Individualized auricular vagus nerve stimulation device based on electroencephalogram feedback

Abstract

The application discloses an individualized ear vagus nerve stimulation device based on electroencephalogram feedback, relates to the technical field of ear vagus nerve stimulation, and comprises a general control computer, wherein the general control computer is electrically connected with an acquisition module and a generating module; the acquisition module comprises an electroencephalogram collector; the electroencephalogram collector is used for collecting electroencephalogram response indexes in a stimulation process of a subject and feeding back to the general control computer; the generating module comprises a stimulation probe and a driving assembly; the driving assembly is used for adjusting the ear-adhesion pressure of the stimulation probe; the stimulation probe comprises a thin film pressure sensor and an electrode piece; the traditional single ear vagus nerve stimulation is combined with the brain-computer interface to acquire electroencephalogram signals of the subject; the electroencephalogram collector is used for acquiring electroencephalogram signal data of the subject in real time; and the individualized effective stimulation parameters are screened or determined to have an effect on the subject, so that targeted stimulation can be carried out, and the awakening auxiliary effect is better.

Description

Technical Field

[0001] This invention relates to the field of auricular vagus nerve stimulation technology, and more particularly to a personalized auricular vagus nerve stimulation device based on electroencephalographic feedback. Background Technology

[0002] For patients with impaired consciousness, including those in coma, unresponsive awakening syndrome / vegetative state, and minimally conscious state, auricular vagus nerve stimulation (AVS) can be effective in promoting arousal. However, existing AVS devices, when used for arousal assistance or neuromodulation parameter optimization, suffer from fixed stimulation parameters, lack of EEG response feedback, difficulty in individualized parameter selection, and inability to balance efficacy and safety in patients without active feedback. This results in insufficient stimulation consistency and safety. Furthermore, because subjects with impaired consciousness cannot provide feedback, including comfort or discomfort, a certain clamping force is usually applied to the ear during AVS to ensure the electrodes fully adhere to the ear wall skin for effective electrical stimulation. If the force is too great, it can easily damage the subject's ear due to the inability to provide active feedback. In patients without active feedback, efficacy and safety cannot be simultaneously achieved, and the fixed clamping pressure cannot be adapted to individual differences in electrical coupling. Therefore, in order to solve the above problems, this application proposes a personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback. Summary of the Invention

[0003] This invention provides a personalized auricular vagus nerve stimulation device based on electroencephalogram (EEG) feedback. The device collects effective stimulation parameters generated by the patient during auricular vagus nerve stimulation through a data acquisition module, and then uses a generation module to provide targeted stimulation to assist in awakening, thereby solving the aforementioned technical problems. To solve the above-mentioned technical problems, the present invention provides a personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback, comprising a central control computer, wherein the central control computer is electrically connected to a data acquisition module and a data generation module; The acquisition module includes an EEG acquisition device, which is used to acquire the EEG response indicators of the subject during stimulation and feed them back to the central control computer. The generating module includes a stimulation probe and a driving component, wherein the driving component adjusts the pressure of the stimulation probe against the ear. The stimulation probe includes a thin-film pressure sensor and an electrode pad. The thin-film pressure sensor provides feedback on the contact pressure of the stimulation probe, and the electrode pad outputs electrical stimulation to the ear.

[0004] Preferably, the generating module includes a housing, with a hollow arm inserted into each of the two sides of the housing. The stimulation probe is fixedly connected to the end of the hollow arm. A partition is fixedly connected inside the housing. The driving component is installed inside the housing. A self-control component is installed inside the housing. The self-control component is located above the driving component, and the partition is located between the driving component and the self-control component.

[0005] Preferably, the stimulation probe further includes a rigid backplate, which is fixedly connected to the end of the hollow arm rod. An airbag is fixedly connected to the outside of the rigid backplate. The thin-film pressure sensor is attached to the outer wall of the airbag. An insulating film is attached to the outer wall of the airbag. The thin-film pressure sensor is located between the airbag and the insulating film. The electrode sheet is attached to the outside of the insulating film.

