Wearable transcutaneous electrical nerve stimulation migraine therapeutic apparatus

Abstract

The invention discloses a wearable transcutaneous electrical nerve stimulation migraine therapeutic apparatus, which comprises a control module and a flexible fitting mechanism, and is characterized in that the flexible fitting mechanism is located on the lower side of the control module; the control module comprises a protective shell, an intelligent regulation and control circuit board, a self-adaptive pulse generator and a wireless communication module, the intelligent regulation and control circuit board is fixedly installed in the protective shell, and the self-adaptive pulse generator and the wireless communication module are integrated at the upper end of the intelligent regulation and control circuit board; and the wireless communication module supports NFC (Near Field Communication) and Bluetooth dual-mode communication. According to the wearable transcutaneous electrical nerve stimulation migraine therapeutic apparatus, the wearing comfort and stability are remarkably improved through the flexible fitting mechanism and the lightweight design, and the therapeutic apparatus is particularly suitable for long-time dynamic use; real-time optimization of a personalized treatment scheme is realized through a dynamic adjustment algorithm based on biological feedback, and the treatment effect is improved.

Description

Technical Field

[0001] This invention relates to the field of medical electronic equipment technology, and in particular to a wearable transcutaneous electrical nerve stimulation (TENS) migraine treatment device. Background Technology

[0002] With the continuous development of neuromodulation technology, transcutaneous electrical nerve stimulation (TENS), as a non-invasive treatment, has gradually gained attention for its application in relieving migraine symptoms. This technology modulates nervous system function by applying electrical stimulation to specific nerve areas, thereby reducing migraine symptoms. However, existing TENS devices still have significant shortcomings in terms of wearability, optimization of stimulation effects, and ease of use, limiting their widespread clinical application and patient experience.

[0003] For example, patent document CN113230539B discloses a stimulator for treating migraines using neuromodulation. It is connected to the main body via a strap mechanism and fixed to the skin using hydrogel. Simultaneously, a screw drive achieves microcirculation traction to prevent nerve paralysis from affecting the neuromodulation effect. However, existing migraine treatment devices have the following drawbacks:

[0004] 1. Rigid electrodes are prone to displacement: Traditional gel electrodes are prone to detachment during dynamic use, leading to interruption of stimulation;

[0005] 2. Limited parameter adjustment: Fixed waveforms and frequencies cannot adapt to individual physiological differences;

[0006] 3. Poor skin adaptability: Dry gel or allergic reactions may affect the comfort of long-term wear. Summary of the Invention

[0007] This invention provides a wearable transcutaneous electrical nerve stimulation (TENS) migraine treatment device to address the problems mentioned in the background section.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] A wearable transcutaneous electrical nerve stimulation (TENS) migraine treatment device includes a control module and a flexible fitting mechanism, the flexible fitting mechanism being located below the control module; the control module includes a protective shell, an intelligent control circuit board, an adaptive pulse generator, and a wireless communication module, the intelligent control circuit board being fixedly installed inside the protective shell, the adaptive pulse generator and the wireless communication module being integrated at the upper end of the intelligent control circuit board, and the wireless communication module supporting NFC and Bluetooth dual-mode communication;

[0010] The flexible bonding mechanism comprises, from top to bottom, a flexible mounting layer, a conductive fabric electrode layer, and a microfluidic gel layer, which are fixed in sequence. The conductive fabric electrode layer is electrically connected to the adaptive pulse generator. The interior of the microfluidic gel layer is filled with conductive liquid, and a large number of microfluidic channels are provided on both the upper and lower surfaces of the microfluidic gel layer.

[0011] As a further improvement to this technical solution: a replaceable protective film is attached to the bottom side of the microfluidic gel layer, which is made of medical-grade polyurethane material. The replaceable protective film is used to prevent the microfluidic gel layer from drying out or becoming contaminated.

[0012] As a further improvement to this technical solution: a skin impedance sensor and an electromyography (EMG) sensor are installed on the bottom side of the microfluidic gel layer. The skin impedance sensor and the EMG sensor are used to feed back the detected skin impedance value and EMG signal value to the intelligent control circuit board.

[0013] As a further improvement to this technical solution: the adaptive pulse generator adopts a dynamic adjustment algorithm based on biological feedback, and the function of the output pulse signal changing with time is:

[0014] f(t) = A·sin(2πf0t)·e -αt +B·cos(2πf1t)·(1-e -βt );

[0015] Where A and B are the amplitudes of the sine and cosine waves, f0 and f1 are the fundamental frequency and modulation frequency, respectively, α and β are the attenuation coefficients, and t is the time variable.

