WO2022214020A1 - 取栓支架、取栓系统、取栓装置、碎栓支架及碎栓装置 - Google Patents

取栓支架、取栓系统、取栓装置、碎栓支架及碎栓装置 Download PDF

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Publication number
WO2022214020A1
WO2022214020A1 PCT/CN2022/085491 CN2022085491W WO2022214020A1 WO 2022214020 A1 WO2022214020 A1 WO 2022214020A1 CN 2022085491 W CN2022085491 W CN 2022085491W WO 2022214020 A1 WO2022214020 A1 WO 2022214020A1
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WIPO (PCT)
Prior art keywords
bracket
stent
thrombus
support
thrombectomy
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PCT/CN2022/085491
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English (en)
French (fr)
Inventor
陈学明
李建民
周祥
王永胜
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杭州唯强医疗科技有限公司
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Publication of WO2022214020A1 publication Critical patent/WO2022214020A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00464Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for use with different instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00469Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001Angioplasty, e.g. PCTA
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320056Tunnelers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320775Morcellators, impeller or propeller like means

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to a thrombectomy stent, a thrombectomy system, a thrombectomy device, a thrombus breaking support and a thrombus breaking device.
  • VTE Venous thromboembolism
  • DVT lower extremity deep vein thrombosis
  • PE pulmonary embolism
  • Deep vein thrombosis of the lower extremities is a high-incidence vascular surgical disease.
  • Pulmonary embolism has become the third leading cause of death from cardiovascular disease. Risk factors for pulmonary embolism include both environmental factors and personal factors. Personal factors include age, previous VTE history, tumor history, cardiopulmonary failure, congenital or acquired coagulation disorders, and hormone therapy. Acute PE can lead to systemic hypotension or even total heart failure, resulting in patient death.
  • thrombus removal can relieve venous obstruction, effectively prevent PE, protect valve function, and reduce the recurrence rate of thrombus.
  • the existing stent for thrombectomy may have insufficient contact force with the vessel wall during thrombectomy, resulting in an unsatisfactory thrombectomy effect.
  • One object of the present application is to provide a stent for thrombectomy, so as to optimize the structure of the stent for thrombus removal in the prior art and improve the effect of thrombectomy on thrombus.
  • An object of the present application is to provide a thrombectomy device, so as to optimize the structure of the thrombectomy device in the prior art and improve the thrombectomy effect on thrombus.
  • An object of the present application is to provide a thrombectomy system, so as to optimize the structure of the thrombectomy system in the prior art and improve the thrombectomy effect on thrombus.
  • An object of the present application is to provide a thrombus-fragmentation stent, so as to optimize the structure of the thrombus-fragmentation stent in the prior art and improve the thrombectomy effect on thrombus.
  • One object of the present application is to provide a thrombectomy device, so as to optimize the structure of the thrombectomy device in the prior art and improve the thrombectomy effect on thrombus.
  • the present application provides a thrombus retrieval stent, which has a compressed state during delivery and an expanded state during thrombus retrieval, and can be elastically expanded from the compressed state to the expanded state
  • the thrombus retrieval stent comprising:
  • the separating stent is used to scrape away the thrombus located on the inner wall of the blood vessel;
  • the supporting stent is connected to the distal end of the separating stent; during thrombectomy, the separating stent and the supporting stent define an inner cavity for accommodating the thrombus , the proximal end of the separation stent is formed with an opening for allowing the thrombus to enter the inner cavity,
  • the elastic support strength of the separation stent is greater than the elastic support strength of the support stent, and the flexibility of the support stent is greater than that of the separation stent and a filter membrane, the filter membrane is connected to at least the support bracket, and the filter membrane is used to filter the thro
  • the present application provides a thrombectomy device, comprising the above-mentioned thrombus retrieval support; a traction catheter connected to the thrombus removal support; and an outer sheath tube, the traction catheter and the thrombus removal support Slidably connected in the outer sheath tube, the traction catheter drives the thrombus removal bracket to extend or retract the outer sheath tube; the expanded state; the thrombectomy stent retracts the outer sheath, and the thrombectomy stent is in the compressed state.
  • the present application provides a thrombus retrieval device, comprising a traction catheter and a thrombus retrieval stent disposed at the distal end of the traction catheter;
  • the thrombus retrieval stent includes: a separation stent, which is radially retractable and the expanded stent structure, the proximal end of which is connected with the traction catheter; the proximal end of the separation stent is formed with an opening;
  • the support stent is a stent structure that can contract and expand in the radial direction, and its proximal end is separated from the The stents are connected in the axial direction, and the distal end thereof forms a closed end that is gradually converged; and a filter screen film is arranged on the peripheral wall of the support stent, and the filter screen film is densely covered with mesh holes; wherein, the separation The radial support force of the stent is greater than that of the support stent; the flexibility of the support stent; the
  • the present application provides a thrombectomy system, comprising the thrombectomy device as described above; and a thrombus breaking device, comprising a thrombus holder and a delivery tube connected to the thrombus holder, the thrombus holder and the delivery tube are slidably connected in the traction catheter, and the delivery tube drives the thrombus stent to extend or retract the traction catheter; the thrombus stent extends out of the traction catheter and enters the thrombectomy inside the bracket, and the bolt-breaking bracket changes from a compressed state to an expanded state; the delivery tube drives the bolt-breaking bracket to rotate in the bolt-removing bracket, and the bolt-removing bracket and the bolt-removing bracket have the same function during rotation. interval.
  • the present application provides a thrombectomy stent and a traction catheter, the traction catheter is connected to the thrombectomy stent, and the thrombectomy stent is used to scrape off the thrombus on the inner wall of the blood vessel.
  • the thrombus is inserted into the thrombectomy stent; the thrombectomy stent and the delivery tube can be slidably connected to the traction catheter; wherein, the delivery tube is connected to the thrombus-breaking stent to drive the thrombus-breaking stent from the thrombectomy stent.
  • the distal end of the traction catheter is discharged into the thrombectomy bracket, and the delivery tube drives the thrombus breaking bracket to rotate in the circumferential direction in the thrombus retrieval bracket to break the thrombus; after the thrombus is broken, the delivery tube also
  • the fragmentation stent can be driven into the distraction catheter from the distal end of the distraction catheter and driven out of the proximal end of the distraction catheter.
  • the present application provides a thrombus retrieval system, comprising: a thrombus retrieval stent, which is a stent structure that can be contracted and expanded in a radial direction, the proximal end of which has an opening and the distal end of which is closed outer sheath tube; traction catheter, the distal end of which is connected with the thrombectomy bracket; the traction catheter is movably arranged in the outer sheath tube, and can move relative to the outer sheath tube in the axial direction; , which is a radially retractable and expandable stent structure; a delivery tube, the distal end of which is connected with the fragmentation stent; the delivery tube movably passes through the traction catheter and can be axially opposite The traction catheter moves; wherein, the delivery pipe can rotate relative to the traction catheter in the circumferential direction, so as to drive the thrombus fragmentation bracket to rotate circumferentially in the internal space of the throm
  • the thrombectomy bracket is slidably connected to the distal end of the traction catheter, so that the thrombus retrieval bracket can move relative to the traction catheter in the axial direction.
  • the thrombectomy system further comprises a joint conduit and a branch conduit connected to the joint conduit; the distal end of the joint conduit is connected with the proximal end of the traction conduit; the delivery conduit is movable It is passed through the joint conduit and the traction conduit, and can be withdrawn from the joint conduit from the proximal end of the joint conduit; the proximal end of the joint conduit is provided with a switch, and the switch is used to connect the joint to the joint conduit.
  • the proximal port of the conduit is opened and closed; one end of the branch conduit is connected to the peripheral wall of the joint conduit and communicated with the lumen of the joint conduit, and the other end of the branch conduit is used for external suction power.
  • the switch includes a screw cap and a sealing ring; the screw cap is rotatably connected to the proximal end of the joint conduit, and the sealing ring is arranged in the proximal port of the joint conduit and clamped between the between the screw cap and the proximal port of the joint conduit; the conveying pipe is movably penetrated in the screw cap and the sealing ring in the axial direction, and can exit the sealing ring; the screw cap can Forward or reverse rotation and synchronously squeeze or release the sealing ring to close or open the proximal port of the connector conduit through the sealing ring.
  • the present application further provides a thrombectomy device, which includes a traction catheter and a thrombus retrieval bracket disposed at the distal end of the traction catheter;
  • the thrombus retrieval bracket includes: a separation bracket, which is A radially retractable and expandable stent structure, the proximal end of which is connected to the traction catheter; an opening is formed at the proximal end of the separation stent;
  • a support stent is a radially retractable and expandable stent structure, the proximal end of which is The end is axially connected to the separating support, and the distal end thereof forms a closed end that is gradually converged; and a filter screen membrane is arranged on the peripheral wall of the support bracket, and the filter screen membrane is densely covered with mesh holes;
  • the radial support force of the separation bracket is greater than that of the support bracket; the flexibility of the support bracket is greater than that of the separation bracket.
  • the wall thickness of the support bracket is smaller than that of the separation bracket.
  • a plurality of diamond-shaped mesh units distributed circumferentially are formed at the proximal end of the support stent, and the proximal apex of the diamond-shaped mesh units is wound and connected to the distal end of the separation stent through a wire.
  • the distal end of the support stent is formed with a plurality of support rods arranged at circumferential intervals; the support rods extend along the axial direction of the support stent, and in the direction from the proximal end to the distal end , the radial dimension of the support rod gradually decreases.
  • the separation bracket includes a support body whose distal end is connected to the support bracket, a plurality of connecting rods connected to the proximal end of the support body, and a connecting ring connected to the proximal ends of the plurality of connecting rods;
  • the support body is a tubular stent structure with a circumferential closed loop; a plurality of the connecting rods are arranged at intervals in the circumferential direction, the proximal ends of the plurality of connecting rods are convergently connected to the connecting ring, and the adjacent connecting rods are between A proximal opening of the separation stent is formed; the connecting ring is connected to the traction catheter.
  • the proximal end of the separation stent is slidably connected to the distal end of the traction catheter.
  • the present application further provides a thrombus fragmentation stent for cutting thrombus in a blood vessel, the thrombus fragmentation stent comprising: a fixing member; a first stent, one end of which is connected to the fixing member, and the fixing member is The rotation of the first bracket drives the first support to rotate to form a first rotating cutting curved surface for cutting the thrombus; the second support has one end connected to the fixing piece, and the fixing piece rotates to drive the second support to rotate to form a surface for cutting the thrombus.
  • a second rotating cutting curved surface for cutting the thrombus wherein, at least part of the first rotating cutting curved surface and the second rotating cutting curved surface are spaced apart.
  • the present application further provides a broken bolt stent, which includes: a first stent, which is a stent structure that can be contracted and expanded in a radial direction, the first stent having a support for cutting A first stem of the thrombus; and a second stent, which is a stent structure capable of contracting and expanding in the radial direction, the second stent is coaxially disposed inside and outside the first stent, and the proximal end of the second stent is connected to the The proximal end of the first stent is connected, and the second stent is provided with a second cutting rod for cutting the thrombus; wherein, in the direction from the proximal end to the distal end, the first cutting rod and the second cutting rod
  • the cutting rods all have varying radial dimensions; when the first support and the second support rotate coaxially, the first cutting rod rotates to form a first rotating cutting surface, and the second cutting rod rotates to
  • the second rotating cutting surface is wrapped within the first rotating cutting surface.
  • a plurality of the first cutting rods and the second cutting rods are respectively provided, and the plurality of the first cutting rods and the plurality of the second cutting rods are respectively arranged at intervals in the circumferential direction, And the first cutting rod and the second cutting rod are arranged at a cross interval in the circumferential direction.
  • the first bracket further includes a coaxially spaced first fixing member and a first annular ring, the first annular ring is located on the distal side of the first fixing member, and the The first cut rod is connected and formed between the first fixing member and the first ring;
  • the second bracket further includes a second fixing member and a second ring that are coaxially spaced apart;
  • the second The fixing member is connected to the distal end of the first fixing member;
  • the second annular ring is located at the distal end side of the second fixing member and at the proximal end side of the first annular ring at intervals;
  • the A second cutting rod is connected and formed between the second fixing member and the second ring.
  • the distal end of the first fixing member is concavely provided with a locking groove
  • the proximal end of the second fixing member is convexly provided with a locking protrusion adapted to the locking groove
  • the inserting protrusion is fitted and connected in the inserting groove, so that the second fixing piece is coaxially connected to the distal end of the first fixing piece.
  • the peripheral wall of the first fixing member is provided with a first opening that communicates with the lumen thereof; the peripheral wall of the second fixing member is provided with a second opening that communicates with the lumen thereof.
  • the second annular rings are provided at intervals on the proximal end side of the first annular ring, or the second annular ring is integrally connected to the proximal end side of the first annular ring.
  • the present application further provides a thrombus breaking device, which comprises a thrombus breaking support and a delivery tube; the thrombus breaking support adopts the above-mentioned thrombus breaking support; the distal end of the delivery tube is pierced through at the axis of the broken bolt support and connected with the broken bolt support; wherein, the proximal ends of the first support and the second support are fixedly sleeved on the conveying tube, and the first support Both the stent and the proximal ends of the second stent are movably sleeved on the delivery tube.
  • a thrombus breaking device which comprises a thrombus breaking support and a delivery tube; the thrombus breaking support adopts the above-mentioned thrombus breaking support; the distal end of the delivery tube is pierced through at the axis of the broken bolt support and connected with the broken bolt support; wherein, the proximal ends of the first support and the second support are fixed
  • the bolt breaking device further includes a driving handle, which is connected to the proximal end of the delivery tube and can drive the delivery tube and the bolt breaking support to rotate in the circumferential direction.
  • the bolt breaking device further includes a loading tube, which is movably sleeved on the conveying tube; the loading tube can move to the distal end of the conveying tube, and is sleeved on the conveying tube.
  • the first bracket and the second bracket are both accommodated in the loading tube.
  • the embodiments of the present application at least have the following advantages and positive effects:
  • the separation stent provides better elastic support strength through its higher elastic performance, which can make the contact force between the separation stent and the inner wall of the blood vessel greater, thereby making the thrombus on the inner wall of the blood vessel easier to scrape
  • the removal of the thrombus improves the thrombectomy effect of the thrombectomy bracket.
  • the flexibility of the support bracket is greater than that of the separation bracket, and the flexibility of the support bracket is greater than that of the separation bracket, so it can be better adapted to the deformation of the filter membrane, and can Reduce the possibility that the support stent is easy to break the filter membrane due to its high elastic support strength, or support the area of the pore structure on the filter membrane to be larger, resulting in a poor blocking effect of the filter membrane on thrombus. possibility.
  • the outer sheath tube is used to accommodate the thrombectomy stent and the traction catheter; the traction catheter is used to accommodate the thrombectomy stent and the delivery tube;
  • the thrombus is contained in the thrombectomy stent; the thrombectomy stent is then used to cooperate with the delivery tube, so that the thrombectomy stent is extended into the thrombectomy stent for rotation, and the thrombus in the thrombectomy stent is cut into small particles, which is beneficial to the treatment of stubborn, The larger and harder thrombus is crushed;
  • the delivery tube is used to drive the thrombectomy stent to exit the traction catheter, and the traction catheter can also be used as a suction catheter. It can effectively prevent pulmonary embolism caused by omission of small thrombus, thereby improving the effect of thrombectomy.
  • FIG. 1 is a schematic diagram of the overall structure of the thrombectomy system according to the first embodiment of the present application.
  • FIG. 2 is a partial perspective view of the thrombectomy system of FIG. 1 .
  • FIG. 3 is a schematic view of the structure of the bolt removal bracket in FIG. 1 .
  • FIG. 4 is a plan view of FIG. 3 .
  • FIG. 5 is an enlarged schematic structural diagram of the area A in FIG. 4 .
  • FIG. 6 is a schematic view of the structure of the separated stent in FIG. 3 .
  • FIG. 7 is a side view of FIG. 6 .
  • FIG. 8 is a schematic structural diagram of the support bracket in FIG. 3 .
  • FIG. 9 is a side view of FIG. 8 .
  • FIG. 10 is a schematic structural diagram of the filter screen membrane in FIG. 3 .
  • FIG. 11 is a side view of FIG. 10 .
  • FIG. 12 is a schematic structural diagram of the plug breaking device in FIG. 1 .
  • FIG. 13 is a schematic view of the structure of the first embodiment of the bolt support in FIG. 12 .
  • FIG. 14 is a side view of FIG. 13 .
  • FIG. 15 is a plan view of FIG. 13 .
  • FIG. 16 is a schematic view of the structure of the second embodiment of the bolt support in FIG. 12 .
  • FIG. 17 is a side view of FIG. 16 .
  • FIG. 18 is a plan view of FIG. 16 .
  • FIG. 19 is a schematic structural diagram of the first bracket in FIG. 16 .
  • FIG. 20 is a schematic structural diagram of the second bracket in FIG. 16 .
  • FIG. 21 is a schematic view of the structure of the third embodiment of the bolt support in FIG. 12 .
  • FIG. 22 is a side view of FIG. 21 .
  • FIG. 23 is a schematic view of the structure of the fourth embodiment of the bolt support in FIG. 12 .
  • FIG. 24 is a schematic structural diagram of the outer sheath tube in FIG. 1 .
  • FIG. 25 is a schematic view of the structure of the sheath joint in FIG. 24 .
  • FIG. 26 is a schematic structural diagram of the traction catheter, the joint catheter, the branch catheter and the suction syringe in FIG. 1 .
  • FIG. 27 is a cross-sectional view of the connector conduit of FIG. 26 .
  • Fig. 28 is a schematic diagram of a diseased portion of the inferior vena cava in a human body.
  • FIG. 29 is a schematic diagram of the thrombectomy system of FIG. 1 puncturing into a lesion.
  • Fig. 30 is a schematic diagram of the start of release of the bolt retrieval stent.
  • Figure 31 is a schematic diagram of the release and adjustment of the bolt retrieval bracket.
  • Fig. 32 is a schematic diagram after the bolt retrieval bracket is released.
  • Figure 33 is a schematic diagram of the thrombectomy stent separating and collecting intravascular thrombus.
  • Fig. 34 is a working schematic diagram of the thrombectomy device for thrombectomy in the thrombectomy stent.
  • Figure 35 is a schematic illustration of the withdrawal of the thrombus device after the thrombus is complete.
  • Figure 36 is a schematic diagram of aspiration of a thrombus.
  • Figure 37 is a schematic diagram of the thrombectomy stent being separated again and collecting the thrombus.
