Wearable transcutaneous electric field stimulation systems, devices and equipment

Abstract

The present application discloses a wearable transcutaneous electric field stimulation system, device, and apparatus. The system includes: a wearable module, an electrode module, and a control module, wherein: the wearable module is configured to be worn on a target subject; the control module is configured to obtain first disease condition data, first body data, and a desired treatment target; formulate a first stimulation plan based on these data; determine a first control instruction corresponding to the first stimulation plan; the electrode module is configured to operate according to the first control instruction and generate a corresponding alternating electric field in the target subject's body, stimulating the target subject through the alternating electric field; the control module is further configured to obtain second disease condition data and second body data; determine whether the desired treatment target has been achieved; and if not, adjust the first stimulation plan to obtain a second stimulation plan. Using the embodiments of the present application, a personalized stimulation plan can be formulated.

Description

Technical Field

[0001] The present application relates to the field of medical technology, and in particular to a wearable transcutaneous electric field stimulation system, device and equipment. Background Art

[0002] Studies have found that medium-frequency alternating electric fields acting on polar structures (such as microtubules) during cell division can cause spindle instability, thereby preventing cancer cells from undergoing mitosis, abnormal division or delayed division, thereby achieving therapeutic purposes.

[0003] Currently, transcutaneous electric field stimulation devices can be used to generate medium-frequency alternating electric fields to treat cancer patients. However, traditional transcutaneous electric field stimulation devices usually use fixed treatment parameters and modes for patients with different physical conditions, ages, and medical conditions. They are unable to develop personalized stimulation plans based on the patient's actual conditions, resulting in poor treatment effects and may even cause negative treatment effects. Therefore, how to develop personalized stimulation plans has become an urgent problem to be solved. Summary of the Invention

[0004] The embodiments of the present application provide a wearable transcutaneous electric field stimulation system, device, and equipment that can formulate personalized stimulation plans.

[0005] In a first aspect, an embodiment of the present application provides a wearable transcutaneous electric field stimulation system, the system comprising: a wearable module, an electrode module, and a control module, wherein:

[0006] The wearable module is used to be worn on the target object, so that the system acts on the target object in a wearable manner;

[0007] The control module is configured to obtain first condition data, first body data, and a desired treatment target of the target subject; formulate a first stimulation plan based on the first condition data, the first body data, and the desired treatment target; and determine a first control instruction corresponding to the first stimulation plan;

[0008] The electrode module is configured to operate according to the first control instruction and generate a corresponding alternating electric field in the target object, thereby stimulating the target object through the alternating electric field;

[0009] The control module is also used to obtain second medical condition data and second body data of the target object after the electrode module stimulates the target object through the alternating electric field; determine whether the desired treatment goal is achieved based on the first medical condition data and the second medical condition data; if not, adjust the first stimulation scheme based on the second medical condition data and the second body data to obtain a second stimulation scheme; the second stimulation scheme is used to perform a new round of transcutaneous electric field stimulation on the target object to achieve the desired treatment goal.

[0010] In a second aspect, an embodiment of the present application provides a wearable transcutaneous electric field stimulation device, which includes the wearable transcutaneous electric field stimulation system as described in the first aspect.

[0011] In a third aspect, an embodiment of the present application provides a wearable transcutaneous electric field stimulation device, which includes the wearable transcutaneous electric field stimulation apparatus as described in the second aspect, or the wearable transcutaneous electric field stimulation system as described in the first aspect.

[0012] The implementation of this application has the following beneficial effects:

[0013] It can be seen that the wearable transcutaneous electric field stimulation system described in this application collects the medical condition data and physical data of the target object (i.e., the patient) through the control module, and analyzes it in combination with the desired treatment goals to generate a stimulation plan that is consistent with the actual situation of the target object. That is, the wearable transcutaneous electric field stimulation system described in this application can formulate personalized stimulation plans. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the background technology, the drawings required for use in the embodiments of the present application or the background technology will be described below.

[0015] Figure 1 This is an application scenario diagram of a wearable transcutaneous electric field stimulation system provided in an embodiment of the present application;

[0016] Figure 2 1 is a schematic structural diagram of a wearable transcutaneous electric field stimulation system provided in an embodiment of the present application;

[0017] Figure 3 is a schematic structural diagram of another wearable transcutaneous electric field stimulation system provided in an embodiment of the present application;

[0018] Figure 4 This is a schematic diagram of the structure of a control module provided in an embodiment of the present application;

[0019] Figure 5This is a flow chart of a method for determining a first stimulation scheme provided in an embodiment of the present application;

[0020] Figure 6 1 is a flow chart of a method for determining a target tolerance provided in an embodiment of the present application;

[0021] Figure 7 This is a flow chart of a method for determining target difference provided in an embodiment of the present application;

[0022] Figure 8 This is a structural diagram of an electrode module provided in an embodiment of the present application. DETAILED DESCRIPTION

[0023] In order to enable those skilled in the art to better understand the present invention, the following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0024] The terms "first," "second," and the like in the specification and claims of this application and the accompanying drawings are used to distinguish between different objects, not to describe a particular order. Furthermore, the terms "including," "having," and any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or apparatus comprising a series of steps or elements is not limited to the listed steps or elements but may optionally include steps or elements not listed, or may optionally include other steps or elements inherent to the process, method, product, or apparatus.

[0025] It should be understood that the term "and / or" in this document is merely a description of the association relationship between associated objects, indicating that three relationships can exist. For example, A and / or B can represent three situations: A exists alone, A and B exist simultaneously, and B exists alone. In addition, the character " / " in this document indicates that the associated objects are in an "or" relationship. The "plurality" appearing in the embodiments of this application refers to two or more.

[0026] In the embodiments of the present application, "at least one item" or similar expressions refers to any combination of these items, including any combination of single items or plural items, and refers to one or more, and multiple refers to two or more. For example, at least one item (item) of a, b, or c can represent the following seven situations: a, b, c, a and b, a and c, b and c, a, b, and c. Among them, each of a, b, and c can be an element or a set containing one or more elements.

[0027] The "connection" appearing in the embodiments of the present application refers to various connection methods such as direct connection or indirect connection to achieve communication between devices, and the embodiments of the present application do not impose any limitations on this.

[0028] References herein to "embodiments" mean that a particular feature, structure, or characteristic described in connection with the embodiments may be included in at least one embodiment of the present application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor does it constitute an independent or alternative embodiment that is mutually exclusive of other embodiments. It is understood, both explicitly and implicitly, by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0029] The following describes the relevant contents, concepts, meanings, technical issues, technical solutions, beneficial effects, etc. involved in the embodiments of this application.

[0030] First, some professional terms involved in this application are explained:

[0031] Alternating electric field: refers to an electric field whose direction and intensity change periodically over time. Its electric field vector changes alternately between positive and negative directions, usually in the form of a sine wave, square wave, or other periodic waveform, with a common frequency range of 100 Hz to 300 kHz. It is generated between electrodes through alternating current. The periodic change in the direction of the electric field can avoid ion deposition and tissue damage caused by direct current, while being able to penetrate the skin and act on deep tissues. Its frequency-dependent biological effects are utilized, such as high-frequency alternating electric fields can interfere with the mitosis of cancer cells, and low-frequency alternating electric fields can regulate the conduction of neural electrical signals. In transcutaneous electric field stimulation, alternating electric fields can penetrate the skin in a non-invasive manner, generating induced currents in tissues within the body, thereby stimulating nerves, muscles, or other tissues.

