Multi-bend mapping catheter

Abstract

The invention provides a multi-bend mapping catheter. The multi-bend mapping catheter comprises a handle; the catheter sequentially comprises a catheter main body, a second bending section and a first bending section from the near end to the far end, and the shear moduli of the catheter main body, the second bending section and the first bending section are sequentially reduced; the electrode is arranged on one side of the far end of the catheter; the first bending adjusting assembly can control the bending degree of the first bending adjusting section on the first plane; and the second bending adjusting assembly can control the bending degree of the second bending adjusting section on a second plane, and the first plane and the second plane are different planes. By means of the scheme, bending adjustment can be conducted on the first bending adjustment section and the second bending adjustment section in different planes and directions, so that the catheter can smoothly enter the atrium through CSO and vena cava, then stimulation of the catheter to the heart can be reduced by adjusting the first bending adjustment section and the second bending adjustment section, and therefore the catheter can enter the atrium smoothly. And the electrodes on the catheter are tightly attached to improve the mapping accuracy and stability.

Description

Technical Field

[0001] This application relates to the technical field of electrophysiological mapping, and particularly to a multi-bend mapping catheter. Background Art

[0002] Electrophysiological mapping achieved through electrophysiological catheters plays a very important role in cardiac intervention surgeries.

[0003] One of the typical positions for placing an electrophysiological catheter is the coronary sinus (CS). The placement of the coronary sinus catheter enters through the orifice of the coronary sinus (CSO) and extends along the great cardiac vein. The overall anatomical structure has the following characteristics: the diameter of the CSO is 5 mm to 15 mm; the opening of the CSO is inclined and faces the right atrium; there are coronary sinus valves with different shapes at the posterior edge of the sinus orifice; the great cardiac vein - coronary sinus duct generally runs along the lateral edge of the mitral annulus. This means that for the coronary sinus catheter to enter the right atrium from the femoral vein upwards, it is necessary to first find the coronary sinus orifice towards the oblique rear, then tilt downwards through the coronary sinus valve, and then extend upwards along the great cardiac vein.

[0004] The existing coronary sinus mapping catheter has a planar bend (i.e., it bends only in one plane). When looking for and entering the CSO with a small diameter and an inclined opening, the planar bend needs to enter at a relatively precise angle, so it is difficult and time-consuming; in addition, the great cardiac vein winds upwards. On the one hand, it is very difficult for the planar bend to extend a long distance in the rugged great cardiac vein. On the other hand, when the planar bend extends upwards, it is easy to fall off from the CSO. On the other hand, due to the hardness of the catheter itself and the limitation of the bend type, the electrodes on the catheter are difficult to stably adhere to the side wall of the great cardiac vein, which results in unstable electrophysiological signals collected. During the process of the catheter extending along the great cardiac vein, it is also extremely easy to fall off from the CSO. All these increase the difficulty of cardiac surgery and prolong the operation time. Summary of the Invention

[0005] To solve the problems in the prior art, this application provides a multi-bend mapping catheter. The technical solution of this application is as follows:

[0006] 1. A multi-bend mapping catheter, which includes:

[0007] A handle;

[0008] A catheter, the catheter sequentially includes a catheter body, a second bending adjustment section, and a first bending adjustment section from the proximal end to the distal end, with the shear modulus decreasing in sequence;

[0009] An electrode, the electrode is arranged on one side of the distal end of the catheter;

[0010] The first bending component, which can control the bending degree of the first bending section in the first plane;

[0011] The second bending component, which can control the bending degree of the second bending section in the second plane, and the first plane and the second plane are different planes.

[0012] 2. The multi-bend mapping catheter according to item 1, wherein,

[0013] The first plane is perpendicular to the second plane.

[0014] 3. The multi-bend mapping catheter according to item 1, wherein,

[0015] A first wire-drawing channel is arranged along the length direction inside the catheter;

[0016] The first bending component includes:

[0017] The first bending mechanism;

[0018] The first wire, which is arranged in the first wire-drawing channel, and the first bending mechanism can pull the first wire to control the bending of the first bending section in the first plane.

[0019] 4. The multi-bend mapping catheter according to item 3, wherein,

[0020] An adjustment channel is arranged on the handle from the distal end to the proximal end direction;

[0021] The first bending mechanism includes:

[0022] The bending adjustment button, the proximal end of which extends deep into the adjustment channel, and the distal end of which is located outside the handle; a first wire-walking channel is axially arranged on the bending adjustment button;

[0023] The damping member, which is arranged between the outer side wall of the bending adjustment button and the inner side wall of the adjustment channel;

[0024] Wherein, the proximal side of the first wire passes through the first wire-walking channel and is fixed on the handle; the proximal end of the catheter is fixed on the bending adjustment button.

