WO2023124904A1 - 可调弯导管 - Google Patents

可调弯导管 Download PDF

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Publication number
WO2023124904A1
WO2023124904A1 PCT/CN2022/137948 CN2022137948W WO2023124904A1 WO 2023124904 A1 WO2023124904 A1 WO 2023124904A1 CN 2022137948 W CN2022137948 W CN 2022137948W WO 2023124904 A1 WO2023124904 A1 WO 2023124904A1
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WO
WIPO (PCT)
Prior art keywords
bevel gear
sheath
pulling wire
adjustable
tube
Prior art date
Application number
PCT/CN2022/137948
Other languages
English (en)
French (fr)
Inventor
刘晓颖
Original Assignee
先健科技(深圳)有限公司
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Filing date
Publication date
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Publication of WO2023124904A1 publication Critical patent/WO2023124904A1/zh

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    • 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
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16H—GEARING
    • F16H1/00—Toothed gearings for conveying rotary motion
    • F16H1/02—Toothed gearings for conveying rotary motion without gears having orbital motion
    • F16H1/20—Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members
    • F16H1/22—Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members with a plurality of driving or driven shafts; with arrangements for dividing torque between two or more intermediate shafts
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16H—GEARING
    • F16H1/00—Toothed gearings for conveying rotary motion
    • F16H1/02—Toothed gearings for conveying rotary motion without gears having orbital motion
    • F16H1/20—Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members
    • F16H1/22—Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members with a plurality of driving or driven shafts; with arrangements for dividing torque between two or more intermediate shafts
    • F16H1/222—Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members with a plurality of driving or driven shafts; with arrangements for dividing torque between two or more intermediate shafts with non-parallel axes
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • 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
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A61M2025/015—Details of the distal fixation of the movable mechanical means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to an adjustable bend catheter.
  • Intravascular technology is to move the catheter along the lumen of the blood vessel to the lesion position (such as coronary artery, carotid artery, celiac artery, renal artery, etc.), and then microscopically perform microscopic examination of the lesion in the body by implanting stents or drugs or other implanted devices. It is an emerging medical method for invasive treatment, in which the catheter is a tool for intracavitary surgery to establish the extracorporeal to the inner body, which plays a vital role.
  • the lesion position such as coronary artery, carotid artery, celiac artery, renal artery, etc.
  • peripheral blood vessels at all levels such as iliac artery, femoral artery, common carotid artery, innominate trunk, and coronary artery, and the aortic blood vessel, it brings certain difficulties for accurate positioning.
  • Most of the catheter tip will be pre-shaped into different curved shapes according to the characteristics of the vascular path of the target lesion, such as the mountain sheath, shuttle sheath, bending sheath, etc.
  • a large number of catheters need to be prepared, which increases the consumption of equipment and operation time.
  • adjustable bend catheters have appeared on the market.
  • the distal end of the adjustable bend catheter can be adjusted to increase its applicability and avoid the need to spend a lot of time selecting the model of the catheter during the operation.
  • the adjustable bend catheters currently on the market usually require an additional locking structure to fix the bend when adjusting the bend, or stop at a certain limit angle, which cannot be adjusted according to the actual situation of the surgical procedure.
  • the present invention provides an adjustable bend catheter to solve the problem that the adjustable bend catheter in the existing market usually needs an additional locking structure to adjust and fix the bend, or it can only stop when it reaches a certain limit angle.
  • an adjustable curved catheter which includes a sheath tube, a housing disposed at the proximal end of the sheath tube, a driving mechanism and a stopper disposed in the housing, and at least one A pulling wire, the distal end of the pulling wire is connected to the distal end of the sheath, the proximal end of the pulling wire extends into the housing and is connected with the driving mechanism, and the driving mechanism is used for pulling and
  • the pulling wire is released to realize the bending of the sheath tube, and the stopper is abutted against the driving mechanism and has an interference fit with it, so that the driving mechanism is stationary relative to the casing without an external force , and move relative to the housing under the action of an external force, and the moving driving mechanism changes the bending state of the sheath during the process of pulling and releasing the pulling wire.
  • the adjustable bend catheter provided by the present invention has the following beneficial effects:
  • the proximal end of the pulling wire extends into the housing and connects with the driving mechanism, and at the same time abuts against the driving mechanism by setting the stopper And with it, the interference fit makes the driving mechanism move relative to the housing under the action of external force.
  • the driving mechanism moves, it can pull and release the traction wire to change the bending state of the sheath tube, and it is still relative to the housing under the action of no external force, that is, Without the action of other external force, the sheath tube can be kept in the original bending state.
  • the adjustable bend catheter of the present invention does not need to be provided with an additional locking structure, can achieve the effect of stopping at any time during bending adjustment, and can stop when you let go, precisely controls the bending angle, saves the time for doctors to perform operations and improves the convenience of operation.
  • Fig. 1 is a schematic structural diagram of an adjustable bend catheter provided by Embodiment 1 of the present invention
  • FIG. 2 is a schematic structural view of the adjustable catheter provided in Embodiment 1 of the present invention without the sheath core;
  • Fig. 3 is a schematic diagram of the adjustable curved catheter provided by Embodiment 1 of the present invention after the sheath core and part of the casing are removed;
  • FIG. 4 is a schematic structural view of the sheath core of the adjustable catheter provided in Embodiment 1 of the present invention.
  • FIG. 5 is a schematic diagram of the internal structure of the sheath of the adjustable catheter provided in Embodiment 1 of the present invention.
  • Fig. 6 is a schematic structural view of the first developing ring of the adjustable bendable conduit provided by Embodiment 1 of the present invention.
  • Fig. 7 is a schematic diagram of the development state of the first notch of the adjustable bendable catheter provided by Embodiment 1 of the present invention.
  • Fig. 8 is a schematic diagram of the developing state of the second notch of the adjustable bendable catheter provided by Embodiment 1 of the present invention.
  • Fig. 9 is a schematic structural view of the anchoring ring of the adjustable bend catheter provided by Embodiment 1 of the present invention.
  • Fig. 10 is a first schematic diagram of the combination of the anchoring ring and the pulling wire of the adjustable bend catheter provided by the first embodiment of the present invention
  • Fig. 11 is a second schematic diagram of the combination of the anchoring ring and the pulling wire of the adjustable catheter provided in the first embodiment of the present invention.
  • Fig. 12 is a schematic diagram of the third combination of the anchoring ring and the pulling wire of the adjustable bend catheter provided by the first embodiment of the present invention.
  • Fig. 13 is a schematic diagram 4 of the combination of the anchoring ring and the pulling wire of the adjustable catheter provided in the first embodiment of the present invention
  • Fig. 14 is a schematic diagram of a modified embodiment of the sheath tube of the adjustable catheter provided in Embodiment 1 of the present invention.
  • Fig. 15 is a schematic diagram of the assembly of the driving mechanism and the adjusting parts of the adjustable bend catheter provided by Embodiment 1 of the present invention.
  • Fig. 16 is a schematic structural view of the adjustment tube of the adjustable bend catheter provided in Embodiment 1 of the present invention.
  • Fig. 17 is a schematic diagram of the combination of the first driven bevel gear, the second driven bevel gear and the support frame of the adjustable bend catheter provided by Embodiment 1 of the present invention;
  • Fig. 18 is a schematic structural view of the support frame of the adjustable bend catheter provided by Embodiment 1 of the present invention.
  • Fig. 19 is a schematic structural view of the first driven bevel gear of the adjustable bend catheter provided in Embodiment 1 of the present invention.
  • Fig. 20 is a schematic diagram of the combination of the first driven bevel gear and the cover of the adjustable bend catheter provided by Embodiment 1 of the present invention.
  • Fig. 21 is a schematic structural view of the cover of the adjustable catheter provided in Embodiment 1 of the present invention.
  • Fig. 22 is a schematic diagram of the combination of the adjustment tube and the sleeve of the adjustable bend catheter provided by Embodiment 1 of the present invention.
  • Fig. 23 is a first structural schematic diagram of the adjustment component of the adjustable bend catheter provided by the first embodiment of the present invention.
  • Fig. 24 is a schematic diagram of the combination of the adjusting part, the limit plate and the limit pin of the adjustable bend catheter provided by the first embodiment of the present invention.
  • Fig. 25 is a second structural schematic diagram of the adjustment component of the adjustable bend catheter provided in the first embodiment of the present invention.
  • Fig. 26 is a schematic diagram of the combination of the limit plate and the limit pin of the adjustable bend catheter provided by Embodiment 1 of the present invention.
  • Fig. 27 is a schematic diagram of the combination of the adjustment tube and the resisting piece of the adjustable bend catheter provided by the second embodiment of the present invention.
  • Fig. 28 is a schematic structural diagram of the adjustable bend catheter provided by Embodiment 3 of the present invention.
  • Fig. 29 is a schematic structural diagram of the adjustable bend catheter provided by Embodiment 3 of the present invention.
  • Fig. 30 is a schematic structural diagram of the adjustable bend catheter provided by the third embodiment of the present invention.
  • Adjustable curved catheter 11. Housing; 12. Sheath core; 13. Sheath tube; 14. Driving mechanism; 15. Adjusting parts; 16. Pulling wire; 17. Limiting mechanism; , the first developing ring; 20, the second developing ring;
  • Can Bending section 132, distal soft section; 133, proximal hard section; 134, anchor ring; 141, driving bevel gear; 142, first driven bevel gear; 143, second driven bevel gear; 144, support frame ; 145, regulating tube; 146, slide block; 147, silica gel ring; 151, keyway; 161, the first drawing wire; 162, the second drawing wire; 171, limit block; 172, limit pin; 173, limit Position plate; 181, limit key; 182, threading piece; 191, first gap; 192, second gap;
  • proximal end the end of a medical device implanted in the human or animal body that is closer to the operator
  • distal end the end of a medical device implanted in the human or animal body that is closer to the operator
  • proximal end the end that is farther from the operator
  • distal end the end that is farther from the operator
  • Principles define the "proximal” and “distal” ends of any component of a medical device.
  • “Axial” generally refers to the length direction of the medical device when it is being transported
  • radial generally refers to the direction perpendicular to the "axial” of the medical device
  • axis" of any part of the medical device is defined according to this principle to” and "radial”.
  • the embodiment of the present invention provides an adjustable bend catheter 10, the adjustable bend catheter 10 includes a housing 11, a sheath core 12, a sheath tube 13, a driving mechanism 14, a stopper 18 and at least one Pulling wire 16, wherein the sheath core 12 has an inner cavity for the guide wire to pass through, the sheath core 12 is accommodated in the sheath tube 13, the distal end of the sheath core 12 passes through the sheath tube 13, and the housing 11 is arranged on the sheath tube At the proximal end of 13, the housing 11 has an accommodating inner cavity q, and the driving mechanism 14 and the stopper 18 are arranged in the accommodating inner cavity q.
  • the distal end of the pulling wire 16 is connected to the distal end of the sheath tube 13, and the proximal end of the pulling wire 16 extends into the housing 11 and is connected with the driving mechanism 14.
  • the driving mechanism 14 is used to pull and release the pulling wire 16 to realize the sheath. 13, the stopper 18 abuts against the drive mechanism 14 and is interference-fitted with it, so that the drive mechanism 14 is stationary relative to the housing 11 under the action of no external force, and moves relative to the housing 11 under the action of an external force.
  • the driving mechanism 14 changes the bending state of the sheath tube 13 during the process of pulling and releasing the pulling wire 16 .
  • the housing 11 is used for convenient gripping during operation, and the housing 11 can provide protection and installation support functions for components such as the drive mechanism 14 at the same time.
  • Inner cavity q, furthermore, anti-slip convex strips 111 can be provided on the outer surfaces of the upper and lower shells, so as to be convenient for the operator to hold.
  • a plurality of reinforcing ribs may be provided in the inner wall of the housing 11, and the setting of the reinforcing ribs can not only enhance the strength of the housing 11, but also can be used for each component in the accommodating cavity q of the housing 11. Provides installation support functions.
  • the proximal end of the sheath tube 13 is passed through the casing 11 so as to be connected with the driving mechanism 14 in the accommodating cavity q of the casing 11 .
  • a protective sheath 112 is provided at the position where the distal end of the housing 11 is docked with the sheath tube 13, and the sheath tube 13 passes through the protective sheath 112. Bending angle is too large and broken.
