WO2020088138A1 - 调弯手柄及可调弯导管 - Google Patents

调弯手柄及可调弯导管 Download PDF

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Publication number
WO2020088138A1
WO2020088138A1 PCT/CN2019/106741 CN2019106741W WO2020088138A1 WO 2020088138 A1 WO2020088138 A1 WO 2020088138A1 CN 2019106741 W CN2019106741 W CN 2019106741W WO 2020088138 A1 WO2020088138 A1 WO 2020088138A1
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WO
WIPO (PCT)
Prior art keywords
adjustable
bending
bend
handle
adjustable bending
Prior art date
Application number
PCT/CN2019/106741
Other languages
English (en)
French (fr)
Inventor
张庭超
蒋权杰
罗建方
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 CN201821787398.8U external-priority patent/CN209884984U/zh
Priority claimed from CN201811292557.1A external-priority patent/CN111110985A/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
Publication of WO2020088138A1 publication Critical patent/WO2020088138A1/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

Definitions

  • the invention relates to the field of medical equipment, in particular to a bending handle and a bending catheter.
  • the distal end of the catheter contains at least two pre-shaped curved sections.
  • the Judkins Left catheter shown in Figure 1a can only be used for left coronary intervention
  • the Judkins Right shown in Figure 1b can only be used for right coronary intervention. Therefore, the left In the interventional operation of coronary and right coronary arteries, the pre-shaped catheter must be replaced. After two punctures, the two pre-shaped catheters enter the left coronary artery and the right coronary artery respectively. The operation process takes a long time and the operation is complicated. . In addition, in actual clinical use, we often encounter individual differences in the anatomical structure of the human lumen.
  • pre-shaped catheters are difficult to adapt to the left or right coronary arteries of different human bodies.
  • doctors usually prepare a variety of pre-shaped catheters with different specifications.
  • the catheter specifications from left to right in Figure 2a are JL6.0, JL5.0, JL4.5, and JL4.
  • the invention provides a bending handle and an adjustable bending catheter including the bending handle.
  • the distal end of the adjustable bending catheter can instantly form different compound bending shapes and different compound bending shapes It can access the physiological anatomy of the left coronary artery and the right coronary artery at different positions in the lumen of the human body, and can also fine-tune each bend shape in real time by manipulating the bend handle, so that the same adjustable bend catheter can be used
  • the operation of the distal shape of the bending catheter has different requirements, such as left coronary intervention surgery and right coronary intervention surgery, and can adapt to the individual differences of the anatomy of the lumen of different patients, reduce the number of punctures, and reduce damage to the human body , Simplify the operation process and shorten the operation time.
  • the bending handle is used to control at least two adjustable bending sections on the distal end of the pipe body connected to the bending handle to bend.
  • the bending handle includes a driving mechanism and a control mechanism connected to the driving mechanism ,
  • the drive mechanism is connected to all the adjustable bending sections; the control mechanism controls the drive mechanism to perform different forms of movement through different actions, and the different forms of movement of the drive mechanism are used to simultaneously drive all
  • the adjustable bending section is bent and each of the adjustable bending sections is individually driven to bend, so that a different composite bending shape is formed at the distal end of the tube body.
  • the adjustable bending catheter includes a tube body, at least two traction members, and the bending handle.
  • the bending handle is connected to the proximal end of the tube body, and at least two spacings are provided at the distal end of the tube body Adjustable bending section; the distal end of each traction member is connected to one of the adjustable bending sections, and the proximal end is connected to the driving mechanism in the bending handle.
  • the bending handle and the adjustable bending catheter provided by the present invention can simultaneously drive the adjustable bending sections to bend at the same time or pull the different adjustable bending sections to bend respectively through the movement of the driving mechanism, thereby making the adjustable
  • the distal end of the curved catheter immediately forms different compound bends.
  • the different compound bends can respectively access the physiological anatomy of the human lumen at different positions, such as the left coronary artery and the right coronary artery, and can also be manipulated in the body by manipulating the bending handle Real-time fine-tuning of each bend shape, so that the same adjustable bend catheter can be used to perform operations with different requirements on the distal shape of the adjustable bend catheter, such as left coronary intervention surgery and right coronary intervention surgery.
  • each adjustable bending section can be adjusted according to the individual differences of the lumen physiological anatomy of different patients to meet the needs of different human bodies, reduce the number of punctures, reduce the damage to the human body, and simplify the surgical process. Shorten the operation time.
  • FIG. 1a is a schematic diagram of an existing pre-shaped catheter suitable for left coronary intervention surgery
  • FIG. 1b is a schematic diagram of the application of an existing pre-shaped catheter suitable for right coronary intervention surgery
  • Figure 2a is a schematic diagram of the existing Judkins Left pre-shaped catheter of different specifications suitable for left coronary intervention surgery
  • 2b is a schematic diagram of the existing Judkins Right pre-shaped catheter of different specifications suitable for right coronary intervention surgery
  • FIG. 3 is a three-dimensional schematic structural view of an adjustable bending catheter according to an embodiment of the present invention.
  • FIG. 4 is a schematic diagram of a stereo structure of an adjustable bending catheter in another direction according to an embodiment of the present invention.
  • FIG. 5 is a schematic diagram of a three-dimensional split structure of an adjustable curved catheter according to an embodiment of the present invention.
  • FIG. 6 is a schematic cross-sectional view of the bending handle of the embodiment of the present invention along its axial direction;
  • FIG. 7 is a schematic cross-sectional view at I-I in FIG. 6;
  • FIG. 8a is a schematic structural diagram of a curved form of a pipe body according to an embodiment of the present invention.
  • FIG. 8b is a schematic structural view of another bending form of the pipe body according to the embodiment of the present invention.
  • FIG. 9 is a three-dimensional split schematic view of the driving mechanism and the control mechanism in the bending handle of the embodiment of the present invention.
  • FIG. 10 is a schematic structural view of a second inner shell in a bending handle according to an embodiment of the invention.
  • FIG. 11 is a schematic structural view of a sliding member in a bending handle according to an embodiment of the present invention.
  • FIG. 12 is a schematic diagram of the structure of the sub-slider of the bending handle according to an embodiment of the present invention.
  • FIG. 13 is a schematic diagram of a specific structure of a pipe body according to an embodiment of the present invention.
  • FIG. 14 is a schematic structural view of a traction member and a pipe body according to an embodiment of the present invention.
  • FIG. 15 is a schematic structural view of a traction member and a pipe body according to another embodiment of the invention.
  • 16 is a schematic structural view of a traction member and a pipe body according to another embodiment of the invention.
  • FIG. 17 is a schematic diagram of the second drive control member moving to a gear position and the distal end of the tube body can intervene in the right coronary artery in the embodiment of the present invention.
  • FIG. 18 is a schematic diagram of the second driving control member of the tube body moved to another gear position and the distal end of the tube body can intervene in the left coronary artery.
  • proximal end and distal end are defined herein as common terms in the field of interventional medicine. Specifically, “distal” means the end far away from the operator during the surgical operation, and “proximal” means the end close to the operator during the surgical operation.
  • the present invention provides a bending handle 20 for controlling the bending direction and curvature of at least two adjustable bending sections 11 at the distal end of the pipe body 10 connected thereto,
  • the distal end of the tube body 10 can immediately form different compound bends to meet the surgical requirements with different requirements on the distal shape of the tube body 10.
  • the bending handle 20 is used to bend the distal end of the tube body 10 so as to meet the requirements of the left coronary artery and the right coronary artery for the distal end of the tube body 10 as an example.
  • the number of the adjustable bending sections 11 is two, and the two adjustable bending sections 11 are arranged on the tube body 10 at intervals.
  • the bending handle 20 includes a handle housing 21, a driving mechanism 22 and a control mechanism 23 connected to the driving mechanism 22.
  • the driving mechanism 22 is connected to all the adjustable bending sections 11 through the same number of traction members 30 as the adjustable bending sections 11.
  • the control mechanism 23 is connected to the drive mechanism 22 to control the movement of the drive mechanism 22, and then the drive mechanism 22 moves to drive the adjustable bending section 11 to bend.
  • the control mechanism 23 controls the drive mechanism 22 to perform different forms of movement through different actions.
  • the different forms of movement of the drive mechanism are used to simultaneously drive all the adjustable bending sections 11 to bend and individually drive each of the The adjustable bending section 11 is bent, so that the distal end of the tube body 10 instantly forms a different composite bending shape.
  • all the adjustable bending sections 11 are driven to bend at the same time by the driving mechanism 22 to improve the bending efficiency, so that the distal end of the tube body 10 can be bent as soon as possible to close to certain human lumen anatomical structures required for surgery Such as the shape of the left coronary artery or the right coronary artery, thereby shortening the operation time.
  • the driving structure 22 separately drives each of the adjustable bending sections 11 to bend, so as to fine-tune the bending curvature of each adjustable bending section 11 to precisely adjust the bending curvature of each adjustable bending section 11, In order to adapt to the individual differences of the physiological anatomy of different patients, the scope of application of the tube body 10 is expanded.
  • the driving mechanism 22 is disposed inside the handle housing 21, and the control mechanism 23 is disposed outside the handle housing 21.
  • the control mechanism 23 drives the drive mechanism 22 to move axially along the handle housing 21 to drive the adjustable bending section 11 connected to the traction member 30 to bend or straighten.
  • the handle housing 21 includes a first inner shell 211, a second inner shell 212, a first outer shell 213, and a second outer shell 214.
  • the first inner shell 211 and the second inner shell 212 are partially sleeved and fixed.
  • the first inner shell 211 is sleeved outside the second inner shell 212.
  • the first outer shell 213 and the second outer shell 214 are spaced on the outer surfaces of the first inner shell 211 and / or the second inner shell 212 and expose a portion of the first inner shell 211.
  • the first inner shell 211, the second inner shell 212, the first outer shell 213 and the second outer shell 214 may all be integrally formed or formed by combining two or more sub-shells.
  • the first outer shell 213, the first inner shell 211, and the second inner shell 212 are all integrally formed, and the second outer shell 214 is formed by assembling two sub-shells. It can be understood that, in some embodiments of the present invention, only the first inner shell 211 or the second inner shell 212 may be included.
  • the driving mechanism 22 is movably accommodated in the second inner shell 212, the control mechanism 23 is located between the first outer shell 213 and the second outer shell 214, and is movably sleeved outside the first inner shell 211.
  • the first inner shell 211 and the second inner shell 212 exposed between the first outer shell 213 and the second outer shell 214 are provided with at least two guide holes 2111, the number of the guide holes 2111 is the same as the number of the adjustable bending sections 11.
  • the guide holes 2111 on the first inner shell 211 and the second inner shell 212 overlap.
