Pulse ablation apparatus and discharge control method for pulse ablation catheter

Abstract

Provided are a pulse ablation apparatus and a discharge control method for a pulse ablation catheter, wherein the pulse ablation apparatus comprises the pulse ablation catheter and a controller. The pulse ablation catheter comprises a plurality of discharge units, and the discharge units are configured for delivering pulsed electric fields. The plurality of discharge units are divided into a plurality of discharge sequences, and each discharge sequence comprises at least two discharge units. The controller is connected to the pulse ablation catheter and is configured for controlling the plurality of discharge sequences in the pulse ablation catheter to sequentially deliver pulsed electric fields in a predetermined order. Since the pulsed electric fields are sequentially delivered in the predetermined order by controlling the discharge sequences, the discharge units deliver the pulsed electric fields in batches for an ablation therapy instead of discharging simultaneously, thereby reducing muscle stimulation in a patient and using local anesthesia to perform pulsed electric field ablation surgery.

Description

A pulse ablation device and a discharge control method for a pulse ablation catheter 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] Currently, several multi-electrode pulsed electric field ablation catheters are used for atrial fibrillation ablation treatment both domestically and internationally. These catheters utilize circumferentially arranged electrodes to achieve "one-shot" pulmonary vein isolation. "One-shot" refers to an ablation procedure that isolates a single pulmonary vein with a single discharge. During a one-shot ablation, multiple electrodes on the catheter discharge simultaneously, generating a pulsed electric field. Studies have found that the simultaneous output of pulsed electric fields by multiple electrodes creates a wide electric field distribution, inevitably causing skeletal muscle stimulation during one-shot ablation. This manifests as muscle tremors and rapid abdominal lift during the discharge process. To minimize patient pain, general anesthesia is required for the procedure. A literature review revealed that the Farapulse multi-electrode petal catheter requires general anesthesia or deep sedation during ablation, making it impossible to perform procedures under local anesthesia. Hospital anesthesiology departments are often short of physicians. If every pulsed electric field ablation procedure for atrial fibrillation requires general anesthesia, it would significantly limit the widespread adoption of this new technology.

[0003] Summary of the Invention

[0004] The present invention mainly solves the technical problem that the existing pulse electric field ablation treatment technology causes excessive muscle stimulation to the patient.

[0005] According to a first aspect, an embodiment provides a pulse ablation device, comprising:

[0006] A pulse ablation catheter, comprising a plurality of discharge units, each of which is configured to emit a pulsed electric field, wherein the plurality of discharge units are divided into a plurality of discharge sequences, each of which comprises at least two of the discharge units;

[0007] 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.

[0008] In some embodiments, different discharge sequences include the same or different numbers of discharge cells.

[0009] In some embodiments, the pulse ablation device further includes a stimulation intensity sensor, which is connected to the controller. The stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyogram signal sensor, and a body surface acceleration sensor;

[0010] The controller is further configured to read the sensor data output by the stimulation intensity sensor at every 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.

[0011] In some embodiments, the controller is further configured to read the sensor data output by the stimulation intensity sensor at every 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.

[0012] In some embodiments, if the discharge units are arranged circumferentially, the multiple discharge sequences emit pulsed electric fields in the order of rotating one week circumferentially; if the discharge units are arranged linearly, the multiple discharge sequences emit pulsed electric fields in the order from one end of the line to the other end of the line.

[0013] In some embodiments, there is at least one overlapping discharge unit between adjacent discharge sequences.

[0014] 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 these two discharge sequences.

[0015] 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:

[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 multiple discharge sequences to cyclically emit pulsed electric fields multiple times.

[0018] In some embodiments, 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.