[0025] 5. The multi-bend mapping catheter according to item 4, wherein,

[0026] A first groove is arranged on the outer side wall of the proximal side of the bending adjustment button or the inner side wall of the adjustment channel, and the damping member is arranged in the first groove.

[0027] 6. The multi-bend mapping catheter according to item 4, wherein,

[0028] A second wire channel is provided along the length direction inside the catheter;

[0029] The second bending adjustment assembly includes:

[0030] A second bending adjustment mechanism;

[0031] A second wire, the second wire is arranged inside the second wire channel, and the second bending adjustment mechanism can pull the second wire to control the bending of the second bending section in a second plane.

[0032] 7. The multi-bend mapping catheter according to item 6, wherein

[0033] The second bending adjustment assembly includes:

[0034] A bending adjustment knob, the bending adjustment knob is arranged at the distal end of the bending adjustment button in a rotatable and transmissible manner, a bending adjustment channel is axially arranged in the bending adjustment knob, and an internal thread is arranged inside the bending adjustment channel;

[0035] A bending adjustment slider, the bending adjustment slider is arranged inside the bending adjustment channel, and an external thread matched with the internal thread is arranged on the bending adjustment slider;

[0036] A limiting member, the limiting member restricts the rotation of the bending adjustment slider;

[0037] Wherein, rotating the bending adjustment knob can drive the bending adjustment slider to move along the direction of the proximal end and the distal end, and the proximal end of at least one of the second wires is fixed on the bending adjustment slider.

[0038] 8. The multi-bend mapping catheter according to item 7, wherein

[0039] The bending adjustment slider includes a limiting protrusion;

[0040] The limiting member is arranged on one side of the distal end of the bending adjustment button, the limiting member includes a limiting chute extending from the proximal end to the distal end, and the limiting protrusion can slide inside the limiting chute.

[0041] 9. The multi-bend mapping catheter according to item 7, wherein

[0042] The second bending adjustment assembly further includes: a steering member, the steering member is fixed at the distal end of the bending adjustment button;

[0043] Two or more of the second wire channels are provided inside the catheter;

[0044] Wherein, the second wire includes at least two, which are respectively located in different second wire channels, the proximal end of one of the second wires is directly fixed on the bending adjustment slider, and the proximal end of the other second wire is fixed on the bending adjustment slider after bypassing the steering member.

[0045] 10. The multi-bend mapping catheter according to item 9, wherein

[0046] the steering member is a circular ring, and the proximal end of the other second pull wire passes through the circular ring and is fixed on the bending adjustment slider.

[0047] 11. The multi-bend mapping catheter according to item 7, wherein

[0048] a circumferential annular groove is further provided along the distal end of the bending adjustment push button;

[0049] the second bending adjustment assembly further includes:

[0050] a pin, the pin passes through one side of the proximal end of the bending adjustment knob and is clamped in the annular groove, so that the bending adjustment knob is arranged at the distal end of the bending adjustment push button in a shaft-driven manner.

[0051] 12. The multi-bend mapping catheter according to item 1, wherein

[0052] a first bending guide channel is arranged along the length direction inside the catheter;

[0053] the second bending adjustment assembly includes a bending guide wire arranged in the first bending guide channel, the distal end of the bending guide wire is preset to be bent, and the shear modulus of the bending guide wire is less than that of the catheter body and greater than that of the second bending section, so as to be able to adjust the distance that the distal end of the bending guide wire enters the second bending section through the first bending guide channel by pulling the bending guide wire to adjust the bending of the second bending section in the first plane.

[0054] 13. The multi-bend mapping catheter according to item 1, wherein

[0055] the material of the bending guide wire is a heat-set shape memory alloy.

[0056] 14. The multi-bend mapping catheter according to item 1, wherein

[0057] the electrode includes a head electrode and a plurality of ring electrodes;

[0058] a magnetic transmission inductor is arranged inside the head electrode.

[0059] 15. The multi-bend mapping catheter according to item 14, wherein

[0060] a second groove is arranged along the circumference of the head electrode.

[0061] 16. The multi-bend mapping catheter according to item 1, wherein

[0062] it further includes a connector, the connector is arranged at the proximal end of the handle, and the connector is electrically connected to the electrode.

[0063] With the multi-bend mapping catheter provided by the present application, it is possible to bend the first bending section and the second bending section in different planes and directions, so that it can smoothly pass through the CSO and the great cardiac vein into the atrium. After that, it is also possible to further adjust the first bending section and the second bending section to reduce the stimulation of the catheter to the heart and make the electrodes on the catheter closely fit to increase the accuracy and stability of mapping.