  • the protective cover 112 can be a silicone protective cover or a rubber protective cover.
  • the adjustable bend catheter 10 also includes a T-shaped joint 101, a hose 102 and a three-way valve 103, one end of the T-shaped joint 101 communicates with the sheath tube 13, and the other end of the T-shaped joint 101 passes through a soft tube.
  • the tube 102 is connected with the three-way valve 103, and the three-way valve 103 can be connected to the sheath tube 13 to inject liquid or extract body fluid through a syringe or other instruments.
  • the sheath core 12 includes a sheath core tube 121 and a sheath core joint 122 located at the proximal end of the sheath core tube 121.
  • the sheath core joint 122 is threadedly connected to the proximal end of the sheath tube 13, preferably half a turn thread.
  • the present invention can withstand greater impact force of blood flow through threaded connection, and prevent the sheath core 12 from detaching from the sheath tube 13 under the impact of blood flow.
  • the sheath tube 13 can realize unidirectional bending, and when the number of pulling wires 16 is greater than 1, the sheath tube 13 can realize multi-directional bending.
  • the embodiment of the present invention is described by taking the adjustable bend catheter 10 including two pulling wires 16 as an example, which should not limit the present invention.
  • the two pulling wires 16 are respectively a first pulling wire 161 and a second pulling wire 162 , and the first pulling wire 161 and the second pulling wire 162 are located at different positions in the circumferential direction of the sheath tube 13 .
  • the driving mechanism 14 can pull and release the first pulling wire 161 and the second pulling wire 162, and when the driving mechanism 14 pulls any one of the first pulling wire 161 and the second pulling wire 162, the sheath The tube 13 is bent toward the pulled wire side, and at the same time, the driving mechanism 14 is also synchronized so that the other undrawn wire is released correspondingly with the bending of the sheath tube 13, for example, when the driving When the mechanism 14 pulls the first pulling wire 161 so that the distal end of the sheath tube 13 is bent towards the side where the first pulling wire 161 is located, the second pulling wire 162 is released in length along with the bending of the sheath tube 13; when the driving mechanism 14 When pulling the second pulling wire 162 and driving the sheath tube 13 to bend toward the side where the second pulling wire 162 is located, the first pulling wire 161 is released in length along with the bending of the sheath tube 13, so that the driving mechanism 14, the second The mutual cooperation of the first pulling wire 161 and the second pulling wire 16
  • the sheath tube 13 By setting the sheath tube 13 with the bendable section 131, and the first pulling wire 161 and the second pulling wire 162 anchored on the bendable section 131 of the sheath tube 13, and setting the driving mechanism 14 for the first pulling wire 161.
  • the second pulling wire 162 is pulled and released.
  • the driving mechanism 14 pulls any one of the first pulling wire 161 and the second pulling wire 162
  • the sheath tube 13 faces the side of the pulled pulling wire.
  • One side is bent, and at the same time, the other pulling wire is released synchronously, so that the sheath tube 13 can be bent in two directions in at least two directions of the sheath tube 13 at its bendable section 131, so as to fully meet the requirements for blood vessel distortion.
  • the need for interventional therapy in complex lesion locations such as variable openings and vascular openings greatly reduces the frequency of catheter adjustments and catheter replacements by clinical operators, making surgery easier and reducing the risk of complications .
  • the sheath 13 includes a bendable section 131, a distal soft section 132 and a proximal hard section 133, the bendable section 131 is located between the distal soft section 132 and the proximal hard section 133, wherein the proximal The end hard section 133 is located at the proximal end of the sheath tube 13, the distal soft section 132 is located at the distal end of the sheath tube 13, and the bendable section 131 is arranged near the distal end of the sheath tube 13, so that the delivery of the sheath tube 13 in the body can be ensured. At the same time, it can also ensure that the sheath tube 13 can be bent at the corresponding position when the diseased tissue needs to establish a curved delivery channel.
  • the flexible section 131 has a three-layer structure
  • the inner layer is a polymer material, such as polytetrafluoroethylene PTFE
  • the middle layer is a spring structure 1311
  • the outer layer is a soft polymer material, such as polyether block polyamide PEBAX, preferably It is PEBAX with a hardness of 35D.
  • the bendable section 131 adopts a three-layer structure and the middle layer is set as a spring structure 1311 . Since the spring structure 1311 has better bending resistance, the bendable section 131 can be adjusted to a larger angle.
  • the distal soft segment 132 has a double-layer structure, the inner layer is PTFE, and the outer layer is PEBAX, preferably PEBAX with a hardness of 35D.
  • the arrangement of the distal soft section 132 enables the sheath tube 13 to reduce damage to the blood vessel.
  • the proximal hard segment 133 has a three-layer structure, the inner layer is PTFE, the middle layer is a braided mesh structure 1331, and the outer layer is PEBAX, preferably PEBAX with a hardness of 72D.
  • the proximal hard segment 133 adopts a three-layer structure and the middle layer is set as a braided mesh structure 1331 . Since the braided mesh structure 1331 has better flexibility, the proximal hard segment 133 has better compliance in the blood vessel.
  • the hardness of the flexible section 131 and the distal soft section 132 is smaller than that of the proximal hard section 133, so that when the flexible section 131 is bent, the distal soft section 132 will not be bent, so that it is easier to maintain the distal end of the sheath tube 13 Coaxial with the target position to achieve precise release.
  • the sheath 13 is provided with a first developing ring 19 and a second developing ring 20, wherein the second developing ring 20 is arranged at the distal end of the proximal hard segment 133 and the bendable segment 131
  • the junction of the proximal end of the sheath tube 13 is used as the development identification of the initial bending point
  • the first development ring 19 is arranged at the distal end of the bendable section 131 as the development identification of the bending angle tracking of the sheath tube 13 .
  • the second developing ring 20 is arranged at the junction of the distal end of the proximal hard section 133 and the proximal end of the bendable section 131, so that the proximal hard section 133 can
  • the braided mesh structure 1331 of segment 133 acts to compress and contract.
  • a first notch 191 and a second notch 192 are provided on opposite sides of the first developing ring 19 respectively, the first notch 191 and the second notch 192 are L-shaped notches with right angles, and the first notch 191 and the second notch
  • the two notches 192 are different in size and/or in different directions, that is, one of the first notch 191 and the second notch 192 is set at the proximal end of the first developing ring 19 , and the other is set at the far end of the first developing ring 19 .
  • the first notch 191 and the second notch 192 are highlighted by means of stereoscopic imaging. When the sheath tube 13 is bent toward the direction of the first notch 191, the developing state is shown in FIG.
  • the development state is shown in Figure 8, and the right angle is at the doctor's right hand position.
  • the first notch 191 and the second notch 192 are different in size and/or notch orientation is different, therefore The imaging results are different, and the doctor can accurately identify the bending direction of the sheath tube 13 accordingly.
  • the first notch 191 and the second notch 192 can also adopt notches of other shapes, as long as the first notch 191 and the second notch 192 can be distinguished in the developed state, so that the doctor can accurately identify the bending direction of the sheath tube 13 That's it.
  • FIG. 9 and FIG. 10 specifically, the side wall of the sheath tube 13 is provided with a threading channel (not shown) through the first drawing wire 161 and the second drawing wire 162, so that both A special moving channel is provided for the first drawing wire 161 and the second drawing wire 162 to ensure their smooth movement, and at the same time provide protection for them from external interference.
  • the distal end of the sheath tube 13 is fixedly connected with an anchoring ring 134.
  • the anchoring ring 134 is fixed on the bendable section 131, and the first pulling wire 161 and the second pulling wire 162 are connected to the anchoring ring 134. superior.
  • two through grooves 1341 are spaced apart on the outer peripheral side wall of the anchoring ring 134, and a partition 1342 is arranged in each through groove 1341, wherein the first pulling wire 161 passes through the partition in a through groove.
  • One side of the through groove passes through the through groove and passes through the through groove from the other side of the dividing plate, and the second drawing wire 162 penetrates through the through groove from one side of the dividing plate in the other through groove and passes through the through groove from the other side of the dividing plate.
  • One side passes through the through slot.
  • the first pulling wire 161 and the second pulling wire 162 can guide the sheath tube 13 to bend in two different directions on different radial planes of the same circumference of the bendable section 131 of the sheath tube 13 .
  • the stress impact on the first pulling wire 161 and the second pulling wire 162 can be reduced, so as to ensure the stability of their connection with the anchor ring 134 and also enable the sheath tube 13 to withstand greater bending force.
  • this embodiment can prevent the pulling wire from protruding from the surface of the anchor ring 134 , thus greatly avoiding the risk of missing wire or ring and the occurrence of false welding or over-welding during the heat-melting process of the sheath tube 13 .
  • the pulling wire is passed from the inside of the anchor ring to the outside of the anchor ring, or from the outside of the anchor ring to the inside of the anchor ring, so as to realize the connection between the anchor ring and the pulling wire.
  • the anchor ring is subjected to the shear stress of the pull wire. Due to the concentration of shear stress, the risk of breaking the anchor ring or the pull wire will be caused.
  • the connection method of the anchor ring and the pull wire in this embodiment can be Avoid breakage of the anchor ring or breakage of the pull wire due to shear stress concentration.
  • two through holes 1343 are spaced apart on the side wall of the anchor ring 134, wherein the first pulling wire 161 passes through one side of a through hole and passes through the other side.
  • the second drawing wire 162 passes through one side of another through hole and passes out from the other side of the through hole.
  • FIG. 12 As yet another specific embodiment, as shown in FIG. 12 , four through holes 1343 are spaced apart on the side wall of the anchor ring 134, wherein two through holes 1343 form a group, and the two ends of the first pulling wire 161 are separated from the Two through holes 1343 of one group penetrate into the anchor ring 134 from the outside of the anchor ring 134, and then protrude from the anchor ring 134.
  • the anchor ring 134 is threaded outwardly into the anchor ring 134 and then protrudes from the anchor ring 134 .
  • This method can reduce the stress impact on the first pulling wire 161 and the second pulling wire 162 , thereby ensuring the stability of their connection with the anchor ring 134 and also enabling the sheath tube 13 to withstand greater bending force.
  • four through holes 1343 are spaced apart on the side wall of the anchor ring 134 , wherein two through holes 1343 form a group, and the anchor ring 134 corresponds to each group of through holes 1343
  • There is a thread passing port 1344 and the two ends of the first pulling wire 161 respectively pass through the two through holes 1343 of one group into the anchoring ring 134 from the outside of the anchoring ring 134, and then protrude from the corresponding thread passing port 1344 of the group
  • the two ends of the second pulling wire 162 pass through the anchor ring 134 from the outside of the anchor ring 134 through the two through holes 1343 of the other group, and then protrude from the corresponding wire openings 1344 of the group.
  • This method can reduce the stress impact on the first pulling wire 161 and the second pulling wire 162 , thereby ensuring the stability of their connection with the anchor ring 134 and also enabling the sheath tube 13 to withstand greater bending force. At the same time, it can also prevent the pulling wire from breaking the membrane of the sheath tube 13 when the pulling wire crosses the inner wall of the anchoring ring 134 .
  • first pulling wire 161 and the second pulling wire 162 can also be located in the same radial plane of the anchor ring 134, that is, in the same radial plane of the same circumference of the bendable section 131 of the sheath tube 13 (not shown in the figure). out).
  • first pulling wire 161 and the second pulling wire 162 can be bent in two opposite directions on the same circumference of the bendable section 131 of the sheath tube 13, so that the appropriate one can be selected according to the individual differences in the physiological and anatomical structures of different patients.
  • the bendable section 131 of the sheath tube 13 can adjust the bending curvature of the bendable section 131 of the sheath tube 13, such as small bend, medium bend, and large bend, so as to meet the needs of different human bodies, reduce the number of punctures and damage to the human body, simplify the operation process and shorten the operation time.
  • two anchoring rings 134 arranged at intervals may also be provided on the bendable section 131 of the sheath 13, and the first pulling wire 161 and the second pulling wire 162 are respectively anchored to the two anchor rings.
  • the first pulling wire 161 and the second pulling wire 162 can pull the sheath tube 13 in different circumferential radial directions of the bendable section 131 of the sheath tube 13 to perform bending in two different directions, It can also meet clinical needs, and this structure is especially suitable for the situation where there are bifurcated blood vessels in different sections of the main blood vessel channel.
