Deflectable catheter assembly

Abstract

A deflectable catheter assembly includes a catheter and a handle coupled to the catheter. The catheter has a deflectable distal section to which a first traction wire and a second traction wire, which are oppositely disposed, are coupled to pull the distal section to achieve bi-directional deflection. The handle includes a first driver including a first member coupled to the first traction wire, a second member coupled to the second traction wire, and a first drive member coupling the first member and the second member. The first drive member is actuated to move one of the first member and the second member while maintaining the other one immovable, thereby pulling the distal section to deflect by proximally tensioning one of the first traction wire and the second traction wire. According to the deflectable catheter assembly, bidirectional deflection of the catheter can be achieved, the operation duration can be greatly shortened, and finally the operation success rate is increased.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a deflectable catheter assembly. Background Art

[0002] With the development of medical technology, interventional surgery is becoming more and more common. Interventional surgery is generally performed by opening a small operation window on the surface of the human body, and the catheter-type interventional device enters the vascular channel through the operation window to reach the treatment area for interventional treatment. In the field of interventional treatment of structural heart disease, commonly used interventional pathways include: femoral vein puncture, which reaches the right atrium / right ventricle through the inferior vena cava, or further reaches the left atrium / left ventricle through the atrial septum; and femoral artery puncture, which reaches the left ventricle through the aortic arch.

[0003] Given the tortuosity of human blood vessels, interventional surgery requires that the catheter of a catheter-type interventional device has a certain degree of adaptability, so as not to cause irreversible damage to the vascular tissue. It is also necessary to precisely control the proximal handle of the catheter-type interventional device to achieve precise bending of the distal end of the catheter, so as to adapt to the different lesion location requirements and ultimately ensure the safety and effectiveness of interventional surgery. However, catheter-type interventional devices in the prior art usually only have a one-way bending function, so their flexibility and adaptability in the vascular channel and heart structure are very poor, which not only easily causes vascular damage, but also makes precise control more difficult, which in turn affects the duration of the operation and the success rate of the operation. Summary of the invention

[0004] The object of the present invention is to provide a deflectable catheter assembly, which can realize bidirectional deflection of the catheter, which can not only greatly shorten the operation time, but also ultimately improve the success rate of the operation.

[0005] In order to achieve the above object, the present invention provides a deflectable catheter assembly, comprising:

[0006] A catheter having a deflectable distal section; a first traction wire and a second traction wire disposed opposite to each other and coupled to the distal section to pull the distal section to deflect in a first direction and a second direction opposite to the first direction; and

[0007] A handle coupled to the catheter; the handle comprising a first actuator, the first actuator comprising:

[0008] a first member coupled to the first traction wire;

[0009] a second member coupled to the second pull wire; and

[0010] A first drive member connects the first member and the second member; the first drive member is actuated to drive one of the first member and the second member to move relative to the catheter, while keeping the other of the first member and the second member stationary relative to the catheter, thereby pulling the distal segment to deflect toward the first direction or the second direction by tightening one of the first traction wire and the second traction wire toward the proximal end.

[0011] The deflectable catheter assembly provided by the present invention realizes bidirectional deflection of the distal section of the catheter by differentially controlling the two traction wires by the first driver, thereby greatly enhancing its flexibility and adaptability in the vascular channel and the heart structure. Therefore, the deflectable catheter assembly of the present invention can not only greatly reduce the damage to the blood vessels, but also improve the accuracy of the regulation, ultimately ensuring that the operation time is greatly shortened and the success rate of the operation is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0013] Figure 1 A schematic diagram of the structure of a deflectable catheter assembly capable of bidirectional deflection in some embodiments is shown.

[0014] Figure 2 Schematic diagrams showing various movement processes of the first driver in some embodiments.

[0015] Figure 3 Shows Figure 1 Schematic diagram of the state of the deflectable catheter assembly when the first drive is in the initial position.

[0016] Figure 4 Shows Figure 1 Schematic diagram of the state of the deflectable catheter assembly when the first drive is in the working position.

[0017] Figure 5 Shows Figure 1 Schematic diagram of the structure in which the first traction wire and the second traction wire are coupled to the anchoring ring.

[0018] Figure 6-7 Schematic diagrams of the structures of retaining components in some embodiments are shown.

[0019] Figure 8-9 Schematic diagrams of two states of the limiting components in some embodiments are shown.

[0020] Fig.10 A three-dimensional structural diagram of a handle in some embodiments is shown.

[0021] Figure 11-13 Shows Figure 8 Three-dimensional structural diagram of the middle limiting component.

[0022] Figure 14-15 Shows Fig.11 Schematic diagram of the limiting component in two states: a compressed state and a reset state.

[0023] Figure 16-20 Schematic diagrams of various states of a deflectable catheter assembly manipulating the catheter to perform bidirectional deflection toward Y+ and Y- in some embodiments are shown.

[0024] Fig.21 A schematic diagram of the structure of a deflectable catheter assembly capable of four-way deflection in other embodiments is shown.

[0025] Fig. 22 Shows Fig.21 A schematic diagram of the structure in which the first traction wire and the second traction wire are coupled to the first anchoring ring, and the third traction wire and the fourth traction wire are coupled to the second anchoring ring.

[0026] Figure 23-25 Schematic diagrams of multiple manipulation states for forming the distal section of the catheter into a double curved curve with two bending directions X and Y are shown.

[0027] Fig.26 Shows Fig.21 Schematic diagram of a scene in which the deflectable catheter assembly enters the right atrium inside the heart through the femoral vein.

[0028] Fig. 27 A partially exploded schematic diagram of a deflectable catheter assembly is shown.

[0029] Fig.28 Shows Fig. 27 Partial cross-sectional view of the middle handle.

[0030] Fig.29 Shows Fig.28 Schematic diagram of the structure after removing the first driving member and the second driving member.

[0031] The following specific implementation manner will further illustrate the present invention in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0032] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] In addition, the following descriptions of the embodiments are made with reference to the attached diagrams to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0034] It should be noted that, in order to more clearly describe the deflectable catheter assembly provided by the present invention, the limiting terms "proximal end" and "distal end" described in the specification of the present invention are all conventional terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end close to the operator during the surgical operation; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial or longitudinal axis; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius. It is worth noting that the "end" in the terms such as "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end" and "lower end" is not limited to the end, end point or end face, but also includes a portion extending from the end, end point, or end face on the element to which the end, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by technicians in the technical field of the present invention. The conventional terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not to be construed as limiting the present invention.

