Pulse ablation apparatus and discharge control method for pulse ablation catheter
Patent Information
- Application Number
- AU2024437896
- Authority / Receiving Office
- AU · AU
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-26
- Filing Date
- 2024-04-09
- Publication Date
- 2026-10-08
Smart Images
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Abstract
Description
TECHNICAL FIELD The present disclosure relates to the technical field of medical devices, and in particular to a pulse ablation apparatus and a discharge control method for a pulse ablation catheter. BACKGROUND Currently, various multi-electrode pulsed electric field ablation catheters are used for ablation therapy of atrial fibrillation domestically and internationally, and these catheters achieve "one-shot" isolation of pulmonary veins through circumferentially arranged electrodes. The so-called "one-shot" refers to an ablation method in which one pulmonary vein is isolated through single discharge treatment, and during "one-shot" ablation, a plurality of electrodes on the catheter discharge simultaneously to output a pulsed electric field. Studies have revealed that when a plurality of electrodes output pulsed electric fields simultaneously, an electric field distribution is extensive. During "one-shot" ablation, skeletal muscle stimulation is inevitably caused, and a patient shows symptoms such as muscle twitching and rapid upward movement of the abdomen during discharge. To minimize the patient's pain during treatment, general anesthesia is required for the surgery. Literature investigations show that when Farapulse's multi-electrode petal catheter is used, general anesthesia or deep sedation is required during ablation, and local anesthesia surgery is infeasible. Hospital anesthesiology departments are typically short of anesthesiologists, and if every pulsed electric field ablation surgery for atrial fibrillation requires general anesthesia by an anesthesiologist, promotion and application of this new technology will be greatly limited. SUMMARY The present disclosure mainly solves the technical problem in the prior art that a pulsed electric field ablation therapy causes excessive muscle stimulation to a patient. According to a first aspect, a pulse ablation apparatus is provided in an embodiment, including: a pulse ablation catheter, where the pulse ablation catheter includes a plurality of discharge units, the discharge units are configured to deliver pulsed electric fields, and the plurality of discharge units are divided into a plurality of discharge sequences, where each of the discharge sequences includes at least two discharge units; and a controller connected to the pulse ablation catheter and configured to control the plurality of discharge sequences in the pulse ablation catheter to sequentially deliver pulsed electric fields in a predetermined order. In some embodiments, the number of the discharge units included in different discharge sequences is identical or different. In some embodiments, the pulse ablation apparatus further includes a stimulation intensity sensor, where the stimulation intensity sensor is connected to the controller, and the stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyography signal sensor, and a body surface acceleration sensor; and the controller is further configured to read sensor data output by the stimulation intensity sensor at a predetermined time interval, and when the sensor data increases, the number of the discharge sequences is increased, and the number of the discharge units included in part or all of the discharge sequences is decreased; and when the sensor data decreases, the number of the discharge sequences is decreased, and the number of the discharge units included in part or all of the discharge sequences is increased. In some embodiments, the controller is further configured to read sensor data output by the stimulation intensity sensor at a predetermined time interval, and when the sensor data increases, an amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is decreased; and when the sensor data decreases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is increased. In some embodiments, if the discharge units are arranged circumferentially, the plurality of discharge sequences deliver the pulsed electric fields in an order of rotating for one full turn circumferentially; and if the discharge units are arranged linearly, the plurality of discharge sequences deliver the pulsed electric fields in an order from one end of a straight line to the other end of the straight line. In some embodiments, there is at least one overlapping discharge unit between adjacent discharge sequences. In some embodiments, the number of overlapping discharge units between two adjacent discharge sequences is smaller than the number of the discharge units in each of the two discharge sequences. In some embodiments, when each of the discharge sequences includes the same number of the discharge units, and the number of overlapping discharge units between adjacent discharge sequences is identical, the number of the discharge sequences is determined by the following formula: Nsq PE n-m where Nsq represents the number of the discharge sequences, PE represents the total number of the discharge units, and n denotes the number of the discharge units included in each of the discharge sequences, 2 — n < PE ; and m denotes the number of overlapping discharge units between adjacent discharge sequences, 0 — m < n , and ^ 1 means rounding up. In some embodiments, the controller is further configured to control the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times. In some embodiments, an amplitude of the pulsed electric field delivered by the discharge unit during a subsequent cycle is equal to or unequal to an amplitude of the pulsed electric field delivered by the discharge unit during a previous cycle. In some embodiments, the number of cycles for the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times is 4 to 8. In some embodiments, a time interval for switching between the discharge sequences does not exceed 0.5 ms. In some embodiments, each of the discharge units includes at least two electrodes. According to a second aspect, a discharge control method for a pulse ablation catheter is provided, where the pulse ablation catheter includes a plurality of discharge units, the discharge units are configured to deliver