Single-needle bipolar pulsed electric field conformal ablation method and system

Abstract

The present application relates to a single-needle bipolar pulse electric field conformal ablation method and system. The single-needle bipolar pulse electric field conformal ablation method sets the number of needle placement operations and needle placement attributes based on the volume of the ablation target area, the three-dimensional spatial position of the ablation target area, the target area center of the ablation target area, and the maximum effective ablation range of each needle placement, and evaluates the coverage quality of this needle placement operation in combination with the relationship between the superimposed effective ablation range of the needle placement operation and the ablation target area, and then determines whether the coverage quality of this needle placement operation meets multiple constraints. The present application can achieve the purpose of single-needle ablation, thereby getting rid of the limitation of the need for two-needle pairing combination, solving the problem of double-needle needle placement operation, and by adopting the adaptive superposition method of fractionated basic electric fields, conformal coverage is performed on the large-size ablation target area to be treated, solving the problem of single-needle pulse electric field ablation treatment of large-size tumors.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a single-needle bipolar pulsed electric field conformal ablation method and system. Background Art

[0002] Tumors, especially malignant tumors, are important diseases that endanger human health. Pulsed electric field is a new minimally invasive ablation treatment for tumors that has emerged in recent years. Pulsed electric field ablation has important clinical and social value.

[0003] However, in actual application, the current pulsed electric field tumor ablation treatment technology also faces shortcomings. When pulsed electric field tumor ablation treatment is currently used clinically, clinicians generally need at least two electrodes to perform treatment operations. The discharge between the two electrode needles, one positive and one negative, generates a high-voltage electric field to form the ablation treatment area. In addition, according to the requirements of the electric field distribution characteristics, the two inserted electrodes need to be as parallel as possible to achieve the best treatment range and effect. This requires high operating experience / level of clinicians. In actual operation, it is difficult to ensure that the two electrodes inserted one after another are parallel to each other. Therefore, the effect of pulsed electric field ablation is actually difficult to fully exert. For larger or irregularly shaped tumors, more electrodes may need to be inserted, which further increases the difficulty of needle placement and needle placement for clinicians.

[0004] To address this issue, a single electrode needle in a single bipolar mode can independently complete the task of generating a high-voltage electric field for treatment. There is no problem of parallelism between the electrode needles / needles, nor is there a problem of limited actual ablation effect due to non-parallelism.

[0005] However, according to the physical principles of electric field transmission / distribution, during single-needle pulsed electric field ablation, the effective electric field distribution range, especially the radial effective electric field distribution range, is limited and cannot be effectively conformally regulated according to clinical needs. It can be applied to the ablation treatment of small-sized tumors, but has difficulties in the ablation treatment of large-sized tumors. Summary of the invention

[0006] Based on this, for single-needle pulsed electric field ablation, the effective electric field distribution range, especially the radial effective electric field distribution range is limited, and cannot be effectively conformally regulated according to clinical needs. It can be applied to the ablation treatment of small-sized tumors, but there are difficulties in the ablation treatment of large-sized tumors. It is necessary to provide a single-needle bipolar pulsed electric field conformal ablation method and system.

[0007] On the one hand, the present application provides a single-needle bipolar pulsed electric field conformal ablation method, comprising:

[0008] Based on the patient's diagnostic image, an ablation target area is delineated in the patient's diagnostic image;

[0009] Mapping the ablation target area into a three-dimensional rectangular coordinate system, and calculating the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area;

[0010] Based on the optional maximum ablation treatment parameters, the maximum effective ablation range of each needle placement is obtained through simulation;

[0011] A set of needle placement operations is performed in the ablation target area, the set of needle placement operations includes I needle placement, and the needle placement attributes of each needle placement are randomly generated until the effective ablation range generated by the I needle placement operation in the ablation target area completely covers the ablation target area after superposition; the needle placement attributes include the center point position of the electrode needle of each needle placement and the axis direction of the needle body of each needle placement;

[0012] Based on the ablation treatment parameters corresponding to the first needle placement in this group, the effective ablation range formed by each needle placement in the first needle placement in this group is obtained through simulation;

[0013] Based on the effective ablation range formed by each needle placement in this group of I needle placements, the effective ablation range after superposition of I needle placements is calculated, which is recorded as the superimposed effective ablation range;

[0014] Based on the effective ablation range formed by each needle placement in this group of I needle placements, the superimposed effective ablation range, the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area, the coverage quality of the I needle placement operation in this group of I needle placements is evaluated to determine whether the coverage quality of the I needle placement in the ablation target area satisfies both the superimposed effective ablation range that completely covers the target area and minimizes the difference between the superimposed effective ablation range and the ablation target area and the number of needle placements I is minimized;

[0015] If the coverage quality of I needle placement in the ablation target area does not satisfy the requirements of minimizing the difference between the superimposed effective ablation range and the ablation target area and minimizing the number of needle placements I, the needle placement properties of each needle placement are optimized to form the next set of needle placement schemes, until the coverage quality of I needle placement in the ablation target area satisfies the requirements of fully covering the target area with the superimposed effective ablation range and minimizing the difference between the superimposed effective ablation range and the ablation target area and minimizing the number of needle placements I, and the needle placement properties of the optimal needle placement scheme are output.

