Readable storage medium, ablation system, and electronic device

Abstract

The application provides a readable storage medium, an ablation system and an electronic device, the readable storage medium stores a computer program, and the computer program is executed by a processor to implement the following steps: controlling an ablation catheter to apply pulse energy to target tissue, and acquiring an electric field energy value and an impedance value in an ablation process; calculating a theoretical ablation lesion size according to the electric field energy value and the impedance value; judging whether a difference between the theoretical ablation lesion size and a target ablation lesion size is within a first preset range; if yes, controlling the ablation catheter to stop applying the pulse energy to the target tissue; and if no, controlling the ablation catheter to continue applying the pulse energy to the target tissue until the difference between the theoretical ablation lesion size and the target ablation lesion size is within the first preset range. The application can realize the prediction of the pulse ablation effect, effectively improve the success rate of the pulse ablation operation, and avoid irreversible thermal damage to the tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a readable storage medium, an ablation system, and an electronic device. Background Technology

[0002] Pulsed ablation is an emerging treatment for atrial fibrillation. Unlike traditional cold / thermal ablation, pulsed electric field ablation uses an irreversible electroporation mechanism, employing high-voltage, short-duration pulse sequences to cause tissue damage. Studies have shown a strong correlation between the duration and electric field intensity of pulsed electric field ablation and cell electroporation damage. As the duration or electric field intensity increases, cells gradually transition from reversible to irreversible electroporation, resulting in an ablation foci in the target tissue. However, to achieve therapeutic efficacy, an ablation foci of appropriate size needs to be formed; controlling the size of the ablation foci remains a critical challenge.

[0003] It should be noted that the information disclosed in the background section of this invention is intended only to enhance the understanding of the general background of this invention, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0004] The purpose of this invention is to provide a readable storage medium, an ablation system, and an electronic device that can solve the problem in the prior art of not being able to effectively control the size of the pulse ablation lesion, thereby improving the success rate of pulse ablation surgery and avoiding irreversible thermal damage to tissues.

[0005] To achieve the above objectives, the present invention provides a readable storage medium storing a computer program. When the computer program is executed by a processor, it performs the following steps: controlling an ablation catheter to apply pulsed energy to a target tissue and acquiring the electric field energy value and impedance value during the ablation process; calculating the theoretical ablation lesion size based on the electric field energy value and the impedance value; determining whether the difference between the theoretical ablation lesion size and the target ablation lesion size is within a first preset range; if yes, controlling the ablation catheter to stop applying pulsed energy to the target tissue; if no, controlling the ablation catheter to continue applying pulsed energy to the target tissue until the difference between the theoretical ablation lesion size and the target ablation lesion size is within the first preset range.

[0006] Optionally, when the computer program is executed by the processor, it also performs the following steps: obtaining the energy utilization efficiency during the ablation process.

[0007] The step of calculating the theoretical ablation stoker size based on the electric field energy value and the impedance value includes: calculating the theoretical ablation stoker size based on the electric field energy value, the impedance value, and the energy utilization rate.

[0008] Optionally, obtaining the energy utilization efficiency during the ablation process includes: obtaining the impedance change value during the ablation process; and obtaining the energy utilization efficiency based on the impedance change value and the following formula.

[0009]

[0010] Where C is the energy efficiency, R0 is the impedance value before ablation begins, and R T The impedance value at time T after the start of ablation, (R0-R T ) represents the impedance change value.

[0011] Optionally, the energy efficiency rate is a preset value, which is between 0.15 and 0.35.

[0012] Optionally, a pressure sensor is provided at the distal end of the ablation catheter, the pressure sensor being used to detect the value and direction of the contact force between the distal end of the ablation catheter and the target tissue.

[0013] The method for obtaining the energy efficiency during the ablation process includes: obtaining the contact angle between the distal end of the ablation catheter and the target tissue based on the direction of the contact force detected by the pressure sensor; determining the energy efficiency based on the contact angle between the distal end of the ablation catheter and the target tissue, wherein the energy efficiency increases as the contact angle between the distal end of the ablation catheter and the target tissue decreases.

[0014] Optionally, calculating the theoretical ablation zone size based on the electric field energy value, the impedance value, and the energy utilization rate includes: calculating the theoretical ablation zone size based on the electric field energy value, the impedance value, the energy utilization rate, and the contact force value between the distal end of the ablation catheter and the target tissue.

[0015] Optionally, the theoretical ablation zone size is calculated based on the electric field energy value, the impedance value, the energy utilization rate, and the contact force between the distal end of the ablation catheter and the target tissue, including calculating the theoretical ablation zone volume according to the following formula.

[0016]

[0017] In the formula, V(T) is the theoretical ablation zone volume at time T after the start of ablation, C is the energy efficiency, and R... t W represents the impedance value at time t after the start of ablation; t F is the electric field energy at time t after the ablation begins. tThe contact force between the distal end of the ablation catheter and the target tissue at time t after the start of ablation is given by K, where K is a proportionality constant, and α, β, and γ are all exponents not equal to 1.

[0018] Optionally, the theoretical ablation zone size is the theoretical ablation zone volume, and the target ablation zone size is the target ablation zone volume.

[0019] Optionally, when the computer program is executed by the processor, it also performs the following steps: calculating the theoretical ablation lesion depth based on the theoretical ablation lesion volume and the following formula.

[0020] V = kD 3

[0021] Where D is the theoretical ablation depth, and k is a proportionality constant; the theoretical ablation depth is the theoretical ablation foci size, and the target ablation depth is the target ablation foci size.

[0022] Optionally, when the computer program is executed by the processor, it further implements the following steps: before controlling the ablation catheter to apply pulse energy to the target tissue, determining whether the distal end of the ablation catheter is in contact with the target tissue.

[0023] Optionally, a pressure sensor is provided at the distal end of the ablation catheter, the pressure sensor being used to detect the contact force between the distal end of the ablation catheter and the target tissue; determining whether the distal end of the ablation catheter is in contact with the target tissue includes: determining whether the contact force value detected by the pressure sensor is greater than or equal to a first threshold; if so, then determining that the distal end of the ablation catheter is in contact with the target tissue.

[0024] Optionally, when the computer program is executed by the processor, it also performs the following steps: before controlling the ablation catheter to apply pulse energy to the target tissue, it determines whether the circuit between the energy output device for delivering pulse energy to the ablation catheter and the ablation catheter is in a short-circuit state.

[0025] Optionally, determining whether the circuit between the energy output device for delivering pulse energy to the ablation catheter and the ablation catheter is in a short-circuit state includes: determining whether the impedance value before ablation is greater than a second threshold; if not, determining that the circuit between the energy output device and the ablation catheter is in a short-circuit state.

[0026] Optionally, when the computer program is executed by the processor, it further performs the following steps: before controlling the ablation catheter to apply pulse energy to the target tissue, selecting pulse parameters and calculating the pulse dose based on the pulse parameters; determining whether the pulse dose is within a second preset range; if not, reselecting the pulse parameters until the pulse dose is within the second preset range.

[0027] Optionally, calculating the pulse dose based on the pulse parameters includes: calculating the pulse dose according to the following formula.

[0028] Dose = U 2 ·a·d·b·n

[0029] In the formula, Dose is the pulse dose, U is the pulse voltage, a is the number of pulses in a single pulse train, d is the number of pulse trains in a single ablation, b is the pulse width, and n is the number of ablation cycles.

