A gastric electrical signal generation method and a gastric electrical signal generation system

Abstract

This invention relates to a method and system for generating gastric electrical signals, comprising the following steps: acquiring the baseline gastric electrical signal of a subject within a set time period after a meal; generating a personalized gastric electrical signal based on the baseline gastric electrical signal according to the feeding control requirements; the feeding control requirements include at least promoting feeding and inhibiting feeding; the personalized gastric electrical signal is used to act on the gastric pacemaker when the subject begins to eat; the generation strategy is as follows: if the feeding control requirement is to promote feeding, the baseline gastric electrical signal is adjusted towards promoting gastric motility to generate a personalized feeding-promoting gastric electrical signal; if the feeding control requirement is to inhibit feeding, the baseline gastric electrical signal is adjusted towards inhibiting gastric motility to generate a personalized feeding-suppressing gastric electrical signal. This invention uses the subject's postprandial gastric electrical signal as a basis and adjusts it for different feeding control purposes to generate a personalized gastric electrical signal that can regulate feeding according to requirements.

Description

Technical Field

[0001] This invention relates to a method and system for generating gastric electrical signals, belonging to the field of health and weight control. Background Technology

[0002] Overeating can lead to health problems such as obesity, fatty liver, and hyperlipidemia; while reduced food intake can lead to functional dyspepsia, malnutrition, and other health problems, especially for people recovering from serious illnesses, such as cancer patients, whose lack of appetite or poor appetite is detrimental to recovery and the smooth progress of radiotherapy and chemotherapy. Extensive basic clinical and research studies have confirmed that abnormal eating habits are associated with certain gastrointestinal motility disorders.

[0003] Neuromodulation is a major trend in the future of bioelectronics, with its primary target being the neuromodulation of organ function through electrical stimulation of the peripheral nervous system. Recent research indicates that neuromodulation therapy can regulate food intake and related energy metabolism. The main factor determining food intake is gastric motility, including gastric capacity and gastric emptying rate. Gastric motility is regulated by gastric myoelectric activity. Gastric myoelectric activity is the final link in triggering gastric electromechanical coupling, such as… Figure 1 As shown, it consists of slow waves and fast waves. Slow waves in the stomach are the stomach's inherent rhythmic electromyographic activity. Fast waves, also known as peak waves, include a series of peak potentials superimposed on the slow waves. The peak potentials of the gastric smooth muscle are superimposed on the slow waves, thereby triggering gastric smooth muscle contraction. The amplitude and intensity of the gastric smooth muscle contraction are closely related to the amplitude and action potential frequency of the superimposed gastric electromyographic activity.

[0004] By applying exogenous pulsed electrical stimulation signals to the gastric pacemaker, gastrointestinal electrical activity can be regulated, thereby improving gastrointestinal motility and adjusting eating behavior.

[0005] In recent years, more research has focused on using external pacing techniques to treat gastric motility disorders, namely acupoint electrical stimulation (or electroacupuncture) for disease treatment or rehabilitation. Numerous research and clinical applications have been documented both domestically and internationally. Currently, gastric electrical stimulators implanted at acupoints exist. However, in existing technologies, whether surface acupoint electrical stimulators or implanted stimulators, the electrical signals used are pulse signals, including single-pulse and double-pulse types. Fixed-frequency pulse waves cannot guarantee that each pulse will effectively land on every peak of the slow gastric wave, thus limiting their impact on the gastric smooth muscle electrical signal and resulting in poor gastric motility regulation. Furthermore, while some existing technologies simulate normal gastric electrical signals, because they target and strengthen abnormal gastrointestinal electrical activity, producing a prokinetic effect, they are ineffective in inhibiting food intake.

[0006] Moreover, when it comes to weight loss, once the target weight is achieved, it is important to maintain it within the standard weight range in the long term. If you continue to control your diet and suppress gastric motility, it may lead to anorexia nervosa or malnutrition. Summary of the Invention

[0007] The purpose of this invention is to provide a method and system for generating gastric electrical signals, in order to solve the problem in the prior art that it is difficult to achieve weight loss or improve nutritional status by inhibiting eating through neural modulation.

[0008] To achieve the above objectives, the present invention includes: A method for generating gastric electrical signals according to the present invention includes the following steps: 1) Obtain the baseline gastric electrical signals of the controlled subjects within a set time period after meals; 2) Based on the postprandial baseline gastric electrical signal, a personalized gastric electrical signal is generated according to the feeding regulation requirements; the feeding regulation requirements include at least promoting feeding and inhibiting feeding; the personalized gastric electrical signal is used to act on the gastric electrical pacemaker when the regulated subject begins to eat; The generation strategy is as follows: if the need for food intake regulation is to promote food intake, then the basic postprandial gastric electrical signal is adjusted towards promoting gastric motility to generate a personalized gastric electrical signal for promoting food intake; if the need for food intake regulation is to inhibit food intake, then the basic postprandial gastric electrical signal is adjusted towards inhibiting gastric motility to generate a personalized gastric electrical signal for inhibiting food intake.

[0009] This invention is based on the postprandial gastric electrical signals of the target population for more targeted regulation. For different feeding regulation purposes (promoting or inhibiting feeding), it adjusts the gastric electrical signals in the direction of promoting or inhibiting gastric motility, thereby adjusting the intensity and rate of gastric motility, and thus changing the amount of food consumed, achieving the goal of regulating feeding according to needs. Furthermore, using the method of this invention, after reaching a standard weight or weight loss goal, the feeding regulation needs can be adjusted (reducing the degree of food inhibition or changing to normal eating), generating new gastric electrical signals, changing or canceling the inhibition of gastric motility, restoring normal gastric electrical rhythm and normal gastric motility, and avoiding adverse events such as malnutrition.

