DC signal output control device

Abstract

The invention relates to a direct current electric signal output control device and a beautifying method. The direct current signal output control device comprises a control module and a direct current signal generation module. The control module is configured to control the direct current signal generation module to generate a direct current voltage signal if the direct current signal generation module is connected with the first type of output module, and provide the direct current voltage signal to the first type of output module, so that a first acting electrode in the first type of output module outputs plasma to act on a first part; if the direct current signal generation module is connected with the second type output module, the direct current signal generation module is controlled to generate a direct current signal, the direct current signal is provided for the second type output module, and a second acting electrode in the second type output module acts the direct current signal on a second part. Therefore, the method is wider in application range and can be used for various scenes.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202511206142.8 (22) Application Date 2025.08.27 (30) Priority Data PV2024-325 2024.08.27 CZ (71) Applicant Zhuhai Fitland Medical Technology Co., Ltd. Address 519085, Building 6, No. 129, Dingxing Road, Tangjiawan Town, High-tech Zone, Zhuhai City, Guangdong Province Applicant Kangpeishi Co., Ltd. (72) Inventor Requests Not to Disclose Name Requests Not to Disclose Name Requests Not to Disclose Name (51) Int.Cl. A61F 9 / 007 (2006.01) H05H 1 / 24 (2006.01) A61B 18 / 04 (2006.01) (54) Invention Title: DC Signal Output Control Device (57) Abstract: This disclosure relates to a DC signal output control device and a cosmetic method. The DC signal output control device includes a control module and a DC signal generation module. The control module is configured to: if the DC signal generation module is connected to a first type of output module, control the DC signal generation module to generate a DC voltage signal and provide the DC voltage signal to the first type of output module, so that the first working electrode in the first type of output module outputs plasma to act on a first part; if the DC signal generation module is connected to a second type of output module, control the DC signal generation module to generate a DC current signal and provide the DC current signal to the second type of output module, so that the second working electrode in the second type of output module acts the DC current signal on a second part. Therefore, it has a wider range of applications and can be used in various scenarios.Claims 4 pages, Description 35 pages, Drawings 11 pages, CN 121041094 A 2025.12.02 CN 1 21 04 10 94 A 1. A DC signal output control device, comprising: a control module and a DC signal generation module, wherein the control module is configured to: if the DC signal generation module is connected to a first type of output module, control the DC signal generation module to generate a DC voltage signal and provide the DC voltage signal to the first type of output module, so that a first working electrode in the first type of output module outputs plasma to act on a first part, wherein the first type of output module includes a first working electrode and a first ground electrode, the first working electrode and the first ground electrode are respectively connected to two output terminals of the DC signal generation module, and the application surface of the first working electrode is spaced apart from the first part by a first distance, and the first ground electrode establishes a conductive path with other parts other than the first part; If the DC signal generation module is connected to the second type of output module, the DC signal generation module is controlled to generate a DC current signal and provide the DC current signal to the second type of output module. This causes the second active electrode in the second type of output module to apply the DC current signal to the second part. The second type of output module includes a second active electrode and a second ground electrode. The second active electrode and the second ground electrode are respectively connected to the two output terminals of the DC signal generation module. The application surface of the second active electrode establishes a conductive path with the second part, and the second ground electrode establishes a conductive path with other parts besides the second part. 2. The DC signal output control device according to claim 1 further includes: an impedance detection module, used to detect human body impedance when the DC signal generation module is connected to the second type of output module. The control module, based on the human body impedance, determines whether the second type of output module forms a circuit with the human body, and if it determines that the second type of output module forms a circuit with the human body, controls the DC signal generation module to generate a DC current signal. 3. The DC signal output control device according to claim 1, wherein the DC signal output control device treats at least one of the following conditions or achieves at least one of the following therapeutic purposes by outputting the DC current signal: hair growth, meibomian gland dysfunction, dry eye syndrome, cervical dysplasia, cervical bleeding, ablation of Nabothian cysts, treatment of cervical ectropion, cervical inflammation, leukoplakia, metaplasia, treatment of transformation zone, cervical mucosal irregularities, adenomyosis, endometriosis, cytological abnormalities, HPV positivity, prevention of cervical insufficiency during pregnancy, contact bleeding, decreased cervical mucus, stress urinary incontinence, vaginal laxity, and tightening of facial and vulvar skin.4. The DC signal output control device according to claim 1, wherein the DC signal output control device treats at least one of the following conditions or achieves at least one of the following therapeutic purposes by outputting the plasma: blepharitis, dry eye syndrome, ptosis, entropion, xanthelasma palpebrae, conjunctival laxity, periocular cosmetic procedures, blepharoplasty, condyloma acuminata, treatment of benign tumors, and removal of epidermal lesions. 5. The DC signal output control device according to claim 1, wherein the DC signal output control device treats at least one of the following conditions in pets by outputting the plasma and / or the DC current signal: evaporative and mixed dry eye syndrome, blepharitis, blepharitis, multidrug treatment for glaucoma secondary to conjunctivitis in pets, chalazion, infectious inflammation of eyelid glands, trichiasis and difilariasis, ectopic cilia, benign tumors of the eyelids and body, peripheral facial paralysis, alopecia, Demodex mites, body keratosis, and papilloma. 6. The DC signal output control device according to claim 1, wherein the second part is the anterior lip of the eyelid, the second active electrode penetrates the second part, and the DC signal output control device treats trichiasis and / or ecchymosis by outputting the DC current signal. 7. The DC signal output control device according to claim 1, wherein the DC current signal includes at least one of a constant DC current signal, a single-pulse DC current signal, and a multi-pulse DC current signal; the constant DC current signal is a current with constant direction and intensity; the single-pulse DC current signal is a current with constant direction and intensity that varies with time; and the multi-pulse DC current signal is a current obtained by superimposing at least two currents with equal amplitude and different frequencies. 8. The DC signal output control device according to claim 7, wherein, when the DC signal generation module is connected to a second type of output module, the control module controls the DC signal generation module to generate a first mode DC current signal in a first time period, and controls the current generation module to generate a second mode DC current signal in a second time period, wherein one output process includes at least one first time period and at least one second time period, and the first mode DC current signal and the second mode DC current signal are taken from two of the constant DC current signal, the single-pulse DC current signal, and the multi-pulse DC current signal.9. The DC signal output control device according to any one of claims 1, 7, and 8, further comprising: an injection module, wherein the injection module is used to deliver a drug or active ingredient to the first site after the plasma is applied to the first site to change the permeability of the stratum corneum of the first site, or the injection module is used to deliver an ionic drug or active ingredient to the second site during the application of the DC current signal to the second site, wherein the permeability of the cell membrane of the second site is increased under the action of the DC electric field of the DC current signal, thereby facilitating the introduction of the ionic drug or active ingredient into the second site. 10. The DC signal output control device according to claim 9, wherein the injection module comprises a storage module, a transport module, and a delivery module; the storage module stores the ionic drug or active ingredient to be introduced; the transport module is connected to the control module; the control module controls the operating parameters of the transport module; during the application of the DC current signal to the second site, the transport module, under the control of the control module, transports the ionic drug or active ingredient to the delivery module, and the delivery module delivers the ionic drug or active ingredient to the second site. 11. The DC signal output control device according to claim 1, further comprising: a first type of output module and a second type of output module, wherein the front end of the first active electrode is a discharge tip, and the front end of the second active electrode is an application surface adapted to the second part. 12. The DC signal output control device according to claim 11, wherein the second active electrode includes a first probe for gynecological treatment, the first probe including a gripping part and an insertion part, the insertion part being designed for insertion into the vagina. 13. The DC signal output control device according to claim 11, wherein the second active electrode includes a second probe for medical aesthetics and / or eye diseases. 14. The DC signal output control device according to claim 1, wherein the first grounding electrode and the second grounding electrode are the same electrode. 15. The DC signal output control device according to claim 1, wherein the first part and the second part are the same part. 16. The DC signal output control device according to claim 1, wherein the DC voltage signal is greater than or equal to the breakdown voltage between the first active electrode and the first part, and / or the plasma allows a maximum current of 3mA to be transmitted between the first active electrode and the first part. Claims 2 / 4, page 3, CN 121041094, A 17. The DC signal output control device according to claim 1, wherein the DC current signal is ≤20mA; and / or the pulse width is 0ms to 5000ms; and / or the frequency is 0Hz to 1MHz.18. The DC signal output control device according to claim 17, wherein the DC current signal is ≤10mA; and / or the pulse width is 0ms to 1000ms; and / or the frequency is 0Hz to 100kHz. 19. The DC signal output control device according to claim 18, wherein the frequency is 10Hz to 50Hz. 20. The DC signal output control device according to claim 1, wherein the first distance is 0.1mm to 5mm. 21. The DC signal output control device according to claim 1, wherein the front end of the first active electrode is made of gold; and / or the front end of the second active electrode is made of metal. 22. The DC signal output control device according to claim 2, wherein the control module sets a second output level based on the human body impedance, and controls the DC signal generation module to ensure that the energy acting on the second part per unit time does not exceed a second threshold, the second output level is positively correlated with the human body impedance, and the second threshold is positively correlated with the second output level. 23. The DC signal output control device according to claim 2, wherein the control module determines whether an indication exists based on the numerical change of the human body impedance, and sets the output strategy of the DC current signal according to the determination result. 24. The DC signal output control device according to claim 2, wherein the second part is the eye, the eye includes at least one of the eyelid, palpebral margin, conjunctiva, and sclera, the DC signal output control device is used to treat dry eye syndrome, and the control module, when determining that dry eye syndrome is an indication based on the numerical change of the human body impedance, sets the energy applied to the eye per unit time based on the degree of change of the human body impedance, wherein the energy applied to the eye per unit time is negatively correlated with the degree of change of the human body impedance, and / or the control module, when determining that dry eye syndrome is not an indication based on the numerical change of the human body impedance, resets the output strategy of the DC current signal. 25. The DC signal output control device according to claim 2, wherein the control module calculates the human body impedance based on the following formula: Z = R + X, where Z represents the human body impedance, R represents the real part of the human body impedance, X represents the imaginary part of the human body impedance, A represents the impedance compensation constant, w represents the angular frequency, P(w) represents the resistivity of the second part corresponding to the angular frequency w, d represents the distance between the two electrodes of the second type of output module, s represents the area where the current acts on the second part, ε1 represents the real part of the dielectric constant, and ε2 represents the imaginary part of the dielectric constant.26. The DC signal output control device according to claim 1, wherein the DC signal generation module includes a boost circuit and a signal modulator, the signal modulator being used to modulate the output signal of the boost circuit, wherein the open-circuit voltage is adjustable to 20kV, the current is adjustable to 20mA, the operating frequency is 0Hz to 1000kHz, and the pulse train repetition frequency is 0Hz to 100Hz. 27. The DC signal output control device according to claim 26, wherein the current is adjustable to 10mA, the operating frequency is 0Hz to 100kHz, and the pulse train repetition frequency is 0Hz to 50Hz. 28. A DC signal output control device, comprising: a control module, a DC signal generation module, a first acting electrode, a second acting electrode, and a grounding electrode, wherein the grounding electrode is connected to a first output terminal of the DC signal generation module, one end of the second acting electrode is connected to a second output terminal of the DC signal generation module, and the other end of the second acting electrode contacts a target area; the control module controls the DC signal generation module to generate a DC current signal and provides the DC current signal to the second acting electrode, causing the second acting electrode to apply the DC current signal to the target area; in response to the output duration of the DC current signal being greater than or equal to a first threshold, and / or the effect of the DC current signal on the target area being lower than expected, the second output terminal is connected to the first acting electrode; the other end of the first acting electrode is spaced apart from the target area by a first distance; the control module controls the DC signal generation module to generate a DC voltage signal and provides the DC voltage signal to the first acting electrode, causing the first acting electrode to output plasma to act on the target area. 29. The DC signal output control device according to claim 28 further includes: an impedance detection module for detecting human body impedance when the second output terminal is connected to the second active electrode; a switching module and / or an output module, wherein the control module determines whether there is an indication based on the numerical change of the human body impedance, and if it determines that there is no indication, instructs the switching module to connect the second output terminal to the first active electrode, or controls the output module to output a first prompt message, the first prompt message being used to prompt the switching of the active electrode currently connected to the DC signal generation module.30. The DC signal output control device according to claim 29, wherein the target part is the eye, the eye includes at least one of the eyelid, palpebral margin, conjunctiva, and sclera, the DC signal output control device is used to treat dry eye syndrome, and in response to the decrease in the human body impedance being less than a third threshold during a first output duration of the DC current signal, the control module adjusts the output parameters of the DC current signal to increase the output power, and in response to the decrease in the human body impedance being less than a fourth threshold during a subsequent second output duration of the DC current signal, the control module instructs the switching module to connect the second output terminal to the first active electrode, or controls the output module to output the first prompt information. Claims 4 / 4 Page 5 CN 121041094 A DC Signal Output Control Device

[0001] This application claims priority to Czech Patent Application No. 2024-325, filed on August 27, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to a DC signal output control device. Background Art

[0003] Plasma discharge technology is not new. The basic electrical principles have been used in medicine and health treatment for many years. The medical applications based on electrical technology and standardized electrocoagulation are more extensive, which allows electrical energy to be converted into heat energy to achieve dissociation and coagulation, and has applications in many different fields. This type of DC electric field is also used in the field of beauty, and is considered to help improve the metabolism of skin surface cells.

[0004] Electrostimulation is a technology that stimulates biological tissues with electric current to produce specific physiological responses, and is widely used in the fields of medicine, sports rehabilitation and beauty.

[0005] Existing electrostimulation devices usually use direct current to achieve different therapeutic purposes, and the fields involved include:

[0006] 1. Gynecological applications: vaginal rejuvenation, urinary incontinence treatment, mucosal regeneration (such as patents CZ306263 B6, WO2020057676A1). The device acts on the vaginal mucosa with a stable direct current, improving blood circulation and promoting tissue regeneration. It includes a portable device with electrodes, which enhances the elasticity and health of the vaginal mucosa through electrical pulse stimulation.

[0007] 2. Skin electrocautery and drying: The device for electrocautery treatment (patent CZ308215B6) uses a stable direct current to remove skin lesions such as warts and growths, and achieves safe and effective treatment through precise electrical pulses.

[0008] 3. Patent US20180147001A1: Describes a portable device for electrocautery and drying, which achieves tissue removal through current.

[0009] Existing patents show that direct current is widely used in the medical field, covering skin treatment, gynecological care, and transdermal drug delivery enhancement, reflecting the trend of using modern technology to achieve non-invasive, safe, and efficient treatment.

[0010] Existing commercially available devices are all based on stable high-voltage direct current, and their mechanism of action on living cells and tissues is as follows:

[0011] Electrochemical gradient and membrane potential: Under normal circumstances, the membrane potential is about -70mV (most cells are in a resting state). An external electric field can artificially change the membrane potential, affecting the behavior of ion channels. As an insulator, the cell membrane separates the charges inside and outside the cell. In the resting state, the charge inside the cell is negative than that outside the cell, mainly maintained by the Na+ / K+ pump (actively transporting 3 Na+ out of the cell and 2 K+ into the cell) and the selective permeability of the membrane to specific ions. When an external electric field is applied, the change in potential difference may lead to: the opening of voltage-gated ion channels, or a change in the direction of ion transmembrane movement.

[0012] Ion channel opening (voltage gating): Some ion channels are voltage-gated. Changes in membrane potential (e.g., depolarization from -70mV to -55mV) can open sodium ion channels, triggering action potentials (e.g., nerve cells). Current can simulate natural nerve or muscle impulses.