  • Figure 38 is a schematic view of the thrombus breaking device re-entering the joint catheter and the traction catheter.
  • FIG. 39 is a schematic diagram of aspirating thrombus according to the second embodiment of the present application.
  • FIG. 40 is a schematic structural diagram of the thrombectomy device in the third embodiment of the present application.
  • FIG. 41 is a schematic structural diagram of FIG. 40 in another state.
  • FIG. 42 is a schematic structural diagram of a fourth embodiment of the present application.
  • FIG. 43 is a schematic structural diagram of a fifth embodiment of the present application.
  • FIG. 44 is a schematic structural diagram of the sixth embodiment of the present application.
  • first and second are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, features defined as “first”, “second” may expressly or implicitly include one or more of said features. In the description of the present application, “plurality” means two or more, unless otherwise expressly and specifically defined.
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • installed should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • proximal end refers to the end of the thrombus removal support or the thrombus removal support that is close to the operating end (driving handle 41)
  • distal end refers to the distal end of the thrombus removal support or the thrombectomy support away from the operation (the drive handle 41).
  • a thrombectomy system provided by an embodiment of the present application can be used for rapid and relatively complete removal of occluded thrombus in a blood vessel.
  • the thrombectomy system of the embodiment of the present application mainly includes an outer sheath tube 1, a thrombectomy device, a thrombectomy device and a suction device.
  • the outer sheath tube 1 is used as a loading container for accommodating the thrombectomy device and the thrombectomy device, and for pulling or guiding the thrombectomy device and the thrombectomy device into the diseased part of the blood vessel .
  • the thrombectomy device includes a traction catheter 2 and an expandable thrombectomy stent 3 .
  • the traction catheter 2 is movably passed through the outer sheath tube 1 and can move relative to the outer sheath tube 1 in the axial direction.
  • the thrombus removal bracket 3 is arranged at the distal end of the traction catheter 2, and can drive the thrombus removal bracket 3 to move axially in the outer sheath tube 1 through the traction catheter 2, so that the thrombus removal bracket 3 extends out of the outer sheath tube 1 or shrinks into the outer sheath tube 1.
  • the thrombectomy stent 3 is a stent structure that can contract and expand in the radial direction, so that the thrombectomy stent 3 can be compressed into the outer sheath tube 1 .
  • the thrombectomy stent 3 can be naturally expanded and attached to the inner wall of the blood vessel.
  • the thrombus retrieval stent 3 has a compressed state during delivery and an expanded state during thrombus retrieval, and can elastically expand from the compressed state to the expanded state.
  • the embolectomy support 3 extends out of the outer sheath tube 1, and the embolectomy support 3 is in an expanded state.
  • the thrombus removal bracket 3 is retracted into the outer sheath tube 1, and the thrombus retrieval bracket 3 is in a compressed state.
  • the proximal end of the thrombectomy stent 3 has an opening, and cooperates with the peripheral wall of the thrombectomy stent 3 to perform thrombus cutting, so that the thrombus in the blood vessel enters the inner space of the thrombectomy stent 3 through the opening. It can be understood that there may be a plurality of the openings.
  • the distal end of the thrombectomy stent 3 is closed, so as to collect and capture the thrombus, so that the thrombus is collected inside the thrombectomy stent 3 .
  • distal end of the thrombectomy stent 3 is closed, so as to collect and capture the thrombus, so that the thrombus is collected inside the thrombectomy stent 3 .
  • distal closure in this application means that the distal end of the thrombectomy stent 3 is sufficient to capture thrombus.
  • the pore size at the end is smaller than the size of the opening at the proximal end.
  • the bolt removal bracket 3 includes a self-expanding separation bracket 31 , a self-expanding support bracket 32 , a filter screen membrane 33 and a guide head 34 .
  • the operator can reciprocate the thrombectomy stent 3 along the axial direction of the blood vessel, and scrape off the thrombus on the inner wall of the blood vessel by separating the stent 31 .
  • a separation bracket 31 is formed at the proximal end of the bolus retrieval bracket 3 .
  • the separation stent 31 is a stent structure that can contract and expand in the radial direction.
  • the proximal end of the separation stent 31 is connected to the traction catheter 2 .
  • the "connected” may be a fixed connection in the axial direction or a sliding connection in the axial direction.
  • This embodiment first introduces the situation of the fixed connection, and the situation of the sliding connection is introduced in the following embodiments.
  • An opening is formed at the proximal end of the separation stent 31 , and the opening serves as the proximal end opening of the thrombectomy stent 3 and is used to collect the thrombus in the blood vessel.
  • the distal end of the separation bracket 31 is connected with the proximal end of the support bracket 32 , so that the separation bracket 31 is connected with the support bracket 32 and the inside of the separation bracket 31 is communicated with the inside of the support bracket 32 .
  • “the separation bracket 31 and the support bracket 32 are connected” means that the separation bracket 31 and the support bracket 32 can be processed independently and then connected together, or the separation bracket 31 and the support bracket 32 can be directly integrally formed. overall.
  • the separation bracket 31 of this embodiment includes a support body 311 whose distal end is connected to the support bracket 32 , a plurality of connecting rods 312 connected to the proximal end of the support body 311 , and a plurality of connecting rods 312 .
  • the connecting ring 313 at the proximal end can also be a connecting piece of other structure without a through hole.
  • the connecting ring 313 is sleeved on the traction catheter 2 , so that the thrombectomy bracket 3 is connected to the traction catheter 2 .
  • the support body 311 is a bare stent structure and is a tubular stent structure with a circumferentially closed loop in the unfolded state; or the support body 311 is annular in the circumferential direction and is a mesh stent structure.
  • the support body 311 can provide a good radial support force for the separation stent 31, so that the separation stent 31 can better fit with the inside of the blood vessel, thereby completely cutting and separating the thrombus in the blood vessel and the inner wall of the blood vessel. And collect the thrombus, so that the thrombus can enter the thrombectomy stent 3 completely.
  • the support body 311 includes a plurality of V-shaped rods that are connected circumferentially and axially.
  • a plurality of circumferentially adjoining plurality of V-shaped rods may form a wave loop.
  • the wave ring has crests and troughs staggered in the circumferential direction, with the crests toward the proximal end and the troughs toward the distal end. According to the number of V-shaped rods connected in the circumferential direction, different numbers of troughs can be formed at the distal end of the support body 311 , and the troughs are used as connection points to facilitate the connection with the support bracket 32 .
  • a plurality of axially connected V-shaped rods can form a plurality of first rhombus mesh units 310 , and when the support body 311 is expanded, the first rhombus mesh units 310 can also directly cut the thrombus, so that the thrombus can enter the separation stent 31 .
  • the proximal end and the distal end of the first diamond mesh unit 310 may also form wave crests and wave troughs, respectively.
  • the number of the V-shaped rods at the proximal end of the support body 311 can be adjusted step by step, so as to form different numbers of wave crests so as to be connected with different numbers of the connecting rods 312 at the proximal end.
  • the number of troughs at the distal end of the support body 311 is greater than the number of wave crests at the proximal end of the support body 311 .
  • the grid cells in this application are not limited to the diamond-shaped grid cells 310, and can also be grid cells of other shapes, such as ellipses, triangles, etc., and the sides of the grid cells can also be straight or curved. side.
  • the first rhombus mesh unit 310 can be stretched and deformed along the axial direction of the support body 311, so that the support body 311 has a strong radial support force and the ability to adhere to the blood vessel, and the separation stent 31 can be extended along the axial direction of the support body 311. Radial compressible and expandable.
  • the filter mesh membrane 33 is at least connected to the support bracket 32, and the filter mesh membrane 33 is provided with a hole structure, so that the filter mesh membrane 33 is used for filtering thrombus and passing blood.
  • the elastic support strength of the separation bracket 31 is greater than that of the support bracket 32 , and the flexibility of the support bracket 32 is greater than the flexibility of the separation bracket 31 .
  • the support body 311 and/or the connecting rod 312 in the separation stent 31 are used to scrape away the thrombus located on the inner wall of the blood vessel.
  • the separation stent 31 provides better elastic support strength through its higher elastic performance, which can make the contact force between the separation stent 31 and the inner wall of the blood vessel greater, so that the thrombus on the inner wall of the blood vessel is easier to scrape off.
  • the filter membrane 33 is connected to the support bracket 32, and the support bracket 32 provides support for the filter membrane 33, so that the filter membrane 33 maintains a relatively stable shape.
  • the elastic support strength of may be smaller than the support strength of the separation bracket 31 . Since the filter membrane 33 is at least connected to the support bracket 32, the flexibility of the support bracket 32 is greater than that of the separation bracket 31, and the flexibility of the support bracket 32 is good, so that it can be better adapted to the deformation of the filter membrane 33, It can prevent the support bracket 32 from easily breaking the filter screen membrane 33 due to its high elastic support strength, or the area of the hole structure on the filter screen membrane 33 is supported to be larger, resulting in the blocking effect of the filter screen membrane 33 on thrombus. not good.
  • the connecting rod 312 is disposed at the proximal end of the support body 311 , and the distal end of the connecting rod 312 is connected to the wave crest at the proximal end of the support body 311 .
  • the plurality of connecting rods 312 are arranged at intervals in the circumferential direction, the proximal ends of the plurality of connecting rods 312 are convergently connected to the connecting ring 313 , and adjacent connecting rods 312 form a proximal end opening for separating the stent 31 .
  • the part with the first diamond mesh unit 310 on the left side in FIG. 7 is the support body 311 , and the elastic support strength of the support body 311 is greater than that of the support bracket 32 .
  • the sizes of the plurality of first diamond mesh units 310 may be different; the connecting rod 321 is a strip-shaped structure, and two ends of the connecting rod 321 are respectively connected to the support body 311 and the connecting ring 313 .
  • the connecting rod 321 is a strip-shaped structure, and two ends of the connecting rod 321 are respectively connected to the support body 311 and the connecting ring 313 .
  • the distal ends of the two connecting rods 312 are respectively connected to different first diamond mesh units 310 , and the proximal ends of the two connecting rods 312 are gathered and connected to the connecting ring 313, wherein the gathering refers to that a plurality of objects are close to each other, which can be connected to each other or not connected to each other.
  • the connecting ring 313 is used to connect the traction catheter 2 .
  • the connecting ring 313 is fixedly sleeved on the distal end of the traction catheter 2 .
  • the connecting ring 313 may be arranged on the axis of the support body 311, or may be arranged eccentrically.
  • the entire separation bracket 31 can be manufactured by using a nickel-titanium alloy tube material through a laser cutting process and a heat setting process.
  • the support bracket 32 in this embodiment is disposed at the distal end of the separation bracket 31 .
  • the support stent 32 is a stent structure that can contract and expand in the radial direction.
  • the proximal end of the support bracket 32 is axially connected to the support body 311 of the separation bracket 31 .
  • the distal end of the support stent 32 forms a closed end that is tapered gradually to facilitate capturing and tucking of the thrombus separated from the vessel by the separation stent 31 .
  • the support bracket 32 includes a plurality of grid units and support rods 321 .
  • the proximal end of the grid unit is connected to the separation support 31, there are multiple grid units distributed in a closed loop along the circumferential direction, there are multiple support rods 321, the proximal end of the support rod 321 is connected to the grid unit, and the distal ends of the multiple support rods 321 are connected. With the ends close to each other, the flexibility of the mesh element is greater than that of the split bracket.
  • the plurality of grid units may be a plurality of second rhombus grid units 320 formed at the proximal end of the support bracket 32 and distributed circumferentially.
  • the plurality of second rhombus mesh units 320 can also be formed by connecting a plurality of V-shaped rods in the circumferential direction and the axial direction.
  • the proximal end of the second rhombus mesh unit 320 forms a wave crest, and the wave crest can be used as a connection point to correspond to the wave trough at the distal end of the support body 311 , and is wound and connected by the wire 35 , as shown in FIG. 5 .
  • the second rhombus mesh unit 320 can be stretched and deformed along the axial direction of the support stent 32, so that the support stent 32 has a strong radial support force and the ability to adhere to the wall of the blood vessel, and makes the support stent 32 compressible and compressible in the radial direction. swell. It can be understood that, in the axial direction of the support bracket 32 , one or more layers of the second rhombus mesh units 320 may be provided. The more layers of the second rhombus mesh units 320 , the stronger the radial bending ability of the support bracket 32 is.
  • the supporting stent 32 is not used as a main structure for scraping the thrombus on the thrombus wall, so the elastic supporting strength of the supporting stent 32 is smaller than that of the separating stent 31 .
  • the flexibility of the support bracket 32 is greater than that of the separation bracket 31, for example is that the flexibility of the second rhombus mesh unit 320 is greater than the flexibility of the separation bracket 31, and further, the flexibility of the second rhombus mesh unit 320 is greater than that of the first rhombus mesh unit 310, and the second rhombus mesh
  • the elastic support strength of the lattice unit 320 is smaller than the elastic support strength of the first diamond mesh unit 310 .
  • a plurality of support rods 32 are disposed at the distal end of the support bracket 32 and distributed along the circumferential direction.
  • the support bracket 32 further includes a fixing ring 322 connected to the distal end of the support rod 321 .
  • the support rod 321 can extend along the axial direction of the support bracket 32, and in the direction from the proximal end to the distal end, the radial dimension of the support rod 321 gradually decreases, so that the proximal ends of the plurality of support rods 321 are gradually converged and connected to the support rod 321.
  • the distal ends of the plurality of support rods 321 are close together, and the closeness may mean that the distal ends of the plurality of support rods 321 are directly connected to each other, or it may mean that the distal ends of the plurality of support rods 321 pass through other parts. indirect interconnection.
  • the radial dimension of the structure enclosed or defined by the plurality of the support rods 321 gradually decreases;
  • the radial dimension of the structure enclosed or defined by the support rods 321 remains unchanged at first and then gradually decreases; it is also possible that the radial dimension of the structure enclosed or defined by a plurality of the support rods 321 first increases and then gradually decreases.
  • the support bracket 32 can also be made of nickel-titanium alloy tube material through laser cutting process and heat setting process.
  • the wall thickness of the support bracket 32 is smaller than the wall thickness of the separation bracket 31, that is, the wall thickness of the pipe material used for the support bracket 32 is smaller than the wall thickness of the pipe material used for the separation bracket 31, so that the separation bracket 31 and the support bracket 32 are suitable for the above embodiment.
  • the relationship between elastic support strength and compliance in ; the wall thickness refers to the thickness from the outer surface to the inner surface of the tubular stent structure.
  • the support bracket 32 retains a certain degree of flexibility while providing a certain radial support force, and utilizes the symmetrical and non-fixed characteristics of the second diamond mesh unit 320 to perform appropriate bending deformation, so as to better fit the patient's blood vessels. tortuous properties. That is, the radial support force of the separating stent 31 is greater than that of the supporting stent 32, and the separating stent 31 has better blood vessel adherence ability. At the same time, the flexibility of the support stent 32 is greater than that of the separation stent 31, and the support stent 32 can better adapt to the tortuous characteristics of the blood vessel.
  • the filter screen film 33 is sewn on the peripheral wall of the support bracket 32 .
  • the pore structure on the filter screen membrane 33 can be a microporous structure, and the size of the microporous structure can be selected with a specific pore size according to actual needs.
  • the filter screen membrane 33 can be sewn from a film material with a microporous structure, and the filter screen membrane 33 is densely covered with mesh holes 331 . It will be appreciated that the microporous structure is adapted to allow the passage of blood and to trap thrombi.
  • the filter membrane 33 may be sewn on the inner peripheral wall of the support bracket 32 . Since the support bracket 32 is compressed in the outer sheath tube 1 during delivery, the filter mesh film 33 is sewn on the inner peripheral wall of the support bracket 32 to prevent the filter mesh membrane 33 from being scratched when the support bracket 32 slides in the outer sheath tube 1 or crushed.
  • the filter screen membrane 33 can be sewn on the support rod 321 of the support bracket 32 by using a wire harness.
  • the proximal opening edge of the filter membrane 33 can be sewn on the proximal connecting point of the support bracket 32 .
  • the axial deformation of the support rod 321 is smaller than that of the first diamond mesh unit 310, so the structure of the proximal connection point between the filter membrane 33 and the support bracket 32 can be relatively stable and not damaged.
  • a small hole 332 is provided at the center of the distal end of the filter screen membrane 33 , and the position of the small hole 332 corresponds to the fixing ring 322 .
  • the guide head 34 is disposed at the distal end of the support bracket 32 .
  • the guide head 34 may be attached to a retaining ring 322 at the distal end of the support bracket 32.
  • the distal end of the guide head 34 is a tip, which is used to guide the thrombectomy device and improve the propulsion capability of the thrombectomy device.
  • the center of the guide head 34 and the fixing ring 322 can be passed through by the guide wire, and the guide wire plays a guiding role.
  • the tether breaking device includes a delivery tube 4 , an expandable tumbler breaking support 5 , a driving handle 41 and a loading tube 42 .
  • the delivery tube 4 is movably passed through the traction catheter 2 .
  • the delivery tube 4 can move relative to the traction catheter 2 in the axial direction and can rotate relative to the traction catheter 2 in the circumferential direction.
  • the thrombus-breaking support 5 is arranged at the distal end of the delivery tube 4, and the thrombus-breaking support 5 can be driven to move axially in the traction catheter 2 through the delivery tube 4, so that the thrombus-breaking support 5 extends out of the distal end of the traction catheter 2, and is removed after the removal of the thrombus-breaking support 5.
  • the tumbler bracket 5 is released in the tumbler bracket 3 , or the tumbler bracket 5 is retracted into the traction catheter 2 , and the tumbler bracket 5 can also be driven to completely withdraw from the traction catheter 2 .
  • the thrombus-crushing stent 5 extends out of the traction catheter 2 and enters the thrombectomy-retrieving stent 3, and the thrombus-crushing stent 5 changes from a compressed state to an expanded state.
  • the delivery tube 4 drives the tumbler support 5 to rotate in the tumbler removal bracket 3 , and there is a gap between the tumbler bracket 5 and the tumbler retrieval bracket 3 during rotation.
  • the delivery tube 4 rotates in the circumferential direction, it can also drive the thrombus fragmentation stent 5 to rotate synchronously in the circumferential direction inside the thrombectomy stent 3 to cut and pulverize the thrombus inside the thrombectomy stent 3 .
  • the thrombus enters the inner space enclosed by the thrombectomy stent 3 through the opening of the separation stent 31 in the thrombectomy stent 3 .
