Binaural time division stimulation system

Abstract

This invention provides a binaural time-division stimulation system, comprising: a stimulation timing processing module and a constant current output module; the timing module retrieves preset stimulation parameters and unit time, and processes the stimulation timing of two electrodes in parallel; firstly, the unit time is divided into one or more equal-length time slices, and then each time slice is divided into a first time segment and a second time segment. The first time segment of one channel is configured as the stimulation period for the first side electrode, and the second time segment of the other channel is configured as the stimulation period for the second side electrode to perform alternating binaural stimulation. The number of time slices per unit time for a single electrode is negatively correlated with the number of outputs within each time slice. After the auditory nerve is activated, the number of time slices per unit time is gradually increased, and the number of stimulations within each time slice is reduced to decrease the stimulation intensity. The constant current output module is configured with two independent isolated electrode paths, respectively connected to the binaural electrodes, to output constant current stimulation waveforms separately.

Description

Technical Field

[0001] This invention relates to the field of auditory nerve stimulation control, and more particularly to a binaural time-division stimulation system. Background Technology

[0002] Percutaneous vagus nerve stimulation (taVNS) is a non-invasive and safe neuromodulation technique widely used in the adjunctive treatment of autonomic dysfunction-related conditions. According to the requirements of section 201.7.9.2.101(h) of the YY9706.210-2021 standard, the instructions for use should include the following recommendations: stimulation should not encircle or pass over the head, act directly on the eyes, cover the mouth, be applied to the front of the head (especially the carotid sinus), or from electrodes placed simultaneously on the chest and upper back, or pass through the heart. Therefore, stimulation should not be applied to both ears simultaneously; an alternating stimulation pattern between the left and right ears should be used to improve intervention efficiency while ensuring safety. Currently, similar products alternate stimulation over time intervals of minutes or tens of seconds, such as alternating stimulation of the left and right ears every 30 seconds or every 5 minutes.

[0003] Chinese patent application (CN202310065820.8) discloses a stimulation system parameter tuning method and a time-segmented stimulation system based on offline detection results. This scheme establishes a calibrated time axis corresponding to the offline detection signal and matches and associates the stimulation mode with this time axis, realizing the segmentation and configuration of the stimulation mode according to a preset duration. However, this scheme mainly focuses on the overall temporal correspondence design of stimulation duration and mode, and does not make targeted improvements in the temporal coordination of alternating binaural stimulation, phase control, and differential matching of bilateral stimulation parameters. It is difficult to achieve precise alternation and synchronous control of left and right ear stimulation signals, and there are still shortcomings in the binaural coordinated stimulation effect and individualized adaptability.

[0004] Chinese patent application (CN201910070510.9) discloses an in-ear non-invasive vagus nerve stimulator and its pulse output method. It mainly designs and optimizes the stimulation mode and pulse output waveform, but does not focus on improving the control strategy and execution efficiency of alternating stimulation of the left and right ears, making it difficult to achieve efficient and accurate bilateral alternating stimulation.

[0005] In summary, existing alternating stimulation methods have significant drawbacks, and related technologies have not been specifically improved, resulting in low user compliance and hindering the widespread adoption of the technology. Therefore, developing a system that can optimize binaural alternating stimulation and improve user compliance has become an urgent problem to be solved in this field. Summary of the Invention

[0006] In order to overcome the shortcomings of the prior art, the present invention provides a packaging structure for internally insulated discrete devices.

[0007] To achieve the above objectives, the present invention provides a binaural time-division stimulation system, applicable to two independent electrode pathways connecting both ears and their corresponding stimulation timing. The binaural time-division stimulation system includes: The stimulation timing processing module is used to acquire preset stimulation parameters and unit time, and to synchronously and parallelly process the stimulation timing of the two electrode pathways. The synchronous and parallel processing includes: dividing the unit time into one or more time slices of equal length; dividing each time slice into a first time slice and a second time slice; configuring the first time slice of one pathway as the stimulation period of the first side electrode, and configuring the second time slice of the other pathway as the stimulation period of the second side electrode, forming a stimulation control signal to make the bilateral ear electrodes alternately stimulate in each time slice; when performing alternating stimulation, for each electrode, the number of time slices per unit time is negatively correlated with the number of stimulations output in each time slice. After the ear nerve is activated, the number of time slices per unit time is gradually increased, and the number of stimulations in each time slice is reduced to reduce the stimulation intensity. The constant current output module includes two independent and isolated electrode paths, each path being connected to an ear electrode on one side. It is used to drive the corresponding path to independently output a constant current stimulation waveform according to the stimulation control signal of the stimulation timing processing module.

