A biofeedback-based gastrointestinal pacemaker testing method and system

Abstract

The present application belongs to the technical field of biological equipment testing, and provides a gastrointestinal pacemaker test method and system based on biological feedback, which comprises: performing gastrointestinal stimulation test in a set test range, continuously collecting physiological signals, judging whether the physiological signals follow successfully, and preliminarily determining that the traction is insufficient if neither of them appears to follow successfully; judging whether there is functional lag through comparison of the stimulation lag of the gastrointestinal pacemaker and the gastrointestinal rhythm fluctuation period of the subject; screening target correction stimulation test through correlation comparison and analysis of the functional lag degree and the traction insufficient degree of the stimulation test to be analyzed, correcting the dominant frequency following error and the amplitude synchronization degree, and re-determining whether the gastrointestinal pacemaker traction is sufficient, so as to prevent the problem of misjudgment of the gastrointestinal pacemaker functional traction test caused by the functional lag interference of the gastrointestinal pacemaker and realize rapid and effective test of the gastrointestinal pacemaker traction capacity.

Description

Technical Field

[0001] This invention belongs to the field of biological device testing technology, specifically a gastrointestinal pacemaker testing method and system based on biofeedback. Background Technology

[0002] Gastrointestinal pacemakers, as key devices that regulate gastrointestinal slow-wave rhythms through external electrical stimulation, are finding increasingly wider applications. Their core function is to output precise stimulation signals to guide abnormal gastrointestinal slow-wave rhythms back to the normal physiological range, thereby improving conditions such as delayed gastric emptying and irritable bowel syndrome. Currently, in the performance testing of gastrointestinal pacemakers, determining traction capacity is a crucial step in evaluating the device's effectiveness and directly impacts the formulation and adjustment of clinical treatment plans.

[0003] However, existing traction capacity testing methods have significant shortcomings and are unable to meet the needs for precise and efficient testing. Current technologies often conduct stimulation tests directly within a set testing range, but they fail to consider the functional lag problem commonly found in gastrointestinal pacemakers. When a pacemaker senses a deviation in gastrointestinal rhythm, there is a time delay in the output adjustment stimulus. When this delay does not match the subject's gastrointestinal rhythm fluctuation cycle, it leads to a time misalignment between the stimulation signal and the physiological signal. This results in low accuracy of the calculated test evaluation indicators, mistakenly identifying "signal failure due to functional lag" as "insufficient true traction," causing serious test misjudgments.

[0004] Meanwhile, existing technical solutions perform indiscriminate analysis on all unsuccessful follow-up tests, failing to focus on "functional lag-related tests," which increases operational complexity and prolongs the testing cycle; moreover, they lack a signal correction mechanism for functional lag, making it difficult to achieve rapid and accurate determination of the traction capability of gastrointestinal pacemakers.

[0005] Therefore, the present invention provides a method and system for testing gastrointestinal pacemakers based on biofeedback. Summary of the Invention

[0006] In order to overcome the shortcomings of the prior art, at least one technical problem raised in the background art is solved.

[0007] The technical solution adopted by this invention to solve its technical problem is: a gastrointestinal pacemaker testing method based on biofeedback, comprising the following steps: Whether to initiate gastrointestinal stimulation is determined based on the subject's slow wave rhythm in the gastrointestinal tract; If activated, gastrointestinal stimulation tests are performed within the set test range, and physiological signals are continuously collected during the stimulation cycle. The dominant frequency following error and amplitude synchronization are calculated to determine whether the physiological signal is successfully followed. If no physiological signal is successfully followed within the set test range, it is preliminarily determined that the gastrointestinal pacemaker traction is insufficient. If the initial assessment is that the traction is insufficient, the presence of functional lag in the gastrointestinal pacemaker can be determined by comparing the stimulation lag of the gastrointestinal pacemaker with the fluctuation period of the subject's gastrointestinal rhythm. If present, gastrointestinal stimulation tests that cause functional lag in the gastrointestinal pacemaker are marked as stimulation tests to be analyzed. By comparing and contrasting the degree of functional lag and the degree of insufficient traction of the stimulation tests to be analyzed, the necessity of correcting the results of the stimulation tests to be analyzed is assessed, and target correction stimulation tests are selected. Based on the target-corrected stimulation test, the dominant frequency following error and amplitude synchronization are corrected. If the physiological signal is successfully followed after correction, the gastrointestinal pacemaker is finally judged to have sufficient traction. Conversely, if no physiological signal is successfully followed, the gastrointestinal pacemaker is finally judged to have insufficient traction.

[0008] As a further aspect of the present invention, the gastrointestinal slow wave rhythm is obtained by collecting the baseline physiological signals of the subject in a fasting state and calculating them in combination with the power spectrum analysis method. If the slow wave rhythm of the gastrointestinal tract is not within the normal rhythm range, it indicates that gastrointestinal stimulation needs to be initiated.

[0009] As a further aspect of the present invention, the process of determining whether the physiological signal has been successfully followed is as follows: Within the set test range, subjects are continuously stimulated according to each set test value and stimulation cycle duration; Based on any set test value; The stimulation cycle is divided into several stimulation analysis windows. The dominant frequency deviation ratio of each stimulation analysis window is calculated and averaged to obtain the dominant frequency following error. Physiological signal sequences and stimulus signal sequences were collected within each stimulus analysis window. Pearson correlation coefficients were calculated and averaged to obtain amplitude synchronization. If the dominant frequency following error is less than the preset threshold and the amplitude synchronization degree is greater than or equal to the preset threshold, it means that the physiological signal following is successful; otherwise, it means that the following is unsuccessful.