  • the delivery tube 4 can be pushed from the proximal end of the delivery tube 4 to the distal direction, so that the delivery tube 4 pushes the thrombus stent 5 to be discharged from the traction catheter 2.
  • the thrombus stent 5 Due to the restriction of the detachment from the traction catheter 2, the thrombus stent 5 can be in itself. Under the elastic force, it expands in the circumferential direction, so that the thrombectomy stent 5 smashes the thrombus inside the thrombectomy stent 3 .
  • FIG. 13 to FIG. 15 are schematic structural diagrams of the first embodiment of the bolt support 5 of the present application.
  • the broken bolt bracket 5 includes a fixing member 51 , a first bracket 52 and a second bracket 53 .
  • the fixing member 51 is a tubular structure. It can be understood that the fixing member 51 may not be a tubular structure, but may also be a fixing member such as a solid rod-shaped structure or a frame structure.
  • the fixing member 51 is fixedly sleeved on the conveying pipe 4 , so that the broken bolt support 5 is fixedly connected with the conveying pipe 4 .
  • the fixing member 51 and the conveying tube 4 can be connected and fixed by means of bonding, for example, medical glue or hot-melt glue is used for fixing.
  • the peripheral wall of the fixing member 51 is provided with an opening, and the opening communicates with the inner cavity of the fixing member 51.
  • Medical glue or hot-melt glue can penetrate into the inner cavity of the fixing member 51 through the opening portion, and the fixing member 51 can be bonded to the inner cavity of the fixing member 51.
  • pipe 4 in order to increase the bonding area between the bolt-breaking bracket 5 and the delivery tube 4, so that the connection between the bolt-breaking bracket 5 and the delivery tube 4 is more stable, and the bolt-breaking bracket 5 has better anti-torsion performance.
  • the first bracket 52 includes two first cutting rods 521 symmetrically distributed in the circumferential direction and a first ring 522 disposed at the distal end of the first cutting rods 521 .
  • the proximal end of the first cutting rod 521 is connected to the fixing member 51
  • the distal end of the first cutting rod 521 is connected to the first ring 522 .
  • the first cutting rod 521 has varying radial dimensions
  • the first annular ring 522 is coaxially arranged with the fixing member 51, and is movably sleeved on the delivery tube 4, so that the The first ring 522 can move relative to the fixing member 51 in the axial direction, and enables the first cutting rod 521 to freely compress and expand, so that the first stent 52 can form a stent structure that can contract and expand in the radial direction.
  • the first cutting rod 521 When the first stent 52 rotates with the fixing member 51 in the circumferential direction, the first cutting rod 521 can form a first rotating cutting curved surface, which can cut the thrombus.
  • the first cutting rod 521 can be semicircular, semielliptical, V-shaped, or W-shaped, etc., so as to form rotating cutting surfaces of different shapes. It can be understood that, the first cutting rods 521 can be provided with three, four or more, and are arranged at intervals in the circumferential direction.
  • the second bracket 53 includes two second cutting rods 531 symmetrically distributed in the circumferential direction and a second ring 532 disposed at the distal end of the second cutting rods 531 .
  • the proximal end of the second cutting rod 531 is connected to the fixing member 51
  • the distal end of the second cutting rod 531 is connected to the second ring 532 .
  • the second cutting rods 531 and the first cutting rods 521 are arranged at staggered intervals in the circumferential direction, while the second circular ring 532 and the first circular ring 522 are coaxially arranged, and there is a space between the second circular ring 532 and the first circular ring 522 interval.
  • the second cutting rod 531 In the direction from the proximal end to the distal end, the second cutting rod 531 has varying radial dimensions, and the second annular ring 532 is movably sleeved on the delivery tube 4, so that the second annular ring 532 can be axially It moves relative to the fixing member 51 and enables the second cutting rod 531 to freely compress and expand, so that the second stent 53 forms a stent structure that can contract and expand in the radial direction.
  • one end of the first cutting rod 521 and the second cutting rod 531 is connected to the fixing member such as the fixing member 51 , and the fixing member such as the fixing member 51 is fixedly connected to the conveying pipe 4 , and one end of the first cutting rod 521 away from the fixing member 51 is connected.
  • a first circular ring 522 is connected, and one end of the second cutting rod 531 away from the fixing member 51 is connected with a second circular ring 532 . That is, one end of the first bracket 52 and the second bracket 53 away from the fixing member such as the fixing member 51 is slidably connected to the conveying pipe 4 .
  • the second cutting rod 531 can form a second rotating cutting curved surface, which can cut the thrombus.
  • the second cutting rod 531 can also be semicircular, semielliptical, V-shaped, or W-shaped, etc., to form rotating cutting curved surfaces of different shapes.
  • a plurality of second cutting rods 531 are also provided and arranged at intervals in the circumferential direction.
  • the plurality of first cutting rods 521 and the plurality of second cutting rods 531 may be arranged at a cross interval, so as to cut the thrombus alternately.
  • one of the first cutting rods 521 , one of the second cutting rods 531 , another first cutting rod 521 and another second cutting rod 531 are sequentially arranged in a counterclockwise or clockwise direction.
  • the whole of the broken bolt bracket 5 can be made by using a nickel-titanium tube through a laser cutting process and a heat setting process.
  • connection point between the second cutting rod 531 and the fixing member 51 is located at the distal end of the connecting point between the first cutting rod 521 and the fixing member 51
  • the second The annular ring 532 is located at the proximal end of the first annular ring 522
  • the radial dimension of the first cutting rod 521 is larger than that of the second cutting rod 531 . Therefore, the second rotating cutting curved surface and the first rotating cutting curved surface are arranged at intervals inside and outside, that is, the second rotating cutting curved surface is wrapped inside the first rotating cutting curved surface, and they form two layers of rotating spherical surfaces with different sizes.
  • the thrombus tissue entering the thrombectomy stent 5 can be cross-cut by the first rotating cutting curved surface and the second rotating cutting curved surface, so that the thrombus tissue can be broken into smaller pieces.
  • the fixing members such as the fixing member 51 can be rotated around the rotation axis, so that the first bracket is rotated to form a first rotary cutting curved surface, and the second bracket is rotated to form a second rotary cutting curved surface.
  • the surface of revolution here should be understood in a broad sense, that is, it is allowed to have a certain thickness.
  • the maximum radial distance of the first support from the axis of rotation is greater than the maximum radial distance of the second support from the axis of rotation.
  • the plane perpendicular to the rotation axis intersects the rotation axis with the first bracket or the second bracket, and the radial distance refers to the distance between the intersection of the plane and the first bracket and the intersection of the rotation axis, and the radial distance for the second bracket The same is true.
  • the first bracket includes a plurality of first cutting rods 521
  • the plurality of first cutting rods 521 are rotated around the axis of rotation to form a plurality of first rotating cutting curved surfaces, and these first rotating cutting curved surfaces may overlap or may Not overlapping, it depends on the respective shapes of these first cutting rods 521 .
  • the first rotating cutting surfaces overlap; for example, when the shapes of the plurality of first cutting rods 521 are different, Then the first rotating cutting curved surfaces formed by the rotation of the first cutting rods 521 around the rotation axis are not completely coincident or non-coincidental.
  • the first and second rotational cutting surfaces are at least partially spaced apart.
  • the first bracket rotates around the first rotation axis to form the above-mentioned first rotary cutting curved surface
  • the second bracket rotates around the second rotation axis to form the above-mentioned second rotary cutting curved surface.
  • the first and second rotating cutting surfaces are said to be coaxial.
  • the connection line with the first rotation axis in the plane perpendicular to the first rotation axis is called the first rotation cutting surface.
  • One of the radial is
  • the line connecting the second rotation axis in the plane perpendicular to the second rotation axis is called the second rotation surface.
  • the first rotating cutting curved surface and the second rotating cutting curved surface are at least partially spaced in the same vertical plane, and the vertical plane can be a plane perpendicular to the first axis of rotation or a plane perpendicular to the second axis of rotation .
  • both the first stent 52 and the second stent 53 can freely contract and expand. And because the first ring 522 at the distal end of the first stent 52 and the second ring 532 at the distal end of the second stent 53 are separated from each other and do not interfere with each other, during the process of rotating and cutting the thrombus, the first stent 52 located on the outer side will not interfere with each other.
  • the formed first rotating cutting curved surface When the formed first rotating cutting curved surface is deformed due to being compressed by the thrombus, its deformation will not affect the second rotating cutting curved surface formed by the second stent 53 located on the inner side, so that the cutting space of the inner rotating cutting curved surface can be ensured, In order to completely cut the thrombus and further improve the effect of thrombus fragmentation.
  • FIG. 16 to FIG. 20 are schematic structural diagrams of the second embodiment of the bolt support 5 of the present application.
  • FIGS. 16 to 20 in conjunction with FIG. 12 , the main body structure of the bolt holder 5 of this embodiment is the same as that of the first embodiment, and the difference lies in the structure of the front end of the bolt holder 5 .
  • the fixing member 51 is divided into a first fixing member 511 and a second fixing member 512 .
  • the second fixing member 512 is spliced to the distal end of the first fixing member 511 in the axial direction, and both the first fixing member 511 and the second fixing member 512 are sleeved and fixed on the conveying tube 4 .
  • the proximal end of the first cutting rod 521 is connected to the first fixing member 511 .
  • the proximal end of the second cutting rod 531 is connected to the second fixing member 512 .
  • the bolt support 5 in this embodiment can be divided into two mutually separated first support 52 and second support 53 .
  • the first bracket 52 and the second bracket 53 can be respectively made of nickel-titanium tubes through a laser cutting process and a heat-setting process, and finally spliced together into one body. This solution can simplify the structures of the first bracket 52 and the second bracket 53 respectively, and reduce the difficulty of the laser cutting process.
  • the distal end of the first fixing member 511 is concavely provided with a locating groove 5111
  • the proximal end of the second fixing member 512 is protrudingly provided with a locating protrusion 5121 that fits with the locating groove 5111 .
  • the catching protrusion 5121 is fitted and connected in the catching groove 5111 , so that the second fixing member 512 is coaxially connected to the distal end of the first fixing member 511 .
  • the locating groove 5111 can also be provided at the proximal end of the second fixing member 512
  • the locating protrusion 5121 is provided at the distal end of the first fixing member 511 .
  • One or more first openings 5112 are formed on the peripheral wall of the first fixing member 511 , and the first openings 5112 communicate with the lumen of the first fixing member 511 .
  • One or more second openings 5122 are formed on the peripheral wall of the second fixing member 512 , and the second openings 5122 communicate with the lumen of the second fixing member 512 .
  • the glue can enter the lumen of the first fixing member 511 through the first opening 5112 to improve the connection firmness between the first fixing member 511 and the conveying tube 4, and can also enter the second fixing member 512 through the second opening 5122 to improve the connection firmness between the second fixing member 512 and the delivery tube 4 .
  • FIG. 21 to FIG. 22 are schematic structural diagrams of the third embodiment of the bolt support 5 of the present application.
  • the main body structure of the thrombus support 5 of the present embodiment is the same as that of the second embodiment, and the difference lies in the structure of the distal end of the thrombus support 5 .
  • the first ring 522 at the distal end of the first stent 52 and the second ring 532 at the distal end of the second stent 53 are connected as a whole, that is, the third ring 54 is formed.
  • the distal ends of the first cutting rod 521 and the second cutting rod 531 are both connected to the third ring 54 , and the third ring 54 is movably sleeved on the delivery tube 4 .
  • the third ring 54 may not be formed by the fixed connection of the first ring 522 and the second bracket 53 , but may be directly fabricated by independent parts.
  • the distal end of the first bracket 52 is connected with the distal end of the second bracket 53 , so the first rotating cutting curved surface formed by the first bracket 52 is connected to the second bracket.
  • the second rotating cutting curved surfaces formed by 53 will affect each other to a certain extent.
  • FIG. 23 is a schematic structural diagram of the fourth embodiment of the broken plug holder 5 of the present application.
  • the main body structure of the bolt support 5 of this embodiment is the same as that of the first embodiment, and the difference is that the structures of the proximal ends of the first support 52 and the second support 53 are different .
  • connection point between the first cutting rod 521 and the fixing member 51 is located on the distal side of the connecting point between the second cutting rod 531 and the fixing member 51 .
  • the end of the distal side of the first stent is located on the distal side of the end of the distal side of the second stent, wherein "the end of the distal side of the first stent” refers to the first cut rod 521 and the first stent.
  • the connection point of the three circular rings 54 “the end on the distal side of the second stent” refers to the connection point between the second cutting rod 531 and the third circular ring 54 .
  • the first rotating cutting curved surface formed by the first cutting rod 521 and the second rotating cutting curved surface formed by the second cutting rod 531 are staggered at the proximal end portion. That is, the first rotational cutting surface and the second rotational cutting surface intersect.
  • the first rotating cutting curved surface and the second rotating cutting curved surface can form interlaced space spherical surfaces, which can better improve the bolt breaking effect of the bolt breaking bracket 5 .
  • the driving handle 41 is used to drive the delivery tube 4 and the tumbler support 5 to rotate in the circumferential direction.
  • the drive handle 41 is detachably provided at the proximal end of the delivery tube 4 .
  • the proximal end of the delivery tube 4 is provided with a drive terminal 401 .
  • the driving handle 41 is provided with a driving interface 411 , and the driving interface 411 can be connected with the driving terminal 401 of the conveying pipe 4 .
  • a gear assembly is arranged in the drive handle 41 , and a drive wrench 412 is hingedly connected to the drive handle 41 , and the drive wrench 412 is connected to the drive interface 411 through the gear assembly.
  • the gear assembly By pressing and holding the drive wrench 412, the gear assembly can be driven to rotate, and the drive interface 411 can be rotated rapidly through the speed change of the gear assembly, and then the drive terminal 401 connected with the drive interface 411 can be rotated, thereby driving the conveying unit integrally connected with the drive terminal 401.
  • the thrombectomy stent 5 at the distal end of the tube 4 and the delivery tube 4 is rapidly rotated circumferentially to cut and smash the thrombus tissue wrapped in the thrombectomy stent 3 .
  • the thrombectomy stent 5 rotates in the circumferential direction in the thrombectomy stent 3, so as to cut and crush the thrombus tissue wrapped in the thrombectomy stent 3.
  • the support bracket 32 By arranging the support bracket 32 to support the filter mesh membrane 33, the filter mesh membrane 33 can maintain a relatively stable shape, preventing the inner wall of the blood vessel from being squeezed and compressing the support bracket 32 and the filter mesh membrane 33 radially inward, thereby causing thrombus breakage
  • the bracket 5 is in contact with the support bracket 32 or the screen membrane 33 , thereby preventing the tumbler bracket 5 from rotating circumferentially within the tumbler retrieval bracket 3 . That is to say, the support bracket 32 needs to have a certain degree of radial support in addition to a certain flexibility. A certain interval is formed, or a certain interval is formed between the filter screen membrane 33 and the broken plug support 5 .
  • a spring mechanism can be arranged in the driving handle 41 to be connected with the driving wrench 412, so that the driving wrench 412 can rebound and reset, and the driving wrench 412 can be repeatedly pressed and held.
  • the loading tube 42 is movably sleeved on the conveying tube 4 , and the loading tube 42 is used for loading the broken bolt support 5 .
  • the loading tube 42 can be moved to the distal end of the conveying tube 4 and is sleeved on the broken bolt bracket 5 so that the broken bolt bracket 5 is accommodated in the loading tube 42 , and both the first bracket 52 and the second bracket 53 can be accommodated in the loading tube 42 .
  • the loading tube 42 can be moved to the proximal end of the delivery tube 4, so that the distal end of the delivery tube 4 and the tumbler stent 5 can be inserted into the traction catheter 2 for use, and the loading tube 42 can be used. Stay outside the traction catheter 2.
  • the distal end of the delivery tube 4 and the broken broken support 5 can be completely withdrawn from the traction catheter 2, and the loading tube 42 can be re-sleeved on the broken broken support 5, so that the broken broken support 5 can be completely removed. Avoid contact with the external environment as much as possible.
  • the proximal end of the delivery tube 4 is also sleeved with a stainless steel tube 402 .
  • the proximal end of the delivery tube 4 is connected to the proximal end of the stainless steel tube 402 .
  • the proximal end of the stainless steel tube 402 is connected to the driving terminal 401 . It will be appreciated that by releasing or securing the stainless steel tube 402, the axial movement of the delivery tube 4 can be limited and controlled.
  • the proximal end of the outer sheath tube 1 is provided with a sheath tube joint 11
  • the proximal end of the sheath tube joint 11 is provided with an adjustment knob 12
  • the adjustment knob 12 is rotatably connected to the proximal end of the sheath joint 11
  • a compression ring 13 and a silicone ring 14 are sandwiched between the adjustment knob 12 and the sheath joint 11 .
  • the silicone ring 14 is sandwiched between the adjusting knob 12 and the pressing ring 13 .
  • the traction catheter 2 is sequentially inserted into the adjusting knob 12 , the silicone ring 14 , the pressing ring 13 and the sheath tube joint 11 , and then extends into the outer sheath tube 1 .
  • the silicone ring 14 can be squeezed, thereby changing the inner diameter of the center of the silicone ring 14, and the traction catheter 2 can be clamped or loosened, thereby controlling whether the traction catheter 2 and the outer sheath 1 can move relative to each other.
  • a branch joint 111 is also formed on the peripheral side of the sheath joint 11 .
  • the branch joint 111 can externally connect the branch hose 15 .
  • the other end of the branch hose 15 can be connected to a standard luer fitting.
  • the suction device includes a joint conduit 6 and a branch conduit 61 connected to the joint conduit 6 .
  • the distal end of the joint catheter 6 is axially connected with the proximal end of the traction catheter 2 .
  • the proximal end of the traction catheter 2 is provided with a fixing cover 21 , and the distal end of the joint catheter 6 can be screwed with the fixing cover 21 to communicate with the joint catheter 6 and the traction catheter 2 .
  • the delivery tube 4 is movably passed through the joint catheter 6 and the traction catheter 2 , and the delivery tube 4 can be completely withdrawn from the joint catheter 6 from the proximal end of the joint catheter 6 .
  • the proximal end of the joint conduit 6 is provided with a switch, and the switch is used to control the opening and closing of the proximal port of the joint conduit 6 .
  • the switch can close the proximal port of the connector catheter 6 when the delivery tube 4 and the tumbler stent 5 are completely withdrawn from the proximal end of the connector catheter 6 and completely withdrawn from the traction catheter 2 and the connector catheter 6 .
  • the switch includes a screw cap 62 and a sealing ring 63 .