[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 a 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 configured to emit a pulsed electric field. The discharge control method includes:

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

[0024] The plurality of discharge sequences are controlled to sequentially release pulse electric fields in 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 electromyographic 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 circumference; 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 pulse ablation catheter of the above-mentioned embodiment, by dividing the multiple discharge units on the pulse ablation catheter into multiple discharge sequences, 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] FIG1 is a schematic structural diagram of a pulse ablation device according to an embodiment;

[0030] FIG2 is a schematic diagram of a linear catheter division sequence according to an embodiment;

[0031] FIG3 is a side view of a balloon catheter according to an embodiment;

[0032] FIG4 is a schematic diagram of dividing the balloon catheter shown in FIG3 into sequences when the number of overlapping discharge units between discharge sequences is the same;

[0033] FIG5 is a schematic diagram of dividing the balloon catheter shown in FIG3 into sequences when the number of overlapping discharge units between discharge sequences is different;

[0034] FIG6 is a side view of a basket catheter according to an embodiment;

[0035] FIG7 is a schematic diagram of dividing the basket catheter shown in FIG6 into sequences when the number of overlapping discharge units between discharge sequences is the same;

[0036] FIG8 is a schematic diagram of dividing the basket catheter shown in FIG6 into sequences when the number of overlapping discharge units between discharge sequences is different;

[0037] FIG9 is a comparison diagram of a discharge sequence of the discharge sequence shown in FIG4 and a discharge sequence of a conventional method;

[0038] FIG10 is a schematic diagram of a discharge order of a discharge sequence in one embodiment;

[0039] FIG11 is a schematic structural diagram of a pulse ablation device according to another embodiment;

[0040] FIG12 is a flow chart of a discharge control method for a pulse ablation catheter according to an embodiment. DETAILED DESCRIPTION

[0041] The present invention will be further described in detail below by means of specific embodiments in conjunction with the accompanying drawings. Similar elements in different embodiments are numbered with associated similar elements. In the following embodiments, many detailed descriptions are provided to enable the present application to be better understood. However, those skilled in the art will readily appreciate that some of the features may be omitted in different circumstances, or may be replaced by other elements, materials, or 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 portion of the present application being overwhelmed by excessive descriptions, and for those skilled in the art, it is not necessary to describe these related operations in detail. They will fully understand the related operations based on 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 may be combined in any appropriate manner to form various embodiments. Furthermore, the steps or actions in the method description may be reordered or adjusted in a manner readily apparent to those skilled in the art. Therefore, the various sequences in the specification and drawings are provided solely for the purpose of clearly describing a particular embodiment and are not intended to be mandatory, unless otherwise specified.

[0043] The serial numbers assigned to components herein, such as "first," "second," etc., are used solely to distinguish the objects being described and do not convey any sequential or technical meaning. References to "connection" and "coupling" herein, unless otherwise specified, include both direct and indirect connections (couplings).

[0044] In order to achieve local anesthesia during pulsed electric field ablation catheter surgeries for atrial fibrillation (e.g., "one-shot" surgeries), the issue of skeletal muscle stimulation during the release of pulsed electric field energy by multi-electrode catheters must be addressed. Some electroporation theories suggest that increasing the voltage and shortening the pulse width to the nanosecond level can avoid skeletal muscle stimulation. However, nanosecond pulses often require voltages of 2000V or even 3000V to cause sufficient transmural damage. Excessively high voltages not only increase the risk of insulation failure but also increase the cost of equipment and catheters. In addition, nanosecond pulses have not yet been verified for clinical use and remain at the theoretical and animal testing stage. Microsecond pulses are still the mainstream of current use, and how to reduce skeletal muscle stimulation to achieve local anesthesia during microsecond pulse ablation remains an unresolved issue.

[0045] This invention uses specialized discharge control to minimize skeletal muscle stimulation during pulse ablation while maintaining the ablation effect. This also reduces skeletal muscle stimulation when using microsecond pulses, enabling local anesthesia. The pulse ablation device and discharge control method for the pulse ablation catheter of this invention can be used in "one-shot" ablation procedures or other pulse ablation procedures.