[0032] Transcutaneous electric field stimulation (TEFS) is a non-invasive physical therapy that applies an alternating electric field through electrodes placed on the skin. This field penetrates the skin and subcutaneous tissue, stimulating or regulating target tissues in the body (such as nerves, muscles, and tumor cells). The electric field affects cell membrane potential, altering ion channel permeability, thereby regulating cell excitability (such as in nerve stimulation) or interfering with cell division (such as in tumor treatment). It does not require surgical implantation, thus avoiding the risk of infection. Furthermore, personalized treatment can be achieved by adjusting electric field parameters (frequency, intensity, and waveform).

[0033] The stimulation parameters of transcutaneous electric field stimulation refer to the key physical quantities used to regulate the effects of transcutaneous electric field stimulation, which may mainly include: electric field intensity, frequency, waveform, stimulation duration, current intensity, electrode position and distribution, etc., which are not limited here.

[0034] Skin impedance: This refers to the resistance created by the skin to the passage of electric current. Composed of both resistance and capacitance, it reflects the skin's conductivity characteristics for electrical signals. Resistance is primarily generated by the skin's stratum corneum (the outermost layer of dead cells). When the stratum corneum has low water content, the resistance is high (up to tens of thousands of ohms), and decreases when it is moist or damaged. Capacitance, formed by the dielectric properties of various layers of skin tissue (such as the stratum corneum and living cell layer), can store and release charge and is more sensitive to the high-frequency components of alternating electric fields. In this application, skin impedance is a key parameter for adjusting current intensity, as varying impedance can lead to uneven current distribution across the skin's surface. Dynamically compensating for impedance differences can make the current intensity in the target area more precise, enhancing the stimulation effect and reducing risks such as localized overheating.

[0035] See also Figure 1 , Figure 1 This is an application scenario diagram of a wearable transcutaneous electric field stimulation system (hereinafter referred to as the system) provided in an embodiment of the present application. It can be seen that the system may include: a wearable module, a control module, and an electrode module, wherein:

[0036] The control module communicates or is physically connected with the electrode module, and the electrode module is also physically connected with the wearable module. The electrode module may include: a first stimulation electrode S1, a second stimulation electrode S2, a third stimulation electrode S3, and a fourth stimulation electrode S4; the wearable module may include a first strap P1 and a second strap P2, through which the electrode module can be tied to the target object (for example, the back or chest), and then the four stimulation electrodes in the electrode module can be set on the back area or chest area of ​​the target object; the electrode module is a key component for generating an alternating electric field. It can work according to the instructions issued by the control module to generate a corresponding alternating electric field in the target object, thereby stimulating the target object.

[0037] Figure 1 The bidirectional arrows in indicate that the control module and the electrode module can communicate with each other.

[0038] See also Figure 2 , Figure 2 This is a schematic structural diagram of a wearable transcutaneous electric field stimulation system provided in an embodiment of the present application; it can be seen that the system includes: a wearable module, an electrode module, and a control module, wherein:

[0039] The wearable module is used to be worn on the target object, so that the system can act on the target object in a wearable form.

[0040] In the embodiment of the present application, the wearable form of the wearable module may include one of the following: strap type, adhesive type, clothing type, headband type, implant type, etc., which is not limited here.

[0041] In a specific embodiment, the target subject can actively wear the wearable module on the body so that the system can be fixed on the surface of the human body to facilitate subsequent stimulation.

[0042] For example, assuming that the wearable module can be worn in a strap-type form, then the wearable module can be composed of an elastic or adjustable length strap, such as an elastic rubber strap, a Velcro strap, etc., by wrapping the strap around specific parts of the body (such as the wrist, ankle, waist, shoulder, etc.), and using the elasticity of the strap or the adjustment buckle to adjust the tightness, thereby fixing the electrode module and other components in the appropriate position. The strap-type is suitable for stimulation of the limbs, torso and other parts. The advantage is that it is easy and quick to wear, and the tightness can be adjusted according to the individual body shape to ensure that the electrode fits closely to the skin and the electric field stimulation effect is guaranteed. At the same time, it has low cost and is easy to produce and replace. For example, a transcutaneous electric field stimulation system for wrist nerve stimulation can be fixed on the wrist through a strap-type wearable module.

[0043] For another example, assuming that the wearable module can be worn in the form of clothing, then the wearable module can be specific clothing (such as vests, sleeves, socks, etc.) or protective gear (such as wrist guards, knee pads, etc.), and the electrode module can be integrated into the clothing or protective gear. The material of the clothing or protective gear is mostly breathable, soft and elastic fabric, which not only ensures the comfort of wearing, but also provides stable support for the electrodes. The clothing type is suitable for situations where transcutaneous electric field stimulation is performed on a large area or multiple parts at the same time, and for treatments that require long-term continuous stimulation. For example, for rehabilitation treatment of large-area muscle strain, patients can wear a vest with integrated electrodes for treatment. The advantage is that it is comfortable to wear, convenient for patients' daily activities, and can cover a larger treatment area. At the same time, it can also be designed according to ergonomics to better fit the body curve.

[0044] The control module is used to obtain first disease condition data, first body data and expected treatment goals of the target object; formulate a first stimulation plan based on the first disease condition data, first body data and expected treatment goals; and determine a first control instruction corresponding to the first stimulation plan.

[0045] In the embodiment of the present application, the first body data may include at least one of the following: age, body mass index, heart rate, blood pressure, blood oxygen, electrolytes and blood indicators (for example, potassium ion content, liver function indicators), etc., which are not limited here.

[0046] In a specific embodiment, the control module can obtain the first medical condition data, first body data and expected treatment goals of the target object. Specifically, the control module can use an interface import method to obtain these data. For example, the control module can include a remote interface, through which it is connected to the hospital information system or electronic medical record system of the target hospital, and obtain structured data (such as disease diagnosis, disease stage, imaging report) from the hospital information system or electronic medical record system. Then, the medical condition data and body data of the target object can be extracted from these structured data to obtain the first medical condition data and first body data.

[0047] Next, the target user can input the desired treatment goal into the control module. For example, the desired treatment goal can be "tumor volume reduction by 20%"; then, these data can be analyzed to formulate a stimulation plan that meets the actual situation of the target object to obtain a first stimulation plan; then, the first control instruction corresponding to the first stimulation plan can be determined. Specifically, the various stimulation parameters included in the first stimulation plan (for example, electric field frequency, electric field strength, electric field duration, etc.) can be obtained first, and these various stimulation parameters can be compiled into a first control instruction according to a specific data format (for example, JSON format).

[0048] It should be explained that the target hospital is the hospital where the target subject is treated; the target user may be the doctor who treats the target subject.

[0049] Optional, see Figure 3 , Figure 3 is a schematic structural diagram of another wearable transcutaneous electric field stimulation system provided in an embodiment of the present application, such as Figure 3 As shown, it can be seen that the system includes not only a wearable module, a control module and an electrode module, but also a battery module, wherein the battery module is used to power the system.

[0050] In one embodiment, see Figure 4 , Figure 4 This is a schematic diagram of the structure of a control module provided in an embodiment of the present application. It can be seen that the control module may include: a processing unit, a display unit, an interaction unit, an interface unit, an alarm unit, and a data recording unit, wherein:

[0051] The processing unit can be an industrial-grade embedded CPU, which can be used to process and analyze the first disease data, the first body data and the desired treatment target to obtain a first stimulation plan. In addition, it can also calculate and adjust the output waveform, voltage, current and other stimulation parameters of the electrode module in real time.

[0052] The display unit can be a small-sized LCD or OLED screen, which can be used to display information such as the treatment time, electrode connection status, battery power, warning information, and the first stimulation plan of the target object, which is not limited here.

