CN209884984U - Bending handle and Bendable conduit - Google Patents

Abstract

The utility model provides a bend-adjusting handle and a bend-adjusting catheter comprising the same. The adjustable bending catheter comprises a catheter body, a bending adjusting handle and at least two traction pieces, wherein the far end of the catheter body is provided with at least two adjustable bending sections arranged at intervals, the bending adjusting handle comprises a driving mechanism and a control mechanism connected with the driving mechanism, each traction piece is connected with one adjustable bending section at the far end, and the near end is connected with a sub-sliding piece of the driving mechanism in the bending adjusting handle. The adjustable bending handle can be controlled to simultaneously drive all the adjustable bending sections to be bent to form different composite bending shapes or independently drive one adjustable bending section to be bent to finely adjust the bending shape of the corresponding adjustable bending section, so that operations with different requirements on the far end shape of the adjustable bending catheter, such as left coronary intervention operation and right coronary intervention operation, can be implemented by using the same adjustable bending catheter, and the individual difference of the physiological anatomical structures of the lumens of different patients can be adapted.

Description

Bending handle and Bendable conduit

technical field

The utility model relates to the field of medical instruments, in particular to a bending handle and an adjustable bending catheter.

Background technique

Currently widely used coronary guide catheters or angiography catheters are mostly pre-shaped catheters, and the distal end of the catheter contains at least two pre-shaped curved sections. However, the existing pre-shaped catheters, such as the Judkins Left catheter shown in Figure 1a, can only be used for left coronary intervention, and the Judkins Right shown in Figure 1b can only be used for right coronary intervention. In the interventional operation of coronary artery and right coronary artery, 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 takes a long time and the operation is more complicated. . In addition, in the actual clinical use process, individual differences in the anatomical structure of the human lumen are often encountered, and even a pre-shaped catheter is difficult to adapt to the left coronary artery or right coronary artery of different human bodies. In order to prevent such problems during surgery, doctors usually prepare a variety of pre-shaped catheters of different specifications, as shown in Figure 2a, the catheter specifications from left to right are JL6. .0, JL3.5 and JL3.0 (where JL represents a Judkins series catheter capable of intervening in the left coronary artery, and the number after JL represents the distance between the two pre-shaped curves), as shown in Figure 2b from left to The specifications of the catheters on the right are JR 6.0, JR5.0, JR4.5, JR4.0, JR3.5 and JR3.0 (where JR represents the Judkins series catheter that can intervene in the right coronary artery, and the numbers after JR represent two pre-operative catheters). The distance between the shaped bends), once it is found that the shape of the distal end of the pre-shaped catheter of a certain specification is not suitable, the catheter is withdrawn and replaced with a pre-shaped catheter of other specifications, and sometimes it is even necessary to Reshaping the distal end of the catheter to the desired shape at the surgical site, depending on the specific anatomy of the patient's left or right coronary artery, further complicates the procedure and prolongs the patient's exposure to X-rays , detrimental to the health of patients.

Utility model content

The utility model provides a bend-adjusting handle and an adjustable-bend catheter including the bend-adjustment handle. By manipulating the bend-adjustment handle, the distal end of the bend-adjustable catheter can instantly form different compound bends, and different compound bends can be The shape can be close to the physiological anatomy of the left coronary artery and the right coronary artery at different positions of the human lumen, and by manipulating the bending handle, each bending shape can be fine-tuned in real time in the body, so that the same bendable catheter can be used to perform corrective actions. The distal shape of the adjustable bendable catheter has different requirements for operations such as left coronary intervention and right coronary intervention, and can adapt to the individual differences in the physiological and anatomical structure of the lumen of different patients, reduce the number of punctures, and reduce the impact on the human body. damage, simplify the surgical procedure and shorten the operation time.

The bend adjustment handle is used to control at least two bendable sections on the distal end of the pipe body connected with the bend adjustment handle to bend, and the bend adjustment handle includes a drive mechanism and a control mechanism connected with the drive mechanism , the drive mechanism is connected with 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 motion of the drive mechanism are respectively used to drive all the The adjustable bendable segments are bent and each of the adjustable bendable segments is independently driven to bend, so that the distal end of the tube body forms different compound bend shapes in real time.

Wherein, the driving mechanism includes a sliding member and at least two sub-sliding members slidably connected to the sliding member, and one of the sub-sliding members is correspondingly connected to one of the adjustable bending sections; the control mechanism includes at least two second sliding members. A driving control member, a first driving control member correspondingly controls a sub-slider; a single action of the first driving control member drives the corresponding sub-slider to move relative to the slider, so as to drive independently Corresponding bendable sections are bent; all the first drive control members act synchronously to drive the sliding members to move along the axial direction of the bending handle, so as to drive all the adjustable bendable sections to bend at the same time.

The sub-slider is a rack; the first drive control member includes a fine-tuning knob and a gear shaft, one end of the gear shaft is provided with a gear meshing with the sub-slider, and the other end is connected to the fine-tuning knob , and the gear shaft is provided with one end of the gear and is rotatably connected to the slider; a single rotation of the fine-tuning knob drives the corresponding gear shaft to rotate to drive the corresponding sub-slider to move relative to the slider, The corresponding adjustable bending section is driven to bend independently; all the fine-tuning knobs move synchronously along the axial direction of the bending handle to drive all the gear shafts to move to drive the slider along the axis of the bending handle to move all of the adjustable segments to bend at the same time.

Wherein, the extension direction of the gear shaft is perpendicular to the axial direction of the bending handle.

Wherein, it also includes a handle housing, the driving mechanism is located inside the handle housing, the control mechanism is located outside the handle housing, and the control mechanism drives the driving mechanism to move relative to the handle housing.

Wherein, the handle housing is provided with a guide hole extending along the axial direction of the bending handle, and the gear shaft passes through the guide hole and moves along the extending direction of the guide hole.

Wherein, the control mechanism further includes a second driving control member, the second driving control member is sleeved outside the handle housing; the second driving control member is provided with a through hole, and the gear shaft passes through the The through hole passes through the second drive control member, and a rotation-stop structure is provided between the fine-tuning knob connected to the gear shaft and the through-hole, and the rotation-stop structure is used to limit the rotation of the fine-tuning knob; The second driving control member moves along the axial direction of the handle housing to drive all the fine adjustment knobs and gear shafts to move synchronously along the axial direction of the bending handle.

Wherein, the inner wall of the through hole is provided with a plurality of clamping grooves, the fine adjustment knob includes a connecting shaft connected with the gear shaft, and the outer surface of the connecting shaft is provided with a plurality of rib positions corresponding to the clamping grooves , the locking groove and the rib position constitute the anti-rotation structure, a first elastic member is arranged between the gear and the fine adjustment knob, and when the first elastic member naturally stretches, the rib position locks into the card slot to prevent the fine adjustment knob from rotating; when the fine adjustment knob is pressed to compress the first elastic member, the rib is disengaged from the card slot, and the fine adjustment knob rotates.

Wherein, the bending handle further includes a locking piece, which is arranged on the handle housing and is used to lock the position of the second driving control piece on the handle housing.