[0046] Please refer to FIG1 . 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] As shown in Figure 1, the pulse ablation catheter 100 includes a plurality of discharge units 110, which are used to emit pulsed 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. The present invention does not limit the type of the pulse ablation catheter 100. The discharge unit 110 is a unit on the pulse ablation catheter 100 that emits a pulsed electric field, and is generally 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 pulse electric fields in sequence according to a preset order. The order in which the discharge sequences release pulse electric fields can be set arbitrarily. In order to ensure the effect of ablation, the controller 200 controls the multiple discharge sequences to continuously release pulse electric fields, 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., or a micro controller 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 can be the same or different. For example, a pulsed ablation catheter includes 12 discharge units, and its discharge units are numbered sequentially from A to L. 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 can be different, 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] To avoid gaps between ablation lesions within a discharge sequence, in some embodiments, adjacent discharge sequences have at least one overlapping discharge unit. The number of overlapping discharge units between different discharge sequences can be the same or different. For ease of illustration, the following uses a pulse ablation catheter as an example to illustrate the sequence division method when there are overlapping discharge units between discharge sequences, assuming that the number of discharge units included in different discharge sequences is the same. The same principle applies when the number of discharge units included in different discharge sequences differs.

[0052] Please refer to Figure 2, which shows a linear conduit comprising nine discharge units, numbered A through I. If each discharge sequence consists of three discharge units, and there is one overlapping discharge unit between discharge sequences, four discharge sequences can be formed. As shown in Figure 2, 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 cells, there is one overlapping discharge cell between some discharge sequences, and there are two overlapping discharge cells between some discharge sequences, then it can be divided into 5 discharge sequences, as shown in Figure 2, where 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. Its distal end is shown in Figures 4 and 5. It should be noted that "proximal" and "distal" are conventional terms in the medical device field. For devices such as balloon catheters, the "proximal" end refers to the end closest to the device operator, and the "distal" end refers to the end away from the device operator. The balloon catheter shown in Figures 3, 4, and 5 has 12 discharge units 110, arranged circumferentially and numbered A to L. 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 a number ending in 1 (A1, B1, etc.) are configured as ground, and the electrodes with a number ending in 2 (A2, B2, etc.) are configured with a high-voltage pulse, and vice versa.

[0054] If each discharge sequence is set to include three discharge cells and there is one overlapping discharge cell between discharge sequences, then six discharge sequences can be divided. As shown in Figure 4, 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 three discharge cells, there is one overlapping discharge cell between some discharge sequences, and there are two overlapping discharge cells between some discharge sequences, then it can be divided into five discharge sequences, as shown in Figure 5. 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, which shows a side view of a basket catheter. It features eight discharge units 110, arranged circumferentially and numbered A through H. Each discharge unit 110 includes three electrodes 111. Figures 7 and 8 show the distal end of the basket catheter shown in Figure 6, with only two electrodes from each discharge unit shown. During discharge, one electrode serves as the ground, while the others receive a high-voltage pulse.

[0056] If each discharge sequence is set to include 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 FIG. 7, 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 is set to include 4 discharge units, there is 1 overlapping discharge unit between some of the discharge sequences, and there are 2 overlapping discharge units between some of the discharge sequences, then it can be divided into 3 discharge sequences. As shown in FIG. 8, 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 duplication of 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, the number of their discharge units is N1 and N2 respectively, then the number of overlapping discharge units between these two discharge sequences should be less than both N1 and N2.

[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] 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.

[0060] For example, for the division method of the discharge sequences of the balloon catheter shown in FIG. 4, the number of discharge sequences can be calculated as:

[0061] For the division method of the discharge sequence of the basket catheter shown in FIG7 , the number of discharge sequences can be calculated as follows:

[0062] In some embodiments, if the discharge units are arranged along the circumference, the multiple discharge sequences release the pulsed electric field in the order of one rotation along the circumference; if the discharge units are arranged along a straight line, the multiple discharge sequences release the pulsed electric field in the order from one end of the straight line to the other end of the straight line.