[0010] Simultaneously, a personalized gastric electrical signal is generated based on the gastric electrical signals of the regulated subject. When applied to the subject through patch electrodes, this signal is closer to the gastric myoelectric signals generated by the subject after eating, making it easier to resonate and excite the subject's own myoelectric signals. This makes it easier to guide the subject's gastric myoelectric signals to align with the generated personalized gastric electrical signal (external stimulus). Compared to the generic simulated normal gastric electrical signals generated by existing technologies (used for external stimulation), this is more likely to influence the subject's actual gastric myoelectric signals, resulting in better adjustment of gastric motility and thus more effective final feeding regulation. Furthermore, the personalized gastric electrical signal used to influence and alter the body's own gastric electrical signals closely resembles these signals, making it easier for the body to restore its original gastric electrical rhythm after regulation and avoiding gastric electrical disturbances.

[0011] Furthermore, the postprandial baseline gastric electrical signal includes a first-stage baseline gastric electrical signal and a second-stage baseline gastric electrical signal; the first-stage baseline gastric electrical signal is the gastric electrical signal collected during the gastric receptive relaxation phase after the subject eats, and the second-stage baseline gastric electrical signal is the gastric electrical signal collected during the gastric emptying phase after the subject eats.

[0012] The collected postprandial baseline gastric electrical signals cover the entire gastric motility process after eating. The obtained baseline gastric electrical signals are accurate and comprehensive, providing a more comprehensive and targeted baseline gastric electrical signal for generating personalized gastric electrical signals.

[0013] Furthermore, the personalized gastric electrical signal includes a first-stage personalized gastric electrical signal and a second-stage personalized gastric electrical signal; the first-stage personalized gastric electrical signal is used to act on the gastric pacemaker during the gastric receptive relaxation phase after the subject has eaten, and the second-stage personalized gastric electrical signal is used to act on the gastric pacemaker during the gastric emptying phase after the subject has eaten.

[0014] The generated personalized gastric electrical signals act on the gastric receptive relaxation and gastric emptying stages respectively. They can increase satiety and thus inhibit food intake by slowing down gastric receptive relaxation and / or slowing down gastric emptying; and increase hunger and thus promote food intake by increasing gastric receptive relaxation and / or increasing gastric emptying. The regulation is precise and effective.

[0015] Furthermore, the baseline gastric electrical signal of the first stage is adjusted to promote gastric motility, resulting in a personalized first-stage gastric electrical signal for increasing gastric receptivity and relaxation; the baseline gastric electrical signal of the second stage is adjusted to promote gastric motility, resulting in a personalized second-stage gastric electrical signal for accelerating gastric emptying; the baseline gastric electrical signal of the first stage is adjusted to inhibit gastric motility, resulting in a personalized first-stage gastric electrical signal for reducing gastric receptivity and relaxation; and the baseline gastric electrical signal of the second stage is adjusted to inhibit gastric motility, resulting in a personalized second-stage gastric electrical signal for slowing gastric emptying. The personalized gastric electrical signal for promoting appetite includes a personalized first-stage gastric electrical signal that increases gastric receptivity and relaxation and a personalized second-stage gastric electrical signal that accelerates gastric emptying; the personalized gastric electrical signal for inhibiting appetite includes a personalized first-stage gastric electrical signal that reduces gastric receptivity and relaxation and a personalized second-stage gastric electrical signal that slows gastric emptying.

[0016] Furthermore, the collected postprandial baseline gastric electrical signals include gastric electrical signals after the subjects ingest different types of food; personalized gastric electrical signals generated based on the gastric electrical signals collected after ingesting a certain type of food are used to act on the gastric electrical pacemaker when the subjects begin to ingest the same type of food; the types of food include two or more of the following: liquid food, solid food, high-protein meal, high-fat meal, and high-carbohydrate meal.

[0017] The gastric electromyography (EMG) generated after eating different types and kinds of food is also different. This invention also takes into account the influence of the energy and state of the ingested food on the EMG. When generating the EMG signal, the basic postprandial EMG signal collected after the food intake is used for different foods, making the regulation more targeted and effective.

[0018] Furthermore, methods for adjusting gastric motility based on postprandial baseline gastric electrical signals include one or more of the following: increasing the proportion of effective waveforms in the postprandial baseline gastric electrical signal, increasing the intensity of fast waves in the postprandial baseline gastric electrical signal, increasing the dominant frequency and dominant power of the postprandial baseline gastric electrical signal, and increasing the proportion of normal slow waves in the postprandial baseline gastric electrical signal; wherein the effective waveform is a waveform in which fast wave peaks are superimposed on slow wave peaks, the dominant frequency of the gastric electrical signal is the slow wave frequency, and the dominant power of the gastric electrical signal is the slow wave intensity.

[0019] Furthermore, methods for adjusting gastric motility inhibition based on postprandial baseline gastric electrical signals include one or more of the following: reducing the proportion of effective waveforms in postprandial baseline gastric electrical signals, reducing the intensity of fast waves in postprandial baseline gastric electrical signals, reducing the main power of postprandial baseline gastric electrical signals, and reducing the proportion of normal slow waves in slow waves in postprandial baseline gastric electrical signals.

[0020] The gastric electrical signal generated by this invention is a gastric electrical stimulation signal (including slow wave and fast wave) designed according to the needs of promoting or suppressing appetite. This gastric electrical signal can be used to transmit the gastric electrical signal to the gastric pacemaker through specific acupoints, guide and drive the electromyographic activity of the gastric smooth muscle, thereby effectively affecting the appetite of the regulated subject, and thus adjusting the eating activity, thereby being used for weight loss or promoting appetite.

[0021] Furthermore, when generating a personalized gastric electrical signal to promote appetite, only the indicators in the postprandial baseline gastric electrical signal adjustment index that are below the set value are adjusted; when generating a personalized gastric electrical signal to suppress appetite, only the indicators in the postprandial baseline gastric electrical signal adjustment index that are above the set value are adjusted; the adjustment indicators include: the proportion of effective waveforms, fast wave intensity, main frequency and main power, and the proportion of normal slow waves in slow waves.