[0053] The interactive unit is used to interact with the target user or target object. For example, the interactive unit may include a one-touch switch button, a restart button, a confirmation button, etc. The target user activates different functions by clicking different buttons, such as turning on the system, turning off the system, and confirming the stimulation parameters.

[0054] The interface unit includes an output interface and a battery interface. The output interface is used to connect the output wire; the battery interface is used to connect to the battery module; the output interface and the battery interface can both be waterproof sockets.

[0055] The alarm unit may include a buzzer and / or an indicator light. The alarm unit is used to issue a corresponding alarm when the system is abnormal (for example, electrode detachment, skin overheating, low battery, etc.). For example, when the system battery is low, the indicator light can emit a red light to alarm. For example, when the skin is overheated, the buzzer can emit a high-frequency beep to alarm.

[0056] The data recording unit is used to record the data generated by the system during operation, such as the daily usage time of the system, electrode replacement time, current and voltage, etc.

[0057] In one embodiment, the above system may also have the following functions:

[0058] Automatic calibration: Automatically detect the connection status between the electrode module and the control module, the electrode resistance and the system temperature when the device is turned on to ensure normal operation of the device.

[0059] Temperature control protection: When the electrode temperature exceeds the preset temperature threshold, the system output power is automatically limited to prevent skin burns.

[0060] Electrode monitoring: If electrode detachment is detected, an alarm will be issued immediately and the output will be suspended to avoid treatment interruption or safety hazards.

[0061] Data management: Record full-cycle treatment data to support subsequent efficacy review and program optimization.

[0062] Security lock: It has protection against misoperation and supports password setting to improve safety.

[0063] Optional, see Figure 5 , Figure 5This is a flow chart of a method for determining a first stimulation scheme provided in an embodiment of the present application. It can be seen that in formulating the first stimulation scheme based on the first condition data, the first body data, and the desired treatment goal, the control module is specifically configured to perform the following steps:

[0064] A1. Determine the disease suffered by the target subject based on the first disease condition data to obtain a target disease;

[0065] A2. Acquire first historical stimulation data corresponding to the target disease; the first historical stimulation data includes m stimulation data, each stimulation data being stimulation data of a human body receiving electric field stimulation for the first time; m is a positive integer;

[0066] A3. determining a reference stimulation scheme based on the first historical stimulation data and the desired treatment goal;

[0067] A4. Determine the body data corresponding to each stimulus data in the first historical stimulus data to obtain m body data;

[0068] A5. Determine a target difference based on the first body data and the m body data;

[0069] A6. Adjust the reference stimulation scheme according to the target difference to obtain the first stimulation scheme.

[0070] In the embodiments of the present application, the target disease may include at least one of the following: glioblastoma, lung cancer, breast cancer, etc., which are not limited here.

[0071] In a specific embodiment, the disease suffered by the target object can be determined based on the first disease data to obtain the target disease. Specifically, the first disease data may include the medical history of the target object, and the target disease can be determined based on the medical history. Then, the first historical stimulation data corresponding to the target disease can be obtained. Specifically, the data screening rules can be determined first. For example, the data screening rules can be "query for stimulation data of patients with the target disease who underwent transcutaneous electric field stimulation for the first time". Then, structured query conditions can be formulated based on the data screening rules. For example, the structured query conditions can be "WHERE disease diagnosis = target disease AND treatment record type = "first electric field stimulation" AND stimulation parameters are complete". According to the structured query conditions, queries are performed from multiple data sources (for example, medical institution databases, scientific research databases, public health databases, etc.) to obtain stimulation data that meets the query conditions, that is, the first historical stimulation data.

[0072] Then, based on the first historical stimulation data and the desired treatment target, an analysis can be performed to generate a reference stimulation scheme. Then, the body data corresponding to each stimulation data in the first historical stimulation data can be determined to obtain m body data. Then, the difference between the first body data and the m body data can be calculated to obtain a target difference. Finally, the reference stimulation scheme can be adjusted according to the target difference to obtain a first stimulation scheme. Specifically, the reference stimulation scheme may include a reference electric field frequency and a reference electric field strength, and the reference electric field frequency and the reference electric field strength are adjusted according to the target difference, as follows:

[0073] f1=f_ref×(1+kf×D);

[0074] E1=E_ref×(1+ke×D)×γ;

[0075] Among them, f1 is the first electric field frequency, E1 is the first electric field strength, f_ref is the reference electric field frequency, E_ref is the reference electric field strength, kf is the preset frequency adjustment coefficient (for example, in tumor treatment, the value range of kf is 0.1~0.2, and in neuroregulation, the value range of kf is 0.05~0.1), ke is the preset intensity adjustment coefficient (usually, the value range of ke is 0.2~0.3), D is the target difference, and γ is the safety correction factor; according to the above formula, the first electric field frequency and the first electric field strength can be obtained, and this first electric field frequency and the first electric field strength constitute the first stimulation plan.

[0076] It should be explained that the safety correction factor γ = max (0.8, 1-0.5×D heat ), where D heat is the thermal effect difference, and the max operator represents the maximum value. The thermal effect difference refers to a quantitative indicator of the difference in thermal effect (degree of heat production) generated by different subjects when receiving electric field stimulation due to differences in electric field parameters (such as frequency and intensity), human tissue characteristics (such as conductivity and thickness), or individual physiological states during transcutaneous electric field stimulation. Since the calculation of the thermal effect difference is an existing technology, it will not be described in detail here.

[0077] In this way, by obtaining the first historical stimulation data of the target disease, the reference stimulation plan can be established on the basis of real clinical cases. For example, if the target disease is glioblastoma, the historical data can provide the frequency, intensity and other parameter distributions of similar patients when they first receive electric field therapy, reflecting the treatment rules of similar diseases. The effective parameter range can be directly reused to reduce the trial and error cost, which is especially suitable for complex cases with a lack of direct clinical experience.

[0078] In addition, by adjusting the reference stimulation scheme according to the target difference, the essence is to correct the parameters individually. For example, if the target difference shows that the patient's tissue heat dissipation ability is poor (such as the average heat dissipation coefficient of similar patients in historical data is 1.0, while the target object is 0.8), the electric field strength can be reduced to reduce the risk of thermal damage.

[0079] Optionally, in determining a reference stimulation scheme according to the first historical stimulation data and the desired treatment goal, the control module is specifically configured to perform the following steps:

[0080] B1. Determine a stimulation scheme and an actual treatment index corresponding to each stimulation data in the first historical stimulation data, and obtain m first historical stimulation schemes and m actual treatment indexes;

[0081] B2. Determine the difference between each of the m actual treatment indicators and the expected treatment indicator, to obtain m differences; the expected treatment indicator is the treatment indicator corresponding to the expected treatment goal;

[0082] B3. adjusting corresponding first historical stimulation schemes among the m first historical stimulation schemes according to the m differences to obtain m second historical stimulation schemes; each second historical stimulation scheme includes an electric field frequency and an electric field intensity;

[0083] B4. determining the average electric field frequency and average electric field intensity corresponding to the m second historical stimulation schemes;

[0084] B5. Acquire second historical stimulation data corresponding to the target object;

[0085] B6. determining a target tolerance based on the second historical stimulation data;

[0086] B7. determining a target adjustment factor corresponding to the target tolerance;

[0087] B8. adjusting the average electric field strength according to the target adjustment factor to obtain a reference electric field strength;

[0088] B9. Determine the reference stimulation scheme based on the average electric field frequency and the reference electric field strength.

[0089] In the embodiment of the present application, the treatment indicators may include at least one of the following: cancer cell apoptosis rate, tumor volume change rate, liver and kidney function parameters (e.g., serum creatinine), immune cell activation rate, etc., which are not limited here.