Wherein, the locking member includes a second elastic member and a button, the button includes a pressing portion and a locking portion vertically connected to the pressing portion, and the second elastic member is connected to the pressing portion and the handle housing In between, when the second elastic member extends naturally, the locking portion locks the position of the second driving control member on the handle housing; when the pressing portion is pressed to compress the second elastic member , releasing the locking of the second driving control member by the locking portion.

Wherein, the handle housing is provided with a gear mark to mark the position of the second drive control member on the handle housing.

The adjustable bendable catheter comprises a pipe body, at least two traction members and the bend adjustment handle, the bend adjustment handle is connected to the proximal end of the pipe body, and the distal end of the pipe body is provided with at least two spaced The distal end of each traction member is connected with one of the adjustable bend segments, and the proximal end is connected with the drive mechanism in the bend adjustment handle.

Wherein, the tube body includes an inner membrane, a reinforcing tube and an outer tube which are sheathed in sequence from the inside to the outside.

Wherein, the hardness of the outer tube corresponding to the adjustable bendable section is smaller than the hardness of other parts of the outer tube.

Wherein, the traction member is embedded in the pipe wall of the pipe body.

Wherein, the traction member includes a traction wire, the distal end of the traction wire is connected to the adjustable bending section, and the proximal end is correspondingly connected to the driving mechanism in the bending handle.

Wherein, the traction wires corresponding to the different adjustable bendable sections are arranged on the same side of the tube body, the parts of the different traction wires located in the corresponding adjustable bendable sections are all parallel to the axis of the tube body, and the different traction wires are located on the same side of the tube body. The parts of the wires located in the corresponding bendable sections respectively coincide with the planes formed by the axis of the pipe body.

Wherein, the traction member further comprises an anchoring ring, the anchoring ring is embedded in the tube wall of the adjustable bend segment and is fixedly connected with the distal end of the traction wire.

Wherein, the traction member further includes a wire covering tube, the part of the pulling wire located in the tube body is movably passed through the wire covering tube, and the hardness of the wire covering tube corresponding to the adjustable bending section is smaller than that of the wire covering tube. Describe the hardness of other parts of the wire wrapping tube.

Wherein, the at least two bendable segments include a first bendable segment located at the distal end of the tube body and a second bendable segment located at the proximal side of the first bendable segment; the first bendable segment The stiffness of the bendable section is smaller than the stiffness of the second bendable section.

Wherein, the hardness of the first bendable segment ranges from 25D to 35D, and the hardness of the second bendable segment ranges from 45D to 55D.

Wherein, the bending angle of the first bendable segment ranges from 0° to 90°, and the bend angle of the second bendable segment ranges from -90° to 180°.

Wherein, the control mechanism controls the driving structure to simultaneously drive the first bendable segment and the second bendable segment to bend, so as to form a bend suitable for intervening the left coronary artery or the right coronary artery; The control mechanism controls the driving structure to individually drive the first bendable segment or the second bendable segment to bend, so as to fine-tune the bend shape. Specifically, the second driving control member slides distally to a gear position close to the first housing and is locked by the locking member, so as to drive the sliding member and all the sub-sliders in the axial direction synchronously Move to the distal end to drive the first adjustable segment and the second adjustable segment to bend at the same time to form a curved shape close to the right coronary artery, and then individually rotate a said fine-tuning knob to drive a corresponding sub-slider to be relatively The sliding member slides in the axial direction, so that the first bendable section or the second bendable section is individually bent to fine-tune the bending shape; the second drive control member slides proximally to be close to the second housing and is locked by the locking piece, so as to drive the sliding piece and all the sub-sliding pieces to move toward the proximal end synchronously in the axial direction, and drive the first adjustable bending section and the second adjustable bending section Simultaneously bend to form a curved shape close to the left coronary artery, and then rotate a fine-tuning knob to drive a corresponding sub-slider to slide relative to the slider in the axial direction, so that the first adjustable bendable segment or the second Bendable segments bend individually to fine tune the bend.

With the bending handle and the adjustable bending guide provided by the present invention, the movement of the driving mechanism can simultaneously drive the adjustable bending sections to bend at the same time or pull the different adjustable bending sections respectively to bend, so that the adjustable bending sections can be bent at the same time. The distal end of the bend-adjusting catheter forms different compound bends in real time, and the different compound bends can approach the physiological anatomy of the left coronary artery and the right coronary artery at different positions of the human lumen respectively, and can also be adjusted by manipulating the bend-adjusting handle. Each bend is fine-tuned in real time in the body, so that the same bendable catheter can be used to perform operations that have different requirements on the distal shape of the bendable catheter, such as left coronary intervention and right coronary intervention. In addition, the bending curvature of each adjustable bendable segment can be adjusted according to the individual differences of the physiological and anatomical structures of the lumen of different patients, so as to meet the needs of different human bodies, reduce the number of punctures, reduce the damage to the human body, and simplify the operation process. Reduce surgery time.

Description of drawings

In order to illustrate the structural features and effects of the present utility model more clearly, it will be described in detail below with reference to the accompanying drawings and specific embodiments.

Fig. 1a is a schematic diagram of the application of an existing pre-shaped catheter suitable for left coronary intervention;

Fig. 1b is an application schematic diagram of an existing pre-shaped catheter suitable for right coronary intervention;

Figure 2a is a schematic structural diagram of the existing Judkins Left pre-shaped catheters of different specifications suitable for left coronary intervention;

Figure 2b is a schematic structural diagram of an existing Judkins Right pre-shaped catheter of different specifications suitable for right coronary intervention;

Fig. 3 is the three-dimensional structure schematic diagram of the adjustable bendable conduit in one direction according to the embodiment of the present invention;

4 is a schematic three-dimensional structural diagram of the adjustable bendable conduit in another direction according to an embodiment of the present invention;

5 is a schematic diagram of a three-dimensional disassembly structure of an adjustable bendable conduit according to an embodiment of the present invention;

6 is a schematic cross-sectional view of the bending handle according to the embodiment of the present invention along its axial direction;

Fig. 7 is a schematic cross-sectional view at I-I in Fig. 6;

8a is a schematic structural diagram of a curved shape of the pipe body according to the embodiment of the present invention;

Figure 8b is a schematic structural diagram of another curved shape of the pipe body according to the embodiment of the present invention;

Fig. 9 is the three-dimensional disassembly schematic diagram of the drive mechanism and the control mechanism in the bending handle according to the embodiment of the present invention;

10 is a schematic structural diagram of the second inner shell in the bending handle according to the embodiment of the present invention;

11 is a schematic structural diagram of a sliding member in a bending handle according to an embodiment of the present invention;

12 is a schematic structural diagram of a sub-slider in a bending handle according to an embodiment of the present invention;

Fig. 13 is the concrete structural schematic diagram of the pipe body of the embodiment of the present invention;

14 is a schematic structural diagram of a traction member and a pipe body according to an embodiment of the present invention;

15 is a schematic structural diagram of a traction member and a pipe body according to another embodiment of the present invention;

16 is a schematic structural diagram of a traction member and a pipe body according to another embodiment of the present invention;

17 is a schematic diagram of the second drive control member moving to the first gear mark in the embodiment of the present invention, and the distal end of the tube body can be inserted into the right coronary artery;

18 is a schematic diagram of the second drive control member of the tube body moving to another gear mark according to the embodiment of the present invention, and the distal end of the tube body can be inserted into the left coronary artery.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Wherein, the accompanying drawings are only used for exemplary description, and are only schematic diagrams, which should not be construed as limitations on the present patent.

