Electrophysiology mapping catheter

Abstract

The utility model relates to the technical field of medical catheters, in particular to an electrophysiology mapping catheter which comprises a far-end catheter body and a near-end catheter body which are connected with each other, the joint of the far-end catheter body and the near-end catheter body is configured to have an included angle B which is kept unchanged, the head end of the far-end catheter body has an initial deflection angle A, the angle A and the angle B are not coplanar, and the angle A and the angle B are not coplanar. The far-end tube body can be bent in the deflection angle direction. According to the electrophysiology mapping catheter, the fixed angle B and the initial deflection angle A are preset on the catheter, the angle B directly meets the requirement that the catheter bends towards the oblique rear portion, and the angle A guides the bending direction to meet the requirement that the catheter bends towards the oblique lower portion, so that when the catheter is bent, an operator only needs to bend the far-end catheter body in the deflection angle direction, and the catheter can be bent in the deflection angle direction. The control difficulty is greatly reduced, the control steps are simplified, the learning cost of an operator is reduced, and the guide pipe is novel in structure, convenient to use and good in effect.

Description

Technical Field

[0001] The utility model relates to the technical field of medical catheters, in particular to an electrophysiological mapping catheter. Background Art

[0002] During cardiac electrophysiological surgery, an electrophysiological mapping catheter is needed to record cardiac electrophysiological activity, including intracardiac electrophysiological waveforms, intracardiac electrical activity sequence, myocardial electrical activity matrix mapping, etc., to provide an important basis for electrophysiological examination and cardiac electrophysiological ablation. The coronary sinus, due to its unique anatomical position, can simultaneously record the intracardiac electrophysiological waveforms of multiple chambers of the heart in the coronary sinus. After the catheter reaches the coronary sinus, it has little interaction with other electrophysiological catheters and is not easily displaced. It is an essential reference position in cardiac electrophysiological examination or cardiac electrophysiological ablation.

[0003] Conventional electrophysiological mapping catheters are inserted through the subclavian vein via the superior vena cava into the coronary sinus (fixed bend) or through the femoral vein via the inferior vena cava into the coronary sinus (adjustable bend).

[0004] There are many restrictions and high risks when the catheter enters the coronary sinus through the superior vena cava route, such as complications such as lung infection and pneumothorax. In addition, patients with pacemakers and venous valve damage are not suitable for the superior vena cava channel. Entering the coronary sinus from the inferior vena cava channel requires the use of an adjustable electrophysiological mapping catheter. The existing adjustable electrophysiological mapping catheter used to enter the coronary sinus is expected to be used in different intracardiac locations. Its catheter shape is not very suitable for placement in the coronary sinus. It is necessary to manipulate the handle under X-ray development to adjust the front end bending angle and finally enter the expected position.

[0005] The coronary sinus is an essential reference electrode placement location in cardiac electrophysiology surgery. The coronary sinus opening is located at about 2 o'clock on the upper part of the tricuspid valve ring. Its diameter is about 5mm to 15mm. The opening is tilted toward the right atrium. There are coronary sinus valves of different shapes at the rear edge of the sinus opening. The coronary sinus runs roughly from the epicardium around the mitral valve ring. If the catheter wants to enter the coronary sinus from the inferior vena cava, it must first find the coronary sinus opening obliquely backward, and then pass through the coronary sinus valve obliquely downward to successfully enter the coronary sinus, which places high demands on the control of traditional adjustable curved electrophysiology catheters. Utility Model Content

[0006] The purpose of the utility model is to provide an electrophysiological mapping catheter to address the problems that the existing electrophysiological mapping catheter in the prior art has many limitations when entering the coronary sinus from the superior vena cava path, and therefore most of them enter the coronary sinus from the inferior vena cava path. However, the catheter in this path needs to bend obliquely backward and then obliquely downward, which has high control requirements for the existing adjustable bend electrophysiological catheter and high learning costs for the operator.

[0007] To achieve the above object, the technical solution adopted by the present utility model is as follows:

[0008] An electrophysiological mapping catheter includes a distal tube body and a proximal tube body connected to each other. The connection between the distal tube body and the proximal tube body is configured to have an included angle ∠B, and ∠B remains unchanged. The head end of the distal tube body has an initial deflection angle ∠A, and ∠A and ∠B are not coplanar. The distal tube body can be bent along the deflection angle direction.

