Handle and medical catheter device

Abstract

According to the handle and the medical catheter device, when the bent shape of the far end of the catheter is controlled through the fixed bending structure and the friction resistance part, the control force at the handle can be gradually increased along with the bending control angle when small-angle bending control is adjusted to large-angle bending control, and the control hand feeling of an operator is improved; the bending control radius of the adjustable bending section of the guide pipe can be changed by controlling the bending auxiliary part to move, so that the bending control radius can be adjusted under the condition that the guide pipe is not replaced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a handle and a medical catheter device. BACKGROUND

[0002] Radiofrequency ablation catheters are medical devices commonly used to treat heart diseases, particularly arrhythmias, by creating a controlled lesion or scar tissue at the target tissue with radiofrequency energy delivered through a distal electrode to repair the electrical activity of the heart and restore normal heart rhythm.

[0003] Radiofrequency ablation catheters are usually elongated and flexible tubular devices that are introduced through a blood vessel, such as the femoral artery or vein, and then guided to the heart. They have different lengths and functional designs to adapt to different clinical applications. The distal electrode is small in size, which aims to maximize energy delivery and minimize damage to surrounding tissues. The temperature sensor built-in the ablation electrode can monitor the electrode temperature in real time. In order to improve the safety and ease of operation of radiofrequency ablation surgery, radiofrequency ablation catheters have added functions such as built-in cooling system, pressure sensing system, magnetic positioning, etc.

[0004] Traditional radiofrequency ablation catheters rely on the operator to push and pull the handle knob and the core rod to drive the pull wire inside the catheter body to form a specific bend at the distal end of the catheter through a certain stroke. The bending control force that the operator intuitively feels includes not only the reaction force that the tube material itself needs to overcome when bending, but also the friction force generated at the handle end to achieve a fixed bend. The traditional radiofrequency ablation catheter can maintain a constant catheter bend during the maximum angle bending control, and the friction force at the handle is often set to be greater than the reaction force of the tube material when the adjustable bend segment is bent to the maximum angle. Moreover, the friction force at the handle does not decrease with the decrease of the bend angle, which will result in a heavy feeling of the catheter control, and further produce negative feedback of the operator.

[0005] There may be differences between the preoperative CTA (CT Angiography) results and the intraoperative angiography results, and there is a risk of misusing the bend of the product. This situation will lead to the replacement of the catheter during the operation, which will greatly increase the cost of the operation. SUMMARY

[0006] The purpose of the present application is to provide a handle and a medical catheter device to solve one or more problems in the prior art.

[0007] To solve the above problems, the present application provides a handle for controlling the bend of the distal end of a catheter, the handle comprising: a bending control knob, a core rod, a shell, a fixed bend structure and a friction resistance structure.

[0008] The control bending push button is used to be fixed to the proximal end of the catheter, the distal end of the core rod is fixedly connected with the proximal end of the control bending push button, the proximal end of the core rod extends into the shell, and the core rod is connected with the distal end of the catheter through a pull wire, the control bending push button is moved relative to the shell to drive the core rod to move the pull wire, thereby changing the bending shape of the distal end of the catheter.

[0009] The bending setting structure is fixed to the proximal end of the shell and is arranged outside the core rod, the friction resistance piece is arranged between the bending setting structure and the core rod, the friction resistance piece can be elastically deformed, and the elastic deformation amount of the friction resistance piece changes with the relative movement between the bending setting structure and the core rod, so that the friction resistance piece can generate different friction forces between the bending setting structure and the core rod.

[0010] Optionally, in the handle, the bending setting structure includes a first bending setting structure, and the friction resistance piece includes a first friction resistance piece; the first bending setting structure is arranged outside the core rod, and the first bending setting structure has a gap with the core rod, the gap gradually decreases as the core rod moves away from the shell, so that the elastic deformation amount of the first friction resistance piece gradually increases, thereby making the friction force between the first friction resistance piece and the first bending setting structure and the core rod gradually increase.

[0011] Optionally, in the handle, the core rod has a gradual change section, the first bending setting structure is arranged outside the gradual change section, and the outer diameter of the gradual change section gradually decreases from the proximal end to the distal end.