pulsed electric fields, and the discharge control method includes: dividing the plurality of discharge units into a plurality of discharge sequences, where each of the discharge sequences includes at least two discharge units; and controlling the plurality of discharge sequences to sequentially deliver the pulsed electric fields in a predetermined order. In some embodiments, the discharge control method further includes: reading sensor data output by the stimulation intensity sensor at a predetermined time interval, where when the sensor data increases, the number of the discharge sequences is increased, and the number of the discharge units included in part or all of the discharge sequences is decreased; when the sensor data decreases, the number of the discharge sequences is decreased, and the number of the discharge units included in part or all of the discharge sequences is increased; and the stimulation intensity sensor includes at least one of a blood pressure sensor, an electromyography signal sensor, and a body surface acceleration sensor. In some embodiments, the discharge control method further includes: reading sensor data output by the stimulation intensity sensor at a predetermined time interval, where when the sensor data increases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is decreased; and when the sensor data decreases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is increased. In some embodiments, the controlling the plurality of discharge sequences to sequentially deliver the pulsed electric fields in a predetermined order includes: if the discharge units are arranged circumferentially, controlling the plurality of discharge sequences to deliver the pulsed electric fields in an order of rotating for one full turn circumferentially; and if the discharge units are arranged linearly, controlling the plurality of discharge sequences to deliver the pulsed electric fields in an order from one end of a straight line to the other end of the straight line. According to the pulse ablation apparatus and the discharge control method for the pulse ablation catheter in the above embodiments, the plurality of discharge units on the pulse ablation catheter are divided into a plurality of discharge sequences, and these discharge sequences are controlled to sequentially deliver the pulsed electric fields in a predetermined order, such that the discharge units deliver the pulsed electric fields in batches for ablation therapy instead of discharging simultaneously, which greatly reduces the muscle stimulation in a patient, thereby enabling pulsed electric field ablation surgery under local anesthesia. DESCRIPTION OF DRAWINGS FIG. 1 is a schematic structural diagram of a pulse ablation apparatus according to an embodiment. FIG. 2 is a schematic diagram of sequence division of a linear catheter according to an embodiment. FIG. 3 is a side view of a balloon catheter according to an embodiment. FIG. 4 is a schematic diagram of sequence division of the balloon catheter shown in FIG. 3 when the number of overlapping discharge units between discharge sequences is identical. FIG. 5 is a schematic diagram of sequence division of the balloon catheter shown in FIG. 3 when the number of overlapping discharge units between discharge sequences is different. FIG. 6 is a side view of a basket catheter according to an embodiment. FIG. 7 is a schematic diagram of sequence division of the basket catheter shown in FIG. 6 when the number of overlapping discharge units between discharge sequences is identical. FIG. 8 is a schematic diagram of sequence division of the basket catheter shown in FIG. 6 when the number of overlapping discharge units between discharge sequences is different. FIG. 9 is a comparison diagram of a discharge order of the discharge sequences shown in FIG. 4 and a discharge order of a conventional method. FIG. 10 is a schematic diagram of a discharge order of discharge sequences according to an embodiment. FIG. 11 is a schematic structural diagram of a pulse ablation apparatus according to another embodiment. FIG. 12 is a flowchart of a discharge control method for a pulse ablation catheter according to an embodiment. DETAILED DESCRIPTIOIN OF EMBODIMENTS The present disclosure will be further described in detail below with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are labeled with associated similar element labels. In the following embodiments, more details are described to facilitate clearer understanding of the present disclosure. However, those skilled in the art can readily recognize that some of the features can be omitted in different cases, or can be replaced by other elements, materials, and methods. In some cases, some operations related to the present disclosure are not shown or described in the specification, with the aim of preventing the important part of the present disclosure from being overwhelmed by excessive description, and for those skilled in the art, it is unnecessary to describe these related operations in detail, and they can gain a thorough understanding of the related operations according to the description in the specification and the general technical knowledge in the field. In addition, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. Furthermore, the steps or actions stated in the methods can also be sequentially exchanged or adjusted in terms of sequence in a manner obvious to those skilled in the art. Therefore, various sequences in the specification and drawings are merely for clear description of an embodiment, and are not intended to be a necessary sequence, unless otherwise specified that a certain sequence must be followed. The serial numbers assigned to the components herein, such as "first", "second", are only used to distinguish the described objects, and do not have any sequence or technical meaning. The terms "connection" and "coupling" mentioned herein include direct and indirect connection (coupling), unless otherwise specified. To achieve local anesthesia in surgeries for treating atrial fibrillation with pulsed electric field ablation catheters (such as "one-shot" surgeries), the problem of skeletal muscle stimulation caused when multi-electrode catheters release pulsed electric field energy must be solved. Some electroporation theories suggest that skeletal muscle stimulation may be eliminated by increasing a voltage and shortening a pulse width to a nanosecond level. However, for