Pulse ablation device and discharge control method of pulse ablation catheter

Abstract

The invention discloses a pulse ablation device and a discharge control method of a pulse ablation catheter, the pulse ablation device comprises the pulse ablation catheter and a controller, the pulse ablation catheter comprises a plurality of discharge units, the discharge units are used for issuing a pulse electric field, and the discharge units are divided into a plurality of discharge sequences; each discharge sequence comprises at least two discharge units; the controller is connected with the pulse ablation catheter and used for controlling the multiple discharge sequences in the pulse ablation catheter to sequentially emit the pulse electric fields according to a preset sequence. The pulse electric fields are sequentially distributed according to the preset sequence by controlling the discharge sequence, so that the discharge unit distributes the pulse electric fields in batches for ablation treatment instead of simultaneous discharge, stimulation to muscles of a patient is reduced, and a pulse electric field ablation operation can be performed by adopting local anesthesia.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a pulse ablation device and a discharge control method of a pulse ablation catheter. Background Art

[0002] At present, there are many multi-electrode pulsed electric field ablation catheters used for atrial fibrillation ablation treatment at home and abroad. These catheters use circumferentially arranged electrodes to achieve "one-shot" isolation of pulmonary veins. The so-called "one-shot" refers to an ablation method that can isolate a pulmonary vein with a single discharge treatment. During "one-shot" ablation, multiple electrodes on the catheter discharge simultaneously and output pulsed electric fields. Studies have found that when multiple electrodes output pulsed electric fields at the same time, the electric field distribution range is very wide. When achieving "one-shot" ablation, it will inevitably cause skeletal muscle stimulation, which is manifested as muscle tremors and rapid abdominal lifting during the discharge process. In order not to increase the pain of patients during treatment, general anesthesia is required for surgery. Based on a literature survey, it was found that Farapulse's multi-electrode petal catheter requires general anesthesia or deep sedation during the ablation process, and local anesthesia (i.e., local anesthesia) surgery cannot be achieved. There is often a shortage of doctors in the anesthesia department of hospitals. If every pulsed electric field ablation surgery for atrial fibrillation requires anesthesia by an anesthesiologist, it will greatly limit the promotion and application of this new technology. Summary of the invention

[0003] The present invention mainly solves the technical problem that the existing pulse electric field ablation treatment technology causes excessive muscle stimulation to the patient.

[0004] According to the first aspect, an embodiment provides a pulse ablation device, comprising:

[0005] A pulse ablation catheter, the pulse ablation catheter comprising a plurality of discharge units, the discharge units being used to emit a pulse electric field, the plurality of discharge units being divided into a plurality of discharge sequences, each discharge sequence comprising at least two of the discharge units;

[0006] The controller is connected to the pulse ablation catheter and is used to control the multiple discharge sequences in the pulse ablation catheter to release pulse electric fields in sequence according to a preset order.

[0007] In some embodiments, different discharge sequences include the same or different numbers of discharge cells.

[0008] In some embodiments, the pulse ablation device further comprises a stimulation intensity sensor, the stimulation intensity sensor is connected to the controller, and the stimulation intensity sensor comprises at least one of a blood pressure sensor, an electromyographic signal sensor, and a body surface acceleration sensor;

[0009] The controller is further configured to read the sensor data output by the stimulation intensity sensor at each preset time interval. If the sensor data increases, the number of discharge sequences is increased, and the number of discharge units included in some or all of the discharge sequences is decreased; if the sensor data decreases, the number of discharge sequences is decreased, and the number of discharge units included in some or all of the discharge sequences is increased.

[0010] In some embodiments, the controller is further configured to read the sensor data output by the stimulation intensity sensor at each preset time interval. If the sensor data increases, the amplitude and / or pulse width of the pulsed electric field emitted by the discharge unit is decreased; if the sensor data decreases, the amplitude and / or pulse width of the pulsed electric field emitted by the discharge unit is increased.

[0011] In some embodiments, if the discharge units are arranged circumferentially, the plurality of discharge sequences emit pulsed electric fields in the order of rotating one week circumferentially; if the discharge units are arranged linearly, the plurality of discharge sequences emit pulsed electric fields in the order from one end of the line to the other end of the line.

[0012] In some embodiments, there is at least one overlapping discharge unit between adjacent discharge sequences.

[0013] In some embodiments, the number of overlapping discharge units between two adjacent discharge sequences is less than the number of discharge units in each of the two discharge sequences.

[0014] In some embodiments, the number of discharge units included in each discharge sequence is the same, the number of overlapping discharge units between adjacent discharge sequences is the same, and the number of discharge sequences is determined by the following formula:

[0015]

[0016] where N sq represents the number of discharge sequences, PE represents the total number of discharge units, n represents the number of discharge units included in each discharge sequence, and 2 ≤ n < PE; m represents the number of overlapping discharge units between adjacent discharge sequences, and 0 ≤ m < n, represents rounding up.

[0017] In some embodiments, the controller is further configured to control the plurality of discharge sequences to cyclically emit pulsed electric fields multiple times.

[0018] In some embodiments, the amplitude of the pulsed electric field emitted by the discharge unit in the subsequent cycle is equal to or different from the amplitude of the pulsed electric field emitted by the discharge unit in the previous cycle.