[0016] On the other hand, the present application also provides a single-needle bipolar pulsed electric field conformal ablation system, the single-needle bipolar pulsed electric field conformal ablation system comprising:

[0017] Energy host;

[0018] A single-needle bipolar electrode needle, the energy host is electrically connected to the single-needle bipolar electrode needle, and the high-voltage electric pulses required for ablation treatment generated by the energy host are delivered to the ablation target area through the single-needle bipolar electrode needle;

[0019] A processing component, the processing component includes a calculation module, a delineation module and a planning module. The calculation module calculates the corresponding electric field distribution and electric energy density distribution that can be generated by the energy host and the single-needle bipolar electrode needle in the target tissue, the delineation module delineates the ablation target area based on the patient's diagnostic images, and the planning module determines the minimum number of needle placements and the optimal needle placement position required for single-needle bipolar pulsed electric field ablation treatment.

[0020] The present application relates to a single-needle bipolar pulse electric field conformal ablation method and system. The single-needle bipolar pulse electric field conformal ablation method sets the number of needle placement operations and needle placement attributes based on the volume of the ablation target area, the three-dimensional spatial position of the ablation target area, the target area center of the ablation target area, and the maximum effective ablation range of each needle placement, and evaluates the coverage quality of this needle placement operation in combination with the relationship between the superimposed effective ablation range of the needle placement operation and the ablation target area, and then determines whether the coverage quality of this needle placement operation meets multiple constraints. The present application can achieve the purpose of single-needle ablation, thereby getting rid of the limitation of the need for two-needle pairing combination, solving the problem of double-needle needle placement operation, and by adopting the adaptive superposition method of fractionated basic electric fields, conformal coverage is performed on the large-size ablation target area to be treated, solving the problem of single-needle pulse electric field ablation treatment of large-size tumors. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A schematic flow chart of a single-needle bipolar pulsed electric field conformal ablation method provided in one embodiment of the present application.

[0022] Figure 2 A schematic structural diagram of a single-needle bipolar pulsed electric field conformal ablation system provided in one embodiment of the present application.

[0023] Figure 3 A schematic diagram of a coverage quality target parameter coefficient of a single-needle bipolar pulsed electric field conformal ablation method provided in one embodiment of the present application.

[0024] Figure 4 A schematic diagram of two needle placements for a single-needle bipolar pulsed electric field conformal ablation method provided in one embodiment of the present application.

[0025] Figure 5 A schematic diagram of three-time needle arrangement when the short diameter of the ablation target area is smaller than the long diameter of the ablation target area in a single-needle bipolar pulsed electric field conformal ablation method provided in one embodiment of the present application.

[0026] Figure 6 A schematic diagram of three-time needle arrangement when the short diameter of the ablation target area is close to the long diameter of the ablation target area in a single-needle bipolar pulsed electric field conformal ablation method provided in one embodiment of the present application.

[0027] Figure 7A schematic diagram of multiple needle arrangements (greater than 3 times) when the short diameter of the ablation target area is close to the long diameter of the ablation target area in a single-needle bipolar pulsed electric field conformal ablation method provided in one embodiment of the present application.

[0028] Figure 8 A schematic diagram of multiple needle placements at specified needle placement angles in a single-needle bipolar pulsed electric field conformal ablation method provided in one embodiment of the present application.

[0029] Reference numerals:

[0030] 100, energy host; 200, single-needle bipolar electrode needle; 300, processing component; 301, computing module;

[0031] 302. Sketching module; 303. Planning module. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solution and advantages of the present application more clearly understood, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0033] The present application provides a single-needle bipolar pulsed electric field conformal ablation method and system.

[0034] like Figure 1 As shown, in one embodiment of the present application, a single-needle bipolar pulsed electric field conformal ablation method is provided, and the single-needle bipolar pulsed electric field conformal ablation method includes:

[0035] S100, based on the patient diagnostic image, delineate an ablation target area in the patient diagnostic image.

[0036] Specifically, the ablation target area completely covers the tumor area and appropriately expands outward to ensure that the tumor area can be completely ablated.

[0037] S200, mapping the ablation target area to a three-dimensional rectangular coordinate system, and calculating the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area.

[0038] S300, based on the optional maximum ablation treatment parameters, a maximum effective ablation range for each needle placement is obtained through simulation.

[0039] Specifically, simulation can be performed through Comsol software.

[0040] S400, a set of needle placement operations is performed in the ablation target area, the set of needle placement operations includes I needle placement, and the needle placement attributes of each needle placement are randomly generated until the effective ablation range generated by the I needle placement operation in the ablation target area completely covers the ablation target area after superposition. The needle placement attributes include the position of the center point of the electrode needle of each needle placement and the direction of the needle body axis of each needle placement.

[0041] S500, based on the corresponding ablation treatment parameters of this group I of needle placements, the effective ablation range formed by each needle placement in this group I of needle placements is obtained through simulation.

[0042] S600, based on the effective ablation range formed by each needle placement in this group of I needle placements, the effective ablation range after the I needle placements are superimposed is calculated and recorded as the superimposed effective ablation range.

[0043] S700, based on the effective ablation range formed by each needle placement in this group of I needle placements, the superimposed effective ablation range, the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area, evaluate the coverage quality of the I needle placement operations in the ablation target area, and judge whether the coverage quality of the I needle placement in the ablation target area satisfies both the superimposed effective ablation range that completely covers the target area and minimizes the difference between the superimposed effective ablation range and the ablation target area, and the number of needle placements I is minimized.