[0010] As a further aspect of the present invention, the process of determining whether the gastrointestinal pacemaker has functional hysteresis is as follows: Based on any single gastrointestinal stimulation test; The stimulation lag time Tlag of the gastrointestinal pacemaker and the gastrointestinal rhythm fluctuation period Tcycle of the subjects were obtained. If Tlag≤ Tcycle then marks the gastrointestinal stimulation test as an acceptable hysteresis test; If Tlag> Tcycle, on the other hand, marks the gastrointestinal stimulation test as a functional lag test; like Tcycle < Tlag ≤ Tcycle, on the other hand, determines whether it is a functional lag test by analyzing the persistence of the dominant frequency following error within the time period corresponding to the stimulus lag time. If a functional lag occurs in any gastrointestinal stimulation test within the set test range, it indicates that the gastrointestinal pacemaker has a functional lag.

[0011] As a further aspect of the present invention, the process of analyzing the persistence of the dominant frequency following error within the time period corresponding to the stimulus lag time is as follows: The time period corresponding to the stimulus lag time is divided into several analysis units. The dominant frequency following error in each analysis unit is calculated, and the proportion of analysis units whose dominant frequency following error exceeds the preset threshold is counted to obtain the following error duration value. If the follow-up error duration value is greater than the follow-up error duration threshold, the gastrointestinal stimulation test will be marked as a functional lag test.

[0012] As a further aspect of the present invention, the process of performing a correlational analysis on the functional lag and traction insufficiency of the stimulus test to be analyzed is as follows: Based on any single stimulus test to be analyzed; The stimulation lag time of the gastrointestinal pacemaker during the stimulation test to be analyzed is obtained, and the absolute deviation ratio is calculated with the functional lag limit value to obtain the functional lag degree value. The dominant frequency following error and amplitude synchronization degree when the physiological signal fails to follow the stimulus during the test are obtained, and the degree of insufficient traction is calculated by the absolute deviation ratio.

[0013] The ratio of the traction insufficiency value to the functional lag value is calculated to obtain the lag traction coupling value; Obtain corrected data for the gastrointestinal pacemaker from multiple historical tests. The corrected data includes the stimulation hysteresis adjustment time and the corresponding changes in dominant frequency follow error and amplitude synchronization. By correcting the data, the normal coupling value of the lag traction is obtained through processing and analysis.

[0014] If the lag traction coupling value is less than or equal to the lag traction normal coupling value, the stimulus test to be analyzed will be marked as the target modified stimulus test.

[0015] If the lag traction coupling value is greater than the lag traction normal coupling value, calculate the coupling deviation between the lag traction coupling value and the lag traction normal coupling value. If the coupling deviation value is greater than or equal to the preset coupling deviation value, mark the stimulus test to be analyzed as the target correction stimulus test.

[0016] As a further aspect of the present invention, the specific method for obtaining the traction deficiency value is as follows: If the dominant frequency following error and amplitude synchronization do not meet the requirements, the absolute deviation ratios of the dominant frequency following error and amplitude synchronization to the corresponding preset thresholds are calculated respectively, and the summation is used to obtain the traction insufficiency value.

[0017] If only the dominant frequency following error does not meet the requirements, then the proportion of the dominant frequency following error exceeding the limit will be used as the value of insufficient traction.

[0018] If only the amplitude synchronization does not meet the requirements, the percentage of amplitude synchronization exceeding the limit will be used as the value of insufficient traction.

[0019] As a further aspect of the present invention, the method for obtaining the delayed traction normal coupling value is as follows: The functional lag adjustment ratio is obtained by calculating the ratio of the stimulus lag adjustment time to the functional lag limit. Calculate the ratio of the change in the dominant frequency following error to the corresponding preset threshold to obtain the ratio of the change in the dominant frequency following error. Calculate the ratio of the change in amplitude synchronization to the corresponding preset threshold to obtain the amplitude synchronization change ratio; If, in the target correction stimulus test, the dominant frequency following error and amplitude synchronization do not meet the requirements, the ratio of the change in following error and the ratio of the change in amplitude synchronization are summed to obtain the ratio of insufficient traction. The ratio of the ratio of insufficient traction to the ratio of functional lag adjustment is then calculated to obtain the normal coupling value of lag traction.

[0020] If the dominant frequency following error alone does not meet the requirements, the ratio between the following error change ratio and the functional lag adjustment ratio is calculated to obtain the normal coupling value of lag traction.

[0021] If only the amplitude synchronization does not meet the requirements, the ratio between the amplitude synchronization change ratio and the functional lag adjustment ratio is calculated to obtain the normal coupling value of lag traction.

[0022] As a further aspect of the present invention, the process of correcting the dominant frequency following error and amplitude synchronization includes: Stimulus test modified based on any objective; The start time point for collecting physiological signals according to the stimulation cycle is obtained, and the start time point for collection is postponed according to the stimulation lag time Tlag to achieve correction of physiological signals within the stimulation cycle. Based on the corrected physiological signals, the dominant frequency following error is recalculated to correct the dominant frequency following error. Based on the correction of physiological signals, the physiological signal sequence within each stimulus analysis window is re-obtained, and the amplitude synchronization degree is recalculated with the stimulus signal sequence to achieve the correction of amplitude synchronization degree.

[0023] A biofeedback-based gastrointestinal pacemaker testing system includes the following modules: Activation judgment module: Determines whether to activate gastrointestinal stimulation based on the subject's slow wave rhythm.

[0024] Signal tracking analysis module: If activated, it performs gastrointestinal stimulation tests within the set test range, continuously collects physiological signals during the stimulation cycle, calculates the dominant frequency tracking error and amplitude synchronization, and determines whether the physiological signal is successfully tracked.

