CN115227337A - Vascular opening device - Google Patents

Vascular opening device Download PDF

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Publication number
CN115227337A
CN115227337A CN202210915653.7A CN202210915653A CN115227337A CN 115227337 A CN115227337 A CN 115227337A CN 202210915653 A CN202210915653 A CN 202210915653A CN 115227337 A CN115227337 A CN 115227337A
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CN
China
Prior art keywords
guide wire
section
wire
control assembly
connecting part
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Granted
Application number
CN202210915653.7A
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Chinese (zh)
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CN115227337B (en
Inventor
杜海洋
夏顺
黄定国
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Shanghai Tendfo Medical Technologies Co Ltd
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Shanghai Tendfo Medical Technologies Co Ltd
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Priority to CN202210915653.7A priority Critical patent/CN115227337B/en
Publication of CN115227337A publication Critical patent/CN115227337A/en
Priority to PCT/CN2023/087196 priority patent/WO2024027190A1/en
Application granted granted Critical
Publication of CN115227337B publication Critical patent/CN115227337B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements 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
    • A61B17/22012Implements 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
    • 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
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • 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
    • A61B17/22004Implements 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
    • A61B17/22012Implements 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
    • A61B2017/22014Implements 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
    • A61B2017/22015Implements 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
    • A61B2017/22017Implements 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
    • 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
    • A61B2017/320733Atherectomy 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
    • 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
    • A61B2017/320741Atherectomy 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

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention provides a vascular opening device. It comprises the following steps: a guidewire, a cannula, and a control assembly; the guide wire comprises a spiral torsion section and a support section which are sequentially connected from the far end to the near end; wherein the helically twisted section is capable of radial expansion and contraction; the guide wire penetrates through the sleeve and can axially move and circumferentially rotate relative to the sleeve; the sleeve pipe near-end links to each other with the control assembly distal end, and the support section near-end links to each other with the control assembly, and the control assembly can drive the relative sleeve pipe axial displacement of seal wire so that the spiral torsion section stretches out or accomodates to the cover intraductally, and the control assembly can also drive the spiral torsion section that stretches out the sleeve pipe distal end along axial displacement. According to the embodiment of the invention, the spiral twisted guide wire is controlled to move axially, so that the thrombus lesion in the vein can be quickly and effectively removed, and the treatment effect is favorably improved.

Description

Vascular opening device
Technical Field
The invention relates to the technical field of medical instruments, in particular to a vascular opening device.
Background
The minimally invasive interventional operation is an important branch of modern minimally invasive operations and is a product produced by people who are in the future under the background of the aging and aggravation of the population of the modern society. Chronic venous lower extremity disease is a progressive, devastating disease that ultimately leads to venous leg ulcers, thereby undermining the quality of life of the patient.
Over 1.2 billion patients with venous disease worldwide are treated annually, with only 1.3% of them. Mainly due to the numerous disadvantages of current treatment techniques: thermal ablation therapy is not accurate enough, and both radio frequency ablation and laser therapy release a large amount of heat, thereby damaging nerves and tissues around the affected part. Sclerotherapy is chemical ablation that causes veins to collapse and close over time by disrupting the lining of cells within the vein. Sclerotherapy is experienced by patients better than thermal ablation therapy, but the treatment effect is poor. Thermal ablation can be as effective as 90%, but sclerotherapy is only 50-80% effective and usually requires multiple surgeries to eliminate symptoms. Chemotherapy with the new cyanoacrylate is as effective as thermal ablation, but it remains in the body and may cause allergic reactions in some people and in some cases, the removal of the affected intravenous lesions is still required.
The minimally invasive interventional therapy does not produce thermal injury, chemical injury and foreign body residues. However, the existing minimally invasive interventional therapy scheme adopts a common guide wire and the like, and needs to be improved in the aspects of treatment effect and treatment efficiency.
It is to be noted that the information disclosed in the above background section is only for enhancement of understanding of the background of the present application and thus may include information that does not constitute related art known to those of ordinary skill in the art.
