Disclosure of Invention
The invention mainly solves the technical problem that the existing pulsed electric field ablation treatment technology has overlarge muscle stimulation on patients.
According to a first aspect, there is provided in one embodiment a pulsed ablation device comprising:
A pulse ablation catheter comprising a plurality of discharge cells for delivering a pulsed electric field, the plurality of discharge cells being divided into a plurality of discharge sequences, each discharge sequence comprising at least two of the discharge cells;
And the controller is connected with the pulse ablation catheter and is used for controlling the plurality of discharge sequences in the pulse ablation catheter to sequentially emit a pulse electric field according to a preset sequence.
In some embodiments, different discharge sequences include the same or different numbers of discharge cells.
In some embodiments, the pulse ablation device further comprises a stimulus intensity sensor, the stimulus intensity sensor is connected with the controller, and the stimulus intensity sensor at least comprises one of a blood pressure sensor, an electromyographic signal sensor and a body surface acceleration sensor;
The controller is also used for reading sensor data output by the stimulation intensity sensor at preset time intervals, if the sensor data are increased, increasing the number of the discharge sequences, reducing the number of the discharge units included in part or all of the discharge sequences, and if the sensor data are reduced, reducing the number of the discharge sequences, and increasing the number of the discharge units included in part or all of the discharge sequences.
In some embodiments, the controller is further configured to read sensor data output by the stimulus intensity sensor at intervals of a preset time interval, decrease the amplitude and/or the pulse width of the pulsed electric field emitted by the discharge unit if the sensor data is increased, and increase the amplitude and/or the pulse width of the pulsed electric field emitted by the discharge unit if the sensor data is decreased.
In some embodiments, the plurality of discharge sequences may issue the pulsed electric fields in a sequence of one rotation in the circumferential direction if the discharge units are arranged in the circumferential direction, and may issue the pulsed electric fields in a sequence of one end of the straight line to the other end of the straight line if the discharge units are arranged in the straight line.
In some embodiments, there is at least one overlapping discharge cell between adjacent ones of the discharge sequences.
In some embodiments, the number of discharge cells overlapping between two adjacent discharge sequences is less than the number of discharge cells of each of the two discharge sequences.
In some embodiments, each of the discharge sequences includes the same number of discharge cells, and the number of discharge cells overlapping between adjacent discharge sequences is the same, and the number of discharge sequences is determined by the following formula:
wherein Nsq represents the number of the discharge sequences, PE represents the total number of the discharge cells, N represents the number of discharge cells included in each of the discharge sequences and 2.ltoreq.n < PE, m represents the number of discharge cells overlapped between adjacent ones of the discharge sequences and 0.ltoreq.m < N,Representing an upward rounding.
In some embodiments, the controller is further configured to control the plurality of discharge sequence cycles to dispense a plurality of pulsed electric fields.
In some embodiments, the magnitude of the pulsed electric field emitted by the discharge unit at the last cycle is equal or unequal to the magnitude of the pulsed electric field emitted by the discharge unit at the previous cycle.
In some embodiments, the plurality of discharge sequence cycles are performed for a number of cycles of the issuing of the pulsed electric field between 4 and 8.
In some embodiments, the time interval for switching between discharge sequences does not exceed 0.5ms.
In some embodiments, each of the discharge cells includes at least two electrodes.
According to a second aspect, in one embodiment, there is provided a discharge control method of a pulse ablation catheter including a plurality of discharge cells for delivering a pulsed electric field, the discharge control method comprising:
Dividing the plurality of discharge cells into a plurality of discharge sequences, wherein each discharge sequence comprises at least two of the discharge cells;
and controlling the discharge sequences to sequentially emit the pulse electric fields according to a preset sequence.
In some embodiments, the discharge control method further comprises reading sensor data output by the stimulation intensity sensor at intervals of a preset time interval, if the sensor data is increased, increasing the number of discharge sequences, reducing the number of discharge units included in part or all of the discharge sequences, if the sensor data is reduced, reducing the number of discharge sequences, and increasing the number of discharge units included in part or all of the discharge sequences, wherein the stimulation intensity sensor at least comprises one of a blood pressure sensor, an electromyographic signal sensor and a body surface acceleration sensor.