In order to describe the structure of the adjustable handle and the adjustable catheter more clearly, the terms "proximal end" and "distal end" are defined herein as common terms 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 close to the operator during the surgical operation.

Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the art. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments, and are not intended to limit the present invention.

Please refer to FIGS. 3 to 7 and FIGS. 8 a and 8 b , 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 to it. , so that the distal end of the tube body 10 can instantly form different composite curved shapes, so as to meet the surgical requirements with different requirements for the distal end shape of the tube body 10 . In this embodiment, an example is described by taking the bending handle 20 to bend the distal end of the tube body 10 to meet the requirements of the interventional operation of the left coronary artery and the right coronary artery on the distal end of the tube body 10 as an example. The number of the adjustable bendable sections 11 is two, and the two adjustable bendable sections 11 are arranged on the pipe body 10 at intervals. In this embodiment, 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 with the driving mechanism 22 to control the movement of the driving mechanism 22 , and then drives the adjustable bending section 11 to bend through the movement of the driving mechanism 22 . The control mechanism 23 controls the driving mechanism 22 to perform different forms of movement through different actions, and the different forms of movement of the driving mechanism are respectively used to simultaneously drive all the adjustable bending sections 11 to bend and individually drive each of the The adjustable bendable section 11 is bent, so that the distal end of the tubular body 10 can instantly form different compound bending shapes. Specifically, the driving mechanism 22 drives all the adjustable bendable segments 11 to bend at the same time, so as to improve the bending efficiency, so that the distal end of the tubular body 10 can be bent as soon as possible to be close to certain human lumen anatomical structures required by the operation Such as the shape of the left coronary artery or the right coronary artery, thereby shortening the operation time. Each of the adjustable bendable segments 11 is individually driven to bend by the drive structure 22, so as to fine-tune the bending curvature of each of the adjustable bendable segments 11, so as to precisely adjust the bending curvature of each of the adjustable bendable segments 11, Therefore, the individual differences of the lumen physiology and anatomical structure of different patients are adapted, and the applicable scope of the tube body 10 is expanded.

Please refer to FIG. 3 to FIG. 9 , the driving mechanism 22 is arranged inside the handle housing 21 , and the control mechanism 23 is arranged 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 bendable section 11 connected to the traction member 30 to bend or straighten. In this embodiment, the handle casing 21 includes a first inner casing 211 , a second inner casing 212 , a first outer casing 213 and a second outer casing 214 . The first inner shell 211 and the second inner shell 212 are partially sleeved and fixed. In this embodiment, 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 sleeved on the outer surface of the first inner shell 211 and/or the second inner shell 212 at intervals and partially expose the first inner shell 211 . Wherein, the first inner shell 211 , the second inner shell 212 , the first outer shell 213 and the second outer shell 214 may be integrally formed or formed by combining two or more sub-shells. In this embodiment, 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 combining 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 . Please refer to FIG. 3 to FIG. 5 and FIG. 10 , at least two guide holes are formed on the first inner shell 211 and the second inner shell 212 exposed between the first outer shell 213 and the second outer shell 214 2111, the number of the guide holes 2111 is the same as the number of the adjustable bending sections 11. In addition, after the first inner shell 211 and the second inner shell 212 are assembled together, the guide holes 2111 on the first inner shell 211 and the second inner shell 212 overlap. In this embodiment, the number of the guide holes 2111 is two, and the two guide holes 2111 are arranged opposite to each other. The proximal end of the second housing 214 is fixedly connected with the luer connector 70 .

Specifically, please refer to FIGS. 5 to 7 and FIGS. 9 to 12 , the driving mechanism 22 includes a sliding member 221 slidably connected to the second inner shell 212 along the axial direction of the handle shell 21 . At least two sub-sliding members 222 are slidably connected to the sliding member 221 . Each of the sub-sliders 222 is correspondingly connected to an adjustable bending section 11 through a pulling member 30. When the sub-slider 222 slides relative to the handle housing 21, it can drive the corresponding pulling member 30 to pull. Therefore, the corresponding bendable section 11 is bent with a certain curvature. In this embodiment, by driving the sliding member 221 to move along the axial direction of the second inner casing 212 within the second inner casing 212 , all the sub-sliding members 222 on the sliding member 221 are driven relative to each other. The second inner shell 212 moves synchronously to adjust the bending shapes of all the adjustable bending sections 11 at the same time, 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, the rough adjustment of the distal end of the tube body 10 is realized. For example, when it is necessary to adjust the distal end shape of the tubular body 10 suitable for left coronary intervention, the sliding member 221 is moved toward the distal end of the tubular body 10, and the two adjustable bendable sections 11 are then moved toward the distal end of the tubular body 10. The left curvature has a certain curvature to form a compound curved shape that can enter the left coronary artery; when it is necessary to adjust the distal end shape of the tube body 10 suitable for right coronary intervention, move the slider toward the proximal end of the tube body 10 221 , the two adjustable bendable segments 11 are then bent to the right with a certain curvature to form a compound bend that can enter the right coronary artery. Further, by keeping the sliding member 221 still and adjusting each of the sub-sliders 222 to slide relative to the sliding member 221 individually, each adjustable bendable segment 11 can be individually adjusted to bend to change the curvature, so that the The distal end of the tubular body 10 can accurately reach the required bending state, that is, fine adjustment of the distal end of the tubular body 10 can be realized, so that the distal end of the tubular body 10 can meet the requirements of different operations and the lumen anatomy of different patients.

In this embodiment, the control mechanism 23 includes at least two first drive control members 231 . The first driving control member 231 is in one-to-one correspondence with the sub-slider 222, so as to drive the corresponding sub-slider 222 to move relative to the slider 221, and can drive the slider 221 to move relative to the handle housing 21, so as to drive the catheter 10 The distal end of the bend to a different shape.

Specifically, please refer to FIG. 11 , the sliding member 221 is a strip-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. The side of the bearing block 2211 facing away from the driving block 2212 is provided with a chute 2213 extending axially along the handle 20 , and the inner wall of the second inner shell 212 is provided with a protrusion adapted to the chute 2213 A strip 2114 , the protruding strip 2114 is installed in the chute 2213 to realize the axial movement of the sliding member 221 in the second inner shell 212 . It can be understood that the chute 2213 can also be provided on the inner wall of the second inner shell 212 , and the protruding strips 2114 can be provided on the bearing block 2211 . Further, the driving block 2212 is provided with a mounting hole 2214 which penetrates the driving block 2212 in a direction perpendicular to the axial direction of the handle 20 . It can be understood that, the mounting holes 2214 can also be two grooves provided on opposite sides of the driving block 2212 . The sliding member 221 is provided with a through hole 2216 penetrating the sliding member 221 in the axial direction of the handle 20 . The through hole 2216 is disposed coaxially with the axis of the handle 20 . Pass through the perforation 2216 and connect with the luer connector 70 at the proximal end of the second housing 214 .