Disclosure of Invention
The embodiment of the invention aims to provide a vascular opening device, which can quickly and effectively remove an intravenous embolism lesion substance by controlling the axial movement of a spiral twisted guide wire, and is favorable for improving the treatment effect.
To solve the above technical problem, an embodiment of the present invention provides a vascular opening device, including: a guidewire, comprising: the spiral torsion section and the support section are sequentially connected from the far end to the near end; wherein the helically twisted section is radially expandable and contractible;
the guide wire penetrates through the sleeve and can axially move and circumferentially rotate relative to the sleeve; and
the control assembly can drive the guide wire to axially move relative to the sleeve so that the spiral torsion section extends out of or is accommodated in the sleeve, and the control assembly can also drive the spiral torsion section extending out of the distal end of the sleeve to axially move.
As an example, the control assembly may also be capable of driving the helically twisted section extending out of the distal end of the cannula to rotate and move in synchronization, or to vibrate radially and rotate and move in synchronization, or to move axially and vibrate radially.
As one example, the control assembly includes a handle housing and a guide wire drive mechanism coupled to the support section; the guide wire transmission mechanism is arranged in the handle shell and is used for driving the guide wire to axially move;
the guide wire transmission mechanism comprises:
a finger wheel rotatably provided on the handle case and having both ends thereof exposed from the handle case;
the rotating shaft is rotatably arranged on the handle shell and is connected with the finger wheel;
a pinion gear connected to the rotating shaft;
a rack engaged with the pinion; the proximal end of the guide wire is connected with the distal end of the rack;
the sliding groove is fixedly arranged in the handle shell and axially extends along the handle shell, and the rack is in sliding fit with the sliding groove; when the finger wheel is rotated, the pinion can drive the rack to axially move relative to the chute;
alternatively, the rotating shaft and the pinion gear are connected by a flat key.
As an embodiment, the control assembly further comprises: the ultrasonic vibration mechanism is arranged in the handle shell, is connected with the guide wire and is used for driving the guide wire to vibrate in the radial direction;
optionally, the ultrasonic vibration mechanism includes: an ultrasonic motor and a motor connector;
the motor connector includes: a first connection portion and a second connection portion;
the first connecting part is arranged in parallel with the axial direction of the handle shell, the second connecting part is obliquely arranged relative to the first connecting part and is connected with the first connecting part, and the other end of the second connecting part is connected with the output end of the ultrasonic motor; the guide wire near end penetrates through the first connecting part, penetrates out of the first connecting part near end and can axially move relative to the first connecting part;
optionally, a transmission spiral groove is formed in the first connecting part, and a transmission thread is formed at the proximal end of the guide wire; the drive screw thread is adapted to the drive helical groove to convert axial movement of the guide wire proximal of the first connection into synchronous rotation and movement of the guide wire distal of the first connection.
As an embodiment, the rack and the chute are provided with mutually matched anti-misoperation mechanisms;
optionally, the anti-false slip mechanism comprises: the protrusions are respectively arranged on the sliding grooves and the anti-slip grooves formed in the racks, and the protrusions are matched with the anti-slip grooves of the racks.
As one embodiment, the control assembly includes a handle housing and a rotational movement transmission mechanism disposed within the handle housing; the rotary transmission mechanism is used for driving the guide wire to synchronously move and rotate;
optionally, the rotation transmission mechanism comprises: a finger wheel; the finger wheel is rotatably arranged on the handle shell, and the axial direction of the finger wheel is parallel to the axial direction of the handle shell; the center of the finger wheel is provided with a transmission thread groove, and the near end of the guide wire is provided with a transmission thread matched with the transmission thread groove so as to drive the guide wire to synchronously rotate and move when the finger wheel rotates.
As an embodiment, the ultrasonic vibration mechanism further comprises 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 for controlling the starting and stopping of the ultrasonic motor and controlling the single working time of the ultrasonic motor;
optionally, the ultrasonic vibration mechanism further comprises a button; the button is arranged on the handle shell and connected with the ultrasonic controller.