In some embodiments, the discharge control method further comprises reading sensor data output by the stimulation intensity sensor at intervals of a preset time interval, if the sensor data is increased, reducing the amplitude and/or the pulse width of the pulse electric field emitted by the discharge unit, and if the sensor data is reduced, increasing the amplitude and/or the pulse width of the pulse electric field emitted by the discharge unit.
In some embodiments, the controlling the plurality of discharge sequences to sequentially emit the pulsed electric fields according to a preset sequence includes controlling the plurality of discharge sequences to sequentially emit the pulsed electric fields according to a sequence of one circumferential rotation if the discharge units are arranged along the circumferential direction, and controlling the plurality of discharge sequences to sequentially emit the pulsed electric fields according to a sequence from one end of a straight line to the other end of the straight line if the discharge units are arranged along the straight line.
According to the pulse ablation device and the discharge control method of the pulse ablation catheter, the discharge units on the pulse ablation catheter are divided into the discharge sequences, and the discharge sequences are controlled to sequentially emit the pulse electric fields according to the preset sequence, so that the discharge units emit the pulse electric fields in batches for performing ablation treatment instead of simultaneous discharge, the stimulation to muscles of a patient is reduced, and the local anesthesia can be adopted for performing the pulse electric field ablation operation.
Detailed Description
The application will be described in further detail below with reference to the drawings by means of specific embodiments. Wherein like elements in different embodiments are numbered alike in association. In the following embodiments, numerous specific details are set forth in order to provide a better understanding of the present application. However, one skilled in the art will readily recognize that some of the features may be omitted, or replaced by other elements, materials, or methods in different situations. In some instances, related operations of the present application have not been shown or described in the specification in order to avoid obscuring the core portions of the present application, and may be unnecessary to persons skilled in the art from a detailed description of the related operations, which may be presented in the description and general knowledge of one skilled in the art.
Furthermore, the described features, operations, or characteristics of the description may be combined in any suitable manner in various embodiments. Also, various steps or acts in the method descriptions may be interchanged or modified in a manner apparent to those of ordinary skill in the art. Thus, the various orders in the description and drawings are for clarity of description of only certain embodiments, and are not meant to be required orders unless otherwise indicated.
The numbering of the components itself, e.g. "first", "second", etc., is used herein merely to distinguish between the described objects and does not have any sequential or technical meaning. The term "coupled" as used herein includes both direct and indirect coupling (coupling), unless otherwise indicated.
In order to achieve local anesthesia in a pulsed electric field ablation catheter-based procedure (e.g., a "one-shot" procedure), skeletal muscle stimulation problems of a multi-electrode catheter when pulsed electric field energy is released must be addressed. Some electroporation theories suggest that increasing the voltage, shortening the pulse width to nanosecond level, can avoid skeletal muscle stimulation. Pulses on the order of nanoseconds often require a voltage of 2000V or even 3000V to cause adequate transmural damage. Excessive voltages not only increase the risk of insulation failure but also result in increased equipment and conduit costs. In addition, nanosecond pulses have not been validated for clinical use and remain only in theoretical and animal testing phases. Pulses on the order of microseconds remain the mainstay of current practice, and how to reduce skeletal muscle stimulation in pulse ablation on the order of microseconds to achieve local anesthesia is a problem to be solved.
The invention minimizes skeletal muscle stimulation caused by pulse ablation process through special discharge control, and simultaneously has no influence on the ablation effect, and can reduce stimulation to skeletal muscle of a patient under the condition of microsecond level pulse, thereby realizing local anesthesia operation. The pulse ablation device and the discharge control method of the pulse ablation catheter can be used in one-shot type ablation surgery or other pulse ablation surgery.
Referring to fig. 1, a pulse ablation device according to some embodiments of the present invention includes a pulse ablation catheter 100 and a controller 200, which are described below.
As shown in fig. 1, the pulse ablation catheter 100 includes a plurality of discharge cells 110, the discharge cells 110 for delivering a pulsed electric field, the plurality of discharge cells 110 being divided into a plurality of discharge sequences sq, each discharge sequence sq including at least two discharge cells 110. The pulse ablation catheter 100 may be a linear catheter, a balloon catheter, a basket catheter, a horn catheter, etc., and the present invention is not limited in the type of pulse ablation catheter 100. The discharge unit 110 is a unit for delivering a pulsed electric field on the pulse ablation catheter 100, and is typically an electrode group consisting of a plurality of electrodes. In some embodiments, each discharge cell 110 includes at least two electrodes, at least one of which is configured as ground and at least one of which is configured with a high voltage pulse. The number of discharge sequences and the number of discharge cells included in each discharge sequence may be set according to actual needs.