[0044] S800, if the coverage quality of the I-time needle placement in the ablation target area does not satisfy the requirements that the superimposed effective ablation range completely covers the target area and the difference between the superimposed effective ablation range and the ablation target area is minimized and the number of needle placements I is minimized, then the needle placement properties of each needle placement are optimized to form the next set of needle placement schemes, until the coverage quality of the I-time needle placement in the ablation target area satisfies the requirements that the superimposed effective ablation range completely covers the target area and the difference between the superimposed effective ablation range and the ablation target area is minimized and the number of needle placements I is minimized, and the needle placement properties of the optimal needle placement scheme are output.

[0045] Specifically, there are three situations for the "superimposed effective ablation range" generated by one needle placement in the ablation target area: (a) From a temporal perspective, the same single needle is placed and ablated I times, with each needle placement position being different, and all the corresponding effective ablation ranges generated in the ablation target area are superimposed. (b) From a spatial perspective, I independent single needles are placed at different positions, and all the corresponding effective ablation ranges generated by all the needles in the ablation target area are superimposed. (c) A mixture of time and space, that is, multiple independent single needles are discharged multiple times at different positions, a total of I times, and all the corresponding effective ablation ranges generated by all the needle placements in the ablation target area are superimposed.

[0046] In the actual operation process, the superimposed effective ablation ranges produced by these three situations are essentially the same, so the present application is applicable to any of the above situations, so the present application uses "I time needle placement" to refer to the above three situations.

[0047] The S100 includes:

[0048] S101, creating a patient diagnostic imaging database and outlining a model.

[0049] S102, obtaining multiple patient diagnostic images and the ablation target area of ​​each patient diagnostic image, establishing a coupling relationship between the patient diagnostic images and the ablation target areas of the patient diagnostic images, and putting the patient diagnostic images, the ablation target areas of the patient diagnostic images, and the coupling relationship between the patient diagnostic images and the ablation target areas of the patient diagnostic images into a patient diagnostic image database.

[0050] Specifically, the ablation target area of ​​the patient's diagnostic image is outlined by the physician based on the patient's diagnostic image.

[0051] S103, selecting a patient diagnostic image, an ablation target area of ​​the patient diagnostic image, and a coupling relationship between the ablation target area of ​​the patient diagnostic image and the patient diagnostic image from a patient diagnostic image database, and inputting the selected patient diagnostic image, the ablation target area of ​​the patient diagnostic image, and the coupling relationship between the ablation target area of ​​the patient diagnostic image and the patient diagnostic image into a delineation model to train the delineation model.

[0052] S104, returning to S103, until all patient diagnostic images in the patient diagnostic image database are selected, and a trained delineation model is obtained.

[0053] S105, determining whether the ablation target area output by the trained delineation model meets a qualified threshold.

[0054] S106: If the ablation target area output by the trained delineation model meets the qualified threshold, the delineation model training is completed.

[0055] S107, if the ablation target area output by the trained delineation model does not meet the qualified threshold, return to input the training set into the delineation model to train the delineation model until the ablation target area output by the trained delineation model meets the qualified threshold.

[0056] S108, inputting the acquired patient diagnostic image into the trained delineation model, and the trained delineation model outputs the ablation target area of ​​the patient diagnostic image.

[0057] S109, based on the ablation target zone, calculating the volume, three-dimensional spatial position and target center of the ablation target zone.

[0058] By training the delineation model, the delineation model can automatically divide the ablation target area of ​​the patient diagnostic image included in the impact according to the input patient diagnostic image.

[0059] After the ablation target area of ​​the patient's diagnostic image is obtained, the volume, three-dimensional spatial position and target area center of the ablation target area can be calculated.

[0060] In this embodiment, the number of needle placements and needle placement attributes of the needle placement operation are set based on the volume of the ablation target area, the three-dimensional spatial position of the ablation target area, the target area center of the ablation target area, and the maximum effective ablation range of each needle placement, and the coverage quality of this needle placement operation is evaluated in combination with the relationship between the superimposed effective ablation range of the needle placement operation and the ablation target area, and then it is determined whether the coverage quality of this needle placement operation meets multiple constraints. The present application can achieve the purpose of single-needle ablation, thereby getting rid of the limitation of the need for two-needle pairing combination, solving the problem of double-needle parallel needle placement operation, and by adopting the adaptive superposition method of the fractionated basic electric field, the large-sized ablation target area to be treated is conformally covered, solving the problem of single-needle pulsed electric field ablation treatment for large-sized tumors.

[0061] In one embodiment of the present application, the S100 further includes:

[0062] S900, when I needle placement is performed in the ablation target area, the needle placement attributes of each needle placement are randomly generated until the effective ablation range generated by I needle placement operations in the ablation target area completely covers the ablation target area after superposition, and the needle body axis direction of each needle placement is controlled within the preset angle range.

[0063] In this embodiment, the present application sets three constraints.

[0064] The first constraint condition is that the coverage quality of the I-time needle placement in the ablation target area satisfies the requirement that the superimposed effective ablation range completely covers the target area and the difference between the superimposed effective ablation range and the ablation target area is minimized. The first constraint condition is mainly to make the shape of the superimposed effective ablation range as consistent as possible with the shape of the ablation target area, that is, to minimize the difference, thereby reducing the ineffective ablation range.

[0065] The first constraint is conformality, that is, under the premise that the superimposed effective ablation range can completely cover the target ROI outlined by the physician, the coverage quality of the needle placement in the ablation target area satisfies the requirement of minimizing the difference between the superimposed effective ablation range and the ablation target area.

[0066] The second constraint is to minimize the number of needle placements I, that is, to reduce the number of needle placements as much as possible, thereby improving the ablation efficiency.