  • the screw cap 62 is screwed to the proximal end of the connector conduit 6 .
  • the sealing ring 63 is arranged in the proximal port of the joint conduit 6 and sandwiched between the screw cap 62 and the proximal port of the joint conduit 6 .
  • the conveying pipe 4 is movably inserted through the screw cap 62 and the sealing ring 63 in the axial direction, and can completely exit the sealing ring 63 .
  • the sealing ring 63 has elasticity and deformability. After the delivery pipe 4 completely exits the joint conduit 6 and the sealing ring 63, the screw cap 62 rotates forward or reversely, and simultaneously squeezes or releases the sealing ring 63 to change the size of the central hole of the sealing ring 63. And when the central hole of the sealing ring 63 disappears due to the extrusion deformation, the proximal port of the joint conduit 6 can be closed. When the central hole of the sealing ring 63 appears, the proximal port of the connector conduit 6 can be opened.
  • the conveying pipe 4 is inserted into the joint conduit 6 and the sealing ring 63, by rotating the cap 62, the size of the central hole of the sealing ring 63 can be squeezed and changed, and the sealing ring 63 can also be clamped, fixed or loosened for conveying.
  • the tube 4 is then controlled to control whether the relative movement in the axial direction is possible between the delivery tube 4 , the joint conduit 6 and the traction conduit 2 .
  • One end of the branch conduit 61 is connected to the peripheral wall of the joint conduit 6 and communicated with the lumen of the joint conduit 6 , and the other end of the branch conduit 61 is used for external suction power.
  • the external suction power can use the suction syringe 64.
  • the suction syringe 64 can be used to draw the thrombus at the proximal port of the traction catheter 2, through the traction catheter 2, the connector catheter 6 and the branches.
  • the catheter 61 is collected inside the suction syringe 64 .
  • the traction catheter 2 is used as a suction catheter, that is, the traction catheter 2 can also be regarded as a part of the suction device.
  • the side wall of the joint conduit 6 is provided with a branch joint 601 communicating with the inside thereof, and the branch conduit 61 is detachably connected to the branch joint 601 to be connected with the joint conduit 6 .
  • FIG. 28 Please refer to FIG. 28 to FIG. 38 , and the working principle of the thrombectomy system of this embodiment will be illustrated below with an example.
  • FIG. 28 is a schematic diagram of the inferior vena cava vessel 01 of the human body.
  • thrombus tissue 02 in the inferior vena cava blood vessel 01 .
  • the guide wire 03 is introduced through the femoral vein or popliteal vein puncture port 04 to establish access for venous thrombectomy.
  • the guide wire 03 is passed through the guide head 34 at the distal end of the thrombectomy device.
  • the thrombectomy device is inserted along the guide wire 03 from the puncture port 04 into the venous blood vessel 01, and is gradually transported forward.
  • the thrombectomy device is gradually transported forward along the guide wire 03 until the distal end of the outer sheath 1 passes through the thrombus tissue 02 .
  • the screw cap 62 can be loosened, so that the delivery tube 4 can move axially relative to the traction catheter 2 . And by pushing the delivery tube 4 to the distal end, the distal end of the delivery tube 4 abuts on the guide head 34 at the distal end of the thrombus removal bracket 3, so as to drive the thrombus removal bracket 3 to extend out of the outer sheath tube 1, and in the thrombus removal bracket 3
  • the proximal end of the thrombectomy tube 1 completely protrudes from the distal port of the outer sheath tube 1, by fixing the traction catheter 2 and the joint catheter 6, and withdrawing the delivery tube 4, the thrombectomy stent 3 is completely released in the blood vessel, and the thrombectomy stent 3 is placed in the blood vessel.
  • Wall-mounted arrangement
  • the thrombus fragmentation bracket 5 can extend out of the traction catheter 2 and into the inside of the thrombus retrieval bracket 3 .
  • the thrombus stent 5 can be compressed by force and enter the interior of the traction catheter 2 .
  • the traction catheter 2 and the joint catheter 6 can also be fixed, and the thrombectomy stent 3 can be released through the retraction of the outer sheath 1 .
  • FIG. 32 is a schematic diagram of the complete release of the thrombectomy stent 3 at the distal end of the thrombus tissue 02 .
  • the thrombectomy system is retracted as a whole, that is, the outer sheath 1 , the traction catheter 2 and the delivery tube 4 are retracted as a whole, thereby driving the thrombus removal bracket 3 to retract.
  • the thrombus tissue 02 is peeled off from the inner wall of the venous blood vessel 01 , enters the thrombectomy stent 3 , and is wrapped and collected by the filter membrane 33 .
  • FIG. 34 in conjunction with FIG. 33 , push the delivery tube 4 forward, so that the bolt-breaking bracket 5 re-enters the inside of the bolt-retrieving bracket 3 .
  • the drive interface 411 of the drive handle 41 Connect the drive interface 411 of the drive handle 41 to the drive terminal 401 of the conveying pipe 4 , and by repeatedly pressing and holding the drive wrench 412 , the drive interface 411 rotates rapidly, and then drives the broken bolt bracket 5 to rotate rapidly, which will be wrapped inside the filter membrane 33
  • the thrombus tissue 02 is cut and crushed.
  • the thrombus breaking support 5 , the delivery tube 4 and other thrombus breaking devices are withdrawn to the proximal end as a whole, and completely withdrawn from the proximal end of the joint catheter 6 .
  • the loading tube 42 is sleeved on the broken bolt bracket 5 , so that the broken bolt bracket 5 is compressed into the loading tube 42 .
  • the screw cap 62 at the proximal end of the swivel joint conduit 6 compresses the inner sealing ring 63 to close the proximal port of the joint conduit 6 .
  • the aspiration syringe 64 is communicated with the branch conduit 61 . By pulling the suction syringe 64, the broken thrombus can be sucked into the suction syringe 64 through the traction catheter 2 and the branch catheter 61 and taken out.
  • a branch switch 611 is provided between the suction syringe 64 and the branch conduit 61 , and the branch switch 611 is used to control whether the branch conduit 61 and the suction syringe 64 communicate with each other. It can be understood that the branch switch 611 can also be used to control whether the branch conduit 61 communicates with the outside world.
  • FIG. 39 is a schematic diagram of aspirating thrombus according to the second embodiment of the present application.
  • a second solution for thrombus aspiration is provided.
  • a suction conduit 65 can be inserted into the traction conduit 2 through the joint conduit 6 and extended out of the traction conduit 2 , so that the distal end of the suction catheter 65 extends into the inside of the thrombectomy bracket 3 .
  • the proximal end of the aspiration catheter 65 is connected to an aspiration device for performing thrombus aspiration through the distal end of the aspiration catheter 65 .
  • the traction catheter 2 is used as a channel for the suction catheter 65 .
  • the distal end of the suction catheter 65 does not protrude into the thrombectomy stent 3, and the thrombus can also be suctioned.
  • the thrombus inside the thrombectomy stent 3 first enters the pulling catheter 2 , and then enters the suction catheter 65 through the distal end of the suction catheter 65 .
  • the distal end of the traction catheter 2 is connected to the proximal end of the thrombus retrieval bracket 3 , and there is no need to enter the inside of the thrombus retrieval bracket 3 .
  • FIG. 40 and FIG. 41 are schematic structural diagrams of the thrombectomy device according to the third embodiment of the present application.
  • a second connection scheme of the thrombus retrieval bracket 3 and the traction catheter 2 in the thrombectomy device is provided, and the proximal end of the thrombus retrieval bracket 3 is movably connected. at the distal end of the traction catheter 2 .
  • the peripheral wall of the distal end of the traction catheter 2 is recessed with a chute 22, and the proximal end of the separation bracket 31 in the bolt removal bracket 3 is movably sleeved on the chute 22, that is, the connecting ring 313 can slide The ground is sleeved on the chute 22 .
  • the connecting ring 313 can slide axially within the range of the sliding groove 22 .
  • the connecting ring 313 is provided with a pulling wire 3131 , and the distal end of the pulling wire 3131 is connected with the connecting ring 313 , that is, the pulling wire 3131 is connected with the separating bracket 31 .
