Nerve stimulation device
By using multiplexed electrodes in the neurostimulation device to provide positive and negative stimulation signals and short-circuit charge elimination, combined with sparse acquisition and historical data adjustment, the problems of hysteresis, individual differences and energy limitations of the neurostimulation device are solved, achieving real-time feedback and extending the device's lifespan.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-12
- Publication Date
- 2026-03-13
AI Technical Summary
Existing neurostimulation devices suffer from problems such as delayed stimulation effects, large individual differences, lack of objective physiological feedback, difficulty in acquiring evoked potentials, charge accumulation and polarization effects, and energy limitations, resulting in poor treatment effects and shortened device lifespan.
Multiplexed electrodes are used for positive and negative stimulation signals and short-circuit charge elimination. Combined with sparse acquisition and historical data adjustment, stimulation parameters are optimized through evoked potential feedback. Batteries and energy transmission modules are used to extend the device's lifespan.
It enables real-time and accurate feedback of stimulation effects, reduces charge accumulation, extends device life, and improves the personalization and effectiveness of treatment.
Smart Images
Figure CN121648466A_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical devices, and more specifically, to a nerve stimulation device. Background Technology
[0002] Neurostimulation has become a relatively common treatment method, used in the diagnosis and treatment of various diseases. For example, electrical stimulation of peripheral or central nervous system structures such as the vagus nerve, sacral nerve, dorsal root ganglion of the spinal cord, trigeminal nerve, and glossopharyngeal nerve can be used to treat neurological diseases such as epilepsy, depression, Parkinson's disease, migraine, chronic inflammation, obesity, hypertension, and heart failure. However, several significant drawbacks exist in clinical application: 1. Delayed stimulation effects and large individual variability: Taking vagus nerve stimulation (VNS) as an example, its anti-epileptic or antidepressant effects usually take weeks or even months to appear, and different patients respond significantly differently to the same stimulation parameters, making it difficult for doctors to determine whether the current parameters are effective; 2. Lack of objective physiological feedback indicators: Currently, clinical practice mainly relies on patient subjective reports or behavioral observations (e.g., for epilepsy). The efficacy of treatment is assessed using metrics such as seizure frequency and mood scales, but objective, real-time, and quantifiable physiological indicators are lacking as feedback. 3. Difficulty in acquiring evoked potentials: Although theoretically evoked potentials can serve as objective indicators of neural response, their amplitude is usually only one-thousandth or even lower than the stimulus signal, and is severely interfered with by stimulus wake and electrode polarization effects. Especially in implantable devices, limited by size, power consumption, and analog front-end noise, traditional amplifiers struggle to acquire clear evoked potential signals immediately after stimulation. 4. Charge accumulation and polarization effects: Long-term stimulation leads to charge accumulation at the electrode-tissue interface, forming polarization voltage, further masking the evoked potential signal, and even causing tissue damage or electrode corrosion. 5. Inconsistency between energy limitations and acquisition frequency: Implantable devices typically rely on batteries or wireless power, with extremely limited energy budgets. While high-frequency acquisition of evoked potentials helps improve feedback accuracy, it significantly shortens battery life or exceeds the safe power threshold for wireless power. To address one or more of these problems, this application proposes a neurostimulation device. Summary of the Invention
[0003] This application provides a nerve stimulation device, comprising: The system comprises a control unit, a stimulation signal generation circuit, a signal acquisition circuit, and a multiplexed electrode. The stimulation signal generation circuit generates a stimulation signal and applies it to a target nerve via the multiplexed electrode. The stimulation signal includes a positive signal and a negative signal. The signal acquisition circuit is configured to acquire evoked potentials generated on the target nerve by the stimulation signal via the multiplexed electrode. After the stimulation signal generated by the stimulation signal generation circuit is applied to the target nerve, the control unit can adjust the parameters of subsequent stimulation signals based on the evoked potentials.