As one example, the guidewire includes a core wire and a wrap wire;
the core wire comprises a core wire twisting section and a core wire supporting section which are sequentially connected from the far end to the near end;
the winding wire is spirally wound on the core wire torsion section;
optionally, the core wire support section has a diameter greater than the diameter of the core wire torsion section.
As an embodiment, the core wire twisting section is formed by spirally winding a shape memory wire with an S-shaped plane.
As an embodiment, the filament winding is provided with capillary fibers;
a guide head is arranged at the far end of the core wire twisting section;
optionally, the surface of the core wire twisting section and/or the winding wire is provided with a developing layer.
According to the technical scheme, the invention at least has the following advantages and positive effects:
according to the vascular opening device provided by the embodiment of the invention, the control assembly drives the spiral torsion section of the guide wire to move along the axial direction, so that the lesion in the blood vessel can be rapidly and uniformly cut and scraped, the clearing effect and clearing efficiency are improved, and the blood vessel is rapidly dredged.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the prior art descriptions will be briefly introduced below, it is understood that the drawings in the following description are only examples of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 is a schematic structural diagram of a vascular access device according to an embodiment of the present invention;
fig. 2 is a schematic structural diagram of a helical twisted section of a guide wire of a vascular access device according to an embodiment of the present invention in a released state;
FIG. 3 is a schematic view of a helically twisted section of a guidewire of a vascular access device according to an embodiment of the present invention received within a cannula;
fig. 4 is a partially enlarged structural diagram of a helically twisted section of a guidewire of a vascular access device provided in an embodiment of the present invention;
fig. 5 is a schematic view of a connection structure of a guide wire and an ultrasonic motor of a vascular access device according to an embodiment of the present invention;
FIG. 6 is a schematic structural diagram of a motor connector of a vascular access device according to an embodiment of the present invention;
fig. 7 is a schematic structural diagram of a guide wire transmission mechanism of a vascular access device according to an embodiment of the present invention;
fig. 8 is a schematic view of a transmission structure of a guide wire transmission mechanism of a vascular opening device provided in an embodiment of the invention;
FIG. 9 is a schematic structural diagram of a rotational movement transmission mechanism of a vascular access device according to an embodiment of the present invention;
FIG. 10 is a schematic view of the connection structure of the ultrasonic vibration mechanism of the vascular access device according to an embodiment of the present invention;
fig. 11 is a schematic structural diagram of a handle housing of a vascular access device according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it will be appreciated by those of ordinary skill in the art that numerous technical details are set forth in order to provide a better understanding of the present invention in its various embodiments. However, the technical solution claimed in the present invention can be implemented without these technical details and various changes and modifications based on the following embodiments.
In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
It should be noted that, unless expressly stated otherwise, the terms "connected," "connected," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements.
In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device in its natural state. The above definitions are for convenience only and should not be construed as limiting the present invention.
Referring to fig. 1, an embodiment of the present invention provides a vascular access device for chronic venous vessel bypass of the lower extremities, thereby alleviating vessel occlusion, improving the blood circulation of the body, and avoiding pain, heaviness and swelling of the legs, eczema and subsequent rupture and ulceration due to vessel occlusion. The vascular access device of the present embodiment mainly includes: a guide wire 1, a cannula 2 and a control assembly 3.
The spiral torsion section at the far end of the guide wire 1 can extend into the blockage position of the pathological changes of the blood vessel, and the blockage materials of the pathological changes in the blood vessel, particularly atherosclerotic materials and the like, are cut and scraped and then are taken out of the body. The sleeve 2 can house the helically twisted section of the guide wire 1. The control component 3 is connected with the proximal ends of the guide wire 1 and the sleeve 2 and can drive the guide wire 1 to axially move relative to the sleeve 2 so that the spiral torsion section of the guide wire 1 extends out of the distal end of the sleeve, and the control component 3 can also drive the spiral torsion section to axially move so as to scrape the blockage in the blood vessel.