  • the pulling wire 3131 can be used to pull the separation bracket 31 and the entire thrombus removal bracket 3 to slide along the chute 22 to the proximal end of the traction catheter 2 , thereby controlling the position of the distal port of the traction catheter 2 inside the thrombus retrieval bracket 3 .
  • the solution structure can effectively suck and suck the residual thrombus tissue 02 in the proximal part of the thrombus stent 3 in the process of sucking the thrombus.
  • FIG. 42 is a schematic structural diagram of the thrombectomy system according to the fourth embodiment of the present application.
  • a compression balloon 16 is sheathed on the outer portion of the distal end of the outer sheath tube 1 .
  • the compression balloon 16 can communicate with external high pressure equipment.
  • the high-pressure device can inject physiological saline into the compression balloon 16, so that the compression balloon 16 expands and sticks to the inner wall of the blood vessel.
  • the use of the compression balloon 16 can effectively prevent the thrombus tissue 02 from flowing backwards, and make all the thrombus tissue 02 squeeze into the thrombectomy stent 3, thereby completing thrombus fragmentation and thrombus suction, and achieving better thrombus removal effect.
  • FIG. 43 is a schematic structural diagram of the thrombectomy system according to the fifth embodiment of the present application.
  • an integrated design solution of the bolt breaking device is provided.
  • the difference between the bolt breaking device of this embodiment and the first embodiment is that the structure of the driving handle 41 is different.
  • the driving handle 41 is integrally formed on the conveying pipe 4 .
  • the proximal end of the delivery tube 4 penetrates the drive handle 41 .
  • the gear assembly in the driving handle 41 can directly drive the conveying pipe 4 to rotate in the circumferential direction.
  • FIG. 44 is a schematic structural diagram of the thrombectomy system according to the sixth embodiment of the present application.
  • an electronically-controlled driven bolt breaking solution is provided.
  • the difference between the bolt breaking device of this embodiment and the first embodiment is that the structure of the driving handle 41 is different.
  • the drive handle 41 does not have a drive wrench 412 , and a rechargeable battery 413 and a drive motor 414 are provided inside the drive handle 41 .
  • the rechargeable battery 413 powers the drive motor 414 to rotate the drive motor 414 .
  • the driving motor 414 can drive the gear assembly to rotate, thereby driving the driving interface 411 to rotate at a high speed.
  • the driving handle 41 is also provided with a control button 415 , and the control button 415 is used to control the driving motor 414 to work.
  • the embodiments of the present application at least have the following advantages and positive effects:
  • the outer sheath tube 1 is used to accommodate the thrombectomy stent 3 and the traction catheter 2; the traction catheter 2 can be used to accommodate the thrombectomy stent 5 and the delivery tube 4;
  • the outer sheath tube 1 cooperates to accommodate the thrombus in the blood vessel in the thrombectomy stent 3; the thrombectomy stent 5 is then used to cooperate with the delivery tube 4, so that the thrombus fragmentation stent 5 extends into the thrombectomy stent 3 for rotation, and the thrombectomy stent 3 is rotated.
  • the thrombus in 3 is cut into small particles, which is conducive to smashing stubborn, large and hard thrombi; finally, the delivery tube 4 is used to drive the thrombus-breaking stent 5 to exit the traction catheter 2, and the traction catheter 2 can be used as a suction catheter at the same time.
  • the small thrombus in the thrombectomy stent 3 is suctioned through the lumen of the traction catheter 2, which effectively prevents pulmonary embolism caused by omission of the small thrombus, thereby improving the thrombectomy effect.

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Abstract

一种取栓支架(3)、取栓系统、取栓装置、碎栓支架(5)及碎栓装置;取栓支架(3)包括分离支架(31)、支撑支架(32)及滤网薄膜(33);分离支架(31)用于刮离位于血管内壁的血栓;支撑支架(32)连接于分离支架(31)的远端;在取栓时,分离支架(31)和支撑支架(32)限定形成用于容置血栓的内腔;分离支架(31)近端形成有用于使血栓进入内腔的开口;分离支架(31)的弹性支撑强度大于支撑支架(32)的弹性支撑强度;支撑支架(32)的柔顺性大于分离支架(31)的柔顺性;滤网薄膜(33)至少连接支撑支架(32);滤网薄膜(33)用于过滤血栓且通过血液。该取栓支架(3)通过分离支架自身较高的弹性性能从而提供更好的弹性支撑强度,可以使分离支架(31)与血管内壁的接触力更大,从而使血管内壁的血栓更容易刮除下来,提高了取栓效果。

Description

取栓支架、取栓系统、取栓装置、碎栓支架及碎栓装置
本申请要求提交中国国家知识产权局、申请号为202110384767.9(申请名称为“取栓系统、取栓装置、碎栓支架及碎栓装置”)、202110820049.1(申请名称为“取栓系统”)、202110820054.2(申请名称为“碎栓支架、碎栓装置及取栓系统”)、202110821331.1(申请名称为“取栓支架、取栓装置及取栓系统”)的中国专利申请的优先权,其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域,特别涉及一种取栓支架、取栓系统、取栓装置、碎栓支架及碎栓装置。
背景技术
静脉血栓栓塞症(VTE)包括下肢深静脉血栓(DVT)和肺栓塞(PE)。
下肢深静脉血栓(DVT)为高发血管外科疾病,多因下肢静脉中血液不正常凝结,使得血液回流阻塞所致。肺栓塞(PE)已成为心血管疾病死亡的第三大原因。肺栓塞的危险因素包括环境因素和个人因素两方面,个人因素包括年龄、既往VTE病史、肿瘤病史、心肺衰竭、先天性或后天性凝血功能障碍、激素治疗等。急性PE会导致系统性低血压甚至全心衰竭,进而造成患者死亡。
因此,尽早迅速有效的清除血栓可以解除静脉阻塞,有效预防PE,保护瓣膜功能,降低血栓复发率。然而,目前现有的取栓支架在取栓时可能与血管壁的接触力不够,导致取栓效果不理想。
发明内容
本申请的一个目的在于提供一种取栓支架,以优化现有技术中取栓支架的结构,提升对血栓的取栓效果。
本申请的一个目的在于提供一种取栓装置,以优化现有技术中取栓装置的结构,提升对血栓的取栓效果。
本申请的一个目的在于提供一种取栓系统,以优化现有技术中取栓系统的结构,提升对血栓的取栓效果。
本申请的一个目的在于提供一种碎栓支架,以优化现有技术中碎栓支架的结构,提升对血栓的取栓效果。
本申请的一个目的在于提供一种碎栓装置,以优化现有技术中碎栓装置的结构,提升对血栓的取栓效果。
为解决上述技术问题,本申请采用如下技术方案:
根据本申请的一个方面,本申请提供一种取栓支架,具有在输送时的压缩状态和在取栓时的膨胀状态,且能由压缩状态弹性膨胀至膨胀状态,所述取栓支架包括:分离支架,用于刮离位于血管内壁的血栓;支撑支架,连接于所述分离支架的远端;在取栓时,所述分离支架和所述支撑支架限定形成用于容置血栓的内腔,所述分离支架近端形成有用于使血栓进入所述内腔的开口,所述分离支架的弹性支撑强度大于所述支撑支架的弹性支撑强度,所述支撑支架的柔顺性大于所述分离支架的柔顺性;以及滤网薄膜,所述滤网薄膜至少连接所述支撑支架,所述滤网薄膜用于过滤血栓且通过血液。
根据本申请的一个方面,本申请提供一种取栓装置,包括如上所述的取栓支架;牵引导管,连接所述取栓支架;以及外鞘管,所述牵引导管和所述取栓支架滑动连接于所述外鞘管内,所述牵引导管驱动所述取栓支架伸出或缩回所述外鞘管;所述取栓支架伸出所述外鞘管,所述取栓支架呈所述膨胀状态;所述取栓支架缩回所述外鞘管,所述取栓支架呈所述压缩状态。
根据本申请的一个方面,本申请提供一种取栓装置,包括牵引导管和设于所述牵引导管远端的取栓支架;所述取栓支架包括:分离支架,其为沿径向能够收缩和膨胀的支架结构,其近端与所述牵引导管相连;所述分离支架的近端形成有开口;支撑支架,其为沿径向能够收缩和膨胀的支架结构,其近端与所述分离支架沿轴向相接,且其远端形成逐渐收束的封闭端;及滤网薄膜,设于所述支撑支架的周壁上,所述滤网薄膜上密布有网孔;其中,所述分离支架的径向支撑力大于所述支撑支架;所述支撑支架的柔顺性大于所述分离支架。
根据本申请的一个方面,本申请提供一种取栓系统,包括如上所述的取栓装置;以及碎栓装置,包括碎栓支架和连接所述碎栓支架的输送管,所述碎栓支架和输送管均滑动连接于所述牵引导管内,所述输送管驱动所述碎栓支架伸出或缩回所述牵引导管;所述碎栓支架伸出所述牵引导管并进入所述取栓支架内,且所述碎栓支架由压缩状态变成膨胀状态;所述输送管驱动所述碎栓支架在所述取栓支架内旋转,旋转时所述碎栓支架与所述取栓支架具有间隔。
根据本申请的一个方面,本申请提供一种,包括:取栓支架和牵引导管,所述牵引导管连接所述取栓支架,所述取栓支架用于将血管内壁的血栓刮落,刮落的血栓进入所述取栓支架内;碎栓支架以及输送管,均可滑动连接于所述牵引导管内;其中,所述输送管连接所述碎栓支架,以驱动所述碎栓支架从所述牵引导管的远端排出并进入所述取栓支架内,所述输送管驱动所述碎栓支架在所述取栓支架内沿周向旋转进行碎栓;碎栓后,所述输送管还能够驱动所述碎栓支架从所述牵引导管的远端进入所述牵引导管内,且驱动所述碎栓支架从所述牵引导管的近端排出。
根据本申请的一个方面,本申请提供一种取栓系统,该取栓系统包括:取栓支架,其为沿径向能够收缩和膨胀的支架结构,其近端具有开口,且其远端封闭;外鞘管;牵引导管,其远端与所述取栓支架相连;所述牵引导管活动地穿设于所述外鞘管内,并能够沿轴向相对所述外鞘管移动;碎栓支架,其为沿径向能够收缩和膨胀的支架结构;输送管,其远端与所述碎栓支架相连;所述输送管活动地穿设于所述牵引导管内,并能够沿轴向相对所述牵引导管移动;其中,所述输送管能够沿周向相对所述牵引导管旋转,以带动所述碎栓支架在所述取栓支架内部空间中进行周向旋转;且所述输送管能够带动所述碎栓支架退出所述牵引导管,以通过所述牵引导管的内腔对所述取栓支架内的血栓进行抽吸。
根据本申请一些实施例,所述取栓支架与所述牵引导管的远端可滑动连接,以使所述取栓支架能够沿轴向相对所述牵引导管移动。
根据本申请一些实施例,所述取栓系统还包括接头导管和连接于接头导管上的分支导管;所述接头导 管的远端与所述牵引导管的近端相连接;所述输送管活动地穿设于所述接头导管和所述牵引导管内,并能够从所述接头导管的近端退出所述接头导管;所述接头导管的近端设有开关,所述开关用于对所述接头导管的近端口进行启闭控制;所述分支导管的一端连接于所述接头导管的周壁并与所述接头导管的内腔相连通,所述分支导管的另一端用于外接抽吸动力。
根据本申请一些实施例,所述开关包括旋盖和密封圈;所述旋盖转动连接于所述接头导管的近端,所述密封圈设于接头导管的近端口内,并夹设于所述旋盖与所述接头导管的近端口之间;所述输送管沿轴向活动地穿设于所述旋盖和所述密封圈内,并能够退出所述密封圈;所述旋盖能够正向或反向旋转,并同步挤压或释放所述密封圈,以通过所述密封圈关闭或打开所述接头导管的近端口。
根据本申请的一个方面,本申请还提供一种取栓装置,该取栓装置包括牵引导管和设于所述牵引导管远端的取栓支架;所述取栓支架包括:分离支架,其为沿径向能够收缩和膨胀的支架结构,其近端与所述牵引导管相连;所述分离支架的近端形成有开口;支撑支架,其为沿径向能够收缩和膨胀的支架结构,其近端与所述分离支架沿轴向相接,且其远端形成逐渐收束的封闭端;及滤网薄膜,设于所述支撑支架的周壁上,所述滤网薄膜上密布有网孔;其中,所述分离支架的径向支撑力大于所述支撑支架;所述支撑支架的柔顺性大于所述分离支架。
根据本申请一些实施例,所述支撑支架的壁厚小于所述分离支架。
根据本申请一些实施例,所述支撑支架的近端形成有周向分布的多个菱形网格单元,所述菱形网格单元的近端顶点通过丝线与所述分离支架的远端缠绕相接。
根据本申请一些实施例,所述支撑支架的远端形成有周向间隔布置的多个支撑杆;所述支撑杆沿所述支撑支架的轴向延伸,且在由近端至远端的方向上,所述支撑杆的径向尺寸逐渐减小。
根据本申请一些实施例,所述分离支架包括远端与所述支撑支架相接的支撑体、连接于支撑体近端的多个连接杆及连接于多个连接杆近端的连接环;所述支撑体呈周向闭环的管状支架结构;多个所述连接杆呈周向间隔布置,多个所述连接杆的近端汇聚连接至所述连接环,且相邻所述连接杆之间形成所述分离支架的近端开口;所述连接环连接于所述牵引导管。
根据本申请一些实施例,所述分离支架的近端可滑动地连接在所述牵引导管的远端。
根据本申请的一个方面,本申请还提供一种碎栓支架用于对血管内的血栓进行切割,所述碎栓支架包括:固定件;第一支架,一端连接所述固定件,所述固定件旋转带动所述第一支架旋转形成用于对所述血栓进行切割的第一旋转切割曲面;第二支架,一端连接所述固定件,所述固定件旋转带动所述第二支架旋转形成用于对所述血栓进行切割的第二旋转切割曲面;其中,所述第一旋转切割曲面和所述第二旋转切割曲面至少有部分具有间隔。
根据本申请的一个方面,本申请还提供一种碎栓支架,该碎栓支架包括:第一支架,其为沿径向能够收缩和膨胀的支架结构,所述第一支架上具有用于切割血栓的第一切杆;及第二支架,其为沿径向能够收缩和膨胀的支架结构,所述第二支架与所述第一支架同轴内外设置,所述第二支架的近端与所述第一支架的近端相连,所述第二支架上有用于切割血栓的第二切杆;其中,在由近端至远端的方向上,所述第一切杆和所述第二切杆均具有变化的径向尺寸;当所述第一支架和所述第二支架同轴旋转时,所述第一切杆旋转形成第一旋转切割曲面,所述第二切杆旋转形成第二旋转切割曲面,且所述第一旋转切割曲面和所述第二旋转切割曲面在径向上具有间隔。
根据本申请一些实施例,所述第二旋转切割曲面被包裹在所述第一旋转切割曲面内。
根据本申请一些实施例,所述第一切杆和所述第二切杆分别设有多个,多个所述第一切杆和多个所述第二切杆分别呈周向间隔布置,且所述第一切杆和所述第二切杆在周向上呈交叉间隔布置。
根据本申请一些实施例,所述第一支架还包括同轴间隔设置的第一固定件和第一圆环,所述第一圆环位于所述第一固定件的远端侧,且所述第一切杆连接并形成于所述第一固定件和所述第一圆环之间;所述第二支架还包括同轴间隔设置的第二固定件和第二圆环;所述第二固定件连接于所述第一固定件的远端;所述第二圆环间隔地环位于所述第二固定件的远端侧,并位于所述第一圆环的近端侧;所述第二切杆连接并形成于所述第二固定件和所述第二圆环之间。
根据本申请一些实施例,所述第一固定件的远端凹设有嵌位槽,所述第二固定件的近端凸设有与所述嵌位槽相适配的嵌位凸起;所述嵌位凸起嵌合连接于所述嵌位槽内,以使所述第二固定件同轴连接于所述第一固定件的远端。
根据本申请一些实施例,所述第一固定件的周壁上设有连通其管腔的第一开孔;所述第二固定件的周壁上设有连通其管腔的第二开孔。