[0013] Electroosmosis and electrophoresis: Under the action of current, ions can move directly across the membrane via electrophoresis (migration of charged particles in an electric field). Water molecules and solutes can move along with ions via electroosmosis. Electrophoresis can drive charged drug molecules to penetrate the membrane structure, while electroosmosis assists drugs to penetrate into deeper tissues.

[0014] Temporary membrane damage - electroporation: High-intensity short-pulse current can temporarily damage the membrane structure, allowing macromolecules to pass through. Electroporation technology is used for gene editing (DNA introduction) and tumor chemotherapy (enhancing drug permeability). After the pulse ends, the membrane usually repairs itself, allowing macromolecules to enter during this period.

[0015] The present disclosure aims to provide a more feature-rich DC signal output control device that can be used in a variety of scenarios.

[0016] According to a first aspect of this disclosure, a DC signal output control device is provided, comprising: a control module and a DC signal generation module. The control module is configured to: if the DC signal generation module is connected to a first type of output module, control the DC signal generation module to generate a DC voltage signal and provide the DC voltage signal to the first type of output module, causing a first active electrode in the first type of output module to output plasma and act on a first part, wherein the first type of output module includes a first active electrode and a first ground electrode, the first active electrode and the first ground electrode are respectively connected to two output terminals of the DC signal generation module, and the application surface of the first active electrode is spaced apart from the first part by a first distance, and the first ground electrode establishes a conductive path with other parts besides the first part; if the DC signal generation module is connected to a second type of output module, control the DC signal generation module to generate a DC current signal and provide the DC current signal to the second type of output module, causing a second active electrode in the second type of output module to act on a second part with the DC current signal. The second type of output module includes a second active electrode and a second ground electrode. The second active electrode and the second ground electrode are respectively connected to the two output terminals of the DC signal generation module. The application surface of the second active electrode establishes a conductive path with the second part, and the second ground electrode establishes a conductive path with other parts other than the second part.

[0017] Optionally, the DC signal output control device further includes: an impedance detection module, used to detect human body impedance when the DC signal generation module is connected to the second type of output module. The control module determines whether the second type of output module forms a loop with the human body based on the human body impedance, and controls the DC signal generation module to generate a DC current signal when it is determined that the second type of output module forms a loop with the human body.

[0018] Optionally, the DC signal output control device treats at least one of the following conditions or achieves at least one of the following therapeutic purposes by outputting the DC current signal: hair growth, meibomian gland dysfunction, dry eye syndrome, cervical dysplasia, cervical bleeding, ablation of Nabothian cysts, treatment of cervical eversion, cervical inflammation, leukoplakia, metaplasia, treatment of transformation zone, cervical mucosal irregularities, adenomyosis, endometriosis, cytological abnormalities, HPV positivity, prevention of cervical insufficiency during pregnancy, contact bleeding, decreased cervical mucus, stress urinary incontinence, vaginal laxity, and tightening of facial and vulvar skin.

[0019] Optionally, the DC signal output control device treats at least one of the following conditions or achieves at least one of the following therapeutic purposes by outputting the plasma: blepharitis, dry eye syndrome, ptosis, entropion, xanthelasma palpebrae, conjunctival laxity, periocular cosmetic procedures, blepharoplasty, condyloma acuminata, treatment of benign tumors, and removal of epidermal lesions.

[0020] Optionally, the DC signal output control device treats at least one of the following conditions in pets by outputting the plasma and / or the DC current signal: evaporative and mixed dry eye syndrome, blepharitis, blepharitis, multidrug treatment for glaucoma secondary to conjunctivitis in pets, chalazion, infectious inflammation of eyelid glands, trichiasis and difilariasis, ectopic cilia, benign tumors of the eyelids and body, peripheral facial paralysis, alopecia, Demodex mites, body keratosis, and papilloma.

[0021] Optionally, the second site is the anterior lip of the eyelid margin, the second active electrode penetrates the second site, and the DC signal output control device treats trichiasis and / or tangled eyelashes by outputting the DC current signal.

[0022] Optionally, the DC current signal includes at least one of a constant DC current signal, a single-pulse DC current signal, and a multi-pulse DC current signal. The constant DC current signal is a current with constant direction and intensity. The single-pulse DC current signal is a current with constant direction and intensity that varies with time. The multi-pulse DC current signal is a current obtained by superimposing at least two currents with equal amplitude and different frequencies.

[0023] Optionally, when the DC signal generation module is connected to the second type of output module, the control module controls the DC signal generation module to generate a first mode DC current signal in a first time period, and controls the current generation module to generate a second mode DC current signal in a second time period. Each output process includes at least one first time period and at least one second time period. The first mode DC current signal and the second mode DC current signal are taken from two of the constant DC current signal, the single-pulse DC current signal, and the multi-pulse DC current signal.

[0024] Optionally, the DC signal output control device further includes: an injection module, which is used to deliver a drug or active ingredient to the first site after the plasma is applied to the first site to change the permeability of the stratum corneum of the first site; or the injection module is used to deliver an ionic drug or active ingredient to the second site during the process of applying the DC current signal to the second site. Under the action of the DC electric field of the DC current signal, the permeability of the cell membrane of the second site is increased, thereby facilitating the introduction of the ionic drug or active ingredient into the second site.

[0025] Optionally, the injection module includes a storage module, a transport module, and a delivery module. The storage module stores the ionic drug or active ingredient to be introduced. The transport module is connected to the control module. The control module controls the operating parameters of the transport module. During the process of applying the DC current signal to the second site, the transport module, under the control of the control module, transports the ionic drug or active ingredient to the delivery module, which then delivers the ionic drug or active ingredient to the second site.

[0026] Optionally, the DC signal output control device further includes: a first type of output module and a second type of output module, wherein the front end of the first active electrode is a discharge tip, and the front end of the second active electrode is an application surface adapted to the second site.

[0027] Optionally, the second active electrode includes a first probe for gynecological treatment. The first probe includes a holding part and an insertion part, and the insertion part is designed to be inserted into the vagina.

[0028] Optionally, the second active electrode includes a second probe for medical aesthetics and / or eye diseases.

[0029] Optionally, the first grounding electrode and the second grounding electrode are the same electrode.

[0030] Optionally, the first part and the second part are the same part.

[0031] Optionally, the DC voltage signal is greater than or equal to the breakdown voltage between the first active electrode and the first part, and / or the plasma allows a maximum current of 3mA to be transmitted between the first active electrode and the first part.

[0032] Optionally, the DC current signal is ≤20mA; and / or

[0033] the pulse width is 0ms to 5000ms; and / or

[0034] the frequency is 0Hz to 1MHz.

[0035] Optionally, the DC current signal is ≤10mA; and / or

[0036] the pulse width is 0ms to 1000ms; and / or

[0037] the frequency is 0Hz to 100kHz.

[0038] Optionally, the frequency is 10Hz to 50Hz.

[0039] Optionally, the first distance is 0.1mm to 5mm. (Page 3 / 35 of the specification, CN 121041094 A)

[0040] Optionally, the front end of the first active electrode is made of gold; and / or the front end of the second active electrode is made of metal.

[0041] Optionally, the control module sets a second output level based on the human body impedance, and controls the DC signal generation module to ensure that the energy applied to the second part per unit time does not exceed a second threshold. The second output level is positively correlated with the human body impedance, and the second threshold is positively correlated with the second output level.

[0042] Optionally, the control module determines whether an indication exists based on the numerical change of the human body impedance, and sets the output strategy of the DC current signal according to the determination result.

[0043] Optionally, the second part is the eye, which includes at least one of the eyelid, palpebral margin, conjunctiva, and sclera. The DC current signal output control device is used to treat dry eye syndrome. When the control module determines that dry eye syndrome is an indication based on the numerical change of the human body impedance, it sets the energy applied to the eye per unit time based on the degree of change of the human body impedance, wherein the energy applied to the eye per unit time is negatively correlated with the degree of change of the human body impedance, and / or when the control module determines that dry eye syndrome is not an indication based on the numerical change of the human body impedance, it resets the output strategy of the DC current signal.

[0044] Optionally, the control module calculates the human body impedance based on the following formula:

[0045] Z = R + X

[0046]

[0047] Wherein, Z represents the human body impedance, R represents the real part of the human body impedance, X represents the imaginary part of the human body impedance, A represents the impedance compensation constant, w represents the angular frequency, P(w) represents the resistivity of the second part corresponding to the angular frequency w, d represents the distance between the two electrodes of the second type of output module, s represents the area of ​​the current acting on the second part, ε1 represents the real part of the dielectric constant, and ε2 represents the imaginary part of the dielectric constant.

[0048] Optionally, the DC signal generation module includes a boost circuit and a signal modulator. The signal modulator is used to modulate the output signal of the boost circuit, wherein the open-circuit voltage is adjustable to 20kV, the current is adjustable to 20mA, the operating frequency is 0Hz to 1000kHz, and the pulse train repetition frequency is 0Hz to 100Hz.

[0049] Optionally, the current can be adjusted to 10mA, the operating frequency is 0Hz to 100kHz, and the pulse train repetition frequency is 0Hz to 50Hz.

[0050] According to a second aspect of this disclosure, a DC signal output control device is provided, comprising: a control module, a DC signal generation module, a first working electrode, a second working electrode, and a ground electrode. The ground electrode is connected to a first output terminal of the DC signal generation module. One end of the second working electrode is connected to a second output terminal of the DC signal generation module, and the other end of the second working electrode contacts a target area. The control module controls the DC signal generation module to generate a DC current signal and provides the DC current signal to the second working electrode, so that the second working electrode applies the DC current signal to the target area. In response to the output duration of the DC current signal being greater than or equal to a first threshold, and / or the effect of the DC current signal on the target area being lower than expected, the second output terminal is connected to the first working electrode. The other end of the first working electrode is spaced apart from the target area by a first distance. The control module controls the DC signal generation module to generate a DC voltage signal and provides the DC voltage signal to the first working electrode, so that the first working electrode outputs plasma to act on the target area. Instruction manual, page 4 / 35, CN 121041094 A

[0051] Optionally, the DC signal output control device further includes: an impedance detection module for detecting human body impedance when the second output terminal is connected to the second active electrode; a switching module and / or an output module, wherein the control module determines whether there is an indication based on the numerical change of the human body impedance, and if it determines that there is no indication, instructs the switching module to connect the second output terminal to the first active electrode, or controls the output module to output a first prompt message, the first prompt message being used to prompt the switching of the active electrode currently connected to the DC signal generation module.

[0052] Optionally, the target area is the eye, which includes at least one of the eyelid, palpebral margin, conjunctiva, and sclera. The DC signal output control device is used to treat dry eye syndrome. In response to the decrease in human body impedance being lower than a third threshold during a first output duration of the DC current signal, the control module adjusts the output parameters of the DC current signal to increase the output power. In response to the decrease in human body impedance being lower than a fourth threshold during a subsequent second output duration of the DC current signal, the control module instructs the switching module to connect the second output terminal to the first action electrode, or controls the output module to output the first prompt information.

[0053] This disclosure can output plasma or DC current signals to act on specific areas as needed, thus having a wider range of applications.

[0054] The above and other objects, features and advantages of this disclosure will become more apparent from the accompanying drawings, which describe exemplary embodiments of the present disclosure in more detail, in conjunction with the accompanying drawings, wherein like reference numerals generally represent like parts.

[0055] FIG1 shows a schematic diagram of a DC signal output control device according to an embodiment of the present disclosure.

[0056] FIG2A shows a schematic diagram of treating conjunctival laxity using a plasma output mode.

[0057] FIG2B shows a schematic diagram of treatment marks after treatment.

[0058] FIG3 shows a schematic diagram of the correspondence between a first output level and a first distance.

[0059] FIG4 shows a schematic diagram of a dual-pulse mode.

[0060] FIG5 shows a schematic diagram of some combined output modes.

[0061] FIG6 shows several schematic diagrams of the structure of a second working electrode.

[0062] FIG7 shows a schematic diagram of the structure of a second working electrode suitable for gynecological use.

[0063] FIG8 shows another schematic diagram of the structure of a second working electrode suitable for gynecological use.

[0064] Figure 9 shows a schematic diagram of the structure of the second working electrode when it acts on the cervical mucosa.

[0065] Figures 10 to 12 show schematic diagrams of the application surface of the second working electrode for cervical mucosal body treatment.

[0066] Figure 13 shows a schematic diagram of the application surface of the second working electrode for cervical mucosal periphery treatment.

[0067] Figure 14 shows a schematic diagram of the second working electrode when it acts on the vagina.

[0068] Figure 15 shows another schematic diagram of the structure of the second working electrode.

[0069] Figure 16 shows a schematic diagram of the structure of a DC signal output control device according to another embodiment of the present disclosure.

[0070] Figure 17 shows a schematic diagram of impedance power curves at different levels.

[0071] Figure 18 shows a schematic diagram of a correspondence table between the second output level and human body impedance.

[0072] Figure 19 shows a schematic flowchart of a cosmetic method according to an embodiment of the present disclosure.

[0073] Figure 20 shows a schematic flowchart of a cosmetic method according to another embodiment of the present disclosure. Specification 5 / 35 pages 10 CN 121041094 A

[0074] Figure 21 shows a schematic flowchart of a cosmetic method according to another embodiment of the present disclosure.

[0075] Figure 22 shows a schematic hardware structure diagram of a DC signal output control device according to an embodiment of the present disclosure. Detailed Description

[0076] Preferred embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. Although preferred embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited to the embodiments set forth herein.Conversely, these embodiments are provided to make this disclosure more thorough and complete, and to fully convey the scope of this disclosure to those skilled in the art.

[0077] Those skilled in the art should understand that the terms "first," "second," etc., in this disclosure are used to distinguish similar objects, and are not used to describe a specific order or sequence, and have no additional limiting effect.

[0078] FIG1 shows a schematic structural diagram of a DC signal output control device according to an embodiment of this disclosure.

[0079] As shown in FIG1, the DC signal output control device includes a control module 110 and a DC signal generation module 120.

[0080] The DC signal generation module 120 is connected to the control module 110 and generates a DC signal under the control of the control module 110. The DC signal includes a DC voltage signal and a DC current signal.

[0081] The DC signal generation module 120 may include, but is not limited to, a crystal oscillator, a frequency adjustment circuit, a PWM (Pulse Width Modulation) system circuit, and a power amplifier circuit. The control module 110 can control the DC signal generation module 120 to generate a DC voltage signal or DC current signal with specific parameters within a specific time period as needed.

[0082] The DC signal generation module 120 can be connected to either a first type of output module or a second type of output module. The device user can switch the output module connected to the DC signal generation module 120 as needed. Optionally, the DC signal output control device may also include a first type of output module and a second type of output module.

[0083] The first type of output module includes a first working electrode 131 and a first ground electrode. The second type of output module includes a second working electrode 132 and a second ground electrode. Figure 1 shows the case where the first type of output module and the second type of output module share a ground electrode 133, that is, the first ground electrode and the second ground electrode are the same electrode. It should be understood that the first ground electrode and the second ground electrode can also be different electrodes. As shown in Figure 1, the first working electrode 131, the second working electrode 132, and the ground electrode 133 can correspond to human tissue 210 at different locations. The first working electrode 131 does not contact the human tissue 210, while the second working electrode 132 and the grounding electrode 133 contact the human tissue. It should be understood that the contact described in this disclosure includes both direct and indirect contact. Direct contact refers to the electrode directly contacting the corresponding part without any conductive medium between them. Indirect contact refers to the electrode contacting the corresponding part through a conductive medium (e.g., conductive gel). In other words, contact with human tissue can refer to either direct or indirect contact.