nanosecond-level pulses, a voltage of 2000V or even 3000V is typically required to cause sufficient transmural lesions. Excessively high voltages not only increase the risk of insulation failure but also increase costs for equipment and catheters. Additionally, nanosecond pulses have not yet been validated in clinical applications and remain only in theoretical and animal testing stages. Microsecond pulses are still the mainstream pulses currently used, and how to reduce skeletal muscle stimulation during microsecond pulse ablation to achieve local anesthesia is a pending problem. Through special discharge control, the present disclosure minimizes skeletal muscle stimulation caused by pulse ablation without compromising the ablation effect; and microsecond pulses also reduce the skeletal muscle stimulation in the patient and enable local anesthesia surgeries. A pulse ablation apparatus and a discharge control method for a pulse ablation catheter of the present disclosure can be applied to "one-shot" ablation surgeries or other pulse ablation surgeries. Referring to FIG. 1, a pulse ablation apparatus in some embodiments of the present disclosure includes a pulse ablation catheter 100 and a controller 200, which are described below respectively. As shown in FIG. 1, the pulse ablation catheter 100 includes a plurality of discharge units 110, the discharge units 110 are configured to deliver pulsed electric fields, and the plurality of discharge units 110 are divided into a plurality of discharge sequences sq, where each of the discharge sequences sq includes at least two discharge units 110. The pulse ablation catheter 100 may be a linear catheter, a balloon catheter, a basket catheter, a trumpet-shaped catheter, or the like, and the type of the pulse ablation catheter 100 is not limited in the present disclosure. Each of the discharge units 110 is a unit on the pulse ablation catheter 100 that delivers a pulsed electric field, and is typically an electrode group composed of a plurality of electrodes. In some embodiments, each of the discharge units 110 includes at least two electrodes, where at least one electrode is configured as a ground electrode and at least one electrode is configured to receive a high-voltage pulse. The number of the discharge sequences and the number of the discharge units included in each of the discharge sequences depend on actual needs. The controller 200 is connected to the pulse ablation catheter 100 and is configured to control the plurality of discharge sequences in the pulse ablation catheter 100 to sequentially deliver pulsed electric fields in a predetermined order. The order in which the discharge sequences deliver the pulsed electric fields can be set arbitrarily. To ensure the ablation effect, the controller 200 controls the plurality of discharge sequences to continuously deliver the pulsed electric fields, and a time interval for switching between two discharge sequences does not exceed 50 ms, preferably not more than 0.5 ms. A switch for switching between the discharge sequences may be an insulated gate bipolar transistor (IGBT), a metal-oxide-semiconductor field-effect transistor (MOSFET), a relay, or the like. The controller 200 can be a central processing unit (CPU), a field programmable gate array (FPGA), or the like; or a micro controller unit (MCU), a digital signal processor (DSP), or the like. The controller 200 may be configured to execute control directly by a hardware controller, or may be configured to execute control in combination with hardware and computer software programs. Division of the discharge sequences and a discharge order will be described in detail below with reference to specific embodiments. The number of the discharge units included in different discharge sequences may be identical or different. For example, for a pulse ablation catheter including 12 discharge units, the discharge units are sequentially numbered from A to L, and the number of the discharge sequences is 4; if different discharge sequences include the same number of the discharge units, a first discharge sequence sq1 includes discharge units A, B, and C, a second discharge sequence sq2 includes discharge units D, E, and F, a third discharge sequence sq3 includes discharge units G, H, and I, and a fourth discharge sequence sq4 includes discharge units J, K, and L; and if different discharge sequences include a different number of the discharge units, one allocation scheme is as follows: the first discharge sequence sq1 includes the discharge units A, B, C, and D, the second discharge sequence sq2 includes the discharge units E, F, and G, the third discharge sequence sq3 includes the discharge units H and I, and the fourth discharge sequence sq4 includes the discharge units J, K, and L. To prevent generation of gaps between ablation lesions of the discharge sequences, 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 identical or different. For ease of illustration, an example of some pulse ablation catheters is given below to illustrate a sequence division method when overlapping discharge units between discharge sequences exist, where different discharge sequences include the same number of the discharge units. The same applies when different discharge sequences include different numbers of discharge units. Referring to FIG. 2, a linear catheter includes 9 discharge units sequentially numbered from A to I. If each of the discharge sequences includes 3 discharge units, and there is 1 overlapping discharge unit between the discharge sequences, 4 discharge sequences may be formed; as shown in FIG. 