Adjustable bend handle and adjustable bend catheter

Abstract

The present invention provides a bending handle and an adjustable bending catheter including the bending handle. The adjustable bending catheter includes a tube body, a bending handle and at least two traction members. The distal end of the tube body is provided with at least two adjustable bending segments arranged at intervals. The bending handle includes a driving mechanism and a control mechanism connected to the driving mechanism. The distal end of each traction member is connected to one of the adjustable bending segments, and the proximal end is connected to a sub-sliding member of the driving mechanism in the bending handle. By manipulating the bending handle, all the adjustable bending segments can be driven to bend to form different composite bending shapes at the same time, or an adjustable bending segment can be driven to bend individually to fine-tune the bending shape of the corresponding adjustable bending segment, so that the same adjustable bending catheter can be used to implement surgeries with different requirements for the distal end morphology of the adjustable bending catheter, such as left coronary artery intervention surgery and right coronary artery intervention surgery, and can adapt to the individual differences in the physiological and anatomical structures of the lumen of different patients.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a bending handle and an adjustable bending catheter. Background Art

[0002] Currently, most of the widely used coronary guiding catheters or angiography catheters are pre-shaped catheters, and the distal end of the catheter contains at least two pre-shaped curved sections. Figure 1a The JudkinsLeft catheter shown in the figure is only suitable for left coronary intervention. Figure 1b The Judkins Right in the literature can only be applied to right coronary artery intervention. Therefore, to perform intervention on the left and right coronary arteries, the pre-shaped catheter must be replaced. After two punctures, the two pre-shaped catheters are respectively inserted into the left and right coronary arteries. The operation is time-consuming and complicated. In addition, in actual clinical use, individual differences in the anatomical structure of the human lumen are often encountered. Even pre-shaped catheters are difficult to adapt to the left or right coronary arteries of different human bodies. In order to prevent such problems during surgery, doctors usually prepare a variety of pre-shaped catheters of different specifications, such as Figure 2a The catheter specifications from left to right are JL6.0, JL5.0, JL4.5, JL4.0, JL3.5 and JL3.0 (JL represents the Judkins series catheter that can be inserted into the left coronary artery, and the number after JL represents the distance between the two pre-shaped bends). Figure 2b The specifications of the catheters from left to right are JR 6.0, JR5.0, JR4.5, JR4.0, JR3.5 and JR3.0 (JR stands for the Judkins series catheters that can intervene in the right coronary artery, and the number after JR represents the distance between two pre-shaped curves). Once it is found that the distal shape of a selected pre-shaped catheter of a certain specification is not suitable, the catheter will be withdrawn and replaced with a pre-shaped catheter of other specifications. Sometimes it is even necessary to reshape the distal end of the catheter into the required shape at the operation site according to the specific physiological and anatomical structure of the patient's left or right coronary artery, which further increases the complexity of the operation process and prolongs the patient's exposure to X-rays, which is not conducive to the patient's health. Summary of the invention

[0003] The present invention provides a bending handle and an adjustable bend catheter comprising the bending handle. By manipulating the bending handle, the distal end of the adjustable bend catheter can be instantly formed into different composite bends, and the different composite bends can respectively approach the physiological anatomical structures of different positions of the human lumen, such as the left coronary artery and the right coronary artery. Furthermore, by manipulating the bending handle, each bend can be fine-tuned in real time in the body, so that the same adjustable bend catheter can be used to perform surgeries with different requirements on the distal end shape of the adjustable bend catheter, such as left coronary artery intervention surgery and right coronary artery intervention surgery, and can adapt to the individual differences in the physiological anatomical structures of the lumen of different patients, reduce the number of punctures, reduce damage to the human body, simplify the surgical process, and shorten the surgical time.

[0004] The bending adjustment handle is used to control the bending of at least two adjustable bending segments on the distal end of the tube body connected to the bending adjustment handle. The bending adjustment handle includes a driving mechanism and a control mechanism connected to the driving mechanism, and the driving mechanism is connected to all the adjustable bending segments; the control mechanism controls the driving mechanism to perform different forms of movement through different actions, and the different forms of movement of the driving mechanism are used to simultaneously drive all the adjustable bending segments to bend and individually drive each adjustable bending segment to bend, so that the distal end of the tube body can instantly form different compound bends.

[0005] In which, the driving mechanism includes a sliding member, at least two sub-sliders slidably connected to the sliding member, and one of the sub-sliders is correspondingly connected to one of the adjustable bending sections; the control mechanism includes at least two first driving control members, and one of the first driving control members controls one of the sub-sliders; one of the first driving control members acts alone to drive the corresponding sub-slider to move relative to the sliding member, so as to drive the corresponding adjustable bending section to bend alone; all of the first driving control members act synchronously to drive the sliding member to move axially along the bending adjustment handle, so as to drive all of the adjustable bending sections to bend simultaneously.

[0006] Among them, the sub-sliding member is a rack; the first driving 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-sliding member, and the other end is connected to the fine-tuning knob, and the gear shaft is provided with one end of the gear rotatably connected to the sliding member; rotating one of the fine-tuning knobs drives the corresponding gear shaft to rotate to drive the corresponding sub-sliding member to move relative to the sliding member, so as to drive the corresponding adjustable bending section to bend individually; all of the fine-tuning knobs move synchronously along the axial direction of the bending adjustment handle to drive all of the gear shafts to move to drive the sliding member to move along the axial direction of the bending adjustment handle, so as to simultaneously drive all of the adjustable bending sections to bend.

[0007] Wherein, the extending direction of the gear shaft is perpendicular to the axial direction of the bending adjustment handle.

[0008] Wherein, it also includes a handle shell, the driving mechanism is located inside the handle shell, the control mechanism is located outside the handle shell, and the control mechanism drives the driving mechanism to move relative to the handle shell.

[0009] Wherein, the handle housing is provided with a guide hole extending along the axial direction of the bending adjustment handle, and the gear shaft passes through the guide hole and moves along the extending direction of the guide hole.

[0010] In which, the control mechanism also includes a second drive control component, which is sleeved on the outside of the handle shell; the second drive control component is provided with a through hole, and the gear shaft passes through the second drive control component through the through hole, and a stop structure is provided between the fine-tuning knob connected to the gear shaft and the through hole, and the stop structure is used to limit the rotation of the fine-tuning knob; the second drive control component moves along the axial direction of the handle shell to drive all the fine-tuning knobs and gear shafts to move synchronously along the axial direction of the bending adjustment handle.

[0011] In which, the inner wall of the through hole is provided with a plurality of slots, the fine-tuning knob includes a connecting shaft connected to the gear shaft, the outer surface of the connecting shaft is provided with a plurality of ribs corresponding to the slots, the slots and the ribs constitute the anti-rotation structure, and a first elastic member is provided between the gear and the fine-tuning knob, when the first elastic member is naturally stretched, the ribs are inserted into the slots to prevent the fine-tuning knob from rotating; when the fine-tuning knob is pressed to compress the first elastic member, the ribs are disengaged from the slots, and the fine-tuning knob rotates.