[0022] After collecting gastric electromyographic (EMG) signals from the subjects after eating, the baseline EMG signals are used as the basis. If the gastric receptivity and relaxation are normal, and gastric emptying is slow, then to promote eating, the rate of gastric emptying can be increased to induce hunger quickly after eating; or to inhibit eating, the rate of gastric receptivity and relaxation can be slowed down to induce satiety after a small amount of food. If the gastric receptivity and relaxation are slow and gastric emptying is normal, eating can be promoted by increasing the rate of gastric receptivity and relaxation, and further inhibited by slowing down gastric emptying. Conversely, if the gastric receptivity and relaxation are rapid and gastric emptying is normal, eating can be promoted by increasing gastric emptying and inhibited by slowing down gastric receptivity and relaxation; and if the gastric receptivity and relaxation are normal and gastric emptying is rapid, eating can be promoted by increasing gastric emptying and inhibited by slowing down gastric receptivity and relaxation.

[0023] Similarly, for gastric adjustment indicators at different gastric motility stages, abnormal indicators (greater than or less than the set value) can be adjusted towards normal to speed up or slow down gastric motility; or for regulatory purposes (to promote or suppress appetite), abnormal indicators can be adjusted excessively, and only normal indicators can be adjusted to regulate gastric motility.

[0024] When the gastric electrical signal generated in this way acts on the human body, it can interfere with the gastric myoelectric activity of the regulated subject as little as possible, the regulation speed is faster, and the gastric myoelectric activity of the regulated subject is less likely to be disordered after food intake regulation and can return to normal more quickly, avoiding a significant impact on the body function of the regulated subject.

[0025] The present invention provides a gastric electrical signal generation system, comprising a processor, wherein the processor executes instructions to implement the gastric electrical signal generation method described above. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of gastric electromyographic activity and gastric motility waveforms; Figure 2This is a flowchart of the gastric electrosignal generation method of the present invention; Figure 3 This is a schematic diagram of the gastric electrical signal generation system of the present invention. Detailed Implementation

[0027] The present invention will now be described in further detail with reference to the accompanying drawings.

[0028] Method Implementation Examples: A method for generating gastric electrical signals according to the present invention, such as Figure 2 As shown, personalized gastric electrical signals are generated based on the subject's dietary needs (promoting or inhibiting food intake). These signals are then applied to the subject's body via patch electrodes to influence and guide the gastric electrical signals towards a personalized pattern, thereby affecting the subject's appetite and regulating their eating behavior. For needs requiring dietary control, such as weight loss, personalized gastric electrical signals are generated based on the subject's postprandial basal gastric electrical signal, aiming to inhibit gastric motility. Conversely, for needs requiring increased appetite, such as nutritional deficiencies, personalized gastric electrical signals are generated based on the subject's postprandial basal gastric electrical signal, aiming to promote gastric motility.

[0029] Clinical and animal studies have shown that transcutaneous acupoint electrostimulation of specific acupoints, such as Neiguan, Sibai, Zusanli, and Liangmen, can have a therapeutic effect on gastrointestinal Cajal pacemakers and signals, significantly affecting gastric electrical activity and altering gastric receptive relaxation and peristaltic emptying functions. The gastric electrical signal generation method of this invention generates personalized gastric electrical signals that stimulate gastric pacemaker sites via external patch electrodes. These pacemaker sites are selected from acupoints that have a therapeutic effect on gastrointestinal pacemaker cells. The patch electrodes use the amplified personalized gastric electrical signals as stimulation current, influencing gastric electrical activity through electrical stimulation of these acupoints, thereby altering the eating behavior of the target user.

[0030] The influence of acupoint electrical stimulation on gastric electrical activity and even gastric motility is an existing technology, which will not be elaborated upon in this invention. For specific examples, please refer to: "Study on the Effects of Transcutaneous Acupoint Electrical Stimulation on Gastric Receptivity and Autonomic Nerves" (Ma Gang, Doctoral Dissertation, Nanjing Medical University, 2019), "Study on Biological Changes and Some Cellular Signal Transduction Pathways in Cajal Cells during Acupuncture Regulation of Gastric Motility" (Chen Huiqun, Master's Thesis, Fourth Military Medical University, 2009), and "Study on the Effects of Electroacupuncture on the Pacing Function of Cajal Interstitial Cells in Diabetic Gastroparesis Rats" (Zhang Chengcheng, Hunan University of Traditional Chinese Medicine, 2018).

[0031] The specific process and principle of generating personalized gastric electrical signals according to the present invention will be explained below.

[0032] In neuromodulation therapy, variations in electrical stimulation parameters such as amplitude, pulse width, or intensity threshold can all affect the clinical efficacy of the therapy. This invention also considers the differences in gastric electrical activity between fasting and postprandial periods. Therefore, it uses the subject's native postprandial gastric electrical signal as a basis to generate a personalized gastric electrical signal, thereby achieving personalized regulation of food intake.

[0033] Specifically, the personalized gastric electrical signal generation of the present invention includes the following steps: 1) Collect gastric electrical signals of the controlled subject after eating using existing gastric electrical acquisition systems (such as commercially available electrogastrometers).

[0034] As a preferred embodiment, the time period for data collection should cover the receptive relaxation phase and the gastric emptying phase of the subject's stomach after food intake.

[0035] The main factors determining food intake are gastric capacity and gastric emptying rate, both of which are the result of gastric smooth muscle electrical activity. Therefore, to achieve personalized regulation of promoting or inhibiting food intake, this can be achieved by altering gastric receptive relaxation and gastric emptying. Thus, the gastric electrical signals following food intake, which form the basis for personalized gastric electrical signal generation, should include gastric electrical signals during both the receptive relaxation and gastric emptying phases after eating.