  • the number of the guide holes 2111 is two, and the two guide holes 2111 are oppositely arranged.
  • the proximal end of the second housing 214 is fixedly connected to the Luer connector 70.
  • the driving mechanism 22 includes a sliding member 221 slidably connected in the second inner shell 212, along the axial direction of the handle housing 21 At least two sub-sliders 222 slidingly connected to the sliding member 221.
  • Each of the sub-sliding members 222 is correspondingly connected to an adjustable bending section 11 through a traction member 30.
  • the corresponding traction member 30 can be driven to traction,
  • the corresponding adjustable bending section 11 is bent with a certain curvature.
  • all sub-sliders 222 located on the slider 221 are driven to move relative to each other
  • the second inner shell 212 moves synchronously to simultaneously adjust the bending shape of all the adjustable bending sections 11 so as to quickly adjust the distal end of the tube body 10 to approach or obtain the desired distal end of the tube body 10 State, that is, coarse adjustment of the distal end of the tube body 10 is achieved.
  • both of the adjustable bends 11 then bend to the right with a certain curvature to form a compound bend that can enter the right coronary artery.
  • each adjustable bending section 11 it is possible to individually adjust each adjustable bending section 11 to bend to change the curvature, so that the The distal end of the tube body 10 accurately reaches the desired bending state, that is, the fine adjustment of the distal end of the tube body 10 can be achieved, so that the distal end of the tube body 10 can meet the needs of different operations and the anatomical structure of the lumen of different patients.
  • the control mechanism 23 includes at least two first drive control parts 231.
  • the first driving control member 231 corresponds to the sub-sliding member 222 one by one to drive the corresponding sub-sliding member 222 to move relative to the sliding member 221, and can drive the sliding member 221 to move relative to the handle housing 21 to move the catheter 10 Adjust the distal end to different shapes.
  • the sliding member 221 is a bar-shaped member extending along the axial direction of the bending handle 20, and includes a bearing block 2211 and a driving block 2212 perpendicular to the middle of the bearing block 2211. That is, the cross section of the sliding member 221 is basically an inverted T shape.
  • a sliding groove 2213 extending along the axial direction of the handle 20 is provided on a side of the bearing block 2211 facing away from the driving block 2212, and a convex portion adapted to the sliding groove 2213 is provided on the inner wall of the second inner shell 212
  • the convex strip 2114 is installed in the sliding groove 2213, so as to realize the axial movement of the sliding member 221 in the second inner shell 212.
  • the chute 2213 may also be provided on the inner wall of the second inner shell 212, and the protrusion 2114 may be provided on the bearing block 2211.
  • the driving block 2212 is provided with a mounting hole 2214 penetrating the driving block 2212 in a direction perpendicular to the axial direction of the handle 20.
  • the mounting hole 2214 may also be two grooves provided on opposite sides of the driving block 2212.
  • the sliding member 221 is provided with a perforation 2216 penetrating the sliding member 221 along the axial direction of the handle 20.
  • the perforation 2216 is coaxial with the axis of the handle 20.
  • the tube body 10 extends from the distal end of the first housing 213 Pass through the perforation 2216 and connect to the proximal luer 70 of the second housing 214.
  • the sub-slider 222 is preferably a rack.
  • there are two sub-sliders 222 which are respectively slidably connected to the bearing block 2211 of the slider 221, and are respectively located on both sides of the driving block 2212.
  • the two opposite side surfaces of the sub-slider 222 are provided with travel grooves 2221 extending axially along the handle 20, and the side of the bearing block 2211 facing the driving block 2212 is provided with a groove 2217.
  • the opposite groove wall of the groove 2217 is provided with a convex rib 2215 that cooperates with the travel groove 2221, the sub-slider 222 is installed in the groove 2217 on the bearing block 2211, and the convex rib 2215 is slidingly connected in the stroke groove 2221 to realize the movement of the sub-slider 222 on the slider 221 in the axial direction.
  • the side of the sub-slider 222 facing away from the bearing block 2211 is provided with a plurality of teeth arranged along the extending direction of the stroke groove 2221.
  • the side of the sub-sliding member 222 facing the bearing block 2211 is provided with an accommodating groove 2223, and the proximal end of the traction member 30 is fixed in the accommodating groove 2223 of the sub-sliding member 222, so that the traction member 30 is approached
  • the end is accommodated in the accommodating groove 2223 and fixed in the sub-sliding member 222 to prevent the traction member 30 from protruding from the surface of the sub-sliding member 222 and affecting the sliding of the sub-sliding member 222 relative to the sliding member 221.
  • the proximal end of the traction member 30 is welded to a connecting block 2224, the connecting block 2224 is embedded in the accommodating groove 2223, so that the traction member 30 is more stably fixed to the sub-sliding member 222 on.
  • each of the first driving control parts 231 includes a fine adjustment knob 2311 and a gear shaft 2312.
  • the axial direction of the gear shaft 2312 is perpendicular to the axial direction of the handle housing 21.
  • One end of the gear shaft 2312 is provided with a gear 2313 that meshes with the sub-slider 222, and the other end is connected to the fine adjustment knob 2311.
  • One end of the gear shaft 2312 provided with the gear 2313 passes through the guide hole 2111 on the handle housing 21, and the gear 2313 meshes with the sub-slider 222.
  • the gear 2313 is provided with a protrusion 2314 on the side away from the fine adjustment knob 2311, the protrusion 2314 penetrates into the mounting hole 2214 on the driving block 2212, and can be inserted into the mounting hole 2214 Internal rotation, that is, the gear shaft 2312 and the sliding member 221 are rotationally connected, so that when the fine adjustment knob 2311 is pushed or pulled in the axial direction, the protrusion 2314 connected to the fine adjustment knob 2311 can push or pull the slide member 221 to drive it on it All the sub-slider pieces 222 move relative to the handle housing 21, thereby simultaneously adjusting the bending forms of all the adjustable bending sections 11 to achieve coarse adjustment of the distal end of the tube body 10.
  • the gear shaft 2312 drives the gear 2313 to rotate, so as to drive the sub-slider 222 meshing with the gear 2313 to move relative to the slider 221, thereby adjusting the adjustable bending section 11 connected to the sub-slider 222 To adjust the bending form, that is, to fine-tune the distal end of the tube body 10.
  • the sub-slider 222 may also be provided with a plurality of groove structures at intervals on the side facing away from the bearing block 2211 along the extending direction of the travel groove 2221
  • one end of the gear shaft 2312 is provided with an engagement member that meshes with the sub-slider 222 instead of a gear
  • the other end of the gear shaft 2312 provided with the engagement member is rotatably connected with the slider 221.
  • the outer surface of the engaging member is provided with a plurality of protrusions corresponding to the grooves of the sub-sliding member 222.
  • the control mechanism 23 further includes a second driving control member 232.
  • the second driving control member 232 is a sleeve.
  • the second driving control part 232 is sleeved outside the first inner shell 211 and is located between the first outer shell 213 and the second outer shell 214, and the second driving control part 232 is provided with opposite two Out the through hole 233.
  • the gear shaft 2312 passes through the through hole 232 and the guide hole 2111 on the handle housing 21, so that the gear 2313 on the gear shaft 2312 meshes with the sub-slider 222.
  • the inner wall of the through hole 233 is provided with a plurality of locking grooves 2331, and the extending direction of the locking groove 2331 is the same as the extending direction of the through hole 233.
  • the fine adjustment knob 2311 includes a knob portion 2311a and a connecting shaft 2311b connected to the knob portion 2311a and located at the center of the knob portion 2311a.
  • the axis of the connecting shaft 2311b is coaxial with the rotation axis of the knob portion 2311a and the axis of the gear shaft 2312.
  • the outer surface of the connecting shaft 2311b is provided with a plurality of rib positions 2311c corresponding to the clamping grooves 2331, and a first elastic member 2315 is provided between the gear 2313 and the fine adjustment knob 2311.
  • the first elastic member When 2315 is naturally extended, the rib 2311c snaps into the slot 2331, and the fine adjustment knob 2311 stops rotation, so that the fine adjustment knob 2311 cannot drive the gear shaft 2312 and the gear 2313 to rotate, thereby preventing the sub-sliding member 222 from sliding relatively
  • the fine adjustment knob 2311 is pressed to compress the first elastic member 2315, the rib 2311c disengages from the slot 2331.
  • the gear shaft 2312 and the gear 2313 can be driven by rotating the fine adjustment knob 2311
  • the rotation allows the sub-slider 222 to slide relative to the slider 221. That is, when it is necessary to simultaneously adjust all the adjustable bending sections 11 for bending, no operation is performed on the fine adjustment knob 2311. Under the action of the first elastic member 2315, the rib position 2311c snaps into the slot 2331, the fine adjustment knob 2311 stops rotation, and prohibits gear
  • the shaft 2312 drives the gear 2313 to rotate, so that the sub-sliding member 222 is fixed relative to the sliding member 221.
  • pushing or pulling the second driving control member 232 along the axial direction of the handle 20 can drive the sliding member 221 and the sliding member All sub-sliders 222 on 221 move synchronously with respect to the handle housing 21 to simultaneously adjust all adjustable bending sections 11 for bending.
  • the second driving control member 232 may be kept still, and the corresponding fine-tuning knob 2311 may be pressed inward to disengage the fine-tuning knob 2311 from the anti-rotation state and rotate the fine-tuning knob 2311 Then, the corresponding gear shaft 2312 and gear 2313 can be driven to rotate, so that the corresponding sub-slider 222 moves relative to the slider 221, thereby realizing fine adjustment of the bending shape of the single adjustable bending section 11.
  • the first elastic member 2315 is preferably a spring, and the first elastic member 2315 is sleeved outside the gear shaft 2312.
  • the connecting shaft 2311b of the fine adjustment knob is hollow, the gear shaft 2312 is inserted into the connecting shaft 2311b, and there is a gap in the axial direction between the connecting shaft 2311b and the gear shaft 2312,
  • the fine adjustment knob 2311 is allowed to move inward along its axis when pressed, so that the rib 2311c is disengaged from the clamping groove 2331 without causing the gear shaft 2312 and the gear 2313 to move relative to the sub-slider 222 along its axis.
  • the bending handle 20 further includes a locking member 40, the locking member 40 is provided on the handle housing 21, and is used to lock the second driving control member 232 in The position on the handle housing 21.
  • the locking member 40 includes a second elastic member 41 and a button 42.
  • the second elastic member 41 is preferably a spring.
  • the button 42 includes a pressing portion 421 and a locking portion 422 perpendicularly connected to the pressing portion 421.
  • the second elastic member 41 is connected between the pressing portion 421 and the handle housing 21.
