WO2023015657A1 - 血管介入导航手术系统 - Google Patents

血管介入导航手术系统 Download PDF

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Publication number
WO2023015657A1
WO2023015657A1 PCT/CN2021/117817 CN2021117817W WO2023015657A1 WO 2023015657 A1 WO2023015657 A1 WO 2023015657A1 CN 2021117817 W CN2021117817 W CN 2021117817W WO 2023015657 A1 WO2023015657 A1 WO 2023015657A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
catheter
control module
wheel set
gear
Prior art date
Application number
PCT/CN2021/117817
Other languages
English (en)
French (fr)
Inventor
沈碧峰
洪炯
Original Assignee
介若医疗科技(上海)有限公司
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Publication of WO2023015657A1 publication Critical patent/WO2023015657A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/25—User interfaces for surgical systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B34/35—Surgical robots for telesurgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes

Definitions

  • the invention relates to the field of medical instruments, and more particularly to a vascular interventional navigation operation system.
  • Vascular interventional surgery is based on imaging, under the guidance of X-ray, ultrasound or CT equipment, using guide wires, catheters or stents, and other medical devices to diagnose and treat diseases. create technology. Manually inserting a catheter or introducer into a patient is a relatively routine surgical procedure. Attempts are underway to roboticize this insertion. Such robotics are complicated by the difficulty of grasping the catheter, the slippery shape of the catheter and the need to maintain sterility during the procedure, all of which increase the difficulty of robotization. Despite these difficulties, the reliability and precision of such robotic systems are the determining factors for their acceptance by the medical community.
  • the present invention develops a vascular interventional navigation surgery system, which can remotely control the rotation, advancement and movement of the guide wire control module, balloon/stent control module and guide catheter control module through the remote microcomputer control terminal. step back.
  • the mechanical braking in the invention is mainly realized by the meshing between the gears and the transmission effect of the transmission rod. The invention is convenient to operate and accurate to adjust.
  • the invention provides a blood vessel interventional navigation operation system, which includes a remote microcomputer control terminal, a surgical positioning robot arm and a terminal execution system.
  • the terminal execution system includes
  • the guide wire control module is used to control the advance, retreat and rotation of the guide wire, and the guide wire control module includes:
  • the rotating assembly is used to control the rotation of the guide wire.
  • the rotating assembly includes a rotating wheel set and a rotating shaft concentrically connected with the rotating wheel set, sleeved on the rotating shaft and movable relative to the rotating shaft. Sliding planetary gears, and sun gears meshing with the planetary gears, wherein the sun gears are provided with wire grooves, and the wire grooves are opened from the valley bottom between the teeth of the sun gears to the center of the sun gear , the wire groove is used to embed the guide wire and ensure the coaxiality of the guide wire rotation; and
  • the travel assembly is used to control the advance or retreat of the guide wire, and the travel assembly includes a travel wheel set, a drive screw concentrically connected with the bevel gear of the travel wheel set, and a fixed frame for supporting the sun gear plate;
  • the balloon/stent control module is used to control the advancement or retreat of the balloon catheter or the stent catheter.
  • the balloon/stent control module includes a transmission wheel assembly, and the transmission wheel assembly includes a friction wheel set.
  • the gears of the friction wheel set are meshed with each other, and the friction wheel set clamps the balloon catheter or the stent catheter to advance or retreat;
  • the guide catheter control module is used to control the advancement or retreat of the guide catheter, the guide catheter control module includes a Y-shaped stage assembly, and the Y-shaped stage assembly includes an upper Y-shaped valve and a lower rack and pinion set,
  • the distal port of the Y-shaped valve is connected to the guide catheter, the proximal port is inserted into the guide wire, the guide wire enters the guide catheter through the Y-valve, and passes through the guide catheter along the guide wire.
  • the cavity reaches the operation site, and the rack and pinion group drives the Y-shaped table assembly forward or backward, thereby driving the guide catheter forward or backward;
  • the rotating wheel set, the traveling wheel set, the friction wheel set and the Y-shaped table assembly are all driven by motors and connected to a remote computer.
  • the rotation of the rotating wheel set in the guide wire control module drives the concentrically connected rotating shaft to rotate together, and the rotating shaft drives the rotation of the planetary wheel, and the planetary wheel passes through The meshing action drives the sun gear to rotate, thereby driving the guide wire to rotate.
  • the rotation of the bevel gear of the traveling wheel set drives the transmission screw to rotate
  • the fixed plate is threadedly connected with the transmission screw, and moves forward or backward with the rotation of the transmission screw, the fixed
  • the advance or retreat of the disc drives the advance or retreat of the guide wire.
  • the friction wheel set gear of the transmission wheel assembly in the balloon/stent control module rotates to drive the upper friction wheel to rotate, and the rotation of the friction wheel drives the balloon held by the friction wheel Advancement or retraction of catheter or stent catheter.
  • the gear in the rack and pinion set of the Y-shaped stage assembly in the guide catheter module drives the rack gear meshed with it to move, so that the Y-shaped table and the connected guide catheter move forward or back.
  • At least two fixed gears are arranged on the fixed plate, and the fixed gears are engaged with the sun gear for fixing the sun gear.
  • the guide wire control module includes a locking device for locking the guide wire, and the locking device is fixed on the sun gear.
  • the locking device includes a locking control assembly, an active component, and a fixed component, wherein the fixed component is fixed on the sun gear and aligned with one side of the wire groove, so The active part is arranged relative to the fixed part and is aligned with the other side of the wire groove, and the locking control assembly is connected to the active part for controlling the movement of the active part relative to the fixed part Positional relationship.
  • the locking control assembly includes a button, a linkage rod, a spring and a limit block, wherein the spring and the limit block are arranged in the inner cavity of the active component, and the The limiting block is fixed, the spring is located between the limiting block and the side wall of the active component, one end of the linkage rod is connected to the button, and the other end is connected to the active component.
  • the guidewire control module includes a slide bar, and the slide bar is arranged between the wheel set and the fixing plate.
  • the operator remotely controls the movement of the guide wire control module, the balloon/stent control module and the guiding catheter control module through signal transmission through the remote microcomputer control terminal.
  • the present invention also provides a vascular interventional navigation surgery system, which is used to manipulate guide wires, balloons or stents during surgery, can control the advance, retreat and rotation of the guide wire, and can also control the balloon catheter or stent catheter,
  • the system includes a remote microcomputer control terminal, a surgical positioning robot arm and a terminal execution system.
  • the terminal execution system includes
  • the guide wire control module is used to control the advance, retreat and rotation of the guide wire.
  • the guide wire control module includes: a rotating assembly, which is used to control the rotation of the guide wire.
  • the rotating assembly includes a rotating bevel gear , a rotating shaft concentrically connected with the rotating bevel gear, a planetary gear sleeved on the rotating shaft and slidable relative to the rotating shaft, and a sun gear meshing with the planetary gear, wherein the sun gear There is a wire groove on it, and the wire groove is used to embed the guide wire;
  • the conveying assembly is used to control the advance and retreat of the guide wire, and the conveying assembly includes a power wheel set, and the power wheel
  • the transmission screw rod connected concentrically to the gears of the group, and the fixed plate used to support the sun gear; wherein, the rotating bevel gear and the power wheel set are both driven by a motor, and the rotation of the rotating bevel gear drives the concentric connection
  • the rotating shaft of the power wheel group rotates together, and
  • the rotating shaft is a hexagonal shaft.
  • the rotation axis is a polygonal axis.
  • both the sun gear and the planetary gear are arranged in the inner cavity of the fixed plate, and move with the forward and backward movement of the fixed plate.
  • the proximal end of the driving screw is connected and fixed to the bevel gear of the traveling wheel set
  • the proximal end of the rotating shaft is connected and fixed to the rotating wheel set
  • the far end of the driving screw is fixed. Both end and the far end of the rotating shaft are fixed on the fixed plate at the far end through bearings.
  • a wire groove similar to the wire groove on the sun gear is provided on the fixing plate to allow the insertion of the guide wire.
  • the initial positions of the rotating wheel set and the traveling wheel set are both located at the proximal end of the system.
  • the rotating wheel set and the traveling wheel set are located on the same section.
  • the length of the driving screw is 100-400mm; preferably, 150-250mm.
  • the length of the rotating shaft is 100-400mm; preferably, 150-250mm.
  • the traveling wheel set includes at least one pair of bevel gears; preferably, the traveling wheel set consists of two pairs of bevel gear sets.
  • the traveling wheel set consisting of more than two pairs of bevel gear sets includes a linked belt for connecting the bevel gears, and the bevel gears of the traveling wheel set are realized through the linked belt. linkage between.