[0025] Traction initial test module: If no physiological signal is successfully followed within the set test range, it is preliminarily determined that the gastrointestinal pacemaker traction is insufficient.

[0026] Functional lag analysis module: If traction is initially determined to be insufficient, the gastrointestinal pacemaker is compared with the stimulation lag of the gastrointestinal pacemaker and the fluctuation period of the subject's gastrointestinal rhythm to determine whether there is functional lag.

[0027] Functional lag screening module: If present, gastrointestinal stimulation tests that cause functional lag in the gastrointestinal pacemaker are marked as stimulation tests to be analyzed. By comparing and analyzing the degree of functional lag and the degree of insufficient traction of the stimulation tests to be analyzed, the necessity of correcting the results of the stimulation tests to be analyzed is evaluated, and target correction stimulation tests are screened.

[0028] Functional lag correction and traction end test module: Based on the target correction stimulus test, the dominant frequency following error and amplitude synchronization are corrected. If the physiological signal is successfully followed after correction, the gastrointestinal pacemaker is finally judged to have sufficient traction. Conversely, if no physiological signal is successfully followed, the gastrointestinal pacemaker is finally judged to have insufficient traction.

[0029] The beneficial effects of this invention are as follows: First, the stimulation is initiated based on the subject's gastrointestinal slow wave rhythm. If initiated, stimulation testing is conducted within a set test range. Physiological signals are continuously collected during the stimulation cycle. The success of signal following is determined by calculating the dominant frequency following error and amplitude synchronization. If the signal following is unsuccessful within the set test range, insufficient traction is initially determined. Then, the pacemaker stimulation lag time is compared with the subject's gastrointestinal rhythm fluctuation cycle to check for functional lag. If functional lag exists, the corresponding test is marked as a test to be analyzed. The degree of functional lag and insufficient traction of the test to be analyzed are then correlated and compared to assess the necessity of correction and select target correction tests. Finally, based on the target correction test, the signal is corrected by delaying the start time of physiological signal acquisition (original start time + stimulation lag time), and relevant indicators are recalculated. If the corrected signal follows successfully, sufficient traction is determined; otherwise, insufficient traction is determined. This invention can prevent misjudgment of gastrointestinal pacemaker functional traction test due to interference from gastrointestinal pacemaker functional lag, improve the accuracy of test evaluation, and efficiently focus on tests that need correction, achieving rapid and effective testing of gastrointestinal pacemaker traction capability. Attached Figure Description

[0030] The invention will now be further described with reference to the accompanying drawings.

[0031] Figure 1 This is a flowchart illustrating the steps of a biofeedback-based gastrointestinal pacemaker testing method according to an embodiment of the present invention.

[0032] Figure 2 This is a logical schematic diagram of a biofeedback-based gastrointestinal pacemaker testing method according to an embodiment of the present invention.

[0033] Figure 3 This is a system module diagram of a biofeedback-based gastrointestinal pacemaker testing system according to an embodiment of the present invention. Detailed Implementation

[0034] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below in conjunction with specific embodiments.

[0035] Example 1: Please refer to Figure 1-2 As shown in the embodiment of the present invention, a gastrointestinal pacemaker testing method based on biofeedback includes the following steps: Step 1: Determine whether to initiate gastrointestinal stimulation based on the subject's slow wave rhythm.

[0036] In step one, a multi-channel gastrointestinal electrocoagulation (GEC) recorder was used to acquire baseline physiological signals of the subjects in a fasting state. The gastrointestinal slow wave rhythm was calculated using power spectral analysis (PSA) and compared with the normal rhythm range. If the slow wave rhythm of the gastrointestinal tract is within the normal rhythm range, it means that gastrointestinal stimulation is not required. If the slow wave rhythm of the gastrointestinal tract is not within the normal rhythm range, it indicates that gastrointestinal stimulation needs to be initiated.

[0037] For example, step one will be explained: Baseline physiological signals of subjects were continuously collected for 30-60 minutes. The continuous baseline physiological signals for 30-60 minutes were divided into multiple analysis windows with a window duration of 5 minutes (to balance rhythm stability and timeliness, avoiding large frequency fluctuations due to excessively short windows and missing details due to excessively long windows).

[0038] A Fast Fourier Transform (FFT) is performed on the signal in each window to obtain the power spectrum curve (horizontal axis: frequency, vertical axis: power, i.e., signal energy). The frequency with the highest power in the power spectrum is extracted, which is the dominant frequency (i.e., the rhythm with the most concentrated energy, representing the main peristaltic rhythm of the gastrointestinal tract). The average value of the dominant frequencies of all analysis windows is taken to obtain the gastrointestinal slow wave rhythm. The gastrointestinal slow wave rhythm is compared with the normal rhythm range to determine whether gastrointestinal stimulation needs to be initiated, as shown in Table 1 below.

[0039]

[0040] Step 2: If started, perform gastrointestinal stimulation test within the set test range, continuously collect physiological signals during the stimulation cycle, calculate the dominant frequency following error and amplitude synchronization degree, and determine whether the physiological signal is successfully followed.

[0041] In step two, the test range is set by the test technicians based on the subject's tolerance and preliminary experiments. For example, the test range is set to 10%-80% of the maximum output intensity of the gastrointestinal pacemaker (safety is determined through preliminary experiments: that is, the maximum intensity at which the subject has no obvious abdominal pain or bloating, and the test range does not exceed 80% of the safety threshold).

[0042] In step two, the stimulation period is set to 15 minutes by the test technician based on the normal rhythmic fluctuation cycle. For example, gastrointestinal slow waves have time scale characteristics, and the fasting-eating / eating-fasting transition cycle is usually 10-30 minutes. The purpose of setting it to 15 (30 / 2) minutes is to ensure that a complete rhythmic fluctuation cycle can be captured.

