Alternating field treating apparatus, device and system, method for controlling output of electrical signal, and electronic device

Abstract

Provided are an alternating field treating apparatus (1), device and system, a method for controlling the output of an electrical signal, and an electronic device. The alternating field treating apparatus (1) comprises a signal generator (15), the signal generator (15) being used for generating one or more electrical signals, so as to generate an alternating electric field for treating a target region; the amplitude output of the electrical signals comprises ascending phases in which the amplitude ascends according to a first predefined rule and descending phases which follow the ascending phases and in which the amplitude descends according to a second predefined rule, which are sequentially arranged, wherein in the ascending phases, the amplitude ascending rate of the electrical signals decreases as the amplitude increases. The alternating field treating device and system, the method for controlling the output of an electrical signal, and the electronic device are all related to the alternating field treating apparatus (1). By means of the described configuration, patients can tolerate higher treatment powers, thereby improving treatment effect and patient compliance.

Description

Alternating field therapy devices, equipment, systems, methods for controlling electrical signal output, and electronic equipment. Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an alternating field therapy device, equipment, system, method for controlling electrical signal output, and electronic equipment. Background Technology

[0002] Tumor treating fields (TTF) are alternating electric fields with a specific frequency range. When a tumor treating field of a certain strength (generally not less than 1 V / cm) is applied to cancer cells or tumor tissue outside the body, it can effectively inhibit the division and proliferation of cancer cells. When this field is applied to the area where a tumor is located in a cancer patient, it can slow down the tumor progression and achieve a therapeutic effect on the tumor.

[0003] The inhibitory effect on tumor division is strongest when the electric field direction is aligned with the tumor division direction; the inhibitory effect is weakest when the electric field direction is perpendicular to the tumor division direction. However, the division direction of cancer cells is random, and using an electric field with a fixed direction has a weak inhibitory effect on some cancer cells. Therefore, a method of sequentially switching the electric field between two directions is usually adopted to generate two electric fields with essentially perpendicular directions to achieve treatment. Preclinical studies have shown that the effect of sequentially switching electric fields is significantly better than using a fixed-direction electric field. As shown in Figure 1, within each switching cycle, the amplitude of the electric field rises from 0 to its maximum value in a short period of time when switching to a certain direction, maintains the maximum value for about 90% of the switching cycle, and then drops from the maximum value to 0 in a short period of time.

[0004] During treatment, when the applied current exceeds a certain threshold, the current will irritate the skin. As the current increases, the patient's skin irritation intensifies, causing discomfort or intolerance due to electrical stimulation. This limits the maximum current the device can apply to the body, thus restricting the treatment effect.

[0005] It should be noted that the information disclosed in the background section of this invention is intended only to enhance the understanding of the general background of this application, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of this application is to provide an alternating field therapy device, equipment, system, method for controlling electrical signal output, and electronic equipment that enables patients to tolerate higher treatment power, thereby improving treatment effectiveness and patient compliance.

[0007] To achieve the above objectives, this application provides an alternating field therapy device, which includes 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 signals includes a rising phase arranged sequentially according to a first predefined rule, and a falling phase following the rising phase according to a second predefined rule, wherein the amplitude rise rate of the electrical signals decreases as the amplitude increases during the rising phase.

[0008] Optionally, the first predefined rule is a cubic logarithmic polynomial rule, wherein the cubic logarithmic polynomial includes one or more adjustable coefficients.

[0009] Selectively, the signal generator is used to provide multiple different levels, and the waveform output rule of the cubic logarithmic polynomial is adopted during the rise phase of the electrical signal amplitude of each level. The adjustable coefficients in the cubic logarithmic polynomial of each level can be adjusted by increasing by the same multiple or by different multiples.

[0010] Selectively, the rising phase includes a first phase and a second phase, and the falling phase is the phase in which the amplitude of the electrical signal rises to a peak after the second phase and then begins to fall. The first phase, the second phase, and the falling phase are output sequentially and adjacent to each other. The duration of the second phase is longer than the duration of the first phase, and the amplitude rise rate of the electrical signal in the first phase is greater than the amplitude rise rate of the electrical signal in the second phase.

[0011] Selectively, in the first stage, for more than 2% to less than 20% of the entire cycle, the electrical signal amplitude rises from the lowest point to more than 70% to less than 90% of the peak value; and / or

[0012] In the second phase, over 10% to 90% of the entire cycle, the electrical signal amplitude increases from 70% to 90% of the peak value to 100%; and / or

[0013] During the descent phase, within 5% of the entire cycle, the current drops from 100% of its peak value to its lowest point.

[0014] Optionally, the amplitude output of the electrical signal may also include a peak stabilization phase immediately following the rising phase and immediately preceding the falling phase.

[0015] Selectively, the falling phase is immediately following the rising phase, such that the falling phase begins after the electrical signal amplitude reaches its peak during the rising phase.

[0016] Optionally, the second predefined rule is a linear rule or a nonlinear rule; and / or the first predefined rule is a Weibull function.

[0017] Selectively, as the amplitude of the electrical signal increases,

[0018] The current frequency gradually decreases as the amplitude of the electrical signal increases; or,

[0019] The current frequency gradually increases from low to high, and then gradually decreases; or,

[0020] The current frequency is constant.

