Alternating electric field tumor therapy instrument with intelligent self-adaptive closed loop system

Abstract

The application discloses an alternating electric field tumor therapeutic instrument with an intelligent adaptive closed loop system, and belongs to the technical field of tumor physical treatment equipment. The instrument comprises a host computer and a multi-channel surface electrode array. The host computer is internally provided with a power supply unit, a signal generation and power amplification unit and a low-power microprocessor unit. The low-power microprocessor unit is internally integrated with an intelligent adaptive closed loop system. The complex impedance spectrum of a target region is collected in real time through an electric field absorption fingerprint monitoring module to establish a bioelectric fingerprint. Then, through a double-parameter adaptive optimization module, on one hand, the amplitude ratio of orthogonal electrodes is regulated to realize automatic optimization of the linear polarization electric field direction, and on the other hand, the best treatment frequency is locked through a reference reference type frequency scanning. The application upgrades the traditional open loop fixed parameter electric field treatment to individualized dynamic closed loop treatment, can accurately match the biological characteristics of tumors without manual adjustment of the electrode position, effectively improves the tumor inhibition effect, and has the advantages of being portable and wearable.

Description

Technical Field

[0001] This invention relates to the field of tumor physical therapy equipment technology, and in particular to an alternating electric field tumor therapy device with an intelligent adaptive closed-loop system. Background Technology

[0002] Tumor Therapy Fields (TTFields) is a physical therapy technique that uses a mid-frequency, low-intensity alternating electric field to interfere with the mitosis of tumor cells. By disrupting microtubule polymerization and inhibiting spindle formation, it induces abnormal division and apoptosis of cancer cells. It has been clinically validated in diseases such as glioblastoma and malignant pleural mesothelioma.

[0003] Existing commercial TTFields devices generally suffer from the following defects: (1) Fixed treatment parameters: The output is mostly based on fixed frequency or preset scheme, and the parameters cannot be dynamically adjusted according to the dielectric characteristics of the individual tumor and the progression of the disease, resulting in large individual differences in efficacy.

[0004] (2) The electric field direction is not adjustable: The electric field direction is determined by the physical attachment position of the electrode patch, which requires manual adjustment by medical staff. It cannot adaptively match the dynamic orientation of the tumor cell division axis, resulting in insufficient stability of the treatment dose.

[0005] (3) No real-time feedback mechanism: It is an open-loop control, which cannot sense the biological response of the target tissue and cannot guarantee that the tumor area is always in the optimal treatment parameter range.

[0006] To address the aforementioned issues, this invention proposes an alternating electric field tumor therapy device integrating an intelligent adaptive closed-loop system. This device achieves automatic optimization of the electric field direction and frequency in two dimensions through real-time bioelectric feedback, thus resolving the pain points of existing technologies. Summary of the Invention

[0007] The purpose of this invention is to provide an alternating electric field tumor therapy device with an intelligent adaptive closed-loop system, in order to solve the shortcomings of existing TTFields devices, such as fixed parameters, cumbersome operation, poor portability, and lack of closed-loop control.

[0008] To achieve the above objectives, the present invention provides an alternating electric field tumor therapy device with an intelligent adaptive closed-loop system, comprising a main unit and a multi-channel surface electrode array; the main unit includes a power supply unit, a signal generation and power amplification unit, and a low-power microprocessor unit; the low-power microprocessor unit integrates an intelligent adaptive closed-loop system, which includes an electric field absorption fingerprint monitoring module and a dual-parameter adaptive optimization module; The electric field absorption fingerprint monitoring module is used to collect the electrical signal at the electrode output end in real time, calculate the complex impedance spectrum of the target tissue, and generate a real-time bioelectric fingerprint. The dual-parameter adaptive optimization module automatically adjusts the amplitude ratio of the orthogonal electrodes to correct the direction of the linearly polarized electric field based on the bioelectric fingerprint, and automatically locks the optimal treatment frequency through a reference frequency scan, forming a dynamic closed-loop control.