[0009] In the art, the distal end refers to the foremost part of the electrophysiological mapping catheter, that is, the part that first enters the human body. The proximal end refers to the end of the electrophysiological mapping catheter that is closer to the operator. The head end is located at the distal end of the electrophysiological mapping catheter, that is, the end that enters the human body. Therefore, those skilled in the art can clearly and unambiguously understand the meanings of the distal tube body and the proximal tube body, and can understand that the head end of the distal tube body is the head end of the electrophysiological mapping catheter.

[0010] The head end of the catheter having an initial deflection angle can be understood as the angle or direction of the head (distal end) of the catheter relative to a specific reference point or direction. Specifically in this application, it means that the direction of the head end of the distal tube body is offset relative to the original axis direction of the distal tube body during production and manufacturing, and has an offset angle of ∠A. Among them, one side of ∠A is the direction pointed by the head end of the distal tube body, and the other side is the original axis direction of the distal tube body; similarly, ∠B is also a fixed angle preset during the production and manufacturing of the catheter.

[0011] For exemplary illustration, see Figure 5 , there is an included angle ∠B between the axis of the distal tube body and the axis of the proximal tube body, and then the head end of the distal tube body is bent and offset outward from the computer screen to form ∠A, Figure 5 and Figure 6 illustrates the bending in the direction perpendicular to the computer screen.

[0012] By presetting the fixed ∠B, the catheter enters the right atrium from the inferior vena cava. The head end of the catheter is initially straight and obliquely backward. Then, when adjusting the angle of the distal tube body, it enters the coronary sinus obliquely downward along the initial deflection angle ∠A, and then pushing the catheter forward can follow the direction of the head end of the catheter along the coronary sinus forward to the great cardiac vein direction until the distal tube body reaches the maximum bending angle.

[0013] When using an electrophysiological mapping catheter according to the present utility model, since the catheter is pre-set with a fixed ∠B and an initial deflection angle ∠A, ∠B directly adapts to the requirement of the catheter to bend obliquely backward, and ∠A guiding the bending direction also adapts to the requirement of the catheter to bend obliquely downward. Therefore, when the catheter is bent, the operator only needs to bend the distal tube body along the deflection angle direction, greatly reducing the difficulty of operation, simplifying the operation steps, and reducing the learning cost of the operator. The catheter has a novel structure, is convenient to use, and has good effects.

[0014] As a preferred technical solution of the present utility model, the included angle between the plane where ∠A is located and the plane where ∠B is located is 45° - 90°.

[0015] As a further preferred technical solution of the present utility model, the plane where ∠A is located is perpendicular to the plane where ∠B is located.

[0016] As a preferred technical solution of the present utility model, ∠A is 15° - 55°.

[0017] As a further preferred technical solution of the present utility model, after the distal tube body is bent, ∠A changes to ∠A', and the maximum value of ∠A' is 210° - 240°.

[0018] Since the existing adjustable electrophysiological mapping catheter is not very suitable for being inserted into the coronary sinus, it is necessary to adjust the front-end bending angle by operating the handle under X-ray imaging and finally enter the expected position, which will inevitably increase the time that doctors and patients are exposed to X-rays, easily cause personal injuries, and the electrophysiological mapping catheter image under X-rays is a two-dimensional image, which requires high requirements for the operator. In view of the above defects of the existing technology, the present utility model adopts the following technical solutions to overcome the above defects.

[0019] As a preferred technical solution of the present utility model, a plurality of magnetic positioning sensors are arranged at intervals along the length direction of the distal tube body, and the magnetic positioning sensors are arranged near the connection of the proximal tube body and the distal tube body.

[0020] With this structural arrangement, through the provided magnetic positioning sensors, the position and shape of the distal end of the catheter can be displayed in real time in the cardiac electrophysiological three-dimensional mapping system, improving the surgical efficiency. During the entire electrophysiological surgery process, X-ray positioning can be used less or not at all, reducing the risk of harm to the operator and the patient.

[0021] As a further preferred technical solution of the present utility model, the magnetic positioning sensor includes a first magnetic positioning sensor, a second magnetic positioning sensor, and a third magnetic positioning sensor. The first magnetic positioning sensor is provided at the head end of the distal tube body. The second magnetic positioning sensor is provided on the proximal tube body, and the second magnetic positioning sensor is close to the connection between the proximal tube body and the distal tube body. The third magnetic positioning sensor is provided on the distal tube body, and the third magnetic positioning sensor is located between the first magnetic positioning sensor and the second magnetic positioning sensor.

