WO2024027190A1 - 血管开通装置 - Google Patents

血管开通装置 Download PDF

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Publication number
WO2024027190A1
WO2024027190A1 PCT/CN2023/087196 CN2023087196W WO2024027190A1 WO 2024027190 A1 WO2024027190 A1 WO 2024027190A1 CN 2023087196 W CN2023087196 W CN 2023087196W WO 2024027190 A1 WO2024027190 A1 WO 2024027190A1
Authority
WO
WIPO (PCT)
Prior art keywords
guide wire
blood vessel
opening device
vessel opening
wire
Prior art date
Application number
PCT/CN2023/087196
Other languages
English (en)
French (fr)
Inventor
杜海洋
夏顺
黄定国
Original Assignee
上海腾复医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海腾复医疗科技有限公司 filed Critical 上海腾复医疗科技有限公司
Publication of WO2024027190A1 publication Critical patent/WO2024027190A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A61B2017/22015—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
    • A61B2017/22017—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member the ultrasonic transmitting members being fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a blood vessel opening device.
  • minimally invasive interventional surgery is a product that emerged in the context of the aging of the population in today's society.
  • Chronic venous disease of the lower extremities is a progressive, devastating disease that ultimately leads to venous ulcers of the lower extremities, disrupting the patient's quality of life.
  • thermal ablation treatment is not precise enough. Whether it is radiofrequency ablation or laser treatment, it will release a large amount of heat, thereby damaging the nerves and tissues around the affected area.
  • Sclerotherapy is chemical ablation that destroys the cellular lining within the vein, causing the vein to collapse and close over time. Sclerotherapy has a better patient experience than thermal ablation, but the treatment effect is not as good.
  • Thermal ablation is 90% effective, but sclerotherapy is only 50-80% effective, and often requires multiple surgeries to eliminate symptoms.
  • Chemotherapy with new cyanoacrylate is as effective as thermal ablation, but it remains in the body and can Can cause allergic reactions in some people, and in some cases may still require removal of the diseased material within the affected vein.
  • Minimally invasive interventional treatment will not cause thermal damage, chemical damage or foreign body residue.
  • the current minimally invasive interventional treatment plan uses ordinary guide wires, etc., and needs to be improved in terms of treatment effect and efficiency.
  • the purpose of some embodiments of the present application is to provide a blood vessel opening device that can quickly and effectively remove intravenous embolism lesions by controlling the axial movement of a spiral torsion guidewire, which is conducive to improving the therapeutic effect.
  • the embodiment of the present application provides a blood vessel opening device, including:
  • a guidewire which includes: a spiral twisted section and a support section connected in sequence from the distal end to the proximal end; wherein the spiral twisted section can expand and contract radially;
  • the guide wire is inserted into the casing and can move axially and rotate circumferentially relative to the casing;
  • a control component the proximal end of the cannula is connected to the distal end of the control component, the proximal end of the support section is connected to the control component, the control component can drive the guide wire to move axially relative to the cannula.
  • the control assembly can also drive the spiral twisting section extending out of the distal end of the casing to move in the axial direction.
  • control assembly can also drive the helical torsion section extending out of the distal end of the sleeve to rotate and move synchronously, or vibrate radially and rotate and move synchronously, or move axially and vibrate radially.
  • the control assembly includes a handle housing and a guide wire transmission mechanism connected to the support section; the guide wire transmission mechanism is provided in the handle housing and used to drive the guide wire to move axially;
  • the wire transmission mechanism includes: a finger wheel, which is rotatably provided on the handle housing and whose two ends are exposed from the handle housing; a rotating shaft, which is rotatably provided on the handle housing and connected with the handle housing; The finger wheel is connected; a pinion is connected to the rotating shaft; a rack is meshed with the pinion; the proximal end of the guide wire is connected to the distal end of the rack; a chute is fixed on In the handle housing and extending axially along the handle housing, the rack is slidably matched with the chute; when the finger wheel is rotated, the pinion can drive the rack relative to the slide.
  • the slot moves axially.
  • the rotating shaft and the pinion gear are connected by a flat key.
  • control component further includes: an ultrasonic vibration mechanism disposed in the handle housing, the ultrasonic vibration mechanism is connected to the guide wire, and is used to drive the guide wire to vibrate radially.
  • the ultrasonic vibration mechanism includes: an ultrasonic motor and a motor connector;
  • the motor connector includes: a first connection part and a second connection part;
  • the first connection part is arranged axially parallel to the handle housing, so
  • the second connecting part is arranged obliquely relative to the first connecting part and is connected to the first connecting part.
  • the other end of the second connecting part is connected to the output end of the ultrasonic motor;
  • the first connecting part is in the shape of Tubular, the proximal end of the guidewire passes through the first connecting part and passes out of the proximal end of the first connecting part and can move axially relative to the first connecting part.
  • the first connection part is provided with a transmission spiral groove
  • the proximal end of the guide wire is provided with a transmission thread
  • the transmission thread is adapted to the transmission spiral groove to connect the proximal end of the first connection part
  • the rack and the chute are provided with mutually matched anti-slip mechanisms.
  • the anti-accidental sliding mechanism includes: protrusions respectively provided on the chute and two protrusions provided on the chute.
  • the anti-slip groove of the rack, the protrusion is adapted to the anti-slip groove of the rack.
  • control assembly includes a handle housing and a rotation transmission mechanism provided in the handle housing; the rotation transmission mechanism is used to drive the guide wire to move and rotate synchronously.
  • the rotation transmission mechanism includes: a finger wheel; the finger wheel is rotatably arranged on the handle housing, and its axial direction is parallel to the axial direction of the handle housing; there is a center of the finger wheel
  • a transmission thread groove, the proximal end of the guide wire is provided with a transmission thread that cooperates with the transmission thread groove to drive the guide wire to rotate and move synchronously when the finger wheel rotates.
  • the ultrasonic vibration mechanism further includes a motor controller and a power supply; the ultrasonic motor, the motor controller and the power supply are electrically connected in sequence; the motor controller is used to control the start and stop of the ultrasonic motor, and is used to control the ultrasonic motor of single working hours.
  • the ultrasonic vibration mechanism further includes a button; the button is provided on the handle housing and connected to the ultrasonic controller.