[0067] The second constraint condition is to perform the optimization design under the first constraint condition while minimizing the number of needle placement times I.

[0068] The third constraint condition is to limit the angle of the needle placement in accordance with clinical practice.

[0069] The third constraint condition is to perform the optimization design under the first constraint condition and the second constraint condition within the limited needle angle range.

[0070] In the actual application process, there are mainly three situations for the application of the first constraint, the second constraint and the third constraint:

[0071] The first situation is to consider the first constraint, the second constraint and the third constraint at the same time, and this situation occurs most often.

[0072] The second situation is to consider the first constraint and the second constraint, but not the third constraint.

[0073] The third situation is to consider only the first constraint, without considering the second and third constraints.

[0074] The first constraint, the second constraint and the third constraint are expressed by formula 14, which corresponds to the first constraint, the second constraint and the third constraint from top to bottom.

[0075] Formula 14.

[0076] in, The coverage quality of the needle placement in the ablation target area satisfies the superimposed effective ablation range. is the volume of the ablation target area, It is the axis direction of the needle body of the cloth needle. It is the minimum value of the angle range that can be used for needle placement. It is the maximum value of the limited angle range for needle placement.

[0077] Furthermore, the coverage quality of the needle placement in the ablation target area calculated by formula 15 satisfies the superimposed effective ablation range.

[0078] Formula 15.

[0079] in, The coverage quality of the needle placement in the ablation target area satisfies the superimposed effective ablation range. is the effective ablation range formed by the i-th needle placement, i is the number of needle placements, i=1,2,...,I, I is the total number of needle placements.

[0080] In one embodiment of the present application, the S400 includes:

[0081] S401, calculating the initial value of the needle placement number I according to formula 1.

[0082] Formula 1.

[0083] in, is the initial value of the number of stitches I, is the volume of the ablation target area, is the maximum effective ablation range that can be achieved by a single electrode needle, and ceil is a rounding function.

[0084] S402, calculating the needle body axis direction of each needle placement by using Formula 2 and Formula 3.

[0085] Formula 2.

[0086] Formula 3.

[0087] in, is the direction of the needle body axis of the i-th needle placement, i=1, 2, ..., I, for The random function of Used to generate random numbers between 0 and 1. It is the minimum value of the angle range that can be used for needle placement. It is the maximum value of the limited angle range for needle placement.

[0088] S403, calculating the center point position of the electrode needle for each needle placement by using Formula 4 and Formula 5.

[0089] Formula 4.

[0090] Formula 5.

[0091] in, is the center point of the electrode needle of the initial needle placement, It is used to generate a random number between 0 and 1. K is the preset maximum number of optimization iterations. is the optimization iteration step size.

[0092] Specifically, the center point position of the electrode needle of the cloth needle refers to the three-dimensional coordinate in the three-dimensional rectangular coordinate system.

[0093] Formula 16.

[0094] in, is the optimization iteration step, R is the maximum distance from the center of the ablation target area to the boundary of the ablation target area, and K is the preset number of iterations.

[0095] In this embodiment, in this application, before starting needle placement, this application estimates the initial value of the number of needle placements to completely cover the ablation target area through a formula based on the maximum effective ablation range that can be achieved by a single electrode needle, and performs subsequent iterations based on the initial value of the number of needle placements.

[0096] The initial position of the center point of the electrode needle is randomly generated through formulas and formulas. The number of needle placements and the position of the needle placement are solved through reverse iterative optimization combined with the initial position of the center point of the electrode needle and the initial value of the number of needle placements.

[0097] In one embodiment of the present application, the S700 includes:

[0098] S710, calculating the coverage quality target parameter coefficients under the multiple needle placements of this group. The coverage quality target parameter coefficients include the complete coverage coefficient, the repeated coverage coefficient, the total over-coverage coefficient and the over-coverage coefficient of each needle placement.

[0099] S720, based on the coverage quality target parameter coefficient, determine whether the coverage quality of the I-time needle placement in the ablation target area satisfies both minimization of the difference between the superimposed effective ablation range and the ablation target area and minimization of the number of needle placements I.

[0100] In this embodiment, the complete coverage coefficient is used as a reward coefficient, and the repeated coverage coefficient, the total over-coverage coefficient and the over-coverage coefficient of each needle placement are used as penalty coefficients. When the repeated coverage coefficient increases, the needle placement needs to be optimized in a more dispersed direction. On the contrary, when the repeated coverage coefficient decreases, the needle placement needs to be maintained and strengthened in a more concentrated direction. When the over-coverage coefficient increases, the needle placement needs to be optimized in a direction close to the center of the target area ROI. On the contrary, when the coverage coefficient decreases, the needle placement needs to be maintained and strengthened in a direction away from the center of the target area ROI.

[0101] The full coverage factor acts as a reinforcing factor for the repeat coverage factor, the total over-coverage factor, and the over-coverage factor for each stitch.

[0102] By using the complete coverage coefficient, repeated coverage coefficient, total over-coverage coefficient and the over-coverage coefficient of each needle placement as the judgment criteria for whether the current needle placement is qualified, the current needle placement can completely cover the ablation target area under the premise of meeting the first constraint condition, the second constraint condition and the third constraint condition, which not only improves the quality of ablation but also ensures the ablation effect.

[0103] In one embodiment of the present application, the S710 includes:

[0104] S711 calculates the value of the complete coverage factor of this group of multiple needle placements through formula 6.

[0105] Formula 6.

[0106] in, is the value of the complete coverage coefficient, X is the number of voxel points in the ablation target area covered by the superimposed effective ablation range, and N is the total number of voxel points in the ablation target area.