[0012] Optionally, in the handle, the included angle a between the generatrix of the gradual change section and the axis is 0.02°-15°, and the gradual change stroke of the gradual change section is 3mm-150mm.

[0013] Optionally, in the handle, the core rod has a gradual change sliding groove arranged in the direction parallel to the axis;

[0014] The bending setting structure includes a second bending setting structure and a second friction resistance piece, part of the second bending setting structure extends into the gradual change sliding groove and is movably arranged along the extension direction of the gradual change sliding groove, and the second friction resistance piece is arranged in the gradual change sliding groove and moves with the movement of the second bending setting structure.

[0015] The depth of the gradual change sliding groove gradually decreases from the distal end to the proximal end, so that when the second bending setting structure moves towards the proximal end or the core rod moves away from the shell, the elastic deformation amount of the second friction resistance piece gradually increases, thereby making the friction force between the second friction resistance piece and the second bending setting structure and the core rod gradually increase.

[0016] The present application also provides a medical catheter device, comprising: a catheter and a handle as claimed in any one of the preceding claims;

[0017] The catheter comprises a main body section, an adjustable bending section and a head section, which are connected in sequence from proximal end to distal end, the bending control knob is fixed at the proximal end of the main body section, and the core rod is connected with the adjustable bending section through a pull wire.

[0018] Optionally, in the medical catheter device, a bending auxiliary member is further included,

[0019] The bending auxiliary member extends from inside the handle to pass through the main body section and extend into the adjustable bending section, and is movably arranged along the axial direction, and the length of the bending auxiliary member in the adjustable bending section is changed by movement to change the controllable bending length of the adjustable bending section.

[0020] Optionally, in the medical catheter device, the main body section and the adjustable bending section each comprise an inner tube and an outer tube sleeved on the inner tube, the outer tube and the inner tube are arranged in a spaced manner, and the bending auxiliary member is arranged around the inner tube in the spacing space between the inner tube and the outer tube.

[0021] Optionally, in the medical catheter device, the bending auxiliary member is a single-lumen tubular structure or a braided tube structure capable of providing support for the main body section.

[0022] Optionally, in the medical catheter device, the outer side wall of the inner tube, the inner side wall of the outer tube and / or the inner and outer surfaces of the bending auxiliary member have a lubricating coating.

[0023] Optionally, in the medical catheter device, a pull wire cavity for the pull wire to pass through and a bending auxiliary member cavity for the bending auxiliary member to pass through are arranged in the main body section and the adjustable bending section, the bending auxiliary member cavity and the pull wire cavity are located on opposite sides of an axial line, and the axial line is the axial line of the main body section and the adjustable bending section.

[0024] Optionally, in the medical catheter device, the bending auxiliary member is a tubular member, and the inner cavity of the tubular member constitutes a channel for the pull wire to pass through.

[0025] Optionally, in the medical catheter device, the tubular member is a metal tube, a coil tube, a hypotube or a braided tube.

[0026] Optionally, in the medical catheter device, the bending auxiliary member is provided with a position adjusting track with a length consistent with the stroke of the bending auxiliary member.

[0027] The hand handle further comprises a curved adjusting gear, which is matched with the position adjusting track and drives the curved auxiliary member to move axially by rotating, the core rod comprises a distal end section, the distal end section has a gear groove, and the curved adjusting gear is arranged in the gear groove and matched with the position adjusting track.

[0028] In conclusion, the hand handle provided by the application can gradually increase the control force at the hand handle when the control bending angle is adjusted from a small angle to a large angle, and improve the control feeling of the operator.