  • one end of the second elastic member 41 is connected to the second inner shell 212 of the handle housing 21, and the other end is connected to the pressing portion 421 through the first outer shell 213 or the second outer shell 214.
  • the locking portion 422 locks the position of the second driving control member 232 on the handle housing 21; pressing the pressing portion 421 to compress the second elastic member 41 At this time, the locking of the second driving control member 232 by the locking portion 422 is released.
  • the locking portion 422 is a hook-shaped member with one end fixed to the pressing portion 421, and the second drive control member 232 is close to an end of the first housing 213 and an end of the second housing 214
  • Each is provided with a groove or an opening 215, and when the second driving control member 232 is moved close to the first housing 213 or the second housing 214, the pressing portion 421 is engaged with the groove or the opening 215, so as to lock the position of the second driving control member 232 on the handle housing 21, at this time, by turning the fine adjustment knob 2311, the shape of the corresponding adjustable bending section 11 can be finely adjusted, and the desired pipe body can be obtained
  • the fine adjustment knob 2311 cooperates with the corresponding through hole 233 on the second drive control member 232 to stop rotation, avoiding the position of the second drive control member 232 and the first drive control member 231 during the operation Variations, that is, to avoid changes in the curved shape of the distal end of the tube body 10 during the operation, so that
  • the distal end of the tube body 10 can be applied to both left coronary intervention surgery and right coronary intervention surgery.
  • the handle housing 21 of the bending handle 20 is provided with a gear mark 50 on the stroke of the second drive control member 232 moving along the axial direction of the handle housing 21 to mark the second drive control member 232 It is located on the handle housing 21.
  • the gear marks 50 are respectively provided at the positions where the two locking pieces 40 are located.
  • the bending handle 20 provided by the present invention controls the driving mechanism 22 to perform different forms of movement through the control structure 23 to perform different actions.
  • the different forms of movement of the driving mechanism 22 are used to simultaneously drive all
  • the bending of the adjustable bending section 11 and the independent driving of the bending of the adjustable bending section 11 are suitable for operations with different requirements on the distal bending shape of the tube body 10, such as left coronary intervention surgery and right coronary intervention surgery, and It can adapt to the individual differences of the anatomy of the lumen of different patients.
  • the present invention provides an adjustable bending catheter 100 including the bending handle 20.
  • the adjustable bendable catheter 100 can be used in various operations that have different requirements on the distal shape of the catheter.
  • the adjustable bendable catheter 100 is used as an example for the interventional operation of the left coronary artery and the right coronary artery.
  • the adjustable bending catheter 100 includes a tube body 10, the bending handle 20 and at least two traction members 30.
  • the bending handle 20 is connected to the proximal end of the tube body 10.
  • the distal end of the tube body 10 is provided with at least two adjustable bending sections 11 arranged at intervals.
  • One end of the traction member 30 is correspondingly connected to the adjustable bending section 11, and the other end is correspondingly connected to a sub-sliding member 222 in the bending handle 20.
  • the traction member 30 is disposed along the pipe body 10 and can move along the pipe body 10, and the bending handle 20 controls the traction member 30 to move along the pipe body 10 to drive the adjustable bending section 11 to bend.
  • all the traction members 30 can be synchronously controlled to move along the tube body 10 to simultaneously drive all
  • the adjustable bend section 11 bends to improve the efficiency of adjusting the adjustable bend conduit 100; by rotating the fine adjustment knob 2311 in each first drive control member 231 to drive the corresponding sub-slider 222 to move relative to the slider 221 in the axial direction It can independently control the corresponding traction member 30 to move along the tube body 10 to drive the corresponding adjustable bending section 11 to bend, and further adjust the distal end of the adjustable bending catheter 100 to a desired bending form.
  • the adjustable bending section 11 may also be three or more sections.
  • the tube body 10 includes an inner membrane 10a, a reinforcing tube 10b sleeved on the inner membrane 10a, and an outer tube 10c sleeved on the reinforcement tube 10b.
  • the inner membrane 10a is a flexible tube made of a flexible material such as PTFE;
  • the reinforcement tube 10b is preferably a metal braided mesh structure, which has a certain rigidity and can be bent in the axial direction, thereby Provide support for the pipe body 10, avoid torsional deformation of the pipe body 10 in the radial direction, improve the torsion control of the pipe body 10, and at the same time, do not affect the bending of each adjustable bending section 11 on the pipe body 10;
  • the outer tube 10c is made of PEBAX and other materials with excellent biocompatibility and certain hardness.
  • the hardness of the portion 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 the adjustable bending section 11 is more likely to bend.
  • the portion of the outer tube 10c corresponding to the adjustable bend 11 and the other parts are made of PEBAX materials of different brands, and the outer tube 10c corresponds to the PEBAX material used by the portion of the adjustable bend 11
  • the hardness is less than the hardness of the PEBAX material used in other parts of the outer tube 10c, so that the hardness of the outer tube 10c corresponding to the portion of the adjustable bend 11 is less than the hardness of the other parts of the outer tube 10c.
  • the inner membrane 10a, the reinforcing 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. It can be understood that, in other embodiments of the present invention, the inner membrane 10a, the reinforcing tube 10b, and the outer tube 10c may also be made of materials other than this embodiment if the usage requirements are met.
  • the distal end of the tube body 10 is a curved end with a smooth surface, that is, a Tip head, and a radiopaque developing ring (not shown), such as tantalum, is provided on the proximal side of the Tip head Ring, etc., so that it can accurately know whether the distal end of the tube body 10 reaches the desired position under the developing device.
  • a radiopaque developing ring such as tantalum
  • the traction member 30 is embedded in the tube wall of the tube body 10, and is disposed along the axial direction of the tube body 10. Specifically, in this embodiment, the traction member 30 is located between the inner membrane 10a and the reinforcement tube 10b.
  • the traction member 30 includes a traction wire 31.
  • the distal end of the traction wire 31 is connected to an adjustable bending section 11.
  • the proximal end passes through the tube wall at the proximal end of the tube body 10 and is connected to the corresponding adjustment handle 20.
  • the sub-slider 222 slides to drive the pulling wire 31 to move the corresponding adjustable bending section 11 to bend.
  • the number of the adjustable bending sections 11 is two, which are respectively the first adjustable bending section 11a and the second adjustable bending section 11b; there are also two traction members 30, which are respectively the first traction Member 30a and second traction member 30b.
  • the first traction member 30a connects the first adjustable bending section 11a and a sub-sliding member 222 in the bending handle 20, and the second traction member 30b connects the second adjustable bending section 11b and Another sub-slider 222 in the bending handle 20.
  • the first adjustable curved section 11a is mainly used to select the left coronary artery or the right coronary artery and control the depth of entry into the coronary artery by adjusting its bending form, so the length of the first adjustable curved section 11a is required to be relatively small, preferably 10mm ⁇ 15mm, and the first adjustable bending section 11a needs to be more flexible than the second adjustable bending section 11b, so that the second adjustable bending section 11b can continue to bend on the basis of the basic fixed shape, so the first The bending section 11a is softer than the second adjustable bending section 11b.
  • the hardness of the first adjustable bending section 11a is preferably 25D to 35D.
  • the second adjustable curved section 11b needs to provide support for the first adjustable curved section 11a, so that the first adjustable curved section 11a can more easily approach the entrance position of the left coronary artery or the right coronary artery, so the second adjustable curved segment 11b is required
  • the length is longer, preferably 25mm to 35mm, and the hardness is higher than that of the first adjustable bending section 11a, preferably 45D to 55D.
  • the other parts of the pipe body 10 should have a higher hardness to ensure the torsion control and supportability of the pipe body 10, so the hardness needs Larger, in this embodiment, the hardness of the other parts of the tube body 10 is 72D.
  • the bending angle of the first adjustable bending section 11a (the angle between the tube body adjacent to the proximal end of the first adjustable bending section 11a and the tangent to the proximal end of the first adjustable bending section 11a) is 0 ° -90 °
  • the bending angle range of the second adjustable bending section 11b is -90 ° -180 ° (the tangent line between the tube body near the proximal end of the second adjustable bending section 11b and the proximal end of the second adjustable bending section 11b Angle) to allow the distal end of the tube 10 to be bi-directionally bent to meet the needs of interventional surgery for the left and right coronary arteries.
  • adjustable bending catheter 100 when used for interventional surgery of other lumens of the human body, three or more adjustable bending sections 11 may be provided as needed, and correspondingly The adjustable bending range of each adjustable bending section 11 is adjusted to meet the needs of surgery.
  • Different bends can be obtained by compounding all the adjustable bends 11, for example, pushing all the traction wires 31 distally to the first position can make all the adjustable bends 11 compound to form a close to the right coronary artery Curved shape, pulling all the traction wires 31 to the second position synchronously to the second position can make all the adjustable bending segments 11 form a curved shape close to the left coronary artery, and push or pull a certain traction wire 31 alone, The pulling wire 31 will drive the corresponding adjustable bending section 11 to achieve a certain angle range of bending, so that after all the pulling wires 31 are controlled synchronously, the corresponding adjustable bending section 11 can be bent by individually controlling a certain pulling wire 31
  • the fine-tuning of the tube makes the distal curve of the tube body 10 suitable for the coronary anatomy of different patients; if the force on the traction wire 31 is cancelled, the corresponding adjustable curve segment 11 can be restored to its original shape under the effect of its own elasticity.
  • the cross-sectional shape of the pulling wire 31 may be circular or flat.
  • the diameter of the pulling wire 31 ranges from 0.05 mm to 0.25 mm.
  • the pulling wire 31 is preferably made of a metal material, such as stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy. It can be understood that, in other embodiments, the pulling wire 31 may also be made of a polymer material with a certain strength. Preferably, in this embodiment, the pulling wire 31 is a stainless steel wire with a diameter of 0.20 mm.
  • an end of the traction wire 31 connected to the adjustable bending section 11 is provided with an anchor ring 32, and the anchor ring 32 is fixedly sleeved on the adjustable bending section 11, that is, the traction wire
  • the distal end of 31 is connected to the adjustable bend 11 through an anchor ring 32.
  • the anchor ring 32 is sleeved on the inner membrane 10a and corresponds to the position of the adjustable bending section 11.
  • the anchor ring 32 increases the contact area between the traction member 30 and the adjustable bending section 11 on the pipe body 10, so that the adjustable bending section 11 can be better bent.
  • the anchor ring 32 may be made of a metal material or a polymer material.
  • the anchor ring 32 is made of metal such as SUS304 stainless steel.
  • the methods for connecting the pulling wire 31 and the anchor ring 32 include, but are not limited to, bonding, welding, hot melting, and knotting, which are not limited herein.