The controller 200 is connected to the pulse ablation catheter 100 for controlling a plurality of discharge sequences in the pulse ablation catheter 100 to sequentially deliver the pulsed electric field in a preset sequence. The order in which the discharge sequences deliver the pulsed electric fields can be arbitrarily set. To ensure the effect of ablation, the controller 200 controls the discharge sequences to continuously deliver the pulsed electric field, and the time interval between switching between the two discharge sequences is not more than 50ms, preferably not more than 0.5ms. The switch that switches between the discharge sequences may be an IGBT, MOSFET, relay, or the like. The controller 200 may be a central processing unit (Central Processing Unit, CPU), a field programmable gate array (Field Programmable GATE ARRAY, FPGA), etc., or may be a micro control unit (Micro Controller Unit, MCU), a digital signal Processor (DIGITAL SIGNAL Processor, DSP), etc. The controller 200 may be configured to perform control directly by a hardware controller or may be configured to perform control in combination with hardware and computer software programs.
The division of the discharge sequence and the sequence of the discharge are described in detail below with reference to specific examples.
The number of discharge cells comprised by different discharge sequences may be the same or different. For example, a pulse ablation catheter comprising 12 discharge units is numbered in sequence by letters A to L, the number of discharge sequences is 4, if the number of discharge units included in different discharge sequences is the same, the first discharge sequence sq1 comprises discharge unit A, B, C, the second discharge sequence sq2 comprises discharge unit D, E, F, the third discharge sequence sq3 comprises discharge unit G, H, I, and the fourth discharge sequence sq4 comprises discharge unit J, K, L, and if the number of discharge units included in different discharge sequences can be different, one allocation scheme is that the first discharge sequence sq1 comprises discharge unit A, B, C, D, the second discharge sequence sq2 comprises discharge unit E, F, G, the third discharge sequence sq3 comprises discharge unit H, I, and the fourth discharge sequence sq4 comprises discharge unit J, K, L.
To avoid gaps between ablation sites of discharge sequences, in some embodiments, at least one overlapping discharge cell is between adjacent discharge sequences, and the number of overlapping discharge cells may be the same or different between different discharge sequences. For convenience of explanation, the following describes a sequential division manner when there are overlapping discharge cells between the discharge sequences by using a number of pulse ablation catheters, taking the same number of discharge cells included in different discharge sequences as an example. The same applies when the different discharge sequences comprise different numbers of discharge cells.
Referring to fig. 2, a linear catheter includes 9 discharge cells, numbered a to I in sequence. If each discharge sequence is configured to include 3 discharge cells, and there are 1 discharge cell overlapping between the discharge sequences, it may be divided into 4 discharge sequences, as shown in fig. 2, where the first discharge sequence sq1 includes the discharge cell A, B, C, the second discharge sequence sq2 includes the discharge cell C, D, E, the third discharge sequence sq3 includes the discharge cell E, F, G, and the fourth discharge sequence sq4 includes the discharge cell G, H, I. If each discharge sequence is configured to include 3 discharge cells, 1 discharge cell is overlapped between the partial discharge sequences, 2 discharge cells are overlapped between the partial discharge sequences, it may be divided into 5 discharge sequences, as shown in fig. 2, where the first discharge sequence sq1 includes the discharge cell A, B, C, the second discharge sequence sq2 includes the discharge cell B, C, D, the third discharge sequence sq3 includes the discharge cell C, D, E, the fourth discharge sequence sq4 includes the discharge cell E, F, G, and the fifth discharge sequence sq5 includes the discharge cell G, H, I.