[0016] As a further improvement to this technical solution: the protective shell is made of high-strength engineering plastic, and the intelligent control circuit board receives external commands and controls the adaptive pulse generator to output an electrical stimulation signal with specific parameters.

[0017] As a further improvement to this technical solution: the control module also includes a status display screen, a multi-function knob, and a touch sensing area. The status display screen, multi-function knob, and touch sensing area are all installed on the upper end of the protective shell, and the status display screen, multi-function knob, and touch sensing area are all electrically connected to the intelligent control circuit board.

[0018] As a further improvement to this technical solution: the status display screen is used to display the current working mode, remaining battery power and treatment progress information; the touch sensing area is used to quickly start the device and switch modes; and the multi-function knob is used to adjust the pulse intensity and frequency.

[0019] As a further improvement to this technical solution: the conductive fabric electrode layer is made of graphene composite material, and the microfluidic gel layer is made of polyacrylamide.

[0020] As a further improvement to this technical solution: a micropump is mounted on the surface of the flexible mounting layer, and the output end of the micropump extends into the interior of the microfluidic gel layer.

[0021] Compared with the prior art, the beneficial effects of the present invention are:

[0022] 1. This wearable transcutaneous electrical nerve stimulation migraine treatment device adopts a flexible fit mechanism and lightweight design, which significantly improves wearing comfort and stability, and is especially suitable for long-term dynamic use;

[0023] 2. This device achieves real-time optimization of personalized treatment plans through a biofeedback-based dynamic adjustment algorithm, thereby improving treatment outcomes;

[0024] 3. The design of conductive fabric electrodes combined with a microfluidic gel layer not only enhances the adhesion between the electrodes and the skin, but also solves the problem of traditional gels drying out easily, further improving the practicality of the device and the user experience.

[0025] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it according to the contents of the specification, the preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings. Specific embodiments of the present invention are given in detail below with reference to the accompanying drawings. Attached Figure Description

[0026] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, illustrate exemplary embodiments of the invention and, together with their description, serve to explain the invention and do not constitute an undue limitation thereof. In the drawings:

[0027] Figure 1 This is a schematic diagram of the structure of the wearable transcutaneous electrical nerve stimulation migraine treatment device proposed in this invention;

[0028] Figure 2 This is a schematic diagram of the microfluidic gel layer structure proposed in this invention;

[0029] Figure 3 This is a frontal cross-sectional view of the wearable transcutaneous electrical nerve stimulation migraine treatment device proposed in this invention.

[0030] Figure 4 for Figure 3 A magnified schematic diagram of part A in the diagram.

[0031] The attached diagram lists the components represented by each number as follows:

[0032] 1. Micropump; 2. Multifunctional knob; 3. Touch sensing area; 4. Conductive fabric electrode layer; 5. Microfluidic gel layer; 6. Replaceable protective film; 7. Flexible mounting layer; 8. Status display screen; 9. Protective shell; 10. Microfluidic channel; 11. Skin impedance sensor; 12. Electromyography sensor; 13. Intelligent control circuit board; 14. Adaptive pulse generator; 15. Wireless communication module; 16. Conductive fluid. Detailed Implementation

[0033] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are for illustrative purposes only and are not intended to limit the scope of the invention. The invention is described more specifically in the following paragraphs by way of example with reference to the accompanying drawings. It should be noted that the drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0035] Please see Figures 1-4 In this embodiment of the invention, a wearable transcutaneous electrical nerve stimulation (TENS) migraine treatment device includes a control module and a flexible fitting mechanism, with the flexible fitting mechanism located below the control module. The control module includes a protective shell 9, an intelligent control circuit board 13, an adaptive pulse generator 14, and a wireless communication module 15. The protective shell 9 is made of high-strength engineering plastic. The intelligent control circuit board 13 is fixedly installed inside the protective shell 9. The adaptive pulse generator 14 and the wireless communication module 15 are integrated on the upper end of the intelligent control circuit board 13. The wireless communication module 15 supports NFC and Bluetooth dual-mode communication and can connect to an external mobile phone APP via radio signals. The APP's treatment modes include scene templates such as "rapid relief," "sleep assistance," and "sports protection."

[0036] The flexible bonding mechanism includes, from top to bottom, a flexible mounting layer 7, a conductive fabric electrode layer 4, and a microfluidic gel layer 5, which are fixed in sequence. The conductive fabric electrode layer 4 is made of graphene composite material, and the microfluidic gel layer 5 is made of polyacrylamide. The conductive fabric electrode layer 4 is electrically connected to the adaptive pulse generator 14. The interior of the microfluidic gel layer 5 is filled with conductive liquid 16. The upper and lower surfaces of the microfluidic gel layer 5 are provided with a large number of microfluidic channels 10. The bottom side of the microfluidic gel layer 5 is covered with a replaceable protective film 6 made of medical-grade polyurethane material. The replaceable protective film 6 is used to prevent the microfluidic gel layer 5 from drying out or becoming contaminated.