[0043] In step two, physiological signals are continuously acquired during the stimulation cycle, and the dominant frequency following error and amplitude synchronization are calculated. The process of determining whether the physiological signal has been successfully followed is as follows: Within the set test range, subjects are continuously stimulated according to each set test value and stimulation cycle duration.

[0044] Based on any set test value; The stimulation cycle is divided into several stimulation analysis windows, and the dominant frequency deviation ratio E of each stimulation analysis window is calculated.

[0045] The specific calculation formula is as follows: , among which, DF stim f is the dominant frequency during stimulation (the maximum frequency of the power spectrum in the stimulation analysis window). target The target stimulation frequency corresponds to the normal physiological rhythm. For example, if the gastric slow wave rhythm of 0.3 needs to be adjusted to the normal physiological rhythm range (0.04-0.06Hz), specifically adjusted to 0.5Hz, then the target stimulation frequency is 0.5Hz.

[0046] The mean of the dominant frequency deviation ratio within all stimulus analysis windows is calculated to obtain the dominant frequency following error.

[0047] Obtain the physiological signal sequence (S_phys) and the stimulus signal sequence (S_stim) within each stimulus analysis window.

[0048] Among them, the physiological signal sequence (S_phys) represents the gastrointestinal electrical signal within the stimulation analysis window (after preprocessing, the amplitude is normalized to 0-1), and the stimulation signal sequence (S_stim) represents the pacemaker output signal (the amplitude is also normalized to 0-1) that is time-aligned with the physiological signal sequence (S_phys).

[0049] The correlation coefficients of the physiological signal sequence (S_phys) and the stimulus signal sequence (S_stim) were calculated using the Pearson correlation coefficient method to obtain the correlation coefficients within the stimulus analysis window. The correlation coefficients within all stimulus analysis windows were then averaged to obtain the amplitude synchronization.

[0050] In some embodiments, the dominant frequency follower error and amplitude synchronization degree are compared with preset thresholds, respectively.

[0051] If the dominant frequency following error is less than the preset threshold (10%) and the amplitude synchronization degree is greater than or equal to the preset threshold (0.6), it indicates that the physiological signal following is successful.

[0052] If the dominant frequency following error is greater than or equal to the preset threshold or the amplitude synchronization degree is less than the preset threshold, it indicates that the physiological signal has not been successfully followed.

[0053] Step 3: If no physiological signal is successfully followed within the set test range, it is preliminarily determined that the gastrointestinal pacemaker traction is insufficient.

[0054] In step three, if, within the set test range, the physiological signal fails to follow successfully every time a gastrointestinal stimulation test is performed at the set test value, it is preliminarily determined that the gastrointestinal pacemaker traction is insufficient. Conversely, if, within the set test range, the physiological signal follows successfully on any one stimulation test, it indicates that the gastrointestinal pacemaker traction is sufficient.

[0055] Step 4: If it is initially determined that the gastrointestinal pacemaker is not traction enough, the gastrointestinal pacemaker is used to determine whether there is functional lag by comparing the stimulation lag of the gastrointestinal pacemaker with the fluctuation period of the subject's gastrointestinal rhythm.

[0056] In step four, the process of determining whether the gastrointestinal pacemaker has functional hysteresis is as follows: Based on any single gastrointestinal stimulation test; The stimulation lag time Tlag of the gastrointestinal pacemaker and the gastrointestinal rhythm fluctuation period Tcycle of the subjects were obtained.

[0057] If Tlag≤ Tcycle indicates that the stimulus lag does not exceed the dynamic changes in the gastrointestinal rhythm, and there is still enough time for synchronization after adjustment. In this case, the gastrointestinal stimulation test is marked as an acceptable lag test.

[0058] If Tlag> Tcycle indicates that the stimulation lag caused the adjustment to miss the key stage of the gastrointestinal rhythm, and the synchronization error existed for a long time. In this case, the gastrointestinal stimulation test was marked as a functional lag test.

[0059] like Tcycle < Tlag ≤ Tcycle, by analyzing the persistence of the dominant frequency following error within the time period corresponding to the stimulus lag time, determines whether it is a functional lag test, specifically including: The time period corresponding to the stimulus lag time is divided into several analysis units. The dominant frequency following error in each analysis unit is calculated, and the proportion of analysis units whose dominant frequency following error exceeds the preset threshold (10%) is counted to obtain the following error duration value.

[0060] If the duration of the follow-up error is greater than the duration threshold of the follow-up error (5 minutes), the gastrointestinal stimulation test will be marked as a functional lag test.

[0061] If the duration of the follow-up error is less than or equal to the duration threshold of the follow-up error, the gastrointestinal stimulation test is marked as an acceptable hysteresis test.

[0062] It should be noted that if the dominant frequency following error does not exceed the preset threshold, the gastrointestinal stimulation test will be marked as an acceptable hysteresis test.

[0063] Among them, the stimulation lag time Tlag represents the total delay after the gastrointestinal pacemaker senses the rhythm deviation (the gastrointestinal slow wave rhythm is not within the normal rhythm range) and outputs an adjusted response before conducting a stimulation test.

[0064] The subject's gastrointestinal rhythm fluctuation cycle (Tcycle) represents the complete time span of the transition from one stable rhythmic state to another in the gastrointestinal slow wave. For example, the specific method for obtaining this value is as follows: A1. Subjects are kept in a fasting state (e.g., fasting for 8-12 hours), and gastric / intestinal electrical signals are continuously collected (sampling frequency ≥1Hz to avoid signal distortion). When the dominant frequency fluctuation is ≤0.1cpm for 5-10 minutes (e.g., gastric electrical signal is stable at 2.5±0.1cpm, 1Hz=60cpm, both are frequency units of gastrointestinal slow wave rhythm), it is determined to be a fasting stable state, and this time is recorded as the cycle start anchor point T0.

