Method for determining ablation endpoint of intravascular nerve ablation and ablation device

Abstract

A method for determining an ablation endpoint of an intravascular nerve ablation, and an ablation device. The determination method comprises the following steps: setting target values and target change ranges of operating parameters, wherein the operating parameters at least include power, temperature, impedance, related operating parameters, ablation duration and the like; sending an ablation catheter to a target ablation position and confirming good electrode contact; periodically collecting operating parameter data at each electrode at set time intervals; and performing corresponding calculation processing on each round of collected data to obtain related processing data such as power, temperature, impedance difference, growth rate, maximum value, minimum value, maximum fluctuation range, and standard deviation; and comprehensively determining an ablation endpoint on the basis of collected data of the power, temperature, impedance, and ablation duration, and processed data of the power, temperature, and impedance.

Description

A method for determining the ablation endpoint of intravascular nerve ablation and an ablation device Technical Field

[0001] The present invention relates to a method for determining an ablation endpoint and also to a radiofrequency ablation device using the determination method, belonging to the technical field of medical devices. Background Art

[0002] Intravascular nerve ablation (IVNA) involves placing an ablation catheter at a specific location in the body through an interventional procedure. Radiofrequency energy is then used to destroy the nerve tissue surrounding the target blood vessels, achieving the desired ablation. It is commonly used to treat conditions related to nerve activity, such as hypertension and diabetes.

[0003] In the prior art, intravascular nerve ablation requires manual control or reliance on single means such as total energy output, single-point tissue impedance changes, and temperature changes to determine the ablation endpoint and terminate the ablation operation. This method cannot accurately determine the specific ablation process and ablation effect, and therefore cannot accurately determine the ablation endpoint. On the other hand, single-point impedance measurement is not comprehensive enough for the assessment of vascular damage and cannot completely avoid vasospasm that may occur during the ablation operation and a series of symptoms that may occur after the operation. Therefore, it is very necessary to provide a multi-parameter comprehensive judgment method for the endpoint of nerve ablation. Summary of the Invention

[0004] The primary technical problem to be solved by the present invention is to provide a method for determining the ablation endpoint of intravascular nerve ablation.

[0005] Another technical problem to be solved by the present invention is to provide an ablation device using the judgment method.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] According to a first aspect of an embodiment of the present invention, a method for determining an ablation endpoint of an intravascular nerve ablation procedure is provided, comprising the following steps:

[0008] (1) setting target values ​​and target variation ranges of operating parameters, the operating parameters including at least power, temperature, impedance, and ablation duration, as well as related operating parameters of the power, temperature, and impedance, and weights of the operating parameters, as well as an overall effective value threshold, a pass number threshold, and a continuous pass number threshold;

[0009] (2) Send the ablation catheter to the target ablation site and confirm that the electrode is well attached to the wall;

[0010] (3) cyclically collecting working parameter data at each electrode at set time intervals, including the power, temperature, impedance, and ablation duration data;

[0011] (4) Starting from the second round of data collection, corresponding calculation processing is performed on each round of data collection to obtain relevant processed data of the power, the temperature, and the impedance at each electrode; the relevant processed data includes the difference, maximum value, minimum value, maximum fluctuation range and standard deviation of the power, the temperature, and the impedance, as well as the growth rate when the power, the temperature, and the impedance all reach the set target variation range for the first time;

[0012] (5) Determine the ablation endpoint based on the collected data of the power, the temperature, the impedance, and the ablation duration, and the processed data of the power, the temperature, and the impedance.

[0013] Preferably, in step (1), the relevant working parameters include the difference and growth rate between the radio frequency power, the ablation temperature, and the tissue impedance in two consecutive acquisition data, and the maximum value, minimum value, and standard deviation value of the radio frequency power, the ablation temperature, and the tissue impedance in the current acquisition data.

[0014] Preferably, the step (3) includes the following sub-steps:

[0015] (31) In the monitoring mode, the impedance data between each electrode and the neutral electrode on the body surface, the impedance data between every two electrodes, and the temperature data at each electrode are collected;

[0016] (32) In radio frequency mode, the power data and the ablation duration data output to each electrode are collected.