Please refer to FIGS. 6 , 7 , 9 , 11 and 12 , the sub-slider 222 is preferably a rack. In this embodiment, there are two sub-sliding members 222 , which are respectively slidably connected to the bearing blocks 2211 of the sliding members 221 and located on both sides of the driving block 2212 . Specifically, two opposite sides of the sub-slider 222 are provided with travel grooves 2221 extending axially along the handle 20, and a side of the bearing block 2211 facing the driving block 2212 is provided with grooves 2217, so The opposite groove wall of the groove 2217 is provided with a convex rib 2215 which is matched with the travel groove 2221. The 2215 is slidably connected in the stroke groove 2221 to realize the axial movement of the sub-slider 222 on the slider 221 . 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 travel groove 2221 . The side of the sub-slider 222 facing the bearing block 2211 is provided with an accommodating groove 2223, and the proximal end of the pulling member 30 is fixed in the accommodating groove 2223 of the sub-sliding member 222, so as to realize the close proximity of the pulling member 30. 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 . Further, in this embodiment, the proximal end of the pulling member 30 is welded to a connecting block 2224, and the connecting block 2224 is embedded in the accommodating groove 2223, so that the pulling member 30 is more stably fixed to the sub-slider 222 superior.

Please refer to FIG. 5 to FIG. 12 , each of the first driving control elements 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 engaged 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 engages with the sub-slider 222 . Further, in the present invention, the side of the gear 2313 away from the fine adjustment knob 2311 is provided with a protrusion 2314, the protrusion 2314 penetrates into the installation hole 2214 on the drive block 2212, and can be inserted into the installation hole 2214 is rotated inwards, that is, the gear shaft 2312 and the sliding member 221 are rotatably connected, so that when the fine-tuning knob 2311 is pushed or pulled in the axial direction, the sliding member 221 can be pushed or pulled by the protrusion 2314 connected with the fine-tuning knob 2311 All the sub-sliders 222 on the upper part move relative to the handle housing 21 , so as to adjust the bending shape of all the adjustable bending sections 11 at the same time, so as to realize the rough adjustment of the distal end of the tube body 10 . When the fine-tuning knob 2311 is rotated, the gear shaft 2312 drives the gear 2313 to rotate, so as to drive the sub-slider 222 engaged with the gear 2313 to move relative to the slider 221 , thereby adjusting the adjustable bending section 11 connected to the sub-slider 222 The bending shape is adjusted, that is, the fine adjustment of the distal end of the tube body 10 is realized.

It can be understood that, in other embodiments of the present invention, the sub-sliding member 222 may also be provided with a plurality of groove structures at intervals along the extending direction of the travel groove 2221 on the side away from the bearing block 2211 One end of the gear shaft 2312 is provided with a meshing member that engages with the sub-slider 222 instead of a gear, and one end of the gear shaft 2312 provided with the meshing member is rotatably connected to the sliding member 221 . The outer surface of the engaging member is provided with a plurality of protrusions corresponding to the grooves of the sub-slider 222 . When the gear shaft 2312 drives the engaging member to rotate, the protrusions on the outer surface of the engaging member engage with the grooves on the sub-slider 222 in sequence to drive the sub-slider 222 to move relative to the slider 221 .

Further, in the present invention, the control mechanism 23 further includes a second driving control member 232 . In this embodiment, the second driving control member 232 is a sleeve. The second driving control member 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 member 232 is provided with two opposite through holes 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 engages with the sub-slider 222 . When the second driving control member 232 is pushed or pulled in the axial direction, all the fine adjustment knobs 2311 can be moved synchronously, thereby making the sliding of the sliding member 221 relative to the handle housing 21 more stable.

Further, in this embodiment, the inner wall of the through hole 233 is provided with a plurality of engaging grooves 2331 , and the extending direction of the engaging grooves 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 in the center of the knob portion 2311a. The outer surface of the connecting shaft 2311b is provided with a plurality of ribs 2311c corresponding to the locking grooves 2331. A first elastic member 2315 is provided between the gear 2313 and the fine adjustment knob 2311. The first elastic member When the 2315 stretches naturally, the rib 2311c snaps into the slot 2331, and the fine-tuning knob 2311 stops rotating, so that the fine-tuning knob 2311 cannot drive the gear shaft 2312 and the gear 2313 to rotate, thereby preventing the relative sliding of the sub-slider 222. When the fine adjustment knob 2311 is pressed to compress the first elastic member 2315, the rib 2311c is disengaged from the slot 2331. At this time, by rotating the fine adjustment knob 2311, the gear shaft 2312 and the gear 2313 can be driven to Rotate so that the sub-slider 222 can slide relative to the slider 221 . That is, when it is necessary to adjust all the adjustable bending sections 11 at the same time for bending, do not do any operation on the fine-tuning knob 2311. Under the action of the first elastic member 2315, the rib 2311c is stuck into the slot 2331, the fine-tuning knob 2311 is stopped, and the gear is prohibited. The shaft 2312 drives the gear 2313 to rotate, so that the sub-sliding member 222 is fixed relative to the sliding member 221. At this time, pushing or pulling the second driving control member 232 in the axial direction of the handle 20 can drive the sliding member 221 and the sliding member All the sub-sliders 222 on the 221 move synchronously relative to the handle housing 21 to adjust all the adjustable bending sections 11 to bend at the same time. When it is necessary to fine-tune a certain adjustable bending section 11 individually, the second driving control member 232 can be kept still, the corresponding fine-tuning knob 2311 can be pressed inward to make the fine-tuning knob 2311 out of the stop state and the fine-tuning knob 2311 can be rotated , it can drive the corresponding gear shaft 2312 and the gear 2313 to rotate, so that the corresponding sub-slider 222 moves relative to the slider 221 , so as to realize the fine adjustment of the bending shape of the single adjustable bending section 11 . In this embodiment, the first elastic member 2315 is preferably a spring, and the first elastic member 2315 is sleeved outside the gear shaft 2312 . Further, in some embodiments of the present invention, the connecting shaft 2311b of the fine adjustment knob is hollow inside, the gear shaft 2312 is inserted into the connecting shaft 2311b, and there is a certain distance in the axial direction between the connecting shaft 2311b and the gear shaft 2312. , allowing the fine-tuning knob 2311 to move inward in its axial direction when it is pressed, so that the rib 2311c escapes from the slot 2331 , without causing the gear shaft 2312 and the gear 2313 to move relative to the sub-slider 222 along its axial direction.