[0030] Optionally, when the computer program is executed by the processor, it also performs the following steps: calculating the maximum current threshold during the ablation process based on the parameter information of the electrode wires in the ablation catheter.

[0031] Optionally, when the computer program is executed by the processor, it also performs the following steps: calculating the minimum impedance threshold during the ablation process based on the maximum current threshold.

[0032] Optionally, when the computer program is executed by the processor, it further performs the following steps: real-time determination of whether the impedance value during the ablation process is greater than the minimum impedance threshold.

[0033] To achieve the above objectives, the present invention also provides an ablation system, including an ablation catheter, an energy output device, and a controller. The ablation catheter and the energy output device are both communicatively connected to the controller. The energy output device is configured to output pulsed energy to the ablation catheter. The controller includes the readable storage medium described above.

[0034] Optionally, a pressure sensor is provided at the distal end of the ablation catheter, the pressure sensor being used to detect the value and direction of the contact force between the distal end of the ablation catheter and the target tissue; the controller is further configured to obtain the contact angle between the distal end of the ablation catheter and the target tissue based on the direction of the contact force detected by the pressure sensor; the ablation system further includes a display device communicatively connected to the controller, the display device being configured to display in real time the impedance value, the value and direction of the contact force between the distal end of the ablation catheter and the target tissue, and the contact angle between the distal end of the ablation catheter and the target tissue.

[0035] Optionally, the distal end of the ablation catheter is further provided with a temperature sensor, which is used to detect the ablation temperature of the target tissue.

[0036] To achieve the above objectives, the present invention also provides an electronic device, including a processor and the readable storage medium described above.

[0037] Compared with existing technologies, the readable storage medium, ablation system, and electronic device provided by this invention have the following advantages: When the computer program stored in the readable storage medium provided by this invention is executed by a processor, it performs the following steps: controlling the ablation catheter to apply pulse energy to the target tissue and acquiring the electric field energy value and impedance value during the ablation process; calculating the theoretical ablation lesion size based on the electric field energy value and the impedance value; then determining whether the difference between the theoretical ablation lesion size and the target ablation lesion size is within a first preset range; if so, stopping the application of pulse energy to the target tissue; if not, continuing to apply pulse energy to the target tissue until the difference between the theoretical ablation lesion size and the target ablation lesion size is within the first preset range. Therefore, this invention, by calculating the theoretical ablation lesion size in real time during pulse ablation and comparing it with the target ablation lesion size, can predict the pulse ablation effect, effectively improve the success rate of pulse ablation surgery, and avoid irreversible thermal damage to tissue.

[0038] Since the ablation system and electronic device provided by this invention belong to the same inventive concept as the readable storage medium provided by this invention, the ablation system and electronic device provided by this invention have all the advantages of the readable storage medium provided by this invention. Therefore, the beneficial effects of the ablation system and electronic device provided by this invention will not be described in detail here. Attached Figure Description

[0039] Figure 1 This is a schematic diagram illustrating the workflow of a readable storage medium provided according to an embodiment of the present invention.

[0040] Figure 2 This is a schematic diagram illustrating the measurement principle of a pressure sensor according to an embodiment of the present invention.

[0041] Figure 3 This is a schematic diagram of force vector decomposition provided for one embodiment of the present invention.

[0042] Figure 4 This diagram illustrates the force vector and electric field influence area when the distal end of the ablation catheter is horizontally attached to the target tissue.

[0043] Figure 5 This diagram illustrates the force vector and electric field influence area when the distal end of the ablation catheter is perpendicularly attached to the target tissue.

[0044] Figure 6 This is a schematic diagram illustrating the relationship between the size of the ablation furnace and the electric field energy, provided in one embodiment of the present invention.

[0045] Figure 7 The discrete distribution histogram of experimental data on the effective utilization rate of pulse energy provided in one embodiment of the present invention.

[0046] Figure 8 A normal distribution diagram of experimental data on the effective utilization rate of pulse energy provided in one embodiment of the present invention.

[0047] Figure 9 This is a standardized residual (PP) diagram between the theoretical ablation zone size and the actual ablation zone size calculated using the calculation formula provided in this invention.

[0048] Figure 10 This is a schematic diagram illustrating the specific workflow of a readable storage medium provided as a specific example of the present invention.

[0049] Figure 11 This is a block diagram of the ablation system according to one embodiment of the present invention.

[0050] Figure 12 This is a block diagram of an electronic device provided according to an embodiment of the present invention.

[0051] The reference numerals in the attached drawings are as follows: ablation catheter-100; head electrode-110; ring electrode-120; energy output device-200; controller-300; display device-400; processor-510; communication interface-520; readable storage medium-530; communication bus-540. Detailed Implementation

[0052] The readable storage medium, ablation system, and electronic device proposed in this invention are further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of this invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, used only to facilitate and clarify the purpose provided by this invention. Please refer to the drawings to make the objectives, features, and advantages of this invention more apparent and understandable. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only for illustrative purposes and to enable those skilled in the art to understand and read them, and are not intended to limit the implementation conditions of this invention. Any modifications to the structure, changes in proportions, or adjustments to the size, provided that the effects and objectives achieved by this invention are the same or similar, should still fall within the scope of the technical content disclosed in this invention.

[0053] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0054] Furthermore, in the description of this specification, the reference to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., means that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples. Furthermore, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0055] The core idea of ​​this invention is to provide a readable storage medium, an ablation system, and an electronic device that can solve the problem in the prior art of not being able to effectively control the size of the ablation lesion, thereby improving the success rate of ablation surgery and avoiding irreversible thermal damage to tissues.

[0056] It should be noted that the readable storage medium provided by this invention can be applied to the ablation system and electronic device provided by this invention. The electronic device provided by this invention can be a personal computer, a mobile terminal, etc., and the mobile terminal can be a mobile phone, tablet computer, or other hardware device with various operating systems. Furthermore, it should be noted that, as those skilled in the art will understand, the term "multiple" as used herein includes two cases, and the term "remote end" as used herein refers to the end furthest from the operator (i.e., the end closer to the target tissue), and the term "proximal end" refers to the end closer to the operator (i.e., the end furthest from the target tissue).

[0057] To achieve the above-mentioned goals, the present invention provides a readable storage medium storing a computer program. Please refer to [reference needed]. Figure 1 The diagram illustrates the workflow of a readable storage medium provided in one embodiment of the present invention. Figure 1 As shown, when the computer program stored in the readable storage medium is executed, it performs the following steps S100 to S400.

[0058] Step S100: Control the ablation catheter to apply pulse energy to the target tissue and obtain the electric field energy value and impedance value during the ablation process.

[0059] Step S200: Calculate the theoretical ablation stoker size based on the electric field energy value and the impedance value;

[0060] Step S300: Determine whether the difference between the theoretical ablation zone size and the target ablation zone size is within a first preset range.

[0061] If yes, proceed to step S400; otherwise, return to step S100.

[0062] Step S400: Control the ablation catheter to stop applying pulse energy to the target tissue.

[0063] Therefore, this invention, by calculating the theoretical ablation lesion size in real time during pulse ablation and comparing it with the target ablation lesion size, can predict the pulse ablation effect, effectively improving the success rate of pulse ablation surgery and avoiding irreversible thermal damage to tissue. It should be noted that, as those skilled in the art will understand, the first preset range can be set according to specific ablation needs, and this invention does not limit it in this regard.

