Nose treatment device based on graphene thermal therapy and acupoint electrical stimulation and acupoint positioning method

Abstract

The invention discloses a nose treatment device based on graphene thermal therapy and acupoint electrical stimulation and an acupoint positioning method, and relates to the technical field of medical instruments, the nose treatment device comprises a contact layer, a functional layer and a supporting layer which are arranged in sequence; the functional layer comprises an electrical stimulation layer and a thermal therapy layer, the electrical stimulation layer and the thermal therapy layer are electrically connected with the control layer, and the control layer is powered by a power supply; the electrical stimulation layer is a conductive film, and an electrode corresponding to the Yingxiang acupoint is arranged on the conductive film; the thermal therapy layer is a graphene heating sheet; the supporting layer comprises a fixed cover body, and the fixed cover body is matched with the outline of a nose wing; by means of the arrangement, the nose treatment device is capable of achieving accurate positioning, low in cost and high in safety degree.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a nasal treatment device based on graphene heat therapy and acupoint electrical stimulation. BACKGROUND

[0002] Existing nasal treatment devices include traditional moxibustion instruments, transdermal electrical stimulation patches, heat therapy, electrical stimulation sharing circuits, and laser physiotherapy equipment, but they have the following defects.

[0003] 1. Traditional moxibustion instrument: there is open fire smoke pollution, stimulation of the respiratory tract, large temperature fluctuations (±5℃), a high risk of burns of more than 3%, poor user experience, and unstable treatment effect.

[0004] 2. Transdermal electrical stimulation patch: low positioning accuracy (deviation > 5mm), unable to accurately cover the Xingxiang point, resulting in poor treatment effect and low user comfort.

[0005] 3. Heat therapy and electrical stimulation sharing circuit: signal crosstalk, unstable treatment effect, difficult to achieve synergistic treatment, and reduce overall efficacy.

[0006] 4. Laser physiotherapy equipment: shallow tissue penetration depth (<2mm), ineffective on deep tissues, limiting the application range.

[0007] 5. Existing equipment cost: high comprehensive cost (> $2000), difficult to popularize, low user acceptance, and heat-electric coupling design resulting in energy utilization rate less than 60%. SUMMARY

[0008] The present application aims to solve the defects in the prior art and proposes a nasal treatment device based on graphene heat therapy and acupoint electrical stimulation.

[0009] To achieve the above purpose, the present application adopts the following technical solutions:

[0010] A nasal treatment device based on graphene heat therapy and acupoint electrical stimulation, comprising a contact layer, a functional layer and a support layer arranged in sequence;

[0011] The functional layer comprises an electrical stimulation layer and a heat therapy layer, the electrical stimulation layer and the heat therapy layer are respectively electrically connected with a control layer, the control layer is powered by a power supply; the electrical stimulation layer is a conductive film; the heat therapy layer is a graphene heating sheet.

[0012] The support layer comprises a fixed cover body, and the fixed cover body is adapted to the contour of the alae nasi.

[0013] Further, the contact layer is an isolation cloth, and the isolation material is a disposable non-sterile medical non-woven fabric.

[0014] Further, the conductive film is provided with symmetrically distributed interdigital silver paste electrodes corresponding to the Xiangxi acupoint.

[0015] Further, the graphene heating sheet is packaged by two layers of polyimide film, and is embedded in the groove of the fixing cover body.

[0016] Further, the graphene heating sheet and the conductive film are bonded by a hot melt glue dot array.

[0017] Further, the controller is further provided with a temperature control module, an electric stimulation parameter module and a safety monitoring module; the temperature control module is connected with the graphene heating sheet, the electric stimulation parameter module is connected with the conductive film, and the safety monitoring module is used for monitoring the temperature of the graphene heating sheet and the current of the conductive film in real time.

[0018] Further, the fixing cover body is provided with a magnetic pole and a gold-plated charging pin, and the magnetic pole and a receiving contact point are embedded in the base corresponding to the composite of the conductive film and the isolation cloth.

[0019] Beneficial effects

[0020] Compared with the prior art, the beneficial effects of the present application are as follows:

[0021] 1. Thermal-electric separation laminated structure: the graphene heating sheet (104) and the conductive film (105) are bonded by a hot melt glue dot array, the bonding area is ≤15%, physical isolation is formed, and signal cross-connection is completely eliminated.

[0022] 2. Accurate acupoint positioning: the positioning error of the Xiangxi acupoint is ≤0.3mm; the Xiangxi acupoint coordinates are calculated based on the nose wing feature points (nose tip point Pn and nose wing point Pw): X=0.82×(Pw-Pn), Y=0.31×(Pwy-Pny), and the positioning error is ≤0.3mm.