Further, please refer to FIG. 5 and FIG. 6 , the bending handle 20 further includes a locking member 40 , and the locking member 40 is provided on the handle housing 21 for locking the second driving control member 232 in the The position on the handle housing 21 . In this embodiment, the locking member 40 includes a second elastic member 41 and a button 42 . In this embodiment, the second elastic member 41 is preferably a spring. The button 42 includes a pressing portion 421 and a locking portion 422 vertically connected to the pressing portion 421 . The second elastic member 41 is connected between the pressing portion 421 and the handle housing 21 . Specifically, 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 . When the second elastic member 41 is naturally stretched, the locking portion 422 locks the position of the second driving control member 232 on the handle housing 21 ; press the pressing portion 421 to compress the second elastic member 41 , the locking of the second driving control member 232 by the locking portion 422 is released. In this embodiment, the locking portion 422 is a hook-shaped member with one end fixed on the pressing portion 421 , and the second driving control member 232 has an end close to the first housing 213 and an end close to the second housing 214 . Both are provided with grooves or openings 215. When the second driving control member 232 is moved to be close to the first housing 213 or the second housing 214, the pressing portion 421 is engaged with the grooves or openings. 215, thereby locking the position of the second drive control member 232 on the handle housing 21. At this time, by rotating the fine-tuning knob 2311, the curved shape of the corresponding adjustable bending section 11 can be fine-tuned, and the desired tube body can be obtained 10 After the distal end is bent, the fine adjustment knob 2311 cooperates with the corresponding through hole 233 on the second drive control member 232 to stop rotation, so as to avoid the position of the second drive control member 232 and the first drive control member 231 during the operation. Change, that is, to avoid the change of the bending shape of the distal end of the tube body 10 during the operation, so that the distal end of the tube body 10 is kept in the desired bending shape. In this embodiment, the distal end of the tubular body 10 is suitable for both left coronary intervention and right coronary intervention. There are two locking members 40 , which are respectively disposed on the first casing 213 and the second casing 213 . On the casing 214: when the second driving control member 232 moves distally to the first casing 213 and is locked by a locking member 40, the curved shape of the distal end of the tube body 10 is close to the physiological anatomy of the right coronary artery , and then fine-tuning the curved shape of each adjustable bendable segment 11 through the fine-tuning knob 2311 can make the distal end of the tube body 10 adapt to the differences in the physiological and anatomical structure of the right coronary artery of different patients and smoothly enter the right coronary artery, which is suitable for right coronary interventional surgery; When the second driving control member 232 moves proximally to the second housing 212 and is locked by another locking member 40, the curved shape of the distal end of the tube body 10 is close to the physiological anatomy of the left coronary artery, and then passes through the The fine-tuning knob 2311 fine-tunes the curved shape of each bendable segment 11 so that the distal end of the tube 10 can smoothly enter the left coronary artery according to the differences in the physiological and anatomical structure of the left coronary artery of different patients, which is suitable for left coronary interventional surgery.

Further, the handle housing 21 of the bending handle 20 is provided with a gear mark 50 on the stroke of the second driving control member 232 along the axial movement of the handle housing 21 to mark the second driving control member 232 . The position on the handle housing 21 . In this embodiment, the gear marks 50 are respectively set at the positions where the two locking members 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 different actions of the control structure 23, and the different forms of movement of the driving mechanism 22 are respectively used to drive all the The adjustable bendable segment 11 is bent and each bendable segment 11 is independently driven to bend, and is suitable for operations that have different requirements on the curved shape of the distal end of the tube body 10, such as left coronary interventional operation and right coronary interventional operation. And it can adapt to the individual differences of the lumen physiology and anatomy of different patients.

Please refer to FIGS. 3 to 7 , 8 a , 8 b , 17 and 18 , the present invention provides an adjustable bendable catheter 100 including the bend adjustment handle 20 . The bendable catheter 100 can be used in various operations that have different requirements on the shape of the distal end of the catheter. The present invention is described by taking the adjustable bendable catheter 100 as an example for the interventional operation of the left coronary artery and the right coronary artery. The adjustable bendable catheter 100 includes a pipe body 10 , the bendable handle 20 and at least two traction members 30 . The bending handle 20 is connected to the proximal end of the tubular body 10 . The distal end of the tubular body 10 is provided with at least two adjustable bendable segments 11 arranged at intervals. One end of the traction member 30 is correspondingly connected to an adjustable bending section 11 , and the other end is correspondingly connected to a sub-slider 222 in the bending adjustment handle 20 . The traction member 30 is disposed along the pipe body 10 and can move along the pipe body 10 . The traction member 30 is controlled to move along the pipe body 10 by the bending handle 20 to drive the adjustable bending section 11 to bend. In the present invention, when the sliding member 221 is driven to move in the axial direction by pushing and pulling the second driving control member 232 on the bending handle 20, all the traction members 30 can be synchronously controlled to move along the pipe body 10, so as to simultaneously drive the sliding member 221 to move along the pipe body 10. All bendable sections 11 are bent to improve the efficiency of adjusting the bendable conduit 100 ; by rotating the fine adjustment knob 2311 in each first drive control member 231 to drive the corresponding sub-slider 222 relative to the slider 221 in the axial direction Moving, the corresponding traction member 30 can be individually controlled to move along the tube body 10 to drive the corresponding bendable segment 11 to bend, and further adjust the distal end of the bendable catheter 100 to a desired bending shape. It can be understood that, according to the different anatomical structures of the lumen into which the bendable catheter 100 is to be inserted, the bendable segment 11 may also have three or more segments.

8a, 8b and 13, 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 reinforcing tube 10b. In this embodiment, the inner membrane 10a is a flexible tube made of flexible materials such as PTFE; the reinforcing 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 twist 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. In addition, the hardness of the portion of the outer tube 10c corresponding to the bendable section 11 is smaller than the hardness of other parts of the outer tube 10c, so that the bendable section 11 is easier to bend. Specifically, in this embodiment, the part of the outer tube 10c corresponding to the adjustable bending section 11 and the other parts respectively use PEBAX materials of different grades, and the part of the outer tube 10c corresponding to the adjustable bending section 11 adopts the PEBAX material of different grades. The hardness is lower than that of the PEBAX material used in other parts of the outer tube 10c, so that the hardness of the part of the outer tube 10c corresponding to the adjustable bendable section 11 is smaller than that of the other parts of the outer tube 10c. Further, in this embodiment, the inner membrane 10a, the reinforcing tube 10b, and the outer tube 10c are formed together by hot-melt composite molding to form at least one delivery cavity completely penetrating 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 can also be made of other materials than this embodiment, provided that the usage requirements are met.

Further, in this embodiment, the distal 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), such as tantalum, is arranged on the proximal side of the Tip head. Rings, etc., so that it can be accurately known whether the distal end of the pipe body 10 reaches the desired position under the developing device.

Referring to FIGS. 8 a , 8 b and FIGS. 13 to 16 , the traction member 30 is embedded in the tube wall of the tube body 10 and disposed along the axial direction of the tube body 10 . Specifically, in this embodiment, the pulling member 30 is located between the inner membrane 10a and the reinforcing tube 10b. The traction member 30 includes a traction wire 31 , the distal end of the traction wire 31 is connected to an adjustable bend section 11 , and the proximal end protrudes from the tube wall at the proximal end of the tube body 10 and is connected to the corresponding bending handle 20 . On the sub-slider 222, the corresponding adjustable bending section 11 is driven to bend by the sub-slider 222 sliding to drive the traction wire 31 to move. In this embodiment, the number of the adjustable bendable segments 11 is two, which are the first adjustable bendable segment 11a and the second adjustable bendable segment 11b, respectively; and there are also two traction members 30, which are respectively the first traction segment member 30a and a second pulling member 30b. The first pulling member 30a is connected to the first adjustable bending section 11a and a sub-slider 222 in the bending handle 20, and the second pulling member 30b is connected to the second adjustable bending section 11b. Another sub-slider 222 in the bending handle 20 .

