CN116617577B - Tumor electric field treatment system capable of closed-loop regulation and control - Google Patents
Tumor electric field treatment system capable of closed-loop regulation and control Download PDFInfo
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Abstract
The application discloses a tumor electric field treatment method and system capable of closed-loop regulation and control, and relates to the technical field of biomedical engineering. The specific implementation scheme is as follows: constructing a head simulation model based on the magnetic resonance imaging data; setting an initial tumor electric field treatment implementation scheme, selecting the optimal electrode patch application position and input current, and measuring the contact impedance and temperature of each electrode and skin; and adjusting the implementation mode according to the measurement result, predicting the skin temperature change under the electrodes and the electric field intensity of the tumor area, optimizing the electric field intensity of the tumor area, and selecting the optimal input current value of each electrode as a new input current under the constraint of proper skin temperature. The tumor electric field treatment method and system capable of realizing closed-loop regulation and control provided by the application can ensure proper skin temperature and simultaneously maximize the electric field intensity transmitted to a tumor area; the temperature and electric field intensity change of the head complex structure is predicted through finite element calculation, and the regulation and control precision is improved.
Description
Technical Field
The application relates to the technical field of biomedical engineering, in particular to a tumor electric field treatment system capable of closed-loop regulation.
Background
Tumor electric field therapy (Tumor Treating Fields) is a non-invasive tumor treatment technique that has been approved by the FDA for the treatment of glioblastoma and mesothelioma. It transmits an intermediate frequency (100-300 kHz) and low-intensity (1-3V/cm) alternating electric field to the tumor area through the external application electrode, thereby inhibiting the proliferation of tumor cells.
The electric field strength and duration of treatment of the tumor region has proven to be critical to the therapeutic effect. In vitro experiments show that the electric field higher than 1V/cm can inhibit the proliferation of tumor cells, and the inhibition effect is better along with the increase of the electric field intensity, and clinical experiments also show that the longer the electric field application time is, the better the treatment effect is. However, in the tumor electric field treatment process, the skin under the electrode can generate heat due to the use of the ceramic electrode plate, and the temperature can be increased along with the increase of the use time. In order to avoid scalding patients, the temperature of the scalp below the electrode is usually detected, and the output current is controlled according to the temperature, and the regulation and control methods of the existing treatment equipment mainly comprise the following steps:
(1) Setting a temperature threshold, reducing the input current when the temperature threshold is exceeded, and increasing the input current to a preset value when the temperature threshold is lower than the temperature threshold; or subdividing a temperature interval, and inputting current with corresponding magnitude in a certain interval;
(2) Setting independent circuit switches and temperature sensors for each electrode, switching off corresponding circuits when the temperature of which sensor exceeds a threshold value, switching on the corresponding circuits when the temperature is reduced below the threshold value; or the magnitude of the current input to the electrode is adjusted by controlling the duty cycle of the open and closed circuits;
however, it is noted that these control methods may cause a dead cycle in which the incoming temperature repeatedly fluctuates above and below the threshold, and more importantly, when the temperature is controlled by adjusting the input current, the electric field intensity of the tumor area may be lower than the effective therapeutic value, thereby affecting the therapeutic effect.
In fact, the main cause of the rise in skin temperature under the electrode is joule heat generated by the therapeutic electric field of the tumor treatment. In addition, drying of the hydrogel under the electrode, hair growth, etc. can increase the impedance between the electrode and the skin, which in turn can lead to higher heat generation at the electrode than at other electrodes. Therefore, how to make the electric field treatment of tumor generate heat in a reasonable range is considered, and the intensity of the treatment field at the brain tumor of an individual is ensured, so that the electric field treatment method has great significance for the safety and effectiveness of the electric field treatment of tumor.
Disclosure of Invention
Based on the above, the application provides a tumor electric field treatment system capable of closed-loop regulation and control in order to solve the problem of maximizing the electric field intensity of a tumor area while ensuring proper skin temperature.