[0021] Optionally, the alternating field therapy device includes a base, a first main body located on a first side of the front end of the base, and a second main body located on a second side of the front end of the base. The alternating field therapy device also has a battery compartment for battery insertion.

[0022] A notch is formed above the second body, which is surrounded by the front end of the base, one side of the first body and the upper part of the second body. The notch is used for the battery to enter and exit the battery compartment.

[0023] Selectively, when the battery is fully inserted into the battery compartment, a portion of the battery is exposed at the notch;

[0024] The battery is provided with a handle and a battery control button. The handle is recessed from the side away from the first body towards the first body, forming a space for hand gripping and forming open ends on both sides of the alternating field treatment device.

[0025] Optionally, the battery control button and the open end of the handle are located on different sides of the battery.

[0026] To achieve the purpose of this application, this application also provides an alternating field therapy device, which includes the alternating field therapy apparatus as described above and one or more pairs of electrodes, wherein each pair of electrodes is subjected to the same or different alternating current signals through the alternating field therapy apparatus to generate an alternating electric field in the target treatment body.

[0027] To achieve the objectives of this application, this 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:

[0028] In one or more pairs of electrodes, adapters, power adapters, and battery charging docks;

[0029] 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 supply power to the alternating field therapy device in conjunction with a power supply, and the battery charging dock is used to charge the battery used by the alternating field therapy device.

[0030] To achieve the objectives of this application, this application also provides a method for controlling the output of electrical signals to generate an alternating electric field in a target area, the method being applied to the alternating field therapy device as described above.

[0031] To achieve the purpose of this application, this application also provides an electronic device, which includes a processor for executing instructions to implement the method of outputting control electrical signals as described above.

[0032] Compared with the prior art, the alternating field therapy device, equipment, system, method and electronic equipment provided in this application have the following advantages:

[0033] The alternating field therapy device provided in this application includes a signal generator for generating one or more electrical signals, thereby generating an alternating electric field for a treatment target area. The amplitude output of the electrical signals includes a rising phase arranged sequentially according to a first predefined rule, and a falling phase following the rising phase, which falls according to a second predefined rule. In the rising phase, the amplitude rise rate of the electrical signal decreases as the amplitude increases. By decreasing the amplitude rise rate of the electrical signal as the amplitude increases, patients can tolerate higher treatment power, i.e., the patient-tolerable input current threshold during treatment can be increased, thereby further improving treatment efficacy and patient compliance.

[0034] Since the alternating field therapy equipment, system, related methods and electronic equipment provided in this application belong to the same inventive concept as the alternating field therapy device provided in this application, they all have corresponding advantages, so their beneficial effects will not be described in detail here. Attached Figure Description

[0035] Figure 1 is a schematic diagram of the AC signal output amplitude of the LR channel and AP channel in a conventional tumor treatment electric field system;

[0036] Figure 2 is a block diagram showing the relationship between the controller, signal generator and electrode pairs of the alternating field therapy device provided in one embodiment of this application;

[0037] Figure 3 is a usage scenario diagram of the alternating field therapy device provided in one embodiment of this application;

[0038] Figure 4 is a schematic representation of the electrical signal amplitudes generated by the signal generator according to an embodiment of this application for the LR electrode pair and the AP electrode pair;

[0039] Figure 5 is another schematic representation of the electrical signal amplitude generated for the LR electrode pair and the AP electrode pair by a signal generator provided in another embodiment of this application;

[0040] Figure 6 is a comparison chart showing the percentage increase in the energy threshold of the subject's tolerance to electrical stimulation compared to existing treatment devices, provided by an embodiment of this application of the alternating field therapy device.

[0041] Figure 7 is a schematic diagram of an alternating field therapy system provided in an embodiment of this application;

[0042] Figure 8 is a block diagram of an electronic device provided in one embodiment of this application. Detailed Implementation

[0043] The alternating field therapy device, equipment, and system proposed in this application will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of this application will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, used only to facilitate and clearly illustrate the purposes provided by the embodiments of this application. Before disclosing and describing this application, it should be understood that this application is not limited to a specific method, specific component, or specific implementation. It should also be understood that the terminology used herein is only for describing specific embodiments and is not intended to be limiting. Please refer to the accompanying drawings to make the purposes, features, and advantages of this application more apparent and understandable. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only used to complement the content disclosed in the specification, for those skilled in the art to understand and read, and are not intended to limit the implementation conditions of this application. Any modifications to the structure, changes in the proportional relationships, or adjustments to the size, if they are the same as or similar to the effects and purposes achieved by this application, should still fall within the scope of the technical content disclosed in this application.

[0044] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0045] Furthermore, in the description of this specification, the reference to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., means that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples. Furthermore, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0046] This application aims to provide an alternating field therapy device, equipment, system, and method that enables patients to tolerate higher treatment power, thereby improving treatment effectiveness and patient compliance.

[0047] To achieve the above objectives, this application provides an alternating field therapy device, equipment, system, method for controlling electrical signal output, and electronic device. Figure 2 shows a schematic block diagram of the alternating field therapy device involved in this application. The alternating field therapy device includes an alternating field therapy unit 1 and one or more pairs of electrode pairs. The multiple pairs of electrodes include at least a first electrode pair 4 and a second electrode pair 5. Each electrode pair is subjected to the same or different alternating current signals through the alternating field therapy unit 1 to generate an alternating electric field in the target treatment body for tumor treatment.