[0064] The above description is only an overview of the technical solution of the present application. In order to make the technical means of the present application clearer and to the extent that those skilled in the art can implement it according to the content of the specification, and in order to make the above and other purposes, features and advantages of the present application more obvious and understandable, the following takes the specific implementation manner of the present application as an example for illustration. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 : Schematic structural diagram of the multi-bend mapping catheter in an embodiment of the present application;

[0066] Figure 2 : Schematic structural diagram of the catheter in an embodiment of the present application;

[0067] Figure 3 : Front view structural diagram of the catheter after both the first bending section and the second bending section are bent in an embodiment of the present application;

[0068] Figure 4 : Top view structural diagram of the catheter after both the first bending section and the second bending section are bent in an embodiment of the present application;

[0069] Figure 5 : In an embodiment of the present application Figure 2 Schematic structural diagram of the cross-section A-A';

[0070] Figure 6 : In another embodiment of the present application Figure 2 Schematic structural diagram of the cross-section A-A';

[0071] Figure 7 : Front view cross-sectional structural diagram of the multi-bend mapping catheter in an embodiment of the present application;

[0072] Figure 8 : Figure 7 Enlarged structural diagram at position B;

[0073] Figure 9 : Schematic structural diagram of the connection between the bending push button and the limiting member in an embodiment of the present application;

[0074] Figure 10 : Figure 9 Left view structural diagram of

[0075] Figure 11 : Front view structural schematic diagram of the bending adjustment knob in an embodiment of the present application;

[0076] Figure 12 : Front view cross-sectional structural schematic diagram of the bending adjustment knob in an embodiment of the present application;

[0077] Figure 13 : Cross-sectional structural schematic diagram of the bending adjustment slider in an embodiment of the present application;

[0078] Figure 14 : Figure 13 Structural schematic diagram of the C-C' cross-section in;

[0079] Figure 15 : Structural schematic diagram of the head electrode in an embodiment of the present application;

[0080] Figure 16 : Cross-sectional structural schematic diagram of the head electrode in an embodiment of the present application.

[0081] Explanation of reference numerals:

[0082] 100, handle; 110, adjustment channel;

[0083] 200, catheter; 210, catheter body; 220, first bending section; 230, second bending section; 240, first wire-drawing channel; 250, second wire-drawing channel; 260, first bending guide channel; 270, wire channel;

[0084] 300, electrode; 310, head electrode; 311, second groove; 312, hollow cavity; 320, ring electrode;

[0085] 411, bending adjustment push button; 411-1, first wire-walking channel; 412, damping member; 413, first groove; 414, annular groove; 420, first wire;

[0086] 511, bending adjustment knob; 511-1, bending channel, 511-2 pin hole; 512, bending adjustment slider; 512-1, limiting protrusion; 512-2, catheter channel; 512-3, second wire-walking channel; 513, limiting member; 513-1, limiting chute; 514, steering member; 515, pin; 520, second wire;

[0087] 600, connector;

[0088] 700, sheath. Detailed implementation manners

[0089] The following embodiments of the present application are only used to illustrate the specific implementation manners of the present application, and these embodiments should not be construed as limitations on the present application. Any other changes, modifications, substitutions, combinations, and simplifications made without departing from the spirit and principle of the present application are regarded as equivalent replacement manners and fall within the protection scope of the present application.

[0090] Those skilled in the art should understand that in the disclosure of the present application, terms such as "first", "second", "third", "fourth", "fifth", etc. are only used to distinguish different structures, and do not limit the quantity, connection relationship, etc. of the specific structure; in addition, the orientation or positional relationship indicated by "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present application and simplifying the description, 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. Therefore, the above terms should not be construed as limitations on the present application.

[0091] In the present application, "proximal end" refers to the end close to the surgical operator, and "distal end" refers to the end far from the surgical operator (the end opposite to the "proximal end"). Specifically, as Figure 1 shown, one side of the connector 600 is the proximal end, and one side of the head electrode 310 is the distal end.

[0092] This embodiment provides a multi-curved mapping catheter, as Figures 1 to 16 shown, including:

[0093] A handle 100;

[0094] A catheter 200, the catheter 200 successively includes a catheter body 210, a second bending section 230, and a first bending section 220 with gradually decreasing shear modulus from the proximal end to the distal end (that is, the shear modulus of the catheter body 210 > the shear modulus of the second bending section 230 > the shear modulus of the first bending section 220);

[0095] An electrode 300, the electrode 300 is arranged on the distal side of the catheter 200;

[0096] A first bending assembly, the first bending assembly can control the bending degree of the first bending section 220 in the first plane;

[0097] A second bending assembly, the second bending assembly can control the bending degree of the second bending section 230 in the second plane, the first plane and the second plane are different planes. Specifically, in this embodiment, the first plane and the second plane are perpendicular planes to each other.