[0019] In some embodiments, the plurality of discharge sequences cycle through the release of multiple pulsed electric fields for a number of cycles ranging from 4 to 8.

[0020] In some embodiments, the time interval between switching between discharge sequences does not exceed 0.5 ms.

[0021] In some embodiments, each of the discharge units includes at least two electrodes.

[0022] According to the second aspect, an embodiment provides a discharge control method for a pulse ablation catheter, wherein the pulse ablation catheter includes a plurality of discharge units, wherein the discharge units are used to emit a pulse electric field, and the discharge control method includes:

[0023] Dividing the plurality of discharge units into a plurality of discharge sequences, wherein each discharge sequence includes at least two of the discharge units;

[0024] The plurality of discharge sequences are controlled to release pulse electric fields in sequence according to a preset order.

[0025] In some embodiments, the discharge control method further includes: reading sensor data output by the stimulation intensity sensor at preset time intervals; if the sensor data increases, increasing the number of the discharge sequences and reducing the number of discharge units included in some or all of the discharge sequences; if the sensor data decreases, reducing the number of the discharge sequences and increasing the number of discharge units included in some or all of the discharge sequences; wherein the stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyography signal sensor and a body surface acceleration sensor.

[0026] In some embodiments, the discharge control method further includes: reading sensor data output by the stimulation intensity sensor at preset time intervals; if the sensor data increases, reducing the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit; if the sensor data decreases, increasing the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit.

[0027] In some embodiments, the controlling of the multiple discharge sequences to release pulsed electric fields in sequence according to a preset order includes: if the discharge units are arranged circumferentially, controlling the multiple discharge sequences to release pulsed electric fields in the order of one rotation along the circumferential direction; if the discharge units are arranged along a straight line, controlling the multiple discharge sequences to release pulsed electric fields in the order from one end of the straight line to the other end of the straight line.

[0028] According to the discharge control method of the pulse ablation device and the pulse ablation catheter of the above-mentioned embodiment, the multiple discharge units on the pulse ablation catheter are divided into multiple discharge sequences, and these discharge sequences are controlled to release pulse electric fields in sequence according to a preset order, so that the discharge units release pulse electric fields in batches for ablation treatment rather than discharging at the same time, thereby reducing the stimulation to the patient's muscles and making it possible to use local anesthesia for pulse electric field ablation surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a schematic structural diagram of a pulse ablation device according to an embodiment;

[0030] Figure 2 A schematic diagram of a linear catheter division sequence according to an embodiment;

[0031] Figure 3 is a side view of a balloon catheter according to an embodiment;

[0032] Figure 4 for Figure 3 The schematic diagram of the balloon catheter dividing the sequence when the number of overlapping discharge units between discharge sequences is the same;

[0033] Figure 5 for Figure 3 The schematic diagram of the balloon catheter shown is a schematic diagram of dividing the sequence when the number of overlapping discharge units between discharge sequences is different;

[0034] Figure 6 A side view of a basket catheter according to an embodiment;

[0035] Figure 7 for Figure 6 The schematic diagram of the basket catheter dividing the sequence when the number of overlapping discharge units between discharge sequences is the same;

[0036] Figure 8 for Figure 6 The schematic diagram of the basket catheter dividing the sequence when the number of overlapping discharge units between discharge sequences is different;

[0037] Fig. 9 for Figure 4 A comparison diagram of a discharge sequence of the discharge sequence shown and a discharge sequence of the conventional method;

[0038] Fig.10 is a schematic diagram of a discharge order of a discharge sequence in an embodiment;

[0039] Fig.11 is a schematic structural diagram of a pulse ablation device according to another embodiment;

[0040] Fig.12The present invention is a flow chart of a discharge control method of a pulse ablation catheter according to an embodiment. DETAILED DESCRIPTION

[0041] The present invention is further described in detail below by specific embodiments in conjunction with the accompanying drawings. Wherein similar elements in different embodiments adopt associated similar element numbers. In the following embodiments, many detailed descriptions are for making the present application better understood. However, those skilled in the art can easily recognize that some features can be omitted in different situations, or can be replaced by other elements, materials, methods. In some cases, some operations related to the present application are not shown or described in the specification, this is to avoid the core part of the present application being overwhelmed by too much description, and for those skilled in the art, it is not necessary to describe these related operations in detail, and they can fully understand the related operations according to the description in the specification and the general technical knowledge in the art.

[0042] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate manner to form various implementations. At the same time, the steps or actions in the method description can also be interchanged or adjusted in a manner that is obvious to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment and are not meant to be a required sequence, unless otherwise specified that a certain sequence must be followed.

[0043] The serial numbers of the components in this document, such as "first", "second", etc., are only used to distinguish the objects described and do not have any order or technical meaning. The "connection" and "coupling" mentioned in this application, unless otherwise specified, include direct and indirect connections (couplings).