[0048] Please refer to Figure 3, which illustrates a specific application scenario of the alternating field therapy device provided in this application. It shows two electrode pairs: the first electrode pair 4 is applied to the front and back of the patient's tumor area (hereinafter referred to as the AP electrode pair), while the second electrode pair 5 is applied to the left and right sides of the patient's tumor area (hereinafter referred to as the LR electrode pair). Of course, in actual implementation, more electrode pairs can be arranged according to different situations. The first electrode pair 4 and the second electrode pair 5 are worn on the patient's target treatment area and connected to the alternating field therapy device 1 via the adapter 2. The alternating field therapy device 1 serves as the AC signal emission source throughout the alternating field therapy process. It is used to periodically apply electrical signals, such as AC signals, to the first electrode pair 4 and the second electrode pair 5 to generate electric fields in corresponding directions between the two electrodes of each electrode pair. The electric field directions of the first electrode pair 4 and the second electrode pair 5 are different from each other, for example, perpendicular or at other angles. Preferably, the electrical signals are applied periodically and sequentially, for example, an electrical signal is applied to the first electrode pair 4 in the first second and an electrical signal is applied to the second electrode pair 5 in the second second. In some other embodiments with more electrode pairs, the electric field directions generated by each electrode pair are at more angles to each other, such as 30°, 45°, 60°, 90°, 120°, etc.

[0049] Referring back to Figure 2, the alternating field therapy device 1 includes a signal generator 15, which generates one or more electrical signals to produce an alternating electric field for the treatment target area, such as an alternating electric field for tumor treatment (also known as a tumor treatment electric field, TTFields, for example, 150 kHz), and transmits 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 waveforms or pulse sequences. The electrical signals can be alternating current signal waveforms in the frequency range of 50 kHz to 500 kHz (e.g., 100 kHz to 200 kHz). This application does not particularly limit the specific current frequency or electric field strength.

[0050] In some embodiments, the alternating field therapy device 1 further includes a controller 14 communicatively connected to the signal generator 15. Under the action of the controller 14, the signal generator 15 periodically sends alternating current signals to one or more pairs of electrodes to generate a tumor therapeutic electric field. In some embodiments, the controller 14 and the signal generator 15 are integrated within the alternating field therapy device 1. In other embodiments, one of the controller 14 and the signal generator 15 may be separately provided in the alternating field therapy device 1. This application does not limit this.

[0051] Figure 4 illustrates the schematic representation of the AC signal amplitude output in the LR electrode pair and AP electrode pair generated using the signal generator 15 disclosed in this application. The amplitude output of the electrical signal includes a rising phase arranged sequentially according to a first predefined rule, and a falling phase following the rising phase according to a second predefined rule, wherein the amplitude rise rate of the electrical signal decreases as the amplitude increases during the rising phase.

[0052] In some embodiments, the first predefined rule is a cubic logarithmic polynomial rule, wherein the cubic logarithmic polynomial includes one or more adjustable coefficients.

[0053] In some embodiments, the rising phase includes a rapid rising first phase A and a slow rising second phase B, and the falling phase is a third phase C, which is the phase in which the electrical signal amplitude rises to its peak after the second phase B and then begins to decline. The first phase A, the second phase B, and the third phase C are output sequentially, adjacent to each other. As shown in Figure 4, the duration of the second phase is greater than the duration of the first phase, and the rate of increase of the electrical signal amplitude in the first phase is greater than the rate of increase of the electrical signal amplitude in the second phase. The duration of the first phase is selectively greater than, equal to, or less than the duration of the falling phase.

[0054] In some embodiments, the electrical signal amplitude reaches 70% to 90% of its peak value from its lowest point over a period of 2% to 20% of the entire cycle; and / or

[0055] In the second phase, over 10% to 90% of the entire cycle, the electrical signal amplitude increases from 70% to 90% of the peak value to 100%; and / or

[0056] During the descent phase, within 5% of the entire cycle, the current drops from 100% of its peak value to its lowest point.

[0057] Specifically, in some embodiments, the first stage A is a rapid rise phase of the electrical signal amplitude, causing the electrical signal amplitude to quickly reach 80% of the peak value from the starting point, for example, after 20% of the entire cycle, the electrical signal amplitude reaches 80% of the peak value from the starting point (e.g., 0); the second stage B is a slow rise phase of the electrical signal amplitude, rising from 80% to 100% of the peak value over a longer period of time, for example, after 75% of the entire cycle, the electrical signal amplitude rises from 80% to 100% of the peak value; the third stage C is a rapid fall phase, where the electrical signal amplitude starts from the peak current of the second stage and rapidly falls to the lowest point, for example, after 5% of the entire cycle, the electrical signal amplitude falls from 100% of the peak value to the lowest point (e.g., 0). As those skilled in the art will understand, in specific implementations, the relationship between the above time periods and peak values ​​can be adjusted accordingly. For example, after 10% of the entire cycle, the electrical signal amplitude can reach 75% of the peak value from the starting point (e.g., 0), and after 85% of the entire cycle, the electrical signal amplitude can rise from 75% of the peak value to 100%. All possible adjustment ranges are within the scope disclosed in this application and will not be listed here one by one.

[0058] In some embodiments, as shown in FIG5, the amplitude output of the electrical signal further includes a peak stabilization phase D immediately following the rising phase and immediately preceding the falling phase.