Referring to fig. 3, a side view of a balloon catheter is shown in fig. 4 and 5 in front view, and it should be noted that "proximal" and "distal" are commonly referred to in the medical device field, and for a device such as a balloon catheter, the "proximal" is that end close to the operator of the device, and the "distal" is that end far from the operator of the device. The balloon catheter shown in fig. 3, 4 and 5 has 12 discharge cells 110 arranged in the circumferential direction, numbered a to L in sequence, each discharge cell 110 including two electrodes 111, two electrodes 111 of discharge cell a being numbered A1 and A2, two electrodes 111 of discharge cell B being numbered B1 and B2, two electrodes 111 of discharge cell C being numbered C1 and C2, and so on. The electrode (A1, B1, etc.) with the number mantissa of 1 is configured as ground, and the electrode (A2, B2, etc.) with the number mantissa of 2 is configured with high voltage pulse, or vice versa.
If each discharge sequence is configured to include 3 discharge cells, and there are 1 discharge cells overlapping each other between the discharge sequences, then the discharge sequences may be divided into 6 discharge sequences, as shown in fig. 4, where the first discharge sequence sq1 includes the discharge cell A, B, C, the second discharge sequence sq2 includes the discharge cell C, D, E, the third discharge sequence sq3 includes the discharge cell E, F, G, the fourth discharge sequence sq4 includes the discharge cell G, H, I, the fifth discharge sequence sq5 includes the discharge cell I, J, K, and the sixth discharge sequence sq6 includes the discharge cell K, L, A. If each discharge sequence is set to include 3 discharge cells, 1 discharge cell is overlapped between the partial discharge sequences, 2 discharge cells are overlapped between the partial discharge sequences, it may be divided into 5 discharge sequences, as shown in fig. 5, where the first discharge sequence sq1 includes the discharge cell A, B, C, D, the second discharge sequence sq2 includes the discharge cell C, D, E, F, the third discharge sequence sq3 includes the discharge cell F, G, H, I, the fourth discharge sequence sq4 includes the discharge cell H, I, J, K, and the fifth discharge sequence sq5 includes the discharge cell J, K, L, A.
Referring to fig. 6, a side view of a basket catheter is shown with 8 discharge cells 110 arranged in a circumferential direction, numbered a through H in sequence, each discharge cell 110 including three electrodes 111. The basket catheter shown in fig. 6 is shown in a distal elevation view in fig. 7 and 8, wherein only two of the electrodes of each discharge cell are shown. During discharge, one electrode is configured as ground, and the other electrode is configured with a high voltage pulse.
If each discharge sequence is configured to include 4 discharge cells, and there are 2 discharge cells overlapping each other, then the discharge sequences may be divided into 4 discharge sequences, as shown in fig. 7, where the first discharge sequence sq1 includes the discharge cell A, B, C, D, the second discharge sequence sq2 includes the discharge cell C, D, E, F, the third discharge sequence sq3 includes the discharge cell E, F, G, H, and the fourth discharge sequence sq4 includes the discharge cell G, H, A, B. If each discharge sequence is set to include 4 discharge cells, 1 discharge cell is overlapped between partial discharge sequences, and 2 discharge cells are overlapped between partial discharge sequences, it may be divided into 3 discharge sequences, as shown in fig. 8, where the first discharge sequence sq1 includes the discharge cell A, B, C, D, the second discharge sequence sq2 includes the discharge cell D, E, F, G, and the third discharge sequence sq3 includes the discharge cell G, H, A, B.
In some embodiments, to avoid repetition of discharge sequences, the number of discharge cells overlapping between adjacent two discharge sequences is less than the number of discharge cells of each of the two discharge sequences. Specifically, when the number of discharge cells included in different discharge sequences is the same, the number of discharge cells included in each discharge sequence is Nc, then the number of discharge cells overlapped between two adjacent discharge sequences should be less than Nc, and when the number of discharge cells included in different discharge sequences is different, assuming that the number of discharge cells of two adjacent discharge sequences are N1 and N2 respectively, then the number of discharge cells overlapped between the two discharge sequences should be less than both N1 and N2.
When each of the discharge sequences includes the same number of discharge cells and the number of discharge cells overlapped between adjacent discharge sequences is the same, the number of discharge sequences is determined by the following formula:
Wherein Nsq represents the number of discharge sequences, PE represents the total number of discharge cells in the pulse ablation catheter, N represents the number of discharge cells each discharge sequence comprises, 2N < PE, m represents the number of overlapping discharge cells between adjacent discharge sequences, 0m < N,Representing an upward rounding. Wherein, when there is no overlapping discharge cell between adjacent discharge sequences, m=0, and when there is overlapping discharge cell between adjacent discharge sequences, 1.ltoreq.m < n.