[0084] The DC signal generation module 120 has two output terminals: a positive output terminal and a negative output terminal.The first working electrode 131 and the second working electrode 132 can be connected to the positive output terminal of the DC signal generation module 120 to form a positive electrode, or connected to the negative output terminal of the DC signal generation module 120 to form a negative electrode.

[0085] In some embodiments, the first working electrode 131 and the second working electrode 132 are both negative electrodes, suitable for connecting to the negative output terminal of the DC signal generation module 120. The first ground electrode and the second ground electrode are both positive electrodes, suitable for connecting to the positive output terminal of the DC signal generation module 120.

[0086] The front end of the first working electrode 131 is a discharge tip, used to output plasma to act on the first part without contacting the first part at close range. That is, the discharge tip of the first working electrode 131 is spaced apart from the first part by a first distance. The first distance can be a small value (i.e., close range). For example, the first distance can be 0.1mm to 5mm. The first grounding electrode, while connected to another output terminal (e.g., positive terminal) of the DC signal generation module, also establishes a conductive path with other parts besides the first part. That is, the first grounding electrode can contact the skin of other locations besides the first part of the patient. In this disclosure, a part (e.g., the first part, the second part) refers to a body part of a living organism (such as a person or pet). Taking a person as an example, a part can refer to human tissue.

[0087] The front end of the second action electrode 132 is an application surface (e.g., a treatment surface) adapted to the shape of the second part. The shape of the application surface may include, but is not limited to, flat, pointed, spherical, ellipsoidal, etc. The second action electrode 132 is used to output a DC current signal to act on the second part when in contact with the second part (e.g., the treatment part). That is, the application surface of the second action electrode establishes a conductive path with the second part. The second grounding electrode can contact other parts besides the second part, such as the skin of other locations. For example, the second grounding electrode can be contacted by hand gripping or by a patch on the patient's body. In addition, the first part and the second part mentioned above may be the same part or different parts.

[0088] For the same type of active electrode, active electrodes of different shapes or sizes can be used in different application scenarios to adapt to the current scenario. That is, the first active electrode 31 and the second active electrode 32 may each include one or more electrodes of different shapes or sizes with different applicable scenarios (such as for treating different diseases). For example, the front end of the first active electrode is made of gold. The front end of the second active electrode is made of metal (e.g., stainless steel, aluminum alloy, etc.).

[0089] If the DC signal generation module 120 is connected to the first type of output module, the control module 110 controls the DC signal generation module to generate a DC voltage signal and provides the DC voltage signal to the first type of output module, so that the first working electrode 131 in the first type of output module outputs plasma to act on the first part. In order to generate plasma, the DC voltage signal should be greater than or equal to the breakdown voltage (e.g., 5kV) between the first type of output module (i.e., the first working electrode 131) and the first part. Continuously output plasma allows a certain current to be transmitted between the first working electrode and the first part, and the maximum value of this current can be, for example, 3mA. For example, the DC signal generation module 120 can provide a DC voltage signal within 10kV (e.g., 500V to 10kV). The corresponding current can be between 0.1mA and 10mA.

[0090] If the DC signal generation module 120 is connected to the second type of output module, the control module 110 controls the DC signal generation module 120 to generate a DC current signal and provides the DC current signal to the second type of output module, so that the second active electrode 132 in the second type of output module applies the DC current signal to the second part. For example, the DC current signal is ≤ 20mA; and / or the pulse width of the DC current signal is 0–5000ms; and / or the frequency of the DC current signal is 0–1MHz. More preferably, for example, the DC current signal is ≤ 10mA; and / or the pulse width is 0ms to 1000ms; and / or the frequency is 0Hz to 100kHz. More preferably, the frequency is 10Hz to 50Hz. Referring to the following description of the DC current signal, the DC current signal in this disclosure can include not only a constant DC current signal, but also a single-pulse DC current signal and a multi-pulse DC current signal. It should be understood that the pulse width and frequency mentioned herein are applicable not only to single-pulse DC current signals and multi-pulse DC current signals, but also to constant DC current signals. For example, a DC current signal with a fixed current intensity and a pulse width and frequency of 0 can be considered a constant DC current signal. In some alternative embodiments, the DC current signal can be ≤10mA (e.g., 0.1mA to 10mA), and the corresponding voltage signal can be, for example, between 0.01V and 10V. The frequency mentioned herein can also be called the pulse train repetition frequency, pulse repetition frequency, or pulse frequency, which characterizes the number of pulse DC current signals output per unit time. The pulse train repetition frequency is equal to 1 / pulse working period. Wherein, the pulse working period is equal to the pulse width (pulse continuous output time, i.e., effective working time) + pulse interval (idle time). For example, the pulse train repetition frequency can be 0Hz to 100Hz, more preferably, for example, 0Hz to 50Hz.

[0091] In addition, the DC signal output control device also relates to the concept of working frequency.The operating frequency is the ratio of the total number of operations to the unit time (e.g., 1 second), and the unit is Hz. The total number of operations refers to the number of times the output signal (e.g., DC current signal) appears. The operating frequency can be determined according to the treatment plan. The operating frequency can affect the energy characteristics and tissue penetration of the output signal. The operating frequency can be set according to the required tissue thickness. For example, the operating frequency is 0Hz to 1000kHz, and more preferably, it can be 0Hz to 100Hz.

[0092] Therefore, the DC signal output control device of this disclosure can provide two output modes: plasma output mode and DC current output mode. The two output modes provided by the DC signal output control device of this disclosure can be used selectively or in combination. In combination, it means that plasma and DC current signals are applied to the same site at different time periods in a complete treatment process to solve the same disease or achieve the same purpose. That is, plasma and DC current signals can be applied to the same site at different time periods under the action of different electrodes.

[0093] The details involved in this disclosure are further explained below.

[0094] I. Plasma Output Mode

[0095] 1) Mechanism of Action

[0096] Plasma is the fourth state of matter, a state of matter composed of ionized gas. Plasma stimulates the formation of new collagen and elastic fibers, thereby reducing tissue inflammation and having many other benefits.

[0097] The plasma continuously generated by the plasma output mode allows current to be conducted within a range of 1 mm to 4 mm from the skin or mucous membrane. The plasma output mode generates a highly concentrated plasma flame that penetrates tissue and can eliminate squamous metaplasia and scar tissue that obstructs the meibomian gland outlet.

[0098] The biological effects of plasma originate from a complex mechanism. The effects that plasma can produce (including biological and physical effects) may include, but are not limited to, the effects listed below.

[0099] Controlled Thermal Effect (Joule Heating)

[0100] Instantaneous heat is generated in the micro-discharge channel and adjacent surface tissue to achieve superficial coagulation / hemostasis or stratum corneum modification.

[0101] One of the direct effects of plasma is skin heating; in certain areas, plasma discharge can heat the skin to a certain temperature. It should be noted that in some exemplary embodiments, the total energy output of the device can be up to 3W at high settings, and the temperature at the skin contact point can exceed 1000°C under ambient conditions. Therefore, when this effect is used for tissue coagulation, precise tissue coagulation is required. The plasma output mode of this disclosure outputs direct current plasma, which has stronger stability and precision, and provides a finer ablation area than plasma generated by alternating current. Therefore, the plasma output mode of this disclosure can meet the need for precise treatment using the thermal effect of plasma.

[0102] Plasma can also be used for non-thermal ablation. Unlike traditional electrocautery or radiofrequency ablation, plasma can achieve tissue coagulation, carbonization, or dekeratination at relatively low temperatures, making it suitable for the treatment of meibomian gland obstruction, pigmented lesions, scar tissue, or abnormal skin proliferation, while protecting adjacent healthy tissue and reducing the risk of thermal damage.

[0103] Reactive Oxygen and Nitrogen Species (RONS) Effect

[0104] Plasma can generate reactive particles such as O3 (ozone), NOx (nitrogen oxides), ·OH (hydroxyl radicals), and 1O2 (singlet oxygen) in the air / air gap, which enter the surface microenvironment of biological tissues (e.g., human or animal tissues) and participate in signal regulation and local antibacterial activity. For example, plasma generates a large number of reactive oxygen species (ROS) and reactive nitrogen species (RNS), thereby regulating cell cycle, antioxidant response, inflammatory factor release, and apoptosis mechanisms.

[0105] Electric Field and Charge Interaction

[0106] An applied electric field and directional charge flow cause transient changes in the transmembrane potential of the cell membrane (depolarization / repolarization), and can regulate the activity and paracrine signals of keratinocytes, fibroblasts, etc.

[0107] During the plasma output process, a directional electric field exists between the tip of the first electrode and the first part. This directional electric field changes the ion distribution and transmembrane potential inside and outside the cell membrane, triggering cell membrane polarization. The change in cell membrane polarization allows for the exchange of substances within it. Specifically, a quiescent cell has a negative membrane potential. When ion channels are opened, the cell loses its membrane potential, altering sodium and potassium channels and their ability to introduce nutrients into the cell. The plasma output mode can stimulate and improve this process.

[0108] Stimulation of Metabolism

[0109] Plasma can stimulate skin metabolism, activate the activity of keratinocytes, and thus improve the appearance of the skin. However, this technology acts very superficially on the skin surface and can be used without damaging the skin's protective barrier, so it can also be used by non-medical professionals, such as beauticians. Plasma can also generate temperature changes at a deeper cellular level, triggering cellular metabolism and internal processes, such as catalyzing chemical reactions.

[0110] Assisting Drug / Active Ingredient Delivery

[0111] Plasma can alter the permeability of the stratum corneum. Therefore, plasma output modes can also be combined with drug / active ingredient delivery to enhance drug / active substance penetration and local metabolism. See the description below for details.

[0112] 2) Indications

[0113] Based on the above-mentioned mechanism of action of plasma output modes, plasma output modes can be used to treat a variety of conditions. Some typical indications of plasma output modes are illustrated below.

[0114] ① Ophthalmology

[0115] Plasma output mode can reduce eyelid flora, kill bacteria and mites, reduce inflammation and biological burden, and is suitable for blepharitis. However, its application scope is not limited to this. In some specific treatment plans, direct current discharge and plasma discharge can also be combined. Moreover, this output method that combines direct current discharge and plasma discharge has also shown efficacy in other diseases, such as minimally invasive ophthalmic plastic surgery, as well as periorbital and facial rejuvenation, ablation surgery, etc.

[0116] Therefore, ophthalmic diseases that plasma is suitable for treatment may include, but are not limited to, blepharitis, ptosis, entropion, xanthelasma, conjunctivochalasis, periorbital cosmetic surgery (such as crow's feet, eye bags, etc.), blepharoplasty, etc.

[0117] The following uses conjunctivochalasis and upper eyelid lifting as examples to illustrate the process of treating these two diseases using plasma output mode. It should be understood that the operating procedures described below can also be used to treat other similar conditions.

[0118] Conjunctival laxity

[0119] Figure 2A shows a schematic diagram of treating conjunctival laxity using a plasma output mode.

[0120] Referring to Figure 2A, after connecting the first grounding electrode to human tissue, liquid gel can be applied to the palpebral conjunctiva. The first action electrode 131 releases plasma in a non-contact manner at a distance of 1mm to 4mm above the surface of the palpebral conjunctiva to ablate the lax conjunctival tissue.

[0121] Figure 2B shows a schematic diagram of the treatment marks after treatment.

[0122] Referring to Figure 2B, treatment marks generated by plasma stimulation can be observed on the palpebral conjunctiva.

[0123] In this embodiment, the material of the application surface of the first action electrode is gold. Preferably, during treatment, the first action electrode should maintain a distance of at least 3mm to 4mm from the limbus to prevent corneal damage, while avoiding areas such as Tenon's capsule (also known as the ocular fascia) or the attachment point of the extraocular muscles.

[0124] Upper eyelid lifting

[0125] First, preoperative preparations can be performed. Preparations include: cleaning and disinfecting the eyelids with a cleaning spray; applying numbing cream and conductive gel to the treatment area; selecting a treatment head with a diameter of 5mm to 10mm for the first active electrode; the working speed can be selected from 1 to 8 (see the description below for speed settings). Instruction manual 9 / 35 pages 14 CN 121041094 A

[0126] After the preparations are complete, place the first active electrode 0.1mm to 4mm above the treatment area and slowly apply it using a dotting method. The dotting method refers to placing the first active electrode above different points and treating each point one by one.Under the action of the plasma output from the first working electrode, the tissue at the treatment site will coagulate, carbonize, and keratinize.

[0127] After the plasma treatment is completed, a drug spray can be used for interventional treatment.

[0128] Finally, a gentle massage can be performed, and the treatment parameters can be recorded.

[0129] In alternating current mode, plasma cannot form a continuous output. The plasma output mode of this disclosure is direct current mode, which can form a continuous output. In upper eyelid lifting treatment, continuous scanning + single point can be performed in the target area.

[0130] Continuous scanning means that the starting point of continuous scanning can be taken from a position about 0.1 mm to 10 mm away from the inner corner of the eye, and the second working electrode is gently contacted with the skin surface at an angle of 45° to 60° with the skin. This angle can ensure that the plasma energy (i.e., plasma) acts on the skin tissue evenly and effectively, avoiding excessive energy concentration or dispersion. According to the pre-designed scanning path, starting from the starting point, it slowly and steadily advances towards the outer corner of the eye along the contour of the upper eyelid. The scanning path is a slightly upward-curving arc or zigzag line, conforming to the natural physiological curve of the upper eyelid to ensure that the entire upper eyelid area receives uniform plasma energy. The scanning speed is controlled at 1mm to 2mm per second. This speed allows the plasma energy to fully penetrate into the skin tissue without causing excessive damage to the skin. During the scanning process, the contact force between the second action electrode and the skin is kept uniform to avoid the second action electrode jumping or being pressed too deeply.

[0131] Single-point scanning refers to determining N single-point positions at the junction of the middle and lower part of the upper eyelid and below the eyebrow tail. The second action electrode is vertically aligned with the single point and gently touches the skin surface or at a distance of 0.1mm to 10mm. Plasma energy is applied to the single point position for 1 to 5 seconds at each single point, with a plasma output power of 0.1W to 5W. During the single-point action, the second action electrode is kept stable to ensure that the plasma energy is concentrated on the target position, stimulating the skin tissue in that area, promoting collagen regeneration and fibrous tissue contraction, thereby achieving a better lifting effect.

[0132] Furthermore, the plasma output mode can also be used to selectively thermally coagulate the lacrimal punctum openings of the upper and lower eyelids, causing them to partially or completely close, thereby reducing tear drainage through the lacrimal ducts and prolonging the retention time of the tear film on the corneal and conjunctival surface. This is a form of lacrimal punctum occlusion, commonly used in the treatment of dry eye diseases (including excessive evaporation and insufficient tear secretion) to improve symptoms such as dryness, foreign body sensation, and visual fluctuations. Therefore, the plasma output mode can also be used to block the lacrimal punctum and to treat corresponding conditions, such as dry eye syndrome.

[0133] Thus far, the indications for the plasma output mode in ophthalmology have been explained by example.

