Multifunctional catheter for superior vena cava triggering focus mapping and phrenic nerve pacing

Abstract

The utility model relates to a multifunctional catheter for superior vena cava triggering focus mapping and phrenic nerve pace-making, which comprises a catheter body and a spiral electrode tip arranged at the far end of the catheter body, and a plurality of pace-making electrode groups are arranged on the spiral electrode tip. The catheter body and the spiral electrode tip are telescopically arranged in the sheath and can extend out of the open end of the sheath; the spiral electrode tip is in a contraction configuration in the sheath, and can be converted to an expansion configuration when extending out of the sheath and extending into a phrenic nerve pace-making area in the superior vena cava; the starting end of the spiral electrode tip is connected with a center mapping catheter coaxial with the catheter body, and a plurality of mapping electrode sets are arranged on the center mapping catheter. Compared with the prior art, the multifunctional catheter has the advantages that the spiral electrode tip can be stably attached to the inner wall of the superior vena cava, and the multifunctional catheter can be matched with a central mapping catheter to map a superior vena cava trigger range while playing a pace-making role.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical equipment technical field especially is related to a kind of multifunctional catheter for upper vena cava trigger focus mapping and phrenic nerve pacing. BACKGROUND

[0002] Atrial fibrillation (AF) is one of the most common tachyarrhythmias in clinical practice. In terms of AF treatment, the efficacy of catheter ablation for AF has been recognized by all, and pulmonary vein isolation is the cornerstone of catheter ablation for AF. Cryoballoon ablation (CBA) is a new ablation method that has emerged in recent years, and has become one of the standard methods for achieving pulmonary vein isolation.

[0003] Phrenic nerve injury is the most common complication of CBA, mainly occurring during the cryoablation of right pulmonary veins and superior vena cava. Anatomically, the right phrenic nerve runs between the right superior pulmonary vein and the superior vena cava. Therefore, it is important to monitor the phrenic nerve during cryoablation of the right pulmonary vein and superior vena cava to avoid injury. After phrenic nerve injury, some patients may have no symptoms, while others may experience dyspnea, shortness of breath after exercise, and other clinical manifestations. Currently, there is no effective treatment for phrenic nerve injury, and only follow-up observation is available. Intraoperative monitoring of phrenic nerve function (such as diaphragmatic muscle beat) can reduce the incidence of phrenic nerve injury to a very low level.

[0004] The most commonly used method for monitoring the phrenic nerve is pacing monitoring. By placing a pacing lead in the superior vena cava (the most commonly used site in clinical practice is the right subclavian vein level, which is the location of the phrenic nerve, and the pacing lead is stable and not easily displaced), applying maximum output energy and pulse width, and recommending 10-15 mA energy and 1500 ms interval during cryoablation of the right superior pulmonary vein and superior vena cava, the phrenic nerve function can be monitored by feeling the diaphragmatic muscle beat by pressing the patient's abdomen with fingers. During cryoablation, if the diaphragmatic muscle movement is weakened or disappeared, the cryoablation should be stopped immediately. Generally, the phrenic nerve function can recover after a few seconds to tens of minutes of cryoablation stop. Most patients recover during postoperative follow-up, and the rate of permanent phrenic nerve injury is extremely low.

[0005] Currently, the main method for monitoring the phrenic nerve in clinical practice is to place a fixed-bend bipolar catheter or an adjustable-bend decapolar catheter in the phrenic nerve running area of the superior vena cava, and to capture the phrenic nerve by high-energy output. In clinical practice, the pacing area of the phrenic nerve is usually small, or the pacing electrode catheter cannot be stably fixed in the pacing area, so the cryoablation often needs to be stopped repeatedly to adjust the position of the pacing catheter, resulting in low surgical efficiency.