[0037] Specifically, a skin impedance sensor 11 and an electromyography (EMG) sensor 12 are installed on the bottom side of the microfluidic gel layer 5. The skin impedance sensor 11 and the EMG sensor 12 are used to feed back the detected skin impedance value and EMG signal value to the intelligent control circuit board 13. The intelligent control circuit board 13 receives external instructions and controls the adaptive pulse generator 14 to output an electrical stimulation signal with specific parameters.

[0038] Specifically, the adaptive pulse generator 14 employs a dynamic adjustment algorithm based on biological feedback, and the function of the output pulse signal changing with time is:

[0039] f(t) = A·sin(2πf0t)·e -αt +B·cos(2πf1t)·(1-e -βt );

[0040] Where f(t) represents the output pulse signal as a function of time; A and B represent the amplitudes of the sine and cosine waves, respectively, which can be dynamically adjusted according to the patient's physiological feedback data, typically ranging from 0.5 to 5V (initial value 2.5V, increasing by 0.3V for every 1kΩ increase in impedance); f0 and f1 are the fundamental frequency and modulation frequency, set to 10Hz and 50Hz, respectively; α and β are attenuation coefficients used to simulate the human body's adaptation process to electrical stimulation, typically ranging from 0.01 to 0.1 (set to 0.05 at rest, increasing to 0.08 during movement to accelerate signal adaptation); t is a time variable, recalculating parameters every 100ms to ensure real-time response. This algorithm monitors the patient's physiological feedback data (skin impedance and muscle response) in real time through the skin impedance sensor 11 and electromyography sensor 12, dynamically adjusting pulse parameters to achieve personalized treatment plans. When an increase in skin impedance is detected, the algorithm automatically increases the pulse amplitude to maintain the stimulation effect; when a decrease in muscle response is detected, the algorithm adjusts the modulation frequency to reactivate the neural pathway.

[0041] The control module also includes a status display screen 8, a multi-function knob 2, and a touch-sensitive area 3. All three are mounted on the upper part of the protective housing 9 and are electrically connected to the intelligent control circuit board 13. The status display screen 8 displays the current operating mode, remaining battery power, and treatment progress information. The touch-sensitive area 3 is used for quickly starting the device and switching modes. The multi-function knob 2 is used to adjust the pulse intensity and frequency. For example, the user can quickly switch to "sleep mode" via the touch-sensitive area 3. In this mode, the device will automatically reduce the pulse intensity and adjust the waveform type to a sine wave to minimize interference with the user.

[0042] Specifically, a micropump 1 is mounted on the surface of the flexible mounting layer 7. The output end of the micropump 1 extends into the interior of the microfluidic gel layer 5. The micropump 1 can actively replenish the conductive liquid 16 in the microfluidic gel layer 5, with a single replenishment volume of 0.1-0.5 μL.

[0043] The working principle of this invention is:

[0044] First, peel off the replaceable protective film 6, then attach the microfluidic gel layer 5 to the forehead or occipital region, depending on the location of pain. The conductive liquid 16 within the microfluidic gel layer 5 can form a uniform conductive layer at the interface between the microfluidic gel layer 5 and the skin through a large number of microfluidic channels 10 capillary structures, reducing impedance fluctuations caused by the drying of traditional gels. Afterward, select the mode via the APP or manually adjust the multi-function knob 2, double-click the touch sensing area 3 to activate the adaptive pulse generator 14, and the status display 8 will show "Treatment in progress". The adaptive pulse generator 14 dynamically generates pulse signals to the conductive fabric electrode layer 4 according to the algorithm. The conductive fabric electrode layer 4 efficiently transmits pulse energy to the skin through the conductive liquid 16. The algorithm dynamically adjusts the pulse parameters and optimizes the electrical stimulation parameters based on the skin impedance value and electromyographic signal value fed back by the skin impedance sensor 11 and the electromyographic sensor 12.

[0045] To verify the practical effects of this invention, the following experiment was conducted. Thirty volunteers suffering from migraines were randomly divided into an experimental group and a control group. The experimental group wore the wearable transcutaneous electrical nerve stimulation migraine treatment device of this invention, while the control group used a traditional gel electrode device. The experimental results showed that in the experimental group (n=15), using the device of this invention, the pain relief rate was 86.7% (VAS score decrease ≥50%), and the comfort score was 4.7 / 5; in the control group (n=15), using the traditional gel electrode device, the relief rate was 60.0%, and the comfort score was 3.2 / 5.