[0008] Preferably, the stimulation parameters include at least the stimulation frequency of each electrode; in the stimulation timing processing module, the stimulation frequency of each electrode, the number of time slices per unit time, and the corresponding number of stimulations output by the ear electrode satisfy the following relationship:

[0009] Where N is the number of time slices per unit time. F represents the number of stimulations output by the electrode for each time slice per unit time, and F is the stimulation frequency of the electrode. The stimulation frequencies of the two electrodes are the same.

[0010] Preferably, for each electrode, the stimulation frequency is a preset fixed frequency, and the stimulation frequency remains unchanged after stimulation is initiated.

[0011] Preferably, for each electrode, the stimulation frequency is a variable stimulation frequency, and the following steps are included before stimulating: The stimulation frequency of each electrode is adjusted separately, and a mapping relationship between the adjusted stimulation frequency and the sequence of stimulation pulse counts is established.

[0012] Preferably, when adjusting the stimulation frequency, the corresponding number of time slices per unit time and the corresponding number of stimulations of the ear electrodes are matched based on the mapping relationship between the adjusted stimulation frequency and the stimulation number sequence, and the ear electrodes are alternately stimulated based on the matched time slices and stimulation numbers.

[0013] Preferably, within each time slice, a time delay with zero stimulation current is provided before and / or after the stimulation of the corresponding stimulation period.

[0014] Preferably, the constant current output module further includes a CPU processing unit connecting the two electrode paths. Each electrode path includes, in series, an isolated output circuit channel, a constant current control circuit channel, an ear-corresponding side electrode, a differential impedance detection circuit channel, and an isolated input circuit channel.

[0015] Preferably, the isolated output circuit channel is equipped with a stimulation state detection sub-circuit, which is connected in series between the constant current control circuit channel and the ear electrode to sample the output current state of the current channel in real time.

[0016] The present invention provides a binaural time-division stimulation system, the beneficial effects of which are: 1. This invention divides a unit of time into one or more time slices using a stimulation timing processing module, and alternates between the left and right ears within each time slice. This time slice division method ensures that, at a given stimulation frequency, the number of time slices is inversely proportional to the number of stimulations within a single time slice. Based on this characteristic, without changing the stimulation frequency, the number of stimulations within a time slice can be reduced by increasing the number of time slices, thereby reducing the stimulation intensity after auditory nerve activation. This reduces the user's tolerance to stimulation and improves compliance while meeting the stimulation frequency requirements for auditory nerve activation.

[0017] 2. After activation of the auditory nerve, the increase in the number of time slices N per unit time also shortens the physical duration of the time slices. Each ear receives a high-frequency cyclic pattern of "brief stimulation - brief rest - brief stimulation - brief rest...". Compared with traditional unilateral long-duration stimulation with larger time intervals, this high-frequency cyclic pattern can effectively shorten the overall stimulation duration and improve stimulation efficiency and effect.

[0018] 3. The variable frequency time-division alternating stimulation method proposed in this invention can automatically match the number of time slices per unit time according to the user-preset target frequency and generate a corresponding decaying stimulation sequence. This variable frequency scheme supports dynamic adjustment of the stimulation frequency and can be flexibly set according to different application scenarios such as clinical treatment and home relaxation, making the device adaptable to more ear nerve stimulation scenarios and effectively expanding the applicability of the device. At the same time, this method can ensure the continuity of binaural high-frequency alternating stimulation in variable frequency mode, achieving a highly efficient stimulation effect.