  • the guide wire includes a core wire and a winding wire;
  • the core wire includes a core wire twisting section and a core wire supporting section connected in sequence from the distal end to the proximal end; the winding wire is spirally wound around the core wire twisting section. part.
  • the diameter of the core wire supporting section is larger than the diameter of the core wire torsion section.
  • the twisted section of the core wire is spirally wound using an S-shaped shape memory wire.
  • the winding wire is provided with capillary fibers; the distal end of the twisted section of the core wire is provided with a guide head.
  • a developing layer is provided on the surface of the twisted section of the core wire and/or the winding wire.
  • the blood vessel opening device in the embodiment of the present application drives the spiral twisted section of the guide wire to move along the axial direction through the control assembly, so that it can quickly and evenly cut and scrape the diseased objects in the blood vessels, improve the removal effect and efficiency, and quickly clear the blood vessels.
  • Figure 1 is a schematic structural diagram of a blood vessel opening device provided by an embodiment of the present application.
  • Figure 2 is a schematic structural diagram of the spiral torsion section of the guidewire of the blood vessel opening device provided by the embodiment of the present application in a released state;
  • Figure 3 is a schematic structural diagram of the spiral twisted section of the guidewire of the blood vessel opening device provided by the embodiment of the present application being accommodated in the cannula;
  • Figure 4 is a partially enlarged structural schematic diagram of the spiral torsion section of the guidewire of the blood vessel opening device provided by the embodiment of the present application;
  • Figure 5 is a schematic diagram of the connection structure between the guide wire and the ultrasonic motor of the blood vessel opening device provided by the embodiment of the present application;
  • Figure 6 is a schematic structural diagram of the motor connector of the blood vessel opening device provided by the embodiment of the present application.
  • Figure 7 is a schematic structural diagram of the guidewire transmission mechanism of the blood vessel opening device provided by the embodiment of the present application.
  • Figure 8 is a schematic diagram of the transmission structure of the guidewire transmission mechanism of the blood vessel opening device provided by the embodiment of the present application.
  • Figure 9 is a schematic structural diagram of the rotation transmission mechanism of the blood vessel opening device provided by the embodiment of the present application.
  • Figure 10 is a schematic diagram of the connection structure of the ultrasonic vibration mechanism of the blood vessel opening device provided by the embodiment of the present application.
  • Figure 11 is a schematic structural diagram of the handle housing of the blood vessel opening device provided by an embodiment of the present application.
  • connection and “connected” should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, It can also be connected indirectly through an intermediary, which can be an internal connection between two components.
  • the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator;
  • the axial direction refers to the end parallel to the natural direction. The direction of the line connecting the distal center and the proximal center of the medical device in the state.
  • An embodiment of the present application provides a blood vessel opening device that can be used to clear chronic lower limb veins, thereby relieving blood vessel obstruction, improving the human blood circulation system, and avoiding pain, heaviness and leg swelling caused by blood vessel obstruction. , eczema and subsequent breakdown, ulcers, etc.
  • the blood vessel opening device of this embodiment mainly includes: a guide wire 1, a cannula 2 and a control component 3.
  • the spiral twisted section at the distal end of the guide wire 1 can extend into the blocked position of the blood vessel lesion, cut and scrape out the blockage of the lesion in the blood vessel, especially atherosclerosis, and then take it out of the body.
  • the sleeve 2 can accommodate the spiral twisted section of the guide wire 1 .
  • the control component 3 is connected to the proximal ends of the guide wire 1 and the cannula 2, and can drive the guide wire 1 to move axially relative to the cannula 2 so that the spiral torsion section of the guide wire 1 extends out of the distal end of the cannula.
  • the control component 3 can also drive the guide wire 1 to move axially relative to the cannula 2.
  • the spiral twisting segment moves axially to scrape out the blockage in the blood vessel.
  • the guidewire 1 includes a spiral torsion section and a support section connected in sequence from the distal end to the proximal end.
  • the spiral twist section can expand and contract radially.
  • the guide wire 1 may include a core wire 11, a winding wire 12, a capillary fiber 13 and a guide head.
  • the core wire 11 may include a core wire twisting section 111 and a core wire supporting section 112 connected in sequence from the distal end to the proximal end.
  • the core wire support section 112 is located in the casing 2 .
  • the diameter of the core wire supporting section 112 can be larger than the diameter of the core wire torsion section 111, so that the movement of the core wire torsion section can be better driven.
  • the twisted section 111 of the core wire can be spirally wound using an S-shaped shape memory wire.
  • the wire material with shape memory ability can be processed into an S-shaped structure in the plane, and then curled along the axial direction to form a spiral twist structure.
  • the S-shaped wire on the plane allows the core wire to have a certain stretch ability, so that the spiral twisted section can elastically expand and contract radially.
  • the core wire twisted section 111 can change with the change of the diameter of the blood vessel, so that the periphery of the guide wire 1 can be tightly adhered
  • the inner wall of blood vessels can also provide support in multiple directions to better support the inner wall of blood vessels. That is, after being released, the length of the spiral twisted section is reduced and the radial size is increased compared with when it is contained in the cannula 2, so that it can be elastically supported on the inner wall of the blood vessel.
  • the winding wire 12 is spirally wound around the core wire twisted section 111. It can be understood that the winding wire 12 can also be wound from the distal end of the core wire to the proximal end of the core wire, which is not specifically limited here. By wrapping the wire 12, the support performance of the guide wire 1 for the inner wall of the blood vessel can be further enhanced. Furthermore, capillary fibers 13 can also be provided on the winding wire 12 . The capillary fibers 13 may be arranged at intervals on the winding wire 12 wound around the core wire twisted section 111, or the capillary fibers 13 may be continuously arranged. The twisted section of the core wire around which the winding wire 12 is wound forms a spiral twisted section of the guide wire 1 .
  • the capillary fiber 13 can disperse the support force of the guide wire on the blood vessel wall, and the bending moments at various locations effectively support each other when the guide wire is advanced, and the guide wire can be rotated back into the cannula 2 when withdrawn.
  • the capillary fibers 13 can also adsorb the tiny blockage dropped by the guide wire to take the blockage out of the body.
  • the capillary fibers 13 can also apply drugs, allowing more precise drug treatment.
  • the spiral twisted section of the guide wire 1 can be unfolded, cleaned and reused after use.