[0004] Optionally, the neurostimulation device of this application may include at least one pair of multiplexed electrodes. The multiplexed electrodes can be of any suitable shape and orientation, as long as they can be configured to generate an electric field within the patient's body. The multiplexed electrodes may also include any suitable conductive material, such as copper, silver, gold, platinum, iridium, platinum-iridium, platinum-gold, conductive polymers, or combinations of conductive materials. In some embodiments, the multiplexed electrodes may include short-wire electrodes, wound electrodes, circular electrodes, and / or pairs of circular electrodes, etc. Additionally, the neurostimulation device of this application may include multiplexed electrodes located at multiple sites.
[0005] The neurostimulation device of this application may be implantable, non-implantable, or semi-implantable.
[0006] Optionally, in the neurostimulation device of this application, the control unit is configured to short-circuit the positive and negative terminals of the multiplexed electrode before acquiring the evoked potential, thereby eliminating accumulated charge. Further, the integrals of the amplitudes of the positive and negative signals over time are equal; or the positive and negative signals are signals with the same amplitude, opposite directions, and equal time.
[0007] Optionally, in the neural stimulation device of this application, the waveform of the stimulation signal is a square wave, a triangular wave, a sawtooth wave, a sine wave, or a cosine wave.
[0008] Optionally, in the neurostimulation device of this application, the stimulation device can selectively perform signal acquisition, such that the ratio of the number of signal acquisitions to the number of stimulation signal transmissions is within a preset ratio range. Preferably, the preset ratio is not less than 1:1000, more preferably not less than 1:100, to ensure that the sampling is not too sparse. Further, the preset ratio does not exceed 1:5, more preferably, the preset ratio does not exceed 1:8, to avoid frequent signal acquisition significantly shortening battery life (signal amplification is required during signal acquisition, which consumes a lot of energy). It is understood that the preset ratio range can be a fixed range or adjusted based on historical data.
[0009] Optionally, in the neurostimulation device of this application, the stimulation device triggers signal acquisition based on information detected from an abnormal physiological event.
[0010] Optionally, in the neurostimulation device of this application, the stimulation device dynamically adjusts the frequency of signal acquisition according to the historical evoked potential change trend.
[0011] Optionally, in the neurostimulation device of this application, the adjustment of subsequent stimulation signal parameters based on evoked potentials includes: eliminating a basic evoked potential from the evoked potentials, obtaining an incremental evoked potential, and using the incremental evoked potential as a response to the stimulation signal to adjust the subsequent stimulation signal parameters; wherein the basic evoked potential is acquired on the target nerve using a signal acquisition circuit before the stimulation signal is applied, or the characteristics of the basic evoked potential are obtained by recording the basic evoked potential before stimulation.
[0012] Optionally, in the neural stimulation device of this application, the positive signal and the negative signal are repeated several times within one stimulation cycle.
[0013] Optionally, the neurostimulation device of this application may also include a battery and / or an unlimited energy transmission module.
[0014] The exemplary embodiments of this application may have some or all of the following beneficial effects: By using positive and negative stimulation signals, the accumulation of charge is greatly reduced, and the duration of the long-tail effect of the stimulation signal is significantly shortened. By setting the time interval between the evoked potential and the stimulation signal in a stimulation cycle, the influence of the long-tail effect of the stimulation signal on the evoked potential is eliminated. While ensuring the stimulation effect, timely feedback on the stimulation signal is obtained. The stimulation signal can be adjusted through the evoked potential to improve the effectiveness of the stimulation.
[0015] By short-circuiting the connection, the accumulated charge can be eliminated, which can further improve the quality of the acquired signal. By using sparse sampling, energy consumption is reduced, battery life is extended, or power limits for safe energy transfer are met; the feedback sampling ratio can also be adjusted in a personalized manner using historical data.
[0016] By using the difference between evoked potentials before and during stimulation as the response value of the stimulus signal, the baseline evoked potentials caused by other reasons are eliminated, which more accurately reflects the evoked potentials generated by the stimulus signal. Some interference information is eliminated, making the feedback and parameter adjustment more accurate.
[0017] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description
[0018] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort.
[0019] Figure 1 A schematic diagram of the stimulation cycle of the nerve stimulation device of this application is shown; Figure 2 The comparison between the stimulation cycle of the neural stimulation system of this application and the prior art shows that the duration of the long-tail effect is significantly shortened, i.e., t2 is significantly less than t1; Figure 3 A schematic diagram illustrating the principle of the neural stimulation system of this application for eliminating basic evoked potentials is shown. Detailed Implementation
[0020] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore their detailed descriptions will be omitted. Furthermore, the drawings are merely illustrative of this application and are not necessarily drawn to scale.