[0064] Specifically, the ablation modes include unipolar and bipolar modes. Unipolar ablation with a pulsed electric field requires an electrically conductive head electrode 110 (see...). Figure 2 The head electrode 110 and at least one reference electrode are used to receive the electrical pulse, forming a unipolar pulsed electric field ablation. The pulsed electric field can also be bipolar ablation, where the electrically conductive head electrode 110 and at least one ring electrode 120 can be selected to receive the electrical pulse, and the head electrode 110 and at least one ring electrode 120 (see...) Figure 2 The polarities of the electrodes are opposite. It should be understood that during bipolar ablation, the polarity of the electrodes can be selected; that is, the negative and positive electrodes are not fixed to a specific head electrode 110 or a specific ring electrode 120, and there can be one or more negative electrodes, and one or more positive electrodes. It should be noted that, as those skilled in the art will understand, in unipolar mode, the term "impedance value" as used herein refers to the impedance value between the electrically conductive head electrode 110 and the reference electrode; in bipolar mode, the term "impedance value" as used herein refers to the impedance value between the electrically conductive head electrode 110 and the ring electrode 120.

[0065] It should be noted that, as those skilled in the art will understand, the readable storage medium provided by this invention can take the form of any combination of one or more computer-readable media. A readable medium can be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples of computer-readable storage media (a non-exhaustive list) include: an electrical connection having one or more wires, a portable computer hard disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In this document, a computer-readable storage medium can be any tangible medium that contains or stores a program that can be used by or in combination with an instruction execution system, apparatus, or device.

[0066] Furthermore, a computer-readable signal medium may include a data signal propagated in baseband or as part of a carrier wave, carrying computer-readable program code. Such propagated data signals may take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. The computer-readable signal medium may also be any computer-readable medium other than a computer-readable storage medium, which can transmit, propagate, or transfer a program for use by or in connection with an instruction execution system, apparatus, or device. The program code contained on the computer-readable medium may be transmitted using any suitable medium, including but not limited to wireless, wireline, optical fiber, RF, etc., or any suitable combination thereof.

[0067] In one exemplary embodiment, when the computer program is executed by a processor, it also performs the following step: obtaining the energy efficiency during the ablation process.

[0068] Correspondingly, the step of calculating the theoretical ablation stoker size based on the electric field energy value and the impedance value includes: calculating the theoretical ablation stoker size based on the electric field energy value, the impedance value, and the energy utilization rate.

[0069] In practice, the pulse energy applied by the ablation catheter to the target tissue will not be fully utilized. That is, there will be a loss of applied pulse energy during the actual ablation process. Therefore, this embodiment introduces the energy utilization rate when calculating the theoretical ablation lesion size, which can ensure that the final calculated theoretical ablation lesion size is more accurate. This allows for better prediction of the pulse ablation effect, further improving the success rate of ablation surgery and effectively avoiding thermal damage to the tissue.

[0070] Furthermore, a pressure sensor is provided at the distal end of the ablation catheter. This pressure sensor detects the value and direction of the contact force between the distal end of the ablation catheter and the target tissue. Thus, the pressure sensor can accurately detect not only the magnitude of the contact force between the distal end of the ablation catheter and the target tissue, but also the direction of the contact force. This allows the operator to control the degree of contact (determined by the magnitude of the contact force) and the angle of contact (determined by the angle between the direction of the contact force and the axis of the distal end of the ablation catheter 100) during the actual ablation process, thereby achieving more precise ablation.

[0071] Please refer to Figure 2 and Figure 3 ,in Figure 2 A schematic diagram illustrating the measurement principle of a pressure sensor according to an embodiment of the present invention is provided. Figure 3 A schematic diagram illustrating force vector decomposition according to an embodiment of the present invention is shown. Figure 2 and Figure 3 As shown, the pressure sensor can detect the components of the contact force F between the distal end of the ablation catheter 100 and the target tissue along the X, Y, and Z axes. x F y and F Z The contact force F between the distal end of the ablation catheter 100 and the target tissue, and the angles θ1, θ2, and θ3 between these forces and the X, Y, and Z axes. Specifically, the value of the contact force F between the distal end of the ablation catheter 100 and the target tissue can be calculated according to the following formula.

[0072] F = F x cosθ1+F y cosθ2+F z cosθ3

[0073] Please continue to refer to this. Figure 4 and Figure 5 ,in Figure 4 A schematic diagram of the force vector and electric field influence area when the distal end of the ablation catheter 100 is horizontally attached to the target tissue is given; Figure 5 A schematic diagram illustrating the force vector and electric field influence area when the distal end of the ablation catheter 100 is perpendicularly attached to the target tissue is shown. Figure 5 The dashed area in the diagram represents the region affected by the electric field energy, while the gray area within it represents the region affected by the electric field on the myocardial tissue (target tissue). For example... Figure 4 and Figure 5As shown, when the distal end of the ablation catheter 100 is horizontally abutted against the target tissue (i.e., the abutment angle is 0°), the direction of the contact force between the distal end of the ablation catheter 100 and the target tissue is perpendicular to the axis of the distal end of the ablation catheter 100 (i.e., the angle between the axis of the distal end of the ablation catheter 100 and the contact force F is 90°). Both the head electrode 110 and the ring electrode 120 on the ablation catheter 100 can contact the target tissue, resulting in a large area for the electric field to provide pulse energy. When the ablation catheter... When the distal end of the ablation catheter 100 is perpendicularly abutted against the target tissue (i.e., the contact angle is 90°), the direction of the contact force between the distal end of the ablation catheter 100 and the target tissue is collinear with the axis of the distal end of the ablation catheter 100 (i.e., the angle between the axis of the distal end of the ablation catheter 100 and the contact force F is 180°). The head electrode 110 on the ablation catheter 100 can contact the target tissue, while the ring electrode 120 cannot contact the target tissue, resulting in a smaller area affected by the electric field used to provide pulse energy. Therefore, in the actual ablation process, precise ablation can be further achieved by controlling the degree of contact (determined by the magnitude of the contact force) and the contact angle (determined by the direction of the contact force) between the distal end of the ablation catheter 100 and the target tissue. It should be noted that, as those skilled in the art will understand, the angle between the axis of the distal end of the ablation catheter 100 and the direction of the contact force minus 90° is the contact angle between the distal end of the ablation catheter 100 and the target tissue.

[0074] In one exemplary embodiment, calculating the theoretical ablation zone size based on the electric field energy value, the impedance value, and the energy efficiency includes: calculating the theoretical ablation zone size based on the electric field energy value, the impedance value, the energy efficiency, and the contact force value between the distal end of the ablation catheter and the target tissue; more specifically, the theoretical ablation zone volume can be calculated according to the following formula (1).

[0075]

[0076] In the formula, V(T) is the theoretical ablation zone volume at time T after the start of ablation, C is the energy efficiency, and R... t W represents the impedance value at time t after the start of ablation; t F is the electric field energy at time t after the ablation begins. t The contact force between the distal end of the ablation catheter and the target tissue at time t after the start of ablation is given by K, where K is a proportionality constant, and α, β, and γ are all exponents not equal to 1.