[0012] Wherein, the bending adjustment handle also includes a locking member, which is arranged on the handle housing and is used to lock the position of the second drive control member on the handle housing.

[0013] 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, the second elastic member is connected between the pressing portion and the handle shell, and when the second elastic member is naturally stretched, the locking portion locks the position of the second drive control member on the handle shell; when the pressing portion is pressed to compress the second elastic member, the locking portion releases the lock on the second drive control member.

[0014] Wherein, a gear mark is provided on the handle housing to mark the position of the second drive control component on the handle housing.

[0015] The adjustable bend catheter includes a tube body, at least two traction members and a bend adjustment handle, wherein the bend adjustment handle is connected to the proximal end of the tube body, and the distal end of the tube body is provided with at least two adjustable bend sections arranged at intervals; the distal end of each of the traction members is connected to one of the adjustable bend sections, and the proximal end is connected to the driving mechanism in the bend adjustment handle.

[0016] The tube body comprises an inner membrane, a reinforcing tube and an outer tube which are sequentially mounted from the inside to the outside.

[0017] Wherein, the hardness of the outer tube corresponding to the adjustable bending section is smaller than the hardness of other parts of the outer tube.

[0018] Wherein, the traction member is embedded in the tube wall of the tube body.

[0019] Wherein, the traction member comprises a traction wire, the distal end of the traction wire is connected to an adjustable bending section, and the proximal end is correspondingly connected to the driving mechanism in the bending adjustment handle.

[0020] Among them, the traction wires corresponding to the different adjustable bends are all arranged on the same side of the tube body, the parts of the different traction wires located in the corresponding adjustable bends are parallel to the axis of the tube body, and the parts of the different traction wires located in the corresponding adjustable bends respectively coincide with the planes formed by the axis of the tube body.

[0021] Wherein, the traction member further comprises an anchoring ring, which is embedded in the tube wall of the adjustable bending section and fixedly connected to the distal end of the traction wire.

[0022] Wherein, the traction member also includes a wire-wrapped tube, the part of the traction wire located in the tube body is movably arranged in the wire-wrapped tube, and the hardness of the wire-wrapped tube corresponding to the adjustable bending section is less than the hardness of other parts of the wire-wrapped tube.

[0023] Wherein, the at least two adjustable bends include a first adjustable bend located at the distal end of the tube body and a second adjustable bend located proximal to the first adjustable bend; the hardness of the first adjustable bend is less than the hardness of the second adjustable bend.

[0024] Among them, the hardness range of the first adjustable bending section is 25D to 35D, and the hardness range of the second adjustable bending section is 45D to 55D.

[0025] The bending angle range of the first adjustable bending section is 0° to 90°, and the bending angle range of the second adjustable bending section is -90° to 180°.

[0026] Among them, the control mechanism controls the driving structure to simultaneously drive the first adjustable bend segment and the second adjustable bend segment to bend, forming a bend shape suitable for intervention in the left coronary artery or the right coronary artery; and the control mechanism controls the driving structure to drive the first adjustable bend segment or the second adjustable bend segment to bend alone, so as to fine-tune the bend shape. Specifically, the second drive control member slides distally to a gear position close to the first shell and is locked by the locking member, so as to drive the sliding member and all the sub-sliders to move axially distally synchronously, drive the first adjustable bend segment and the second adjustable bend segment to bend simultaneously, and form a bend close to the right coronary artery, and then rotate the fine-tuning knob alone to drive a corresponding sub-slider to slide axially relative to the sliding member, so that the first adjustable bend segment or the second adjustable bend segment bends alone to fine-tune the bend; the second drive control member slides proximally to a gear position close to the second shell and is locked by the locking member, so as to drive the sliding member and all the sub-sliders to move axially proximally synchronously, drive the first adjustable bend segment and the second adjustable bend segment to bend simultaneously, and form a bend close to the left coronary artery, and then rotate the fine-tuning knob alone to drive a corresponding sub-slider to slide axially relative to the sliding member, so that the first adjustable bend segment or the second adjustable bend segment bends alone to fine-tune the bend.

[0027] The bending handle and adjustable bending catheter provided by the present invention can simultaneously drive the adjustable bending segments to bend simultaneously or pull different adjustable bending segments to bend separately through the movement of the driving mechanism, so that the distal end of the adjustable bending catheter can instantly form different composite bending shapes, and the different composite bending shapes can respectively approach the physiological anatomical structures of different positions of the human lumen, such as the left coronary artery and the right coronary artery, and each bending shape can be fine-tuned in real time in the body by manipulating the bending handle, so that the same adjustable bending catheter can be used to implement surgeries with different requirements for the distal shape of the adjustable bending catheter, such as left coronary artery intervention surgery and right coronary artery intervention surgery. In addition, the bending curvature of each adjustable bending segment can be adjusted according to the individual differences in the physiological anatomical structures of the lumen of different patients to adapt to the needs of different human bodies, reduce the number of punctures, reduce damage to the human body, simplify the surgical process, and shorten the surgical time. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the structural features and effects of the present invention, it is described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0029] Figure 1a It is a schematic diagram of the application of an existing pre-shaped catheter suitable for left coronary intervention surgery;

[0030] Figure 1b It is a schematic diagram of an existing application of a pre-shaped catheter suitable for right coronary intervention surgery;

[0031] Figure 2a It is a schematic diagram of the structure of the existing Judkins Left pre-shaped catheters of different specifications suitable for left coronary intervention surgery;

[0032] Figure 2b It is a schematic diagram of the structure of the existing Judkins Right pre-shaped catheters of different specifications suitable for right coronary intervention surgery;

[0033] Figure 3 It is a schematic diagram of the three-dimensional structure of an adjustable curved conduit in one direction according to an embodiment of the present invention;

[0034] Figure 4 is a schematic diagram of the three-dimensional structure of the adjustable curved conduit in another direction according to an embodiment of the present invention;

[0035] Figure 5 It is a schematic diagram of the three-dimensional split structure of the adjustable curved conduit according to an embodiment of the present invention;

[0036] Figure 6 is a schematic cross-sectional view of a bending adjustment handle along its axial direction according to an embodiment of the present invention;

[0037] Figure 7 yes Figure 6 Schematic diagram of the cross section at II;

[0038] Figure 8a This is a schematic structural diagram of a tube body in a curved form according to an embodiment of the present invention;

[0039] Figure 8b is a schematic structural diagram of another bending form of a tube body in an embodiment of the present invention;

[0040] Fig. 9 It is a three-dimensional split schematic diagram of the driving mechanism and the control mechanism in the bending adjustment handle according to an embodiment of the present invention;

[0041] Fig.10 is a schematic structural diagram of a second inner shell in a bending adjustment handle according to an embodiment of the present invention;

[0042] Fig.11 is a schematic structural diagram of a sliding member in a bending adjustment handle according to an embodiment of the present invention;

[0043] Fig.12 2 is a schematic structural diagram of a sub-sliding member in a bending adjustment handle according to an embodiment of the present invention;

[0044] Fig.13 is a schematic diagram of the specific structure of the pipe body of an embodiment of the present invention;

[0045] Fig.14 is a schematic structural diagram of a traction member and a pipe body according to an embodiment of the present invention;

[0046] Fig.15is a schematic structural diagram of a traction member and a tube body according to another embodiment of the present invention;

[0047] Fig.16 is a schematic structural diagram of a traction member and a tube body according to another embodiment of the present invention;

[0048] Fig.17 It is a schematic diagram of the second driving control member in the embodiment of the present invention moving to a first gear mark and the distal end of the tube body being able to intervene in the right coronary artery;

[0049] Fig.18 It is a schematic diagram showing that the second driving control member of the tube body of an embodiment of the present invention moves to another gear mark and the distal end of the tube body can intervene in the left coronary artery. DETAILED DESCRIPTION

[0050] The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. The accompanying drawings are only used for exemplary description and represent only schematic diagrams, and cannot be understood as limiting the present patent.