Referring to fig. 1 to 4, the guide wire 1 includes a helically twisted section and a supporting section connected in series from the distal end to the proximal end. Wherein the helically twisted section is capable of radial expansion and contraction. After the seal wire 1 reaches the vascular jam position (or patient position), the spiral torsion section that drives the seal wire 1 through the control assembly 3 stretches out 2 distal ends of sleeve pipes and stretches into to the vascular plug in, can attach after the spiral torsion section is released and support the vascular inner wall, then drives seal wire axial displacement through the control assembly 3 to constantly cut, strike off the plug of vascular wall through the spiral torsion section, the rethread spiral torsion section is taken the plug out of body at last.
The guide wire 1 may comprise a core wire 11, a winding wire 12, a capillary fiber 13 and a guiding 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 within the casing 2. The diameter of the core wire support section 112 may be larger than the diameter of the core wire twisting section 111, so that the core wire twisting section may be better driven to move. The core wire twisting section 111 may be formed by spirally winding a shape memory wire having an S-shaped plane. Specifically, the wire with shape memory capability can be processed into a structure with an S-shaped plane, and then the wire is curled and shaped along the axial direction to form a spiral torsion structure. The core wire has certain telescopic capacity due to the S-shaped wire, so that the spiral torsion section can be radially and elastically expanded and contracted, the core wire torsion section 111 can change along with the diameter size of the blood vessel, the periphery of the guide wire 1 is tightly attached to the inner wall of the blood vessel, and meanwhile, supporting force in multiple directions can be provided, and the inner wall of the blood vessel can be better supported. That is, the length of the helically twisted section is reduced and the radial dimension thereof is increased after the helically twisted section is released as compared with the length of the helically twisted section when the helically twisted section is accommodated in the cannula 2, so that the helically twisted section can be elastically supported on the inner wall of the blood vessel.
The winding wire 12 is helically wound around the twisted section 111 of the core wire, it being understood that the winding wire 12 may be wound from the distal end of the core wire to the proximal end of the core wire, and is not particularly limited herein. The support of the guide wire 1 against the inner wall of the blood vessel can be further enhanced by the winding 12. Further, the filament 12 may be provided with a capillary fiber 13. The capillary fibers 13 may be provided at intervals on the winding wire 12 wound around the core wire twisting section 111, or the capillary fibers 13 may be provided continuously. The helically twisted section of the guide wire 1 is formed around the twisted section of the core wire provided with the winding wire 12. The capillary fiber 13 can disperse the supporting force of the guide wire to the vessel wall, the bending moments at all positions are mutually effectively supported when the guide wire is pushed, and the guide wire can rotate back to be collected into the sleeve 2 when the guide wire is withdrawn. The capillary fibres 13 also enable the suction of the guide wire to clear the small plugs that have fallen off, in order to bring them out of the body. The capillary fibers 13 can also be coated with a drug, allowing for more precise medication. The spiral torsion section of the guide wire 1 can be unfolded and cleaned after use and can be reused.
The guiding head 14 is arranged at the far end of the core wire twisting section 111, and the near end of the guiding head 14 can be welded with the far end of the core wire twisting section 111. The distal end of the guide head 14 may have a spherical guide surface to facilitate advancement of the guide wire through the blood vessel to the site of the lesion.
The surface of the core wire twisting segment 111 and/or the surface of the wire winding may be provided with a visualization layer, which may be made of a radiopaque material, such as platinum-tungsten, to provide better visualization of the guidewire in an X-ray environment and facilitate intraoperative viewing and adjustment of the position of the helically twisted segment. It is understood that the vascular access device may also adopt other visualization structures as long as the guide wire has certain visibility, and is not limited in particular.