[0107] S712 calculates the value of the repeated coverage coefficient using Formula 7.

[0108] Formula 7.

[0109] in, is the value of the repeated coverage coefficient, Y is the cumulative number of voxel points in the ablation target area that are repeatedly covered by the effective ablation range generated by all single needle placements, and N is the total number of voxel points in the ablation target area.

[0110] S713 calculates the value of the total super coverage coefficient under multiple needle placement of this group through formula 8.

[0111] Formula 8.

[0112] in, is the value of the total over-coverage coefficient, Z is the number of voxel points whose superimposed effective ablation range exceeds the ablation target area, and N is the total number of voxels in the ablation target area.

[0113] S714 calculates the value of the super coverage coefficient of each stitch in the group of multiple stitches using formula 9.

[0114] Formula 9.

[0115] in, is the super coverage factor of each needle, T i is the number of voxel points whose effective ablation range produced by the i-th needle placement exceeds the ablation target area, i=1, 2, …, I, Q i is the total number of voxels within the effective ablation range generated by the i-th needle placement.

[0116] In this embodiment, Figure 3 (a) shows the total number of voxels in the ablation target area, such as Figure 3 (b) shows the number of voxel points in the ablation target area covered by the superimposed effective ablation range, such as Figure 3 (c) shows the cumulative number of voxel points in the ablation target area that are repeatedly covered by the effective ablation range generated by all single needle placements, as shown in Figure 3 (d) shows the number of voxel points whose superimposed effective ablation range exceeds the ablation target area. Figure 3 (e) shows that when i=4, the effective ablation range generated by the 4th needle placement exceeds the number of voxel points in the ablation target area, as shown in Figure 3 (f) shows the total number of voxels within the effective ablation range in the ablation target area generated by four needle placements.

[0117] In one embodiment of the present application, the S700 further includes:

[0118] S730, determining whether the value of the complete coverage coefficient is equal to 1.

[0119] S740, if the value of the complete coverage coefficient is equal to 1, further determine whether the value of the repeated coverage coefficient, the value of the total super coverage coefficient and the value of the super coverage coefficient satisfy the formula.

[0120] S750, if the value of the repeated coverage coefficient, the value of the total super coverage coefficient and the value of the super coverage coefficient satisfy the formula, then determine whether the coverage quality of the I-time needle placement in the ablation target area satisfies both the minimization of the difference between the superimposed effective ablation range and the ablation target area and the minimization of the number of needle placements I.

[0121] Specifically, the threshold of the repeated coverage factor is set to , set the threshold of total super coverage coefficient to , set the threshold of the super coverage coefficient of each needle to .

[0122] Step S730 can be expressed as Formula 17.

[0123] Formula 17.

[0124] Step S740 can be expressed as Formula 18.

[0125] Formula 18.

[0126] When the values ​​of the repeated coverage coefficient, the total super coverage coefficient and the super coverage coefficient satisfy Formula 17 and Formula 18 at the same time, the needle arrangement can be considered qualified.

[0127] Specifically, in practical applications, the threshold of the repeated coverage factor, the threshold of the total super coverage factor, and the threshold of the super coverage factor of each needle placement can be set according to the actual situation.

[0128] In this embodiment, the reason why it is necessary to "determine whether the value of the complete coverage coefficient is equal to 1" is actually to determine whether the number of voxel points covered by the superimposed effective ablation range in the ablation target area is consistent with the total number of voxel points in the ablation target area. When the value of the complete coverage coefficient is equal to 1, the superimposed effective ablation range in the ablation target area just completely covers the ablation target area.

[0129] The judgment process described in step S730 is performed under the constraint of the first constraint condition. Then, in order to meet the second constraint condition, the judgment process described in step S740 needs to be performed.

[0130] In one embodiment of the present application, the S800 includes:

[0131] S810 If the value of the complete coverage coefficient is not equal to 1, or the value of the repeated coverage coefficient, the value of the total super coverage coefficient and the value of the super coverage coefficient do not satisfy Formula 1, then add 1 to the value of I, and return to the calculation of the coverage quality target parameter coefficient under the current group of multiple needle placements. The coverage quality target parameter coefficient includes the complete coverage coefficient, the repeated coverage coefficient, the total super coverage coefficient and the super coverage coefficient of each needle placement.

[0132] In this embodiment, when at least one of the two judgments is not met, that is, the value of the complete coverage coefficient is not equal to 1 and / or the value of the repeated coverage coefficient, the value of the total super coverage coefficient and the value of the super coverage coefficient do not satisfy the formula, it is necessary to reset the needle properties.

[0133] Before resetting the needle placement properties, the number of needle placements for the next iteration needs to be increased by 1. The reason for increasing the number of needle placements is that the effective ablation range superimposed in the ablation target area of ​​this needle placement cannot cover the ablation target area, that is, under the current needle placement properties, it is impossible to complete the ablation of the ablation target area, so more needle placements are required to complete the ablation of the ablation target area. The reason why the number of needle placements is only increased by 1 is to meet the second constraint, that is, to complete the ablation process of the ablation target area with as few needle placements as possible.

[0134] After resetting the needle properties, continue to perform reverse iteration until the value of the complete coverage factor is equal to 1 and the value of the repeated coverage factor, the value of the total super coverage factor, and the value of the super coverage factor satisfy the formula.

[0135] In one embodiment of the present application, the S810 includes:

[0136] S811, optimize the axial direction of the needle through formula 10 and formula 11.

