WO2020134219A1 - 可调弯导管 - Google Patents

可调弯导管 Download PDF

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Publication number
WO2020134219A1
WO2020134219A1 PCT/CN2019/106738 CN2019106738W WO2020134219A1 WO 2020134219 A1 WO2020134219 A1 WO 2020134219A1 CN 2019106738 W CN2019106738 W CN 2019106738W WO 2020134219 A1 WO2020134219 A1 WO 2020134219A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
protective sleeve
proximal end
bending
adjustable
Prior art date
Application number
PCT/CN2019/106738
Other languages
English (en)
French (fr)
Inventor
张庭超
蒋权杰
黄桥
Original Assignee
杭州唯强医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201811653891.5A external-priority patent/CN111375120A/zh
Priority claimed from CN201822272379.8U external-priority patent/CN209885000U/zh
Application filed by 杭州唯强医疗科技有限公司 filed Critical 杭州唯强医疗科技有限公司
Priority to EP19901652.8A priority Critical patent/EP3903872A4/en
Publication of WO2020134219A1 publication Critical patent/WO2020134219A1/zh
Priority to US17/355,666 priority patent/US20210316112A1/en

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Classifications

    • 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
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Definitions

  • the invention relates to the technical field of medical equipment, in particular to an adjustable curved catheter.
  • interventional surgery has less damage to the human body and can effectively shorten the operation time, it is a medical technology that has rapidly emerged and popularized in recent years.
  • catheters are mainly used to establish a channel between human blood vessels and the outside world for delivery Diagnostic and/or therapeutic equipment.
  • adjustable curved catheters In order to adapt to the individual differences in human anatomy and anatomy, adjustable curved catheters have been widely used.
  • the adjustable bending catheter is to set an adjustable bending section at the distal end of the tube body of the catheter, and the traction wire connected to the adjustable bending section is driven to move in the axial direction by manipulating the handle of the catheter, so that the distal end of the tube body repeatedly bends between different angles.
  • the bending angle conforms to the specific physiological structural characteristics of the human lumen, then lock the bending angle, align the distal end of the tube with the target lumen entrance (such as a certain blood vessel), and then deliver the diagnostic and/or therapeutic instruments through the tube to the target Lumen.
  • the existing adjustable bending catheter usually sets the pulling wire in the threading tube 320, and the threading tube 320 is mostly embedded in the tube wall of the tube body 1000, and the proximal end is from the tube of the tube body 1000
  • the proximal end of the pulling wire 310 passes through the threading tube 320 and is connected to the slider 2210 in the handle.
  • the movement of the slider 2210 drives the pulling wire 310 to move in the axial direction, thereby driving the tube 1000 far
  • the adjustable bend at the end is bent.
  • the pulling wire 310 is generally very thin, when the pulling wire 310 is pushed toward the distal end of the tube body 1000 by the slider 2210, if the pushing force is large and the pushing speed is too fast, the process of pulling the wire 310 into the threading tube 320 will lag behind The moving process of the slider 2210 makes it easy for the pulling wire 310 to be severely bent or even broken near the proximal port of the threading tube 320 (such as position A in FIG. 1 ), which hinders the realization of the function of the adjustable bending catheter.
  • the purpose of the present invention is to provide an adjustable bending catheter, which can avoid serious bending or breaking of the pulling wire near the proximal end of the threading tube, and ensure the smooth realization of the function of the adjustable bending catheter.
  • the adjustable bending catheter includes a tube body and a traction member.
  • An adjustable bending section is provided at the distal end of the tube body;
  • the wire tube, the protective sleeve and the crimping tube, the distal end of the pulling wire is connected to the adjustable bending section, the proximal end is wrapped and fixed in the crimping tube, and the other parts are movably arranged in the order from far to near
  • the threading tube and the protective sleeve; the proximal end of the threading tube is relatively fixed to the distal end of the protective sleeve, and the proximal end of the threading tube and the distal end of the protective sleeve are at There is no gap in the axial direction of the two, the distal end of the crimping tube is movably penetrated in the protective sleeve, and the crimping tube moves in the protective sleeve to drive the pulling wire in the protective
  • the proximal end of the threading tube is docked with the distal end of the protective sleeve or the proximal end of the threading tube penetrates into the distal end of the protective sleeve.
  • the protective sleeve includes an inclined section, a transition section and a straight section connected in sequence, the transition section smoothly connects the inclined section and the straight section, the inclined section is close to the threading tube
  • the ends are relatively fixed, and the proximal end of the crimping tube is movably disposed in the straight section.
  • the inner diameter of the protective sleeve is 0.1 mm-0.3 mm larger than the outer diameter of the crimping tube, and the inner diameter of the protective sleeve is 0.3 mm-0.6 mm larger than the diameter of the pulling wire.
  • the length of the protective sleeve is greater than the distance that the pulling wire needs to move when the adjustable bending section is switched between straight and maximum bending angle.
  • the proximal end of the threading tube protrudes from the tube body, and the remaining part is embedded in the tube wall of the tube body.
  • the adjustable bending catheter further includes a bending handle connected to the proximal end of the tube body and connected to the proximal end of the crimping tube; the bending handle controls the crimping tube at The protective sleeve moves inside.
  • the bending handle includes a fixed base body, a driving mechanism and a drive control mechanism; the proximal end of the tube body is penetrated and fixed in the fixed base body, and the protective sleeve is fixed relative to the fixed base body.
  • the crimp tube is connected to the drive mechanism, the drive control mechanism is connected to the drive mechanism and controls the movement of the drive mechanism relative to the fixed base body, the drive mechanism moves to drive the crimp tube in the protection Move inside the casing.
  • the driving mechanism includes a slider and a fixing block fixed to the slider, the crimping tube is fixed to the fixing block, a screw groove is provided on the surface of the slider, and the driving control mechanism includes a rotating cylinder A screw thread meshing with the screw groove is provided in the rotating cylinder, and rotating the rotating cylinder drives the slider to move relative to the fixed base body.
  • the length of the protective sleeve is greater than the maximum stroke of the slider.
  • the fixed base is provided with an axial groove provided along the axial direction of the fixed base; the slider is movably placed in the axial groove, and the spinning cylinder is rotated to drive the slider along the The axial groove moves.