  • the traction member 30 further includes a covered wire tube 33, and a portion of the drawn wire 31 located in the tube body 10 is movably penetrated in the covered wire tube 33 to define the drawing direction of the drawn wire 31 by the covered wire tube 33 and pass through
  • the wire covering tube 33 protects the pulling wire 31.
  • the inner diameter of the wire-wrapped tube 33 is slightly larger than the diameter of the pulling wire 31 for the pulling wire 31 to pass through, which can prevent the tube body 10 from holding the pulling wire 31 tightly when the hot melt shrinks, causing the pulling wire 31 to fail It slides smoothly in the axial direction and prevents the pulling wire 31 from being broken due to bending.
  • the inner diameter of the covered tube 33 can be selected to be 0.40 mm.
  • the hardness of the portion of the covered wire tube 33 corresponding to the adjustable bending section 11 should be less than the hardness of other parts, that is, the portion of the covered wire tube 33 corresponding to the adjustable bending section 11 is flexible, so as not to affect the adjustment.
  • the portion of the threading tube 33 embedded in the adjustable bend 11 may be a soft PTFE thin tube, and the other part may be a PI thin tube or a stainless steel thin tube.
  • the pulling wire 31 passes through the proximal end of the tube body 10 and is fixedly connected to the corresponding sub-slider 222 in the bending handle 20.
  • the pulling wire 31 is fixedly provided with a hardened tube (not shown in the figure) outside the portion connected to the sub-slider 222, and the strength of the hardened tube is greater than that of the covered wire tube 33 to increase the pulling wire 31
  • the strength of the connecting part of the sub-slider 222 avoids pulling the pulling wire 31 and facilitates connecting the pulling wire 31 with the sub-slider 222.
  • the hardened tube includes but is not limited to stainless steel tube.
  • this embodiment further includes a splitting head (not shown). After each pulling wire 31 passes out of the tube body 10, different splitting wires 31 are guided into the bending handle 20 through the splitting head The path is extended so as to connect different sub-slides 222.
  • the traction wires 31 corresponding to different adjustable bending sections 11 are all provided on the same side of the tube body 10, and the traction wires 31 of the first traction member 30 a correspond to the first adjustable bending section 11 a And the traction wire 31 of the second traction member 30b corresponding to the second adjustable bending section 11 are parallel to the axis of the tube body 10, and the traction wire 31 of the first traction member 30a corresponds to the first adjustable
  • the portion of the bent section 11a coincides with the plane formed by the axis of the tube body 10 and the traction wire 31 of the second traction member 30b corresponds to the plane of the axis formed by the axis of the tube body 10
  • the two anchoring rings 32 are respectively provided with an arc-shaped portion that is concave inwardly or convexly with respect to the outer circumference of the anchoring ring 32, and the two covered wire tubes 33 are respectively Fixed in the arc-shaped portion, the covered wire tube 33 on the first traction member 30a is stacked on the covered wire tube 33 on the second traction member 30b in the radial direction of the tube body 10, and the traction wire 31 is passed through Inside the filament tube 33, so that the plane formed by the pulling wire 31 of the first pulling member 30a and the axis of the pipe body 10 and the plane formed by the pulling wire 31 of the second pulling member 30b and the axis of the pipe body 10 coincide, the first The plane where the adjustable bending section 11a bends when driven by the traction wire 31 in the corresponding wire covering tube 33 and the plane where the second adjustable bending section 11b bends when driven by the traction wire 31 in the corresponding wire covering pipe 33 are coplanar.
  • the two anchoring rings 32 are provided with arc-shaped portions convex outwardly from the outer circumference of the anchoring ring 32, and the two covered wire tubes 33 are fixed in the arc-shaped portions, respectively, and the first traction member 30 a
  • the portion of the upper covered wire tube 33 corresponding to the first adjustable bending section 11a and the portion of the covered wire tube 33 on the second traction member 30b corresponding to the second adjustable bending section 11b are parallel to the axis of the tube body 10 and are On the same straight line, the pulling wire passes through the wire covering tube, so that the pulling wire 31 of the first pulling member 30a corresponds to the plane formed by the portion of the first adjustable bending section 11a and the axis of the tube body 10 and the second pulling member 30b
  • the portion of the traction wire 31 corresponding to the second adjustable bending section 11 coincides with the plane formed by the axis of the tube body 10, which can also cause the first adjustable bending section 11a to occur when the traction wire 31
  • the covered wire tube 33 on the first traction member 30a and the covered wire tube 33 on the second traction member 30b may also be arranged in parallel, that is, two drawing wires 31 is arranged in parallel, so that the plane where the first traction member 30a drives the first adjustable bending section 11a to bend and the plane where the second traction member 30b drives the second adjustable bending section 11b to bend are not coplanar.
  • the distal end of the tube body 10 can form different compound bends instantly, and the different compound bends can respectively approach different positions of the human body lumen
  • the physiological anatomy of the left coronary artery and the right coronary artery and by manipulating the bending handle 20, it is also possible to fine-tune the bending shape of each adjustable bending section 11 in real time in the body, so that the same adjustable bending catheter 100 can be used to implement the adjustment.
  • the operation of the distal shape of the curved catheter has different requirements such as left coronary intervention surgery and right coronary intervention surgery, and can adapt to the individual differences of the anatomical anatomy of different patients, reduce the number of punctures, and reduce the damage to the human body. Simplify the operation process and shorten the operation time.
  • the tube body 10 When performing the left coronary intervention operation and the right coronary intervention operation using the flexible catheter 100, the tube body 10 reaches the entrance of the coronary artery through the radial artery. Manually manipulate the second drive control member 232 to slide distally to a position close to the first housing 213, and lock the second drive control member 232 through the locking member 40.
  • the second driving control member 232 drives the first driving control member 231, the sub-sliding member 222 and the sliding member 221 along Axial movement, the sub-slider 222 pushes all the traction wires 31 towards the distal end, so that all the adjustable bends 11 can be instantly compounded to form a bend that can intervene in the right coronary artery, and then push the fine adjustment knob 2311 to make the tendon
  • the position 2311c is separated from the slot 2331 and the fine adjustment knob 2311 is rotated, so that the corresponding sub-sliding member 222 can be driven to slide axially on the sliding member 221, thereby driving the pulling wire 31 to act on the corresponding adjustable bending section 11 and adjusting the corresponding Fine adjustment of the bending shape of the bending section 11 can enable the distal end of the tube body 10 to smoothly enter the right coronary artery.
  • the rib position 2311c on the fine adjustment knob 2311 snaps in The slot 2331, the gear 2313 will not rotate, so that the position of the sub-slider 222 relative to the slider 221 remains unchanged, and the second drive control member 232 drives the first drive control member 231 and the sub-slider 222, the slide member 221 along In axial movement, the sub-slider 222 pulls all the traction wires 31 towards the proximal end, so that all the adjustable bends 11 can be instantly compounded to form a bend that can intervene in the left coronary artery, and then the tendon 2311c can be made by pushing the fine adjustment knob 2311 By disengaging the slot 2331 and rotating the fine adjustment knob 2311, the corresponding sub-sliding member 222 can be driven to slide axially on the sliding member 221, thereby driving the pulling wire 31 to act on the corresponding adjustable bending section 11 Curved Fine adjustment, it is possible that the distal end of the catheter smoothly into the left coronary artery.
  • the adjustable bending catheter 100 of the present invention can realize that one adjustable bending catheter 100 can be applied to both left coronary intervention surgery and right coronary intervention surgery, and each adjustable bending segment 11 can be real-time It can be fine-tuned to adapt to the coronary anatomy of different patients.
  • the above embodiment only takes two adjustable bending sections 11 on the pipe body 10 as an example.
  • a larger number of adjustable bending sections 11 may be provided, as long as A corresponding number of sub-sliding members 222 and the first driving control member 232 can be arranged in the bending handle 20.