[0137] Formula 10.

[0138] Formula 11.

[0139] in, is the axis direction of the optimized needle. is the initial needle axis direction, Used to generate a range between 0 and A random number between .

[0140] S812, optimizing the center point position of the electrode needle of the needle distribution through formula 12 and formula 13.

[0141] Formula 12.

[0142] Formula 13.

[0143] in, is the center point position of the electrode needle of the optimized needle placement. is the center point of the electrode needle of the initial needle placement, To generate between arrive A random number between is the optimization iteration step size.

[0144] In this embodiment, As a reward factor, , and As a penalty coefficient, when the repeated coverage coefficient increases, the needle layout needs to be optimized in a more dispersed direction; conversely, when the repeated coverage coefficient decreases, the needle layout needs to be maintained and strengthened in a more concentrated direction; when the over-coverage coefficient increases, the needle layout needs to be optimized in a direction close to the center of the target area ROI; conversely, when the coverage coefficient decreases, the needle layout needs to be maintained and strengthened in a direction away from the center of the target area ROI; the complete coverage coefficient As an adjustment , and reinforcement factor.

[0145] Since the needle placement properties include the center point position of the electrode needle for each needle placement and the axis direction of the needle body for each needle placement, before the next iteration, the center point position of the electrode needle for the next needle placement and the axis direction of the needle body for the next needle placement need to be randomly regenerated.

[0146] However, in this generation, the range of random numbers is reduced, so compared with the electrode needle center point position and the needle body axis direction of the cloth needle generated last time, the invalid range can be reduced, thereby improving the quality of the cloth needle attributes.

[0147] In one embodiment of the present application, after S800, the following steps are included:

[0148] K100, outputs the axial direction of the cloth needle obtained by the last optimization, the position of the electrode needle center point of the cloth needle, and the axial direction of the needle body obtained by the last optimization.

[0149] K200, ablate the ablation target area according to the axial direction of the needle obtained by the last optimization, the position of the center point of the electrode needle of the needle, and the axial direction of the needle body obtained by the last optimization.

[0150] In this embodiment, when the value of the complete coverage coefficient is equal to 1, and the value of the repeated coverage coefficient, the value of the total super coverage coefficient and the value of the super coverage coefficient satisfy the formula, it can be considered that the needle layout properties of this time are able to ablate the entire ablation target area, so the target area can be ablated according to the needle layout properties and the number of needle layouts.

[0151] like Figure 2 As shown, in one embodiment of the present application, a single-needle bipolar pulsed electric field conformal ablation system is provided, which is applied to the single-needle bipolar pulsed electric field conformal ablation method described in any one of the aforementioned embodiments, and the single-needle bipolar pulsed electric field conformal ablation system includes an energy host, a single-needle bipolar electrode needle and a processing component.

[0152] The energy host is electrically connected to the single-needle bipolar electrode needle, and the high-voltage electric pulses required for ablation therapy generated by the energy host are delivered to the ablation target area through the single-needle bipolar electrode needle. The processing component includes a calculation module, a delineation module and a planning module. The calculation module calculates the corresponding electric field distribution and electric energy density distribution that can be generated by the energy host and the single-needle bipolar electrode needle in the target tissue, the delineation module delineates the ablation target area based on the patient's diagnostic image, and the planning module determines the minimum number of needle placements and the optimal needle placement position required for single-needle bipolar pulse electric field ablation therapy.

[0153] In this embodiment, the energy required for ablation is provided by the energy host, and the energy is delivered to the ablation target area through the single-needle bipolar electrode needle.

[0154] In the present application, a single-needle bipolar electrode needle is used to form an electric field for ablation treatment, thereby avoiding the limitation of a double-needle pairing combination and solving the problem of parallel needle arrangement operation.

[0155] like Figure 4 As shown, Figure 4 (a) represents the ablation target area. Figure 4 (b) indicates that the effective ablation range of the two needle placements fully covers the ablation target area. Figure 4 (c) shows the electric field intensity distribution of two superpositions of needle placement.

[0156] like Figure 5 As shown, Figure 5 (a) represents the ablation target area. Figure 5 (b) indicates that when the short diameter of the ablation target area is smaller than the long diameter of the ablation target area, the effective ablation range of the three-time needle arrangement superposition fully covers the ablation target area. Figure 5 (c) The electric field intensity distribution of three superpositions of needles.

[0157] like Figure 6 As shown, Figure 6 (a) represents the ablation target area. Figure 6(b) indicates that when the short diameter of the ablation target area is close to the long diameter of the ablation target area, the effective ablation range of the three-time needle arrangement superposition fully covers the ablation target area. Figure 6 (c) The electric field intensity distribution of three superpositions of needles.

[0158] like Figure 7 As shown, Figure 7 (a) represents the ablation target area. Figure 7 (b) indicates that when the short diameter of the ablation target area is close to the long diameter of the ablation target area, the effective ablation range of multiple needle placement superpositions fully covers the ablation target area. Figure 7 (c) The electric field intensity distribution of multiple needle placement superpositions.

[0159] like Figure 8 As shown, Figure 8 (a) represents the ablation target area. Figure 8 (b) indicates that the effective ablation range of three superpositions of needle placements fully covers the ablation target area when the needle placement angle is not specified. Figure 8 (c) shows the electric field intensity distribution of three superpositions of needle placement when the needle placement angle is not specified. Figure 8 (d) indicates that the effective ablation range of the four superimposed needle placements at a specified needle placement angle fully covers the ablation target area. Figure 8 (e) The electric field intensity distribution of four stitches superimposed at a specified stitch angle.