[0051] In order to more clearly describe the structure of the bending handle and the adjustable bending catheter, the terms "proximal end" and "distal end" are defined here as commonly used 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.

[0052] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meanings as those 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.

[0053] See also Figures 3 to 7 and Figure 8a and Figure 8bThe present invention provides a bending handle 20, which is used to control the bending direction and curvature of at least two adjustable bending sections 11 at the distal end of the tube body 10 connected thereto, so that the distal end of the tube body 10 can instantly form different compound bending shapes to meet the surgical requirements with different requirements for the distal end of the tube body 10. In this embodiment, the bending handle 20 is used to bend the distal end of the tube body 10 to meet the requirements of the interventional surgery of the left coronary artery and the right coronary artery on the distal end of the tube body 10. The number of the adjustable bending sections 11 is two, and the two adjustable bending sections 11 are arranged at intervals on the tube body 10. 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 a traction member 30 of an equal number to the adjustable bending sections 11. The control mechanism 23 is connected to the driving mechanism 22 to control the movement of the driving mechanism 22, and then the movement of the driving mechanism 22 drives the adjustable bending sections 11 to bend. The control mechanism 23 controls the driving mechanism 22 to perform different forms of movement through different actions. The different forms of movement of the driving mechanism are respectively used to drive all the adjustable bends 11 to bend at the same time and drive each adjustable bend 11 to bend individually, so that the distal end of the tube body 10 can instantly form different compound bends. Specifically, the driving mechanism 22 drives all the adjustable bends 11 to bend at the same time to improve the bending efficiency, so that the distal end of the tube body 10 can be bent as soon as possible to the shape close to certain human luminal anatomical structures such as the left coronary artery or the right coronary artery required for surgery, thereby shortening the operation time. The driving structure 22 drives each adjustable bend 11 to bend individually, so as to fine-tune the bending curvature of each adjustable bend 11, so as to accurately adjust the bending curvature of each adjustable bend 11, thereby adapting to the individual differences in the physiological anatomical structures of the luminal cavities of different patients and expanding the scope of application of the tube body 10.

[0054] Please read further Figures 3 to 9, the driving mechanism 22 is arranged in the handle housing 21, and the control mechanism 23 is arranged outside the handle housing 21. The control mechanism 23 drives the driving 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. In this embodiment, 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. 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 expose a part of the first inner shell 211. Among them, the first inner shell 211, the second inner shell 212, the first outer shell 213 and the second outer shell 214 can all be integrally formed or formed by splicing two or more sub-shells. In this embodiment, the first outer shell 213 and the first inner shell 211 and the second inner shell 212 are all integrally formed structures, and the second outer shell 214 is formed by splicing two sub-shells. It is understandable 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, and 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 Figures 3 to 5 and Fig.10 , at least two guide holes 2111 are provided 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, and the number of the guide holes 2111 is the same as the number of the adjustable bending section 11. Moreover, after the first inner shell 211 and the second inner shell 212 are fitted 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 outer shell 214 is fixedly connected to the Luer connector 70.

[0055] Specifically, see Figures 5 to 7 and Figures 9 to 12The driving mechanism 22 includes a sliding member 221 slidably connected to the second inner shell 212, and at least two sub-sliders 222 slidably connected to the sliding member 221 along the axial direction of the handle shell 21. Each of the sub-sliders 222 is connected to an adjustable curved section 11 through a traction member 30. When the sub-sliders 222 slide relative to the handle shell 21, the corresponding traction member 30 can be driven to be pulled, so that the corresponding adjustable curved 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 shell 212 in the second inner shell 212, all the sub-sliders 222 located on the sliding member 221 are driven to move synchronously relative to the second inner shell 212, so as to adjust the bending shapes of all the adjustable curved 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 state of the distal end of the tube body 10, that is, to achieve a rough adjustment of the distal end of the tube body 10. For example, when it is necessary to adjust the distal end of the tube body 10 to be suitable for left coronary intervention surgery, the sliding member 221 is moved toward the distal end of the tube body 10, and the two adjustable curved segments 11 are then bent to the left with a certain curvature to form a composite curved shape that can enter the left coronary artery; when it is necessary to adjust the distal end of the tube body 10 to be suitable for right coronary intervention surgery, the sliding member 221 is moved toward the proximal end of the tube body 10, and the two adjustable curved segments 11 are then bent to the right with a certain curvature to form a composite curved shape that can enter the right coronary artery. Further, by keeping the sliding member 221 stationary and adjusting each of the sub-sliders 222 to slide relative to the sliding member 221, each of the adjustable curved segments 11 can be adjusted to bend and change the curvature, so that the distal end of the tube body 10 accurately reaches the desired bending state, that is, the distal end of the tube body 10 can be fine-tuned, so that the distal end of the tube body 10 can meet the requirements of different surgeries and the anatomical structure of the lumen of different patients.

[0056] In this embodiment, the control mechanism 23 includes at least two first drive control members 231. The first drive control members 231 correspond to the sub-slide members 222 one by one to drive the corresponding sub-slide member 222 to move relative to the slide member 221, and can drive the slide member 221 to move relative to the handle housing 21 to adjust the distal end of the catheter 10 to a different shape.

[0057] Specifically, see Fig.11The sliding member 221 is a strip 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 substantially in an inverted T shape. A sliding groove 2213 extending along the axial direction of the handle 20 is provided on the side of the bearing block 2211 away from the driving block 2212, and a convex strip 2114 adapted to the sliding groove 2213 is provided on the inner wall of the second inner shell 212, and the convex strip 2114 is installed in the sliding groove 2213 to realize the axial movement of the sliding member 221 in the second inner shell 212. It can be understood that the sliding groove 2213 can also be provided on the inner wall of the second inner shell 212, and the convex strip 2114 is provided on the bearing block 2211. Further, 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. It is understandable that 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 through hole 2216 penetrating the sliding member 221 in the axial direction of the handle 20, and the through hole 2216 is coaxially arranged with the axis of the handle 20. The tubular body 10 passes through the through hole 2216 from the distal end of the first housing 213 and is connected to the Luer connector 70 at the proximal end of the second housing 214.