[0036] Generally, gastric motility is mainly receptive relaxation within 0–30 minutes after a meal, and mainly gastric emptying through peristalsis within 30–120 minutes. Therefore, the data collection period should at least cover 0–120 minutes after the subjects ingest food.

[0037] 2) The gastric electrical signals of the subject after eating are transmitted to the gastric electrical signal generation system. Based on the collected gastric electrical signals, the gastric electrical signal generation system will adjust the following aspects (adjustment indicators) of the gastric electrical signals at different time periods (0.5, 1, 2 hours) after eating, according to the individual's different eating regulation needs (promoting eating, inhibiting eating, different food intake), using a self-designed eating / gastric electrical regulation program: including the frequency and amplitude of slow gastric waves; the ratio of normal slow gastric waves to abnormal slow gastric waves; and the intensity of fast waves, ultimately forming a personalized eating gastric electrical signal.

[0038] The specific control strategies are as follows: When eating begins, the tension of the smooth muscles in the fundus and body of the stomach decreases through chewing and swallowing, resulting in receptive relaxation of the stomach. This increases the gastric capacity from 50ml on an empty stomach to 1.5L after eating to accommodate the influx of large amounts of food. Therefore, adjustments are primarily made to receptive relaxation of the stomach within 0-30 minutes postprandial. To promote food intake, it is necessary to increase receptive relaxation of the stomach after meals to reduce the patient's feeling of fullness and increase the maximum tolerable food intake. Therefore, in this practical example, the gastric electrical signals collected from the user within 0-30 minutes after eating will be adjusted individually or in combination as follows: 1) increasing the proportion of fast wave peak potentials loaded on slow wave peaks after eating; 2) increasing fast wave intensity; 3) increasing the dominant frequency and power of gastric electrical signals; 4) increasing the ratio of normal to abnormal slow waves. To inhibit food intake, it is necessary to reduce receptive relaxation of the stomach within 15-30 minutes postprandial to increase the patient's feeling of fullness and reduce the maximum tolerable food intake. Therefore, the following adjustments are made, either individually or in combination, to the gastric electrical signals collected from users within 0–30 minutes after eating: 1) reducing the proportion of fast wave peak potentials loaded on slow wave peaks; 2) reducing the main power of gastric electrical signals; 3) increasing or suppressing the main frequency of gastric electrical signals to increase bradykinesia or tachykinesia, thereby reducing the proportion of normal and abnormal slow waves. The adjusted gastric electrical signals serve as the first-stage personalized gastric electrical signals corresponding to the feeding regulation needs (feeding promotion or feeding suppression).

[0039] After food enters the stomach, the pyloric sphincter opens, and gastric motility increases, causing the intragastric pressure to exceed the duodenal pressure. This allows the stomach contents to enter the duodenum; this physiological process is called gastric emptying. Therefore, the period 30–120 minutes after a meal is primarily focused on adjusting gastric emptying. Accelerated gastric emptying can induce hunger and promote eating. Conversely, delayed gastric emptying leads to a greater feeling of fullness and inhibits food intake. Therefore, in this practical example, promoting food intake also requires promoting gastric emptying. At this time, the following adjustments are made, either individually or in combination, to the gastric electrical signals within 30–120 minutes after eating: 1) increasing the proportion of fast wave peaks loaded on slow wave peaks; 2) increasing fast wave intensity; 3) increasing the main power of gastric electrical signals; 4) increasing the ratio of normal to abnormal slow waves. Inhibiting food intake requires delaying gastric emptying. At this point, the gastric electrical signals within 30–120 minutes after food intake are adjusted individually or in combination as follows: 1) reducing the proportion of fast wave peak potentials loaded on slow wave peaks; 2) reducing the main power of gastric electrical signals; 3) reducing the proportion of normal and abnormal slow waves by increasing bradykinesia or tachykinesia. The adjusted gastric electrical signals serve as the second-stage personalized gastric electrical signals corresponding to the feeding regulation needs (feeding promotion or feeding suppression).

[0040] Therefore, in order to achieve personalized dietary regulation, this invention collects the baseline gastric electrical activity of the target user from 0 to 120 minutes after a standard meal, and uses this as a basis to adjust and generate personalized gastric electrical signals. The personalized gastric electrical signals obtained in this way are more targeted and can achieve better regulation effects.

[0041] Meanwhile, the adjustment indicators of baseline gastric electrical activity (including main frequency, main power, and the ratio of normal to abnormal slow waves) vary among different users, as do their gastric electrical activity at different postprandial time periods and after consuming different foods. Therefore, the adjustment of baseline gastric electrical activity should prioritize correcting abnormal (non-optimal) states towards normal, while avoiding further adjustments that push abnormal states further into abnormal directions. Specifically, based on the collected postprandial baseline gastric electrical signals, if the subject's receptive relaxation is normal after eating, but gastric emptying is slow (abnormal, non-optimal), then to promote eating, only the gastric emptying phase should be adjusted to increase the gastric emptying rate and bring it to normal, thus achieving the goal of promoting appetite. If it is necessary to suppress eating, further slowing down the gastric emptying rate will cause the already slow (abnormal) gastric emptying of the subject to become even slower. Therefore, in this case, only the gastric motility during the receptive relaxation phase should be adjusted to achieve the goal of suppressing appetite by slowing down gastric receptive relaxation. If the subject experiences slow (abnormal) gastric receptivity relaxation after eating, but gastric emptying is normal, then to promote eating, only the gastric receptivity relaxation phase should be adjusted to increase the rate of gastric receptivity relaxation, bringing it to a normal level while simultaneously promoting eating. If it is necessary to suppress eating, further slowing down the rate of gastric receptivity relaxation will cause the subject's already slow (abnormal) gastric receptivity relaxation to adjust in an even slower direction. Therefore, in this case, only the gastric motility during the gastric emptying phase should be adjusted to slow down gastric emptying in order to suppress eating.

