Alternating field treatment device, alternating field treatment equipment, alternating field treatment system, method for controlling output of electric signals and electronic equipment
By using the three-log polynomial rule of electrical signal rise phase waveform in tumor treatment electric field equipment, the rate of electrical signal rise is reduced, and the problem of patients' intolerance to current stimulation is solved, and the treatment effect and patient compliance are improved.
Patent Information
- Application Number
- CN202411527219.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-29
- Publication Date
- 2025-02-07
AI Technical Summary
When existing tumor treatment electric field equipment applies current, patients are prone to skin irritation, which limits the maximum current that the equipment can apply to the human body, thereby restricting the treatment effect.
Design an alternating field therapy device, the amplitude output of the electrical signal generated by the signal generator includes an ascending stage and a downward stage. In the ascending stage, the amplitude increase rate of the electrical signal decreases with the increase of the amplitude, and a three-order logarithmic polynomial is adopted. Rules are used as waveform output rules for the rising stage.
By reducing the rate of rising electrical signals, patients can tolerate higher treatment power, improving treatment effectiveness and patient compliance.
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Figure CN119385673A_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of medical equipment, and in particular to an alternating field therapy device, equipment, system, method for controlling electrical signal output, and electronic equipment. Background Art
[0002] Tumor Treating Fields (TTF) is an alternating electric field with a specific frequency range. When a tumor treating field with a certain intensity (generally not less than 1V / cm) is applied to cancer cells or tumor tissue in vitro, it can effectively inhibit the division and proliferation of cancer cells. When the electric field is applied to the tumor area of a tumor patient, it can slow down the tumor progression process and achieve the effect of treating the tumor.
[0003] When the direction of the electric field is consistent with the direction of tumor division, the inhibitory effect is the strongest; when the direction of the electric field is perpendicular to the direction of tumor division, the inhibitory effect is the weakest. However, the division direction of cancer cells is random, and the inhibitory effect of using an electric field with a fixed direction is weak on some cancer cells. Therefore, the electric field is usually switched sequentially between two directions to generate two basically perpendicular electric fields to achieve treatment. Preclinical research results show that the effect of using sequentially switching electric fields is significantly better than using fixed-direction electric fields. Figure 1 As shown, in each switching cycle, the amplitude of the electric field rises from 0 to a maximum value in a short time when switching to one direction, maintains at the maximum value for about 90% of the switching cycle, and then drops from the maximum value to 0 in a short time.
[0004] During the treatment, when the applied current exceeds a certain threshold, the current will irritate the skin. As the current increases, the patient's skin irritation will increase, causing discomfort or intolerance to the patient, thus limiting the maximum current that the device can apply to the human body and restricting the treatment effect.
[0005] It should be noted that the information disclosed in the background technology section of the invention is only intended to deepen the understanding of the general background technology of the present application, and should not be regarded as an admission or suggestion in any form that the information constitutes prior art already known to those skilled in the art. Summary of the invention
[0006] The purpose of the present application is to provide an alternating field therapy device, equipment, system, method for controlling electrical signal output and electronic equipment, which can enable patients to tolerate higher treatment power, thereby improving treatment effects and patient compliance.
[0007] To achieve the above-mentioned purpose, the present application provides an alternating field therapy device, which includes a signal generator, which is used to generate one or more electrical signals, thereby generating an alternating electric field for treating a target area; the amplitude output of the electrical signal includes a rising phase arranged in sequence and rising according to a first predefined rule, and a falling phase located after the rising phase and falling according to a second predefined rule, in which the amplitude rising rate of the electrical signal decreases as the amplitude increases.
[0008] Optionally, the first predefined rule is a cubic logarithmic polynomial rule, and the cubic logarithmic polynomial includes one or more adjustable coefficients.
[0009] Optionally, the signal generator is used to provide a plurality of different gears, and the waveform output rule of the cubic logarithmic polynomial is adopted in the rising stage of the electrical signal amplitude of each gear, and the adjustable coefficient in the cubic logarithmic polynomial of each gear can be adjusted in the same multiple or different multiples.
[0010] Optionally, the rising phase includes a first phase and a second phase, and the falling phase is a phase in which the amplitude of the electrical signal rises to a peak value in the second phase and then begins to decline, and the first phase, the second phase and the falling phase are output in sequence adjacent to each other; the duration of the second phase is greater than the duration of the first phase, and the amplitude rising rate of the electrical signal in the first phase is greater than the amplitude rising rate of the electrical signal in the second phase.
[0011] Optionally, in the first stage, the amplitude of the electrical signal reaches more than 70% and less than 90% of the peak value from the lowest point over more than 2% and less than 20% of the time of the entire cycle; and / or In the second stage, the amplitude of the electrical signal rises from more than 70% to less than 90% of the peak value to 100% over more than 10% to less than 90% of the time of the entire cycle; and / or In the falling phase, the current drops from 100% of the peak value to the lowest point within 5% of the entire cycle.
[0012] Optionally, the amplitude output of the electrical signal further includes a peak stabilization phase immediately after the rising phase and immediately before the falling phase.
[0013] Optionally, the falling phase is immediately after the rising phase, so that when the amplitude of the electrical signal rises to a peak value during the rising phase, the falling phase begins.
[0014] Optionally, the second predefined rule is a linear rule or a nonlinear rule; and / or the first predefined rule is a Weibull function.
[0015] Optionally, the amplitude of the electrical signal increases as the amplitude of the electrical signal increases. The current frequency gradually decreases as the amplitude of the electrical signal increases; or, The current frequency gradually increases from low to high, and then gradually decreases; or, The current frequency is a constant frequency.
[0016] Optionally, the alternating field therapy device comprises a base, a first body located at a first side of the front end of the base, and a second body located at a second side of the front end of the base, and a battery compartment for inserting a battery is further provided inside the alternating field therapy device; A notch is formed above the second body, and the notch is surrounded by the front end portion of the base, one side of the first body and the upper portion of the second body. The notch is used for allowing the battery to enter and exit the battery compartment.