[0035] The present invention provides a deflectable catheter assembly 100, which is used to establish a path from outside the patient's body to tissue inside the body, such as heart tissue, and to position its distal end to a target position in the tissue inside the body, thereby providing a channel for medical devices for treatment to be delivered to the treatment area, thereby achieving interventional treatment under different paths.

[0036] Specifically, see Figure 1As shown, the deflectable catheter assembly 100 includes a catheter 20 and a handle 30 coupled to the catheter 20. The catheter 20 has a deflectable distal section 200. The first traction wire 21 and the second traction wire 22 arranged opposite to each other are coupled to the distal section 200 to pull the distal section 200 to deflect in a first direction and a second direction opposite to the first direction. Further, the handle 30 includes a first driver 31, and the first driver 31 includes a first member 311, a second member 312, and a first drive member 313. The first member 311 is coupled to the first traction wire 21, the second member 312 is coupled to the second traction wire 22, and the first drive member 313 connects the first member 311 and the second member 312.

[0037] Then, when the first driving member 313 is actuated, the first driving member 313 can drive one of the first member 311 and the second member 312 to move relative to the catheter 20, while keeping the other of the first member 311 and the second member 312 stationary relative to the catheter 20, thereby pulling the distal section 200 to deflect in the first direction or the second direction by tightening one of the first traction wire 21 and the second traction wire 22 proximally.

[0038] In some embodiments, the first direction and the second direction are two opposite directions, the Y+ direction and the Y- direction, respectively. The first member 311 is coupled to the proximal end of the first traction wire 21. Preferably, after the proximal end of the first traction wire 21 passes through the proximal wall of the catheter 20, it will be coupled to the first member 311. The second member 312 is coupled to the proximal end of the second traction wire 22. Preferably, after the proximal end of the second traction wire 22 passes through the proximal wall of the catheter 20, it will be coupled to the second member 312.

[0039] In other embodiments, Figure 2 As shown, the first driving member 313 can be connected to the first member 311 and the second member 312 at the same time by one of the structures selected from gears, racks, screws, nuts, threads, winding wheels, and cams, or a combination of two or more structures. Therefore, in the embodiments of the above various combinations, the movement of the first member 311 and the second member 312 relative to the catheter 20 can be an axial movement as shown by arrow C1, or an angular movement toward the proximal end or the distal end as shown by arrow C2, or a rotational movement as shown by arrow C3 to wind the traction wire.

[0040] In the present invention, the deflectable catheter assembly 100 realizes bidirectional deflection of the distal section 200 of the catheter 20 by differentially controlling the first traction wire 21 and the second traction wire 22 by the first driver 31, thereby greatly enhancing its flexibility and adaptability in the vascular channel and the heart structure. Therefore, the deflectable catheter assembly 100 of the present invention not only greatly reduces the damage to the blood vessels, but also improves the accuracy of the regulation, ultimately ensuring that the operation time is greatly shortened and the success rate of the operation is improved.

[0041] It is understandable that when the distal section 200 is subjected to a unidirectional deflection operation, the released traction wire is very likely to be redundant due to the control method of releasing another traction wire by tightening one traction wire. Therefore, the present invention can achieve unidirectional deflection of the distal section 200 by only tightening one traction wire toward the proximal end, that is, a unidirectional bending control method, thereby avoiding the huge risk of another traction wire being easily entangled with the first driver 31 or other components of the handle 30 due to redundancy.

[0042] Furthermore, if Figure 3-4 As shown in FIG. 1 , the first driver 31 has an initial position and a working position. The first driver 31 can be actuated between the initial position and the working position to switch the distal section 200 of the catheter 20 between the original state and the deflected state. Specifically, the original state of the distal section 200 is a natural state when no force is applied, for example, Figure 3 The unshaped original state shown can also be Fig.23 The pre-shaped pre-shaped original state shown has a curved curve. The deflected state of the distal section 200 is an unnatural state that is bent relative to the original state. Figure 4 shown.

[0043] When the first driver 31 is in the initial position, Figure 3 As shown, the first traction wire 21 and the second traction wire 22 will remain in a straight state, for example, the first traction wire 21 maintains a first tensioning force to maintain the straight state, and the second traction wire 22 maintains a second tensioning force to maintain the straight state, but neither will apply a force to the distal section 200 of the catheter 20. The first drive member 313 is actuated to switch the first driver 31 between the initial position and the working position. For example, under the actuation of the first drive member 313, the second member 312 does not move and does not apply a force to the proximal end of the second traction wire 22. The first member 311 will move relative to the catheter 20, such as moving axially toward the proximal end to tighten the first traction wire 21 at the proximal end, so that the first traction wire 21 moves axially toward the proximal end in the catheter 20, thereby moving the distal section 200 of the catheter 20 from as shown in the figure. Figure 3 The original state shown is switched to Figure 4Then, when the first driving member 313 is actuated in the reverse direction, the second member 312 remains stationary, while the first member 311 is actuated to move axially toward the distal end to release the tightened first traction wire 21 until it is completely restored to the straight state, thereby moving the distal section 200 of the catheter 20 from the position shown in FIG. Figure 4 The deflection state shown is reset to Figure 3 Original condition shown.

[0044] It is understandable that the first tensioning force and the second tensioning force can be set equal or unequal according to different requirements of the designer, or can be 0. In order to ensure the controllability and accuracy of the deflection of the deflectable catheter assembly 100, the present invention preferably sets the first tensioning force and the second tensioning force equal.

[0045] In some embodiments, Figure 5 As shown, the distal ends of the first traction wire 21 and the second traction wire 22 are respectively coupled to the anchor ring 23 in the distal section 200 of the catheter 20. The anchor ring 23 is a thin ring structure, which is fixedly arranged, for example, hot-melted, in the distal wall of the distal section 200 of the catheter 20. The distal ends of the first traction wire 21 and the second traction wire 22 are coupled to the opposite sides of the anchor ring 23, and their corresponding proximal ends extend through the traction wire cavities respectively opened on the opposite walls of the catheter 20, until they pass through the proximal wall of the catheter 20 and are coupled to the first driver 31.