[0077] For ease of understanding, the derivation of formula (1) will be explained in detail below. Specifically, the formation of the ablation focus is related to the electric field strength, impedance value, contact force between the distal end of the ablation catheter 100 and the target tissue, and the duration of ablation. Based on this, the inventors proposed that the volume V of the ablation focus is proportional to the product of the impedance R, electric field energy W, contact force F and ablation duration t after ablation, thus deriving the following formula (2).

[0078] V=K·C·R·W·F·t (2)

[0079] In the formula, C represents the energy efficiency.

[0080] The electric field energy W can be calculated using the following formulas (3) and (4).

[0081]

[0082]

[0083] In the formula, τ is the volume of the electric field space, E is the electric field intensity, Q is the charge, ε is the dielectric constant, and r is the radius of the electric field space.

[0084] When the distal electrode of the ablation catheter 100 is approximately spherical, the calculation formula (3) for the electric field energy W formed by the distal electrode can be simplified to the following formula (5).

[0085]

[0086] It should be noted that, as those skilled in the art will understand, the size of the electric field space formed by the distal electrode is related to the shape and size of the distal electrode. Therefore, the volume τ and radius r of the electric field space can be determined based on the shape and size of the distal electrode.

[0087] Formula (2) establishes a linear functional relationship between the ablation zone size and several influencing factors, including the effective utilization rate of pulse energy C, the ablation impedance R, the electric field energy W, and the contact force F. However, in practice, the relationship between these influencing factors—the ablation impedance R, the electric field energy W, and the contact force F—and the ablation zone size V is non-linear. Please refer to [the relevant documentation] for details. Figure 6 The diagram illustrates the relationship between the size of the ablation cauldron and the electric field energy according to an embodiment of the present invention. Figure 6As shown, the size of the ablation site is exponentially related to the electric field energy; the greater the electric field energy, the larger the ablation site size. Similarly, the size of the ablation site is also exponentially related to the contact force between the distal end of the ablation catheter 100 and the target tissue; the greater the contact force, the larger the ablation site size. The size of the ablation site is also exponentially related to the impedance value; the smaller the impedance value, the larger the ablation site size. Based on this, exponents α, β, and γ are introduced to optimize formula (2) to obtain the following formula (6).

[0088] V = K·C·R α ·W β ·F γ ·t (6)

[0089] Furthermore, when the distal electrode of the ablation catheter 100 is approximately spherical, according to the charge formula: Based on the above formulas (5) and (6), we can obtain the following formula (7).

[0090]

[0091] Where I represents the current during the ablation process.

[0092] Since the electric field energy and contact force during the ablation process are not constant, in order to further reduce the error between the theoretical ablation stoker size and the actual ablation stoker size, the formula (6) is further optimized by using integration, thereby obtaining the calculation formula (1) for the theoretical ablation stoker size proposed in this invention.

[0093] It should be noted that, as those skilled in the art will understand, α, β, and γ are all exponents not equal to 1. The specific values ​​of K, α, β, and γ can be obtained through experiments. Specifically, the specific values ​​of K, α, β, and γ can be obtained by performing principal component and weight analysis on the experimental data.

[0094] Further, in the first embodiment, obtaining the energy efficiency during the ablation process includes: obtaining the impedance change value during the ablation process; and obtaining the energy efficiency based on the impedance change value and the following formula (8).

[0095]

[0096] Where C is the energy efficiency, R0 is the impedance value before ablation begins, and R T The impedance value at time T after the start of ablation, (R0-R T ) represents the impedance change value.

[0097] As can be seen from formula (8), when the energy efficiency C is obtained according to the first embodiment, the energy efficiency C changes dynamically as the ablation process proceeds. Since the energy efficiency C obtained through the first embodiment is calculated by the impedance change value during the ablation process, the energy efficiency obtained through the first embodiment is more in line with reality. Therefore, when the energy efficiency obtained through the first embodiment is used to calculate the theoretical ablation lesion size, the final calculated theoretical ablation lesion size can be guaranteed to be more accurate, making the calculated theoretical ablation lesion size closer to the actual ablation lesion size, thereby achieving a more accurate prediction of the pulse ablation effect.

[0098] Specifically, formula (8) can be derived from formula (9) below.

[0099]

[0100] Where, ΔR=R0-R T .

[0101] Furthermore, by substituting formula (8) into the above formula (1), we can obtain the following formula (10).

[0102]

[0103] Furthermore, in the second embodiment, the energy efficiency rate is a preset value, which is between 0.15 and 0.35. Specifically, please refer to 7 and... Figure 8 ,in Figure 7 A discrete distribution histogram of experimental data on the effective utilization rate of pulse energy provided by one embodiment of the present invention is shown schematically. Figure 8 A normal distribution diagram of experimental data on the effective utilization rate of pulse energy provided by one embodiment of the present invention is shown schematically. For example... Figure 7 and Figure 8 As shown, extensive experimental data revealed that the energy utilization rate C during pulse ablation is approximately 0.15–0.35. Therefore, by setting the energy utilization rate to a value between 0.15 and 0.35, this invention ensures that the theoretical ablation lesion size calculated is close to the actual ablation lesion size.

[0104] Furthermore, based on the above regarding Figure 4 and Figure 5As described in the relevant description, when the distal end of the ablation catheter 100 is horizontally abutted against the target tissue (i.e., the abutment angle is 0°), both the head electrode 110 and the ring electrode 120 on the ablation catheter 100 can contact the target tissue, resulting in a larger area for the electric field to provide pulse energy. When the distal end of the ablation catheter 100 is perpendicularly abutted against the target tissue (i.e., the abutment angle is 90°), the head electrode 110 on the ablation catheter 100 can contact the target tissue, while the ring electrode 120 cannot, resulting in a smaller area for the electric field to provide pulse energy. Therefore, the abutment angle between the distal end of the ablation catheter 100 and the target tissue also affects the energy utilization efficiency. Therefore, this invention also proposes a third embodiment for obtaining the energy utilization efficiency during pulse ablation.

[0105] Specifically, in the third embodiment, obtaining the energy efficiency during the ablation process includes: obtaining the contact angle between the distal end of the ablation catheter and the target tissue based on the direction of the contact force between the distal end of the ablation catheter and the target tissue detected by the pressure sensor; determining the energy efficiency based on the contact angle between the distal end of the ablation catheter and the target tissue, wherein the energy efficiency increases as the contact angle between the distal end of the ablation catheter and the target tissue decreases.

[0106] It should be noted that, as those skilled in the art can understand, in practice, a large amount of experimental data can be used to obtain the mapping relationship between the contact angle and the energy efficiency. Therefore, based on the contact angle in the actual ablation process, the corresponding energy efficiency can be determined. Thus, for different ablation sites or ablation techniques, different mapping relationships between the contact angle and the energy efficiency can be set in the computer program. This invention does not limit this.

[0107] In one exemplary embodiment, when the computer program is executed by the processor, it also performs the following steps: calculating the theoretical ablation depth based on the theoretical ablation foci volume and the following formula (11).

[0108] V = kD 3 (11)

[0109] Where D is the theoretical ablation depth and k is a proportionality constant, the specific value of which can be obtained through experiments. Therefore, after calculating the theoretical volume V of the ablation lesion according to formula (1), the theoretical ablation depth D can be calculated by combining it with formula (11).