In this embodiment, the first adjustable segment 11a is mainly used to select the left coronary artery or the right coronary artery and control the depth of the coronary entry by adjusting its curved shape. Therefore, the length of the first adjustable segment 11a is required to be relatively small, preferably 10mm to 15mm, and the first adjustable bending section 11a needs to be more flexible than the second adjustable bending section 11b, so that the bending can be continued on the basis that the bending shape of the second adjustable bending section 11b is basically fixed. The bending section 11a is softer than the second bending section 11b. In this embodiment, the hardness of the first bending section 11a is preferably 25D-35D. The second bendable section 11b needs to provide support for the first bendable section 11a, so that the first bendable section 11a can more easily approach the entrance of the left coronary artery or the right coronary artery. The length is relatively long, preferably 25mm to 35mm, and the hardness is higher than that of the first adjustable bending section 11a, preferably 45D to 55D. Except for the tip, the first adjustable bending section 11a and the second adjustable bending section 11b, other parts of the pipe body 10 should have higher hardness to ensure the torsion control and support of the pipe body 10, so the hardness needs to be higher. Larger, in this embodiment, the hardness of other parts of the tube body 10 is 72D. Further, the bending angle of the first adjustable bendable segment 11a (the angle between the tube body adjacent to the proximal end of the first adjustable bendable segment 11a and the tangent to the proximal end of the first adjustable bendable segment 11a) ranges from 0°. -90°, the bending angle of the second adjustable bendable section 11b ranges from -90° to 180° (the distance between the tube body adjacent to the proximal end of the second adjustable bendable section 11b and the tangent to the proximal end of the second adjustable bendable section 11b The included angle between them) to allow the distal end of the tube body 10 to be bent in both directions, so as to meet the needs of interventional surgery of the left coronary artery and the right coronary artery. It can be understood that, in other embodiments of the present invention, when the bendable catheter 100 is used for interventional operations in other lumen of the human body, three or more bendable sections 11 may be provided as required, and Adjust the bendable range of each bendable segment 11 accordingly to meet the needs of the operation.

In this embodiment, if all the traction wires 31 are pulled or pushed synchronously at the proximal end of the tube body 10 , all the adjustable bendable segments 11 are bent, and the proximal ends of all the traction wires 31 are synchronously controlled at different positions, that is, Different bends formed by the composite of all the adjustable segments 11 can be obtained. For example, simultaneously pushing all the traction wires 31 distally to the first position can make all the adjustable segments 11 composite to form a shape close to the one that can intervene in the right coronary artery. Curved, pulling all the traction wires 31 toward the proximal end simultaneously to the second position can make all the flexible segments 11 composite to form a curved shape close to the left coronary artery, and push or pull a certain traction wire 31 alone, The traction wire 31 will drive the corresponding adjustable bendable segment 11 to achieve bending within a certain angle range, so that after synchronously controlling all the traction wires 31 , the corresponding adjustable bendable segment 11 can be bent by individually controlling a certain traction wire 31 . The fine adjustment of the distal end of the tube body 10 makes it suitable for the coronary anatomy of different patients; if the force on the traction wire 31 is withdrawn, the corresponding bendable segment 11 can be restored to its original shape under the action 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 can 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.

Further, please refer to FIGS. 13 to 16 , the end of the traction wire 31 connected to the adjustable bending section 11 is provided with an anchoring ring 32 , and the anchoring 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 bendable segment 11 through the anchoring ring 32 . In this embodiment, the anchoring ring 32 is sleeved on the inner membrane 10a at a position corresponding to the adjustable bending section 11 . By increasing the contact area between the traction member 30 and the adjustable bendable section 11 on the tube body 10 by the anchoring ring 32, the adjustable bendable section 11 can be better driven to bend. The anchoring ring 32 can be made of metal material or polymer material. In this embodiment, the anchoring ring 32 is made of metal such as SUS304 stainless steel. The manner of connecting the pulling wire 31 and the anchoring ring 32 includes, but is not limited to, bonding, welding, thermal fusion, knotting, etc., which are not limited herein.

The pulling member 30 also includes a wire wrapping tube 33, and the portion of the pulling wire 31 located in the tube body 10 is movably passed through the wire wrapping tube 33, so as to limit the pulling direction of the pulling wire 31 through the wire wrapping tube 33, and pass through the wire wrapping tube 33. The wire covering tube 33 protects the pulling wire 31 . In the present invention, the inner diameter of the wire wrapping 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 pulling wire 31 from being tightly held by the tube body 10 during thermal shrinkage. It cannot slide smoothly along the axial direction, and prevent the pulling wire 31 from being broken due to bending. In this embodiment, the inner diameter of the wire covering tube 33 can be selected as 0.40 mm. It is worth noting that the hardness of the part of the wire covering tube 33 corresponding to the adjustable bending section 11 should be smaller than the hardness of other parts, that is, the part of the wire covering tube 33 corresponding to the adjustable bending section 11 is flexible, so that it will not affect the adjustable bending section. Bending of the curved section 11 . For example, the part of the wire threading tube 33 embedded in the bendable section 11 can be selected from a relatively soft PTFE thin tube, while the other part can be selected from a PI thin tube or a stainless steel thin tube.

Further, in the present invention, the traction wire 31 is fixedly connected to the corresponding sub-slider 222 in the bending handle 20 after passing through the proximal end of the tube body 10 . In addition, the traction wire 31 is fixedly sleeved with a stiffening tube (not shown in the figure) at the part connected to the sub-slider 222 , and the strength of the stiffening tube is greater than that of the wire wrapping tube 33 to increase the traction wire 31 The strength of the connecting part of the sub-slider 222 prevents the pulling wire 31 from being broken, and facilitates the connection of the pulling wire 31 and the sub-slider 222 . In this embodiment, the hardened pipe includes but is not limited to a stainless steel pipe. Further, this embodiment also includes a wire splitting head (not shown), after each pulling wire 31 is pierced from the tube body 10, the different pulling wires 31 are guided into the bending handle 20 through the wire dividing head. A path is extended to connect the different sub-slides 222 .

Please refer to FIG. 14 and FIG. 15 , the pulling wires 31 connected to the different bendable sections 11 are all disposed on the same side of the tube body 10 , and the pulling wires 31 of the first pulling member 30 a correspond to the first adjustable bending section 11 a The part corresponding to the second adjustable bending section 11 of the pulling wire 31 of the second pulling member 30b is parallel to the axis of the tube body 10, and the pulling wire 31 of the first pulling member 30a corresponds to the first adjustable bending section 11. The plane formed by the part of the bending section 11a and the axis of the pipe body 10 and the part of the pulling wire 31 of the second pulling member 30b corresponding to the second adjustable bending section 11 coincide with the plane formed by the axis of the pipe body 10, so that the plane formed by the axis of the pipe body 10 coincides. When the first adjustable section 11a and the second adjustable section 11b are driven to bend by the pulling wires 31 of the first pulling member 30a and the second pulling member 30b, the first adjustable section 11a and the second adjustable section The planes where 11b is bent are coplanar, so that the distal end of the bendable catheter 100 can be more easily controlled, and the bent distal end of the bendable catheter 100 can more easily enter the target lumen.

