Ear edge vagus nerve stimulation device

Abstract

The invention relates to an ear edge vagus nerve stimulation device which comprises stimulation modules of multiple parts, a heart rate measurement module, a data processing module and a control module. The stimulation modules are used for initiating stimulation in different modes in an intensity increasing mode; the heart rate measuring module is used for monitoring heart rate data in real time until the sinus heart rate is reduced, and critical parameters in all modes are obtained; the data processing module is used for calculating adjusting parameters of each stimulation module according to the critical parameters in each mode; and the control module is used for adjusting the stimulation modules according to the adjusting parameters. According to the ear edge vagus nerve stimulation device, stimulation parameters can be automatically fed back and adjusted according to the actual stimulation effect, manual operation of personnel is not needed, the optimal stimulation effect can be achieved, side effects can be reduced, and the ear edge vagus nerve stimulation device is automatic in adjustment, excellent in effect and small in side effects.

Description

Technical Field

[0001] The present invention relates to the field of automatic control, and in particular to an ear edge vagus nerve stimulation device Background Art

[0002] Vagus nerve stimulation (VNS) refers to the technology of stimulating the vagus nerve. It is widely used in the treatment of sepsis, epilepsy, severe depression, obesity, heart failure, tinnitus, migraine, inflammation, anxiety, Alzheimer's disease, drug addiction, cancer, fibromyalgia, autism and other diseases. Based on the anatomical basis, it is shown that stimulating the auricular branch of the vagus nerve can also achieve the same therapeutic effect as stimulating the cervical vagus nerve branch. The auricular branch of the vagus nerve originates from the superior ganglion and is distributed posteriorly and outwardly behind the auricle and the skin of the external auditory canal. Therefore, auricular vagus nerve stimulation has received widespread attention. However, conventional auricular vagus nerve stimulation has the side effect of lowering heart rate and blood pressure, which requires observing the actual stimulation effect in order to continuously adjust the stimulation parameters.

[0003] The invention patent with application number: 202011309805.6 discloses an ear vagus nerve stimulation system, which can stimulate multiple parts of the ear, including: the cymba concha, the triangular fossa, the antihelix, the crus of the helix, and the external auditory canal, etc. At the same time, it can view the vagus nerve stimulation information and heart rate information, PPG waveform, etc. in real time to understand the actual stimulation effect in real time and prevent the risk of tachycardia or bradycardia. The invention patent with application number: CN202311260897.7 discloses an ear vagus nerve stimulation device, which also has a heart rate monitoring module, can monitor ECG signals and HRV analysis in real time, evaluate the immediate physiological effects of vagus nerve stimulation, adjust the stimulation parameters according to the indicators, and provide a basis for the selection of personalized stimulation parameters while reducing risks, thereby improving the effect of vagus nerve stimulation therapy and reducing its side effects.

[0004] However, the existing technology only states that the stimulation parameters need to be adjusted according to the actual stimulation effect, and there is little research on how to adjust the stimulation parameters. Adjustments can only be made based on experience, and optimization adjustments cannot be made quickly, especially when facing multi-site stimulation. It is even more difficult to start, which may lead to poor stimulation effects and large side effects to a certain extent. Therefore, how to adjust the various parameters of the vagus nerve stimulation device to make its stimulation effect better and the side effects smaller is a technical problem that needs to be solved in this field. Summary of the invention

[0005] In order to solve at least one of the above technical problems, the present invention provides an ear edge vagus nerve stimulation device, comprising: a stimulation module for multiple parts, a heart rate measurement module, a data processing module and a control module;

[0006] Each stimulation module is used to initiate stimulation in different modes and with increasing intensity;

[0007] Heart rate measurement module, used to monitor heart rate data in real time until the sinus heart rate decreases, and obtain critical parameters in each mode;

[0008] A data processing module, used to calculate the adjustment parameters of each stimulation module according to the critical parameters in each mode;

[0009] The control module is used to adjust each stimulation module according to the adjustment parameters.