[0110] Please continue to refer to this. Figure 9The diagram schematically illustrates the standardized residual (PP) plot between the theoretical ablation zone size and the actual ablation zone size calculated using the formula provided in this invention. The expected cumulative probability is obtained from the theoretical ablation zone size, and the measured cumulative probability is obtained from the actual ablation zone size. Figure 9 As shown, the difference between the theoretical ablation lesion size calculated using formula (1) and the actual ablation lesion size is extremely small. This indicates that the theoretical ablation lesion size calculated using formula (1) is very close to the actual ablation lesion size, thus ensuring that the readable storage medium provided by this invention can effectively control the ablation lesion size, thereby improving the success rate of ablation surgery and avoiding irreversible thermal damage to tissue. It should be noted that, as those skilled in the art will understand, the specific details of how to obtain standardized residual PP diagrams based on each group of theoretical and actual ablation lesion sizes can be found in existing technologies and will not be elaborated upon here.

[0111] In one exemplary embodiment, when the computer program is executed by the processor, it further performs the following step: determining whether the distal end of the ablation catheter 100 is in contact with the target tissue before controlling the ablation catheter 100 to apply pulse energy to the target tissue.

[0112] Therefore, by determining the ablation catheter 100 (see...) Figure 2 After the distal end of the ablation device comes into contact with the target tissue, ablation is then performed. This ensures that the pulse energy (such as pulsed electric field energy) covers the target tissue as much as possible rather than the blood, thus achieving a better ablation effect.

[0113] Further, determining whether the distal end of the ablation catheter 100 is in contact with the target tissue includes: determining whether the contact force value detected by the pressure sensor is greater than or equal to a first threshold; if so, then determining that the distal end of the ablation catheter 100 is in contact with the target tissue.

[0114] Specifically, when the contact force value detected by the pressure sensor is greater than or equal to the first threshold, it indicates that the distal end of the ablation catheter 100 is in contact with the target tissue; when the contact force value detected by the pressure sensor is less than the first threshold (e.g., 5 gf), it indicates that the distal end of the ablation catheter 100 is not yet in contact with the target tissue. In this case, the operator can adjust the posture of the distal end of the ablation catheter 100 to make it in contact with the target tissue. It should be noted that, as those skilled in the art will understand, the first threshold can be set according to specific ablation requirements, and the present invention does not limit this.

[0115] Furthermore, as those skilled in the art will understand, by detecting the contact force between the distal end of the ablation catheter 100 and the target tissue in real time, it is also possible to effectively prevent the problem of increased safety risks due to excessive contact force between the distal end of the ablation catheter 100 and the target tissue.

[0116] In one exemplary embodiment, when the computer program is executed by the processor, it further performs the following steps: before controlling the ablation catheter 100 to apply pulse energy to the target tissue, determining whether the circuit between the energy output device 200 for delivering pulse energy to the ablation catheter 100 and the ablation catheter 100 is in a short-circuit state.

[0117] When the circuit between the energy output device 200 and the ablation catheter 100 is short-circuited, the energy output device 200 will be unable to deliver pulse energy to the ablation catheter 100. Therefore, by determining that the circuit between the ablation catheter 100 and the energy output device 200 is in a normal state (i.e., there is no short circuit or other situation that prevents normal discharge) before performing ablation, the effectiveness of the ablation procedure can be further guaranteed. It should be noted that, as those skilled in the art will understand, when a short circuit is determined to occur between the energy output device 200 and the ablation catheter 100, the cause of the short circuit can be investigated, and corresponding measures can be taken to correct it, so that the circuit between the energy output device 200 and the ablation catheter 100 is in a normal state, thereby ensuring that the ablation catheter 100 can perform ablation normally under the action of the energy output device 200.

[0118] Further, determining whether the circuit between the energy output device 200, which delivers pulse energy to the ablation catheter 100, and the ablation catheter 100 is in a short-circuit state includes: determining whether the impedance value before ablation is greater than a second threshold; if not, then determining that the circuit between the energy output device 200 and the ablation catheter 100 is in a short-circuit state. Specifically, when a short circuit occurs in the circuit between the ablation catheter 100 and the energy output device 200, the impedance value between the head electrode 110 and the target electrode of the ablation catheter 100 is relatively small before ablation is performed; when the circuit between the ablation catheter 100 and the energy output device 200 is normal, the impedance value between the head electrode 110 and the target electrode of the ablation catheter 100 is relatively large before ablation is performed. Therefore, by determining whether the impedance value before ablation is greater than the second threshold, it is possible to accurately determine whether a short circuit occurs in the circuit between the energy output device 200 and the ablation catheter 100. It should be noted that, as those skilled in the art will understand, in unipolar mode, the target electrode refers to the reference electrode mentioned above; in bipolar mode, the target electrode refers to the ring electrode 120 mentioned above. Furthermore, it should be noted that, as those skilled in the art will understand, the second threshold can be set according to specific circumstances, for example, set to 60 ohms; this invention does not limit this setting.

[0119] In one exemplary embodiment, when the computer program is executed by a processor, it further performs the following steps: before applying pulse energy to the target tissue via the ablation catheter 100, selecting pulse parameters and calculating the pulse dose based on the pulse parameters; determining whether the pulse dose is within a second preset range; if not, reselecting the pulse parameters until the pulse dose is within the second preset range. Thus, by determining appropriate pulse parameters based on the pulse dose before performing ablation, it can be ensured that subsequent ablation produces an ablation foci of sufficient size in the target tissue. It should be noted that, as those skilled in the art will understand, the second preset range can be set according to the specific characteristics of the target tissue; for example, when the target tissue is myocardial tissue, the second preset range can be set to 800V. 2 ·s~2000V 2 ·s.

[0120] Further, the step of calculating the pulse dose based on the pulse parameters includes: calculating the pulse dose according to the following formula (12).

[0121] Dose = U 2 ·a·d·b·n (12)

[0122] In the formula, Dose is the pulse dose, U is the pulse voltage, a is the number of pulses in a single pulse train, d is the number of pulse trains in a single ablation, b is the pulse width (width of a single pulse), and n is the number of ablation cycles.

[0123] Please continue to refer to this. Figure 10 The diagram illustrates the specific workflow of a readable storage medium provided in a specific example of the present invention. Figure 10 As shown, before performing pulse ablation, pulse parameters are selected, and then the pulse dose (Dose) is calculated based on the selected pulse parameters. If the calculated pulse dose is within the second preset range (e.g., 800V), the pulse dose is determined accordingly. 2 ·s~2000V 2 If the impedance value is greater than the second threshold (e.g., 60 ohms), then it is determined whether the contact force value is greater than or equal to the first threshold (e.g., 5gf). If so, ablation is performed. During the ablation process, the theoretical ablation lesion size is calculated in real time, and it is determined whether the difference between the calculated theoretical ablation lesion size and the target ablation lesion size is within the first preset range. If so, ablation is stopped; otherwise, ablation continues.

[0124] In one exemplary embodiment, when the computer program is executed by the processor, it also performs the following steps: calculating the maximum current threshold during the ablation process based on the parameter information of the electrode wires in the ablation catheter 100.

[0125] Specifically, the maximum current threshold can be calculated using the following formula (13).

[0126]

[0127] In the formula, ΔT is the temperature change (in °C), c is the specific heat capacity, and m is the mass (in g).