  • the wire groove opening is arranged at the valley bottom between the teeth of the sun gear, so as not to affect the meshing between the sun gear and other gears.
  • the wire groove is opened from the bottom of the valley between the teeth of the sun gear to the center of the sun gear.
  • the wire groove on the sun gear is tapered along the radius from the outside to the inside, so as to be used for inserting guide wires of different diameters.
  • At least two fixed gears are provided on the fixed plate, and the fixed gears are engaged with the sun gear for fixing the sun gear.
  • Fixed gear can be two, also can be a plurality of.
  • the fixed disc is a hollow disc
  • the sun gear, the planetary gear and the fixed gear are placed in the hollow cavity of the fixed disc
  • the fixed disc is also provided with radial An opening for insertion of the guide wire.
  • the sun gear and the fixed plate are concentrically aligned.
  • the system includes a locking device for locking the guide wire, and the locking device is fixed on the sun gear.
  • the locking device includes a locking control assembly, an active component, and a fixed component, wherein the fixed component is fixed on the sun gear and aligned with one side of the wire groove, so The active part is arranged relative to the fixed part and is aligned with the other side of the wire groove, and the locking control assembly is connected to the active part for controlling the movement of the active part relative to the fixed part Positional relationship.
  • the locking control component controls the active component to be away from the fixed component, that is, the wire groove forms a passage, and the guide wire can be embedded.
  • the locking control assembly controls the active part to abut against the fixed part, so as to clamp the guide wire embedded in the wire groove.
  • the locking device may be an electric clamp structure driven by electric power.
  • the locking device may be a pneumatic clamp structure driven by pneumatics.
  • the locking control assembly includes a button, a linkage rod, a spring and a limit block, wherein the spring and the limit block are arranged in the inner cavity of the active component, and the The limiting block is fixed, the spring is located between the limiting block and the side wall of the active component, one end of the linkage rod is connected to the button, and the other end is connected to the active component.
  • the linkage rod When the locking device is in the released state, by pressing the button, the linkage rod is driven to move outward, thereby driving the active part to move radially outward, and the active part is far away from the fixed part. , the spring is in a compressed state.
  • the pressing control on the button is released, and under the elastic force of the spring, the active part moves radially inward and abuts against the fixed part, and the button Return to the original position.
  • the contact surface between the active part and the fixed part is a tooth-shaped clamping surface, so as to provide greater clamping force for the guide wire.
  • the system includes a sliding rod arranged between the sun gear and the fixed plate.
  • the sliding rod is slidable along the axial direction of the guide wire.
  • the slide bar includes a support frame and pulleys on both sides, wherein the support frame is provided with wire grooves corresponding to the wire grooves on the sun gear and the fixed plate.
  • the guide wire is embedded in the wire groove, and the pulleys on both sides can move in the sliding grooves on the corresponding two wall surfaces respectively.
  • the chute starts from the two side wall surfaces corresponding to the middle section of the sun gear and the fixing plate, and ends on the two side wall surfaces corresponding to the fixing plate.
  • the chute starts from the two side walls corresponding to the sun gear and ends on the two side walls corresponding to the fixing plate, wherein, between the sun gear and the fixing plate A stopper is provided on the chute section corresponding to the middle section of the plate, and the stopper is used to stop the slide bar from continuing to slide toward the sun gear.
  • the sliding rod is provided with a first magnet
  • the fixed plate is provided with a second magnet
  • the first magnet and the second magnet attract each other.
  • the intermediate support In the operation of feeding the guide wire, the intermediate support is initially located in the middle section of the sun gear and the fixed plate and the guide wire is placed in the groove, along with the fixed plate along the drive wire
  • the rod moves to the distal end, the second magnet and the first magnet generate an attractive effect, and the intermediate support continues to move distally together with the fixed disk; in the operation of retracting the guide wire, the intermediate The support member and the fixed plate are retracted to the proximal end together.
  • the intermediate support When retracted to the middle position of the sun gear and the fixed plate, under the blocking effect of the stopper or the chute wall, the The intermediate support is fixed without retraction, and the fixed plate can continue to retract.
  • the above-mentioned configuration of the present disclosure prevents the guide wire from sagging seriously due to its long span.
  • all wire grooves form a passage from the proximal end to the center of the Y-shaped valve, so that the guide wire can be easily inserted and removed, and facilitate the rapid exchange of the guide wire and the balloon or stent during the operation.
  • the system includes at least one pair of wire drive wheels for supporting and delivering the guide wire at the distal end.
  • the guide wire driving wheel is arranged on the distal side of the fixing plate, and is 5-15 mm away from the fixing plate (center distance).
  • the junction of the guide wire drive wheel corresponds to the slot on the fixing plate.
  • the guide wire is placed between at least one pair of the guide wire drive wheels, and the guide wire is transported through friction between at least one pair of the guide wire drive wheels.
  • At least one pair of the guide wire drive wheels is equipped with at least one lock switch, and the lock switch is used to control the distance between the pair of guide wire drive wheels, thereby controlling at least one pair of guide wire drive wheels.
  • the system includes at least one set of driving wheels, and the driving wheels are used to support and deliver the balloon catheter or stent catheter.
  • the balloon catheter or stent is placed between at least one set of transmission wheels, and the balloon catheter or stent catheter is delivered through friction between at least one set of transmission wheels.
  • At least one set of transmission wheels is equipped with at least one pair of locking switches, and the locking switch is used to control the distance between a set of transmission wheels, thereby controlling the locking condition of at least one set of transmission wheels.
  • the system includes a Y-shaped combination, the Y-shaped combination is used for the Y-shaped quick combination of the guide wire and the guide catheter, the Y-shaped combination is movable, through The movement of the Y-shaped combination controls the forward and backward movement of the guiding catheter.
  • the movement of the Y-shaped combination can deliver or retract the guiding catheter, thereby providing a suitable recoil force for the guiding catheter and facilitating the advancement of the guide wire in the guiding catheter.
  • the Y-shaped combination is arranged at the distal end of the system, 10-200 mm away from the fixing plate (center-to-center distance); preferably, 80-120 mm.
  • the Y-shaped combination moves forward and backward through the engagement of the gear and the rack.
  • the Y-shaped combination is fixedly connected to the rack, the gear is connected to a motor, and the gear and the rack mesh with each other.
  • the motor drives the gear to rotate, and under meshing action, the rack moves forward or backward, thereby driving the Y-shaped combination to move forward or backward.
  • the number of the gears is two, namely a driving gear and a driven gear, the driving gear and the driven gear mesh with each other, and two racks are correspondingly provided, so The driving gear and the driven gear mesh with the two racks respectively.
  • the Y-shaped combination is openable and closable, and in the open state, rapid exchange of the guide wire and the balloon catheter or stent catheter can be implemented.
  • the Y-shaped combination is foldable, and the turning angle of the Y-shaped combination is 0-60 degrees, so that the guide wire and the balloon catheter or stent catheter can be folded. Exchange is more convenient.
  • the operator remotely controls the movement of the guide wire control module, the balloon/stent control module and the guide catheter module through signal transmission through the remote microcomputer control terminal.
  • the front end of the Y-shaped table (Y-shaped assembly) is connected to the guiding catheter, and the forward and backward movement of the Y-shaped table is controlled to control the forward and backward movement of the guiding catheter;
  • the transmission wheel set clamps the balloon catheter or the stent catheter to advance or Backward;
  • the rotating wheel set and the advancing wheel set control the rotation, forward or backward of the wheel set holding the guide wire; and the rotation, forward or backward of all parts can be completed by the operator operating the terminal controller outside the operating room.
  • the system communicates with the terminal controller through wired, wireless (WiFi, Bluetooth, etc.) or Internet.
  • the operation terminal is a computer.
  • the operation terminal includes a tablet computer and a joystick
  • the surgeon can adjust the distance of the guidewire advance or retreat and the guidewire rotation angle by adjusting the parameters displayed on the tablet computer.
  • the guiding catheter advances or retreats, and adjusts the advancing or retreating distance of the balloon catheter or the stent catheter, and then operates the joystick to control the guide wire to rotate, advance or retreat, and operates the joystick
  • the balloon catheter or the stent catheter is controlled to advance or retreat, and the joystick is operated to control the guide catheter to advance or retreat.
  • the system is placed in the outer box, and the outer box has a length of 400-600 mm, a width of 150-250 mm, and a height of 100-150 mm.
  • the diameter of the sun gear is 40-70mm.
  • the specifications of the planetary gear and at least two of the fixed gears are the same, and their diameters are both 15-30 mm.