[0022] The existing adjustable curve electrophysiological mapping catheter uses a unipolar mapping technology to determine the catheter position. Usually, an in-vivo mapping electrode and a body surface reference electrode are used as a pair of electrodes to measure the intracardiac unipolar signal. However, the body surface electrophysiological signal is relatively complex, and the body surface reference electrode is often interfered by various far-field electrophysiological signals, which has a great impact on the surgical process. In view of the above defects of the existing technology, the present utility model adopts the following technical solutions to overcome the above defects.

[0023] As a preferred technical solution of the present utility model, a plurality of electrodes are arranged at intervals along the length direction of the distal tube body, and the electrodes are provided on the proximal tube body.

[0024] With this structural arrangement, by providing a single electrode on the proximal tube body, which is located in the inferior vena cava during normal use, it can be used as a reference electrode when performing unipolar mapping on each of the electrodes on the distal tube body, avoiding the influence of far-field electrophysiological signals on the unipolar mapping waveform. At the same time, since the catheter is pre-shaped, the electrodes on the catheter can be in good contact with the coronary sinus and are not easily slipped out.

[0025] As a further preferred technical solution of the present utility model, the electrode includes a head electrode, a first ring electrode, and a second ring electrode. The head electrode is provided at the head end of the distal tube body. One first ring electrode or 2 to 9 spaced-apart first ring electrodes are provided on the distal tube body, and the first ring electrode is located between the head end of the distal tube body and the proximal tube body. The second ring electrode is provided on the proximal tube body.

[0026] As a preferred technical solution of the present utility model, the hardness of the proximal tube body on the side close to the distal tube body is lower than the hardness on the side far from the distal tube body.

[0027] As a preferred technical solution of the present utility model, the tube wall of the proximal tube body is a multi-layer composite structure.

[0028] As a preferred technical solution of the present utility model, the distal tube body includes a first cavity and a second cavity. The first cavity is arranged through along the length direction of the distal tube body, a traction wire is arranged in the first cavity, the second cavity is arranged through along the length direction of the distal tube body, and a wire is arranged in the second cavity. Wherein, the wire can be the wire of the magnetic positioning sensor or the wire of the electrode.

[0029] With this structural arrangement, the traction wire and the wire are separated by the first cavity and the second cavity, preventing the abrasion of the insulating layer of the wire caused by the pulling of the traction wire when the distal tube body bends, which may cause the wire to fail.

[0030] As a preferred technical solution of the present utility model, the proximal tube body is connected to the handle, and a push button is arranged on the handle. The push button is used to control the bending of the distal tube body.

[0031] To sum up, due to the adoption of the above technical solutions, the beneficial effects of the present utility model are as follows:

[0032] For the electrophysiological mapping catheter of the present utility model, since the catheter is pre-set with a fixed ∠B and an initial deflection angle ∠A, ∠B directly adapts to the requirement of the catheter to bend obliquely backward, and ∠A guiding the bending direction also adapts to the requirement of the catheter to bend obliquely downward. Therefore, when adjusting the bending of the catheter, the operator only needs to bend the distal tube body along the deflection angle direction, which greatly reduces the difficulty of operation, simplifies the operation steps, and reduces the learning cost of the operator. The catheter has a novel structure, is convenient to use, and has good effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 is a schematic structural diagram of the electrophysiological mapping catheter;

[0034] Figure 2 is a schematic structural diagram of the initial prefabricated bending shape of the distal tube body;

[0035] Figure 3 is a detailed schematic diagram of the electrophysiological mapping catheter;

[0036] Figure 4 is a schematic diagram of the installation position of the magnetic positioning sensor of the electrophysiological mapping catheter;

[0037] Figure 5 For Figure 2 the plane projection schematic diagram of the initial prefabricated bending shape in (showing the prefabricated ∠B);

[0038] Figure 6 For Figure 5 the view in the C direction in (showing the initial bending ∠A);

[0039] Figure 7Schematic diagram of the bent structure of the distal tube body after bending;

[0040] Figure 8 is Figure 7 Schematic diagram of the planar projection after bending in (showing the fixed angle ∠B);

[0041] Figure 9 is Figure 8 View in the C direction in (showing ∠A' after the maximum bending of ∠A).