[0009] Preferably, the electric field absorption fingerprint monitoring module includes a high-precision current / voltage acquisition circuit and a complex impedance calculation submodule; the complex impedance calculation submodule is used to calculate the complex impedance of the target tissue, and the calculation formula is: ; In the formula, The complex impedance of the tissue is expressed in Ω. The equivalent resistance component is represented by Ω. The equivalent reactance component is expressed in Ω; It is the imaginary unit.

[0010] Preferably, the sampling accuracy of the high-precision current / voltage acquisition circuit is not less than 16 bits, and the sampling rate is not less than 1MHz; the bioelectric fingerprint is the complex impedance spectrum of the target tissue in the 100~300kHz frequency band, which includes the frequency response characteristics of impedance magnitude and phase angle.

[0011] Preferably, the multi-channel surface electrode array includes at least two pairs of orthogonally arranged independent electrode units, and the dual-parameter adaptive optimization module includes an automatic electric field direction correction submodule; The automatic electric field direction correction submodule changes the direction angle of the linearly polarized electric field in the two-dimensional target area by adjusting the output amplitude ratio of the orthogonal electrode channels.

[0012] Preferably, in the automatic electric field direction correction submodule, the orthogonal X and Y electrodes output in-phase alternating electric fields, and the direction angle of the synthesized linearly polarized electric field satisfies: ; In the formula, , These are the electric field amplitudes for the X and Y channels, respectively, in V / cm. The angle between the combined electric field and the X-axis is denoted as .

[0013] Preferably, the dual-parameter adaptive optimization module includes an optimal frequency auto-locking submodule, which pre-stores the reference complex impedance spectrum of the target area tissue and calculates the relative rate of change of impedance through frequency scanning to locate the optimal treatment frequency.

[0014] Preferably, the formula for calculating the relative rate of change of impedance is: ; In the formula, For frequency The relative rate of change of impedance under the following conditions; This represents the real-time complex impedance magnitude at the current frequency. This represents the impedance magnitude at the corresponding frequency in the reference spectrum.

[0015] Preferably, the optimal frequency automatic locking submodule adopts a two-stage scanning strategy of coarse scanning followed by fine scanning: first, a coarse scan of the entire frequency band is performed with a large step size to locate the peak range, and then a fine scan is performed within the peak range with a small step size to accurately lock the optimal frequency.

[0016] Preferably, the output frequency range of the signal generation and power amplification unit is 100kHz~300kHz, the output power range is 0.8W~1.5W, and the corresponding effective field strength of the target area is 1V / cm~3V / cm; the power supply unit supports the device to work continuously for no less than 48 hours.

[0017] Preferably, the intelligent adaptive closed-loop system adopts a dual mechanism combining timed periodic updates and impedance change-triggered updates: the timed periodic updates are performed every 5 minutes by default; when the tissue impedance change exceeds a set threshold, the optimization is triggered immediately.

[0018] Therefore, the beneficial effects of the alternating electric field tumor therapy device with intelligent adaptive closed-loop system described above in this invention are as follows: (1) This invention uses adaptive optimization in both direction and frequency to keep the tumor region under the optimal electric field parameters, thereby maximizing the interference with tumor cell mitosis and significantly improving the inhibition efficiency compared to fixed parameter devices.

[0019] (2) The present invention does not require preset parameters corresponding to tumor types, automatically matches the dielectric characteristics of individual tumors of patients, and can be dynamically adjusted as the disease progresses, making it more adaptable.

[0020] (3) The present invention achieves electric field deflection through electronic control, eliminating the need for repeated manual adjustment of electrode patch positions, thus reducing the difficulty of medical and nursing operations and the threshold for patient use.

[0021] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the composition structure of an embodiment of an alternating electric field tumor therapy device with an intelligent adaptive closed-loop system according to the present invention; Figure 2 This is a schematic diagram of the workflow of the intelligent adaptive closed-loop system of the present invention. Detailed Implementation

[0023] The technical solution of the present invention will be further described below with reference to the accompanying drawings and embodiments.