[0098] Regarding the material of the handle, specifically, it can be a polymer material, an inorganic non-metallic material, or a metallic material. Considering easy molding and comfort in use, the handle in this application preferably uses a polymer material. Regarding the specific polymer material, those skilled in the art can make specific selections according to specific circumstances, such as using a medical polymer material.

[0099] Regarding the materials of each section of the catheter 200 in this application, this application has no specific limitations. On the premise that the shear modulus of the catheter body 210 > the shear modulus of the second bending section 230 > the shear modulus of the first bending section 220, those skilled in the art can make specific selections according to the circumstances. Specifically, in this embodiment, the polymer materials in the catheter body 210, the first bending section 220, and the second bending section 230 can be selected from PEBAX, TPU, and PA.

[0100] In this embodiment, since the shear modulus of the catheter body 210 > the shear modulus of the second bending section 230 > the shear modulus of the first bending section 220, when using the first bending assembly to bend the first bending section, the catheter body 210 and the second bending section 230 have a smaller bending degree relative to the first bending section 220 and can play a supporting role. Thus, the first bending assembly mainly adjusts the bending degree of the first bending section 220; similarly, when using the second bending assembly to bend the second bending section 230, the catheter body 210 has a smaller bending degree relative to the second bending section 230 and can play a supporting role. Thus, the second bending assembly mainly adjusts the bending degree of the second bending section 230.

[0101] Preferably, the first bending section 220 is provided with a pre-bending angle in the first plane. Providing a pre-bending angle can facilitate entry into the CSO during surgery.

[0102] When using the multi-bend mapping catheter of this embodiment, before entering the coronary sinus, bend the second bending section 230, adjust the angle of the second bending section 230 (the included angle between the tangent of the proximal end and the tangent of the distal end of the second bending section 230) from 0° to 30° - 45°, and at the same time bend the first bending section 220 to adjust the distal end of the catheter to match the coronary sinus, facilitating the catheter to enter the coronary sinus; after the distal end of the catheter enters the coronary sinus, the bending can be appropriately released, such as releasing the second bending section 230 to adjust and reduce the acting force between the catheter and the heart tissue, avoiding the catheter slipping out of the coronary sinus during use, adjusting the first bending section 220 to make the catheter closely fit the heart, making the catheter bend shape match the blood vessel, improving the signal stability, and reducing the stimulation to the heart during the catheter pushing process.

[0103] With the above-mentioned multi-bend mapping catheter of this embodiment, the first bending section 220 and the second bending section 230 can be bent in different planes and directions, so that it can smoothly pass through the CSO and the great cardiac vein into the atrium. After that, the first bending section 220 and the second bending section 230 can be further adjusted to reduce the stimulation of the catheter to the heart, and the electrodes on the catheter can be closely attached to increase the accuracy and stability of mapping.

[0104] In one embodiment, as Figures 2 to 5 shown, a first wire-drawing channel 240 is arranged along the length direction of the catheter. The first wire-drawing channel 240 extends from the proximal end of the catheter body 210 to at least the distal end of the first bending section 220; the first bending assembly includes: a first bending mechanism; a first wire (not shown in the figure), the first wire is arranged in the first wire-drawing channel 240, and the first bending mechanism can pull the first wire to control the bending of the first bending section 220 in the first plane.

[0105] Regarding the first wire-drawing channel 240 and the second wire-drawing channel 250 below, those skilled in the art know that they should be eccentrically arranged in the catheter 200 for bending.

[0106] This embodiment provides a solution in which the first bending mechanism bends the first bending section 220 through the first wire. Among them, as Figure 5 shown, only one first wire-drawing channel and a corresponding first wire can be provided. The distal end of the first wire is fixed at the distal end of the first wire-drawing channel 240 (the distal end inside the first bending section 220). The first bending mechanism can increase the bending degree of the first bending section 220 by tightening the first wire. In addition, the first wire can be relaxed, and the first bending section 220 can reduce its bending degree through its own elasticity.