[0063] For example, the balloon catheter shown in Figure 4 uses a conventional method of having 12 discharge units simultaneously emit pulsed electric fields. However, in one embodiment of the present invention, each discharge sequence emits pulsed electric fields in sequence from sq1 to sq6, as shown in Figure 9. This batch discharge method reduces muscle stimulation. For another example, the balloon catheter shown in Figure 4 is divided into 12 discharge sequences in such a way that each discharge sequence includes two discharge units, and there is one 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. Then, each discharge sequence can be made to emit pulsed electric fields in sequence from sq1 to sq12, as shown in Figure 10. Of course, the discharge sequence as the starting point may also be any other discharge sequence except sq1. For example, if sq2 is the starting point, the pulse electric field may be released in sequence in the order of sq2, sq3, sq4, sq5, sq6, and sq1 in FIG4.

[0064] For the linear catheter shown in Figure 2, when the number of overlapping discharge units is the same, each discharge sequence can be made to emit a pulse electric field in sequence from sq1 to sq4 or from sq4 to sq1; when the number of overlapping discharge units can be different, each discharge sequence can be made to emit a pulse electric field in sequence from sq1 to sq5 or from sq5 to sq1.

[0065] In some embodiments, the discharge sequence can also be arranged in any other order to sequentially deliver pulsed electric fields. For example, the balloon catheter shown in FIG4 can have each discharge sequence sequentially deliver pulsed electric fields in the order of sq3, sq6, sq2, sq5, sq1, and sq4. For the linear catheter shown in FIG2 , when the number of overlapping discharge units is the same, each discharge sequence can be arranged sequentially to deliver pulsed electric fields in the order of sq3, sq1, sq2, and sq4. When the number of overlapping discharge units is different, each discharge sequence can be arranged sequentially to deliver pulsed electric fields in the order of sq3, sq4, sq2, sq5, and sq1, and so on.

[0066] In some embodiments, the controller 200 is further configured to control multiple discharge sequences to cycle through multiple pulsed electric fields. Each discharge sequence sequentially performs a pulsed electric field once to complete a cycle. For example, in FIG4 , each discharge sequence sequentially performs a pulsed electric field once in the order from sq1 to sq6, which constitutes a cycle. Subsequently, each discharge sequence can continue to sequentially perform pulsed electric fields in the order from sq1 to sq6 to achieve multiple cycles. The number of cycles in which multiple discharge sequences cycle through multiple pulsed electric fields can be set according to actual needs, preferably 4 to 8.

[0067] 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. Specifically, the amplitude of the pulsed electric field emitted by the discharge unit from the first cycle to the last cycle can remain unchanged, or show an overall trend of increasing or decreasing, or the amplitude of the pulsed electric field emitted some times is greater than the amplitude of the pulsed electric field emitted in the previous cycle, and the amplitude of the pulsed electric field emitted some times is less than the amplitude of the pulsed electric field emitted in the previous cycle. 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 subsequent cycle can be equal to or increased compared to the amplitude of the pulsed electric field emitted by the discharge unit in the previous cycle.

[0068] In some embodiments, the increase or decrease in the amplitude of the pulsed electric field can be determined based on feedback from the patient's muscle stimulation level. For example, the muscle stimulation level is detected by a stimulation intensity sensor. When the sensor data output by the stimulation intensity sensor is too large (e.g., greater than a set threshold), the amplitude of the pulsed 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 (e.g., less than or equal to the set threshold), the amplitude of the pulsed electric field emitted by the discharge unit in the next cycle can be increased to enhance the ablation depth. A detailed introduction to the stimulation intensity sensor is provided below.

[0069] Referring to FIG11 , the 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 configured to detect physiological parameters representing muscle stimulation intensity of the patient and transmit the detected 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.

[0070] In some embodiments, the controller 200 is further configured to read 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 will 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 surface acceleration sensor is the acceleration of the patient's surface movement (e.g., abdominal lifting).