[0023] 3. Dynamic impedance regulation: based on the Cole-Cole model, the tissue impedance is solved in real time (sampling rate 100Hz, response time <200ms), and the optimal treatment parameters are dynamically matched: Z=R∞+(R0-R∞) / 1+(jωτ)a (where Z is the tissue impedance, ω is the angular frequency, and τ is the time constant)

[0024] Long-acting: the 24h symptom recurrence rate is reduced to 12.6% (from the original 4.73%);

[0025] Electrical safety: the scald accident rate is <1%, and the leakage current is <0.1mA.

[0026] High efficiency: heat utilization rate 89% (traditional 52%), clinical nasal congestion VAS score decreased by 67.8% (60 cases of RCT);

[0027] Low cost: the design of magnetic consumables reduces the cost of single treatment to $0.8. BRIEF DESCRIPTION OF DRAWINGS

[0028] The accompanying drawings are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification, illustrate embodiments of the application and are used to explain the application, but do not constitute a limitation on the application.

[0029] Figure 1 It is a schematic diagram of the overall structure of the nasal treatment device.

[0030] Figure 2 It is a schematic diagram of the working process of the nasal treatment device.

[0031] Figure 3 It is a schematic diagram of the cooperation structure of the conductive film and the graphene heating sheet.

[0032] Figure 4 It is a schematic diagram of the layout of the interdigital electrode of the conductive film and the positioning of the Yingxiang acupoint.

[0033] In the figure: 101: controller; 101a: temperature control module; 101b: electric stimulation parameter module; 101c: safety monitoring module; 102: power adapter; 103: fixed cover body; 103a: nose pad; 103b: adjustable headband; 103c: magnetic attraction interface; 104: graphene heating sheet; 104a: graphene coating; 105: conductive film; 105a: interdigital electrode; 106: isolation cloth. DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the application will be described below in detail with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only a part of the embodiments of the application, not all the embodiments of the application.

[0035] In the description of the application, it should be understood that the terms "upper", "lower", "front", "back", "left", "right", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore it cannot be understood as a limitation on the application.

[0036] Reference Figure 1 The present application adopts a four-layer laminated structure design:

[0037] 1. Contact layer: Isolation cloth 106: Disposable non-sterile medical non-woven cloth, covering the outer side of the conductive film, with a grammage of 30 g / m2 and a moisture permeability of ≥1000 g / (m2·24h).

[0038] 2. Functional layer: Conductive film 105: A type of medical device attached to the outer surface of the graphene heating sheet, containing symmetrically distributed interdigital silver paste electrodes (line width 0.5 mm, spacing 1 mm), with a square resistance ≤0.1 Ω / sq (containing zinc oxide whiskers); The electrode layout is determined based on CT three-dimensional reconstruction data (n=50) to locate the Xingxiang acupoint coordinates, with a positioning error ≤0.3 mm and an impedance ≤100 Ω. Graphene heating sheet 104: Thickness 0.35 nm±0.2 nm, micropore array density 500-800 holes / mm2, composed of two layers of polyimide film packaging graphene coating, heating area 20×30 mm, working temperature 40-50℃±0.5℃, emitting far infrared wavelength 8-10 μm, embedded in the groove of the nose holder part.

[0039] 3. Support layer: Fixed cover 103: Made of medical silicone material, containing a nose holder part 103a and an adjustable headband 103b, the inner surface of the nose holder part is set to correspond to the contour of the alae nasi, containing a magnetic interface, which can be detached and replaced with consumables.

[0040] 4. Control layer: Controller 101: Controller with built-in STM32H743 chip, integrating temperature control module, electrical stimulation parameter module and safety monitoring module; Power adapter 102: Output DC voltage 5-12V, maximum current ≤3A, with overcurrent protection function.

[0041] The various components of the nasal treatment device cooperate with each other through precise physical interfaces and electrical connections to achieve the treatment function together. The core cooperation relationship is as follows:

[0042] (I) Laminated cooperation of detachable consumable assembly (from inside to outside):

[0043] Cooperation of isolation cloth 106 and conductive film 105:

[0044] Cooperation method: Isolation cloth 106 is fully attached to the outer surface of conductive film 105 (i.e. the side facing the skin) by medical pressure-sensitive adhesive.