[0134] When plasma output mode is applied to ophthalmology, it represents a revolution in the field, offering not only a wide range of treatment options but also a robust scientific approach based on reversible electroporation and cell membrane depolarization, sometimes combined with highly controlled tissue electrocautery in ablation treatments. This innovation has become the cornerstone of comprehensive treatment for various ocular, periocular, and facial aesthetic conditions, marking a milestone in modern ophthalmology and periocular and facial cosmetic medicine.

[0135] ② Cosmetic Field

[0136] In cosmetic dermatology, plasma influences cellular biochemical processes, tissue regeneration, wound scab formation, reduction of elastic fibers, scar treatment, and the treatment of wrinkles, spots, and aging. Furthermore, it can be applied to other treatment scenarios, such as the treatment of hyperhidrosis and cellulite.

[0137] The skin consists of two layers: the dermis and the epidermis. In plasma output mode, the plasma acts on the epidermis, the outermost layer of the skin, which is epithelial tissue mainly composed of keratinocytes. The interaction between these cells and the plasma is important. The plasma output mode operates continuously at the same energy through its direct current, generating ions under the action of an electric field. These ions can pass through the cell membrane and be released from the cell membrane, thereby changing the permeability of the cell membrane. Improvement in skin quality can be observed in this process. Specification 10 / 35 pages 15 CN 121041094 A

[0138] Plasma is a state of matter composed of ionized gas with a certain radiation frequency. It can be used for eyelid surgery, reducing benign tumors, and removing epidermal lesions. Depending on the treatment, the use of active ingredients can achieve better results.

[0139] The inventors of this disclosure have also experimentally verified the accuracy of infrared thermal imagers in detecting the increase in skin temperature after plasma application. Analysis of patients showed that the local temperature above the application site increased by an average of 2.4°C. The results can quantitatively determine the temperature increase and indicate that it is possible to achieve skin regeneration, wrinkle reduction, and stimulation of biosensors through plasma therapy.

[0140] When using the plasma output mode for cosmetic purposes, a relatively low temperature can be generated by micro-plasma to act on the epidermis. This technology generates heat by allowing charged particles to penetrate the target tissue area. The generation of heat causes the dermal tissue to be enhanced, starting with the immediate contraction and denaturation of collagen fibers. Over a period of time, new collagen is formed.

[0141] Exemplary indications for plasma output modes in the cosmetic field may include, but are not limited to: fine lines, wrinkles, sunspots, stretch marks, tissue laxity, induction of collagen and new elastin fibers, eyelid rejuvenation, epidermal lesions, wound scab formation, reduction of elastin fibers, scar treatment, and conditions such as wrinkles, spots, and aging.

[0142] ③ Benign tumors, genital warts

[0143] The plasma output mode can also be used to treat benign tumors and genital warts.

[0144] Benign tumors that can be treated by the plasma output mode may include, but are not limited to, seborrheic keratosis, milia, squamous cell papilloma, and basal cell papilloma.

[0145] Genital warts, also known as condyloma acuminata, are a very common sexually transmitted disease. Clinically visible condyloma acuminata accounts for only a small fraction of HPV infections. More than 20 subtypes of HPV are associated with condyloma acuminata, of which types 6 and 11 are the most common to cause these lesions.

[0146] When treating condyloma acuminata using the plasma output mode, the use of plasma follows the principle of electrocautery, which involves applying electrical energy in the form of current at a specific frequency. This technique carbonizes the wart-like lesions, which are then removed by scraping. This technique is particularly effective in treating small condyloma acuminata, especially in the vulvar area. However, it is not recommended for large lesions as it may cause permanent scarring. The use of energy on skin or mucous membranes requires randomization and experimental control to achieve a high clearance rate (e.g., 94%).

[0147] 3) Output parameters

[0148] Under the condition that the first grounding electrode is in complete contact with the human tissue and the first working electrode is at a distance d (i.e., the first distance mentioned above) from the tissue and is not in contact, the control module controls the DC signal generation module to establish a high potential difference Uo between the first working electrode and the first grounding electrode. When the air gap electric field strength E = Uo / d ≥ 3kV / mm between the first working electrode and the first part, the gap air between the first working electrode and the first part is broken down and ionized, generating cold plasma (containing electrons, ions and active neutral particles) characterized by micro-discharge.

[0149] The DC signal output control device maintains the charge migration direction through DC bias and discharges stably in a current-limiting / pulse mode (duty cycle and repetition frequency are adjustable) to avoid continuous arcing and overheating.

[0150] The first grounding electrode provides a low-resistance return path, allowing the potential difference of the internal energy storage element to transfer in the air gap between the tip and the tissue and form a plasma sheath.

[0151] For example, the value of Uo ranges from 0.8kV to 10kV, preferably from 1.5kV to 6kV; the value of d ranges from 0.1mm to 5.0mm, preferably from 0.3mm to 2.0mm; the peak discharge current is ≤4mA, the equivalent average power is 0.1W to 3W; the pulse width is 1μs to 500μs, and the pulse repetition frequency is 0.1kHz to 50kHz (depending on the target tissue and indication). Specification 11 / 35 pages 16 CN 121041094 A

[0152] The output energy value in the plasma output mode is positively correlated with the distance between the application surface of the first working electrode and the first part (i.e., the first distance mentioned above).Figure 3 shows a schematic diagram of the correspondence between the first output level and the first distance. As shown in Figure 3, multiple (e.g., 5) first output levels can be preset, each first output level has an energy output value and corresponds to a distance range. The device operator can select the matching level according to the distance between the application surface of the first working electrode and the first part so as to output appropriate energy.

[0153] In plasma output mode, a large amount of energy will be generated on the human body surface to cause single-point damage. Therefore, cold spray technology is needed to repair the patient's epidermis after plasma treatment. Plasma output causes instantaneous damage to the human epidermis. At this time, adding cold spray technology can effectively reduce the residual temperature of the epidermis, protect the epidermis from excessive damage, reduce pain during treatment, and provide a good guarantee for later repair.

[0154] II. DC current output mode

[0155] 1) Circuit judgment

[0156] DC current output mode outputs DC current signal when both electrodes (i.e., the second working electrode and the second ground electrode) are connected to the human body and form a circuit with the human body. In view of this, the present disclosure proposes that the DC signal output control device may further include an impedance detection module, which is used to automatically determine whether a human body forms a circuit.

[0157] The impedance detection module is used to detect human body impedance when the DC signal generation module is connected to the second type of output module. Based on the human body impedance, the control module determines whether the second type of output module forms a circuit with the human body, and if it is determined that the second type of output module forms a circuit with the human body, it controls the DC signal generation module to generate a DC current signal.

[0158] In some exemplary embodiments, the impedance detection module may collect the impedance values ​​between the positive and negative electrodes (i.e., the second active electrode and the second ground electrode) at different frequencies at predetermined time intervals (e.g., 0.2s). At each collection time, the frequency of the electrical stimulation (i.e., the output DC current signal) is linearly swept from 0.5kHz to 5kHz, with a frequency change step of 0.1kHz each time, and the corresponding impedance value is recorded. A total of 10 sets of data are collected, and each set of data contains 50 impedance values ​​at different frequencies. The control module (e.g., the data processing and analysis module within the control module) first preprocesses the 10 sets of collected data, for example, by using a median filtering algorithm to remove outliers. Then, it calculates the average and standard deviation of the impedance values ​​at different frequencies for each set of data. Based on these statistical parameters, a curve showing impedance versus frequency is constructed. Observation and analysis of the curve reveal that the impedance curve exhibits a relatively stable trend within the normal frequency range, and both the average and standard deviation are within the pre-defined impedance range for normal electrode contact. The processed impedance characteristics are then compared with preset judgment criteria.Since the impedance value and its change characteristics meet the standard of normal contact, it can be determined that the positive and negative electrodes are in complete contact at the human application site, and the DC output mode can be performed normally. The DC signal output control device may also include a display and alarm module. If it is determined that the positive and negative electrodes are in complete contact at the human application site, the display and alarm module can display the information "electrode contact is good" on the display screen, and no alarm signal is issued.

[0159] 2) Mechanism of action of pulsed DC stimulation

[0160] Existing electrical stimulation devices usually use a constant DC current with constant direction and intensity to achieve the corresponding therapeutic purpose.

[0161] In the DC current output mode of this disclosure, the DC current signal generated by the DC signal generation module mainly includes a pulsed DC current signal. The pulsed DC current signal is a current with constant direction and intensity that changes with time. It should be known that the DC signal generation module can also generate a constant DC current signal in the DC current output mode.

[0162] In addition, the terms "pulse", "oscillation" and "pulsation" mentioned in this disclosure are used interchangeably. That is to say, pulsed DC can also be called oscillating DC or pulsating DC. In addition, the “low-frequency pulsed DC” mentioned in this disclosure refers to a pulsed DC power source with a relatively low frequency, such as a pulsed DC power source with a frequency between 0.1 Hz and 300 Hz. For example, the current intensity of a low-frequency pulsed DC power source can fluctuate periodically and with low amplitude within a small range. For example, the reference current intensity fluctuation of a low-frequency pulsed DC power source can be between ±5% and ±20%, and the duration of a single oscillation can be between 10 ms and 1000 ms.

[0163] For the mechanism of action of constant DC current, please refer to the description in the background section.

[0164] The mechanism of action of pulsed DC stimulation is described below.

[0165] After in-depth research, the inventors of this disclosure have found that there are several significant differences between pulsed DC power (e.g., low-frequency pulsed DC power) and constant DC power.

[0166] A constant DC current signal provides a continuous unidirectional charge flow. As the current flows continuously, a significant chemical effect occurs at the active electrode (i.e., the second active electrode mentioned above): alkaline products (NaOH and H2) accumulate at the cathode, and acidic products (HCl) are generated at the anode, which can cause changes in tissue pH and irritation. This electrolytic effect can lead to tissue irritation or even burns when the current amplitude is high or the duration is long. That is, constant direct current can cause electrolytic decomposition, ion formation, and pH changes, thereby potentially damaging cells and tissues.

[0167] In contrast, pulsed direct current (e.g., low-frequency direct current oscillation) reduces ion accumulation and pH changes around the electrode, thereby minimizing the damage to healthy cells and tissues caused by constant direct current stimulation.

[0168] Furthermore, the oscillation of pulsed direct current generates a variable electric field that stimulates various cellular processes, such as proliferation and differentiation. It also improves the transport of ions and water molecules across the cell membrane and promotes better exchange of nutrients and waste.

[0169] The electric field formed by pulsed direct current is a dynamic electric field with a constant direction but dynamically changing intensity. The dynamic electric field can promote cell activity and tissue regeneration, improve the transport of nutrients and waste across the cell membrane, and activate various intracellular signaling pathways, promoting cell growth and division. The dynamic electric field also stimulates cells to produce growth factors, such as IGF-1, which is essential for tissue regeneration and improves microcirculation in tissues, increasing the supply of oxygen and nutrients.

[0170] Proteins such as Wnt, Notch, and Hedgehog are part of signaling pathways that regulate cell proliferation and differentiation. These molecules play a key role in embryonic development and maintaining tissue homeostasis. Important proteins that affect cell proliferation include cyclins and cyclin-dependent kinases (CDKs) that regulate the cell cycle. Cyclins are proteins that bind to and activate CDKs, enabling cells to switch between different stages of the cell cycle. Other important proteins are growth factors, such as epidermal growth factor (EGF) and vascular endothelial growth factor (VEGF), which bind to their specific receptors, triggering signaling cascades that lead to cell proliferation. Proteins like p53 and Rb (retinoblastoma protein) regulate the cell cycle and prevent uncontrolled cell proliferation. When DNA is damaged, these proteins can stop the cell cycle and initiate DNA repair or apoptosis.

[0171] On the other hand, a constant direct current without oscillation causes more pronounced electrolytic breakdown, leading to ion formation and pH changes, which can damage cells and tissues. A constant current cannot provide the dynamic stimulation of cellular processes as effectively as an oscillating current. Therefore, DC oscillation can more effectively influence cell proliferation and differentiation by activating membrane transport and altering gene expression.

[0172] The basic process that occurs when using DC oscillation is also reversible cell electroporation, a process that temporarily disrupts the cell membrane using an electric field, the efficiency of which is affected by the time integral of the electric field strength. The magnitude of the voltage and the conductivity of the environment play a key role, and monitoring the thermal effects to avoid thermal damage to the battery is also important.

[0173] The hydrophobic lipid bilayer of the plasma membrane can be viewed as a simple capacitor that stores charge and acts as a dielectric between the extracellular medium and the cytoplasm. When a cell is exposed to an electric field, the membrane can accumulate charge in the form of a transmembrane potential. The electric field orients molecular dipoles, from proteins to carbohydrates, relative to the field.Then, they diffuse within the battery and around the periphery, causing the cathode-facing side of the battery to be “depolarized” and the anode-facing side to be “hyperpolarized” due to the difference in charge accumulation on both sides of the plasma. Once the field-induced transmembrane potential exceeds the dielectric strength of the membrane (typically about 500 mV), the membrane undergoes a permeation process, resulting in the formation of hydrophobic pores that allow water to move and restrict ion flow. As the field time increases, the unstable membrane and hydrophobic pores tend to stabilize, forming larger pores that allow larger impermeable molecules to enter and exit the cell. In fact, studies on human embryonic stem cells have shown that the introduction of propidium iodide and other small molecules requires a short pulse time of 0.05 ms, while for DNA transfection with the same field strength, the pulse time is 0.5 ms or longer. Once the field is removed, the pores become unstable and close over time (in minutes), allowing the membrane to close again.

[0174] Direct current oscillation helps to clear damaged cells and initiate programmed cell death—apoptosis. Because damaged or infected cells are more sensitive to external influences, they are preferentially eliminated, allowing healthy cells with full regenerative potential to replace them in infected or damaged tissues. This process is crucial for maintaining tissue health and preventing cancer. Oscillating electric fields can activate signaling pathways, leading to apoptosis of damaged cells, thus ensuring their effective elimination.

[0175] Direct current oscillations have a significant impact on pathogens and infections, which is important for combating various infectious diseases. This effect is caused by several mechanisms induced by oscillating electric fields. One of the main mechanisms is the disruption of pathogen cell membranes. Oscillating electric fields also cause changes in membrane polarization, leading to membrane instability and thus disrupting cell integrity. This process leads to the dissolution (decomposition) of pathogen cells, which is an effective way to eliminate infectious agents from the body.

[0176] Another important mechanism is the induction of apoptosis in damaged or infected cells. Oscillating direct current activates signaling pathways that lead to apoptosis, thus ensuring the effective elimination of damaged or infected cells. This process is important not only for eliminating pathogens but also for preventing the development of chronic infections and inflammation.

[0177] Oscillating direct currents also affect the microenvironment in which pathogens reside. Improving microcirculation and increasing the oxygen and nutrient supply to tissues can create unfavorable conditions for the growth and survival of pathogens. For example, increased oxygen supply can promote oxidative stress in pathogenic cells, leading to their damage and death.

[0178] Furthermore, oscillating electric fields can affect the body's immune response. Activation of various signaling pathways within immune cells can enhance their activity and ability to recognize and eliminate pathogens. This effect can be used in various therapeutic applications, including treating infectious diseases and promoting wound healing.

[0179] In general, DC oscillation is a promising approach to combating pathogens and infections.This technology offers several advantages, including the ability to disrupt the cell membranes of pathogens, induce apoptosis in damaged cells, improve the microenvironment, and promote immune responses.