[0042] Markings in the figure: 100 - distal tube body, 101 - first cavity, 102 - second cavity, 103 - head electrode, 104 - first ring electrode, 105 - wire, 106 - traction wire, 200 - proximal tube body, 201 - inner layer, 202 - outer layer, 203 - braided wire, 204 - second ring electrode, 205 - spring coil, 206 - plastic tube, 300 - handle, 301 - push button, 401 - first magnetic positioning sensor, 402 - third magnetic positioning sensor, 403 - second magnetic positioning sensor. Detailed implementation manners

[0043] The present invention will be further described in detail below in combination with test examples and specific implementation manners. However, this should not be construed as limiting the scope of the above - mentioned subject matter of the present invention to the following embodiments. All technologies implemented based on the content of the present invention belong to the scope of the present invention.

[0044] In the description of the specific embodiments of the present invention, without special explanation, the expression terms indicating the orientation or positional relationship such as "upper", "lower", "left", "right", "center", "inner", "outer", etc. are all based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the invention product / device / device is commonly used. These terms of orientation or positional relationship are only for the convenience of describing the solution of the present invention or simplifying the description in the specific embodiments, so as to facilitate technicians to quickly understand the solution, rather than indicating or implying that a specific device / component / element must have a specific orientation or be constructed and operated in a specific positional relationship. Therefore, it cannot be understood as a limitation to the present invention.

[0045] In addition, when terms such as "horizontal", "vertical", "hanging", and "parallel" appear, it does not mean that the corresponding device / component / element is required to be absolutely horizontal or vertical or hanging or parallel, but it can be slightly inclined or deviated. For example, "horizontal" only means that its direction is more horizontal relative to "vertical", and it does not mean that the structure must be completely horizontal, but it can be slightly inclined. Or, it can be simply understood that the corresponding device / component / element is arranged in directions such as "horizontal", "vertical", "hanging", "parallel", etc., and can have an error / deviation of ±10% relative to the corresponding direction setting, more preferably an error / deviation within ±8%, more preferably an error / deviation within ±6%, more preferably an error / deviation within ±5%, more preferably an error / deviation within ±4%. As long as the corresponding device / component / element is within the error / deviation range, it can still achieve its function in the solution of the present invention.

[0046] In addition, when expressions such as "first", "second", "third", etc. appear in the terms, they are only used to distinguish the description of the same or similar components, and should not be understood as emphasizing or implying the relative importance of specific components.

[0047] In addition, in the description of the embodiments of the present invention, "several", "multiple", and "a number of" represent at least 2. It can be any situation such as 2, 3, 4, 5, 6, 7, 8, 9, etc., and even can be a situation of more than 9.

[0048] In addition, in the description of the technical solution of the present invention, unless otherwise clearly specified / defined / restricted, when terms such as "set", "installed", "connected", "connected", "provided with", "laid", "arranged" appear, they should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection. It can be connection means commonly used in the art such as welding, riveting, bolting, and threaded connection. Such a connection can be a mechanical connection, an electrical connection, or a communication connection; it can be directly connected, or indirectly connected through an intermediate medium, and can be the communication inside two components.

[0049] In the related art, in the first aspect, there are many limitations and high risks for the existing electrophysiological mapping catheter to enter the coronary sinus through the superior vena cava path. For example, it can cause complications such as pulmonary infection and pneumothorax. Moreover, patients with pacemakers and patients with venous valve injuries are not suitable for the superior vena cava channel. Therefore, it is often necessary to enter the coronary sinus through the inferior vena cava path. However, in this path, the catheter needs to first bend obliquely backward to find the coronary sinus orifice and then bend obliquely downward to pass through the coronary sinus valve to smoothly enter the coronary sinus, which requires high control requirements for the existing adjustable electrophysiological catheter and high learning costs for the operator. In the second aspect, since the shape of the existing adjustable electrophysiological mapping catheter is not very suitable for being placed in the coronary sinus, it is necessary to adjust the front-end bending angle by operating the handle under X-ray imaging and finally enter the expected position, which will inevitably increase the time for doctors and patients to be exposed to X-rays, easily cause personal injuries, and the electrophysiological mapping catheter image under X-rays is a two-dimensional image, which requires high requirements for the operator. In the third aspect, the existing adjustable electrophysiological mapping catheter uses a unipolar mapping technology to determine the catheter position. Usually, an in-vivo mapping electrode and a body surface reference electrode are used as a pair of electrodes to measure the intracardiac unipolar signal. However, the body surface electrophysiological signal is relatively complex, and the body surface reference electrode is often interfered by various far-field electrophysiological signals, which has a great impact on the surgical process. Therefore, the technical solution of this application is thus generated. The following will be described in conjunction with Figures 1 to 9 for elaboration.