[0042] If the subject's receptive relaxation is normal after eating, but gastric emptying is rapid (abnormal), accelerating gastric emptying to promote eating will further disrupt the already rapid (abnormal) gastric emptying process. Therefore, only the receptive relaxation phase should be adjusted to promote appetite by accelerating gastric emptying. If appetite suppression is needed, only the abnormally rapid gastric emptying rate should be adjusted to suppress appetite by slowing down gastric emptying.

[0043] If the gastric receptivity and gastric emptying phases of the regulated subject are both relatively normal, then any phase can be adjusted according to the regulatory needs, or both phases can be adjusted to enhance the regulatory effect. Those skilled in the art should understand that normal gastric receptivity and gastric emptying phases mean that the intensity and speed of gastric motility during these phases after eating are within the medically recognized normal range. Therefore, gastric motility can be quantified using indicators such as grams (indicating intensity) and the number of motility movements per minute (indicating speed). Based on this, a threshold value can be set to reflect whether gastric motility is normal in the corresponding phase. If the corresponding indicator is greater than the upper limit or less than the lower limit of the set value, it can be considered that gastric motility is abnormal in the corresponding phase; if the corresponding indicator is within the set value range, gastric motility in the corresponding phase can be considered normal.

[0044] In this embodiment, after collecting the postprandial baseline gastric electrical signals of the subject being regulated, the user's gastric electromyography should first be analyzed to determine whether the user's gastric receptive relaxation and gastric emptying are normal and whether there is a trend of deviation from the normal. This is used to formulate a feeding regulation strategy after obtaining the user's feeding regulation needs, select an appropriate stage for adjustment, and ensure that the adjusted gastric receptive relaxation and gastric emptying stages are as close as possible to the normal indicators, so as to prevent over-regulation from causing gastric motility disorders.

[0045] For example, if the target user has the intention to suppress food intake, and the user's baseline gastric electrical activity already shows significant delayed gastric receptive relaxation 0-30 minutes after a meal, then the goal will be to change the gastric electrical activity 30-120 minutes after a meal, thereby delaying gastric emptying to suppress food intake.

[0046] Similarly, when adjusting specific adjustment indicators to specifically regulate gastric motility, it is necessary to retain as much of the corresponding indicators of the postprandial baseline gastric electrical signal generated by the regulated object as possible, while adjusting abnormal indicators as much as possible. In this embodiment, the gastric electrical adjustment indicators that can affect gastric motility include: the number or proportion of effective waves, fast wave intensity, dominant frequency and dominant power, and normal slow wave proportion. Among them, the effective wave is the waveform of fast wave peak superimposed on slow wave peak, the proportion of effective waveform is the proportion of effective waveform to the total waveform, the dominant frequency of the gastric electrical signal is the slow wave frequency, the dominant power of the gastric electrical signal is the slow wave intensity, and the normal slow wave proportion is the proportion of normal gastric slow waves in the gastric electrical signal. There are naturally some waveforms in the gastric slow waves that cannot effectively cause gastric smooth muscle peristalsis due to low intensity or other reasons. These slow wave waveforms are called abnormal slow waves. Slow waves that can match fast waves and cause gastric motility are called normal slow waves. There is a certain proportion of abnormal slow waves in the gastric electrical signals of normal people. If the proportion of abnormal slow waves is too high (the proportion of normal slow waves is too low), it will lead to slow gastric motility.

[0047] For example, after collecting basal gastric electrical activity (GEO) data from the subjects after meals, it was found that the proportion of effective waveforms was low, fast wave intensity was high, dominant frequency and power were normal, and the proportion of normal slow waves was low. If gastric receptive relaxation needs to be increased according to the needs of food intake regulation, considering that the fast wave intensity is already high, further increasing the fast wave intensity would cause the gastric fast waves of the subjects to deviate further from the normal range. Therefore, fast wave intensity should be considered last in food intake regulation. The dominant frequency and power are within the normal range. In the case of low effective waveform proportion and low normal slow wave proportion, the gastric electrical dominant frequency and power should not be adjusted. Therefore, when generating personalized GEO signals, the timing of the fast wave (pulse wave) generation of the basal gastric electrical activity within 0-30 minutes can be adjusted so that the fast wave pulse is generated at the peak of the slow wave, thereby increasing the proportion of effective waveforms in the personalized GEO signal to accelerate gastric receptive relaxation of the subjects and also improving the problem of low effective waveform proportion of the subjects. Alternatively, based on the baseline gastric electrical activity, the number of normal slow waves can be increased to accelerate gastric receptive relaxation by increasing the proportion of normal slow waves. Alternatively, both the effective waveform ratio and the normal slow wave ratio can be adjusted simultaneously to increase the intensity and effect of the modulation.

[0048] If gastric emptying needs to be slowed according to the needs of food intake regulation, since the effective waveform and the normal ratio of slow waves are already low, the fast wave intensity of the baseline gastric electrical activity within 30 to 120 minutes after a meal can be reduced first to slow gastric emptying. If the effect of slowing gastric emptying (reducing food intake) cannot be effectively achieved at this time, the current main frequency and main power can be further reduced, and should be reduced as much as possible within the normal range.

[0049] The personalized gastric electrical signal generated based on the subject's baseline gastric electrical signal, compared to the subject's own postprandial baseline gastric electrical signal, only modifies relevant parameters used as adjustment indicators. Everything else is similar to the subject's baseline gastric electrical signal, making it easier to resonate with the subject's autogenous electromyographic (EMG) signal. This makes it easier to guide the subject's gastric EMG to align with the generated personalized gastric electrical signal (external stimulus), and more effectively influences the subject's actual gastric EMG signal, resulting in better adjustment of gastric motility and thus more effective final food intake control. Simultaneously, the adjusted gastric electrical signal closely resembles the user's own generated gastric electrical signal, avoiding significant overall modifications to the user's signal, preventing signal disturbance, and facilitating the recovery of the user's gastric electrical signal after regulation.