[0160] The technical features of the above-described embodiments may be arbitrarily combined, and the execution order of the method steps is not limited. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0161] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the present application. It should be noted that, for a person of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the attached claims.

Claims

1. A single-needle bipolar pulsed electric field conformal ablation system, characterized in that: The single-needle bipolar pulsed electric field conformal ablation system comprises: Energy host; A single-needle bipolar electrode needle, the energy host is electrically connected to the single-needle bipolar electrode needle, and the high-voltage electric pulses required for ablation treatment generated by the energy host are delivered to the ablation target area through the single-needle bipolar electrode needle; A processing component, the processing component includes a calculation module, a delineation module and a planning module, wherein the calculation module calculates the corresponding electric field distribution and electric energy density distribution that can be generated by the energy host and the single-needle bipolar electrode needle in the target tissue, the delineation module delineates the ablation target area based on the patient's diagnostic image, and the planning module determines the minimum number of needle placements and the optimal needle placement position required for single-needle bipolar pulsed electric field ablation treatment; The single-needle bipolar pulsed electric field conformal ablation system is applied to a single-needle bipolar pulsed electric field conformal ablation method, and the single-needle bipolar pulsed electric field conformal ablation method comprises: Based on the patient's diagnostic image, an ablation target area is delineated in the patient's diagnostic image; Mapping the ablation target area into a three-dimensional rectangular coordinate system, and calculating the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area; Based on the optional maximum ablation treatment parameters, the maximum effective ablation range of each needle placement is obtained through simulation; simulation is performed using Comsol software; A set of needle placement operations is performed in the ablation target area, the set of needle placement operations includes I needle placement, and the needle placement attributes of each needle placement are randomly generated until the effective ablation range generated by the I needle placement operation in the ablation target area completely covers the ablation target area after superposition; the needle placement attributes include the center point position of the electrode needle of each needle placement and the axis direction of the needle body of each needle placement; Based on the ablation treatment parameters corresponding to the first needle placement in this group, the effective ablation range formed by each needle placement in the first needle placement in this group is obtained through simulation; Based on the effective ablation range formed by each needle placement in this group of I needle placements, the effective ablation range after superposition of I needle placements is calculated, which is recorded as the superimposed effective ablation range; Based on the effective ablation range formed by each needle placement in this group of I needle placements, the superimposed effective ablation range, the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area, the coverage quality of the I needle placement operation in this group of I needle placements is evaluated to determine whether the coverage quality of the I needle placement in the ablation target area satisfies both the superimposed effective ablation range that completely covers the target area and minimizes the difference between the superimposed effective ablation range and the ablation target area and the number of needle placements I is minimized; If the coverage quality of I needle placement in the ablation target area does not satisfy the requirements that the superimposed effective ablation range completely covers the target area, the difference between the superimposed effective ablation range and the ablation target area is minimized, and the number of needle placements I is minimized, the needle placement properties of each needle placement are optimized to form the next set of needle placement schemes, until the coverage quality of I needle placement in the ablation target area satisfies the requirements that the superimposed effective ablation range completely covers the target area, the difference between the superimposed effective ablation range and the ablation target area is minimized, and the number of needle placements I is minimized, and the needle placement properties of the optimal needle placement scheme are output.

2. The single-needle bipolar pulsed electric field conformal ablation system according to claim 1, characterized in that: When needle placement is performed I times in the ablation target area, the needle placement properties of each time are randomly generated until the effective ablation range generated by the I needle placement operation in the ablation target area completely covers the ablation target area after superposition, and the axis direction of the needle body of each needle placement is controlled within the preset angle range.

3. The single-needle bipolar pulsed electric field conformal ablation system according to claim 2, characterized in that: The needle placement is performed once in the ablation target area, and the needle placement attributes of each needle placement are randomly generated, until the effective ablation range generated by the needle placement operation once in the ablation target area completely covers the ablation target area after being superimposed, including: Calculate the initial value of the number of stitches I according to formula 1; Formula 1; in, is the initial value of the number of stitches I, is the volume of the ablation target area, It is the maximum effective ablation range that a single electrode needle can reach. is the ceiling function; Calculate the needle body axis direction of each needle placement by using formula 2 and formula 3; Formula 2: Formula 3: in, is the direction of the needle body axis of the i-th needle placement, i=1, 2, …, I; for The random function of Used to generate random numbers between 0 and 1. It is the minimum value of the preset angle range for needle placement. It is the maximum value of the preset angle range for needle placement; The center point position of the electrode needle for each needle placement is calculated by using formula 4 and formula 5; Formula 4: Formula 5: in, is the center point of the electrode needle of the initial needle placement, It is used to generate a random number between 0 and 1. K is the preset maximum number of optimization iterations. is the optimization iteration step size.

4. The single-needle bipolar pulsed electric field conformal ablation system according to claim 3, characterized in that: The method of evaluating the coverage quality of the ablation target area by the I-time needle placement operation in the group based on the effective ablation range formed by each needle placement in the group I-time needle placement, the superimposed effective ablation range, the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area, and judging whether the coverage quality of the I-time needle placement in the ablation target area satisfies the requirements of the superimposed effective ablation range completely covering the target area and minimizing the difference between the superimposed effective ablation range and the ablation target area and minimizing the number of needle placements I, includes: Calculate the coverage quality target parameter coefficients under multiple needle placements of this group; the coverage quality target parameter coefficients include complete coverage coefficient, repeated coverage coefficient, total over-coverage coefficient and over-coverage coefficient of each needle placement; Based on the coverage quality target parameter coefficient, it is judged whether the coverage quality of the I-time needle placement in the ablation target area satisfies both the requirement of complete coverage of the target area by the superimposed effective ablation range and minimization of the difference between the target area and the ablation target area and minimization of the number of needle placements I.