[0010] The auricular vagus nerve stimulation device provided by the present invention can automatically adjust the stimulation parameters according to the actual stimulation effect without manual operation by personnel. It can achieve the optimal stimulation effect and reduce side effects. It is an auricular vagus nerve stimulation device with automatic adjustment, superior effect and small side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 A schematic structural diagram of an embodiment of the ear vagus nerve stimulation device of the present invention;

[0012] Figure 2 The figure is a schematic structural diagram of an embodiment of a stimulation module of the auricular vagus nerve stimulation device of the present invention. DETAILED DESCRIPTION

[0013] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0014] It should be noted that if the embodiments of the present invention involve directional indications, such as up, down, left, right, front, back, etc., then the directional indication is only used to explain the relative position relationship, movement status, etc. between the components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly. In addition, if the embodiments of the present invention involve descriptions of "first, second", "S1, S2", "step one, step two", etc., then such descriptions are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of indicated technical features or indicating the execution order of the method, etc. Those skilled in the art can understand that anything that does not violate the gist of the invention under the technical concept of the invention should be included in the protection scope of the present invention.

[0015] like Figure 1As shown, the present invention provides an ear edge vagus nerve stimulation device, comprising a stimulation module 100 for multiple parts, a heart rate measurement module 200, a data processing module 300 and a control module 400;

[0016] Each stimulation module is used to initiate stimulation in different modes and with increasing intensity;

[0017] Heart rate measurement module, used to monitor heart rate data in real time until the sinus heart rate decreases, and obtain critical parameters in each mode;

[0018] A data processing module, used to calculate the adjustment parameters of each stimulation module according to the critical parameters in each mode;

[0019] The control module is used to adjust each stimulation module according to the adjustment parameters.

[0020] In this embodiment, the ear edge vagus nerve stimulation device of the present invention is provided, which first includes stimulation of multiple parts, and initiates stimulation in different modes and increasing intensities, so as to obtain the critical parameters for reducing the sinus heart rate through the heart rate measurement module, that is: the stimulation intensity is adjusted to the lowest intensity that can change the heart rate, at which time the maximum stimulation effect can be achieved, and the critical side effects can be reduced; then the data processing module is fed back to calculate the adjustment parameters of each stimulation module according to the critical parameters in each mode, so as to control the output parameters of each stimulation module through feedback control of the control module, and control the stimulation intensity. It can be seen that it can automatically feedback and adjust the stimulation parameters according to the actual stimulation effect, without manual operation by personnel, and can achieve the optimal stimulation effect and reduce side effects. It is an ear edge vagus nerve stimulation device with automatic adjustment, superior effect and small side effects.

[0021] Preferably, the stimulation module 100 may include, but is not limited to, stimulation modules such as the cymba concha, the cavum concha, the external auditory canal, the tragus, the triangular fossa, the antihelix, and the crus of the helix. Each stimulation module may be installed at a different stimulation site of the ear by a fixing clip to output stimulation of appropriate intensity according to the signal strength.

[0022] For example, Figure 2As shown, there are three stimulation modules including 01-concha, 02-cavum concha and 03-external auditory canal. The adjustable parameters in the stimulator are optional but not limited to: output current, pulse width, frequency, etc.; by feeding back the critical parameters that reduce sinus rhythm in each mode, such as maximum output current, maximum pulse width, maximum frequency, etc., the respective adjustment parameters are calculated and controlled through the control module. For example, taking the above three stimulation modules as an example, the output current of the external auditory canal and the concha cavity is 1.2-1.8mA, and the output current of the hymen concha is 1.8-2.8mA, and the current output parameter set by the instrument is 0-3.5mA; the pulse width of the external auditory canal and the concha cavity is 0.15-0.25ms, and the pulse width of the hymen concha is 0.25-0.5mA, and the pulse width parameter set by the instrument is 0.1-1.0ms; the stimulation frequency of the external auditory canal and the concha cavity is 10-20Hz, and the stimulation frequency of the hymen concha is 20-30Hz, and the stimulation frequency parameter set by the instrument is 1-30Hz.

[0023] More preferably, the heart rate measurement module 200 can be selected as a heart rate measuring instrument, which is connected to the subsequent data processing module through wired or wireless means such as WiFi, Bluetooth, CAN bus, etc., so as to feed back the measured heart rate signal to the data processing module.