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 of the discharge sequences includes 3 discharge units, there is 1 overlapping discharge unit between some adjacent discharge sequences, and there are 2 overlapping discharge units between some adjacent discharge sequences, 5 discharge sequences may be formed; as shown in FIG. 2, the first discharge sequence sq1 includes discharge units A, B, and C; the second discharge sequence sq2 includes discharge units B, C, and D; the third discharge sequence sq3 includes discharge units C, D, and E; the fourth discharge sequence sq4 includes discharge units E, F, and G; and a fifth discharge sequence sq5 includes discharge units G, H, and I. FIG. 3 is a side view of a balloon catheter, and a distal end thereof is shown in FIG. 4 and FIG. 5 (front views); it should be noted that "proximal end" and "distal end" are conventional terms in the field of medical devices; and for a device such as a balloon catheter, the "proximal end" refers to an end close to an operator of the device, and the "distal end" refers to an end away from the operator of the device. The balloon catheter shown in FIGS. 3, 4, and 5 has 12 discharge units 110 arranged circumferentially and sequentially numbered from A to L, and each of the discharge units 110 includes two electrodes 111; and 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 suffix of 1 (A1, B1, and the like) are configured as ground electrodes, and the electrodes with a suffix of 2 (A2, B2, and the like) are configured to receive a high-voltage pulse, or vice versa. If each of the discharge sequences includes 3 discharge units, and there is 1 overlapping discharge unit between discharge sequences, 6 discharge sequences may be formed; as shown in FIG. 4, 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; the fourth discharge sequence sq4 includes discharge units G, H, and I; the fifth discharge sequence sq5 includes discharge units I, J, and K; and a sixth discharge sequence sq6 includes discharge units K, L, and A. If each of the discharge sequences includes 3 discharge units, there is 1 overlapping discharge unit between some adjacent discharge sequences, and there are 2 overlapping discharge units between some adjacent discharge sequences, 5 discharge sequences may be formed; as shown in FIG. 5, the first discharge sequence sq1 includes discharge units A, B, C, and D; the second discharge sequence sq2 includes discharge units C, D, E, and F; the third discharge sequence sq3 includes discharge units F, G, H, and I; the fourth discharge sequence sq4 includes discharge units H, I, J, and K; and the fifth discharge sequence sq5 includes discharge units J, K, L, and A. FIG. 6 is a side view of a basket catheter having 8 discharge units 110 arranged circumferentially and sequentially numbered from A to H, and each of the discharge units 110 includes three electrodes 111. A distal end of the basket catheter shown in FIG. 6 is shown in FIG. 7 and FIG. 8 (front views), and only two electrodes of each of the discharge units are shown. During discharge, one electrode is configured as a ground electrode, and the other electrodes are configured to receive a high-voltage pulse. If each of the discharge sequences includes 4 discharge units, and there are 2 overlapping discharge units between the discharge sequences, 4 discharge sequences may be formed; as shown in FIG. 7, the first discharge sequence sq1 includes discharge units A, B, C, and D; the second discharge sequence sq2 includes discharge units C, D, E, and F; the third discharge sequence sq3 includes discharge units E, F, G, and H; and the fourth discharge sequence sq4 includes discharge units G, H, A, and B. If each of the discharge sequences includes 4 discharge units, there is 1 overlapping discharge unit between some adjacent discharge sequences, and there are 2 overlapping discharge units between some adjacent discharge sequences, 3 discharge sequences may be formed; as shown in FIG. 8, 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; and the third discharge sequence sq3 includes discharge units G, H, A, and B. In some embodiments, to prevent repetition of discharge sequences, the number of overlapping discharge units between two adjacent discharge sequences is smaller than the number of the discharge units in each of the two discharge sequences. Specifically, when different discharge sequences include the same number of the discharge units, assuming that the number of the discharge units included in each of the discharge sequences is Nc, the number of overlapping discharge units between two adjacent discharge sequences should be smaller than Nc; and when different discharge sequences include different numbers of discharge units, assuming that numbers of discharge units in two adjacent discharge sequences are N1 and N2 respectively, the number of overlapping discharge units between the two discharge sequences should be smaller than both N1 and N2. When each of the discharge sequences includes the same number of the discharge units, and the number of overlapping discharge units between adjacent discharge sequences is identical, the number of the discharge sequences is determined by the following formula: Nsq PE n-m where Nsq represents the number of the discharge sequences, PE represents the total number of the discharge units in the pulse ablation catheter, and n denotes the number of the discharge units included in each of the discharge sequences, 2 — n < PE ; and m denotes the number of overlapping discharge units between adjacent discharge sequences, 0 — m <n , and । । means rounding up. When there is no overlapping discharge unit between adjacent discharge sequences, m=0; and when there is an overlapping discharge unit between adjacent discharge sequences, 1 — m < n. For example, according to a method for dividing discharge sequences of the balloon catheter shown in FIG. 4, the number of the discharge sequences is calculated as follows: Nsq PE n-m 12 3-1 =6 According to a method for dividing discharge sequences of the basket catheter shown in FIG. 7, the number of the discharge sequences is calculated as follows: Nsq PE n-m 8 4-2 =4 In some embodiments, if the discharge units are arranged circumferentially, the plurality of discharge sequences deliver the pulsed electric fields in an order of rotating for one full turn circumferentially; and if the discharge units are arranged linearly, the plurality of discharge sequences deliver the pulsed electric fields in an order from one end of a straight line to the other end of the straight line. For example, according to a conventional method, 12 discharge units of the balloon catheter shown in FIG. 4 deliver the pulsed electric fields simultaneously, and in one embodiment of the present disclosure, the discharge sequences sequentially deliver the pulsed electric fields in an order from sq1 to sq6, as shown in FIG. 9. This batch discharge method reduces muscle stimulation. For another example, the balloon catheter shown in FIG. 4 has 12 discharge sequences where each of the discharge sequences includes 2 discharge units and there is 1 overlapping discharge unit between adjacent discharge sequences; where 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; and the