根据本申请一些实施例,所述第二圆环间隔地设于所述第一圆环的近端侧,或所述第二圆环一体连接于所述第一圆环的近端侧。
根据本申请的一个方面,本申请还提供一种碎栓装置,该碎栓装置包括碎栓支架和输送管;所述碎栓支架采用上述的碎栓支架;所述输送管的远端穿设于所述碎栓支架的轴线处,并与所述碎栓支架相连;其中,所述第一支架和所述第二支架的近端均固定套设在所述输送管上,所述第一支架和所述第二支架的近端均活动套设在所述输送管上。
根据本申请一些实施例,所述碎栓装置还包括驱动手柄,所述驱动手柄连接于所述输送管的近端,并能够带动所述输送管和所述碎栓支架沿周向进行旋转。
根据本申请一些实施例,所述碎栓装置还包括装载管,所述装载管活动地套设在所述输送管上;所述装载管能够移动至所述输送管的远端,并套设在所述碎栓支架上,以使所述第一支架和所述第二支架均收容于所述装载管内。
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:
本申请实施例的取栓支架中,分离支架通过自身较高的弹性性能从而提供更好的弹性支撑强度,可以使分离支架与血管内壁的接触力更大,从而使血管内壁的血栓更容易刮除下来,提高了取栓支架的取栓效果。由于滤网薄膜至少连接于支撑支架,支撑支架的柔顺性大于所述分离支架的柔顺性,支撑支架的柔顺性大于分离支架的柔顺性,从而可以更好的适于滤网薄膜的变形,可以降低支撑支架因为自身弹性支撑强度较大而容易将滤网薄膜撑破的可能性,或者将滤网薄膜上的孔结构的面积撑的较大,而导致滤网薄膜对血栓的拦截效果不好的可能性。
本申请实施例的取栓系统中,利用外鞘管收容取栓支架和牵引导管;利用牵引导管可收容碎栓支架和输送管;利用牵引导管、取栓支架与外鞘管配合,将血管内的血栓收容于取栓支架内;再利用碎栓支架与输送管配合,使碎栓支架伸入取栓支架内进行旋转,将取栓支架内的血栓切割为细小颗粒,有利于对顽固性、较大较硬的血栓进行粉碎;最后利用输送管带动碎栓支架退出牵引导管,牵引导管同时可作为抽吸导管使用,通过牵引导管的内腔对取栓支架内的细小血栓进行抽吸,有效地预防细小血栓遗漏造成肺栓塞,从而提高取栓效果。
附图说明
图1是本申请的第一实施例的取栓系统的整体结构示意图。
图2是图1的取栓系统的局部透视图。
图3是图1中取栓支架的结构示意图。
图4是图3的俯视图。
图5是图4中A区域的放大结构示意图。
图6是图3中分离支架的结构示意图。
图7是图6的侧视图。
图8是图3中支撑支架的结构示意图。
图9是图8的侧视图。
图10是图3中滤网薄膜的结构示意图。
图11是图10的侧视图。
图12是图1中碎栓装置的结构示意图。
图13是图12中碎栓支架的第一实施例的结构示意图。
图14是图13的侧视图。
图15是图13的俯视图。
图16是图12中碎栓支架的第二实施例的结构示意图。
图17是图16的侧视图。
图18是图16的俯视图。
图19是图16中第一支架的结构示意图。
图20是图16中第二支架的结构示意图。
图21是图12中碎栓支架的第三实施例的结构示意图。
图22是图21的侧视图。
图23是图12中碎栓支架的第四实施例的结构示意图。
图24是图1中外鞘管的结构示意图。
图25是图24中鞘管接头的结构示意图。
图26是图1中牵引导管、接头导管、分支导管及抽吸针筒的结构示意图。
图27是图26中接头导管的剖视图。
图28是人体下腔静脉病变部分的示意图。
图29是图1的取栓系统穿刺进入病灶的示意图。
图30是取栓支架开始释放时的示意图。
图31是取栓支架进行释放和调整的示意图。
图32是取栓支架进行释放后示意图。
图33是取栓支架分离并收集血管内血栓的示意图。
图34是碎栓装置对取栓支架内的血栓进行碎栓时的工作示意图。
图35是在碎栓完成后碎栓装置撤出的示意图。
图36是抽吸血栓的示意图。
图37是取栓支架再次分离并收集血栓的示意图。
图38是碎栓装置再次进入接头导管及牵引导管内的示意图。
图39是本申请的第二实施例的抽吸血栓的示意图。
图40是本申请的第三实施例中取栓装置的结构示意图。
图41是图40在另一状态下的结构示意图。
图42本申请的第四实施例的结构示意图。
图43本申请的第五实施例的结构示意图。
图44本申请的第六实施例的结构示意图。
附图标记说明如下:
01、静脉血管;02、血栓组织;03、导丝;04、穿刺口;1、外鞘管;11、鞘管接头;12、调节旋钮;13、压紧环;14、硅胶圈;15、分支软管;16、压缩球囊;111、分支接头;2、牵引导管;21、固定盖;22、滑槽;3、取栓支架;31、分离支架;32、支撑支架;33、滤网薄膜;34、导向头;35、丝线;310、第一菱形网格单元;311、支撑体;312、连接杆;313、连接环;320、第二菱形网格单元;321、支撑杆;322、固定环;331、网孔;332、小孔;3131、拉线;4、输送管;41、驱动手柄;42、装载管;401、驱动端子;402、不锈钢管;411、驱动接口;412、驱动扳手;413、可充电电池;414、驱动马达;415、控制按钮;5、碎栓支架;51、固定件;52、第一支架;53、第二支架;54、第三圆环;511、第一固定件;512、第二固定件;521、第一切杆;522、第一圆环;531、第二切杆;532、第二圆环;5111、嵌位槽;5112、第一开孔;5121、嵌位凸起;5122、第二开孔;6、接头导管;61、分支导管;62、旋盖;63、密封圈;64、抽吸针筒;65、抽吸导管;601、分管接头;611、分支开关。
具体实施方式
体现本申请特征与优点的典型实施方式将在以下的说明中详细叙述。应理解的是本申请能够在不同的实施方式上具有各种的变化,其皆不脱离本申请的范围,且其中的说明及图示在本质上是当作说明之用,而非用以限制本申请。
在本申请的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”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”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个所述特征。在本申请的描述中,“多个”的含义是两个或两个以上,除非另有明确具体的限定。
在本申请的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”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;可以是机械连接,也可以是电连接;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。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本申请中的具体含义。
在本申请的描述中,“径向”、“轴向”应做广义理解。“径向”不限于绝对圆形对象,“轴向”也不限于绝对柱形对象。
在本申请的描述中,“近端”是指碎栓支架或取栓支架的靠近操作端(驱动手柄41)的一端,“远端”是指碎栓支架或取栓支架的远离操作端(驱动手柄41)的一端。
请参阅图1,本申请实施例提供的一种取栓系统,可用于血管内阻塞血栓的快速和较为彻底地清除。本申请实施例的取栓系统主要包括外鞘管1、取栓装置、碎栓装置及抽吸装置。
请参阅图1,并结合图28至图31,外鞘管1作为装载容器,用于收容取栓装置和碎栓装置,并用于牵引或引导取栓装置和碎栓装置进入血管内的病变部位。
请参阅图1和图2,取栓装置包括牵引导管2和可扩张的取栓支架3。
牵引导管2活动地穿设于外鞘管1内,并能够沿轴向相对外鞘管1移动。
取栓支架3设于牵引导管2的远端,可通过牵引导管2带动取栓支架3在外鞘管1内轴向移动,以使取栓支架3伸出外鞘管1或收缩进入外鞘管1。取栓支架3为沿径向能够收缩和膨胀的支架结构,以使取栓支架3能够被压缩进入外鞘管1内。同时,在取栓支架3伸出外鞘管1时,取栓支架3能够自然膨胀,并贴设在血管的内壁上。换而言之,取栓支架3具有在输送时的压缩状态和在取栓时的膨胀状态,且能由压缩状态弹性膨胀至膨胀状态。取栓支架3伸出外鞘管1,取栓支架3呈膨胀状态。取栓支架3缩回外鞘管1,取栓支架3呈压缩状态。
取栓支架3的近端具有开口,并配合取栓支架3的周壁进行血栓切割,以使血管内的血栓通过该开口进入取栓支架3的内部空间中。可以理解的是,该开口可以设置多个。同时,取栓支架3的远端封闭,以便于收拢和捕获血栓,使血栓收集在取栓支架3内部。同时,取栓支架3的远端封闭,以便于收拢和捕获血栓,使血栓收集在取栓支架3内部。需要说明的是,本申请中的“远端封闭”指的是取栓支架3的远端足以捕获血栓,例如,远端可以开设用于通过血液或导丝的孔隙,从整体上说,远端的孔隙尺寸小于近端的开口的尺寸。
请参阅图3至图5所示,取栓支架3包括自扩式的分离支架31、自扩式的支撑支架32、滤网薄膜33及导向头34。工作时,操作者可以沿血管的轴向往复移动取栓支架3,通过分离支架31将血管内壁的血栓刮落。
请参阅图6和图7,并结合图3至图5,分离支架31形成于取栓支架3的近端。分离支架31为沿径向能够收缩和膨胀的支架结构。
分离支架31的近端与牵引导管2相连。其中,所述的“相连”可以是沿轴向固定连接也可以沿轴向滑动连接,本实施例先介绍固定连接的情况,滑动连接的情况在下述的实施例中介绍。分离支架31的近端形成有开口,该开口即作为取栓支架3的近端开口,用于收取血管内的血栓。分离支架31的远端与支撑支架32的近端相连,以使分离支架31与支撑支架32相衔接,并使分离支架31的内部与支撑支架32内部连通。需要说明的是,“分离支架31与支撑支架32相衔接”指的是,分离支架31与支撑支架32可以分别独立加工然后连接在一起,也可以是分离支架31与支撑支架32直接一体成型形成整体。
请参阅图6和图7,本实施例的分离支架31包括远端与支撑支架32相接的支撑体311、连接于支撑体311近端的多个连接杆312及连接于多个连接杆312近端的连接环313,所述连接环313还可以为不设有通孔的其它结构的连接件。
请参阅图6,并结合图2,连接环313套设在牵引导管2上,以使取栓支架3与牵引导管2相连。
仍请参阅图6和图7,支撑体311为裸支架结构,在展开状态下呈周向闭环的管状支架结构;或者支撑体311在周向上呈环形,且为网状支架结构。支撑体311可为分离支架31提供良好的径向支撑力,以使分离支架31更好地与血管的内部进行贴合,进而对血管内的血栓与血管的内壁之间进行完整的切割、分离并收集血栓,使血栓完整地进入取栓支架3内。
在本实施例中,支撑体311包括多个周向相接和轴向相接的V形杆。多个周向相接的多个V形杆可形成波形圈。该波形圈具有沿周向相交错的波峰和波谷,波峰朝向近端,波谷朝向远端。根据周向相接的V形杆数量,可在支撑体311的远端形成不同数量的波谷,该波谷作为连接点,以便于与支撑支架32相接。
多个轴向相接的V形杆可形成多个第一菱形网格单元310,该第一菱形网格单元310在支撑体311膨胀时,也能够直接切割血栓,以使血栓进入分离支架31内。该第一菱形网格单元310的近端和远端也可分别形成波峰和波谷。可逐步调节支撑体311近端V形杆的数量,进而形成不同数量的波峰,以便于与近端的不同数量的连接杆312相接。在本实施中,支撑体311远端的波谷数量多于支撑体311近端波峰的数量。需要说明的是,本申请中的网格单元并不限于菱形网格单元310,也可以为其它形状的网格单元,例如椭圆形、三角形等,网格单元的边也可以为直边或曲边。
可以理解的是,第一菱形网格单元310可沿支撑体311的轴向进行伸缩形变,进而使支撑体311具有较强的径向支撑力和血管的贴壁能力,并使分离支架31沿径向可压缩和膨胀。
滤网薄膜33至少连接支撑支架32,滤网薄膜33上设置有孔结构,以使滤网薄膜33用于过滤血栓且通过血液。
如图3所示,分离支架31的弹性支撑强度大于支撑支架32的弹性支撑强度,支撑支架32的柔顺性 大于分离支架31的柔顺性。分离支架31中的支撑体311和/或连接杆312用于刮离位于血管内壁的血栓。分离支架31通过自身较高的弹性性能从而提供更好的弹性支撑强度,可以使分离支架31与血管内壁的接触力更大,从而使血管内壁的血栓更容易刮除下来。而滤网薄膜33连接支撑支架32,支撑支架32为滤网薄膜33提供支撑,使滤网薄膜33保持较为稳定的外形,由于支撑支架32不作为核心的刮除血栓的零件,因此支撑支架32的弹性支撑强度可以小于分离支架31的支撑强度。由于滤网薄膜33至少连接于支撑支架32,支撑支架32的柔顺性大于所述分离支架31的柔顺性,支撑支架32的柔顺性好,从而可以更好的适于滤网薄膜33的变形,可以防止支撑支架32因为自身弹性支撑强度较大而容易将滤网薄膜33撑破,或者将滤网薄膜33上的孔结构的面积撑的较大,而导致滤网薄膜33对血栓的拦截效果不好。
连接杆312设于支撑体311的近端,连接杆312的远端与支撑体311近端的波峰相连。多个连接杆312呈周向间隔布置,多个连接杆312的近端汇聚连接至连接环313,且相邻连接杆312之间形成分离支架31的近端开口。
如图7所示,图7中左侧的具有第一菱形网格单元310的部分为支撑体311,支撑体311的弹性支撑强度大于支撑支架32的弹性支撑强度。其中多个第一菱形网格单元310之间的尺寸可以不同;连接杆321为条状结构,连接杆321的两端分别连接支撑体311和连接环313。例如,在图6所示的实施例中,有两条连接杆312,两条连接杆312的远端分别连接于不同的第一菱形网格单元310上,两条连接杆312的近端聚拢并连接于连接环313,其中所述的聚拢指的是多个对象相互靠近,可以相互连接,也可以相互不连接。
连接环313用于连接牵引导管2。在本实施例中,连接环313固定套设在牵引导管2的远端。可以理解的是,连接环313可以设置在支撑体311的轴心线上,也可以是采用偏心设置。
需要说明的是,分离支架31整体可采用镍钛合金管材通过激光切割工艺、热定型工艺制作而成。
请参阅图8和图9,本实施例的支撑支架32设于分离支架31的远端。支撑支架32为沿径向能够收缩和膨胀的支架结构。支撑支架32的近端与分离支架31的支撑体311沿轴向相接。支撑支架32的远端形成逐渐收束的封闭端,以便于捕获和收拢经分离支架31从血管内分离的血栓。
支撑支架32包括多个网格单元和支撑杆321。网格单元的近端连接分离支架31,网格单元沿周向呈闭环状分布有多个,支撑杆321有多个,支撑杆321的近端连接网格单元,多个支撑杆321的远端相互靠拢,网格单元的柔顺性大于分离支架的柔顺性。
请参阅图8和图9,并结合图5,在本实施例中,多个网格单元可以为形成于支撑支架32的近端并周向分布的多个第二菱形网格单元320。的多个第二菱形网格单元320,该多个第二菱形网格单元320也可以采用多个V形杆沿周向相接和轴向相接而成。第二菱形网格单元320的近端形成波峰,该波峰可作为连接点与支撑体311远端的波谷一一对应,并通过丝线35进行缠绕相接,如图5所示。
第二菱形网格单元320可沿支撑支架32的轴向进行伸缩形变,进而使支撑支架32具有较强的径向支撑力和血管的贴壁能力,并使支撑支架32沿径向可压缩和膨胀。可以理解的是,在支撑支架32的轴向方向上,第二菱形网格单元320可以设置一层或多层。第二菱形网格单元320的层数越多,则支撑支架32的径向弯曲能力越强。需要说明的是,支撑支架32并不作为主要的刮除血栓壁上的血栓的结构,因此支撑支架32弹性支撑强度小于分离支架31的弹性支撑强度。为了使支撑支架32适于滤网薄膜33的变形,防止将滤网薄膜33撑破或将滤网薄膜33上的孔结构撑大,支撑支架32的柔顺性大于分离支架31的柔顺性,例如是第二菱形网格单元320的柔顺性大于所述分离支架31的柔顺性,进一步是第二菱形网格单元320的柔顺性大于第一菱形网格单元310的柔顺性,且第二菱形网格单元320的弹性支撑强度小于第一菱形网格单元310的弹性支撑强度。
仍请参阅图8和图9,多个支撑杆32设于支撑支架32的远端并沿周向分布,支撑支架32还包括连接于支撑杆321远端的固定环322。支撑杆321可沿支撑支架32的轴向延伸,且在由近端至远端的方向上,支撑杆321的径向尺寸逐渐减小,进而使多个支撑杆321的近端逐步汇聚连接于固定环322上,在其它实施例中,多个支撑杆321的远端靠拢,靠拢可以指多个支撑杆321的远端直接相互连接,也可以指多个支撑杆321的远端通过其它零件间接的相互连接。多个支撑杆321的远端靠拢时,在由近端至远端的方向上,多个所述支撑杆321合围或限定的结构的径向尺寸逐渐减小;也可以是,多个所述支撑杆321合围或限定的结构的径向尺寸先不变然后逐渐减小;也可以是,多个所述支撑杆321合围或限定的结构的径向尺寸先增大然后逐渐减小。
请参阅图3至图5,需要说明的是,与分离支架31相同,支撑支架32也可采用镍钛合金管材通过激光切割工艺、热定型工艺制作而成。但支撑支架32的壁厚小于分离支架31的壁厚,即支撑支架32所采用的管材壁厚小于分离支架31所采用的管材壁厚,以使分离支架31和支撑支架32适于上述实施例中的弹性支撑强度和柔顺性关系;所述壁厚是指从管状的支架结构从外表面至内表面方向的厚度。因此支撑支架32在提供一定的径向支撑力的同时,保留了一定的柔顺性,并利用第二菱形网格单元320对称不固定的特性,进行适当弯曲变形,便于更好地契合患者血管的曲折特性。即分离支架31的径向支撑力大于支撑支架32,分离支架31具有更好的血管贴壁能力。同时支撑支架32的柔顺性大于分离支架31,支撑支架32更能适应血管的曲折特性。
请参阅图10至图11,并参阅图3至图5,滤网薄膜33缝制于支撑支架32的周壁上。滤网薄膜33上的孔结构可以为微孔结构,微孔结构的尺寸可以根据实际需要选择具体的孔径。滤网薄膜33可采用具有微孔结构的薄膜材料缝制而成,滤网薄膜33上密布有网孔331。可以理解的是,微孔结构适于使血液通过,并拦截血栓。
如图3所示,滤网薄膜33可以缝制在支撑支架32的内周壁上。由于支撑支架32在输送时压缩于外鞘管1内,将滤网薄膜33缝制在支撑支架32的内周壁上,可以防止支撑支架32在外鞘管1内滑动时将滤网薄膜33刮破或压破。
滤网薄膜33可采用线束缝制在支撑支架32的支撑杆321上。滤网薄膜33的近端开口边沿可缝制在支撑支架32的近端连接点上。在支撑支架32中,支撑杆321的轴向形变量小于第一菱形网格单元310,故可以保护滤网薄膜33和支撑支架32的近端连接点的结构相对稳定而不会破损。滤网薄膜33的远端中心处设有小孔332,小孔332的位置与固定环322对应。
请参阅图3至图5,并结合图8和图9,导向头34设于支撑支架32的远端。导向头34可连接在支撑 支架32远端的固定环322上。导向头34的远端为尖端,用于对取栓装置进行导向,并提高取栓装置的推进能力。导向头34和固定环322的中心均可供导丝穿过,导丝起到导向作用。
请参阅图12,并结合图1,碎栓装置包括输送管4、可扩张的碎栓支架5、驱动手柄41及装载管42。
输送管4活动地穿设于牵引导管2内。输送管4能够沿轴向相对牵引导管2移动,并能够沿周向相对牵引导管2旋转。
碎栓支架5设于输送管4的远端,可通过输送管4带动碎栓支架5在牵引导管2内轴向移动,以使碎栓支架5伸出牵引导管2的远端,并在取栓支架3内进行释放碎栓支架5,或使碎栓支架5收缩进入牵引导管2内部,还可以带动碎栓支架5完全退出牵引导管2。碎栓支架5伸出牵引导管2并进入取栓支架3内,且碎栓支架5由压缩状态变成膨胀状态。输送管4驱动碎栓支架5在取栓支架3内旋转,旋转时碎栓支架5与取栓支架3具有间隔。同时输送管4进行周向旋转时,还能够带动碎栓支架5在取栓支架3内部进行同步地周向旋转,以对取栓支架3内部的血栓进行切割、粉碎。具体地,当取栓支架3将血管内的血栓切割下来之后,血栓通过取栓支架3中的分离支架31的开口进入取栓支架3围成的内部空间中。此后可以由输送管4的近端向远端的方向推动输送管4,以使输送管4推动碎栓支架5从牵引导管2排出,由于脱离牵引导管2的限制使碎栓支架5可以在自身弹性力下沿周向胀开,以使碎栓支架5对取栓支架3内部的血栓进行粉碎。
图13至图15为本申请的碎栓支架5的第一实施例的结构示意图。
请参阅图13至图15,并结合图1,在本实施例中,碎栓支架5包括固定件51、第一支架52和第二支架53。其中,固定件51为管状结构。可以理解的是,固定件51也可以不是管状结构,也可以是实心棒状结构或框架结构等固定件。
固定件51固定套设在输送管4上,以使碎栓支架5与输送管4固定连接。固定件51与输送管4之间可采用粘接的方式相连接固定,如选用医用胶水或热熔胶进行固定。
固定件51的周壁上设有开孔,开孔连通固定件51的内腔,医用胶水或热熔胶可通过该开孔部分渗入固定件51的内腔,并使固定件51粘接在输送管4上,以提高碎栓支架5与输送管4之间的粘接面积,使碎栓支架5与输送管4之间的连接更为稳固,并使碎栓支架5具有更好的抗扭转性能。