[0090] In a specific embodiment, the stimulation scheme and actual treatment index corresponding to each stimulation data in the first historical stimulation data can be determined to obtain m first historical stimulation schemes and m actual treatment indexes. Specifically, for each stimulation data, the data can be first standardized and cleaned. For example, the recording format of the stimulation parameters is unified (for example, the frequency unit is unified as kHz, and the intensity unit is unified as V / cm), invalid data with a parameter missing rate greater than 30% is eliminated, and the specific values ​​of ambiguous records (for example, "medium-intensity electric field") are supplemented through historical treatment logs or doctor's notes (for example, the intensity is inferred to be 1.2 V / cm through the records of the equipment during the same period). Then, the stimulation parameters can be extracted from the stimulation data to obtain multiple stimulation parameters, and these multiple stimulation parameters are filled into a preset stimulation scheme template to form a standardized stimulation scheme (that is, a historical stimulation scheme). For example, a standardized stimulation scheme can be "200 kHz, 1.1 V / cm, 3 h / time, 2 times / day, 28 days, bilateral temporal lobes, 4 electrodes". In this way, m first historical stimulation schemes can be obtained.

[0091] Similarly, for each stimulation data, the patient's treatment index after one week (or one month) of stimulation can be obtained to obtain the actual treatment index. For example, the actual treatment index can be the tumor volume change rate. Each stimulation data can include an imaging report. The first volume before stimulation and the second volume after stimulation can be extracted from the imaging report. The calculation is performed based on the first volume and the second volume as follows:

[0092] Tumor volume change rate = (second volume - first volume) / first volume × 100%;

[0093] According to the above formula, the tumor volume change rate can be determined. For example, assuming that "the tumor volume drops from 12 square centimeters to 8 square centimeters", the tumor volume change rate is -33%, that is, the tumor volume drops by 33%. In this way, m actual treatment indicators can be obtained; then, the difference between each actual treatment indicator and the expected treatment indicator among the m actual treatment indicators can be determined to obtain m differences. Specifically, the expected treatment indicator can be subtracted from the m actual treatment indicators to obtain m differences.

[0094] Then, the corresponding first historical stimulation schemes in the m first historical stimulation schemes can be adjusted according to the m difference values ​​to obtain m second historical stimulation schemes. Specifically, the mapping relationship between the preset difference values ​​and the adjustment parameters can be pre-stored, and the m adjustment parameters corresponding to the m difference values ​​can be determined based on the mapping relationship. The corresponding first historical stimulation schemes in the m first historical stimulation schemes can be adjusted according to the m adjustment parameters to obtain m second historical stimulation schemes.

[0095] Next, the average electric field frequency and average electric field strength corresponding to the m second historical stimulation schemes can be determined. Specifically, the m electric field frequencies and m electric field strengths corresponding to the m second historical stimulation schemes can be determined first, and the average value of the m electric field frequencies can be calculated to obtain the average electric field frequency. Similarly, the average value of the m electric field strengths can be calculated to obtain the average electric field strength. Next, the second historical stimulation data corresponding to the target object can be obtained. Specifically, the stimulation data of the target object can be obtained from the hospital information system of the target hospital to obtain the second historical stimulation data.

[0096] Next, a target tolerance can be determined based on the second historical stimulation data; then, a target adjustment factor corresponding to the target tolerance can be determined. For example, a mapping relationship between a preset tolerance and an adjustment factor can be pre-stored, and the target adjustment factor corresponding to the target tolerance can be determined based on the mapping relationship, wherein the target adjustment factor can have a value range of -0.25 to 0.25; then, the average electric field strength is adjusted according to the target adjustment factor, as follows:

[0097] Reference electric field strength = average electric field strength × (1 + target adjustment factor);

[0098] According to the above formula, the reference electric field strength can be obtained; finally, the reference stimulation scheme can be constructed by the average electric field frequency and the reference electric field strength.

[0099] In this way, by calculating the difference between the treatment index and the expected index of each historical stimulation data (for example, the expected tumor reduction rate is 50%, and a historical plan only reaches 30%, the difference is -20%), and adjusting the stimulation parameters of the plan accordingly (for example, increasing the electric field intensity or adjusting the frequency), the "empirical adjustment" is transformed into "goal-oriented precise optimization" by mathematically quantifying the gap, thereby improving the accuracy of the stimulation.

[0100] Optional, see Figure 6 , Figure 6 is a flow chart of a method for determining a target tolerance provided by an embodiment of the present application. It can be seen that in determining the target tolerance based on the second historical stimulation data, the control module is specifically configured to perform the following steps:

[0101] C1. determining the historical number of stimulations and the historical average stimulation duration of the target object based on the second historical stimulation data;

[0102] C2. determining a target total stimulation duration based on the historical number of stimulations and the historical average stimulation duration;

[0103] C3. Determining a first tolerance corresponding to the target total stimulation duration;

[0104] C4. Acquire historical electric field intensity data in the second historical stimulation data;

[0105] C5. Sampling the historical electric field strength data to obtain n electric field strength values ​​and n sampling times; each electric field strength value corresponds to one sampling time; n is an integer greater than 1;

[0106] C6. Determine the target mean square error corresponding to the n electric field strength values;

[0107] C7. Performing straight line fitting based on the n electric field strength values ​​and the n sampling times to obtain a target straight line, wherein the abscissa of the target straight line is time and the ordinate is the electric field strength value;

[0108] C8. determining a target slope of the target straight line;

[0109] C9. Determine a second tolerance corresponding to the target slope;

[0110] C10. Determine a target optimization factor corresponding to the target mean square error;

[0111] C11. Optimizing the second tolerance according to the target optimization factor to obtain a third tolerance;

[0112] C12. Determine the target tolerance according to the first tolerance and the third tolerance.

[0113] In an embodiment of the present application, the historical number of stimulations and the historical average stimulation duration of the target object are determined based on the second historical stimulation data. Specifically, the second historical stimulation data can be counted to determine the number of data contained in the second historical stimulation data, that is, the historical number of stimulations. Then, the stimulation duration of each stimulation in the historical number of stimulations can be obtained to obtain multiple stimulation durations, and the average value of these multiple stimulation durations, that is, the historical average stimulation duration, is calculated.

[0114] Then, the target total stimulation duration can be determined based on the historical number of stimulations and the historical average stimulation duration. Specifically, the historical number of stimulations and the historical average stimulation duration can be multiplied to obtain the target total stimulation duration; then, the first tolerance corresponding to the target total stimulation duration can be determined. For example, a mapping relationship between a preset total stimulation duration and tolerance can be pre-stored, and the first tolerance corresponding to the target total stimulation duration can be determined based on the mapping relationship; then, the historical electric field strength data in the second historical stimulation data can be obtained. Specifically, all electric field strength data in the second historical stimulation data can be extracted to obtain historical electric field strength data; then, the historical electric field strength data can be sampled based on a preset sampling interval to obtain n electric field strength values ​​and n sampling times; the preset sampling interval can be preset or defaulted in advance, for example, the preset sampling interval can be 1 hour.

[0115] Furthermore, the mean square error of the n electric field strength values ​​can be calculated to obtain a target mean square error; then, a straight line fitting can be performed based on the n electric field strength values ​​and the n sampling times to obtain a target straight line. Specifically, the n electric field strength values ​​and the corresponding sampling times in the n sampling times can be combined as coordinate points to obtain n coordinate points. Then, a straight line fitting method (for example, least squares method, robust fitting method, maximum likelihood estimation, etc.) is used to fit the n coordinate points to obtain a target straight line.