[0029] In addition, the medical catheter device provided by the application can change the control bending radius of the adjustable bending section of the catheter by arranging the curved auxiliary member in the catheter and controlling the movement of the curved auxiliary member, so that the control bending radius can be adjusted without replacing the catheter. BRIEF DESCRIPTION OF DRAWINGS

[0030] Those skilled in the art will understand that the provided drawings are used to better understand the application, and do not constitute any limitation on the scope of the application, in which:

[0031] Figure 1 FIG. 1 is a schematic view of a whole structure of a medical catheter in an embodiment of the application;

[0032] Figure 2 FIG. 2 is a schematic view of a comparison of different control bending radii of a medical catheter in an embodiment of the application;

[0033] Figure 3 FIG. 3 is a schematic view of a first arrangement of a curved auxiliary member in an embodiment of the application;

[0034] Figure 4 FIG. 4 is a schematic view of a second arrangement of a curved auxiliary member in an embodiment of the application;

[0035] Figure 5 FIG. 5 is a schematic view of a third arrangement of a curved auxiliary member in an embodiment of the application;

[0036] Figure 6 FIG. 6 is a schematic view of a structure of a core rod in an embodiment of the application;

[0037] Figure 7 FIG. 7 is a schematic view of a structure of a core rod in a conventional control bending catheter product in an embodiment of the application;

[0038] Figure 8 FIG. 8 is another schematic view of a structure of a core rod in a conventional control bending catheter product in an embodiment of the application;

[0039] The following is a description of the reference numerals in the drawings:

[0040] 1-adjustable bending section, 101-first inner tube, 102-first outer tube, 2-pull wire, 301-bending auxiliary cavity,

[0041] 302-bending auxiliary, 303-position adjusting track, 4-main section, 401-second inner tube, 402-second outer tube, 5-handle, 6-head section, 501-bending control push button, 502-core rod, 503-adjusting gear, 5041-first bending fixing structure, 5042-first friction resistance element, 505-pull wire fixing part, 506-outer shell, 507-reinforcing ring, 50201-outer ring thread, 50202-distal section, 50203-gear groove, 50204-gradual change section, 50205-sliding groove, 50206-proximal section, 50801-second friction resistance element, 50802-second bending fixing structure. DETAILED DESCRIPTION

[0042] The present application will be further described below in conjunction with the drawings and specific embodiments. The advantages and features of the present application will be more apparent from the following description. It should be noted that the drawings are very simplified and all use non-precise proportions, only for the purpose of facilitating and clearly assisting the description of the embodiments of the present application. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different proportions are sometimes used in the drawings to emphasize different aspects. It should also be understood that, unless specifically described or indicated, the terms "first", "second", "third" and the like in the description are only used to distinguish the components, elements, steps and the like in the description, and not to represent the logical relationship or sequence relationship between the components, elements, steps and the like, therefore, the features with "first", "second", "third" can explicitly or implicitly include one or at least two features.

[0043] In this application, "proximal" and "distal" are the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of the doctor using the medical device, although "proximal" and "distal" are not restrictive, but "proximal" generally refers to the end of the medical device close to the doctor during normal operation, and "distal" generally refers to the end first entering the patient's body.

[0044] Please refer to Figure 1 and Figure 8 , the embodiment of the present application provides a handle 5 for controlling the bending of the distal end of the catheter, the handle 5 comprising: a bending control push button 501, a core rod 502, an outer shell 506, a bending fixing structure and a friction resistance structure.

[0045] The bending control button 501 is used to be fixed to the proximal end of the catheter. The distal end of the core rod 502 is fixedly connected to the proximal end of the bending control button 501. The proximal end of the core rod 502 extends into the housing 506, and the core rod 502 is connected to the distal end of the catheter via the pull wire 2. The bending control button 501 moves relative to the housing 506 to drive the core rod 502 to move the pull wire 2, thereby changing the bend of the distal end of the catheter. The bending control button 501 is the direct force-bearing component when the handle 5 is applied to the catheter. During use, the bending control button 501 and the catheter remain relatively stationary. By driving the core rod 502 away from the housing 506, the pull wire 2 is pulled and the adjustable bending section 1 is bent accordingly.

[0046] The fixed bending structure is fixed to the proximal end of the shell 506 and is arranged outside the core rod 502. The friction resistance member is arranged between the fixed bending structure and the core rod 502. The friction resistance member can undergo elastic deformation, and the elastic deformation amount of the friction resistance member changes with the relative movement between the fixed bending structure and the core rod 502, so that the friction resistance member can generate friction forces of different sizes between the fixed bending structure and the core rod 502.