Referring to fig. 7 and 8, 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 arranged in the handle shell 31 and is used for driving the guide wire 1 to move axially. The guide wire transmission mechanism 5 may include: a finger wheel 51, a slide groove 52, a rack 53, a pinion 54, and a rotation shaft 55. The finger wheel 51 is rotatably disposed on the handle housing 31 and both ends of the finger wheel are exposed out of the handle housing 31, so that the finger wheel 51 can be operated by both sides of the handle. The rotating shaft 55 is rotatably provided to the handle housing 31 and connected to the finger wheel 51. The rotation shaft 55 may be connected at both ends to the handle housing 31 through bearings 57. The finger wheel 51 may have a center hole, and the rotation shaft 55 may pass through the center hole of the finger wheel 51 and be fixedly coupled to the finger wheel 51. The pinion gear 54 is connected to a rotating shaft 55. Specifically, the pinion 54 is sleeved on the rotating shaft 55, and the rotating shaft 55 and the pinion 54 may be fixedly connected by a flat key 56, or the rotating shaft 55 may also be fixedly bonded to the pinion 54 by glue, and the connection manner of the rotating shaft 55 and the pinion 54 is not particularly limited in this embodiment. The sliding slot 52 is fixedly arranged in the handle shell 31 and extends along the axial direction of the handle shell 31, and the rack 53 is in sliding fit with the sliding slot 52. The rack 53 is also meshed with the pinion 54. The tail end of the guide wire 1 passes through the first connecting part 421 and is connected with the distal end of the rack 53, so that the rack 53 can drive the guide wire 1 to move axially.
When the finger wheel 51 is rotated, the pinion 54 can drive the rack 53 to move axially relative to the chute 52, thereby driving the guide wire 1 to move. When the finger wheel 51 rotates, the pinion 54 is driven to rotate, the pinion drives the rack 53 to move back and forth along the sliding groove 52, and the range of the back and forth movement of the rack 53 is the treatment range. Illustratively, the length of the chute 52 may be 150 to 250mm, the length of the rack may be 80 to 130mm, and the treatment range is a range in which the rack 53 can move along the chute 52, and specifically, the treatment range may be set according to a range required by treatment, and the value thereof is not particularly limited.
Wherein, the far end of the rack 53 can be provided with a connecting hole, and the near end of the guide wire 1 is connected with the connecting hole. The sliding groove 52 can be provided with two limiting grooves extending along the axial direction of the sliding groove, and correspondingly, the two ends of one side of the rack 53 facing the sliding groove are provided with convex ribs matched with the limiting grooves, and the convex ribs can slide in the limiting grooves of the sliding groove 52, so that the motion precision of the guide wire 1 is ensured.
It should be noted that the pinion 54 may be a gear with a small module, which can effectively improve the position control precision when the guide wire moves.
The rack 53 and the chute 52 are provided with anti-misoperation mechanisms which are matched with each other. Specifically, the anti-slip mechanism may include: the protrusions arranged on the sliding grooves and the anti-slip grooves arranged on the racks respectively, the protrusions of the sliding grooves 52 are matched with the anti-slip grooves of the racks 53, the racks can be prevented from sliding randomly, and the racks can move only by applying enough force.
It is worth mentioning that the control assembly 3 is also capable of driving radial vibrations of the helically twisted section extending out of the distal end of the cannula 2. Accordingly, the control assembly 3 may further include an ultrasonic vibration mechanism 4 disposed within the handle housing 31. The ultrasonic vibration mechanism 4 is connected with the guide wire 1 and used for driving the guide wire 1 to vibrate in the radial direction, so that the effect of deeply removing the blockage is achieved.
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 with the proximal end of the guide wire through a motor connecting piece 42 and is used for driving the support section of the guide wire 1 to vibrate radially, so as to drive 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 may be a shaft capable of outputting radial vibration. A motor coupling 42 couples the output shaft of the ultrasonic motor 41 to the guide wire 1. The ultrasonic motor 41 can output vibration with a certain frequency, so as to drive the spiral torsion section of the guide wire 1 to vibrate radially according to a certain frequency, and the spiral torsion section can effectively remove the blockage.