  • the size of said planetary gear is different from the size of at least two of said fixed gears.
  • the diameter of the gears of the traveling wheel set is 15-30mm.
  • the diameter of the guide wire driving wheel is 5-20 mm.
  • the sleeve has a diameter of 80-150mm and a length of 250-500mm.
  • the length of the Y-shaped combination is 50-90 mm, the width is 30-60 mm, and the height is 10-40 mm.
  • the diameters of the driving gear and the connecting gear of the Y-shaped table assembly are both 5-20 mm.
  • the integral part composed of the rotating assembly, the delivery assembly and its accessories that is, the number of guidewire control modules can be superimposed to deliver multiple different guidewires to realize guidewire exchange during surgery .
  • the system is made of plastic materials such as PC and nylon or metal materials such as 304 and 316 stainless steel, which are non-toxic to the human body, can be sterilized, and are cheap and suitable for one-time use.
  • Robotic operation can enable the operator to remotely control the instrument outside the operating room, avoiding radiation damage to the operator;
  • Figure 1a is a schematic diagram of the layout of an operating room with a vascular interventional navigation surgery system in an example of the present invention
  • Fig. 1b is an operation flowchart of a surgical system with vascular interventional navigation in an example of the present invention
  • Fig. 2 is a perspective view of a vascular interventional navigation surgery system of an example of the present invention
  • Fig. 3 is a top view of the system in Fig. 2;
  • Fig. 4 is a sectional view taken along the A-A section of Fig. 3;
  • Fig. 5 is a sectional view taken along the B-B section of Fig. 3;
  • Fig. 6 is the perspective view of the sun gear with locking device of an example of the present invention.
  • Fig. 7 is a sectional view of the locking device of an example of the present invention, wherein the locking device is in a locked state;
  • Fig. 8 is a sectional view of the locking device of an example of the present invention, wherein the locking device is in a released state;
  • Fig. 9 is a top view of the drive wheel in a locked state of an example of the present invention.
  • Fig. 10 is a top view of the transmission wheel in Fig. 9 in a loosened state
  • Fig. 11 is a top view of the Y-shaped combination of an example of the present invention in an advancing state
  • Figure 12 is a top view of the Y-shaped combination in Figure 11 in a withdrawn state
  • Fig. 13 is a schematic diagram of the kinematic mechanism of the Y-type assembly of an example of the present invention.
  • Fig. 14 is the perspective view of the Y-type assembly of an example of the present invention.
  • Fig. 15 is a perspective view of the Y-shaped combination in Fig. 14 in a raised state
  • Fig. 16 is a perspective view of the Y-shaped combination in Fig. 14 in an open state.
  • the inventor developed a vascular interventional navigation surgery system for the first time through a large number of screenings. Remotely control the advance, retreat and rotation of the guide wire, and also control the advancement or retreat of the balloon catheter or stent catheter, and the guide catheter at the same time, combining a variety of interventional surgery consumables in one system, in which the mechanical brake is mainly composed of gears.
  • the invention realizes the robotization of vascular interventional navigation surgery and avoids the operator from being injured by a large number of rays during the operation.
  • the robotization of vascular interventional navigation surgery improves the stability of the operation.
  • the operator reduces the risk of cross-infection between doctors and patients through remote control, and the present invention is completed on this basis.
  • the vascular interventional navigation surgery system of this embodiment is shown in Figures 1a-16.
  • the vascular interventional navigation surgery system comprises a remote microcomputer control terminal, a surgical positioning robot arm and a terminal execution system.
  • the terminal execution system includes a guide wire control module, a balloon/stent control module and a guide catheter control module, which can control the advance, retreat and rotation of the guide wire, and can also control the movement of the balloon catheter or stent catheter, and the guide catheter. Forward or backward.
  • the guidewire control module includes a rotating assembly and a traveling assembly.
  • the rotating assembly is used to control the rotation of the guide wire.
  • the rotating assembly includes a rotating wheel set, a rotating shaft 8 concentrically connected with the traveling wheel set 5, a planetary wheel 16 sleeved on the rotating shaft 8 and slidable relative to the rotating shaft, and The sun gear 15 meshed with the planetary gear 16, wherein the sun gear 15 is provided with a wire groove 14 for inserting a wire groove.
  • the slot 14 is opened at the bottom of the valley between the teeth of the sun gear 15, which will not affect the meshing between the sun gear 15 and other gears.
  • the wire groove 14 is opened from the valley bottom between the teeth of the sun gear 15 to the center of the sun gear 15, and the wire groove 14 is used to embed the guide wire and ensure the coaxiality of the guide wire rotation.
  • the rotating shaft 8 is a hexagonal shaft.
  • the advancing assembly is used to control the advancement or retreat of the guide wire, and the advancing assembly includes an advancing wheel set 5, a drive screw mandrel 2 connected concentrically with the gear of the advancing wheel set 5, and a fixed disc 10 for supporting the sun gear 15. Both the sun gear 15 and the planetary gear 16 are placed in the inner cavity of the fixed plate 10 and move with the forward and backward movement of the fixed plate 10 .
  • the proximal end of the transmission screw mandrel 2 is connected and fixed with the travel bevel gear 11 of the travel wheel set 5, the proximal end of the rotating shaft 8 is connected and fixed with the rotating wheel set, and the far end of the drive screw mandrel 2 and the far end of the rotating shaft are all fixed by bearings On the fixed plate 24 at the far end.
  • a wire groove 14 is provided on the fixing plate 24 to allow insertion of a guide wire.
  • the traveling wheel set 5 is composed of two groups of traveling bevel gears 11 groups.
  • the traveling wheel set 5 also includes an interlocking belt 12 for connecting the traveling bevel gears 11 , and the interlocking movement between the traveling bevel gears 11 of the traveling wheel set 5 is realized through the interlocking belt 12 .
  • the fixed disk 10 is a hollow disk, the sun gear 15 is placed in the hollow cavity of the fixed disk 10, and the fixed disk 10 is also provided with a radial opening for the insertion of the guide wire.
  • the sun gear 15 and the fixed disk 10 are concentrically aligned.
  • the rotating wheel set and the traveling wheel set 5 are all located on the same section.
  • the rotating wheel group and the traveling wheel group 5 are all driven by a motor, and the rotation of the rotating wheel group drives the concentrically connected rotating shaft 8 to rotate together, and the rotating shaft 8 drives the planetary wheel 16 to rotate, and the planetary wheel 16 drives the sun gear 15 to rotate through meshing.
  • the rotation of the gear of the traveling wheel set 5 drives the transmission screw mandrel 2 to rotate, and the fixed disk 10 is threadedly connected with the transmission screw mandrel 2, and moves forward or backward along with the rotation of the transmission screw mandrel 2 .
  • At least two fixed gears 13 are arranged on the fixed plate 10 , and the fixed gears 13 are meshed with the sun gear 15 for fixing the sun gear 15 .
  • the fixed gear 13 is arranged symmetrically on the upper part of the fixed plate 10 to provide a symmetrical support force for the sun gear 15 and a clamping force corresponding to the rotating shaft 8 .
  • the combination of the sun gear 15 , the fixed gear 13 , the planetary gear 16 and the fixed disc 10 is called the wheel set 3 .
  • the guide wire control module includes a locking device for locking the guide wire, and the locking device is fixed on the sun gear 15 .
  • the locking device includes a locking control assembly, an active part 21, and a fixed part 22, wherein the fixed part 22 is fixed on the sun gear 15 and is aligned with one side of the wire groove 14, and the active part 21 is arranged relative to the fixed part 22, and Aligned with the other side of the trunking 14 , the locking control assembly is connected to the active component 21 for controlling the positional relationship of the active component 21 relative to the fixed component 22 .
  • the locking control assembly controls the active part 21 to be far away from the fixed part 22, that is, the wire slot 14 forms a passage for inserting a guide wire.
  • the locking control assembly controls the active part 21 to abut against the fixed part 22 to clamp the guide wire embedded in the wire groove 14 .
  • the locking device can be actuated electrically or pneumatically.
  • the locking control assembly includes a button 17, a linkage rod 18, a spring 19 and a stop block 20, wherein the spring 19 and the stop block 20 are arranged in the inner cavity of the active component 21, the stop block 20 is fixed, and the spring 19 Located between the limiting block 20 and the side wall of the active component 21 , one end of the linkage rod 18 is connected to the button 17 , and the other end is connected to the active component 21 .
  • the linkage rod 18 is driven to move outward, thereby driving the active part 21 to move radially outward, and the active part 21 is far away from the fixed part 22.
  • the spring 19 is in a compressed state .