[0046] Preferably, the first traction wire 21 and the second traction wire 22 are flexible filaments with a certain length and toughness, such as stainless steel braided wire, steel wire, nickel titanium wire, or non-metallic braided rope such as ordinary suture. In view of the good toughness, folding resistance and softness of the stainless steel braided wire, the present invention preferably uses stainless steel braided wire for the first traction wire 21 and the second traction wire 22. The preferred material of the anchoring ring 23 is tantalum, which has a better imaging effect under ultrasound than stainless steel.

[0047] Furthermore, if Figure 6-8 As shown, the first driver 31 further includes a retaining member 314, which is configured to abut against and retain the first member 311 or the second member 312 from moving. It can be understood that the retaining member 314 includes at least one of a locking member, a biasing member, and a limiting member.

[0048] In some embodiments, the retaining member 314 includes a locking member that can move between a locked position and an unlocked position to switch between locking and unlocking the first member 311 or between locking and unlocking the second member 312. Figure 6As shown, the locking member can be a latch 314a, which can be detachably plugged into the first member 311 or the second member 312. Before the deflectable catheter assembly 100 is manipulated for deflection manipulation, the latch 314a is switched from the unlocked position removed from the handle 30 to the locked position where the latch 314a is plugged into the first member 311 or the second member 312, thereby locking the first member 311 or the second member 312 to the handle 30 to remain immobile. Of course, the locking member can also be an abutment member 314b, which can be movably abutted to the first member 311 or the second member 312. Before the deflectable catheter assembly 100 is manipulated for deflection manipulation, the abutment member 314b is switched from the release position of being disengaged from the abutment of the first member 311 or the second member 312 to the locked position of abutting each other to generate engagement friction, thereby locking the first member 311 or the second member 312 to the handle 30 to remain immobile.

[0049] In other embodiments, Figure 7 As shown, the holding member 314 includes a biasing member 314c, and the first member 311 or the second member 312 can switch between balancing the biasing force of the biasing member 314c and releasing the biasing force of the biasing member 314c. That is, the biasing member 314c can provide a biasing force to keep the first member 311 or the second member 312 immobile to balance the force applied by the first driving member 313. Preferably, the biasing member 314c is one of a compression spring, a spring, and a wave spring.

[0050] Specifically, the biasing member 314c includes a first biasing member 314c1 for generating a first biasing force on the first member 311, and a second biasing member 314c2 for generating a second biasing force on the second member 312. The first driving member 313 can generate a first pair of opposite forces acting on the first member 311 and the second member 312, such as a first pair of opposite forces F1 and F2. Under the force F1, the first member 311 can release the first biasing force of the first biasing member 314c1 and move in a direction away from the first biasing member 314c1, such as rotating to wind the first traction wire 21, or moving toward the proximal end to tighten the first traction wire 21. At this time, the first traction wire 21 is in a tensioned state. Under the force F2, the second member 312 can resist and balance the second biasing force of the second biasing member 314c2 to keep the second member 312 from moving. At this time, the second traction wire 22 can maintain its initial straight state. Therefore, the first driver 31 forms different forces applied to the first traction wire 21 and the second traction wire 22 by different control of the first component 311 and the second component 312, so as to achieve deflection in a single direction.

[0051] It should be particularly noted that the second component 312 not moving represents that the second component 312 is substantially stationary, and slight movement of the second component 312 due to process errors or other considerations is still included in the protection scope of the present invention.

[0052] In some embodiments, the first member 311 and the second member 312 are spaced and symmetrically arranged along the radial direction of the handle 30. Under the actuation of the first driving member 313, the first member 311 and the second member 312 can move axially relative to the catheter 20; and the first biasing member 314c1 and the second biasing member 314c2 are arranged on the same side of the first member 311 and the second member 312, so as to generate different forces on the first member 311 and the second member 312 respectively under the first pair of opposite forces F1 and F2. Preferably, the first biasing member 314c1 and the second biasing member 314c2 are two independent elastic members, such as compression springs. Of course, in other embodiments, the first biasing member 314c1 and the second biasing member 314c2 are two elastic parts on an independent elastic member, such as independent springs that can be connected to the first member 311 and the second member 312 at the same time.

[0053] Furthermore, if Figure 8 As shown, the first driving member 313 can also generate a second pair of opposite forces F3 and F4 that are opposite to the first pair of opposite forces, such as F1 and F2, to reset the first member 311 and the second member 312 and move them in another opposite direction, so as to achieve another single direction deflection. Among them, F1 and F3 are opposite to each other, that is, the directions of the forces F1 and F3 are opposite; F2 and F4 are opposite to each other, that is, the directions of the forces F2 and F4 are opposite.

[0054] In order to ensure that the first member 311 and the second member 312 can still keep one of the first traction wire 21 and the second traction wire 22 moving and the other one not moving during the resetting process, the retaining member 314 also includes a limiting member 314d. Under the force F3, the first member 311 moves in the direction close to the first biasing member 314c1 until it is reset. For example, the first member 311 is rotated in the opposite direction to loosen the winding of the first traction wire 21, or moves toward the distal end to release the first traction wire 21, thereby restoring the first traction wire 21 from the tensioned state to the initial straight state. Under the force F4, the second member 312 is restricted by the limiting member 314d and cannot move in the direction away from the second biasing member 314c2. At this time, the second traction wire 22 still remains in the initial straight state. Therefore, the first driver 31 realizes the resetting after deflection by further distinguishing and controlling the first member 311 and the second member 312.

[0055] In some embodiments, please also refer to Figure 8 and Fig. 9 As shown, the limiting member 314d has a compression state and a reset state. The limiting member 314d abuts between the first member 311 and the second member 312 to form a compression state. Fig. 9 However, the limiting member 314d is separated from the abutment of the first member 311 and the second member 312 to form a reset state, see Figure 8 Wherein, in the reset state, the second member 312 is limited therein by the second biasing member 314c2 and the limiting member 314d, thereby ensuring that the second member 312 remains stationary during the reset process.

[0056] Specifically, the limiting member 314d includes a housing, a first gear located in the housing, two racks meshed with the first gear, and a reset member disposed between the housing and the first gear, each rack having a limiting portion that can extend and retract into the housing. Figure 11-15 The description will not be repeated here.