[0044] In order to achieve local anesthesia in pulsed electric field ablation catheter surgery for atrial fibrillation (such as "one-shot" surgery), it is necessary to solve the problem of skeletal muscle stimulation when the multi-electrode catheter releases pulsed electric field energy. Some electroporation theories believe that increasing the voltage and shortening the pulse width to the nanosecond level can avoid skeletal muscle stimulation. However, nanosecond pulses often require a voltage of 2000V or even 3000V to cause sufficient transmural damage. Excessive voltage not only increases the risk of insulation failure but also increases the cost of equipment and catheters. In addition, nanosecond pulses have not been verified for clinical use and remain only in the theoretical and animal testing stage. Microsecond pulses are still the mainstream of current use. How to reduce skeletal muscle stimulation to achieve local anesthesia in microsecond pulse ablation is a problem to be solved.

[0045] The present invention minimizes the skeletal muscle stimulation caused by the pulse ablation process through special discharge control, while the ablation effect is not affected; when using microsecond pulses, the stimulation to the patient's skeletal muscles can also be reduced to achieve local anesthesia surgery. The pulse ablation device and the discharge control method of the pulse ablation catheter of the present invention can be used in "one-shot" ablation surgery or other pulse ablation surgery.

[0046] Please refer to Figure 1 The pulse ablation device in some embodiments of the present invention includes a pulse ablation catheter 100 and a controller 200, which are described below respectively.

[0047] like Figure 1 As shown, the pulse ablation catheter 100 includes a plurality of discharge units 110, and the discharge units 110 are used to emit pulse electric fields. The plurality of discharge units 110 are divided into a plurality of discharge sequences sq, and each discharge sequence sq includes at least two discharge units 110. The pulse ablation catheter 100 can be a linear catheter, a balloon catheter, a basket catheter, a trumpet-shaped catheter, etc., and the present invention does not limit the type of the pulse ablation catheter 100. The discharge unit 110 is a unit for emitting a pulse electric field on the pulse ablation catheter 100, and is usually an electrode group composed of a plurality of electrodes. In some embodiments, each discharge unit 110 includes at least two electrodes, wherein at least one electrode is configured as a ground, and at least one electrode is configured with a high voltage pulse. The number of discharge sequences and the number of discharge units included in each discharge sequence can be set according to actual needs.

[0048] The controller 200 is connected to the pulse ablation catheter 100, and is used to control the multiple discharge sequences in the pulse ablation catheter 100 to release the pulse electric field in sequence according to a preset order. Among them, the order of the discharge sequence to release the pulse electric field can be set arbitrarily. In order to ensure the effect of ablation, the controller 200 controls multiple discharge sequences to continuously release the pulse electric field, and the time interval for switching between two discharge sequences does not exceed 50ms, preferably does not exceed 0.5ms. The switch for switching between discharge sequences can be an IGBT, MOSFET or relay, etc. The controller 200 can be a central processing unit (CPU), a field programmable gate array (FPGA), etc., and can also be a micro control unit (MCU), a digital signal processor (DSP), etc. The controller 200 can be configured to be directly controlled by a hardware controller, or it can be configured to be controlled in combination with hardware and computer software programs.

[0049] The division of the discharge sequence and the order of discharge are described in detail below with reference to specific examples.

[0050] The number of discharge units included in different discharge sequences may be the same or different. For example, a pulse ablation catheter including 12 discharge units has its discharge units numbered in sequence from A to L, and the number of discharge sequences is 4. If the number of discharge units included in different discharge sequences is the same, then the first discharge sequence sq1 includes discharge units A, B, and C, the second discharge sequence sq2 includes discharge units D, E, and F, the third discharge sequence sq3 includes discharge units G, H, and I, and the fourth discharge sequence sq4 includes discharge units J, K, and L; if the number of discharge units included in different discharge sequences may be different, then one allocation scheme is: the first discharge sequence sq1 includes discharge units A, B, C, and D, the second discharge sequence sq2 includes discharge units E, F, and G, the third discharge sequence sq3 includes discharge units H and I, and the fourth discharge sequence sq4 includes discharge units J, K, and L.

[0051] In order to avoid gaps between ablation lesions of a discharge sequence, in some embodiments, there is at least one overlapping discharge unit between adjacent discharge sequences, and the number of overlapping discharge units between different discharge sequences may be the same or different. For the sake of convenience, the following takes the same number of discharge units included in different discharge sequences as an example, and uses some pulse ablation catheters to illustrate the sequence division method when there are overlapping discharge units between discharge sequences. The same applies when the number of discharge units included in different discharge sequences is different.

[0052] Please refer to Figure 2 , is a linear conduit, which includes 9 discharge units, numbered from A to I. If each discharge sequence is set to include 3 discharge units, and there is 1 overlapping discharge unit between the discharge sequences, it can be divided into 4 discharge sequences, such as Figure 2 As shown, the first discharge sequence sq1 includes discharge units A, B, and C, the second discharge sequence sq2 includes discharge units C, D, and E, the third discharge sequence sq3 includes discharge units E, F, and G, and the fourth discharge sequence sq4 includes discharge units G, H, and I. If each discharge sequence is set to include 3 discharge units, there is 1 overlapping discharge unit between some discharge sequences, and there are 2 overlapping discharge units between some discharge sequences, then it can be divided into 5 discharge sequences, such as Figure 2 As shown, the first discharge sequence sq1 includes discharge cells A, B, and C, the second discharge sequence sq2 includes discharge cells B, C, and D, the third discharge sequence sq3 includes discharge cells C, D, and E, the fourth discharge sequence sq4 includes discharge cells E, F, and G, and the fifth discharge sequence sq5 includes discharge cells G, H, and I.