  • the pressing control on the button 17 is released, and under the elastic force of the spring 19, the active part 21 moves radially inward and abuts against the fixed part 22, and the button 17 returns to the initial position.
  • the contact surface between the active part 21 and the fixed part 22 is a tooth-shaped clamping surface to provide greater clamping force for the guide wire.
  • the guide wire control module includes a slide bar, which is arranged between the sun gear 15 and the fixed plate 24 .
  • the slide bar is slidable in the axial direction of the guide wire.
  • the slide bar includes a support frame 25 and pulleys 9 on both sides, wherein the support frame 25 is provided with a wire groove corresponding to the wire groove on the sun gear 15 and the fixed plate 24, and in the state of use, the guide wire is embedded in the wire groove , the pulleys 9 on both sides can move in the slide grooves on the corresponding two side walls respectively.
  • the chute starts from the two side walls corresponding to the middle section of the sun gear 15 and the fixed plate 24 , and ends on the two side walls corresponding to the fixed plate 24 .
  • the chute starts from the two side walls corresponding to the sun gear 15 and ends on the two side walls corresponding to the fixed plate 24, wherein a stopper is provided on the chute section corresponding to the middle section of the sun gear 15 and the fixed plate 24 The stopper is used to block the sliding of the intermediate support.
  • a magnet is arranged on the slide bar, and correspondingly, another magnet is arranged on the wheel cover, and the two magnets are mutually attracting.
  • the slide bar In the operation of conveying the guide wire, the slide bar is initially located in the middle section of the sun gear 15 and the fixed plate 24 and the guide wire is placed in the wire groove. As the fixed disc 10 moves to the far end along the transmission screw rod 2, the two magnets produce an attraction effect.
  • the slide bar continues to move distally together with the fixed plate 10; in the operation of withdrawing the guide wire, the slide bar is withdrawn together with the fixed plate 10 to the proximal end, when it is withdrawn to the middle position of the sun gear 15 and the fixed plate 24 , under the blocking effect of the stopper or the wall of the chute, the slide bar is no longer retracted and fixed, and the fixed plate 10 can continue to retract.
  • the above configuration prevents the guide wire from sagging seriously due to the excessively long span.
  • a pair of guide wire driving wheels 1 are arranged at a distance of 5-15 mm from the fixing plate 24 (center distance), for supporting and transporting the guide wire at the far end.
  • the joint of the wire guide wheel 1 is corresponding to the wire groove 14 on the fixing plate 24 .
  • the guide wire is placed between the guide wire driving wheels 1, and the guide wire is transported through the friction between the guide wire driving wheels 1.
  • the pair of guide wire drive wheels 1 is equipped with a pair of guide wire drive wheel locks 4 for controlling the distance between the guide wire drive wheels 1 and further controlling the locking condition of the guide wire drive wheels 1 .
  • the balloon/stent control module includes a transmission wheel set 7, which is used to control the advancement or retreat of the balloon catheter or the stent catheter.
  • Transmission wheel set 7 comprises two pairs of friction wheel sets, and the gear set that is connected below, and gear is connected with motor. When in use, the motor drives the gear to rotate, and the gear drives the upper friction wheel group to rotate, and the balloon catheter or stent catheter held by the friction wheel group advances or retreats accordingly.
  • the drive wheel set 7 is also equipped with a secondary drive wheel set locking switch 23, which is used to control the distance between a set of drive wheel sets 7, and then control the locking situation of the drive wheel set 7.