  • the guide head 14 is disposed at the distal end of the core wire twisting section 111, and the proximal end of the guide head 14 can be welded to the distal end of the core wire twisting section 111.
  • the distal end of the guide head 14 may have a spherical guide surface to facilitate the guide wire to advance in the blood vessel and reach the patient.
  • the surface of the core wire twisted section 111 and/or the surface of the winding wire can be provided with a developing layer.
  • the developing layer can be made of radiopaque material, such as platinum tungsten material, so that the guide wire can have better reliability in the X-ray environment. Visibility makes it easy to observe and adjust the position of the spiral torsion segment during surgery. It can be understood that the blood vessel opening device can also adopt other developing structures, as long as the guide wire has a certain degree of visibility, and there is no specific limitation here.
  • the control assembly 3 includes a handle housing 31 and a guide wire transmission mechanism 5 connected to the support section.
  • the guide wire transmission mechanism 5 is disposed in the handle housing 31 and is used to drive the guide wire 1 to move axially.
  • the guide wire transmission mechanism 5 may include: a finger wheel 51 , a chute 52 , a rack 53 , a pinion 54 and a rotating shaft 55 .
  • the finger wheel 51 is rotatably disposed on the handle housing 31 and its two ends are exposed from the handle housing 31 , so that the finger wheel 51 can be operated through both sides of the handle.
  • the rotating shaft 55 is rotatably arranged on The handle housing 31 is connected to the finger wheel 51 .
  • Both ends of the rotating shaft 55 can be connected to the handle housing 31 through bearings 57 .
  • the finger wheel 51 may have a central hole, and the rotating shaft 55 may pass through the central hole of the finger wheel 51 and be fixedly connected with the finger wheel 51 .
  • the pinion 54 is connected to the rotation shaft 55 .
  • the pinion gear 54 is sleeved on the rotating shaft 55.
  • the rotating shaft 55 and the pinion gear 54 can be fixedly connected through the flat key 56, or the rotating shaft 55 can also be bonded and fixed with the pinion gear 54 through glue.
  • the connection method between 55 and pinion 54 is not specifically limited.
  • the chute 52 is fixed in the handle housing 31 and extends axially along the handle housing 31 .
  • the rack 53 slides with the chute 52 .
  • the rack 53 also meshes with the pinion 54 .
  • the tail end of the guide wire 1 passes through the first connecting portion 421 and is connected to the distal end of the rack 53 , so that the rack 53 can drive
  • the pinion 54 can drive the rack 53 to move axially relative to the chute 52, thereby driving the guide wire 1 to move.
  • the finger wheel 51 rotates, it drives the pinion 54 to rotate, and the pinion drives the rack 53 to move forward and backward along the chute 52.
  • the range in which the rack 53 moves forward and backward is the treatment range.
  • the length of the chute 52 can be 150-250mm, and the length of the rack can be 80-130mm.
  • the treatment range is the range in which the rack 53 can move along the chute 52, which can be set according to the range required for treatment. There are no specific restrictions on its value.
  • the distal end of the rack 53 can be provided with a connecting hole, and the proximal end of the guide wire 1 is connected to the connecting hole.
  • the chute 52 can be provided with two limiting grooves extending along its own axis.
  • the rack 53 is provided with convex ribs at both ends of the side facing the chute that are adapted to the limiting grooves.
  • the convex ribs can be The slide groove 52 slides in the limit groove to ensure the movement accuracy of the guide wire 1 .
  • the pinion gear 54 can select a gear with a small module, which can effectively improve the position control accuracy when the guide wire moves.
  • the rack 53 and the chute 52 are provided with mutually matched anti-slip mechanisms.
  • the anti-slip mechanism may include: protrusions respectively provided on the chute and anti-slip grooves provided on the rack.
  • the protrusions of the chute 52 and the rack The anti-slip grooves of 53 are matched to prevent the rack from sliding at will. The rack can only move if sufficient force is applied.
  • control component 3 can also drive the spiral torsion section extending out of the distal end of the sleeve 2 to vibrate radially.
  • control assembly 3 may also include an ultrasonic vibration mechanism 4 disposed in the handle housing 31 .
  • the ultrasonic vibration mechanism 4 is connected to the guide wire 1 and is used to drive the guide wire 1 to vibrate radially to achieve the effect of deeply clearing the blockage.
  • the ultrasonic vibration mechanism 4 may include: an ultrasonic motor 41 , a motor connector 42 , a motor controller 43 , a power supply 44 and a button 45 .
  • the ultrasonic motor 41 is connected to the proximal end of the guide wire through the motor connector 42 and is used to drive the support section of the guide wire 1 to vibrate radially, thereby driving the spiral torsion section of the guide wire 1 to vibrate radially.
  • the ultrasonic motor 41 is an ultrasonic generator, and the output end of the ultrasonic motor 41 can be a shaft capable of outputting radial vibration.
  • the motor connector 42 connects the output shaft of the ultrasonic motor 41 with the guide wire 1 .
  • the ultrasonic motor 41 can output vibrations of a certain frequency, thereby driving the spiral torsion section of the guide wire 1 to vibrate radially at a certain frequency, so that the helical torsion section can clear blockages more effectively.
  • the motor connector 42 may include a first connection part 421 and a second connection part 422 .
  • the first connecting part 421 is arranged axially parallel to the handle housing 31
  • the second connecting part 422 is arranged obliquely relative to the first connecting part 421 and is connected to the first connecting part 421 .
  • the other end of the second connection part 422 is connected to the output end of the ultrasonic motor 41 .
  • the first connecting part 421 is tubular, and the distal end of the first connecting part 421 can be connected to the proximal end of the sleeve 2 , or the proximal end of the sleeve 2 can be connected to the distal end of the handle housing 31 .
  • the proximal end of the guide wire 1 passes through the first connecting part 421 and passes out of the proximal end of the first connecting part 421 .
  • the guide wire 1 can be in close contact with the inner wall of the first connection part 421.
  • the ultrasonic motor 41 outputs vibration
  • the vibration is transmitted to the first connection part 421 through the second connection part, and then the first connection part 421 drives the guide wire to vibrate radially.
  • the guide wire 1 can move axially relative to the first connecting part.
  • the control assembly 3 can drive the guidewire to vibrate radially and move axially. Furthermore, in some examples, the control assembly 3 can also drive the helical torsion section of the guide wire to rotate and move synchronously, and at the same time, can also drive the helical torsion section to vibrate radially.