[0128] Assuming the electrode wire is made of pure copper with a specific heat capacity c, mass m, and impedance R of 0.39 J / (g·℃), 0.15 g, and 3 ohms respectively, and the maximum withstand temperature of the electrode wire insulation layer is 250℃, and the ablation duration is 0.01 s, the maximum operating current can be calculated as 20 A using formula (13). Therefore, when the maximum current during the ablation process does not exceed 20 A, the electrode wire insulation will not fail, thus effectively avoiding thermal damage to the target tissue caused by electrode wire insulation failure during the ablation process, thereby effectively improving the safety of the ablation process.

[0129] In one exemplary embodiment, when the computer program is executed by the processor, it also performs the following steps: calculating the minimum impedance threshold during the ablation process based on the maximum current threshold.

[0130] Specifically, the initial temperature of the target tissue was 37°C, and the specific heat capacity and density of human tissue were close to those of water, at 4.2 J / (g·°C) and 1 g / cm³, respectively. 3 Assuming the target tissue's maximum tolerable temperature is 60℃, the ablation time is 0.004s, and the ablation volume of the target tissue is 1cm³,... 3 The maximum current threshold is 20A, and the minimum impedance threshold during the ablation process can be calculated as 60 ohms according to formula (13).

[0131] In one exemplary embodiment, when the computer program is executed by the processor, it also performs the following steps: determining in real time whether the impedance value during the ablation process is greater than the minimum impedance threshold.

[0132] Specifically, according to formula (13), when the impedance value during the ablation process is less than the minimum impedance threshold (e.g., 60 ohms), the current during the ablation process will exceed the maximum current threshold (e.g., 20A), resulting in thermal damage to the target tissue due to electrode wire insulation failure. Therefore, by judging whether the impedance value is greater than the minimum impedance threshold in real time during the ablation process, thermal damage to the target tissue due to electrode wire insulation failure can be effectively prevented. It should be noted that, as those skilled in the art will understand, ablation should be stopped immediately when the impedance value at a certain moment is less than the minimum impedance threshold.

[0133] The beneficial effects of the readable storage medium provided by the present invention will be described below through specific embodiments.

[0134] Example 1

[0135] In this embodiment, the target ablation depth is 4mm, and the first preset range is -0.5mm to 0.5mm. The operator selects a peak pulse voltage of 2000V (biphase), a rectangular waveform, a pulse width of 5μs, and an ablation time of 0.010s in the device's parameter selection module. The device's data processing module calculates the pulse dose (Dose) value. Since the calculated pulse dose (Dose) value is within the second preset range (e.g., 800V),... 2 ·s~2000V 2 Within ·s), the impedance value is detected and it is determined whether the impedance value is greater than the second threshold (e.g., 60 ohms). Since the detected impedance value is 167 ohms, which is greater than 60 ohms, the contact force value is then detected and it is determined whether the contact force value is greater than or equal to the first threshold (e.g., 5gf). Since the detected contact force value is 5gf, which is equal to 5gf, ablation is started. The actual electric field energy during the ablation process is 36J. In this embodiment, the energy utilization rate C is not introduced when calculating the theoretical ablation lesion volume, that is, in this embodiment, according to The theoretical ablation zone volume is calculated, and the theoretical ablation zone depth is calculated using formula (11). When the impedance change value is 16 ohms, the calculated theoretical ablation zone depth is 4.5 mm. Since the difference between the calculated theoretical ablation zone depth and the target ablation zone depth is within the first preset range, ablation is stopped at this time. The actual ablation zone depth is 3.5 mm by measuring the actual ablation zone.

[0136] Example 2

[0137] In this embodiment, the target ablation depth is 4mm, and the first preset range is -0.5mm to 0.5mm. The operator selects a peak pulse voltage of 2000V (biphase), a rectangular waveform, a pulse width of 5μs, and an ablation time of 0.010s in the device's parameter selection module. The device's data processing module calculates the pulse dose (Dose) value. Since the calculated pulse dose (Dose) value is within the second preset range (e.g., 800V),... 2 ·s~2000V 2 Within ·s), the impedance value is detected and it is determined whether the impedance value is greater than the second threshold (e.g., 60 ohms). Since the detected impedance value is 164 ohms, which is greater than 60 ohms, the contact force value is then detected and it is determined whether the contact force value is greater than or equal to the first threshold (e.g., 5gf). Since the detected contact force value is 7gf, which is greater than 5gf, ablation is started. The actual electric field energy during the ablation process is 67J. During the ablation process, the energy utilization rate C is calculated based on the impedance change value and the theoretical ablation depth is calculated using formulas (1) and (11). When the impedance change value is 21 ohms, the calculated theoretical ablation depth is 4.3mm. Since the difference between the calculated theoretical ablation depth and the target ablation depth is within the first preset range, ablation is stopped at this time. The actual ablation depth is 4.1mm when the actual ablation depth is measured. Therefore, by using the calculation formula for the theoretical ablation foci size provided by this invention, it can be ensured that the actual ablation foci size after ablation is close to the calculated theoretical ablation foci size, thereby making the actual ablation foci size close to the target ablation foci size.

[0138] Example 3

[0139] In this embodiment, the target ablation depth is 5mm, and the first preset range is -0.5mm to 0.5mm. The operator selects a peak pulse voltage of 1500V (biphase), a rectangular waveform, a pulse width of 2μs, and an ablation time of 0.020s in the device's parameter selection module. The device's data processing module calculates the pulse dose (Dose) value. Since the calculated pulse dose (Dose) value is within the second preset range (e.g., 800V),... 2 ·s~2000V 2Within ·s), the impedance value is detected and it is determined whether the impedance value is greater than the second threshold (e.g., 60 ohms). Since the detected impedance value is 175 ohms, which is greater than 60 ohms, the contact force value is then detected and it is determined whether the contact force value is greater than or equal to the first threshold (e.g., 5gf). Since the detected contact force value is 9gf, which is greater than 5gf, ablation is started. The actual electric field energy during the ablation process is 120J. During the ablation process, the theoretical ablation depth is calculated in real time based on the impedance change value and in combination with formulas (10) and (11). When the impedance change value is 30 ohms, the calculated theoretical ablation depth is 5.5mm. Since the difference between the calculated theoretical ablation depth and the target ablation depth is within the first preset range, ablation is stopped at this time. The actual ablation depth is 5.3mm when measured on the actual ablation site. Since this embodiment calculates the energy efficiency C based on the impedance change value, and calculates the theoretical ablation lesion size based on the calculated energy efficiency C, the actual ablation lesion size after ablation is close to the calculated theoretical ablation lesion size, thus making the actual ablation lesion size close to the target ablation lesion size.

[0140] As can be seen from the above embodiments, although the depth of the ablation lesion can be judged and its size controlled by the calculation method provided by the present invention even without the energy utilization rate C in the formula, the accuracy of the judgment is not ideal because the difference between the actual ablation lesion depth and the theoretical ablation lesion depth is large. However, after the energy utilization rate C is introduced into the calculation formula, the difference between the actual ablation lesion depth and the theoretical ablation lesion depth is smaller, and the calculation result is more accurate.