[0059] In some embodiments, the second rule is a linear rule; of course, in other embodiments, the descent phase may also use other rules for descent, and this application does not make any special limitation on this.

[0060] The amplitude of the electrical signal in this application can be the current amplitude of an AC signal or the voltage amplitude of an AC signal.

[0061] The inventive principles, concepts, technical problems solved, and technical effects of the various embodiments of this application will be further described below.

[0062] Existing alternating current signals, after rising to a peak value linearly, maintain a constant value for a period before declining. For example, as shown in Figure 1, this is the peak-constant holding phase between the rising phase A and the falling phase B. That is, the current linearly increases from 0 to its maximum value, then remains constant at that value for a certain period before declining. In this type of existing scheme, the purpose of initially using a linear rise followed by maintaining a stable current is to reduce skin irritation caused by sudden current changes. Although a current rising at a certain rate will not cause the patient to feel electrical stimulation at lower current levels, when the current exceeds a certain threshold, the patient can clearly feel the electrical stimulation caused by the current rise. This stimulation only disappears after the current stabilizes. Therefore, existing technologies maintain a constant current for a relatively large period throughout the cycle at the maximum current threshold that the patient can tolerate (hereinafter referred to as the patient's tolerance current threshold). For example, in the existing scheme shown in Figure 1, the current is maintained at the patient's tolerance current threshold for 90% of the time period. The inventors of this application have innovatively discovered during their research that the sensation of electrical stimulation is related to two variables: the current rise rate and the current amplitude. First, when the current is low, there will be no irritation even if the current rise rate is fast; second, when the current rise rate is low, there will still be no irritation even if the current amplitude is large. Therefore, this application innovatively designs a new current waveform output scheme as shown in Figure 4, in which the current rise rate decreases as the current increases. This allows the current to continue to rise slowly for a certain period above the patient's tolerance current threshold reflected in the existing technology, and then rise to a peak and begin to decline. This can effectively improve the patient's tolerance current threshold and improve the treatment effect.

[0063] Furthermore, the inventors of this application have discovered that if the current can rise using a new rule that simultaneously allows for a rapid rise in small currents and a slow rise in large currents, while maintaining a slow rise phase for as long as possible, it is beneficial to effectively improve the patient's tolerance current threshold while reducing control steps and improving the stability of the AC signal output. Based on this, the inventors have further innovatively discovered that, mathematically defined, the current output waveform is a concave function, meaning the second partial derivative of the function is less than 0. Common types of concave functions include logarithmic functions, polynomial functions, and power functions. For the purposes of this application, it is desired that this concave function rises rapidly to near its maximum value and then maintains a smooth rise for a relatively long period, thereby maintaining a high level of output power without causing stimulation to the patient. However, the inventors have also found that conventional concave functions cannot meet the specific requirements of tumor electric field therapy. Therefore, through an innovative method combining testing and fitting, a cubic logarithmic polynomial was ultimately formed as the waveform output rule for the current rise phase (including phases A and B) as shown in Figure 4 of this application, which can meet the above-mentioned specific requirements. Furthermore, the inventors discovered that, in addition to the above-mentioned cubic logarithmic polynomial, the Weibull function can also be used as a waveform output rule for the rising phase of the current output amplitude.

[0064] The cubic logarithmic polynomial can be established as follows: y = ax 3 +bx 2 +cx, x=log(t+d) (Formula 1)

[0065] Where y represents current, t represents time, and a, b, c, and d are adjustable coefficients.

[0066] Figure 6 shows the percentage increase in the energy threshold (patient tolerance current threshold) of electrical stimulation felt by subjects treated with the improved alternating field therapy device of this application compared to existing treatment systems. This trial selected seven subjects (5 males and 2 females). The new waveform of this application (Figure 4, including a cubic logarithmic polynomial regularly rising waveform) and the old waveform (Figure 1) were applied to the anterior and posterior electrode pairs and the left and right side electrode pairs, respectively. The energy output of the device when the subjects felt electrical stimulation was recorded in both cases, and the ratio of the two waveforms was calculated. It can be seen that the energy output was increased under the new waveform condition, both anterior and posterior and bilaterally. Based on the percentage increase of the horizontal line representing 100% output capacity in the figure: anterior and posterior: 59% ± 29%; bilaterally: 49% ± 32%. Clearly, the waveform provided by this application allows patients to tolerate higher treatment power, thereby improving treatment efficacy and patient compliance with electrical stimulation.

[0067] Because each patient has a different sensitivity to electrical stimulation, and different areas of the body also have different sensitivities to electrical stimulation, in a further embodiment, the adjustable coefficients are adjusted according to the electrical stimulation tolerance of different patients or different body areas to achieve different electrical signal output waveforms for targeted treatment. In some embodiments, the signal generator can provide multiple different levels, such as three different levels of electrical signal output. The waveform output rule of a cubic logarithmic polynomial is used during the amplitude rise phase of the electrical signal at each level to generate different electrical signal outputs to cope with the electrical stimulation tolerance of different patients or different body areas. The adjustable coefficients of the cubic logarithmic polynomial at each level can increase by the same multiple, as shown in Table 1 below. The adjustable coefficients for the first level are a, b, c, and d, while the adjustable coefficients for the second level are Qa, Qb, Qc, and Qd. Of course, in some embodiments, as shown in Table 2 below, the adjustable coefficients may not be in a multiple relationship but may be adjusted according to the actual situation. The various relationships between the adjustable parameters are adjusted according to the specific application scenario, and this application does not limit them.