[0116] Next, the target slope of the target straight line can be determined. Specifically, the linear equation of the target straight line y=jx+b can be obtained, where j is the target slope and b is the intercept of the target straight line. The target slope can be extracted from the linear equation; then, the second tolerance corresponding to the target slope can be determined. For example, a mapping relationship between a preset slope and tolerance can be pre-stored, and the second tolerance corresponding to the target slope can be determined based on the mapping relationship.

[0117] Then, the target optimization factor corresponding to the target mean square error can be determined. Similarly, a mapping relationship between a preset mean square error and an optimization factor can be pre-stored, and the target optimization factor corresponding to the target mean square error can be determined based on the mapping relationship. The value range of the target optimization factor can be -0.2 to 0.2. Then, the second tolerance can be optimized according to the target optimization factor, as follows:

[0118] Third tolerance = second tolerance × (1 + target optimization factor);

[0119] According to the above formula, the third tolerance can be obtained; finally, the target tolerance can be determined according to the first tolerance and the third tolerance. Specifically, the average value of the first tolerance and the third tolerance can be calculated and used as the target tolerance.

[0120] In one embodiment, in determining the target tolerance level according to the first tolerance level and the third tolerance level, the control module may be configured to perform the following steps:

[0121] Obtain the target treatment stage of the target object at the current moment; determine the first reference weight corresponding to the first tolerance and the second reference weight corresponding to the third tolerance according to the target treatment stage. The target treatment stage may include one of the following: induction stage, consolidation stage, and maintenance stage. For example, in the induction stage, it is necessary to quickly establish effective intensity to avoid early intolerance. The first reference weight may be 0.4, and the second reference weight may be 0.6; in the consolidation stage, it is necessary to ensure sustained effect and control adverse reactions. The first reference weight may be 0.6, and the second reference weight may be 0.4; in the maintenance stage, it is necessary to maintain long-term efficacy and prioritize safety. The first reference weight may be 0.7, and the second reference weight may be 0.3.

[0122] Next, the abnormal stimulation data in which the stimulation object has an adverse reaction in the first historical stimulation data can be determined, and s abnormal stimulation data can be obtained, where s is an integer greater than 1. Specifically, each stimulation data in the first historical stimulation data can be traversed to find the abnormal stimulation data in which the stimulation object has an adverse reaction, thereby obtaining s abnormal stimulation data.

[0123] Then, the abnormal cause corresponding to each abnormal stimulation data in the s abnormal stimulation data is determined, and s abnormal causes are obtained. Each abnormal cause includes one of the following: the stimulation time is too long, the electric field strength is too large. Specifically, for each abnormal stimulation data, its corresponding stimulation duration and electric field strength can be obtained. If only the stimulation duration is greater than the preset duration threshold, the abnormal cause is determined to be that the stimulation time is too long; if only the electric field strength is greater than the preset electric field strength threshold, the abnormal cause is determined to be that the electric field strength is too large; if the stimulation duration is greater than the preset duration threshold, and the electric field strength is greater than the preset electric field strength threshold, first determine whether the "intensity acute risk" is triggered (for example, an electric field strength greater than 2.5V / cm may immediately cause muscle twitching). If triggered, the abnormal cause is determined to be that the electric field strength is too large; if not triggered, it can be determined that the abnormal cause is that the stimulation time is too long.

[0124] Then, the first number among the s abnormal reasons, in which the abnormal reason is that the stimulation time is too long, and the second number, in which the abnormal reason is that the electric field intensity is too large, can be found; the target ratio is obtained by dividing the first number by the second number, and then the weight adjustment factor corresponding to the target ratio can be determined. For example, the mapping relationship between the preset ratio and the adjustment factor can be pre-stored, and the weight adjustment factor corresponding to the target ratio is determined based on the mapping relationship, wherein the value range of the weight adjustment factor can be -0.12~0.12; the first reference weight is adjusted according to the target weight adjustment factor to obtain the first target weight, and then, the first target weight is subtracted from 1 to obtain the second target weight, and finally, a weighted operation is performed based on the first target weight, the second target weight, the first tolerance and the third tolerance to obtain the target tolerance.

[0125] In this way, by deriving the first tolerance through the target total stimulation duration, the basic impact of long-term treatment on tolerance can be quantified, avoiding insufficient or excessive intensity of the program due to ignoring the cumulative effect. In addition, by adjusting the second tolerance through the mean square error, the tolerance misjudgment caused by data fluctuations can be corrected, thereby improving the reliability of the final target tolerance. For example, if the mean square error is high, it means that the tolerance assessment needs to be more cautious, and the optimization factor will reduce the third tolerance to avoid the electric field intensity of the stimulation program being too high.

[0126] Optional, see Figure 7 , Figure 7is a flow chart of a method for determining a target difference provided by an embodiment of the present application. It can be seen that in determining the target difference based on the first body data and the m body data, the control module is specifically configured to:

[0127] D1. Determine a difference between the first physical data and each of the m physical data to obtain m differences;

[0128] D2. Determine the target time interval corresponding to the m pieces of physical data;

[0129] D3. Divide the target time interval according to preset time intervals to obtain k time intervals, where k is an integer greater than 1;

[0130] D4. Determine a weight corresponding to each of the k time intervals to obtain k weights;

[0131] D5. Place the m differences into the k time intervals to obtain k difference sets;

[0132] D6. Determine the target difference according to the k weights and the k difference sets.

[0133] In the embodiment of the present application, the preset time interval can be preset in advance or defaulted.

[0134] In a specific embodiment, a difference between the first body data and each of the m body data can be calculated to obtain m differences. For example, each body data can be a body mass index. Assuming that the first body data is a first body mass index equal to 22, the second body data is a second body mass index equal to 28, and the second body data is any of the m body data, the first difference between the first body data and the second body data is calculated as follows:

[0135] First difference = (25-21) / 25×100%=16%;

[0136] It can be seen that the first difference is equal to 16%. In this way, by repeating the calculation m times, m differences can be obtained. Then, the target time interval corresponding to the m body data can be determined. Specifically, the collection time of each body data in the m body data can be obtained to obtain m collection times, and the earliest time and the latest time among the m collection times can be determined. The target time interval can be determined based on the earliest time and the latest time. For example, assuming that the earliest time is January 1, 2000, and the latest time is January 10, 2000, then the target time interval is: January 1, 2000 to January 10, 2000; then, the target time interval can be divided into k time intervals according to the preset time interval. For example, the preset time interval can be 2 days, and the target time interval can be divided into 5 time intervals, that is, k=5; then, the weight corresponding to each time interval in the k time intervals can be determined to obtain k weights.

[0137] It should be explained that the sum of the k weights is 1, and the time interval closer to the current moment has a larger corresponding weight.

[0138] Furthermore, m differences can be placed into k time intervals to obtain k difference sets. Specifically, the m acquisition times can be placed into k time intervals first, and then the m differences corresponding to the m acquisition times can be placed into corresponding time intervals in the k time intervals. For example, assuming that a certain acquisition time t1 is equal to January 2, 2000, and t1 falls into the interval from January 1, 2000 to January 2, 2000, then the difference corresponding to t1 also falls into the interval. In this way, after m cycles, all m differences can be placed into k time intervals.

[0139] Finally, the target difference can be determined based on the k weights and the k difference sets. Specifically, the average difference of each of the k difference sets can be calculated to obtain k average differences. Then, a weighted operation can be performed based on the k weights and the k average differences to obtain the target difference.

[0140] It needs to be explained that there can be an empty set among the k difference sets.