[0006] In addition, pulmonary vein isolation is the cornerstone of catheter ablation for atrial fibrillation. However, ectopic foci originating outside the pulmonary veins can also trigger and maintain atrial fibrillation. The superior vena cava (SVC) is one of the most common origins of non-pulmonary vein triggers. In the clinical practice of atrial fibrillation cryoballoon ablation, doctors often need to pace the phrenic nerve through an adjustable bend decapole mapping electrode. If the patient has frequent atrial premature beats (atrial premature beats), atrial tachycardia (atrial tachycardia) or repeated atrial premature beats triggering atrial fibrillation during the operation, the possibility of SVC origin is considered in combination with the surface electrocardiogram. After completing the electrical isolation of the pulmonary vein, the ring mapping catheter is withdrawn from the left atrium to the right atrium, and then sent to the SVC. Therefore, the current SVC trigger mapping often requires the cooperation of an adjustable bend decapole catheter and a ring mapping catheter, which greatly reduces the operation efficiency.

[0007] Therefore, it is urgent to develop a multifunctional catheter that can measure the superior vena cava trigger and pace the phrenic nerve to solve the practical problems encountered in the above-mentioned clinical practice. Content of the utility model

[0008] The utility model discloses a multifunctional catheter for superior vena cava trigger mapping and phrenic nerve pacing to improve the operation efficiency by considering the superior vena cava trigger mapping and the phrenic nerve pacing in the atrial fibrillation cryoballoon ablation.

[0009] The utility model discloses a multifunctional catheter for superior vena cava trigger mapping and phrenic nerve pacing to improve the operation efficiency by considering the superior vena cava trigger mapping and the phrenic nerve pacing in the atrial fibrillation cryoballoon ablation.

[0010] A multifunctional catheter for superior vena cava trigger mapping and phrenic nerve pacing, comprising a catheter body and a spiral electrode head arranged at the distal end of the catheter body, a plurality of pacing electrode groups are arranged on the spiral electrode head.

[0011] The catheter body and the spiral electrode head are telescopically arranged in the sheath and can be extended out of the opening end of the sheath; the spiral electrode head is in a contracted configuration in the sheath and can be transformed into an expanded configuration when extended out of the sheath and into the phrenic nerve pacing area in the superior vena cava.

[0012] The starting end of the spiral electrode head is connected with a central mapping catheter coaxially arranged with the catheter body, and a plurality of mapping electrode groups are arranged on the central mapping catheter.

[0013] Further, the spiral electrode head comprises a first spiral zone and a second spiral zone with gradually increasing diameters.

[0014] Further, the starting end of the first spiral zone is the center of the spiral electrode head, and the first spiral zone spirally extends from the starting end to a diameter of 17 mm.

[0015] Further, the variable diameter range of the second spiral zone is 17-25 mm.

[0016] Further, two groups of pacing electrode groups are arranged on the first spiral region and the second spiral region.

[0017] Further, the spiral electrode head gradually increases in diameter from the starting end to the catheter body.

[0018] Further, the electrode groups on the spiral electrode head can be attached to the superior vena cava in the expanded configuration.

[0019] Further, each group of the pacing electrode groups comprises a positive electrode and a negative electrode, and a bipolar pacing loop is formed between the positive electrode and the negative electrode.

[0020] Further, the central mapping catheter comprises a catheter distal end and a catheter proximal end, and the connection between the catheter distal end and the catheter proximal end is the starting end of the spiral electrode head.

[0021] Further, the catheter distal end extends towards the superior vena cava.

[0022] Further, the catheter proximal end is integrally formed with the catheter body.

[0023] Further, the catheter distal end is distributed with two groups of mapping electrode groups, and the catheter proximal end is uniformly distributed with four groups of mapping electrode groups.

[0024] Further, the mapping electrode groups each comprise a positive electrode and a negative electrode, and the electrode spacing between the positive electrode and the negative electrode is 3-5 mm, and the spacing between adjacent mapping electrode groups is 8-12 mm.