[0068] Table 1: Waveform Output Rules for the Rising Phase of Electrical Signal Amplitude at Each Gear Level 1

[0069] Table 2: Waveform Output Rules for the Rising Phase of Electrical Signal Amplitude at Each Gear Level

[0070] During treatment, a higher setting can be applied to electrode pairs in areas where the patient has a high tolerance for stimulation, and a lower setting can be applied to electrode pairs in areas where the patient has a low tolerance. Similarly, a higher setting can be used for patients with a high tolerance for electrical stimulation.

[0071] In addition, to adapt to different treatment scenarios, this application also provides an electrical signal output scheme as shown in Figure 5. The electrical signal amplitude output in this scheme includes four stages in sequence: a first stage A in which the electrical signal amplitude rises rapidly, a second stage B in which the electrical signal amplitude rises slowly, a peak stabilization stage D after rising to the peak value, and a decline stage C. The peak stabilization stage has a significantly shorter duration than the peak stabilization stage in existing schemes, so as to further improve the treatment effect while maintaining patient compliance.

[0072] In some embodiments, the alternating field therapy device includes one or more temperature sensors and an electromyography (EMG) signal feedback device. To further improve the therapeutic effect, the controller of the alternating field therapy device automatically adjusts the duty cycle of each electrode pair based on the EMG signals and temperature signals from the human body EMG signal feedback device and / or temperature sensors, thereby improving the patient's treatment experience and reducing stimulation.

[0073] The inventors of this application have also discovered that if a first higher frequency is used during the current rise, and then immediately switched to a second lower frequency after the current reaches its peak, theoretically, this method can reduce the electrical stimulation response to the human body. However, in actual implementation, the rapid switch of the current frequency from the first higher frequency to the second lower frequency causes a momentary change in the current, which then gradually adjusts to the peak stabilization period. This makes it impossible to provide a stable therapeutic current, still causing discomfort to the patient and / or reducing the therapeutic effect. Therefore, a new frequency adjustment rule can be combined to more effectively reduce the stimulation to the patient while improving the therapeutic effect. This new frequency adjustment rule is as follows: during the rise 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.

[0074] Referring again to Figure 7, which is a schematic diagram of the alternating field therapy system involved in this application, the system includes the alternating field therapy device (which includes an alternating field therapy apparatus 1 and one or more electrodes) as described above, an adapter 2, a power adapter 3, and a battery charging dock 6. The alternating field therapy apparatus 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 alternating field therapy apparatus 1 to the first electrode 4 and the second electrode pair 5; the power adapter 3 is used to connect the alternating field therapy apparatus 1 to a power source and provide suitable power to the alternating field therapy apparatus during operation; the battery charging dock 6 is used to charge the battery after it has been removed from the alternating field therapy apparatus.

[0075] The alternating field therapy device 1 is a portable device, comprising a base 10, a first main body 11 located on a first side of the front end of the base 10, and a second main body 12 located on a second side of the front end of the base 10. The alternating field therapy device also includes a battery compartment (not shown) for inserting a battery 13. Laterally, the width of the base 10 is greater than the dimensions 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. Vertically, the heights of the base 10 and the first main body 11 are approximately equal, but both are greater than the height of the second main body 12. Therefore, a notch 16 is formed above the second main body 12, which is surrounded by the front end of the base 10, one side of the first main body 11, and the upper part of the second main body 12. The notch 16 is used to facilitate the insertion and removal of the battery 13 into the battery compartment. As shown in Figure 7, the battery 13 is fully inserted into the alternating field therapy device 1. At this time, part of the battery 13 is exposed at the notch 16 on the alternating field therapy device, so that the entire alternating field therapy device 1 and the exposed part of the battery 13 form a roughly cuboid structure. The battery is provided with a handle position 130 and a battery control button 131. The handle position 130 is recessed from the side away from the first body 11 towards the side closer to the first body 11, forming a space for hand gripping and is also exposed on one side of the alternating field therapy device, which facilitates the insertion and removal of 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 alternating field therapy device to achieve safe operation.

[0076] In this embodiment, the electrodes include a first electrode pair 4 and a 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 the AP electrode pair in this document), 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 connected to the first electrode 41 and the second electrode 42 in a fixed or detachable manner via wires, respectively. Correspondingly, 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. (Hereinafter also referred to 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 mating terminals 20 for connecting to the first connection terminal 43, the second connection terminal 44, the third connection terminal 53, and the fourth connection terminal 54. The mating terminals 20 are, for example, sockets, 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, to simplify the electrode structure, the positions of the plugs and sockets can be interchanged, and this application does not limit this. In addition, this application does not limit the specific number of electrodes or electrode pairs. For example, in some embodiments, it may include three, four, six, or more electrodes. Each electrode has a multilayer structure, including a stacked flexible circuit board layer, a conductive layer, a hydrogel layer, and an isolation layer located on the upper and lower outer layers. Of course, in some other embodiments, the electrodes may also be in the form of existing ceramic elements. This application does not particularly limit the specific configuration of the electrodes.