[0057] The following description takes the first driving member 313 as an example of connecting the first member 311 and the second member 312 by means of a screw rod and a gear structure, and other structural combinations are not described in detail. Fig.10 As shown, the first member 311 and the second member 312 are nuts, the first driving member 313 is a coaxial driving wheel that can rotate relative to the catheter 20, and the first biasing member 314c1 ( Fig.10 The second biasing member 314c2 (not shown) is a compression spring.

[0058] For details, please continue to see Fig.10 The first driver 31 includes two screw shafts 315, two guide rods 316 and two second gears 317 arranged opposite to each other. The first member 311 and the second member 312 are respectively threadedly sleeved to the corresponding screw shaft 315, and are respectively axially movably sleeved to the corresponding guide rod 316. The two second gears 317 are respectively arranged on one side of the corresponding screw shaft 315, and can be meshed with the first driving member 313.

[0059] In some embodiments, the two second gears 317 are fixedly arranged on one side of the corresponding screw shaft 315, such as being arranged on the same side or different sides. The first drive member 313 has internal meshing teeth for meshing and connecting with the two second gears 317. For some applications, the two threads of the two screw shafts 315 have opposite rotation directions, such as left-handed threads and right-handed threads, but the same pitch. When the first drive member 313 is actuated to rotate, the two second gears 317 can be synchronously driven and rotate in the same direction, thereby driving the two screw shafts 315 to rotate in the same direction. In view of the opposite rotation directions of the two threads of the two screw shafts 315, the first member 311 and the second member 312 can be axially moved in opposite directions under the guiding action of the corresponding guide rod 316. For other applications, the two threads of the two screw shafts 315 have the same rotation direction, such as both are left-handed threads or right-handed threads, and the pitch is the same. When the first driving component 313 is actuated to rotate, the two second gears 317 can be synchronously driven and rotate in opposite directions, thereby driving the two screw shafts 315 to rotate in opposite directions. Since the two threads of the two screw shafts 315 have the same rotation direction, the first component 311 and the second component 312 can respectively move axially in opposite directions under the guidance of the corresponding guide rods 316.

[0060] It should be noted that in the above two different applications, the meshing directions and meshing modes of the first driving member 313 and the two second gears 317 are different. For example, in some applications, the first driving member 313 has one or two sets of circumferential meshing teeth in the same direction. In other applications, the first driving member 313 has two sets of circumferential meshing teeth in opposite directions.

[0061] Furthermore, if Fig.10 As shown, the handle 30 also includes a body 32, and the proximal end of the catheter 20 is coupled to the body 32. Two screw shafts 315 are rotatably connected to the body 32, and two guide rods 316 are fixedly connected to the body 32. Specifically, the body 32 is configured as an I-shaped structure, so that the two ends of the two screw shafts 315 are respectively rotatably connected to the plates at the two ends of the body 32, and the two ends of the two guide rods 316 are respectively fixedly connected to the above plates. Two second gears 317 are each positioned on the inner side of one of the plates adjacent to the body 32 to engage with the first drive member 313 respectively. The first drive member 313 is arranged around the body 32 and can rotate relative to the body 32 along the central axis of the catheter 20, so as to drive the first member 311 and the second member 312 to move axially relative to the body 32. In some embodiments, the two screw shafts 315 and the two guide rods 316 are symmetrically arranged relative to the central axis of the catheter 20; the two second gears 317 are respectively arranged on the same side of the two screw shafts 315, such as the distal side.

[0062] It can be understood that in some embodiments, the proximal end of the catheter 20 is fixedly coupled to the body 32, and the first traction wire 21 ( Fig.10 The first and second traction wires 21, 22 are led out from the proximal tube wall of the catheter 20, and after further passing through the traction wire groove provided on the main body 32, they are respectively fixedly connected to the first component 311 and the second component 312. Specifically, one end of the first component 311 and one end of the second component 312 are both provided with threaded holes, which are respectively used for threaded engagement with the corresponding screw shaft 315. The other end of the first component 311 and the other end of the second component 312 are both provided with through holes, which are respectively used for active connection with the corresponding guide rod 316, and can move axially under the guidance of the guide rod 316. The middle part of the first component 311 and the middle part of the second component 312 are both provided with mounting holes for the traction wire to pass through, and the first traction wire 21 or the second traction wire 22 can pass through the corresponding mounting holes and be fixed to the first component 311 or the second component 312 in a winding and knotting manner.

[0063] In some embodiments, the first biasing member 314c1 is sleeved on the corresponding guide rod 316 and elastically compressed between the main body 32 and the first member 311. The first biasing member 314c1 can make the first member 311 and the corresponding screw shaft 315 enter into meshing. The second biasing member 314c2 is sleeved on another guide rod 316 and elastically compressed between the main body 32 and the second member 312. The second biasing member 314c2 can make the second member 312 and the corresponding screw shaft 315 enter into meshing. For example, in the absence of external force, the first biasing member 314c1 can make the first member 311 and the corresponding screw shaft 315 keep the thread fit and enter into meshing, and the second biasing member 314c2 can make the second member 312 and the corresponding screw shaft 315 keep the thread fit and enter into meshing. It can be understood that the design of the biasing member allows the present invention to only retain the length of the screw shaft that actually needs to be bent, thereby effectively shortening the length of the screw shaft to shorten the overall length of the handle.

[0064] Furthermore, the limiting member 314d is fixedly disposed on the main body 32 and positioned between the first member 311 and the second member 312. The limiting member 314d can cooperate with the first biasing member 314c1 or the second biasing member 314c2 to limit the first member 311 or the second member 312 between the two without axial movement.

[0065] In some embodiments, please also refer to Figure 11-13The limiting member 314d includes a housing 331, a first gear 332 located in the housing 331, two racks 333 meshed with the first gear 332, and a reset member 334 disposed between the housing 331 and the first gear 332. The rack 333 has a limiting portion 3330 extending out of and retracting into the housing 331, so as to switch between limiting the first member 311 or the second member 312 and releasing the limitation by using the limiting portion 3330.