  • the proximal end of the tube body is embedded in the fixed base body, and the central axis of the tube body coincides with the central axis of the fixed base body, the fixed base body is provided with an inclined groove, and one end of the inclined groove It extends to the tube body, and the other end extends to the axial groove, and the protective sleeve is fixed in the inclined groove.
  • the adjustable bending catheter provided by the invention is provided with the crimping tube to wrap and fix the pulling wire, and the protective sleeve is arranged between the threading tube and the crimping tube, and the threading
  • the proximal end of the tube and the distal end of the protective sleeve are seamless in the axial direction of the two, and the distal end of the crimping tube is movably disposed in the protective sleeve, so that the pulling wire is located in the The part between the wire tube and the crimping tube is penetrated in the protective sleeve.
  • the crimping tube drives the pulling wire to move in the protective sleeve and the threading tube, so that the pulling wire is located
  • the part between the wire tube and the crimping tube is always located in the protective sleeve.
  • the inner cavity of the protective sleeve limits the degree of bending deformation of the pulling wire, which can avoid the bending of the pulling wire near the proximal end of the threading tube or Breaking to ensure the smooth realization of the bending function of the adjustable bending catheter.
  • FIG. 1 is a schematic diagram of a severe bending of a tow wire in an existing adjustable bending catheter
  • FIG. 2 is a three-dimensional structural schematic diagram of an adjustable curved catheter according to an embodiment of the present invention.
  • FIG. 3 is a three-dimensional exploded schematic view of an adjustable curved catheter of an embodiment of the present invention.
  • FIG. 4 is a schematic cross-sectional view of an adjustable bending catheter according to an embodiment of the present invention.
  • FIG. 5 is a partially enlarged schematic view at II in FIG. 4;
  • FIG. 6 is a schematic structural diagram of the distal end of the traction member and the tube body of the adjustable bend catheter of the embodiment of the present invention.
  • FIG. 7 is a schematic view of the position and state of the traction wire, the threading tube, the protective sleeve and the crimping tube in the adjustable bending section of the adjustable bending catheter of the embodiment of the present invention at the maximum bending angle;
  • FIG. 8 is a schematic view of the position state of the pulling wire, the threading tube, the protective sleeve and the crimping tube when the adjustable bending section of the adjustable bending catheter of the embodiment of the present invention returns to a straight state;
  • FIG. 9 is a schematic structural view of the proximal end of the traction member and the tube in the adjustable bend catheter of the embodiment of the present invention.
  • FIG. 10 is a schematic structural diagram of a protective sleeve in an adjustable curved catheter according to an embodiment of the present invention.
  • proximal and distal are defined herein as commonly used in the field of interventional medicine. Specifically, the “distal end” refers to the end away from the operator during the surgical operation, and the “proximal end” refers to the end near the operator during the surgical operation.
  • the present invention provides an adjustable bending catheter 100.
  • the adjustable bending catheter 100 includes a tube body 10, a bending handle 20, and a traction member 30.
  • the bending handle 20 is connected to the proximal end of the tube body 10.
  • An adjustable bending section 11 is provided at the distal end of the tube body 10, and the bending angle of the adjustable bending section 11 can be adjusted according to actual needs.
  • an adjustable bending section 11 is provided on the pipe body 10. It can be understood that, in other embodiments of the present application, the tube body 10 may also be provided with multiple adjustable bending sections 11.
  • the tube body 10 includes an inner film 10a, a reinforcing tube 10b sleeved on the inner film 10a, and an outer tube 10c sleeved on the reinforcing tube 10b.
  • the inner membrane 10a is a flexible tube made of a flexible material such as PTFE, which is easy to bend;
  • the reinforcing tube 10b is a metal braided mesh structure, which has a certain rigidity and can be in the axial direction Perform bending to provide support for the tube body 10 to avoid torsional deformation of the tube body 10 in the radial direction without affecting the bending of the adjustable bending section 11 of the tube body 10;
  • the outer tube 10c passes PEBAX It is made of materials with a certain hardness to achieve the protection of the tube body 10.
  • the hardness of the outer tube 10c corresponding to the adjustable bending section 11 is less than the hardness of other parts of the outer tube 10c, so that while protecting the tube body 10, the adjustable bending section 11 is avoided The effect of bending.
  • the hardness of the PEBAX material used for the portion of the outer tube 10c corresponding to the adjustable bending section 11 is less than the hardness of other portions of the outer tube 10c.
  • the inner membrane 10a, the reinforcement tube 10b, and the outer tube 10c are formed by hot-melt compounding to form at least one delivery cavity that completely penetrates from the proximal end to the distal end.
  • the tube body 10 may only include the inner membrane 10a and/or the outer tube 10c, and the inner membrane 10a and the reinforced tube 10b when the usage requirements are met
  • the outer tube 10c may be made of materials other than this embodiment.
  • the end of the tube body 10 is an arc-shaped end with a smooth surface, that is, a Tip head, and a radiopaque developing ring (not shown in the figure) is provided on the proximal side of the Tip head , Such as a tantalum ring, etc., so that it can accurately know whether the distal end of the tube body 10 reaches a designated position under the developing device.
  • the traction member 30 includes a traction wire 31, a threading tube 32, a protective sleeve 33 and a crimping tube 34.
  • the distal end of the pulling wire 31 is connected to the adjustable bending section 11, the proximal end is wrapped around and fixed in the crimping tube 34, and the remaining parts are sequentially threaded through the threading tube 32 and Said in the protective sleeve 33.
  • the pulling wire 31 is used to pull the adjustable bending section 11 to bend or restore straightness, and has a certain strength.
  • the pulling wire 31 has a single structure, or a multi-strand structure may also be used.
  • the cross-sectional shape of the pulling wire 31 may be various shapes such as a circle, and it is not specifically limited here.
  • the radial cross section should be as small as possible, so the diameter range of the pulling wire 31 is preferably 0.05 mm to 0.25 mm.
  • the pulling wire 31 may be made of a metal material, such as stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, or may be made of a polymer having a certain strength, and the material is not specifically limited here.
  • the pulling wire 31 is preferably a stainless steel wire with a diameter of 0.25 mm.
  • the anchoring ring 35 is a ring-shaped member, which is sleeved on the adjustable bending section 11, that is, the traction
  • the distal end of the wire 31 is connected to the adjustable bending section 11 through the anchor ring 35.
  • the anchor ring 35 is sleeved on the inner membrane 10a to correspond to the position of the adjustable bending section 11.