[0071] Taking Figure 4 as an example, if the sensor data increases, the number of discharge sequences can be increased to 12, and the number of discharge cells included in all discharge sequences can be reduced to 2, resulting in the 12 discharge sequences listed in Figure 10. Alternatively, the number of discharge sequences can be increased to 9, and the number of discharge cells included in some discharge sequences can be reduced to 2. In this case, one division method 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 cells included in all discharge sequences can be increased to 4, where the first discharge sequence sq1 includes discharge cells A, B, C, and D, the second discharge sequence sq2 includes discharge cells D, E, F, and G, the third discharge sequence sq3 includes discharge cells G, H, I, and J, and the fourth discharge sequence sq4 includes discharge cells J, K, L, and A. Alternatively, only the number of discharge sequences can be reduced to 5, and the number of discharge cells included in some discharge sequences can be increased to 4. In this case, one division method is: the first discharge sequence sq1 includes discharge cells A, B, and C, the second discharge sequence sq2 includes discharge cells C, D, E, and F, the third discharge sequence sq3 includes discharge cells F, G, and H, the fourth discharge sequence sq4 includes discharge cells H, I, and J, and the fifth discharge sequence sq5 includes discharge cells J, K, L, and A.

[0072] 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.

[0073] In this embodiment, when the sensor data increases, it indicates 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.

[0074] 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.

[0075] In this embodiment, when the sensor data increases, the amplitude and / or pulse width of the pulse electric field emitted by the discharge unit can be reduced, so that the intensity of the pulse electric field during each discharge can be reduced, 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, so as to ensure the treatment effect and save operation time.

[0076] Based on the above-mentioned pulse ablation device, the present invention further provides a discharge control method for a pulse ablation catheter. The method can be executed by a controller 200. Please refer to FIG12 . In one embodiment, the method includes steps 10 to 20.

[0077] 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.

[0078] The number of discharge cells included in different discharge sequences can be the same or different. In some embodiments, adjacent discharge sequences have at least one overlapping discharge cell. In some embodiments, 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. The specific method for dividing discharge sequences is described above and will not be repeated here.

[0079] Step 20: Control multiple discharge sequences to release pulse electric fields in a preset order.

[0080] The order in which the discharge sequences deliver pulsed electric fields can be set arbitrarily. In some embodiments, if the discharge units are arranged circumferentially, the multiple discharge sequences deliver pulsed electric fields in the order of one rotation along the circumference. If the discharge units are arranged along a straight line, the multiple discharge sequences deliver pulsed electric fields in the order from one end of the line to the other end. For the specific discharge sequence, please refer to the relevant description above and will not be repeated here.

[0081] In some embodiments, the discharge control method of the present invention further includes controlling multiple discharge sequences to cycle through multiple pulsed electric fields. The number of cycles for cycling through multiple pulsed electric fields can be set based on actual needs, preferably ranging from 4 to 8. In some embodiments, the amplitude of the pulsed electric field emitted by the discharge unit during a subsequent cycle is equal to or different from the amplitude of the pulsed electric field emitted by the discharge unit during a previous cycle. For details, please refer to the relevant description above and will not be repeated here.

[0082] In some embodiments, the discharge control method of the present invention further includes: reading sensor data output by a stimulation intensity sensor at predetermined time intervals; if the sensor data increases, increasing the number of discharge sequences and reducing the number of discharge cells included in some or all discharge sequences; and in some embodiments, if the sensor data decreases, reducing the number of discharge sequences and increasing the number of discharge cells included in some or all discharge sequences. For details, please refer to the relevant description above and will not be repeated here.

[0083] 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.

[0084] The applicants used the balloon catheter shown in Figure 4 and the corresponding sequence division method to test the effectiveness of the pulse ablation device and discharge control method of the present invention. First, an in vitro potato experiment was conducted and compared with a traditional method. The experiment used a biphasic pulse waveform with a voltage of 800V and a sample size of 24. The sample means and sample standard deviations of the ablation depths are shown in Table 1.