[0066] Specifically, the housing 331 includes a base 335 and a cover plate 336 that are approximately square, and the base 335 and the cover plate 336 are interlocked and fixed to form an internal accommodation space of the housing 331. The first gear 332, the two racks 333, and the reset member 334 are all accommodated in the internal accommodation space of the housing 331. The limiting member 314d is bonded to the main body 32 using the outer side surface of the base 335 to achieve fixation. In addition, the inner side surface of the base 335, such as the approximate center position of the inner side surface, is convexly provided with a cylindrical structure, and the first gear 332 is sleeved on the cylindrical structure and can rotate around the cylindrical structure. At the same time, a receiving groove for accommodating the reset member 334 is formed on the cylindrical structure of the base 335, and a side end groove is formed that penetrates the side wall of the cylindrical structure and is connected to the receiving groove. In some embodiments, the reset member 334 is a torsion spring; one end of the torsion spring 334 is limited in the side end groove, and the other end is limited on the first gear 332, for example, received in a groove structure opened on the first gear 332.

[0067] Further, please also refer to Figure 14-15 , a through movable groove 3351 is respectively provided on one of the two opposite side walls of the base 335. The two racks 333 are meshed with the opposite sides of the first gear 332, and the limiting portion 3330 of the rack 333 is at least partially accommodated in the movable groove 3351, and can extend or retract from the movable groove 3351 under the meshing drive of the first gear 332 to switch between the reset state and the compressed state of the limiting member 314d. In some embodiments, the rack 333 is generally L-shaped, and the tooth shape and the limiting portion 3330 of the rack 333 are respectively located on two vertical strip structures, so that when the limiting member 314d is in the compressed state, the limiting portions 3330 of the two racks 333 can be symmetrically positioned on both sides of the first gear 332 and on the same horizontal line, so as to ensure that the two limiting portions 3330 move on the same horizontal line.

[0068] Meanwhile, a through guide groove 3352 is respectively formed on the other two opposite side walls of the base 335, and a protrusion 3331 is convexly formed on the surface of the rack 333 opposite to the tooth shape. When the two racks 333 are respectively engaged with the first gear 332, the two racks 333 will respectively abut against the opposite inner side walls of the base 335, and can move horizontally under the guidance of the guide groove 3352, so as to drive the limiter 3330 to extend from the movable groove 3351 or retract into the housing 331 in the horizontal direction.

[0069] Since the limiting member 314d needs to cooperate with the first member 311 and the second member 312 to form the compressed state and the reset state thereof, in order to ensure that the limiting member 314d can smoothly switch freely between the compressed state and the reset state and can play the role of limiting the first member 311 or the second member 312, please continue to refer to Figure 14-15 The end of each limiting portion 3330 has a first guide surface 3330a and a second guide surface 3330b arranged opposite to each other to play a bidirectional guiding role. The blocking surface 3330c is located on the same surface of the second guide surface 3330b and intersects with the second guide surface 3330b to play a limiting guiding role. The first guide surface 3330a and the second guide surface 3330b are both inclined surfaces, the blocking surface 3330c is a non-inclined surface, and the length of the first guide surface 3330a is greater than the length of the second guide surface 3330b.

[0070] Thus, when the limiting member 314d is in a compressed state, Fig.14 As shown in FIG. 1 , the two first guide surfaces 3330a of the two limiter parts 3330 are symmetrically arranged, and the two second guide surfaces 3330b are also symmetrically arranged. Moreover, the blocking surface 3330c is hidden in the housing 331 due to the contraction of the limiter part 3330, and the first guide surface 3330a and the second guide surface 3330b are at least partially exposed outside the housing 331. When the limiter member 314d is in the reset state, as shown in FIG. Fig.15 As shown, the blocking surface 3330c is exposed outside the housing 331 due to the extension of the stopper 3330, so as to resist and block the first component 311 or the second component 312. In addition, the first guide surface 3330a and the second guide surface 3330b are completely exposed outside the housing 331.

[0071] The following will take the example of the deflectable catheter assembly 100 manipulating the distal section 200 of the catheter 20 to perform bidirectional deflection toward Y+ and Y- to explain the deflection process of the deflectable catheter assembly 100 in detail. Figure 16-20 shown.

[0072] like Fig.16When the deflectable catheter assembly 100 is in the initial state, the distal section 200 of the catheter 20 is in the 0 position, the first driver 31 is in the initial position, the first traction wire 21 and the second traction wire 22 are both in the straight state, but no force is applied to the distal section 200 of the catheter 20. At this time, the first biasing member 314c1 ( Fig.16 The first member 311 and the second member 312 are respectively engaged with the corresponding screw shaft 315 by 0.5-1 turns, and the two racks 333 are squeezed by the first member 311 and the second member 312 so that the limiting member 314d is in a compressed state.

[0073] When the distal section 200 of the catheter 20 needs to be deflected from the 0 position to the Y+ direction, the first driving member 313 is rotated to switch the first driver 31 from the initial position to the working position. In the process of switching the first driver 31 from the initial position to the working position, the two second gears 317 and the two screw shafts 315 are driven by the first driving member 313 to rotate, and a first pair of opposite forces acting on the first member 311 and the second member 312 are generated. Fig.17 As shown, under the first pair of opposing forces, the first member 311 is applied with a force to move toward the proximal end, and is guided by the corresponding guide rod 316 to move axially toward the proximal end, thereby disengaging from the first biasing member 314c1 and the limiting member 314d. The second member 312 is applied with a force to move toward the distal end, and is guided by the corresponding guide rod 316 to move slightly axially toward the distal end, thereby further compressing the second biasing member 314c2 until it is disengaged from the corresponding screw shaft 315. Therefore, under the balance of the first driving member 313 and the second biasing member 314c2, the second member 312 can continue to remain at the same position of the corresponding screw shaft 315 without moving.