  • the driving mechanism 14 includes a driving part and a driven part, the driving part and the driven part are connected by a bevel gear, the proximal end of the pulling wire 16 is connected with the driven part, and the driving part drives the driven part.
  • the moving part pulls and releases the pulling wire 16 .
  • the driving mechanism 14 includes at least one driven part and the driven part corresponds to the pulling wire 16 one by one;
  • the bevel gear is connected with the corresponding traction wire, and the driving bevel gear 141 drives the driven bevel gear to pull and release the traction wire connected thereto.
  • the driving part is a driving bevel gear 141
  • the driven part includes a first driven part linked with the driving part (in this embodiment, the first driven part is the first driven bevel gear 142) and a driving part linked with the driving part.
  • the second follower (in this embodiment, the second follower is the second driven bevel gear 143), the first driven bevel gear 142 is connected with the first pulling wire 161, and the second driven bevel gear 143 Connected with the second traction wire 162, the driving bevel gear 141 drives any one of the first driven bevel gear 142 and the second driven bevel gear 143 to pull the traction wire connected to it, and synchronously drives the first driven bevel gear The other one of the bevel gear 142 and the second driven bevel gear 143 releases the pulling wire connected thereto, so as to realize bidirectional bending adjustment.
  • the driving element may also be a worm
  • the first driven element may be a worm gear engaged with the worm
  • the second driven element may be another worm gear engaged with the worm.
  • the driving bevel gear 141 and the sheath tube 13 are arranged coaxially, the first driven bevel gear 142 and the second driven bevel gear 143 are all meshed with the driving bevel gear 141, and the first driven bevel gear 142 Be connected with the first drawing wire 161, the second driven bevel gear 143 is connected with the second drawing wire 162, in the embodiment of the present invention, the first driven bevel gear 142, the second driven bevel gear 143 are connected with the driving bevel At least one axial plane of the gear 141 is symmetrically arranged, that is, the first driven bevel gear 142 and the second driven bevel gear 143 are located at different circumferential positions of the driving bevel gear 141, so that the driving bevel gear 141, the first driven bevel gear
  • the driving bevel gear 142 and the second driven bevel gear 143 have relatively stable structural stability and relatively stable transmission performance, and at the same time, it can also ensure that the first driven bevel gear 142 and the second driven bevel gear 143 are synchronized respectively
  • the sheath tube 13 can be realized.
  • the two-way bending can also accommodate and release the first pulling wire 161 and the second pulling wire 162 synchronously.
  • the rotation center axis of the first driven bevel gear 142 is coaxially arranged with the rotation center axis of the second driven bevel gear 143 , and the rotation centers of the first driven bevel gear 142 and the second driven bevel gear 143
  • the axes are all perpendicular to the central axis of the driving bevel gear 141 .
  • the radial stress applied to the driving bevel gear 141 by the first driven bevel gear 142 and the second driven bevel gear 143 in the radial direction will be more balanced, thereby making the structure of the whole bevel gear transmission system more stable, and the The transmission is also more balanced, so that the synchronization between the first pulling wire 161 and the second pulling wire 162 will be better when pulling and releasing.
  • first driven bevel gear 142 and the second driven bevel gear 143 are meshed with the driving bevel gear 141, when the driving bevel gear 141 drives the first driven bevel gear 142 and the second driven bevel gear 143 When rotating simultaneously, the rotation directions of the first driven bevel gear 142 and the second driven bevel gear 143 will be opposite.
  • the second drawing wire 162 is also wound on the second driven bevel gear 143 in the counterclockwise direction, that is, the winding directions of the first drawing wire 161 and the second drawing wire 162 are the same (that is, they are all wound in the clockwise direction, or they are all wound in the counterclockwise direction).
  • first drawing wire 161 and the second drawing wire 162 can be realized through one bevel gear and two driven bevel gears. It is necessary to achieve precise control, and the volume should not be too large to facilitate manipulation.
  • the rotation directions of the first driven bevel gear 142 and the second driven bevel gear 143 are the same, and the winding directions of the first drawing wire 161 and the second drawing wire 162 are opposite, for example, the first drawing wire One of the first drawing wire 161 and the second drawing wire 162 is wound in a clockwise direction, and the other of the first drawing wire 161 and the second drawing wire 162 is wound in a counterclockwise direction.
  • the drive mechanism 14 further includes a support frame 144, wherein the support frame 144 includes a support ring 1441, a first rotating shaft 1442, and a second rotating shaft 1443, and the first rotating shaft 1442 and the second rotating shaft 1443 are both connected to
  • the support ring 1441 is fixedly connected, the first rotating shaft 1442 and the second rotating shaft 1443 are coaxially arranged, and the first rotating shaft 1442 and the second rotating shaft 1443 are located in the same radial plane of the sheath tube 13, wherein the first rotating shaft 1442 and the first rotating shaft 1443
  • the central portion of the driven bevel gear 142 is rotationally connected, the second shaft 1443 is rotationally connected with the central portion of the second driven bevel gear 143 , and the central axis of the driving bevel gear 141 passes through the center of the support ring 1441 of the support frame 144 .
  • the support frame 144 can be made of a metal material with better rigidity, so as to better withstand the relatively large radial stress of the first driven bevel gear 142 and the second driven bevel gear 143 .
  • the surface where the first shaft 1442 is in rotatable contact with the first driven bevel gear 142 is a smoother surface
  • the surface where the second shaft 1443 is in rotatable contact with the second driven bevel gear 143 is also a smoother surface .
  • smooth surface means that the roughness does not exceed 6.4Ra, the roughness of the contact surface between the first rotating shaft 1442 and the first driven bevel gear 142, and the rotating contact surface between the second rotating shaft 1443 and the second driven bevel gear 143 Lower, it is necessary to better reduce the friction between the contact surfaces, so that the first rotating shaft 1442 and the second rotating shaft 1443 can rotate relatively smoothly, so that the driving force driving their rotation is small, so as to save time and effort
  • the objective is to improve the overall reliability of the driving mechanism 14 at the same time.
  • the driving mechanism 14 can also be configured in the form of using two sets of bevel gear assemblies to respectively control the first pulling wire 161 and the second pulling wire 162 .
  • the driving part includes a first driving bevel gear and a second driving bevel gear, the first driving bevel gear and the second driving bevel gear are arranged coaxially, but are set in opposite directions, and the first driving bevel gear and the second driving bevel gear are arranged coaxially.
  • the first driven bevel gear 142 is meshed, and the second driven bevel gear is meshed with the second driven bevel gear 143.
  • the rotation directions of the first driven bevel gear 142 and the second driven bevel gear 143 respectively driven by it are also the same.
  • the winding directions of the two pulling wires 162 and the second driven bevel gear 143 are respectively wound in opposite directions, so that when any pulling wire in the first pulling wire 161 and the second pulling wire 162 is pulled, The other pulling wire is released correspondingly, and then the sheath tube 13 is controlled bidirectionally to bend.
  • the first driven bevel gear 142 includes a gear part 1421 meshed with the driving bevel gear 141 and a winding reel 1422 connected to the gear part 1421, the proximal end of the first pulling wire 161 Fixedly connected to the reel 1422, specifically, the reel 1422 includes a cylindrical reel 14221 and a first fence 14222 and a second fence 14223 protruding from the outer surface of the reel 14221 , the first fence 14222 and the second fence 14223 are arranged at intervals, the first pulling wire 161 can be wound on the winding wheel 14221, that is, the middle part between the first fence 14222 and the second fence 14223, and on the winding reel 1422 There is a threading opening 14224 for the drawing wire to pass through.
  • the first driven bevel gear 142 rotates, it will drive the first pulling wire 161 fixedly connected to the winding disk 1422 to circle around the winding disk 1422 to recover or loosen, so as to realize the storage and release of the first pulling wire 16
  • the winding reel 1422 is covered with a cover 1423 for limiting the first drawing wire 161, and the cover 1423 is provided with an opening 14231 for the first drawing wire 161 to pass through. More specifically, the cover 1423 sets It is arranged on the winding wheel 14221 of the winding disk 1422 and surrounds with the winding disk 1422 to form an independent space for the first drawing wire 161 to be wound. The setting of the cover 1423 can restrict the first drawing wire 161 to move within the independent space enclosed by the winding reel 1422 and the cover 1423, thereby preventing the first drawing wire 161 from jumping away from the winding reel 1422 when it is in a relaxed state. If it is taken off and mistakenly wound on other parts, it will cause jamming.
  • the driving mechanism 14 includes an adjustment tube 145, the distal end of the adjustment tube 145 is connected to the driving bevel gear 141, the sheath tube 13 is passed through the adjustment tube 145, and the adjustment tube 145 is sleeved with silica gel.
  • the washer 1452, the stopper 18 and the silicone washer 1452 are abutted and have an interference fit, thereby increasing the friction between the casing and the silicone washer 1452, and without the action of other external forces, the sheath tube 13 can be maintained for a long time original bent state.
  • the adjustable bending catheter 10 of the present invention does not need to be provided with an additional locking structure, and can achieve the effect of stopping at any time during the bending adjustment, and can stop when you let go, accurately control the bending angle, save the doctor's time for surgery and improve the convenience of operation.
  • the regulating tube 145 is provided with at least one stopper 1451, the stopper 1451 is an annular protruding strip protruding from the outer peripheral surface of the regulating tube 145, and the silicone gasket 1452 is sleeved on the annular protruding strip to stop
  • the stopper 18 abuts against the silicone gasket 1452 and interferes with it so that the adjustment tube 145 is stationary relative to the housing 11 under the action of no external force, and moves relative to the housing 11 under the action of an external force.
  • the moving adjustment tube 145 drives the active cone
  • the gear 141 drives the first driven bevel gear 142 and the second driven bevel gear 143 to pull and release the pulling wire 16 .
  • the stopping member 18 is a sleeve sleeved on the outer peripheral side of the limiting member 1451 , and the sleeve is rotatably sleeved on the silicone gasket 1452 and abuts against the silicone gasket 1452 and has an interference fit therewith.
  • the limiting member 1451 is integrally formed on the regulating tube 145 .
  • the limiter 1451 is a spherical body protruding from the outer peripheral surface of the adjustment tube 145, the stopper 18 abuts against the spherical body and remains stationary relative to the housing 11, the spherical body and the stopper 18 interference fit.
  • the stopper 18 abuts against the spherical body so that the adjustment pipe 145 is stationary relative to the housing 11 under the action of no external force, and moves relative to the housing 11 under the action of an external force.
  • the moving adjustment pipe 145 drives the driving bevel gear 141 to drive the first
  • the driven bevel gear 142 and the second driven bevel gear 143 pull and release the pulling wire 16 .
  • the limiting member 1451 is integrally formed on the regulating tube 145 .
  • the driving bevel gear 141 is integrally formed at the distal end of the regulating tube 145 .
  • the adjustable curved catheter 10 provided by the present invention is provided with at least one stopper 1451 on the adjustment tube 145, the stopper 1451 protrudes from the outer peripheral surface of the adjustment tube 145, and a silicone gasket is sleeved on the stopper 1451 1452.
  • a casing is sleeved on the silicone gasket 1452, wherein the regulating tube 145 is pierced with a sheath 13, and the casing remains stationary relative to the housing 11.
  • the casing and the silicone gasket 1452 have an interference fit, so that the regulating tube 145 is in the non- Under the action of external force, it is stationary relative to the housing 11 and moves relative to the housing 11 under the action of external force.
  • the moving regulating tube 145 drives the driving bevel gear 141 to drive the first driven bevel gear 142 and the second driven bevel gear 143 for pulling and pulling. Release the traction wire 16, so that the driving mechanism 14 moves relative to the housing 11 under the action of an external force. When the driving mechanism 14 moves, it can pull and release the traction wire 16 to change the bending state of the sheath tube 13, and it can move relative to the housing under the action of no external force. 11 is static, that is, without the action of other external forces, the sheath tube 13 can be kept in the original bending state, and the effect of stopping at any time and stopping immediately when the hand is released is achieved when the bending is adjusted.
  • the limiting member 1451 protrudes from the outer peripheral surface of the adjusting tube 145, which can prevent the tube wall of the adjusting tube 145 from being abraded during the rotation of the adjusting tube 145 relative to the sleeve, and improve its service life.