For example, for the division of the discharge sequences of the balloon catheter shown in fig. 4, the number of discharge sequences may be calculated as:
for the division manner of the discharge sequences of the basket catheter shown in fig. 7, the number of discharge sequences can be calculated as follows:
in some embodiments, if the discharge cells are arranged in the circumferential direction, the plurality of discharge sequences dispense the pulse electric fields in the order of one rotation in the circumferential direction, and if the discharge cells are arranged in the straight line, the plurality of discharge sequences dispense the pulse electric fields in the order from one end of the straight line to the other end of the straight line.
For example, the balloon catheter shown in fig. 4, the conventional method is to make 12 discharge units simultaneously emit pulsed electric fields, and in one embodiment of the present invention, each discharge sequence sequentially emits pulsed electric fields in the order from sq1 to sq6, as shown in fig. 9. The stimulation of the muscles is reduced by this way of batch discharge. For example, the balloon catheter shown in fig. 4 is divided into 12 discharge sequences in such a manner that each discharge sequence includes 2 discharge cells, and adjacent discharge cells have 1 discharge cell overlapping each other, wherein the first discharge sequence sq1 includes the discharge cell A, B, the second discharge sequence sq2 includes the discharge cell B, C, the third discharge sequence sq3 includes the discharge cell C, D, and so on, and the respective discharge sequences can be sequentially caused to emit pulsed electric fields in order from sq1 to sq12, as shown in fig. 10. Of course, the discharge sequence to be the starting point may be any other discharge sequence other than the sq1, for example, the discharge sequence may be started at the sq2, and the respective discharge sequences may be sequentially given a pulsed electric field in the order of the sq2, the sq3, the sq4, the sq5, the sq6, and the sq1 in fig. 4.
For the linear duct shown in fig. 2, when the number of overlapped discharge cells is the same, the respective discharge sequences may be sequentially given pulsed electric fields in the order of from sq1 to sq4 or from sq4 to sq1, and when the number of overlapped discharge cells may be different, the respective discharge sequences may be sequentially given pulsed electric fields in the order of from sq1 to sq5 or from sq5 to sq 1.
In some embodiments, the discharge sequence may sequentially deliver pulsed electric fields in any other order. For example, the balloon catheter shown in fig. 4 may have each discharge sequence sequentially deliver a pulsed electric field in the order of sq3, sq6, sq2, sq5, sq1, sq 4. The linear duct shown in fig. 2 can sequentially discharge the pulse electric fields in the order of sq3, sq1, sq2, sq4 when the number of overlapped discharge cells is the same, sequentially discharge the pulse electric fields in the order of sq3, sq4, sq2, sq5, sq1 when the number of overlapped discharge cells is different, and so on.
In some embodiments, the controller 200 is further configured to control the plurality of discharge sequence cycles to dispense the pulsed electric field a plurality of times. The discharge sequences sequentially perform the pulse electric field emission once to complete a cycle, for example, in fig. 4, the discharge sequences sequentially perform the pulse electric field emission once in the order from sq1 to sq6 to form a cycle, and then the discharge sequences sequentially perform the pulse electric field emission in the order from sq1 to sq6 to realize a plurality of cycles. The number of the cycles for performing the discharge of the multiple pulsed electric fields in the multiple discharge sequence cycles can be set according to practical needs, and is preferably 4 to 8.
In some embodiments, the magnitude of the pulsed electric field delivered by the discharge unit in the last cycle is equal or unequal to the magnitude of the pulsed electric field delivered by the discharge unit in the previous cycle. Specifically, the amplitude of the pulsed electric field emitted from the discharge unit from the first cycle to the last cycle may be kept constant, or may generally be in a trend of increasing or decreasing, or the amplitude of the pulsed electric field emitted a part of times may be increased compared to the amplitude of the pulsed electric field emitted a previous time, and the amplitude of the pulsed electric field emitted a part of times may be decreased compared to the amplitude of the pulsed electric field emitted a previous time. In order to enhance the depth of ablation and increase the therapeutic effect, the amplitude of the pulsed electric field emitted by the discharge unit in the last cycle may be equal to or greater than the amplitude of the pulsed electric field emitted by the discharge unit in the previous cycle.