[0050] Gastric electrogastrography (GEG) is related to gastric distension, gastric contraction, and antral motility. The frequency and amplitude of postprandial GEG undergo a changing process, which is related to the nature and quantity of food. Different forms of food (solid and liquid diets) and foods with different caloric values ​​result in different postprandial GEG changes. Therefore, this invention also regulates postprandial antral motility and gastric emptying based on the different energy levels of ingested food (high-protein, high-fat, and high-carbohydrate meals) and the different purposes of food regulation (promoting or inhibiting food intake). It uses GEG signals from different programmed postprandial time periods (0–0.5 hours, 0.5–2 hours) as stimulation parameters (these stimulation signals include slow and fast waves). Therefore, as another implementation, this invention also considers specific food intake regulation needs when generating personalized GEG signals. For example, the need to inhibit food intake during group meals, or the need to promote high-protein meals. On the one hand, the gastric emptying rates of the three main food components (carbohydrates, proteins, and lipids) differ, with carbohydrates emptying fastest, followed by proteins, and lipids emptying slowest. On the other hand, the time it takes for the stomach to completely empty after consuming the same food varies among different individuals. In addition, the physical properties of the food consumed (liquid food, semi-liquid food, solid food, etc.) also affect gastric electromyographic activity and the intensity and speed of gastric motility.

[0051] Therefore, to achieve more targeted and precise personalized dietary control, this invention also collects basal gastric electrical activity (GEO) data from 0 to 120 minutes after meals of different components, calories, and textures, such as standard liquid meals, solid meals, protein meals, and high-fat meals, from the subjects to clarify and incorporate the impact of meals on individual GEO, thereby achieving more precise personalized dietary control. Specifically, when the subjects eat, personalized GEO signals corresponding to the type of food are selected for control. The personalized GEO signal corresponding to this type of food is the basal GEO signal collected after the subjects eat the same or similar types and textures of food, which is used as the base signal. The personalized GEO signal is generated by adjusting the indicators in the base signal according to the dietary control requirements. When collecting the basal GEO signals after meals (including the basal GEO signals during the receptive relaxation phase and the gastric emptying phase after eating), several typical types of food should be set. After the subjects eat the above types of food respectively, the basal GEO of the subjects is collected, and the collected basal GEO is labeled with the corresponding food type.

[0052] For example, if the user aims to promote high-protein meals (or aims to increase food intake while preparing to eat high-protein meals), but their baseline gastric electrical activity (GEO) shows insufficient gastric receptivity and relaxation, with normal gastric emptying, 0-30 minutes after a protein meal, then a personalized GEO signal to increase gastric receptivity and relaxation after a protein meal will be retrieved from the signal storage module and applied to the user's gastric pacemaker. This personalized GEO signal is generated based on the target user's usual baseline GEO after a protein meal, with the GEO value from 0-30 minutes postprandial as the adjustment target, and is used to increase gastric receptivity and relaxation.

[0053] After collecting baseline gastric electrical signals from subjects after different food intakes, a regulatory strategy is determined based on the regulatory needs (promoting or suppressing appetite) and the parameters of the baseline gastric electrical signals. This strategy may involve adjusting the gastric receptivity relaxation phase, the gastric emptying phase, or both. If adjusting the gastric receptivity relaxation phase, which specific adjustment parameter should be used? Once the regulatory strategy is established, the corresponding adjustment parameters are adjusted to generate an independent set of personalized gastric electrical signals. (If the adjustment only involves slow waves according to the regulatory strategy, only slow waves can be generated as the personalized gastric electrical signal; alternatively, both slow and fast waves can be generated simultaneously as personalized gastric electrical signals, with the fast waves being the same as the baseline gastric electrical signal and not adjusted; the same applies if only fast waves are involved). The personalized gastric electrical signal is generated by a gastric electrical signal generation system. The difference between the generated personalized gastric electrical signal and the baseline gastric electrical signal lies only in the gastric electrical parameters corresponding to the adjustment parameters used for regulation.

[0054] The final generated personalized gastric electrocardiogram (ECG) signal should also be a personalized ECG signal generated based on the user's current regulatory needs after consuming different foods. During use, the user can select according to the food consumed, and the system will retrieve the personalized ECG signal output corresponding to the consumed food to achieve dietary regulation according to needs.

[0055] To achieve more precise adjustment of food intake, statistical data can be used to find the correspondence between gastric motility intensity and food intake at different gastric motility stages, as well as the relationship between gastric motility intensity and gastric electrical signals (effective waveform percentage, main power, and other parameters) at different gastric motility stages. By accurately generating corresponding personalized gastric electrical signals, further control of food intake can be achieved on the basis of inhibiting or promoting food intake.

[0056] The gastric electrocardiogram (ECG) signal generation method of this invention can generate ECG signals that inhibit food intake for weight loss and weight control, or promote food intake to improve nutritional status, based on personalized food intake regulation needs and by adjusting regulation parameters. Furthermore, the basis for personalized ECG generation is collected from the regulated individual themselves, generating a personalized ECG signal based on their own gastric electrical signals, rather than simple pulses or generic, untargeted ECG signals from normal individuals. Such generic signals cannot guarantee compatibility with the regulated individual's ECG signals. In contrast, the personalized ECG signal generated by this invention, based on the individual's own ECG signals, can more accurately adjust regulation parameters such as the effective waveform ratio of gastric electrical signals, precisely controlling gastric motility, thus enabling precise regulation of food intake.

[0057] System Implementation Example: This embodiment provides a gastric electrical signal generation system, such as Figure 3 As shown, it includes a communication module, a memory, a processor, and an internal bus. The processor, memory, and communication module communicate with each other through the internal bus.

[0058] The processor can be a microprocessor (MCU), a programmable logic device (FPGA), or other processing device.