  • the setting of the sleeve can also provide radial support for the adjustment tube 145 and enhance its radial force bearing function, so as to make up for the deficiency of the large radial stress of the driving mechanism 14 .
  • the adjusting tube 145 is provided with two limiters 1451, that is, the outer peripheral surface of the adjusting tube 145 is provided with two ring-shaped convex lines, and the inner wall of the housing 11 is provided with two ring-shaped protrusions. Shaped protruding strips correspond to the limiting ribs 113 that resist each other.
  • the two annular ribs can be located between the two limiting ribs 113.
  • the two limiting ribs 113 can also be located between the two rings. between the ridges (not shown in the figure).
  • only one stopper 1451 is provided on the adjustment tube 145, that is, an annular protruding line is provided on the outer peripheral surface of the adjustment tube 145, and the inner wall of the housing 11 is provided with a stopper 1451 for clamping the annular protrusion.
  • the two limiting ribs 113 of the convex line are provided.
  • two limit keys 181 for circumferentially limiting the sleeve are arranged symmetrically on the outer peripheral side of the sleeve, and the inner wall of the housing 11 is provided with support ribs that are opposed to the two limit keys 181 one by one ( (not shown in the figure), can limit the casing in the circumferential direction, and prevent the adjusting tube 145 from driving the casing to rotate when it rotates.
  • the embodiment of the present invention provides an adjustment component 15 for adjusting the driving mechanism 14 , and then can select and adjust the bending direction and bending angle of the sheath tube 13 .
  • the adjustable curved catheter 10 also includes an adjustment part 15 connected to the proximal end of the adjustment tube 145, the adjustment part 15 is at least partly exposed to the housing 11, the adjustment part 15 can specifically be a knob, and the adjustment part 15 drives the drive mechanism 14 to rotate . In this way, for complex lesion positions with twisted blood vessels and multiple openings, the bending direction and bending angle of the sheath tube 13 inside the body can be selected and adjusted by adjusting the adjusting member 15 outside the body, so as to realize bidirectional bending.
  • the adjustment member 15 and the adjustment tube 145 are connected by a key connection.
  • the proximal end of the adjustment tube 145 is provided with a connection key 1453
  • the position of the adjustment component 15 corresponding to the connection key 1453 is provided with a key groove 151
  • the connection key 1453 of the adjustment tube 145 is matched with the key groove 151 on the adjustment component 15 through a key.
  • the rotation of the adjustment member 15 drives the adjustment tube 145 to rotate, the adjustment tube 145 rotates and the driving bevel gear 141 rotates, thereby driving the first driven bevel gear 142 and the second driven bevel gear 143 on both sides to perform reverse rotation.
  • the traction wire is crimped and wound on the winding disk of the corresponding driven bevel gear. Since the first driven bevel gear 142 and the second driven bevel gear 143 do reverse rotation, one side of the traction wire is tightened, and the other The side pull wire is in a relaxed state, and the pull wire on one side can drive the bendable section 131 of the sheath tube 13 to bend to a predetermined angle in one direction by pulling the anchor ring 134 to achieve the purpose of bending on one side.
  • the adjustment member 15 is rotated in the opposite direction, the adjustment tube 145 is rotated in the opposite direction, the pulling wire on the originally tensioned side is loosened, and the pulling wire on the original loosening side is tightened, so as to achieve reverse bending adjustment.
  • the handle part of the adjustable curved catheter 10 of the present invention adopts a bevel gear meshing method, which can reduce the size of the handle and realize single-handed operation by the doctor.
  • the adjustable bend catheter 10 of the present invention can greatly simplify the doctor's operation steps and reduce the complexity of the operation, ensuring that the doctor can perform the bend adjustment of the sheath tube 13 with one hand, and at the same time, it can stop at any time and let go The effect of stopping, the precise control of the bending angle, the structure is stable and labor-saving, and the response speed is fast, which greatly reduces the delay of the bending.
  • the adjustable curved catheter 10 of the present invention takes into account the small size and the realization of one-handed operation, by properly regulating the diameter a of the winding disk of the driven bevel gear, the diameter b of the driven bevel gear, the diameter c of the driving bevel gear and adjusting
  • the diameter d of the component makes the final ratio of ac/bd 1:0.6 to 1:0.1, in other words, it means that the bending adjustment force required by the operator is greatly reduced, and the casing 11 can be used to the maximum extent in this ratio range
  • the internal space also makes the operation the most labor-saving and convenient for one-handed operation.
  • the proximal end of the adjustment tube 145 is connected to the adjustment component 15, and the distal end is connected to the driving bevel gear 141.
  • Silicone gasket 1452 is provided, and the stopper 18 abuts against the silicone washer 1452 and has an interference fit with it, that is, the stopper 18 is arranged between the adjustment part at the proximal end of the adjustable curved catheter 10 and the bevel gear meshing driving part at the far end , it can ensure that the adjustable bend catheter 10 can stop at any time during the bend adjustment process, and stop immediately after letting go.
  • this embodiment can make the bending adjustment of the adjustable bend catheter 10 more stable and the bending effect is better.
  • this embodiment can reduce the adjustable angle.
  • the length of the casing 11 of the catheter 10 greatly reduces the risk of dropping the casing 11 or even taking the sheath tube 13 out of the patient's body during the operation.
  • the adjustable curved catheter 10 also includes a limit mechanism 17, the limit mechanism 17 includes two limit stops 171 and at least one limit pin 172, the limit stop 171 and One of the limiting pins 172 is connected to the adjusting component 15 and rotates synchronously with the adjusting component 15 , and the other of the limiting stopper 171 and the limiting pin 172 remains stationary relative to the sheath tube 13 .
  • the two limit stops 171 define a rotation space r (as shown by the dotted line in FIG. 25 ), and the limit pin 172 rotates relative to the limit stop 171 in the rotation space r.
  • the limiting mechanism 17 further includes a limiting plate 173, which is arranged at a distance from the adjusting member 15, and the limiting plate 173 remains stationary relative to the sheath tube 13, and the limiting pin 172 is positioned at On the limiting plate 173 , two limiting blocks 171 are arranged on the adjusting component 15 and rotate synchronously with the adjusting component 15 .
  • the bending angle in the embodiment of the present invention is 0-210 degrees.
  • the limiting plate 173 is provided with two limiting pins 172, and the two limiting pins 172 can be symmetrically distributed on the limiting plate 173 by taking the short axis of the limiting plate 173 as a symmetrical axis. It can be asymmetrically distributed on the limiting plate 173 .
  • Embodiment 2 abuts against at least one side of the outer peripheral side of the adjusting tube 145 , and the abutting piece is in interference fit with the stop piece 18 .
  • the abutting piece abuts at least one side of the outer peripheral side of the limiting piece 1451 , and the embodiment of the present invention is described by taking the abutting piece separately disposed on both sides of the limiting piece 1451 as an example, which should not be construed as a limitation.
  • the moving regulating tube 145 drives the driving bevel gear 141 to drive the first driven bevel gear 142 and the second driven bevel gear 143 to pull and release the pulling wire 16 .
  • the drive mechanism 14 moves relative to the housing 11 under the action of an external force through the abutting fit between the abutment member and the stopper 1451, and the drive mechanism 14 can be pulled when moving. and release the pulling wire 16 to change the bending state of the sheath tube 13, and be stationary relative to the housing 11 under the action of no external force, that is, under the action of no other external force, the sheath tube 13 can be kept in the original bending state. It can achieve the effect of stopping at any time and stopping when you let go.
  • Embodiment 3 The same or similarities between Embodiment 3 and Embodiment 1 will not be repeated here.
  • the main difference between the two is that, as shown in FIG.
  • the sleeve is sleeved on the outer peripheral side of the slider 146 , the slider 146 can move axially relative to the sleeve, and the housing 11 is provided with a slot (not shown) for the slider 146 to slide.
  • a silicone ring 147 is embedded in the inner wall of the sleeve, and the sliding block 146 is in interference fit with the sleeve through the silicone ring 147 .
  • the pulling wire 16 is connected to the slider 146 , specifically to the distal end of the slider 146 .
  • a threading member 182 is set at the bottom of the sleeve, preferably a fixed ring or a rotating wheel, and the pulling wire 16 passes through the slide block 146 and the threading member 182 and is connected to the proximal end of the slide block 146.
  • the slider 146 when the slider 146 is moved axially, the slider 146 pulls and releases the traction wire 16 to change the bending state of the sheath tube 13, and under no external force, the slider 146 is stationary relative to the housing 11, that is, Without the action of other external forces, the sheath tube 13 can be kept in the original bending state, and the effect of stopping at any time and stopping immediately when the hand is released can be achieved when the bending is adjusted.
  • the driving mechanism 14 of Embodiment 4 includes two sliding blocks 146 that can slide relatively.
  • the stopper 18 is a sleeve, and the sleeve is sleeved on the outer peripheral side of the two sliders 146, and the two sliders 146 can move axially relative to the sleeve. slot (not shown).
  • a silicone ring 147 is embedded in the inner wall of the sleeve, and the two sliders 146 are in interference fit with the sleeve through the silicone ring 147 , and the two sliders 146 can be connected by guide rails and slide grooves.
  • the first pulling wire 161 is connected to a slider 146 , specifically to the distal end of the slider 146 .
  • a threader 182 is provided at the bottom of the sleeve, preferably a fixed ring or a rotating wheel, and the first pulling wire 161 is connected to the proximal end of the slider 146 after passing through the slider 146 and the threader 182 .
  • the second drawing wire 162 is connected to another slider 146 , and the connection method can be designed in the same way as the first drawing wire 161 , which will not be repeated here.
  • the two sliders 146 are independent of each other, and the two sliders 146 control the first pulling wire 161 and the second pulling wire 162 independently.
  • the slider 146 pulls and release the corresponding pulling wire to change the bending state of the sheath tube 13, and under the action of no external force, the slider 146 is stationary relative to the housing 11, that is, without the action of other external forces, the sheath tube 13 can maintain the original bending state, to achieve the effect of stopping at any time and stopping when you let go of your hands when adjusting the bend.
  • Embodiment 5 and Embodiment 3 will not be repeated here.
  • the main difference between the two is that, as shown in FIG.
  • the sleeve is sleeved on the outer peripheral side of the slider 146 , the slider 146 can move axially relative to the sleeve, and the housing 11 is provided with a slot (not shown) for the slider 146 to slide.
  • a silicone ring 147 is embedded in the inner wall of the sleeve, and the sliding block 146 is in interference fit with the sleeve through the silicone ring 147 .
  • One of the first pulling wire 161 and the second pulling wire 162 is connected with the far end of the slide block 146, and a threading member 182 is set at the bottom of the sleeve simultaneously, preferably a fixed ring or a rotating wheel, the first pulling wire 161 and the second pulling wire 162.
  • the other of the second pulling wire 162 is connected to the proximal end of the slider 146 after passing through the slider 146 and the threader 182 .
  • the slider 146 when the slider 146 is moved axially, when any one of the first pulling wire 161 and the second pulling wire 162 is pulled, the other pulling wire is released accordingly, and then the The sheath 13 performs bi-directional bending control. And under the action of no external force, the slider 146 is still relative to the housing 11, that is, without the action of other external forces, the sheath tube 13 can be kept in the original bending state, and the effect of stopping at any time and stopping when you let go .