Referring to fig. 5 and 6, the motor connecting member 42 may include: a first connection portion 421 and a second connection portion 422. The first connecting portion 421 is axially arranged parallel to the handle housing 31, and the second connecting portion 422 is obliquely arranged relative to the first connecting portion 421 and connected to the first connecting portion 421. The other end of the second connection portion 422 is connected to an output end of the ultrasonic motor 41. The first connection portion 421 has a tubular shape, and a distal end of the first connection portion 421 may be connected to a proximal end of the cannula 2, or a proximal end of the cannula 2 may be connected to a distal end of the handle housing 31. The proximal end of the guide wire 1 passes through the first connection portion 421 and out of the proximal end of the first connection portion 421. The guide wire 1 can be in close contact with the inner wall of the first connection portion 421, when the ultrasonic motor 41 outputs vibration, the vibration is transmitted to the first connection portion 421 through the second connection portion, and the guide wire is driven by the first connection portion 421 to vibrate radially. The guide wire 1 is axially movable relative to the first connection portion.
The control assembly 3 in the foregoing embodiment is capable of driving the guide wire to vibrate radially and move axially. Further, in some examples, the control assembly 3 is also capable of driving the helically twisted section of the guidewire to rotate and move in synchronization, and at the same time is also capable of driving the helically twisted section to vibrate radially. Specifically, a transmission spiral groove 4211 is further formed in the first connection portion 421, and a transmission thread is formed at the proximal end of the guide wire 1. The drive screw is adapted to the drive helical groove 4211 to convert axial movement of the guide wire at the proximal end of the first coupling portion 421 into synchronous rotation and movement of the guide wire at the distal end of the first coupling portion 421. That is, the transmission spiral groove 4211 in the first connection portion 421 and the transmission thread 1121 on the guide wire constitute a rotation control mechanism of the guide wire, the rotation control mechanism can drive the spiral torsion section of the guide wire 1 to rotate and move synchronously in cooperation with the guide wire transmission mechanism 5, and the guide wire can also be driven to vibrate in the radial direction by the ultrasonic vibration mechanism 4. When the spiral twisting section rotates, force can be applied to the blockage from multiple directions, so that the blockage in the blood vessel can be removed more uniformly and efficiently. It can be understood that when the inner wall of the first connection portion 421 is not provided with the transmission thread groove, the guide wire transmission mechanism 5 can drive the spiral torsion section to move axially without rotating, and can well remove the blockage in the blood vessel.
As an alternative to the above-mentioned rotation transmission mechanism, in some examples, as shown in fig. 9, the rotation transmission mechanism may include: a finger wheel 51, the finger wheel 51 is rotatably disposed on the handle housing 31, and the finger wheel 61 is axially disposed parallel to the handle housing 31. The finger wheel 51 is provided with a transmission spiral groove at the center, and the proximal end of the guide wire 1 is provided with a transmission thread 1121 matched with the transmission thread groove so as to drive the guide wire to synchronously rotate and move when the finger wheel 51 rotates. When the control assembly further comprises the aforementioned ultrasonic vibration mechanism 4, a smooth inner wall may be employed in the first connection portion 41, and a transmission thread groove is not required, so that the guide wire 1 can be moved and rotated synchronously in the first connection portion 41. The driving thread 1121 at the proximal end of the guide wire 1 may be directly formed at the proximal end of the support section of the guide wire, or a threaded sleeve with a driving thread may be fixedly sleeved at the proximal end of the support section of the guide wire 1. When the finger wheel 51 is transversely pulled, the screw transmission force acts on the guide wire to drive the guide wire to synchronously move and rotate. When the doctor transversely dials the finger wheel 51 and rotates, the doctor can directly feel the feedback of the leading-in withdrawing force and the rotating force of the guide wire 1, so that the doctor can better complete the operation. The length of the drive thread segment with drive thread of the guide wire 1 support segment 112 may be determined according to the treatment range.