  • the anchor ring 35 increases the contact area between the retractor 30 and the adjustable bending section 11 of the pipe body 10, so that the bending of the adjustable bending section 11 can be better pulled.
  • the anchor ring 35 may be made of a metal material or a polymer material. In this embodiment, the anchor ring 35 is made of metal such as SUS304 stainless steel.
  • the methods for connecting the pulling wire 31 and the anchor ring 35 include, but are not limited to, bonding, welding, hot melting, and knotting.
  • Most of the pulling wire 31 is threaded in the threading tube 32 to define the pulling direction of the pulling wire 31 by the threading tube 32 and protect the pulling wire by the threading tube 32 31.
  • Most of the threading tube 32 is embedded in the tube wall of the tube body 10 and extends along the axial direction of the tube body 10 so that the pulling wire 31 threaded in the threading tube 32 When moving in the threading tube 32, the pulling wire 31 moves along the axial direction of the tube body 10.
  • the proximal end of the threading tube 32 protrudes from the tube wall of the tube body 10 at a specific angle, so that the pulling wire 31 threaded therein can exit the threading tube 32 at a specific angle Wear out.
  • the threading tube 32 is embedded between the inner membrane 10a and the reinforcing tube 10b.
  • the diameter of the tube body 10 can be reduced to ensure that the tube body 10 can easily move in the target lumen of the human body.
  • the material of the threading tube 32 may be various materials suitable for medical devices such as metal or polymer.
  • the difference between the inner diameter of the threading tube 32 and the diameter of the pulling wire 31 is greater than 0 and less than 0.1 mm.
  • the proximal end of the crimping tube 34 is connected to the bending handle 20 so that the proximal end of the pulling wire 31 is connected to the bending handle 20 through the crimping tube 34 to avoid the thinning of the pulling wire 31 Therefore, when the pulling wire 31 and the bending handle 20 are directly connected, the risk of breaking the wire is easy, and the connection strength between the pulling wire 31 and the bending handle 20 is increased.
  • the distal end of the crimping tube 34 is movably disposed in the protective sleeve 33, that is, the bending handle 20 drives the crimping tube 34 and the pulling wire 31 to adjust the bending state of the adjustable bending section 11
  • the distal end of the crimping tube 34 is always located in the protective sleeve 33.
  • the proximal end of the threading tube 32 and the distal end of the protective sleeve 33 are relatively fixed, and the proximal end of the threading tube 32 and the distal end of the protective sleeve 33 are both Seamless in the axial direction.
  • relatively fixed means that the proximal end of the threading tube 32 and the distal end of the protective sleeve 33 are fixed by welding, bonding, etc., or by a fixing member, or the threading tube 32 may also be fixed They are respectively fixed with the protective sleeve 33 to keep the proximal end of the threading tube 32 and the distal end of the protective sleeve 33 from moving relative to each other.
  • the proximal end of the threading tube 32 is wrapped in the distal end of the protective sleeve 33 and fixed to each other. It can be understood that the proximal end of the threading tube 32 can also be docked with the distal end of the protective sleeve 33, that is, the distal end of the protective sleeve 33 and the proximal end of the threading tube 31 They are in contact with each other and fixed together; alternatively, the protective sleeve 33 may be extended from the proximal end of the threading tube 32, that is, the protective sleeve 33 and the threading tube 32 are an integral structure.
  • the inner diameter of the protective sleeve 33 can not hinder the smooth movement of the crimping tube in the protective sleeve 33, and needs to be connected with the pulling wire 31 There is a small gap between them to reduce the moving space of the pulling wire 31 in the radial direction, limit the degree of bending of the pulling wire 31, and prevent the bending of the pulling wire.
  • the inner diameter of the protective sleeve 33 is larger than the outer diameter of the crimping tube 34 by 0.1 mm-0.3 mm, and the inner diameter of the protective sleeve 33 is larger than the diameter of the pulling wire 31 by 0.3 mm-0.6 mm.
  • the length of the protective sleeve 33 needs to be longer than the moving length of the pulling wire 31 during the process of adjusting the adjustable bending section 11 on the pipe body 10 from the initial straight state to the maximum bending angle.
  • the proximal end of the crimping tube 34 is always located in the protective sleeve 33, so that the stretch wire 31 exposed between the threading tube 32 and the crimping tube 34 is always wrapped by the protective sleeve 33,
  • the inner cavity of the protective sleeve 33 always limits the degree of bending deformation of the stretch wire 31, and once the stretch wire 31 contacts the inner cavity of the protective sleeve 33 due to bending, the inner cavity of the protective sleeve 33 Then, the pulling force of the bent pulling wire 31 will be generated to push the pulling wire 31 into the threading tube 32, so that the pulling wire 31 returns to a relatively straight state, thereby reducing or even preventing the pulling wire 31 from wearing.
  • the risk of severe bending or breaking occurs near the proximal end of the wire tube 32 to ensure that the adjustable bending section 11 of the tube body 10 can be smoothly adjusted or restored to straight.
  • the protective sleeve 33 is preferably made of metal, such as stainless steel, copper, aluminum alloy, etc. It can be understood that, in other embodiments, the protective sleeve 33 may also be made of a polymer having a certain strength.
  • the protective sleeve 33 is a stainless steel tube with an inner diameter of 0.7 mm and an outer diameter of 1.0 mm.
  • the protective sleeve 33 includes a straight section 331 parallel to the axial direction of the tube body 10, and the threading tube 31 passes through the tube body 10
  • the inclined portion 332 of the portion of the pipe wall having the same inclination angle, and the transition section 333 connected between the straight section 331 and the inclined section 332.
  • the transition section 333 is arc-shaped, and smoothly connects the inclined section 332 and the straight section 331 to ensure that the pulling wire 31 moves smoothly in the protective sleeve 33.
  • the inclined section 332 and the proximal end of the portion of the threading tube 31 that penetrates the tube wall of the tube body 10 are relatively fixed and have the same tilt angle to avoid hindering the movement of the pulling wire 31 in the protective sleeve 33 Dayton; the crimping tube 34 is movably installed in the straight section 331, and the length of the straight section 331 is greater than the adjustable bending section 11 from the initial straight state to the maximum bending angle in the process of bending The length of movement of the wire 31 so that the proximal end of the crimp tube 34 is always located within the protective sleeve 33.
  • the bending handle 20 includes a fixed base 21, a driving mechanism and a driving control mechanism.