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Abstract

一种可调弯导管（10），包括鞘管（13）、设于鞘管（13）近端处的壳体（11）、设于壳体（11）内的驱动机构（14）和止停件（18）、以及至少一牵引丝（16），牵引丝（16）的远端与鞘管（13）的远端相连，牵引丝（16）的近端伸入壳体（11）内并与驱动机构（14）连接，驱动机构（14）用于牵拉和释放牵引丝（16）以实现鞘管（13）的弯曲，止停件（18）与驱动机构（14）抵接并与之过盈配合，以使得驱动机构（14）在非外力作用下相对壳体（11）静止、以及在外力作用下相对壳体（11）运动，运动的驱动机构（14）在牵拉和释放牵引丝（16）的过程中改变鞘管（13）的弯曲状态。当鞘管（13）处于弯曲状态时，在没有其他外力的作用下，能够使得鞘管（13）保持原来的弯曲状态，无需设置额外的锁止结构，在进行调弯时达到随时停止、松手即停的效果。

Description

可调弯导管 技术领域
本发明涉及介入医疗器械技术领域，特别是涉及一种可调弯导管。
背景技术
血管腔内技术是借助于导管沿血管管腔运动到病变位置(如冠脉，颈动脉，腹腔干动脉，肾动脉等)，然后通过植入支架或药物或其它植入器械对体内病变进行微创治疗的新兴医疗方法，其中，导管是腔内手术建立体外至体内的工具，起到了至关重要的作用。由于各级外周血管如髂动脉、股动脉、颈总动脉、无名干及冠脉等与主动脉血管的开口位置多变性、复杂性，为准确定位带来一定的困难。大部分的导管头端，会针对靶病变位置的血管路径特点，预塑形成不同的弯曲形状，如翻山鞘、梭子鞘、折弯鞘等。但需治疗多处血管疾病或血管解剖复杂的疾病时，需要准备大量的导管，增加器械的消耗和手术时间。
为了解决上述问题，市面上出现了可调弯导管，可调弯导管的远端一段管体可调弯，可增加其适用性，避免需要手术过程中需要花费大量的时间选择导管的型号。
然而，目前市场上的可调弯导管在调弯时通常需要额外的锁止结构进行调弯固定，或者达到一定的限位角度才能停止，无法根据手术过程的实际情况进行按需调弯。
发明内容
基于此，本发明提供一种可调弯导管，以解决现有市场上的可调弯导管在 调弯时通常需要额外的锁止结构进行调弯固定，或者达到一定的限位角度才能停止，无法根据手术过程的实际情况进行按需调弯的问题。
本发明为解决上述技术问题，提出一种可调弯导管，包括鞘管、设于所述鞘管近端处的壳体、设于所述壳体内的驱动机构和止停件、以及至少一牵引丝，所述牵引丝的远端与所述鞘管的远端相连，所述牵引丝的近端伸入所述壳体内并与所述驱动机构连接，所述驱动机构用于牵拉和释放所述牵引丝以实现所述鞘管的弯曲，所述止停件与所述驱动机构抵接并与之过盈配合，以使得所述驱动机构在非外力作用下相对所述壳体静止、以及在外力作用下相对所述壳体运动，运动的所述驱动机构在牵拉和释放所述牵引丝的过程中改变所述鞘管的弯曲状态。
与现有技术相比，本发明所提供的一种可调弯导管具有如下的有益效果：
本发明提供的可调弯导管，通过将牵引丝的远端与鞘管的远端相连，牵引丝的近端伸入壳体内并与驱动机构连接，同时通过设置止停件与驱动机构抵接并与之过盈配合，使得驱动机构在外力作用下相对壳体运动，驱动机构运动时能够牵拉和释放牵引丝以改变鞘管的弯曲状态，以及在非外力作用下相对壳体静止，即在没有其他外力的作用下，能够使得鞘管保持原来的弯曲状态。在介入医疗器械领域中，医生在使用可调弯导管进行手术时，由于血管路径的复杂性，在进行鞘管的调弯时角度的精准控制就显得尤为重要。并且，医生在进行手术时，分秒必争，操作便捷性也很重要，如果需要额外的锁止结构来配合，一方面容易影响到已调整好的鞘管的角度，另一方面则需要多名医生配合，对配合的同步性也有要求。本发明的可调弯导管无需设置额外的锁止结构，能够在进行调弯时达到随时停止、松手即停的效果，精准控制调弯角度，节省医生进行手术的时间和提高操作便捷性。
附图说明
图1为本发明实施例一提供的可调弯导管的结构示意图；
图2为本发明实施例一提供的可调弯导管去掉鞘芯的结构示意图；
图3为本发明实施例一提供的可调弯导管去掉鞘芯和壳体的部分壳体后的示意图；
图4为本发明实施例一提供的可调弯导管的鞘芯的结构示意图；
图5为本发明实施例一提供的可调弯导管的鞘管的内部结构示意图；
图6为本发明实施例一提供的可调弯导管的第一显影环的结构示意图；
图7为本发明实施例一提供的可调弯导管的第一缺口的显影状态示意图；
图8为本发明实施例一提供的可调弯导管的第二缺口的显影状态示意图；
图9为本发明实施例一提供的可调弯导管的锚固环的结构示意图；
图10为本发明实施例一提供的可调弯导管的锚固环和牵引丝的组合示意图一；
图11为本发明实施例一提供的可调弯导管的锚固环和牵引丝的组合示意图二；
图12为本发明实施例一提供的可调弯导管的锚固环和牵引丝的组合示意图三；
图13为本发明实施例一提供的可调弯导管的锚固环和牵引丝的组合示意图四；
图14为本发明实施例一提供的可调弯导管的鞘管的变形实施例的示意图；
图15为本发明实施例一提供的可调弯导管的驱动机构与调节部件组装后的示意图；
图16为本发明实施例一提供的可调弯导管的调节管的结构示意图；
图17为本发明实施例一提供的可调弯导管的第一从动锥齿轮、第二从动锥齿轮与支撑架的组合示意图；
图18为本发明实施例一提供的可调弯导管的支撑架的结构示意图；
图19为本发明实施例一提供的可调弯导管的第一从动锥齿轮的结构示意图；
图20为本发明实施例一提供的可调弯导管的第一从动锥齿轮与罩套的组合示意图；
图21为本发明实施例一提供的可调弯导管的罩套的结构示意图；
图22为本发明实施例一提供的可调弯导管的调节管与套管的组合示意图；
图23为本发明实施例一提供的可调弯导管的调节部件的结构示意图一；
图24为本发明实施例一提供的可调弯导管的调节部件、限位板与限位销的组合示意图；
图25为本发明实施例一提供的可调弯导管的调节部件的结构示意图二；
图26为本发明实施例一提供的可调弯导管的限位板与限位销的组合示意图；
图27为本发明实施例二提供的可调弯导管的调节管与抵持件的组合示意图；
图28为本发明实施例三提供的可调弯导管的结构示意图；
图29为本发明实施例三提供的可调弯导管的结构示意图；
图30为本发明实施例三提供的可调弯导管的结构示意图。
附图标识说明：
10、可调弯导管；11、壳体；12、鞘芯；13、鞘管；14、驱动机构；15、调节部件；16、牵引丝；17、限位机构；18、止停件；19、第一显影环；20、第二显影环；
101、T型接头；102、软管；103、三通阀；111、防滑凸条；112、保护套；113、限位筋板；121、鞘芯管；122、鞘芯接头；131、可弯曲段；132、远端软段；133、近端硬段；134、锚固环；141、主动锥齿轮；142、第一从动锥齿轮；143、第二从动锥齿轮；144、支撑架；145、调节管；146、滑块；147、硅胶圈；151、键槽；161、第一牵引丝；162、第二牵引丝；171、限位挡块；172、限位销；173、限位板；181、限位键；182、穿丝件；191、第一缺口；192、第二缺口；
1311、弹簧结构；1331、编织网结构；1341、通槽；1342、隔板；1343、通孔；1344、过丝口；1421、齿轮部；1422、绕线盘；1423、罩套；1441、支撑环；1442、第一转轴；1443、第二转轴；1451、限位件；1452、硅胶垫圈；1453、连接键；
14221、绕线轮；14222、第一栏板；14223、第二栏板；14224、穿线口；14231、开口；
q、容置内腔；r、转动空间。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施方式。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施方式。相反地，提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。 本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。还需要说明的是，本实施例中的左、右、上、下等方位用语，仅是互为相对概念或是以产品的正常使用状态为参考的，而不应该认为是具有限制性的。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
在介入医疗器械领域，一般将植入人体或动物体内的医疗器械的距离操作者较近的一端称为“近端”，将距离操作者较远的一端称为“远端”，并依据此原理定义医疗器械的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向，“径向”一般是指医疗器械的与其“轴向”垂直的方向，并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
实施例一
参阅图1-图4，本发明实施例提供一种可调弯导管10，该可调弯导管10包括壳体11、鞘芯12、鞘管13、驱动机构14、止停件18及至少一牵引丝16，其中，鞘芯12内具有可供导丝穿过的内腔，鞘芯12收容于鞘管13内，鞘芯12的远端穿出鞘管13，壳体11设于鞘管13近端处，壳体11具有容置内腔q，驱动机构14和止停件18设于该容置内腔q内。牵引丝16的远端与鞘管13的远端相连，牵引丝16的近端伸入壳体11内并与驱动机构14连接，驱动机构14用于牵拉和释放牵引丝16以实现鞘管13的弯曲，止停件18与驱动机构14抵接并与之过盈配合，以使得驱动机构14在非外力作用下相对壳体11静止、以及在外力作用下相对壳体11运动，运动的驱动机构14在牵拉和释放牵引丝16 的过程中改变鞘管13的弯曲状态。
具体地，壳体11用于在操作时方便进行握持，壳体11同时可为驱动机构14等部件提供防护功能及安装支持功能，壳体11可以由上壳和下壳对接并形成容置内腔q，进一步地，在上下壳体的外表面上均可设置防滑凸条111，从而便于操作人员进行握持。进一步地，壳体11的内壁内可以设置多个加强筋(图未示)，加强筋的设置既可增强壳体11的强度，也可为壳体11的容置内腔q内的各部件提供安装支持功能。
进一步地，鞘管13的近端穿设于壳体11中，以便于在壳体11的容置内腔q内与驱动机构14进行连接。壳体11的远端与鞘管13对接的位置设置有保护套112，鞘管13自保护套112中穿出，该保护套112用于避免与该保护套112接触的鞘管13的部分的弯曲角度过大而折断。可选地，保护套112可以为硅胶保护套或橡胶保护套。
继续参阅图3，进一步地，可调弯导管10还包括T型接头101、软管102和三通阀103，T型接头101的一端与鞘管13连通，T型接头101的另一端通过软管102与三通阀103相连，可以通过注射器或者其他器械连接三通阀103向鞘管13中注入液体或者抽取体液。
具体地，如图4所示，鞘芯12包括鞘芯管121和设于鞘芯管121近端的鞘芯接头122，鞘芯接头122与鞘管13的近端螺纹连接，优选为半圈螺纹。相比于相关技术中将鞘芯与鞘管卡接的方式，本发明通过螺纹连接的方式能够承受更大的血流冲击力，防止鞘芯12在血流的冲击下脱离鞘管13。
可以理解，当牵引丝16的数量为1时，鞘管13可以实现单向调弯，当牵引丝16的数量大于1时，鞘管13可以实现多向调弯。为便于理解，本发明实施例以可调弯导管10包括两个牵引丝16为例进行描述，不应对本发明构成限 定。其中，这两个牵引丝16分别为第一牵引丝161和第二牵引丝162，且第一牵引丝161和第二牵引丝162位于鞘管13的周向不同的位置。