In some embodiments, the increase or decrease in the magnitude of the pulsed electric field may be determined based on feedback of the degree of muscle stimulation of the patient. For example, the muscle stimulation level is detected by the stimulation intensity sensor, when the sensor data output by the stimulation intensity sensor is too large (for example, is larger than a set threshold value), the amplitude of the pulse electric field emitted by the discharge unit in the next cycle is reduced, and when the sensor data output by the stimulation intensity sensor is still in a proper range (for example, is smaller than or equal to the set threshold value), the amplitude of the pulse electric field emitted by the discharge unit in the next cycle is increased to enhance the ablation depth. The description of the stimulus intensity sensor is detailed below.
Referring to fig. 11, the pulse ablation device in some embodiments of the present invention further includes a stimulus intensity sensor 300, wherein the stimulus intensity sensor 300 is coupled to the controller 200 for detecting a physiological parameter indicative of the intensity of muscle stimulation of the patient and transmitting the physiological parameter to the controller 200. The stimulus intensity sensor 300 includes at least one of a blood pressure sensor, an electromyographic signal sensor, and a body surface acceleration sensor.
In some embodiments, the controller 200 is further configured to read the sensor data output by the stimulus intensity sensor 300 at intervals of a preset time interval, and if the sensor data is increased, increase the number of discharge sequences and decrease the number of discharge cells included in a part or all of the discharge sequences, and in some embodiments, if the sensor data is decreased, decrease the number of discharge sequences and increase the number of discharge cells included in a part or all of the discharge sequences. It can be understood that, in the stimulus intensity sensor 300, the sensor data output by the blood pressure sensor is the blood pressure of the patient, the sensor data output by the electromyographic signal sensor is the electromyographic signal of the muscle of the patient, and the sensor data output by the body surface acceleration sensor is the acceleration of the body surface movement (such as lifting the abdomen) of the patient.
Taking fig. 4 as an example, if the sensor data is increased, the number of discharge sequences may be increased to 12, the number of discharge units included in all the discharge sequences may be decreased to 2, to obtain 12 discharge sequences listed in fig. 10, or only the number of discharge sequences may be increased to 9, the number of discharge units included in part of the discharge sequences may be decreased to 2, then one division is that the first discharge sequence sq1 includes the discharge unit A, B, C, the second discharge sequence sq2 includes the discharge unit C, D, E, the third discharge sequence sq3 includes the discharge unit E, F, G, the fourth discharge sequence sq4 includes the discharge unit G, H, the fifth discharge sequence sq5 includes the discharge unit H, I, the sixth discharge sequence sq6 includes the discharge unit I, J, the seventh discharge sequence sq7 includes the discharge unit J, K, the eighth discharge sequence sq8 includes the discharge unit K, L, and the ninth discharge sequence sq9 includes the discharge unit L, A. If the sensor data is reduced, the number of discharge sequences may be reduced to 4, the number of discharge units included in the total discharge sequences may be increased to 4, wherein the first discharge sequence sq1 includes the discharge unit A, B, C, D, the second discharge sequence sq2 includes the discharge unit D, E, F, G, the third discharge sequence sq3 includes the discharge unit G, H, I, J, the fourth discharge sequence sq4 includes the discharge unit J, K, L, A, or the number of discharge sequences may be reduced to 5 only, and the number of discharge units included in the partial discharge sequences may be increased to 4, one division manner is that the first discharge sequence sq1 includes the discharge unit A, B, C, the second discharge sequence sq2 includes the discharge unit C, D, E, F, the third discharge sequence sq3 includes the discharge unit F, G, H, the fourth discharge sequence sq4 includes the discharge unit H, I, J, and the fifth discharge sequence sq5 includes the discharge unit J, K, L, A.
The sensor data may be considered to be reduced if the difference between the sensor data read at the current time and the sensor data read at the previous time is less than 0 and the absolute value is greater than the change threshold, and the sensor data may be considered to be increased if the difference between the sensor data read at the current time and the sensor data read at the previous time is greater than 0 and the absolute value is greater than the change threshold.