[0065] A2. Starting from time T0, the subject is fed, and the feeding process is controlled within 5 minutes (to shorten the instantaneous interference of feeding itself on the rhythm). The time when feeding ends is recorded as the state switching trigger anchor point T1.

[0066] A3, starting from T1, continuously collect physiological signals and monitor changes in the dominant frequency in real time: when the dominant frequency fluctuates ≤0.1cpm for 5-10 minutes (e.g., stabilizes at 3.8±0.1cpm), and the frequency value increases ≥0.5cpm from the fasting baseline (consistent with the physiological characteristics of increased rhythm after eating), it is determined to be a stable state after eating, and this time is recorded as the cycle endpoint anchor point T2.

[0067] Based on the anchor point, calculate the subject's gastrointestinal rhythm fluctuation period Tcycle: Tcycle = T2 - T0.

[0068] It should be noted that if the gastrointestinal rhythm fluctuation cycle of a subject who has been eating and is fasting is observed, the subject is asked to continue fasting after T2, and the above operation is repeated: when the dominant frequency drops back to the fasting baseline level ±0.1 cpm for 5-10 consecutive minutes, it is recorded as T3. At this time, the subject's gastrointestinal rhythm fluctuation cycle is T3-T2.

[0069] Based on functional lag testing and acceptable lag testing, if a functional lag test occurs in any gastrointestinal stimulation test within the set test range, it indicates that the gastrointestinal pacemaker has functional lag.

[0070] Conversely, if no functional lag test occurs during gastrointestinal stimulation tests within the set test range, it indicates that the gastrointestinal pacemaker does not have functional lag, and no operation is performed, indicating that the gastrointestinal pacemaker has insufficient traction.

[0071] Step 5: If present, mark the gastrointestinal stimulation tests that cause functional lag in the gastrointestinal pacemaker as stimulation tests to be analyzed. By comparing and analyzing the degree of functional lag and the degree of insufficient traction of the stimulation tests to be analyzed, assess the necessity of correcting the results of the stimulation tests to be analyzed and screen the target correction stimulation tests.

[0072] In step five, the process of performing a correlational analysis on the degree of functional lag and the degree of insufficient traction in the stimulus test to be analyzed is as follows: Based on any single stimulus test to be analyzed; Obtain the stimulation lag time Tlag of the gastrointestinal pacemaker during the stimulation test to be analyzed, and compare it with the functional lag limit (Tlag). The absolute deviation ratio of Tcycle is calculated to obtain the functional lag value.

[0073] Wherein, the functional lag value = (|Tlag- Tcycle|) / Tcycle.

[0074] The dominant frequency following error and amplitude synchronization degree are obtained when the physiological signal fails to follow the stimulus during the test.

[0075] If the dominant frequency following error and amplitude synchronization do not meet the requirements (the dominant frequency following error is greater than or equal to the preset threshold and the amplitude synchronization is less than the preset threshold), then the absolute deviation ratios of the dominant frequency following error and amplitude synchronization to the corresponding preset thresholds are calculated respectively to obtain the proportion of the dominant frequency following error exceeding the limit and the proportion of amplitude synchronization exceeding the limit, and then the sum is used to obtain the traction insufficiency value.

[0076] If only the dominant frequency following error does not meet the requirements (the dominant frequency following error is greater than or equal to the preset threshold), then the proportion of the dominant frequency following error exceeding the limit will be used as the traction insufficiency value.

[0077] If only the amplitude synchronization does not meet the requirements (amplitude synchronization is less than the preset threshold), then the amplitude synchronization exceeding the limit ratio will be used as the traction insufficiency value.

[0078] The ratio of the traction insufficiency value to the functional lag value is calculated to obtain the lag traction coupling value; Obtain corrected data from multiple historical tests of the gastrointestinal pacemaker. The corrected data includes the stimulation hysteresis adjustment time and the corresponding changes in dominant frequency follow error and amplitude synchronization.

[0079] Among them, the stimulation lag adjustment time refers to adjusting the stimulation lag time Tlag of the gastrointestinal pacemaker to the functional lag limit value. The time adjustment amount for Tcycle.

[0080] The functional lag adjustment ratio is obtained by calculating the ratio of the stimulus lag adjustment time to the functional lag limit.

[0081] The ratio of the change in the dominant frequency following error to the corresponding preset threshold is calculated to obtain the ratio of the change in the dominant frequency following error.

[0082] Calculate the ratio of the change in amplitude synchronization to the corresponding preset threshold to obtain the amplitude synchronization change ratio.

[0083] If, in the target correction stimulus test, the dominant frequency following error and amplitude synchronization do not meet the requirements (the dominant frequency following error is greater than or equal to the preset threshold and the amplitude synchronization is less than the preset threshold), then the change ratio of the following error and the change ratio of the amplitude synchronization are summed to obtain the traction insufficiency change ratio. The ratio between the traction insufficiency change ratio and the functional lag adjustment ratio is calculated to obtain the lag traction normal coupling value.

[0084] If the dominant frequency following error alone does not meet the requirements, the ratio between the following error change ratio and the functional lag adjustment ratio is calculated to obtain the normal coupling value of lag traction.

[0085] If only the amplitude synchronization does not meet the requirements, the ratio between the amplitude synchronization change ratio and the functional lag adjustment ratio is calculated to obtain the normal coupling value of lag traction.