[0017] Preferably, in step (4), the power difference Pd between each round of collected data and the previous round of collected data is ij , temperature difference Td ij , impedance difference Zd ij and Zd iij The calculation is as follows: Pd ij =P ij -P i(j-1) Td ij =T ij -T i(j-1) Zd ij =Z ij -Z i(j-1) Zd iij =Z iij -Z ii(j-1)

[0018] Wherein, j represents the jth round of data collection, j-1 represents the previous round of data collection; Pij and Tij are the power data and temperature data in the jth round of data collection, Zij and Ziij are the impedance data in the jth round of data collection; P i(j-1) 、T i(j-1) is the power data and temperature data in the j-1th round of data collection, Z i(j-1) and Z ii(j-1) is the impedance data in the j-1th round of data acquisition; i represents the electrode number, and ii represents the number between two electrodes.

[0019] Preferably, in step (4), after each round of data collection, it is determined whether the power data, temperature data, and impedance data all reach the set target variation range for the first time; if the three all reach the set target variation range for the first time, the growth rates of the power data, temperature data, and impedance data are calculated; if the three do not reach the set target variation range at the same time or not for the first time, the process proceeds to the next step;

[0020] When the power, temperature and impedance all reach the target range after the jth round of data collection, the power growth rate Pin ij , temperature growth rate Tin ij , impedance growth rate Zin ij and Zin iij The calculation of is as follows:

[0021] Wherein, j represents the jth round of data collection, Pij and Tij are the power data and temperature data in the jth round of data collection, Zij and Ziij are the impedance data in the jth round of data collection, and t j is the ablation duration in the jth round of data acquisition; i represents the electrode number, ii represents the number between two electrodes; P is 、T is are the initial power and temperature values ​​obtained from the first data collection, Z is and Z iis is the initial impedance value obtained from the first data acquisition.

[0022] Preferably, in step (4), after each round of data acquisition, the maximum power Pmax in the current ablation process is ij 、Minimum value Pmin ij and maximum fluctuation range PD ij The calculation is as follows: PD ij =Pmax ij -Pmin ij

[0023] After each round of data collection, the maximum temperature Tmax during the current ablation process ij , minimum value Tmin ij and maximum fluctuation range TD ij The calculation is as follows: TD ij =Tmax ij -Tmin ij

[0024] After each round of data collection, the maximum impedance Zmax during the current ablation process ij and Zmax iij 、Minimum value Zmin ij and Zmin iij And the maximum fluctuation range ZD ij and ZD iij The calculation is as follows: ZD ij =Zmax ij -Zmin ij ZD iij =Zmax iij -Zmin iij

[0025] Among them, j represents the jth round of data collection, n represents the order number of each round of data collection, P in To show the power value in each data collection, T in To show the temperature value in each data collection, Z in and Z iin Indicates the impedance value collected each time, i represents the electrode number, and ii represents the number between the two electrodes.

[0026] Preferably, in step (4), after each round of data acquisition, the power standard deviation Pstd in the current ablation process is ij , temperature standard deviation Tstd ij , impedance standard deviation Zstd ij and Zstd iij The calculation is as follows:

[0027] Among them, j represents the jth round of data collection, n represents the order number of each round of data collection, P in To show the power value in each data collection, T in To show the temperature value in each data collection, Z in and Z iin Indicates the impedance value collected each time, i represents the electrode number, and ii represents the number between the two electrodes.

[0028] Preferably, the step (5) includes the following sub-steps:

[0029] (51) After each round of data collection, calculate the effective value r of each parameter data k-j :

[0030] Wherein, j represents the jth round of data collection, k represents the number of the collected data and processed data obtained in a round of data collection, k = 1, 2, 3, ...; X k-j Represents specific collected data or processed data, ω k Represents the set weight corresponding to specific collected data or processed data, Y k Represents a set target value corresponding to specific collected data or processed data;

[0031] (52) Calculate the overall effective value N j :

[0032] Among them, 232 is the total number of collected data and processed data obtained in one round of data collection;

[0033] (53) Accumulation of the total number of qualified times Q and the maximum number of consecutive qualified times Q1:

[0034] The overall effective value after each round of data collection is compared with the set overall effective value threshold. When the overall effective value after data collection is greater than or equal to the overall effective value threshold, this data collection is recorded as a qualified number and added to the total qualified number (Q); at the same time, the maximum value of the consecutive qualified number (Q 1) is recorded.