[0107] In addition, this embodiment provides a solution for the first bending mechanism. As Figure 7 , Figure 9 etc. shown, the handle 100 is provided with an adjustment channel 110 from the distal end to the proximal end direction;

[0108] The first bending mechanism includes:

[0109] A bending push button 411, the proximal end of the bending push button 411 extends deep into the adjustment channel 110, and the distal end of the bending push button 411 is located outside the handle 100; a first wire-walking channel 411-1 is axially arranged on the bending push button 411;

[0110] A damping member 412, the damping member 412 is arranged between the outer side wall of the bending push button 411 and the inner side wall of the adjustment channel 110;

[0111] Wherein, one side of the proximal end of the first pulling wire 420 passes through the first wire routing channel 411-1 and is fixed on the handle 100; the proximal end of the catheter 200 is fixed on the bending adjustment push button 411 (specifically fixed at the distal end of the first wire routing channel 411-1 in this embodiment).

[0112] This embodiment provides a solution for a first bending mechanism. One side of the proximal end of the first pulling wire 420 passes through the first wire routing channel 411-1 and is fixed on the handle 100. The proximal end of the catheter 200 is fixed on the bending adjustment push button 411. Thus, by pushing and pulling the bending adjustment push button 411, the relative distance between the first bending section 220 and the proximal end of the first pulling wire 420 can be adjusted, so as to tighten or loosen the distal end of the first bending section 220, and the bending degree of the first bending section 220 can be adjusted. The damping member 412 can increase the damping between the bending adjustment push button 411 and the adjustment channel 110, so that the relative position between the bending adjustment push button 411 and the adjustment channel 110 remains unchanged after adjustment, so as to maintain the bending degree of the first bending section 220.

[0113] For the first wire routing channel 411-1, it can also be used to arrange wires for connecting the following connector 600, electrode 300 and the following magnetic transmission sensor. Of course, in order to more smoothly adjust the first bending section 220 through the first bending mechanism, a dedicated channel can also be set to arrange the wires, and those skilled in the art can make appropriate settings according to the situation.

[0114] In addition, a first groove 413 can be provided on the outer wall of the proximal end side of the bending adjustment push button 411 or the inner wall of the adjustment channel to arrange the damping member 412, so as to limit the position of the damping member 412. As Figure 8 shown, in this embodiment, the first groove 413 is annularly arranged on the outer surface of the bending adjustment push button 411, and the annular damping member 412 is sleeved on the first groove 413.

[0115] Regarding the material of the damping member 412, specifically, materials such as rubber can be used.

[0116] In one embodiment, as Figures 2 to 5 shown, a second pulling wire channel 250 is arranged along the length direction of the catheter 200; the second pulling wire channel 250 extends from the proximal end of the catheter main body 210 at least to the distal end of the second bending section 220; the second bending assembly includes: a second bending mechanism; a second pulling wire (not shown in the figure), the second pulling wire is arranged in the second pulling wire channel 250, and the second bending mechanism can pull the second pulling wire to control the bending degree of the second bending section 230 in the second plane.

[0117] This embodiment provides a solution in which the second bending mechanism bends the second bending section 230 through a second pulling wire. The bending principle is similar to the solution in which the first bending mechanism bends the first bending section 220 in the previous embodiment. Among them, only one second pulling wire channel 250 and a corresponding second pulling wire can be provided. The distal end of the second pulling wire is fixed to the distal end of the second pulling wire channel 250 (the distal end inside the second bending section 230). The second bending mechanism can increase the bending degree of the second bending section 230 by tightening the second pulling wire. In addition, the second pulling wire can also be relaxed, and the second bending section 230 reduces the bending degree of the second bending section 230 through its own elasticity; in addition, for example Figure 5 As shown, a pair of second pulling wire channels 250 and a corresponding pair of second pulling wires can be provided. The two second pulling wires are respectively arranged in different second pulling wire channels 250. The distal ends of the second pulling wires are respectively fixed to the distal ends of the second pulling wire channels 250 (the distal ends inside the second bending section 230). The second bending mechanism can bend the second bending section 230 toward the corresponding side by tightening one side of the second pulling wire and relaxing the other side of the second pulling wire.

[0118] On the basis of the above solutions, those skilled in the art know that if the two-way adjustment of the second bending section 230 is in one plane, the two second pulling wire channels 250 should be located on opposite sides of the axis of the catheter.

[0119] In addition, this embodiment provides a solution for a second bending assembly. As Figures 7 to 14 shown, it includes:

[0120] A bending adjustment knob 511, the bending adjustment knob 511 is rotatably arranged at the distal end of the bending push button 411. The bending adjustment knob 511 is axially provided with a bending adjustment channel 511-1, and an internal thread is arranged in the bending adjustment channel 511-1;

[0121] A bending adjustment slider 512, the bending adjustment slider 512 is arranged in the bending adjustment channel 511-1, and the bending adjustment slider 512 is provided with an external thread that cooperates with the internal thread;

[0122] A limiting member 513, the limiting member 513 restricts the rotation of the bending adjustment slider 512;

[0123] Among them, rotating the bending adjustment knob 511 can drive the bending adjustment slider 512 to move along the direction of the proximal end and the distal end. The proximal end of at least one second pulling wire 520 is fixed to the bending adjustment slider 512.