[0046] The pain relief rate in the experimental group was significantly higher than that in the control group, and the user comfort score was also significantly better in the experimental group. This indicates that the flexible fitting mechanism and biofeedback-based dynamic adjustment algorithm of the present invention can effectively improve the treatment effect and user experience.

[0047] In summary, the wearable transcutaneous electrical nerve stimulation migraine treatment device of the present invention significantly improves wearing comfort and stability through a flexible fit mechanism and lightweight design, making it particularly suitable for long-term dynamic use; the biofeedback-based dynamic adjustment algorithm enables real-time optimization of personalized treatment plans, improving treatment efficacy; the design of conductive fabric electrodes combined with a microfluidic gel layer not only enhances the adhesion between the electrodes and the skin, but also solves the problem of traditional gels drying out easily, further improving the practicality of the device and user experience.

[0048] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Those skilled in the art can readily implement the present invention based on the accompanying drawings and the above description. However, any modifications, alterations, or variations made by those skilled in the art without departing from the scope of the present invention, utilizing the disclosed technical content, are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, or variations made to the above embodiments based on the essential technology of the present invention are still within the protection scope of the present invention.

Claims

1. A wearable transcutaneous electrical nerve stimulation (TENS) migraine treatment device, comprising a control module and a flexible fitting mechanism, characterized in that, The flexible bonding mechanism is located on the lower side of the control module; the control module includes a protective shell (9), an intelligent control circuit board (13), an adaptive pulse generator (14) and a wireless communication module (15). The intelligent control circuit board (13) is fixedly installed inside the protective shell (9). The adaptive pulse generator (14) and the wireless communication module (15) are integrated on the upper end of the intelligent control circuit board (13). The wireless communication module (15) supports NFC and Bluetooth dual-mode communication. The flexible bonding mechanism includes, from top to bottom, a flexible mounting layer (7), a conductive fabric electrode layer (4), and a microfluidic gel layer (5) fixed in sequence. The conductive fabric electrode layer (4) is electrically connected to the adaptive pulse generator (14). The interior of the microfluidic gel layer (5) is filled with conductive liquid (16). The upper and lower surfaces of the microfluidic gel layer (5) are provided with a large number of microfluidic channels (10).

2. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 1, characterized in that, The bottom side of the microfluidic gel layer (5) is covered with a replaceable protective film (6), which is made of medical-grade polyurethane material. The replaceable protective film (6) is used to prevent the microfluidic gel layer (5) from drying out or becoming contaminated.

3. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 2, characterized in that, A skin impedance sensor (11) and an electromyography (EMG) sensor (12) are installed on the bottom side of the microfluidic gel layer (5). The skin impedance sensor (11) and the EMG sensor (12) are used to feed back the detected skin impedance value and EMG signal value to the intelligent control circuit board (13).

4. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 3, characterized in that, The adaptive pulse generator (14) employs a dynamic adjustment algorithm based on biological feedback, and the function of the output pulse signal changing with time is: f(t)=A·sin(2πf0t)·e -αt +B·cos(2πf1t)·(1-e -βt ); Where A and B are the amplitudes of the sine and cosine waves, f0 and f1 are the fundamental frequency and modulation frequency, respectively, α and β are the attenuation coefficients, and t is the time variable.

5. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 4, characterized in that, The protective shell (9) is made of high-strength engineering plastic, and the intelligent control circuit board (13) receives external instructions and controls the adaptive pulse generator (14) to output an electrical stimulation signal with specific parameters.

6. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 5, characterized in that, The control module also includes a status display screen (8), a multi-function knob (2), and a touch sensing area (3). The status display screen (8), the multi-function knob (2), and the touch sensing area (3) are all installed on the upper end of the protective shell (9). The status display screen (8), the multi-function knob (2), and the touch sensing area (3) are all electrically connected to the intelligent control circuit board (13).

7. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 6, characterized in that, The status display screen (8) is used to display the current working mode, remaining battery power and treatment progress information. The touch sensing area (3) is used to quickly start the device and switch modes. The multi-function knob (2) is used to adjust the pulse intensity and frequency.

8. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 7, characterized in that, The conductive fabric electrode layer (4) is made of graphene composite material, and the microfluidic gel layer (5) is made of polyacrylamide.

9. The wearable transcutaneous electrical nerve stimulation migraine treatment device according to claim 8, characterized in that, A micropump (1) is mounted on the surface of the flexible mounting layer (7), and the output end of the micropump (1) extends into the interior of the microfluidic gel layer (5).

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