[0024] More preferably, the stimulation module initiates stimulation in different modes and with increasing intensity; the heart rate measurement module obtains critical parameters in each mode; optional but not limited to include:

[0025] Each stimulation module initiates stimulation in an increasing intensity manner until the sinus heart rate decreases. The heart rate measurement module obtains the single stimulation critical parameter α when each module is stimulated individually. i ;

[0026] Or / and each stimulation module, any two modes initiate stimulation in an increasing intensity manner until the sinus heart rate decreases, and the heart rate measurement module obtains the dual stimulation critical parameter β when two modules are stimulated simultaneously ij ;

[0027] Or / and each stimulation module, any three modes initiate stimulation in an increasing intensity manner until the sinus heart rate decreases, and the heart rate measurement module obtains the three stimulation critical parameters γ when the three modules are stimulated simultaneously ijk .

[0028] In this embodiment, the structure of the stimulation module, the stimulation method, and multiple preferred embodiments of the heart rate measurement module are given, which include stimulation modules for multiple parts, which can initiate stimulation in single stimulation, double stimulation, triple stimulation, etc., so as to obtain single stimulation critical parameters, double stimulation critical parameters, and triple stimulation critical parameters through the heart rate measurement module, so as to subsequently calculate the adjustment parameters of each stimulation module. Under this design mode, it is possible to obtain the critical parameters in the individual stimulation modes of various parts, to know the situation when each module is stimulated individually, and to understand the uniqueness of the stimulation of each part; it is also possible to obtain the critical parameters in the stimulation modes of each mode, to know the situation when each mode is stimulated, and to understand the versatility of the stimulation of each mode of each part; to fully obtain the characteristics and commonalities of each module, and subsequently calculate the adjustment parameters of each stimulation module based on this, which can further improve the stimulation effect and reduce side effects.

[0029] Preferably, several buttons, such as several push buttons, rotating buttons, etc., corresponding to single stimulation mode, double stimulation mode, triple stimulation mode, etc., can be optionally provided on the ear edge vagus nerve stimulation device to select the corresponding single stimulation mode, multiple stimulation mode, etc. For example: in the single stimulation mode, the stimulation modules of each part can be controlled to send out a single stimulation signal in sequence, and in the double stimulation mode, the combination of two parts can be controlled to send out a double stimulation signal in sequence. By providing buttons for medical staff to choose to use, there is no need to manually adjust in sequence, which can reduce the workload and further improve the intelligence and automation of the stimulation device.

[0030] It is worth noting that obtaining single stimulation or / and double stimulation or / and triple stimulation is only a few preferred embodiments, but is not limited thereto, and does not exclude stimulation modes including other modes. For example, when the stimulation modules include multiple, such as 4, N (N is any integer greater than 0), any four modes or N modes can be selected to initiate stimulation in an increasing intensity manner until the sinus heart rate decreases, and the four stimulation critical parameters δ ijkm , N stimulation critical parameters, etc., where i / j / k / m is any integer greater than 0 and less than or equal to N, indicating random selection from multiple stimulation modules; it is even possible to select several relatively important site patterns according to the characteristics of the nerves involved in each site; or to select several effective site patterns based on the actual situation of the patient, etc. The above preferred embodiments only obtain single stimulation critical parameters, double stimulation critical parameters, and triple stimulation critical parameters. This is mainly because the process of obtaining four stimulations and N stimulations during use of the stimulation device is more complicated, and the stimulation device may only include 2 sites, 3 sites, etc. This implementation method can take into account the stimulation effect while reducing the difficulty of using the device, reducing the adjustment time and calculation complexity. It can be seen that the above examples are only preferred embodiments. This stimulation method can only obtain single stimulation critical parameters, or only obtain double stimulation critical parameters, or obtain both, or obtain critical parameters of more modes, and its mode method can be selected arbitrarily - N is the number of sites in the stimulation module.