[0086] The delayed traction coupling value is compared and analyzed with the delayed traction normal coupling value.

[0087] If the delayed traction coupling value is greater than the delayed traction normal coupling value: Calculate the coupling deviation between the lagging traction coupling value and the lagging traction normal coupling value, where the coupling deviation value = (lagging traction coupling value - lagging traction normal coupling value) / lagging traction normal coupling value.

[0088] If the coupling deviation value is greater than or equal to the preset coupling deviation value, it means that the traction deficiency (dominant frequency following error and amplitude synchronization) is corrected according to the correlation between the normal traction deficiency and functional hysteresis of the gastrointestinal pacemaker and the degree of functional hysteresis (stimulation hysteresis time). If the result after correction still shows that the gastrointestinal pacemaker is likely to have insufficient traction, then no correction is needed and no operation is performed.

[0089] If the coupling deviation value is greater than or equal to the preset coupling deviation value, it means that the traction deficiency (dominant frequency following error and amplitude synchronization) is corrected according to the correlation between the normal traction deficiency and functional lag of the gastrointestinal pacemaker and the degree of functional lag (stimulation lag time). If the result after correction still shows that the possibility of traction deficiency of the gastrointestinal pacemaker is low, then correction is required, and the stimulation test to be analyzed is marked as the target correction stimulation test.

[0090] If the hysteresis coupling value is less than or equal to the normal hysteresis coupling value, it indicates that the traction deficiency (dominant frequency following error and amplitude synchronization) is corrected according to the degree of functional hysteresis (stimulation lag time) based on the correlation between the normal traction deficiency and functional hysteresis of the gastrointestinal pacemaker. If the corrected result still shows that the possibility of traction deficiency of the gastrointestinal pacemaker is low, then further correction is required, and the stimulation test to be analyzed is marked as the target correction stimulation test.

[0091] Understandably, in step five, the delayed traction coupling value is calculated as the ratio between the insufficient traction value and the functional lag value. It reflects the actual proportional relationship between the stimulus time lag and the traction capacity of the gastrointestinal pacemaker during the stimulus test. The delayed traction normal coupling value reflects the change in the traction capacity of the gastrointestinal pacemaker under the stimulus time lag adjustment during the historical stimulus correction process. Specifically, it is the normal effect of stimulus time lag adjustment on the traction capacity of the gastrointestinal pacemaker. If the delayed traction coupling value is greater than the delayed traction normal coupling value and the degree is high, it indicates that in the current stimulus test to be analyzed, if the traction capacity is corrected according to the stimulus time lag, the traction capacity of the gastrointestinal pacemaker is still likely to be insufficient. In order to quickly and effectively test and verify whether the traction capacity of the gastrointestinal pacemaker is really sufficient, the necessity of correcting the traction capacity of the gastrointestinal pacemaker during the stimulus test to be analyzed is weaker, thereby improving the efficiency of the gastrointestinal pacemaker traction capacity test and verification.

[0092] Step Six: Based on the target-corrected stimulation test, correct the dominant frequency following error and amplitude synchronization. If the physiological signal follows successfully after correction, the gastrointestinal pacemaker is finally determined to have sufficient traction. Conversely, if no physiological signal follows successfully, the gastrointestinal pacemaker is finally determined to have insufficient traction.

[0093] In step six, the process of correcting the dominant frequency following error and amplitude synchronization includes: Stimulus test modified based on any objective; The starting time point for collecting physiological signals according to the stimulation cycle is obtained, and the starting time point is postponed according to the stimulation lag time Tlag to achieve the correction of physiological signals within the stimulation cycle.

[0094] For example, if the start time for collecting physiological signals according to the stimulation cycle is 8:00 and the stimulation lag time Tlag is 5 minutes, then the start time for collection is postponed to 8:05 to align the physiological signals and stimulation signals in time.

[0095] It should be noted that physiological signals are continuously recorded. Collecting physiological signals according to the stimulation cycle only extracts the physiological signals that have already been recorded. The correction of physiological signals within the stimulation cycle does not mean that the physiological signals of the subject are re-collected.

[0096] Based on the corrected physiological signals, the dominant frequency following error is recalculated, thereby correcting the dominant frequency following error.

[0097] Based on the correction of physiological signals, the physiological signal sequence within each stimulus analysis window is re-obtained, and the amplitude synchronization degree is recalculated with the stimulus signal sequence to achieve the correction of amplitude synchronization degree.

[0098] Based on the corrected dominant frequency following error and amplitude synchronization, a new assessment is made as to whether physiological signal following is successful. If physiological signal following is successful in all target correction stimulation tests, the gastrointestinal pacemaker is ultimately deemed to have sufficient traction. Conversely, if no physiological signal following is successful, the gastrointestinal pacemaker is ultimately deemed to have insufficient traction.

[0099] The technical solution of this invention is as follows: First, the stimulation is initiated based on the subject's gastrointestinal slow wave rhythm. If initiated, stimulation testing is conducted within a set test range. Physiological signals are continuously collected during the stimulation cycle. The success of signal following is determined by calculating the dominant frequency following error and amplitude synchronization. If the signal following is unsuccessful within the set test range, insufficient traction is initially determined. Then, the pacemaker stimulation lag time is compared with the subject's gastrointestinal rhythm fluctuation cycle to check for functional lag. If functional lag exists, the corresponding test is marked as a test to be analyzed. The degree of functional lag and insufficient traction of the test to be analyzed are then correlated and compared to assess the necessity of correction and select target correction tests. Finally, based on the target correction test, the signal is corrected by delaying the start time of physiological signal acquisition (original start time + stimulation lag time), and relevant indicators are recalculated. If the corrected signal follows successfully, sufficient traction is determined; otherwise, insufficient traction is determined. This invention can prevent misjudgment of gastrointestinal pacemaker functional traction test due to interference from gastrointestinal pacemaker functional lag, improve the accuracy of test evaluation, and efficiently focus on tests that need correction, achieving rapid and effective testing of gastrointestinal pacemaker traction capability.