  • the first connecting part 421 is also provided with a transmission spiral groove 4211, and the proximal end of the guide wire 1 is provided with a transmission thread.
  • the driving thread is adapted to the driving spiral groove 4211 to convert the axial movement of the guide wire at the proximal end of the first connecting part 421 into the synchronous rotation and movement of the guide wire at the distal end of the first connecting part 421 .
  • the transmission spiral groove 4211 in the first connection part 421 and the transmission thread 1121 on the guide wire constitute a rotation movement control mechanism of the guide wire.
  • the rotation movement control mechanism cooperates with the guide wire transmission mechanism 5 to drive the spiral twist of the guide wire 1
  • the segments rotate and move synchronously, and the ultrasonic vibration mechanism 4 can also drive the guide wire to vibrate radially.
  • the spiral twisting section rotates and moves, it can exert force on the blockage from multiple directions, thereby clearing the blockage in the blood vessel more evenly and efficiently.
  • the guide wire transmission mechanism 5 can drive the spiral twist section to move axially instead of rotating, and can also effectively clear the blood vessels. Blockage.
  • the rotation transmission mechanism may include: a finger wheel 51 , the finger wheel 51 is rotatably provided on the handle housing 31 , and The finger wheel 61 is axially arranged parallel to the handle housing 31 .
  • the center of the finger wheel 51 is provided with a transmission spiral groove, and the proximal end of the guide wire 1 is provided with a transmission thread 1121 that matches the transmission thread groove to drive the guide wire to rotate and move synchronously when the finger wheel 51 rotates.
  • a smooth inner wall can be used in the first connecting part 41 without providing a transmission thread groove, so that the guide wire 1 can move and rotate synchronously in the first connecting part 41 .
  • the transmission thread 1121 at the proximal end of the guide wire 1 can be directly formed at the proximal end of the support section of the guide wire, or a thread sleeve with a transmission thread can be fixedly placed on the proximal end of the support section of the guide wire 1 .
  • the guide wire 1 introduces feedback of retraction force and rotation force, allowing the doctor to better complete the operation.
  • the length of the transmission thread section of the guide wire 1 support section 112 with transmission threads can be determined according to the treatment range.
  • the motor controller 43 is electrically connected to the power supply 44 , and the motor controller 43 is electrically connected to the ultrasonic motor 41 .
  • the motor controller 43 is used to control the start and stop of the ultrasonic motor 41 and the duration of a single operation.
  • the button 45 is provided on the handle housing 31 , and is connected to the motor controller 43 .
  • the motor controller 43 has a timing function. When the button 45 is pressed, the motor controller 43 controls the ultrasonic motor 41 to start working and continue to output radial vibration until the preset single working time is reached.
  • the motor controller 43 controls the ultrasonic motor. 41 stops working, or the motor controller 43 controls the ultrasonic motor 41 to stop working after the button 45 is pressed again during work.
  • the button 45 can be arranged in the middle of the side of the handle housing 31 to facilitate the doctor to operate the button. Click the button 45 once to start the ultrasonic motor 41. Click the button 45 again to stop the ultrasonic motor 41, so that the guide wire 1 can be manually controlled to advance or retreat.
  • the handle housing 31 is used for the doctor's grasp.
  • the entire handle housing 31 adopts a straight handle slightly inclined structure, and an ultrasonic motor 41 is arranged in the triangular slightly inclined structure at the front end. Finger wheels can be adjusted on both sides of the front end of the handle for easy operation.
  • the handle shell can be made of polymer ABS, PC and other materials, and has the advantages of light weight and easy sterilization.
  • other parts in the device except the standard parts can be made of polymer materials, PC, ABS and other materials.
  • the pinions, racks, etc. can be made of stainless steel.
  • the casing 2 can be made of materials such as Pebax, and its outer surface can be attached with a hydrophilic coating.
  • the guide wire is percutaneously inserted into the vascular disease site, and the guide wire is pushed out of the cannula until the tip of the guide wire completely exceeds the patient's position.
  • the capillary fibers of the guide wire are fully Contact with the vascular patient's position, turn on the ultrasonic vibration, and at the same time push the finger wheel to reciprocate, and the blood vessel
  • the tiny blockage inside is twisted and removed by the spiral, and then absorbed by the capillary fibers, and then pulled into the casing and out of the body.
  • the blood vessel opening device can be reused to continue removing blockages. If the blockage is effectively removed, the handle can be dragged to withdraw the vascular opening device as a whole.
  • the blood vessel opening device in the embodiment of the present application drives the spiral twisted section of the guide wire to move along the axial direction through the control assembly, which can quickly and evenly cut and scrape the diseased objects in the blood vessels, improve the removal effect and efficiency, and quickly clear the blood vessels.