[0077] The battery charging stand 6 is provided with multiple charging slots 60, each of which is the size of the battery 13, for charging one or more batteries 13. Furthermore, the battery charging stand 6 is provided with indicator elements at corresponding positions of the charging slots, such as displaying different colors of light according to different charging stages of the battery.

[0078] In some embodiments, the alternating field therapy system disclosed in this application includes an alternating field therapy device (including an alternating field therapy apparatus 1 and one or more electrodes) as described above, and any one or more of the adapter 2, power adapter 3, and battery charging dock 6. The adapter is used to establish a connection between the alternating field therapy apparatus and the one or more pairs of electrodes. The power adapter is used to provide electrical energy to the alternating field therapy apparatus in conjunction with a power supply. The battery is used to charge the battery used by the alternating field therapy apparatus. This application does not particularly limit the specific configuration of the alternating field therapy system.

[0079] In some embodiments, this application also discloses a method for controlling the output of an electrical signal to generate an alternating electric field in a target area, the method being applied to the alternating field therapy device as described above. Specifically, the method includes:

[0080] The electrical signal is controlled by a predefined rule to output a rising waveform during the rising phase.

[0081] After the rising phase, a falling waveform is output according to a second predefined rule, wherein the rate of increase of the amplitude of the electrical signal decreases as the amplitude increases during the rising phase.

[0082] Optionally, the first predefined rule is a cubic logarithmic polynomial rule, wherein the cubic logarithmic polynomial includes one or more adjustable coefficients, and the method includes adjusting the adjustable system according to the actual scenario.

[0083] Optionally, the method includes providing multiple different gears, such that the waveform output rule of the cubic logarithmic polynomial is adopted during the amplitude rise phase of the electrical signal at each gear, and the adjustable coefficients in the cubic logarithmic polynomial of each gear can be adjusted by increasing by the same multiple or by different multiples.

[0084] Optionally, the convenience includes making the rising phase include a first phase and a second phase, and the falling phase is the phase in which the amplitude of the electrical signal rises to a peak after the second phase and then begins to fall, with the first phase, the second phase and the falling phase being output sequentially in close succession; the duration of the second phase is greater than the duration of the first phase, the duration of the first phase is greater than the duration of the falling phase, and the rate of increase of the amplitude of the electrical signal in the first phase is greater than the rate of increase of the amplitude of the electrical signal in the second phase.

[0085] Optionally, the method includes causing the electrical signal amplitude to rise from a minimum point to a maximum of 70% to a minimum of 90% of its peak value during the first phase, after a period of more than 2% to less than 20% of the entire cycle; and / or

[0086] In the second phase, over 10% to 90% of the entire cycle, the electrical signal amplitude increases from 70% to 90% of the peak value to 100%; and / or

[0087] During the descent phase, within 5% of the entire cycle, the current drops from 100% of its peak value to its lowest point.

[0088] Optionally, the method includes outputting a peak stabilization phase immediately following the rising phase and immediately preceding the falling phase.

[0089] Optionally, the method includes the falling phase immediately following the rising phase, such that the falling phase begins after the electrical signal amplitude reaches its peak value during the rising phase.

[0090] Optionally, the method includes employing a second predefined rule as a linear rule or a nonlinear rule; and / or the first predefined rule as a Weibull function.

[0091] Optionally, the method includes causing the amplitude of the electrical signal to rise,

[0092] The current frequency gradually decreases as the amplitude of the electrical signal increases; or,

[0093] The current frequency gradually increases from low to high, and then gradually decreases; or,

[0094] The current frequency is constant.

[0095] As shown in Figure 8, this application discloses an electronic device 7, which includes a processor 71. The processor 71 is used to execute instructions to implement the method for controlling the output of electrical signals described above.

[0096] In some implementations, the electronic device further includes a memory 73, and the processor 71 executes a computer program stored in the memory 73 to implement the method for controlling the output of AC signals described above.

[0097] 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 interaction between the electronic device and other devices, such as a Bluetooth interface, through which communication can be established with other devices such as mobile phones and computers to transmit information such as device information and user treatment information.

[0098] The processor 71 referred to in this application may be a Central Processing Unit (CPU), or other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor may be a microprocessor or any conventional processor. The processor 71 is the control center of the electronic device, connecting various parts of the entire electronic device through various interfaces and lines.

[0099] The memory 73 is used to store the computer program. The processor 73 implements various functions of the electronic device by running or executing the computer program stored in the memory 73 and calling 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. By way of illustration and not limitation, RAM is available in various forms, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), dual data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous link DRAM (SLDRAM), RAMbus direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and RAMbus dynamic RAM (RDRAM), etc.

[0100] In some embodiments, the electronic device 7 and the alternating field therapy device 1 are integrated into the same device for implementing alternating electric field therapy.

[0101] It should be noted that, as those skilled in the art will understand, further details regarding the methods and steps that can be implemented when the computer program stored in the memory is executed by the processor can be found in the relevant descriptions above, and will not be repeated here.

[0102] It should be noted that embodiments of this application may provide a readable storage medium storing a computer program as described above, which may employ 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. Computer-readable storage media may be, for example, but not limited to, electrical, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatuses, or devices, or any combination thereof. More specific examples of computer-readable storage media (a non-exhaustive list) include: electrical connections having one or more wires, portable computer hard disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fibers, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof. In this document, a computer-readable storage medium may be any tangible medium containing or storing a program that can be used by or in combination with an instruction execution system, apparatus, or device.