[0019] 4. By setting a time delay at the beginning and end of each stimulation period, this invention can ensure that the stimulation current does not form a loop in the head, thus guaranteeing the safety of the stimulation. Attached Figure Description

[0020] Figure 1The flowchart illustrates the synchronous parallel processing of the stimulation timing of two electrode pathways by the stimulation timing processing module in a binaural time-division stimulation system provided by this invention. Figure 2 This invention provides a schematic diagram illustrating the principle of a stimulation timing processing module that synchronously and parallelly processes the stimulation timing of two electrode pathways in a binaural time-division stimulation system. Figure 3 This is an example diagram illustrating the synchronous parallel processing of the stimulation timing of two electrode pathways by the stimulation timing processing module in a binaural time-division stimulation system provided by the present invention. Figure 4 The present invention provides a schematic diagram of the constant current output module in a binaural time-division stimulation system. Detailed Implementation

[0021] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0022] Example 1 like Figure 1 As shown, the present invention provides a binaural time-division stimulation system, applied to two independent electrode pathways connecting both ears and their corresponding stimulation timing. The binaural time-division stimulation system includes: The stimulation timing processing module is used to acquire preset stimulation parameters and unit time, and to perform synchronous parallel processing on the stimulation timing of the two electrode pathways. The synchronous parallel processing includes: dividing the unit time into one or more time slices of equal length; dividing each time slice into a first time slice and a second time slice; configuring the first time slice of one pathway as the stimulation period of the first side electrode, and configuring the second time slice of the other pathway as the stimulation period of the second side electrode, forming a stimulation control signal to cause the bilateral electrodes to alternately stimulate within each time slice; when performing alternating stimulation, for each electrode, the number of time slices per unit time is negatively correlated with the number of stimulations output within each time slice. The constant current output module includes two independent and isolated electrode paths, each path being connected to an ear electrode on one side. It is used to drive the corresponding path to independently output a constant current stimulation waveform according to the stimulation control signal of the stimulation timing processing module.

[0023] It should be noted that the "unit time" referred to in this invention refers to the settable stimulation duration, which can be 1 second, 10 seconds, or 1 minute, etc., and is not specifically limited here.

[0024] Specifically, this invention obtains preset stimulation parameters and divides a unit time into multiple time slices of equal duration, i.e., it segments the unit time. The stimulation parameters include at least the stimulation frequency F of each electrode and the preset unit time; wherein the stimulation frequency F of the two electrodes is the same. Each time slice is then divided into a first time segment and a second time segment, and the first time segment of one channel is configured as the stimulation period of the first side electrode, and the second time segment of the other channel is configured as the stimulation period of the second side electrode. That is, the first side electrode performs stimulation during the first side electrode stimulation period, and the second side electrode performs stimulation during the second side electrode stimulation period, forming a stimulation control signal. In this way, the binaural electrodes can achieve time-division alternating stimulation within the same time slice.

[0025] For example, within each time slice of 1 second, the stimulation period for the left ear electrode is the first half, and the stimulation period for the right ear electrode is the second half. The left and right ear electrodes output stimulation through their respective independent physical pathways. This invention, through this method of alternating stimulation within the same time slice, can achieve alternating stimulation of both ears while remaining safe and compliant. Compared to existing technologies that use a longer duration of stimulation in one ear followed by a longer duration of stimulation in the other ear, this invention effectively shortens the overall stimulation duration, improving stimulation efficiency and effectiveness.

[0026] Furthermore, the stimulation intensity output by the ear electrodes gradually decreases. During alternating stimulation, for each electrode, there is a negative correlation between the number of time slices per unit time and the number of stimulation outputs within each time slice; that is, as the number of time slices increases, the number of stimulation outputs from the alternating left and right ear electrodes decreases accordingly. Since ear nerve stimulation does not require maintaining the same level of stimulation intensity output continuously after the nerve is activated, this invention, through this design, can effectively reduce the user's tolerance requirements for stimulation and improve user compliance.

[0027] To activate the auditory nerves, the stimulation signal typically needs to meet certain frequency and intensity requirements. However, continuous high-frequency stimulation is difficult for users to tolerate, resulting in poor compliance. In reality, once activated, the auditory nerves do not require a continuous output of the same level of stimulation intensity. Therefore, this invention precisely adjusts the stimulation intensity after auditory nerve activation by "dividing time slices + adjusting the number of time slices after activation".