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Abstract

本申请部分实施例提供了一种血管开通装置。其包括：导丝（1）、套管（2）以及控制组件（3）；导丝（1）包括从远端到近端依次相连的螺旋扭转段以及支撑段；其中，螺旋扭转段能够径向膨胀和收缩；导丝（1）穿设于套管（2）内，并能够相对套管（2）轴向移动以及周向旋转；套管（2）近端与控制组件（3）远端相连，支撑段近端与控制组件（3）相连，控制组件（3）能够驱动导丝（1）相对套管（2）轴向移动以使螺旋扭转段伸出或者收容至套管（2）内，控制组件（3）还能够驱动伸出套管（2）远端的螺旋扭转段沿轴向移动。

Description

血管开通装置
交叉引用
本申请引用于2022年08月01日递交的名称为“血管开通装置”的第202210915653.7号中国专利申请，其通过引用被全部并入本申请。
技术领域
本申请涉及医疗器械技术领域，特别涉及一种血管开通装置。
背景技术
微创介入手术作为当代微创手术的一个重要分支，是当今社会人口老龄化加剧背景下应运而生的产物。慢性下肢静脉疾病是一种渐进的、毁灭性的疾病，最终导致下肢静脉溃疡，从而破坏患者的生活质量。
全世界每年有超过1.2亿的静脉疾病患者，其中只有1.3％接受治疗。主要是由于目前的治疗技术存在诸多的不足：热消融治疗不够精准，无论是射频消融还是激光治疗，都会释放大量热量，从而损害患处周围的神经和组织。硬化疗法是化学消融，通过破坏静脉内细胞衬里，会造成静脉随着时间的推移塌陷并关闭。硬化疗法相较于热消融治疗患者体验好，但治疗效果不佳。热消融疗效可达90％，但硬化疗法疗效只有50-80％，并且通常需要多次手术才能消除症状。采用新型的氰基丙烯酸酯化疗与热消融一样有效，但它仍留在体内并可 能导致某些人出现过敏反应，在某些情况下，仍需要去除受影响的静脉内的病变物。
微创介入治疗不会产生热损伤、化学损伤和异物残留。但目前的微创介入治疗方案采用普通导丝等，在治疗效果以及治疗效率方面亟需改进。
需要说明的是，在上述背景技术部分公开的信息仅用于加强对本申请的背景的理解，因此可以包括不构成对本领域普通技术人员已知的相关技术的信息。
发明内容
本申请部分实施例的目的在于提供一种血管开通装置，通过控制螺旋扭转导丝轴向移动从而可快速有效清除静脉内栓塞病变物，有利于提高治疗效果。
本申请实施例提供了一种血管开通装置，包括：
导丝，其包括：从远端到近端依次相连的螺旋扭转段以及支撑段；其中，所述螺旋扭转段能够径向膨胀和收缩；
套管，所述导丝穿设于所述套管内，并能够相对所述套管轴向移动以及周向旋转；以及
控制组件，所述套管近端与所述控制组件远端相连，所述支撑段近端与所述控制组件相连，所述控制组件能够驱动所述导丝相对所述套管轴向移动以使所述螺旋扭转段伸出或者收容至所述套管内，所述控制组件还能够驱动伸出所述套管远端的螺旋扭转段沿轴向移动。
例如，所述控制组件还能够驱动伸出所述套管远端的螺旋扭转段同步旋转和移动、或者径向振动以及同步旋转和移动、或者沿轴向移动和径向振动。
例如，所述控制组件包括手柄壳体以及与所述支撑段相连的导丝传动机构；所述导丝传动机构设置于所述手柄壳体内并用于驱动所述导丝轴向移动；所述导丝传动机构包括：手指轮，其可转动地设置于所述手柄壳体上且其两端露出所述手柄壳体；转动轴，所述转动轴可转动地设置于所述手柄壳体且与所述手指轮相连；小齿轮，其与所述转动轴相连；齿条，其与所述小齿轮啮合；所述导丝近端与所述齿条远端相连；滑槽，其固设于所述手柄壳体内且沿所述手柄壳体轴向延伸，所述齿条与所述滑槽滑动配合；当转动所述手指轮时，所述小齿轮能够驱动所述齿条相对所述滑槽轴向移动。
例如，所述转动轴和所述小齿轮通过平键相连。
例如，所述控制组件还包括：设置于所述手柄壳体内的超声波振动机构，所述超声波振动机构与所述导丝相连，并用于驱动所述导丝径向振动。
例如，所述超声波振动机构包括：超声波电机以及电机连接件；所述电机连接件包括：第一连接部以及第二连接部；所述第一连接部平行所述手柄壳体轴向设置，所述第二连接部相对所述第一连接部倾斜设置并与所述第一连接部相连，所述第二连接部的另一端与所述超声波电机的输出端相连；所述第一连接部呈管状，所述导丝近端穿设于所述第一连接部并穿出所述第一连接部近端且能够相对第一连接部轴向移动。
例如，所述第一连接部内设有传动螺旋槽，所述导丝近端设有传动螺纹；所述传动螺纹与所述传动螺旋槽相适配，以将所述第一连接部近端的导丝轴向移动转换成所述第一连接部远端的导丝的同步旋转和移动。
例如，所述齿条和所述滑槽上设有相互配合的防误滑机构。
例如，所述防误滑机构包括：分别设置于所述滑槽的凸起和设置于所述 齿条的防滑槽，所述凸起与所述齿条的防滑槽相适配。
例如，所述控制组件包括手柄壳体以及设置于所述手柄壳体内的旋移传动机构；所述旋移传动机构用于驱动所述导丝同步移动和旋转。
例如，所述旋移传动机构包括：手指轮；所述手指轮可转动地设置于所述手柄壳体，且其轴向平行于所述手柄壳体轴向设置；所述手指轮中心设有传动螺纹槽，所述导丝近端设有与所述传动螺纹槽配合的传动螺纹，以在所述手指轮转动时驱动所述导丝同步旋转和移动。
例如，所述超声波振动机构还包括电机控制器以及电源；所述超声波电机、电机控制器以及电源依次电连接；所述电机控制器用于控制所述超声波电机启停，并用于控制所述超声波电机的单次工作时长。
例如，所述超声波振动机构还包括按钮；所述按钮设置于所述手柄壳体且与所述超声波控制器相连。
例如，所述导丝包括芯丝以及绕丝；所述芯丝包括从远端到近端依次相连的芯丝扭转段以及芯丝支撑段；所述绕丝螺旋绕设于所述芯丝扭转段。
例如，所述芯丝支撑段的直径大于所述芯丝扭转段的直径。
例如，所述芯丝扭转段采用平面呈S型的形状记忆丝呈螺旋形绕制而成。
例如，所述绕丝上设有毛细纤维；所述芯丝扭转段远端设有导向头。
例如，所述芯丝扭转段和/或所述绕丝的表面设有显影层。
由上述技术方案可知，本申请至少具有如下优点和积极效果：