Abstract

一种调弯手柄(20)及包括调弯手柄(20)的可调弯导管(100)。可调弯导管(100)包括管体(10)、调弯手柄(20)以及至少两个牵引件(30)，管体(10)远端设有至少两个间隔设置的可调弯段(11)，调弯手柄(20)包括驱动机构(22)及与驱动机构(22)连接的控制机构(23)，每个牵引件(30)的远端与一可调弯段(11)连接，近端与调弯手柄(20)内驱动机构(22)的一子滑动件(221)连接。通过操控调弯手柄(20)能够同时驱动所有的可调弯段(11)弯曲形成不同的复合弯形或单独驱动一可调弯段(11)弯曲以微调相应可调弯段(11)的弯形，实现了使用同一可调弯导管(100)便能够实施对可调弯导管(100)的远端形态有不同要求的手术如左冠脉介入手术与右冠脉介入手术，并能够适应不同病人管腔生理解剖结构的个体化差异。

Description

调弯手柄及可调弯导管 技术领域
本发明涉及医疗器械领域，尤其涉及一种调弯手柄及可调弯导管。
背景技术
目前广泛应用的冠脉指引导管或者造影导管大多为预塑形导管，导管远端至少包含有预塑形的两个弯曲段。但现有的预塑形导管，如图1a中所示的Judkins Left导管只能适用于左冠脉介入手术，图1b中的Judkins Right只能适用于右冠脉介入手术，因此，要进行左冠脉与右冠脉的介入手术，必须更换预塑形的导管，经两次穿刺使得两种预塑形的导管分别进入左冠脉、右冠脉，手术过程耗时较长，操作较复杂。此外，在实际的临床使用过程中，经常遇到人体管腔解剖结构的个体化差异，即使是已经预塑形的导管也难以适应不同人体的左冠脉或右冠脉。为了防备手术过程中出现此类问题，医生通常会预备多种不同规格的预塑形导管，如图2a中自左至右的导管规格分别为JL6.0、JL5.0、JL4.5、JL4.0、JL3.5及JL3.0(其中JL表示能够介入左冠脉的Judkins系列导管，JL之后的数字表示两个预塑形的弯形之间的距离)，如图2b中自左至右的导管规格分别为JR 6.0、JR5.0、JR4.5、JR4.0、JR3.5及JR3.0(其中JR表示能够介入右冠脉的Judkins系列导管，JR之后的数字表示两个预塑形的弯形之间的距离)，一旦发现所选的某个规格的预塑形导管的远端形状不适合，就撤出该导管，再更换其他规格的预塑形导管，有时甚至需要根据病人左冠脉或右冠脉的特定生理解剖结构，在手术现场将导管远端重新塑形成所需的形状，进一步增加了手术过程的复杂性，而且会延长病人暴露于X射线下的时间，不利于患者的健康。
发明内容
本发明提供一种调弯手柄及包括所述调弯手柄的可调弯导管，通过操控调弯手柄能够使得所述可调弯导管的远端即时形成不同的复合弯形，不同的复合弯形分别能够接近人体管腔不同位置处如左冠脉与右冠脉的生理解剖结构，并且通过操控调弯手柄还能够在体内实时微调各弯形，从而使用同一可调弯导管便能够实施对可调弯导管的远端形态有不同要求的手术如左冠脉介入手术与右冠脉介入手术，并能够适应不同病人管腔生理解剖结构的个体化差异，减少穿刺次数，减小对人体的损伤，简化手术过程，缩短手术时间。
所述调弯手柄用于操控与所述调弯手柄连接的管体远端上的至少两个可调弯段发生弯曲，所述调弯手柄包括驱动机构及与所述驱动机构连接的控制机构，所述驱动机构与所有的所述可调弯段连接；所述控制机构通过不同的动作控制所述驱动机构作不同形式的运动，所述驱动机构不同形式的运动分别用于同时驱动所有的所述可调弯段弯曲以及单独驱动各个所述可调弯段弯曲，以使得所述管体远端即时形成不同的复合弯形。
所述可调弯导管包括管体、至少两个牵引件以及所述调弯手柄，所述调弯手柄连接于所述管体的近端，所述管体远端设有至少两个间隔设置的可调弯段；每个所述牵引件的远端与一所述可调弯段连接，近端与所述调弯手柄内的所述驱动机构连接。
本发明提供的调弯手柄及可调弯导管，通过所述驱动机构运动能够同时带动各所述可 调弯段同时弯曲或者分别牵引各个不同的所述可调弯段进行弯曲，从而使得可调弯导管的远端即时形成不同的复合弯形，不同的复合弯形分别能够接近人体管腔不同位置处如左冠脉与右冠脉的生理解剖结构，并且通过操控调弯手柄还能够在体内实时微调各弯形，从而使用同一可调弯导管便能够实施对可调弯导管的远端形态有不同要求的手术如左冠脉介入手术与右冠脉介入手术。并且，能够根据不同病人管腔生理解剖结构的个体化差异调整每个所述可调弯段的弯曲曲率，以适应不同人体的需求，减少穿刺次数，减小对人体的损伤，简化手术过程，缩短手术时间。
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1a为现有的一种适于左冠脉介入手术的预塑形导管的应用示意图；
图1b为现有的一种适于右冠脉介入手术的预塑形导管的应用示意图；
图2a是现有的适于左冠脉介入手术的不同规格的Judkins Left预塑形导管的结构示意图；
图2b是现有的适于右冠脉介入手术的不同规格的Judkins Right预塑形导管的结构示意图；
图3是本发明实施例的可调弯导管一个方向的立体结构示意图；
图4是本发明实施例的可调弯导管另一个方向的立体结构示意图；
图5是本发明实施例的可调弯导管的立体拆分结构示意图；
图6是本发明实施例的调弯手柄的沿其轴向的截面示意图；
图7是图6中I-I处的截面示意图；
图8a是本发明实施例的管体一种弯曲形态的结构示意图；
图8b是本发明实施例的管体另一种弯曲形态的结构示意图；
图9是本发明实施例的调弯手柄内驱动机构与控制机构的立体拆分示意图；
图10是本发明实施例的调弯手柄内第二内壳的结构示意图；
图11是本发明实施例的调弯手柄内滑动件的结构示意图；
图12是本发明实施例的调弯手柄内子滑动件的结构示意图；
图13是本发明实施例的管体的具体结构示意图；
图14是本发明实施例的牵引件与管体的结构示意图；
图15是本发明另一实施例的牵引件与管体的结构示意图；
图16是本发明另一实施例的牵引件与管体的结构示意图；
图17是本发明实施例中第二驱动控制件移动至一档位标识处、管体远端能够介入右冠脉的示意图；
图18是本发明实施例的管体的第二驱动控制件移动至另一档位标识处、管体远端能够介入左冠脉的示意图。
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3至图7及图8a与图8b，本发明提供一种调弯手柄20，用于操控与其连接的管体10远端的至少两个可调弯段11的弯曲方向及曲率，使得管体10远端能够即时形成不同的复合弯形，以满足对管体10的远端形态有不同要求的手术需求。本实施例中，以所述调弯手柄20调弯所述管体10远端以使其满足左冠脉与右冠脉的介入手术对所述管体10远端的要求为例进行说明，所述可调弯段11的数量为两个，且两个可调弯段11在管体10上间隔设置。本实施例中，所述调弯手柄20包括手柄壳体21、驱动机构22及与所述驱动机构22连接的控制机构23。所述驱动机构22通过与可调弯段11对等数量的牵引件30与所有的可调弯段11连接。所述控制机构23与所述驱动机构22连接以控制所述驱动机构22运动，进而通过驱动机构22运动以带动可调弯段11弯曲。所述控制机构23通过不同的动作控制所述驱动机构22作不同形式的运动，所述驱动机构不同形式的运动分别用于同时驱动所有的所述可调弯段11弯曲以及单独驱动各个所述可调弯段11弯曲，以使得所述管体10远端即时形成不同的复合弯形。具体地，通过所述驱动机构22同时驱动所有的可调弯段11弯曲，以提高调弯效率，使得所述管体10远端能够尽快弯曲至手术所需的接近某些人体管腔解剖结构如左冠脉或右冠脉的形态，从而缩短手术时间。通过所述驱动结构22分别单独驱动各个所述可调弯段11弯曲，以对各个所述可调弯段11的弯曲曲率进行微调，以精确调节各所述可调弯段11的弯曲曲率，从而适应不同病人管腔生理解剖结构的个体化差异，扩大管体10的适用范围。
请进一步参阅图3至图9，所述驱动机构22设于手柄壳体21内，控制机构23设于手柄壳体21外。所述控制机构23驱动所述驱动机构22沿所述手柄壳体21轴向移动，以带动牵引件30连接的可调弯段11弯曲或回直。本实施例中，所述手柄壳体21包括第一内壳211、第二内壳212、第一外壳213及第二外壳214。所述第一内壳211与所述第二内壳212部分套合并固定，本实施例中，所述第一内壳211套设于所述第二内壳212外。所述第一外壳213及第二外壳214间隔套设于所述第一内壳211和/或第二内壳212的外表面并露出部分所述第一内壳211。其中，所述第一内壳211、第二内壳212、第一外壳213及第二外壳214均可以为一体成型或者有两个或多个子壳体拼合形成。本实施例中，所述第一外壳213及第一内壳211、第二内壳212均为一体成型结构，所述第二外壳214为两个子壳体拼 合形成。可以理解的是，在本发明的一些实施例中，可以仅包括所述第一内壳211或所述第二内壳212。驱动机构22活动收容于所述第二内壳212内，所述控制机构23位于所述第一外壳213与第二外壳214之间，并活动套设于所述第一内壳211外。请进一步参阅图3至图5及图10，所述第一外壳213与第二外壳214之间露出的所述第一内壳211及所述第二内壳212上设有至少两个导向孔2111，所述导向孔2111的数量与可调弯段11的数量相同。并且，所述第一内壳211与所述第二内壳212套合后，所述第一内壳211与第二内壳212上的所述导向孔2111重合。本实施例中，所述导向孔2111的数量为两个，且两个导向孔2111相对设置。所述第二外壳214的近端与鲁尔接头70固定连接。
具体地，请参阅图5至图7及图9至图12，所述驱动机构22包括滑动连接于所述第二内壳212内的滑动件221、沿所述手柄壳体21的轴向方向滑动连接于所述滑动件221上的至少两个子滑动件222。每个所述子滑动件222通过一牵引件30对应与一可调弯段11连接，当所述子滑动件222相对于手柄壳体21滑动时，便能够带动相应的牵引件30进行牵引，从而使得相应的可调弯段11进行一定曲率的弯曲。本实施例中，通过驱动所述滑动件221在所述第二内壳212内沿所述第二内壳212的轴向移动，来带动位于滑动件221上的所有的子滑动件222相对所述第二内壳212同步移动，以同时调节所有可调弯段11的弯形，从而对所述管体10的远端进行快速的调弯，以接近或得到所需的管体10远端的状态，即实现对所述管体10远端的粗调。例如，当需要调节得到适于左冠脉介入手术的管体10的远端形态时，朝向所述管体10远端移动所述滑动件221，两个所述可调弯段11随即均向左弯曲一定的曲率形成能够进入左冠脉的复合弯形；当需要调节得到适于右冠脉介入手术的管体10的远端形态时，朝向所述管体10近端移动所述滑动件221，两个所述可调弯段11随即均向右弯曲一定的曲率形成能够进入右冠脉的复合弯形。进一步地，通过保持所述滑动件221不动，分别单独调节各个所述子滑动件222相对所述滑动件221滑动，能够单独调节各个可调弯段11进行弯曲来改变曲率，以使所述管体10远端准确达到所需的弯曲状态，即能够实现所述管体10远端的微调，使得所述管体10远端能够满足不同的手术及不同病人的管腔解剖结构的需求。