[0141] Corresponding to the aforementioned readable storage medium, the present invention also provides an ablation system, please refer to... Figure 11 A schematic block diagram of the ablation system provided in one embodiment of the present invention is shown. Figure 11 As shown, the ablation system includes an ablation catheter 100, an energy output device 200, and a controller 300. Both the ablation catheter 100 and the energy output device 200 are communicatively connected to the controller 300. The energy output device 200 is configured to output pulsed energy to the ablation catheter 100. The controller 300 includes the readable storage medium described above. Therefore, the ablation system provided by this invention can predict the ablation effect by calculating the theoretical ablation lesion size in real time during the ablation process and comparing it with the target ablation lesion size, thereby effectively improving the success rate of ablation surgery and avoiding irreversible thermal damage to tissue.

[0142] Specifically, the energy output device 200 is a pulse generator, which is used to transmit pulse current to the ablation catheter 100 to form a unipolar or bipolar pulse discharge to achieve ablation.

[0143] In one exemplary embodiment, a pressure sensor is provided at the distal end of the ablation catheter 100. The pressure sensor detects the value and direction of the contact force between the distal end of the ablation catheter 100 and the target tissue. The controller is further configured to obtain the contact angle between the distal end of the ablation catheter and the target tissue based on the direction of the contact force detected by the pressure sensor. Therefore, in actual ablation, precise ablation can be further achieved by controlling the degree of contact (determined by the magnitude of the contact force) and the contact angle (determined by the direction of the contact force) between the distal end of the ablation catheter 100 and the target tissue.

[0144] In one exemplary embodiment, the distal end of the ablation catheter 100 is further provided with a temperature sensor for detecting the ablation temperature of the target tissue. Since excessively high ablation temperatures will cause irreversible thermal damage to the target tissue, real-time monitoring of the target tissue's temperature during the ablation process (i.e., the ablation temperature) ensures that irreversible thermal damage is not caused. It should be noted that, as those skilled in the art will understand, when the ablation temperature of the target tissue is detected to be too high, cooling can be achieved by increasing the flow rate of saline solution to ensure that the ablation temperature of the target tissue remains within a suitable range.

[0145] Please continue to refer to this. Figure 11 ,like Figure 11 As shown, in an exemplary embodiment, the ablation system further includes a display device 400 communicatively connected to the controller 300. Thus, the display device 400 can display in real time the impedance value, the magnitude of the contact force between the distal end of the ablation catheter 100 and the target tissue, the direction of the contact force, the contact angle, and the ablation temperature during the ablation process, for the operator's reference, thereby providing a basis for achieving precise contact ablation. Specifically, the contact angle between the axis of the distal end of the ablation catheter 100 and the direction of the contact force minus 90° is the contact angle between the distal end of the ablation catheter 100 and the target tissue.

[0146] Furthermore, by creating a three-dimensional model of the ablation catheter and target tissue, according to... Figure 4 and Figure 5 As shown, the magnitude (i.e., degree of contact) and direction of the contact force between the distal end of the ablation catheter 100 and the target tissue, as well as the contact angle between the distal end of the ablation catheter 100 and the target tissue, are displayed on the three-dimensional model of the ablation catheter and the target tissue.

[0147] Based on the same inventive concept, the present invention also provides an electronic device, please refer to [reference needed]. Figure 12 The diagram illustrates a block structure of an electronic device according to an embodiment of the present invention. Figure 12 As shown, the electronic device includes a processor 510 and the readable storage medium 530 described above. Since the electronic device provided by this invention and the readable storage medium 530 described above belong to the same inventive concept, the electronic device provided by this invention has all the advantages of the readable storage medium 530 described above. Therefore, the beneficial effects of the electronic device provided by this invention will not be elaborated further here.

[0148] like Figure 12 As shown, the electronic device also includes a communication interface 520 and a communication bus 540, wherein the processor 510, the communication interface 520, and the readable storage medium 530 communicate with each other via the communication bus 540. The communication bus 540 can be a Peripheral Component Interconnect (PCI) bus or an Extended Industry Standard Architecture (EISA) bus, etc. This communication bus 540 can be divided into an address bus, a data bus, a control bus, etc. For ease of illustration, only one thick line is used to represent it in the figure, but this does not indicate that there is only one bus or one type of bus. The communication interface 520 is used for communication between the aforementioned electronic device and other devices.

[0149] The processor 510 referred to in this invention can be a Central Processing Unit (CPU), or other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor can be a microprocessor or any conventional processor. The processor 510 is the control center of the electronic device, connecting various parts of the entire electronic device through various interfaces and lines.

[0150] The processor 510 implements various functions of the electronic device by running or executing computer programs stored in the readable storage medium 530 and calling data stored in the readable storage medium 530.

[0151] It should be noted that, as those skilled in the art will understand, computer program code for performing the operations of this invention can be written in one or more programming languages ​​or a combination thereof. These programming languages ​​include object-oriented programming languages ​​such as Java, Smalltalk, and C++, as well as conventional procedural programming languages ​​such as C or similar languages. The program code can be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In cases involving remote computers, the remote computer can be connected to the user's computer via any type of network—including a local area network (LAN) or a wide area network (WAN)—or can be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0152] In summary, compared with the prior art, the readable storage medium, ablation system, and electronic device provided by the present invention have the following advantages: When the computer program stored in the readable storage medium provided by the present invention is executed by a processor, it performs the following steps: controlling the ablation catheter to apply pulse energy to the target tissue, and acquiring the electric field energy value and impedance value during the ablation process; calculating the theoretical ablation lesion size based on the electric field energy value and the impedance value, and then determining whether the difference between the theoretical ablation lesion size and the target ablation lesion size is within a first preset range. If yes, the application of pulse energy to the target tissue is stopped; if no, the application of pulse energy to the target tissue continues until the difference between the theoretical ablation lesion size and the target ablation lesion size is within the first preset range. Therefore, by calculating the theoretical ablation lesion size in real time during the pulse ablation process and comparing it with the target ablation lesion size, the present invention can predict the pulse ablation effect, effectively improve the success rate of pulse ablation surgery, and avoid irreversible thermal damage to tissues.

[0153] Since the ablation system and electronic device provided by this invention belong to the same inventive concept as the readable storage medium provided by this invention, the ablation system and electronic device provided by this invention have all the advantages of the readable storage medium provided by this invention. Therefore, the beneficial effects of the ablation system and electronic device provided by this invention will not be described in detail here.

[0154] It should be noted that the apparatus and methods disclosed in the embodiments herein can also be implemented in other ways. The apparatus embodiments described above are merely illustrative; for example, the flowcharts and block diagrams in the accompanying drawings show the architecture, functionality, and operation of possible implementations of apparatus, methods, and computer program products according to various embodiments herein. In this regard, each block in a flowchart or block diagram may represent a module, program, or part of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions marked in the blocks may occur in a different order than those marked in the drawings. For example, two consecutive blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in a block diagram and / or flowchart, and combinations of blocks in block diagrams and / or flowcharts, can be implemented using a dedicated hardware-based system to perform the specified function or action, or can be implemented using a combination of dedicated hardware and computer instructions.

[0155] In addition, the functional modules in the various embodiments of this article can be integrated together to form an independent part, or each module can exist independently, or two or more modules can be integrated to form an independent part.

[0156] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the protection scope of the present invention. Obviously, those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the present invention and its equivalents, the present invention also intends to include these modifications and variations.