[0047] In an optional embodiment, please refer to Figure 1 The fixed bending structure includes a first fixed bending structure 5041, and the friction resistance member includes a first friction resistance member 5042; the first fixed bending structure 5041 is sleeved outside the core rod 502, and there is a gap between the first fixed bending structure 5041 and the core rod 502. The gap gradually decreases as the core rod 502 moves away from the shell 506, so that the elastic deformation of the first friction resistance member 5042 gradually increases, thereby gradually increasing the friction force between the first friction resistance member 5042 and the first fixed bending structure 5041 and the core rod 502. Preferably, as Figure 7 As shown, the core rod 502 has a gradient section 50204 , the first fixed bending structure 5041 is sleeved outside the gradient section 50204 , and the outer diameter of the gradient section 50204 gradually decreases from the proximal end to the distal end.

[0048] The first friction resistance member 5042 can be a silicone ring or other material capable of generating frictional resistance. The sum of the frictional forces between the first friction resistance member 5042, the core rod 502, and the first bending control structure 5041 must be greater than or equal to the reaction force required to overcome when bending the tension wire 2. During bending, the reaction force required to be overcome increases as the bending angle increases. That is, when the core rod 502 reaches its maximum displacement relative to the housing 506, the frictional forces between the silicone ring, the core rod 502, and the first bending control structure 5041 must be greater than or equal to the bending reaction force at that time. Therefore, the gradual section 50204 of the core rod 502 is configured to gradually decrease in diameter from the proximal end to the distal end, forming a frustum. When the bending angle is small, the gap between the core rod 502 and the first bending control structure 5041 is large, the degree of compression of the silicone ring is small, and the friction between the three is low. When the bending angle is large, the gap between the core rod 502 and the first bending control structure 5041 is tightened, the degree of compression of the silicone ring is increased, and the friction between the three increases. The gradient section 50204 of the core rod 502 can achieve the goal of ensuring the stability of the maximum bending control angle while reducing unnecessary additional friction when reaching a small bend, further improving the operator's feel for use. The bending control force of the handle 5 can be further adjusted by adjusting the wire diameter of the silicone ring or the tightness of the fit between the first fixed bending structure 5041 and the distal thread of the shell 506. According to different catheter application scenarios, products with different diameters and hardness can be equipped with core rods 502 and silicone rings with different diameter gradients and strokes (lengths) to achieve modular performance improvement for the controllability of the handle 5. According to different catheter diameters and bending control angle requirements, the busbar of the gradient section 50204 (reference Figure 6 and Figure 7 The angle a between the longitudinal outer edge line (shown in the figure) and the axis can be set to 0.02-15°, the gradient stroke of the gradient section 50204 can be set to 3-150mm according to different bend shapes, and the wire diameter of the silicone ring can be set to 0.5-5.0mm according to the minimum bending force requirement.

[0049] In another optional embodiment, please refer to Figure 8The core rod 502 has a gradient sliding groove 50205 arranged along a direction parallel to the axis; the bending setting structure comprises a second bending setting structure 50802 and a second friction resistance element 50801, the second bending setting structure 50802 partially extends into the gradient sliding groove 50205 and is movably arranged along the extending direction of the gradient sliding groove 50205, and the second friction resistance element 50801 is arranged in the gradient sliding groove 50205 and moves with the second bending setting structure 50802; the depth of the gradient sliding groove 50205 gradually decreases from the distal end to the proximal end, so that the elastic deformation amount of the second friction resistance element 50801 gradually increases when the second bending setting structure 50802 moves towards the proximal end or the core rod 502 moves away from the shell 506, thereby gradually increasing the friction between the second friction resistance element 50801 and the second bending setting structure 50802 and the core rod 502.

[0050] Figure 8 The arrow indicates the direction of movement of the second bending setting structure 50802 relative to the core rod 502 during bending control, the depth of the gradient sliding groove 50205 gradually decreases along this direction, providing gradually increasing pressure to the second friction resistance element 50801, thereby gradually increasing the friction in the handlebar 5 and providing a gradually changing bending control force. The depth of the gradient sliding groove 50205 and the height and shape of the second friction resistance element 50801 can be determined according to the bending force requirement, the greater the deformation of the second friction resistance element 50801 when it is pressed, the greater the friction provided by the handlebar 5. The second friction resistance element 50801 can be made of materials with good elasticity, such as silicone rubber, fluororubber and polyurethane.