In this embodiment, when the sensor data is increased, it is indicated that the stimulus intensity is increased, and by increasing the number of discharge sequences and decreasing the number of discharge cells included in a part or all of the discharge sequences, the intensity of the pulsed electric field at each discharge can be decreased to thereby decrease muscle stimulus, and when the sensor data is decreased, the number of discharge sequences can be appropriately decreased to increase the number of discharge cells included in a part or all of the discharge sequences to thereby save operation time.
In some embodiments, the controller 200 is further configured to read the sensor data output by the stimulus intensity sensor 300 at intervals of a preset time interval, and if the sensor data is increased, decrease the amplitude and/or pulse width of the pulse electric field emitted by the discharge unit, and in some embodiments, if the sensor data is decreased, increase the amplitude and/or pulse width of the pulse electric field emitted by the discharge unit.
In the embodiment, when the sensor data is increased, the intensity of the pulse electric field emitted by the discharge unit can be reduced by reducing the amplitude and/or the pulse width of the pulse electric field emitted by the discharge unit, so that muscle stimulation is reduced, and when the sensor data is reduced, the treatment effect can be ensured and the operation time is saved by properly increasing the amplitude and/or the pulse width of the pulse electric field emitted by the discharge unit.
Based on the above pulse ablation device, the present invention further provides a method for controlling discharge of a pulse ablation catheter, which can be executed by the controller 200, please refer to fig. 12, and in one embodiment, the method includes steps 10-20.
Step 10, dividing a plurality of discharge units of the pulse ablation catheter into a plurality of discharge sequences, wherein each discharge sequence comprises at least two discharge units.
Wherein the number of discharge cells comprised by different discharge sequences may be the same or different. In some embodiments, there is at least one overlapping discharge cell between adjacent discharge sequences. In some embodiments, to avoid repetition of discharge sequences, the number of discharge cells overlapping between adjacent two discharge sequences is less than the number of discharge cells of each of the two discharge sequences. Please refer to the above related description for specific dividing manner of the discharge sequence, and the description is omitted herein.
And step 20, controlling a plurality of discharge sequences to sequentially emit the pulse electric fields according to a preset sequence.
The order in which the discharge sequences deliver the pulsed electric fields can be arbitrarily set. In some embodiments, if the discharge cells are arranged in the circumferential direction, the plurality of discharge sequences dispense the pulse electric fields in the order of one rotation in the circumferential direction, and if the discharge cells are arranged in the straight line, the plurality of discharge sequences dispense the pulse electric fields in the order from one end of the straight line to the other end of the straight line. Please refer to the above related description for specific discharging sequence, and the detailed description is omitted herein.
In some embodiments, the discharge control method of the present invention further comprises controlling a plurality of discharge sequence cycles to dispense the pulsed electric field a plurality of times. The number of the cycles for performing the discharge of the multiple pulsed electric fields in the multiple discharge sequence cycles can be set according to practical needs, and is preferably 4 to 8. In some embodiments, the amplitude of the pulse electric field emitted by the discharge unit in the last cycle is equal to or different from the amplitude of the pulse electric field emitted by the discharge unit in the previous cycle, and the description is omitted herein.
In some embodiments, the discharge control method further comprises reading sensor data output by the stimulation intensity sensor at intervals of a preset time interval, if the sensor data is increased, increasing the number of discharge sequences, and reducing the number of discharge units included in part or all of the discharge sequences, and in some embodiments, if the sensor data is reduced, reducing the number of discharge sequences, and increasing the number of discharge units included in part or all of the discharge sequences. Please refer to the above related descriptions, and the detailed descriptions are omitted herein.
In some embodiments, the discharge control method of the present invention further includes reading sensor data output by the stimulus intensity sensor at intervals of a preset time interval, and if the sensor data is increased, decreasing the amplitude and/or the pulse width of the pulse electric field emitted by the discharge unit, and in some embodiments, if the sensor data is decreased, increasing the amplitude and/or the pulse width of the pulse electric field emitted by the discharge unit.