[0006] Preferably, both the rigid backplate and the airbag have wiring holes, the two wiring holes are interconnected, and the wiring hole on the rigid backplate is connected to the interior of the hollow arm.

[0007] Preferably, the drive assembly includes a dual-axis motor, which is fixedly connected to the bottom of the inner part of the housing. Both ends of the output shaft of the dual-axis motor are fixedly connected to threaded rods. The ends of the threaded rods are movably connected to the inner sidewall of the housing. The outer end of the threaded rod is threadedly connected to a connecting block, which is fixedly connected to the bottom of the end of the hollow arm.

[0008] Preferably, the threads on the two threaded rods are opposite, and the portion of the hollow arm inserted into the housing is located below the partition.

[0009] Preferably, the automatic control component includes a control chip and a battery, both of which are fixedly connected to the top of the partition, with the control chip located on one side of the battery.

[0010] Preferably, the self-control component further includes a clamping button and a releasing button, both of which are fixedly connected to the front side of the housing. The clamping button is located on the side of the releasing button, and the stimulation probe, driving component, battery, clamping button, and releasing button are all electrically connected to the control chip.

[0011] Preferably, a wiring port is provided at the top center of the partition, and the wiring port is located between the control chip and the battery.

[0012] Compared with related technologies, the personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback provided by this invention has the following beneficial effects: 1. By combining traditional single vagus nerve stimulation with brain-computer interface to collect the subject's EEG signals, the subject's EEG signal data is collected in real time through an EEG collector. Individualized effective stimulation parameters are then selected or determined to have an effect on the subject, thus enabling targeted stimulation and better arousal assistance.

[0013] 2. By integrating a thin-film pressure sensor into the stimulation probe, along with a drive assembly and a self-control assembly, the risk of pressure injury is reduced, the stability of electrode fit is improved, poor contact is reduced, and repeatable pressure control is achieved. This ensures that the electrode pads fit fully against the subject's ear wall and avoids damage to the subject's ear due to excessive pressure, making it convenient and safer to use. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the system structure of the present invention; Figure 2 This is a schematic diagram of the EEG acquisition device of the present invention; Figure 3 This is a schematic diagram of the generation module structure of the present invention; Figure 4 This is a partial cross-sectional view of the generating module of the present invention; Figure 5 This is a schematic diagram of the hollow boom structure of the present invention; Figure 6 This is an exploded view of the stimulation probe of the present invention.

[0015] Numbered in the diagram: 1. Central control computer; 2. Acquisition module; 21. EEG acquisition device; 3. Generating module; 31. Outer shell; 32. Hollow arm; 33. Stimulation probe; 331. Rigid backplate; 332. Airbag; 333. Thin-film pressure sensor; 334. Insulating membrane; 335. Electrode plate; 336. Wire hole; 34. Partition plate; 35. Drive assembly; 351. Dual-axis motor; 352. Threaded rod; 353. Connecting block; 36. Automatic control assembly; 361. Control chip; 362. Battery; 363. Clamping button; 364. Releasing button; 37. Wire hole. Detailed Implementation

[0016] Please see Figure 1-6 The technical solution provided by the present invention specifically includes the following embodiments:

[0017] A personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback includes a central control computer 1, which is electrically connected to a data acquisition module 2 and a data generation module 3.

[0018] The acquisition module 2 includes an EEG acquisition device 21, which is used to acquire the EEG response indicators of the subject during the stimulation process and feed them back to the central control computer 1.

[0019] The generation module 3 includes a stimulation probe 33 and a driving component 35, wherein the driving component 35 adjusts the pressure of the stimulation probe 33 against the ear.

[0020] The stimulation probe 33 includes a thin-film pressure sensor 333 and an electrode 335. The thin-film pressure sensor 333 provides feedback on the contact pressure of the stimulation probe 33, and the electrode 335 outputs electrical stimulation to the ear.