请参阅图13至图15,第一支架52包括两个呈周向对称分布的第一切杆521和设于第一切杆521远端的第一圆环522。第一切杆521的近端连接在固定件51上,第一切杆521的远端连接在第一圆环522上。
在由近端至远端的方向上,第一切杆521具有变化的径向尺寸,且第一圆环522与固定件51同轴设置,并活动地套设在输送管4上,以使第一圆环522能够沿轴向相对固定件51移动,并使第一切杆521能够自由地压缩和膨胀,进行使第一支架52形成沿径向能够收缩和膨胀的支架结构。
当第一支架52随固定件51进行周向旋转时,第一切杆521能够形成第一旋转切割曲面,可以对血栓进行切割。第一切杆521可以采用半圆形、半椭圆形、V字形或W字形等,以形成不同形状的旋转切割曲面。可以理解的是,第一切杆521可以设置三个、四个或多个,并呈周向间隔布置。
仍请参阅图13至图15,第二支架53包括两个呈周向对称分布的第二切杆531和设于第二切杆531远端的第二圆环532。第二切杆531的近端连接在固定件51上,第二切杆531的远端连接在第二圆环532上。第二切杆531与第一切杆521在周向上呈交错间隔设置,同时第二圆环532与第一圆环522同轴设置,且第二圆环532与第一圆环522之间具有间隔。
在由近端至远端的方向上,第二切杆531具有变化的径向尺寸,且第二圆环532活动地套设在输送管4上,以使第二圆环532能够沿轴向相对固定件51移动,并使第二切杆531能够自由的压缩和膨胀,进行使第二支架53形成沿径向能够收缩和膨胀的支架结构。也就是说,第一切杆521和第二切杆531的一端连接固定件51等固定件,固定件51等固定件固定连接于输送管4,第一切杆521的远离固定件51的一端连接有第一圆环522,第二切杆531的远离固定件51的一端连接有第二圆环532,第一圆环522和第二圆环532均滑动连接于输送管4。即第一支架52和第二支架53远离固定件51等固定件的一端滑动连接于输送管4。
同时,当第二支架53随固定件51进行周向旋转时,第二切杆531能够形成第二旋转切割曲面,可以对血栓进行切割。第二切杆531也可以采用半圆形、半椭圆形、V字形或W字形等,以形成不同形状的旋转切割曲面。可以理解的是,第二切杆531也以设置多个,并呈周向间隔布置。并且多个第一切杆521与多个第二切杆531可呈交叉间隔布置,以对血栓进行交替切割。例如,在周向上,沿逆时针或顺时针的方向,依次布置其中一个第一切杆521、其中一个第二切杆531、另一个第一切杆521和另一个第二切杆531。
需要说明的是,碎栓支架5整体可采用镍钛管经过激光切割工艺、热定型工艺制作而成。
请参阅图13至图15,在本实施例中,第二切杆531与固定件51之间的连接点位于第一切杆521与固定件51之间的连接点的远端,同时第二圆环532位于第一圆环522的近端,且第一切杆521的径向尺寸大于第二切杆531。因此,第二旋转切割曲面与第一旋转切割曲面呈内外间隔布置,即第二旋转切割曲面被包裹在第一旋转切割曲面内部,两者形成内外两层尺寸不同的旋转球面。此种结构可以使进入碎栓支架5内部的血栓组织被第一旋转切割曲面和第二旋转切割曲面交叉切割,把血栓组织打碎的更加细小。
在其中一个实施例中,固定件51等固定件能够绕旋转轴线旋转,使第一支架旋转形成第一旋转切割曲面,使第二支架旋转形成第二旋转切割曲面。此处的旋转曲面应当做广义理解,即允许其具有一定的厚度。第一支架与旋转轴线的最大径向距离大于第二支架与旋转轴线的最大径向距离。其中,垂直于旋转轴线的平面与旋转轴线与第一支架或第二支架相交,径向距离是指该平面与第一支架的交点和旋转轴线的交点的距离,对于第二支架的径向距离也同理。
在一些实施例中,如果第一支架包括了多个第一切杆521,多个第一切杆521绕旋转轴线旋转形成多个第一旋转切割曲面,这些第一旋转切割曲面可以重合也可以不重合,这取决于这些第一切杆521各自的形态。例如,当多个第一切杆521绕旋转轴线阵列排布时,即这些第一切杆521形态相同时,这些第一旋转切割曲面重合;例如多个第一切杆521的形态不同时,那么这些第一切杆521绕旋转轴线旋转所形成的这些第一旋转切割曲面是不完全重合或不重合的。
在一些实施例中,第一旋转切割曲面和第二旋转切割曲面至少有部分具有间隔。第一支架绕第一旋转轴线旋转形成上述的第一旋转切割曲面,第二支架绕第二旋转轴线旋转形成上述的第二旋转切割曲面。当第一旋转轴线与第二旋转轴线同轴时,称为第一旋转切割曲面和第二旋转切割曲面同轴。其中,垂直于第 一旋转轴线的平面与第一旋转切割曲面的交线上任意一点,在垂直于第一旋转轴线的平面内的与第一旋转轴线的连线称为第一旋转切割曲面的其中一个径向。同理,垂直于第二旋转轴线的平面与第二旋转切割曲面的交线上任意一点,在垂直于第二旋转轴线的平面内的与第二旋转轴线的连线称为第二旋转曲面的其中一个径向。第一旋转切割曲面和所述第二旋转切割曲面至少有部分在同一个垂面内具有间隔,该垂面可以是垂直于第一旋转轴线的平面,也可以是垂直于第二旋转轴线的平面。
可以理解的是,当第二旋转切割曲面与第一旋转切割曲面呈内外间隔布置时,第一旋转切割曲面和第二旋转切割曲面具有间隔。
可以理解的是,当第二旋转切割曲面一部分位于第一旋转切割曲面内、另一部分位于第一旋转切割曲面外时,第二旋转切割曲面与第一旋转切割曲面相交的部分是没有间隔的。
需要说明的是,在碎栓支架5整体旋转的过程中,第一支架52和第二支架53都能够自由的收缩和扩张。且因第一支架52远端的第一圆环522和第二支架53远端的第二圆环532相互分离、互不干扰,故在旋转切割血栓过程中,位于外侧的第一支架52所形成的第一旋转切割曲面因受到血栓压迫而导致形变时,其形变不会对位于内侧的第二支架53所形成的第二旋转切割曲面造成影响,从而可以确保内侧旋转切割曲面的切割空间,以使血栓切割完全,进一步提高碎栓效果。
图16至图20为本申请的碎栓支架5的第二实施例的结构示意图。
请参阅图16至图20,并结合体图12,本实施例的碎栓支架5与第一实施例的碎栓支架5的主体结构相同,区别在于碎栓支架5前端的结构不同。
在本实施例的碎栓支架5中,将固定件51分为第一固定件511和第二固定件512。第二固定件512沿轴向拼接于第一固定件511的远端,且第一固定件511和第二固定件512均套接固定在输送管4上。第一切杆521的近端连接于第一固定件511上。第二切杆531的近端连接于第二固定件512上。
需要说明的是,本实施例的碎栓支架5可分成两个相互分离的第一支架52和第二支架53。第一支架52和第二支架53可分别采用镍钛管经过激光切割工艺、热定型工艺制作而成,最后再相互拼接成一体。此方案可以分别简化第一支架52和第二支架53的结构,减小激光切割工艺的难度。
在本实施例,第一固定件511的远端凹设有嵌位槽5111,第二固定件512的近端凸设有与嵌位槽5111相适配的嵌位凸起5121。嵌位凸起5121嵌合连接于嵌位槽5111内,以使第二固定件512同轴连接于第一固定件511的远端。可以理解的是,嵌位槽5111也可以设于第二固定件512的近端,同时嵌位凸起5121设于第一固定件511的远端。
第一固定件511的周壁上开设有一个或多个第一开孔5112,第一开孔5112连通第一固定件511的管腔。第二固定件512的周壁上开设有一个或多个第二开孔5122,第二开孔5122连通第二固定件512的管腔。胶水可通过第一开孔5112进入第一固定件511的管腔,以提高第一固定件511与输送管4之间的连接牢固性,也可以通过第二开孔5122进入第二固定件512的管腔,以提高第二固定件512与输送管4之间的连接牢固性。
图21至图22为本申请的碎栓支架5的第三实施例的结构示意图。
请参阅图21至图22,并结合体图12,本实施例的碎栓支架5与第二实施例的碎栓支架5的主体结构相同,区别在于碎栓支架5远端的结构不同。
在本实施例的碎栓支架5中,第一支架52远端的第一圆环522和第二支架53远端的第二圆环532连接为一体,即形成第三圆环54。第一切杆521和第二切杆531的远端均连接在第三圆环54上,且第三圆环54活动套接在输送管4上。当然,第三圆环54可以不是由第一圆环522和第二支架53固定连接形成,而是有独立的零件直接制作成。
需要说明的是,本实施例的碎栓支架5中,第一支架52的远端与第二支架53的远端相连接,故第一支架52所形成的第一旋转切割曲面与第二支架53所形成的第二旋转切割曲面会相互造成一定地影响。
图23为本申请的碎栓支架5的第四实施例的结构示意图。
请参阅图23,并结合体图12,本实施例的碎栓支架5与第一实施例的碎栓支架5的主体结构相同,区别在于第一支架52和第二支架53近端的结构不同。
在本实施例的碎栓支架5中,第一切杆521与固定件51的连接点位于第二切杆531与固定件51的连接点的远端侧。第一支架的远端侧的端部位于所述第二支架的远端侧的端部的远端侧,其中“第一支架的远端侧的端部”是指第一切杆521与第三圆环54的连接处,“第二支架的远端侧的端部”是指第二切杆531与第三圆环54的连接处。
因此第一切杆521所形成的第一旋转切割曲面与第二切杆531所形成的第二旋转切割曲面,在近端部分会形成交错。也就是说,第一旋转切割曲面和第二旋转切割曲面相交。此种结构方案,可以使第一旋转切割曲面和第二旋转切割曲面形成相互交错的空间球面,能够更好地提高碎栓支架5的碎栓效果。
仍请参阅图12,驱动手柄41用于带动输送管4和碎栓支架5进行周向旋转。在本实施例中,驱动手柄41可拆卸地设置在输送管4的近端。输送管4的近端设置有驱动端子401。驱动手柄41上设有驱动接口411,该驱动接口411可与输送管4的驱动端子401对接。驱动手柄41内设有齿轮组件,驱动手柄41上还铰接有驱动扳手412,该驱动扳手412通过齿轮组件与驱动接口411传动连接。通过压握驱动扳手412,可以带动齿轮组件转动,并通过齿轮组件的变速带动驱动接口411快速旋转,进而通过与驱动接口411对接的驱动端子401进行旋转,进而带动与驱动端子401一体连接的输送管4及输送管4远端的碎栓支架5进行快速地周向旋转,将包裹在取栓支架3内的血栓组织进行切割粉碎。
需要说明的是,碎栓支架5在取栓支架3内周向旋转,从而将包裹在取栓支架3内的血栓组织进行切割粉碎。通过设置支撑支架32对滤网薄膜33进行支撑,能够使滤网薄膜33保持较为稳定的外形,防止血管内壁挤压使支撑支架32和滤网薄膜33沿径向向内压缩,从而导致碎栓支架5与支撑支架32或滤网薄膜33接触,从而妨碍碎栓支架5在取栓支架3内周向旋转。也就是说,支撑支架32除了具有一定的柔顺性还需要具有一定的径向支撑性,通过支撑支架32提供了一定的径向向外的支撑力,使支撑支架32与碎栓支架5之间形成一定的间隔,或使滤网薄膜33与碎栓支架5之间形成一定的间隔。
可以理解的是,驱动手柄41内可设置弹簧机构和驱动扳手412相连,以使驱动扳手412可以回弹复位,保持驱动扳手412可以反复的压握。
仍请参阅图12,装载管42活动地套设在输送管4上,装载管42用于装载碎栓支架5。装载管42能 够移动至输送管4的远端,并套设在碎栓支架5上,以使碎栓支架5收容于装载管42内,即可将第一支架52和第二支架53均收容于装载管42内。
当需要使用碎栓支架5时,可将装载管42移动至输送管4的近端,使输送管4的远端和碎栓支架5一起伸入牵引导管2内进行使用,并使装载管42停留在牵引导管2外部。
当碎栓支架5使用完毕时,可将输送管4的远端和碎栓支架5完全退出牵引导管2,并将装载管42重新套设在碎栓支架5上,以使碎栓支架5尽可能地避免与外部环境接触。
仍请参阅图12,输送管4的近端还套设有不锈钢管402。输送管4的近端与不锈钢管402的近端相连。在本实施例中,不锈钢管402的近端连接驱动端子401。可以理解的是,通过释放或固定不锈钢管402,可以对输送管4的轴向移动进行限定和控制。
请参阅图24和图25,并结合图1,在本实施例中,外鞘管1的近端设有鞘管接头11,鞘管接头11的近端设有调节旋钮12。调节旋钮12可旋转地连接在鞘管接头11的近端,并且在调节旋钮12与鞘管接头11之间夹设有压紧环13和硅胶圈14。硅胶圈14夹设在调节旋钮12与压紧环13之间。
牵引导管2依次穿设于调节旋钮12、硅胶圈14、压紧环13及鞘管接头11内,进而伸入外鞘管1内。通过旋转调节旋钮12可以挤压硅胶圈14,从而改变硅胶圈14中心的内径,可以夹持或松开牵引导管2,进而实现控制牵引导管2与外鞘管1之间是否能够相对移动。
在本实施例中,鞘管接头11的周侧还形成有分支接头111,该分支接头111与压紧环13内部相连通,进而与鞘管接头11及外鞘管1的内部相连通。该分支接头111可外接分支软管15。分支软管15的另一端可连接标准鲁尔接头。
请参阅图26和图27,并结合图1,抽吸装置包括接头导管6和连接于接头导管6上的分支导管61。
接头导管6的远端与牵引导管2的近端沿轴向相连接。在本实施例中,牵引导管2的近端设有固定盖21,接头导管6的远端可与固定盖21螺纹连接,以连通接头导管6和牵引导管2。输送管4活动地穿设于接头导管6和牵引导管2内,并且输送管4能够从接头导管6的近端完全退出接头导管6。
接头导管6的近端设有开关,该开关用于能够对接头导管6的近端口进行启闭控制。当输送管4及碎栓支架5完全从接头导管6的近端完全退出牵引导管2及接头导管6后,该开关能够关闭接头导管6的近端口。
在本实施例中,该开关包括旋盖62和密封圈63。旋盖62螺纹连接于接头导管6的近端。密封圈63设于接头导管6的近端口内,并夹设于旋盖62与接头导管6的近端口之间。输送管4沿轴向活动地穿设于旋盖62和密封圈63内,并能够完全退出密封圈63。
密封圈63具有弹性和形变能力。输送管4完全退出接头导管6及密封圈63后,通过旋盖62正向或反向旋转,并同步挤压或释放密封圈63,以改变密封圈63中心孔的大小。且当密封圈63中心孔因挤压形变而消失时,即可关闭接头导管6的近端口。当密封圈63中心孔出现时,可以开启接头导管6的近端口。同时,当输送管4穿设于接头导管6及密封圈63内时,通过旋转旋盖62,挤压改变密封圈63中心孔的大小,也可以使密封圈63能够夹持固定或松开输送管4,进而控制输送管4与接头导管6及牵引导管2之间是否能够沿轴向相对移动。
分支导管61的一端连接于接头导管6的周壁并与接头导管6的内腔相连通,分支导管61的另一端用于外接抽吸动力。外接的抽吸动力可以采用抽吸针筒64,当接头导管6的近端口关闭时,利用抽吸针筒64可将牵引导管2近端口处的血栓,经牵引导管2、接头导管6及分支导管61,收集到抽吸针筒64内部。此时,牵引导管2作为抽吸导管进行使用,即牵引导管2也可以视为抽吸装置的一组成部分。
在本实施例中,接头导管6的侧壁上设有与其内部相连通的分管接头601,分支导管61可拆卸地连接在该分管接头601上,以与接头导管6进行连接。
请结合参阅图28至图38,下面对本实施例的取栓系统的工作原理进行举例说明。
请参阅图28所示,图28中显示的是人体下腔静脉血管01的示意图。在下腔静脉血管01内有血栓组织02。经股静脉或腘静脉穿刺口04引入导丝03,为静脉取栓建立通路。
请参阅图29所示,导丝03从取栓装置远端的导向头34穿出。将取栓装置沿导丝03从穿刺口04进入静脉血管01,逐步向前输送。
请参阅图30所示,将取栓装置沿导丝03逐步向前输送,直至外鞘管1的远端穿过血栓组织02时为止。
请参阅图31所示,固定鞘管接头11,继续推送牵引导管2和接头导管6,使取栓支架3伸出外鞘管1的远端,以使取栓支架3能够在血管内逐步释放。并在取栓支架3的近端完全伸出外鞘管1的远端端口时,停止推送牵引导管2和接头导管6。
在取栓支架3释放的过程中,可以松开旋盖62,使输送管4能够相对牵引导管2轴向移动。并通过向远端推送输送管4,使输送管4的远端抵靠在取栓支架3远端的导向头34上,以带动取栓支架3伸出外鞘管1,并在取栓支架3的近端完全伸出外鞘管1的远端端口时,通过固定牵引导管2和接头导管6,并回撤输送管4,使取栓支架3在血管内进行完全释放,取栓支架3在血管内贴壁布置。
需要说明的是,在输送管4向前推送的过程中,碎栓支架5可以伸出牵引导管2,并伸入到取栓支架3内部。在输送管4回撤的过程中,碎栓支架5可以受力压缩进入到牵引导管2内部。
可以理解的是,也可以固定牵引导管2和接头导管6,通过外鞘管1的回撤来释放取栓支架3。
请参阅图32所示,图32为取栓支架3在血栓组织02的远端完全释放的示意图。
请参阅图33所示,通过取栓系统整体回撤,即外鞘管1、牵引导管2及输送管4整体回撤,进而带动取栓支架3回撤。利用取栓支架3近端的开口及支架结构,将血栓组织02从静脉血管01的内壁上剥离,并进入到取栓支架3内部,被滤网薄膜33包裹收集。
请参阅图34,并结合图33,将输送管4向前推送,使碎栓支架5重新进入取栓支架3内部。将驱动手柄41的驱动接口411与输送管4的驱动端子401进行对接,通过反复压握驱动扳手412,驱动接口411快速转动,进而带动碎栓支架5快速旋转,将包裹在滤网薄膜33内部的血栓组织02进行切割粉碎。
请参阅图35所示,完成碎栓后,将碎栓支架5、输送管4等碎栓装置整体向近端后撤,并完全从接头导管6的近端撤出。碎栓支架5撤出接头导管6后,将装载管42套设在碎栓支架5上,使碎栓支架5压缩进入装载管42内。
请参阅图36所示,旋转接头导管6近端的旋盖62,压缩内部的密封圈63,使接头导管6的近端口封闭。将抽吸针筒64与分支导管61连通。通过拉动抽吸针筒64,可将打碎的血栓通过牵引导管2和分支导管61吸入到抽吸针筒64内部取出。
需要说明的是,在抽吸针筒64与分支导管61之间设有分支开关611,分支开关611用于控制分支导管61与抽吸针筒64之间是否连通。可以理解的是,分支开关611也可以用于控制分支导管61与外界是否连通。
请参阅图37所示,继续使取栓支架3后撤,继续分离血栓并收集到滤网薄膜33内部。
请参阅图38所示,反向旋转接头导管6近端的旋盖62,释放内部的密封圈63,使接头导管6的近端口打开。通过装载管42重新将碎栓支架5及输送管4推送进入接头导管6内部,并继续推送进入牵引导管2内,重复图34至图36的操作,直至血栓组织02全部从静脉血管01中取出,最后通过固定鞘管接头11,回撤接头导管6将取栓支架3收缩进入外鞘管1内,一起撤出体外,完成取栓。
图39是本申请第二实施例的抽吸血栓的示意图。
请参阅图39所示,在本申请的第二实施例中,提供了抽吸血栓的第二种方案。
在本实施例中,当碎栓完成后,碎栓装置整体从接头导管6的近端撤出时,可将一抽吸导管65通过接头导管6伸入牵引导管2,并伸出牵引导管2,使抽吸导管65的远端伸入取栓支架3内部。抽吸导管65的近端与抽吸设备相连,以通过抽吸导管65的远端进行血栓抽吸操作。此过程中,牵引导管2作为抽吸导管65的通道使用。当然,在操作时,抽吸导管65的远端没有伸入取栓支架3内部,也可以对血栓进行抽吸,具体是通过抽吸导管65和牵引导管2共同对血栓进行抽吸。例如,抽吸导管65的远端位于牵引导管2内时,取栓支架3内部的血栓先进入牵引导管2内,然后经抽吸导管65的远端进入抽吸导管65。
需要说明的是,在抽吸操作中,牵引导管2的远端与取栓支架3的近端相连,无需进入取栓支架3的内部。
图40和图41是本申请第三实施例的取栓装置的结构示意图。
请参阅图40至图41所示,在本申请的第三实施例中,提供了取栓装置内取栓支架3与牵引导管2的第二种连接方案,取栓支架3的近端活动连接在牵引导管2的远端。
在本实施例中,牵引导管2的远端的周壁上凹设有滑槽22,取栓支架3中的分离支架31的近端活动地套设在滑槽22上,即连接环313可滑动地套设在滑槽22上。连接环313可在滑槽22的范围内轴向滑动。连接环313上设置有拉线3131,拉线3131的远端与连接环313相连,即拉线3131与分离支架31相连。拉线3131可用于拉动分离支架31及整个取栓支架3沿滑槽22向牵引导管2的近端滑动,进而控制牵引导管2的远端端口在取栓支架3内部的位置。该方案结构能够在抽吸血栓的过程中,有效地抽吸取栓支架3近端部分的残余血栓组织02。
图42是本申请第四实施例的取栓系统的结构示意图。
请参阅图42所示,在本申请的第四实施例中,提供了外鞘管1的改进方案。
在本实施例中,外鞘管1远端的外部套设有一压缩球囊16。压缩球囊16可连通外部高压设备。在取栓支架3完成血栓剥离时,高压设备可向压缩球囊16内注入生理盐水,使压缩球囊16扩张并紧贴血管内壁。利用压缩球囊16可以有效地阻止血栓组织02逆流,并使血栓组织02全部挤压进入取栓支架3内部,进而完成碎栓和血栓抽吸,达到更好的血栓清除效果。
图43是本申请第五实施例的取栓系统的结构示意图。
请参阅图43所示,在本申请的第五实施例中,提供了碎栓装置的一体式的设计方案。本实施例的碎栓装置与第一实施例的区别在于驱动手柄41的结构不同。
在本实施例中,驱动手柄41一体成型在输送管4上。输送管4的近端贯穿驱动手柄41。在压握驱动扳手412时,驱动手柄41内的齿轮组件能够直接带动输送管4进行周向旋转。