[0017] Optionally, when the battery is fully inserted into the battery compartment, a portion of the battery is exposed at the notch; The battery is provided with a handle and a battery control button. The handle is recessed from a side away from the first body toward a direction close to the first body to form a space for hand grasping and form open ends on both sides of the alternating field therapy device.
[0018] Optionally, the battery control button and the open end of the handle are located on different sides of the battery.
[0019] To achieve the purpose of this application, the present application also provides an alternating field therapy device, which includes the alternating field therapy device as described above and one or more pairs of electrodes, and each pair of electrodes is applied with the same or different alternating current signals through the alternating field therapy device to generate an alternating electric field in the target treatment body.
[0020] To achieve the purpose of the present application, the present application also provides an alternating field therapy system, which includes the alternating field therapy device as described above and any one or more of the following combinations: One or more pairs of electrodes, an adapter, a power adapter, and a battery charging stand; The adapter is used to establish a connection between the alternating field therapy device and the one or more pairs of electrode pairs, the power adapter is used to cooperate with a power supply to provide power to the alternating field therapy device, and the battery charging stand is used to charge the battery used by the alternating field therapy device.
[0021] To achieve the purpose of the present application, the present application also provides a method for controlling the output of an electrical signal to generate an alternating electric field in a target area, and the method is applied to the alternating field therapy device as described above.
[0022] To achieve the purpose of the present application, the present application further provides an electronic device, which includes a processor, and the processor is used to execute instructions to implement the method for controlling the output of an electrical signal as described above.
[0023] Compared with the prior art, the alternating field therapy device, equipment, system, method and electronic equipment provided by the present application have the following advantages: The alternating field treatment device provided by the present application includes a signal generator, which is used to generate one or more electrical signals, thereby generating an alternating electric field for treating a target area; the amplitude output of the electrical signal includes a rising phase arranged in sequence and rising according to a first predefined rule, and a falling phase located after the rising phase and falling according to a second predefined rule, in which the amplitude rising rate of the electrical signal decreases as the amplitude increases. By reducing the amplitude rising rate of the electrical signal as the amplitude increases, the patient can tolerate a higher treatment power, that is, the input current threshold that the patient can tolerate during the treatment process can be increased, thereby further improving the treatment effect and patient compliance.
[0024] Since the alternating field therapy equipment, system, related methods and electronic equipment provided in the present application belong to the same inventive concept as the alternating field therapy device provided in the present application, they all have corresponding advantages, so their beneficial effects will not be described one by one here. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Figure 1 It is a schematic diagram of the AC signal output amplitude of the LR channel and the AP channel in the prior art tumor treatment electric field system; Figure 2 A block diagram of the relationship between the controller, signal generator and electrode pairs of the alternating field therapy device provided in one embodiment of the present application; Figure 3 A diagram showing a usage scenario of an alternating field therapy device provided in one embodiment of the present application; Figure 4 A schematic representation of the amplitude of the electrical signal for the LR electrode pair and the AP electrode pair generated by the signal generator provided in one embodiment of the present application; Figure 5 Another schematic representation of the amplitude of the electrical signal for the LR electrode pair and the AP electrode pair generated by the signal generator provided in another embodiment of the present application; Figure 6 A comparison chart showing the percentage increase in the energy threshold of electrical stimulation that can be tolerated by a subject treated with an alternating field therapy device provided in one embodiment of the present application compared with existing therapy devices; Figure 7 A schematic diagram of an alternating field therapy system provided in one embodiment of the present application; Figure 8A block diagram of an electronic device provided in accordance with an embodiment of the present application. DETAILED DESCRIPTION
[0026] The alternating field therapy device, equipment and system proposed in the present application are further described in detail below in conjunction with the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the present application will be clearer. It should be noted that the drawings are in a very simplified form and all use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose provided by the embodiments of the present application. Before disclosing and describing the present application, it should be understood that the present application is not limited to a specific method, a specific component or a specific implementation. It should also be understood that the terms used herein are only used for the purpose of describing specific embodiments and are not intended to be limiting. In order to make the purposes, features and advantages of the present application more obvious and easy to understand, please refer to the accompanying drawings. It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of the present specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present application. Any structural modification, change in proportional relationship or adjustment of size, if the effects and purposes that can be achieved by the present application are the same or similar, should still fall within the scope of the technical content disclosed in the present application.
[0027] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.
[0028] In addition, in the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.
[0029] The present application is to provide an alternating field therapy device, equipment, system and method that can enable patients to tolerate higher treatment power, thereby improving treatment effects and patient compliance.
[0030] To achieve the above-mentioned purpose, the present application provides an alternating field therapy device, equipment, system, method for controlling the output of electrical signals and electronic equipment. Figure 2 A schematic block diagram of an alternating field therapy device involved in the present application is shown, wherein the alternating field therapy device comprises an alternating field therapy device 1 (also referred to as a host) and one or more pairs of electrode pairs, wherein the multiple pairs of electrodes comprise at least a first electrode pair 4 and a second electrode pair 5, and each electrode pair is applied with the same or different alternating current signals through the host 1 to generate an alternating electric field in a target treatment body for tumor treatment.