The application provides a tumor electric field treatment system capable of being regulated and controlled in a closed loop, which is used for realizing a tumor electric field treatment method capable of being regulated and controlled in a closed loop, and comprises the following steps:
constructing a head simulation model based on the magnetic resonance imaging data;
the construction of the head simulation model includes,
segmenting the magnetic resonance imaging data, and dividing the individual head model structure into skin, skull, cerebrospinal fluid, gray matter, white matter, tumor edema and tumor necrosis areas;
placing a hydrogel layer on the surface of the head, and placing a ceramic electrode on the hydrogel layer;
performing finite element gridding on the individual head model by using an iso2mesh tool, generating a three-dimensional grid, performing structural restoration, and converting the segmented magnetic resonance imaging into a tetrahedral grid by using a cgalv2m function;
defining material parameters required by electric field and temperature field calculation, wherein the material parameters comprise conductivity, dielectric constant, density, heat conductivity and specific heat capacity of each tissue layer, electrodes and hydrogel;
an initial tumor electric field treatment implementation scheme is established, an electric field and a temperature field are solved by a finite element method, optimization is carried out aiming at the electric field intensity of a tumor area and the skin temperature under the electrodes, the optimal electrode sheet application position and input current are selected, and the contact impedance of each electrode and the skin temperature under the electrodes are measured;
specific operations for formulating an initial tumor electric field treatment embodiment include,
a1: setting an initial electrode plate position and an initial input current, performing frequency domain-transient finite element calculation, calculating the maximum temperature of the skin under the electrode to obtain a time-dependent change value of the skin temperature under the electrode and electric field distribution of a tumor area, and calculating the maximum temperature of the skin under the electrode;
the calculation of the maximum temperature of the skin under the electrode includes,
a curve of the skin temperature T under the electrode over time T is fitted,
wherein C is 1 、C 2 、C 3 Representing the coefficients obtained by fitting;
based on fitting coefficient C 1 、C 3 Final steady state maximum T of skin temperature under counter electrode max Predicting and recording the average electric field intensity and the maximum skin temperature of the tumor area;
T max ＝lim t→∞ T＝C 1 +C 3 。
it should be noted that: the calculation of the maximum temperature of the skin under the electrode is to save calculation time. For example, the maximum steady-state temperature can be reached only in 30 minutes normally, but only the time-varying data of the temperature in the first 5 minutes can be calculated, and then a curve is fitted to obtain the maximum steady-state temperature by limiting.
A2: changing an input current value, repeating frequency domain-transient finite element calculation, obtaining electric field distribution of a tumor area and skin temperature under an electrode, and selecting an input current which enables the electric field intensity of the tumor area to be maximum and the maximum skin temperature to be lower than a threshold value as an alternative scheme;
a3: changing the electrode plate positions, repeating the step A2 until all positions are traversed, selecting the electrode plate position which maximizes the electric field intensity of the tumor area in all alternatives, and setting the electrode plate position which maximizes the electric field intensity of the tumor area and the input current as an initial tumor electric field treatment embodiment;
a4: calculating an electric field transmission matrix of each electrode on the electrode sheet through the frequency domain finite element;
a5: and changing the input current and the contact impedance of each electrode on the electrode sheet, calculating the skin temperature change under the electrodes through transient finite elements, and carrying out fitting calculation on the maximum skin temperature under each electrode and the input current and the contact impedance of each electrode.
It should be noted that: finite element computing requires relatively high CPU and memory requirements, and typically requires the use of high performance computers. However, the treatment equipment needs to be carried about, is a small device, and is limited in calculation power by a microcontroller such as a singlechip and a raspberry pie. The simulation model is fixed, the electrode position is also determined, the steps A4 and A5 simplify the calculation of the subsequent deployment to equipment by calculating an electric field transmission matrix and a temperature fitting formula, and the electric field and the temperature can be obtained only by substituting the measured value and the current value into the matrix and the formula;
and adjusting the implementation scheme according to the measured contact impedance between each electrode and the skin and the measured skin temperature under the electrodes, substituting the measured contact impedance into a head simulation model, setting the measured skin temperature under the electrodes as an initial temperature, predicting the skin temperature change under the electrodes and the electric field intensity of a tumor area, optimizing the electric field intensity of the tumor area, and selecting the optimal input current value of each electrode as a new input current under the constraint of the proper skin temperature.