[0103] Computer-readable signal media may include data signals propagated in baseband or as part of a carrier wave, carrying computer-readable program code. Such propagated data signals may take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. Computer-readable signal media may also be any computer-readable medium other than computer-readable storage media, capable of transmitting, propagating, or transmitting programs for use by or in connection with an instruction execution system, apparatus, or device. The program code contained on the computer-readable medium may be transmitted using any suitable medium, including but not limited to wireless, wireline, optical fiber, RF, etc., or any suitable combination thereof.

[0104] It should be noted that computer program code for performing the operations of this application can be written in one or more programming languages ​​or a combination thereof. These programming languages ​​include object-oriented programming languages ​​such as Java, Smalltalk, and C++, as well as conventional procedural programming languages ​​such as C or similar languages. The program code can be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In cases involving remote computers, the remote computer can be connected to the user's computer via any type of network—including a local area network (LAN) or a wide area network (WAN), or it can be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0105] It should be noted that the apparatus and methods disclosed in the embodiments herein can also be implemented in other ways. The apparatus embodiments described above are merely illustrative; for example, the flowcharts and block diagrams in the accompanying drawings show the architecture, functionality, and operation of possible implementations of the apparatus, methods, and computer program products provided according to various embodiments herein. In this regard, each block in a flowchart or block diagram may represent a module, program, or part of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions marked in the blocks may occur in a different order than those marked in the drawings. For example, two consecutive blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in a block diagram and / or flowchart, and combinations of blocks in block diagrams and / or flowcharts, can be implemented using a dedicated hardware-based system to perform the specified function or action, or can be implemented using a combination of dedicated hardware and computer instructions. In addition, the functional modules in the various embodiments of this article can be integrated together to form an independent part, or each module can exist independently, or two or more modules can be integrated to form an independent part.

[0106] Compared with the prior art, the alternating field therapy device, equipment, system, method and electronic equipment provided in this application have the following advantages:

[0107] The alternating field therapy device provided in this application includes a signal generator for generating one or more electrical signals, thereby generating an alternating electric field for a target treatment area. The amplitude output of the electrical signals includes sequentially arranged rising phases that increase according to a first predefined rule, and falling phases that decrease according to a second predefined rule following the rising phases. In the rising phases, the rate of increase of the electrical signal amplitude decreases as the amplitude increases. This configuration allows patients to tolerate higher treatment power, thereby improving treatment efficacy and patient compliance.

[0108] 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 current and the slow rise of large current, and maintain the slow rise phase for as long as possible, it is beneficial to effectively improve the patient's tolerance current threshold / tolerance to higher treatment power, while reducing control steps and improving the stable output of AC signal.

[0109] Furthermore, by using the signal generator to provide multiple different levels, the waveform output rule of the cubic logarithmic polynomial is adopted during the rise phase of the electrical signal amplitude of each level, and the adjustable coefficients in the cubic logarithmic polynomial of each level can be adjusted by increasing by the same multiple or by different multiples. The adjustable coefficients can be adjusted according to the different tolerances of different patients or different treatment areas to electrical stimulation, so as to achieve targeted treatment and further improve patient compliance.

[0110] Furthermore, by making the rising phase include a first phase and a second phase, and the falling phase is the phase in which the amplitude of the electrical signal rises to a peak after the second phase and then begins to decline, the first phase, the second phase, and the falling phase are output sequentially and adjacent to each other; the duration of the second phase is longer than the duration of the first phase, and the rate of increase of the amplitude of the electrical signal in the first phase is greater than the rate of increase of the amplitude of the electrical signal in the second phase, it is possible to improve patient compliance while extending the high-energy output treatment time as much as possible, thereby improving the treatment effect.

[0111] Furthermore, by ensuring that during the first stage, over a period of 2% to 20% of the entire cycle, the electrical signal amplitude rises from its lowest point to 70% to 90% of its peak value; and / or

[0112] In the second phase, over 10% to 90% of the entire cycle, the electrical signal amplitude increases from 70% to 90% of the peak value to 100%; and / or

[0113] During the descent phase, within 5% of the entire cycle, the current drops from 100% of its peak value to its lowest point, allowing patients to tolerate higher treatment power and significantly improving treatment efficacy and patient compliance.

[0114] Furthermore, by including a peak stabilization phase immediately following the rising phase and immediately preceding the falling phase in the amplitude output of the electrical signal, targeted selection can be made according to different treatment scenarios, such as different patients, different treatment areas, and different cancer cell division processes. By selecting to extend the peak stabilization time after rising to the peak, the treatment time in the peak current state can be extended without increasing the patient's electrical stimulation sensation, thereby improving the treatment effect.

[0115] Furthermore, by placing the falling phase immediately after the rising phase, the falling phase begins after the electrical signal amplitude reaches its peak during the rising phase. This improves treatment effectiveness and patient compliance while ensuring stable electrical signal output.

[0116] Furthermore, by making the second predefined rule a linear or nonlinear rule; and / or the first predefined rule a Weibull function, more treatment strategies are provided to expand the treatment scope.

[0117] Furthermore, as the amplitude of the electrical signal increases,

[0118] The current frequency gradually decreases as the amplitude of the electrical signal increases; or,

[0119] The current frequency gradually increases from low to high, and then gradually decreases; or,

[0120] The current frequency is constant, which makes the treatment signal more stable and avoids sudden changes in current amplitude during rapid switching of current frequency, which could cause discomfort to the patient and / or reduce the treatment effect.