[0035] Preferably, when the total number of qualified times obtained after a round of data collection reaches a set qualified times threshold, or when the maximum number of consecutive qualified times reaches a set consecutive qualified times threshold, it is determined that the ablation has reached the endpoint.

[0036] According to a second aspect of an embodiment of the present invention, a radiofrequency ablation device is provided, comprising an ablation catheter, an operating handle, and a radiofrequency ablation host, wherein the ablation catheter, the operating handle, and the radiofrequency ablation host are connected in sequence; wherein:

[0037] The front end of the ablation catheter is provided with a plurality of electrodes and a plurality of temperature sensing elements;

[0038] The radiofrequency ablation host at least includes a radiofrequency signal generating module and an ablation control module;

[0039] The ablation control module is used to control the entire ablation process and the ablation endpoint, and is composed of a processor and a memory, and the processor and the memory are coupled; wherein the memory is used to store a computer program, and the processor is used to run the computer program stored in the memory to execute the above-mentioned method for determining the ablation endpoint of intravascular nerve ablation.

[0040] Compared with existing technologies, the method for determining the ablation endpoint of intravascular nerve ablation provided by the present invention cyclically collects the power, temperature, impedance, and ablation duration operating parameters at each electrode. Through data processing, multiple power, temperature, and impedance related operating parameters are obtained. This allows for a precise and comprehensive assessment of the ablation progress and ablation endpoint, ensuring both the ablation effect and safety. Therefore, the method for determining the ablation endpoint of intravascular nerve ablation provided by the present invention has the beneficial effects of safety, accuracy, and optimized ablation effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] FIG1 is a schematic diagram of the operation of a typical radiofrequency ablation device in the prior art;

[0042] FIG2 is a schematic structural diagram of the ablation catheter and electrode arrangement in the above-mentioned radiofrequency ablation device;

[0043] FIG3 is a schematic diagram of a curve showing changes in power, temperature, and impedance during radiofrequency ablation in an embodiment of the present invention;

[0044] FIG4 is a flow chart of a method for determining an ablation endpoint of intravascular nerve ablation according to an embodiment of the present invention;

[0045] FIG5 is a schematic structural diagram of a radiofrequency ablation device provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0046] The technical content of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0047] As shown in Figures 1 and 2, a typical radiofrequency ablation device generates radiofrequency microcurrent to supply the ablation catheter and control the entire ablation process and ablation endpoint. The ablation catheter is placed at a designated location in the body through interventional surgery. When opened, the catheter takes on a basket-shaped columnar shape. Six electrodes are installed on the basket-shaped columnar catheter, which, in conjunction with neutral electrodes on the surface of the body, detect the tissue impedance of the ablation area. Each electrode is also equipped with a temperature sensor. During the ablation process, the system needs to monitor the changes in power, temperature, and impedance parameters at each electrode in real time to control the ablation process and determine the ablation endpoint. Figure 3 shows the real-time changes in power P5, temperature T5, and impedance Z5 at electrode 5 as a function of ablation duration t.

[0048] As shown in FIG4 , an embodiment of the present invention provides a method for determining the ablation endpoint of intravascular nerve ablation, comprising the following steps:

[0049] S1: Set the target value and target variation range of the working parameters. The working parameters include at least RF power, ablation temperature, tissue impedance and ablation duration, as well as related working parameters of RF power, ablation temperature and tissue impedance, and also include the weights of the above parameters, as well as the overall effective value threshold, the qualified number threshold and the connection qualified number threshold. Among them, the relevant working parameters include the difference and growth rate between the RF power, ablation temperature and tissue impedance in two consecutive acquisitions, as well as the maximum, minimum and standard deviation values ​​of the RF power, ablation temperature and tissue impedance in the current acquisition data.

[0050] Radiofrequency power refers to the radiofrequency signal power output to each electrode during ablation, hereinafter referred to as power, with a target value of P and a target variation range of [P L , P H ] RF power is an important working parameter that affects ablation effect and ablation safety. Its target value setting varies depending on the ablation area. During the ablation process, the system dynamically adjusts the RF power within the power target variation range based on temperature data.