The fitting calculation specifically includes,
T max ＝X+BY+Z
wherein T is max A vector representing the maximum temperature composition of the skin under each electrode, X representing the vector of the input current value composition of each electrode, Y representing the vector of the contact impedance composition of each electrode, Z representing the vector of the initial temperature composition of each electrode, A, B representing the coefficient matrix obtained by fitting;
Z＝[T 1 ,T 2 ,…,T n ] T
wherein,the maximum temperature of the skin under the electrode with the number I is shown as I i The electrode input current value, sigma, with the index i i The electrode contact resistance with the number i is represented by T i The initial temperature of the electrode with the number i is shown, and n is the number of the electrodes. Specific operations for adjusting the embodiment based on the measured contact resistance of each electrode with the skin and the temperature of the skin under the electrode include,
substituting the measured contact impedance of the electrode and the skin and the measured skin temperature under the electrode into the transmission matrix obtained in the step A4 and the fitting calculation formula obtained in the step A5 to obtain the electric field intensity of the tumor area and the maximum skin temperature under each electrode;
the input current of each electrode is changed, and an optimization algorithm is used, so that the optimal input current of each electrode is calculated under the constraint of the proper temperature of the skin, and the electric field intensity of a tumor area is maximized.
The expression of the optimization algorithm is as follows:
s.t.T i max (I i )≤T 0
wherein I represents the electrode number, I i Indicating the input current value of the electrode, I i0 Represents the electrode input current value of the initial embodiment,represents the electric field strength caused by a single electrode of the initial embodiment, T 0 Representing a skin temperature threshold.
The construction of the head simulation model and the establishment of an initial tumor electric field treatment implementation scheme are all carried out in a high-performance computer; then, the initial tumor electric field treatment implementation mode, the electric field transmission matrix and the temperature fitting formula are stored in a tumor electric field treatment implementation terminal; the implementation is then adjusted in the terminal according to the measured values.
The device comprises a main control module, an electric field stimulation generation module, a stimulation measurement integrated electrode slice, an impedance monitoring module, a temperature monitoring module, an energy supply module, a communication module and an interaction module;
the main control module is connected with the electric field stimulation generation module, the impedance monitoring module, the temperature monitoring module, the energy supply module, the communication module and the interaction module, and the stimulation measurement integrated electrode is connected with the electric field stimulation generation module, the temperature monitoring module and the impedance monitoring module;
the main control module consists of a microprocessor and a microprocessor peripheral circuit and is used for communication, control and data interaction processing of the whole system;
the electric field stimulation generation module is provided with a plurality of stimulation channels, and each channel can independently and programmatically output tumor electric field treatment signals of 0 to +/-150 mA and 50 to 400kHz for generating a tumor treatment electric field;
the stimulation and measurement integrated electrode slice can be used for tumor treatment electric field output and temperature and impedance measurement;
the impedance monitoring module is used for monitoring the contact impedance change of each stimulation electrode;
the temperature monitoring module is used for measuring the real-time temperature under each electrode in real time;
the energy supply module is used for supplying energy to the whole system;
the communication module is used for communication of the whole system;
the interaction module is used for realizing data interaction of the system.
The beneficial effects are that:
(1) The tumor electric field treatment system capable of closed loop regulation and control provided by the application can ensure proper skin temperature and maximize electric field intensity transmitted to a tumor area, and compared with the prior art that only scalp temperature is ignored by considering electric field intensity or only input current is regulated to ensure proper skin temperature, the tumor electric field treatment system not only avoids scalding skin, but also improves transmitted therapeutic electric field dosage, and is beneficial to improving therapeutic effect;
(2) The implementation scheme can be adjusted according to the contact impedance of the electrode and the skin and the measured value of the temperature of the electrode, so that a closed-loop regulation and control system is formed;
(3) According to the method, the temperature and electric field intensity change of the head complex structure is predicted through finite element calculation, and compared with the method based on experience judgment, the method improves the regulation and control precision; and when an initial implementation scheme is formulated, a fitting formula of a transmission matrix and temperature of an electric field is obtained, and the calculated amount of a subsequent step is reduced, so that the condition of hardware deployment is met.
It should be understood that the description of this section is not intended to identify key or critical features of the embodiments of the application or to delineate the scope of the application. Other features of the present application will become apparent from the description that follows.
Drawings
The drawings are for better understanding of the present solution and do not constitute a limitation of the present application. Wherein:
FIG. 1 is a flow chart of a method provided in accordance with the present application;
FIG. 2 is a block diagram of the system components provided in accordance with the present application;
FIG. 3 is a schematic illustration of constructing a head simulation model according to the present application;
FIG. 4 is a scalp temperature distribution and intra-brain electric field distribution diagram provided in accordance with the present application;
fig. 5 is a graph showing the maximum scalp temperature over time for different current levels input according to the present application.