[0100] Example 2: Please refer to Figure 3 As shown in the embodiment of the present invention, a biofeedback-based gastrointestinal pacemaker testing system includes: Activation judgment module: Determines whether to initiate gastrointestinal stimulation based on the subject's slow wave rhythm; Signal tracking analysis module: If activated, it performs gastrointestinal stimulation tests within the set test range, continuously collects physiological signals during the stimulation cycle, calculates the dominant frequency tracking error and amplitude synchronization, and determines whether the physiological signal is successfully tracked. Traction initial test module: If no physiological signal is successfully followed within the set test range, it is preliminarily determined that the gastrointestinal pacemaker traction is insufficient; Functional lag analysis module: If traction is initially determined to be insufficient, the gastrointestinal pacemaker is compared with the stimulation lag of the gastrointestinal pacemaker and the fluctuation period of the subject's gastrointestinal rhythm to determine whether there is functional lag in the gastrointestinal pacemaker; Functional lag screening module: If present, gastrointestinal stimulation tests with functional lag caused by the gastrointestinal pacemaker are marked as stimulation tests to be analyzed. By comparing and analyzing the degree of functional lag and the degree of insufficient traction of the stimulation tests to be analyzed, the necessity of correcting the results of the stimulation tests to be analyzed is evaluated, and target correction stimulation tests are screened. Functional lag correction and traction end test module: Based on the target correction stimulus test, the dominant frequency following error and amplitude synchronization are corrected. If the physiological signal is successfully followed after correction, the gastrointestinal pacemaker is finally judged to have sufficient traction. Conversely, if no physiological signal is successfully followed, the gastrointestinal pacemaker is finally judged to have insufficient traction.

[0101] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A biofeedback-based method for testing gastrointestinal pacemakers, characterized in that: Includes the following steps: Whether to initiate gastrointestinal stimulation is determined based on the subject's slow wave rhythm in the gastrointestinal tract; If activated, gastrointestinal stimulation tests are performed within the set test range, and physiological signals are continuously collected during the stimulation cycle. The dominant frequency following error and amplitude synchronization are calculated to determine whether the physiological signal is successfully followed. The process for determining whether the physiological signal has been successfully followed is as follows: Within the set test range, subjects are continuously stimulated according to each set test value and stimulation cycle duration; Based on any set test value; The stimulation cycle is divided into several stimulation analysis windows. The dominant frequency deviation ratio of each stimulation analysis window is calculated and averaged to obtain the dominant frequency following error. Physiological signal sequences and stimulus signal sequences were collected within each stimulus analysis window. Pearson correlation coefficients were calculated and averaged to obtain amplitude synchronization. If the dominant frequency following error is less than the preset threshold and the amplitude synchronization degree is greater than or equal to the preset threshold, it means that the physiological signal following is successful; otherwise, it means that the following is unsuccessful. If no physiological signal is successfully followed within the set test range, it is preliminarily determined that the gastrointestinal pacemaker traction is insufficient. If the initial assessment is that the traction is insufficient, the presence of functional lag in the gastrointestinal pacemaker can be determined by comparing the stimulation lag of the gastrointestinal pacemaker with the fluctuation period of the subject's gastrointestinal rhythm. The process for determining whether a gastrointestinal pacemaker has functional hysteresis is as follows: Based on any single gastrointestinal stimulation test; The stimulation lag time Tlag of the gastrointestinal pacemaker and the gastrointestinal rhythm fluctuation period Tcycle of the subjects were obtained. If Tlag≤ Tcycle then marks the gastrointestinal stimulation test as an acceptable hysteresis test; If Tlag> Tcycle, on the other hand, marks the gastrointestinal stimulation test as a functional lag test; like Tcycle < Tlag ≤ Tcycle, on the other hand, determines whether it is a functional lag test by analyzing the persistence of the dominant frequency following error within the time period corresponding to the stimulus lag time. If a functional lag occurs in any gastrointestinal stimulation test within the set test range, it indicates that the gastrointestinal pacemaker has a functional lag. The process of analyzing the persistence of the dominant frequency following error within the time period corresponding to the stimulus lag time is as follows: The time period corresponding to the stimulus lag time is divided into several analysis units. The dominant frequency following error in each analysis unit is calculated, and the proportion of analysis units whose dominant frequency following error exceeds the preset threshold is counted to obtain the following error duration value. If the follow-up error persists beyond the follow-up error threshold, the gastrointestinal stimulation test will be marked as a functional lag test. If present, gastrointestinal stimulation tests that cause functional lag in the gastrointestinal pacemaker are marked as stimulation tests to be analyzed. By comparing and contrasting the degree of functional lag and the degree of insufficient traction of the stimulation tests to be analyzed, the necessity of correcting the results of the stimulation tests to be analyzed is assessed, and target correction stimulation tests are selected. The process of performing a correlational analysis on the degree of functional lag and the degree of insufficient traction in the stimulus test to be analyzed is as follows: Based on any single stimulus test to be analyzed; The stimulation lag time of the gastrointestinal pacemaker during the stimulation test to be analyzed is obtained, and the absolute deviation ratio is calculated with the functional lag limit value to obtain the functional lag degree value. The dominant frequency following error and amplitude synchronization degree when the physiological signal fails to follow the stimulus test are obtained, and the degree of insufficient traction is calculated by the absolute deviation ratio. The ratio of the traction insufficiency value to the functional lag value is calculated to obtain the lag traction coupling value; Obtain corrected data for the gastrointestinal pacemaker from multiple historical tests. The corrected data includes the stimulation hysteresis adjustment time and the corresponding changes in dominant frequency follow error and amplitude synchronization. By correcting the data and processing and analyzing it, the normal coupling value of the lag traction is obtained; If the lag traction coupling value is less than or equal to the lag traction normal coupling value, the stimulus test to be analyzed will be marked as the target modified stimulus test. If the lag traction coupling value is greater than the lag traction normal coupling value, calculate the coupling deviation value between the lag traction coupling value and the lag traction normal coupling value. If the coupling deviation value is greater than or equal to the preset coupling deviation value, mark the stimulus test to be analyzed as the target correction stimulus test. The specific method for obtaining the traction insufficiency value is as follows: If the dominant frequency following error and amplitude synchronization do not meet the requirements, the absolute deviation ratios of the dominant frequency following error and amplitude synchronization to the corresponding preset thresholds are calculated respectively, and the summation is used to obtain the traction insufficiency value. If only the dominant frequency following error does not meet the requirements, then the proportion of the dominant frequency following error exceeding the limit will be used as the value of insufficient traction. If only the amplitude synchronization does not meet the requirements, the amplitude synchronization exceeding the limit ratio will be used as the traction insufficiency value. The method for obtaining the hysteresis normal coupling value is as follows: The functional lag adjustment ratio is obtained by calculating the ratio of the stimulus lag adjustment time to the functional lag limit. Calculate the ratio of the change in the dominant frequency following error to the corresponding preset threshold to obtain the ratio of the change in the dominant frequency following error. Calculate the ratio of the change in amplitude synchronization to the corresponding preset threshold to obtain the amplitude synchronization change ratio; If, in the target correction stimulus test, the dominant frequency following error and amplitude synchronization do not meet the requirements, the ratio of the change in following error and the ratio of the change in amplitude synchronization are summed to obtain the ratio of insufficient traction. The ratio of the ratio of insufficient traction to the ratio of functional lag adjustment is then calculated to obtain the normal coupling value of lag traction. If only the dominant frequency following error does not meet the requirements, the ratio between the following error change ratio and the functional lag adjustment ratio is calculated to obtain the lag traction normal coupling value. If only the amplitude synchronization does not meet the requirements, calculate the ratio between the amplitude synchronization change ratio and the functional lag adjustment ratio to obtain the normal coupling value of lag traction. Based on the target-corrected stimulation test, the dominant frequency following error and amplitude synchronization are corrected. If the physiological signal is successfully followed after correction, the gastrointestinal pacemaker is finally judged to have sufficient traction. Conversely, if no physiological signal is successfully followed, the gastrointestinal pacemaker is finally judged to have insufficient traction. The process of correcting the dominant frequency following error and amplitude synchronization includes: Stimulus test modified based on any objective; The start time point for collecting physiological signals according to the stimulation cycle is obtained, and the start time point for collection is postponed according to the stimulation lag time Tlag to achieve correction of physiological signals within the stimulation cycle. Based on the corrected physiological signals, the dominant frequency following error is recalculated to correct the dominant frequency following error. Based on the correction of physiological signals, the physiological signal sequence within each stimulus analysis window is re-obtained, and the amplitude synchronization degree is recalculated with the stimulus signal sequence to achieve the correction of amplitude synchronization degree.