[0024] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "first," "second," and similar terms used in this invention do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0025] Example 1: like Figure 1 As shown, this embodiment provides an alternating electric field tumor therapy device with an intelligent adaptive closed-loop system, including a main unit and a multi-channel surface electrode array. The main unit integrates a power supply unit, a signal generation and power amplification unit, and a low-power microprocessor unit. The power supply unit uses a 7.4V / 10000mAh lithium polymer battery, supporting continuous operation for ≥48 hours, and is equipped with a Type-C charging interface. The output frequency of the signal generation and power amplification unit is continuously adjustable from 100kHz to 300kHz, and the output power is continuously adjustable from 0.8W to 1.5W, supporting independent amplitude and phase control for multiple channels. The multi-channel surface electrode array uses a medical-grade silicone substrate and contains four independent electrode units orthogonally distributed in a 2×2 pattern. The electrode contact surface is made of conductive hydrogel, allowing it to adhere to the scalp, chest wall, and other body surface areas.

[0026] The low-power microprocessor unit integrates an intelligent adaptive closed-loop system, which includes an electric field absorption fingerprint monitoring module and a dual-parameter adaptive optimization module.

[0027] The electric field absorption fingerprint monitoring module includes a high-precision current / voltage acquisition circuit and a complex impedance calculation submodule. The high-precision current / voltage acquisition circuit uses a 16-bit ADC acquisition circuit with a sampling rate of 2MHz to acquire the output voltage and loop current of each electrode channel in real time. The complex impedance calculation submodule is used to calculate the complex impedance spectrum of the target tissue and establish a real-time bioelectric fingerprint.

[0028] The formula for calculating tissue complex impedance is: In the formula, The complex impedance of the tissue is expressed in Ω. The equivalent resistance component is represented by Ω. The equivalent reactance component is expressed in Ω; It is the imaginary unit.

[0029] Bioelectric fingerprinting is defined as the complex impedance spectrum data of target tissue in the 100-300 kHz frequency band, including the impedance modulus |Z| and phase angle. The frequency response characteristics can reflect biological information such as tumor cell density, division state, and microenvironment ion concentration.

[0030] The biophysical mechanism is as follows: During mitosis, tumor cells undergo significant changes in cell membrane capacitance, cytoplasmic conductivity, and cell morphology, resulting in differences in dielectric properties compared to cells in the resting phase. When the electric field parameters match the sensitive conditions of tumor cells, the force on charged particles within the cell is strongest, and at the same time, it causes a measurable characteristic shift in the overall complex impedance of the target tissue.

[0031] The dual-parameter adaptive optimization module includes an automatic electric field direction correction submodule and an optimal frequency automatic locking submodule. Based on bioelectric fingerprinting, it automatically adjusts the amplitude ratio of orthogonal electrodes to correct the direction of the linearly polarized electric field. At the same time, it automatically locks the optimal treatment frequency through a reference frequency scan, forming a dynamic closed-loop control.

[0032] The automatic electric field direction correction submodule changes the direction angle of the linearly polarized electric field in the two-dimensional target area by adjusting the output amplitude ratio of the orthogonal electrode channels, thus achieving continuous deflection of the direction of the linearly polarized electric field in the two-dimensional target area without moving the electrode patch.

[0033] For the orthogonally arranged X and Y electrode channels, the output alternating electric fields are in phase, and their instantaneous values ​​are as follows: The combined electric field is a linearly polarized electric field, and its direction makes an angle with the X-axis. satisfy: In the formula, , These are the electric field amplitudes for the X and Y channels, respectively, in V / cm. ω is the angular frequency of the alternating electric field, expressed in rad / s. Time, in seconds; The angle between the combined electric field and the X-axis is expressed in rad.

[0034] The system adjusts the output amplitude ratio of the two electrodes to traverse and change the electric field direction angle. The system synchronously records the tissue complex impedance modulus |Z| corresponding to each direction. When the electric field direction is parallel to the tumor cell division axis, the tissue absorbs the electric field energy most strongly, and the complex impedance modulus reaches its trough. The system automatically locks the amplitude ratio corresponding to the trough value to achieve optimal matching of the electric field direction.

[0035] The system can also generate a rotating electric field by adjusting the phase difference between the two electrodes, covering more oriented cell division axes and improving the inhibitory effect.

[0036] The optimal frequency auto-locking submodule pre-stores the reference complex impedance spectrum of the target tissue and adopts a reference-based frequency scanning strategy to eliminate the interference of the tissue's inherent dielectric dispersion and accurately locate the optimal inhibition frequency of the tumor.