[0121] Furthermore, the alternating field therapy device includes a base, a first main body located on a first side of the front end of the base, and a second main body located on a second side of the front end of the base. The alternating field therapy device also has a battery compartment for battery insertion inside. A notch is formed above the second main body, which is surrounded by the front end portion of the base, one side of the first main body, and the upper part of the second main body. The notch is used for the battery to enter and exit the battery compartment, which can reduce complex components such as the dust isolation cover of the battery compartment and improve the simplicity of operation.

[0122] Furthermore, 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 the side away from the first body towards the first body, forming a space for hand gripping and forming open ends on both sides of the alternating field treatment device; the battery control button and the open ends of the handle are located on different sides of the battery; these features enable convenient and quick operation of the battery. For example, while operating the battery control button, the other fingers of the same hand can grip the handle through the open ends to complete the installation or removal of the battery.

[0123] Since the alternating field therapy equipment, system, related methods and electronic equipment provided in this application belong to the same inventive concept as the alternating field therapy device provided in this application, they all have corresponding advantages, so their beneficial effects will not be described in detail here.

[0124] The above description is merely a description of preferred embodiments of this application and is not intended to limit the scope of this application in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the protection scope of this application. Obviously, those skilled in the art can make various modifications and variations to this application without departing from the spirit and scope of this application. Therefore, if these modifications and variations fall within the scope of this application and its equivalents, this application also intends to include these modifications and variations.

Claims

1. An alternating field therapy device, characterized in that, Includes a signal generator for generating one or more electrical signals, thereby generating an alternating electric field for treating the target area; The amplitude output of the electrical signal includes an ascending phase arranged sequentially according to a first predefined rule, and a descending phase following the ascending phase according to a second predefined rule. In the ascending phase, the rate of increase of the amplitude 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, wherein 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 multiple different levels. During the rise phase of the electrical signal amplitude at each level, the waveform output rule of the cubic logarithmic polynomial is adopted. The adjustable coefficients in the cubic logarithmic polynomial of each level can be adjusted by the same multiple or by different multiples.

4. The alternating field therapy device according to claim 1, characterized in that, The rising phase includes a first phase and a second phase. The falling phase is the phase in which the amplitude of the electrical signal rises to a peak after the second phase and then begins to decline. The first phase, the second phase, and the falling phase are output sequentially and adjacent to each other. The duration of the second phase is longer than the duration of the first phase, and the rate of increase of the amplitude of the electrical signal in the first phase is greater than the rate of increase of the amplitude of the electrical signal in the second phase.

5. The alternating field therapy device according to claim 4, characterized in that, In the first stage, over a period of 2% to 20% of the entire cycle, the electrical signal amplitude rises from its lowest point to 70% to 90% of its peak value; and / or In the second phase, over 10% to 90% of the entire cycle, the electrical signal amplitude increases from 70% to 90% of the peak value to 100%; and / or During the descent phase, within 5% of the entire cycle, the current drops from 100% of its peak value to its lowest point.

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 following the rising phase and immediately preceding the falling phase.

7. The alternating field therapy device according to claim 1, characterized in that, The falling phase immediately follows the rising phase, such that the falling phase begins after the electrical signal amplitude reaches its peak value during the rising 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 constant.

10. The alternating field therapy device according to claim 1, characterized in that, It includes a substrate, a first main body located on the first side of the front end of the substrate, and a second main body located on the second side of the front end of the substrate. The alternating field therapy device also has a battery compartment for battery insertion. A notch is formed above the second body, which is surrounded by the front end of the base, one side of the first body and the upper part of the second body. The notch is used for 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 the side away from the first body towards the first body, forming a space for hand gripping and forming open ends on both sides of the alternating field treatment 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. The alternating field therapy device according to claim 2 or 3, characterized in that, The cubic logarithmic polynomial is established by the following formula: y = ax 3 +bx 2 +cx, x = log(t + d) Where y represents current, t represents time, and a, b, c, and d are adjustable coefficients.

14. An alternating field therapy device, characterized in that, It includes an alternating field therapy device as described in any one of claims 1-13 and one or more pairs of electrodes, each of the electrode pairs being subjected to the same or different alternating current signals through the alternating field therapy device to generate an alternating electric field in the target therapeutic body.

15. The alternating field therapy device according to claim 14, characterized in that, The alternating field therapy device also includes a controller that is communicatively connected to the signal generator, and the signal generator periodically sends alternating current signals to one or more pairs of electrodes under the action of the controller.

16. An alternating field therapy system, characterized in that, It includes the alternating field therapy device as described in any one of claims 1-13, and a combination of any one or more of the following: In one or more pairs of electrodes, adapters, power adapters, and battery charging docks; 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 supply power to the alternating field therapy device in conjunction with a power supply, and the battery charging dock is used to charge the battery used by the alternating field therapy device.

17. A method for controlling the output of an electrical signal to generate an alternating electric field in a target region, characterized in that, The method is applied to the alternating field therapy device as described in any one of claims 1-13.

18. An electronic device, characterized in that, The electronic device includes a processor for executing instructions to implement the method for controlling electrical signal output as described in claim 17.

Images