[0124] In addition, as Figure 7 、 Figure 8As shown, a sheath 700 can also be provided between the bending adjustment knob 511 and the catheter 200 to reduce the bending stress at the connection between the catheter 200 and the bending adjustment knob 511 and protect the connection part from being easily damaged. The sheath 700 can specifically be made of rubber material, and rubber has good wear resistance and flexibility to improve the service life of the catheter 200.

[0125] Through the second bending adjustment assembly provided in the present application, the bending adjustment slider 512 can be driven to move from the proximal end to the distal end or from the distal end to the proximal end by rotating the bending adjustment knob 511, so as to tighten or loosen the second pull wire 520, thereby adjusting the bending degree of the second bending section 230.

[0126] Specifically, the bending adjustment slider 512 includes a limit protrusion 512-1; the limiting member 513 is arranged on the distal side of the bending adjustment button 411, and the limiting member 513 includes a limit chute 513-1 extending from the proximal end to the distal end, and the limit protrusion 512-1 can slide in the limit chute. Thus, the rotation of the bending adjustment slider 512 is restricted by the limit chute 513-1, and the bending adjustment slider 512 can move along the direction where the proximal end and the distal end are located.

[0127] In addition, the second bending adjustment assembly further includes: a steering member 514, and the steering member 514 is fixed to the distal end of the bending adjustment button 411; there are more than two second pull wire channels 250 (specifically two in this embodiment) provided in the catheter 200; wherein, the second pull wire 520 includes at least two (specifically two in this embodiment), which are respectively located in different second pull wire channels 250, the proximal end of one second pull wire 520 is directly fixed on the bending adjustment slider, and the proximal end of the other second pull wire 520 is fixed on the bending adjustment slider 512 after bypassing the steering member 514.

[0128] Refer to Figure 8 the shown structure. When the bending adjustment knob 511 is rotated to move the bending adjustment slider 512 from the distal end to the proximal end, the upper second pull wire 520 can be pulled to move from the distal end to the proximal end to tighten the second pull wire 520, and the lower second pull wire 520 is loosened, and the second bending section 230 bends upward towards the Figure 8 plane; when the bending adjustment knob 511 is rotated to move the bending adjustment slider 512 from the proximal end to the distal end, the proximal end of the lower second pull wire 520 can be pulled to move from the proximal end to the distal end to tighten the second pull wire 520, and the upper second pull wire 520 is loosened, and the second bending section 230 bends downward towards the Figure 8 plane. Thus, the two-way adjustment of the second bending section 230 can be realized.

[0129] In addition, based on the above solutions, those skilled in the art know that a second wire routing channel 512-3 can be provided on the bending slider 512 to enable the other second pull wire 520 (such as Figure 8 the second pull wire 520 on the lower side shown) to be routed.

[0130] Such as Figure 8 shown, in this embodiment, the turning member 514 is specifically implemented as a circular ring, and the proximal end of the other second pull wire 520 ( Figure 8 the second pull wire 520 on the lower side shown) passes through the circular ring and is fixed on the bending slider.

[0131] Regarding the fixing method of the proximal end of the second pull wire 520 to the bending slider 512, it can be achieved by existing adhesive methods or the like.

[0132] Furthermore, in this embodiment, as Figure 7 、 Figure 9 shown, a circumferential annular groove 414 is further provided along the distal end of the bending push button 411; the second bending assembly further includes: a pin 515, the pin 515 passes through the proximal side of the bending knob 511 and is clamped in the annular groove 414, so that the bending knob 511 is rotatably arranged at the distal end of the bending push button 411.

[0133] Such as Figures 1 to 14 shown, when the above two specific first bending assemblies and second bending assemblies are used in combination, the first bending section 220 can be bent by the bending push button 411, and the second bending section 230 can be bent by the bending knob 511, and their independent operations do not interfere with each other.