Specifically, please refer to FIG. 14 , in an embodiment of the present invention, the two anchoring rings 32 are respectively provided with an arc-shaped portion or an arc-shaped portion that is concave inward relative to the outer circumference of the anchoring ring 32, and the two wraps of wire tubes 33 They are respectively fixed in the arc-shaped portion, the wire wrapping tube 33 on the first traction member 30a is superimposed on the wire wrapping tube 33 on the second traction member 30b in the radial direction of the tube body 10, and the wire wrapping tube 31 passes through the wire wrapping tube 33. Inside the wire wrapping tube 33, the plane formed by the pulling wire 31 of the first pulling member 30a and the axis of the tube body 10 coincides with the plane formed by the pulling wire 31 of the second pulling member 30b and the axis of the tube body 10. The plane where the first adjustable bendable section 11a is bent under the driving of the pulling wire 31 in the corresponding wire covering tube 33 is coplanar with the plane where the second adjustable bending section 11b is bent under the driving of the pulling wire 31 in the corresponding wire covering tube 33 . Please refer to FIG. 15 , in another embodiment of the present invention, two anchoring rings 32 are provided with an arc-shaped portion that is convex relative to the outer periphery of the anchoring ring 32 , and the two bundles of wire tubes 33 are respectively fixed in the arc-shaped portion. The first traction member The part of the wire covering tube 33 on the 30a corresponding to the first adjustable bending section 11a and the part of the wire covering tube 33 on the second pulling member 30b corresponding to the second adjustable bending section 11b are both parallel to the axis of the tube body 10 and are parallel to each other. On the same straight line, the pulling wire is passed through the wire wrapping tube, so that the pulling wire 31 of the first pulling member 30a corresponds to the plane formed by the part of the first adjustable bending section 11a and the axis of the tube body 10 and the second pulling member. The part of the pulling wire 31 of 30b corresponding to the second adjustable bending section 11 coincides with the plane formed by the axis of the tube body 10, which can also make the first adjustable bending section 11a driven by the pulling wire 31 in the corresponding wire wrapping tube 33. The plane where the bending occurs is coplanar with the plane where the second adjustable bendable section 11b is driven by the pulling wire 31 in the corresponding wire covering tube 33; however, the wire covering tube 33 on the first pulling member 30a is close to the first pulling The position of the anchoring ring 32 of the member 30b is bent, so that the wire covering tube 33 on the first pulling member 30a corresponds to the other part of the first adjustable bending section 11a and the wire covering tube 33 on the second pulling member 30b. side-by-side setup.

It can be understood that, referring to FIG. 16, in other embodiments of the present invention, the wire covering tube 33 on the first pulling member 30a and the wire covering tube 33 on the second pulling member 30b can also be arranged side by side, that is, two pulling The wires 31 are arranged side by side, so that the plane where the first pulling member 30a drives the first bendable segment 11a to bend is not coplanar with the plane where the second pulling member 30b drives the second bendable segment 11b to bend.

In the adjustable bendable catheter 100 provided by the present invention, by manipulating the bend adjustment handle 20, the distal end of the pipe body 10 can instantly form different compound bend shapes, and the different compound bend shapes can be approached to different positions of the human lumen respectively. Such as the physiological anatomical structures of the left coronary artery and the right coronary artery, and by manipulating the bending handle 20, the bend shape of each bendable segment 11 can be fine-tuned in real time in vivo, so that the same bendable catheter 100 can be used. The distal shape of the bending catheter has different requirements for operations such as left coronary intervention and right coronary intervention, and can adapt to the individual differences in the physiological and anatomical structure of the lumen 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.

Please refer to FIGS. 3 to 9 and FIGS. 17 and 18 at the same time. When using the bendable catheter 100 to perform left coronary intervention and right coronary intervention, the catheter 10 passes through the radial artery to approach the entrance of the coronary artery. The second driving control member 232 is manually controlled to slide to the distal end to a gear position close to the first housing 213 , and the second driving control member 232 is locked by the locking member 40 . During the process that the second driving control member 232 slides to the distal end to a gear position close to the first housing 213 , the second driving control member 232 drives the first driving control member 231 , the sub-slider 222 and the sliding member 221 to synchronize along the edge Axial movement, the sub-slider 222 pushes all the traction wires 31 towards the distal end, so that all the adjustable segments 11 can be instantly compounded to form a bend close to the right coronary artery, and then push the fine-tuning knob 2311 inward to make the tendons. When the position 2311c is released from the slot 2331 and the fine adjustment knob 2311 is rotated, the corresponding sub-slider 222 can be driven to slide axially on the slider 221, thereby driving the traction wire 31 to act on the corresponding adjustable bending section 11, and the corresponding adjustable The curved shape of the curved section 11 is fine-tuned, so that the distal end of the tubular body 10 can smoothly enter the right coronary artery. When the diagnosis and treatment of the right coronary artery is completed and the left coronary artery needs to be treated, manually press down the locking member 40 that locks the second driving control member 232, the second driving control member 232 is unlocked, and the second driving control member 232 is unlocked and pulled The second driving control member 232 slides proximally to the gear position close to the second housing 214, and locks the second driving control member 232 through the other locking member 40. During this process, the rib 2311c on the fine adjustment knob 2311 snaps into place. The slot 2331 and the gear 2313 will not rotate, so 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 and the slider 221 along the synchronous edge Axial movement, the sub-slider 222 pulls all the traction wires 31 toward the proximal end, so that all the adjustable segments 11 can be instantly compounded to form a bend close to the left coronary artery, and then by pushing the fine-tuning knob 2311 inward to make the tendon position 2311c After disengaging from the slot 2331 and rotating the fine adjustment knob 2311, the corresponding sub-slider 222 can be driven to slide on the slider 221 in the axial direction, thereby driving the traction wire 31 to act on the corresponding adjustable bending section 11. The curved shape of the catheter can be fine-tuned, so that the distal end of the catheter can smoothly enter the left coronary artery. Therefore, the bendable catheter 100 of the present invention can realize that one bendable catheter 100 can be applied to both left coronary interventional surgery and right coronary interventional surgery, and each bendable segment 11 can be performed separately. It can be fine-tuned in real time to adapt to the coronary anatomy of different patients.

It can be understood that, the above embodiment is only an example of setting two adjustable bending sections 11 on the pipe body 10. In other embodiments, a larger number of adjustable bending sections 11 can be provided, as long as the flexible bending section 11 is adapted to A corresponding number of the sub-sliders 222 and the first driving control members 232 may be arranged in the bending handle 20 .

The above is the preferred embodiment of the present invention. It should be pointed out that for those skilled in the art, without departing from the principle of the present invention, several improvements and modifications can also be made. These improvements and modifications It is also regarded as the protection scope of the present invention.

Claims (23)

1. A bending adjusting handle is characterized by being used for controlling at least two bending adjustable sections on the far end of a pipe body connected with the bending adjusting handle to bend, the bending adjusting handle comprises a driving mechanism and a control mechanism connected with the driving mechanism, and the driving mechanism is connected with all the bending adjustable sections; the control mechanism controls the driving mechanism to move in different forms through different actions, and the movements in different forms of the driving mechanism are respectively used for driving all the adjustable bending sections to bend simultaneously and driving each adjustable bending section to bend independently, so that different composite bending shapes are formed at the far end of the pipe body in real time.