[0031] More preferably, the data processing module can optionally calculate the average value of the critical parameters related to each stimulation module according to the critical parameters in each mode, which is the adjustment parameter of each stimulation module. For example, the critical parameter of single stimulation of the hymen concha is 2mA, the critical parameter of single stimulation of the cavum concha is 1.5mA, and the critical parameter of single stimulation of the external auditory canal is 1.6mA, then the adjustment parameter of each stimulation module can be selected as the average value mA, optionally expressed as: For the dual stimulation mode, triple stimulation mode, etc., the adjustment parameters of each stimulation module can be obtained according to the average value of the respective related critical parameters, and the average value is used as the unified adjustment value of each stimulation module.

[0032] In a preferred embodiment, the data processing module includes:

[0033] A weight determination unit, used to determine the weight coefficient of each mode critical parameter according to the weight coefficient of each stimulation module;

[0034] The parameter calculation unit is used to calculate the adjustment parameters of each stimulation module according to the critical parameters in each mode and their corresponding weight coefficients.

[0035] In this embodiment, a specific implementation method of how the data processing module calculates the adjustment parameters is given. In the preferred method, the adjustment parameters of each stimulation module are calculated according to the weights based on each critical parameter by setting the weight coefficients. This is because: the specific nerve branches contained in each stimulation site are different, and their specific stimulation effects and accompanying side effects are also different. Therefore, the stimulation modules of each stimulation site can be configured with the same or different weight coefficients, and the adjustment parameters of each stimulation module are calculated according to each weight coefficient to further improve the stimulation effect and reduce side effects.

[0036] More preferably, taking the above-mentioned single stimulation critical parameter, double stimulation critical parameter, and triple stimulation critical parameter as an example, assuming that the weight determination unit needs to determine the weight coefficients of these mode critical parameters, it includes:

[0037] The single stimulus weight coefficient calculation unit can optionally use formula (1) to determine the weight coefficient of each single stimulus critical parameter:

[0038]

[0039] Or / and, a dual stimulation weight coefficient calculation subunit, optionally using formula (2) to determine the weight coefficient of each dual stimulation critical parameter:

[0040]

[0041] Or / and, the three-stimulus weight coefficient calculation subunit can optionally use formula (3) to determine the weight coefficient of each three-stimulus critical parameter:

[0042]

[0043] Among them, q i is the weight coefficient of each stimulation module, ρ i is the weight coefficient of each single stimulus critical parameter; σ ij is the weight coefficient of each dual stimulation critical parameter, τ ijk are weight coefficients of the three stimulation critical parameters; i, j, k are all integers greater than 0 and less than or equal to N, j≠i, k≠i,j; N is the number of parts of the stimulation module.

[0044] In this embodiment, a preferred embodiment of the weight determination unit is given, and further provided is how to calculate the weight coefficient of each critical parameter. Based on the weight coefficient of the stimulation module of each part, the corresponding weight coefficient is calculated under different stimulation modes, which can further highlight the weight level of each critical parameter, give play to the mode parameters with great advantages and small side effects, and avoid the mode parameters with small advantages and large side effects, so as to further improve the overall stimulation effect and reduce the overall side effects.

[0045] It is worth noting that the weight calculation unit may be illustrated by taking the above-mentioned single stimulation weight coefficient calculation unit, double stimulation weight coefficient calculation unit, and triple stimulation weight coefficient calculation unit as examples, but is not limited thereto. For example, assuming that the stimulation device only includes stimulation modules for two parts, there is no need to calculate the three stimulation weight coefficients, and its weight determination unit does not need to include the three stimulation weight calculation unit; if the stimulation device includes stimulation modules for four or more parts, it may optionally include a four stimulation weight calculation unit, etc.

[0046] More preferably, the weight determination unit may further optionally include:

[0047] Input unit, used to input the weight coefficient of each stimulation module.

[0048] In this embodiment, a further preferred embodiment of the weight determination unit is given. Although it only adds a small input unit, for the device as a whole, the operator can set the weight coefficient of each stimulation module according to the nerve branches involved in the stimulation modules of each part, the nerve branches that should be stimulated according to the patient's actual condition, etc., so that the weight coefficient of each critical parameter calculated by the weight determination unit is more suitable for the current user, so as to further improve the stimulation effect and reduce side effects. The technical effect is very significant.