[0051] Ablation temperature refers to the tissue temperature at each electrode during the ablation process, hereinafter referred to as temperature, with a target value of T and a target variation range of [T L , T H ]. Ablation temperature is also an important working parameter that affects the ablation effect and ablation safety. For safety reasons, the ablation temperature is usually set at 60°C. At this ablation temperature, it takes a period of time for nerve cells to be irreversibly destroyed.

[0052] Tissue impedance refers to the tissue impedance between each electrode and the neutral electrode on the body surface and the tissue impedance between each two electrodes, hereinafter referred to as impedance. Its target value is Z and the target variation range is [Z L , Z H ]. During the normal ablation process, as the nerves are damaged by high temperature, the tissue impedance value will gradually decrease. Therefore, real-time detection of tissue impedance value can monitor the state of the tissue and the ablation effect during nerve ablation. When the impedance value changes abnormally, it means that there is a problem with the electrode wall during the ablation process, and the system needs to stop ablation or make adjustments. By monitoring the impedance value changes between each electrode, the changes in the nerve tissue between each two electrodes during the ablation process can be more comprehensively evaluated, and thus the ablation effect can be more carefully evaluated to ensure that the ablation is completed without damaging the blood vessel wall.

[0053] S2: Send the ablation catheter to the target ablation site and confirm that the electrode is well attached to the wall.

[0054] Electrode adhesion is determined based on the impedance value reported by each electrode, which can be displayed and confirmed on the display. Generally, when the impedance value is within the range of 50Ω to 500Ω, the electrode adhesion is confirmed to be good. If the impedance value exceeds this range, it is considered that the electrode adhesion is abnormal, and the system will issue an early warning.

[0055] S3: Cyclic acquisition of operating parameter data at each electrode, including power data, temperature data, impedance data, and ablation duration data. The first acquisition of each parameter data is called the initial value. After the first acquisition, data acquisition is repeated every set time interval. In one embodiment of the present invention, the set time interval is 0.5 seconds. The specific process of each data acquisition is as follows:

[0056] S31: In the monitoring mode, the impedance data between each electrode and the neutral electrode on the body surface is collected as the first impedance data, the impedance data between every two electrodes is collected as the second impedance data, and the temperature data at each electrode is collected.

[0057] In each data collection, there are six electrodes on the catheter, numbered i, where i = 1, 2, 3, 4, 5, and 6. The numbering between two electrodes is ii, for a total of 15 numbers, such as 12, 13, 14, 23, 24, and 25. Therefore, each data collection yields six temperature data points, six first impedance data points, and 15 second impedance data points, for a total of 21 impedance data points.

[0058] S32: In radio frequency mode, power data and ablation duration data output to each electrode are collected.

[0059] In each data acquisition, the power data is collected in 6 data points and the ablation duration is collected in 1 data point. Therefore, each acquisition generates 34 data points, which is called a round of acquisition data. This data is stored in real time and transmitted to the data processing module for corresponding data processing.

[0060] S4: Starting with the second round of data collection, each round of data is processed accordingly to obtain the power, temperature, and impedance related data at each electrode. This related processed data includes the difference, maximum value, minimum value, maximum fluctuation range, and standard deviation of power, temperature, and impedance, as well as the growth rate when power, temperature, and impedance first reach the set target fluctuation range.

[0061] S41: Calculate the corresponding differences of power data, temperature data, and impedance data between each round of collected data and the previous round of collected data to obtain the change value of each parameter.

[0062] Assume that in the jth round of data collection, the power data is Pij, the temperature data is Tij, and the impedance data are Zij and Ziij; where i represents the electrode number 1, 2, 3, 4, 5, 6, and Zii represents the impedance data between 15 electrodes. The difference between each parameter is calculated as follows: Pd ij =P ij -P i(j-1) (1)

[0063] Among them, Pd ij is the difference between the power collected in round j and round j-1; P i(j-1) Td is the power value collected in the j-1th round. ij =T ij -T i(j-1) (2)

[0064] Among them, Td ij is the difference between the temperature collected in round j and round j-1; T i(j-1) is the temperature value collected in the j-1 round. ij =Z ij -Z i(j-1) , Zd iij =Z iij -Z ii(j-1) (3)

[0065] Among them, Zd ij and Zd iij It represents the difference between the acquisition impedance of round j and round j-1; Z i(j-1) and Z ii(j-1) Indicates the impedance value collected in the j-1th round.