[0028] Specifically, given a fixed stimulation frequency, the more time slices N there are, the more stimulations are allocated to each time slice. The fewer there will be. Therefore, in After the auditory nerve is activatedSubsequently, the stimulus timing processing module can actively adjust the intensity of the activated stimulus by changing the number of time slices without altering the stimulus frequency (i.e., keeping the number of stimuli constant per unit time). This invention will form: actively dividing time slices → utilizing the negative correlation between the number of time slices and the number of stimuli within each time slice, increasing... After the auditory nerve is activated The complete solution involves: reducing the number of time slices per unit time; decreasing the number of stimulations per time slice; reducing stimulation intensity while maintaining the same frequency; and reducing tolerance while improving compliance. This solution lowers the user's tolerance requirements for stimulation by setting a frequency to activate the auditory nerves and adjusting the number of time slices per unit time after activation, achieving bidirectional compatibility between auditory nerve activation and tolerance.

[0029] The principle behind alternating stimulation over time is as follows: In this invention, the left and right ear electrodes are driven by two independent physical pathways, which are electrically isolated from each other. For example... Figure 2 As shown, preset stimulation parameters are obtained, including at least the stimulation frequencies F corresponding to the first and second ear electrodes. A preset unit time is obtained, and the stimulation sequence of the two independent electrode pathways is planned by dividing the unit time into N equal-length time slices. Then, each time slice is divided into a first time segment. Second time period The first time period of one of the routes Set the stimulation time period of the first side electrode as the second time period of the other path. This is defined as the stimulation period for the second side electrode. That is, the first side electrode during... Stimulation is applied to the first segment, and the second electrode is placed on the second side. Stimulate the segment. For example: Figure 3 As shown in the figure, this diagram illustrates the stimulation sequence of the bilateral ear electrodes within a unit time of 1 second. Since the stimulation frequency F of the electrodes represents the number of periodic changes completed per unit time, 1 second is divided into N equal segments, and each segment is further divided into... and Two segments are used as the stimulation time for the first and second ear electrodes, respectively. This time-division alternating stimulation method can shorten the duration of a single stimulation while ensuring safety, thus achieving high-efficiency stimulation.

[0030] In this embodiment, for the bilateral ear electrode stimulation process, the stimulation frequency of each electrode is set to F, and both electrodes have the same stimulation frequency. The number of ear electrode output stimulations per unit time for each time slice is set to... Therefore, in the stimulation timing processing module, the relationship between the stimulation frequency of each electrode, the number of time slices per unit time, and the corresponding number of stimulation outputs from the ear electrode is expressed as follows: , Where N is the number of time slices per unit time. The values ​​can be rounded down, F∈[1,100]Hz, N≥1. The method for determining the number of time slices N per unit time is not uniquely limited. Besides the software design mode, it can also be dynamically determined based on stimulation frequency adjustment, clinical application scenarios, and user skin impedance, tolerance, and other parameters. It only needs to satisfy that N is a positive integer and matches the alternating bilateral stimulation logic of two segments within the time slice; the formula n=F / N is used as the core calculation basis. See the following example for details: When F=6Hz, the number of time slices per unit time can be 1, 2, or 3, respectively forming the output pulse sequence of the ear electrode: { The actual stimulation effect is as follows: When N=1 (the length of the time slice is the unit time), and Each ear electrode will be stimulated 6 times. ; When N=2, and Each ear electrode will be stimulated 3 times. ; When N=3 and Each ear electrode will be stimulated twice. .

[0031] When initiating stimulation, N=1 can be set per unit time, activating the auditory nerve through 6 consecutive stimulations. After activation, the number of time slices per unit time can be increased, such as setting N to 2 or 3, to reduce the number of stimulations within each time slice, thereby reducing the stimulation intensity. However, the present invention does not impose any limitations on this. In other embodiments, N=2 can also be set when initiating stimulation, activating the auditory nerve with 3 consecutive pulses, and then N=3 can be set to reduce the number of stimulations within each time slice.