[0053] Please refer to Figure 3 , which is a side view of a balloon catheter, and its distal end front view is as follows Figure 4 and Figure 5 As shown, it should be noted that “proximal” and “distal” are conventional terms in the field of medical devices. For devices such as balloon catheters, the “proximal” refers to the end close to the device operator, and the “distal” refers to the end away from the device operator. Figure 3 , Figure 4 and Figure 5 The balloon catheter shown has 12 discharge units 110, which are arranged in the circumferential direction and numbered A to L in sequence. Each discharge unit 110 includes two electrodes 111. The two electrodes 111 of discharge unit A are numbered A1 and A2, the two electrodes 111 of discharge unit B are numbered B1 and B2, the two electrodes 111 of discharge unit C are numbered C1 and C2, and so on. During discharge, the electrodes with the last digit of the number being 1 (A1, B1, etc.) are configured as ground, and the electrodes with the last digit of the number being 2 (A2, B2, etc.) are configured with high voltage pulses, and vice versa.

[0054] If each discharge sequence is set to include 3 discharge units, and there is one overlapping discharge unit between the discharge sequences, then it can be divided into 6 discharge sequences, such as Figure 4 As shown, the first discharge sequence sq1 includes discharge cells A, B, and C, the second discharge sequence sq2 includes discharge cells C, D, and E, the third discharge sequence sq3 includes discharge cells E, F, and G, the fourth discharge sequence sq4 includes discharge cells G, H, and I, the fifth discharge sequence sq5 includes discharge cells I, J, and K, and the sixth discharge sequence sq6 includes discharge cells K, L, and A. If each discharge sequence is set to include 3 discharge cells, there is 1 overlapping discharge cell between some discharge sequences, and there are 2 overlapping discharge cells between some discharge sequences, then it can be divided into 5 discharge sequences, such as Figure 5 As shown, the first discharge sequence sq1 includes discharge cells A, B, C, and D, the second discharge sequence sq2 includes discharge cells C, D, E, and F, the third discharge sequence sq3 includes discharge cells F, G, H, and I, the fourth discharge sequence sq4 includes discharge cells H, I, J, and K, and the fifth discharge sequence sq5 includes discharge cells J, K, L, and A.

[0055] Please refer to Figure 6 , is a side view of a basket catheter, which has 8 discharge units 110 arranged along the circumferential direction and numbered from A to H in sequence, and each discharge unit 110 includes three electrodes 111. Figure 6 The distal end of the basket catheter is shown in front view. Figure 7 and Figure 8 As shown, only two electrodes of each discharge unit are shown. During discharge, one of the electrodes is configured as ground, and the other electrodes are configured with high voltage pulses.

[0056] If each discharge sequence includes 4 discharge units and there are 2 overlapping discharge units between the discharge sequences, then it can be divided into 4 discharge sequences. As shown in Figure 7 Figure 2, the first discharge sequence sq1 includes discharge units A, B, C, D, the second discharge sequence sq2 includes discharge units C, D, E, F, the third discharge sequence sq3 includes discharge units E, F, G, H, and the fourth discharge sequence sq4 includes discharge units G, H, A, B. If each discharge sequence includes 4 discharge units and there is 1 overlapping discharge unit between some of the discharge sequences and 2 overlapping discharge units between some other discharge sequences, then it can be divided into 3 discharge sequences. As shown in Figure 8 Figure 3, the first discharge sequence sq1 includes discharge units A, B, C, D, the second discharge sequence sq2 includes discharge units D, E, F, G, and the third discharge sequence sq3 includes discharge units G, H, A, B.

[0057] In some embodiments, in order to avoid repetition of the discharge sequences, the number of overlapping discharge units between two adjacent discharge sequences is less than the number of discharge units in each of these two discharge sequences. Specifically, when the number of discharge units included in different discharge sequences is the same, let the number of discharge units included in each discharge sequence be N c , then the number of overlapping discharge units between two adjacent discharge sequences should be less than N c ; when the number of discharge units included in different discharge sequences is different, assume that for two adjacent discharge sequences, their numbers of discharge units are N 1 and N 2 , then the number of overlapping discharge units between these two discharge sequences should be less than both N 1 and N 2 .

[0058] When the number of discharge units included in each discharge sequence is the same and the number of overlapping discharge units between adjacent discharge sequences is the same, the number of discharge sequences is determined by the following formula:

[0059]

[0060] where N sq represents the number of discharge sequences, PE represents the total number of discharge units in the pulsed ablation catheter, n represents the number of discharge units included in each discharge sequence, 2 ≤ n < PE, m represents the number of overlapping discharge units between adjacent discharge sequences, 0 ≤ m < n, represents rounding up. Among them, when there are no overlapping discharge units between adjacent discharge sequences, m = 0; when there are overlapping discharge units between adjacent discharge sequences, 1 ≤ m < n.

[0061] For example, for Figure 4 The division method of the discharge sequence of the balloon catheter shown in the figure can calculate the number of discharge sequences as follows:

[0062]

[0063] for Figure 7 The division method of the discharge sequence of the basket catheter shown in the figure can calculate the number of discharge sequences as follows:

[0064]

[0065] In some embodiments, if the discharge units are arranged along the circumferential direction, the multiple discharge sequences emit pulse electric fields in the order of one rotation along the circumferential direction; if the discharge units are arranged along a straight line, the multiple discharge sequences emit pulse electric fields in the order from one end of the straight line to the other end of the straight line.