可以理解地，驱动机构14可对第一牵引丝161、第二牵引丝162进行牵拉和释放，驱动机构14牵拉第一牵引丝161、第二牵引丝162中的任意一个时，使得鞘管13朝向该被牵引的牵引丝的那一侧进行弯曲，与此同时，驱动机构14还同步使得另一个未被牵引的牵引丝随着鞘管13的弯曲而进行相应释放，例如，当驱动机构14牵拉第一牵引丝161使鞘管13的远端朝向第一牵引丝161所在一侧弯曲时，第二牵引丝162则随鞘管13的弯曲而进行长度的释放；当驱动机构14牵拉第二牵引丝162并带动鞘管13朝向第二牵引丝162所在一侧弯曲时，第一牵引丝161则随鞘管13的弯曲而进行长度的释放，这样，通过驱动机构14、第一牵引丝161、第二牵引丝162的相互配合使得鞘管13在可弯曲段131可进行两个方向的弯曲，从而可实现双向弯曲。通过设置具有可弯曲段131的鞘管13，及锚固于鞘管13的可弯曲段131上的第一牵引丝161和第二牵引丝162，并设置了驱动机构14用于对第一牵引丝161、第二牵引丝162进行牵拉和释放，该驱动机构14牵拉第一牵引丝161、第二牵引丝162中的任意一个牵引丝时，鞘管13朝向该被牵引的牵引丝的那一侧进行弯曲，与此同时，另一个牵引丝则进行同步释放，从而使得鞘管13在其可弯曲段131可分别朝鞘管13的至少两个方向进行双向弯曲，从而充分满足对于血管扭曲及血管开口位置多变等复杂病变位置进行介入治疗的需要，大大地降低了临床操作人员需要多次调整导管及更换导管的频率，从而使手术更易于操作，同时也降低了并发症产生的风险。
结合图3和图5，鞘管13包括可弯曲段131、远端软段132和近端硬段133，可弯曲段131位于远端软段132和近端硬段133之间，其中，近端硬段133位于鞘管13的近端，远端软段132位于鞘管13的远端，且可弯曲段131靠近鞘 管13的远端设置，这样，既能保证鞘管13在体内输送时具有一定的刚度从而减小与人体组织的触碰及剐蹭，同时，也能保证在病变组织需要建立弯曲输送通道时鞘管13在相应位置可进行弯曲的目的。
具体地，可弯曲段131为三层结构，内层为高分子材料，如聚四氟乙烯PTFE，中层为弹簧结构1311，外层为软体高分子材料，如聚醚嵌段聚酰胺PEBAX，优选为硬度35D的PEBAX。可弯曲段131采用三层结构并将中层设置为弹簧结构1311的方式，由于弹簧结构1311的抗折性更优，使得可弯曲段131可以调节更大的角度。
具体地，远端软段132为双层结构，内层为PTFE，外层为PEBAX，优选为硬度35D的PEBAX。远端软段132的设置，使得鞘管13在血管内能够减少对血管的伤害。
具体地，近端硬段133为三层结构，内层为PTFE，中层为编织网结构1331，外层为PEBAX，优选为硬度72D的PEBAX。近端硬段133采用三层结构并将中层设置为编织网结构1331的方式，由于编织网结构1331具有更好的柔顺性，使得近端硬段133在血管内有更好的顺应性。
可以理解，可弯曲段131和远端软段132的硬度小于近端硬段133，使得可弯曲段131弯曲时，不会带动远端软段132弯曲，从而更容易保持鞘管13的远端与靶位置同轴，实现精准释放。
结合图5-图8，具体地，鞘管13上设置有第一显影环19和第二显影环20，其中，第二显影环20设于近端硬段133的远端和可弯曲段131的近端的交界处，作为起始调弯点的显影识别，第一显影环19设于可弯曲段131的远端，作为鞘管13的调弯角度追踪的显影识别。本实施例中，由于近端硬段133具有编织网结构1331，将第二显影环20设于近端硬段133的远端和可弯曲段131的近端的 交界处，能够对近端硬段133的编织网结构1331起到压紧收缩的作用。
具体地，第一显影环19的相对两侧分别开设有第一缺口191和第二缺口192，第一缺口191和第二缺口192均为具有直角的L形缺口，且第一缺口191和第二缺口192大小不同和/或缺口朝向不同，即第一缺口191和第二缺口192之一设于第一显影环19的近端，另一设于第一显影环19的远端。通过采用立体显影的方式将第一缺口191和第二缺口192突显出来，当鞘管13朝向第一缺口191的方向调弯时，显影状态如图7所示，直角在医生的左手位，当鞘管13朝向第二缺口192的方向调弯时，显影状态如图8所示，直角在医生的右手位，同时由于第一缺口191和第二缺口192大小不同和/或缺口朝向不同，因此显影结果不同，医生据此能够准确辨别出鞘管13的调弯方向。当然，第一缺口191和第二缺口192也可以采用其他形状的缺口，只要满足在显影状态下第一缺口191和第二缺口192能够区分，使得医生能够准确辨别出鞘管13的调弯方向即可。
结合图3、图9和图10，具体地，鞘管13的侧壁内设置有穿设第一牵引丝161和第二牵引丝162的穿丝通道(图中未示出)，从而既能为第一牵引丝161和第二牵引丝162提供专门的移动通道，保证其顺畅移动，同时也能为其提供防护，避免受外界的干扰。
本实施例中，鞘管13的远端固定连接有锚固环134，本发明实施例中锚固环134固定在可弯曲段131上，第一牵引丝161和第二牵引丝162连接在锚固环134上。
作为一具体实施方式，锚固环134的外周侧壁上间隔开设有两个通槽1341，每个通槽1341内均设有一隔板1342，其中，第一牵引丝161从一通槽内的隔板的一侧穿入该通槽并从该隔板的另一侧穿出该通槽，第二牵引丝162从另一通槽内的隔板的一侧穿入通槽并从该隔板的另一侧穿出通槽。这样，第一牵引丝 161、第二牵引丝162就可在鞘管13的可弯曲段131的同一圆周的不同径向平面上引导鞘管13进行两个不同方向的弯曲。通过这样设置，能够减小第一牵引丝161和第二牵引丝162所受到的应力冲击，从而保证其与锚固环134连接的稳固性，也使得鞘管13能够承受更大的调弯力。同时，此种实施方式可避免牵引丝凸出于锚固环134的表面，从而极大地避免鞘管13加工热熔过程中出现漏丝或漏环的风险以及虚焊或过焊现象的发生。相关技术中也有将牵引丝对折后，将牵引丝从锚固环内穿到锚固环外，或者从锚固环外穿到锚固环内，进而实现锚固环和牵引丝的连接，此种方式的连接会导致在调弯过程中，锚固环受到牵引丝的剪切应力，由于剪切应力集中，会导致锚固环断开或者牵引丝断丝的风险，本实施例的锚固环和牵引丝的连接方式能够避免由于剪切应力集中导致的锚固环断开或者牵引丝断丝。
作为另一具体实施方式，参阅图11所示，锚固环134的侧壁上间隔开设有两个通孔1343，其中，第一牵引丝161从一通孔的一侧穿入并从另一侧穿出，第二牵引丝162从另一通孔的一侧穿入并从该通孔的另一侧穿出。这种方式穿丝工艺简单且成本交底，具有较大实用性。
作为又一具体实施方式，参阅图12所示，锚固环134的侧壁上间隔开设有四个通孔1343，其中，两个通孔1343为一组，第一牵引丝161的两端分别从其中一组的两个通孔1343从锚固环134外穿入锚固环134内，随后从锚固环134伸出，第二牵引丝162的两端分别从其中另一组的两个通孔1343从锚固环134外穿入锚固环134内，随后从锚固环134伸出。这种方式能够减小第一牵引丝161和第二牵引丝162所受到的应力冲击，从而保证其与锚固环134连接的稳固性，也使得鞘管13能够承受更大的调弯力。
作为再一具体实施方式，参阅图13所示，锚固环134的侧壁上间隔开设有 四个通孔1343，其中，两个通孔1343为一组，锚固环134对应每组的通孔1343开设有过丝口1344，第一牵引丝161的两端分别从其中一组的两个通孔1343从锚固环134外穿入锚固环134内，随后从该组对应的过丝口1344伸出，第二牵引丝162的两端分别从其中另一组的两个通孔1343从锚固环134外穿入锚固环134内，随后从该组对应的过丝口1344伸出。这种方式能够减小第一牵引丝161和第二牵引丝162所受到的应力冲击，从而保证其与锚固环134连接的稳固性，也使得鞘管13能够承受更大的调弯力。同时还能避免牵引丝在锚固环134内壁交叉导致的在对牵引丝进行牵拉时划破鞘管13的膜。
当然，第一牵引丝161和第二牵引丝162也可位于锚固环134的同一径向平面内，也即位于鞘管13的可弯曲段131的同一圆周的同一径向平面内(图未示出)。这样，第一牵引丝161、第二牵引丝162可在鞘管13的可弯曲段131的同一圆周进行两个方向完全相反的弯曲，从而可根据不同病人生理解剖结构的个体化差异，选择合适的导管，并可调整鞘管13的可弯曲段131的弯曲曲率，如小弯、中弯、大弯，以适应不同人体的需求，减少穿刺次数及对人体的损伤，简化手术过程及缩短手术时间。
作为另一替代实施例，参见图14，还可在鞘管13的可弯曲段131上设置两个间隔设置的锚固环134，第一牵引丝161、第二牵引丝162分别锚固于这两个锚固环134上，这样，第一牵引丝161、第二牵引丝162可在鞘管13的可弯曲段131的不同周向的径向方向上牵拉鞘管13进行两个不同方向的弯曲，亦可满足临床需求，此种结构尤其适用于在主血管通道不同部段具有分叉支血管的情形。
结合图3、图15和图16，具体地，驱动机构14包括主动件和从动件，主动件和从动件锥齿轮连接，牵引丝16的近端与从动件连接，主动件带动从动件 牵拉和释放牵引丝16。其中，驱动机构14包括至少一从动件且从动件与牵引丝16一一对应；主动件为主动锥齿轮141，从动件为与主动锥齿轮141啮合设置的从动锥齿轮，从动锥齿轮与对应的牵引丝相连，主动锥齿轮141带动从动锥齿轮对与之相连的牵引丝进行牵拉和释放。
本发明实施例中，主动件为主动锥齿轮141，从动件包括与主动件联动的第一从动件(本实施例中第一从动件为第一从动锥齿轮142)以及与主动件联动的第二从动件(本实施例中第二从动件为第二从动锥齿轮143)，第一从动锥齿轮142与第一牵引丝161相连，第二从动锥齿轮143与第二牵引丝162相连，主动锥齿轮141驱动第一从动锥齿轮142、第二从动锥齿轮143中的任一个对与之相连的牵引丝进行牵拉，并同步驱动第一从动锥齿轮142、第二从动锥齿轮143中的另外之一对与之相连的牵引丝进行释放，从而可实现双向调弯。需要说明的是，在其他实施例中，主动件还可以是蜗杆，第一从动件可以是与蜗杆啮合的蜗轮，第二从动件可以是与蜗杆啮合的另一蜗轮。
作为一具体实施方式，主动锥齿轮141与鞘管13为同轴设置，第一从动锥齿轮142、第二从动锥齿轮143均与主动锥齿轮141啮合设置，第一从动锥齿轮142与第一牵引丝161连接，第二从动锥齿轮143与第二牵引丝162相连接，在本发明的实施例中，第一从动锥齿轮142、第二从动锥齿轮143关于主动锥齿轮141的至少一个轴向平面对称设置，即第一从动锥齿轮142、第二从动锥齿轮143位于主动锥齿轮141的周向不同位置，这样，可使得主动锥齿轮141、第一从动锥齿轮142、第二从动锥齿轮143之间具有较稳定的结构稳定性及较平稳的传动性，同时，也能保证第一从动锥齿轮142、第二从动锥齿轮143分别同步驱动第一牵引丝161、第二牵引丝162进行收容或释放，当主动锥齿轮141驱动第一从动锥齿轮142、第二从动锥齿轮143中的任一个转动时，相应地对与之相连的牵 引丝进行牵拉时，可同步驱动第一从动锥齿轮142、第二从动锥齿轮143中的另一个从动锥齿轮转动，并对与该另一个从动锥齿轮相连接的牵引丝进行相应释放。这样，即可通过主动锥齿轮141、第一从动锥齿轮142、第二从动锥齿轮143、第一牵引丝161、第二牵引丝162的相互配合和联动，从而既能实现鞘管13的双向弯曲，还能对第一牵引丝161、第二牵引丝162进行同步收容和释放。
更具体地，第一从动锥齿轮142的转动中心轴线与第二从动锥齿轮143的转动中心轴线同轴设置，且第一从动锥齿轮142和第二从动锥齿轮143的转动中心轴线均垂直于主动锥齿轮141的中轴线。这样，第一从动锥齿轮142、第二从动锥齿轮143在径向方向上施加给主动锥齿轮141的径向应力将更为均衡，从而使得整个锥齿轮传动系统结构更稳固，力的传递也更为均衡，使得第一牵引丝161、第二牵引丝162在进行牵拉和释放时同步性也将更好。