[0058] See also Figure 6 , Figure 7 , Fig. 9 and Fig.11 , Fig.12, the sub-slider 222 is preferably a rack. In this embodiment, the sub-slider 222 is two, which are respectively slidably connected to the bearing block 2211 of the sliding member 221 and are respectively located on both sides of the driving block 2212. Specifically, the two opposite sides of the sub-slider 222 are provided with a travel groove 2221 extending along the axial direction of the handle 20, the side of the bearing block 2211 facing the driving block 2212 is provided with a groove 2217, and the opposite groove wall of the groove 2217 is provided with a convex rib 2215 matching 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 slidably connected in the travel groove 2221, so as to realize the axial movement of the sub-slider 222 on the sliding member 221. The side of the sub-slider 222 away from the bearing block 2211 is provided with a plurality of teeth arranged along the extending direction of the travel groove 2221. The sub-sliding member 222 is provided with a receiving groove 2223 on one side facing the bearing block 2211, and the proximal end of the traction member 30 is fixed in the receiving groove 2223 of the sub-sliding member 222, so that the proximal end of the traction member 30 is received in the receiving groove 2223 and fixed in the sub-sliding member 222, thereby preventing 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. Furthermore, in this embodiment, the proximal end of the traction member 30 is welded to a connecting block 2224, and the connecting block 2224 is embedded in the receiving groove 2223, so that the traction member 30 is more stably fixed on the sub-sliding member 222.

[0059] Please read further Figures 5 to 12Each of the first driving control members 231 includes a fine-tuning 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 meshing with the sub-slider 222, and the other end is connected to the fine-tuning 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. Furthermore, in the present invention, a protrusion 2314 is provided on a side of the gear 2313 away from the fine-tuning knob 2311, and the protrusion 2314 penetrates into the mounting hole 2214 on the driving block 2212 and can rotate in the mounting hole 2214, that is, the gear shaft 2312 is rotationally connected to the sliding member 221, so that when the fine-tuning knob 2311 is pushed or pulled axially, the sliding member 221 can be pushed or pulled by the protrusion 2314 connected to the fine-tuning knob 2311 to drive all the sub-slides 222 located thereon to move relative to the handle housing 21, thereby simultaneously adjusting the bending shapes of all the adjustable bending sections 11 to achieve coarse 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, thereby driving the sub-slider 222 meshing with the gear 2313 to move relative to the slide 221, thereby adjusting the bending shape of the adjustable bend section 11 connected to the sub-slider 222, that is, achieving fine-tuning of the distal end of the tube body 10.

[0060] It is understandable that in other embodiments of the present invention, the sub-slider 222 may also be a strip-shaped member having a plurality of groove structures arranged at intervals along the extending direction of the travel groove 2221 on the side away from the carrier block 2211, one end of the gear shaft 2312 is provided with a meshing member meshing with the sub-slider 222 to replace the gear, and the end of the gear shaft 2312 provided with the meshing member is rotatably connected to the slider 221. The outer surface of the meshing member is provided with a plurality of protrusions corresponding to the grooves of the sub-slider 222. When the gear shaft 2312 drives the meshing member to rotate, the protrusions on the outer surface of the meshing member sequentially mesh with the grooves on the sub-slider 222 to drive the sub-slider 222 to move relative to the slider 221.

[0061] Further, in the present invention, the control mechanism 23 also includes a second drive control member 232. In this embodiment, the second drive control member 232 is a sleeve. The second drive 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 two opposite through holes 233 are provided on the second drive control member 232. 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 is engaged with the sub-slider 222. When the second drive control member 232 is pushed or pulled along the axial direction, all the fine-tuning knobs 2311 can be moved synchronously, thereby making the sliding of the slider 221 relative to the handle housing 21 more stable.

[0062] Furthermore, in this embodiment, the inner wall of the through hole 233 is provided with a plurality of slots 2331, and the extending direction of the slots 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, and the axis of the connecting shaft 2311b is coaxial with the rotating 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 ribs 2311c corresponding to the slot 2331, and a first elastic member 2315 is provided between the gear 2313 and the fine-tuning knob 2311. When the first elastic member 2315 is naturally extended, the rib 2311c is inserted 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 sub-sliding member 222 from sliding relative to the sliding member 221; when the fine-tuning knob 2311 is pressed to compress the first elastic member 2315, the rib 2311c is disengaged from the slot 2331. At this time, the gear shaft 2312 and the gear 2313 can be driven to rotate by rotating the fine-tuning knob 2311, so that the sub-sliding member 222 can slide relative to the sliding member 221. That is, when it is necessary to adjust all the adjustable bending sections 11 for bending at the same time, no operation is performed on the fine-tuning knob 2311. Under the action of the first elastic member 2315, the rib position 2311c is inserted into the slot 2331, and the fine-tuning knob 2311 stops rotating, and the gear shaft 2312 is prohibited from driving the gear 2313 to rotate, so that the sub-slider 222 is fixed relative to the sliding member 221. At this time, pushing or pulling the second drive control member 232 along the axial direction of the handle 20 can drive the sliding member 221 and all the sub-slider 222 on the sliding member 221 to move synchronously relative to the handle housing 21, so as to adjust all the adjustable bending sections 11 for bending at the same time. When it is necessary to fine-tune a certain adjustable bending section 11 separately, the second driving control member 232 can be kept stationary, and the corresponding fine-tuning knob 2311 can be pressed inward to make the fine-tuning knob 2311 out of the fixed state and rotated, so that the corresponding gear shaft 2312 and the gear 2313 can be driven to rotate, so that the corresponding sub-slider 222 moves relative to the slider 221, thereby achieving fine-tuning 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.Furthermore, in some embodiments of the present invention, the connecting shaft 2311b of the fine-tuning knob is hollow, the gear shaft 2312 is inserted into the connecting shaft 2311b, and there is a gap of a certain distance between the connecting shaft 2311b and the gear shaft 2312 in the axial direction, allowing the fine-tuning knob 2311 to move inward along its axial direction when pressed to disengage the rib 2311c from the slot 2331 without causing the gear shaft 2312 and the gear 2313 to move along their axial direction relative to the sub-slider 222.