discharge sequences sequentially deliver the pulsed electric fields in an order from sq1 to sq12, as shown in FIG. 10. Notably, a starting discharge sequence may be any other discharge sequence except sq1, and for example, if sq2 serves as the starting discharge sequence, the discharge sequences sequentially deliver the pulsed electric fields in an order of sq2, sq3, sq4, sq5, sq6, and sq1, as shown in FIG. 4. For the linear catheter shown in FIG. 2, when the number of overlapping discharge units between the discharge sequences is identical, the discharge sequences sequentially deliver the pulsed electric fields in an order from sq1 to sq4 or from sq4 to sq1; and when the number of overlapping discharge units is different, the discharge sequences sequentially deliver the pulsed electric fields in an order from sq1 to sq5 or from sq5 to sq1. In some embodiments, the discharge sequences may sequentially deliver the pulsed electric fields in any other order. For example, for the balloon catheter shown in FIG. 4, the discharge sequences may sequentially deliver the pulsed electric fields in an order of sq3, sq6, sq2, sq5, sq1, and sq4. For the linear catheter shown in FIG. 2, when the number of overlapping discharge units is identical, the discharge sequences may sequentially deliver the pulsed electric fields in an order of sq3, sq1, sq2, and sq4; and when the number of overlapping discharge units is different, the discharge sequences may sequentially deliver the pulsed electric fields in an order of sq3, sq4, sq2, sq5, and sq1, and so on. In some embodiments, the controller 200 is further configured to control the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times. Each of the discharge sequences sequentially delivers one pulsed electric field in order to complete one cycle; and for example, as shown in FIG. 4, the discharge sequences sequentially deliver the pulsed electric fields in an order from sq1 to sq6 to complete one cycle, and subsequently, the discharge sequences continue to sequentially deliver the pulsed electric fields in an order from sq1 to sq6 to complete a plurality of cycles. The number of cycles for the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times depends on actual needs, and is preferably 4 to 8. In some embodiments, an amplitude of the pulsed electric field delivered by the discharge unit during a subsequent cycle is equal to or unequal to an amplitude of the pulsed electric field delivered by the discharge unit during a previous cycle. Specifically, the amplitude of the pulsed electric field delivered by the discharge unit from a first cycle to a last cycle may remain unchanged or show an overall trend of increasing or decreasing; or the amplitude of the pulsed electric field delivered in some cycles may be greater than the amplitude of the pulsed electric field delivered in the previous cycle, and the amplitude of the pulsed electric field delivered in some cycles may be less than the amplitude of the pulsed electric field delivered in the previous cycle. To increase an ablation depth and improve the treatment effect, the amplitude of the pulsed electric field delivered by the discharge unit during the subsequent cycle is equal to or greater than the amplitude of the pulsed electric field delivered by the discharge unit during the previous cycle. In some embodiments, an increase or decrease in the amplitude of the pulsed electric field is determined based on feedback on the patient's muscle stimulation degree. For example, the muscle stimulation degree is detected by a stimulation intensity sensor, and when sensor data output by the stimulation intensity sensor is too large (e.g., greater than a predetermined threshold), the amplitude of the pulsed electric field delivered by the discharge unit during the subsequent cycle is decreased; and when the sensor data output by the stimulation intensity sensor still falls within an appropriate range (e.g., less than or equal to the predetermined threshold), the amplitude of the pulsed electric field delivered by the discharge unit during the subsequent cycle may be increased to enhance the ablation depth. Details of the stimulation intensity sensor are described below. Referring to FIG. 11, the pulse ablation apparatus in some embodiments of the present disclosure further includes a stimulation intensity sensor 300, and the stimulation intensity sensor 300 is connected to the controller 200 and configured to detect physiological parameters characterizing the patient's muscle stimulation degree and transmit the physiological parameters to the controller 200. The stimulation intensity sensor 300 includes at least one of a blood pressure sensor, an electromyography signal sensor, and a body surface acceleration sensor. In some embodiments, the controller 200 is further configured to read sensor data output by the stimulation intensity sensor 300 at a predetermined time interval, and when the sensor data increases, the number of the discharge sequences is increased, and the number of the discharge units included in part or all of the discharge sequences is decreased; and in some embodiments, when the sensor data decreases, the number of the discharge sequences is decreased, and the number of the discharge units included in part or all of the discharge sequences is increased. It will be appreciated that for 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 electromyography signal sensor is an electromyography signal of the patient's muscle, and the sensor data output by the body surface acceleration sensor is an acceleration of the patient's body surface movement (e.g., abdominal lifting). Taking FIG. 4 as an example, when the sensor data increases, the number of the discharge sequences may be increased to 12, and the number of the discharge units included in all the discharge sequences is decreased to 2, such that 12 discharge sequences listed in FIG. 10 are formed; or when the number of the discharge sequences is increased to 9, and the number of the discharge units included in some discharge sequences is decreased to 2, one division method is as follows: 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; the fourth discharge sequence sq4 includes discharge units G and H; the fifth discharge sequence sq5 includes discharge units H and I; the sixth discharge sequence sq6 includes discharge units I and J; a seventh discharge sequence sq7 includes discharge units J