[0141] In this way, by dividing m differences into k time intervals according to time to form a difference set, and then calculating the average value of the difference set, the influence of single abnormal data can be weakened through statistics. For example, the mutation data at a certain moment will be classified into the corresponding interval and calculated together with other data to avoid single-point deviation dominating the results.

[0142] The electrode module is configured to operate according to the first control instruction and generate a corresponding alternating electric field in the body of the target object, thereby stimulating the target object through the alternating electric field.

[0143] In an embodiment of the present application, the electrode module can receive a first control instruction issued by the control module and operate according to the first control instruction, thereby generating a corresponding alternating electric field in the target object and stimulating the target object through the alternating electric field.

[0144] Optional, see Figure 8 , Figure 8 This is a structural diagram of an electrode module provided in an embodiment of the present application. It can be seen that the electrode module may include: an electrode housing, a conductive electrode layer, a wire interface, an adhesion layer, and a data acquisition unit; wherein:

[0145] The electrode shell is a flexible patch structure with a preset shape, which is used to fit the skin of the target object; the preset shape can include one of the following: square, circle, diamond, etc., which are not limited here; the circumference of the electrode shell can be 3~10 cm.

[0146] The conductive electrode layer includes a stimulation electrodes; the a stimulation electrodes can be used to emit a medium-frequency alternating electric field of 150~200kHz to uniformly cover the treatment area of ​​the target object; in one embodiment, a can be equal to 4, and the conductive electrode layer is a 2×2 array consisting of 4 stimulation electrodes, where the size of a single electrode can be 2cm×2cm.

[0147] The wire interface can be located at the bottom center of the electrode module, and the wire interface is a waterproof interface; the wire interface is used to connect the output wire; the wire interface receives the control instruction of the control module through the output wire and transmits the control instruction to the conductive electrode layer;

[0148] The adhesive layer has an adhesive function and is used to adhere the electrode module to the skin of the target object. Specifically, the adhesive layer can be a medical-grade adhesive patch (or flexible conductive silicone) that is adapted to different skin types to ensure that the stimulation electrode is firmly attached. It is usually replaced every 3 to 4 days.

[0149] The data acquisition unit may include a temperature sensor and a resistance sensor (equipped with each stimulation electrode). The data acquisition unit can collect the temperature and resistance of each stimulation electrode among a stimulation electrodes to obtain a temperature data and a resistance data; the a temperature data and a resistance data are fed back to the control module to realize feedback adjustment. For example, if the control module finds that there is temperature data greater than a preset temperature threshold (for example, 41 degrees Celsius) among the a temperature data, the current of the corresponding stimulation electrode can be reduced, thereby avoiding local overheating or current abnormality causing skin damage.

[0150] Optionally, the first control instruction includes a first electric field frequency and a first electric field strength; in terms of operating according to the first control instruction, the electrode module is specifically configured to perform the following steps:

[0151] E1. Obtaining the electrode position of each of the a stimulation electrodes on the target object to obtain a electrode positions;

[0152] E2. Determine the skin impedance corresponding to each of the a electrode positions to obtain a skin impedance;

[0153] E3. Acquire the area to be stimulated of the target object;

[0154] E4. Allocating corresponding current intensities to the a stimulation electrodes based on a preset current intensity distribution algorithm, the area to be stimulated, the a electrode positions, and the first electric field strength to obtain a first current intensities;

[0155] E5. Adjusting corresponding first current intensities among the a first current intensities according to the a skin impedances and the a resistances to obtain a second current intensities;

[0156] E6. Determine a fine-tuning factor corresponding to each of the a temperature data to obtain a fine-tuning factor;

[0157] E7. Adjust corresponding second current intensities among the a second current intensities according to the a fine-tuning factors to obtain a third current intensities;

[0158] E8. Control the a stimulation electrodes to operate according to the first electric field frequency and the a third current intensities.

[0159] In the embodiment of the present application, the preset current intensity distribution algorithm can be preset or defaulted in advance.

[0160] In a specific embodiment, each stimulation electrode may include a position sensor and an impedance sensor, and the position sensor of each stimulation electrode among a stimulation electrodes can be used to detect the electrode position of each stimulation electrode on the target object, thereby obtaining a electrode positions; then, the skin impedance corresponding to each electrode position among the a electrode positions can be determined, thereby obtaining a skin impedance. Similarly, the skin impedance of the corresponding electrode position among the above-mentioned a electrode positions can be detected by the impedance sensor of each stimulation electrode, thereby obtaining a skin impedance.

[0161] Next, the area to be stimulated of the target object can be obtained. Specifically, the area to be stimulated can be determined according to the target disease. For example, a mapping relationship between preset diseases and stimulation areas can be pre-stored, and the area to be stimulated corresponding to the target disease can be determined based on the mapping relationship.

[0162] Then, corresponding current intensities can be allocated to a stimulation electrodes based on a preset current intensity allocation algorithm, the area to be stimulated, a electrode positions and the first electric field strength to obtain a first current intensities, each first current intensity corresponding to a stimulation electrode. For example, the preset current intensity allocation algorithm can be a finite element method. A 3D geometric model including skin, muscle, bone, etc. can be constructed based on CT or MRI data of human tissue. Then, measured conductivity can be assigned to different tissue areas in the model (for example, muscle σ=0.2S / m, fat σ=0.05S / m), and a dense grid (for example, 1mm unit) can be divided in the area to be stimulated, and a coarse grid can be divided in the non-to-be-stimulated area to save time. Computing power; obtain a spatial coordinates corresponding to a electrode positions in the model, and then calculate the transfer matrix. Specifically, the following steps can be performed for each stimulation electrode h (the value range of h is 1~a): apply a unit current (for example, 1 mA) to the stimulation electrode k, and set the current of the other stimulation electrodes to 0; solve the Poisson equation to obtain the potential distribution data, and determine the unit electric field vector of the center point (or key point) of the area to be stimulated based on the potential distribution data; in this way, a unit electric field vectors can be obtained, and these a unit electric field vectors can form a transfer matrix K (3×a matrix). Based on the transfer matrix K, a first current intensities can be obtained, as follows:

[0163] E target =K×I;

[0164] Among them, E target is the first electric field strength; I=[I1, I2, ..., I a ] is the current vector to be determined; E target Given a and K, I can be solved. Based on the current vector I to be determined, a first current intensities can be obtained. Then, corresponding first current intensities among the a first current intensities can be adjusted based on a skin impedances and a resistances to obtain a second current intensities.

[0165] Then, a fine-tuning factor corresponding to each of the a temperature data can be determined to obtain a fine-tuning factors. For example, a mapping relationship between preset temperature data and fine-tuning factors can be pre-stored, and the a fine-tuning factors corresponding to the a temperature data can be determined based on the mapping relationship, where each fine-tuning factor can have a value range of -0.15 to 0.15. Then, the corresponding second current intensities of the a second current intensities can be adjusted according to the a fine-tuning factors, as follows:

[0166] Target third current intensity = target second current intensity × (1 + target fine-tuning factor);

[0167] Among them, the target second current intensity is any second current intensity among a second current intensities; the target fine-tuning factor is the fine-tuning factor corresponding to the target second current intensity among a fine-tuning factors; the target third current intensity is the third current intensity corresponding to the target second current intensity; according to the above formula, by calculating a times, a third current intensities can be obtained.

[0168] Finally, a stimulation electrodes can be controlled to work according to the first electric field frequency and a third current intensities. Taking the target stimulation electrode as an example, the target stimulation electrode is any stimulation electrode among the a stimulation electrodes. The target third current intensity corresponding to the target stimulation electrode among the a third current intensities can be determined first, and the target stimulation electrode can be controlled to work at the first electric field frequency and the target third current intensity.