本实施例中，所述控制机构23包括至少两个第一驱动控制件231。第一驱动控制件231与子滑动件222一一对应，以驱动对应的子滑动件222相对于滑动件221移动，并能够驱动滑动件221相对所述手柄壳体21移动，以将所述导管10远端的调弯至不同的形态。
具体地，请参阅图11，所述滑动件221为沿所述调弯手柄20的轴向方向延伸的条状件，其包括承载块2211及垂直于所述承载块2211中部的驱动块2212，即所述滑动件221的截面基本呈倒T型。所述承载块2211背离所述驱动块2212的一面设有沿所述手柄20轴向延伸的滑槽2213，所述第二内壳212的内壁上设有与所述滑槽2213适配的凸条2114，所述凸条2114装设于滑槽2213内，以实现所述滑动件221在所述第二内壳212内沿轴向的移动。可以理解的是，所述滑槽2213也可以设于所述第二内壳212的内壁上，所述凸条2114设于所述承载块2211上。进一步地，所述驱动块2212上设有沿垂直于手柄20轴向方向贯穿该驱动块2212的安装孔2214。可以理解的是，所述安装孔2214也可以为设于所述驱动块2212相对两侧上的两个凹槽。所述滑动件221上设有一沿手柄20轴向贯穿该滑动件221的穿孔2216，所述穿孔2216与手柄20的轴线同轴设置，所述管体10从所述第一外壳213 的远端穿过所述穿孔2216并与所述第二外壳214的近端的鲁尔接头70连接。
请参阅图6、图7、图9及图11、图12，所述子滑动件222优选为齿条。本实施例中，所述子滑动件222为两条，分别滑动连接在所述滑动件221的承载块2211上，并分别位于所述驱动块2212的两侧。具体地，所述子滑动件222的相对两个侧面设有沿所述手柄20轴向延伸的行程槽2221，所述承载块2211上朝向所述驱动块2212的一面设有凹槽2217，所述凹槽2217的相对的槽壁上设有与所述行程槽2221相配合的凸肋2215，所述子滑动件222装设于所述承载块2211上的凹槽2217内，并使凸肋2215滑动连接于行程槽2221内，以实现子滑动件222在滑动件221上沿轴向的移动。所述子滑动件222背离所述承载块2211的一侧设有沿所述行程槽2221延伸方向设置的多个齿。所述子滑动件222朝向所述承载块2211的一面设有容置槽2223，牵引件30的近端固定于所述子滑动件222的容置槽2223内，从而实现将牵引件30的近端容置于所述容置槽2223内并固定于子滑动件222内，避免所述牵引件30突出于子滑动件222的表面而影响子滑动件222相对于滑动件221的滑动。进一步地，本实施例中，牵引件30的近端焊接在一连接块2224上，所述连接块2224内嵌于所述容置槽2223，使得牵引件30更稳定的固定在子滑动件222上。
请进一步参阅图5至图12，每个所述第一驱动控制件231包括微调旋钮2311及齿轮轴2312。所述齿轮轴2312的轴向与所述手柄壳体21的轴向垂直。所述齿轮轴2312一端设有与子滑动件222啮合的齿轮2313，另一端与所述微调旋钮2311连接。所述齿轮轴2312设有所述齿轮2313的一端穿过所述手柄壳体21上的导向孔2111，齿轮2313与子滑动件222啮合。进一步地，本发明中，齿轮2313远离所述微调旋钮2311的一面设有凸起2314，所述凸起2314穿入所述驱动块2212上的安装孔2214内，并可在所述安装孔2214内旋转，即实现齿轮轴2312与滑动件221转动连接，从而使得沿轴向推动或拉动微调旋钮2311时，通过与微调旋钮2311连接的凸起2314即可推动或拉动滑动件221带动位于其上的所有子滑动件222相对于手柄壳体21移动，从而同时调节所有的可调弯段11的弯曲形态，实现对管体10远端粗调。旋转微调旋钮2311时，所述齿轮轴2312带动所述齿轮2313转动，以驱动与齿轮2313啮合的子滑动件222相对滑动件221移动，从而对与该子滑动件222连接的可调弯段11的弯曲形态进行调节，即实现对管体10远端的微调。
可以理解的是，在本发明的其它实施例中，所述子滑动件222也可以为在背离所述承载块2211的一侧沿所述行程槽2221延伸方向间隔设置有多个凹槽结构的条形件，所述齿轮轴2312的一端设有与子滑动件222啮合的啮合件来代替齿轮，且所述齿轮轴2312设有所述啮合件的一端与所述滑动件221转动连接。所述啮合件的外表面设有与所述子滑动件222的凹槽对应的多个凸起。所述齿轮轴2312带动所述啮合件转动时，所述啮合件外表面的凸起依次与所述子滑动件222上的凹槽啮合，以带动所述子滑动件222相对滑动件221移动。
进一步地，本发明中，所述控制机构23还包括第二驱动控制件232。本实施例中，所述第二驱动控制件232为套筒。所述第二驱动控制件232套设于所述第一内壳211外并位于所述第一外壳213与第二外壳214之间，且所述第二驱动控制件232上设有相对的两个贯穿孔233。所述齿轮轴2312穿过所述贯穿孔232及所述手柄壳体21上的导向孔2111，使得齿轮轴2312上的齿轮2313与子滑动件222啮合。沿轴向推动或拉动所述第二驱动控 制件232时，能够使得所有的微调旋钮2311同步移动，进而使得滑动件221相对于手柄壳体21的滑动更加地稳定。
进一步地，本实施例中，所述贯穿孔233的内壁设有多个卡槽2331，所述卡槽2331的延伸方向与所述贯穿孔233的延伸方向相同。所述微调旋钮2311包括旋钮部2311a以及与旋钮部2311a连接并位于旋钮部2311a中心的连接轴2311b，所述连接轴2311b的轴线与旋钮部2311a的旋转轴及齿轮轴2312的轴线共轴。所述连接轴2311b的外表面设有与所述卡槽2331对应的多个筋位2311c，所述齿轮2313与所述微调旋钮2311之间设有第一弹性件2315，所述第一弹性件2315自然伸长时，所述筋位2311c卡入所述卡槽2331内，微调旋钮2311止转，从而微调旋钮2311不能够带动齿轮轴2312与齿轮2313进行转动，进而避免子滑动件222相对滑动件221滑动；按压所述微调旋钮2311以压缩所述第一弹性件2315时，所述筋位2311c脱离所述卡槽2331，此时，通过旋转微调旋钮2311能够带动齿轮轴2312与齿轮2313进行转动，使得子滑动件222能够相对滑动件221滑动。即在需要同时调节所有可调弯段11进行弯曲时，不对微调旋钮2311做任何操作，在第一弹性件2315的作用下，筋位2311c卡入卡槽2331，微调旋钮2311止转，禁止齿轮轴2312带动齿轮2313转动，使得子滑动件222相对滑动件221固定，此时，沿所述手柄20的轴向方向推动或拉动所述第二驱动控制件232便能够带动滑动件221及滑动件221上的所有子滑动件222相对手柄壳体21同步移动，以同时调节所有可调弯段11进行弯曲。当需要对某一个可调弯段11单独进行微调时，可以保持所述第二驱动控制件232不动，向内按压相应的微调旋钮2311使微调旋钮2311脱离止转状态并旋转该微调旋钮2311，便能够带动相应的齿轮轴2312与齿轮2313转动，使得相应的子滑动件222相对滑动件221移动，从而实现对单个可调弯段11弯曲形态的微调。本实施例中，所述第一弹性件2315优选为弹簧，所述第一弹性件2315套设于所述齿轮轴2312外。进一步地，本发明的一些实施例中，微调旋钮的连接轴2311b内中空，齿轮轴2312插入连接轴2311b内，且连接轴2311b与齿轮轴2312之间在其轴向上存在一定距离的间隙，允许微调旋钮2311受按压时沿其轴向向内移动使筋位2311c脱离卡槽2331，而不会引起齿轮轴2312及齿轮2313沿其轴向相对于子滑动件222发生移动。
进一步地，请参阅图5及图6，所述调弯手柄20还包括锁定件40，所述锁定件40设于所述手柄壳体21上，用于锁定所述第二驱动控制件232在所述手柄壳体21上的位置。本实施例中，所述锁定件40包括第二弹性件41以及按钮42。本实施例中，所述第二弹性件41优选为弹簧。所述按钮42包括按压部421以及与所述按压部421垂直连接的锁定部422。所述第二弹性件41连接于所述按压部421与所述手柄壳体21之间。具体地，所述第二弹性件41一端连接于所述手柄壳体21的第二内壳212上，另一端穿过第一外壳213或第二外壳214与所述按压部421连接。所述第二弹性件41自然伸长时，所述锁定部422锁定所述第二驱动控制件232在手柄壳体21上的位置；按压所述按压部421以压缩所述第二弹性件41时，解除所述锁定部422对所述第二驱动控制件232的锁定。本实施例中，所述锁定部422为一端固定于所述按压部421上的钩状件，所述第二驱动控制件232靠近所述第一外壳213的一端及靠近第二外壳214的一端均设有凹槽或者开孔215，所述第二驱动控制件232被移动至靠近所述第一外壳213或第二外壳214时，所述按压部421卡合于所 述凹槽或者开孔215内，从而锁定所述第二驱动控制件232在所述手柄壳体21上的位置，此时通过旋转微调旋钮2311便能微调相应可调弯段11的弯形，在获得期望的管体10远端的弯曲形态后，微调旋钮2311与第二驱动控制件232上相应的贯穿孔233配合而止转，避免在手术过程中第二驱动控制件232及第一驱动控制件231的位置发生变化，即避免手术过程中管体10远端的弯曲形态发生变化，使得管体10远端保持在期望的弯曲形态。本实施例中，所述管体10远端既能适用于左冠脉介入手术也能适用于右冠脉介入手术，所述锁定件40有两个，分别设于第一外壳213及第二外壳214上：当所述第二驱动控制件232朝远端移动至靠近第一外壳213并被一锁定件40锁定时，所述管体10远端的弯曲形态接近右冠脉的生理解剖结构，再通过微调旋钮2311微调各可调弯段11的弯形便能够使得管体10远端适应不同病人右冠脉生理解剖结构的差异而顺畅进入右冠脉，适用于右冠脉介入手术；当所述第二驱动控制件232朝近端移动至靠近第二外壳212并被另一锁定件40锁定时，所述管体10远端的弯曲形态接近左冠脉的生理解剖结构，再通过微调旋钮2311微调各可调弯段11的弯形便能够使得管体10远端顺适应不同病人左冠脉生理解剖结构的差异而顺畅进入左冠脉，适用于左冠脉介入手术。
进一步地，所述调弯手柄20的手柄壳体21上在第二驱动控制件232沿所述手柄壳体21轴向移动的行程上设有档位标识50，以标志第二驱动控制件232位于所述手柄壳体21上的位置。本实施例中，所述档位标识50分别设于两个锁定件40所在的位置。