and K; an eighth discharge sequence sq8 includes discharge units K and L; and a ninth discharge sequence sq9 includes discharge units L and A. When the sensor data decreases, the number of the discharge sequences may be decreased to 4, and the number of the discharge units included in all the discharge sequences may be increased to 4, where 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 when the number of the discharge sequences is decreased to 5, and the number of the discharge units included in some discharge sequences is increased to 4, one division method is as follows: 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. A change threshold may be preset, and if a difference between the sensor data read at a current moment and the sensor data read at a previous moment is less than 0 and an absolute value of the difference is greater than the change threshold, it is considered that the sensor data decreases; and 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 of the difference is greater than the change threshold, it is considered that the sensor data increases. In the present embodiment, when the sensor data increases, it indicates that the stimulation intensity increases; the intensity of the pulsed electric field during each discharge may be reduced by increasing the number of the discharge sequences and decreasing the number of the discharge units included in part or all of the discharge sequences, to reduce muscle stimulation; and when the sensor data decreases, the number of the discharge sequences may be appropriately decreased, and the number of the discharge units included in part or all of the discharge sequences may be increased, to save surgical time. In some embodiments, the controller 200 is further configured to read sensor data output by the stimulation intensity sensor 300 at a predetermined time interval, and when the sensor data increases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is decreased; and in some embodiments, when the sensor data decreases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is increased. In the present embodiment, when the sensor data increases, the intensity of the pulsed electric field during each discharge may be reduced by decreasing the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit, to reduce muscle stimulation; and when the sensor data decreases, the treatment effect is ensured and surgical time is saved by appropriately increasing the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit. Based on the above pulse ablation apparatus, the present disclosure further provides a discharge control method for a pulse ablation catheter, and the discharge control method may be implemented by the controller 200; and referring to FIG. 12, in one embodiment, the method includes steps 10-20. Step 10: divide the plurality of discharge units of the pulse ablation catheter into a plurality of discharge sequences, where each of the discharge sequences includes at least two discharge units. The number of the discharge units included in different discharge sequences may be identical or different. In some embodiments, there is at least one overlapping discharge unit between adjacent discharge sequences. In some embodiments, to prevent repetition of discharge sequences, the number of overlapping discharge units between two adjacent discharge sequences is smaller than the number of the discharge units in each of the two discharge sequences. Reference may be made to the relevant descriptions above for a specific method of dividing the discharge sequences, which will not be repeated herein. Step 20: control the plurality of discharge sequences to sequentially deliver the pulsed electric fields in a predetermined order. The order in which the discharge sequences deliver the pulsed electric fields can be set arbitrarily. In some embodiments, if the discharge units are arranged circumferentially, the plurality of discharge sequences deliver the pulsed electric fields in an order of rotating for one full turn circumferentially; and if the discharge units are arranged linearly, the plurality of discharge sequences deliver the pulsed electric fields in an order from one end of a straight line to the other end of the straight line. Reference may be made to the relevant descriptions above for a specific discharge order, which will not be repeated herein. In some embodiments, the discharge control method of the present disclosure further includes: control the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times. The number of cycles for the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times depends on actual needs, and is preferably 4 to 8. In some embodiments, an amplitude of the pulsed electric field delivered by the discharge unit during a subsequent cycle is equal to or unequal to an amplitude of the pulsed electric field delivered by the discharge unit during a previous cycle. For details, reference may be made to the relevant descriptions above, which will not be repeated herein. the discharge control method of the present disclosure further includes: read sensor data output by the stimulation intensity sensor at a predetermined time interval, where when the sensor data increases, the number of the discharge sequences is increased, and the number of the discharge units included in part or all of the discharge sequences is decreased; and in some embodiments, when the sensor data decreases, the number of the discharge sequences is decreased, and the number of the discharge units included in part or all of the discharge sequences is increased. Reference may be made to the relevant descriptions above, which will not be repeated herein. In some embodiments, the discharge control method of the present disclosure further includes: read sensor data output by the stimulation intensity sensor at a predetermined time interval, and when the sensor data increases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is decreased; and in some embodiments, when the sensor data decreases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is increased. The applicant(s) tested the effects of the pulse ablation apparatus and the discharge control method of the present disclosure using the balloon catheter shown in FIG. 4 and the corresponding sequence division method. First, an in vitro potato experiment was conducted, and a comparison with a conventional method was made, where a biphasic pulse