[0066] For example Figure 4 The balloon catheter shown in the figure, the conventional method is to make 12 discharge units emit pulse electric field simultaneously, while in one embodiment of the present invention, each discharge sequence is made to emit pulse electric field in sequence from sq1 to sq6, as shown in FIG. Fig. 9 As shown. This batch discharge method reduces the stimulation to the muscles. Figure 4 The balloon catheter shown is divided into 12 discharge sequences in the manner that each discharge sequence includes 2 discharge units, and there is an overlapping discharge unit between adjacent discharge units. The first discharge sequence sq1 includes discharge units A and B, the second discharge sequence sq2 includes discharge units B and C, the third discharge sequence sq3 includes discharge units C and D, and so on. Each discharge sequence can be made to emit pulse electric fields in sequence from sq1 to sq12, as shown in FIG. Fig.10 Of course, the discharge sequence as the starting point can also be any other discharge sequence except sq1. For example, taking sq2 as the starting point, Figure 4 The pulse electric field can be released in sequence in the order of sq2, sq3, sq4, sq5, sq6, and sq1.

[0067] For Figure 2 For the linear catheter shown in the figure, when the number of overlapping discharge units is the same, each discharge sequence can emit a pulse electric field in sequence from sq1 to sq4 or from sq4 to sq1; when the number of overlapping discharge units is different, each discharge sequence can emit a pulse electric field in sequence from sq1 to sq5 or from sq5 to sq1.

[0068] In some embodiments, the discharge sequence may also discharge the pulsed electric field in any other order. Figure 4The balloon catheter shown can release pulse electric fields in each discharge sequence in the order of sq3, sq6, sq2, sq5, sq1, and sq4. Figure 2 For the linear catheter shown, when the number of overlapping discharge units is the same, each discharge sequence can emit a pulse electric field in sequence in the order of sq3, sq1, sq2, and sq4; when the number of overlapping discharge units is different, each discharge sequence can emit a pulse electric field in sequence in the order of sq3, sq4, sq2, sq5, and sq1, and so on.

[0069] In some embodiments, the controller 200 is further used to control multiple discharge sequences to cycle and release multiple pulse electric fields. Each discharge sequence sequentially releases a pulse electric field once to complete a cycle, for example Figure 4 In the embodiment, each discharge sequence is sequentially made to release a pulse electric field in the order from sq1 to sq6, which is a cycle. Subsequently, each discharge sequence can be sequentially made to release a pulse electric field in the order from sq1 to sq6 to achieve multiple cycles. The number of cycles of multiple discharge sequences releasing multiple pulse electric fields can be set according to actual needs, preferably 4 to 8.

[0070] In some embodiments, the amplitude of the pulsed electric field emitted by the discharge unit in the next cycle is equal to or different from the amplitude of the pulsed electric field emitted by the discharge unit in the previous cycle. Specifically, the amplitude of the pulsed electric field emitted by the discharge unit from the first cycle to the last cycle may remain unchanged, or may show an overall increasing or decreasing trend, or the amplitude of the pulsed electric field emitted partly is greater than the amplitude of the pulsed electric field emitted last time, and the amplitude of the pulsed electric field emitted partly is less than the amplitude of the pulsed electric field emitted last time. In order to enhance the ablation depth and improve the treatment effect, the amplitude of the pulsed electric field emitted by the discharge unit in the next cycle may be equal to or greater than the amplitude of the pulsed electric field emitted by the discharge unit in the previous cycle.

[0071] In some embodiments, the increase or decrease of the pulse electric field amplitude can be determined based on the feedback of the patient's muscle stimulation degree. For example, the muscle stimulation degree is detected by a stimulation intensity sensor. When the sensor data output by the stimulation intensity sensor is too large (for example, greater than a set threshold), the amplitude of the pulse electric field emitted by the discharge unit in the next cycle is reduced; when the sensor data output by the stimulation intensity sensor is still within an appropriate range (for example, less than or equal to a set threshold), the amplitude of the pulse electric field emitted by the discharge unit in the next cycle can be increased to enhance the ablation depth. See below for an introduction to the stimulation intensity sensor.

[0072] Please refer to Fig.11The pulse ablation device in some embodiments of the present invention further includes a stimulation intensity sensor 300, which is connected to the controller 200 and is used to detect physiological parameters representing the muscle stimulation intensity of the patient and send the parameters to the controller 200. The stimulation intensity sensor 300 includes at least one of a blood pressure sensor, an electromyographic signal sensor, and a body surface acceleration sensor.

[0073] In some embodiments, the controller 200 is further configured to read the sensor data output by the stimulation intensity sensor 300 at preset time intervals. If the sensor data increases, the number of discharge sequences is increased, and the number of discharge units included in some or all discharge sequences is reduced. In some embodiments, if the sensor data decreases, the number of discharge sequences is reduced, and the number of discharge units included in some or all discharge sequences is increased. It can be understood that in the stimulation intensity sensor 300, the sensor data output by the blood pressure sensor is the patient's blood pressure, the sensor data output by the electromyographic signal sensor is the electromyographic signal of the patient's muscles, and the sensor data output by the body surface acceleration sensor is the acceleration of the patient's body surface movement (such as lifting the abdomen).