[0025] Compared with the prior art, the utility model has the following beneficial effects:

[0026] (1) The utility model discloses a spiral electrode head and a central mapping catheter are combined together, which can make the spiral electrode head firmly attached to the inner wall of the superior vena cava, and the spiral electrode head can be used for pacing and mapping the superior vena cava trigger focus together with the central mapping catheter.

[0027] (2) The multifunctional catheter can be used for mapping the superior vena cava trigger focus and diaphragmatic nerve pacing in atrial fibrillation cryoballoon ablation, and two catheters are integrated, so that the operation efficiency is improved.

[0028] (3) The diameter of the spiral electrode head can be changed to adapt to the size of the superior vena cava, and when the pacing electrode group enters the superior vena cava, the inner diameter is gradually changed to completely attach to the superior vena cava, so that the pacing electrode can be stably attached to the inner wall of the superior vena cava, and the spiral design also helps the catheter to quickly position the diaphragmatic nerve pacing area.

[0029] (4) The helical electrode head of the utility model is connected with the center mapping catheter as a whole, can keep the position of the center mapping catheter relatively fixed while guaranteeing the helical electrode metal electrode and the superior vena cava to adhere to each other, so as to guarantee the mapping work of the center mapping catheter. BRIEF DESCRIPTION OF DRAWINGS

[0030] Figure 1 It is the structural schematic diagram of the utility model's multifunctional catheter.

[0031] Figure 2 It is the structural schematic diagram of the helical electrode head of the utility model embodiment 2.

[0032] Figure 3 It is the structural schematic diagram of the helical electrode head of the utility model embodiment 3.

[0033] Marking explanation in the drawing:

[0034] 1-catheter body;

[0035] 2-helical electrode head, 21-pace electrode group, 22-first helical area, 23-second helical area;

[0036] 3-sheath;

[0037] 4-center mapping catheter, 41-mapping electrode group, 42-catheter distal end, 43-catheter proximal end. DETAILED DESCRIPTION

[0038] The utility model will be explained in detail in combination with the drawings and specific embodiment. The embodiment is implemented under the premise of the technical scheme of the utility model, gives detailed implementation mode and specific operation process, but the protection scope of the utility model is not limited to the following embodiment.

[0039] In the utility model, it needs to be explained that, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the utility model and simplifying the description, and thus cannot be understood as limiting the utility model; the terms "first", "second", "third" are only for the purpose of description, and cannot be understood as indicating or implying relative importance; in addition, unless explicitly specified and limited, the terms "mounting", "connection" and "connection" should be understood broadly, for example, it can be fixed connection, or detachable connection, or integrally connected; it can be mechanical connection, or electrical connection; it can be direct connection, or indirect connection through an intermediate medium, or the communication between two elements. For ordinary skilled persons in the art, the specific meaning of the above terms in the utility model can be understood according to the specific circumstances.

[0040] It should be noted that: similar reference numbers and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0041] Embodiment 1:

[0042] A multifunctional catheter for superior vena cava trigger focus mapping and phrenic nerve pacing, comprising a catheter body 1 and a spiral electrode head 2 arranged at the distal end of the catheter body 1, a plurality of pacing electrode groups 21 for forming a pacing loop are arranged on the spiral electrode head. As shown in the figure, the catheter body 1 and the spiral electrode head 2 are telescopically arranged in the sheath 3 and can be stretched out of the opening end of the sheath 3. The spiral electrode head 2 is in a contracted configuration in the sheath 3, and when the spiral electrode head 2 is stretched out of the sheath 3 and into the phrenic nerve pacing area in the superior vena cava, it can be converted to an expanded configuration, so that the spiral electrode head 2 quickly locates the phrenic nerve pacing area, and the pacing electrode group 21 is stably attached to the inner wall of the superior vena cava. Figure 1

[0043] The starting end of the spiral electrode head 2 is connected with a center mapping catheter 4 coaxially arranged with the catheter body 1, and a plurality of mapping electrode groups 41 are arranged on the center mapping catheter 4, which can be used to measure the farthest muscle sleeve potential of the superior vena cava before ablation, whether there is potential inversion, shedding and other parameters before and after ablation, and record the electrical activity in the superior vena cava, and can be used for mapping the superior vena cava trigger focus mapping.