[0050] Example 1

[0051] As Figure 1 shown, an electrophysiological mapping catheter of the present utility model includes a distal tube body 100, a proximal tube body 200, and a handle 300 that are sequentially connected. A push button 301 is provided on the handle 300 near the connection with the proximal tube body 200.

[0052] In some alternative embodiments, as Figure 1 and Figure 2 shown, the outer diameters of the distal tube body 100 and the proximal tube body 200 are 5F or 6F (3F = 1 mm).

[0053] In some alternative embodiments, as Figure 3 shown, the tube wall of the proximal tube body 200 is a multi-layer composite structure. The proximal tube body 200 is provided with only one lumen, and the lumen is arranged through along the length direction of the proximal tube body 200. The tube wall of the proximal tube body 200 includes an inner layer 201 and an outer layer 202. Both the inner layer 201 and the outer layer 202 are made of biocompatible polymer materials, such as some thermoplastic resins. A braided wire 203 is provided between the inner layer 201 and the outer layer 202. The braided wire 203 can be made of steel wire, which provides good strength and anti-bending property for the proximal tube body 200 and is beneficial for the proximal tube body 200 to maintain its shape.

[0054] In some alternative embodiments, such as Figure 3 shown, a coil spring 205 is provided in the cavity of the proximal tube body 200. The coil spring 205 is coated with a plastic tube 206. The coil spring 205 plays a role in supporting the proximal tube body 200, and the plastic tube 206 plays a role in isolating the coil spring 205.

[0055] In some alternative embodiments, the hardness of the proximal tube body 200 on the side close to the distal tube body 100 is lower than that on the side close to the push button 301, that is, the proximal tube body 200 adopts a multi-segment design with different tube body hardnesses. For example, both the inner layer 201 and the outer layer 202 on the side close to the push button 301 are made of PA (Polyamide), and both the inner layer 201 and the outer layer 202 on the side close to the distal tube body 100 are made of PEBAX (polyether block polyamide). The inner layer 201 and the outer layer 202 in the middle section can be cross-welded and transitioned by two materials, PA and PEBAX, to finally achieve the effect of gradually transitioning the hardness of the proximal tube body 200.

[0056] In some alternative embodiments, the distal tube body 100 adopts a multi-chamber design, such as Figure 3 shown, the distal tube body 100 adopts a double-chamber tube body structure, including a first cavity 101 and a second cavity 102. The inner diameter of the first cavity 101 can be smaller than or equal to the inner diameter of the second cavity 102. Both the first cavity 101 and the second cavity 102 are provided in a through manner along the length direction of the distal tube body 100. A traction wire 106 is provided in the first cavity 101, and a wire 105 is provided in the second cavity 102. Among them, with this structural arrangement, the traction wire 106 and the wire 105 are isolated through the first cavity 101 and the second cavity 102, preventing the wear of the insulating layer of the wire 105 caused by the pulling of the traction wire 106 when the distal tube body 100 bends, resulting in possible failure of the wire 105.

[0057] Among them, the bending shape of the distal tube body 100 is adjusted through the traction wire 106 to generate an axial compression force. A good support is formed by providing the coil spring 205 in the proximal tube body 200, which can effectively prevent the proximal tube body 200 from deforming due to insufficient support force; and the plastic tube 206 isolates the coil spring 205, preventing the wire 105 from directly rubbing against the coil spring 205, causing insulation failure or breakage of the wire 105.

[0058] In some alternative embodiments, the distal tube body 100 is designed such that the hardness of the forward tube gradually decreases from the side close to the proximal tube body 200. The distal tube body 100 is made of a biocompatible polymer material, such as some thermoplastic resins, preferably PEBAX.

[0059] As Figure 1 , Figure 2 , Figures 5 to 9 shown, the transition section connecting the distal tube body 100 and the proximal tube body 200 is made of a polymer material with a relatively high hardness. The connection between the distal tube body 100 and the proximal tube body 200 is configured to have a fixed angle ∠B and ∠B remains unchanged. The head end of the distal tube body 100 has an initial deflection angle ∠A, and ∠A and ∠B are not coplanar. The distal tube body 100 can be bent along the deflection angle direction, that is, the bending shape of the catheter is preset when the push button 301 is in the initial position; optionally, the angle between the plane where ∠A is located and the plane where ∠B is located is 45° to 90°. As preferably in this embodiment, in combination with Figure 5 and Figure 6 it can be seen that the plane where ∠A is located is perpendicular to the plane where ∠B is located.