[0021] The EEG acquisition device 21 can collect the subject's EEG response indicators, such as frequency band power, frequency band power ratio, EEG complexity, functional connectivity, event-related potentials, etc. It performs baseline acquisition, stimulation parameter scanning, feature extraction, threshold judgment / model discrimination, and selection of optimal parameters. When the activation module 3 stimulates the subject's auricular vagus nerve, the EEG acquisition device 21 collects the subject's EEG response in real time, screens or determines individualized effective stimulation parameters to achieve the desired effect on the subject. In conjunction with the drive component 35 and stimulation probe 33, the central control computer 1, based on the neural recruitment efficiency, makes the clamping force smaller and the stimulation current smaller under the same therapeutic effect, ensuring both efficacy and safety for subjects without feedback.

[0022] Pre-set the target EEG response threshold, the upper limit of the contact pressure, and the upper limit of the stimulation current. Within the safe pressure range, apply a small perturbation to the contact pressure and record the ratio of "EEG response / stimulation current" at each pressure point, i.e., the neural recruitment efficiency. Adjust the contact pressure perturbation / hill climbing optimization along the direction of increasing neural recruitment efficiency until the efficiency converges, and lock the individualized optimal contact pressure for the subject. Under the locked contact pressure, gradually increase the stimulation current from the minimum until the EEG response reaches the target response threshold, and then stop to obtain the minimum effective stimulation current. Monitor throughout the process, and if either the contact pressure or the stimulation current reaches the upper limit of the safety, the process will regress and trigger an alarm.

[0023] The generating module 3 includes a housing 31, with a hollow arm 32 inserted into each of the two sides of the housing 31. The stimulation probe 33 is fixedly connected to the end of the hollow arm 32. A partition 34 is fixedly connected inside the housing 31. The driving component 35 is installed inside the housing 31. A self-control component 36 is installed inside the housing 31. The self-control component 36 is located above the driving component 35, and the partition 34 is located between the driving component 35 and the self-control component 36.

[0024] The stimulation probe 33 also includes a rigid backplate 331, which is fixedly connected to the head end of the hollow arm 32. An air bladder 332 is fixedly connected to the outside of the rigid backplate 331. A thin-film pressure sensor 333 is attached to the outer wall of the air bladder 332. An insulating film 334 is attached to the outer wall of the air bladder 332. The thin-film pressure sensor 333 is located between the air bladder 332 and the insulating film 334. An electrode sheet 335 is attached to the outside of the insulating film 334. The air bladder 332 in the stimulation probe 33 has good elasticity and cushioning effect to avoid pressure damage when pressing on the subject's ear. The electrode sheet 335 can stimulate the vagus nerve of the subject. When the stimulation probe 33 presses on the subject's ear wall, the thin-film pressure sensor 333 can detect... The pressure applied to the subject's ear is measured to avoid injury due to excessive pressure, and also to avoid insufficient contact between the electrode pad 335 and the subject's ear wall due to insufficient pressure. The insulating film 334 separates the thin-film pressure sensor 333 and the electrode pad 335, preventing the electrical stimulation signal output by the electrode pad 335 from interfering with or damaging the thin-film pressure sensor 333. Based on the parameters collected by the acquisition module 2, the central control computer 1 performs data analysis and ultimately controls the electrode pad 335 in the generation module 3 to effectively electrically stimulate the subject's vagus nerve with targeted stimulation frequency, current intensity, pulse width, stimulation duration, duty cycle / interval, and other parameters. The surface of the stimulation probe 33 is easy to clean, and the insulating film 334 can not only be used for insulation but also to prevent the seepage of liquids such as sweat.

[0025] Both the rigid backplate 331 and the airbag 332 have wire holes 336. The two wire holes 336 are interconnected, and the wire hole 336 on the rigid backplate 331 is connected to the inside of the hollow arm 32. The wire hole 336 facilitates the guiding of the wires of the electrode plate 335 and the thin film pressure sensor 333 to the inside of the hollow arm 32, and finally through the hollow arm 32 into the inside of the outer shell 31 to connect with the control chip 361.