[0180] Low-frequency direct current oscillations represent a promising approach to stimulating cells and tissues in a variety of applications, including regenerative medicine and tissue engineering. This approach minimizes the risk of damage associated with constant direct current while providing dynamic stimulation of cellular processes. Research in this area continues, providing new insights into how electric fields affect cellular processes and contributing to a better understanding and utilization of these technologies in medicine. Low-frequency direct current oscillations, through slight intensity fluctuations, reduce the risk of continuous stimulation by constant direct current, while maintaining a moderate permeation-promoting effect on biological barriers.

[0181] 3) Types of Pulsed Direct Current Signals

[0182] Pulsed direct current signals include single-pulse direct current signals and multi-pulse direct current signals.

[0183] The output waveform of a single-pulse direct current mode may include, but is not limited to, square waves, spikes, triangles, sine waves, exponential waves, sawtooth waves, 0-amplitude waves, 1-amplitude waves, star waves, circular waves, and trapezoidal waves.

[0184] Compared to a constant DC current signal, a single-pulse DC current signal breaks down DC into short pulses and intervals, for example, each pulse lasts on the order of microseconds, with pauses between pulses (duty cycle <100%). Due to the "off" intervals, the continuous electrolysis effect is significantly reduced, thus minimizing chemical stimulation to tissues. In addition, the single-pulse DC current signal accumulates charge within each pulse sequence, also exhibiting a polarity effect. Under the action of directional current forms such as DC current or single-pulse DC, the fixed direction of the current causes different physical, chemical, or biological effects in the anode and cathode regions of the medium through which the current flows (such as biological tissue, electrolyte solution, etc.). This asymmetric effect caused by the different polarity (direction) of the current is called the polarity effect.

[0185] In short, a constant DC current signal has a fixed polarity, producing a continuous electric field and significant chemical effects. Simulating the internal electric field of a wound can induce effects such as electrochemotaxis and electrophoresis, but prolonged high current may irritate tissues. A single-pulse DC current signal is an intermittent current pulse with the same polarity direction, but the chemical effect is minimal because the pulse interval avoids charge accumulation. By adjusting the frequency and duty cycle, both efficacy and safety can be considered, and patient tolerance can be improved.

[0186] A multi-pulse DC current signal is a current obtained by superimposing at least two currents with equal amplitude and different frequencies. Multi-pulse mode includes double-pulse mode. Double-pulse mode is a current obtained by superimposing two currents with equal amplitude and different frequencies. Figure 4 shows a schematic diagram of a double-pulse mode.

[0187] As shown in Figure 4, double-pulse mode can be a current obtained by superimposing a low-frequency current with a medium-frequency current of equal amplitude.Low-frequency current can refer to current with a frequency of 0 to 1000 Hz. Medium-frequency current can refer to current with a frequency of 1 k to 1 MHz. Low-frequency current is superimposed with medium-frequency current of equal amplitude, that is, the medium-frequency current is modulated by low-frequency current.

[0188] The dual-pulse mode can be regarded as a weighted dual-pulse mode of medium-frequency current modulated by low-frequency current. The modulated dual-pulse mode contains both medium-frequency and low-frequency electrical components. Therefore, the dual-pulse mode belongs to medium-low frequency current. The electrical stimulation effect of the dual-pulse mode can avoid the disadvantages of low-frequency current, which can only act on the skin surface, causing great skin stimulation and electrolysis; at the same time, the human tissue impedance is significantly reduced in the medium-low frequency mode, the output is more stable, no electrolysis occurs, and better muscle treatment effect can be produced, and patients are less likely to develop adaptation. The "adaptability" mentioned here can be understood as a "habitualized" response of the human body to continuous or single-mode stimulation. When the body receives electrical stimulation of a fixed frequency, waveform, and intensity for a long period of time, the nervous system, muscle tissue, etc., will gradually adapt to this stimulation signal, and the therapeutic indications will gradually weaken. It may even require continuously increasing the stimulation intensity to achieve the initial effect. The dual-pulse mode avoids the shortcomings of the single stimulation mode, thereby reducing patient adaptation.

[0189] In some embodiments, when the DC signal generation module 120 is connected to the second type of output module, the control module 110 controls the DC signal generation module 120 to generate a first-mode DC current signal in a first time period, and controls the current generation module 120 to generate a second-mode DC current signal in a second time period. A single output process includes at least one first time period and at least one second time period. The first-mode DC current signal and the second-mode DC current signal are taken from two of the following: a constant DC current signal, a single-pulse DC current signal, and a multi-pulse DC current signal. By applying different modes of DC current signals to the same area at different time periods in a single output process, the same area can receive different electrical stimulation effects, thus providing support for improving the final therapeutic effect.

[0190] 4) Combined Output Method

[0191] In some exemplary embodiments, an output process may include one or more output cycles. Each output cycle may include a first time period and a second time period, and the time interval between the first time period and the second time period may be greater than or equal to 0. Furthermore, this disclosure does not limit the order of the first time period and the second time period; that is, within each output cycle, the first time period may precede the second time period, and the specific order can be set according to the current treatment needs. Thus, in one output process, the first mode and the second mode can be applied alternately to the same location. In addition, this disclosure does not limit the length relationship between the first time period and the second time period; that is, the first time period may be greater than, equal to, or less than the second time period, and the specific time interval can be set according to the treatment needs.

[0192] Figure 5 shows a schematic diagram of some combined output modes. (Pages 15 / 35 of the specification, 20 CN 121041094 A)

[0193] The horizontal axis in Figure 5 represents time, and the vertical axis represents the current amplitude. As shown in Figure 5, the combined output includes: dual-pulse + single-pulse combined output; dual-pulse + constant DC combined output; and single-pulse + constant DC combined output. It should be understood that a single output process is not limited to a combination of two current modes, but can also include a greater number (e.g., three) of current modes combined outputs.

[0194] The dual-pulse + single-pulse combined output mode refers to the alternating output of single-pulse DC current signals and dual-pulse DC current signals, so that these two signals can alternately act on the same part. The dual-pulse + single-pulse combined output mode has at least the following advantages: 1) Flexible adjustment of energy output; a single pulse can provide a high-energy instantaneous impact, while multiple pulses are output in a lower energy, higher frequency manner, which can be used for gentle and continuous stimulation of tissues. Combining the two allows for flexible adjustment of the energy output mode according to treatment needs. For example, during treatment, a single pulse can be used for initial high-intensity treatment, followed by multi-pulse for subsequent consolidation and conditioning to optimize the treatment effect. 2) Reduce the risk of tissue damage; the high energy of a single pulse may cause certain risks of tissue damage, but the low energy and multiple stimulation of multi-pulse can reduce this damage to a certain extent. The multiple gentle stimulation of multi-pulse helps tissue adapt to energy changes and promotes tissue self-repair and adjustment. In some physical therapies, a single pulse can be used for necessary treatment first, but in order to avoid excessive damage, multi-pulse is used for reparative stimulation. While ensuring the treatment effect, the risk of tissue damage is reduced, and the safety and comfort of treatment are improved.

[0195] The dual-pulse + constant DC combined output mode refers to the alternating output of dual-pulse DC current signal and constant DC current signal so that the two signals can act alternately on the same part. The dual-pulse + constant DC combined output mode has at least the following advantages: 1) Promote tissue repair and regeneration; the DC energy of the DC mode can provide continuous energy support for tissues (such as treatment sites), which helps maintain the normal metabolism and physiological function of cells. The dual-pulse mode's dual-pulse energy can activate cell activity and promote cell division and proliferation through frequent pulse stimulation. 2) Improves the uniformity of treatment effects; the DC energy of a single-pulse DC current signal is relatively uniformly distributed in the tissue, but the energy intensity may decrease with depth. The multi-pulse mode's multi-pulse energy can generate multiple energy application points at different depths and locations, compensating for the insufficient DC energy in certain areas and making the energy distribution of the entire treatment area more uniform.In addition, DC energy can improve the overall skin texture, while multi-pulse energy can provide supplementary treatment for skin problems at different levels, so that all layers of the skin can be better improved and the uniformity of the treatment effect can be improved.

[0196] The single-pulse + constant DC combined output mode refers to the alternating output of single-pulse DC current signal and constant DC current signal so that the two signals can act on the same site alternately. The single-pulse + constant DC combined output mode has at least the following advantages: 1) Enhanced treatment depth; DC energy in DC mode has strong penetrability and can penetrate deep into the tissue to provide continuous energy to the deep tissue. The single-pulse energy in single-pulse DC mode can provide an additional high-energy impact at a specific moment. This impact can further enhance the effect on deep lesion tissue on the basis of DC energy, so that the treatment energy can reach the deep tissue more effectively and improve the depth and intensity of treatment. 2) Optimized treatment precision; DC energy in DC mode can provide a stable basic energy field, so that the tissue is in a relatively stable energy state. The single-pulse DC power mode can release the single-pulse energy precisely at a specific location and time according to the specific condition of the lesion site, playing a "targeted strike" role. The DC power mode can maintain a certain level of nerve excitability, and the single-pulse DC power mode can precisely stimulate specific nerve fibers, improve the accuracy of treatment, and better regulate nerve function.

[0197] When outputting a combination of at least two current modes, it can be continuous output or intermittent output. Continuous output means that the current is output without interruption. For example, referring to the dual-pulse + constant DC combination output mode in Figure 5, after the dual-pulse DC power signal output ends, the constant DC current signal is output immediately, without any interruption. Intermittent output means that the current is not always present during one output process, but a certain interval is set to not output the current. The specific interval duration can be flexibly adjusted as needed according to the instructions on page 16 / 35, 21 CN 121041094 A. For example, referring to the dual-pulse + single-pulse combination output mode in Figure 5, after the first output of the combination of dual pulse and single pulse, the combination of dual pulse and single pulse can be output again after a period of time, and the interval duration can be increased.

[0198] The interval output setting is mainly based on the following considerations: 1) Adapting to different tissue characteristics: Different tissues absorb and react differently to energy. By adjusting the time interval of the intermittent output, energy can be deposited more precisely in the target tissue. This prevents excessive energy concentration and provides energy adjustability for different locations and tissues, accurately matching treatment needs. 2) Reducing tissue damage: The interval output mode allows sufficient cooling time between energy pulses, helping to maintain the normal physiological functions of surrounding tissues without causing overtreatment and irreversible tissue damage.3) Adapting to individual differences: Different patients have different tolerance and response to energy therapy. The intermittent output mode makes it easy for doctors to make personalized adjustments according to the specific situation of the patients. 4) Reducing the risk of adverse reactions: By precisely setting the time interval of intermittent output, adverse reactions caused by excessive energy or excessive duration of action can be avoided.

[0199] Different types of current will trigger different biological responses in tissue cells, thus having different applicable scenarios. For example, typical applications of direct current stimulation are microcurrent wound treatment, iontophoresis / electroporation, transcranial direct current stimulation, etc.; typical applications of alternating current stimulation are TENS (Transcutaneous Electrical Nerve Stimulation) analgesia, EMS (Electrical Muscle Stimulation) muscle training, high-frequency radio frequency heating, etc.; typical applications of pulsed direct current stimulation are HVPC (High Voltage Pulsed Current) wound therapy, neuromodulation, such as pacemakers, DBS (Deep Brain Stimulation), etc.

[0200] Since each type of electrical stimulation has its corresponding typical application scenario, existing electrical stimulation schemes usually select one of the above three current forms for output based on the current treatment scenario. That is, different current forms are output independently for different scenarios.

[0201] Unlike existing electrical stimulation schemes, this disclosure can output multiple types of DC current for the same scenario.

[0202] Specifically, this disclosure combines different current modes, and in one output process (i.e., one treatment process), at least two current modes are combined and applied to the same treatment site. The combination output of different current modes refers to outputting different current modes at different time periods to apply to the same treatment site, rather than outputting multiple current modes at the same time to apply to the same treatment site.

[0203] The combination of different current modes can provide diverse electrical stimulation signals. By applying diverse electrical stimulation signals to the same treatment site at different time periods, the diverse electrical stimulation signals can complement each other, improving the electrical stimulation effect of the treatment site in multiple dimensions. During the treatment process, the specific combination of different current modes can be flexibly adjusted according to specific treatment needs to improve treatment uniformity, safety, comfort, etc.

[0204] 5) Indications

[0205] Typical diseases suitable for treatment using DC output mode are mainly divided into three categories: ophthalmology, gynecology, and medical aesthetics.

[0206] In this disclosure, the working mode of DC output mode includes two types: contact DC and electrolytic DC.

[0207] Contact DC refers to the physical effect of current, which is based on "current acting directly on tissue".The electrode contact requirement for the second active electrode in contact direct current is that the second active electrode is attached to the surface of the second site (i.e., non-invasive contact). The current intensity of contact direct current can be adjusted according to treatment needs, directly stimulating or inhibiting nerves and muscles through current. The tissue reaction type of contact direct current is mainly physical effect (electric stimulation). The technical feature of contact direct current is a broad-spectrum treatment method based on the physical effect of current. Instruction manual 17 / 35 pages 22 CN 121041094 A

[0208] Electrolytic direct current (also known as direct current-electrolytic dissociation) is based on "electrochemical reaction", and current is the medium for initiating the reaction. The electrode contact requirement for the second active electrode in electrolytic direct current is that the second active electrode (such as a fine needle electrode) needs to be inserted into the hair follicle (i.e., minimally invasive). The current intensity of electrolytic direct current is low and is mainly used to generate electrolytic reaction. The tissue reaction type of electrolytic direct current is mainly chemical damage (decomposition of hair follicle proteins). The technical feature of electrolytic direct current is that it is a targeted hair follicle destruction technology based on electrochemical reactions.

[0209] In the disclosure, electrolytic direct current is mainly used to treat trichiasis / disordered eyelashes in the field of ophthalmology.

[0210] When using the direct current output mode to treat other conditions besides trichiasis / disordered eyelashes, it belongs to contact direct current.

[0211] ① Ophthalmology

[0212] The ophthalmological conditions suitable for treatment by the direct current output mode are mainly meibomian gland dysfunction (MGD) or evaporative dry eye caused by meibomian gland dysfunction. The main treatment mechanism is: the direct current signal will generate ionization, which will ionize the oil that causes meibomian gland dysfunction and expel it from the body; at the same time, the direct current signal will also generate a small vibration effect, which will further promote the discharge of meibomian gland secretions and the uniform distribution of the tear film lipid layer.

[0213] When using the direct current output mode to treat dry eye syndrome, direct current biostimulation can treat dry eye syndrome from the root cause and reduce inflammatory response, effectively relieving symptoms. The second working electrode can act on the meibomian conjunctiva to promote goblet cell secretion of mucin. The second working electrode can also act on the eyelid margin to promote eyelid margin epithelial cell regeneration / healing. By outputting pulsed direct current signals, the second working electrode can promote the periodic contraction and emptying of the meibomian glands, improve gland obstruction, reduce keratin accumulation, and damage the eyelid margin biomembrane.

[0214] When using the direct current output mode to treat meibomian gland dysfunction, the second working electrode can be a planar metal working electrode with a flat application surface and made of metal (such as silver). The planar metal working electrode can conduct the modulated direct current energy to the conjunctiva, softening the lipids blocking the meibomian glands, promoting lipid expulsion through astringent action, improving the tear film lipid ratio, reducing tear evaporation, and simultaneously alleviating meibomian gland inflammation.