本实施例中，由于第一从动锥齿轮142、第二从动锥齿轮143均与主动锥齿轮141啮合，当主动锥齿轮141驱动第一从动锥齿轮142、第二从动锥齿轮143同时转动时，第一从动锥齿轮142、第二从动锥齿轮143的转动方向将相反，此时，将第一牵引丝161按逆时针方向缠绕于第一从动锥齿轮142上，将第二牵引丝162亦按逆时针方向缠绕于第二从动锥齿轮143上，即第一牵引丝161、第二牵引丝162的缠绕方向相同(即都按顺时针方向缠绕，或者都按逆时针方向缠绕)，可实现通过主动锥齿轮141的驱动，第一牵引丝161在进行牵拉时，第二牵引丝162则进行释放，反之亦然。此时，通过一个锥齿轮、两个从动锥齿轮即可实现对第一牵引丝161、第二牵引丝162的同步控制，其结构紧凑，占据空间较小，可较好的满足医疗器械既要实现精准控制，且体积不宜过大而不便于操控的要求。当然，在其他实施例中，第一从动锥齿轮142、第二从动锥齿轮143的转动方向相同，第一牵引丝161和第二牵引丝162的缠绕方向相反， 例如，第一牵引丝161与第二牵引丝162其中之一按照顺时针方向缠绕，第一牵引丝161与第二牵引丝162其中之另一按照逆时针方向缠绕。
参见图17和图18，进一步地，驱动机构14还包括支撑架144，其中，支撑架144包括支撑环1441、第一转轴1442、第二转轴1443，第一转轴1442、第二转轴1443均与支撑环1441固定连接，第一转轴1442与第二转轴1443为同轴设置，且第一转轴1442和第二转轴1443位于鞘管13的同一径向平面内，其中，第一转轴1442与第一从动锥齿轮142的中心部位转动连接，第二转轴1443与第二从动锥齿轮143的中心部位转动连接，主动锥齿轮141的中轴线穿过支撑架144的支撑环1441的中心。这样，可在结构上保证第一从动锥齿轮142、第二从动锥齿轮143的中轴线始终在同一中轴线上，从而使得第一牵引丝161、第二牵引丝162尽可能的保持同步运动。作为一实施方式，支撑架144可采用刚性较好的金属材料制成，从而可较好的承受第一从动锥齿轮142和第二从动锥齿轮143较大的径向应力。具体实施时，第一转轴1442与第一从动锥齿轮142可转动接触的表面为较光滑的表面，第二转轴1443与第二从动锥齿轮143可转动接触的表面亦为较光滑的表面。此处“光滑的表面”是指粗糙度不超过6.4Ra，第一转轴1442与第一从动锥齿轮142转动接触面、第二转轴1443与第二从动锥齿轮143转动接触面的粗糙度较低，需较好的降低接触面之间的摩擦力，使得第一转轴1442、第二转轴1443均可相对顺畅的转动，从而使得驱动其转动的驱动力较小，以达到省时省力的目的，同时也可提高驱动机构14整体的可靠性。
作为驱动机构14的替代实施例，驱动机构14还可设置为采用两组锥齿轮组件分别对第一牵引丝161、第二牵引丝162进行控制的形式。具体地，本实施例中主动件包括第一主动锥齿轮和第二主动锥齿轮，第一主动锥齿轮与第二主动锥齿轮为同轴设置，但为反向设置，第一主动锥齿轮与第一从动锥齿轮142 啮合设置，第二主动锥齿轮与第二从动锥齿轮143啮合设置，当第一主动锥齿轮与第二主动锥齿轮转动时，其转动方向相同，根据锥齿轮副的转向传动规则，其分别驱动的第一从动锥齿轮142、第二从动锥齿轮143转动方向亦相同，此时将第一牵引丝161与第一从动锥齿轮142的缠绕方向、第二牵引丝162与第二从动锥齿轮143的缠绕方向分别往互为相反的方向缠绕，亦可实现对第一牵引丝161、第二牵引丝162中的任一牵引丝进行牵拉时，另一牵引丝则进行相应释放，继而对鞘管13进行双向弯曲控制。
参阅图19-图21，具体地，第一从动锥齿轮142包括与主动锥齿轮141啮合的齿轮部1421及与齿轮部1421连接的绕线盘1422，第一牵引丝161的近端端部固定连接于该绕线盘1422上，具体地，绕线盘1422包括呈圆筒状的绕线轮14221及凸设于绕线轮14221的外表面的第一栏板14222和第二栏板14223，第一栏板14222和第二栏板14223间隔设置，第一牵引丝161可缠绕于绕线轮14221上，即第一栏板14222和第二栏板14223中间的部位，绕线盘1422上开设有供牵引丝穿设的穿线口14224。当第一从动锥齿轮142转动时，将带动固定连接于绕线盘1422上的第一牵引丝161环绕绕线盘1422进行回收或放松，从而实现第一牵引丝161的收容与释放。
可以理解地，第二从动锥齿轮143的具体结构及第二牵引丝162与第二从动锥齿轮143的连接关系均可参照第一从动锥齿轮142的结构而进行相同设计，在此不予赘述。
进一步地，绕线盘1422上套设有用于限位第一牵引丝161的罩套1423，罩套1423上设置有供第一牵引丝161穿设的开口14231，更具体地，罩套1423套设于绕线盘1422的绕线轮14221上，并与绕线盘1422围合形成一供所述第一牵引丝161缠绕的独立空间。罩套1423的设置，可将第一牵引丝161限制在绕 线盘1422与罩套1423围合的独立空间内活动，从而避免第一牵引丝161在放松状态的时候，偏离绕线盘1422跳脱而误绕于其它部件上造成卡丝的情况。
可以理解地，可在第二从动锥齿轮143上亦设置相应的罩套来避免第二牵引丝162发生卡丝的情况，在此不作赘述。
结合图3和图22，具体地，驱动机构14包括调节管145，调节管145的远端与主动锥齿轮141连接，鞘管13穿设于调节管145内，在调节管145上套设硅胶垫圈1452，止停件18与硅胶垫圈1452抵接并过盈配合，进而使得套管与硅胶垫圈1452之间的摩擦力加大，在没有其他外力的作用下，使得鞘管13能够长时间保持原来的弯曲状态。在介入医疗器械领域中，医生在使用可调弯导管10进行手术时，由于血管路径的复杂性，在进行鞘管13的调弯时角度的精准控制就显得尤为重要。并且，医生在进行手术时，分秒必争，操作便捷性也很重要，如果需要额外的锁止结构来配合，一方面容易影响到已调整好的鞘管的角度，另一方面则需要多名医生配合，对配合的同步性也有要求。本发明的可调弯导管10无需设置额外的锁止结构，能够在进行调弯时达到随时停止、松手即停的效果，精准控制调弯角度，节省医生进行手术的时间和提高操作便捷性。
进一步地，调节管145上设置有至少一限位件1451，限位件1451为凸出于调节管145的外周面的环状凸条，硅胶垫圈1452套设在该环状凸条上，止停件18通过与硅胶垫圈1452抵接并与之过盈配合使得调节管145在非外力作用下相对壳体11静止、以及在外力作用下相对壳体11运动，运动的调节管145带动主动锥齿轮141驱动第一从动锥齿轮142和第二从动锥齿轮143进行牵拉和释放牵引丝16。本实施例中止停件18为套设于限位件1451外周侧的套管，套管转动套设于硅胶垫圈1452上并与硅胶垫圈1452抵接且与之过盈配合。优选地， 限位件1451一体成型于调节管145。
作为另一替代实施方式，限位件1451为凸出于调节管145的外周面的球状体，止停件18抵接该球状体且相对壳体11保持静止，该球状体与止停件18过盈配合。止停件18通过与该球状体抵接使得调节管145在非外力作用下相对壳体11静止、以及在外力作用下相对壳体11运动，运动的调节管145带动主动锥齿轮141驱动第一从动锥齿轮142和第二从动锥齿轮143进行牵拉和释放牵引丝16。优选地，限位件1451一体成型于调节管145。
本发明实施例中，主动锥齿轮141一体成型于调节管145的远端处。
本发明提供的可调弯导管10，其通过在调节管145上设置有至少一限位件1451，限位件1451凸出于调节管145的外周面，在限位件1451上套设硅胶垫圈1452，同时在硅胶垫圈1452上套设套管，其中调节管145内穿设有鞘管13，套管相对壳体11保持静止，套管与硅胶垫圈1452过盈配合，使得调节管145在非外力作用下相对壳体11静止、以及在外力作用下相对壳体11运动，运动的调节管145带动主动锥齿轮141驱动第一从动锥齿轮142和第二从动锥齿轮143进行牵拉和释放牵引丝16，使得驱动机构14在外力作用下相对壳体11运动，驱动机构14运动时能够牵拉和释放牵引丝16以改变鞘管13的弯曲状态，以及在非外力作用下相对壳体11静止，即在没有其他外力的作用下，能够使得鞘管13保持原来的弯曲状态，在进行调弯时达到随时停止、松手即停的效果。此外，限位件1451凸出于调节管145的外周面，能够避免调节管145相对套管转动的过程中对调节管145的管壁的磨损，提高其使用寿命。此外，套管的设置，还能够给调节管145提供径向支撑的作用，增强其径向受力功能，以弥驱动机构14传动径向应力较大的不足。
作为一具体实施方式，本实施例中，调节管145上设置有两限位件1451， 也即调节管145外周面上设置有两环状凸条，壳体11的内壁上设置有与两环状凸条一一对应相抵持的限位筋板113，作为一具体实施方式，两环状凸条可位于两限位筋板113之间，当然，两限位筋板113也可位于两环状凸条之间(图中未示出)。通过这样的设置方式，使得环状凸条与限位筋板113的配合对调节管145在轴向方向上的前进和后退均进行限位与定位。
作为另一替代实施方式，调节管145上仅设置有一限位件1451，也即调节管145外周面上设置有一环状凸条，壳体11的内壁上设置有与用于夹持该环状凸条的两限位筋板113。通过这样的设置方式，使得环状凸条与限位筋板113的配合对调节管145在轴向方向上的前进和后退均进行限位与定位。
进一步地，套管的外周侧对称设置有用于对套管进行周向限位的两限位键181，壳体11的内壁上设置有与两限位键181一一对应相抵持的支撑肋(图中未示出)，能够对套管在周向方向上进行限位，避免调节管145在转动时带动套管转动。
结合图3、图15、图22和图23，本发明实施例提供调节部件15用于对驱动机构14进行调节，进而可对鞘管13的弯曲方向及弯曲角度进行选择及调节。进一步地，可调弯导管10还包括与调节管145的近端连接的调节部件15，调节部件15至少部分外露与壳体11，调节部件15具体可为旋钮，调节部件15驱动驱动机构14转动。这样，对于血管扭曲及血管多开口的复杂病变位置，通过在体外调节调节部件15，即可对在体内的鞘管13的弯曲方向及弯曲角度进行选择及调节，实现双向弯曲。
具体地，调节部件15和调节管145通过键连接的方式进行连接。作为一具体实施方式，调节管145近端设置有连接键1453，调节部件15对应连接键1453的位置开设有键槽151，调节管145的连接键1453与调节部件15上的键槽151 通过键配合，以实现调节管145的周向固定和传递转矩。通过旋转调节部件15带动调节管145旋转，调节管145转动进而主动锥齿轮141转动，从而带动两侧的第一从动锥齿轮142和第二从动锥齿轮143做反向旋转运动。牵引丝压接并绕在对应的从动锥齿轮的绕线盘上，由于第一从动锥齿轮142和第二从动锥齿轮143做反向旋转运动，一侧牵引丝拉紧，另一侧牵引丝则处于放松状态，一侧牵引丝即可通过牵拉锚固环134来带动鞘管13的可弯曲段131向一个方向调弯至预定角度，达到一侧调弯的目的。将调节部件15反向旋转，调节管145逆向旋转，原拉紧侧牵引丝放松，原放松侧牵引丝拉紧，从而达到反向调弯。
优选地，相比相关技术中非锥齿轮啮合的方式，本发明的可调弯导管10，手柄部分采用锥齿轮啮合的方式，能够减少手柄尺寸，实现医生单手操作，在需要进行鞘管13调弯的手术中，本发明的可调弯导管10能够大程度简化医生操作步骤和降低操作复杂性，保证医生单手即可进行鞘管13的调弯，同时又能达到随时停止、松手即停的效果，精准控制调弯角度，结构稳定而且省力，同时反应速度快，极大地降低了调弯延迟。