[0051] In this embodiment, the core rod can further comprise a distal end section 50202, and the distal end part of the distal end section 50202 can be designed to have an outer ring thread 50201 to facilitate threaded connection with the bending control knob 501.

[0052] In some alternative embodiments, the bending setting structure can simultaneously comprise a combination structure of the first bending setting structure 5041 and the first friction resistance element 5042, and a combination structure of the second bending setting structure 50802 and the second friction resistance element 50801, and the two combination structures are used to cooperate to control bending. At this time, please refer to Figure 7 The core rod 502 comprises a distal end section 50202 for arranging the outer ring thread 50201, a gradient section 50204 and a proximal end section 50206 for arranging the gradient sliding groove 50205.

[0053] In addition, the handle 5 may further include a wire fixing component 505 and other components provided in the housing 506, such as a reinforcement ring 507 provided at the proximal end of the housing 506. The wire fixing component 505 may be a fixed pulley, and the proximal end of the wire 2 is fixed to the core rod 502 after passing around the fixed pulley.

[0054] In addition, if Figure 1 As shown, an embodiment of the present invention further provides a medical catheter device, which includes: a handle 5, a main body section 4, an adjustable bending section 1, a head section 6 and a bending auxiliary member 302;

[0055] The handle 5, the main body section 4, the adjustable bending section 1 and the head section 6 are connected in sequence from the proximal end to the distal end; the handle 5 is connected to the adjustable bending section 1 through a pull wire 2, and the bending shape of the adjustable bending section 1 is changed by controlling the movement of the pull wire 2;

[0056] The bending auxiliary piece 302 extends from the handle 5 to pass through the main body section 4 and extends into the adjustable bending section 1. The bending auxiliary piece 302 is movably arranged along the axial direction, and changes its own length in the adjustable bending section 1 by movement to change the controllable bending length of the adjustable bending section 1.

[0057] The medical catheter device provided by the embodiment of the present invention is as follows Figure 2 As shown in , when the bending auxiliary part 302 is adjusted toward the distal end, the controllable bending length of the adjustable bending section 1 can be gradually shortened, thereby gradually reducing the controllable bending radius of the adjustable bending section 1. When the bending auxiliary part 302 is adjusted toward the proximal end, the controllable bending length of the adjustable bending section 1 can be gradually increased, thereby gradually increasing the controllable bending radius of the adjustable bending section 1. In this way, the controllable bending radius can be adjusted without replacing the catheter.

[0058] The medical catheter device provided in this embodiment can be a radiofrequency ablation catheter or other electrophysiological mapping catheter. When it is a radiofrequency ablation catheter, the head section 6 can be provided with multiple ablation electrodes. When it is a mapping catheter, the head section 6 can be provided with a mapping sensor, such as a temperature sensor, etc. Alternatively, the medical catheter device provided in this embodiment is a catheter device integrating ablation and mapping, and the head section 6 can be provided with ablation electrodes and other mapping electrodes at the same time.

[0059] Furthermore, the main body section 4 and the adjustable bending section 1 each include an inner tube and an outer tube sleeved thereon, the outer tube and the inner tube being spaced apart. The bending aid 302 is axially movably disposed within the space between the inner and outer tubes. Specifically, the space serves as a bending aid cavity 301 for passage of the bending aid 302. Preferably, the outer wall of the inner tube, the inner wall of the outer tube, and / or the inner and outer surfaces of the bending aid 302 are provided with a lubricating coating.