2. The bend-adjusting handle according to claim 1, wherein the driving mechanism comprises a sliding member, at least two sub-sliding members slidably connected to the sliding member, and one of the sub-sliding members is correspondingly connected to one of the adjustable bending sections; the control mechanism comprises at least two first driving control pieces, and one first driving control piece correspondingly controls one sub-sliding piece; the first driving control piece independently acts to drive the corresponding sub-sliding piece to move relative to the sliding piece so as to independently drive the corresponding adjustable bending section to bend; all the first driving control pieces synchronously act to drive the sliding piece to move along the axial direction of the bending adjusting handle so as to simultaneously drive all the bending adjustable sections to bend.

3. A bend-adjusting handle as set forth in claim 2, wherein said sub-slider is a rack; the first driving control part comprises a fine adjustment knob and a gear shaft, one end of the gear shaft is provided with a gear meshed with the sub-sliding part, the other end of the gear shaft is connected with the fine adjustment knob, and one end of the gear shaft, provided with the gear, is rotatably connected with the sliding part; independently rotating the fine adjustment knob to drive the corresponding gear shaft to rotate so as to drive the corresponding sub-sliding part to move relative to the sliding part, so as to independently drive the corresponding adjustable bending section to bend; all the fine adjustment knobs synchronously move along the axial direction of the bending adjustment handle to drive all the gear shafts to move so as to drive the sliding pieces to move along the axial direction of the bending adjustment handle, and all the adjustable bending sections are driven to bend simultaneously.

4. The bend-adjusting handle according to claim 3, wherein the gear shaft extends in a direction perpendicular to the axial direction of the bend-adjusting handle.

5. A bend-adjusting handle as set forth in claim 4 further comprising a handle housing, said drive mechanism being located within said handle housing, said control mechanism being located outside said handle housing, said control mechanism moving said drive mechanism relative to said handle housing.

6. The bend-adjusting handle according to claim 5, wherein the handle housing is provided with a guide hole extending in an axial direction of the bend-adjusting handle, and the gear shaft passes through the guide hole and moves in an extending direction of the guide hole.

7. The bend-adjusting handle according to claim 5 or 6, wherein the control mechanism further comprises a second driving control member, the second driving control member is sleeved outside the handle housing; a through hole is formed in the second driving control piece, the gear shaft penetrates through the second driving control piece through the through hole, a rotation stopping structure is arranged between the fine adjustment knob connected with the gear shaft and the through hole, and the rotation stopping structure is used for limiting the rotation of the fine adjustment knob; the second driving control piece moves along the axial direction of the handle shell to drive all the fine adjustment knobs and the gear shafts to synchronously move along the axial direction of the bending adjusting handle.

8. The bending adjusting handle according to claim 7, wherein a plurality of clamping grooves are formed in the inner wall of the through hole, the fine adjustment knob comprises a connecting shaft connected with the gear shaft, a plurality of rib positions corresponding to the clamping grooves are formed in the outer surface of the connecting shaft, the clamping grooves and the rib positions form the rotation stopping structure, a first elastic member is arranged between the gear and the fine adjustment knob, and when the first elastic member naturally extends, the rib positions are clamped into the clamping grooves to prevent the fine adjustment knob from rotating; when the fine adjustment knob is pressed to compress the first elastic piece, the rib position is separated from the clamping groove, and the fine adjustment knob rotates.

9. A bend adjusting handle as set forth in claim 7 further comprising a locking member disposed on said handle housing for locking the position of said second drive control member on said handle housing.

10. A bending adjustment handle according to claim 9, wherein the locking member comprises a second elastic member and a button, the button comprises a pressing portion and a locking portion perpendicularly connected to the pressing portion, the second elastic member is connected between the pressing portion and the handle housing, and the locking portion locks the position of the second driving control member on the handle housing when the second elastic member is naturally extended; when the pressing part is pressed to compress the second elastic part, the locking part releases the locking of the second driving control part.

11. A bend-adjusting handle as set forth in claim 10 wherein said handle housing is provided with a gear indicator to indicate where said second drive control is located on said handle housing.

12. An adjustable bending catheter, which comprises a catheter body, at least two traction members and a bending adjusting handle according to any one of claims 1 to 11, wherein the bending adjusting handle is connected to the proximal end of the catheter body, and the distal end of the catheter body is provided with at least two adjustable bending sections arranged at intervals; the far end of each traction piece is connected with one adjustable bending section, and the near end of each traction piece is connected with the driving mechanism in the adjustable bending handle.

13. The adjustable bend catheter of claim 12, wherein the tubular body comprises an inner membrane, a reinforcing tube and an outer tube, which are sequentially sleeved from inside to outside.

14. The adjustable bend catheter of claim 13, wherein the outer tube has a stiffness corresponding to the adjustable bend section that is less than a stiffness of other portions of the outer tube.

15. The adjustable bend catheter of claim 12, wherein the pulling member is embedded within the wall of the tubular body.

16. The adjustable bending catheter of claim 15, wherein the pull member comprises a pull wire having a distal end coupled to one of the adjustable bending segments and a proximal end coupled to the drive mechanism within the bending handle.

17. The catheter of claim 16, wherein the pull wires associated with different of the sections are disposed on the same side of the catheter body, wherein the portions of the different pull wires located in the corresponding sections are parallel to the axis of the catheter body, and wherein the portions of the different pull wires located in the corresponding sections are coincident with the plane defined by the axis of the catheter body.

18. The steerable catheter of claim 16, wherein the puller further comprises an anchoring ring embedded within the wall of the steerable segment and affixed to the distal end of the puller wire.

19. The adjustable bending catheter according to claim 16, wherein the pulling member further comprises a wire wrapping tube, a portion of the pulling wire located in the catheter body is movably disposed in the wire wrapping tube, and the hardness of the wire wrapping tube corresponding to the adjustable bending section is less than that of other portions of the wire wrapping tube.

20. The adjustable bend catheter of claim 12, wherein said at least two adjustable bend segments comprise a first adjustable bend segment at a distal end of said catheter body and a second adjustable bend segment proximal to said first adjustable bend segment; the hardness of the first adjustable bending section is less than the hardness of the second adjustable bending section.

21. The adjustable bend catheter of claim 20, wherein the first adjustable bend segment has a stiffness in the range of 25D to 35D and the second adjustable bend segment has a stiffness in the range of 45D to 55D.

22. The catheter of claim 20 or 21, wherein the first adjustable bend section has a bend angle in a range of 0 ° to 90 ° and the second adjustable bend section has a bend angle in a range of-90 ° to 180 °.

23. The adjustable curve catheter of claim 22, wherein the control mechanism controls the drive mechanism to simultaneously drive the first adjustable curve segment and the second adjustable curve segment to curve to form a curve suitable for intervention in a left coronary artery or a right coronary artery; and the control mechanism controls the driving mechanism to independently drive the first adjustable bending section or the second adjustable bending section to bend so as to finely adjust the bending shape.

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