[0169] By measuring the skin impedance at each electrode location, the current intensity can be adjusted based on Ohm's law to compensate for current attenuation caused by impedance differences. For example, the current intensity is increased in areas with high impedance to ensure that the actual electric field strength is consistent across all areas, avoiding variations in stimulation effect caused by uneven impedance.

[0170] The control module is also used to obtain second condition data and second body data of the target object after the electrode module stimulates the target object through an alternating electric field; determine whether the desired treatment goal is achieved based on the first condition data and the second condition data; if not, adjust the first stimulation scheme based on the second condition data and the second body data to obtain a second stimulation scheme; the second stimulation scheme is used to perform a new round of transcutaneous electric field stimulation on the target object to achieve the desired treatment goal.

[0171] In an embodiment of the present application, the control module is also used to obtain second disease condition data and second body data of the target object after the electrode module stimulates the target object through an alternating electric field. Specifically, the target object's body can be scanned and examined by medical detection equipment (for example, CT, MRI, ultrasound, PET-CT, etc.) to obtain examination data, and the second disease condition data and second body data can be obtained from the examination data.

[0172] Then, whether the expected treatment goal is achieved can be determined based on the first condition data and the second condition data. Specifically, a first condition index can be extracted from the first condition data, and a second condition index can be extracted from the second condition data. The target actual treatment index is determined based on the second condition index and the first condition index. If the target actual treatment index is greater than or equal to the expected treatment index, it is determined that the expected treatment goal has been achieved and no subsequent operation is required. Conversely, if the target actual treatment index is less than the expected treatment index, it is determined that the expected treatment goal has not been achieved. Each condition index can include at least one of the following: the number of cancer cells, the tumor volume, etc., which are not limited here.

[0173] If it is not achieved, the first stimulation plan can be adjusted according to the second medical condition data and the second body data to obtain a second stimulation plan. For example, assuming that the second medical condition data has worsened compared to the first medical condition data, the stimulation parameters of the first stimulation plan can be appropriately enhanced, and then the stimulation parameters of the first stimulation plan can be fine-tuned according to the first body data to obtain the second stimulation plan.

[0174] It can be seen that the wearable transcutaneous electric field stimulation system described in this application collects the medical condition data and physical data of the target object (i.e., the patient) through the control module, and analyzes it in combination with the desired treatment goals to generate a stimulation plan that is consistent with the actual situation of the target object. That is, the wearable transcutaneous electric field stimulation system described in this application can formulate personalized stimulation plans based on the actual situation of the patient.

[0175] An embodiment of the present application also provides a wearable transcutaneous electric field stimulation device, which includes any wearable transcutaneous electric field stimulation system described in the above embodiments.

[0176] An embodiment of the present application also provides a wearable transcutaneous electric field stimulation device, which includes the above-mentioned wearable transcutaneous electric field stimulation device, or any wearable transcutaneous electric field stimulation system described in the above-mentioned embodiments.

[0177] It should be noted that for the aforementioned method embodiments, for the sake of simplicity, they are all expressed as a series of action combinations, but those skilled in the art should be aware that this application is not limited by the order of the actions described, because according to this application, certain steps can be performed in other orders or simultaneously. Secondly, those skilled in the art should also be aware that the embodiments described in the specification are all preferred embodiments, and the actions and modules involved are not necessarily required by this application.

[0178] In the above embodiments, the description of each embodiment has its own focus. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0179] In the several embodiments provided in this application, it should be understood that the disclosed devices can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For example, the division of the above units is merely a logical functional division. In actual implementation, other division methods may be used. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not implemented.

[0180] On the other hand, the mutual coupling or direct coupling or communication connection shown or discussed may be an indirect coupling or communication connection through some interface, device or unit, which may be electrical or other forms.

[0181] Those skilled in the art can understand that to implement all or part of the processes in the above-mentioned embodiment method, the process can be completed by a computer program to instruct the relevant hardware, and the program can be stored in a computer-readable storage medium. When the program is executed, it can include the processes of the above-mentioned method embodiments.

[0182] The aforementioned storage medium may include: ROM or random access memory RAM, magnetic disk or optical disk and other media that can store program codes.

[0183] The steps of the methods or algorithms described in the embodiments of the present application may be implemented in hardware or by a processor executing software instructions. The software instructions may be composed of corresponding software modules, which may be stored in RAM, flash memory, ROM, EPROM, electrically erasable programmable read-only memory (EEPROM), registers, hard disks, removable hard disks, compact discs (CD-ROMs), or any other form of storage medium known in the art.

[0184] An exemplary storage medium is coupled to the processor such that the processor can read information from, and write information to, the storage medium.

[0185] Of course, the storage medium can also be an integral part of the processor. The processor and storage medium can be located in an ASIC. Alternatively, the ASIC can be located in a terminal device or a management device. Of course, the processor and storage medium can also exist as discrete components in a terminal device or a management device.

[0186] Those skilled in the art will appreciate that in one or more of the above examples, the functions described in the embodiments of the present application can be implemented in whole or in part through software, hardware, firmware, or any combination thereof. When implemented using software, they can be implemented in whole or in part in the form of a computer program product.

[0187] The computer program product includes one or more computer instructions. When the computer program instructions are loaded and executed on a computer, the process or function described in the embodiments of the present application is generated in whole or in part.

[0188] The computer may be a general-purpose computer, a special-purpose computer, a computer network, or other programmable devices. The computer instructions may be stored in a computer-readable storage medium or transferred from one computer-readable storage medium to another.

[0189] For example, the computer instructions may be transmitted from one website, computer, server, or data center to another website, computer, server, or data center via wired (e.g., coaxial cable, optical fiber, digital subscriber line (DSL)) or wireless (e.g., infrared, wireless, microwave, etc.) means.

[0190] The computer-readable storage medium can be any available medium that can be accessed by a computer or a data storage device such as a server or a data center that includes one or more available media.

[0191] The available medium may be a magnetic medium (eg, a floppy disk, a hard disk, a magnetic tape), an optical medium (eg, a digital video disc (DVD)), or a semiconductor medium (eg, a solid state disk (SSD)).

[0192] The modules / units included in the devices and products described in the above embodiments may be software modules / units or hardware modules / units, or may be partially software modules / units and partially hardware modules / units.

[0193] For example, for each device or product applied to or integrated into a chip, each module / unit contained therein may be implemented in the form of hardware such as circuits, or at least some of the modules / units may be implemented in the form of software programs, which run on a processor integrated inside the chip, and the remaining (if any) modules / units may be implemented in the form of hardware such as circuits; for each device or product applied to or integrated into a chip module, each module / unit contained therein may be implemented in the form of hardware such as circuits, and different modules / units may be located in the same component (such as a chip, circuit module, etc.) or different components of the chip module, or at least some of the ... It is implemented in the form of a software program, which runs on the processor integrated inside the chip module, and the remaining (if any) modules / units can be implemented in the form of hardware such as circuits; for various devices and products applied to or integrated in the terminal equipment, the various modules / units contained therein can be implemented in the form of hardware such as circuits, and different modules / units can be located in the same component (for example, chip, circuit module, etc.) or different components in the terminal equipment, or at least some modules / units can be implemented in the form of a software program, which runs on the processor integrated inside the terminal equipment, and the remaining (if any) modules / units can be implemented in the form of hardware such as circuits.