  • the proximal end of the tube body 10 is fixed to the fixed base body 21, the protective sleeve 33 is preferably fixed to the fixed base body 21, the crimping tube 34 is connected to the drive mechanism, and the drive control mechanism is
  • the drive mechanism is connected to control the movement of the drive mechanism relative to the fixed base 21, and the drive mechanism moves to drive the crimping tube 34 to move within the protective sleeve 33, thereby driving the pulling wire 31 to adjust The bending state of the adjustable bending section 11.
  • the fixing base 21 is substantially columnar, and the tube body 10 passes through the center of the fixing base 21 and is fixed to the fixing base 21.
  • the fixing base 21 is divided into a first part 211 and a second part 212 that are engaged with each other, and corresponding grooves are provided on the first part 211 and the second part 212, the first A part 211 and the groove on the second part 212 together form a central hole for penetrating the pipe body 10, thereby facilitating the pipe body 10 to be penetrated into the fixed base 21 and
  • the fixing base 21 is fixed.
  • the fixed base 21 is provided with an axial groove 213 provided along the axial direction of the fixed base 21, and an inclined groove 214 extending from the tube body 10 to the axial groove 213.
  • the inclined groove 214 includes an inclined section and a straight section connected to the inclined section, one end of the inclined section is connected to the straight section, and the other end extends to the pipe body 10, So that the threading tube 32 extending from the tube wall of the tube body 10 extends into the inclined section; one end of the straight section is connected to the inclined section, and the other end extends to the axial groove 213.
  • the inclination angle of the inclined section is the same as the inclination angle of the inclined section 332 of the protective sleeve 33, and the inclined section 332 and the threading tube 32 extend out of the tube of the tube body 10
  • the part of the wall is preferably fixed in the inclined section by means of glue
  • the straight section 331 of the protective sleeve 33 is preferably fixed in the straight section by means of glue, so that the protection The sleeve 33 can be stably fixed in the adjustable bending catheter 100.
  • the driving mechanism includes a slider 221 and a fixing block 222 fixed to the slider 221.
  • the slider 221 is provided with a groove, and the fixing block 222 is embedded and fixed in the groove.
  • the proximal end of the crimp tube 34 is fixed to the fixing block 222.
  • the crimping tube 34 and the fixing block 222 are preferably fixed by welding. It can be understood that, in other embodiments of the present application, the crimping tube 34 and the fixing block 222 may also be fixed by adhesion or the like.
  • the slider 221 is movably disposed in the axial groove 213.
  • a screw groove 2211 is provided on the surface of the slider 221.
  • the driving control mechanism includes a rotating cylinder 231, and a screw thread 2311 meshing with the screw groove 2211 is provided in the rotating cylinder 231, and the rotating screw cylinder 231 can be driven by the screw thread 2311 meshing with the screw groove 2211
  • the slider 221 moves in the axial direction of the fixed base 21 in the axial groove 213.
  • the crimping tube 34 is fixed to the fixing block 222, and the movement of the slider 221 in the axial groove 213 can drive the crimping tube 34 to move in the protective sleeve 33, and the crimping tube 34.
  • the fixed pulling wire 31 pulls the adjustable bending section 11 to adjust or restore straightness.
  • the driving control mechanism further includes a rotating grip portion 232 provided on the outer peripheral surface of the proximal end of the spin cylinder 231, and an outer surface of the rotating grip portion 232 is provided with a non-slip structure so that The rotating grip 232 can rotate the drum 231 more easily.
  • a luer connector 40 is fixed to the proximal end of the rotating cylinder 231, and the tube body 10 passes through the fixed base 21 and is connected to the luer connector 40, so that the diagnostic and/or therapeutic instruments pass in sequence
  • the luer connector 40 and the tube body 10 reach the target lumen of the human body.
  • the bending handle 20 further includes a housing 50 through which the structure provided therein is protected. Both the fixed base 21 and the driving mechanism are accommodated in the housing 50, the distal end of the rotary cylinder 231 is accommodated in the housing 50 and is rotatably connected with the housing 50, and the rotary grip portion 232 is provided in The housing 50 is outside for rotating operation. Specifically, the inner wall of the proximal end of the housing 50 is provided with a snap ring 51, and the outer circumferential surface of the spin cylinder 231 is provided with a snap groove 2312. The snap ring 51 is held in the snap groove 2312 to achieve The rotating cylinder 231 is rotatably connected to the housing 50. Further, in this embodiment, the housing 50 includes two parts that are detachably connected, so as to more easily fix the fixing base 21, the driving mechanism, and the like in the housing 50.
  • the bending handle 20 further includes an end cover 60 fixed to the distal end of the housing 50, and the tube body 10 passes through the end cover 60 and penetrates into the fixed base 21.
  • the adjustable bending catheter 100 of the present invention is provided with the crimping tube 34 to wrap and fix the pulling wire 31, and the protective sleeve 33 is provided between the threading tube 32 and the crimping tube 34,
  • the proximal end of the threading tube 32 and the distal end of the protective sleeve 33 are seamless in the axial direction of the two, and the distal end of the crimping tube 34 is movably disposed in the protective sleeve 33 Therefore, the portion of the pulling wire 31 between the threading tube 32 and the crimping tube 34 is inserted into the protective sleeve 33.
  • the crimping tube 34 drives the pulling wire 31 to move in the protective sleeve 33 and the threading tube 32, Therefore, the portion of the pulling wire 31 between the threading tube 32 and the crimping tube 34 is always located in the protective sleeve 33, and the inner cavity of the protective sleeve 33 limits the degree of bending deformation of the pulling wire 31, and can The drawing wire 31 is prevented from being severely bent or broken near the proximal end of the threading tube 32, and the smooth adjustment function of the adjustable bending catheter 100 is ensured.