Referring to fig. 10 and 11, the motor controller 43 is electrically connected to the power source 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 single operation time period. The button 45 is provided on the handle case 31, and the button 45 is connected to the motor controller 43. The motor controller 43 has a timing function, and when the button 45 is pressed, the motor controller 43 controls the ultrasonic motor 41 to start working and continuously output radial vibration until a preset single working time period is reached, and the motor controller 43 controls the ultrasonic motor 41 to stop working, or when the button 45 is pressed again in working, the motor controller 43 controls the ultrasonic motor 41 to stop working. The button 45 can be arranged in the middle of the side face of the handle shell 31, so that a doctor can operate the button conveniently, the ultrasonic motor 41 can be started by clicking the button 45 once, and the ultrasonic motor 41 can be stopped by clicking the button 45 again, so that the guide wire 1 can be manually controlled to advance or retreat.
The handle shell 31 is used for a doctor to grasp, the handle shell 31 integrally adopts a straight-handle slightly-inclined structure, and the ultrasonic motor 41 is arranged in the front-end triangular slightly-inclined structure. The finger wheel can be adjusted on both sides of the front end of the handle, and the operation is convenient. The handle shell can be made of materials such as high polymer ABS, PC and the like, and has the advantages of light weight and convenience in sterilization.
In the vascular access device of the present embodiment, components other than the standard component can be made of materials such as polymer materials, PC, ABS, etc., and stainless steel can be used for the pinion, rack, etc. for strength improvement. The sleeve 2 can be made of Pebax and other materials, and the outer surface of the sleeve can be attached with a hydrophilic coating.
The vascular access device of this embodiment is used as follows:
during interventional operation, the guide wire is inserted into an affected part of vascular diseases through the skin, the guide wire is pushed out from the sleeve until the head end of the guide wire completely exceeds the position of the disease, after the spiral torsion section of the guide wire is completely released, the capillary fibers of the guide wire are fully contacted with the position of the vascular diseases, ultrasonic vibration is started, the finger wheel is pushed to reciprocate simultaneously, small blockages in the blood vessel are twisted by the spiral to be removed, then are adsorbed by the capillary fibers, and then are pulled into the sleeve to be pulled out of the body. And after cleaning the guide wire, the vascular opening device can be repeatedly used to continuously remove the blockage. If the blockage is effectively removed, the handle can be dragged to be integrally withdrawn from the vascular access device.
Based on the technical scheme, the invention at least has the following advantages and positive effects:
the vascular opening device provided by the embodiment of the invention drives the spiral torsion section of the guide wire to move along the axial direction through the control assembly, so that the pathological substances in the blood vessel can be quickly and uniformly cut and scraped, the clearing effect and clearing efficiency are improved, and the blood vessel is quickly dredged.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for carrying out the invention, and that various changes in form and details may be made therein without departing from the spirit and scope of the invention in practice.

Claims (10)

1. A vascular access device, comprising:
a guidewire, comprising: the spiral torsion section and the support section are sequentially connected from the far end to the near end; wherein the helically twisted section is radially expandable and contractible;
the guide wire penetrates through the sleeve and can axially move and circumferentially rotate relative to the sleeve; and
the control assembly, the sleeve pipe proximal end with the control assembly distal end links to each other, the support section proximal end with the control assembly links to each other, the control assembly can drive the seal wire relative sleeve pipe axial displacement so that the spiral turns round the section and stretches out or accept to in the sleeve pipe, the control assembly can also drive the spiral that stretches out the sleeve pipe distal end turns round the section and moves along the axial.
2. The vascular access device of claim 1, wherein the control assembly is further configured to drive the helically twisted section extending distally from the cannula to rotate and move in unison, or to vibrate radially and rotate and move in unison, or to move axially and vibrate radially.