[0031] Please combine Figure 3As shown, it is a specific application scenario diagram of the alternating field therapy device provided by the present application, which shows two pairs of electrodes, the first electrode pair 4 is applied to the front and back of the patient's tumor area (hereinafter referred to as AP electrode pair), and the second electrode pair 5 is applied to the left and right sides of the patient's tumor area (hereinafter referred to as LR electrode pair). Of course, in the specific implementation, more electrode pairs can be arranged according to different situations. The first electrode pair 4 and the second electrode pair 5 are worn to the target treatment area of the patient and connected to the host 1 through the adapter 2. The host 1 serves as an AC signal transmitter during the entire alternating field therapy process, and is used to periodically apply electric signals, for example, AC electric signals, to the first electrode pair 4 and the second electrode pair 5, so as to cyclically generate an electric field of corresponding directions between the two electrodes of each electrode pair, wherein the electric field directions of the first electrode pair 4 and the second electrode pair 5 are different from each other, for example, vertical or at other angles, and are preferably periodically applied with electric signals in sequence, for example, applying an electric signal to the first electrode pair 4 in the first second and applying an electric signal to the second electrode pair 5 in the second second. In some other embodiments with more electrode pairs, the directions of the electric fields generated by the electrode pairs present more angles to each other, for example, 30°, 45°, 60°, 90°, 120°, etc.
[0032] return Figure 2 As shown, the alternating field therapy device / host 1 includes a signal generator 15, which is used to generate one or more electrical signals, thereby generating an alternating electric field for treating a target area, such as generating an alternating electric field for tumor treatment (also known as tumor treatment field, TTFields, for example, 150 kHz), and transmitting the alternating electric field to the target treatment area of the body through one or more electrodes. In some embodiments, the signal generator 15 can generate one or more electrical signals in the form of a waveform or a pulse sequence, and the electrical signal can be an alternating current signal waveform at a frequency in the range of 50 kHz to 500 kHz (for example, 100 kHz to 200 kHz). The present application does not specifically limit the specific current frequency and electric field strength.
[0033] In some embodiments, the host 1 further includes a controller 14 that is communicatively connected to the signal generator 15. The signal generator 15 periodically sends an alternating current signal to the one or more pairs of electrodes under the action of the controller 14 to generate a tumor treatment electric field. In some embodiments, the controller 14 and the signal generator 15 are integrated into the host 1. In other embodiments, one of the controller 14 and the signal generator 15 may be separately provided in the host 1, and this application does not limit this.
[0034] like Figure 4, which is a schematic representation of the amplitude output of the alternating current signal in the LR electrode pair and the AP electrode pair generated by the signal generator 15 disclosed in the present application. The amplitude output of the electrical signal includes a rising phase arranged in sequence to rise according to a first predefined rule, and a falling phase located after the rising phase to fall according to a second predefined rule, in which the amplitude rising rate of the electrical signal decreases as the amplitude increases.
[0035] In some embodiments, the first predefined rule is a cubic logarithmic polynomial rule, and the cubic logarithmic polynomial includes one or more adjustable coefficients.
[0036] In some embodiments, the rising stage includes a fast rising first stage A and a slow rising second stage B, the falling stage is a third stage C and is a stage in which the amplitude of the electrical signal rises to a peak value in the second stage B and then begins to fall, and the first stage A, the second stage B and the third stage C are output in sequence adjacent to each other. Figure 4 As shown, the duration of the second stage is greater than the duration of the first stage, the amplitude rise rate of the first stage electrical signal is greater than the amplitude rise rate of the second stage electrical signal. The duration of the first stage is selectively greater than, equal to or less than the duration of the descending stage.
[0037] In some embodiments, the amplitude of the electrical signal reaches more than 70% and less than 90% of the peak value from the lowest point over more than 2% and less than 20% of the time of the entire cycle; and / or In the second stage, the amplitude of the electrical signal rises from more than 70% to less than 90% of the peak value to 100% over more than 10% to less than 90% of the time of the entire cycle; and / or In the falling phase, the current drops from 100% of the peak value to the lowest point within 5% of the entire cycle.
[0038] Specifically, in some embodiments, the first stage A is a stage in which the amplitude of the electric signal rises rapidly, so that the amplitude of the electric signal quickly reaches 80% of the peak value from the starting point, for example, after 20% of the entire cycle, the amplitude of the electric signal reaches 80% of the peak value from the starting point (for example, 0); the second stage B is an extreme stage in which the amplitude of the electric signal rises slowly, and it takes a long time to rise from 80% of the peak value to 100%, for example, after 75% of the entire cycle, the amplitude of the electric signal rises from 80% of the peak value to 100%; the third stage C is a stage of rapid decline, and the amplitude of the electric signal starts from the peak current of the second stage and rapidly declines to the lowest point, for example, after 5% of the entire cycle, the amplitude of the electric signal declines from 100% of the peak value to the lowest point (0, for example). As can be understood by those skilled in the art, in a specific implementation process, the relationship between the above time periods and the peak values can be adjusted accordingly. For example, after 10% of the entire cycle, the amplitude of the electrical signal reaches 75% of the peak value from the starting point (e.g., 0). After 85% of the entire cycle, the amplitude of the electrical signal rises from 75% of the peak value to 100%. All possible adjustment ranges are within the scope disclosed in this application and are not listed here one by one.
[0039] In some embodiments, Figure 5 As shown, the amplitude output of the electrical signal also includes a peak stabilization phase D immediately after the rising phase and immediately before the falling phase.
[0040] In some embodiments, the second rule is a linear rule; of course, in some other embodiments, the descending stage may also adopt other rules for descending, and the present application does not make any special limitation on this.
[0041] The electrical signal amplitude in the present application may be the current amplitude of an alternating current signal, or the voltage amplitude of an alternating current signal.
[0042] The invention principles, concepts, technical problems solved and technical effects achieved by each embodiment of the present application are further introduced as follows.