[0049] More preferably, the parameter calculation unit may optionally use formula (4)-(6) or a combination thereof to calculate the adjustment parameters of each stimulation module:

[0050] Single stimulus: ω i =α i ×ρ i (4)

[0051] Or, double stimulation:

[0052] Or, three stimuli:

[0053] Example, combination: single stimulus and double stimulus:

[0054] Or, single stimulus and three stimulus:

[0055] Or, double and triple stimulation: Or single stimulus and double stimulus and triple stimulus:

[0056] Among them, ω i is the adjustment parameter of the ith stimulation module.

[0057] In this embodiment, a further preferred embodiment of the parameter calculation unit is provided, which determines its adjustment parameters based on the single stimulation critical parameter or / and the double stimulation critical parameter or / and the triple stimulation critical parameter and their corresponding weight coefficients, and can integrate the characteristics and commonalities of the critical parameters in each stimulation mode to further improve the stimulation effect and reduce side effects. It is worth noting that formulas (4)-(10) are only examples of adaptability. If the stimulation device only includes two part stimulation modules, the three stimulation critical parameters and their corresponding weight coefficients can be set to 0; if the stimulation device also includes four or more stimulation modules, the product of the four stimulation critical parameters and their corresponding weight coefficients can be optionally added.

[0058] More preferably, the parameter calculation unit can optionally calculate each multi-stimulation critical parameter index and its weight coefficient, and then determine the adjustment parameter of each stimulation module according to the product of the two. For the above-mentioned single stimulation, double stimulation, and triple stimulation, the multi-stimulation, that is, including double stimulation and triple stimulation, can include stimulation of two or more parts; in addition, the index can be optionally represented by an average value, a maximum value, a minimum value, etc.

[0059] For example, taking the combination of single stimulation, double stimulation and triple stimulation as an example, the average values ​​of the double stimulation critical parameters and the triple stimulation critical parameters can be calculated using formulas (11) and (12) respectively, the average values ​​of the double stimulation weight coefficients and the triple stimulation weight coefficients can be calculated using formulas (13)-(14) respectively, and then the average value of the product of the two can be calculated using formula (15) to determine the adjustment parameters of each stimulation module:

[0060]

[0061]

[0062] Among them, β i , γ i are the double stimulus critical parameter index and the triple stimulus critical parameter index respectively; σ i , τ i are the weight coefficients of the dual-stimulation critical parameter index and the tri-stimulation critical parameter index respectively; N1 and N2 are the numbers of dual-stimulation critical parameters and tri-stimulation critical parameters respectively; N3 and N4 are the numbers of weight coefficients of dual-stimulation critical parameters and tri-stimulation critical parameters respectively; ω i is the adjustment parameter of the ith stimulation module.

[0063] In this embodiment, another preferred embodiment of the parameter calculation unit is given, which is based on the single stimulation critical parameters, double stimulation critical parameters, triple stimulation critical parameters and their corresponding weight coefficients. It first determines the index value of each critical parameter and the corresponding index weight coefficient, and then determines its adjustment parameters accordingly. It can more fully reflect the importance of the critical parameters in each mode and further optimize the accuracy of the adjustment parameters.

[0064] More preferably, since the cymba concha, cavum concha and external auditory canal are the key locations of the vagus nerve at the edge of the ear, these three stimulation sites are preferably taken as examples for further explanation below.

[0065] In a specific embodiment, Figure 2 As shown in the figure, it includes a cymba-concha stimulation module, a cavum-concha stimulation module and an external auditory canal stimulation module; the optional ones are:

[0066] The cymba concha stimulation module, the cavum concha stimulation module and the external auditory canal stimulation module are stimulated in increasing intensity respectively until the sinus heart rate decreases, and the heart rate measurement module obtains the single stimulation critical parameters when each module is stimulated separately; optionally, α1, α2, and α3 respectively represent the single stimulation critical parameters when the cymba concha stimulation module, the cavum concha stimulation module and the external auditory canal stimulation module are stimulated separately;