  • the guiding catheter control module includes a Y-shaped combination body 6, the Y-shaped combination body 6 is used for the Y-shaped combination of a guide wire (not shown) and a guiding catheter (not shown), the Y-shaped combination body 6 is movable, The movement of the Y-shaped assembly 6 can deliver or withdraw the guide catheter, thereby providing a suitable recoil force for the guide catheter, and facilitating the advance of the guide wire in the guide catheter.
  • the Y-shaped combination 6 is arranged at the distal end of the system, and it moves back and forth through the engagement of the gears (26, 28) and the rack 27. Wherein, the Y-shaped combination body 6 is fixedly connected with the rack 27, and the driving gear 26 is connected with the motor.
  • the driving gear 26 drives the interlocking gear 28 to rotate through the mutual meshing 26 between the gears, and the gears (26, 28) interact with the rack 27 again. engage.
  • the motor drives the driving gear 26 to rotate, and under the meshing action, the rack 27 advances or retreats, and then drives the Y-shaped combination 6 to advance or retreat.
  • the operator remotely controls the movement of the guide wire control module, the balloon/stent control module and the guide catheter module through signal transmission through the remote computer control terminal.
  • the front end of the Y-shaped table (Y-shaped assembly 6) is connected to the guiding catheter, and the forward and backward movement of the Y-shaped table is controlled to control the forward and backward movement of the guiding catheter; the transmission wheel set 7 clamps the balloon catheter or the stent ball
  • the balloon catheter advances or retreats; the rotating wheel set and the advancing wheel set 5 control the guide wire to rotate, advance or retreat; and the rotation, advance or retreat of all components can be completed by the operator operating the terminal controller outside the operating room.
  • the system communicates with the operating terminal through wired, wireless (WiFi, Bluetooth, etc.) or the Internet.
  • the operating terminal is a computer, including a joystick and a tablet computer.
  • the operator adjusts the distance of the guide wire advance or retreat and the rotation angle of the guide wire, adjusts the distance of the guide catheter advance or retreat, and adjusts the balloon.
  • the advance or retreat distance of the catheter or stent catheter and then operate the joystick to control the guide wire to advance, retreat or rotate, operate the joystick to control the advance or retreat of the balloon catheter or stent catheter, and operate the joystick to control the guide catheter to advance or retreat.
  • wire slots 14 there are more than two wire slots 14 on the fixing plate 24 , and when 2-3 guide wires are used in the operation, the wire slots 14 are respectively embedded in the guide wires.
  • the system is made of plastic materials such as PC and nylon or metal materials such as 304 and 316 stainless steel, which are non-toxic to the human body, can also be sterilized, and are cheap and suitable for one-time use.

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Abstract

一种血管介入导航手术系统，包括终端执行系统，终端执行系统包括导丝控制模块、球囊/支架控制模块和导引导管控制模块。导丝控制模块包括转动组件，其包括转动轮组、与转动轮组同心连接的转动轴（8），套设在转动轴（8）上且相对于转动轴（8）可滑动的行星轮（16），和与行星轮（16）啮合的太阳轮（15），其中太阳轮（15）上设有用于嵌入导丝的线槽（14）；行进组件，其包括行进轮组（5）、与行进轮组（5）的锥齿轮（11）同心连接的传动丝杆（2），和用于支撑太阳轮（15）的固定盘（10）。该血管介入导航手术系统用于手术中远程控制导丝的旋转、前进及后退，也可以同时控制球囊导管或支架导管，以及导引导管的前进或后退，将多种介入手术耗材组合在一个系统中，兼容各个生产厂家的介入手术耗材，操作简单，精确度高。

Description

血管介入导航手术系统 技术领域
本发明涉及医疗器械领域，更具体地涉及一种血管介入导航手术系统。
背景技术
血管介入手术是以影像学为基础，在X射线、超声或CT等设备的引导下，利用导丝、导管或支架，以及其他的医疗器械对疾病进行诊断和治疗，是一种较先进的微创技术。将导管或导引装置手动插入患者体内是相对常规的外科手术。目前正在尝试将这种插入实现机器人化。这类机器人化都很复杂，因为要抓住导管是很困难的，而且导管呈光滑状且在手术过程中必须保持无菌状态，这些因素都提高了其机器人化的难度。尽管存在着这些困难，但这种机器人系统的可靠性，精确性仍是其被医疗界所接受的决定因素。
因此，本领域尚缺乏一种操作更简洁、可靠性更高的血管介入导航手术系统。
发明内容
本发明基于此领域的市场需求，开发出一种血管介入导航手术系统，可以通过远程微机操控端，远程操控导丝控制模块、球囊/支架控制模块和导引导管控制模块的旋转、前进及后退。发明中的机械制动主要通过齿轮之间的啮合与传动杆的传动效应所实现。本发明操作方便，且调节精确。
本发明提供了一种血管介入导航手术系统，该系统包括远程微机操控端、手术定位机械臂和终端执行系统。其中，终端执行系统包括
导丝控制模块，用于控制导丝的前进、后退及旋转，所述导丝控制模块包括：
转动组件，用于控制所述导丝的旋转，所述转动组件包括转动轮组、与所述转动轮组同心连接的转动轴，套设在所述转动轴上且相对于所述转动轴可滑动的行星轮，和与所述行星轮啮合的太阳轮，其中所述太阳轮上设有线槽，所述线槽由所述太阳轮的齿与齿之间的谷底开至所述太阳轮圆心，所述线槽用于嵌入所述导丝并保证所述导丝转动的同轴性；和
行进组件，用于控制所述导丝的前进或后退，所述行进组件包括行进 轮组、与所述行进轮组的锥齿轮同心连接的传动丝杆，和用于支撑所述太阳轮的固定盘；
球囊/支架控制模块，用于控制球囊导管或支架导管的前进或后退，所述球囊/支架控制模块包括传动轮组件，所述传动轮组件包括摩擦轮组，所述摩擦轮组下方有摩擦轮组齿轮互相啮合连接，所述摩擦轮组夹持所述球囊导管或所述支架导管前进或后退；以及