[0134] In one embodiment, as Figure 6 shown, another solution for bending the second bending section 230 is given. A first bending guide channel 260 is provided in the catheter 200 along its length direction; the first bending guide channel 260 extends from the proximal end of the catheter body 210 at least to the distal end of the second bending section 230; the second bending assembly includes a bending wire (not shown in the figure) provided in the first bending guide channel 260, the distal end of the bending wire is preset to be bent, and the shear modulus of the bending wire is less than that of the catheter body 210 and greater than that of the first bending section 220, so as to be able to control the distance that the distal end of the bending wire enters the second bending section 230 through the first bending guide channel 260 by pulling the bending wire to adjust the bending degree of the second bending section 230 in the second plane.

[0135] This embodiment provides another solution for the second bending mechanism to bend the second bending section 230 through a bending guide wire. The second bending section 230 is bent by inserting a bending guide wire with a preset distal end bend into the first bending guide channel 260, and the bending degree of the second bending section 230 is reduced by its own elasticity by withdrawing the bending guide wire, so as to realize the bending of the second bending section 230 by the second bending assembly. To facilitate the operation of the bending guide wire by the surgical operator, a through-channel communicating with the first bending guide channel 260 can be provided on the handle 100, and the surgical operator can then perform the pulling operation on the bending guide wire by pulling the proximal end of the bending guide wire exposed from the through-channel.

[0136] Especially when combined with Figure 7 、 Figure 9 the first bending assembly shown, the through-channel can be a through-hole provided in the bending push button along the length direction of the bending push button. Thus, the first bending section can be bent by the first bending assembly, etc., and the second bending section can be bent by the bending guide wire of the above solution, and the two work independently without interference.

[0137] Regarding the material of the bending guide wire, it can be a heat-set shape memory alloy. Specifically, in this embodiment, the bending guide wire is a heat-set nickel-titanium memory alloy wire. One of the important properties of shape memory alloys is pseudoelasticity (also known as superelasticity), which is manifested as that under the action of external force, the shape memory alloy has a much greater deformation recovery ability than ordinary metals, that is, the large strain generated during the loading process will recover with unloading. This property enables the distal end of the bending guide wire to unload the acting force of the catheter body 210 on the distal end of the bending guide wire when entering the proximal end of the second bending section 230 from the distal end of the catheter body 210, and can better recover the preset original bending shape to better realize the bending of the second bending section 230.

[0138] In one embodiment, as Figure 1 、 Figures 15 to 16 shown, the electrode 300 includes a head electrode 310 and a plurality of ring electrodes 320 (specifically, 10 ring electrodes 320 are provided in this embodiment); a magnetic transmission sensor (not shown in the figure) is provided in the head electrode 310.

[0139] By providing a magnetic transmission sensor in the head electrode 310, it is convenient to display the position of the catheter 200 in an external three-dimensional mapping system, so as to provide position guidance for other surgical procedures.

[0140] Regarding the specific structure of the head electrode 310, a hollow cavity 312 can be provided inside it to accommodate the magnetic transmission sensor. Additionally, a second groove 311 is provided along the circumferential direction of the head electrode to facilitate the tight connection between the head electrode and the first bending section 220. Regarding the material of the head electrode 310, an existing suitable head electrode material can be selected. In this embodiment, the head electrode is made of medical stainless steel.

[0141] Regarding the material, structure, installation method, etc. of the ring electrode, they are all existing solutions and will not be elaborated in this application. In this embodiment, the ring electrode is made of platinum-iridium alloy.

[0142] It should be noted that as Figure 1 , Figures 5 to 9 shown, the multi-bend type mapping catheter of this embodiment further includes a connector 600. The connector 600 is arranged at the proximal end of the handle 100, and the connector 600 is electrically connected to the electrodes (including the head electrode 310 and the ring electrode 320) and the magnetic transmission sensor. Specifically, a wire channel 270 is provided inside the catheter, and the electrodes 300 (including the head electrode 310 and the ring electrode 320) and the magnetic transmission sensor are connected to the connector 600 through the wires arranged in the wire channel 270.

[0143] Although the embodiments of this application have been described above, this application is not limited to the above specific embodiments and application fields. The above specific embodiments are merely illustrative and guiding, rather than restrictive. Those of ordinary skill in the art can also make many forms under the inspiration of this specification and without departing from the scope protected by the claims of this application, and all of these belong to the scope required to be protected by this application.

Claims

1. A multi-bend mapping catheter, wherein: include: handle; A catheter, wherein the catheter includes, from the proximal end to the distal end, a catheter body, a second bending adjustment section, and a first bending adjustment section, the shear modulus of which decreases in sequence; An electrode, wherein the electrode is disposed on a distal end side of the catheter; A first bending adjustment component, wherein the first bending adjustment component can control the bending degree of the first bending adjustment section in a first plane; a second bending adjustment component, wherein the second bending adjustment component can control the bending degree of the second bending adjustment section in a second plane, and the first plane and the second plane are different planes; Preferably, the first plane is perpendicular to the second plane.