[0026] The drive assembly 35 includes a dual-axis motor 351, which is fixedly connected to the bottom of the inner casing 31. Both ends of the output shaft of the dual-axis motor 351 are fixedly connected to threaded rods 352. The ends of the threaded rods 352 are movably connected to the inner wall of the casing 31. A connecting block 353 is threadedly connected to the outer end of the threaded rod 352, and the connecting block 353 is fixedly connected to the bottom of the hollow arm 32. The threads on the two threaded rods 352 are opposite. The portion of the hollow arm 32 inserted into the casing 31 is located below the partition 34. When the dual-axis motor 351 drives the two threaded rods 352 to rotate, causing the two connecting blocks 353 to move away from each other, the two hollow arm 32 will also move the two stimulation probes 33 away from each other, making them easy to put on or take off. Conversely, moving them closer together allows the two stimulation probes 33 to be clipped onto the subject's ear. The tightness is automatically adjusted throughout the entire wearing process, requiring no manual adjustment and making it convenient to use.

[0027] The self-control component 36 includes a control chip 361 and a battery 362, as well as a stimulation generation circuit, a pressure signal conditioning circuit, a current detection circuit, a communication module, and a power management module. The electrode 335 is electrically connected to the stimulation generation circuit and outputs electrical stimulation to the ear. The control chip 361 and the battery 362 are both fixedly connected to the top of the partition 34. The control chip 361 is located on one side of the battery 362. The battery 362 supplies power to the control chip 361, the drive component 35, and the stimulation generation circuit through the power management module. The control chip 361 can work with the thin-film pressure sensor 333 and the drive component 35 to automatically adjust the tightness of the stimulation probe 33 on the subject's ear. It can also receive instructions from the central control computer to control the electrode 335 to emit electrical stimulation at a response frequency. The control chip 361 sets the safety threshold of the thin-film pressure sensor 333, which are the first safety threshold and the second safety threshold.

[0028] The self-control component 36 also includes a clamping button 363 and a releasing button 364. Both the clamping button 363 and the releasing button 364 are fixedly connected to the front side of the housing 31. The clamping button 363 is located on the side of the releasing button 364. The stimulation probe 33, the drive component 35, the battery 362, the clamping button 363, and the releasing button 364 are all electrically connected to the control chip 361. When the clamping button 363 is pressed, the drive component 35 can drive the two stimulation probes 33 to move closer to each other and clamp them on the subject's ear. Conversely, the releasing button 364 is used to control the two stimulation probes 33 to move further apart, so that the device can be removed after initial wearing and use.

[0029] A wire passage 37 is provided at the top center of the partition 34. The wire passage 37 is located between the control chip 361 and the battery 362. The wire passing through the hollow arm 32 can pass through the wire passage 37 and connect to the control chip 361. Similarly, the control wire of the dual-axis motor 351 can also pass through the wire passage 37 and connect to the control chip 361.

[0030] Working principle:

[0031] During use, the EEG signal parameters of the subject are collected by the EEG acquisition device 21 in the acquisition module 2, and then the vagus nerve of the subject is stimulated by the generation module 3. During this period, the central control computer 1 controls the generation module 3 to perform electrical stimulation on the subject at different intensities, and the acquisition module 2 collects the subject's EEG response in real time. When the preset EEG response index reaches the threshold, it indicates that the generation module 3 has a significant effect on the subject's vagus nerve stimulation at this intensity, thereby realizing real-time interactive stimulation to promote awakening.