[0085] Table 1 Comparison of the effectiveness of the pulse ablation device and discharge control method of the present invention with the traditional method

[0086] Conduct hypothesis testing on the test results. The overall variance σ of this test is 2 If it is unknown, use t-test, consider the significance level α = 0.02, and conduct t-test on the sample mean μ. Establish hypothesis: H0: μ 顺 =μ 同, H1:μ 顺 ≠μ 同 , μ0=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 mean ablation depth of the population when the traditional method is used, and μ0 represents the difference between the mean ablation depths of the two populations. Then reject H0, otherwise accept H0, where The mean of the difference between the two groups of samples, S * is the sample standard deviation, n0 is the sample size, t 1-α / 2 (n0-1)=2.4999.

[0087] The final calculation is Therefore, we accept H0, which means that the damage depth of the pulse ablation device and discharge control method of the present invention is the same as that of the traditional method, that is, the effectiveness is the same.

[0088] Secondly, in vivo ablation experiments were conducted. Three anatomical locations were selected for the experiment in experimental pigs. Balloon catheters were placed in the superior vena cava, right atrial appendage, and right superior pulmonary vein of the experimental pigs for ablation. Eight ablation samples were performed. A surface accelerometer was fixed to the abdomen of the experimental pigs. Acceleration data along the Z axis (perpendicular to the operating table) of the experimental pigs during ablation using the conventional 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 due to gravity).

[0089] Table 2 Comparison of stimulation intensity between the pulse ablation device and discharge control method of the present invention and the traditional method

[0090] When the acceleration is less than 0.5g, there is no obvious visible muscle contraction (Reference: Dong Shoulong, Experimental and Mechanistic Study of Irreversible Electroporation Ablation of Tumors with High-Frequency Bipolar Microsecond Pulsed Electric Fields). This shows that the pulse ablation device and discharge control method of the present invention significantly stimulates muscles less than traditional methods, and the stimulation intensity is very low.

[0091] In summary, the pulse ablation device and discharge control method of the present invention are as effective as traditional methods in ablation, but the stimulation to muscles is greatly reduced.

[0092] The discharge control method of the pulse ablation device and 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, it greatly reduces the stimulation to the patient's muscles, so that local anesthesia can be used for pulse electric field ablation surgery.

[0093] Those skilled in the art will appreciate that all or part of the functions of the various methods in the above embodiments can be implemented by hardware or by computer program. When all or part of the functions in the above embodiments are implemented by computer program, 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 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 functions can be implemented. In addition, when all or part of the functions in the above embodiments are implemented by computer program, 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 saved in the memory of the local device by downloading or copying, or the system of the local device is updated. When the program in the memory is executed by the processor, all or part of the functions in the above embodiments can be implemented.

[0094] The above examples are used to illustrate the present invention, which are only used to help understand the present invention and are not intended to limit the present invention. Those skilled in the art can make several simple deductions, modifications or substitutions based on the concept of the present invention.

Claims

1. A pulse ablation device, characterized in that: include: A pulse ablation catheter, comprising a plurality of discharge units, each of which is configured to emit a pulsed electric field, wherein the plurality of discharge units are divided into a plurality of discharge sequences, each of which comprises 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, wherein: 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 included is 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 further configured to read 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 included is 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 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 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, wherein: The number of overlapping discharge cells between two adjacent discharge sequences is smaller than the number of 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 discharge sequences is determined by the following formula: Where N sq represents the number of the discharge sequences, PE represents the total number of the discharge units, n represents the number of the discharge units included in each of the discharge sequences, and 2 ≤ n < PE; m represents the number of the overlapping discharge units between adjacent ones of the discharge sequences, and 0 ≤ m < n, Indicates rounding up.

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

10. The pulse ablation device according to claim 9, wherein: 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 discharging multiple pulse electric fields is 4 to 8.

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

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

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

15. The discharge control method according to claim 14, wherein: 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 electromyographic signal sensor, and a body surface acceleration sensor.

16. The discharge control method according to claim 14, wherein: 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 electromyographic signal sensor, and a body surface acceleration sensor.

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

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