导引导管控制模块，用于控制导引导管的前进或后退，所述导引导管控制模块包括Y型台组件，所述Y型台组件包括上方的Y型阀和下方的齿轮齿条组，所述Y型阀远端端口连接所述导引导管，近端端口穿入所述导丝，所述导丝通过所述Y型阀进入所述导引导管，并沿着所述导引导管内腔到达手术部位，所述齿轮齿条组带动所述Y型台组件前进或后退，从而带动所述导引导管的前进或后退；
其中，所述转动轮组、所述行进轮组、所述摩擦轮组和所述Y型台组件均通过电机驱动，并与远程微机连接。
在另一优选例中，所述导丝控制模块中的所述转动轮组的转动带动同心连接的所述转动轴一同转动，所述转动轴又带动所述行星轮转动，所述行星轮通过啮合作用带动所述太阳轮转动，从而带动导丝的转动。
所述行进轮组的锥齿轮的转动带动所述传动丝杆转动，所述固定盘与所述传动丝杆螺纹啮合连接，并随着所述传动丝杆的转动而前进或后退，所述固定盘的前进或后退，带动导丝的前进或后退。
在另一优选例中，所述球囊/支架控制模块中传动轮组件的摩擦轮组齿轮转动，带动上方摩擦轮转动，所述摩擦轮的转动，带动所述摩擦轮夹持着的球囊导管或支架导管的前进或后退。
在另一优选例中，所述导引导管模块中Y型台组件的齿轮齿条组中的齿轮带动与之啮合的齿条移动，使所述Y型台和连接的所述导引导管前进或后退。
在另一优选例中，在整个系统的纵向方向上，从近端到远端设有多个可以自上而下直接放置导丝的线槽，包括外盒、轮盘组、滑轮和固定板，便于手术前放置导丝和手术中取出及交换导丝，也便于导丝和球囊导管或支架导管的配合使用。
在另一优选例中，在所述固定盘上设有至少两个固定齿轮，所述固定齿轮与 所述太阳轮齿轮啮合连接，用于固定所述太阳轮。
在另一优选例中，所述导丝控制模块包括用于锁紧所述导丝的锁紧装置，所述锁紧装置固定在所述太阳轮上。
在另一优选例中，所述锁紧装置包括锁紧控制组件、主动部件、和固定部件，其中，所述固定部件固定在所述太阳轮上且与所述线槽的一侧对齐，所述主动部件相对于所述固定部件设置，且与所述线槽的另一侧对齐，所述锁紧控制组件与所述主动部件连接，用于控制所述主动部件相对于所述固定部件的位置关系。
在另一优选例中，所述锁紧控制组件包括按键、连动杆、弹簧和限位块，其中，所述弹簧和所述限位块设置在所述主动部件的内腔中，所述限位块固定不动，所述弹簧位于所述限位块和所述主动部件的侧壁之间，所述连动杆的一端与所述按键连接，另一端与所述主动部件的连接。
在另一优选例中，所述导丝控制模块包括滑杆，所述滑杆设置在轮盘组和所述固定板之间。
在另一优选例中，术者通过远程微机操控端，利用信号传输远程控制所述导丝控制模块、球囊/支架控制模块和导引导管控制模块的运动。
本发明还提供了一种血管介入导航手术系统，该系统用于手术中操控导丝、球囊或支架，可以控制导丝的前进、后退及旋转，同时也可以控制球囊导管或支架导管，以及导引导管的前进或后退，所述系统包括远程微机操控端、手术定位机械臂和终端执行系统。其中，终端执行系统包括
导丝控制模块，用于控制导丝的前进、后退及旋转，所述导丝控制模块包括：转动组件，所述转动组件用于控制所述导丝的旋转，所述转动组件包括转动锥齿轮、与所述转动锥齿轮同心连接的转动轴，套设在所述转动轴上且相对于所述转动轴可滑动的行星轮，和与所述行星轮啮合的太阳轮，其中所述太阳轮上设有线槽，所述线槽用于嵌入所述导丝；输送组件，所述输送组件用于控制所述导丝的前进和后退，所述输送组件包括动力轮组、与所述动力轮组的齿轮同心连接的传动丝杆，和用于支撑所述太阳轮的固定盘；其中，所述转动锥齿轮和所述动力轮组均通过电动机驱动，所述转动锥齿轮的转动带动同心连接的所述转动轴一同转动，所述转动轴又带动所述行星轮转动，所述行星轮通过啮合 作用带动所述太阳轮转动；所述动力轮组的所述齿轮的转动带动所述传动丝杆转动，所述固定盘与所述传动丝杆螺纹啮合连接，并随着所述传动丝杆的转动而前进或后退。
在另一优选例中，所述转动轴为六边形轴。
在另一优选例中，所述转动轴为多边形轴。
在另一优选例中，所述太阳轮和所述行星轮均设置在所述固定盘的内腔中，且随所述固定盘的前后运动而运动。
在另一优选例中，所述传动丝杆的近端与所述行进轮组的锥齿轮连接固定，所述转动轴的近端与所述转动轮组连接固定，所述传动丝杆的远端和所述转动轴的远端均通过轴承固定在远端的固定板上。
在另一优选例中，在所述固定板上设置有与所述太阳轮上的线槽类似的线槽，以允许所述导丝的嵌入。
在另一优选例中，所述转动轮组和所述行进轮组的初始位置均位于所述系统的近端。
在另一优选例中，所述转动轮组和所述行进轮组均位于同一截面上。
在另一实施例中，所述传动丝杆的长度为100-400mm；优选地，150-250mm。
在另一实施例中，所述转动轴的长度为100-400mm；优选地，150-250mm。
在另一实施例中，所述行进轮组包括至少一对锥齿轮；优选地，所述行进轮组由两对锥齿轮组构成。
在另一实施例中，由两对以上锥齿轮组构成的行进轮组中包括用于连接所述锥齿轮的连动皮带，通过所述连动皮带实现所述行进轮组的所述锥齿轮之间的连动。
在另一实施例中，所述线槽开口设在所述太阳轮的齿与齿之间的谷底部，不会影响所述太阳轮和其它齿轮间的啮合。
在另一实施例中，所述线槽由太阳轮的齿与齿之间谷底部开至太阳轮的圆心。
在另一优选例中，所述太阳轮上的线槽沿半径从外向内的方向是渐缩的，以便用于嵌入不同直径的导丝。
在另一优选例中，在所述固定盘上设有至少两个固定齿轮，所述固定齿轮与所述太阳轮齿轮啮合连接，用于固定所述太阳轮。固定齿轮可以是两个，也可 以是多个。
在另一优选例中，所述固定盘为中空盘，所述太阳轮、所述行星轮和所述固定轮置于所述固定盘的中空内腔中，所述固定盘还设有径向开口，用于所述导丝的嵌入。
在另一优选例中，所述太阳轮和所述固定盘同心对齐。
在另一优选例中，所述系统包括用于锁紧所述导丝的锁紧装置，所述锁紧装置固定在所述太阳轮上。
在另一优选例中，所述锁紧装置包括锁紧控制组件、主动部件、和固定部件，其中，所述固定部件固定在所述太阳轮上且与所述线槽的一侧对齐，所述主动部件相对于所述固定部件设置，且与所述线槽的另一侧对齐，所述锁紧控制组件与所述主动部件连接，用于控制所述主动部件相对于所述固定部件的位置关系。
在另一优选例中，所述锁紧控制组件控制所述主动部件远离所述固定部件，即所述线槽形成通路，可嵌入所述导丝。
在另一优选例中，所述锁紧控制组件控制所述主动部件抵靠所述固定部件，将嵌入所述线槽中的所述导丝夹紧。
在另一优选例中，所述锁紧装置可以是电动夹结构，通过电动驱动。
在另一优选例中，所述锁紧装置可以是气动夹结构，通过气动驱动。
在另一优选例中，所述锁紧控制组件包括按键、连动杆、弹簧和限位块，其中，所述弹簧和所述限位块设置在所述主动部件的内腔中，所述限位块固定不动，所述弹簧位于所述限位块和所述主动部件的侧壁之间，所述连动杆的一端与所述按键连接，另一端与所述主动部件的连接。
在所述锁紧装置处于松开状态下，通过按压所述按键，带动所述连动杆外移，从而带动所述主动部件径向向外移动，所述主动部件远离所述固定部件，此时，所述弹簧处于压缩状态。在所述锁紧装置处于锁紧状态下，解除对所述按键的按压控制，在所述弹簧的弹力作用下，所述主动部件径向向内移动并抵靠所述固定部件，所述按键回复到初始位置。
在另一优选例中，所述主动部件和所述固定部件之间的接触面为齿状夹面，以对所述导丝提供更大的夹持力。
在另一优选例中，所述系统包括滑杆，所述滑杆设置在所述太阳轮和固定板 之间。
在另一优选例中，所述滑杆在沿所述导丝轴向方向是可滑动的。
在另一优选例中，所述滑杆包括支撑架和两侧滑轮，其中在所述支撑架上设有与所述太阳轮和所述固定板上的线槽相对应的线槽，在使用状态下，所述导丝嵌于所述线槽中，两侧的滑轮可分别在与之对应的两侧壁面上的滑槽中移动。
在另一优选例中，所述滑槽起始于与所述太阳轮和所述固定板的中段对应的两侧壁面，终止于与所述固定板对应的两侧壁面。
在另一优选例中，所述滑槽起始于与所述太阳轮对应的两侧壁面，终止于与所述固定板对应的两侧壁面，其中，在与所述太阳轮和所述固定板的中段对应的滑槽段上设有止挡件，所述止挡件用于阻挡所述滑杆向太阳轮方向继续滑动。
在另一优选例中，所述滑杆上设有第一磁铁，与之对应的，所述固定盘上设有第二磁铁，所述第一磁铁和所述第二磁铁相互吸引。
在输送导丝的操作中，所述中间支撑件初始位于所述太阳轮和所述固定板的中段且所述导丝置于所述凹槽中，随着所述固定盘沿所述传动丝杆向远端移动，所述第二磁铁和所述第一磁铁产生吸引作用，所述中间支撑件连同所述固定盘一起继续向远端移动；在回撤导丝的操作中，所述中间支撑件连同所述固定盘一起向近端回撤，当回撤到所述太阳轮和所述固定板的中段位置时，在所述止挡件或者所述滑槽壁的阻挡作用下，所述中间支撑件不再回撤而被固定，所述固定盘则可继续回撤。本公开的上述配置使得所述导丝不会因为跨度过长而下垂严重。
在另一优选例中，所有线槽形成一条从近端至Y型阀圆心的通路，使所述导丝能够被轻松嵌入和取出，方便手术中导丝和球囊或支架的快速交换。
在另一优选例中，所述系统包括至少一对导丝传动轮，所述导丝传动轮用于在远端支撑并输送所述导丝。
在另一优选例中，所述导丝传动轮设置在所述所述固定板的远端侧，并距离所述固定板(中心距)5-15mm。
在另一优选例中，所述导丝传动轮的接合处与所述固定板上的线槽是相对应的。
在另一优选例中，所述导丝置于至少一对所述导丝传动轮之间，通过至少一对所述导丝传动轮之间的摩擦输送所述导丝。
在另一优选例中，至少一对所述导丝传动轮配有至少一副锁紧开关，所述锁紧开关用于控制一对所述导丝传动轮之间的距离，进而控制至少一副所述导丝传动轮的锁紧情况。
在另一优选例中，所述系统包括至少一组传动轮组，所述传动轮组用于支撑并输送所述球囊导管或支架导管。
在另一优选例中，所述球囊导管或支架置于至少一组传动轮之间，通过至少一组传动轮之间的摩擦输送所述球囊导管或支架导管。