[0060] Specifically, the adjustable bending section 1 comprises a first inner tube 101 and a first outer tube 102 sleeved on the first inner tube 101. The first inner tube 101 can use an inner lining braid layer, a single-lumen or multi-lumen structure without braid layer according to performance requirements. The inner cavity of the first inner tube 101 is used for passing wires, cold saline and the like. The first outer tube 102 is provided in a single-lumen structure. According to different application scenarios, the first outer tube 102 can selectively embed a braid wire, a spring or the like in the pipe material to enhance the support. There is a clear size difference between the outer diameter of the first inner tube 101 and the inner diameter of the first outer tube 102, so as to ensure that there is a spacing space between the first inner tube 101 and the first outer tube 102 for use as a bending auxiliary member cavity 301. The outer wall of the first inner tube 101 and the inner wall of the first outer tube 102 are both provided with a lubricating coating made of PTFE or the like to reduce the surface friction and ensure that the bending auxiliary member 302 can be smoothly pushed and withdrawn in the bending auxiliary member cavity 301. The length of the adjustable bending section 1 can be set according to different application scenarios to have a minimum controllable bending length (when applied to small-diameter blood vessels such as renal arteries, the minimum controllable bending length can be set to 10-30 mm; when applied to organs with larger space such as heart, the minimum controllable bending length can be set to 30-55 mm) and a maximum controllable bending length (which can be set to 30-150 mm). The difference between the maximum controllable bending length and the minimum controllable bending length is set as the adjustable stroke of the bending auxiliary member 302. The minimum controllable bending length is the length between the distal end of the adjustable bending section 1 and the farthest end of the stroke of the bending auxiliary member 302. The spacing space between the first inner tube 101 and the first outer tube 102 is eliminated by welding or the like to block the bending auxiliary member cavity 301, and the farthest end of the stroke of the bending auxiliary member 302 is limited.

[0061] The main body section 4 comprises a second inner tube 401 and a second outer tube 402 sleeved on the second inner tube 401, the second inner tube 401 is connected with the first inner tube 101 by means of gluing, hot melting welding or the like to limit the bending auxiliary member 302 and isolate the internal pipeline, brine pipe and other structures. Meanwhile, the second inner tube 401 can adopt inner lining woven wire, coiled spring and other structures to enhance the main body support. The proximal end of the second inner tube 401 extends to the proximal end of the bending auxiliary member 302 to ensure that the internal structure of the second inner tube 401 is not damaged when the bending auxiliary member 302 is moved. The second outer tube 402 is a single cavity tube of high polymer material, which can increase woven wire and coiled spring structures according to application requirements, the distal end is connected with the first outer tube 102, and the proximal end is fixed with the handle 5. In addition to providing certain support to the catheter, the second outer tube 402 also limits the radial position of the bending auxiliary member 302. When the bending auxiliary member 302 is removed, the axial support of the composite tube material of the main body section 4 needs to be similar to that of the adjustable bending section 1, and cannot be less than the latter, that is, the support of the non-control bending area of the catheter control bending is mainly provided by the bending auxiliary member 302. The bending auxiliary member 302 penetrates through the main body section 4 of the catheter, and no matter how the bending auxiliary member 302 is moved, the main body section 4 needs to be lined with the bending auxiliary member 302.

[0062] When the bending auxiliary member 302 moves towards the distal end of the catheter (forward movement), the spacing space between the inner tube and the outer tube of the adjustable bending section 1 is gradually occupied by the bending auxiliary member 302. The proximal end section of the spacing space occupied by the bending auxiliary member 302 and the distal end cavity section not lined with the bending auxiliary member 302 form an obvious hardness difference. When the catheter is controlled to bend, the adjustable bending section 1 is shortened to the region from the distal end of the bending auxiliary member 302 to the distal end of the catheter, realizing that the bending changes from large to small. When the bending auxiliary member 302 is moved towards the proximal end of the catheter (backward movement), the cavity section between the inner tube and the outer tube of the adjustable bending section 1 increases, and the length of the controllable bending section of the adjustable bending section 1 increases, and the bending becomes larger.

[0063] The bending auxiliary member 302 adopts a metal material (such as medical stainless steel, nickel-titanium alloy, etc.) or a high polymer material (such as polyimide, etc.) with high rigidity, which can be a single cavity tube or a woven tube structure. The inside is partially provided with the first inner tube 101 and the second inner tube 401 as a whole, which provides sufficient support and stress dispersion to the catheter. The inner surface and the outer surface of the bending auxiliary member 302 are provided with a lubricating coating (such as silicone oil, PTFE film) to ensure smooth movement in the bending auxiliary member cavity 301.