[0066] Each round of data collection is calculated by the above formulas (1) to (3), and 6 power difference data, 6 temperature difference data and 21 impedance difference data are obtained respectively.

[0067] S42: After each round of data collection, it is determined whether the power data, temperature data, and impedance data all reach the set target variation range for the first time ([P L , P H ]、[T L , T H ]、[Z L , Z H ]); if all three reach the set target variation range for the first time, the growth rates of the power data, temperature data, and impedance data are calculated; if all three do not reach the set target variation range at the same time or not for the first time, proceed to the next step.

[0068] Assume that the initial power value collected for the first time is Pis , the initial temperature is T is , the initial impedance value is Z is and Z iis , the ablation time is zero; in the jth round of data collection, the power data Pij, temperature data Tij, impedance data Zij and Ziij all reach the set target variation range, and the ablation time is t j The growth rate of each parameter data is calculated as follows:

[0069] Among them, Pin ij is the growth rate of the collection power in the jth round.

[0070] Among them, Tin ij is the growth rate of the temperature collected in the jth round.

[0071] Among them, Zin ij and Zin iij is the growth rate of the acquisition impedance in the jth round.

[0072] The jth round of data collection is calculated using formulas (4) to (6) above, yielding six power growth rate data, six temperature growth rate data, and 21 impedance growth rate data. It should be noted that the power, temperature, and impedance growth rate data are calculated only once when all three reach the set target variation range for the first time. This data value is always referenced in subsequent endpoint judgments.

[0073] S43: After each round of data collection, the maximum value, minimum value, and maximum fluctuation range of the power data, temperature data, and impedance data in the current ablation process are calculated.

[0074] First, calculate the maximum, minimum, and maximum fluctuation range of the power data as follows: PD ij =Pmax ij -Pmin ij (9)

[0075] Among them, Pmax ij 、Pmin ij , PD ij They are the maximum, minimum, and maximum fluctuation range of the power after the jth round of data collection and during the current ablation process; n represents the order number of each round of data collection, P in Indicates the power value collected each time.

[0076] Each round of data collection is calculated using the above formulas (7) to (9) to obtain 6 maximum power values, 6 minimum power values, and 6 maximum power fluctuation ranges.

[0077] Secondly, calculate the maximum value, minimum value and maximum fluctuation range of the temperature data as follows: TD ij =Tmax ij -Tmin ij (12)

[0078] Among them, Tmax ij 、Tmin ij , TD ij are the maximum, minimum, and maximum fluctuation range of the temperature after the jth round of data collection and during the current ablation process; n represents the order number of each round of data collection, T in Indicates the temperature value collected each time.

[0079] Each round of data collection is calculated using the above formulas (10) to (12) to obtain 6 maximum temperature values, 6 minimum temperature values, and 6 maximum temperature fluctuation ranges.

[0080] Next, calculate the maximum, minimum, and maximum fluctuation range of the impedance data as follows: ZD ij =Zmax ij -Zmin ij , ZD iij =Zmax iij -Zmin iij (15)

[0081] Among them, Zmax ij and Zmax iij 、Zmin ij and Zmin iij 、ZD ij and ZD iij are the maximum value, minimum value, and maximum fluctuation range of impedance after the jth round of data collection and during the current ablation process; n represents the order number of each round of data collection, and Z in and Z iin Indicates the impedance value of each acquisition.

[0082] Each round of data collection is calculated by the above formulas (13) to (15), and 21 impedance maximum values, 21 impedance minimum values ​​and 21 impedance maximum fluctuation ranges are obtained respectively.

[0083] S44: After each round of data collection, the standard deviation of the impedance data, temperature data, and power data in the current ablation process is calculated.

[0084] Among them, Pstd ij 、Tstd ij 、Zstd ij and Zstd iij are the standard deviation of power, temperature, and impedance after the jth round of data collection and during the current ablation process; n represents the order number of each round of data collection, P in 、T in 、Z in and Z iin Indicates the power value, temperature value, and impedance value collected each time.