本申请实施例的血管开通装置，通过控制组件驱动导丝的螺旋扭转段沿轴向移动，可以快速均匀地切割、刮除血管内病变物，提高清除效果以及清除效率、快速疏通血管。
附图说明
一个或多个实施例通过与之对应的附图中的图片进行示例性说明，这些示例性说明并不构成对实施例的限定，附图中具有相同参考数字标号的元件表示为类似的元件，除非有特别申明，附图中的图不构成比例限制。
图1为本申请实施例提供的血管开通装置的结构示意图；
图2为本申请实施例提供的血管开通装置的导丝的螺旋扭转段处于释放状态的结构示意图；
图3为本申请实施例提供的血管开通装置的导丝的螺旋扭转段收容于套管的结构示意图；
图4为本申请实施例提供的血管开通装置的导丝的螺旋扭转段的局部放大结构示意图；
图5为本申请实施例提供的血管开通装置的导丝与超声波电机的连接结构示意图；
图6为本申请实施例提供的血管开通装置的电机连接件的结构示意图；
图7为本申请实施例提供的血管开通装置的导丝传动机构的结构示意图；
图8为本申请实施例提供的血管开通装置的导丝传动机构的传动结构示意图；
图9为本申请实施例提供的血管开通装置的旋移传动机构的结构示意图；
图10为本申请实施例提供的血管开通装置的超声波振动机构的连接结构示意图；
图11为本申请实施例提供的血管开通装置的手柄壳体的结构示意图。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请部分实施例进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”、“第三”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
需要说明的是，除非另有明确的规定，术语“相连”、“连接”等应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。
在本申请的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于自然状态下的医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便，并不能理解为对本申请的限制。
请参阅图1所示，本申请实施例提供一种血管开通装置，可用于慢性下肢静脉血管疏通，从而缓解血管阻塞、改善人体血液循环系统，避免因血管堵塞引发的疼痛、沉重和腿部肿胀、湿疹和随后的破裂、溃疡等。本实施例的血管开通装置主要包括：导丝1、套管2以及控制组件3。
导丝1远端的螺旋扭转段能够伸入血管病变堵塞位置，对血管内病变堵塞物，尤其粥样硬化物等进行切割、刮除后带出体外。套管2能够收容导丝1的螺旋扭转段。控制组件3与导丝1和套管2近端相连，并能够驱动导丝1相对套管2轴向移动以使导丝1的螺旋扭转段伸出套管远端，控制组件3还能够驱动螺旋扭转段轴向移动以刮除血管内堵塞物。
请参阅图1至图4所示，导丝1包括从远端到近端依次相连的螺旋扭转段以及支撑段。其中，螺旋扭转段能够径向膨胀和收缩。导丝1到达血管堵塞位置(或称病患位置)后，通过控制组件3驱动导丝1的螺旋扭转段伸出套管2远端并伸入至血管的堵塞物内，螺旋扭转段被释放后能够贴附支撑血管内壁，然后通过控制组件3驱动导丝轴向移动，从而通过螺旋扭转段不断切割、刮除血管壁的堵塞物，最后再通过螺旋扭转段将堵塞物带出体外。
导丝1可包括芯丝11、绕丝12、毛细纤维13以及导向头。其中，芯丝11可包括从远端到近端依次相连的芯丝扭转段111以及芯丝支撑段112。芯丝支撑段112位于套管2内。芯丝支撑段112的直径可大于芯丝扭转段111的直径，从而可以更好地驱动芯丝扭转段运动。芯丝扭转段111可采用平面呈S型的形状记忆丝呈螺旋形绕制而成。具体地，可以先将具有形状记忆能力的丝材加工成平面呈S型的结构，再沿轴向卷曲定型成螺旋扭转结构。平面呈S型的丝使得芯丝具有一定的伸缩能力，从而使得螺旋扭转段能够径向弹性膨胀和收缩，芯丝扭转段111能够随血管直径尺寸变化而变化，使导丝1外围紧密贴附血管内壁，同时还能提供多个方向的支撑力，更好地支撑血管内壁。即螺旋扭转段在被释放后相较于收容于套管2内时其长度减小而径向尺寸增大，从而能够弹性支撑于血管内壁。
绕丝12螺旋绕设于芯丝扭转段111，可以理解的是，绕丝12也可以从芯丝远端绕设至芯丝近端，在此不做具体限制。通过绕丝12可以进一步增强导丝1对于血管内壁的支撑性能。进一步地，绕丝12上还可设有毛细纤维13。在绕设于芯丝扭转段111上的绕丝12上可以间隔设置毛细纤维13，也可以连续设置毛细纤维13。绕设有绕丝12的芯丝扭转段形成导丝1的螺旋扭转段。毛细纤维13能够分散导丝对血管壁的支撑力，在导丝推进时各处弯矩相互有效支撑，撤回时导丝可旋转回收入套管2内。毛细纤维13还能够吸附导丝清除掉落的微小堵塞物，以将堵塞物带出体外。毛细纤维13还能够敷涂药物，可以更精准地进行药物治疗。导丝1的螺旋扭转段在使用后可展开清洗，重复使用。
导向头14设置于芯丝扭转段111的远端，导向头14近端可与芯丝扭转段111远端焊接。导向头14远端可具有球形导向面，便于导丝在血管中推进到达病患处。
芯丝扭转段111的表面和/或绕丝的表面可设有显影层，显影层可采用不透射线的材料，比如铂钨材料制成，从而可使导丝在X射线环境具备较佳可视性，便于在术中观察并调整螺旋扭转段的位置。可以理解的是，血管开通装置还可采用其他显影结构，只要能够使得导丝具备一定的可视性即可，在此不做具体限制。