[0044] Embodiment 2:

[0045] ​A multi-functional catheter for mapping the trigger focus of superior vena cava and pacing diaphragm nerve comprises a catheter body 1 and a spiral electrode head 2 arranged at the distal end of the catheter body 1, and a plurality of pacing electrode groups 21 for forming a pacing loop are arranged on the spiral electrode head.

[0046] The difference between the embodiment 1 and the embodiment 2 is that, as shown in the figure, the spiral electrode head 2 of the embodiment 2 gradually increases in diameter from the starting end to the catheter body 1, so as to be as close as possible to the inner wall of the superior vena cava from the moment of entering the superior vena cava. Figure 2 The diameter of the superior vena cava is about 2cm at the proximal end, about 1.9-2.1cm at the middle segment, and about 1.7-1.9cm at the distal end. The starting end of the first spiral zone 22 is at the center of the spiral electrode head 2, and the first spiral zone 22 extends spirally from the starting end to a diameter of 17mm. The variable diameter of the second spiral zone 23 is 17-25mm. The diameter of the superior vena cava is about 2cm at the proximal end, about 1.9-2.1cm at the middle segment, and about 1.7-1.9cm at the distal end. The spiral electrode head 2 of the embodiment 2 is made of super-elastic material, and high-performance alloy materials such as Nitinol or MP35N can be selected.

[0047] Two pacing electrode groups 21 are arranged on the first spiral zone 22 and the second spiral zone 23 of the embodiment 2. Each pacing electrode group 21 comprises a positive electrode and a negative electrode, and a pacing loop is formed between the two electrodes.

[0048] Embodiment 3:

[0049] A multi-functional catheter for mapping the trigger focus of superior vena cava and pacing diaphragm nerve comprises a catheter body 1 and a spiral electrode head 2 arranged at the distal end of the catheter body 1, and a plurality of pacing electrode groups 21 for forming a pacing loop are arranged on the spiral electrode head.

[0050] The difference between the embodiment 1 and the embodiment 2 is that, as shown in the figure, the spiral electrode head 2 of the embodiment 2 gradually increases in diameter from the starting end to the catheter body 1, so as to be as close as possible to the inner wall of the superior vena cava from the moment of entering the superior vena cava. Figure 3 The pacing electrode groups 21 on the spiral electrode head 2 can be close to the superior vena cava in the expanded configuration, and the metal electrodes on the spiral electrode head 2 can be kept in close contact with the superior vena cava while the position of the spiral electrode head 2 can be kept relatively fixed when other catheters are operated in the superior vena cava.

[0051] Embodiment 4:

[0052] The utility model provides a multi-functional catheter for superior vena cava trigger focus mapping and phrenic nerve pacing, which comprises a catheter body 1 and a spiral electrode head 2 arranged at the distal end of the catheter body 1, and a plurality of pacing electrode groups 21 for forming a pacing loop are arranged on the spiral electrode head. The catheter body 1 and the spiral electrode head 2 are telescopically arranged in a sheath 3 and can be extended out of the open end of the sheath 3. The spiral electrode head 2 is in a contracted configuration in the sheath 3 and can be transformed into an expanded configuration when being extended out of the sheath 3 and into the phrenic nerve pacing area in the superior vena cava.

[0053] The starting end of the spiral electrode head 2 is connected with a central mapping catheter 4 coaxially arranged with the catheter body 1, and a plurality of mapping electrode groups 41 are arranged on the central mapping catheter 4 for measuring the distal muscle sleeve potential of the superior vena cava before ablation. The difference from the embodiment 1 is that the central mapping catheter 4 of the embodiment comprises a catheter distal end 42 and a catheter proximal end 43, and the connection between the catheter distal end 42 and the catheter proximal end 43 is the starting end of the spiral electrode head 2. The catheter distal end 42 extends in the direction of the superior vena cava, and the catheter proximal end 43 is integrally formed with the catheter body 1.