5. The single-needle bipolar pulsed electric field conformal ablation system according to claim 4, characterized in that: The calculation of the coverage quality target parameter coefficient under multiple needle placements of this group; the coverage quality target parameter coefficient includes a complete coverage coefficient, a repeated coverage coefficient, a total over-coverage coefficient and an over-coverage coefficient of each needle placement, including: The value of the complete coverage factor under multiple needle placements in this group is calculated using Formula 6; Formula 6: in, is the value of the complete coverage factor, X is the number of voxel points in the ablation target area covered by the superimposed effective ablation range, and N is the total number of voxel points in the ablation target area; The value of the repeated coverage factor is calculated by formula 7; Formula 7: in, is the value of the repeated coverage coefficient, Y is the cumulative number of voxel points in the ablation target area that are repeatedly covered by the effective ablation range generated by all single needle placements, and N is the total number of voxel points in the ablation target area; The total super coverage coefficient of this group of multiple needle placements is calculated using Formula 8; Formula 8: in, is the value of the total over-coverage factor, Z is the number of voxel points whose superimposed effective ablation range exceeds the ablation target area, and N is the total number of voxels in the ablation target area; The value of the super coverage coefficient of each needle placement in this group of multiple needle placements is calculated by formula 9; Formula 9: in, is the over-coverage coefficient of each needle, is the number of voxel points whose effective ablation range produced by the i-th needle placement exceeds the ablation target area, i=1, 2, …, I; is the total number of voxels within the effective ablation range generated by the i-th needle placement.

6. The single-needle bipolar pulsed electric field conformal ablation system according to claim 5, characterized in that: Based on the effective ablation range formed by each needle placement, the superimposed effective ablation range, the volume of the ablation target area and the three-dimensional coordinates of the target area center of the ablation target area, the coverage quality of the needle placement in the ablation target area is evaluated, and it is judged whether the coverage quality of the needle placement in the ablation target area satisfies the requirements that the superimposed effective ablation range completely covers the target area and the difference between the superimposed effective ablation range and the ablation target area is minimized and the number of needle placements I is minimized, and it also includes: Determine whether the value of the complete coverage factor is equal to 1; If the value of the complete coverage coefficient is equal to 1, it is further determined whether the value of the repeated coverage coefficient, the value of the total super coverage coefficient and the value of the super coverage coefficient of each needle placement satisfy the formula; the formula is: ； in, is the threshold of the repeated coverage factor, is the threshold of total super coverage factor, is the threshold value of the needle over-coverage coefficient each time; If the values ​​of the repeated coverage coefficient, the total over-coverage coefficient and the over-coverage coefficient of each needle placement satisfy the formula, then the coverage quality of the I-time needle placement in the ablation target area is determined to simultaneously satisfy the superimposed effective ablation range to completely cover the target area and minimize the difference between the superimposed effective ablation range and the ablation target area and minimize the number of needle placements I.

7. The single-needle bipolar pulsed electric field conformal ablation system according to claim 6, characterized in that: The needle placement properties of each needle placement are optimized to form the next set of needle placement schemes, until the coverage quality of the needle placement in the ablation target area satisfies both the superimposed effective ablation range to completely cover the target area and minimize the difference between the target area and the ablation target area and the number of needle placements I is minimized, and the needle placement properties of the optimal needle placement scheme are output, including: If the value of the complete coverage coefficient is not equal to 1, or the value of the repeated coverage coefficient, the value of the total over-coverage coefficient and the value of the over-coverage coefficient of each needle placement do not satisfy the formula, then the value of I is increased by 1, and the calculation of the coverage quality target parameter coefficient under this group of multiple needle placements is returned; the coverage quality target parameter coefficient includes the complete coverage coefficient, repeated coverage coefficient, total over-coverage coefficient and the over-coverage coefficient of each needle placement.

8. The single-needle bipolar pulsed electric field conformal ablation system according to claim 7, characterized in that: If the value of the complete coverage coefficient is not equal to 1, or the value of the repeated coverage coefficient, the value of the total super coverage coefficient and the value of the super coverage coefficient of each needle placement do not satisfy the formula, then the value of I is increased by 1, and the calculation of the coverage quality target parameter coefficient under multiple needle placements of this group is returned, including: Optimize the axial direction of the needle by using formula 10 and formula 11; Formula 10: Formula 11: in, is the axis direction of the optimized needle. is the initial needle axis direction, To generate a value between 0 and A random number between The center point position of the electrode needle of the needle distribution is optimized by formula 12 and formula 13; Formula 12: Formula 13: in, is the center point position of the electrode needle of the optimized needle distribution. is the center point of the electrode needle of the initial needle placement, To generate between arrive A random number between is the optimization iteration step size.

9. The single-needle bipolar pulsed electric field conformal ablation system according to claim 8, characterized in that: The single-needle bipolar pulse electric field conformal ablation method further comprises: Output the axis direction of the needle and the center point position of the electrode needle of the needle obtained by the last optimization; The ablation target area is ablated according to the axial direction of the needle arrangement and the center point position of the electrode needle of the needle arrangement obtained by the last optimization.

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