waveform with a voltage of 800V was used for the experiment, with a sample size of 24. Sample means and sample standard deviations of ablation depths are shown in Table 1. Table 1 Effectiveness comparison between the pulse ablation apparatus and the discharge control method of the present disclosure and the conventional method Ablation mode Conventional method Present disclosure Sample mean of ablation depth (mm) 5.52 5.90 Sample standard deviation of ablation depth 1.06 0.88 A hypothesis test was performed on experimental results; since a population variance ^2 was unknown, a t-test was performed with a significance level of a=0.02; and a t-test was performed on a sample mean it. The following hypotheses were established: H0: Lt shun ft tong, H1: ftshun^fttong, ft0=0, ftshun represents a population mean ablation depth when the pulse ablation apparatus and discharge control method of the present disclosure are used, fttong represents a population mean ablation depth when the conventional method is adopted, and ft 0 represents a difference between the population mean ablation depths. If z - A) s 7 n^ — ti-a 2(n 0 1) , H0 is rejected, otherwise, H0 is accepted, where z is a mean difference between two sets of samples, S* is a sample standard deviation, n0 is a sample size, and t1-a / 2(n0-1)=2.4999. Final calculation yielded z - A = 0.375 - 0 = 0.375 =1.289<2.4999 , so H0 s 7 44 s 7 TnT 1.424 / 4.899 is accepted, i.e., meaning that a lesion depth achieved by the pulse ablation apparatus and the discharge control method of the present disclosure is the same as that achieved by the conventional method, i.e., their effectiveness is equivalent. Secondly, an in vivo ablation experiment was conducted on animals. Three anatomical locations of an experimental pig were selected for the experiment, and the balloon catheter was placed in the superior vena cava, the right atrial appendage, and the right superior pulmonary vein of the experimental pigs for ablation, with an ablation sample size of 8. A body surface acceleration sensor was fixed to the abdomen of the experimental pig, and Z-axis (an axial direction perpendicular to an operating table) acceleration data of the experimental pig during ablation using the conventional method and the pulse ablation apparatus and the discharge control method of the present disclosure were recorded and shown in Table 2 (where g represents an acceleration of gravity). Table 2 Comparison of stimulation intensity between the pulse ablation apparatus and the discharge control method of the present disclosure and the conventional method Ablation mode Conventional method Present disclosure 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 When the acceleration is < 0.5g, it indicates that there is no obvious visible muscle contraction (Reference: Dong Shoulong, Experimental and Mechanistic Study on Irreversible Electroporation Ablation of Tumors with High-Frequency Bipolar Microsecond Pulsed Electric Fields). It can be seen that the intensity of muscle stimulation by the pulse ablation apparatus and the discharge control method of the present disclosure is significantly lower than that of the conventional method, and the muscle stimulation degree is very low. In summary, the pulse ablation apparatus and the discharge control method of the present disclosure have the same ablation effectiveness as the conventional method, but the muscle stimulation degree is greatly reduced. The pulse ablation apparatus and the discharge control method for the pulse ablation catheter are provided in the embodiments of the present disclosure, the plurality of discharge units on the pulse ablation catheter are divided into a plurality of discharge sequences, and these discharge sequences are controlled to sequentially deliver the pulsed electric fields in a predetermined order, such that the discharge units deliver the pulsed electric fields in batches for an ablation therapy instead of discharging simultaneously, which ensures the ablation therapy effect, and greatly reduces the muscle stimulation in a patient, thereby enabling pulsed electric field ablation surgery under local anesthesia. Those skilled in the art will appreciate that all or part of the functions of various methods in the above embodiments may be implemented by hardware, or may be implemented by a computer program. When all or part of the functions in the above embodiments are implemented by a computer program, the program may be stored in a computer-readable storage medium; and the storage medium may include: a read-only memory, a random access memory, a magnetic disk, an optical disk, a hard disk drive, or the like, and the functions are implemented by a computer executing the program. For example, the program is stored in a memory of a device, and when the program in the memory is executed by a processor, all or part of the above functions may be implemented. Additionally, when all or part of the functions in the above embodiments are implemented by a computer program, the program may be stored in a storage medium such as a server, another computer, a magnetic disk, an optical disk, a flash drive, or a mobile hard disk, and saved in a memory of a local device by downloading or copying, or a system of the local device may be updated in version. When the program in the memory is executed by a processor, all or part of the functions in the above embodiments may be implemented. The above specific examples are applied to describe the present disclosure, are only intended to help understand the present disclosure, and are not intended to limit the present disclosure. For those skilled in the art to which the present disclosure belongs, several simple deductions, modifications, or substitutions may also be made according to the ideas presented in the present disclosure.
Claims
1. A pulse ablation apparatus, comprising:a pulse ablation catheter, wherein the pulse ablation catheter comprises a plurality of discharge units, the discharge units are configured to deliver pulsed electric fields, and the plurality of discharge units are divided into a plurality of discharge sequences, wherein each of the discharge sequences comprises at least two discharge units; anda controller connected to the pulse ablation catheter and configured to control the plurality of discharge sequences in the pulse ablation catheter to sequentially deliver pulsed electric fields in a predetermined order.