The applicant has carried out experiments on the effects of the pulse ablation device and the discharge control method of the present invention using the balloon catheter shown in fig. 4 and the corresponding sequential division. An in vitro potato test was first performed and compared with the conventional method using a biphasic pulse waveform at a voltage of 800V, a sample size of 24, and the sample mean and sample standard deviation statistics for ablation depth as shown in table 1.
Table 1 effectiveness of the pulse ablation apparatus and discharge control method of the present invention compared to conventional methods
| Ablation pattern | Conventional method | The invention is that |
| Sample mean value (mm) of ablation depth | 5.52 | 5.90 |
| Standard deviation of samples of ablation depth | 1.06 | 0.88 |
And carrying out hypothesis test on test results, wherein the overall variance sigma2 of the test is unknown, and adopting t test to consider the significant level alpha=0.02, and carrying out t test on the sample mean mu. Let h0:μ Cis-cis＝μ As same as,H1：μ Cis-cis≠μ As same as,μ0 =0, where μ Cis-cis represents the overall ablation depth average with the pulse ablation device and discharge control method of the invention, μ As same as represents the overall ablation depth average with the conventional method, and μ0 represents the difference between the two overall ablation depth averages. If it isReject H0, otherwise accept H0, whereFor the mean of the differences between the two sets of samples, S* is the standard deviation of the samples, n0 is the sample size, t1-α/2(n0 -1) = 2.4999.
Finally calculate to obtainThe depth of damage of the pulse ablation device and the discharge control method of the present invention is considered to be the same as that of the conventional method, i.e., the same effectiveness, in receiving H0.
Next, an ablation experiment in animals was performed. 3 anatomical positions of the test pig are selected for experiments, namely balloon catheters are respectively placed in the superior vena cava, the right auricle and the right superior pulmonary vein of the test pig for ablation, and the ablation sample size is 8. The body surface accelerometer was fixed on the abdomen of a test pig, and acceleration data recorded in the Z-axis direction (the axis direction perpendicular to the operation table) of the test pig at the time of performing ablation by the conventional method and the pulse ablation device and discharge control method of the present invention are shown in table 2 (where g represents gravitational acceleration).
Table 2 comparison of stimulation intensity of the pulse ablation device and discharge control method of the present invention with conventional method
| Ablation pattern | Conventional method | The invention is that |
| Superior vena cava | 2.25±0.07g | 0.38±0.04g |
| Right auricle | 2.15±0.05g | 0.44±0.08g |
| Right superior pulmonary vein | 1.12±0.16g | 0.44±0.21g |
At acceleration <0.5g, no apparent muscle contraction was noted (ref: dong Shoulong, experimental and mechanistic studies of irreversible electroporation ablation of tumors with high frequency bipolar microsecond pulsed electric fields). It can be seen that the pulse ablation device and the discharge control method of the present invention have significantly less stimulation to the muscle than the conventional method, and the stimulation intensity is very small.
In summary, the pulse ablation device and the discharge control method of the present invention are the same as conventional methods in ablation effectiveness, but the stimulation to muscles is greatly reduced.
According to the pulse ablation device and the discharge control method of the pulse ablation catheter, provided by the embodiment of the invention, the plurality of discharge units on the pulse ablation catheter are divided into the plurality of discharge sequences, and the discharge sequences are controlled to sequentially emit the pulse electric fields according to the preset sequence, so that the discharge units emit the pulse electric fields in batches to perform ablation treatment instead of simultaneous discharge, the ablation treatment effect is ensured, and meanwhile, the stimulation to the muscles of a patient is greatly reduced, so that the pulse electric field ablation operation can be performed by adopting local anesthesia.
Those skilled in the art will appreciate that all or part of the functions of the 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 means of a computer program, the program may be stored in a computer-readable storage medium, which may include a read-only memory, a random access memory, a magnetic disk, an optical disk, a hard disk, etc., and the program is executed by a computer to implement the 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 functions described above can be realized. In addition, when all or part of the functions in the above embodiments are implemented by means of 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 disk, or a removable hard disk, and the program in the above embodiments may be implemented by downloading or copying the program into a memory of a local device or updating a version of a system of the local device, and when the program in the memory is executed by a processor.
The foregoing description of the invention has been presented for purposes of illustration and description, and is not intended to be limiting. Several simple deductions, modifications or substitutions may also be made by a person skilled in the art to which the invention pertains, based on the idea of the invention.