[0021] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of an icon to another, these terms are used only for convenience, such as according to the orientation of the examples in the accompanying drawings. It is understood that if the device of the icon is flipped so that it is upside down, the component described as "upper" will become the component described as "lower." When a structure is "upper" of another structure, it may mean that the structure is integrally formed on the other structure, or that the structure is "directly" mounted on the other structure, or that the structure is "indirectly" mounted on the other structure through another structure.
[0022] The terms “a,” “one,” “the,” and “at least one” are used to indicate the existence of one or more elements / components / etc.; the terms “including” and “having” are used to indicate an open-ended inclusion and to mean that there may be other elements / components / etc. in addition to the listed elements / components / etc.; the terms “first” and “second” are used only as markers and are not a limitation on the number of objects. Example
[0023] Reference Figure 1One embodiment of this application discloses a neurostimulation device, comprising a stimulation unit, a stimulation signal generation circuit, a signal acquisition circuit, and a multiplexed electrode. The stimulation unit is configured to generate a stimulation signal and apply it to a target nerve via the multiplexed electrode. The signal acquisition circuit is configured to acquire evoked potentials generated on the target nerve by the stimulation signal via the multiplexed electrode. After the stimulation signal generated by the stimulation signal generation circuit is applied to the target nerve, the stimulation unit can adjust subsequent stimulation signal parameters based on the evoked potentials. Further, the adjustment includes eliminating a basic evoked potential from the evoked potentials, obtaining an incremental evoked potential, and using the incremental evoked potential as a response to the stimulation signal to adjust subsequent stimulation signal parameters.
[0024] The stimulation signal generation circuit and signal acquisition circuit are connected to the multiplexed electrodes via a switch (not shown). The stimulation signal generated by the stimulation signal generation circuit includes both positive and negative signals, ensuring that the absolute value of the signal amplitude integral over time is the same; that is, the area of the positive signal is equal to the area of the negative signal. It can be understood that the equality of the absolute values of the positive and negative signals does not limit the amplitude, pulse width, waveform, or number of pulses; for example, the number of pulses for the positive signal can differ from the number of pulses for the negative signal. Based on received command information or preset information, the control unit controls the stimulation signal generation circuit to generate stimulation signals. These stimulation signals are applied to the target nerve through the multiplexed electrodes. During stimulation, an analog switch connects the stimulation signal generation circuit to the multiplexed electrodes, while disconnecting the signal acquisition circuit from the multiplexed electrodes. The application of both positive and negative signals reduces charge accumulation, shortening the duration and amplitude of the tail.
[0025] refer to Figure 2 The control unit is configured to short-circuit the positive and negative electrodes of the multiplexed electrode before acquiring the evoked potential, eliminating accumulated charge and making t2 significantly less than t1. A short circuit between the two electrodes of the multiplexed electrode is achieved through the setting of an analog switch. The multiplexed electrode can be configured as one or more pairs for applying stimulation to one or more target nerves and acquiring signals.
[0026] Within a stimulation cycle, the positive signal and the negative signal are repeated a number of times. For example, a stimulation cycle includes 4 positive signals and 4 negative signals.
[0027] Stimulation signal parameters may include stimulation amplitude, pulse sequence length, single pulse frequency, single pulse duration, target stimulation amplitude, hold duration, pulse sequence interval, duty cycle, and / or delay time. In one embodiment, the initial stimulation signal parameters are: current amplitude: 0.8 mA, pulse width: 100 μs, frequency: 30 Hz, and stimulation duration: 0.5 seconds; the stimulation signal parameters are then adjusted based on these parameters.
[0028] The stimulation device can selectively perform signal acquisition, ensuring that the ratio of signal acquisition frequency to stimulation signal transmission frequency is within a preset range. Preferably, the preset ratio is not less than 1:1000, more preferably not less than 1:100, to ensure that sampling is not too sparse. Further, the preset ratio does not exceed 1:5, more preferably not more than 1:8, to avoid frequent signal acquisition which significantly shortens battery life (signal amplification is required during signal acquisition, a process with high energy consumption). Reducing the number of signal acquisitions can effectively reduce energy consumption, extend battery life, or reduce the power of wireless power transmission.