Detailed Description
Exemplary embodiments of the present application are described below in conjunction with the accompanying drawings, which include various details of the embodiments of the present application to facilitate understanding, and should be considered as merely exemplary. Accordingly, one of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the present application. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.
Example 1
Referring to fig. 1-2, for one embodiment of the present application, there is provided a tumor electric field treatment system capable of closed loop regulation, comprising:
as shown in fig. 1, the tumor electric field treatment method capable of closed-loop regulation mainly comprises three parts of head simulation construction, establishment of an initial tumor electric field treatment implementation scheme and adjustment of the implementation scheme according to measurement results.
The application provides a tumor electric field treatment system capable of being regulated and controlled in a closed loop, which is used for realizing a tumor electric field treatment method capable of being regulated and controlled in a closed loop, and comprises the following steps:
s1: based on the magnetic resonance imaging data, a head simulation model is constructed. It should be noted that:
the construction of the head simulation model includes,
segmenting the magnetic resonance imaging data, and dividing the individual head model structure into skin, skull, cerebrospinal fluid, gray matter, white matter, tumor edema and tumor necrosis areas;
placing a hydrogel layer on the surface of the head, and placing a ceramic electrode on the hydrogel layer;
performing finite element gridding on the individual head model by using an iso2mesh tool, generating a three-dimensional grid, performing structural restoration, and converting the segmented magnetic resonance imaging into a tetrahedral grid by using a cgalv2m function;
the material parameters required for electric and temperature field calculations are defined and include the conductivity, dielectric constant, density, thermal conductivity, specific heat capacity of each tissue layer and electrode and hydrogel.
S2: an initial tumor electric field treatment implementation scheme is formulated, an electric field and a temperature field are solved by a finite element method, optimization is carried out aiming at the electric field intensity of a tumor area and the skin temperature under the electrodes, the optimal electrode sheet application position and input current are selected, and the contact impedance of each electrode and the skin temperature under the electrodes are measured. It should be noted that:
specific operations for formulating an initial tumor electric field treatment embodiment include,
a1: setting an initial electrode plate position and an initial input current, performing frequency domain-transient finite element calculation to obtain a time-dependent change value of skin temperature under the electrode and electric field distribution of a tumor area, and calculating the maximum skin temperature under the electrode;
the calculation of the maximum temperature of the skin under the electrode includes,
a curve of the skin temperature T under the electrode over time T is fitted,
wherein C is 1 、C 2 、C 3 Representing the coefficients obtained by fitting;
based on fitting coefficient C 1 、C 3 Final steady state maximum T of skin temperature under counter electrode max Predicting and recording the average electric field intensity and the maximum skin temperature of the tumor area;
T max ＝lim t→∞ T＝C 1 +C 3 。
it should be noted that: the calculation of the maximum temperature of the skin under the electrode is to save calculation time. For example, the maximum steady-state temperature can be reached only in 30 minutes normally, but only the time-varying data of the temperature in the first 5 minutes can be calculated, and then a curve is fitted to obtain the maximum steady-state temperature by limiting.
A2: changing an input current value, repeating frequency domain-transient finite element calculation, obtaining electric field distribution of a tumor area and skin temperature under an electrode, and selecting an input current which enables the electric field intensity of the tumor area to be maximum and the maximum skin temperature to be lower than a threshold value as an alternative scheme;
a3: changing the electrode plate positions, repeating the step A2 until all positions are traversed, selecting the electrode plate position which maximizes the electric field intensity of the tumor area in all alternatives, and setting the electrode plate position which maximizes the electric field intensity of the tumor area and the input current as an initial tumor electric field treatment embodiment;
a4: calculating an electric field transmission matrix of each electrode on the electrode sheet through the frequency domain finite element;
a5: and changing the input current and the contact impedance of each electrode on the electrode sheet, calculating the skin temperature change under the electrodes through transient finite elements, and carrying out fitting calculation on the maximum skin temperature under each electrode and the input current and the contact impedance of each electrode.