[0060] Figure 1 and Figure 2 illustrate the three-dimensional view of the bending shape of the catheter in the initial state before the distal tube body 100 is bent. Figure 7 illustrates the three-dimensional view of the bending shape of the catheter after the distal tube body 100 is bent to the maximum deformation.

[0061] Figure 5 illustrates the projection view of the catheter in the plane where ∠B is located in the initial state before the distal tube body 100 is bent. Figure 8 illustrates the projection view of the catheter in the plane where ∠B is located after the distal tube body 100 is bent to the maximum deformation. The preset angle size of ∠B is 120° to 160°, and preferably 140° is adopted in this embodiment.

[0062] Figure 6 is Figure 5 the C-direction view in Figure 9 which illustrates the projection view of the catheter in the plane where ∠A is located in the initial state before the distal tube body 100 is bent. Figure 8 is Figure 5 the C-direction view in Figure 8 which illustrates the projection view of the catheter in the plane where ∠A is located after the distal tube body 100 is bent to the maximum deformation. Among them, the distal tube body 100 is preset with the maximum bending deformation angle ∠A′. Refer to Figure 6 and Figure 9One end of the proximal tube body 200 close to the distal tube body 100 to the end away from the distal tube body 100 inclines towards the inside of the computer screen; the initial angle size of ∠A is 15° to 55°, and 35° is preferably adopted in this embodiment.

[0063] In some alternative embodiments, such as Figures 5 to 9 shown, the push button 301 is connected to the traction wire 106, the traction wire 106 is connected to the head end of the distal tube body 100. When the push button 301 is pushed, the traction wire 106 is pulled to constrain the distal tube body 100 to bend according to a preset bending shape, and the bending angle of the distal tube body 100 is changed from ∠A to ∠A′. The maximum value of ∠A′ can reach 240°, or ∠A′ can be preset to a certain bending angle less than 240° according to requirements. Generally, the maximum value of ∠A′ adopts a certain bending angle in 210° to 240°; during the process of using the push button 301 to control the bending of the distal tube body 100, the angle of ∠B remains unchanged.

[0064] In some alternative embodiments, such as Figure 2 and Figure 3 shown, a plurality of electrodes are arranged at intervals along the length direction of the distal tube body 100. The electrodes are arranged on the proximal tube body 200. The outer diameter of the electrodes is 5F or 6F, which matches the outer diameters of the distal tube body 100 and the proximal tube body 200. The electrodes include a head electrode 103, a first ring electrode 104 and a second ring electrode 204. The length (along the axial direction of the distal tube body 100) of the head electrode 103 is 1 mm to 2 mm, and 1.5 mm is preferably adopted in this embodiment. The widths (along the axial direction of the distal tube body 100) of the first ring electrode 104 and the second ring electrode 204 are 0.5 mm to 2 mm, and 1 mm is preferably adopted in this embodiment.

[0065] In some alternative embodiments, such as Figure 2 and Figure 3As shown, the head electrode 103 is disposed at the head end of the distal tube body 100. One first ring electrode 104 or two to nine spaced-apart first ring electrodes 104 are provided on the distal tube body 100. The first ring electrode 104 is located between the head end of the distal tube body 100 and the proximal tube body 200. The first ring electrode 104 is embedded in the distal tube body 100. The first ring electrode 104 is used to record intracardiac electrophysiological waveforms in the coronary sinus or deliver pacing signals. The spacing between the electrodes on the distal tube body 100 is 1 mm to 10 mm. As a preferred technical solution of this embodiment, nine first ring electrodes 104 are provided on the distal tube body 100, that is, a total of ten electrodes are provided on the distal tube body 100. These ten electrodes can be evenly spaced or paired into five electrode pairs. For example, the spacing between the two electrodes in the electrode pair is 1 mm, and the spacing between adjacent electrode pairs is 10 mm.

[0066] In some alternative embodiments, as Figure 2 and Figure 3 shown, a second ring electrode 204 is provided on the proximal tube body 200. The second ring electrode 204 is embedded in the proximal tube body 200. The second ring electrode 204 is 70 mm to 160 mm away from the head end of the distal tube body 100. In this embodiment, 130 mm is preferably adopted. When the head electrode 103 and the first ring electrode 104 enter the coronary sinus with the distal tube body 100, the second ring electrode 204 is still in the inferior vena cava, and there is no electrophysiological signal in the inferior vena cava. When the electrodes in the coronary sinus perform unipolar mapping, using the second ring electrode 204 as a reference electrode can effectively filter out far-field electrophysiology and reduce electrophysiological signal interference.