[0063] For further information, see Figure 5 and Figure 6The bending handle 20 further includes a locking member 40, which is disposed on the handle housing 21 and is used to lock the position of the second drive control member 232 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 passes through the first outer shell 213 or the second outer shell 214 and is connected to the pressing portion 421. When the second elastic member 41 is naturally extended, the locking portion 422 locks the position of the second drive control member 232 on the handle housing 21; when the pressing portion 421 is pressed to compress the second elastic member 41, the locking portion 422 is released from locking the second drive control member 232. In this embodiment, the locking portion 422 is a hook-shaped member with one end fixed on the pressing portion 421. The end of the second drive control member 232 close to the first shell 213 and the end close to the second shell 214 are both provided with a groove or an opening 215. When the second drive control member 232 is moved close to the first shell 213 or the second shell 214, the pressing portion 421 is engaged in the groove or the opening 215, thereby locking the position of the second drive control member 232 on the handle housing 21. At this time, the bending shape of the corresponding adjustable bending section 11 can be fine-tuned by rotating the fine-tuning knob 2311. After obtaining the desired bending shape of the distal end of the tube body 10, the fine-tuning knob 2311 cooperates with the corresponding through hole 233 on the second drive control member 232 to stop rotation, thereby avoiding changes in the positions of the second drive control member 232 and the first drive control member 231 during the operation, that is, avoiding changes in 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 remains in the desired bending shape.In this embodiment, the distal end of the tube body 10 can be used for both left coronary artery intervention surgery and right coronary artery intervention surgery. There are two locking members 40, which are respectively arranged on the first shell 213 and the second shell 214: when the second drive control member 232 moves toward the distal end to be close to the first shell 213 and is locked by a locking member 40, the bending shape of the distal end of the tube body 10 is close to the physiological anatomical structure of the right coronary artery, and then the bending shape of each adjustable bending segment 11 is fine-tuned by the fine-tuning knob 2311 to make the distal end of the tube body 10 adapt to different The tube body 10 can smoothly enter the right coronary artery according to the difference in the physiological and anatomical structure of the right coronary artery of the patient, and is suitable for right coronary intervention surgery; when the second drive control component 232 moves proximally to close to the second shell 212 and is locked by another locking component 40, the bending shape of the distal end of the tube body 10 is close to the physiological and anatomical structure of the left coronary artery, and then by fine-tuning the bending shape of each adjustable bend 11 with the fine-tuning knob 2311, the distal end of the tube body 10 can adapt to the difference in the physiological and anatomical structure of the left coronary artery of different patients and smoothly enter the left coronary artery, which is suitable for left coronary intervention surgery.

[0064] Furthermore, a gear mark 50 is provided on the handle housing 21 of the bending handle 20 at the stroke of the second drive control member 232 moving axially along the handle housing 21, so as to mark the position of the second drive control member 232 on the handle housing 21. In this embodiment, the gear mark 50 is respectively provided at the positions where the two locking members 40 are located.

[0065] The bending adjustment handle 20 provided by the present invention controls the driving mechanism 22 to perform different forms of movement by performing different actions through the control structure 23. The different forms of movement of the driving mechanism 22 are used to simultaneously drive all the adjustable bending segments 11 to bend and to individually drive each adjustable bending segment 11 to bend. It is suitable for surgeries with different requirements on the distal bending shape of the tube body 10, such as left coronary artery intervention surgery and right coronary artery intervention surgery, and can adapt to the individual differences in the physiological and anatomical structures of the lumen of different patients.

[0066] See also Figures 3 to 7 , Figure 8a , Figure 8b , Fig.17 and Fig.18The present invention provides an adjustable bend catheter 100 including the bending handle 20. The adjustable bend catheter 100 can be applied to various surgeries with different requirements for the distal end morphology of the catheter. The present invention is described by taking the adjustable bend catheter 100 used for interventional surgery of the left coronary artery and the right coronary artery as an example. The adjustable bend 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 bend sections 11 arranged at intervals. One end of the traction member 30 is correspondingly connected to one of the adjustable bend sections 11, and the other end is correspondingly connected to a sub-sliding member 222 in the bending handle 20. The traction member 30 is arranged along the tube body 10 and can move along the tube body 10. The traction member 30 is controlled by the bending handle 20 to move along the tube body 10 to drive the adjustable bend section 11 to bend. In the present invention, by pushing and pulling the second driving control member 232 on the bending handle 20 to drive the sliding member 221 to move axially, all the traction members 30 can be synchronously controlled to move along the tube body 10, so as to drive all the adjustable bend sections 11 to bend at the same time, thereby improving the efficiency of adjusting the adjustable bend catheter 100; by rotating the fine-tuning knob 2311 in each first driving control member 231 to drive the corresponding sub-sliding member 222 to move axially relative to the sliding member 221, the corresponding traction member 30 can be individually controlled to move along the tube body 10, so as to drive the corresponding adjustable bend section 11 to bend, and further adjust the distal end of the adjustable bend catheter 100 to the desired bending shape. It can be understood that, depending on the different anatomical structures of the lumen to be intervened by the adjustable bend catheter 100, the adjustable bend section 11 can also be three or more sections.

[0067] See also Figure 8a , Figure 8b and Fig.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 a flexible material such as PTFE; the reinforcing tube 10b is preferably a metal woven mesh structure, which has a certain rigidity and can be bent in the axial direction, thereby providing support for the tube body 10, avoiding torsional deformation of the tube body 10 in the radial direction, improving the torsion control of the tube body 10, and not affecting the bending of the adjustable bends 11 on the tube body 10; the outer tube 10c is made of a material with excellent biocompatibility and a certain hardness, such as PEBAX. In addition, the hardness of the outer tube 10c corresponding to the adjustable bend 11 is less than the hardness of other parts of the outer tube 10c, so that the adjustable bend 11 is easier to bend. Specifically, in this embodiment, the part of the outer tube 10c corresponding to the adjustable bend 11 and the other parts use different grades of PEBAX materials, and the hardness of the PEBAX material used in the part of the outer tube 10c corresponding to the adjustable bend 11 is less than the hardness of the PEBAX material used in the other parts of the outer tube 10c, so that the hardness of the part of the outer tube 10c corresponding to the adjustable bend 11 is less than the hardness of the other parts of the outer tube 10c. Further, in this embodiment, the inner film 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 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 film 10a, the reinforcing tube 10b and the outer tube 10c can also be made of other materials other than this embodiment when the use requirements are met.

[0068] Furthermore, in the present embodiment, the distal end of the tube body 10 is an arc-shaped end with a smooth surface, i.e., a Tip head, and a radiopaque developing ring (not shown), such as a tantalum ring, is arranged proximal to the Tip head, so that it can be accurately known whether the distal end of the tube body 10 has reached the desired position under the developing equipment.

[0069] Please combine Figure 8a , Figure 8b and Figures 13 to 16, the traction member 30 is embedded in the tube wall of the tube body 10 and is arranged 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 reinforcing tube 10b. The traction member 30 includes a traction wire 31, the distal end of which is connected to an adjustable bend section 11, and the proximal end passes through the tube wall of the proximal end of the tube body 10 and is connected to the corresponding sub-slider 222 in the bending handle 20, and the sub-slider 222 slides to drive the traction wire 31 to move so as to drive the corresponding adjustable bend section 11 to bend. In this embodiment, the number of the adjustable bend sections 11 is two, namely the first adjustable bend section 11a and the second adjustable bend section 11b; the traction members 30 are also two, namely the first traction member 30a and the second traction member 30b. The first traction member 30 a connects the first adjustable bending section 11 a and a sub-sliding member 222 in the bending adjustment handle 20 , and the second traction member 30 b connects the second adjustable bending section 11 b and another sub-sliding member 222 in the bending adjustment handle 20 .