本发明提供的所述调弯手柄20，通过所述控制结构23做不同的动作控制所述驱动机构22作不同形式的运动，所述驱动机构22不同形式的运动分别用于同时驱动所有的所述可调弯段11弯曲以及单独驱动各个所述可调弯段11弯曲，适用于对管体10的远端弯曲形态有不同要求的手术如左冠脉介入手术与右冠脉介入手术，并能够适应不同病人管腔生理解剖结构的个体化差异。
请参阅图3至图7、图8a、图8b、图17与图18，本发明提供一种包括所述调弯手柄20的可调弯导管100。所述可调弯导管100可应用于各种对导管远端形态有不同要求的手术中。本发明以所述可调弯导管100用于左冠脉与右冠脉的介入手术为例进行说明。所述可调弯导管100包括管体10、所述调弯手柄20以及至少两个牵引件30。所述调弯手柄20与所述管体10的近端连接。所述管体10远端设有至少两个间隔设置的可调弯段11。一所述牵引件30的一端与一所述可调弯段11对应连接，另一端对应连接所述调弯手柄20内的一子滑动件222。所述牵引件30沿所述管体10设置并可沿所述管体10移动，通过所述调弯手柄20控制牵引件30沿管体10移动，以带动可调弯段11弯曲。本发明中，通过推拉所述调弯手柄20上的第二驱动控制件232来驱动所述滑动件221沿轴向移动时能够同步控制所有的牵引件30沿管体10移动，以同时带动所有的可调弯段11弯曲，提高调整所述可调弯导管100的效率；通过旋转各第一驱动控制件231中的微调旋钮2311来驱动相应的子滑动件222相对滑动件221沿轴向移动，能够单独控制相应的牵引件30沿管体10移动，以带动相应的可调弯段11弯曲，进一步调整所述可调弯导管100远端至所需的弯曲形态。可以理解的是，依据可调弯导管100要介入的管腔解剖结构不同，所述可调弯段11也可以为三段或者更多段。
请参阅图8a、图8b及图13，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PTFE等柔性材料制成的柔性管；所述增强管10b优选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沿径向方向的扭转变形，提升管体10的扭控性，同时又不影响所述管体10上各可调弯段11的弯曲；所述外管10c由PEBAX等具有优良的生物相容性与一定硬度的材料制成。并且，所述外管10c对应于可调弯段11部分的硬度小于外管10c其它部分的硬度，使得可调弯段11较易发生弯曲。具体地，本实施例中，外管10c对应于可调弯段11的部分与其它部分分别采用不同牌号的PEBAX材料，且外管10c对应于可调弯段11的部分所采用的PEBAX材料的硬度小于外管10c其他部分所采用的PEBAX材料的硬度，从而使得外管10c对应于可调弯段11部分的硬度小于外管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，本实施例中，所述管体10的远端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(未图示)，如钽环等，从而在显影设备下能够准确得知所述管体10远端是否到达期望位置。
请结合图8a、图8b与图13至图16，所述牵引件30内嵌于所述管体10的管壁内，并沿所述管体10的轴向方向进行设置。具体地，本实施例中，所述牵引件30位于所述内膜10a与增强管10b之间。所述牵引件30包括牵引丝31，所述牵引丝31的远端连接一可调弯段11，近端从管体10近端的管壁穿出并连接至所述调弯手柄20内对应的子滑动件222上，通过子滑动件222滑动以带动牵引丝31移动来实现带动相应的可调弯段11进行弯曲。本实施例中，所述可调弯段11的数量为两个，分别为第一可调弯段11a及第二可调弯段11b；所述牵引件30也有两个，分别为第一牵引件30a以及第二牵引件30b。所述第一牵引件30a连接所述第一可调弯段11a与所述调弯手柄20内的一子滑动件222，所述第二牵引件30b连接所述第二可调弯段11b与所述调弯手柄20内的另一子滑动件222。
本实施例中，第一可调弯段11a主要用于通过调整其弯曲形态选取左冠脉或右冠脉以及控制入冠深度，所以要求第一可调弯段11a的长度相对较小，优选10mm～15mm，并且第一可调弯段11a需要比第二可调弯段11b更加灵活，从而能够在第二可调弯段11b弯形基本固定的基础上继续调弯，所以要求第一可调弯段11a较第二可调弯段11b更加柔软，本实施例中，所述第一可调弯段11a的硬度优选25D～35D。第二可调弯段11b需要为第一可调弯段11a提供支撑，使第一可调弯段11a更容易接近左冠脉或右冠脉入口位置，所以要求第二可调弯段11b的长度较长，优选25mm～35mm，硬度较第一可调弯段11a要高，优选45D～55D。除去Tip头、第一可调弯段11a与第二可调弯段11b之外，管体10的其他部分要具有更高的硬度来保证管体10的扭控性及支撑性，因此硬度需要较大，本实施例中，管体10其他部分的硬度为72D。进一步地，所述第一可调弯段11a的弯曲角度(邻近第一可调弯段11a近端的管体与第一可调弯段11a近端切线之间的夹角)范围为0°-90°，所述第二可调弯段11b的弯曲角度范围为-90°-180°(邻近第二可调弯段11b近端的管体与第二可调弯段11b近端切线之间的夹角)，以允许管体10远端可以双向弯曲，满足左冠 脉与右冠脉的介入手术的需求。可以理解的是，在本发明的其它实施例中，当所述可调弯导管100用于人体其它管腔的介入手术时，可以根据需要设置三个或以上的可调弯段11，且相应调整各可调弯段11的可调弯范围，以满足手术的需求。
本实施例中，若在管体10近端同步牵拉或推顶所有牵引丝31，则所有的可调弯段11均发生弯曲，且同步控制所有牵引丝31近端所处的位置不同即能够得到所有可调弯段11复合而成的不同的弯形，例如，同步朝远端推顶所有牵引丝31至第一位置可以使得所有可调弯段11复合形成接近能够介入右冠脉的弯形，同步朝近端牵拉所有牵引丝31至第二位置可以使得所有可调弯段11复合形成接近能够介入左冠脉的弯形，而单独推顶或牵拉某一牵引丝31，该牵引丝31则会带动相应的可调弯段11实现一定角度范围的弯曲，从而在同步控制所有牵引丝31后，可以通过单独控制某一牵引丝31来进行相应可调弯段11弯形的微调，使得管体10远端的弯形能够适合不同病人的冠脉解剖形态；若撤销对牵引丝31的作用力，则相应的可调弯段11在自身弹性的作用下能够恢复原状。
所述牵引丝31的截面形状可以为圆形或者扁平形状。牵引丝31的直径范围为0.05mm～0.25mm。牵引丝31优选由金属材料制成，例如不锈钢、钨合金、钴铬合金或者镍钛合金等。可以理解的是，在其他实施例中，牵引丝31也可以由具有一定强度的高分子材料制成。优选地，本实施例中，牵引丝31为直径0.20mm的不锈钢丝。
进一步地，请参阅图13至图16，所述牵引丝31与可调弯段11连接的一端设有锚定环32，锚定环32固定套设于可调弯段11上，即牵引丝31的远端通过锚定环32与可调弯段11连接。本实施例中，锚定环32套设于内膜10a上对应于可调弯段11的位置。通过锚定环32增大牵引件30与管体10上可调弯段11的接触面积，能够更好地带动可调弯段11弯曲。锚定环32可以由金属材料或者高分子材料制成，本实施例中，锚定环32选用金属如SUS304不锈钢制成。牵引丝31与锚定环32连接的方式包括但不限于粘合、焊接、热熔、打结等方式，在此不做限定。
所述牵引件30还包括包丝管33，牵引丝31位于管体10内的部分活动穿设于所述包丝管33内，以通过包丝管33限定牵引丝31的牵引方向，并通过包丝管33保护所述牵引丝31。本发明中，所述包丝管33的内径略大于牵引丝31的直径以供牵引丝31穿设其中，能够避免管体10在热熔收缩的时候将牵引丝31抱紧导致牵引丝31无法顺畅的沿轴向滑动，并防止牵引丝31因弯曲而折断。在本实施例中，包丝管33的内径可选择0.40毫米。值得注意的是，包丝管33对应于可调弯段11部分的硬度应小于其它部分的硬度，即包丝管33对应于可调弯段11的部分为柔性的，从而不会影响可调弯段11的弯曲。例如，穿丝管33包埋在可调弯段11内的部分可选用较柔软的PTFE细管，而其它部分可选用PI细管或不锈钢细管。
进一步地，本发明中，所述牵引丝31从所述管体10的近端穿出后固定连接在调弯手柄20内相应的子滑动件222上。并且，牵引丝31在与子滑动件222连接的部位外固定套设有加硬管(图中未示出)，所述加硬管的强度大于包丝管33的强度，以增加牵引丝31子滑动件222连接部分的强度，避免拉断牵引丝31，并便于将牵引丝31与子滑动件222连接。本实施例中，所述加硬管包括但不限于不锈钢管。进一步地，本实施例中还包括分丝头(未图示)，各牵引丝31从管体10中穿出后，通过所述分丝头来引导不同牵引丝31进 入调弯手柄20后的延伸路径，以便连接不同的子滑动件222。
请参阅图14及图15，不同可调弯段11对应连接的牵引丝31均设于管体10的同一侧，所述第一牵引件30a的牵引丝31对应于第一可调弯段11a的部分与第二牵引件30b的牵引丝31对应于第二可调弯段11的部分均与所述管体10的轴线平行，且第一牵引件30a的牵引丝31对应于第一可调弯段11a的部分与管体10的轴线所构成的平面和第二牵引件30b的牵引丝31对应于第二可调弯段11的部分与管体10的轴线所构成的平面重合，从而使得通过第一牵引件30a及第二牵引件30b的牵引丝31带动第一可调弯段11a及第二可调弯段11b进行弯曲时，第一可调弯段11a与第二可调弯段11b发生弯曲所在的平面共面，使得可调弯导管100的远端更易受控，且弯曲后的可调弯导管100的远端能够更容易地进入目标管腔。
具体地，请参阅图14，本发明一实施例中，两锚定环32分别设置有相对锚定环32外周向内凹陷的弧形部或外凸的弧形部，两包丝管33分别固定在弧形部内，第一牵引件30a上的包丝管33在所述管体10的径向方向上叠置于第二牵引件30b上的包丝管33上，牵引丝31穿设于包丝管33内，从而第一牵引件30a的牵引丝31与管体10的轴线所构成的平面和第二牵引件30b的牵引丝31与管体10的轴线所构成的平面重合，第一可调弯段11a在相应包丝管33内牵引丝31带动下发生弯曲所在的平面和第二可调弯段11b在相应包丝管33内牵引丝31带动下发生弯曲所在的平面共面。请参阅图15，本发明另一实施例中，两锚定环32均设置相对锚定环32外周外凸的弧形部，两包丝管33分别固定在弧形部内，第一牵引件30a上的包丝管33对应于第一可调弯段11a的部分与第二牵引件30b上的包丝管33对应于第二可调弯段11b的部分均平行于管体10的轴线并处于同一直线上，牵引丝穿设于包丝管内，从而第一牵引件30a的牵引丝31对应于第一可调弯段11a的部分与管体10的轴线所构成的平面和第二牵引件30b的牵引丝31对应于第二可调弯段11的部分与管体10的轴线所构成的平面重合，同样可以使得第一可调弯段11a在相应包丝管33内牵引丝31带动下发生弯曲所在的平面和第二可调弯段11b在相应包丝管33内牵引丝31带动下发生弯曲所在的平面共面；但第一牵引件30a上的包丝管33在接近第一牵引件30b的锚定环32的位置弯折，使得第一牵引件30a上的包丝管33除对应于第一可调弯段11a外的其它部分与第二牵引件30b上的包丝管33并列设置。