[0194] The specific implementation methods described above further illustrate the purpose, technical solutions and beneficial effects of the embodiments of the present application. It should be understood that the above description is only a specific implementation method of the embodiments of the present application and is not intended to limit the scope of protection of the embodiments of the present application. Any modifications, equivalent replacements, improvements, etc. made on the basis of the technical solutions of the embodiments of the present application should be included in the scope of protection of the embodiments of the present application.

Claims

1. A wearable transcutaneous electric field stimulation system, characterized in that: The system includes: a wearable module, an electrode module, and a control module, wherein: The wearable module is used to be worn on the target object, so that the system acts on the target object in a wearable manner; The control module is configured to obtain first condition data, first body data, and a desired treatment target of the target subject; formulate a first stimulation plan based on the first condition data, the first body data, and the desired treatment target; and determine a first control instruction corresponding to the first stimulation plan; The electrode module is configured to operate according to the first control instruction and generate a corresponding alternating electric field in the target object, thereby stimulating the target object through the alternating electric field; The control module is further configured to obtain second condition data and second body data of the target object after the electrode module stimulates the target object via the alternating electric field; determine whether the desired treatment goal has been achieved based on the first condition data and the second condition data; and if not, adjust the first stimulation protocol based on the second condition data and the second body data to obtain a second stimulation protocol; the second stimulation protocol is used to perform a new round of transcutaneous electric field stimulation on the target object to achieve the desired treatment goal; In terms of formulating a first stimulation plan based on the first condition data, the first body data, and the desired treatment goal, the control module is specifically configured to: determining the disease suffered by the target subject according to the first disease condition data to obtain a target disease; Acquire first historical stimulation data corresponding to the target disease; the first historical stimulation data includes m stimulation data, each stimulation data being stimulation data of a human body receiving electric field stimulation for the first time; m is a positive integer; determining a reference stimulation scheme based on the first historical stimulation data and the desired treatment goal; determining body data corresponding to each stimulus data in the first historical stimulus data to obtain m body data; determining a target difference according to the first body data and the m body data; Adjusting the reference stimulation scheme according to the target difference to obtain the first stimulation scheme; In terms of determining a reference stimulation scheme based on the first historical stimulation data and the desired treatment goal, the control module is specifically configured to: Determining a stimulation scheme and an actual treatment index corresponding to each stimulation data in the first historical stimulation data, to obtain m first historical stimulation schemes and m actual treatment indexes; Determining the difference between each of the m actual treatment indicators and an expected treatment indicator to obtain m differences; the expected treatment indicator is a treatment indicator corresponding to the expected treatment goal; Adjusting corresponding first historical stimulation schemes among the m first historical stimulation schemes according to the m differences to obtain m second historical stimulation schemes; each second historical stimulation scheme includes an electric field frequency and an electric field intensity; Determining the average electric field frequency and average electric field intensity corresponding to the m second historical stimulation schemes; Acquiring second historical stimulation data corresponding to the target object; determining a target tolerance based on the second historical stimulation data; Determining a target adjustment factor corresponding to the target tolerance; Adjusting the average electric field strength according to the target adjustment factor to obtain a reference electric field strength; The reference stimulation scheme is determined according to the average electric field frequency and the reference electric field strength.

2. The system according to claim 1, wherein In determining the target tolerance according to the second historical stimulation data, the control module is specifically configured to: determining the historical number of stimulations and the historical average stimulation duration of the target object according to the second historical stimulation data; Determining a target total stimulation duration according to the historical number of stimulations and the historical average stimulation duration; Determining a first tolerance corresponding to the target total stimulation duration; Acquiring historical electric field intensity data in the second historical stimulation data; Sampling the historical electric field strength data to obtain n electric field strength values ​​and n sampling times; Each electric field strength value corresponds to a sampling time; n is an integer greater than 1; Determining a target mean square error corresponding to the n electric field strength values; Performing straight line fitting based on the n electric field strength values ​​and the n sampling times to obtain a target straight line, wherein the abscissa of the target straight line is time and the ordinate is the electric field strength value; determining a target slope of the target straight line; determining a second tolerance corresponding to the target slope; Determining a target optimization factor corresponding to the target mean square error; Optimizing the second tolerance according to the target optimization factor to obtain a third tolerance; The target tolerance level is determined according to the first tolerance level and the third tolerance level.

3. The system according to claim 1 or 2, characterized in that In determining the target difference based on the first body data and the m body data, the control module is specifically configured to: determining a difference between the first physical data and each of the m physical data to obtain m differences; Determining a target time interval corresponding to the m pieces of physical data; The target time interval is divided according to a preset time interval to obtain k time intervals; k is an integer greater than 1; Determine a weight corresponding to each of the k time intervals to obtain k weights; Put the m differences into the k time intervals to obtain k difference sets; The target difference is determined according to the k weights and the k difference sets.

4. The system according to claim 1 or 2, characterized in that The system further includes a battery module for powering the system; the control module includes: a processing unit, a display unit, an interaction unit, an interface unit, an alarm unit, and a data recording unit, wherein: The processing unit is configured to process and analyze the first condition data, the first body data, and the desired treatment goal to obtain the first stimulation plan; The display unit is configured to display the first stimulation scheme; The interaction unit is used to interact with the target user or the target object; The interface unit includes an output interface and a battery interface, wherein the output interface is used to connect the output wire; the battery interface is used to connect to the battery module; The alarm unit includes a buzzer and / or an indicator light, and is used to issue a corresponding alarm when the system is abnormal; The data recording unit is used to record the data generated by the system during operation.

5. The system according to claim 4, wherein: The electrode module includes: an electrode shell, a conductive electrode layer, a wire interface, an adhesive layer, and a data acquisition unit; wherein: The electrode housing is a flexible patch structure in a preset shape, adapted to fit the skin of the target subject; The conductive electrode layer includes a stimulation electrodes; the a stimulation electrodes are used to emit an alternating electric field to uniformly cover the treatment area of ​​the target object; a is a positive integer; The wire interface is used to connect the output wire; the wire interface receives the control instruction of the control module through the output wire, and transmits the control instruction to the conductive electrode layer; The adhesive layer has an adhesive function, and is used to make the electrode module adhere to the skin of the target object; The data acquisition unit is used to collect the temperature and resistance of each of the a stimulation electrodes to obtain a temperature data and a resistance data; and feed the a temperature data and the a resistance data back to the control module to achieve feedback regulation.

6. The system according to claim 5, wherein: The first control instruction includes a first electric field frequency and a first electric field strength; in terms of operating according to the first control instruction, the electrode module is specifically configured to: Obtaining an electrode position of each of the a stimulation electrodes on the target object to obtain a electrode positions; Determining the skin impedance corresponding to each of the a electrode positions to obtain a skin impedance; Acquiring the area to be stimulated of the target object; allocating corresponding current intensities to the a stimulation electrodes based on a preset current intensity allocation algorithm, the area to be stimulated, the a electrode positions, and the first electric field strength, to obtain a first current intensities; adjusting corresponding first current intensities among the a first current intensities according to the a skin impedances and the a resistances to obtain a second current intensities; Determine a fine-tuning factor corresponding to each temperature data in the a temperature data to obtain a fine-tuning factor; Adjusting corresponding second current intensities among the a second current intensities according to the a fine-tuning factors to obtain a third current intensities; The a stimulation electrodes are controlled to operate according to the first electric field frequency and the a third current intensities.

7. A wearable transcutaneous electric field stimulation device, characterized in that: The device comprises the wearable transcutaneous electric field stimulation system according to any one of claims 1 to 6.

8. A wearable transcutaneous electric field stimulation device, characterized in that: The device includes the wearable transcutaneous electric field stimulation device as described in claim 7, or the wearable transcutaneous electric field stimulation system as described in any one of claims 1-6.

Images