请参阅图7、图8所示，控制组件3包括手柄壳体31以及与支撑段相连的导丝传动机构5。导丝传动机构5设置于手柄壳体31内并用于驱动导丝1轴向移动。导丝传动机构5可包括：手指轮51、滑槽52、齿条53、小齿轮54以及转动轴55。其中，手指轮51可转动地设置于手柄壳体31上且其两端露出手柄壳体31，从而可以通过手柄两侧操作手指轮51。转动轴55可转动地设置于 手柄壳体31且与手指轮51相连。转动轴55两端可通过轴承57与手柄壳体31相连。手指轮51可具有中心孔，转动轴55可穿过手指轮51的中心孔并与手指轮51固定连接。小齿轮54与转动轴55相连。具体地，小齿轮54套设于转动轴55，转动轴55和小齿轮54可通过平键56固定连接，或者转动轴55也可以通过胶水与小齿轮54粘结固定，本实施例对于转动轴55和小齿轮54的连接方式不做具体限制。滑槽52固设于手柄壳体31内且沿手柄壳体31轴向延伸，齿条53与滑槽52滑动配合。齿条53还与小齿轮54啮合。导丝1尾端穿出第一连接部421并与齿条53远端相连，从而使得齿条53能够驱动导丝1轴向移动。
当转动手指轮51时，小齿轮54能够驱动齿条53相对滑槽52轴向移动，从而驱动导丝1运动。手指轮51转动时带动小齿轮54转动，小齿轮带动齿条53沿滑槽52前后移动，齿条53前后移动的范围即为治疗范围。示例性地，滑槽52的长度可以为150～250mm，齿条的长度可以为80～130mm，治疗范围即为齿条53能够沿滑槽52移动的范围，具体可以根据治疗所需范围设置，对其取值不做具体限制。
其中，齿条53远端可设置连接孔，导丝1近端与连接孔相连。滑槽52可设置有两个沿自身轴向延伸的限位凹槽，相应地，齿条53朝向滑槽的一侧两端设有与限位凹槽适配的凸筋，凸筋能够在滑槽52的限位凹槽内滑动，保证导丝1运动精度。
值得一提的是，小齿轮54可以选择模数小的齿轮，可有效提高导丝移动时的位置控制精度。
齿条53和滑槽52上设有相互配合的防误滑机构。具体地，防误滑机构可包括：分别设置于滑槽的凸起和设置于齿条的防滑槽，滑槽52的凸起与齿条 53的防滑槽相适配，可防止齿条随意滑动，只有施加足够的力齿条才能移动。
值得一提的是，控制组件3还能够驱动伸出套管2远端的螺旋扭转段径向振动。相应地，控制组件3还可包括设置于手柄壳体31内的超声波振动机构4。其中，超声波振动机构4与导丝1相连，并用于驱动导丝1径向振动，达到深入清除堵塞物的效果。
超声波振动机构4可包括：超声波电机41、电机连接件42、电机控制器43、电源44以及按钮45。
超声波电机41通过电机连接件42与导丝近端相连，并用于驱动导丝1的支撑段径向振动，从而带动导丝1的螺旋扭转段径向振动。需要说明的是，超声波电机41为超声波发生器，超声波电机41的输出端可以为能够输出径向振动的轴。电机连接件42将超声波电机41的输出轴与导丝1相连。超声波电机41能够输出一定频率的振动，从而带动导丝1的螺旋扭转段按照一定的频率径向振动，使得螺旋扭转段能够更有效地清除堵塞物。
请参阅图5、图6所示，电机连接件42可包括：第一连接部421以及第二连接部422。第一连接部421平行手柄壳体31轴向设置，第二连接部422相对第一连接部421倾斜设置并与第一连接部421相连。第二连接部422的另一端与超声波电机41的输出端相连。第一连接部421呈管状，第一连接部421远端可与套管2近端相连，或者套管2近端可与手柄壳体31远端相连。导丝1近端穿设于第一连接部421并穿出第一连接部421近端。导丝1可以与第一连接部421内壁紧密接触，当超声波电机41输出振动时，通过第二连接部将振动传递至第一连接部421，再通过第一连接部421带动导丝径向振动。导丝1能够相对第一连接部轴向移动。
前述实施例中控制组件3能够驱动导丝径向振动和轴向移动。进一步地，在一些例子中，控制组件3还能够驱动导丝的螺旋扭转段同步旋转和移动，且同时还能够驱动螺旋扭转段径向振动。具体地，第一连接部421内还设有传动螺旋槽4211，导丝1近端设有传动螺纹。传动螺纹与传动螺旋槽4211相适配，以将第一连接部421近端的导丝轴向移动转换成第一连接部421远端的导丝的同步旋转和移动。即通过第一连接部421内的传动螺旋槽4211和导丝上的传动螺纹1121构成了导丝的旋转运动控制机构，旋转运动控制机构与导丝传动机构5配合能够驱动导丝1的螺旋扭转段同步旋转和移动，且通过超声波振动机构4还能够驱动导丝径向振动。螺旋扭转段旋转移动时能够从多个方向对堵塞物施加作用力，从而能够更均匀高效地清除血管内堵塞物。可以理解的是，当第一连接部421内壁未设置传动螺纹槽时，导丝传动机构5能够驱动螺旋扭转段做轴向移动，而不再做旋转运动，也能够很好地清除血管内的堵塞物。
作为上述旋移传动机构的一种替换方式，在一些例子中，请参阅图9所示，旋移传动机构可包括：手指轮51，手指轮51可转动地设置于手柄壳体31上，且手指轮61轴向平行于手柄壳体31轴向设置。手指轮51中心设有传动螺旋槽，导丝1近端设有与传动螺纹槽配合的传动螺纹1121，以在手指轮51转动时驱动导丝同步旋转和移动。当控制组件还包括前述超声波振动机构4时，此时，第一连接部41内可采用光滑的内壁，无需设置传动螺纹槽，使得导丝1能够在第一连接部41内同步移动和旋转。其中，导丝1近端的传动螺纹1121可直接在导丝的支撑段近端形成，或者可在导丝1的支撑段近端固定套设带有传动螺纹的螺纹套。当横向拨动手指轮51时，螺旋传动力作用于导丝上驱动导丝同步进行移动和旋转。医生横向拨动手指轮51旋转的时候，可以直接感受到 导丝1导入回撤力和旋转力的反馈，使医生更好的完成手术。导丝1支撑段112的具有传动螺纹的传动螺纹段的长度可以根据治疗范围确定。
请参阅图10、图11所示，电机控制器43与电源44电连接，电机控制器43与超声波电机41电连接。电机控制器43用于控制超声波电机41的启停以及单次工作时长。按钮45设置于手柄壳体31上，按钮45与电机控制器43相连。电机控制器43具有计时功能，当按钮45被按下后，电机控制器43控制超声波电机41开始工作并持续输出径向振动，直到达到预设的单次工作时长后电机控制器43控制超声波电机41停止工作，或者工作中再次按下按钮45后电机控制器43控制超声波电机41停止工作。按钮45可设置在手柄壳体31侧面的中部，便于医生操作按钮，按钮45点击一次即可启动超声波电机41，再次点击按钮45超声波电机41停止，从而可手动控制导丝1前进或后退。
手柄壳体31用于医生的抓握，手柄壳体31整体采用直柄微斜结构，前端三角形微斜结构内设置超声波电机41。手柄前端两侧均可调整手指轮，操作方便。该手柄壳体可采用高分子ABS、PC等材料制作，具有质量轻及便于灭菌的优点。