[0045] Function: As a disposable sanitary barrier, its high moisture permeability (≥1000 g / (m2·24h) ensures the evaporation of sweat during treatment, preventing skin from being hot and humid, while ensuring that the electrical stimulation current can be effectively conducted to the skin.

[0046] Cooperation of conductive film 105 and graphene heating sheet 104:

[0047] Cooperation mode: This is the key to achieve "thermal-electric separation". The conductive film 105 is bonded to the outer surface of the graphene heating sheet 104 through a dot matrix of hot melt adhesive 107. The bonding points are uniformly distributed in a matrix, and the total bonding area is ≤15%.

[0048] Function: The minimum bonding area physically isolates the heating sheet 104 from the conductive film 105, fundamentally eliminating signal crosstalk and thermal conduction interference between the thermal therapy circuit and the electrical stimulation circuit, and improving the heat utilization rate to 89%.

[0049] (II) Integration of core functional modules and fixed cover:

[0050] Cooperation of graphene heating sheet 104 and nose pad 103a:

[0051] Cooperation mode: The graphene heating sheet 104 is completely embedded in the pre-prepared groove on the inner surface of the nose pad 103a, and is fixed by medical silicone around, realizing sealing and insulation.

[0052] Function: The silicone groove ensures the fixed position of the heating sheet 104, and the heat is concentrated forward (towards the nasal cavity) and radiated, while protecting the internal circuit from external damage.

[0053] Cooperation of magnetic interface 103c: Cooperation mode: There is a magnet (N pole) and a gold-plated charging pin in the nose pad 103a. Correspondingly, a magnet (S pole) and a receiving contact point are embedded in the base of the consumable assembly (the composite of conductive film 105 and isolation cloth 106).

[0054] Function: Quick alignment and connection are achieved through magnetic attraction. The magnetic design ensures that users can easily and correctly replace consumables, and the electrical contacts are automatically connected, providing electrical stimulation signals for the conductive film 105. The magnetic force (≥3N) ensures stable connection during treatment.

[0055] (III) Connection of electrical system:

[0056] Cooperation of controller 101 and execution end:

[0057] Cooperation mode: The controller 101 is connected to the interface in the nose pad 103a through a flexible FPC ribbon, independently controlling the heating circuit of the graphene heating sheet 104 and the electrical stimulation circuit of the conductive film 105, respectively.

[0058] Function: Double-way independent output realizes precise and independent control of thermal therapy and electrical stimulation parameters, which is the basis for realizing multi-stage cooperative mode.

[0059] Cooperation of power adapter 102 and controller 101:

[0060] Cooperation mode: Standard DC interface connection, providing 5-12V / 3A stable DC power supply.

[0061] Function: Built-in overcurrent protection circuit, when the controller 101 monitors the abnormality (such as temperature > 50℃ or current fluctuation ≥ ± 10%), it will send a signal to the power management chip, and cut off the output instantly, realizing double safety protection.

[0062] A nasal acupoint positioning method comprises:

[0063] Obtain the coordinates of the user's nasal feature points (Pn, Pw) through a 3D camera;

[0064] Calculate the coordinates of the Yingxiang acupoint according to the formula X = 0.82 × (Pw-Pn), Y = 0.31 × (Pwy-Pny). Control the movement of the electrode (error ≤ 0.3mm).

[0065] A dynamic impedance regulation method,

[0066] Real-time collection of tissue impedance (sampling frequency 100Hz);

[0067] Solve the dielectric properties through the Cole-Cole model Z = R∞ + (R0-R∞) / 1+(jωτ)a (where Z is the tissue impedance, ω is the angular frequency, and τ is the time constant).

[0068] Dynamic matching of electrical stimulation parameters (response time < 200ms).

[0069] (Four) Effect characteristics

[0070] 1. Thermal-electric separation laminated structure: graphene heating sheet 104 and conductive film 105 are bonded by hot melt glue dot array, the bonding area is ≤ 15%, physical isolation is formed, and signal stringing is completely eliminated.

[0071] 2. Accurate acupoint positioning: calculate the coordinates of the Yingxiang acupoint based on the nasal wing feature points (nose tip point Pn, ala nasi point Pw): X = 0.82 × (Pw-Pn), Y = 0.31 × (Pwy-Pny), positioning error ≤ 0.3mm;

[0072] 3. Dynamic impedance regulation: real-time solution of tissue impedance based on Cole-Cole model (sampling rate 100Hz, response time < 200ms), dynamic matching of optimal treatment parameters: Z = R∞ + (R0-R∞) / 1+(jωτ)a (where Z is the tissue impedance, ω is the angular frequency, and τ is the time constant).