[0070] In this embodiment, the first adjustable curved section 11a is mainly used to select the left coronary artery or the right coronary artery and control the coronary depth by adjusting its bending shape, so the length of the first adjustable curved section 11a is required to be relatively small, preferably 10mm to 15mm, and the first adjustable curved section 11a needs to be more flexible than the second adjustable curved section 11b, so that it can continue to bend on the basis of the second adjustable curved section 11b being basically fixed in shape, so the first adjustable curved section 11a is required to be softer than the second adjustable curved section 11b, and in this embodiment, the hardness of the first adjustable curved 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 is easier to approach the entrance position of the left coronary artery or the right coronary artery, so the length of the second adjustable curved section 11b is required to be longer, preferably 25mm to 35mm, and the hardness is higher than that of the first adjustable curved section 11a, preferably 45D to 55D. Except for the Tip head, the first adjustable bend 11a and the second adjustable bend 11b, the other parts of the tube body 10 need to have a higher hardness to ensure the torsion control and support of the tube body 10, so the hardness needs to be relatively large. In this embodiment, the hardness of the other parts of the tube body 10 is 72D. Furthermore, the bending angle of the first adjustable bend 11a (the angle between the tube body adjacent to the proximal end of the first adjustable bend 11a and the tangent of the proximal end of the first adjustable bend 11a) ranges from 0° to 90°, and the bending angle of the second adjustable bend 11b ranges from -90° to 180° (the angle between the tube body adjacent to the proximal end of the second adjustable bend 11b and the tangent of the proximal end of the second adjustable bend 11b), so as to allow the distal end of the tube body 10 to be bidirectionally bent to meet the requirements of interventional surgery of the left and right coronary arteries. It is understandable that in other embodiments of the present invention, when the adjustable bend catheter 100 is used for interventional surgery in other lumens of the human body, three or more adjustable bend sections 11 can be set as needed, and the adjustable bend range of each adjustable bend section 11 can be adjusted accordingly to meet the needs of the surgery.

[0071] In this embodiment, if all the traction wires 31 are synchronously pulled or pushed at the proximal end of the tube body 10, all the adjustable curved segments 11 are bent, and the positions of the proximal ends of all the traction wires 31 are synchronously controlled to be different, so that different curved shapes formed by all the adjustable curved segments 11 can be obtained. For example, synchronously pushing all the traction wires 31 toward the distal end to the first position can make all the adjustable curved segments 11 compositely form a curved shape close to that capable of intervening in the right coronary artery, and synchronously pulling all the traction wires 31 toward the proximal end to the second position can make all the adjustable curved segments 11 compositely form a curved shape close to that capable of intervening in the right coronary artery. By pushing or pulling a certain traction wire 31 alone, the traction wire 31 will drive the corresponding adjustable bend segment 11 to bend within a certain angle range. After synchronously controlling all the traction wires 31, the bend of the corresponding adjustable bend segment 11 can be fine-tuned by controlling a certain traction wire 31 alone, so that the bend of the distal end of the tube body 10 can be suitable for the coronary anatomical morphology of different patients; if the force on the traction wire 31 is cancelled, the corresponding adjustable bend segment 11 can return to its original state under the action of its own elasticity.

[0072] The cross-sectional shape of the traction wire 31 can be circular or flat. The diameter of the traction wire 31 ranges from 0.05 mm to 0.25 mm. The traction wire 31 is preferably made of a metal material, such as stainless steel, tungsten alloy, cobalt-chromium alloy or nickel-titanium alloy. It is understood that in other embodiments, the traction wire 31 can also be made of a polymer material with a certain strength. Preferably, in this embodiment, the traction wire 31 is a stainless steel wire with a diameter of 0.20 mm.

[0073] For further information, see Figures 13 to 16 , an anchoring ring 32 is provided at one end of the traction wire 31 connected to the adjustable bend section 11, and the anchoring ring 32 is fixedly sleeved on the adjustable bend section 11, that is, the distal end of the traction wire 31 is connected to the adjustable bend section 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 bend section 11. The contact area between the traction member 30 and the adjustable bend section 11 on the tube body 10 is increased by the anchoring ring 32, which can better drive the adjustable bend section 11 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 connection method between the traction wire 31 and the anchoring ring 32 includes but is not limited to bonding, welding, hot melting, knotting and the like, which are not limited here.

[0074] The traction member 30 also includes a wire wrapping tube 33, and the part of the traction wire 31 located in the tube body 10 is movably arranged in the wire wrapping tube 33, so as to limit the traction direction of the traction wire 31 through the wire wrapping tube 33, and protect the traction wire 31 through the wire wrapping tube 33. In the present invention, the inner diameter of the wire wrapping tube 33 is slightly larger than the diameter of the traction wire 31 so that the traction wire 31 can be passed through it, which can prevent the tube body 10 from holding the traction wire 31 tightly during the hot melt shrinkage, causing the traction wire 31 to be unable to slide smoothly along the axial direction, and prevent the traction wire 31 from breaking due to bending. In this embodiment, the inner diameter of the wire wrapping tube 33 can be selected to be 0.40 mm. It is worth noting that the hardness of the part of the wire wrapping tube 33 corresponding to the adjustable bend section 11 should be less than the hardness of other parts, that is, the part of the wire wrapping tube 33 corresponding to the adjustable bend section 11 is flexible, so as not to affect the bending of the adjustable bend section 11. For example, the portion of the threading tube 33 embedded in the adjustable bend section 11 can be made of a softer PTFE tube, while the other portion can be made of a PI tube or a stainless steel tube.

[0075] Further, in the present invention, the traction 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. In addition, a hardened tube (not shown in the figure) is fixedly sleeved outside the portion where the traction wire 31 is connected to the sub-slider 222, and the strength of the hardened tube is greater than the strength of the wire wrapping tube 33, so as to increase the strength of the connection portion between the traction wire 31 and the sub-slider 222, avoid breaking the traction wire 31, and facilitate the connection between the traction wire 31 and the sub-slider 222. In this embodiment, the hardened tube includes but is not limited to a stainless steel tube. Further, in this embodiment, a wire splitting head (not shown) is also included, and after each traction wire 31 passes through the tube body 10, the wire splitting head is used to guide different traction wires 31 to enter the extension path after the bending handle 20, so as to connect different sub-slider 222.

[0076] See also Fig.14 and Fig.15The traction wires 31 corresponding to the different adjustable bends 11 are all arranged on the same side of the tube body 10, the portion of the traction wire 31 of the first traction member 30a corresponding to the first adjustable bend 11a and the portion of the traction wire 31 of the second traction member 30b corresponding to the second adjustable bend 11 are both parallel to the axis of the tube body 10, and the plane formed by the portion of the traction wire 31 of the first traction member 30a corresponding to the first adjustable bend 11a and the axis of the tube body 10 and the traction wire 31 of the second traction member 30b The portion corresponding to the second adjustable bend section 11 coincides with the plane formed by the axis of the tube body 10, so that when the first adjustable bend section 11a and the second adjustable bend section 11b are driven to bend by the traction wire 31 of the first traction member 30a and the second traction member 30b, the planes where the first adjustable bend section 11a and the second adjustable bend section 11b bend are coplanar, so that the distal end of the adjustable bend catheter 100 is easier to control, and the distal end of the adjustable bend catheter 100 after bending can more easily enter the target lumen.