[0043] The existing AC signal rises to a peak value according to the linear rule, then maintains a constant value for a period of time and then begins to decrease, for example Figure 1The peak constant holding stage shown is located between the ramp-up stage A and the ramp-down stage B, that is, the current increases linearly from 0 to the maximum value, and then maintains a constant current at the maximum value for a certain period of time before starting to decrease. In this type of existing scheme, the purpose of using a linear increase at the beginning and then maintaining a stable current is to reduce skin irritation caused by sudden current changes. Although when the current is low, the current rising at a certain rate will not cause the patient to feel electrical stimulation, but when the current exceeds a certain threshold, the patient can clearly feel the electrical stimulation caused by the rising current, and the electrical stimulation will not disappear until the current stabilizes. Therefore, the prior art uses a longer period of time in the entire cycle to keep the current constant to the maximum current threshold that the patient can accept (hereinafter also referred to as the patient tolerance current threshold), for example Figure 1 The current is maintained at the patient's tolerance current threshold for 90% of the time period used in the existing solution. The inventors of this application innovatively discovered during the research process that the electrical stimulation sensation is related to two variables: the current rise rate and the current amplitude. First, when the current is low, there will be no stimulation even if the current rise rate is fast; second, when the current rise rate is low, there will be no stimulation even if the current amplitude is large. Therefore, the innovative design of this application is as follows: Figure 4 The new current waveform output scheme shown, that is, the current rise rate decreases as the current increases, so that the current can continue to rise slowly for a certain period above the patient's tolerance current threshold reflected in the prior art, and then begin to decline after rising to the peak value, which can effectively increase the patient's tolerance current threshold and improve the treatment effect.
[0044] Furthermore, the inventors of the present application have also found that if the current can be increased by a new rule, which allows the current to simultaneously meet the requirements of a small current rising rapidly, a large current rising slowly, and to maintain a slow rising stage for as long as possible, it is beneficial to effectively improve the patient's tolerance current threshold while reducing the control steps and improving the stable output of the AC signal. Based on this, the inventors of the present application have further innovatively found that, mathematically defined, the current output waveform is a concave function, that is, the quadratic partial derivative of the function is less than 0. Common types of concave functions include logarithmic functions, polynomial functions, power functions, etc., and based on the purpose of the present application, it is hoped that the concave function can rise rapidly to a value close to the maximum value and then maintain a gentle rise and maintain for a long time, so as to maintain the output power at a high level without causing stimulation to the patient. However, the inventors have also found that conventional concave functions cannot meet the special requirements of tumor electric field therapy. Therefore, through the innovative use of a method combining testing and fitting, a cubic logarithmic polynomial is finally formed as the waveform output rule of the current rising stage (including A and B stages) as shown in 4 in the present application, which can meet the above special needs. The inventors have further discovered that, in addition to the above cubic logarithmic polynomial, for example, the Weibull function can also be used as a waveform output rule in the current output amplitude rising stage.
[0045] The cubic logarithmic polynomial can be established as the following formula: y=ax 3 +bx 2 +cx, x=log(t+d) (Formula 1) Among them, y represents current, t represents time, and a, b, c, and d are adjustable coefficients.
[0046] like Figure 6 As shown in FIG. 1 , the energy threshold (patient tolerance current threshold) of the electric stimulation felt by the subjects treated with the alternating field therapy device improved by the present application is improved by a percentage compared with the existing treatment system. The experiment selected 7 subjects (5 males and 2 females) and applied the new waveform of the present application to the front and back electrode pairs and the left and right electrode pairs respectively (such as Figure 4 , including cubic logarithmic polynomial regular rising waveform) and old waveform ( Figure 1 The waveform shown in the figure) records the energy output by the device when the subjects feel electrical skin stimulation in both cases and calculates the ratio of the two. It can be found that the energy output under the new waveform condition is improved, both front and back and on both sides. The percentage increase based on the horizontal line in the figure representing the existing 100% output capacity is: front and back: 59% ± 29%; both sides: 49% ± 32%). Obviously, the waveform provided by the idea of this application enables patients to tolerate higher treatment power, thereby improving the treatment effect and the patient's compliance with electrical stimulation.
[0047] Since each patient has different sensitivity to electrical stimulation, and different areas of the body have different sensitivity to electrical stimulation, therefore, in a further embodiment, the above adjustable coefficients are adjusted for the electrical stimulation tolerance of different patients or different areas of the body, to achieve different electrical signal output waveforms, and to carry out targeted treatment. In some embodiments, the signal generator can provide a variety of different gears, such as electrical signal outputs of three different gears, and the waveform output rule of the cubic logarithmic polynomial is adopted in the rising stage of the amplitude of the electrical signal of each gear to generate different electrical signal outputs to cope with the electrical stimulation tolerance of different patients or different areas of the body, and the adjustable coefficients of the cubic logarithmic polynomial of each gear can be increased in the same multiple, as shown in Table 1 below, the adjustable coefficients of the first gear are a, b, c, d, and the adjustable coefficients of the second gear are Qa, Qb, Qc, Qd, of course, in some embodiments, as shown in Table 2 below, the adjustable coefficients may not be in multiples and may be adjusted according to actual conditions. The various relationships between the adjustable parameters are adjusted according to the specific application scenario, and this application does not limit this.
[0048] Table 1: Waveform output rules for the rising phase of the electrical signal amplitude at each gear 1
[0049] Table 2: Waveform output rules for the rising phase of the electrical signal amplitude at each gear 2
[0050] During treatment, a high gear can be applied to the electrode pairs in the areas where the patient has a strong tolerance to stimulation, and correspondingly, a low gear can be applied to the electrode pairs in the areas with a weak tolerance. Similarly, a higher gear can be used for patients with a strong tolerance to electrical stimulation.
[0051] In addition, in order to adapt to different treatment scenarios, the present application also provides Figure 5 The electrical signal output scheme shown in the figure includes four stages in sequence: the first stage A in which the electrical signal amplitude rises rapidly, the second stage B in which the electrical signal amplitude rises slowly, the peak stabilization stage D after rising to the peak value, and the decline stage C. The peak stabilization stage is significantly shortened compared with the peak stabilization stage in the existing scheme, so as to further improve the treatment effect while maintaining patient compliance.