[0085] Each round of data collection is calculated by the above formulas (16) to (18), and 6 power standard deviation data, 6 temperature standard deviation data and 21 impedance standard deviation data are obtained respectively.

[0086] In one embodiment of the present invention, each round of collected data is processed through the above steps S41 to S44 to obtain a total of 198 parameter data called processed data, plus 34 collected data, for a total of 232 parameter data.

[0087] S5: Determine the ablation endpoint based on the collected data of power, temperature, impedance and ablation duration and the processed data of power, temperature and impedance.

[0088] Each round of collected data and processed data is compared with the respective set target values ​​to determine whether each data reaches the set target value, and then the following method is used to determine whether the ablation endpoint is reached.

[0089] The collected data and processed data obtained in each round of data collection are recorded as X k-j , the target value of each parameter is recorded as Y k , the weight value of each parameter is recorded as ω k ; Among them, j represents the number of times of a round of data collection, that is, the jth data collection; k represents the number of collected data and processed data obtained in a round of data collection, k = 1, 2, 3, ... 232.

[0090] The determination of the ablation endpoint and related calculations are as follows:

[0091] S51: Calculate the effective value r of each parameter data k-j :

[0092] Among them, through the calculation of formula (19), when the collected data value of a certain parameter reaches (is greater than or equal to) the set target value, its effective value is 1, otherwise it is 0.

[0093] S52: Calculate the overall effective value Nj :

[0094] By calculating formula (20), the set weights of the parameter data that reach the set target value are accumulated to obtain the overall effective value after each round of data collection.

[0095] S53: Accumulation of the total number of qualified times Q and the maximum number of consecutive qualified times Q1:

[0096] The total effective value N after each round of data collection j Compared with the set overall effective value threshold M, when the overall effective value N after data collection is j When the value is greater than or equal to the overall effective value threshold M, this data collection is recorded as a qualified number and accumulated in the total qualified number Q. Among them, the maximum value Q1 of the consecutive qualified number will also be statistically recorded.

[0097] Determination of the ablation endpoint: When the total number of qualified times Q obtained after a round of data collection reaches the set qualified times threshold, or when the maximum value of the consecutive qualified times Q1 reaches the set consecutive qualified times threshold, it is determined that the ablation has reached the endpoint.

[0098] In one embodiment of the present invention, for different ablation areas, the set qualified times threshold range is 60-200, and the set continuous qualified times threshold range is 40-120.

[0099] The above is a detailed description of the method for determining the ablation endpoint of intravascular nerve ablation provided by an embodiment of the present invention. Based on the method for determining the ablation endpoint, an embodiment of the present invention further provides a radiofrequency ablation device. As shown in Figure 5, the radiofrequency ablation device includes an ablation catheter, an operating handle and a radiofrequency ablation host, and the ablation catheter, the operating handle and the radiofrequency ablation host are connected in sequence; wherein, a plurality of electrodes and a plurality of temperature sensing elements are provided at the front end of the ablation catheter. The radiofrequency ablation host includes at least a radiofrequency signal generating module and an ablation control module, and the ablation control module is used to control the entire ablation process and the ablation endpoint, and is composed of one or more processors and memories. wherein, the memory is coupled to the processor for storing one or more computer programs, and when the one or more computer programs are executed by one or more processors, the one or more processors implement the method for determining the ablation endpoint of intravascular nerve ablation as in the above embodiment. wherein, the processor is used to control the overall operation of the radiofrequency ablation device to complete all or part of the steps of the above-mentioned method for determining the ablation endpoint of intravascular nerve ablation. The processor module may be a central processing unit (CPU), a graphics processing unit (GPU), a field programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a digital signal processing (DSP) chip, etc. The memory is used to store various types of data to support operations on the radiofrequency ablation device. Such data may include, for example, instructions for any application or method used to operate the ablation device, as well as application-related data. The memory module may be implemented by any type of volatile or non-volatile storage device or a combination thereof, such as static random access memory (SRAM), electrically erasable programmable read-only memory (EEPROM), erasable programmable read-only memory (EPROM), programmable read-only memory (PROM), read-only memory (ROM), magnetic memory, flash memory, etc.