3. The vascular access device of claim 2, wherein the control assembly includes a handle housing and a guidewire transmission coupled to the support segment; the guide wire transmission mechanism is arranged in the handle shell and is used for driving the guide wire to axially move;
the guide wire transmission mechanism comprises:
a finger wheel rotatably provided on the handle case with both ends thereof exposed from the handle case;
the rotating shaft is rotatably arranged on the handle shell and is connected with the finger wheel;
a pinion gear connected to the rotating shaft;
a rack engaged with the pinion; the near end of the guide wire is connected with the far end of the rack;
the sliding groove is fixedly arranged in the handle shell and axially extends along the handle shell, and the rack is in sliding fit with the sliding groove; when the finger wheel is rotated, the pinion can drive the rack to axially move relative to the sliding groove;
alternatively, the rotating shaft and the pinion gear are connected by a flat key.
4. The vascular access device of claim 3, wherein the control assembly further comprises: the ultrasonic vibration mechanism is arranged in the handle shell, is connected with the guide wire and is used for driving the guide wire to vibrate in the radial direction;
optionally, the ultrasonic vibration mechanism includes: an ultrasonic motor and a motor connector;
the motor connector includes: a first connection portion and a second connection portion;
the first connecting part is arranged parallel to the axial direction of the handle shell, the second connecting part is obliquely arranged relative to the first connecting part and is connected with the first connecting part, and the other end of the second connecting part is connected with the output end of the ultrasonic motor; the first connecting part is tubular, and the proximal end of the guide wire penetrates through the first connecting part, penetrates out of the proximal end of the first connecting part and can axially move relative to the first connecting part;
optionally, a transmission spiral groove is formed in the first connecting part, and a transmission thread is formed at the proximal end of the guide wire; the drive screw thread is adapted to the drive helical groove to convert axial movement of the guide wire proximal of the first connection into synchronous rotation and movement of the guide wire distal of the first connection.
5. The vascular opening device according to claim 3, wherein the rack and the chute are provided with anti-slipping mechanisms which are matched with each other;
optionally, the anti-false slip mechanism comprises: the protrusions are respectively arranged on the sliding grooves and the anti-slip grooves formed in the racks, and the protrusions are matched with the anti-slip grooves of the racks.
6. The vascular access device of claim 2, wherein the control assembly includes a handle housing and a rotational movement transmission mechanism disposed within the handle housing; the rotary transmission mechanism is used for driving the guide wire to synchronously move and rotate;
optionally, the rotational movement transmission mechanism comprises: a finger wheel; the finger wheel is rotatably arranged on the handle shell, and the axial direction of the finger wheel is parallel to the axial direction of the handle shell; the center of the finger wheel is provided with a transmission thread groove, and the near end of the guide wire is provided with a transmission thread matched with the transmission thread groove so as to drive the guide wire to synchronously rotate and move when the finger wheel rotates.
7. The vascular access device of claim 4, wherein the ultrasonic vibration mechanism further comprises a motor controller and a power source;
the ultrasonic motor, the motor controller and the power supply are electrically connected in sequence; the motor controller is used for controlling the starting and stopping of the ultrasonic motor and controlling the single working time of the ultrasonic motor;
optionally, the ultrasonic vibration mechanism further comprises a button; the button is arranged on the handle shell and connected with the ultrasonic controller.
8. The vascular access device of claim 1, wherein the guidewire comprises a core wire and a wrap wire;
the core wire comprises a core wire twisting section and a core wire supporting section which are sequentially connected from the far end to the near end;
the winding wire is spirally wound on the core wire torsion section;
optionally, the core wire support section has a diameter greater than the diameter of the core wire torsion section.
9. The vessel opening device according to claim 8, wherein the twisted section of the core wire is formed by spirally winding a shape memory wire with an S-shaped plane.
10. The vascular access device of claims 8 or 9, wherein the wire wrap has a capillary fiber disposed thereon;
a guide head is arranged at the far end of the core wire twisting section;
optionally, the surface of the core wire twisting section and/or the winding wire is provided with a developing layer.
CN202210915653.7A 2022-08-01 2022-08-01 Vascular opening device Active CN115227337B (en)

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CN202210915653.7A CN115227337B (en) 2022-08-01 2022-08-01 Vascular opening device
PCT/CN2023/087196 WO2024027190A1 (en) 2022-08-01 2023-04-10 Vascular recanalization apparatus

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