[0052] In some embodiments, the alternating field therapy device includes one or more temperature sensors and an electromyographic signal feedback device. In order to further improve the therapeutic effect, the controller of the alternating field therapy device automatically adjusts the duty cycle of each electrode pair according to the electromyographic signal and temperature signal from the human electromyographic signal feedback device and / or the temperature sensor, thereby improving the patient's treatment experience and reducing the sense of stimulation. The inventor of the present application also found that if the first higher frequency is used during the current rising process, when the current reaches the peak, it is immediately switched to the second lower frequency. In theory, the electrical stimulation response to the human body can be reduced in this way. However, in the actual implementation process, the current frequency will cause an instantaneous mutation in the process of quickly switching from the first higher frequency to the second lower frequency, and then it can be gradually adjusted to the peak stable period. It is impossible to provide a stable and changing treatment current, which will still cause electrical stimulation discomfort to the patient and / or reduce the treatment effect. Therefore, a new frequency adjustment rule can be combined to more effectively reduce the stimulation to the patient and improve the efficacy. This new frequency adjustment rule is: during the rising process of the output waveform of the electrical signal amplitude, the current frequency gradually decreases as the electrical signal amplitude rises; or the frequency gradually increases from low to high, and then gradually decreases; or a suitable constant frequency is used.
[0053] Continue to refer Figure 7, is a schematic diagram of the alternating field therapy system involved in the present application, which includes the alternating field therapy device as described above (the device includes a host 1 and one or more electrodes), an adapter 2, a power adapter 3, and a battery charging stand 6. The host 1 is used to generate a tumor treatment electric field and transmit it to the target treatment area through the first electrode pair 4 and the second electrode pair 5; the adapter 2 is used to connect the host 1 with the first electrode 4 and the second electrode pair 5; the power adapter 3 is used to connect the host to a power source when the host is working and provide appropriate power to the host 2; the battery charging stand 6 is used to charge the battery removed from the host.
[0054] The host 1 is a portable device, which includes a base 10, a first main body 11 located at a first side of the front end of the base 10, and a second main body 12 located at a second side of the front end of the base 10. A battery compartment (not shown) for inserting a battery 13 is also provided inside the host; in the horizontal direction, the width of the base 10 is greater than the width of the first main body 11 and the second main body 12, but corresponds to the sum of the widths of the first main body 11 and the second main body 12; in the vertical direction, the heights of the base 10 and the first main body 11 are equivalent, but both are greater than the height of the second base 12, so a notch 16 is formed above the second base 12, and the notch 16 is surrounded by the front end portion of the base 10, one side of the first main body 11 and the upper portion of the second base 12, and the notch 16 is used for conveniently entering and exiting the battery compartment for the battery 13, Figure 7 As shown, the battery 13 has been fully plugged into the host 1. At this time, part of the battery 13 is just exposed at the notch 16 on the host, so that the entire host 1 and the exposed part of the battery 13 form a roughly rectangular structure, and a handle position 130 and a battery control button 131 are provided on the battery. The handle position 130 is recessed from the side away from the first main body 11 to the direction close to the first main body 11, forming a space for hand grasping and also just exposed on one side of the host, which is convenient for plugging and unplugging the battery; the battery control button 131 and the handle position 130 are located on different sides of the battery, and are used to control the locking or unlocking of the battery in the host to achieve safe operation.
[0055] In this embodiment, the electrodes include the first electrode pair 4 and the second electrode pair 5. The first electrode pair 4 includes a first electrode 41 and a second electrode 42 for the front and rear sides of the target treatment area (also referred to as AP electrode pair herein), and a first plug 43 and a second plug 44 for connecting the first electrode 41 and the second electrode 42 to the adapter 2, respectively. The first connection end 43 and the second connection end 44 are respectively connected to the first electrode 41 and the second electrode 42 in a fixed or detachable manner through a wire; accordingly, the second electrode pair 5 includes a third electrode pair 51 and a fourth electrode pair 52 for the left and right sides of the target treatment area. (also referred to herein as LR electrode pairs) and third connection terminals 53 and 54 for connecting the third electrode pair 51 and the fourth electrode pair 52 to the adapter 2 respectively; the adapter 2 is provided with four docking terminals 20 for connecting with the first connection terminal 43, the second connection terminal 44, the third connection terminal 53, and the fourth connection terminal 54, and the docking terminal 20 is, for example, a socket, and correspondingly, the first connection terminal 43, the second connection terminal 44, the third connection terminal 53, and the fourth connection terminal 54 are plugs. Of course, in some embodiments, in order to simplify the electrode structure, the positions of the plug and the socket can also be swapped, and this application does not limit this. In addition, this application does not limit the number of specific electrodes and electrode pairs. For example, in some embodiments, it can include three, four, six, and other multiple electrodes. Each electrode is a multi-layer structure, including a stacked flexible circuit board layer, a conductive layer, a hydrogel layer, and an isolation layer located at the upper and lower outer layers. Of course, in some other embodiments, the electrode can also be in the form of an existing ceramic component, and this application does not specifically limit the specific arrangement of the electrode.
[0056] The battery charging stand 6 is provided with a plurality of charging slots 60, each of which is matched to the size of the battery 13, and is used to charge one or more batteries 13. Furthermore, the battery charging stand 6 is provided with a prompt element at a position corresponding to each charging slot, for example, displaying different colors of light according to different charging processes of the battery.
[0057] In some embodiments, the alternating field therapy system disclosed in the present application includes the alternating field therapy device as described above (the device includes a host 1 and one or more electrodes) and any one or more of the adapter 2, the power adapter 3 and the battery charging stand 6. The adapter is used to establish a connection between the alternating field therapy device and the one or more pairs of electrodes, the power adapter is used to cooperate with the power supply to provide power to the alternating field therapy device, and the battery is used to charge the battery used by the alternating field therapy device. The present application does not specifically limit the specific composition of the alternating field therapy system.