Abstract

一种可调弯导管，包括管体（10）以及牵引件（30），管体（10）远端设有可调弯段（11）；牵引件（30）包括牵引丝（31）、穿丝管（32）、防护套管（33）及压接管（34），牵引丝（31）的远端连接可调弯段（11），近端被包绕并固定在压接管内（34），其余部分自远至近依次活动穿设于穿丝管（32）与防护套管（33）内；穿丝管（32）的近端与防护套管（33）的远端相对固定，且穿丝管（32）的近端与防护套管（33）的远端在二者的轴向方向上无缝隙，压接管（34）的远端活动穿设于防护套管（33）内；压接管（34）在防护套管（33）内移动，以带动牵引丝（31）在防护套管（33）及穿丝管（32）内移动，使得可调弯段（11）弯曲或恢复平直。防护套管（33）的内腔限制牵引丝（31）发生弯折变形的程度，能够避免牵引丝在穿丝管（31）近端附近严重弯折或折断，保证可调弯导管调弯功能的顺利实现。

Description

可调弯导管 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种可调弯导管。
背景技术
由于介入手术对人体的损伤较小、且能有效缩短手术时间，是近些年来迅速兴起并推广的医疗技术，导管作为介入手术的辅助器械，主要用于建立起人体血管与外界的通道以输送诊断和/或治疗器械。
为了适应人体生理解剖结构的个体化差异，可调弯导管得到了较为广泛地应用。可调弯导管即在导管的管体远端设置可调弯段，通过操控导管的手柄带动连接可调弯段的牵引丝沿轴向运动而使得管体远端反复地在不同角度间弯曲，直至弯曲角度符合人体管腔特定的生理结构特征，然后锁定该弯曲角度，使管体远端对准目标管腔入口(如某一条血管)，然后通过管体输送诊断和/或治疗器械至目标管腔内。
请参阅图1，现有的可调弯导管通常将牵引丝设于穿丝管320内，穿丝管320大部分被包埋在管体1000的管壁中，近端从管体1000的管壁穿出，牵引丝310的近端从穿丝管320中穿出并连接至手柄中的滑块2210，通过滑块2210的移动来带动牵引丝310沿轴向运动，从而带动管体1000远端的可调弯段弯曲。由于牵引丝310一般非常细，当牵引丝310被滑块2210推送朝向管体1000远端运动时，若推送力较大、推送速度过快，牵引丝310进入穿丝管320的进程会滞后于滑块2210的移动进程，从而牵引丝310很容易在穿丝管320近端端口附近(如图1中的位置A)发生严重弯折甚至折断，阻碍可调弯导管调弯功能的实现。
发明内容
本发明的目的在于提供一种可调弯导管，能够避免牵引丝在穿丝管近端附近发生严重弯折或折断，保证可调弯导管调弯功能的顺利实现。
为了实现上述目的，本发明提供一种可调弯导管，所述可调弯导管包括管 体以及牵引件，所述管体远端设有可调弯段；所述牵引件包括牵引丝、穿丝管、防护套管及压接管，所述牵引丝的远端连接所述可调弯段，近端被包绕并固定在所述压接管内，其余部分自远至近依次活动穿设于所述穿丝管与所述防护套管内；所述穿丝管的近端与所述防护套管的远端相对固定，且所述穿丝管的近端与所述防护套管的远端在二者的轴向方向上无缝隙，所述压接管的远端活动穿设于所述防护套管内，所述压接管在所述防护套管内移动，以带动所述牵引丝在所述防护套管及所述穿丝管内移动，使得所述可调弯段弯曲或恢复平直。
其中，所述穿丝管的近端与所述防护套管的远端对接或所述穿丝管的近端穿入所述防护套管的远端内。
其中，所述防护套管包括依次连接的倾斜段、过渡段以及平直段，所述过渡段平滑连接所述倾斜段与所述平直段，所述倾斜段与所述穿丝管的近端相对固定，所述压接管的近端活动穿设于所述平直段内。
其中，所述防护套管的内径比所述压接管的外径大0.1mm-0.3mm，所述防护套管的内径比所述牵引丝的直径大0.3mm-0.6mm。
其中，所述防护套管的长度大于所述可调弯段在平直与最大弯曲角度之间切换时所述牵引丝需移动的距离。
其中，所述穿丝管的近端伸出所述管体，其余部分内嵌于所述管体的管壁内。
其中，所述可调弯导管还包括调弯手柄，所述调弯手柄连接于所述管体的近端并与所述压接管的近端连接；所述调弯手柄控制所述压接管在所述防护套管内移动。
其中，所述调弯手柄包括固定基体、驱动机构及驱动控制机构；所述管体的近端穿设并固定于所述固定基体内，所述防护套管相对于所述固定基体固定，所述压接管与所述驱动机构连接，所述驱动控制机构与所述驱动机构连接并控制所述驱动机构相对于所述固定基体运动，所述驱动机构运动以带动所述压接管在所述防护套管内移动。
其中，所述驱动机构包括滑块以及与所述滑块固定的固定块，所述压接管与所述固定块固定，所述滑块的表面设有螺槽，所述驱动控制机构包括旋筒，所述旋筒内设有与所述螺槽啮合的螺纹，旋转所述旋筒带动所述滑块相对所述 固定基体移动。
其中，所述防护套管的长度大于所述滑块的最大行程。
其中，所述固定基体上设有沿所述固定基体轴向设置的轴向槽；所述滑块活动置于所述轴向槽内，旋转所述旋筒以带动所述滑块沿所述轴向槽移动。
其中，所述管体近端内嵌于所述固定基体内，且所述管体的中心轴与所述固定基体的中心轴重合，所述固定基体上设有倾斜槽，所述倾斜槽一端延伸至所述管体，另一端延伸至所述轴向槽，所述防护套管固定于所述倾斜槽内。
本发明提供的可调弯导管，设置所述压接管来包绕并固定所述牵引丝，并在所述穿丝管与所述压接管之间设置所述防护套管，且所述穿丝管的近端与所述防护套管的远端在二者的轴向方向上无缝隙，所述压接管的远端活动穿设于所述防护套管内，从而所述牵引丝位于所述穿丝管与压接管之间的部分穿设于所述防护套管内。在所述管体的可调弯段弯曲或恢复平直的过程中，所述压接管带动着所述牵引丝在所述防护套管及所述穿丝管内移动，从而所述牵引丝位于穿丝管与压接管之间的部分始终位于所述防护套管内，所述防护套管的内腔限制牵引丝发生弯折变形的程度，能够避免牵引丝在穿丝管近端附近严重弯折或折断，保证所述可调弯导管调弯功能的顺利实现。
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作简单地介绍，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1为现有的可调弯导管中牵引丝发生严重弯折时的示意图；