[0215] In the field of ophthalmology, the DC signal output control device of this disclosure can also be combined with high-end intraocular lenses. For example, patients who have high-end intraocular lenses (such as Hanita pentafocal Intensity Lens) implanted during refractive cataract surgery often have varying degrees of ocular surface diseases (such as meibomian gland dysfunction and dry eye syndrome) before and after surgery. Therefore, the DC signal output control device of this disclosure can be used in combination before and after surgery to improve the accompanying ocular surface diseases. Specifically, in the preoperative stage, the DC current output mode and / or plasma output mode of the DC signal output control device of this disclosure can be used. For different causes of dry eye, low-frequency biocurrent stimulation of the meibomian glands or plasma mode treatment of conjunctival laxity can be used to enhance meibomian gland secretion, improve tear film stability, and reduce the risk of intraoperative stimulation. In the postoperative stage, the ocular surface repair status can be monitored based on impedance feedback. If the local impedance reflects slow tissue repair, electrical stimulation therapy can be performed to promote epithelial recovery and tissue tightening.

[0216] For example, the entire treatment process can be combined with the type of intraocular lens and surgical parameters, and a preset therapy template can be used. According to the therapy template, the matching output mode, energy density and probe type can be automatically called. In this way, personalized perioperative treatment can be achieved, which helps to improve the visual quality and patient satisfaction after refractive surgery.

[0217] When using the DC output mode to treat trichiasis / disordered eyelashes, the second site is the anterior lip of the eyelid margin. The second active electrode can penetrate into the second site. At this time, under the electrodissociation effect of the output DC current signal, trichiasis and / or disordered eyelashes can be treated. Among them, the second active electrode can enter the hair follicle along the hair shaft of the trichiasis (or disordered eyelashes) to the vicinity of the papillary area (without penetrating the dermis), and then output a DC current signal (such as a constant DC current signal). Thus, electrolysis and a localized increase in pH (OH- enrichment) occur in the vicinity of the second active electrode (such as the tip of the second active electrode). Na+ and OH- in the tissue form NaOH, inducing denaturation / chemical coagulation of proteins in the hair follicle papilla and outer root sheath. This action generates very little heat (non-thermal dominant), enabling selective and irreversible damage to individual hair follicles, reducing the probability of abnormal hair regrowth. The return path is provided by the second grounding electrode, and the control module can precisely deliver the DC current signal dosage in a constant current + timing manner. For example, the output parameters for treating ingrown eyelashes / clumped eyelashes may include: a constant direct current of 0.1mA to 1.0mA, preferably 0.2mA to 0.6mA; a single energizing time of 5s / follicle to 40s / follicle (preferably 8s / follicle to 20s / follicle), which can be repeated 1 to 3 times for a single follicle if necessary; the second active electrode is negative, and the second grounding electrode is positive and connected to the human body through a patch.

[0218] The following is an exemplary description of the process of treating dry eye syndrome using direct current output mode.

[0219] First, preoperative preparations can be performed. Preparations include: cleaning and disinfecting the eye with a cleaning spray; applying anesthetic, corneal protection, and conductive gel to the treatment site; using a treatment head with a diameter of 3mm as the second electrode; the working level can be selected from 1 to 8 levels (see the description below for the levels), the working current is less than 1mA, and the low-frequency pulse can be from 0 to 300Hz.

[0220] After the preparations are complete, the second electrode is brought into contact with the treatment site inside the eyelid, and then the second electrode is controlled to move slowly and uniformly (for example, the movement speed is 1mm / s to 10mm / s), releasing a direct current signal in contact with the currently contacted treatment site inside the eyelid. Under the reversible electroporation and cell membrane depolarization of the direct current signal, the treatment of dry eye syndrome can be achieved.

[0221] After the direct current signal treatment is completed, a drug spray can be used for interventional treatment.

[0222] Finally, gentle massage can be performed, and the treatment parameters can be recorded.

[0223] ②Gynecology

[0224] Direct current signals (especially pulsed direct current) can affect living tissues (such as mucous membranes, skin, and cervical mucosa) through cell membrane depolarization, eliminating HPV infection and inflammation of the cervical mucosa, urinary incontinence, vaginal dryness and atrophy, cervical mucosal swelling and erosion, etc.

[0225] By providing pulsed direct current (including single-pulse direct current and double-pulse direct current) to act on the cell membrane of HPV-infected cervical mucosa, cellular immunity can be enhanced, HPV infection can be corrected, and cervical mucosal and tissue inflammation can be reduced. The treatment method of outputting pulsed direct current to the target site can treat cervical precancerous lesions that do not require conization, and also has a preventive effect, which is suitable for healthy women and patients after cervical conization.

[0226] In addition, the direct current output mode can also be used for non-ablative stimulation of mucous membranes (such as dry eye syndrome-conjunctiva, urinary incontinence-vaginal mucosa) and cervical inflammation (reducing HPV).

[0227] The DC output mode can be used to correct the invasion of human papillomavirus (HPV) into cervical mucosal cells and reduce inflammation on the cervical mucosa and tissues, wherein the immunity of the invaded HPV cells is enhanced by pulsed DC current and a high-intensity electric field on these cell membranes.

[0228] In some embodiments, the open-circuit voltage in the DC output mode can reach up to 20 kV and is modulated by a carrier frequency on the order of tens of kHz (typically 70 kHz), then switched in repetitive bursts on the order of Hz (typically 1 Hz–100 Hz), wherein the circuit is closed such that the patient is conductively connected to the positive field through a ground electrode, and the cervical mucosa with a neutral gel layer is treated by the conductive portion of the vaginal applicator connected to the negative field of the power supply. The power supply is equipped with an adjustable current limiter, and the DC modulated current flows through the treatment site, generating a high-intensity pulsed electric field on the cervical mucosal cell membrane.

[0229] Using the direct current output mode, precancerous cervical cancer can be treated without conization. This method also has a preventive effect and is recommended for healthy patients and patients after embolization.

[0230] In general, the gynecological conditions that the direct current output mode is suitable for treating may include, but are not limited to: cervical dysplasia, cervical bleeding, ablation of cervical Nabothian cysts, treatment of cervical eversion, cervical inflammation, leukoplakia, metaplasia, treatment of transformation zone, uneven cervical mucosa, adenomyosis, endometriosis, cytological abnormalities, HPV positivity, prevention of cervical insufficiency during pregnancy, contact bleeding, decreased cervical mucus, stress urinary incontinence, vaginal laxity, and tightening of facial and vulvar skin.

[0231] The following are exemplary descriptions of some typical gynecological conditions that the direct current output mode is suitable for treating.

[0232] Vulvar and vaginal laxity

[0233] Weakness of the pelvic floor muscles and vaginal wall syndrome, especially after vaginal delivery, can lead to laxity in the vulvar and vaginal area. The main cause of this laxity is hormonal changes, particularly the excessive changes during menopause. This process can also be caused by insufficient vaginal lubrication, cervical erosion, or vaginal infections.

[0234] One consequence is urinary incontinence due to changes in the pelvic floor muscles, as well as sexual dysfunction. In addition to decreased tightness, elasticity, and sensitivity, this is also closely related to women's psychological problems. During menopause, decreased ovarian function and reduced estrogen secretion lead to atrophy of the vaginal mucosa.

[0235] The vaginal mucosa is composed of multiple layers of non-keratinized stratified squamous epithelium. Due to the decline in estrogen levels, progressive atrophy occurs. Vaginal dryness becomes more pronounced, making the vaginal tissue more susceptible to microtrauma from activities such as intercourse or exercise. In addition, the natural acidic pH of the vaginal mucosa becomes more alkaline; therefore, the vaginal mucosa is more susceptible to infection. Infection of the vaginal mucosa can lead to increased vaginal discharge and itching.

[0236] Vulvar and vaginal laxity can also worsen after vaginal delivery, and pelvic floor muscle fatigue is one of the most common negative consequences.

[0237] During vaginal delivery, the pelvic floor is subjected to pressure from adjacent areas. Due to this outward pressure, anatomical and functional changes may occur. Approximately 30% of women experience damage to the pelvic floor fibers after vaginal delivery. Other factors include estrogen deficiency.

[0238] These changes can be reversed by electrode-output pulsed direct current stimulation therapy, which promotes tissue regeneration through technical stimulation.

[0239] Exemplarily, the output parameters for treating vaginal laxity may include: a direct current of 0.1 mA to 10 mA, preferably 1 mA to 4 mA; and a single energizing duration of 5 min to 20 min. Low-frequency pulses of 0-300 Hz can be added to improve treatment efficiency and comfort.

[0240] Menopausal Urogenital Syndrome

[0241] Menopausal urogenital syndrome (GSM), also known as vulvovaginal atrophy, is a condition caused by a decrease in the level of estrogen produced by the ovaries. GSM can occur in postmenopausal women, affecting approximately 50% of women.

[0242] A potential therapeutic mechanism for GSM is reversible electroporation, which stimulates cell membranes by applying controlled electrical energy. This stimulation causes temporary changes in the cell membrane, allowing charged molecules, atoms, and macromolecules to enter the cell. Water molecules, with their large dipole moments, respond to an electric field. Under the influence of the electric field, water molecules partially align but then rapidly randomize, generating heat. This heat generation requires energy and is related to the current and exposure time. Therefore, controlling the energy, current, and time can modulate the therapeutic effect and improve the tissue condition of the vulva and vagina.

[0243] Urinary Incontinence

[0244] Stress urinary incontinence (SUI) is the most common type of urinary incontinence. Stress urinary incontinence is caused by damage to the natural supporting structures below the bladder (pelvic floor muscles and fascia) due to increased intra-abdominal pressure, resulting in urine leakage. In healthy individuals, these supporting structures are able to maintain the position of the bladder. However, in various pathological conditions, such as vaginal delivery and estrogen deficiency, these supporting structures may be weakened. The therapeutic effect has been demonstrated by deliberately improving this support using plasma energy. Instructions for use 20 / 35 pages 25 CN 121041094 A

[0245] Experiments have shown that by stimulating with action electrodes, each treatment lasts 15 minutes, and 3 to 6 treatments are performed. Patients experience a reduction in involuntary urine leakage and improved sexual function. Overall, the treatment is generally well tolerated and is positively evaluated for its comfort.

[0246] In summary, by applying a direct current signal to the vaginal mucosa, vaginal laxity and symptoms associated with atrophy can be improved, including but not limited to pain and unsatisfactory sexual activity, stress and urge urinary incontinence.

[0247] Under the stimulation of the direct current signal, most vaginal functions can be restored, including increased secretion, absorption, elasticity, and vaginal epithelial thickness (vaginal rejuvenation). The direct current signal can also revitalize and restore the elasticity and moisture of the vaginal mucosa, stimulate new collagen production, that is, activate collagen-forming fibroblasts, stimulate cell division, and restore the intercellular matrix. Subsequently, the atrophied mucosa thickens, and the submucosal tissue forms papillae. The fascia on the anterior and posterior vaginal walls, composed of collagen, closes and hardens. It closes the pelvic floor fascia, supports the lax bladder, and restores urinary incontinence. The complex of these changes and mucosal responses leads to narrowing of the vaginal canal.Ultimately, the thickening of the mucosa and the increase in vascularization in the submucosal tissue lead to a reduction in symptoms such as vaginal dryness, itching, irritation, and vaginal discomfort. Last but not least, dyspareunia is resolved. The procedure is painless, requires no local anesthesia, and addresses the rejuvenation of atrophic vaginal mucosa. It is also suitable for cases where topical estrogen vaginal creams cannot be used. Spontaneous urinary incontinence is reduced to almost disappear, and patients experience improved sexual function.

[0248] Therefore, in some embodiments, a direct current signal is applied to the vaginal mucosa using a direct current output mode, and the therapeutic goal of non-ablative electroporation stimulation of the vaginal mucosa can be to improve symptoms related to vaginal laxity and atrophy (including dyspareunia), especially stress and urge urinary incontinence. The mechanism of action includes: restoring vaginal secretion, absorption, elasticity, and epithelial thickness (vaginal rejuvenation); stimulating fibroblasts to produce collagen; promoting cell division and extracellular matrix repair; thickening atrophic mucosa and forming submucosal papillae; tightening the anterior and posterior vaginal wall fascia composed of collagen; enhancing pelvic floor fascia tension; supporting weak urethral sphincter muscles; restoring urinary control function; and ultimately reducing vaginal dryness, itching, irritation, and difficulty in intercourse through mucosal thickening and vascularization. The procedure is painless and requires no local anesthesia, making it suitable for patients who cannot use topical estrogen vaginal creams. It significantly reduces or even eliminates urinary incontinence and improves the quality of sexual life.

[0249] During the application of a direct current signal to the vaginal mucosa using a direct current output mode, the second working electrode outputs a direct current signal for treating the vaginal mucosa, and the second grounding electrode is connected to the patient's skin to establish contact between the two electrodes. Exemplarily, the second working electrode includes a first probe for gynecological treatment. The first probe may include a grip and an insertion portion. The insertion portion is designed for insertion into the vagina. The surface of the insertion portion for applying a direct current signal to the vaginal mucosa may be a metallic surface. During the treatment, the insertion part of the first probe can be gradually inserted into the vagina and pulled out.

[0250] The following is an exemplary description of the process of treating gynecological diseases using the direct current output mode.

[0251] First, preoperative preparations can be performed. Preparations include: cleaning and disinfecting the vagina with a cleaning spray; applying anesthetic and conductive gel to the treatment site; the second action electrode can be a roller or a long strip (S-shaped as described below) treatment head; the working level can be selected from 1 to 8 levels (see the description below for the levels), and the working current is less than 4mA.

[0252] After the preparations are complete, the second action electrode is brought into contact with the vaginal wall, and then the second action electrode is slowly moved to release a direct current signal to the currently contacted vaginal wall. Under the effects of tissue mucosal remodeling and collagen regeneration generated by the direct current signal, the corresponding treatment effect can be achieved.

[0253] After the direct current signal treatment is completed, drug spray can be used for interventional treatment.

[0254] Finally, gentle massage can be performed, and treatment parameters can be recorded.

[0255] ③Medical Aesthetics

[0256] The application of DC output mode in medical aesthetics mainly includes facial and vulvar tightening (collagen regeneration), hair growth.

[0257] DC current signal can stimulate fibroblasts to generate collagen, promote cell division and extracellular matrix repair, and therefore can be used for facial and vulvar tightening.

[0258] In some embodiments, DC output mode can be combined with the introduction of active ingredients (e.g., vitamin C) to achieve skin brightening and facial rejuvenation. The applicable sites may include the face and body surface. Output parameters may include, but are not limited to: constant DC current signal (current intensity up to 2mA; meeting the upper limit of current density); the diameter of the second working electrode is less than or equal to 20mm, and the contact surface can be a hydrophilic conductive interface; the second grounding electrode can be a patch type, and the area can be 1.5 times that of the second working electrode; the device can integrate impedance detection, maximum dose detection and abnormal shutdown functions.

[0259] For example, when the applicable area is the face, a 1mA-2mA, low-frequency pulse of 0-300Hz is commonly used. This can control the second active electrode to move in a "C" shape / grid for 10-30 minutes (3-5 round trips per unit area), maintaining the current density limit, attaching the circuit electrode, and completing the contact self-test (skin-electrode impedance < threshold). If the dominant active ingredient is anionic (such as some antioxidant derivatives, HA), the second active electrode is set as the cathode; if the dominant active ingredient is cationic, the second active electrode is set as the anode. That is, the polarity of the second active electrode is the same as the polarity of the dominant active ingredient used. Among them, neutral / lipid-soluble ingredients such as Vitamin C Brightening Cream (BV-OSC) are mainly electroosmotic and do not depend on polarity. Vitamin C Brightening Cream (BV-OSC) can be evenly spread in the treatment area, and one or more of Nonapeptide-1, shiitake mushroom extract, GigaWhite™ (a compound ingredient composed of 7 kinds of alpine plant extracts), and bearberry extracts can also be selected.