在另一优选例中，至少一组传动轮配有至少一副锁紧开关，所述锁紧开关用于控制一组传动轮之间的距离，进而控制至少一组传动轮的锁紧情况。
在另一优选例中，所述系统包括Y型组合体，所述Y型组合体用于所述导丝和导引导管的Y型快速组合，所述Y型组合体是可移动的，通过所述Y型组合体的移动控制所述导引导管的前后移动。
需要说明的是，所述Y型组合体的移动可以输送或回撤所述导引导管，从而为所述导引导管提供合适的后座力，便于导丝在导引导管中的前进。
在另一实施例中，所述Y型组合体设置在所述系统的远端，距离所述固定板(中心距)10-200mm；优选的，80-120mm。
在另一优选例中，所述Y型组合体通过齿轮和齿条的啮合而进行前后运动。
在另一实施例中，所述Y型组合体与所述齿条固定连接，所述齿轮与电机连接，所述齿轮和所述齿条相互啮合。
使用时，所述电机驱动所述齿轮转动，在啮合作用下，所述齿条前进或后退，进而带动所述Y型组合体前进或后退。
在另一实施例中，所述齿轮的数量为两个，分别是主动齿轮和从动齿轮，所述主动齿轮和所述从动齿轮相互啮合，且对应的设置两个所述齿条，所述主动齿轮和所述从动齿轮与两个所述齿条分别啮合。
在另一实施例中，所述齿轮的数量为一个，齿条的数量为一个，齿轮与齿条啮合。
在另一实施例中，所述Y型组合体是可开闭的，在打开状态下，可实施所述导丝和所述球囊导管或支架导管的快速交换。
在另一实施例中，所述Y型组合体是可翻折的，所述Y型组合体的翻折角度为0-60度，使所述导丝和所述球囊导管或支架导管的交换更加方便。
在另一优选例中，术者通过远程微机操控端，利用信号传输远程控制所述导引导丝控制模块、球囊/支架控制模块和导引导管模块的运动。
需要说明的是，Y型台(Y型组合体)的前端连接导引导管，通过控制Y型台的前后移动控制导引导管的前后移动；传动轮组夹持球囊导管或者支架导管前进或后退；转动轮组、行进轮组控制夹持导丝的轮盘组转动、前进或后退；而所有部件的旋转、前进或后退，都可以通过术者在手术室外操控终端控制器完成。
在另一实施例中，所述系统与所述终端控制器通过有线、无线(WiFi，蓝牙等)或互联网进行通讯。
在另一实施例中，所述操作终端为计算机。
在另一实施例中，所述操作终端包括平板电脑和操纵杆，术者通过调整显示在所述平板电脑上的参数，调整所述导丝前进或后退距离和所述导丝旋转角度，调整所述导引导管前进或后退距离，以及调整所述球囊导管或所述支架导管的前进或后退距离，然后操作所述操纵杆控制所述导丝旋转、前进或后退，操作所述操纵杆控制所述球囊导管或所述支架导管前进或后退，操作所述操纵杆控制所述导引导管前进或后退。
在另一实施例中，所述系统置于所述外盒中，所述外盒的长为400-600mm，宽为150-250mm，高为100-150mm。
在另一实施例中，所述太阳轮的直径为40-70mm。
在另一实施例中，所述行星轮和至少两个所述固定齿轮的规格相同，其直径均为15-30mm。
在另一实施例中，所述行星轮的规格不同于和至少两个所述固定齿轮的规格。
在另一实施例中，所述行进轮组的齿轮的直径为15-30mm。
在另一实施例中，所述导丝传动轮的直径为5-20mm。
在另一实施例中，所述套筒的直径为80-150mm，长度为250-500mm。
在另一实施例中，所述Y型组合体的长为50-90mm，宽为30-60mm，高为10-40mm。
在另一实施例中，所述Y型台组合体主动齿轮和连动齿轮的直径均为5-20mm。
在另一实施例中，所述转动组件、所述输送组件及其配件构成的整体部件， 即导丝控制模块的数量可叠加，以输送多个不同的导丝，实现手术中的导丝交换。在另一实施例中，所述固定板上有两个以上的线槽，手术中使用2-3个所述导丝时，线槽分别嵌入所述导丝。
在另一实施例中，系统的材质采用PC、尼龙等塑料材料或304、316不锈钢等金属材料，对人体无毒害，还可以消毒灭菌，且价格低廉，适合一次性使用。
本发明的主要优点包括：
(a)机器人操作可以使术者在手术室外远程操控器械，避免射线对术者的伤害；
(b)机器人操作相比人工操作，提高了操作精度；
(c)机器人操作不会如人工操作般，因为长时间集中注意力导致疲劳或其他原因出现失误，稳定性更好；
(d)远程机器人操作实现了医患分离，减少术者和病患感染的风险。
应理解，在本发明范围内中，本发明的上述各技术特征和在下文(如实施例)中具体描述的各技术特征之间都可以互相组合，从而构成新的或优选的技术方案。限于篇幅，在此不再一一累述。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图做简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1a是本发明一个实例中的具有血管介入导航手术系统的手术室布局示意图；
图1b是本发明一个实例中的具有血管介入导航手术系统的操作流程图；
图2是本发明一个实例的血管介入导航手术系统的立体图；
图3是图2中系统的俯视图；
图4是沿图3的A-A截面截取的剖视图；
图5是沿图3的B-B截面截取的剖视图；
图6是本发明一个实例的附有锁紧装置的太阳轮的立体图；
图7是本发明一个实例的锁紧装置剖视图，其中锁紧装置处于锁紧状态；
图8是本发明一个实例的锁紧装置剖视图，其中锁紧装置处于松开状态；
图9是本发明一个实例的传动轮处于锁紧状态的俯视图；
图10是图9中的传动轮处于松开状态的俯视图；
图11是本发明一个实例的Y型组合体处于前进状态的俯视图；
图12是图11中的Y型组合体处于回撤状态的俯视图；
图13是本发明一个实例的Y型组合体的运动机制原理图；
图14是本发明一个实例的Y型组合体的立体图；
图15是图14中的Y型组合体处于抬起状态的立体图；
图16是图14中的Y型组合体处于打开状态的立体图。
各附图中，各标示如下：
1-导丝传动轮；2-传动丝杆；3-轮盘组；4-导丝传动轮锁；5-行进轮组；6-Y型组合体；7-传动轮组；8-转动轴；9-滑轮；10-固定盘；11-行进锥齿轮；12-连动皮带；13-固定齿轮；14-线槽；15-太阳轮；16-行星轮；17-按键；18-连动杆；19-弹簧；20-限位块；21-主动部件；22-固定部件；23-传动轮组锁紧开关；24-固定板；25-支撑架；26-主动齿轮；27-齿条；28-连动齿轮。
具体实施方式
本发明人经过广泛而深入的研究，通过大量筛选，首次开发了一种血管介入导航手术系统，与现有技术相比，本申请的系统通过远程操作机器人进行血管介入导航手术，以实现手术中远程控制导丝的前进、后退及旋转，也可以同时控制球囊导管或支架导管，以及导引导管的前进或后退，将多种介入手术耗材组合在一个系统中，其中机械制动主要由齿轮间啮合或通过传动杆进行传动实现，本发明实现了血管介入导航手术的机器人化，避免了术者在手术中受到大量的射线伤害，同时，血管介入导航手术的机器人化，提高了手术的稳定性和精确性，进一步的，术者通过远程操控，减少医患交叉感染的风险，在此基础上完成了本发明。
下面结合具体实施例，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外，附图为示意图，因此本发明装置和设备的并不受所述示意图的尺寸或比例限制。
需要说明的是，在本专利的权利要求和说明书中，诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
实施例
本实施例的血管介入导航手术系统如图1a-16所示。该血管介入导航手术系统远程微机操控端、手术定位机械臂和终端执行系统。其中终端执行系统包括导丝控制模块、球囊/支架控制模块和导引导管控制模块，可以控制导丝的前进、后退及旋转，同时也可以控制球囊导管或支架导管，以及导引导管的前进或后退。
其中，导丝控制模块包括转动组件和行进组件。
转动组件用于控制导丝的旋转，转动组件包括转动轮组、与行进轮组5同心连接的转动轴8，套设在转动轴8上且相对于转动轴可滑动的行星轮16，和与行星轮16啮合的太阳轮15，其中太阳轮15上设有线槽14，用于嵌入导丝线槽沿半径从外向内的方向是渐缩的，以便用于嵌入不同直径的导丝。线槽14开口设在太阳轮15的齿与齿之间的谷底部，不会影响太阳轮15和其它齿轮间的啮合。线槽14由太阳轮15齿与齿之间的谷底开至太阳轮15圆心，所述线槽14用于嵌入所述导丝并保证导丝转动的同轴性。转动轴8为六边形轴。
行进组件用于控制导丝的前进或后退，行进组件包括行进轮组5、与行进轮 组5的齿轮同心连接的传动丝杆2，和用于支撑太阳轮15的固定盘10。太阳轮15和行星轮16均放置在固定盘10的内腔中，且随固定盘10的前后运动而运动。传动丝杆2的近端与行进轮组5的行进锥齿轮11连接固定，转动轴8的近端与转动轮组连接固定，传动丝杆2的远端和转动轴的远端均通过轴承固定在远端的固定板24上。在固定板24上设置有线槽14，以允许导丝的嵌入。行进轮组5由两组行进锥齿轮11组构成。行进轮组还5包括用于连接行进锥齿轮11的连动皮带12，通过连动皮带12实现行进轮组5的行进锥齿轮11之间的连动。固定盘10为中空盘，太阳轮15置于固定盘10的中空内腔中，固定盘10还设有径向开口，用于导丝的嵌入。太阳轮15和固定盘10同心对齐。
转动轮组和行进轮组5均位于同一截面上。转动轮组和行进轮组5均通过电机驱动，转动轮组的转动带动同心连接的转动轴8一同转动，转动轴8又带动行星轮16转动，行星轮16通过啮合作用带动太阳轮15转动。
行进轮组5的齿轮的转动带动传动丝杆2转动，固定盘10与传动丝杆2螺纹啮合连接，并随着传动丝杆2的转动而前进或后退。
在固定盘10上设有至少两个固定齿轮13，固定齿轮13与太阳轮15啮合连接，用于固定太阳轮15。固定齿轮13对称设置在固定盘10上部，用以为太阳轮15提供对称的支撑力，并提供与转动轴8相对应的夹持力。
其中，太阳轮15、固定齿轮13、行星轮16和固定盘10的组合称为轮盘组3。