[0059] Memory can be categorized into various types that store information using electrical energy, such as RAM and ROM; various types that store information using magnetic energy, such as hard disks, floppy disks, magnetic tapes, magnetic core memory, bubble memory, and USB flash drives; and various types that store information using optical methods, such as CDs and DVDs. Of course, there are other types of memory, such as quantum memory and graphene memory.

[0060] The communication module is used to acquire the baseline gastric electrical signal of the regulated subject after a meal. The processor can call logical instructions in memory to implement a method for generating gastric electrical signals. This method is described in detail in the method embodiments and will not be repeated here.

Claims

1. A method for generating gastric electrical signals, characterized in that, Includes the following steps: 1) Obtain the baseline gastric electrical signals of the controlled subjects within a set time period after meals; 2) If the need for food intake regulation is to promote food intake, then the adjustment index of the postprandial baseline gastric electrical signal that is lower than the set value is adjusted to promote gastric motility to obtain a personalized gastric electrical signal; If the need for food intake regulation is to suppress food intake, then the adjustment index of the postprandial baseline gastric electrical signal that is higher than the set value is adjusted towards inhibiting gastric motility to obtain a personalized gastric electrical signal; The personalized gastric electrical signal is used to act on the gastric pacemaker when the subject begins to eat. The personalized gastric electrical signal stimulates the gastric pacemaker site through an external patch electrode to affect the gastric electrical activity of the subject through electrical stimulation, thereby changing the subject's eating behavior.

2. The gastric electrical signal generation method of claim 1, wherein, The postprandial baseline gastric electrical signal includes a first-stage baseline gastric electrical signal and a second-stage baseline gastric electrical signal. The first-stage baseline gastric electrical signal is the gastric electrical signal collected during the gastric receptive relaxation stage after the subject eats, and the second-stage baseline gastric electrical signal is the gastric electrical signal collected during the gastric emptying stage after the subject eats. If the feeding regulation requirement is to promote feeding, then at least one adjustment index of the first-stage baseline gastric electrical signal and / or the second-stage baseline gastric electrical signal is adjusted towards promoting gastric motility to obtain the personalized gastric electrical signal; If the feeding regulation requirement is to suppress feeding, then at least one adjustment index of the first-stage baseline gastric electrical signal and / or the second-stage baseline gastric electrical signal is adjusted towards inhibiting gastric motility to obtain the personalized gastric electrical signal; The first stage, after adjustment of the baseline gastric electrical signal, is used to act on the gastric pacemaker during the gastric receptive relaxation phase after the subject has eaten. The second stage, after adjustment of the baseline gastric electrical signal, is used to act on the gastric pacemaker during the gastric emptying phase after the subject has eaten.

3. The method for generating gastric electrical signals according to claim 2, characterized in that, Adjustments were made to the adjustment parameters in the first-stage baseline gastric electrical signal to promote gastric motility, resulting in a first-stage personalized gastric electrical signal for increasing gastric receptive relaxation. Adjustments were made to the modulatory indices in the second-stage baseline gastric electrical signal to promote gastric motility, resulting in a second-stage personalized gastric electrical signal for accelerating gastric emptying. Adjusting the adjustment index in the first-stage baseline gastric electrical signal towards inhibiting gastric motility yields a first-stage personalized gastric electrical signal for reducing gastric receptive relaxation; adjusting the adjustment index in the second-stage baseline gastric electrical signal towards inhibiting gastric motility yields a second-stage personalized gastric electrical signal for slowing gastric emptying.

4. The gastric electrical signal generation method according to claim 1, 2 or 3, characterized by, The adjustment indicators include: the proportion of effective waveforms, fast wave intensity, main frequency of gastric electrical activity, main power of gastric electrical activity, and the proportion of normal slow waves in slow waves. The effective waveform is a waveform in which fast wave peaks are superimposed on slow wave peaks. The adjustment indicators for promoting gastric motility include: increasing the proportion of effective waveforms in the postprandial baseline gastric electrical signal, increasing the intensity of fast waves in the postprandial baseline gastric electrical signal, increasing the main frequency and main power of the postprandial baseline gastric electrical signal, and increasing the proportion of normal slow waves in the postprandial baseline gastric electrical signal. The adjustment indicators for inhibiting gastric motility include: decreasing the proportion of effective waveforms in the postprandial baseline gastric electrical signal, decreasing the intensity of fast waves in the postprandial baseline gastric electrical signal, decreasing the main power of the postprandial baseline gastric electrical signal, and decreasing the proportion of normal slow waves in the postprandial baseline gastric electrical signal.

5. The method of claim 1, 2 or 3, wherein, The collected postprandial baseline gastric electrical signals include gastric electrical signals after the controlled subject ingests different types of food; the personalized gastric electrical signals obtained based on the gastric electrical signals collected after ingesting a certain type of food are used to act on the gastric pacemaker when the controlled subject begins to ingest the same type of food; the types of food include two or more of the following: liquid food, solid food, high-protein meal, high-fat meal, and high-carbohydrate meal.

6. The method of claim 1, 2 or 3, wherein, When the personalized gastric electrical signal is obtained: abnormal adjustment indicators are adjusted to the normal direction to meet the control requirements; the abnormal adjustment indicators are adjustment indicators that are greater than or less than the set value; or the normal adjustment indicators are further adjusted on this basis to meet the control requirements.

7. The method for generating gastric electrical signals according to claim 2 or 3, characterized in that, When the personalized gastric electrical signal is obtained: the adjustment index of the stage with abnormal gastric motility in the gastric receptive relaxation stage and the gastric emptying stage is adjusted towards the normal direction to meet the control requirements; if the gastric motility of the controlled object is normal in both the gastric receptive relaxation stage and the gastric emptying stage, the adjustment index can be adjusted in any stage according to the control requirements, or the adjustment index of both stages can be adjusted in order to increase the control effect.