[0074] Specifically, during the process of the first member 311 axially moving toward the proximal end and the second member 312 synchronously moving toward the distal end axially, the limiting member 314d gradually breaks away from the extrusion of the first member 311 and the second member 312. That is, under the action of the elastic restoring force of the reset member 334, the first gear 332 is driven to rotate, so as to drive the two racks 333 to gradually extend out of the housing 331, and then gradually guide the two blocking surfaces 3330c hidden in the housing 331 out of the housing 331. Among them, under the action of the two racks 333, the first member 311 will be guided along the first guide surface 3330a of the corresponding rack 333, and gradually break away from the limiting member 314d; the second member 312 will be guided along the second guide surface 3330b of the corresponding rack 333 to the corresponding blocking surface 3330c, so as to better limit the second member 312. When the limiting member 314d is completely separated from the extrusion of the first member 311 and the second member 312, the two racks 333 will also be fully unfolded. In view of the fact that the two second guide surfaces 3330b of the two racks 333 are always kept flush with the leftmost starting position of the threads of the two screw shafts 315. Therefore, the second member 312 is blocked by the blocking surface 3330c at the corresponding position, and will not be guided by the corresponding second guide surface 3330b, thereby preventing the second member 312 from engaging with the corresponding screw shaft 315 to avoid further generation of force. At the same time, the blocking surface 3330c at the corresponding position of the second member 312 can further resist and balance the second biasing force applied to the second member 312 by the second biasing member 314c2, so as to further keep the second member 312 motionless. Finally, the distal section 200 of the catheter 20 achieves deflection toward the Y+ direction under the differential control of the first traction wire 21 and the second traction wire 22.

[0075] When the distal section 200 of the catheter 20 needs to be reset to the 0 position from the Y+ direction, the first driving member 313 is rotated in the reverse direction to reset the first driver 31 from the working position to the initial position. Fig.18As shown, during the process of resetting the first driver 31 from the working position to the initial position, the two second gears 317 and the two screw shafts 315 will be driven by the first driving member 313 to rotate in the opposite direction, and generate a second pair of opposite forces acting on the first member 311 and the second member 312. Under the second pair of opposite forces, the first member 311 moves axially toward the distal end, that is, moves toward the direction close to the limiting member 314d. In view of the fact that during the resetting process, the second member 312 has been disengaged from the meshing of the corresponding screw shaft 315, and is jointly restricted by the second biasing member 314c2 and the blocking surface 3330c of the limiting member 314d, and cannot move axially. At this time, the risk of the distal section 200 of the catheter 20 not being completely reset to the 0 position, the second member 312 has begun to enter the meshing and move axially under the second pair of opposite forces, and the second traction wire 22 is pulled in advance is avoided if the limiting member 314d is not provided. After all, if the anchoring ring 23 in the catheter 20 is always in a state of bidirectional traction, it is very easy to cause the risk of the anchoring ring 23 being pulled out of position or deflected, thereby affecting the normal performance of the catheter 20.

[0076] Please continue reading Fig.18 When the first member 311 continues to move to abut the limiting member 314d, under the guidance of the first guide surface 3330a of the limiting member 314d, the first member 311 can gradually squeeze the two racks 333 back to the housing 331, so as to return the limiting member 314d from the reset state to the compressed state (see Fig.19 At this time, the two blocking surfaces 3330c of the two racks 333 will be gradually retracted into the housing 331 again. That is, the second member 312 is no longer blocked by the corresponding blocking surface 3330c, but will be restored to the position where it is pressed together with the first member 311 to the position where the limiting member 314d is in a compressed state under the guidance of the second guide surface 3330b and the elastic restoring force of the second biasing member 314c2 (see Fig.19 ). At this time, if Fig.19 As shown, the first member 311 and the second member 312 are reset to be in threaded engagement with the corresponding screw shaft 315 for 0.5-1 turns. Finally, the distal section 200 of the catheter 20 is reset to the 0 position under the further differential control of the first traction wire 21 and the second traction wire 22.

[0077] When the first driving member 313 is rotated in the reverse direction to deflect the distal section 200 of the catheter 20 from the 0 position to the Y-direction, as shown in FIG. Fig. 20 As shown, the movement process of the first component 311 and the second component 312 is similar to that of the attached Figure 17-19 The descriptions in are just interchangeable, but the working principles are the same and will not be repeated here.

[0078] In some embodiments, the deflectable catheter assembly 100 can achieve multi-directional deflection, such as four-directional deflection. Figure 1-20 Based on the above, the deflectable catheter assembly 100 further includes: Fig.21 As shown, the third traction wire 24 and the fourth traction wire 25 arranged opposite to each other are coupled to the distal section 200 of the catheter 20 to pull the distal section 200 to deflect toward the third direction and the fourth direction opposite to the third direction. The handle 30 also includes a second driver 34, which includes a third member 341 coupled to the third traction wire 24, a fourth member 342 coupled to the fourth traction wire 25, and a second driving member 343 connecting the third member 341 and the fourth member 342.

[0079] Then, when the second drive member 343 is actuated, the second drive member 343 can drive one of the third member 341 and the fourth member 342 to move relative to the catheter 20, while keeping the other of the third member 341 and the fourth member 342 stationary relative to the catheter 20, thereby pulling the distal section 200 to deflect toward the third direction or the fourth direction by tightening one of the third traction wire 24 and the fourth traction wire 25 proximally.

[0080] In some embodiments, the third direction and the fourth direction are respectively an X+ direction and an X- direction which are opposite to each other (see Figure 25-26 ). Among them, Fig.21 As shown, the plane formed by the Y+ and Y- structures is defined as the first deflection plane P1, and the plane formed by the X+ and X- structures is defined as the second deflection plane P2. Preferably, the second deflection plane P2 is perpendicular to the first deflection plane P1, that is, the second deflection plane P2 is offset by 90 degrees relative to the first deflection plane P1. At this time, the third traction wire 24 and the fourth traction wire 25 are offset or staggered by 90 degrees relative to the first traction wire 21 and the second traction wire 22. Of course, in other embodiments, the second deflection plane P2 is offset by any angle between 1 degree and 89 degrees relative to the first deflection plane P1, such as 15 degrees, 30 degrees, 45 degrees, 60 degrees, etc. That is, the third traction wire 24 and the fourth traction wire 25 can be oriented to be offset or staggered at various angles relative to the first traction wire 21 and the second traction wire 22.

[0081] It is understandable that the first traction wire 21, the second traction wire 22, the third traction wire 24 and the fourth traction wire 25 can all be coupled to Figure 5 On the same anchoring ring 23, and each is staggered at a certain angle, such as 90 degrees, to form a single curved curve in four different directions.