导丝控制模块包括用于锁紧导丝的锁紧装置，锁紧装置固定在太阳轮15上。锁紧装置包括锁紧控制组件、主动部件21、和固定部件22，其中，固定部件22固定在太阳轮15上且与线槽14的一侧对齐，主动部件21相对于固定部件22设置，且与线槽14的另一侧对齐，锁紧控制组件与主动部件21连接，用于控制主动部件21相对于固定部件22的位置关系。锁紧控制组件控制主动部件21远离固定部件22，即线槽14形成通路，可嵌入导丝。锁紧控制组件控制主动部件21抵靠固定部件22，将嵌入线槽14中的导丝夹紧。锁紧装置可通过电动或气动驱动。
锁紧控制组件包括按键17、连动杆18、弹簧19和限位块20，其中，弹簧19和限位块20设置在主动部件21的内腔中，限位块20固定不动，弹簧19位于限位块20和主动部件21的侧壁之间，连动杆18的一端与按键17连接，另一端与主动部件21连接。在锁紧装置处于松开状态下，通过按压按键17，带动 连动杆18外移，从而带动主动部件21径向向外移动，主动部件21远离固定部件22，此时，弹簧19处于压缩状态。在锁紧装置处于锁紧状态下，解除对按键17的按压控制，在弹簧19的弹力作用下，主动部件21径向向内移动并抵靠固定部件22，按键17回复到初始位置。
主动部件21和固定部件22之间的接触面为齿状夹面，以对导丝提供更大的夹持力。
导丝控制模块包括滑杆，滑杆设置在太阳轮15和固定板24之间。滑杆在沿导丝轴向方向是可滑动的。
滑杆包括支撑架25和两侧滑轮9，其中在支撑架25上设有与太阳轮15和固定板24上的线槽相对应的线槽，在使用状态下，导丝嵌于线槽中，两侧的滑轮9可分别在与之对应的两侧壁面上的滑槽中移动。
滑槽起始于与太阳轮15和固定板24的中段对应的两侧壁面，终止于与固定板24对应的两侧壁面。
滑槽起始于与太阳轮15对应的两侧壁面，终止于与固定板24对应的两侧壁面，其中，在与太阳轮15和固定板24的中段对应的滑槽段上设有止挡件，止挡件用于阻挡中间支撑件的滑动。
滑杆上设有一磁铁，与之对应的，轮盘罩上设有另一磁铁，这两个磁铁是相互吸引的关系。在输送导丝的操作中，滑杆初始位于太阳轮15和固定板24的中段且导丝置于线槽中，随着固定盘10沿传动丝杆2向远端移动，两磁铁产生吸引作用，滑杆连同固定盘10一起继续向远端移动；在回撤导丝的操作中，滑杆连同固定盘10一起向近端回撤，当回撤到太阳轮15和固定板24的中段位置时，在止挡件或者滑槽壁的阻挡作用下，滑杆不再回撤而被固定，固定盘10则可继续回撤。上述配置使得导丝不会因为跨度过长而下垂严重。
在固定板24的远端侧，并距离固定板24(中心距)5-15mm处设有一对导丝传动轮1，用于在远端支撑并输送导丝。该导丝传动轮1的接合处与固定板24上的线槽14是相对应的。导丝置于导丝传动轮1之间，通过导丝传动轮1之间的摩擦输送导丝。该对导丝传动轮1配有一副导丝传动轮锁4，用于控制导丝传动轮1之间的距离，进而控制导丝传动轮1的锁紧情况。
球囊/支架控制模块包括传动轮组7，传动轮组7用于控制球囊导管或支架导管的前进或后退。传动轮组7包括两对摩擦轮组，和连接在下方的齿轮组，齿 轮与电机连接。使用时，电机驱动齿轮转动，齿轮带动上方的摩擦轮组转动，摩擦轮组夹持的球囊导管或支架导管随之前进或后退。该传动轮组7同样配有一副传动轮组锁紧开关23，该传动轮组锁紧开关23用于控制一组传动轮组7之间的距离，进而控制传动轮组7的锁紧情况。
导引导管控制模块包括Y型组合体6，Y型组合体6用于导丝(未示出)和导引导管(未示出)的Y型组合，Y型组合体6是可移动的，Y型组合体6的移动可以输送或回撤导引导管，从而为导引导管提供合适的后座力，便于导丝在导引导管中的前进。Y型组合体6设置在系统的远端，其通过齿轮(26、28)和齿条27的啮合而进行前后运动。其中，Y型组合体6与齿条27固定连接，主动齿轮26与电机连接，主动齿轮26通过齿轮间的相互啮合26带动连动齿轮28转动，齿轮(26、28)又和齿条27相互啮合。使用时，电机驱动主动齿轮26转动，在啮合作用下，齿条27前进或后退，进而带动Y型组合体6前进或后退。
术者通过远程微机操控端，利用信号传输远程控制导引导丝控制模块、球囊/支架控制模块和导引导管模块的运动。需要说明的是，Y型台(Y型组合体6)的前端连接导引导管，通过控制Y型台的前后移动控制导引导管的前后移动；传动轮组7夹持球囊导管或者支架球囊导管前进或后退；转动轮组和行进轮组5控制导丝旋转、前进或后退；而所有部件的旋转、前进或后退，都可以通过术者在手术室外操控终端控制器完成。系统与操作终端通过有线、无线(WiFi，蓝牙等)或互联网进行通讯。操作终端为计算机，包括操纵杆和平板电脑，术者通过调整显示在平板电脑上的参数，调整导丝前进或后退距离和导丝旋转角度，调整导引导管前进或后退距离，以及调整球囊导管或支架导管的前进或后退距离，然后操作操纵杆控制导丝前进、后退或旋转，操作操纵杆控制球囊导管或支架导管前进或后退，操作操纵杆控制导引导管前进或后退。
需要说明的是，固定板24上有两个以上的线槽14，手术中使用2-3个导丝时，线槽14分别嵌入导丝。
该系统的材质采用PC、尼龙等塑料材料或304、316不锈钢等金属材料，对人体无毒害，还可以消毒灭菌，且价格低廉，适合一次性使用。
在本发明提及的所有文献都在本申请中引用作为参考，就如同每一篇文献被单独引用作为参考那样。此外应理解，在阅读了本发明的上述讲授内容之后， 本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。

Claims (10)

  1. 一种血管介入导航手术系统，其特征在于，所述系统包括远程微机操控端、手术定位机械臂和终端执行系统。其中，终端执行系统包括
    导丝控制模块，用于控制导丝的前进、后退及旋转，所述导丝控制模块包括：
    转动组件，用于控制所述导丝的旋转，所述转动组件包括转动轮组、与所述转动轮组同心连接的转动轴，套设在所述转动轴上且相对于所述转动轴可滑动的行星轮，和与所述行星轮啮合的太阳轮，其中所述太阳轮上设有线槽，所述线槽由所述太阳轮的齿与齿之间的谷底开至所述太阳轮圆心，所述线槽用于嵌入所述导丝并保证所述导丝转动的同轴性；和
    行进组件，用于控制所述导丝的前进或后退，所述行进组件包括行进轮组、与所述行进轮组的锥齿轮同心连接的传动丝杆，和用于支撑所述太阳轮的固定盘；
    球囊/支架控制模块，用于控制球囊导管或支架导管的前进或后退，所述球囊/支架控制模块包括传动轮组件，所述传动轮组件包括摩擦轮组，所述摩擦轮组下方有摩擦轮组齿轮互相啮合连接，所述摩擦轮组夹持所述球囊导管或所述支架导管前进或后退；以及
    导引导管控制模块，用于控制导引导管的前进或后退，所述导引导管控制模块包括Y型台组件，所述Y型台组件包括上方的Y型阀和下方的齿轮齿条组，所述Y型阀远端端口连接所述导引导管，近端端口穿入所述导丝，所述导丝通过所述Y型阀进入所述导引导管，并沿着所述导引导管内腔到达手术部位，所述齿轮齿条组带动所述Y型台组件前进或后退，从而带动所述导引导管的前进或后退；
    其中，所述转动轮组、所述行进轮组、所述摩擦轮组和所述Y型台组件均通过电机驱动，并与远程微机连接。
  2. 如权利要求1所述的系统，其特征在于，所述导丝控制模块中的所述转动轮组的转动带动同心连接的所述转动轴一同转动，所述转动轴又带动所述行星轮转动，所述行星轮通过啮合作用带动所述太阳轮转动，从而带动导丝的转动；
    所述行进轮组的锥齿轮的转动带动所述传动丝杆转动，所述固定盘与所述传动丝杆螺纹啮合连接，并随着所述传动丝杆的转动而前进或后退，所述固定盘的前进或后退，带动导丝的前进或后退。
  3. 如权利要求1所述的系统，其特征在于，所述球囊/支架控制模块中传动轮组件的摩擦轮组齿轮转动，带动上方摩擦轮转动，所述摩擦轮的转动，带动所述摩擦轮夹持着的球囊导管或支架导管的前进或后退。
  4. 如权利要求1所述的系统，其特征在于，所述导引导管模块中Y型台组件的齿轮齿条组中的齿轮带动与之啮合的齿条移动，使所述Y型台和连接的所述导引导管前进或后退。
  5. 如权利要求1所述的系统，其特征在于，在整个系统的纵向方向上，从近端到远端设有多个可以自上而下直接放置导丝的线槽，包括外盒、轮盘组、滑轮和固定板，便于手术前放置导丝和手术中取出及交换导丝，也便于导丝和球囊导管或支架导管的配合使用。
  6. 如权利要求1所述的系统，其特征在于，在所述固定盘上设有至少两个固定齿轮，所述固定齿轮与所述太阳轮齿轮啮合连接，用于固定所述太阳轮。
  7. 如权利要求1所述的系统，其特征在于，所述导丝控制模块包括用于锁紧所述导丝的锁紧装置，所述锁紧装置固定在所述太阳轮上。
  8. 如权利要求7所述的系统，其特征在于，所述锁紧装置包括锁紧控制组件、主动部件、和固定部件，其中，所述固定部件固定在所述太阳轮上且与所述线槽的一侧对齐，所述主动部件相对于所述固定部件设置，且与所述线槽的另一侧对齐，所述锁紧控制组件与所述主动部件连接，用于控制所述主动部件相对于所述固定部件的位置关系；
    所述锁紧控制组件包括按键、连动杆、弹簧和限位块，其中，所述弹簧和所述限位块设置在所述主动部件的内腔中，所述限位块固定不动，所述弹簧位于所述限位块和所述主动部件的侧壁之间，所述连动杆的一端与所述按键连接，另一端与所述主动部件的连接。
  9. 如权利要求1所述的系统，其特征在于，所述导丝控制模块包括滑杆，所述滑杆设置在轮盘组和所述固定板之间。
  10. 如权利要求1所述的系统，其特征在于，术者通过远程微机操控端，利用信号传输远程控制所述导丝控制模块、球囊/支架控制模块和导引导管控制模 块的运动。
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CN116617547A (zh) * 2023-07-07 2023-08-22 江苏普力优创科技有限公司 用于血管介入的分段式微导管
CN116617547B (zh) * 2023-07-07 2024-01-30 江苏普力优创科技有限公司 用于血管介入的分段式微导管

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