图44是本申请第六实施例的取栓系统的结构示意图。
请参阅图44所示,在本申请的第六实施例中,提供了一种电控驱动的碎栓方案。本实施例的碎栓装置与第一实施例的区别在于驱动手柄41的结构不同。
在本实施例中,驱动手柄41没有驱动扳手412,同时在驱动手柄41内部设有可充电电池413和驱动马达414。可充电电池413为驱动马达414提供动力,使驱动马达414旋转。驱动马达414可带动齿轮组件转动,进而带动驱动接口411进行高速旋转。驱动手柄41上还设置有控制按钮415,该控制按钮415用于控制驱动马达414工作。
基于上述技术方案,本申请实施例至少具有如下优点和积极效果:
本申请实施例的取栓系统中,利用外鞘管1收容取栓支架3和牵引导管2;利用牵引导管2可收容碎栓支架5和输送管4;利用牵引导管2、取栓支架3与外鞘管1配合,将血管内的血栓收容于取栓支架3内;再利用碎栓支架5与输送管4配合,使碎栓支架5伸入取栓支架3内进行旋转,将取栓支架3内的血栓切割为细小颗粒,有利于对顽固性、较大较硬的血栓进行粉碎;最后利用输送管4带动碎栓支架5退出牵引导管2,牵引导管2同时可作为抽吸导管使用,通过牵引导管2的内腔对取栓支架3内的细小血栓进行抽吸,有效地预防细小血栓遗漏造成肺栓塞,从而提高取栓效果。
虽然已参照几个典型实施方式描述了本申请,但应当理解,所用的术语是说明和示例性、而非限制性的术语。由于本申请能够以多种形式具体实施而不脱离申请的精神或实质,所以应当理解,上述实施方式不限于任何前述的细节,而应在随附权利要求所限定的精神和范围内广泛地解释,因此落入权利要求或其等效范围内的全部变化和改型都应为随附权利要求所涵盖。

Claims (71)

  1. 一种取栓支架,其特征在于,具有在输送时的压缩状态和在取栓时的膨胀状态,且能由压缩状态弹性膨胀至膨胀状态,所述取栓支架包括:
    分离支架,用于刮离位于血管内壁的血栓;
    支撑支架,连接于所述分离支架的远端;在取栓时,所述分离支架和所述支撑支架限定形成用于容置血栓的内腔,所述分离支架近端形成有用于使血栓进入所述内腔的开口,所述分离支架的弹性支撑强度大于所述支撑支架的弹性支撑强度,所述支撑支架的柔顺性大于所述分离支架的柔顺性;以及
    滤网薄膜,所述滤网薄膜至少连接所述支撑支架,所述滤网薄膜用于过滤血栓且通过血液。
  2. 根据权利要求1所述的取栓支架,其特征在于,所述分离支架包括:
    支撑体,所述支撑体呈环形且为网状支架结构,所述支撑体的远端连接所述支撑支架,所述支撑体的弹性支撑强度大于所述支撑支架的弹性支撑强度;
    连接件;以及
    连接杆,所述连接杆呈条状,所述连接杆的两端分别连接所述支撑体的近端和所述连接件,所述连接杆和所述支撑体形成所述开口,所述支撑体和/或所述连接杆用于刮离位于血管内壁的血栓。
  3. 根据权利要求1所述的取栓支架,其特征在于,所述支撑支架包括网格单元和支撑杆,所述网格单元的近端连接所述分离支架,所述网格单元沿周向呈闭环状分布有多个,所述支撑杆有多个,所述支撑杆的近端连接所述网格单元,多个所述支撑杆的远端相互靠拢,所述网格单元的柔顺性大于所述分离支架的柔顺性。
  4. 根据权利要求3所述的取栓支架,其特征在于,所述网格单元的近端通过丝线与所述分离支架的远端缠绕相接;或所述网格单元的近端与所述分离支架一体成型。
  5. 根据权利要求2所述的取栓支架,其特征在于,所述网格单元为菱形。
  6. 根据权利要求3所述的取栓支架,其特征在于,在由近端至远端的方向上,多个所述支撑杆限定的结构的径向尺寸逐渐减小。
  7. 根据权利要求1所述的取栓支架,其特征在于,所述支撑支架的壁厚小于所述分离支架的壁厚。
  8. 根据权利要求1所述的取栓支架,其特征在于,所述滤网薄膜连接于所述支撑支架的周壁上。
  9. 根据权利要求8所述的取栓支架,其特征在于,所述滤网薄膜连接于所述支撑支架的内周壁上。
  10. 根据权利要求1所述的取栓支架,其特征在于,所述滤网薄膜采用具有孔结构的膜材料制成。
  11. 一种取栓装置,其特征在于,包括:
    权利要求1-10任意一项所述的取栓支架;
    牵引导管,连接所述取栓支架;以及
    外鞘管,所述牵引导管和所述取栓支架滑动连接于所述外鞘管内,所述牵引导管驱动所述取栓支架伸出或缩回所述外鞘管;所述取栓支架伸出所述外鞘管,所述取栓支架呈所述膨胀状态;所述取栓支架缩回所述外鞘管,所述取栓支架呈所述压缩状态。
  12. 根据权利要求11所述的取栓装置,其特征在于,所述分离支架的近端可滑动地连接在所述牵引导管的远端。
  13. 根据权利要求12所述的取栓装置,其特征在于,所述牵引导管的远端周壁上开设有滑槽,所述分离支架的近端滑动连接于所述滑槽。
  14. 根据权利要求11所述的取栓装置,其特征在于,所述分离支架的近端固定连接于所述牵引导管的远端。
  15. 一种取栓装置,其特征在于,包括牵引导管和设于所述牵引导管远端的取栓支架;所述取栓支架包括:
    分离支架,其为沿径向能够收缩和膨胀的支架结构,其近端与所述牵引导管相连;所述分离支架的近端形成有开口;
    支撑支架,其为沿径向能够收缩和膨胀的支架结构,其近端与所述分离支架沿轴向相接,且其远端形成逐渐收束的封闭端;及
    滤网薄膜,设于所述支撑支架的周壁上,所述滤网薄膜上密布有网孔;
    其中,所述分离支架的径向支撑力大于所述支撑支架;所述支撑支架的柔顺性大于所述分离支架。
  16. 如权利要求15所述的取栓装置,其特征在于,所述支撑支架的壁厚小于所述分离支架。
  17. 如权利要求15所述的取栓装置,其特征在于,所述支撑支架的近端形成有周向分布的多个菱形网格单元,所述菱形网格单元的近端顶点通过丝线与所述分离支架的远端缠绕相接。
  18. 如权利要求17所述的取栓装置,其特征在于,所述支撑支架的远端形成有周向间隔布置的多个支撑杆;所述支撑杆沿所述支撑支架的轴向延伸,且在由近端至远端的方向上,所述支撑杆的径向尺寸逐渐减小。
  19. 如权利要求17所述的取栓装置,其特征在于,所述分离支架包括远端与所述支撑支架相接的支撑体、连接于支撑体近端的多个连接杆及连接于多个连接杆近端的连接环;
    所述支撑体呈周向闭环的管状支架结构;
    多个所述连接杆呈周向间隔布置,多个所述连接杆的近端汇聚连接至所述连接环,且相邻所述连接杆之间形成所述分离支架的近端开口;
    所述连接环连接于所述牵引导管。
  20. 如权利要求15所述的取栓装置,其特征在于,所述分离支架的近端可滑动地连接在所述牵引导管的远端。
  21. 一种取栓系统,其特征在于,包括:
    权利要求11-14任意一项所述的取栓装置;以及
    碎栓装置,包括碎栓支架和连接所述碎栓支架的输送管,所述碎栓支架和输送管均滑动连接于所述牵引导管内,所述输送管驱动所述碎栓支架伸出或缩回所述牵引导管;所述碎栓支架伸出所述牵引导管并进入所述取栓支架内,且所述碎栓支架由压缩状态变成膨胀状态;所述输送管驱动所述碎栓支架在所述取栓 支架内旋转,旋转时所述碎栓支架与所述取栓支架具有间隔。
  22. 根据权利要求21所述的取栓系统,其特征在于,所述碎栓支架的一端固定连接所述输送管,另一端滑动连接所述输送管。
  23. 根据权利要求21所述的取栓系统,其特征在于,还包括连接所述输送管并驱动所述输送管旋转的驱动手柄。
  24. 根据权利要求23所述的取栓系统,其特征在于,所述驱动手柄与所述输送管一体成型,或可拆卸地连接。
  25. 根据权利要求23所述的取栓系统,其特征在于,所述驱动手柄内设有齿轮组件,所述驱动手柄还铰接有驱动扳手,所述驱动扳手通过所述齿轮组件传动连接有驱动接口,所述驱动接口对接所述输送管,压握所述驱动扳手可以带动所述输送管旋转。
  26. 根据权利要求23所述的取栓系统,其特征在于,所述驱动手柄内设置有电池、电连接所述电池的驱动马达、以及由所述驱动马达驱动的齿轮组件,所述齿轮组件连接有驱动接口,所述驱动接口对接所述输送管,所述驱动马达可以驱动所述输送管旋转。
  27. 一种取栓系统,其特征在于,包括:
    取栓支架和牵引导管,所述牵引导管连接所述取栓支架,所述取栓支架用于将血管内壁的血栓刮落,刮落的血栓进入所述取栓支架内;
    碎栓支架以及输送管,均可滑动连接于所述牵引导管内;
    其中,所述输送管连接所述碎栓支架,以驱动所述碎栓支架从所述牵引导管的远端排出并进入所述取栓支架内,所述输送管驱动所述碎栓支架在所述取栓支架内沿周向旋转进行碎栓;碎栓后,所述输送管还能够驱动所述碎栓支架从所述牵引导管的远端进入所述牵引导管内,且驱动所述碎栓支架从所述牵引导管的近端排出。
  28. 根据权利要求27所述的取栓系统,其特征在于,还包括抽吸导管,所述碎栓支架从所述牵引导管的近端退出后,所述抽吸导管伸入所述牵引导管,所述抽吸导管用于外接抽吸动力,所述外接抽吸动力通过所述抽吸导管和/或所述牵引导管对所述取栓支架内的血栓进行抽吸。
  29. 根据权利要求27所述的取栓系统,其特征在于,所述碎栓支架从所述牵引导管的近端退出后,所述牵引导管用于外接抽吸动力,所述外接抽吸动力通过所述牵引导管对所述取栓支架内的血栓进行抽吸。
  30. 根据权利要求27所述的取栓系统,其特征在于,所述取栓系统还包括抽吸装置,所述抽吸装置包括接头导管和分支导管,所述接头导管连通所述牵引导管,所述分支导管连通所述接头导管或所述分支导管;所述分支导管用于连接外接抽吸动力,所述接头导管连接有用于启闭控制所述接头导管的开关;
    所述输送管能够驱动所述碎栓支架从所述牵引导管的近端退出并进入所述接头导管,且从所述接头导管的近端退出。
  31. 根据权利要求30所述的取栓系统,其特征在于,所述开关包括旋盖和具有弹性的密封圈,所述密封圈至少在不被所述旋转挤压时具有中心孔;所述旋盖转动连接于所述接头导管;所述密封圈夹设于所述旋盖与所述接头导管的近端口之间,所述中心孔与所述接头导管的内腔连通;旋转所述旋盖,所述旋盖弹性挤压或释放所述密封圈以打开或关闭所述中心孔。
  32. 根据权利要求31所述的取栓系统,其特征在于,所述输送管穿过所述中心孔时,旋转所述旋盖,所述旋盖弹性挤压或释放所述密封圈以控制所述中心孔的大小,从而夹持固定或松开所述输送管。
  33. 根据权利要求30所述的取栓系统,其特征在于,所述分支导管连接有用于启闭控制所述分支导管的分支开关。
  34. 根据权利要求27所述的取栓系统,其特征在于,所述碎栓支架从所述牵引导管退出后沿径向胀开。
  35. 根据权利要求27所述的取栓系统,其特征在于,所述取栓系统还包括装载管,所述装载管能够移动并套设在所述碎栓支架上,以使所述碎栓支架沿径向压缩收容于所述装载管内,使所述碎栓支架能够装入所述牵引导管。
  36. 根据权利要求35所述的取栓系统,其特征在于,所述装载管活动地套设于所述输送管上,将所述装载管移动至所述输送管的近端,使所述输送管的远端和所述碎栓支架一起伸入所述牵引导管内,并使所述装载管停留在所述牵引导管的外部。
  37. 根据权利要求27所述的取栓系统,其特征在于,所述取栓系统还包括外鞘管,所述取栓支架和牵引导管均连接于所述外鞘管内,且在所述外鞘管内在可滑动状态和固定状态之间转变,至少所述取栓支架能够滑出所述外鞘管。
  38. 根据权利要求37所述的取栓系统,其特征在于,所述外鞘管连接有鞘管接头,所述鞘管接头可旋转地连接有调节旋钮,在所述调节旋钮与所述鞘管接头之间夹设有具有内孔的硅胶圈;
    所述牵引导管穿过所述鞘管接头、调节旋钮和硅胶圈,旋转所述调节旋钮,挤压所述硅胶圈改变所述内孔的大小,以夹持或松开所述牵引导管。
  39. 根据权利要求38所述的取栓系统,其特征在于,所述调节旋钮与所述鞘管接头之间夹设有压紧环,所述压紧环与所述调节旋钮共同夹持所述硅胶圈。
  40. 根据权利要求38所述的取栓系统,其特征在于,所述鞘管接头连通有分支软管。
  41. 根据权利要求27所述的取栓系统,其特征在于,所述输送管的近端固定套设有不锈钢管。
  42. 根据权利要求27所述的取栓系统,其特征在于,所述取栓支架与所述牵引导管滑动连接,以使所述取栓支架能够沿轴向相对所述牵引导管移动。
  43. 根据权利要求42所述的取栓系统,其特征在于,所述牵引导管的周壁上开设有滑槽,所述取栓支架活动地套设于所述滑槽,所述取栓支架连接有拉线。
  44. 根据权利要求27所述的取栓系统,其特征在于,所述取栓支架与所述牵引导管固定连接。
  45. 一种取栓系统,其特征在于,包括:
    取栓支架,其为沿径向能够收缩和膨胀的支架结构,其近端具有开口,且其远端封闭;
    外鞘管;
    牵引导管,其远端与所述取栓支架相连;所述牵引导管活动地穿设于所述外鞘管内,并能够沿轴向相对所述外鞘管移动;
    碎栓支架,其为沿径向能够收缩和膨胀的支架结构;
    输送管,其远端与所述碎栓支架相连;所述输送管活动地穿设于所述牵引导管内,并能够沿轴向相对所述牵引导管移动;
    其中,所述输送管能够沿周向相对所述牵引导管旋转,以带动所述碎栓支架在所述取栓支架内部空间中进行周向旋转;且所述输送管能够带动所述碎栓支架退出所述牵引导管,以通过所述牵引导管的内腔对所述取栓支架内的血栓进行抽吸。
  46. 如权利要求45所述的取栓系统,其特征在于,所述取栓支架与所述牵引导管的远端可滑动连接,以使所述取栓支架能够沿轴向相对所述牵引导管移动。
  47. 如权利要求45所述的取栓系统,其特征在于,所述取栓系统还包括接头导管和连接于接头导管上的分支导管;
    所述接头导管的远端与所述牵引导管的近端相连接;所述输送管活动地穿设于所述接头导管和所述牵引导管内,并能够从所述接头导管的近端退出所述接头导管;
    所述接头导管的近端设有开关,所述开关用于对所述接头导管的近端口进行启闭控制;
    所述分支导管的一端连接于所述接头导管的周壁并与所述接头导管的内腔相连通,所述分支导管的另一端用于外接抽吸动力。
  48. 如权利要求47所述的取栓系统,其特征在于,所述开关包括旋盖和密封圈;所述旋盖转动连接于所述接头导管的近端,所述密封圈设于接头导管的近端口内,并夹设于所述旋盖与所述接头导管的近端口之间;
    所述输送管沿轴向活动地穿设于所述旋盖和所述密封圈内,并能够退出所述密封圈;
    所述旋盖能够正向或反向旋转,并同步挤压或释放所述密封圈,以通过所述密封圈关闭或打开所述接头导管的近端口。
  49. 一种碎栓支架,其特征在于,用于对血管内的血栓进行切割,所述碎栓支架包括:
    固定件;
    第一支架,一端连接所述固定件,所述固定件旋转带动所述第一支架旋转形成用于对所述血栓进行切割的第一旋转切割曲面;
    第二支架,一端连接所述固定件,所述固定件旋转带动所述第二支架旋转形成用于对所述血栓进行切割的第二旋转切割曲面;
    其中,所述第一旋转切割曲面和所述第二旋转切割曲面至少有部分具有间隔。
  50. 根据权利要求49所述的碎栓支架,其特征在于,所述第二旋转切割曲面被包裹在所述第一旋转切割曲面内。
  51. 根据权利要求49所述的碎栓支架,其特征在于,所述固定件能够绕旋转轴线旋转,使所述第一支架旋转形成所述第一旋转切割曲面,使所述第二支架旋转形成所述第二旋转切割曲面,所述第一支架与所述旋转轴线的最大径向距离大于所述第二支架与所述旋转轴线的最大径向距离。
  52. 根据权利要求49所述的碎栓支架,其特征在于,所述第二旋转切割曲面和所述第一旋转切割曲面相交。
  53. 根据权利要求52所述的碎栓支架,其特征在于,所述第一支架与所述固定件的连接处位于所述第二支架与所述固定件的连接处的远端侧;
    所述第一支架的远端和所述第二支架的远端固定连接,且所述第一支架的远端侧的端部位于所述第二支架的远端侧的端部的远端侧。
  54. 根据权利要求49所述的碎栓支架,其特征在于,所述碎栓支架包括第一圆环和第二圆环,所述第一支架的另一端连接所述第一圆环,所述第二支架的另一端连接所述第二圆环。
  55. 根据权利要求54所述的碎栓支架,其特征在于,所述第一圆环和所述第二圆环分离设置。
  56. 根据权利要求55所述的碎栓支架,其特征在于,所述第二圆环位于所述第一圆环和所述固定件之间。
  57. 根据权利要求49所述的碎栓支架,其特征在于,所述碎栓支架包括第三圆环,所述第一支架和所述第二支架的另一端均连接所述第三圆环。
  58. 根据权利要求49所述的碎栓支架,其特征在于,所述第一支架为弹性支架,所述第一支架的另一端能够弹性靠近或远离所述固定件;所述第二支架为弹性支架,所述第二支架的另一端能够弹性靠近或远离所述固定件。
  59. 根据权利要求49所述的碎栓支架,其特征在于,所述第一支架包括多个第一切杆,多个所述第一切杆的一端均连接所述固定件,多个所述第一切杆的另一端固定连接;
    所述第二支架包括多个第二切杆,多个所述第二切杆的一端均连接所述固定件,多个所述第二切杆的另一端固定连接。
  60. 根据权利要求59所述的碎栓支架,其特征在于,在周向上所述第一切杆和所述第二切杆交错排布。
  61. 根据权利要求60所述的碎栓支架,其特征在于,所述第一切杆和所述第二切杆均具有变化的径向尺寸;当所述第一支架和所述第二支架同轴旋转时,所述第一切杆旋转形成所述第一旋转切割曲面,所述第二切杆旋转形成所述第二旋转切割曲面,且所述第一旋转切割曲面和所述第二旋转切割曲面在径向上具有间隔。
  62. 根据权利要求49所述的碎栓支架,其特征在于,所述固定件为具有内腔的管状结构,所述固定件的周壁上开设有与所述内腔连通的开孔,所述开孔用于使胶进入所述内腔以固定连接所述固定件和穿入所述内腔的输送管。
  63. 根据权利要求49所述的碎栓支架,其特征在于,所述固定件包括第一固定件和第二固定件,所述第二固定件连接于所述第一固定件的远端,所述第一支架连接所述第一固定件,所述第二支架连接所述第二固定件。
  64. 根据权利要求63所述的碎栓支架,其特征在于,所述第一固定件的远端凹设有嵌位槽,所述第二固定件的近端凸设有与所述嵌位槽相适配的嵌位凸起;所述嵌位凸起嵌合连接于所述嵌位槽内,以使所述第二固定件同轴连接于所述第一固定件的远端。
  65. 如权利要求49所述的碎栓支架,其特征在于,所述第一支架还包括同轴间隔设置的第一固定件和第一圆环,所述第一圆环位于所述第一固定件的远端侧,且所述第一切杆连接并形成于所述第一固定件和所述第一圆环之间;
    所述第二支架还包括同轴间隔设置的第二固定件和第二圆环;所述第二固定件连接于所述第一固定件的远端;所述第二圆环间隔地环位于所述第二固定件的远端侧,并位于所述第一圆环的近端侧;所述第二切杆连接并形成于所述第二固定件和所述第二圆环之间。
  66. 如权利要求65所述的碎栓支架,其特征在于,所述第一固定件的周壁上设有连通其管腔的第一开孔;所述第二固定件的周壁上设有连通其管腔的第二开孔。
  67. 如权利要求65所述的碎栓支架,其特征在于,所述第二圆环间隔地设于所述第一圆环的近端侧,或所述第二圆环一体连接于所述第一圆环的近端侧。
  68. 一种碎栓装置,其特征在于,包括碎栓支架和输送管;所述碎栓支架采用如权利要求49-67中任一项所述的碎栓支架;所述输送管的远端穿设于所述碎栓支架的轴线处,并与所述碎栓支架相连;其中,所述第一支架和所述第二支架的近端均固定套设在所述输送管上,所述第一支架和所述第二支架的远端均活动套设在所述输送管上。
  69. 如权利要求68所述的碎栓装置,其特征在于,所述碎栓装置还包括驱动手柄,所述驱动手柄连接于所述输送管的近端,并能够带动所述输送管和所述碎栓支架沿周向进行旋转。
  70. 如权利要求68所述的碎栓装置,其特征在于,所述碎栓装置还包括装载管,所述装载管活动地套设在所述输送管上;所述装载管能够移动至所述输送管的远端,并套设在所述碎栓支架上,以使所述第一支架和所述第二支架均收容于所述装载管内。
  71. 一种取栓系统,其特征在于,包括:权利要求68-70任一项所述的碎栓装置,
    还包括取栓装置,所述取栓装置包括取栓支架、连接所述取栓支架的牵引导管,以及外鞘管,所述牵引导管和所述取栓支架滑动连接于所述外鞘管内,所述牵引导管驱动所述取栓支架伸出或缩回所述外鞘管;所述取栓支架伸出所述外鞘管,所述取栓支架呈膨胀状态;所述取栓支架缩回所述外鞘管,所述取栓支架呈压缩状态;
    所述碎栓支架和输送管均滑动连接于所述牵引导管内,所述输送管驱动所述碎栓支架伸出或缩回所述牵引导管;所述碎栓支架伸出所述牵引导管并进入所述取栓支架内,且所述碎栓支架由压缩状态变成膨胀状态;所述输送管驱动所述碎栓支架在所述取栓支架内旋转,旋转时所述碎栓支架与所述取栓支架具有间隔。
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