[0029] The preset ratio can be a fixed value based on statistical data, or a personalized, variable empirical value based on previous data of an individual.
[0030] See attached document Figure 3 The stimulation device adjusts subsequent stimulation signal parameters based on evoked potentials, including: eliminating the cancellation of a basic evoked potential from the evoked potentials, acquiring an incremental evoked potential, and using the incremental evoked potential as a response to the stimulation signal to adjust the subsequent stimulation signal parameters; wherein, the basic evoked potentials are acquired on the target nerve using a signal acquisition circuit before the stimulation signal is applied. The basic evoked potentials can be characterized by evaluation using the basic evoked potentials recorded before stimulation, thereby eliminating the basic evoked potentials through characteristic parameters after stimulation begins.
[0031] For example, the system can also employ a differential induced potential algorithm: ΔEP(n) = EP_stim(n) - EP_baseline(n) Where: EP_stim(n): the average potential collected within 5–20 ms after the nth stimulus; EP_baseline(n): Baseline potential acquired within 100 ms before stimulation; ΔEP(n): As the effective response to this stimulus, it is used to adjust the stimulus signal parameters.
[0032] Based on the foregoing embodiments, the neurostimulation device of this application further includes a battery and / or an unlimited energy transmission module.
[0033] Based on the foregoing embodiments, the neurostimulation device of this application further includes a communication module for communicating with external devices and transmitting data. The external devices may include those configured to communicate with the stimulation device and / or transmit energy, perform human-computer interaction, and set stimulation protocols.
[0034] Other embodiments of this application will readily conceive of by those skilled in the art upon consideration of the specification and practice of the embodiments thereof. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not claimed in this application. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of this application are indicated by the appended claims.
Claims
1. A nerve stimulation device, characterized in that, include: The system comprises a control unit, a stimulation signal generation circuit, a signal acquisition circuit, and a multiplexed electrode. The stimulation signal generation circuit generates a stimulation signal and applies it to a target nerve via the multiplexed electrode. The stimulation signal includes a positive signal and a negative signal. The signal acquisition circuit is configured to acquire evoked potentials generated on the target nerve by the stimulation signal via the multiplexed electrode. After the stimulation signal generated by the stimulation signal generation circuit is applied to the target nerve, the control unit can adjust the parameters of subsequent stimulation signals based on the evoked potentials. The adjustment includes eliminating a basic evoked potential from the evoked potentials, obtaining an incremental evoked potential, and using the incremental evoked potential as a response to the stimulation signal to adjust the parameters of subsequent stimulation signals.
2. The nerve stimulation device according to claim 1, characterized in that, The control unit is configured to short-circuit the positive and negative terminals of the multiplexed electrode before acquiring the evoked potential.
3. The nerve stimulation device according to claim 1, characterized in that, The integrals of the amplitudes of the positive and negative signals over time are equal.
4. A nerve stimulation device according to claim 3, characterized in that, The positive signal and the negative signal are signals with the same amplitude, opposite direction, and equal time.
5. A nerve stimulation device according to claim 3, characterized in that, The waveform of the signal is a square wave, a triangular wave, a sawtooth wave, a sine wave, or a cosine wave.
6. A nerve stimulation device according to claim 1, characterized in that, The stimulation device can selectively perform signal acquisition, so that the ratio of the number of signal acquisitions to the number of stimulation signal transmissions is within a preset range.
7. A nerve stimulation device according to claim 6, characterized in that, The preset ratio range is a fixed range.
8. A nerve stimulation device according to claim 6, characterized in that, The stimulation device triggers signal acquisition based on the detection of information about abnormal physiological events.
9. A nerve stimulation device according to claim 6, characterized in that, The stimulation device dynamically adjusts the frequency of signal acquisition based on historical evoked potential changes.
10. A nerve stimulation device according to claim 1, characterized in that, The basic evoked potentials are acquired on the target nerve using the signal acquisition circuit before the stimulation signal is applied.