2. The multi-bend mapping catheter according to claim 1, wherein: A first wire pulling channel is arranged inside the catheter along its length direction; The first bending adjustment component comprises: The first bending adjustment mechanism; A first pulling wire is disposed in the first pulling wire channel, and the first bending mechanism can pull the first pulling wire to control the first bending section to bend in a first plane.

3. The multi-bend mapping catheter according to claim 2, wherein: The handle is provided with an adjustment channel from the distal end to the proximal end; The first bending adjustment mechanism comprises: A bending adjustment button, wherein the proximal end of the bending adjustment button extends into the adjustment channel, and the distal end of the bending adjustment button is located outside the handle; a first wiring channel is axially arranged on the bending adjustment button; A damping member, the damping member is arranged between the outer side wall of the bending adjustment button and the inner side wall of the adjustment channel; Wherein, one side of the proximal end of the first pull wire passes through the first wiring channel and is fixed on the handle; the proximal end of the catheter is fixed on the bending adjustment knob; Preferably, an outer wall on the proximal end of the bending adjustment button or an inner wall of the adjustment channel is provided with a first groove, and the damping member is provided in the first groove.

4. The multi-bend mapping catheter according to claim 3, wherein: A second wire pulling channel is provided in the catheter along its length direction; The second bending adjustment component comprises: The second bending adjustment mechanism; A second pull wire, the second pull wire is arranged in the second pull wire channel, and the second bending adjustment mechanism can pull the second pull wire to control the second bending adjustment section to bend in the second plane.

5. The multi-bend mapping catheter according to claim 4, wherein: The second bending adjustment component comprises: A bending knob, which is axially driveably arranged at the distal end of the bending knob, and the bending knob is axially provided with a bending channel, and the bending channel is provided with an internal thread; A bending adjustment slider, the bending adjustment slider is arranged in the bending adjustment channel, and the bending adjustment slider is provided with an external thread matching the internal thread; A limiting member, wherein the limiting member limits the rotation of the bending adjustment slider; The bending adjustment knob is rotated to drive the bending adjustment slider to move in the direction of the proximal end and the distal end, and the proximal end of at least one of the second pull wires is fixed on the bending adjustment slider.

6. The multi-bend mapping catheter according to claim 5, wherein: The bending adjustment slider includes a limiting protrusion; The limiting member is arranged on the distal end side of the bending adjustment push button, and the limiting member comprises a limiting sliding groove extending from the proximal end to the distal end, and the limiting protrusion can slide in the limiting sliding groove.

7. The multi-bend mapping catheter according to claim 5, wherein: The second bending adjustment assembly further includes: a steering member, the steering member being fixed at the distal end of the bending adjustment push button; The catheter is provided with two or more of the second pull-wire channels; Wherein, the second pull wires include at least two, which are respectively located in different second pull wire channels, the proximal end of one of the second pull wires is directly fixed on the bending adjustment slider, and the proximal end of the other second pull wire is fixed on the bending adjustment slider after passing through the steering member; Preferably, the steering member is a circular ring, and the proximal end of the other second pull wire passes through the circular ring and is fixed on the bending adjustment slider.

8. The multi-bend mapping catheter according to claim 5, wherein: The distal end of the bending adjustment button is also provided with an annular groove along the circumferential direction; The second bending adjustment component also includes: A pin is provided, wherein the pin passes through a proximal end of the bending adjustment knob and is clamped in the annular groove, so that the bending adjustment knob can be arranged at the distal end of the bending adjustment push button in a shaft-driven manner.

9. The multi-bend mapping catheter according to claim 1, wherein: A first bend guiding channel is arranged in the conduit along its length direction; The second bending adjustment component includes a bending guide wire disposed in the first bending guide channel, the distal end of the bending guide wire is preset to be bent, and the shear modulus of the bending guide wire is smaller than the catheter body and larger than the second bending adjustment section, so that the bending of the second bending adjustment section in the first plane can be adjusted by pulling the bending guide wire to control the distance that the distal end of the bending guide wire enters the second bending adjustment section through the first bending guide channel; Preferably, the bending guide wire material is a heat-set shape memory alloy.

10. The multi-bend mapping catheter according to claim 1, wherein: The electrodes include a head electrode and a plurality of ring electrodes; A magnetic sensor is arranged in the head electrode; Preferably, the head electrode is provided with a second groove along its circumference; Further preferably, the multi-bend mapping catheter further comprises a connector, wherein the connector is disposed at the proximal end of the handle, and the connector is electrically connected to the electrode.

Images