8. The gastric electrical signal generation method of claim 7, wherein, During the receptive relaxation and emptying phases of the stomach, normal gastric motility means that the intensity and speed of gastric motility during this phase after eating are within the normal range as understood in medicine.

9. A gastric electrical signal generation system, comprising: The system includes a processor that executes instructions to implement a method for generating gastric electrical signals, the method comprising the following steps: 1) Obtain the baseline gastric electrical signals of the controlled subjects within a set time period after meals; 2) If the need for food intake regulation is to promote food intake, then the adjustment index of the postprandial baseline gastric electrical signal that is lower than the set value is adjusted to promote gastric motility to obtain a personalized gastric electrical signal; If the need for food intake regulation is to suppress food intake, then the adjustment index of the postprandial baseline gastric electrical signal that is higher than the set value is adjusted towards inhibiting gastric motility to obtain a personalized gastric electrical signal; The personalized gastric electrical signal is used to act on the gastric pacemaker when the subject begins to eat. The personalized gastric electrical signal stimulates the gastric pacemaker site through an external patch electrode to affect the gastric electrical activity of the subject through electrical stimulation, thereby changing the subject's eating behavior.

10. The gastric electrical signal generation system of claim 9, wherein, The postprandial baseline gastric electrical signal includes a first-stage baseline gastric electrical signal and a second-stage baseline gastric electrical signal. The first-stage baseline gastric electrical signal is the gastric electrical signal collected during the gastric receptive relaxation stage after the subject eats, and the second-stage baseline gastric electrical signal is the gastric electrical signal collected during the gastric emptying stage after the subject eats. If the feeding regulation requirement is to promote feeding, then at least one adjustment index of the first-stage baseline gastric electrical signal and / or the second-stage baseline gastric electrical signal is adjusted towards promoting gastric motility to obtain the personalized gastric electrical signal; If the feeding regulation requirement is to suppress feeding, then at least one adjustment index of the first-stage baseline gastric electrical signal and / or the second-stage baseline gastric electrical signal is adjusted towards inhibiting gastric motility to obtain the personalized gastric electrical signal; The first stage, after adjusting the baseline gastric electrical signal, is used to act on the gastric pacemaker during the gastric receptive relaxation phase after the subject has eaten. The second stage, after adjusting the baseline gastric electrical signal, is used to act on the gastric pacemaker during the gastric emptying phase after the subject has eaten.

11. The gastric electrical signal generation system of claim 10, wherein, Adjustments were made to the adjustment parameters in the first-stage baseline gastric electrical signal to promote gastric motility, resulting in a first-stage personalized gastric electrical signal for increasing gastric receptive relaxation. Adjustments were made to the modulatory indices in the second-stage baseline gastric electrical signal to promote gastric motility, resulting in a second-stage personalized gastric electrical signal for accelerating gastric emptying. Adjusting the adjustment index in the first-stage baseline gastric electrical signal towards inhibiting gastric motility yields a first-stage personalized gastric electrical signal for reducing gastric receptive relaxation; adjusting the adjustment index in the second-stage baseline gastric electrical signal towards inhibiting gastric motility yields a second-stage personalized gastric electrical signal for slowing gastric emptying.

12. The gastric electrical signal generation system of claim 9, 10, or 11, wherein, The adjustment indicators include: the proportion of effective waveforms, fast wave intensity, main frequency of gastric electrical activity, main power of gastric electrical activity, and the proportion of normal slow waves in slow waves. The effective waveform is a waveform in which fast wave peaks are superimposed on slow wave peaks. The adjustment indicators for promoting gastric motility include: increasing the proportion of effective waveforms in the postprandial baseline gastric electrical signal, increasing the intensity of fast waves in the postprandial baseline gastric electrical signal, increasing the main frequency and main power of the postprandial baseline gastric electrical signal, and increasing the proportion of normal slow waves in the postprandial baseline gastric electrical signal. The adjustment indicators for inhibiting gastric motility include: decreasing the proportion of effective waveforms in the postprandial baseline gastric electrical signal, decreasing the intensity of fast waves in the postprandial baseline gastric electrical signal, decreasing the main power of the postprandial baseline gastric electrical signal, and decreasing the proportion of normal slow waves in the postprandial baseline gastric electrical signal.

13. The gastric electrical signal generation system of claim 9, 10, or 11, wherein, The collected postprandial baseline gastric electrical signals include gastric electrical signals after the controlled subject ingests different types of food; the personalized gastric electrical signals obtained based on the gastric electrical signals collected after ingesting a certain type of food are used to act on the gastric pacemaker when the controlled subject begins to ingest the same type of food; the types of food include two or more of the following: liquid food, solid food, high-protein meal, high-fat meal, and high-carbohydrate meal.

14. The gastric electrical signal generation system of claim 9, 10, or 11, wherein, When the personalized gastric electrical signal is obtained: abnormal adjustment indicators are adjusted to the normal direction to meet the control requirements; the abnormal adjustment indicators are adjustment indicators that are greater than or less than the set value; or the normal adjustment indicators are further adjusted on this basis to meet the control requirements.

15. The gastric electrosignal generation system according to claim 10 or 11, characterized in that, When the personalized gastric electrical signal is obtained: the adjustment index of the stage with abnormal gastric motility in the gastric receptive relaxation stage and the gastric emptying stage is adjusted towards the normal direction to meet the control requirements; if the gastric motility of the controlled object is normal in both the gastric receptive relaxation stage and the gastric emptying stage, the adjustment index can be adjusted in any stage according to the control requirements, or the adjustment index of both stages can be adjusted in order to increase the control effect.

16. The gastric electrosignal generation system according to claim 15, characterized in that, During the receptive relaxation and emptying phases of the stomach, normal gastric motility means that the intensity and speed of gastric motility during this phase after eating are within the normal range as understood in medicine.

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