[0032] In this embodiment, as the number of time slices N increases, the physical duration of each time slice will shorten, and each ear will receive a high-frequency cyclical pattern of "brief stimulation - brief rest - brief stimulation - brief rest...". Providing a very short rest after each stimulation can effectively slow down the speed at which the nerves adapt to the stimulation, thereby significantly improving user tolerance and reducing discomfort without changing the stimulation frequency.

[0033] In this embodiment, for each electrode, the stimulation frequency is a preset fixed frequency, which remains unchanged after stimulation is initiated. That is, the stimulation frequency in this embodiment is a fixed frequency with a limited number of selectable levels, such as 5Hz, 10Hz, 20Hz, etc. provided by the device. The stimulation frequency does not change when stimulation begins, and the binaural electrodes complete the alternating stimulation process simultaneously based on the selected frequency level.

[0034] In embodiments of the present invention, within each time slice, a time delay with zero stimulation current is provided before and / or after the stimulation of the corresponding stimulation period. This time window, or time limit, is used to ensure that the stimulation current does not form a loop in the head, thus ensuring the safety of the stimulation. Preferably, during electrode stimulation, a detection circuit (isolated output channel circuit) can detect whether a single-segment stimulation pulse for one ear electrode has been completed. Once stimulation of that ear electrode is finished, the output on that side is immediately stopped, and after a preset time delay, stimulation is applied to the other ear electrode within the same time period. This time delay can also be directly integrated into the output pulse waveform as an inherent part of the waveform. The time delay... The specific duration can be determined by clinical trials and can be set by embedded software in the ear stimulation device.

[0035] It should be noted that the stimulation output forms of the electrodes in this invention include, but are not limited to, constant current electrical stimulation forms such as pulsed, square wave, and constant current intermittent output. All electrical stimulation forms that can achieve auditory nerve modulation are applicable to the binaural time-division stimulation method of this invention. It should also be noted that for the constant current stimulation waveform, the horizontal axis represents time, and the vertical axis represents voltage / level. During operation, the output current remains constant and is unaffected by changes in operating conditions.

[0036] Example 2 The difference between this embodiment and Embodiment 1 is that the stimulation frequency in this embodiment can be adjusted in real time, achieving dual adjustment of both frequency and the number of time slices per unit time. Compared to Embodiment 1, this dual adjustment method offers greater flexibility.

[0037] In this embodiment, based on the adjusted target stimulation frequency F, the number of time slices that can be divided into per unit time for each electrode and the number of stimulations output by the corresponding electrode in each time slice can be calculated, thereby realizing real-time adjustment of the stimulation frequency and adapting to more application scenarios.

[0038] In this embodiment, for each electrode, the stimulation frequency is a variable stimulation frequency. Before starting stimulation, the following steps are included: The stimulation frequency of each electrode is adjusted separately, and a mapping relationship between the adjusted stimulation frequency and the sequence of stimulation pulse counts is established.

[0039] Specifically, stimulation frequency The adjustment range is Based on comprehensive clinical effectiveness, stimulation frequency The preset frequency is usually within 1~100Hz, but can be dynamically adjusted according to product iterations.

[0040] Then, establish the stimulation frequency. The mapping relationship with the stimulation pulse number sequence, i.e., based on the stimulation frequency set by the user. The system automatically decomposes the time into multiple usable time slices N, which can be divided into units of time (in practice, the final number of usable time slices N should be as large as possible), and finally generates the stimulation pulse sequence corresponding to each time slice. To create different stimulation frequencies Corresponding to different stimulus pulse sequences The effect. Among them, the number of stimulation pulses. As the number of time slices N increases, it eventually shows a decaying trend.

[0041] After stimulation is initiated, based on the mapping relationship between the adjusted stimulation frequency and the number of stimulations, the corresponding time slice and the number of stimulation pulses corresponding to the time slice are matched, and the binaural electrodes perform alternating stimulation based on the matched time slice and the number of stimulation pulses.