[0082] Of course, the first traction wire 21, the second traction wire 22, the third traction wire 24, and the fourth traction wire 25 can also be coupled to two different anchoring rings arranged at intervals, so as to form a double curved curve with two bending directions. Fig. 22 As shown, the distal section 200 of the catheter 20 includes a first distal section 200a and a second distal section 200b connected in series, and the second distal section 200b is located at the proximal end of the first distal section 200a. The first anchoring ring 23a is arranged at the distal end of the first distal section 200a, and the second anchoring ring 23b is arranged at the distal end of the second distal section 200b. The distal end of the first traction wire 21 and the distal end of the second traction wire 22 are respectively coupled to the first anchoring ring 23a to pull the entire distal section 200 to deflect in the first deflection plane P1, such as deflecting toward Y+ or Y-. The distal end of the third traction wire 24 and the distal end of the fourth traction wire 25 are respectively coupled to the second anchoring ring 23b to pull the second distal section 200b to deflect in the second deflection plane P2, such as deflecting toward X+ or X-.

[0083] In some embodiments, the distal ends of the first traction wire 21 and the distal ends of the second traction wire 22 are coupled to opposite sides of the first anchoring ring 23a, and their corresponding proximal ends extend through the traction wire lumens respectively opened on the opposite tube walls of the catheter 20, until they pass through the proximal tube wall of the catheter 20, and are respectively coupled to the first component 311 and the second component 312. The distal ends of the third traction wire 24 and the distal ends of the fourth traction wire 25 are coupled to opposite sides of the second anchoring ring 23b, and their corresponding proximal ends extend through the traction wire lumens respectively opened on the other opposite tube wall of the catheter 20, until they pass through the proximal tube wall of the catheter 20, and are respectively coupled to the third component 341 and the fourth component 342.

[0084] The following will be Fig. 22 The deflection control of the deflectable catheter assembly 100 is described by taking the layout of the traction wire shown in FIG. 1 and establishing an intervention path from the outside of the patient to the tricuspid valve inside the heart as an example. Figure 24-25 A in), posterior leaflet (see Figure 24-25 P in), and septalleaflet (see Figure 24-25 According to the position to be repaired, a medical device such as a valve clip is used to clamp the anterior leaflet A and the posterior leaflet P, or the anterior leaflet A and the septal leaflet S, or the posterior leaflet P and the septal leaflet S, to repair tricuspid regurgitation.

[0085] See also Fig.23As shown, the distal end of the catheter 20 of the deflectable catheter assembly 100 is introduced into the target position inside the human body through an interventional path. For example, the distal section 200 of the catheter 20 can reach the inferior vena cava orifice through the femoral vein. At this time, the center of the valve ring of the tricuspid valve from the inferior vena cava orifice to the right atrium can be approximately equivalent to a plane curve, rather than a three-dimensional space shape. Therefore, in order to improve the adaptability of the deflectable catheter assembly 100 in the right atrium and reduce the resistance during the deflection process, in some embodiments, the first distal section 200a of the catheter 20 is pre-shaped with a curved curve. That is, when the first distal section 200a is in a natural state without external force, its first distal section 200a can deviate from the central axis of the catheter 20 to form a curved curve. Among them, after the first distal section 200a passes through the inferior vena cava orifice and enters the right atrium, and is positioned above the valve ring plane D of the tricuspid valve, its pre-shaped curved curve bends in the direction of the valve ring plane D of the tricuspid valve. Therefore, the pre-shaping design can not only reduce the squeezing and wear on the blood vessels, but also facilitate the subsequent bending operation of the bending adjustment device and the operation of the interventional valve clip of the interventional device.

[0086] When it is necessary to use the deflectable catheter assembly 100 to perform a deflection operation on the distal section 200 of the catheter, such as Fig.24 As shown, the first driver 31 is actuated to control the first traction wire 21 and the second traction wire 22 respectively, thereby pulling the distal section 200 of the catheter 20 to deflect toward the Y+ or Y- direction to approach or move away from the annular plane D of the tricuspid valve. Fig.25 As shown, the second driver 34 is actuated to control the third traction wire 24 and the fourth traction wire 25 respectively, thereby pulling the second distal section 200b of the catheter 20 to deflect toward the X+ or X- direction to deflect toward the AP junction or the AS junction on the annular plane D of the tricuspid valve. Fig.26 As shown, the distal section 200 of the catheter 20 forms a double curved curve S having two bending directions X and Y.

[0087] In this embodiment, if Figure 27-28 As shown, the second driver 34 further includes a second holding member 344, a second screw shaft 345, a second guide rod 346 and a third gear 347. In view of the fact that the third member 341, the fourth member 342, the second driving member 343, the second holding member 344, the second screw shaft 345, the second guide rod 346 and the third gear 347 have the same specific structures as the corresponding parts of the first driver 31, and the connection relationship and driving principle between the various parts are also the same, therefore, they are not described in detail here.

[0088] Furthermore, if Fig. 27 and Fig.29As shown, the first drive member 313 and the second drive member 343 are arranged on the main body 32 of the handle 30 and are connected in series along the axial length of the main body 32. Moreover, the first drive member 313 and the second drive member 343 can move relative to the main body 32. Specifically, the main body 32 has a first section 321 and a second section 322 that are connected in series axially. The first member 311 and the second member 312 are arranged on opposite sides of the first section 321, such as the upper and lower sides. The first drive member 313 is arranged around the first section 321 and can rotate relative to the first section 321 along the central axis of the catheter 20. The third member 341 and the fourth member 342 are arranged on opposite sides of the second section 322, such as the left and right sides. The second drive member 343 is arranged around the second section 322 and can rotate relative to the second section 322 along the central axis of the catheter 20.

[0089] It can be understood that in order to correspond to the two groups of traction wires that are staggered circumferentially, the two groups of traction components are also staggered circumferentially with each other. For example, the first component 311 and the second component 312 are staggered circumferentially by 90 degrees relative to the third component 341 and the fourth component 342 to form an arrangement pattern on the upper and lower sides of the first section 321 located on the main body 32, and on the left and right sides of the second section 322 thereof.

[0090] Of course, in Fig.10 and Fig. 27 In the illustrated embodiment, the handle 30 further includes a fixing seat 35 and a third driver 36. Fig.10 As shown, the first driving member 313, the fixing seat 35 and the third driver 36 are sequentially connected in series along the axial length of the main body 32 to form a handle 30 that is generally cylindrical in shape as a whole, so as to facilitate the operator's manipulation. Fig. 27 As shown, the second driving member 343, the first driving member 313, the fixing seat 35 and the third driver 36 can also be sequentially connected in series along the axial length of the main body 32 to form a handle 30 that is generally cylindrical in shape as a whole, so as to facilitate the operator's manipulation.