[0058] In some embodiments, the present application further discloses a method for controlling the output of an electrical signal to generate an alternating electric field in a target area, and the method is applied to the alternating field therapy device as described above. Specifically, the method includes: Controlling the electrical signal to output a rising waveform in a rising phase according to a predefined rule; After the rising stage, a falling waveform is output according to a second predefined rule. In the rising stage, the amplitude rising rate of the electrical signal decreases as the amplitude increases.
[0059] Optionally, the first predefined rule is a cubic logarithmic polynomial rule, the cubic logarithmic polynomial includes one or more adjustable coefficients, and the method includes adjusting the adjustable system according to an actual scenario.
[0060] Optionally, the method includes providing a plurality of different gears, so that the waveform output rule of the cubic logarithmic polynomial is adopted in the rising phase of the electrical signal amplitude of each gear, and the adjustable coefficient in the cubic logarithmic polynomial of each gear can be adjusted in the same multiple or different multiples.
[0061] Optionally, the convenience includes making the rising stage include a first stage and a second stage, the falling stage is a stage in which the amplitude of the electrical signal rises to a peak value in the second stage and then begins to decline, and the first stage, the second stage and the falling stage are output in sequence adjacent to each other; the duration of the second stage is greater than the duration of the first stage, the duration of the first stage is greater than the duration of the falling stage, and the amplitude rising rate of the electrical signal in the first stage is greater than the amplitude rising rate of the electrical signal in the second stage.
[0062] Optionally, the method includes making the amplitude of the electrical signal reach more than 70% and less than 90% of the peak value from the lowest point over more than 2% and less than 20% of the time of the entire cycle in the first stage; and / or In the second stage, the amplitude of the electrical signal rises from more than 70% to less than 90% of the peak value to 100% over more than 10% to less than 90% of the time of the entire cycle; and / or In the falling phase, the current drops from 100% of the peak value to the lowest point within 5% of the entire cycle.
[0063] Optionally, the method includes outputting a peak stabilization phase immediately after the rising phase and immediately before the falling phase.
[0064] Optionally, the method includes that the falling phase is immediately after the rising phase, so that when the amplitude of the electrical signal rises to a peak value in the rising phase, it begins to enter the falling phase.
[0065] Optionally, the method includes: the second predefined rule adopted is a linear rule or a nonlinear rule; and / or the first predefined rule is a Weibull function.
[0066] Optionally, the method includes causing the amplitude of the electrical signal to increase during the increase. The current frequency gradually decreases as the amplitude of the electrical signal increases; or, The current frequency gradually increases from low to high, and then gradually decreases; or, The current frequency is a constant frequency.
[0067] like Figure 8 As shown, the present application discloses an electronic device 7, which includes a processor 71, and the processor 71 is used to execute instructions to implement the method for controlling the output of electrical signals described above.
[0068] In some implementations, the electronic device further includes a memory 73 , and the processor 71 implements the method for controlling the output of an alternating current signal described above when executing a computer program stored in the memory 73 .
[0069] In some embodiments, the electronic device further includes a communication interface 72, wherein the processor 71, the communication interface 72, and the memory 73 are communicatively connected. The communication interface 72 is used for data exchange between the electronic device and other devices, such as a Bluetooth interface, through which communication can be performed with other devices such as mobile phones and computers to transmit, for example, device information, user treatment information, etc.
[0070] The processor 71 referred to in this application may be a central processing unit (CPU), or other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field-programmable gate arrays (FPGA) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. A general-purpose processor may be a microprocessor or any conventional processor, etc. The processor 71 is the control center of the electronic device, and uses various interfaces and lines to connect various parts of the entire electronic device.
[0071] The memory 73 is used to store the computer program, and the processor 73 implements various functions of the electronic device by running or executing the computer program stored in the memory 73 and calling the data stored in the memory 73. The memory 73 may include non-volatile and / or volatile memory. Non-volatile memory may include read-only memory (ROM), programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM) or flash memory. Volatile memory may include random access memory (RAM) or external cache memory. As an illustration and not limitation, RAM is available in many forms, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous link (Synchlink) DRAM (SLDRAM), memory bus (Rambus) direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM).
[0072] In some embodiments, the electronic device 7 and the host 1 are integrated into the same device for implementing alternating electric field therapy.
[0073] It should be noted that, as can be understood by those skilled in the art, more method steps that can be implemented when the computer program stored in the memory is executed by the processor can be referred to the relevant description above and will not be repeated here.
[0074] It should be noted that the embodiment of the present application may provide a readable storage medium, in which a computer program as described above is stored, which may adopt any combination of one or more computer-readable media. The readable medium may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared or semiconductor system, device or device, or any combination of the above. More specific examples (non-exhaustive list) of computer-readable storage media include: an electrical connection with one or more wires, a portable computer hard disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above. In this article, a computer-readable storage medium may be any tangible medium containing or storing a program, which may be used by an instruction execution system, device or device or used in combination with it.
[0075] Computer-readable signal media may include data signals propagated in baseband or as part of a carrier wave, which carry computer-readable program codes. Such propagated data signals may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. Computer-readable signal media may also be any computer-readable medium other than a computer-readable storage medium, which may send, propagate, or transmit a program for use by or in conjunction with an instruction execution system, device, or device. The program code contained on the computer-readable medium may be transmitted using any suitable medium, including but not limited to wireless, wire, optical cable, RF, etc., or any suitable combination of the above.
[0076] It should be noted that the computer program code for performing the operation of the present application can be written in one or more programming languages or a combination thereof, and the programming language includes an object-oriented programming language-such as Java, Smalltalk, C++, and also includes a conventional procedural programming language-such as "C" language or similar programming language. The program code can be executed entirely on the user's computer, partially on the user's computer, as an independent software package, partially on the user's computer and partially on a remote computer, or completely on a remote computer or server. In the case of a remote computer, the remote computer can be connected to the user's computer through any type of network-including a local area network (LAN) or a wide area network (WAN), or can be connected to an external computer (for example, using an Internet service provider to connect through the Internet).