[0037] When the device is first started, a reference complex impedance spectrum of the full frequency band of 100~300kHz is collected to record the inherent dielectric characteristics of the tissue when there is no therapeutic effect.

[0038] During frequency scanning during treatment, the output frequency is fine-tuned in fixed steps within ±20kHz of the current operating frequency, while the real-time complex impedance at each frequency point is simultaneously acquired, and the relative rate of change of impedance is calculated. In the formula, For frequency The relative rate of change of impedance under the following conditions; This is the real-time complex impedance magnitude at the current frequency, in Ω. This represents the impedance magnitude at the corresponding frequency in the reference spectrum, in Ω.

[0039] When the output frequency approaches the optimal inhibition frequency for tumor cells, the change in cell dielectric properties is most significant, and a characteristic peak appears in the relative rate of change of impedance. The system automatically searches for and locks the frequency corresponding to the peak as the current optimal treatment frequency.

[0040] The intelligent adaptive closed-loop system employs a dual mechanism: timed periodic updates and impedance change-triggered updates. Scheduled updates: By default, a complete direction and frequency optimization is performed every 5 minutes to adapt to the slow changes in the tumor microenvironment; Triggered Update: When the detected change in tissue impedance exceeds the set threshold (e.g., ±15%), an optimization process is immediately triggered to deal with emergencies such as changes in body position or electrode displacement.

[0041] like Figure 2 As shown, the intelligent adaptive closed-loop workflow of this embodiment is as follows: ① Initialization and self-test: After the device is started, the default output frequency is 200kHz, the initial amplitude ratio is 1:1, and the output power is 1W. Electrode contact impedance detection is performed. If the contact impedance exceeds the threshold, an audible and visual alarm will be triggered.

[0042] ② Reference spectrum acquisition: When using for the first time or changing the treatment site, acquire a reference complex impedance spectrum across the entire frequency band from 100 to 300 kHz. And store.

[0043] ③ Adaptive correction of electric field direction: Keeping the current frequency and total power constant, adjust the direction angle of the linearly polarized electric field in 5° increments within the range of 0° to 90°. Simultaneously record the tissue complex impedance modulus |Z| corresponding to each direction; Filter out the direction angle corresponding to the minimum value of |Z|, lock the corresponding amplitude ratio, and complete the direction optimization.

[0044] ④ Optimal frequency adaptive locking: Keeping the optimized direction unchanged, perform frequency scanning in 1kHz steps within the current frequency range of ±20kHz. Calculate the relative rate of change of impedance at each frequency point. ; position The frequency corresponding to the peak value is locked as the current optimal treatment frequency.

[0045] ⑤ Dynamic closed-loop update: Maintain the continuous output of optimized parameters and repeat the optimization once every 5 minutes; if an impedance change exceeding ±15% is detected, trigger re-optimization immediately.

[0046] ⑥ Abnormal protection: When an electrode is detected to be detached, the contact resistance is abnormally increased, or the battery power is too low, the output will be immediately suspended and an audible and visual alarm will be triggered.

[0047] Example 2: Based on Example 1, this embodiment performs a two-stage optimization of the frequency scanning strategy of the optimal frequency automatic locking submodule. It adopts a two-stage scanning strategy: first, a coarse scan is performed across the entire frequency band with a large step size to locate the peak range; then, a fine scan is performed within the peak range with a small step size to accurately lock the optimal frequency, balancing speed and accuracy. Coarse scanning stage: During the initial optimization, a rapid scan is performed across the entire frequency band of 100~300kHz with a step size of 5kHz to locate the approximate range of the peak value of the relative rate of change of impedance.

[0048] Fine scanning phase: Fine scanning is performed in 0.5kHz steps within the peak range of ±10kHz to accurately lock the optimal frequency point.

[0049] This mode reduces the computational load on the microprocessor, lowers device power consumption, and further extends battery life.

[0050] Therefore, the present invention adopts the above-mentioned alternating electric field tumor therapy device with intelligent adaptive closed-loop system, which upgrades the traditional open-loop fixed parameter electric field therapy to individualized dynamic closed-loop therapy. It can accurately match the biological characteristics of tumors without manual adjustment of electrode positions, effectively improving the tumor suppression effect, while also having the advantage of being portable and wearable.