[0064] In this embodiment, the curved auxiliary member 302 is provided with a position adjustment track 303 that corresponds to its travel range. Accordingly, the handle 5 may also include a curved adjustment gear 503. The curved adjustment gear 503 cooperates with the position adjustment track 303 to control the axial forward and backward movement of the curved auxiliary member 302 through rotation. Furthermore, the distal end 50202 of the core rod 502 may also have a gear groove 50203, and the curved adjustment gear 503 is disposed within the gear groove 50203 and cooperates with the position adjustment track 303.

[0065] In some other embodiments, the curved adjustment gear 503 can also be replaced by other mechanical structures. For example, the curved auxiliary member 302 can be driven directly by a sliding member moving in a direction parallel to the axial direction of the curved auxiliary member 302. The sliding member is directly mechanically connected to the curved auxiliary member 302, and the handle 5 is provided with a through groove for the movement of the sliding member.

[0066] See Figure 4 In some other embodiments, the main body section 4 and the adjustable bend section 1 are both provided with a wire drawing cavity for the wire drawing 2 to pass through and a bend auxiliary piece cavity 301 for the bend auxiliary piece 302 to pass through. The bend auxiliary piece cavity 301 and the wire drawing cavity are located on opposite sides of an axis, which is the axis of the main body section 4 and the adjustable bend section 1. That is, a separate channel can be provided on the opposite side of the wire drawing 2 inside the catheter for the bend auxiliary piece 302 to pass through. At this time, the bend auxiliary piece 302 can be set as a solid metal rod or a braided structure according to the support requirements of the pipe. The adjustable bend section 1 and the main body section 4 can both be set as single-layer pipes. At the same time, the adjustable bend section 1 and the main body section 4 can be set to have similar support. The support of the catheter during bending is mainly provided by the bend auxiliary piece 302.

[0067] See Figure 5 In other embodiments, the bending auxiliary member 302 may also be a tubular member, the inner lumen of which forms a passage for the pull wire 2 to pass through. A metal tube is preferably used as the bending auxiliary member 302, but a winding tube, a hypotube, or a braided structure may also be used, and this application does not impose any restrictions. In this embodiment, the bending auxiliary member 302 not only increases the bending control capability, but also ensures the support of the main body, while also saving space within the tube.

[0068] As can be seen from the above description, the handle 5 provided in the embodiment of the present invention can be applied to the catheter with the bending auxiliary member 302 provided in this embodiment, and can also be applied to conventional catheter products with bending control requirements.

[0069] To sum up, the hand handle provided by the embodiment of the present application can realize that the control force at the hand handle gradually increases with the control bending angle when the bending structure and the friction resistance member are used to control the bending of the distal end of the catheter from a small angle to a large angle, and the control feeling of the operator is improved. In addition, the medical catheter device provided by the embodiment of the present application can change the control bending radius of the adjustable bending section of the catheter by setting the bending auxiliary member in the catheter and controlling the movement of the bending auxiliary member, so that the adjustment of the control bending radius can be realized without replacing the catheter.

[0070] The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application in any way. Any modification or modification made by a person skilled in the art according to the above disclosure is within the protection scope of the claims.

Claims

1. A handle for controlling the distal end bend of a catheter, characterized in that: The handle comprises a bending control knob, a core rod, a shell, a bending setting structure and a friction resistance structure. The bending control knob is fixed to the proximal end of the catheter, the distal end of the core rod is fixedly connected to the proximal end of the bending control knob, the proximal end of the core rod extends into the shell, and the core rod is connected to the distal end of the catheter through a pull wire, the bending control knob drives the core rod to move the pull wire by moving relative to the shell, thereby changing the bending shape of the distal end of the catheter. The bending setting structure is fixed to the proximal end of the shell and is arranged outside the core rod, the friction resistance structure is arranged between the bending setting structure and the core rod, the friction resistance structure can be elastically deformed, and the elastic deformation amount of the friction resistance structure changes with the relative movement between the bending setting structure and the core rod, so that the friction resistance structure can generate different friction forces with the bending setting structure and the core rod.