The fitting calculation specifically includes,
T max ＝X+BY+Z
wherein T is max A vector representing the maximum temperature composition of the skin under each electrode, X representing the vector of the input current value composition of each electrode, Y representing the vector of the contact impedance composition of each electrode, Z representing the vector of the initial temperature composition of each electrode, A, B representing the coefficient matrix obtained by fitting;
Z＝[T 1 ,T 2 ,…,T n ] T
wherein T is i max The maximum temperature of the skin under the electrode with the number I is shown as I i The electrode input current value, sigma, with the index i i The electrode contact resistance with the number i is represented by T i The initial temperature of the electrode with the number i is shown, and n is the number of the electrodes.
It should be noted that: finite element computing requires relatively high CPU and memory requirements, and typically requires the use of high performance computers. However, the treatment equipment needs to be carried about, is a small device, and is limited in calculation power by a microcontroller such as a singlechip and a raspberry pie. The simulation model is fixed, the electrode position is also determined, the steps A4 and A5 simplify the calculation of the subsequent deployment to equipment by calculating an electric field transmission matrix and a temperature fitting formula, and the electric field and the temperature can be obtained only by substituting the measured value and the current value into the matrix and the formula.
S3: and adjusting the implementation scheme according to the measured contact impedance between each electrode and the skin and the measured skin temperature under the electrodes, substituting the measured contact impedance into a head simulation model, setting the measured skin temperature under the electrodes as an initial temperature, predicting the skin temperature change under the electrodes and the electric field intensity of a tumor area, optimizing the electric field intensity of the tumor area, and selecting the optimal input current value of each electrode as a new input current under the constraint of the proper skin temperature. It should be noted that:
specific operations for adjusting the embodiment based on the measured contact resistance of each electrode with the skin and the temperature of the skin under the electrode include,
substituting the measured contact impedance of the electrode and the skin and the measured skin temperature under the electrode into the transmission matrix obtained in the step A4 and the fitting calculation formula obtained in the step A5 to obtain the electric field intensity of the tumor area and the maximum skin temperature under each electrode;
the input current of each electrode is changed, and an optimization algorithm is used, so that the optimal input current of each electrode is calculated under the constraint of the proper temperature of the skin, and the electric field intensity of a tumor area is maximized.
The expression of the optimization algorithm is:
wherein I represents the electrode number, I i Representing electricityInput current value of pole, I i0 Represents the electrode input current value of the initial embodiment,represents the electric field strength caused by a single electrode of the initial embodiment, T 0 Representing a skin temperature threshold.
The construction of the head simulation model and the establishment of the initial tumor electric field treatment implementation scheme are all carried out in a high-performance computer; then, the initial tumor electric field treatment implementation mode, the electric field transmission matrix and the temperature fitting formula are stored in a tumor electric field treatment implementation terminal; the implementation is then adjusted in the terminal according to the measured values.
As shown in fig. 2, the tumor electric field treatment system capable of closed-loop regulation provided by the present application includes: the device comprises a main control module, an electric field stimulation generation module, a stimulation measurement integrated electrode slice, an impedance monitoring module, a temperature monitoring module, an energy supply module, a communication module and an interaction module;
the main control module is connected with the electric field stimulation generation module, the impedance monitoring module, the temperature monitoring module, the energy supply module, the communication module and the interaction module, and the stimulation measurement integrated electrode is connected with the electric field stimulation generation module, the temperature monitoring module and the impedance monitoring module;
the main control module consists of a microprocessor and a microprocessor peripheral circuit and is used for communication, control and data interaction processing of the whole system;
the electric field stimulation generation module is provided with a plurality of stimulation channels, and each channel can independently and programmatically output tumor electric field treatment signals of 0 to +/-150 mA and 50 to 400kHz for generating tumor treatment electric fields;
the stimulation and measurement integrated electrode slice can be used for tumor treatment electric field output and temperature and impedance measurement;
the impedance monitoring module is used for monitoring the contact impedance change of each stimulation electrode;
the temperature monitoring module is used for measuring the real-time temperature under each electrode in real time;
the energy supply module is used for supplying energy to the whole system;
the communication module is used for communication of the whole system;
the interaction module is used for realizing data interaction of the system.
Example 2
Referring to fig. 3 to 5, a second embodiment of the present application, which is different from the first embodiment, provides a verification test of a tumor electric field treatment system capable of being controlled in a closed loop, and is used for verifying and describing the technical effects adopted in the present application so as to verify the actual effects of the present application.