本实施例的血管开通装置中，除标准件外装置中的其他零部件可采用高分子材料、PC、ABS等材料制作，为提高强度小齿轮、齿条等可采用不锈钢制作。套管2可以采用Pebax等材料制作，且其外表面可附亲水涂层。
本实施例的血管开通装置的使用方法如下：
介入手术时经皮将导丝插入到血管病患处，将导丝从套管内推出直到导丝头端完全超过病患位置，待导丝的螺旋扭转段完全释放后，导丝的毛细纤维充分与血管病患位置接触，开启超声波振动，同时推动手指轮往复运动，血管 内微小堵塞物被螺旋扭转掉清除掉后被毛细纤维吸附，然后被拉入套管内，拉出体外。再对导丝进行清洗后，可重复使用该血管开通装置继续清除堵塞物。如堵塞物被有效清除，可拖动手柄整体撤出血管开通装置。
基于上述技术方案本申请至少具有如下优点和积极效果：
本申请实施例的血管开通装置通过控制组件驱动导丝的螺旋扭转段沿轴向移动，可以快速均匀地切割、刮除血管内病变物，提高清除效果以及清除效率、快速疏通血管。
本领域的普通技术人员可以理解，上述各实施例是实现本申请的具体实施例，而在实际应用中，可以在形式上和细节上对其作各种改变，而不偏离本申请的精神和范围。

Claims (18)

  1. 一种血管开通装置，包括：
    导丝，其包括：从远端到近端依次相连的螺旋扭转段以及支撑段；其中，所述螺旋扭转段能够径向膨胀和收缩；
    套管，所述导丝穿设于所述套管内，并能够相对所述套管轴向移动以及周向旋转；以及
    控制组件，所述套管近端与所述控制组件远端相连，所述支撑段近端与所述控制组件相连，所述控制组件能够驱动所述导丝相对所述套管轴向移动以使所述螺旋扭转段伸出或者收容至所述套管内，所述控制组件还能够驱动伸出所述套管远端的螺旋扭转段沿轴向移动。
  2. 如权利要求1所述的血管开通装置，其中，所述控制组件还能够驱动伸出所述套管远端的螺旋扭转段同步旋转和移动、或者径向振动以及同步旋转和移动、或者沿轴向移动和径向振动。
  3. 如权利要求1所述的血管开通装置，其中，所述控制组件包括手柄壳体以及与所述支撑段相连的导丝传动机构；所述导丝传动机构设置于所述手柄壳体内并用于驱动所述导丝轴向移动；
    所述导丝传动机构包括：
    手指轮，其可转动地设置于所述手柄壳体上且其两端露出所述手柄壳体；
    转动轴，所述转动轴可转动地设置于所述手柄壳体且与所述手指轮相连；
    小齿轮，其与所述转动轴相连；
    齿条，其与所述小齿轮啮合；所述导丝近端与所述齿条远端相连；
    滑槽，其固设于所述手柄壳体内且沿所述手柄壳体轴向延伸，所述齿条与所述滑槽滑动配合；当转动所述手指轮时，所述小齿轮能够驱动所述齿条相对所述滑槽轴向移动。
  4. 如权利要求3所述的血管开通装置，其中，所述转动轴和所述小齿轮通过平键相连。
  5. 如权利要求3所述的血管开通装置，其中，所述控制组件还包括：设置于所述手柄壳体内的超声波振动机构，所述超声波振动机构与所述导丝相连，并用于驱动所述导丝径向振动。
  6. 如权利要求5所述的血管开通装置，其中，所述超声波振动机构包括：超声波电机以及电机连接件；
    所述电机连接件包括：第一连接部以及第二连接部；
    所述第一连接部平行所述手柄壳体轴向设置，所述第二连接部相对所述第一连接部倾斜设置并与所述第一连接部相连，所述第二连接部的另一端与所述超声波电机的输出端相连；所述第一连接部呈管状，所述导丝近端穿设于所述第一连接部并穿出所述第一连接部近端且能够相对第一连接部轴向移动。
  7. 如权利要求6所述的血管开通装置，其中，所述第一连接部内设有传动螺旋槽，所述导丝近端设有传动螺纹；所述传动螺纹与所述传动螺旋槽相适配，以将所述第一连接部近端的导丝轴向移动转换成所述第一连接部远端的导丝的同步旋转和移动。
  8. 如权利要求3所述的血管开通装置，其中，所述齿条和所述滑槽上设有相互配合的防误滑机构。
  9. 如权利要求8所述的血管开通装置，其中，所述防误滑机构包括：分别 设置于所述滑槽的凸起和设置于所述齿条的防滑槽，所述凸起与所述齿条的防滑槽相适配。
  10. 如权利要求2所述的血管开通装置，其中，所述控制组件包括手柄壳体以及设置于所述手柄壳体内的旋移传动机构；所述旋移传动机构用于驱动所述导丝同步移动和旋转。
  11. 如权利要求10所述的血管开通装置，其中，所述旋移传动机构包括：手指轮；所述手指轮可转动地设置于所述手柄壳体，且其轴向平行于所述手柄壳体轴向设置；所述手指轮中心设有传动螺纹槽，所述导丝近端设有与所述传动螺纹槽配合的传动螺纹，以在所述手指轮转动时驱动所述导丝同步旋转和移动。
  12. 如权利要求6所述的血管开通装置，其中，所述超声波振动机构还包括电机控制器以及电源；
    所述超声波电机、电机控制器以及电源依次电连接；所述电机控制器用于控制所述超声波电机启停，并用于控制所述超声波电机的单次工作时长。
  13. 如权利要求12所述的血管开通装置，其中，所述超声波振动机构还包括按钮；所述按钮设置于所述手柄壳体且与所述超声波控制器相连。
  14. 如权利要求1所述的血管开通装置，其中，所述导丝包括芯丝以及绕丝；
    所述芯丝包括从远端到近端依次相连的芯丝扭转段以及芯丝支撑段；
    所述绕丝螺旋绕设于所述芯丝扭转段。
  15. 如权利要求14所述的血管开通装置，其中，所述芯丝支撑段的直径大于所述芯丝扭转段的直径。
  16. 如权利要求14所述的血管开通装置，所述芯丝扭转段采用平面呈S型的形状记忆丝呈螺旋形绕制而成。
  17. 如权利要求14至16任一项所述的血管开通装置，所述绕丝上设有毛细纤维；
    所述芯丝扭转段远端设有导向头。
  18. 如权利要求17所述的血管开通装置，所述芯丝扭转段和/或所述绕丝的表面设有显影层。
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