2. The method for testing a gastrointestinal pacemaker based on biofeedback according to claim 1, characterized in that: The gastrointestinal slow wave rhythm was obtained by collecting baseline physiological signals of the subjects in a fasting state and calculating them using power spectrum analysis. If the slow wave rhythm of the gastrointestinal tract is not within the normal rhythm range, it indicates that gastrointestinal stimulation needs to be initiated.

3. A biofeedback-based gastrointestinal pacemaker testing system, used to implement the biofeedback-based gastrointestinal pacemaker testing method according to any one of claims 1-2, characterized in that, Includes the following modules: Activation judgment module: Determines whether to initiate gastrointestinal stimulation based on the subject's slow wave rhythm; Signal tracking analysis module: If activated, it performs gastrointestinal stimulation tests within the set test range, continuously collects physiological signals during the stimulation cycle, calculates the dominant frequency tracking error and amplitude synchronization, and determines whether the physiological signal is successfully tracked. Traction initial test module: If no physiological signal is successfully followed within the set test range, it is preliminarily determined that the gastrointestinal pacemaker traction is insufficient; Functional lag analysis module: If traction is initially determined to be insufficient, the gastrointestinal pacemaker is compared with the stimulation lag of the gastrointestinal pacemaker and the fluctuation period of the subject's gastrointestinal rhythm to determine whether there is functional lag in the gastrointestinal pacemaker; Functional lag screening module: If present, gastrointestinal stimulation tests with functional lag caused by the gastrointestinal pacemaker are marked as stimulation tests to be analyzed. By comparing and analyzing the degree of functional lag and the degree of insufficient traction of the stimulation tests to be analyzed, the necessity of correcting the results of the stimulation tests to be analyzed is evaluated, and target correction stimulation tests are screened. Functional lag correction and traction end test module: Based on the target correction stimulus test, the dominant frequency following error and amplitude synchronization are corrected. If the physiological signal is successfully followed after correction, the gastrointestinal pacemaker is finally judged to have sufficient traction. Conversely, if no physiological signal is successfully followed, the gastrointestinal pacemaker is finally judged to have insufficient traction.

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