1. Building head simulation model
As shown in fig. 3, the magnetic resonance imaging data is first segmented using SPM12 software, the individual head model structure is segmented into skin, skull, cerebrospinal fluid, white matter and grey matter, and then the tumor edema and tumor necrosis areas are manually segmented in a3 Dslicer; then, performing segmentation post-processing by using MATLAB script functions, wherein the segmentation post-processing comprises operations such as filling holes, removing free voxels, smoothing and the like; then placing electrodes on the skin surface, placing a pair of 3*3 electrode arrays on the skin according to the electrode layout commonly used in the market, and placing a hydrogel layer under the electrodes; performing finite element gridding on the model by using an iso2mesh tool in MATLAB, generating a three-dimensional grid and performing structural repair, wherein a cgalv2m function is used for generating a tetrahedral grid from the segmented magnetic resonance imaging; finally, the conductivity, dielectric constant, density, thermal conductivity and specific heat capacity of each tissue and electrode are defined.
2. Formulation of initial tumor electric field treatment embodiment
(1) Defining the input current of each electrode as 100mA (total current 900 mA) in finite element computing software COMSOL, wherein the initial temperature is 25 ℃ of the ambient temperature; then selecting a frequency domain-transient solution type to perform electric field and temperature field coupling calculation, wherein the frequency is 200kHz, and calculating a transient result of 5min, as shown in FIG. 4; the average electric field intensity of the tumor area was calculated, and then a MATLAB curve fitting kit was used to fit a curve of skin temperature T over time T (fig. 5), resulting in the following formula:
wherein C is 1 、C 2 、C 3 Representing the coefficients obtained by fitting;
and thus the final steady-state maximum T of the skin temperature can be predicted max ：
The average electric field intensity of the tumor area and the maximum skin temperature were recorded.
(2) The electrode position was kept unchanged, the result of 10mA step length of the input current between 40mA and 100mA was calculated respectively using the parameterized scan option in COMSOL as a parameter (FIG. 5), and then the input current with the largest average electric field intensity in the tumor area was selected as an alternative from the results of the maximum skin temperature being lower than 39.5 ℃.
(3) Changing the position of the electrode array, repeating the above steps until all positions are traversed. The electrode array position that maximizes the average electric field strength of the tumor region is then selected among all alternatives, and the electrode array position and input current are the initial tumor electric field treatment embodiments.
(4) In order to reduce the hardware calculation amount when the implementation mode is adjusted in the subsequent steps, carrying out finite element calculation again according to the implementation mode to obtain an electric field transmission matrix of each electrode; then changing the input current of each electrode in the electrode array and the impedance of hydrogel under the electrode, calculating the maximum skin temperature under each electrode, and finally fitting the calculated results to obtain a fitting formula of the maximum skin temperature under each electrode and the input current and the contact impedance of each electrode:
T max ＝AX+BY+Z
wherein T is max A vector representing the maximum temperature composition of the skin under each electrode, X representing the vector representing the composition of the input current value of each electrode, Y representing the vector representing the composition of the contact resistance of each electrode, Z representing the vector representing the initial temperature composition of each electrode, A, BRepresenting the coefficient matrix obtained by fitting.
Y＝[σ 1 ,σ 2 ,…,σ n ] T
Z＝[T 1 ,T 2 ,…,T n ] T
Wherein i represents the electrode number,indicating the maximum temperature of the skin under the corresponding electrode, I i Representing the input current value sigma of the corresponding electrode i Representing the contact resistance of the corresponding electrode, T i The initial temperature of the corresponding electrode is shown, and n is the number of electrodes.
3. Treatment is carried out and measured
Tumor electric field therapy is implemented according to the established initial scheme, the contact impedance of each electrode and the skin is measured through an impedance monitoring module, and the temperature of each electrode is measured through a temperature monitoring module.
4. Adjusting embodiments based on measurements
Substituting the measured result into a finite element calculation model, adding the measured contact impedance of each electrode to the corresponding hydrogel layer, and taking the measured actual temperature of each electrode as the initial temperature of subsequent calculation; the input current of the electrode with higher temperature is reduced, the input current of the electrode with lower temperature is increased, and the electric field intensity of the tumor area and the maximum temperature of the skin are predicted through the electric field transmission matrix and the temperature fitting formula; then, under the condition that the maximum temperature of the skin is not higher than 39.5 ℃, calculating the input current of each electrode which makes the electric field intensity of the tumor area maximum by using an optimization algorithm, wherein the optimization expression is as follows:
wherein I is i Indicating the input current value of the electrode, I i0 Represents the electrode input current value of the initial embodiment,representing the strength of the electric field induced by the individual electrodes of the initial embodiment.