[0100] In summary, compared with the prior art, the method for determining the ablation endpoint of intravascular nerve ablation provided by the embodiment of the present invention cyclically collects the power, temperature, impedance, and ablation duration working parameters at each electrode, and obtains multiple power, temperature, and impedance related working parameters through data processing, thereby achieving an accurate comprehensive judgment of the ablation process and ablation endpoint to ensure the ablation effect and ablation safety. Therefore, the method for determining the ablation endpoint of intravascular nerve ablation provided by the embodiment of the present invention has the beneficial effects of safety, accuracy, and optimized ablation effect.

[0101] It should be noted that the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Therefore, features defined as "first" or "second" may explicitly or implicitly include one or more of such features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0102] The above describes in detail the method for determining the ablation endpoint of intravascular nerve ablation and the ablation device provided by the present invention. For those skilled in the art, any obvious modification made to the present invention without departing from the essence of the present invention will constitute an infringement of the patent rights of the present invention and will result in corresponding legal liability.

Claims

1. A method for determining the ablation endpoint of intravascular nerve ablation, characterized in that The steps include: (1) setting target values and target variation ranges of operating parameters, the operating parameters including at least power, temperature, impedance, and ablation duration, as well as related operating parameters of the power, temperature, and impedance, and weights of the operating parameters, as well as an overall effective value threshold, a pass number threshold, and a continuous pass number threshold; (2) Send the ablation catheter to the target ablation site and confirm that the electrode is well attached to the wall; (3) cyclically collecting working parameter data at each electrode at set time intervals, including the power, temperature, impedance, and ablation duration data; (4) Starting from the second round of data collection, corresponding calculation processing is performed on each round of data collection to obtain relevant processed data of the power, the temperature, and the impedance at each electrode; The relevant processed data includes the difference, maximum value, minimum value, maximum fluctuation range and standard deviation of the power, temperature and impedance, as well as the growth rate when the power, temperature and impedance all reach the set target variation range for the first time; (5) Determine the ablation endpoint based on the collected data of the power, the temperature, the impedance, and the ablation duration, and the processed data of the power, the temperature, and the impedance.

2. The method for judging the ablation endpoint of endovascular nerve ablation as described in claim 1, wherein In step (1), the relevant working parameters include the difference and growth rate between the radio frequency power, the ablation temperature, and the tissue impedance in two consecutive acquisition data, and the maximum value, minimum value, and standard deviation value of the radio frequency power, the ablation temperature, and the tissue impedance in the current acquisition data.

3. The method for determining the ablation endpoint of endovascular nerve ablation as described in claim 1, wherein The step (3) includes the following sub-steps: (31) In the monitoring mode, the impedance data between each electrode and the neutral electrode on the body surface, the impedance data between every two electrodes, and the temperature data at each electrode are collected; (32) In radio frequency mode, the power data and the ablation duration data output to each electrode are collected.

4. The method for determining the ablation endpoint of endovascular nerve ablation according to claim 1, characterized in that In the said step (4), the power difference Pd ij , temperature difference Td ij , impedance difference Zd ij and Zd iij are calculated as follows: Pd ij = P ij - P i(j-1) Td ij = T ij - T i(j-1) Zd ij = Z ij - Z i(j-1) Zd iij = Z iij - Z ii(j-1) Among them, j represents the j-th round of data acquisition, and j - 1 represents the previous round of data acquisition; Pij and Tij are the power data and temperature data in the j-th round of data acquisition, and Zij and Ziij are the impedance data in the j-th round of data acquisition; P i(j-1) , T i(j-1) are the power data and temperature data in the (j - 1)-th round of data acquisition, and Z i(j-1) and Z ii(j-1) are the impedance data in the (j - 1)-th round of data acquisition; i represents the electrode number, and ii represents the number between two electrodes.

5. The method for determining the ablation endpoint of endovascular nerve ablation as claimed in claim 1, wherein In the step (4), after each round of data collection, it is determined whether the power data, temperature data, and impedance data all reach the set target variation range for the first time; if the three all reach the set target variation range for the first time, the growth rates of the power data, temperature data, and impedance data are calculated; if the three do not reach the set target variation range at the same time or not for the first time, the process proceeds to the next step; When the power, temperature, and impedance all reach the set target change range after the data collection in the j-th round, the power growth rate Pin ij , the temperature growth rate Tin ij , the impedance growth rate Zin ij and Zin iij are calculated as follows: Among them, j represents the j-th round of data acquisition, Pij and Tij are the power data and temperature data in the j-th round of data acquisition, Zij and Ziij are the impedance data in the j-th round of data acquisition, and t j is the ablation duration in the j-th round of data acquisition; i represents the electrode number, and ii represents the number between two electrodes; P is and T is are the initial power value and initial temperature value obtained from the first data acquisition, Z is and Z iis are the initial impedance values obtained from the first data acquisition.