[0054] The catheter distal end 42 of the embodiment is provided with two groups of mapping electrode groups 41, and the catheter proximal end 43 is uniformly provided with four groups of mapping electrode groups 41. Each mapping electrode group 41 comprises a positive electrode and a negative electrode, the electrode spacing between the positive electrode and the negative electrode is 4 mm, and the spacing between adjacent mapping electrode groups 41 is 10 mm.

[0055] The mapping electrode groups 41 of the embodiment can help doctors to measure the distal muscle sleeve potential in the superior vena cava before ablation, whether there is potential inversion, shedding and other parameters before and after ablation, and are also used for recording the electrical activity in the superior vena cava. During the freezing process, the central electrode can record the impulse sequence originating from the sinoatrial node in real time, and if the excitation sequence changes, it indicates that there may be sinoatrial node function inhibition, thereby playing a warning and protection function for the sinoatrial node.

[0056] The above description of the embodiments is for the purpose of enabling a person of ordinary skill in the art to understand and use the utility model. Those skilled in the art can easily make various modifications to the embodiments and apply the general principles described herein to other embodiments without creative labor. Therefore, the utility model is not limited to the above embodiments, and any improvement and modification made by those skilled in the art without departing from the scope of the utility model should be within the protection scope of the utility model.

Claims

1. A multifunctional catheter for superior vena cava triggering foci mapping and phrenic nerve pacing, characterized in that, It includes a catheter body (1) and a spiral electrode head (2) located at the distal end of the catheter body (1), and the spiral electrode head is provided with multiple pacing electrode groups (21). The spiral electrode head (2) extends from its starting end toward the catheter body (1) and its diameter gradually increases; the spiral electrode head includes a first spiral region (22) and a second spiral region (23) with gradually increasing diameter; the starting end of the first spiral region (22) is the center of the spiral electrode head (2), the first spiral region (22) extends spirally from the starting end to a diameter of 17 mm, the variable diameter range of the second spiral region (23) is 17-25 mm, and two sets of electrode groups (21) are provided on both the first spiral region (22) and the second spiral region (23), and the electrode groups (21) on the spiral electrode head (2) can fit with the superior vena cava under the expansion configuration; The catheter body (1) and the spiral electrode head (2) are telescopically disposed within the sheath (3) and can extend out from the opening end of the sheath (3); the spiral electrode head (2) is in a contracted configuration within the sheath (3) and can change to an expanded configuration when it extends out from the sheath (3) and into the phrenic nerve pacing area in the superior vena cava. The starting end of the spiral electrode head (2) is connected to a central mapping catheter (4) coaxially arranged with the catheter body (1). The central mapping catheter (4) includes a distal end (42) and a proximal end (43). The connection between the distal end (42) and the proximal end (43) is the starting end of the spiral electrode head (2). The central mapping catheter (4) is provided with multiple sets of mapping electrode groups (41).

2. The multifunctional catheter for superior vena cava triggering foci mapping and phrenic nerve pacing according to claim 1, characterized in that, Each electrode group (21) includes a positive electrode and a negative electrode, which form a pacemaker loop.

3. The multifunctional catheter for superior vena cava triggering foci mapping and phrenic nerve pacing according to claim 1, characterized in that, The distal end (42) of the catheter extends toward the superior vena cava; The proximal end (43) of the catheter is integrally formed with the catheter body (1).

4. A multifunctional catheter for superior vena cava triggering foci mapping and phrenic nerve pacing according to claim 1, characterized in that, Each of the calibration electrode groups (41) includes a positive electrode and a negative electrode. The distance between the positive electrode and the negative electrode is 3-5 mm, and the distance between adjacent calibration electrode groups (41) is 8-12 mm.

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