本发明的可调弯导管10在兼顾小巧和实现单手操作的情况，通过适当调控从动锥齿轮的绕线盘的直径a、从动锥齿轮的直径b、主动锥齿轮的直径c和调节部件的直径d，使得ac/bd的最终比例为1:0.6～1:0.1，换言之意味着操作者使用时所需要的调弯力被大大降低了，该比例范围下能够最大限度利用壳体11内部的空间，同时也使得操作最为省力，便于单手操作。
综上，本发明提供的可调弯导管10，调节管145的近端与调节部件15连接，远端与主动锥齿轮141连接，调节管145上设置限位件1451，限位件1451上套设硅胶垫圈1452，止停件18与硅胶垫圈1452抵接并与之过盈配合，即将止停件18设置在可调弯导管10近端的调节部分和远端的锥齿轮啮合驱动部分之间， 能够保证可调弯导管10在调弯过程中达到随时停止、松手即停的效果。同时，相比于相关技术将止停的结构设置于调节部件15近端(即壳体11近端)，本实施例能够使得可调弯导管10的调弯更加稳定，调弯效果更好。同时，相比于相关技术采用自锁螺纹形式，在调节角度时需要更多的行程，导致手柄尺寸更长，在手术过程中，会带来更高的风险，本实施例能够减少可调弯导管10的壳体11的长度，极大地减少手术过程中带来的如壳体11掉落甚至将鞘管13从患者体内带出的风险。
进一步地，结合图3、图24-图26，可调弯导管10还包括限位机构17，限位机构17包括两限位挡块171和至少一限位销172，限位挡块171和限位销172其中之一与调节部件15相连且与调节部件15同步转动，限位挡块171和限位销172其中之另一相对鞘管13保持静止。两限位挡块171界定一转动空间r(如图25中虚线所示)，限位销172在转动空间r内相对限位挡块171转动。
具体地，在本实施例中，限位机构17还包括限位板173，限位板173与调节部件15相对间隔设置，且限位板173相对鞘管13保持静止，限位销172定位在限位板173上，两限位挡块171设置在调节部件15上并与调节部件15同步转动。
优选地，本发明实施例中调弯角度为0-210度。
在本发明实施例中，限位板173上设有两个限位销172，两个限位销172可以限位板173的短轴为对称轴，可对称分布在限位板173上，也可不对称的分布在限位板173上。当对称分布在限位板173上，调节部件15上的限位挡块171旋转到与限位板173上的限位销172接触时，调节部件15被限位，停止转动，反向同理，两侧限位销172对称分布，双向调弯角度相同；当限位销172不对称分布在限位板173上时，调节部件15上的限位挡块171旋转到与一侧限位板 173上的限位销172接触时，调节部件15被限位，停止转动，反向同理。
实施例二
实施例二与实施例一的相同或相似之处在此不再赘述，两者的主要区别在于，如图27所示，实施例二中的止停件18为设置于壳体11内壁上并抵接调节管145的外周侧至少一侧的抵持件，抵持件与止停件18过盈配合。
进一步地，抵持件抵接限位件1451的外周侧的至少一侧，本发明实施例以该抵持件分设于限位件1451两侧为例进行描述，不应对此构成限定。当调节管145置于壳体11的容置内腔q内时，抵持件对限位件1451进行夹持，使得调节管145在非外力作用下相对壳体11静止、以及在外力作用下相对壳体11运动，运动的调节管145带动主动锥齿轮141驱动第一从动锥齿轮142和第二从动锥齿轮143进行牵拉和释放牵引丝16。
本发明实施例提供的可调弯导管10，通过抵持件与限位件1451之间的抵接配合，使得驱动机构14在外力作用下相对壳体11运动，驱动机构14运动时能够牵拉和释放牵引丝16以改变鞘管13的弯曲状态，以及在非外力作用下相对壳体11静止，即在没有其他外力的作用下，能够使得鞘管13保持原来的弯曲状态，在进行调弯时达到随时停止、松手即停的效果。
实施例三
实施例三与实施例一的相同或相似之处在此不再赘述，两者的主要区别在于，如图28所示，实施例三的驱动机构14包括一个滑块146，止停件18为套筒，套筒套设于滑块146的外周侧，滑块146可相对套筒轴向运动，壳体11上开设有供滑块146滑动的槽位(未图示)。
具体地，套筒内壁嵌设有硅胶圈147，滑块146通过硅胶圈147与套筒过盈配合。牵引丝16与滑块146连接，具体为与滑块146的远端连接。或者在套筒 的筒底设置穿丝件182，优选为固定环或转动轮，牵引丝16穿过滑块146和穿丝件182后与滑块146的近端连接。
本实施例中，当轴向移动滑块146时，滑块146牵拉和释放牵引丝16以改变鞘管13的弯曲状态，以及在非外力作用下，滑块146相对壳体11静止，即在没有其他外力的作用下，能够使得鞘管13保持原来的弯曲状态，在进行调弯时达到随时停止、松手即停的效果。
实施例四
实施例四与实施例三的相同或相似之处在此不再赘述，两者的主要区别在于，如图29所示，实施例四的驱动机构14包括可相对滑动的两个滑块146，止停件18为套筒，套筒套设于两个滑块146的外周侧，两个滑块146均可相对套筒轴向运动，壳体11上开设有供两个滑块146滑动的槽位(未图示)。
具体地，套筒内壁嵌设有硅胶圈147，两个滑块146通过硅胶圈147与套筒过盈配合，两个滑块146之间可通过导轨和滑槽连接。第一牵引丝161与一滑块146连接，具体为与滑块146的远端连接。或者在套筒的筒底设置穿丝件182，优选为固定环或转动轮，第一牵引丝161穿过滑块146和穿丝件182后与滑块146的近端连接。第二牵引丝162与另一滑块146连接，连接方式均可参照第一牵引丝161进行相同设计，在此不予赘述。
本实施例中，两个滑块146彼此独立，两个滑块146对第一牵引丝161和第二牵引丝162单独控制，当轴向移动任一滑块146时，该滑块146牵拉和释放对应的牵引丝以改变鞘管13的弯曲状态，以及在非外力作用下，该滑块146相对壳体11静止，即在没有其他外力的作用下，能够使得鞘管13保持原来的弯曲状态，在进行调弯时达到随时停止、松手即停的效果。
实施例五
实施例五与实施例三的相同或相似之处在此不再赘述，两者的主要区别在于，如图30所示，实施例五的驱动机构14包括一个滑块146，止停件18为套筒，套筒套设于滑块146的外周侧，滑块146可相对套筒轴向运动，壳体11上开设有供滑块146滑动的槽位(未图示)。
具体地，套筒内壁嵌设有硅胶圈147，滑块146通过硅胶圈147与套筒过盈配合。第一牵引丝161和第二牵引丝162其中之一与滑块146的远端连接，同时在套筒的筒底设置穿丝件182，优选为固定环或转动轮，第一牵引丝161和第二牵引丝162其中另一穿过滑块146和穿丝件182后与滑块146的近端连接。
本实施例中，当轴向移动滑块146时，可实现对第一牵引丝161、第二牵引丝162中的任一牵引丝进行牵拉时，另一牵引丝则进行相应释放，继而对鞘管13进行双向弯曲控制。以及在非外力作用下，滑块146相对壳体11静止，即在没有其他外力的作用下，能够使得鞘管13保持原来的弯曲状态，在进行调弯时达到随时停止、松手即停的效果。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (16)

  1. 一种可调弯导管，其特征在于：包括鞘管、设于所述鞘管近端处的壳体、设于所述壳体内的驱动机构和止停件、以及至少一牵引丝，所述牵引丝的远端与所述鞘管的远端相连，所述牵引丝的近端伸入所述壳体内并与所述驱动机构连接，所述驱动机构用于牵拉和释放所述牵引丝以实现所述鞘管的弯曲，所述止停件与所述驱动机构抵接并与之过盈配合，以使得所述驱动机构在非外力作用下相对所述壳体静止、以及在外力作用下相对所述壳体运动，运动的所述驱动机构在牵拉和释放所述牵引丝的过程中改变所述鞘管的弯曲状态。
  2. 根据权利要求1所述的可调弯导管，其特征在于：所述驱动机构包括主动件和从动件，所述主动件和所述从动件锥齿轮连接，所述牵引丝的近端与所述从动件连接，所述主动件带动所述从动件牵拉和释放所述牵引丝。
  3. 根据权利要求2所述的可调弯导管，其特征在于：所述驱动机构包括至少一从动件且所述从动件与所述牵引丝一一对应；
    所述主动件为主动锥齿轮，所述从动件为与所述主动锥齿轮啮合设置的从动锥齿轮，所述从动锥齿轮与对应的牵引丝相连，所述主动锥齿轮带动所述从动锥齿轮对与之相连的牵引丝进行牵拉和释放。
  4. 根据权利要求3所述的可调弯导管，其特征在于：所述从动锥齿轮包括与主动锥齿轮啮合的齿轮部及与所述齿轮部连接的绕线盘，所述牵引丝缠绕于所述绕线盘上，所述主动锥齿轮带动所述齿轮部对缠绕于所述绕线盘上的牵引丝进行牵拉和释放。
  5. 根据权利要求4所述的可调弯导管，其特征在于：所述从动锥齿轮还包括罩套，所述罩套套设于所述绕线盘上并与绕线盘围合形成一供所述牵引丝缠绕的独立空间，所述罩套上开设有供所述牵引丝穿设的开口。
  6. 根据权利要求2所述的可调弯导管，其特征在于：所述驱动机构还包括 调节管，所述调节管的远端与所述主动件相连，所述调节管上设置有至少一限位件，所述限位件凸出于所述调节管的外周面，所述限位件上套设有硅胶垫圈，所述止停件通过所述硅胶垫圈与所述限位件过盈配合。
  7. 根据权利要求6所述的可调弯导管，其特征在于：所述可调弯导管还包括与所述调节管的近端连接的调节部件，所述调节部件至少部分外露于所述壳体，所述调节部件驱动所述调节管相对所述壳体运动。
  8. 根据权利要求7所述的可调弯导管，其特征在于：所述可调弯导管还包括限位机构，所述限位机构包括两限位挡块和至少一限位销，所述限位挡块和所述限位销其中之一与所述调节部件相连且与所述调节部件同步运动，所述限位挡块和所述限位销其中之另一相对所述壳体保持静止；
    两所述限位挡块界定一转动空间，所述限位销在所述转动空间内相对所述限位挡块运动。
  9. 根据权利要求1所述的可调弯导管，其特征在于：所述驱动机构包括至少一个滑块，所述止停件套设于所述滑块的外周侧，所述滑块可相对所述止停件轴向运动，所述止停件内壁嵌设有硅胶圈，所述滑块通过所述硅胶圈与所述止停件过盈配合。
  10. 根据权利要求1-9任一项所述的可调弯导管，其特征在于：所述鞘管的远端固定连接有锚固环，所述锚固环的外周侧壁上开设有通槽，所述通槽内设有一隔板，所述牵引丝从所述隔板的一侧穿入所述通槽并从所述隔板的另一侧穿出所述通槽。
  11. 根据权利要求1-9任一项所述的可调弯导管，其特征在于：所述鞘管的远端固定连接有锚固环，所述锚固环的侧壁上开设有通孔和过丝口，所述牵引丝穿过所述通孔后从过丝口伸出。
  12. 根据权利要求1-9任一项所述的可调弯导管，其特征在于：所述鞘管包括远端软段、可弯曲段和近端硬段，所述可弯曲段位于所述远端软段与所述近端硬段之间。
  13. 根据权利要求12所述的可调弯导管，其特征在于：所述鞘管上设有第一显影环和第二显影环，所述第一显影环设于所述可弯曲段的远端，所述第二显影环设于所述近端硬段的远端和所述可弯曲段的近端之间。
  14. 根据权利要求13所述的可调弯导管，其特征在于：所述第一显影环的相对两侧分别开设有第一缺口和第二缺口，所述第一缺口和所述第二缺口的大小不同和/或缺口朝向不同。
  15. 根据权利要求12所述的可调弯导管，其特征在于：所述可弯曲段为三层结构，内层为PTFE，中层为弹簧结构，外层为PEBAX；
    和/或，所述远端软段为双层结构，内层为PTFE，外层为PEBAX；
    和/或，所述近端硬段为三层结构，内层为PTFE，中层为编织网结构，外层为PEBAX。
  16. 根据权利要求1-9任一项所述的可调弯导管，其特征在于：所述可调弯导管还包括鞘芯，所述鞘芯的近端与所述鞘管的近端螺纹连接并收容于所述鞘管内，所述鞘芯的远端穿出所述鞘管。
PCT/CN2022/137948 2021-12-30 2022-12-09 可调弯导管 WO2023124904A1 (zh)

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