6. The method for determining the ablation endpoint of endovascular nerve ablation according to claim 1, characterized in that In the step (4), after collecting data in each round, the maximum value Pmax of the power during the current ablation process ij , the minimum value Pmin ij and the maximum fluctuation range PD ij are calculated as follows: PD ij = Pmax ij - Pmin ij After each round of data acquisition, the maximum temperature Tmax ij , the minimum temperature Tmin ij and the maximum fluctuation range TD ij are calculated as follows: TD ij = Tmax ij - Tmin ij After each round of data collection, the maximum value of impedance Zmax during the current ablation process ij and Zmax iij 、the minimum value Zmin ij and Zmin iij and the maximum fluctuation range ZD ij and ZD iij are calculated as follows: ZD ij = Zmax ij - Zmin ij ZD iij = Zmax iij - Zmin iij Among them, j represents the j-th round of data acquisition, n represents the sequence number of the data collected in each round, and P in represents the power value in each data acquisition, and T in represents the temperature value in each data acquisition, and Z in and Z iin represent the impedance value of each acquisition. i represents the electrode number, and ii represents the number between two electrodes.

7. The method for determining the ablation endpoint of endovascular nerve ablation according to claim 1, characterized in that In the step (4), after collecting data in each round, the power standard deviation Pstd ij , the temperature standard deviation Tstd ij , the impedance standard deviation Zstd ij and Zstd iij are calculated as follows: Among them, j represents the j-th round of data acquisition, n represents the sequence number of the data acquired in each round, and P in represents the power value in each acquired data, and T in represents the temperature value in each acquired data, Z in and Z iin represent the impedance value of each acquisition. i represents the electrode number, and ii represents the number between two electrodes.

8. The method for determining the ablation endpoint of endovascular nerve ablation as claimed in claim 1, wherein The step (5) includes the following sub-steps: After collecting data in each round, calculate the effective value r of each parameter data k-j : Among them, j represents the j-th round of data acquisition, k represents the number of the acquired data and processed data obtained from one round of data acquisition, k = 1, 2, 3, ……; X k-j represents the specific acquired data or processed data, ω k represents the set weight corresponding to the specific acquired data or processed data, Y k represents the set target value corresponding to the specific acquired data or processed data; (52) Calculate the overall effective value N j : Among them, 232 is the total number of collected data and processed data obtained in one round of data collection; (53) Accumulation of the total number of qualified times Q and the maximum number of consecutive qualified times Q1: Compare the overall effective value after each round of data collection with the set overall effective value threshold. When the overall effective value after data collection is greater than or equal to the overall effective value threshold, this data collection is recorded as a qualified number and added to the total qualified number (Q); at the same time, record the maximum value of the consecutive qualified number (Q1).

9. The method for determining the ablation endpoint of intravascular nerve ablation according to claim 8, wherein: When the total number of qualified times obtained after a round of data collection reaches the set qualified times threshold, or when the maximum number of consecutive qualified times reaches the set consecutive qualified times threshold, it is determined that the ablation has reached the end point.

10. A radiofrequency ablation device, characterized in that It includes an ablation catheter, an operating handle and a radiofrequency ablation host, wherein the ablation catheter, the operating handle and the radiofrequency ablation host are connected in sequence; wherein, The front end of the ablation catheter is provided with a plurality of electrodes and a plurality of temperature sensing elements; The radiofrequency ablation host at least includes a radiofrequency signal generating module and an ablation control module; The ablation control module is used to control the entire ablation process and the ablation endpoint, and is composed of a processor and a memory, and the processor and the memory are coupled; wherein the memory is used to store a computer program, and the processor is used to run the computer program stored in the memory to execute the method for determining the ablation endpoint of intravascular nerve ablation as described in any one of claims 1 to 9.

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