[0067] The concha stimulation module, the concha cavity stimulation module and the external auditory canal stimulation module are stimulated in pairs in an increasing intensity manner until the sinus heart rate decreases, and the heart rate measurement module obtains the dual stimulation critical parameters when the two modules are stimulated simultaneously. 12 , β 13 , β 23 , respectively represent the double stimulation critical parameters when the cymba concha stimulation module and the cavum concha stimulation module are stimulated simultaneously, the double stimulation critical parameters when the cymba concha stimulation module and the external auditory canal stimulation module are stimulated simultaneously, and the double stimulation critical parameters when the cavum concha stimulation module and the external auditory canal stimulation module are stimulated simultaneously;

[0068] The three modes of the concha stimulation module, the concha cavity stimulation module and the external auditory canal stimulation module are stimulated in an increasing intensity manner until the sinus heart rate decreases, and the heart rate measurement module obtains the three stimulation critical parameters when the three modules are stimulated simultaneously; optionally, γ 123 express.

[0069] On this basis, the weight determination unit can determine the weight coefficients of the critical parameters in each single stimulation, double stimulation and triple stimulation mode according to the pre-stored weight coefficients of each stimulation module or the weight coefficients of each stimulation module input by the input subunit according to the actual situation of the service object.

[0070] Preferably, for the weight coefficient of each stimulation module: for example, Figure 2 As shown, there are three stimulation modules, 01-concha, 02-cavum concha, and 03-external auditory canal. Among them, the cymbotomy of the concha is completely controlled by the vagus nerve, and its stimulation effect is excellent. A higher weight coefficient q1 can be configured; the external auditory canal is controlled by the auricular branch of the vagus nerve, the facial nerve branch, the glossopharyngeal nerve branch, the greater auricular nerve and the lesser occipital nerve from the cervical plexus, and the auriculotemporal branch of the mandibular nerve, and is also mixed with other nerves. Its stimulation effect is acceptable, and the nerves involved in the side effects are not fatally injured. The second highest weight coefficient q2 can be configured; the cavity concha is equivalent to the chest cavity, which is distributed by the vagus, glossopharyngeal, and mixed branches of the facial nerves and the greater auricular nerve, and the heart exists in the chest cavity. Therefore, stimulating the cavity concha is more likely to affect the heart rate, and there will be different degrees of side effects due to the stimulation of other nerves. It can be seen that although its stimulation effect is good, the nerves involved in the side effects are fatally injured, and a lower weight coefficient q3 can be configured.

[0071] On this basis, the weight coefficients ρ1, ρ2, ρ3 of the critical parameters of the single stimulation when the cymba-concha stimulation module, the cavum-concha stimulation module and the external auditory canal stimulation module are stimulated separately can be calculated according to formula (1):

[0072]

[0073] According to formula (2), the weight coefficient σ of the dual stimulation critical parameter when the concha stimulation module and the concha cavity stimulation module are stimulated simultaneously is calculated. 12 , σ 21 , the weight coefficient σ of the double stimulation critical parameter when the concha stimulation module and the external auditory canal stimulation module are stimulated simultaneously 13 , σ 31 , the weight coefficient σ of the double stimulation critical parameter when the concha stimulation module and the external auditory canal stimulation module are stimulated simultaneously 23 , σ 32 :

[0074]

[0075]

[0076] According to formula (3), the weight coefficient τ of the critical parameters of the three stimulations when the concha stimulation module, the concha cavity stimulation module and the external auditory canal stimulation module are stimulated simultaneously is calculated. 123 :

[0077]

[0078] Then, the parameter calculation unit can use formulas (4)-(6) or a combination thereof to calculate the adjustment parameters of each stimulation module according to the critical parameters in each mode and their corresponding weight coefficients:

[0079] More preferably, the parameter calculation unit may also optionally use formula (11) to calculate the dual stimulation critical indexes of the cymba-concha stimulation module, the cavum-concha stimulation module and the external auditory canal stimulation module respectively:

[0080]

[0081] Formula (13) is used to calculate the weight coefficients of the dual stimulation critical indexes of the cymba-concha stimulation module, the cavum-concha stimulation module and the external auditory canal stimulation module respectively:

[0082]

[0083]

[0084] Similarly, formula (12) can be used to calculate the three stimulation critical parameter indexes of the cymba-concha stimulation module, the cavum-concha stimulation module and the external auditory canal stimulation module; formula (14) can be used to calculate the corresponding weight coefficients. It is worth noting that since the stimulation device is only exemplified as a stimulation module including three parts, there is only one case of the three stimulation modes, and its three stimulation critical parameter index γ1 = γ 123 ,γ2=γ 123 ,γ3=γ 123 ; Corresponding weight coefficient: τ1 = τ 123 ,τ2=τ 213 ,τ3=τ 312 It is worth noting that if the stimulation device includes stimulation modules for more than three parts, then its three stimulation modes include multiple ones. In this case, the three stimulation critical parameter indicators and their corresponding weight coefficients calculated by formulas (12) and (14) are different from those calculated by formulas (2) and (3), and will not be illustrated here.

[0085] On this basis, formula (15) is used to calculate the adjustment parameters of the cymba-concha stimulation module, the cavum concha stimulation module and the external auditory canal stimulation module:

[0086]

[0087] In this embodiment, the hymena concha, the cavum concha and the external auditory canal are used as examples for illustration. The hymena concha is the best stimulation site. If only the hymena concha is stimulated, the stimulation effect of the vagus nerve at the edge of the ear will be affected. However, if the hymena concha, the cavum concha and the external auditory canal are stimulated at the same intensity, side effects of varying degrees will occur. Therefore, by using the vagus nerve stimulation device at the edge of the ear of the present invention, stimulation can be initiated in different modes through the stimulation module, and critical parameters in each mode can be obtained by monitoring through the heart rate measurement module. Most importantly, the adjustment parameters of each stimulation module can be calculated through the data processing module, and the three sites can be stimulated with different degrees of stimulation intensity, so as to maximize the stimulation effect and accuracy of the vagus nerve stimulation and minimize the side effects.

[0088] More preferably, in order to further improve the safety of the stimulation device, the control module can optionally adjust each stimulation module according to the adjustment parameter, using data of 80%-95% of the adjustment parameter.

[0089] In this embodiment, a preferred embodiment of the control module is given. The heart rate is monitored while stimulating. The stimulation intensity is first adjusted to the lowest intensity that can change the heart rate, and then 80%-95% of the calculated adjustment parameters are used for non-invasive ear edge vagus nerve stimulation, that is, low-intensity stimulation. It can effectively improve the stimulation effect without affecting the heart rate and blood pressure. It can be optionally used in the treatment of sepsis, epilepsy, severe depression, obesity, heart failure, tinnitus, migraine, inflammation, anxiety, Alzheimer's disease, drug addiction, cancer, fibromyalgia, autism and other diseases; taking sepsis as an example, it can effectively improve the sepsis inflammatory response and increase the sepsis survival rate without affecting the heart rate and blood pressure; more preferably, it can be selected to stimulate for a period of time every day, such as 30 minutes, until the sepsis inflammatory response subsides. Here, it is proposed to use low-intensity ear edge vagus nerve stimulation to achieve the purpose of non-invasive electrical stimulation of the vagus nerve.

[0090] The technical features of the above-described embodiments can be implemented in any mode. To make the description concise, not all possible modes of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the modes of these technical features, they should be considered to be within the scope of this specification. The above-described embodiments only express several implementation methods of the present invention, and the description is relatively specific and detailed, but it cannot be understood as a limitation on the scope of the invention patent. It should be pointed out that for ordinary technicians in this field, without departing from the concept of the present invention, several variations and improvements can be made, which all belong to the scope of protection of the present invention.

Claims

1. An ear vagus nerve stimulation device, characterized in that: include: Stimulation modules for multiple parts, heart rate measurement modules, data processing modules and control modules; Each stimulation module is used to initiate stimulation in different modes and with increasing intensity; Heart rate measurement module, used to monitor heart rate data in real time until the sinus heart rate decreases, and obtain critical parameters in each mode; A data processing module, used to calculate the adjustment parameters of each stimulation module according to the critical parameters in each mode; The control module is used to adjust each stimulation module according to the adjustment parameters.