[0051] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the technical solutions of the present invention, and these modifications or equivalent substitutions cannot cause the modified technical solutions to deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. An alternating electric field tumor therapy device with an intelligent adaptive closed-loop system, characterized in that: It includes a host and a multi-channel surface electrode array; the host includes a power supply unit, a signal generation and power amplification unit, and a low-power microprocessor unit; the low-power microprocessor unit integrates an intelligent adaptive closed-loop system, which includes an electric field absorption fingerprint monitoring module and a dual-parameter adaptive optimization module. The electric field absorption fingerprint monitoring module is used to collect the electrical signal at the electrode output end in real time, calculate the complex impedance spectrum of the target tissue, and generate a real-time bioelectric fingerprint. The dual-parameter adaptive optimization module automatically adjusts the amplitude ratio of the orthogonal electrodes to correct the direction of the linearly polarized electric field based on the bioelectric fingerprint, and automatically locks the optimal treatment frequency through a reference frequency scan, forming a dynamic closed-loop control.

2. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 1, characterized in that: The electric field absorption fingerprint monitoring module includes a high-precision current / voltage acquisition circuit and a complex impedance calculation submodule; the complex impedance calculation submodule is used to calculate the complex impedance of the target tissue, and the calculation formula is: ； In the formula, The complex impedance of the tissue is expressed in Ω. The equivalent resistance component is represented by Ω. The equivalent reactance component is expressed in Ω; It is the imaginary unit.

3. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 2, characterized in that: The high-precision current / voltage acquisition circuit has a sampling accuracy of no less than 16 bits and a sampling rate of no less than 1MHz; the bioelectric fingerprint is the complex impedance spectrum of the target tissue in the 100~300kHz frequency band, which includes the frequency response characteristics of impedance magnitude and phase angle.

4. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 1, characterized in that: The multi-channel surface electrode array includes at least two pairs of orthogonally arranged independent electrode units, and the dual-parameter adaptive optimization module includes an automatic electric field direction correction submodule. The automatic electric field direction correction submodule changes the direction angle of the linearly polarized electric field in the two-dimensional target area by adjusting the output amplitude ratio of the orthogonal electrode channels.

5. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 4, characterized in that: In the automatic electric field direction correction submodule, the orthogonal X and Y electrodes output in-phase alternating electric fields, and the direction angle of the synthesized linearly polarized electric field satisfies: ； In the formula, , These are the electric field amplitudes for the X and Y channels, respectively, in V / cm. The angle between the combined electric field and the X-axis is denoted as .

6. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 1, characterized in that: The dual-parameter adaptive optimization module includes an optimal frequency auto-locking submodule. This submodule pre-stores the reference complex impedance spectrum of the target tissue and calculates the relative rate of change of impedance through frequency scanning to locate the optimal treatment frequency.

7. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 6, characterized in that: The formula for calculating the relative rate of change of impedance is: ； In the formula, For frequency The relative rate of change of impedance under the following conditions; This represents the real-time complex impedance magnitude at the current frequency. This represents the impedance magnitude at the corresponding frequency in the reference spectrum.

8. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 7, characterized in that: The optimal frequency auto-locking submodule adopts a two-stage scanning strategy of coarse scanning followed by fine scanning: first, a coarse scan of the entire frequency band is performed with a large step size to locate the peak range, and then a fine scan is performed within the peak range with a small step size to accurately lock the optimal frequency.

9. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 1, characterized in that: The signal generation and power amplification unit has an output frequency range of 100kHz to 300kHz and an output power range of 0.8W to 1.5W, corresponding to an effective field strength of 1V / cm to 3V / cm in the target area; the power supply unit supports continuous operation of the equipment for no less than 48 hours.

10. The alternating electric field tumor therapy device with intelligent adaptive closed-loop system according to claim 1, characterized in that: The intelligent adaptive closed-loop system adopts a dual mechanism combining timed periodic updates and impedance mutation-triggered updates: the timed periodic updates are performed every 5 minutes by default; when the tissue impedance change exceeds the set threshold, the optimization is triggered immediately.

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