2. The pulse ablation apparatus according to claim 1, wherein the number of the discharge units included in different discharge sequences is identical or different.
3. The pulse ablation apparatus according to claim 1 or 2, further comprising a stimulation intensity sensor, wherein the stimulation intensity sensor is connected to the controller, and the stimulation intensity sensor comprises at least one of a blood pressure sensor, an electromyography signal sensor, and a body surface acceleration sensor; andthe controller is further configured to read sensor data output by the stimulation intensity sensor at a predetermined time interval, and when the sensor data increases, the number of the discharge sequences is increased, and the number of the discharge units included in part or all of the discharge sequences is decreased; and when the sensor data decreases, the number of the discharge sequences is decreased, and the number of the discharge units included in part or all of the discharge sequences is increased.
4. The pulse ablation apparatus according to claim 1 or 2, further comprising a stimulation intensity sensor, wherein the stimulation intensity sensor is connected to the controller, and the stimulation intensity sensor comprises at least one of a blood pressure sensor, an electromyography signal sensor, and a body surface acceleration sensor; andthe controller is further configured to read sensor data output by the stimulation intensity sensor at a predetermined time interval, and when the sensor data increases, an amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is decreased; and when the sensor data decreases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is increased.
5. The pulse ablation apparatus according to any one of claims 1-4, wherein if the discharge units are arranged circumferentially, the plurality of discharge sequences deliver the pulsed electric fields in an order of rotating for one full turn circumferentially; and if the discharge units are arranged linearly, the plurality of discharge sequences deliver the pulsed electric fields in an order from one end of a straight line to the other end of the straight line.
6. The pulse ablation apparatus according to any one of claims 1-5, wherein there is at least one overlapping discharge unit between adjacent discharge sequences.
7. The pulse ablation apparatus according to claim 6, wherein the number of overlapping discharge units between two adjacent discharge sequences is smaller than the number of the discharge units in each of the two discharge sequences.
8. The pulse ablation apparatus according to any one of claims 1-7, wherein when each ofthe discharge sequences comprises the same number of the discharge units, and the number of overlapping discharge units between the adjacent discharge sequences is identical, the number of the discharge sequences is determined by the following formula:NsqPEn-min the formula, Nsq represents the number of the discharge sequences, PE represents the total number of the discharge units, and n denotes the number of the discharge units included in each of the discharge sequences, 2 — n < PE ; and m denotes the number of overlapping discharge units between the adjacent discharge sequences, 0— m <n , and I” 1 means rounding up.
9. The pulse ablation apparatus according to any one of claims 1-8, wherein the controller is further configured to control the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times.
10. The pulse ablation apparatus according to claim 9, wherein an amplitude of the pulsed electric field delivered by the discharge unit during a subsequent cycle is equal to or unequal to an amplitude of the pulsed electric field delivered by the discharge unit during a previous cycle.
11. The pulse ablation apparatus according to claim 9 or 10, wherein the number of cycles for the plurality of discharge sequences to cyclically deliver the pulsed electric fields for a plurality of times is 4 to 8.
12. The pulse ablation apparatus according to claim 1, wherein a time interval for switching between the discharge sequences does not exceed 0.5 ms.
13. The pulse ablation apparatus according to claim 1, wherein each of the discharge units comprises 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, the discharge units are configured to deliver pulsed electric fields, and the discharge control method comprises:dividing the plurality of discharge units into a plurality of discharge sequences, wherein each of the discharge sequences comprises at least two discharge units; andcontrolling the plurality of discharge sequences to sequentially deliver the pulsed electric fields in a predetermined order.
15. The discharge control method according to claim 14, further comprising: reading sensor data output by the stimulation intensity sensor at a predetermined time interval, wherein when the sensor data increases, the number of the discharge sequences is increased, and the number of the discharge units included in part or all of the discharge sequences is decreased; when the sensor data decreases, the number of the discharge sequences is decreased, and the number of the discharge units included in part or all of the discharge sequences is increased; and the stimulation intensity sensor comprises 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, further comprising: reading sensor data output by the stimulation intensity sensor at a predetermined time interval, wherein when thesensor data increases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is decreased; when the sensor data decreases, the amplitude and / or pulse width of the pulsed electric field delivered by the discharge unit is increased; and the stimulation intensity sensor comprises 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 14-16, wherein the controlling the plurality of discharge sequences to sequentially deliver the pulsed electric fields in a predetermined order comprises: if the discharge units are arranged circumferentially, controlling the plurality of discharge sequences to deliver the pulsed electric fields in an order of rotating for one full turn circumferentially; and if the discharge units are arranged linearly, controlling the plurality of discharge sequences to deliver the pulsed electric fields in an order from one end of a straight line to the other end of the straight line.