[0067] In some alternative embodiments, as Figure 3 and Figure 4As shown, a plurality of magnetic positioning sensors are arranged at intervals along the length direction of the distal tube body 100, and the magnetic positioning sensors are arranged near the connection of the proximal tube body 200 and the distal tube body 100. The magnetic positioning sensors include a first magnetic positioning sensor 401, a second magnetic positioning sensor 403, and a third magnetic positioning sensor 402. Among them, the first magnetic positioning sensor 401 is provided at the head end of the distal tube body 100. The first magnetic positioning sensor 401 can be a 6D or 5D magnetic positioning sensor. When the first magnetic positioning sensor 401 is a 6D magnetic positioning sensor, the orientation and position of the catheter head end can be displayed in the cardiac electrophysiology three-dimensional mapping system. When the first magnetic positioning sensor 401 is a 5D magnetic positioning sensor, only the position of the catheter head end can be displayed in the cardiac electrophysiology three-dimensional mapping system. The second magnetic positioning sensor 403 is provided on the proximal tube body 200. The second magnetic positioning sensor 403 is close to the connection of the proximal tube body 200 and the distal tube body 100, that is, the second magnetic positioning sensor 403 is arranged at the position of the proximal tube body 200 behind ∠B. The third magnetic positioning sensor 402 is provided on the distal tube body 100. The third magnetic positioning sensor 402 is located between the first magnetic positioning sensor 401 and the second magnetic positioning sensor 403. As a preferred technical solution of this embodiment, the third magnetic positioning sensor 402 is arranged in the second cavity 102 and is located inside the ring of the first ring electrode 104 close to the proximal tube body 200.

[0068] Denote the first magnetic positioning sensor 401 as point M1, denote the third magnetic positioning sensor 402 as point M2, and denote the second magnetic positioning sensor 403 as point M3. The positions of M1, M2, and M3 in the cardiac electrophysiology three-dimensional mapping system are respectively recorded as P1(X1, Y1, Z1), P2(X2, Y2, Z2), and P3(X3, Y3, Z3). Since the tube body lengths between M1 and M2 and between M2 and M3 are fixed, when manipulating the catheter, the spatial distances P1 - P2 and P2 - P3 of the three points change, and the real-time shape of the catheter front-end area (including the distal tube body 100 and a part of the proximal tube body 200 adjacent thereto) can be indirectly calculated through integral conversion, and finally the position and shape of the catheter front-end area can be displayed in real time in the cardiac electrophysiology three-dimensional mapping system.

[0069] As Figure 3 shown, the wire 105 can be the wire of the magnetic positioning sensor or the wire of the electrode.

[0070] In this embodiment, with a preset fixed ∠B, the catheter enters the right atrium from the inferior vena cava. The distal end of the catheter is initially directed straight obliquely backward. Then, when adjusting the angle of the distal tube body 100, it enters the coronary sinus obliquely downward along the initial deflection angle ∠A. Then, pushing the catheter forward can make the catheter tip face forward along the coronary sinus towards the great cardiac vein until the distal tube body 100 reaches the maximum bending angle.

[0071] For the electrophysiological mapping catheter described in this embodiment, since the catheter is preset with a fixed ∠B and an initial deflection angle ∠A, ∠B directly meets the requirement for the catheter to bend obliquely backward, and ∠A guiding the bending direction also meets the requirement for the catheter to bend obliquely downward. Therefore, when adjusting the catheter's bend, the operator only needs to bend the distal tube body 100 along the deflection angle direction, greatly reducing the difficulty of operation, simplifying the operation steps, and reducing the learning cost of the operator. This catheter has a novel structure, is convenient to use, and has good effects.

[0072] For the electrophysiological mapping catheter described in this embodiment, through the provided magnetic positioning sensor, the position and shape of the distal end of the catheter can be real-time displayed in the cardiac electrophysiological three-dimensional mapping system, improving the surgical efficiency. During the entire electrophysiological surgery process, X-ray positioning can be used less or not at all, reducing the risk of harm to the operator and the patient.

[0073] For the electrophysiological mapping catheter described in this embodiment, by setting a single electrode (i.e., the second ring electrode 204) on the proximal tube body 200, which is located in the inferior vena cava during normal use, it can be used as a reference electrode when performing monopolar mapping on each electrode on the distal tube body 100, avoiding the influence of far-field electrophysiological signals on the monopolar mapping waveform. At the same time, due to the preset bend of the catheter, the electrodes on the catheter can be in good contact with the coronary sinus and are not likely to slip out.