[0077] Specifically, see Fig.14 In one embodiment of the present invention, the two anchoring rings 32 are respectively provided with an arc-shaped portion that is recessed inward or convex relative to the outer circumference of the anchoring ring 32, and the two wire wrapping tubes 33 are respectively fixed in the arc-shaped portions. 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 traction wire 31 is passed through the wire wrapping tube 33, so that the plane formed by the traction wire 31 of the first traction member 30a and the axis of the tube body 10 coincides with the plane formed by the traction wire 31 of the second traction member 30b and the axis of the tube body 10, and the plane where the first adjustable bend section 11a bends under the drive of the traction wire 31 in the corresponding wire wrapping tube 33 and the plane where the second adjustable bend section 11b bends under the drive of the traction wire 31 in the corresponding wire wrapping tube 33 are coplanar. Please refer to Fig.15In another embodiment of the present invention, the two anchor rings 32 are both provided with arc-shaped portions convex relative to the outer periphery of the anchor rings 32, and the two wire wrapping tubes 33 are respectively fixed in the arc-shaped portions. The portion of the wire wrapping tube 33 on the first traction member 30a corresponding to the first adjustable bend section 11a and the portion of the wire wrapping tube 33 on the second traction member 30b corresponding to the second adjustable bend section 11b are both parallel to the axis of the tube body 10 and are on the same straight line. The traction wire is passed through the wire wrapping tubes, so that the traction wire 31 of the first traction member 30a corresponding to the first adjustable bend section 11a and the plane formed by the axis of the tube body 10 and the traction wire 31 of the second traction member 30b are aligned with each other. The part of the second adjustable bend 11 should coincide with the plane formed by the axis of the tube body 10, and similarly, the plane where the first adjustable bend 11a bends when driven by the traction wire 31 in the corresponding wire wrapping tube 33 and the plane where the second adjustable bend 11b bends when driven by the traction wire 31 in the corresponding wire wrapping tube 33 can be coplanar; but the wire wrapping tube 33 on the first traction member 30a is bent at a position close to the anchoring ring 32 of the first traction member 30b, so that the other parts of the wire wrapping tube 33 on the first traction member 30a except for the part corresponding to the first adjustable bend 11a are arranged side by side with the wire wrapping tube 33 on the second traction member 30b.

[0078] Understandably, see Fig.16 In some other embodiments of the present invention, the wire wrapping tube 33 on the first traction member 30a and the wire wrapping tube 33 on the second traction member 30b can also be arranged side by side, that is, the two traction wires 31 are arranged side by side, so that the plane where the first traction member 30a drives the first adjustable bending section 11a to bend is not coplanar with the plane where the second traction member 30b drives the second adjustable bending section 11b to bend.

[0079] The adjustable bend catheter 100 provided by the present invention can instantly form different composite bends at the distal end of the tube body 10 by manipulating the bend adjustment handle 20. The different composite bends can respectively approach the physiological and anatomical structures of different positions of the human lumen, such as the left coronary artery and the right coronary artery. In addition, by manipulating the bend adjustment handle 20, the bends of each adjustable bend segment 11 can be fine-tuned in real time in the body. Thus, the same adjustable bend catheter 100 can be used to perform surgeries with different requirements for the distal end morphology of the adjustable bend catheter, such as left coronary artery intervention surgery and right coronary artery intervention surgery. The catheter can also adapt to the individual differences in the physiological and anatomical structures of the lumen of different patients, thereby reducing the number of punctures, reducing damage to the human body, simplifying the surgical process, and shortening the surgical time.

[0080] Please also see Figures 3 to 9 and Fig.17 and Fig.18When the adjustable bend catheter 100 is used to perform left coronary intervention and right coronary intervention, the catheter body 10 reaches the coronary artery entrance through the radial artery. The second drive control member 232 is manually controlled to slide distally to a position close to the first housing 213, and the second drive control member 232 is locked by the locking member 40. During the process of the second drive control member 232 sliding toward the distal end to the gear position close to the first shell 213, the second drive control member 232 drives the first drive control member 231, the sub-slider 222 and the slide 221 to move axially synchronously. The sub-slider 222 pushes all the traction wires 31 toward the distal end, so that all the adjustable bends 11 can be instantly combined to form a bend shape close to being able to intervene in the right coronary artery. Then, by pushing the fine-tuning knob 2311 inward to disengage the rib position 2311c from the slot 2331 and rotating the fine-tuning knob 2311, the corresponding sub-slider 222 can be driven to slide axially on the slide 221, thereby driving the traction wire 31 to act on the corresponding adjustable bend segment 11, and fine-tuning the bend shape of the corresponding adjustable bend segment 11, so that the distal end of the tube body 10 can smoothly enter the right coronary artery. When the diagnosis and treatment of the right coronary artery is completed and the diagnosis and treatment of the left coronary artery is required, the locking member 40 that locks the second drive control member 232 is manually pressed downward, the second drive control member 232 is unlocked, and the second drive control member 232 is pulled to slide proximally to a position close to the second housing 214, and the second drive control member 232 is locked by another locking member 40. During this process, since the rib 2311c on the fine-tuning knob 2311 is engaged in the slot 2331, the gear 2313 does not rotate, so that the position of the sub-sliding member 222 relative to the sliding member 221 remains unchanged, and the second drive control member 232 drives the first drive control member 232 to rotate. The control member 231 and the sub-slider 222 and the slider 221 move axially synchronously. The sub-slider 222 pulls all the traction wires 31 toward the proximal end so that all the adjustable curved segments 11 can be instantly combined to form a curved shape close to that capable of intervening in the left coronary artery. Then, by pushing the fine-tuning knob 2311 inward to disengage the rib position 2311c from the slot 2331 and rotating the fine-tuning knob 2311, 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 curved segment 11, and fine-tuning the curved shape of the corresponding adjustable curved segment 11, so that the distal end of the catheter can smoothly enter the left coronary artery. Therefore, the adjustable curved catheter 100 of the present invention can realize that one adjustable curved catheter 100 can be applicable to both left coronary artery intervention surgery and right coronary artery intervention surgery, and each adjustable curved segment 11 can be fine-tuned in real time, respectively, to adapt to the coronary anatomical morphology of different patients.

[0081] It can be understood that the above embodiment only takes the arrangement of two adjustable bend sections 11 on the tube body 10 as an example. In other embodiments, a greater number of adjustable bend sections 11 can be arranged as long as a corresponding number of sub-sliders 222 and first drive control components 232 are adaptively configured in the bending handle 20.