[0073] 4. Safety monitoring

[0074] The safety monitoring module in the controller real-time collects the temperature of the graphene heating sheet and the current of the conductive film, and automatically cuts off the heating sheet power when the humidity > 50℃ (error ± 0.5℃), and closes the electrical stimulation output when the current fluctuation > ± 10% (for 5 seconds).

[0075] (V) The working process of the nasal treatment device is as follows (with reference to Figure 2 )

[0076] Therapeutic synergy of heat and electrical stimulation

[0077] First stage (0-5 min): Start graphene heating sheet (42°C) preheating, turn off electrical stimulation.

[0078] Second stage (5-15 min): Maintain 42°C heat therapy, start 2Hz / 0.8mA electrical stimulation;

[0079] Third stage (15-20 min): Increase temperature to 45°C, switch electrical stimulation to 10Hz / 1.2mA;

[0080] In use, the user connects the nasal treatment device through the mobile phone APP, selects the corresponding treatment mode (such as "acute nasal congestion mode"). The controller automatically adjusts the temperature of the graphene heating sheet and the electrical stimulation parameters of the conductive film according to the selected mode. During treatment, the safety monitoring module monitors the temperature and current in real time to ensure treatment safety.

[0081] Built-in anti-edema mode:

[0082] Constant temperature heat therapy 45°C±0.5°C; 5KHz medium frequency square wave electrical stimulation, current 1.5mA±0.2mA, duty cycle 50%; last for 20 minutes.

[0083] (VI) Key steps in the preparation process

[0084] 1. Graphene heating sheet production:

[0085] A graphene coating is grown using the CVD method, with a thickness controlled at 0.35nm. The graphene coating is encapsulated between two layers of polyimide film to form a graphene heating sheet.

[0086] 2. Conductive film attachment: Attach a conductive film to the outer surface of the graphene heating sheet, bonded by a hot melt glue dot array, with a bonding area ratio ≤15%.

[0087] 3. Isolation cloth covering: Cover the isolation cloth on the outside of the conductive film to form a complete nose pad assembly.

[0088] Assembly: Assemble the controller, power adapter, and fixed cover to complete the production of the nasal treatment device.

[0089] Experimental Example 1: Graphene heating sheet life

[0090] Sample information: CVD method to grow graphene coating (thickness 0.35±0.02mm), encapsulated in polyimide film test standard:

[0091] Life evaluation: GB / T34986-2017 Appendix C (Arrhenius model)

[0092] Performance degradation: IEC60068-2-14 temperature cycle test

[0093] 1) Accelerated aging test design

[0094]

[0095] Equivalent life conversion:

[0096] Equivalent life accelerated test time x AF = 408h x 12.3 = 5018h (meet >5000h requirement)

[0097] 2) Performance degradation test results - key parameter changes

[0098]

[0099] 3) Safety margin verification - extreme stress test

[0100]

[0101]

[0102] 4) Life prediction model - extrapolation based on degradation data

[0103] Life end = (allowable attenuation / unit time attenuation rate) x use intensity coefficient

[0104] The attenuation of square resistance to 110Ω / sq (+29.4%) is the failure threshold

[0105] Measured attenuation rate: 0.0167%h→Predicted life = 29.4% / 0.0167% / h = 1760h

[0106] Convert actual life: 1760h x 12.3 = 21,648h

[0107] Conclusion: Under the working condition of 40℃, graphene heating sheet:

[0108] 1. Guaranteed life: 5018 hours (equivalent value of accelerated test)

[0109] 2. Predicted life: 21,648 hours (extrapolated value of degradation model)

[0110] 3. Safety level: no degradation of insulation / pressure resistance performance

[0111] Experimental Example 2: Clinical effectiveness

[0112] Methods: 120 patients with chronic rhinitis were randomly divided into treatment group (n=60) and control group (n=60), the treatment group used the device for 20 minutes every day, the control group used the placebo device without heat therapy / electrical stimulation, for 4 weeks.

[0113] Evaluation index: VAS score of nasal congestion (0-10)

[0114] Results:

[0115] Group Baseline score Endpoint score VAS reduction rate Treatment group 6.8±1.2 2.2±0.8 67.6％ Control group 6.5±1.1 5.1±1.0 5.72％

[0116] (p<0.01 compared with the control group)

[0117] Conclusion: The efficacy is significantly better than the control

[0118] Group Effective rate (%) 24h recurrence rate Adverse reaction rate The device 92.3 12.6％ 0.8％ Laser physiotherapy 74.1 41.7％ 0.12 P value <0.01 <0.001 0.02

[0119] Multi-center RCT study (n=120)

[0120] Conclusion: The efficacy is significantly better than the control (OR=3.24, 95% CI 1.87-5.62)

[0121] Experimental Example 3: Biocompatibility

[0122] The device obtained in the examples is tested according to the medical device biological evaluation standard.