[0074] by Figure 4 For example, if the sensor data increases, the number of discharge sequences can be increased to 12, and the number of discharge units included in all discharge sequences can be reduced to 2, and the result is Fig.10There are 12 discharge sequences listed in ; it is also possible to only increase the number of discharge sequences to 9 and reduce the number of discharge cells included in some discharge sequences to 2. Then one way of division is: the first discharge sequence sq1 includes discharge cells A, B, and C, the second discharge sequence sq2 includes discharge cells C, D, and E, the third discharge sequence sq3 includes discharge cells E, F, and G, the fourth discharge sequence sq4 includes discharge cells G and H, the fifth discharge sequence sq5 includes discharge cells H and I, the sixth discharge sequence sq6 includes discharge cells I and J, the seventh discharge sequence sq7 includes discharge cells J and K, the eighth discharge sequence sq8 includes discharge cells K and L, and the ninth discharge sequence sq9 includes discharge cells L and A. If the sensor data decreases, the number of discharge sequences can be reduced to 4, and the number of discharge units included in all discharge sequences can be increased to 4, wherein the first discharge sequence sq1 includes discharge units A, B, C, and D, the second discharge sequence sq2 includes discharge units D, E, F, and G, the third discharge sequence sq3 includes discharge units G, H, I, and J, and the fourth discharge sequence sq4 includes discharge units J, K, L, and A; or only the number of discharge sequences can be reduced to 5, and the number of discharge units included in some discharge sequences can be increased to 4, then one division method is: the first discharge sequence sq1 includes discharge units A, B, and C, the second discharge sequence sq2 includes discharge units C, D, E, and F, the third discharge sequence sq3 includes discharge units F, G, and H, the fourth discharge sequence sq4 includes discharge units H, I, and J, and the fifth discharge sequence sq5 includes discharge units J, K, L, and A.

[0075] Among them, a change threshold can be set in advance. If the difference between the sensor data read at the current moment and the sensor data read at the previous moment is less than 0 and the absolute value is greater than the change threshold, it is considered that the sensor data has decreased; if the difference between the sensor data read at the current moment and the sensor data read at the previous moment is greater than 0 and the absolute value is greater than the change threshold, it is considered that the sensor data has increased.

[0076] In this embodiment, when the sensor data increases, it means that the stimulation intensity increases. By increasing the number of discharge sequences and reducing the number of discharge units included in some or all discharge sequences, the intensity of the pulse electric field during each discharge can be reduced, thereby reducing muscle stimulation. When the sensor data decreases, the number of discharge sequences can be appropriately reduced, and the number of discharge units included in some or all discharge sequences can be increased, thereby saving surgical time.

[0077] In some embodiments, the controller 200 is also used to read the sensor data output by the stimulation intensity sensor 300 at preset time intervals. If the sensor data increases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit is reduced; in some embodiments, if the sensor data decreases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit is increased.

[0078] In this embodiment, when the sensor data increases, the intensity of the pulse electric field during each discharge can be reduced by reducing the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit, thereby reducing muscle stimulation; when the sensor data decreases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit can be appropriately increased to ensure the treatment effect and save surgical time.

[0079] Based on the above-mentioned pulse ablation device, the present invention also provides a discharge control method of a pulse ablation catheter, which can be executed by the controller 200. Fig.12 In one embodiment, the method includes steps 10 to 20.

[0080] Step 10: Divide the multiple discharge units of the pulse ablation catheter into multiple discharge sequences, wherein each discharge sequence includes at least two discharge units.

[0081] The number of discharge cells included in different discharge sequences may be the same or different. In some embodiments, there is at least one overlapping discharge cell between adjacent discharge sequences. In some embodiments, in order to avoid duplication of discharge sequences, the number of overlapping discharge cells between two adjacent discharge sequences is less than the number of discharge cells in each of the two discharge sequences. For the specific division method of the discharge sequence, please refer to the relevant description above, which will not be repeated here.

[0082] Step 20: Control multiple discharge sequences to release pulse electric fields in a preset order.

[0083] The order of the discharge sequence to release the pulse electric field can be set arbitrarily. In some embodiments, if the discharge units are arranged along the circumferential direction, the multiple discharge sequences release the pulse electric field in the order of rotating one circle along the circumferential direction; if the discharge units are arranged along a straight line, the multiple discharge sequences release the pulse electric field in the order from one end of the straight line to the other end of the straight line. Please refer to the above description for the specific discharge sequence, which will not be repeated here.

[0084] In some embodiments, the discharge control method of the present invention further includes: controlling multiple discharge sequences to cycle to release multiple pulse electric fields. The number of cycles of multiple discharge sequences to cycle to release multiple pulse electric fields can be set according to actual needs, preferably 4 to 8. In some embodiments, the amplitude of the pulse electric field released by the discharge unit in the latter cycle is equal to or different from the amplitude of the pulse electric field released by the discharge unit in the previous cycle. For details, please refer to the relevant description above, which will not be repeated here.