Then, tumor electric field treatment was performed according to a new protocol, and the contact resistance of each electrode to the skin and its temperature were measured, after which the above steps were repeated.
In the several embodiments provided in this application, it should be understood that the disclosed apparatus and method may be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative, e.g., the division of the modules or units is merely a logical functional division, and there may be additional divisions when actually implemented, e.g., multiple units or components may be combined or integrated into another apparatus, or some features may be omitted, or not performed.
The units may or may not be physically separate, and the components shown as units may be one physical unit or a plurality of physical units, may be located in one place, or may be distributed in a plurality of different places. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.
In addition, each functional unit in the embodiments of the present invention may be integrated in one processing unit, or each unit may exist alone physically, or two or more units may be integrated in one unit. The integrated units may be implemented in hardware or in software functional units.
The integrated units, if implemented in the form of software functional units and sold or used as stand-alone products, may be stored in a readable storage medium. Based on such understanding, the technical solution of the embodiments of the present invention may be essentially or a part contributing to the prior art or all or part of the technical solution may be embodied in the form of a software product stored in a storage medium, including several instructions for causing a device (may be a single-chip microcomputer, a chip or the like) or a processor (processor) to perform all or part of the steps of the method described in the embodiments of the present invention. And the aforementioned storage medium includes: a U-disk, a removable hard disk, a Read-Only Memory (ROM), a random access Memory (Random Access Memory, RAM), a magnetic disk, or an optical disk, or other various media capable of storing program codes.
The foregoing is merely illustrative of specific embodiments of the present invention, and the scope of the present invention is not limited thereto, but any changes or substitutions within the technical scope of the present invention should be covered by the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims (6)
1. A tumor electric field treatment system capable of closed-loop regulation and control, which is used for realizing a tumor electric field treatment method capable of closed-loop regulation and control, and is characterized by comprising the following steps:
constructing a head simulation model based on the magnetic resonance imaging data;
the construction of the head simulation model includes,
segmenting the magnetic resonance imaging data, and dividing the individual head model structure into skin, skull, cerebrospinal fluid, gray matter, white matter, tumor edema and tumor necrosis areas;
placing a hydrogel layer on the surface of the head, and placing a ceramic electrode on the hydrogel layer;
performing finite element gridding on the individual head model by using an iso2mesh tool, generating a three-dimensional grid, performing structural restoration, and converting the segmented magnetic resonance imaging into a tetrahedral grid by using a cgalv2m function;
defining material parameters required by electric field and temperature field calculation, wherein the material parameters comprise conductivity, dielectric constant, density, heat conductivity and specific heat capacity of each tissue layer, electrodes and hydrogel;
an initial tumor electric field treatment implementation scheme is established, an electric field and a temperature field are solved by a finite element method, optimization is carried out aiming at the electric field intensity of a tumor area and the skin temperature under the electrodes, the optimal electrode sheet application position and input current are selected, and the contact impedance of each electrode and the skin temperature under the electrodes are measured;
specific operations for formulating an initial tumor electric field treatment embodiment include,
a1: setting an initial electrode plate position and an initial input current, performing frequency domain-transient finite element calculation to obtain a time-dependent change value of skin temperature under the electrode and an electric field of a tumor area, and calculating the maximum skin temperature under the electrode;
a2: changing an input current value, repeating frequency domain-transient finite element calculation, obtaining electric field distribution of a tumor area and skin temperature under an electrode, and selecting an input current which enables the electric field intensity of the tumor area to be maximum and the maximum skin temperature to be lower than a threshold value as an alternative scheme;
a3: changing the electrode plate positions, repeating the step A2 until all positions are traversed, selecting the electrode plate position which maximizes the electric field intensity of the tumor area in all alternatives, and setting the electrode plate position which maximizes the electric field intensity of the tumor area and the input current as an initial tumor electric field treatment embodiment;
a4: calculating an electric field transmission matrix of each electrode on the electrode sheet through the frequency domain finite element;
a5: changing the input current and contact impedance of each electrode on the electrode sheet, calculating the skin temperature change under the electrodes through transient finite elements, and carrying out fitting calculation on the maximum skin temperature under each electrode and the input current and contact impedance of each electrode;
and adjusting the implementation scheme according to the measured contact impedance between each electrode and the skin and the measured skin temperature under the electrodes, substituting the measured contact impedance into a head simulation model, setting the measured skin temperature under the electrodes as an initial temperature, predicting the skin temperature change under the electrodes and the electric field intensity of a tumor area, optimizing the electric field intensity of the tumor area, and selecting the optimal input current value of each electrode as a new input current under the constraint of the proper skin temperature.