[0260] The second active electrode can also contact the scalp, outputting a direct current signal to the scalp to promote hair growth. When using a direct current signal to promote hair growth, the output parameters can be similar to those for skin quantification. The diameter of the second active electrode can be less than or equal to 10 mm. Furthermore, it can be combined with HA (hyaluronic acid) and exosomes to stimulate hair growth. Experimental verification showed that three months after the end of treatment, an increase in growth factors in the biotinylated peptide region was observed. At the end of the treatment, new hair growth was observed, while the loss of existing hair remained unchanged.

[0261] Electrical stimulation can induce apoptosis of adipocytes, achieving fat ablation. Therefore, the application of direct current output mode in medical aesthetics can also include conditions related to fat ablation, such as eye bags and double chins.When used for conditions related to fat ablation, the output end of the second action electrode can be inserted into the fat layer beneath the epidermis or dermis, i.e., the second site mentioned above can refer to the fat layer. By applying a direct current signal to the fat layer, adipocyte apoptosis can be induced, thereby achieving fat ablation.

[0262] For example, the output parameters of fat ablation may include: a constant direct current of 0-20mA, preferably 5mA-10mA; and a single-point energizing duration of 5s-30s.

[0263] 6) The effect of direct current signal parameters on the electrical stimulation effect

[0264] The parameters of the direct current signal include, but are not limited to, current density, pulse frequency, pulse width, and duty cycle.

[0265] Current density refers to the distribution of current intensity relative to the electrode contact area. Current density affects the acceptable stimulation intensity and safety of cells. Extremely low density (microampere level, such as tens of μA / cm2) is close to the physiological current level and does not trigger action potentials, but can activate cell repair pathways. For example, microcurrents (<1 mA) are comparable to the endogenous healing current in the human body and are called "subthreshold" stimulation. They can increase ATP (adenosine triphosphate) production and protein synthesis, promoting cell metabolism. Medium density (hundreds of μA / cm2 – several mA / cm2) can cause sensory nerve excitation and cell membrane depolarization, triggering signals such as calcium ion influx, thereby affecting gene expression (such as growth factors). High density (> several mA / cm2) is close to the stimulation pain threshold or even the damage threshold, causing forced neuromuscular excitation or thermal effects. It should usually be applied in pulses or for a limited time to avoid tissue damage.

[0266] For pulsed direct current (including single pulses and double pulses), the frequency determines the speed of pulse repetition and has a significant impact on neuromuscular response and cell signal rhythm. Low-frequency (Hz level) pulses trigger discrete cellular events, such as each pulse triggering a neuronal discharge or muscle twitching. Low-frequency pulsed direct current is often used to promote cell migration and proliferation: Studies have shown that a 2Hz micropulse (200μA) can significantly promote the migration and proliferation of human skin fibroblasts towards the cathode. This electromigration helps cells move directionally toward the wound center during wound healing. Mid-frequency (tens to hundreds of Hz) pulses can induce sustained sensory / motor effects; for example, pulsed currents of 50Hz to 100Hz have an analgesic effect on sensory nerves and produce tetanic contractions in muscles, helping to improve circulation. HVPC (high-voltage low-frequency pulsed electrotherapy) commonly uses frequencies around 100Hz in wound treatment to continuously provide chemotactic signals while avoiding significant muscle contraction. Higher frequency (kHz level) short pulses can lead to the fusion of nerve excitations or even nerve block. For example, continuous alternating current at several kHz has been used for high-frequency peripheral nerve block.Similarly, if a high-frequency pulsed DC current signal is applied, it may temporarily block pain transmission by causing a prolonged refractory period of the nerve membrane through rapid and repeated depolarization, which can be used for pain management. However, a trade-off is needed. High frequency also increases the risk of charge accumulation, so it is often combined with biphasic or duty cycle control.

[0267] Pulse width refers to the duration of each pulse, and duty cycle is the percentage of pulse energization time relative to the total cycle. Both determine the total charge delivered by a single pulse and the degree of resemblance to DC. Short pulses / low duty cycles (such as pulse width of tens of microseconds, duty cycle <1%) approximate peak current, and the charge of a single pulse is extremely small, so no significant electrolytic products are produced. HVPC is of this type: typical pulse width 20–100 μs, duty cycle about 1% (99% of the time is without current). This makes the total average current of HVPC as low as 1 mA to 2 mA but the instantaneous voltage is high, effectively stimulating tissues while avoiding skin pH changes and burning. Extended pulses / high duty cycles gradually approach constant DC current.

[0268] 100% duty cycle is equivalent to pure DC. Studies show that the duty cycle has a significant impact on cellular effects: under the same intensity of 200 μA and 2 Hz, when different duty cycles are applied to human skin fibroblasts, a medium duty cycle (10%) pulse results in the highest expression of α-SMA protein and TGF-β1 gene, which promote healing, while a high duty cycle (500%–90%) leads to a decrease in cell viability. This indicates that appropriate intervals are beneficial for cell recovery and signal optimization; excessively long pulses may cause stress and toxicity. Although continuous DC (100% duty cycle) can most strongly polarize the cell membrane and upregulate the expression of collagen, TGF-β, etc., long-term effects may lead to excessive cell contraction and apoptosis, requiring careful dose control.

[0269] In summary, different parameter combinations determine the biological action mode of electrical stimulation in various tissues. Therefore, the parameter values ​​of the current output DC current signal can be set according to the actual application requirements.

[0270] III. Combined with Drug / Active Ingredient Delivery

[0271] In some embodiments, the DC signal output control device of this disclosure may further include an injection module. The injection module may be combined with a plasma output mode or a DC output mode. That is, both plasma output mode and DC output mode can assist in drug / active ingredient delivery.

[0272] 1) Plasma Output Mode + Drug / Active Ingredient Delivery

[0273] The permeability of the skin area after plasma treatment is increased, so the plasma output mode can be combined with drug / active ingredient delivery to promote the penetration of drug / active ingredient into the deep skin tissue and achieve efficient transdermal drug delivery.

[0274] In some embodiments, the injection module may be used to deliver a drug or active ingredient to the first site after the permeability of the stratum corneum of the skin at the first site is changed by applying plasma.

[0275] For example, the injection module may include a micropump, a storage device, and a nozzle.After skin pretreatment is complete, the control module activates the injection module. The micropump delivers the drug or active ingredient from the storage device to the drug delivery nozzle according to a preset flow rate and time, completing the pretreatment drug or active ingredient delivery process. Next, the plasma output mode can be activated, and the second electrode generates low-temperature plasma to pretreatment the skin at the treatment site, altering the permeability of the stratum corneum. Once the skin permeability reaches the desired effect, the control module activates the drug delivery module. The micropump extracts the drug or active ingredient from the storage device and delivers it to the nozzle according to a preset dose and rate. The nozzle evenly sprays the drug or active ingredient in a mist form onto the plasma-treated skin area. The drug or active ingredient rapidly penetrates into the deep skin tissue through increased skin permeability, achieving highly efficient transdermal drug or active ingredient delivery. The polarity of the drug or active ingredient can be negative. The active ingredient (e.g., in solution form) may include, but is not limited to, at least one or any combination of vitamin C, vitamin E, hyaluronic acid and retinoic acid, exosomes, and collagen.

[0276] 2) DC output mode + drug / active ingredient delivery

[0277] In DC current signal output mode, the DC current signal can produce electroporation / electrophoresis and other effects on human tissue. The human body can apply or spray (of the same polarity) drugs or active ingredients at the site of action. Under the action of electroporation / electrophoresis and other effects, the drugs or active ingredients are accurately introduced to the site of action to achieve deep (e.g., penetrating the dermis) therapeutic effect.

[0278] The injection module includes a storage module (i.e., storage device), a transport module (e.g., micropump), and a delivery module (e.g., nozzle). The storage module stores the drugs (e.g., ionic drugs) or active ingredients to be introduced. The transport module is connected to the control module, which controls the operating parameters of the transport module (e.g., parameters controlling the speed of drug delivery). During the process of applying a DC current signal to the second site, the transport module, under the control of the control module, transports the drug or active ingredient to the delivery module, which then delivers the drug or active ingredient to the second site. Under the action of the DC electric field of the DC current signal, the permeability of the cell membrane in the second site increases, thereby facilitating the introduction of the drug or active ingredient into the second site. The polarity of the drug or active ingredient can be negative. The active ingredient (e.g., in solution form) can include, but is not limited to, at least one or any combination of vitamin C, vitamin E, hyaluronic acid and retinoic acid, exosomes, and collagen.

[0279] In some embodiments, the injection module can be integrated into the action electrode (first action electrode or second action electrode). Thus, the action electrode can also have the function of drug administration. In this case, the action electrode can also be called a drug applicator or a swab applicator.

[0280] When using DC output mode to assist in drug / active ingredient delivery, any one or more combinations of the above three types of DC current signals can be used to achieve drug or active ingredient delivery. For example, a stable constant DC current can be used to achieve drug delivery; a single-pulse DC current signal can be used to achieve drug delivery; a multi-pulse DC current signal can be used to achieve drug delivery; and a constant DC current + pulse (including single-pulse or multi-pulse) DC current signal can be used to achieve drug delivery. The appropriate delivery method can be selected according to the specific scenario. For example, the appropriate DC current signal can be selected to assist in drug delivery according to the required depth and uniformity of delivery.

[0281] The following uses drug delivery as an example to illustrate the positive role of DC current signals (especially combinations of different types of DC current signals) in the drug delivery process. It should be understood that DC current signals can also play a similar role in the delivery of active ingredients as drug delivery.

[0282] The electric field force of direct current drives charged drug molecules to move towards electrodes with opposite polarity, thus enhancing the targeting and local concentration of the drug. Many drug molecules have difficulty passing through the stratum corneum or mucosal barrier. Direct current changes the structure of the stratum corneum, temporarily increasing intercellular spaces, promoting pore opening, reducing skin impedance, and improving the ability to penetrate biological membranes, allowing the drug to bypass the obstacles of the skin and mucosal barrier during delivery. Direct current itself may have certain physiological effects on tissues, promoting local blood circulation, relieving inflammation, etc., forming a synergistic effect with the delivered atomized drugs such as anti-inflammatory drugs, analgesics, and neurotrophic drugs, further enhancing the therapeutic effect.

[0283] When using the combined output method of "dual-pulse direct current + single-pulse direct current" for drug delivery, the dual-pulse direct current signal is a low-to-medium frequency current, which can avoid the low-frequency current only acting on the skin surface. The single-pulse direct current signal can intermittently deliver the drug to the treatment site, forming an ion pile and prolonging the drug's action time. The combination of the two can further enrich the current stimulation mode.

[0284] When using the combined output method of "single-pulse DC current + constant DC current" for drug delivery, the single-pulse DC current can temporarily change the structure of the stratum corneum of the skin, increasing the drug penetration channels. Combined with constant DC current, it can improve the depth and efficiency of drug delivery and also leverage the polarity of constant DC current.

[0285] When using the combined output method of "double-pulse DC current + constant DC current" for drug delivery, the double-pulse DC current can reduce the impedance of human tissue, allowing the current to act more deeply and stably on deep tissues, promoting more effective drug delivery to the target site. Constant DC current can provide a stable electric field, ensuring the directional migration of drug ions.The combination of the two can reduce skin irritation and avoid electrolysis by utilizing the advantages of dual pulses, and improve the accuracy and effectiveness of drug delivery by utilizing the directional delivery characteristics of constant DC.

[0286] 3) Delivery technology

[0287] When delivering drugs or active ingredients to the skin surface using a delivery module (e.g., a nozzle), ultrasonic spray technology, pressure spray technology, and electrostatic spray technology can be used, but are not limited to. The following uses drug delivery as an example to illustrate these spray technologies.

[0288] Ultrasonic spray technology refers to generating high-frequency vibrations (usually 1MHz to 5MHz) through an ultrasonic generator. The vibration is transmitted to the surface of the liquid medicine, causing the liquid medicine to undergo violent mechanical vibration, thereby being broken into fine droplets. For example, the drug preparation can be added to the liquid medicine tank of the ultrasonic spray device first to ensure that the liquid medicine is in full contact with the ultrasonic vibrating plate; then, the ultrasonic generator is turned on, and the vibration frequency and power are adjusted to control the droplet diameter within the range of 1μm to 10μm according to the drug properties and drug delivery requirements. Under the powerful compression of the airflow, the droplets are subjected to a certain pressure, and the spray is ejected from the treatment surface by the pipeline.

[0289] Pressure spray technology refers to using compressed gas as a power source to apply pressure to the drug solution or suspension in a sealed container. When the spray valve is opened, the drug is atomized into fine droplets under pressure and sprayed out through the nozzle. For example, an appropriate amount of compressed gas can be filled into the container to maintain a certain pressure, usually 0.2MPa to 1.5MPa. The specific pressure value is determined according to the characteristics of the drug and the atomization requirements. In addition, a special spray valve and nozzle are installed. The nozzle orifice diameter is 0.01mm to 0.5mm and the shape can be direct spray, protruding, concealed spray, etc., to control the droplet size and spray pattern. When in use, the valve is pressed, and the drug is sprayed out from the nozzle under pressure to form a spray.

[0290] Electrostatic spraying technology refers to setting a high-voltage electrode at the spray nozzle to charge the sprayed droplets. Utilizing the mutual repulsion between charges and the electrostatic attraction between the droplets and the target surface, the adhesion efficiency of the droplets to the target surface is improved. The drug preparation is loaded into the storage tank of the spraying device and connected to a high-voltage power supply, set to DC voltage 5kV~30kV, to the electrode at the nozzle. The spray flow rate and high-voltage electric field strength are adjusted to ensure uniform charge on the droplets. During spraying, the charged droplets move directionally under the action of the electric field force and adhere to the target drug delivery site.

[0291] IV. Structure of the Action Electrode

[0292] The front end of the first action electrode should be designed as a discharge tip to generate plasma.

[0293] The overall shape of the first action electrode can be pen-shaped; therefore, the first action electrode can also be called a plasma pen.

[0294] The front end of the second action electrode should be an application surface adapted to the second part to be contacted. Adaptation here includes both shape and size adaptation.For example, when the second action electrode is used for external skin tightening, the application surface of the second action electrode should be designed as a plane, and the size of the application surface should be on the order of magnitude of the external skin to be tightened. As another example, when the second action electrode is used to treat ophthalmic conditions, the size of the action surface (i.e., the application surface) of the second action electrode should be designed to be small to achieve precise treatment.

[0295] Exemplarily, the application surface of the second action electrode may include, but is not limited to, a plane, a sphere, and other curved surfaces.

[0296] Exemplarily, the second action electrode may include a first probe for gynecological treatment, the first probe including a holding portion and an insertion portion, the insertion portion being designed to be inserted into the vagina. Specification 25 / 35 pages 30 CN 121041094 A

[0297] Exemplarily, the second action electrode may also include a second probe for medical aesthetics and / or eye diseases. In some embodiments, the second probe can be used for both medical aesthetics and eye diseases. According to the mechanism of action, the second probe can be divided into two types. The first type is where the action site of the second probe is located on the skin surface, and the tip of the second probe does not need to be inserted below the epidermal layer. For example, for eye diseases such as meibomian gland dysfunction and dry eye, as well as for cosmetic purposes such as facial tightening and hair growth, the direct current signal is applied to the tissue surface. The second type is where the second probe is applied to the tissue interior rather than the skin surface, and the tip of the second probe needs to be inserted below the epidermis. For example, for fat ablation (such as eye bags and double chins), the tip of the second probe needs to be applied to the fat layer under the epidermis. Another example is for ingrown eyelashes and frizzy eyelashes, where the second probe needs to be inserted along the hair shaft of the ingrown (or frizzy) eyelashes into the hair follicle to the vicinity of the papillary area. Therefore, the application surface of the first type of second probe can be planar, for example, when used for the treatment of eye diseases, the diameter of the application surface of the second probe can be 1mm to 15mm. Correspondingly, the tip of the second type of second probe should be designed as a sharp point to penetrate deep into the tissue.