[0074] Embodiment 2

[0075] For an electrophysiological mapping catheter as described in Embodiment 1, its usage process is as follows:

[0076] Step 1: Perform vascular puncture and place the electrophysiological mapping catheter at the position of the right atrium.

[0077] Step 2: With the assistance of the cardiac electrophysiological three-dimensional mapping system, use the electrophysiological mapping catheter to construct a three-dimensional model of the interior of the right atrium, and real-time display the position and shape of the catheter tip area in the cardiac electrophysiological three-dimensional mapping system through the positioning of the magnetic positioning sensor.

[0078] Step 3: Locate the coronary sinus ostium in the three-dimensional model of the right atrium.

[0079] Step 4: Manipulate the push button 301 on the handle 300 to adjust the bending angle of the distal tube body 100, and place all the electrodes on the distal tube body 100 into the coronary sinus with the assistance of the three-dimensional model.

[0080] Step 5: Continue with subsequent electrophysiological operations. Using the electrophysiological signals collected by the electrophysiological mapping catheter as a reference, the operator can collect the bipolar electrophysiological waveforms between the electrodes on the distal tube body 100 or separately collect the unipolar electrophysiological waveforms between each electrode on the distal tube body 100 and the second annular electrode 204 according to the actual situation.

[0081] The above are only the preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An electrophysiological mapping catheter, comprising a distal tube body (100) and a proximal tube body (200) connected to each other, characterized in that the connection between the distal tube body (100) and the proximal tube body (200) is configured to have an included angle ∠B and ∠B remains unchanged; the head end of the distal tube body (100) has an initial deflection angle ∠A, ∠A and ∠B are not coplanar, and the distal tube body (100) can be bent along the deflection direction.

2. The electrophysiological mapping catheter according to claim 1, wherein The plane where ∠A is located is perpendicular to the plane where ∠B is located.

3. The electrophysiological mapping catheter according to claim 1, characterized in that a plurality of magnetic positioning sensors are arranged at intervals along the length direction of the distal tube body (100); the magnetic positioning sensors are arranged on the proximal tube body (200) near the connection with the distal tube body (100).

4. The electrophysiological mapping catheter according to claim 3, wherein, The magnetic positioning sensors include a first magnetic positioning sensor (401), a second magnetic positioning sensor (403) and a third magnetic positioning sensor (402); the first magnetic positioning sensor (401) is provided at the head end of the distal tube body (100); the second magnetic positioning sensor (403) is provided on the proximal tube body (200), and the second magnetic positioning sensor (403) is close to the connection between the proximal tube body (200) and the distal tube body (100); the third magnetic positioning sensor (402) is provided on the distal tube body (100), and the third magnetic positioning sensor (402) is located between the first magnetic positioning sensor (401) and the second magnetic positioning sensor (403).

5. The electrophysiological mapping catheter according to claim 1, wherein A plurality of electrodes are arranged at intervals along the length direction of the distal tube body (100), and the electrodes are arranged on the proximal tube body (200).

6. The electrophysiological mapping catheter according to claim 5, wherein The electrodes include a head electrode (103), a first ring electrode (104) and a second ring electrode (204); the head electrode (103) is provided at the head end of the distal tube body (100); 1 first ring electrode (104) is provided on the distal tube body (100) or 2 to 9 spaced first ring electrodes (104) are provided, and the first ring electrode (104) is located between the head end of the distal tube body (100) and the proximal tube body (200); the second ring electrode (204) is provided on the proximal tube body (200).

7. The electrophysiological mapping catheter according to claim 1, wherein, The hardness of the proximal tube body (200) on the side close to the distal tube body (100) is lower than the hardness on the side far from the distal tube body (100).

8. The electrophysiological mapping catheter according to claim 1, wherein The tube wall of the proximal tube body (200) is a multi-layer composite structure.

9. The electrophysiological mapping catheter according to claim 1, wherein, The distal tube body (100) includes a first cavity (101) and a second cavity (102); the first cavity (101) is arranged through along the length direction of the distal tube body (100), and a traction wire (106) is arranged in the first cavity (101); the second cavity (102) is arranged through along the length direction of the distal tube body (100), and a wire (105) is arranged in the second cavity (102).

10. The electrophysiological mapping catheter according to any one of claims 1-9, characterized in that, The proximal tube body (200) is connected to the handle (300), and a push button (301) is provided on the handle (300). The push button (301) is used to control the bending of the distal tube body (100).

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