2. The tumor electric field treatment system capable of closed loop control according to claim 1, wherein: the calculation of the maximum temperature of the skin under the electrode includes,
a curve of the skin temperature T under the electrode over time T is fitted,
wherein C is 1 、C 2 、C 3 Representing the coefficients obtained by fitting;
based on fitting coefficient C 1 、C 3 Final steady state maximum T of skin temperature under counter electrode max Predicting and recording the average electric field intensity and the maximum skin temperature of the tumor area;
T max ＝lim t→∞ T＝C 1 +C 3 。
3. the tumor electric field treatment system capable of closed loop control according to claim 2, wherein: the fitting calculation specifically includes,
T max ＝AX+BY+Z
wherein T is max A vector representing the maximum temperature composition of the skin under each electrode, X represents a vector representing the composition of the input current value of each electrode, Y represents a vector representing the composition of the contact impedance of each electrode, Z represents a vector representing the initial temperature composition of each electrode, and sigma and B represent coefficient matrixes obtained by fitting;
Y＝[σ 1 ,σ 2 ,…,σ n ] T
X＝[T 1 ,T 2 ,…,T n ] T
wherein,the maximum temperature of the skin under the electrode with the number I is shown as I i The electrode input current value, sigma, with the index i i The electrode contact resistance with the number i is represented by T i The initial temperature of the electrode with the number i is shown, and n is the number of the electrodes.
4. A tumor electric field therapy system capable of closed loop control according to any one of claims 1 to 3, characterized in that: specific operations for adjusting the embodiment based on the measured contact resistance of each electrode with the skin and the temperature of the skin under the electrode include,
substituting the measured contact impedance of the electrode and the skin and the measured skin temperature under the electrode into the transmission matrix obtained in the step A4 and the fitting calculation formula obtained in the step A5 to obtain the electric field intensity of the tumor area and the maximum skin temperature under each electrode;
the input current of each electrode is changed, and an optimization algorithm is used, so that the optimal input current of each electrode is calculated under the constraint of the proper temperature of the skin, and the electric field intensity of a tumor area is maximized.
5. The tumor electric field treatment system capable of closed loop control according to claim 4, wherein: the expression of the optimization algorithm is as follows:
wherein I represents the electrode number, I i Indicating the input current value of the electrode, I i0 Represents the electrode input current value of the initial embodiment,represents the electric field strength caused by a single electrode of the initial embodiment, T 0 Representing a skin temperature threshold.
6. The closed-loop regulatable tumor electric field therapy system according to claim 1, comprising:
the device comprises a main control module, an electric field stimulation generation module, a stimulation measurement integrated electrode slice, an impedance monitoring module, a temperature monitoring module, an energy supply module, a communication module and an interaction module;
the main control module is connected with the electric field stimulation generation module, the impedance monitoring module, the temperature monitoring module, the energy supply module, the communication module and the interaction module, and the stimulation measurement integrated electrode is connected with the electric field stimulation generation module, the temperature monitoring module and the impedance monitoring module;
the main control module consists of a microprocessor and a microprocessor peripheral circuit and is used for communication, control and data interaction processing of the whole system;
the electric field stimulation generation module is provided with a plurality of stimulation channels, and each channel can independently and programmatically output tumor electric field treatment signals of 0 to +/-150 mA and 50 to 400kHz for generating a tumor treatment electric field;
the stimulation and measurement integrated electrode slice can be used for tumor treatment electric field output and temperature and impedance measurement;
the impedance monitoring module is used for monitoring the contact impedance change of each stimulation electrode;
the temperature monitoring module is used for measuring the real-time temperature under each electrode in real time;
the energy supply module is used for supplying energy to the whole system;
the communication module is used for communication of the whole system;
the interaction module is used for realizing data interaction of the system.
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| CN117563139B (en) * | 2024-01-12 | 2024-04-09 | 湖南安泰康成生物科技有限公司 | Device and processor for inhibiting tumor proliferation by using electric field |
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