拉动，将所述血栓牵引至所述吸栓头附近；以及
    所述吸栓头将附近的所述血栓吸入，通过所述碎栓刀将所述血栓切碎，并将切碎后的所述血栓排出。
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BR112021010894A2 (pt) 2021-08-31
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