[0032] When wearing the generating module 3, first press the release button 364 once to drive the two hollow arms 32, carrying the two stimulation probes 33, away from each other. Then, initially place the generating module 3 on the subject's ear, i.e., when the stimulation probes 33 are in the inner and outer positions of the concha, press the clamping button 363 again. At this time, the drive assembly 35 will drive the two hollow arms 32, carrying the two stimulation probes 33, closer together until the two stimulation probes 33 are clamped on the ear. As the two stimulation probes 33 continue to approach, the membrane pressure sensor 333 begins to detect pressure signals. When the membrane pressure... Once the pressure signal from the force sensor 333 reaches the set first safety threshold, the drive component 35 immediately stops operating and can output stimulation. If it exceeds the set second safety threshold, it immediately relaxes in the opposite direction or stops continuing electrical stimulation. This ensures that the electrode 335 is fully attached to the ear wall to achieve qualified electrical stimulation, while the stimulation probe 33 does not put too much pressure on the subject's ear to cause discomfort. At the same time, the central control computer will also limit the contact pressure and stimulation current within their respective safety thresholds based on neural recruitment efficiency, so as to achieve the same arousal assistance effect under the minimum pressure and minimum current conditions.

Claims

1. A personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback, comprising a central control computer (1), characterized in that: The central control computer (1) is electrically connected to a data acquisition module (2) and a data generation module (3); The acquisition module (2) includes an EEG acquisition device (21), which is used to acquire the EEG response indicators of the subject during the stimulation process and feed them back to the central control computer (1). The generating module (3) includes a stimulation probe (33) and a driving component (35), wherein the driving component (35) adjusts the pressure of the stimulation probe (33) against the ear. The stimulation probe (33) includes a thin-film pressure sensor (333) and an electrode (335). The thin-film pressure sensor (333) provides feedback on the contact pressure of the stimulation probe (33), and the electrode (335) outputs electrical stimulation to the ear.

2. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 1, characterized in that, The generating module (3) includes a housing (31), with a hollow arm (32) inserted into each side of the housing (31). The stimulation probe (33) is fixedly connected to the end of the hollow arm (32). A partition (34) is fixedly connected inside the housing (31). The driving component (35) is installed inside the housing (31). A self-control component (36) is installed inside the housing (31). The self-control component (36) is located above the driving component (35), and the partition (34) is located between the driving component (35) and the self-control component (36).

3. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 2, characterized in that, The stimulation probe (33) also includes a rigid backplate (331), which is fixedly connected to the head end of the hollow arm (32). An airbag (332) is fixedly connected to the outside of the rigid backplate (331). A thin film pressure sensor (333) is attached to the outer wall of the airbag (332). An insulating film (334) is attached to the outer wall of the airbag (332). The thin film pressure sensor (333) is located between the airbag (332) and the insulating film (334). An electrode sheet (335) is attached to the outside of the insulating film (334).

4. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 3, characterized in that, Both the rigid backplate (331) and the airbag (332) have wire holes (336), the two wire holes (336) are interconnected, and the wire hole (336) on the rigid backplate (331) is connected to the interior of the hollow arm (32).

5. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 2, characterized in that, The drive assembly (35) includes a dual-axis motor (351), which is fixedly connected to the bottom of the housing (31). Both ends of the output shaft of the dual-axis motor (351) are fixedly connected to threaded rods (352). The ends of the threaded rods (352) are movably connected to the inner sidewall of the housing (31). The outer end of the threaded rods (352) is threadedly connected to a connecting block (353), which is fixedly connected to the bottom of the end of the hollow arm (32).

6. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 5, characterized in that, The threads on the two threaded rods (352) are opposite, and the portion of the hollow arm (32) inserted into the housing (31) is located below the partition (34).

7. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 2, characterized in that, The self-control component (36) includes a control chip (361) and a battery (362). The control chip (361) and the battery (362) are both fixedly connected to the top of the partition (34), and the control chip (361) is located on one side of the battery (362).

8. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 7, characterized in that, The self-control component (36) also includes a clamping button (363) and a releasing button (364). The clamping button (363) and the releasing button (364) are both fixedly connected to the front side of the housing (31). The clamping button (363) is located on the side of the releasing button (364). The stimulation probe (33), the drive component (35), the battery (362), the clamping button (363) and the releasing button (364) are all electrically connected to the control chip (361).

9. The personalized vagus nerve stimulation device based on electroencephalogram (EEG) feedback according to claim 7, characterized in that, The partition (34) has a wire passage (37) at the top center, and the wire passage (37) is located between the control chip (361) and the battery (362).

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