[0123] In vitro cytotoxicity test: according to the method of GB / T16886.5-2017 "Medical devices-Biological evaluation Part 5: Test for Cytotoxicity".

[0124] Body

[0125] In vitro cytotoxicity test: according to the method of GB / T16886.5-2017 "Medical devices-Biological evaluation Part 5: Test for Cytotoxicity".

[0126] Skin irritation and sensitization test: according to the method of GB / T16886.10-2017 "Medical devices-Biological evaluation Part 10: Test for Irritation and Skin Sensitization".

[0127] Test results:

[0128]

[0129] Conclusion: The device of the application has good biological safety, the relative proliferation rate of cells is >98.5%, and the results of skin irritation and skin sensitization test are negative.

[0130] Experimental Example 4: Electrical safety

[0131] EMC detection has completed electrostatic discharge resistance (±8KV contact discharge), radio frequency electromagnetic field radiation resistance (3V / m) test, the results meet the requirements of YY9706.102-2021, GB4824-2019 in group B of class I; the general requirements for the basic safety and basic performance of medical electrical equipment and the special requirements for the basic safety and basic performance of nerve and muscle stimulators shall meet GB9706.1-2020, YY9706.102-2021 standards respectively, at present in the detection, the final report is expected to be completed in October 2025.

[0132] The above is only the preferred specific embodiment of the present application, but the protection scope of the present application is not limited to this, any person skilled in the art can make equivalent replacement or change according to the technical scheme and the inventive concept of the present application within the technical range disclosed by the present application, which should be covered in the protection scope of the present application.

Claims

1. A nasal treatment device based on graphene heat therapy and acupoint electrical stimulation, characterized in that, The contact layer, the functional layer and the support layer are sequentially arranged. The functional layer comprises an electric stimulation layer and a thermal therapy layer, and the electric stimulation layer and the thermal therapy layer are electrically connected with a control layer, and the control layer is powered by a power supply; the electric stimulation layer is a conductive film, and the conductive film is provided with an electrode corresponding to the Xingxi acupoint; the thermal therapy layer is a graphene heating sheet. The support layer comprises a fixed cover body, and the fixed cover body is adapted to the contour of a nasal ala.

2. The nasal treatment device based on graphene heat therapy and acupoint electrical stimulation according to claim 1, characterized in that, The contact layer is an isolation cloth, and the isolation material is a disposable non-sterile medical non-woven fabric.

3. The nasal treatment device based on graphene heat therapy and acupoint electrical stimulation according to claim 1, characterized in that, The conductive film is provided with symmetrically distributed interdigital silver paste electrodes corresponding to the Xingxi acupoint.

4. The nasal treatment device based on graphene heat therapy and acupoint electrical stimulation according to claim 1, characterized in that, The graphene heating sheet is a graphene coating encapsulated by two polyimide films, and is embedded in the groove of the fixed cover body; the graphene heating sheet is covered by medical silica gel and fixed in the groove.

5. The nasal treatment device based on graphene heat therapy and acupoint electrical stimulation according to claim 1, characterized in that, The graphene heating sheet and the conductive film are bonded by a hot melt glue dot array.

6. The nasal treatment device based on graphene heat therapy and acupoint electrical stimulation according to claim 1, characterized in that, Further comprising a controller, the controller is provided with a temperature control module, an electric stimulation parameter module and a safety monitoring module; the temperature control module is connected with the graphene heating sheet, the electric stimulation parameter module is connected with the conductive film, and the safety monitoring module is used for real-time monitoring of the temperature of the graphene heating sheet and the current of the conductive film.

7. The nasal treatment device based on graphene heat therapy and acupoint electrical stimulation according to claim 1, characterized in that, The fixed cover body is provided with a magnetic pole and a gold-plated charging pin, and the magnetic pole and a receiving contact point are embedded in the base corresponding to the composite of the conductive film and the isolation cloth.

8. A nose acupoint positioning method, characterized in that, S1: obtaining the coordinates of the nose feature points (Pn, Pw) of a user through a 3D camera; S2: calculating the coordinates of the Xingxi acupoint according to the formula X = 0.82×(Pw-Pn), Y = 0.31×(Pwy-Pny) and controlling the movement of the electrode.

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