可以理解的是，请参阅图16，本发明另一些实施例中，也可以将第一牵引件30a上的包丝管33与第二牵引件30b上的包丝管33并列设置即两牵引丝31并列设置，从而使得第一牵引件30a带动第一可调弯段11a发生弯曲所在的平面与第二牵引件30b带动第e二可调弯段11b发生弯曲所在的平面非共面。
本发明提供的所述可调弯导管100，通过操控所述调弯手柄20能够使得管体10的远端即时形成不同的复合弯形，不同的复合弯形分别能够接近人体管腔不同位置处如左冠脉与右冠脉的生理解剖结构，并且通过操控调弯手柄20还能够在体内实时微调各可调弯段11的弯形，从而使用同一可调弯导管100便能够实施对可调弯导管的远端形态有不同要求的手术如左冠脉介入手术与右冠脉介入手术，并能够适应不同病人管腔生理解剖结构的个体化差异，减少穿刺次数，减小对人体的损伤，简化手术过程，缩短手术时间。
请同时参阅图3至图9及图17与图18，使用该可调弯导管100实施左冠脉介入手术 与右冠脉介入手术时，管体10经桡动脉到达接近冠脉入口处。手动操控第二驱动控制件232向远端滑动至靠近所述第一外壳213的档位，并通过锁定件40锁定第二驱动控制件232。在第二驱动控制件232向远端滑动至靠近所述第一外壳213的档位的过程中，第二驱动控制件232带动第一驱动控制件231、子滑动件222及滑动件221同步沿轴向运动，所述子滑动件222朝远端推顶所有牵引丝31可以使得所有可调弯段11即时复合形成接近能够介入右冠脉的弯形，然后通过向内推动微调旋钮2311使筋位2311c脱离卡槽2331并旋转微调旋钮2311，便能够驱动相应的子滑动件222在滑动件221上沿轴向滑动，从而带动牵引丝31作用于相应的可调弯段11，对相应可调弯段11的弯形进行微调，能够使得管体10的远端顺利进入右冠脉。当执行完右冠脉的诊疗，需要对左冠脉做诊疗时，手动向下按压锁定所述第二驱动控制件232的锁定件40，所述第二驱动控制件232解锁，拉动所述第二驱动控制件232向近端滑动至靠近第二外壳214的档位，并通过另一锁定件40锁定第二驱动控制件232，这一过程中，由于微调旋钮2311上的筋位2311c卡入卡槽2331，齿轮2313不会发生旋转，从而子滑动件222相对于滑动件221的位置不变，第二驱动控制件232带动第一驱动控制件231以及子滑动件222、滑动件221同步沿轴向运动，子滑动件222朝近端牵拉所有牵引丝31可以使得所有可调弯段11即时复合形成接近能够介入左冠脉的弯形，然后通过向内推动微调旋钮2311使筋位2311c脱离卡槽2331并旋转微调旋钮2311便能够驱动相应的子滑动件222在滑动件221上沿轴向滑动，从而带动牵引丝31作用于相应的可调弯段11，对相应可调弯段11的弯形进行微调，能够使得导管远端顺利进入左冠脉。因此，本发明可调弯导管100，能够实现一根可调弯导管100既能适用于左冠脉介入手术，又能适用于右冠脉介入手术，并且各可调弯段11可以分别进行实时地微调，能够适应不同病人的冠脉解剖形态。
可以理解的是，以上实施例仅是以管体10上设置两个可调弯段11为例，在其它的实施例中，可以设置更多数量的可调弯段11，只要适应性地在调弯手柄20内配置对应数量的子滑动件222及第一驱动控制件232即可。
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 (23)

  1. 一种调弯手柄，其特征在于，用于操控与所述调弯手柄连接的管体远端上的至少两个可调弯段发生弯曲，所述调弯手柄包括驱动机构及与所述驱动机构连接的控制机构，所述驱动机构与所有的所述可调弯段连接；所述控制机构通过不同的动作控制所述驱动机构作不同形式的运动，所述驱动机构不同形式的运动分别用于同时驱动所有的所述可调弯段弯曲以及单独驱动各个所述可调弯段弯曲，以使得所述管体远端即时形成不同的复合弯形。
  2. 如权利要求1所述的调弯手柄，其特征在于，所述驱动机构包括滑动件、滑动连接于所述滑动件上的至少两个子滑动件，一所述子滑动件对应连接一所述可调弯段；所述控制机构包括至少两个第一驱动控制件，一所述第一驱动控制件对应控制一所述子滑动件；一所述第一驱动控制件单独动作驱动对应的所述子滑动件相对所述滑动件移动，以单独驱动对应的可调弯段弯曲；所有的所述第一驱动控制件同步动作驱动所述滑动件沿所述调弯手柄的轴向移动，以同时驱动所有的所述可调弯段弯曲。
  3. 如权利要求2所述的调弯手柄，其特征在于，所述子滑动件为齿条；所述第一驱动控制件包括微调旋钮及齿轮轴，所述齿轮轴一端设有与所述子滑动件啮合的齿轮，另一端与所述微调旋钮连接，且所述齿轮轴设有所述齿轮的一端与所述滑动件转动连接；单独旋转一所述微调旋钮带动对应的齿轮轴转动以驱动对应的所述子滑动件相对所述滑动件移动，以单独驱动对应的可调弯段弯曲；所有的所述微调旋钮同步沿所述调弯手柄的轴向移动带动所有的所述齿轮轴移动以驱动所述滑动件沿所述调弯手柄的轴向移动，以同时驱动所有的所述可调弯段弯曲。
  4. 如权利要求3所述的调弯手柄，其特征在于，所述齿轮轴的延伸方向与所述调弯手柄的轴向垂直。
  5. 如权利要求4所述的调弯手柄，其特征在于，还包括手柄壳体，所述驱动机构位于所述手柄壳体内，所述控制机构位于所述手柄壳体外，所述控制机构带动所述驱动机构相对所述手柄壳体移动。
  6. 如权利要求5所述的调弯手柄，其特征在于，所述手柄壳体上设有沿所述调弯手柄的轴向延伸的导向孔，所述齿轮轴穿过所述导向孔并沿所述导向孔的延伸方向移动。
  7. 如权利要求5或6所述的调弯手柄，其特征在于，所述控制机构还包括第二驱动控制件，所述第二驱动控制件套设于所述手柄壳体外；所述第二驱动控制件上设有贯穿孔，所述齿轮轴通过所述贯穿孔穿过所述第二驱动控制件，与所述齿轮轴连接的所述微调旋钮与所述贯穿孔之间具有止转结构，所述止转结构用于限制所述微调旋钮旋转；所述第二驱动控制件沿所述手柄壳体的轴向移动以带动所有的所述微调旋钮及齿轮轴同步沿所述调弯手柄的轴向移动。
  8. 如权利要求7所述的调弯手柄，其特征在于，所述贯穿孔的内壁设有多个卡槽，所述微调旋钮包括与所述齿轮轴连接的连接轴，所述连接轴的外表面设有与所述卡槽对应的多个筋位，所述卡槽与所述筋位构成所述止转结构，所述齿轮与所述微调旋钮之间设有第一弹性件，所述第一弹性件自然伸长时，所述筋位卡入所述卡槽内，阻止所述微调旋钮旋转；按压所述微调旋钮以压缩所述第一弹性件时，所述筋位脱离所述卡槽，所述微调旋钮 旋转。
  9. 如权利要求7所述的调弯手柄，其特征在于，所述调弯手柄还包括锁定件，所述锁定件设于所述手柄壳体上，用于锁定所述第二驱动控制件在所述手柄壳体上的位置。
  10. 如权利要求9所述的调弯手柄，其特征在于，所述锁定件包括第二弹性件以及按钮，所述按钮包括按压部以及与所述按压部垂直连接的锁定部，所述第二弹性件连接于所述按压部与所述手柄壳体之间，所述第二弹性件自然伸长时，所述锁定部锁定所述第二驱动控制件在所述手柄壳体上的位置；按压所述按压部以压缩所述第二弹性件时，解除所述锁定部对所述第二驱动控制件的锁定。
  11. 如权利要求10所述的调弯手柄，其特征在于，所述手柄壳体上设有档位标识，以标志所述第二驱动控制件位于所述手柄壳体上的位置。
  12. 一种可调弯导管，其特征在于，包括管体、至少两个牵引件以及如权利要求1-11任一项所述的调弯手柄，所述调弯手柄连接于所述管体的近端，所述管体远端设有至少两个间隔设置的可调弯段；每个所述牵引件的远端与一所述可调弯段连接，近端与所述调弯手柄内的所述驱动机构连接。
  13. 如权利要求12所述的可调弯导管，其特征在于，所述管体包括由内至外依次套装的内膜、增强管以及外管。
  14. 如权利要求13所述的可调弯导管，其特征在于，所述外管对应于所述可调弯段的硬度小于所述外管其它部分的硬度。
  15. 如权利要求12所述的可调弯导管，其特征在于，所述牵引件内嵌于所述管体的管壁内。
  16. 如权利要求15所述的可调弯导管，其特征在于，所述牵引件包括牵引丝，所述牵引丝的远端连接一所述可调弯段，近端连接所述调弯手柄内的所述驱动机构。
  17. 如权利要求16所述的可调弯导管，其特征在于，与不同所述可调弯段对应连接的牵引丝均设于所述管体的同一侧，不同牵引丝位于相应可调弯段的部分均平行于所述管体的轴线，且不同牵引丝位于相应可调弯段的部分分别与所述管体的轴线所构成的平面重合。
  18. 如权利要求16所述的可调弯导管，其特征在于，所述牵引件还包括锚定环，所述锚定环内嵌于所述可调弯段的管壁内并与所述牵引丝的远端固定相连。
  19. 如权利要求16所述的可调弯导管，其特征在于，所述牵引件还包括包丝管，所述牵引丝位于所述管体内的部分活动穿设于所述包丝管内，所述包丝管对应于所述可调弯段的硬度小于所述包丝管其它部分的硬度。
  20. 如权利要求12所述的可调弯导管，其特征在于，所述至少两个可调弯段包括位于所述管体远端的第一可调弯段与位于所述第一可调弯段近侧的第二可调弯段；所述第一可调弯段的硬度小于所述第二可调弯段的硬度。
  21. 如权利要求20所述的可调弯导管，其特征在于，所述第一可调弯段的硬度范围为25D至35D，所述第二可调弯段的硬度范围为45D至55D。
  22. 如权利要求20或21所述的可调弯导管，其特征在于，所述第一可调弯段的弯曲角度范围为0°至90°，所述第二可调弯段的弯曲角度范围为-90°至180°。
  23. 如权利要求22所述的可调弯导管，其特征在于，所述控制机构控制所述驱动结构 同时驱动所述第一可调弯段与所述第二可调弯段弯曲，形成适用于介入左冠脉或右冠脉的弯形；并且，所述控制机构控制所述驱动结构单独驱动所述第一可调弯段或第二可调弯段弯曲，以微调所述弯形。
PCT/CN2019/106741 2018-10-31 2019-09-19 调弯手柄及可调弯导管 WO2020088138A1 (zh)

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