图2是本发明实施例的可调弯导管的立体结构示意图；
图3是本发明实施例的可调弯导管的立体爆炸示意图；
图4是本发明实施例的可调弯导管的剖面示意图；
图5是图4中II处的局部放大示意图；
图6是本发明实施例的可调弯导管中牵引件与管体的远端的结构示意图；
图7是本发明实施例的可调弯导管中可调弯段在最大弯曲角度时牵引丝、 穿丝管、防护套管及压接管的位置状态示意图；
图8是本发明实施例的可调弯导管中可调弯段在恢复平直状态时时所述牵引丝、穿丝管、防护套管及压接管的位置状态示意图；
图9是本发明实施例的可调弯导管中牵引件与管体的近端的结构示意图；
图10是本发明实施例的可调弯导管中防护套管的结构示意图。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
为了更加清楚地描述调弯手柄及可调弯导管的结构，此处限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端，“近端”表示手术操作过程中靠近操作人员的一端。
除非另有定义，本发明所使用的所有的技术和科学术语与本领域技术人员通常理解的含义相同。本发明在说明书中所使用的术语只是为了描述具体实施例的目的，不是旨在限制本发明。
请参阅图2至图5，本发明提供一种可调弯导管100。所述可调弯导管100包括管体10、调弯手柄20以及牵引件30。所述调弯手柄20与所述管体10的近端连接。所述管体10远端设有可调弯段11，所述可调弯段11的弯曲角度可根据实际需要做调整。本实施例中，所述管体10上设有一段可调弯段11。可以理解的是，在本申请的其它实施例中，所述管体10上也可设置多段可调弯段11。
结合图2与图6，所述管体10包括内膜10a、套设于所述内膜10a上的增强管10b以及套设于所述增强管10b上的外管10c。本实施例中，所述内膜10a为由PTFE等柔性材料制成的柔性管，易于发生弯曲；所述增强管10b为金属编织网状结构，具有一定刚度的同时，能够在轴向方向上进行弯曲，从而为所述管体10提供支撑，避免管体10沿径向方向发生扭转变形，同时又不影响所述管体10的可调弯段11的弯曲；所述外管10c通过PEBAX等具有一定硬度 的材料制成，以实现对所述管体10的保护。并且，所述外管10c对应于所述可调弯段11的硬度小于所述外管10c其它部分的硬度，从而在实现对所述管体10的保护的同时，避免对可调弯段11的弯曲的影响。具体地，本实施例中，所述外管10c对应于可调弯段11的部分采用的所述PEBAX材料的硬度小于所述外管10c其它部分的硬度。进一步地，本实施例中，所述内膜10a、增强管10b以及外管10c通过热熔复合成型在一起，形成至少一个自近端完全贯通到远端的输送腔。可以理解的是，在本发明的其它实施例中，在满足使用需求的情况下，所述管体10也可以只包括内膜10a和/或外管10c，所述内膜10a、增强管10b以及外管10c也可以为除本实施例外的其它材料制成。
进一步地，本申请的一些实施例中，所述管体10的末端为具有光滑表面的弧形端头，即Tip头，Tip头近侧设置不透射线的显影环(图中未示出)，如钽环等，从而在显影设备下能够准确的得知所述管体10的远端是否到达指定位置。
请参阅图3至图9，所述牵引件30包括牵引丝31、穿丝管32、防护套管33及压接管34。所述牵引丝31的远端连接所述可调弯段11，近端被包绕并固定在所述压接管34内，其余部分自远至近依次活动穿设于所述穿丝管32与所述防护套管33内。
所述牵引丝31用于牵引所述可调弯段11进行弯曲或者恢复平直，具有一定的强度。本实施例中，所述牵引丝31为单根结构，也可以采用多股结构。牵引丝31的截面形状可以为圆形等各种形状，在此不对其进行具体地限定。所述牵引丝31在具有一定强度以实现牵引功能的基础上，径向截面应尽量细小，所以牵引丝31的直径范围优选为0.05毫米至0.25毫米。牵引丝31可以由金属材料制成，例如不锈钢、钨合金、钴铬合金或者镍钛合金等，也可以由具有一定强度的高分子制成，在此不对其材料进行具体地限定。本实施例中，牵引丝31优选直径为0.25毫米的不锈钢丝。
所述牵引丝31与所述可调弯段11连接的一端设有锚定环35，所述锚定环35为环状件，套设于所述可调弯段11上，即所述牵引丝31的远端通过所述锚定环35与所述可调弯段11连接。本实施例中，所述锚定环35套设于所述内膜10a上对应于所述可调弯段11的位置。通过所述锚定环35增大所述牵 引件30与所述管体10的可调弯段11的接触面积，从而能够更好的牵引所述可调弯段11的弯曲。所述锚定环35可以为金属材料或者高分子材料制成，本实施例中，所述锚定环35选用金属如SUS304不锈钢制成。牵引丝31与锚定环35连接的方式包括但不限于粘合、焊接、热熔、打结等方式。
所述牵引丝31大部分活动穿设于所述穿丝管32内，以通过所述穿丝管32限定所述牵引丝31的牵引方向，并通过所述穿丝管32保护所述牵引丝31。所述穿丝管32的大部分内嵌于所述管体10的管壁内，并沿所述管体10的轴向方向延伸，使得穿设于所述穿丝管32内的牵引丝31在所述穿丝管32内活动时，所述牵引丝31沿所述管体10的轴向移动。所述穿丝管32的近端从所述管体10的管壁上以一特定的角度伸出，以使得穿设于其中的牵引丝31能够以特定的角度从所述穿丝管32中穿出。本实施例中，所述穿丝管32包埋于所述内膜10a与增强管10b之间。通过将所述穿丝管32包埋于所述管体10内，能够减小所述管体10的直径，以保证所述管体10容易在人体目标管腔内运动。所述穿丝管32的材质可以为金属或者高分子等各种适用于医疗器械中的材料。穿丝管32的内径与牵引丝31直径之间具有适当的间隙以使得牵引丝31在穿丝管32内顺畅移动。本实施例中，所述穿丝管32的内径与所述牵引丝31的直径的差值大于0且小于0.1mm。