[0085] In some embodiments, the discharge control method of the present invention further includes: reading sensor data output by the stimulation intensity sensor at preset time intervals, and if the sensor data increases, increasing the number of discharge sequences and reducing the number of discharge units included in some or all discharge sequences; in some embodiments, if the sensor data decreases, reducing the number of discharge sequences and increasing the number of discharge units included in some or all discharge sequences. For details, please refer to the above related descriptions, which will not be repeated here.

[0086] In some embodiments, the discharge control method of the present invention further includes: reading the sensor data output by the stimulation intensity sensor at preset time intervals, and if the sensor data increases, reducing the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit; in some embodiments, if the sensor data decreases, increasing the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit.

[0087] Applicant adopts Figure 4 The balloon catheter and the corresponding sequence division method shown in the figure were used to test the effect of the pulse ablation device and discharge control method of the present invention. First, an in vitro potato test was conducted and compared with the traditional method. The test used a biphasic pulse waveform with a voltage of 800V and a sample size of 24. The sample mean and sample standard deviation of the ablation depth are shown in Table 1.

[0088] Table 1 Comparison of effectiveness of the pulse ablation device and discharge control method of the present invention with the traditional method

[0089] Ablation mode Traditional methods The present invention Sample mean of ablation depth (mm) 5.52 5.90 Sample standard deviation of ablation depth 1.06 0.88

[0090] Conduct hypothesis test on the test results. The overall variance of this test is σ 2 Unknown, use t test, consider the significance level α = 0.02, and conduct t test on sample mean μ. Establish hypothesis: H0: μ 顺 =μ 同 , H1: μ 顺 ≠μ 同 , μ 0 =0, where μ 顺 represents the overall mean ablation depth when the pulse ablation device and discharge control method of the present invention are used, μ 同represents the overall mean ablation depth when using the traditional method, μ 0 represents the difference in the mean ablation depth of the two populations. Then reject H0, otherwise accept H0, where S is the mean of the difference between the two groups of samples. * is the sample standard deviation, n 0 is the sample size, t 1-α / 2 (n 0 -1)=2.4999.

[0091] The final calculation is Therefore, H0 is accepted, that is, it is believed that the damage depth of the pulse ablation device and discharge control method of the present invention is the same as the damage depth of the traditional method, that is, the effectiveness is the same.

[0092] Secondly, an ablation experiment was conducted in animals. Three anatomical positions of the test pigs were selected for the experiment, that is, the balloon catheter was placed in the superior vena cava, right atrial appendage and right superior pulmonary vein of the test pigs for ablation, and the ablation sample size was 8. The surface accelerometer was fixed on the abdomen of the test pigs, and the acceleration data of the Z-axis (perpendicular to the axis of the operating table) of the test pigs during ablation using the traditional method and the pulse ablation device and discharge control method of the present invention were recorded as shown in Table 2 (where g represents the acceleration of gravity).

[0093] Table 2 Comparison of stimulation intensity between the pulse ablation device and discharge control method of the present invention and the conventional method

[0094] Ablation Mode Traditional methods The present invention Superior vena cava 2.25±0.07g 0.38±0.04g right atrial appendage 2.15±0.05g 0.44±0.08g Right superior pulmonary vein 1.12±0.16g 0.44±0.21g

[0095] When the acceleration is less than 0.5g, it means that there is no obvious visible muscle contraction phenomenon (reference: Dong Shoulong, Experimental and Mechanism Study on Irreversible Electroporation and Ablation of Tumors by High-Frequency Bipolar Microsecond Pulse Electric Field). It can be seen that the pulse ablation device and discharge control method of the present invention have much lower muscle stimulation than traditional methods, and the stimulation intensity is very small.

[0096] In summary, the pulse ablation device and discharge control method of the present invention are as effective as the traditional method in ablation, but the stimulation to the muscles is greatly reduced.

[0097] The discharge control method of the pulse ablation device and the pulse ablation catheter provided in the embodiments of the present invention divides the multiple discharge units on the pulse ablation catheter into multiple discharge sequences, and controls these discharge sequences to release pulse electric fields in sequence according to a preset order, so that the discharge units release pulse electric fields in batches for ablation treatment rather than discharging at the same time. While ensuring the ablation treatment effect, the stimulation to the patient's muscles is greatly reduced, so that local anesthesia can be used for pulse electric field ablation surgery.

[0098] Those skilled in the art will appreciate that all or part of the functions of the various methods in the above-mentioned embodiments can be implemented by hardware or by computer programs. When all or part of the functions in the above-mentioned embodiments are implemented by computer programs, the program can be stored in a computer-readable storage medium, and the storage medium can include: read-only memory, random access memory, disk, optical disk, hard disk, etc., and the program is executed by a computer to implement the above-mentioned functions. For example, the program is stored in the memory of the device, and when the program in the memory is executed by the processor, all or part of the above-mentioned functions can be implemented. In addition, when all or part of the functions in the above-mentioned embodiments are implemented by computer programs, the program can also be stored in a storage medium such as a server, another computer, disk, optical disk, flash disk or mobile hard disk, and can be downloaded or copied and saved in the memory of the local device, or the system of the local device is updated, and when the program in the memory is executed by the processor, all or part of the functions in the above-mentioned embodiments can be implemented.