[0042] The number of time slices per unit time period can be determined through methods including, but not limited to, using a frequency-segmentation mapping table pre-set according to the clinical scenario, or a dynamic adjustment algorithm based on the user's skin impedance / tolerance. The key is that the number of time slices N per unit time period is a positive integer and matches the time-division stimulation frequency. Regarding the segmentation of time slices, this embodiment provides a segmentation method based on frequency... The method for factoring is as follows: Stimulus frequency of prime numbers Using the number of hold pulses = Frequency of composite numbers Factorization can be used ( The method to obtain the minimum number of stimulation pulses and number of segments Preferably, We should try to choose the largest possible number from the finite factorization, that is... for The largest factor; correspondingly, In factorization, it will be the smallest possible number; that is, when N = At that time, the number of electrode stimulations on one ear n= .

[0043] Table 1 shows the minimum number of stimulation pulses obtainable by factorization from frequencies of 1 to 25 Hz. and number of segments The actual number of stimulation pulses on one ear gradually decreases as the number of time slices N increases, thus ensuring the effectiveness of the patient's regulation while reducing the user's tolerance requirements, thereby improving patient compliance.

[0044]

[0045] in, The stimulation frequency of the variable electrodes. is the sequence of stimulation pulses output by the electrode for each time slice per unit time, where j is the index of the frequency. The minimum number of stimulus pulses that can be allocated corresponds to the number of time slices. . The maximum number of time slices that can be divided is . The largest true factor.

[0046] Based on the above analysis, the frequency-division alternating stimulation implementation method proposed in this invention can match the time slices (e.g., N=) within a unit time period according to the user-preset target frequency. This process generates a corresponding attenuated pulse sequence. The frequency conversion scheme supports dynamic adjustment of the stimulation frequency, allowing for flexible settings based on different application scenarios such as clinical treatment and home-based relaxation. This enables the device to adapt to more ear nerve stimulation scenarios, effectively expanding its applicability. Simultaneously, the scheme ensures the continuity of alternating high-frequency stimulation in both ears under frequency conversion mode, achieving highly efficient stimulation effects.

[0047] In this embodiment, the constant current output module ensures that the two ear electrode channels output stimulation independently, and that the two channels are isolated from each other, with no signal interference. Specifically, as shown... Figure 4 As shown, the constant current output module also includes a CPU processing unit that connects the two electrode paths. Each electrode path includes: an isolated output circuit channel, a constant current control circuit channel, an electrode corresponding to the ear, a differential impedance detection circuit channel, and an isolated input circuit channel connected in series.

[0048] The isolated output channel incorporates a built-in stimulation state detection sub-circuit, connected in series between the constant current control circuit and the ear electrodes. This sub-circuit samples the current output current of the current channel in real time. When the current returns to zero (i.e., the preset pulse output is complete), a termination signal is sent to the CPU processing unit, ensuring no overlap in stimulation output between the two channels. This detection sub-circuit is an integral part of the isolated output channel. Specifically, the stimulation state detection sub-circuit can be a zero-crossing detection circuit.

[0049] The constant current control channel is the core driving module for stimulation output. The CPU processing unit presets a fixed output current (typically a minimum effective current of 0.1mA, with a human safety upper limit of 5mA). Through a constant current chip and feedback adjustment circuit, it compensates in real time for current fluctuations caused by changes in skin impedance. Regardless of how human skin impedance varies within a certain range (typically 0.5kΩ~20kΩ), the electrode output current remains constant, ensuring that the stimulation intensity is up to standard and stable, avoiding stinging or ineffective stimulation due to current fluctuations.

[0050] The differential impedance detection channel, serving as a functional module for skin impedance adaptation, uses a differential amplifier circuit to monitor the loop impedance formed by the electrode and the skin in real time. It accurately identifies impedance differences caused by factors such as skin dryness / wetness and stratum corneum thickness, and can quickly determine abnormal states such as short circuits (where impedance ≈ 0). The detected impedance data is transmitted to the CPU in real time, providing a voltage adjustment basis for the feedback regulation circuit in the constant current control channel (V = I × R, where V is the CPU output voltage, I is the required constant current, and R is the user's skin impedance). This ensures adaptation to different user skin conditions within a safe voltage range (generally ≤ 20V), and triggers circuit protection to stop stimulation output in the event of a short circuit.