所述压接管34的近端与所述调弯手柄20连接，使得所述牵引丝31的近端通过所述压接管34连接所述调弯手柄20，以避免由于所述牵引丝31较细，牵引丝31与调弯手柄20直接连接时容易断丝的风险，并增加牵引丝31与调弯手柄20之间的连接强度。并且，所述压接管34的远端活动穿设于所述防护套管33内，即所述调弯手柄20带动压接管34及牵引丝31移动以调整所述可调弯段11的弯曲状态时，所述压接管34的远端始终位于所述防护套管33内。值得注意的是，所述穿丝管32的近端与所述防护套管33的远端相对固定，且所述穿丝管32的近端与所述防护套管33的远端在二者的轴向方向上无缝隙。其中，“相对固定”是指所述穿丝管32的近端与所述防护套管33的远端通过焊接、粘接等方式固定或者通过固定件固定，也可以将所述穿丝管32与所述防护套管33分别固定，以保持所述穿丝管32的近端与所述防护套管33的远端不会发生相对运动。
本实施例中，所述穿丝管32的近端被包覆在防护套管33的远端内并相互固定。可以理解的是，也可以将所述穿丝管32的近端与所述防护套管33的远端对接，即所述防护套管33远端末端与所述穿丝管31的近端末端相抵接并固定在一起；或者，与可以设置所述防护套管33由所述穿丝管32的近端延伸出来，即防护套管33与穿丝管32为一体结构。
由于所述压接管34的远端活动穿设于所述防护套管33内，所述防护套管33的内径既不能阻碍压接管在防护套管33内顺畅移动，又需与牵引丝31之间具有较小的间隙，以减小牵引丝31在径向上的活动空间，限制牵引丝31发生弯折的程度，防止牵引丝过度弯折。优选的，所述防护套管33的内径比压接管34的外径大0.1mm-0.3mm，防护套管33的内径比牵引丝31的直径大0.3mm-0.6mm。
请一并参阅图7及图8，防护套管33的长度需大于管体10上可调弯段11由初始的平直状态调弯至最大弯曲角度的过程中牵引丝31的移动长度，以使得所述压接管34的近端始终位于防护套管33内，从而使得暴露于所述穿丝管32与压接管34之间的这段牵引丝31始终被所述防护套管33包裹着，防护套管33的内腔始终会限制这段牵引丝31发生弯折变形的程度，并且，一旦这段牵引丝31因弯折而接触防护套管33的内腔，防护套管33的内腔随即会对弯折的牵引丝31产生抵推作用力而促使牵引丝31进入穿丝管32，使得这段牵引丝31恢复到较为平直的状态，从而能够减小甚至避免牵引丝31在穿丝管32的近端附近发生严重弯折或折断的风险，保证管体10的可调弯段11能够顺利调弯或恢复平直。本实施例中，防护套管33的截面形状和牵引丝31的截面形状保持一致，防护套管33优选由金属制成，例如不锈钢、紫铜、铝合金等。可以理解的是，在其它实施例中，防护套管33也可以由具有一定强度的高分子制成。优选地，本实施例中，防护套管33为内径0.7mm，外径1.0mm的不锈钢管。
进一步地，请参阅图9及图10，本实施例中，所述防护套管33包括与管体10轴向平行的平直段331、与所述穿丝管31穿出所述管体10的管壁的部分的倾斜角度相同的倾斜段332，及连接于平直段331与倾斜段332之间的过渡段333。其中，所述过渡段333呈弧形，并平滑连接所述倾斜段332与所述 平直段331，以保证所述牵引丝31在所述防护套管33内顺畅移动。所述倾斜段332与所述穿丝管31穿出所述管体10的管壁的部分的近端相对固定且倾斜角度相同，以避免对牵引丝31在防护套管33内的移动造成阻顿；所述压接管34活动穿设于所述平直段331内，且所述平直段331的长度大于可调弯段11由初始的平直状态调弯至最大弯曲角度的过程中牵引丝31的移动长度，以使得所述压接管34的近端始终位于防护套管33内。
请重新参阅图2至图5，所述调弯手柄20包括固定基体21、驱动机构及驱动控制机构。所述管体10的近端与所述固定基体21固定，所述防护套管33优选固定于所述固定基体21上，所述压接管34与所述驱动机构连接，所述驱动控制机构与所述驱动机构连接以控制所述驱动机构相对于所述固定基体21运动，所述驱动机构运动以带动所述压接管34在所述防护套管33内移动，从而带动牵引丝31移动以调整所述可调弯段11的弯曲状态。所述固定基体21大体为柱状，所述管体10穿设于所述固定基体21的中心并与所述固定基体21固定。本实施例中，所述固定基体21分为相互扣合的第一部分211及第二部分212，并在所述第一部分211与所述第二部分212上设置相对应的凹槽，所述第一部分211与所述第二部分212上的凹槽合在一起则形成用于穿设所述管体10的中心孔，从而便于将所述管体10穿设于所述固定基体21内并与所述固定基体21固定。进一步地，所述述固定基体21上设有沿所述固定基体21轴向设置的轴向槽213，以及从管体10延伸至所述轴向槽213的倾斜槽214。具体地，所述倾斜槽214包括倾斜区段及与所述倾斜区段连接的平直区段，所述倾斜区段一端连接所述平直区段，另一端延伸至所述管体10，以使得从所述管体10的管壁伸出的穿丝管32伸入所述倾斜区段内；所述平直区段一端连接所述倾斜区段，另一端延伸至所述轴向槽213。本实施例中，所述倾斜区段的倾斜角度与所述防护套管33的倾斜段332的倾斜角度相同，所述倾斜段332以及所述穿丝管32伸出所述管体10的管壁的部分优选通过胶粘的方式固定于所述倾斜区段内，所述防护套管33的平直段331优选通过胶粘的方式固定于所述平直区段内，以使得所述防护套管33在所述可调弯导管100内能够稳定的固定。
所述驱动机构包括滑块221以及与所述滑块221固定的固定块222。本实 施例中，所述滑块221上设有一凹槽，所述固定块222嵌设固定于所述凹槽内。所述压接管34的近端与所述固定块222固定。本实施例中，所述压接管34与所述固定块222优选通过焊接的方式固定。可以理解的是，在本申请的其它实施例中，所述压接管34与所述固定块222也可以通过粘接等方式固定。所述滑块221活动设于所述轴向槽213内。所述滑块221的表面设有螺槽2211。所述驱动控制机构包括旋筒231，所述旋筒231内设有与所述螺槽2211啮合的螺纹2311，通过所述螺纹2311与螺槽2211的啮合，使得旋转所述旋筒231能够带动所述滑块221在轴向槽213内沿固定基体21的轴向移动。本申请中，所述压接管34与所述固定块222固定，所述滑块221在轴向槽213内移动能够带动所述压接管34在所述防护套管33中移动，与所述压接管34固定的牵引丝31便牵引所述可调弯段11进行调弯或恢复平直。进一步地，所述驱动控制机构包括还包括设于所述旋筒231的近端外周面上的旋转握持部232，所述旋转握持部232的外表面设有防滑结构，从而通过旋转所述旋转握持部232能够更容易地旋转所述旋筒231。