2. The handle of claim 1, wherein The bending setting structure comprises a first bending setting structure, and the friction resistance structure comprises a first friction resistance structure; the first bending setting structure is sleeved outside the core rod, and the first bending setting structure and the core rod have a gap therebetween, the gap gradually decreases as the core rod moves away from the shell, so that the elastic deformation amount of the first friction resistance structure gradually increases, thereby making the friction force between the first friction resistance structure and the first bending setting structure and the core rod gradually increase.

3. The handle of claim 2, wherein, The core rod has a gradually changing section, the first bending setting structure is sleeved outside the gradually changing section, and the outer diameter of the gradually changing section gradually decreases from the proximal end to the distal end.

4. The handle of claim 1, wherein The included angle a between the generatrix of the gradually changing section and the axis is 0.02°-15°, and the gradually changing stroke of the gradually changing section is 3mm-150mm.

5. The handle of claim 1 or 2, wherein The core rod has a gradually changing sliding groove arranged in a direction parallel to the axis; The bending setting structure comprises a second bending setting structure and a second friction resistance structure, part of the second bending setting structure extends into the gradually changing sliding groove and is movably arranged along the extension direction of the gradually changing sliding groove, and the second friction resistance structure is arranged in the gradually changing sliding groove and moves with the movement of the second bending setting structure; The depth of the gradually changing sliding groove gradually decreases from the distal end to the proximal end, so that the elastic deformation amount of the second friction resistance structure gradually increases when the second bending setting structure moves towards the proximal end or the core rod moves away from the shell, thereby making the friction force between the second friction resistance structure and the second bending setting structure and the core rod gradually increase.

6. A medical catheter device, characterized by It comprises: a catheter and the handle according to any one of claims 1-5; The catheter comprises a main body section, an adjustable bending section and a head section, the main body section, the adjustable bending section and the head section are connected in sequence from the proximal end to the distal end, the bending control knob is fixed to the proximal end of the main body section, and the core rod is connected to the adjustable bending section through a pull wire.

7. The medical catheter device of claim 6, wherein, It further comprises: a bending auxiliary member, the bending auxiliary member extends from the handle, passes through the main body section and extends into the adjustable bending section, and is movably arranged in the axial direction, and the length of the bending auxiliary member in the adjustable bending section is changed by moving to change the controllable bending length of the adjustable bending section.

8. The medical catheter device of claim 7, wherein, The main body section and the adjustable bending section each comprise an inner tube and an outer tube sleeved on the inner tube, the outer tube and the inner tube are spaced apart, and the bending auxiliary member is arranged around the inner tube in the space between the inner tube and the outer tube.

9. The medical catheter device of claim 8, wherein, The bending auxiliary member is a single-lumen tubular structure or a braided tube structure capable of providing support for the main body section.

10. The medical catheter device of claim 8, wherein, The outer side wall of the inner tube, the inner side wall of the outer tube, and / or the inner and outer surfaces of the bending auxiliary member have a lubricating coating.

11. The medical catheter device of claim 7, wherein, The main body section and the adjustable bending section each have a pull wire cavity for the pull wire to pass through and a bending auxiliary member cavity for the bending auxiliary member to pass through, the bending auxiliary member cavity and the pull wire cavity are located on opposite sides of an axis, and the axis is the axis of the main body section and the adjustable bending section.

12. The medical catheter device of claim 7, wherein, The bending auxiliary member is a tubular member, and the inner cavity of the tubular member constitutes a channel for the pull wire to pass through.

13. The medical catheter device of claim 12, wherein, The tubular member is a metal tube, a round tube, a hypotube, or a braided tube.

14. The medical catheter device of claim 7, wherein, The bending auxiliary member is provided with a position adjusting track with a length consistent with the stroke of the bending auxiliary member. The handle further comprises a bending adjusting gear cooperating with the position adjusting track and being rotated to drive the bending auxiliary member to move axially, the core rod comprises a distal end section having a gear groove, and the bending adjusting gear is arranged in the gear groove and cooperates with the position adjusting track.

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