[0099] The above specific examples are used to illustrate the present invention, which is only used to help understand the present invention and is not intended to limit the present invention. For those skilled in the art, according to the concept of the present invention, some simple deductions, modifications or substitutions can be made.

Claims

1. A pulse ablation device, characterized in that: include: A pulse ablation catheter, the pulse ablation catheter comprising a plurality of discharge units, the discharge units being used to emit a pulse electric field, the plurality of discharge units being divided into a plurality of discharge sequences, each discharge sequence comprising at least two of the discharge units; The controller is connected to the pulse ablation catheter and is used to control the multiple discharge sequences in the pulse ablation catheter to release pulse electric fields in sequence according to a preset order.

2. The pulse ablation device according to claim 1, characterized in that: Different discharge sequences may include the same or different numbers of discharge cells.

3. The pulse ablation device according to claim 1 or 2, characterized in that: Also includes a stimulation intensity sensor, the stimulation intensity sensor is connected to the controller, and the stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyographic signal sensor, and a body surface acceleration sensor; The controller is also used to read the sensor data output by the stimulation intensity sensor at preset time intervals. If the sensor data increases, the number of discharge sequences is increased, and the number of discharge units included in some or all of the discharge sequences is reduced; if the sensor data decreases, the number of discharge sequences is reduced, and the number of discharge units included in some or all of the discharge sequences is increased.

4. The pulse ablation device according to claim 1 or 2, characterized in that: Also includes a stimulation intensity sensor, the stimulation intensity sensor is connected to the controller, and the stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyographic signal sensor, and a body surface acceleration sensor; The controller is also used to read the sensor data output by the stimulation intensity sensor at preset time intervals. If the sensor data increases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit is reduced; if the sensor data decreases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit is increased.

5. The pulse ablation device according to any one of claims 1 to 4, characterized in that: If the discharge units are arranged along the circumferential direction, the plurality of discharge sequences emit pulse electric fields in the order of rotating one circle along the circumferential direction; If the discharge units are arranged along a straight line, the plurality of discharge sequences emit pulse electric fields in sequence from one end of the straight line to the other end of the straight line.

6. The pulse ablation device according to any one of claims 1 to 5, characterized in that: There is at least one overlapping discharge cell between adjacent discharge sequences.

7. The pulse ablation device according to claim 6, characterized in that: The number of the discharge cells overlapped between two adjacent discharge sequences is less than the number of the discharge cells in each of the two discharge sequences.

8. The pulse ablation device according to any one of claims 1 to 7, characterized in that: Each of the discharge sequences includes the same number of discharge cells, and adjacent discharge sequences have the same number of overlapping discharge cells. The number of the discharge sequences is determined by the following formula: Where N sq represents the number of said discharge sequences, PE represents the total number of said discharge cells, n represents the number of discharge cells included in each said discharge sequence, and 2 ≤ n < PE; m represents the number of overlapping discharge cells between adjacent said discharge sequences, and 0 ≤ m < n, represents rounding up.

9. The pulse ablation device according to any one of claims 1 to 8, characterized in that: The controller is also used to control the multiple discharge sequences to cycle and release multiple pulse electric fields.

10. The pulse ablation device according to claim 9, characterized in that: The amplitude of the pulse electric field emitted by the discharge unit in the next cycle is equal to or different from the amplitude of the pulse electric field emitted by the discharge unit in the previous cycle.

11. The pulse ablation device according to claim 9 or 10, characterized in that: The number of cycles of the multiple discharge sequences for performing multiple pulse electric field discharges is 4 to 8.

12. The pulse ablation device according to claim 1, characterized in that: The time interval between switching between discharge sequences does not exceed 0.5ms.

13. The pulse ablation device according to claim 1, characterized in that: Each of the discharge cells includes at least two electrodes.

14. A discharge control method for a pulse ablation catheter, the pulse ablation catheter comprising a plurality of discharge units, the discharge units being used to emit a pulse electric field, characterized in that: The discharge control method comprises: Dividing the plurality of discharge units into a plurality of discharge sequences, wherein each discharge sequence includes at least two of the discharge units; The plurality of discharge sequences are controlled to release pulse electric fields in sequence according to a preset order.

15. The discharge control method according to claim 14, characterized in that: Also includes: The sensor data output by the stimulation intensity sensor is read at preset time intervals. If the sensor data increases, the number of the discharge sequences is increased, and the number of discharge units included in some or all of the discharge sequences is reduced; if the sensor data decreases, the number of the discharge sequences is reduced, and the number of discharge units included in some or all of the discharge sequences is increased; wherein the stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyography signal sensor, and a body surface acceleration sensor.

16. The discharge control method according to claim 14, characterized in that: Also includes: The sensor data output by the stimulation intensity sensor is read at preset time intervals. If the sensor data increases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit is reduced; if the sensor data decreases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit is increased; wherein the stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyography signal sensor and a body surface acceleration sensor.

17. The discharge control method according to any one of claims 14 to 16, characterized in that: The controlling the multiple discharge sequences to release the pulse electric field in sequence according to a preset order includes: if the discharge units are arranged along the circumferential direction, controlling the multiple discharge sequences to release the pulse electric field in the order of one rotation along the circumferential direction; if the discharge units are arranged along a straight line, controlling the multiple discharge sequences to release the pulse electric field in the order from one end of the straight line to the other end of the straight line.

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