[0091] Please refer again Figure 28-29 As shown, specifically, the fixing seat 35 is fixedly coupled to the main body 32, such as fixedly coupled to the third section 323 of the main body 32. The deflectable catheter assembly 100 is fixedly arranged on the surgical support through the fixing seat 35 to facilitate the interventional operation of the operator during the operation. And, the third driver 36 is fixedly coupled to the proximal end of the catheter 20 and is rotationally coupled to the main body 32. The third driver 36 can rotate relative to the main body 32, such as rotating relative to the main body 32 along the central axis of the catheter 20 to drive the catheter 20 to twist. In some embodiments, the third driver 36 is arranged around the fourth section 324 of the main body 32, and the proximal end of the catheter 20 extends through the main body 32 and is fixedly coupled to the third driver 36 to achieve rotation relative to the main body 32 to drive the catheter 20 to twist.

[0092] It is understandable that the deflectable catheter assembly 100 can be applied to tricuspid valve repair to establish an interventional path from outside the patient's body to inside the heart, and to deliver and use medical devices such as valve clips to clamp two of the anterior leaflet, posterior leaflet, and septal leaflet of the tricuspid valve to avoid tricuspid valve regurgitation. Of course, it can also be applied to other cardiac interventional medical devices such as mitral valve repair and aortic repair. Therefore, in order to adapt to different application scenarios, all technical features discussed in the deflectable catheter assembly 100 can be used in combination with each other, and will not be repeated here.

[0093] The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention. The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A deflectable catheter assembly, characterized in that: include: a catheter having a deflectable distal section; A first traction wire and a second traction wire arranged opposite to each other are coupled to the distal segment to pull the distal segment to deflect toward a first direction and a second direction opposite to the first direction; as well as A handle coupled to the catheter; the handle comprising a first actuator, the first actuator comprising: a first member coupled to the first traction wire; a second member coupled to the second pull wire; and A first drive member connects the first member and the second member; the first drive member is actuated to drive one of the first member and the second member to move relative to the catheter, while keeping the other of the first member and the second member stationary relative to the catheter, thereby pulling the distal segment to deflect toward the first direction or the second direction by tightening one of the first traction wire and the second traction wire toward the proximal end.

2. The deflectable catheter assembly according to claim 1, wherein: The first driver further includes a retaining member configured to abut and retain the first member or the second member from moving.

3. The deflectable catheter assembly of claim 2, wherein: The retaining member comprises: a locking member movable between a locked position and an unlocked position to switch between locking and unlocking the first member or between locking and unlocking the second member; and / or The biasing member, the first member or the second member is switchable between balancing the biasing force of the biasing member and releasing the biasing force of the biasing member.

4. The deflectable catheter assembly according to claim 3, wherein: The biasing member includes a first biasing member for generating a first biasing force on the first member, and a second biasing member for generating a second biasing force on the second member; The first driving member is capable of generating a first pair of opposing forces acting on the first member and the second member to force the first member to release the first biasing force of the first biasing member and move in a direction away from the first biasing member, and to force the second member to resist and balance the second biasing force of the second biasing member and remain stationary.

5. The deflectable catheter assembly according to claim 4, wherein: The retaining member also includes a limiting member, and the first driving member can also generate a second pair of opposing forces that are opposite to the first pair of opposing forces to force the first member to move in a direction close to the first biasing member until it is reset, while the second member is restricted by the limiting member and cannot move in a direction away from the second biasing member.

6. The deflectable catheter assembly according to claim 5, wherein: The limiting member has a compression state and a reset state; the limiting member abuts between the first member and the second member to form the compression state; The limiting member is separated from the abutment between the first member and the second member to form the reset state; In the reset state, the second member is restrained therein by the second biasing member and the restraining member.

7. The deflectable catheter assembly according to claim 5, wherein: The limiting component includes a shell, a first gear located in the shell, two racks meshed with the first gear, and a reset component arranged between the shell and the first gear, and each of the racks has a limiting portion that can extend out of and retract into the shell.

8. The deflectable catheter assembly of claim 1, wherein: The first driver includes two screw shafts, two guide rods and two second gears arranged opposite to each other; the first component and the second component are respectively threadedly sleeved on the corresponding screw shaft, and are respectively axially movably sleeved on the corresponding guide rods; the two second gears are respectively arranged on one side of the corresponding screw shaft and can engage with the first driving component.

9. The deflectable catheter assembly of claim 8, wherein: The handle further comprises a main body, to which the proximal end of the catheter is coupled; the two screw shafts are rotatably connected to the main body, and the two guide rods are fixedly connected to the main body.

10. The deflectable catheter assembly of claim 9, wherein: The first driver further comprises a first biasing member and a second biasing member; the first biasing member is sleeved on the corresponding guide rod and elastically compressed between the main body and the first member, and the first biasing member can make the first member and the corresponding screw shaft enter into meshing; The second biasing member is sleeved on the corresponding other guide rod and elastically compressed between the main body and the second member. The second biasing member can make the second member and the corresponding screw shaft engage with each other.

11. The deflectable catheter assembly of claim 10, wherein: The driving of the first driving member can force the first member or the second member to disengage from the corresponding screw shaft; The first member or the second member can also be continuously maintained at the same position corresponding to the screw shaft under the balance of the first driving member and the first biasing member or the second biasing member.

12. The deflectable catheter assembly of claim 10, wherein: A limiting member is fixedly disposed on the main body, and the limiting member can cooperate with the first biasing member or the second biasing member to limit the first member between the limiting member and the first biasing member, or to limit the second member between the limiting member and the second biasing member.

13. The deflectable catheter assembly according to any one of claims 1 to 12, characterized in that: The third and fourth traction wires arranged opposite to each other are coupled to the distal section of the catheter to pull the distal section to deflect toward a third direction and a fourth direction opposite to the third direction; the handle includes a second driver, the second driver includes a third member coupled to the third traction wire, a fourth member coupled to the fourth traction wire, and a second drive member connecting the third member and the fourth member, and the second drive member is actuated to drive one of the third and fourth members to move relative to the catheter, and at the same time keep the other of the third and fourth members from moving relative to the catheter, thereby pulling the distal section to deflect toward the third direction or the fourth direction by tightening one of the third and fourth traction wires toward the proximal end.

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