[0077] It should be noted that the devices and methods disclosed in the embodiments of this article can also be implemented in other ways. The device embodiments described above are merely schematic. For example, the flowcharts and block diagrams in the accompanying drawings show the possible architecture, functions and operations of the devices, methods and computer program products provided according to the multiple embodiments of this article. In this regard, each box in the flowchart or block diagram can represent a part of a module, program or code, and the module, program segment or part of the code contains one or more executable instructions for implementing the specified logical function, and the module, program segment or part of the code contains one or more executable instructions for implementing the specified logical function. It should also be noted that in some alternative implementations, the functions marked in the box can also occur in a different order from the order marked in the accompanying drawings. For example, two consecutive boxes can actually be executed substantially in parallel, and they can sometimes be executed in the opposite order, depending on the functions involved. It should also be noted that each box in the block diagram and / or flowchart, and the combination of boxes in the block diagram and / or flowchart can be implemented by a dedicated hardware-based system for performing a specified function or action, or can be implemented with a combination of dedicated hardware and computer instructions. In addition, the functional modules in the various embodiments of this document may be integrated together to form an independent part, or each module may exist independently, or two or more modules may be integrated to form an independent part.
[0078] Compared with the prior art, the alternating field therapy device, equipment, system, method and electronic equipment provided by the present application have the following advantages: The alternating field treatment device provided by the present application includes a signal generator, which is used to generate one or more electrical signals, thereby generating an alternating electric field for treating a target area; the amplitude output of the electrical signal includes a rising phase arranged in sequence to rise according to a first predefined rule, and a falling phase located after the rising phase to fall according to a second predefined rule, and in the rising phase, the amplitude rising rate of the electrical signal decreases as the amplitude increases. Through this setting, patients can tolerate higher treatment power, thereby improving treatment effects and patient compliance.
[0079] Furthermore, by making the first predefined rule a cubic logarithmic polynomial rule, the cubic logarithmic polynomial includes one or more adjustable coefficients, which can simultaneously satisfy the rapid rise of small currents, the slow rise of large currents, and maintain the slow rise stage for as long as possible, which is beneficial to effectively improve the patient's tolerance current threshold / tolerance to higher treatment power, while reducing the control steps and improving the stable output of the AC signal.
[0080] Furthermore, by enabling the signal generator to provide a plurality of different gears, the waveform output rule of the cubic logarithmic polynomial is adopted in the rising stage of the electrical signal amplitude of each gear, and the adjustable coefficients in the cubic logarithmic polynomial of each gear can be adjusted in the form of increasing by the same multiple or by different multiples. The above adjustable coefficients can be adjusted according to the different tolerance of different patients or different treatment areas to electrical stimulation, thereby achieving targeted treatment and further improving patient compliance.
[0081] Furthermore, by making the rising stage include a first stage and a second stage, the falling stage is a stage in which the amplitude of the electric signal rises to a peak value in the second stage and then begins to decline, and the first stage, the second stage and the falling stage are output in sequence adjacent to each other; the duration of the second stage is greater than the duration of the first stage, and the amplitude rising rate of the electric signal in the first stage is greater than the amplitude rising rate of the electric signal in the second stage, it is possible to extend the high-energy output treatment time as much as possible while improving patient compliance, thereby improving the treatment effect.
[0082] Further, in the first stage, the amplitude of the electrical signal reaches more than 70% and less than 90% of the peak value from the lowest point over more than 2% and less than 20% of the time of the entire cycle; and / or In the second stage, the amplitude of the electrical signal rises from more than 70% to less than 90% of the peak value to 100% over more than 10% to less than 90% of the time of the entire cycle; and / or In the descending phase, the current drops from 100% of the peak value to the lowest point within 5% of the entire cycle, which enables the patient to tolerate a higher treatment power and significantly improves the treatment effect and patient compliance.
[0083] Furthermore, by making the amplitude output of the electrical signal also include a peak stabilization phase immediately after the rising phase and immediately before the falling phase, targeted selection can be made according to different treatment scenarios, such as different patients, different treatment areas, different cancer cell division processes, etc., and it is possible to choose to extend the peak stabilization time after rising to the peak value, thereby extending the treatment time in the peak current state without increasing the patient's sense of electrical stimulation, thereby improving the treatment effect.
[0084] Furthermore, by placing the descending phase immediately after the ascending phase, when the electrical signal amplitude rises to a peak value during the ascending phase, the descending phase begins, thereby improving the treatment effect and patient compliance while enabling stable electrical signal output.
[0085] Furthermore, by making the second predefined rule a linear rule or a nonlinear rule; and / or making the first predefined rule a Weibull function, more treatment strategies are provided to expand the treatment scope.
[0086] Furthermore, when the amplitude of the electrical signal increases, The current frequency gradually decreases as the amplitude of the electrical signal increases; or, The current frequency gradually increases from low to high, and then gradually decreases; or, The current frequency is a constant frequency, which makes the treatment signal more stable and avoids sudden changes in the current amplitude caused by rapid switching of the current frequency, thereby causing electrical stimulation discomfort to the patient and / or reducing the treatment effect.
[0087] Furthermore, the alternating field therapy device includes a base, a first main body located at a first side of the front end of the base, and a second main body located at a second side of the front end of the base. A battery compartment for battery insertion is also provided inside the alternating field therapy device. A notch is formed above the second main body, and the notch is surrounded by the front end portion of the base, one side of the first main body, and the upper portion of the second main body. The notch is used for allowing the battery to enter and exit the battery compartment, which can reduce complex components such as a dust isolation cover for the battery compartment and improve the simplicity of operation.