Claims

1. A readable storage medium, characterized in that, The readable storage medium stores a computer program, which, when executed by a processor, performs the following steps: The ablation catheter is controlled to apply pulsed energy to the target tissue, and the electric field energy value and impedance value are obtained during the ablation process; The theoretical ablation stoker size is calculated based on the electric field energy value and the impedance value. Determine whether the difference between the theoretical ablation zone size and the target ablation zone size is within a first preset range; If so, then control the ablation catheter to stop applying pulse energy to the target tissue; If not, the ablation catheter is controlled to continue applying pulsed energy to the target tissue until the difference between the theoretical ablation foci size and the target ablation foci size is within a first preset range; When the computer program is executed by the processor, it also performs the following steps: To obtain the energy efficiency during the ablation process; The step of calculating the theoretical ablation venous unit size based on the electric field energy value and the impedance value includes: The theoretical ablation stoker size is calculated based on the electric field energy value, the impedance value, and the energy utilization rate.

2. The readable storage medium according to claim 1, characterized in that, The method of obtaining the energy efficiency during the ablation process includes: Obtain the impedance change value during the ablation process; The energy utilization efficiency is obtained based on the impedance change value and the following formula: in, For energy efficiency, The impedance value before ablation begins. The impedance value at time T after the start of ablation. This represents the impedance change value.

3. The readable storage medium according to claim 1, characterized in that, The energy utilization efficiency is a preset value, which is between 0.15 and 0.

35.

4. The readable storage medium according to claim 1, characterized in that, The distal end of the ablation catheter is equipped with a pressure sensor, which is used to detect the value and direction of the contact force between the distal end of the ablation catheter and the target tissue; The method of obtaining the energy efficiency during the ablation process includes: Based on the direction of the contact force between the distal end of the ablation catheter and the target tissue detected by the pressure sensor, the contact angle between the distal end of the ablation catheter and the target tissue is obtained. The energy utilization rate is determined based on the contact angle between the distal end of the ablation catheter and the target tissue, wherein the energy utilization rate increases as the contact angle between the distal end of the ablation catheter and the target tissue decreases.

5. The readable storage medium according to claim 1, characterized in that, The step of calculating the theoretical ablation venous unit size based on the electric field energy value, the impedance value, and the energy utilization rate includes: The theoretical ablation zone size is calculated based on the electric field energy value, the impedance value, the energy utilization rate, and the contact force between the distal end of the ablation catheter and the target tissue.

6. The readable storage medium according to claim 5, characterized in that, The theoretical ablation zone size is calculated based on the electric field energy value, the impedance value, the energy efficiency, and the contact force between the distal end of the ablation catheter and the target tissue, including: The theoretical ablation zone volume can be calculated using the following formula: In the formula, V(T) is the theoretical ablation zone volume at time T after the start of ablation, and C is the energy efficiency. The impedance value at time t after the start of ablation. Let be the electric field energy at time t after the ablation begins. K represents the contact force between the distal end of the ablation catheter and the target tissue at time t after the start of ablation, where K is a proportionality constant. , and All are exponents that are not equal to 1.

7. The readable storage medium according to claim 6, characterized in that, The theoretical ablation zone size is the theoretical ablation zone volume, and the target ablation zone size is the target ablation zone volume.

8. The readable storage medium according to claim 6, characterized in that, When the computer program is executed by the processor, it also performs the following steps: Calculate the theoretical ablation zone depth based on the theoretical ablation zone volume and the following formula: Where D is the theoretical ablation depth, and k is a proportionality constant; the theoretical ablation depth is the theoretical ablation foci size, and the target ablation depth is the target ablation foci size.

9. The readable storage medium according to claim 1, characterized in that, When the computer program is executed by the processor, it also performs the following steps: Before applying pulsed energy to the target tissue using the ablation catheter, it is determined whether the distal end of the ablation catheter is in contact with the target tissue.

10. The readable storage medium according to claim 9, characterized in that, The distal end of the ablation catheter is equipped with a pressure sensor, which is used to detect the contact force between the distal end of the ablation catheter and the target tissue; The determination of whether the distal end of the ablation catheter is in contact with the target tissue includes: Determine whether the contact force value detected by the pressure sensor is greater than or equal to a first threshold. If so, it is determined that the distal end of the ablation catheter is in contact with the target tissue.

11. The readable storage medium according to claim 1, characterized in that, When the computer program is executed by the processor, it also performs the following steps: Before controlling the ablation catheter to apply pulse energy to the target tissue, it is determined whether the circuit between the energy output device used to deliver pulse energy to the ablation catheter and the ablation catheter is in a short-circuit state.

12. The readable storage medium according to claim 11, characterized in that, The determination of whether the circuit between the energy output device used to deliver pulse energy to the ablation catheter and the ablation catheter is in a short-circuit state includes: Determine whether the impedance value before ablation is greater than the second threshold; If not, it is determined that the circuit between the energy output device and the ablation catheter is in a short-circuit state.

13. The readable storage medium according to claim 1, characterized in that, When the computer program is executed by the processor, it also performs the following steps: Before controlling the ablation catheter to apply pulse energy to the target tissue, pulse parameters are selected, and the pulse dose is calculated based on the pulse parameters; Determine whether the pulse dose is within a second preset range; If not, then reselect the pulse parameters until the pulse dose is within the second preset range.

14. The readable storage medium according to claim 13, characterized in that, The step of calculating the pulse dose based on the pulse parameters includes: Calculate the pulse dose using the following formula: In the formula, U is the pulse dose, a is the pulse voltage, d is the number of pulses in a single pulse train, b is the pulse width, and n is the number of ablation cycles.

15. The readable storage medium according to claim 1, characterized in that, When the computer program is executed by the processor, it also performs the following steps: The maximum current threshold during the ablation process is calculated based on the parameter information of the electrode wires in the ablation catheter.

16. The readable storage medium according to claim 15, characterized in that, When the computer program is executed by the processor, it also performs the following steps: The minimum impedance threshold during the ablation process is calculated based on the maximum current threshold.

17. The readable storage medium according to claim 16, characterized in that, When the computer program is executed by the processor, it also performs the following steps: The impedance value during the ablation process is determined in real time to be greater than the minimum impedance threshold.

18. An ablation system, characterized in that, The device includes an ablation catheter, an energy output device, and a controller, wherein the ablation catheter and the energy output device are both communicatively connected to the controller, the energy output device is configured to output pulsed energy to the ablation catheter, and the controller includes a readable storage medium according to any one of claims 1 to 17.

19. The ablation system according to claim 18, characterized in that, The distal end of the ablation catheter is equipped with a pressure sensor, which is used to detect the value and direction of the contact force between the distal end of the ablation catheter and the target tissue; The controller is further configured to obtain the contact angle between the distal end of the ablation catheter and the target tissue based on the direction of the contact force between the distal end of the ablation catheter and the target tissue detected by the pressure sensor. The ablation system also includes a display device that is communicatively connected to the controller. The display device is configured to display in real time the impedance value, the value and direction of the contact force between the distal end of the ablation catheter and the target tissue, and the contact angle between the distal end of the ablation catheter and the target tissue.

20. The ablation system according to claim 18, characterized in that, The distal end of the ablation catheter is also equipped with a temperature sensor, which is used to detect the ablation temperature of the target tissue.

21. An electronic device, characterized in that, It includes a processor and a readable storage medium as described in any one of claims 1 to 17.

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