进一步地，所述旋筒231的近端固定有鲁尔接头40，所述管体10穿过所述固定基体21并连接至所述鲁尔接头40，以使得诊断和/或治疗器械依次通过鲁尔接头40及管体10到达人体目标管腔内。
进一步地，所述调弯手柄20还包括外壳50，通过所述外壳50对设于其内的结构进行保护。所述固定基体21、驱动机构均收容于所述外壳50内，所述旋筒231的远端收容于所述外壳50内并与所述外壳50转动连接，所述旋转握持部232设于所述外壳50外以便进行旋转操作。具体地，所述外壳50的近端的内壁设有卡环51，所述旋筒231的外周面环设有卡槽2312，所述卡环51卡持于所述卡槽2312内，以实现旋筒231与所述外壳50的转动连接。进一步地，本实施例中，所述外壳50包括可拆卸连接的两部分，以便于将固定基体21、驱动机构等更容易地固定于外壳50内。
进一步地，本申请中，所述调弯手柄20还包括固定于所述外壳50远端的端盖60，所述管体10穿过所述端盖60穿入所述固定基体21中。
本发明的可调弯导管100，设置所述压接管34来包绕并固定所述牵引丝31，并在所述穿丝管32与所述压接管34之间设置所述防护套管33，且所述 穿丝管32的近端与所述防护套管33的远端在二者的轴向方向上无缝隙，所述压接管34的远端活动穿设于所述防护套管33内，从而所述牵引丝31位于所述穿丝管32与压接管34之间的部分穿设于所述防护套管33内。在所述管体10的可调弯段11弯曲或恢复平直的过程中，所述压接管34带动着所述牵引丝31在所述防护套管33及所述穿丝管32内移动，从而所述牵引丝31位于穿丝管32与压接管34之间的部分始终位于所述防护套管33内，所述防护套管33的内腔限制牵引丝31发生弯折变形的程度，能够避免牵引丝31在穿丝管32近端附近严重弯折或折断，保证所述可调弯导管100调弯功能的顺利实现。
以上所揭露的仅为本发明一种较佳实施例而已，当然不能以此来限定本发明之权利范围，本领域普通技术人员可以理解实现上述实施例的全部或部分流程，并依本发明权利要求所作的等同变化，仍属于发明所涵盖的范围。

Claims (13)

  1. 一种可调弯导管，其特征在于，包括管体以及牵引件，所述管体远端设有可调弯段；所述牵引件包括牵引丝、穿丝管、防护套管及压接管，所述牵引丝的远端连接所述可调弯段，近端被包绕并固定在所述压接管内，其余部分自远至近依次活动穿设于所述穿丝管与所述防护套管内；所述穿丝管的近端与所述防护套管的远端相对固定，且所述穿丝管的近端与所述防护套管的远端在二者的轴向方向上无缝隙，所述压接管的远端活动穿设于所述防护套管内；所述压接管在所述防护套管内移动，以带动所述牵引丝在所述防护套管及所述穿丝管内移动，使得所述可调弯段弯曲或恢复平直。
  2. 如权利要求1所述的可调弯导管，其特征在于，所述穿丝管的近端与所述防护套管的远端对接或所述穿丝管的近端穿入所述防护套管的远端内。
  3. 如权利要求1或2所述的可调弯导管，其特征在于，所述防护套管包括依次连接的倾斜段、过渡段以及平直段，所述过渡段平滑连接所述倾斜段与所述平直段，所述倾斜段与所述穿丝管的近端相对固定，所述压接管的近端活动穿设于所述平直段内。
  4. 如权利要求1所述的可调弯导管，其特征在于，所述防护套管的内径比所述压接管的外径大0.1mm-0.3mm，所述防护套管的内径比所述牵引丝的直径大0.3mm-0.6mm。
  5. 如权利要求1所述的可调弯导管，其特征在于，所述防护套管的长度大于所述可调弯段在平直与最大弯曲角度之间切换时所述牵引丝需移动的距离。
  6. 如权利要求1所述的可调弯导管，其特征在于，所述穿丝管的近端伸出所述管体，其余部分内嵌于所述管体的管壁内。
  7. 如权利要求1所述的可调弯导管，其特征在于，所述可调弯导管还包括调弯手柄，所述调弯手柄连接于所述管体的近端并与所述压接管的近端连接；所述调弯手柄控制所述压接管在所述防护套管内移动。
  8. 如权利要求7所述的可调弯导管，其特征在于，所述调弯手柄包括固定基体、驱动机构及驱动控制机构；所述管体的近端穿设并固定于所述固定基 体内，所述防护套管相对于所述固定基体固定，所述压接管与所述驱动机构连接，所述驱动控制机构与所述驱动机构连接并控制所述驱动机构相对于所述固定基体运动，所述驱动机构运动以带动所述压接管在所述防护套管内移动。
  9. 如权利要求8所述的可调弯导管，其特征在于，所述驱动机构包括滑块以及与所述滑块固定的固定块，所述压接管与所述固定块固定，所述滑块的表面设有螺槽，所述驱动控制机构包括旋筒，所述旋筒内设有与所述螺槽啮合的螺纹，旋转所述旋筒带动所述滑块相对所述固定基体移动。
  10. 如权利要求9所述的可调弯导管，其特征在于，所述防护套管的长度大于所述滑块的最大行程。
  11. 如权利要求9所述的可调弯导管，其特征在于，所述固定基体上设有沿所述固定基体轴向设置的轴向槽；所述滑块活动置于所述轴向槽内，旋转所述旋筒以带动所述滑块沿所述轴向槽移动。
  12. 如权利要求11所述的可调弯导管，其特征在于，所述管体近端内嵌于所述固定基体内，且所述管体的中心轴与所述固定基体的中心轴重合，所述固定基体上设有倾斜槽，所述倾斜槽一端延伸至所述管体，另一端延伸至所述轴向槽，所述防护套管固定于所述倾斜槽内。
  13. 如权利要求9所述的可调弯导管，其特征在于，所述调弯手柄还包括外壳，所述驱动机构收容于所述外壳内，所述旋筒的远端收容于所述外壳内并与所述外壳转动连接。
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