[0051] In another embodiment of the invention, the binaural time-division stimulation system further includes a frequency input module for adjusting the stimulation frequency output by each electrode.

[0052] Based on the aforementioned circuit, this invention features an isolated, independent output design for both ear electrodes. The module also has an output status detection function, allowing it to output to the other ear electrode only after outputting to one side. This time delay effectively ensures that the stimulation pulse does not form a loop in the body. Furthermore, the differential impedance detection channel module in this system can identify the skin impedance within the loop. Based on the different skin impedance levels of different individuals, the output voltage is adjusted within a safe and controllable range while ensuring stable output current, thus adapting to varying skin impedance levels and ensuring effective stimulation even when individuals have different skin impedances.

[0053] Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort should fall within the scope of protection of the present invention.

Claims

1. A binaural time-division stimulation system, characterized in that, The binaural time-division stimulation system, applicable to two independent electrode pathways connecting both ears and their corresponding stimulation timing, includes: The stimulation timing processing module is used to acquire preset stimulation parameters and unit time, and to synchronously and parallelly process the stimulation timing of the two electrode pathways. The synchronous and parallel processing includes: dividing the unit time into one or more time slices of equal length; dividing each time slice into a first time slice and a second time slice; configuring the first time slice of one pathway as the stimulation period of the first side electrode, and configuring the second time slice of the other pathway as the stimulation period of the second side electrode, forming a stimulation control signal to cause the bilateral ear electrodes to alternately stimulate within each time slice; when performing alternating stimulation, for each electrode, the number of time slices per unit time is negatively correlated with the number of stimulations output within each time slice. After the ear nerve is activated, the number of time slices per unit time is gradually increased, and the number of stimulations within each time slice is reduced to decrease the stimulation intensity. The constant current output module includes two independent and isolated electrode paths, each path being connected to an ear electrode on one side. It is used to drive the corresponding path to independently output a constant current stimulation waveform according to the stimulation control signal of the stimulation timing processing module.

2. The binaural time-division stimulation system according to claim 1, characterized in that, The stimulation parameters include at least the stimulation frequency of each electrode; in the stimulation timing processing module, the stimulation frequency of each electrode, the number of time slices per unit time, and the corresponding number of stimulation outputs from the ear electrode satisfy the following relationship: ； Where N is the number of time slices per unit time. F represents the number of stimulations output by the electrode for each time slice per unit time, and F is the stimulation frequency of the electrode. The stimulation frequencies of the two electrodes are the same.

3. The binaural time-division stimulation system according to claim 2, characterized in that, For each electrode, the stimulation frequency is a preset fixed frequency, and the stimulation frequency remains unchanged after stimulation is initiated.

4. The binaural time-division stimulation system according to claim 2, characterized in that, For each electrode, the stimulation frequency is a variable stimulation frequency, and the following steps are included before stimulation is initiated: The stimulation frequency of each electrode is adjusted separately, and a mapping relationship between the adjusted stimulation frequency and the sequence of stimulation pulse counts is established.

5. The binaural time-division stimulation system according to claim 4, characterized in that, When the stimulation frequency is adjusted, the corresponding number of time slices per unit time and the corresponding number of stimulations of the ear electrodes are matched based on the mapping relationship between the adjusted stimulation frequency and the stimulation number sequence. The ear electrodes are then used to alternately stimulate based on the matched time slices and stimulation numbers.

6. The binaural time-division stimulation system according to claim 1, characterized in that, Within each time slice, a time delay with zero stimulation current is set before and / or after the stimulation of the corresponding stimulation period.

7. The binaural time-division stimulation system according to claim 1, characterized in that, The constant current output module also includes a CPU processing unit that connects the two electrode paths. Each electrode path includes, in series, an isolated output circuit channel, a constant current control circuit channel, an ear-corresponding side electrode, a differential impedance detection circuit channel, and an isolated input circuit channel.

8. The binaural time-division stimulation system according to claim 7, characterized in that, The isolated output circuit channel is equipped with a stimulation state detection sub-circuit, which is connected in series between the constant current control circuit channel and the ear electrode to sample the output current state of the current channel in real time.

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