[0082] The above is a preferred embodiment of the present invention. It should be pointed out that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A bending handle, characterized in that: Used to control the bending of at least two adjustable bending segments on the distal end of the tube body connected to the bending handle, the bending handle comprises a driving mechanism and a control mechanism connected to the driving mechanism, the driving mechanism is connected to all the adjustable bending segments; the control mechanism controls the driving mechanism 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 segments to bend and to drive each of the adjustable bending segments to bend individually, so that the distal end of the tube body instantly forms different compound bending shapes; The driving mechanism comprises a sliding member, at least two sub-sliders slidably connected to the sliding member, one of the sub-sliders correspondingly connected to one of the adjustable bending sections; the sliding member is a strip-shaped member extending along the axial direction of the bending adjustment handle; the control mechanism comprises at least two first driving control members, one of the first driving control members correspondingly controls one of the sub-sliders; one of the first driving control members independently drives the corresponding sub-slider to move relative to the sliding member, so as to independently drive the corresponding adjustable bending section to bend; all of the first driving control members synchronously drive the sliding member to move along the axial direction of the bending adjustment handle, so as to simultaneously drive all of the adjustable bending sections to bend; The sub-slider is a rack; the first drive control component 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 that is rotatably connected to the sliding member; rotating one of the fine-tuning knobs drives the corresponding gear shaft to rotate to drive the corresponding sub-slider to move relative to the sliding member, so as to drive the corresponding adjustable bending section to bend individually; all of the fine-tuning knobs move synchronously along the axial direction of the bending adjustment handle to drive all of the gear shafts to move to drive the sliding member to move along the axial direction of the bending adjustment handle, so as to simultaneously drive all of the adjustable bending sections to bend.

2. The bending handle according to claim 1, characterized in that: The extending direction of the gear shaft is perpendicular to the axial direction of the bending adjustment handle.

3. The bending handle according to claim 2, characterized in that: 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.

4. The bending handle according to claim 3, characterized in that: The handle housing is provided with a guide hole extending along the axial direction of the bending adjustment handle, and the gear shaft passes through the guide hole and moves along the extending direction of the guide hole.

5. The bending handle according to claim 3 or 4, characterized in that: The control mechanism also includes a second drive control component, which is sleeved on the outside of the handle housing; a through hole is provided on the second drive control component, and the gear shaft passes through the second drive control component through the through hole, and a stop structure is provided between the fine-tuning knob connected to the gear shaft and the through hole, and the stop structure is used to limit the rotation of the fine-tuning knob; the second drive control component moves along the axial direction of the handle housing to drive all the fine-tuning knobs and gear shafts to move synchronously along the axial direction of the bending adjustment handle.

6. The bending handle according to claim 5, characterized in that: The inner wall of the through hole is provided with a plurality of slots, the fine-tuning knob includes a connecting shaft connected to the gear shaft, the outer surface of the connecting shaft is provided with a plurality of ribs corresponding to the slots, the slots and the ribs constitute the anti-rotation structure, a first elastic member is provided between the gear and the fine-tuning knob, when the first elastic member is naturally stretched, the ribs are inserted into the slots to prevent the fine-tuning knob from rotating; when the fine-tuning knob is pressed to compress the first elastic member, the ribs are disengaged from the slots to allow the fine-tuning knob to rotate.

7. The bending handle according to claim 5, characterized in that: The bending adjustment handle also includes a locking member, which is arranged on the handle housing and is used to lock the position of the second drive control member on the handle housing.

8. The bending handle according to claim 7, characterized in that: 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, the second elastic member is connected between the pressing portion and the handle housing, and when the second elastic member is naturally extended, the locking portion locks the position of the second drive control member on the handle housing; when the pressing portion is pressed to compress the second elastic member, the locking portion releases the lock on the second drive control member.

9. The bending handle according to claim 8, characterized in that: The handle housing is provided with a gear mark to mark the position of the second drive control component on the handle housing.

10. An adjustable curved conduit, characterized in that: It comprises a tube body, at least two traction members and a bending adjustment handle as described in any one of claims 1 to 9, wherein the bending adjustment handle is connected to the proximal end of the tube body, and the distal end of the tube body is provided with at least two adjustable bending sections arranged at intervals; the distal end of each of the traction members is connected to one of the adjustable bending sections, and the proximal end is connected to the driving mechanism in the bending adjustment handle.

11. The adjustable curved conduit according to claim 10, characterized in that: The tube body comprises an inner membrane, a reinforcing tube and an outer tube which are sequentially mounted from the inside to the outside.

12. The adjustable curved conduit according to claim 11, characterized in that: The hardness of the outer tube corresponding to the adjustable bending section is smaller than the hardness of other parts of the outer tube.

13. The adjustable curved conduit according to claim 10, characterized in that: The traction member is embedded in the tube wall of the tube body.

14. The adjustable curved conduit according to claim 13, characterized in that: The traction member comprises a traction wire, the distal end of which is connected to an adjustable bending section, and the proximal end of which is connected to the driving mechanism in the bending adjustment handle.

15. The adjustable curved conduit according to claim 14, characterized in that: The traction wires corresponding to the different adjustable bends are all arranged on the same side of the tube body, the parts of the different traction wires located in the corresponding adjustable bends are parallel to the axis of the tube body, and the parts of the different traction wires located in the corresponding adjustable bends coincide with the planes formed by the axis of the tube body.

16. The adjustable curved conduit according to claim 14, characterized in that: The traction member also includes an anchoring ring, which is embedded in the tube wall of the adjustable bending section and fixedly connected to the distal end of the traction wire.

17. The adjustable curved conduit according to claim 14, characterized in that: The traction member also includes a wire-wrapped tube, and the portion of the traction wire located in the tube body is movably inserted into the wire-wrapped tube. The hardness of the portion of the wire-wrapped tube corresponding to the adjustable bending section is smaller than the hardness of other portions of the wire-wrapped tube.

18. The adjustable curved conduit according to claim 10, characterized in that: The at least two adjustable bends include a first adjustable bend located at the distal end of the tube body and a second adjustable bend located proximal to the first adjustable bend; the hardness of the first adjustable bend is less than the hardness of the second adjustable bend.

19. The adjustable curved conduit according to claim 18, characterized in that: The hardness range of the first adjustable bending section is 25D to 35D, and the hardness range of the second adjustable bending section is 45D to 55D.

20. The adjustable curved conduit according to claim 18 or 19, characterized in that: The bending angle range of the first adjustable bending section is 0° to 90°, and the bending angle range of the second adjustable bending section is -90° to 180°.

21. The adjustable curved conduit as claimed in claim 20, characterized in that: The control mechanism controls the driving mechanism to simultaneously drive the first adjustable bend segment and the second adjustable bend segment to bend, thereby forming a bend suitable for intervention in the left coronary artery or the right coronary artery; and the control mechanism controls the driving mechanism to drive the first adjustable bend segment or the second adjustable bend segment to bend alone, thereby fine-tuning the bend shape.

Images