2. The stimulation device according to claim 1, characterized in that The stimulation module initiates stimulation in different modes and with increasing intensity. The heart rate measurement module obtains critical parameters in each mode. Specifically, it includes: Each stimulation module initiates stimulation in an increasing intensity manner until the sinus heart rate decreases, and the heart rate measurement module obtains the single stimulation critical parameters when each module is stimulated individually; Or / and each stimulation module, any two modes initiate stimulation in an increasing intensity manner until the sinus heart rate decreases, and the heart rate measurement module obtains the dual stimulation critical parameters when two modules are stimulated simultaneously; Or / and each stimulation module, any three modes initiate stimulation in an increasing intensity manner until the sinus heart rate decreases, and the heart rate measurement module obtains the three stimulation critical parameters when the three modules are stimulated simultaneously.

3. The stimulation device according to claim 2, characterized in that Several buttons are provided to select a single stimulation mode, a double stimulation mode, and a triple stimulation mode.

4. The stimulation device according to claim 2, characterized in that The data processing module calculates the average value of the critical parameters related to each stimulation module according to the critical parameters in each mode, which is the adjustment parameter of each stimulation module.

5. The stimulation device according to claim 2, characterized in that Data processing module, including: A weight determination unit, used to determine the weight coefficient of each mode critical parameter according to the weight coefficient of each stimulation module; The parameter calculation unit is used to calculate the adjustment parameters of each stimulation module according to the critical parameters in each mode and their corresponding weight coefficients.

6. The stimulation device according to claim 5, characterized in that A weight determination unit, comprising: The single stimulus weight coefficient calculation unit uses formula (1) to determine the weight coefficient of each single stimulus critical parameter: Or / and, the dual stimulation weight coefficient calculation unit uses formula (2) to determine the weight coefficient of each dual stimulation critical parameter: Or / and, the three-stimulus weight coefficient calculation unit uses formula (3) to determine the weight coefficient of each three-stimulus critical parameter: Among them, q i is the weight coefficient of each stimulation module, ρ i is the weight coefficient of each single stimulus critical parameter; σ ij is the weight coefficient of each dual stimulation critical parameter, τ ijk are weight coefficients of the three stimulation critical parameters; i, j, k are all integers greater than 0 and less than or equal to N, j≠i, k≠i,j; N is the number of parts of the stimulation module.

7. The stimulation device according to claim 6, characterized in that The weight determination unit further includes: Input unit, used to input the weight coefficient of each stimulation module.

8. The stimulation device according to claim 5, characterized in that The parameter calculation unit calculates the adjustment parameters of each stimulation module using formula (4)-(6) or a combination thereof: Single stimulus: ω i =α i ×ρ i (4) Or, double stimulation: Or, three stimuli: Among them, α i , β ij , γ ijk They are the single stimulus critical parameter, double stimulus critical parameter, and triple stimulus critical parameter respectively; ω i is the adjustment parameter of the ith stimulation module.

9. The stimulation device according to claim 6, characterized in that The parameter calculation unit calculates the critical parameter index of each multi-stimulation and its weight coefficient, and then determines the adjustment parameters of each stimulation module according to the product of the two.

10. The stimulation device according to claim 9, characterized in that Formulas (11)-(15) are used to calculate the adjustment parameters of each stimulation module: Among them, β i , γ i are the double stimulus critical parameter index and the triple stimulus critical parameter index respectively; σ i , τ i are the weight coefficients of the dual-stimulation critical parameter index and the tri-stimulation critical parameter index respectively; N1 and N2 are the numbers of dual-stimulation critical parameters and tri-stimulation critical parameters respectively; N3 and N4 are the numbers of weight coefficients of dual-stimulation critical parameters and tri-stimulation critical parameters respectively; ω i is the adjustment parameter of the ith stimulation module.

11. The stimulation device according to any one of claims 1 to 10, characterized in that: The control module adjusts each stimulation module according to the adjustment parameter and the data of 80%-95% of the adjustment parameter.

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