[0088] Furthermore, when the battery is fully inserted into the battery compartment, part of the battery is exposed at the notch; a handle and a battery control button are provided on the battery, the handle is recessed from the side away from the first body to the direction close to the first body, forming a space for hand grasping and forming open ends on both sides of the alternating field therapy device; the battery control button and the open ends of the handle are located on different sides of the battery; these settings can operate the battery conveniently and quickly, for example, the thumb of one hand can operate the battery control button while the other fingers of the hand pass through the open end to grasp the handle, thereby completing the installation or pulling of the battery.
[0089] Since the alternating field therapy equipment, system, related methods and electronic equipment provided in the present application belong to the same inventive concept as the alternating field therapy device provided in the present application, they all have corresponding advantages, so their beneficial effects will not be described one by one here.
[0090] The above description is only a description of the preferred implementation mode of the present application, and is not intended to limit the scope of the present application. Any changes and modifications made by a person skilled in the art in the field of the present application based on the above disclosure are within the scope of protection of the present application. Obviously, a person skilled in the art can make various changes and modifications to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations fall within the scope of the present application and its equivalents, the present application is also intended to include these modifications and variations.
Claims
1. An alternating field therapy device, characterized in that: comprising a signal generator for generating one or more electrical signals to generate an alternating electric field for treating a target area; The amplitude output of the electrical signal includes a rising phase arranged in sequence according to a first predefined rule, and a falling phase arranged after the rising phase according to a second predefined rule. In the rising phase, the amplitude rising rate of the electrical signal decreases as the amplitude increases.
2. The alternating field therapy device according to claim 1, characterized in that: The first predefined rule is a cubic logarithmic polynomial rule, and the cubic logarithmic polynomial includes one or more adjustable coefficients.
3. The alternating field therapy device according to claim 2, characterized in that: The signal generator is used to provide a plurality of different gears. The waveform output rule of the cubic logarithmic polynomial is adopted in the rising stage of the electrical signal amplitude of each gear, and the adjustable coefficient in the cubic logarithmic polynomial of each gear can be adjusted in the same multiple or different multiples.
4. The alternating field therapy device according to claim 1, characterized in that: The rising stage includes a first stage and a second stage, and the falling stage is a stage in which the amplitude of the electrical signal rises to a peak value in the second stage and then begins to decline. The first stage, the second stage and the falling stage are output in sequence adjacent to each other; the duration of the second stage is greater than the duration of the first stage, and the amplitude rising rate of the electrical signal in the first stage is greater than the amplitude rising rate of the electrical signal in the second stage.
5. The alternating field therapy device according to claim 4, characterized in that: In the first stage, the amplitude of the electrical signal reaches more than 70% and less than 90% of the peak value from the lowest point over more than 2% and less than 20% of the entire cycle; and / or In the second stage, the amplitude of the electrical signal rises from more than 70% to less than 90% of the peak value to 100% over more than 10% to less than 90% of the time of the entire cycle; and / or In the falling phase, the current drops from 100% of the peak value to the lowest point within 5% of the entire cycle.
6. The alternating field therapy device according to claim 1, characterized in that: The amplitude output of the electrical signal also includes a peak stabilization phase immediately after the rising phase and immediately before the falling phase.
7. The alternating field therapy device according to claim 1, characterized in that: The falling phase is immediately after the rising phase, so that when the amplitude of the electrical signal rises to a peak value during the rising phase, it begins to enter the falling phase.
8. The alternating field therapy device according to claim 1, characterized in that: The second predefined rule is a linear rule or a nonlinear rule; and / or the first predefined rule is a Weibull function.
9. The alternating field therapy device according to claim 1, characterized in that: As the amplitude of the electrical signal increases, The current frequency gradually decreases as the amplitude of the electrical signal increases; or, The current frequency gradually increases from low to high, and then gradually decreases; or, The current frequency is a constant frequency.
10. The alternating field therapy device according to claim 1, characterized in that: It comprises a base, a first body located at a first side of the front end of the base, and a second body located at a second side of the front end of the base. A battery compartment for battery insertion is also provided inside the alternating field therapy device. A notch is formed above the second body, and the notch is surrounded by the front end portion of the base, one side of the first body and the upper portion of the second body. The notch is used for allowing the battery to enter and exit the battery compartment.
11. The alternating field therapy device according to claim 10, characterized in that: When the battery is fully inserted into the battery compartment, part of the battery is exposed at the notch; The battery is provided with a handle and a battery control button. The handle is recessed from a side away from the first body toward a direction close to the first body to form a space for hand grasping and form open ends on both sides of the alternating field therapy device.
12. The alternating field therapy device according to claim 11, characterized in that: The battery control button and the open end of the handle are located on different sides of the battery.
13. An alternating field therapy device, characterized in that: It comprises an alternating field therapy device as described in any one of claims 1 to 12 and one or more pairs of electrodes, and each pair of electrodes is applied with the same or different alternating current signals through the alternating field therapy device to generate an alternating electric field in a target treatment body.
14. An alternating field therapy system, characterized in that: It comprises the alternating field therapy device according to any one of claims 1 to 12 and any one or more of the following combinations: One or more pairs of electrodes, an adapter, a power adapter, and a battery charging stand; The adapter is used to establish a connection between the alternating field therapy device and the one or more pairs of electrode pairs, the power adapter is used to cooperate with a power supply to provide power to the alternating field therapy device, and the battery charging stand is used to charge the battery used by the alternating field therapy device.
15. A method for controlling the output of an electrical signal to generate an alternating electric field in a target area, characterized in that: The method is applied to the alternating field therapy device as described in any one of claims 1-12.
16. An electronic device, characterized in that: The electronic device comprises a processor, wherein the processor is used to execute instructions to implement the method for controlling the output of an electrical signal as described in claim 15 above.
Citation Information
Cited By
Alternating field treating apparatus, device and system, method for controlling output of electrical signal, and electronic device
WO2026092037A1