[0298] Figure 6 shows several structural schematic diagrams of the second action electrode.

[0299] Referring to the left view of Figure 6, the front section of the second active electrode can be conical 9-1. In this case, the application surface of the second active electrode can be a small circle, for example, a circle with a diameter of 1mm to 15mm. The conical second active electrode shown on the left side of Figure 6 has a small application surface, which is suitable for treating eye diseases. That is, the second active electrode shown on the left side of Figure 6 can refer to the second probe mentioned above.

[0300] Referring to the right view of Figure 6, the application surface of the second active electrode is a flat surface 9-2. The application surface of the second active electrode can be a large circle. The second active electrode shown on the right side of Figure 6 can be used for skin tightening. That is, the second active electrode shown on the right side of Figure 6 can refer to the second probe mentioned above.

[0301] The second working electrode may be made of EN AW 5038 (aluminum-magnesium alloy), AISI 302 (high-carbon austenitic stainless steel), AISI 304 (general-purpose austenitic stainless steel), or other materials with similar properties.

[0302] FIG7 shows a schematic diagram of one structure of the second working electrode suitable for gynecological use.

[0303] The second working electrode shown in FIG7 corresponds to the first probe mentioned above. The first probe may also be called a gynecological probe or a gynecological applicator. As shown in FIG7, the second working electrode includes an application surface 10, a cylindrical body 11, a handle 12, and a connector 15. The connector 15 is used to connect to a DC signal generation module. The head of the second working electrode suitable for direct contact with the vaginal mucosa preferably includes a hollow cylinder (i.e., cylindrical body 11) of plastic (acetal) with a length of 100mm-400mm and a diameter of 10mm-40mm.

[0304] FIG8 shows another schematic diagram of the structure of the second working electrode suitable for gynecological use.

[0305] The second working electrode shown in Figure 8 corresponds to the first probe mentioned above. Referring to Figure 8, the second working electrode is generally wavy and S-shaped. The second working electrode includes a rectangular application surface 13, a handle 12, and a connector 15. The connector 15 is used to connect to the DC signal generation module.

[0306] Figure 9 shows a schematic diagram of the structure of the second working electrode when it acts on the cervical mucosa.

[0307] As shown in Figure 9, when the application surface 1 (i.e., the treatment surface) of the second working electrode is introduced into the mucosa / tissue of the patient's vulva 2 and modulated pulsed DC current is introduced through it, ionic drugs are injected into the working vulva. The injected ionic drugs can be introduced into the tissue under the electroporation effect of the pulsed DC current to achieve the corresponding therapeutic purpose. The second working electrode in Figure 9 can also be called a cervical treatment head. The front section of the cervical treatment head in Figure 9 can be regarded as the application surface. The application surface has a certain length and the shape of the application surface is adapted to the contact area so as to insert it into the appropriate position. The shape of the application surface at the front end of the cervical treatment head shown in Figure 9 can be circular or conical.

[0308] Figures 10 to 12 show schematic diagrams of the application surface of the second active electrode for cervical mucosal treatment. Specification 26 / 35 pages 31 CN 121041094 A

[0309] As shown in Figures 10 to 12, the application surface of the second active electrode for cervical mucosa can be a roller type, which includes a first segment 122, an outwardly convex structure 121, and a second segment 123 from front to back. The outwardly convex structure 121 is located between the first segment 122 and the second segment 123, and can be a disk with a diameter larger than that of the first segment 122 and the second segment 123. The first segment 122 is a tubular shape with a diameter decreasing from back to front. The front end of the first segment 122 is a spherical surface. The second segment 123 can be a cylindrical structure.During treatment, the first segment 122 can be inserted deep into the cervix to treat the cervical mucosa deep within the cervix, while the outwardly protruding structure 121 can be used to treat the periphery of the cervical mucosa.

[0310] Figure 13 shows a schematic diagram of the application surface of the second working electrode used for treating the periphery of the cervical mucosa.

[0311] As shown in Figure 13, the application surface of the second working electrode used for the cervical mucosa can also remove the first segment 122, and only include the outwardly protruding structure 121 and the second segment 123. During treatment, only the outwardly protruding structure 121 can contact the periphery of the cervical mucosa.

[0312] It should be understood that the specific dimensional data shown in Figures 10 to 13 are only exemplary illustrations. In practical applications, other dimensional data can also be set to suit different patients.

[0313] Figure 14 shows a schematic diagram of the second working electrode acting on the vagina.

[0314] Referring to Figure 14, the second working electrode may include a holding portion 125 and an insertion portion 126. The insertion portion 126 is adapted to be inserted into the vagina to treat vaginal-related conditions. Specific treatable vaginal-related conditions can be found in the relevant description above.

[0315] Figure 15 shows another structural schematic diagram of the second working electrode.

[0316] Referring to Figure 15, the front end of the second working electrode is a metal probe 128, and the length of the metal probe 128 can be about 0.5 mm. The number of metal probes 128 of the same second working electrode can be one (shown on the left side of Figure 15) or two (shown on the right side of Figure 15). The other parts of the second working electrode except for the metal probe 128 (e.g., the lower part of the metal probe 128) are insulated. In this embodiment, the metal probe 128 can contact the fat layer under the epidermis, output a DC current signal to act on the fat layer, and use electrical stimulation to induce apoptosis of fat cells, thereby achieving fat ablation. Specifically, it can be used to treat diseases related to fat ablation, such as eye bags and double chin.

[0317] V. Several optional functions that can be realized based on impedance detection

[0318] (1) Impedance matching

[0319] Human body impedance is dynamic. The impedance of different parts is also different. Therefore, it is necessary to detect human body impedance in real time and adjust the impedance characteristics in the circuit in real time according to the detected human body impedance to achieve impedance matching.

[0320] Figure 16 shows a schematic diagram of the structure of a DC signal output control device according to another embodiment of the present disclosure.

[0321] As shown in Figure 16, the DC signal output control device may further include an impedance detection module 150, an impedance matching module 140, and a feedback adjustment module 160. The impedance detection module 140 is used to detect human body impedance when the DC signal generation module is connected to the second type of output module. The impedance matching module is used to adjust the impedance characteristics in the circuit to match the internal resistance of the signal source with the load impedance (i.e., human body impedance) (i.e., conjugate matching), thereby maximizing the transmission of signal energy and reducing reflection.

[0322] The feedback adjustment module 160 is used to adjust the impedance characteristics in the circuit according to the detected human body impedance, so that the adjusted signal source internal resistance matches the currently detected human body impedance, thereby enabling the current output process to be in an impedance-matched state in real time. By configuring impedance detection and impedance matching functions for the electrical stimulation device 100, human body impedance can be monitored in real time, impedance matching guidance can be provided, the safety and effectiveness of the output can be ensured, and the problem of inaccurate energy output can be avoided.

[0323] In some embodiments, the impedance characteristics of the impedance matching module 140 are adjustable. The control module 110 can adjust the impedance characteristics of the impedance matching module 140 through the feedback adjustment module 160 so that impedance matching can be achieved after adjustment. In other embodiments, the impedance characteristics of the impedance matching module 140 can be a fixed value that is not adjustable. The control module 110 can adjust the impedance characteristics of the feedback adjustment module 160 itself through the feedback adjustment module 160 to achieve impedance matching.

[0324] For example, the impedance detection module 150 may include an impedance acquisition circuit, a signal amplification circuit, a high-speed analog-to-digital converter (i.e., a high-speed ADC), and a field-programmable gate array (FPGA) connected in sequence. The impedance acquisition circuit is connected to the output module 130.

[0325] After the second type of output module 130 forms a circuit with the human body, such as when both electrodes in the second type of output module 130 are in contact with the human body and form a circuit with the human body, the impedance acquisition circuit will detect the signal value fed back by the human body in real time. Since the signal value detected by the impedance acquisition circuit is very small, it is necessary to use the signal amplification module to amplify the signal.

[0326] The signal after being amplified by the signal amplification module is transmitted through the high-speed ADC. The reason for using the high-speed ADC is that it can select the specific frequency of the signal and transmit the signal quickly after filtering without being interfered with by the external frequency. To achieve real-time impedance matching, the impedance signal value needs to be processed quickly. Since FPGA has the ability to process signals quickly, this disclosure does not directly transmit the digital signal after high-speed ADC conversion to the control module 110 for processing, but instead transmits it to the FPGA. The FPGA receives the acquired signal and processes it using the FFT (Fast Fourier Transform) algorithm, then transmits the processed frequency domain signal back to the control module 110 for algorithmic integration. The control module 110 calculates the human body impedance based on a preset algorithm.

[0327] Human body impedance includes resistive and capacitive components. The algorithm Z = V / I treats the human body as a real resistance to calculate impedance, which is inconsistent with the actual situation and has a large error. In view of this, this disclosure designs the following new formula for calculating human body impedance.

[0328] The formula for calculating the capacitive component (i.e., capacitance value) of human body impedance can be expressed as:

[0329]

[0330] Where, C is the capacitance value. A is the impedance compensation constant. ε is the dielectric constant, ε1 represents the real part of the dielectric constant, and ε2 represents the imaginary part of the dielectric constant. d represents the distance between the two electrodes of the second type of output module, and d can be regarded as the length of human tissue in the circuit. When one electrode (i.e., the second action electrode) contacts or is close to the second part, and the other electrode (i.e., the second ground electrode) contacts other parts of the human body to form a circuit, d can also be expressed as the distance between the other electrode and the second part. s represents the area of ​​the treatment site where the current acts, and this area can refer to the cross-sectional area.

[0331] The formula for estimating the real part resistance of the human body can be expressed as:

[0332]

[0333] Wherein, R represents the real part resistance of the human body impedance; w is the angular frequency; e(w) represents the conductivity of biological tissue (such as the second part) at the angular frequency w; P(w) represents the resistivity of biological tissue (such as the second part) at the angular frequency w.

[0334] The formula for estimating the imaginary part impedance of the human body can be expressed as:

[0335]

[0336] Therefore, the control module 110 can calculate the human body impedance based on the following formula:

[0337] Z=R+X

[0338]

[0339] The meaning of each symbol in the formula can be found in the relevant description above. The specific value of the angular frequency w can be determined by signal acquisition and processing, for example, the angular frequency w can be obtained based on the frequency domain signal processed by the field programmable gate array mentioned above. (Pages 28 / 35, CN 121041094 A) The value of P(w) is related to the dielectric constant ε and the angular frequency w. The dielectric constant ε (ε1 and ε2) can be a known value, such as the dielectric constant of human tissue (or a specific treatment site) can be obtained by querying. Therefore, after the value of the angular frequency w is determined, the value of P(w) is also determined. The values ​​of d and / or s can be a pre-set default value. For example, when the user connects the two electrodes to the human body in a pre-set manner, the values ​​of d and s can be considered to be fixed values. In addition, the values ​​of d and / or s can also be determined by on-site measurement. The impedance compensation constant A can be obtained by simulation. For example, the impedance compensation constant A can be obtained by building a circuit model with simulation software (such as Ansys) and simulating the interaction of biological tissue at the human treatment site.

[0340] (2) Gear setting

[0341] In some embodiments, the control module 110 can also set a second output gear according to the detected human body impedance, and control the DC signal generation module 120 to ensure that the energy acting on the second part per unit time does not exceed the second threshold. Among them, the second output level is positively correlated with human body impedance, and the second threshold is positively correlated with the second output level.That is, the greater the human body impedance, the larger the second output level, the larger the second threshold, and the higher the energy (i.e., power) that can be applied to the second part per unit time.

[0342] Figure 17 shows a schematic diagram of impedance power curves for different levels.

[0343] The horizontal axis in Figure 17 represents current, and the vertical axis represents power. As shown in Figure 17, the second output level can be set to an adjustable mode of 1-8 levels. As the level increases, the energy applied per unit time also increases sequentially, and the impedance bandwidth also increases. Therefore, as can be seen from Figure 17, each level has an optimal human body impedance point. At the optimal impedance point, the energy output is the maximum, and there is no reflection phenomenon. Therefore, impedance detection and matching are particularly important.

[0344] For example, this disclosure can pre-set a correspondence table between the second output level and the human body impedance. Figure 18 shows a schematic diagram of the correspondence table between the second output level and the human body impedance. As shown in Figure 18, the correspondence table can record the correspondence between the human body impedance range and the second output level, as well as the maximum energy output value under different second output levels.

[0345] Thus, after detecting human body impedance, the current second output level and the maximum energy output value can be determined based on the corresponding table. For example, if the impedance of the human body treatment site is detected to be 300Ω, the recommended second output level is level 3 or level 4, and its output energy can be limited to 0.0028W of level 5.

[0346] (3) Determine whether there is an indication

[0347] In some embodiments, the control module 110 can also determine whether there is an indication based on the change in the value of human body impedance. Determining whether there is an indication is to determine whether the current output mode has a therapeutic effect on the symptoms to be solved. The change in the value of human body impedance (such as the impedance of the treatment site) can reflect the quality of the treatment effect to a certain extent. Therefore, the change in the value of human body impedance can be used to determine whether there is an indication.

[0348] The following uses dry eye syndrome as an example to illustrate the correlation between the change in the value of human body impedance and whether there is an indication. The main cause of dry eye syndrome is abnormal tear secretion or excessive tear evaporation, which leads to an imbalance in the microenvironment of the ocular surface. Although human impedance values ​​are affected by factors such as skin moisture content, temperature, sweat gland secretion, and individual differences (e.g., age, skin thickness), making it difficult to accurately reflect the tear film state of each individual, this disclosure focuses on impedance testing of the same individual. Under the condition that all other variable factors are the same, only the ocular moisture content and ion concentration are variable factors. These factors can reflect whether and specifically what kind of effect electrotherapy is effective for dry eye syndrome. This allows us to determine whether an indication is appropriate by observing changes in impedance values, and to make corresponding adjustments accordingly.

[0349] Specifically, if a user suffers from dry eye syndrome, the detected human body impedance value (i.e., the impedance value of the eye) can be recorded as A at the beginning of treatment. At this time, the water content and ion concentration of the eye are low, so A should be a relatively large value. The detected human body impedance value A can refer to the impedance detected when determining the connection between the positive and negative electrodes and the human body. After a period of electrical stimulation, the human body impedance value (i.e., the impedance value of the eye) can be detected again, and the detected impedance value is recorded as B. If A > B, it indicates that the dry eye treatment has improved, and dry eye syndrome is an indication. Moreover, the larger the difference between A and B, the better the dry eye treatment effect. Therefore, the difference between A and B can also be used as a basis for judging whether dry eye syndrome still exists. For example, if the difference between A and B is greater than a predetermined threshold, it indicates that the dry eye syndrome has been greatly relieved. If the DC current signal continues to be output, the output energy of the device can be reduced. If A = B, it indicates that the dry eye treatment is ineffective and the current DC current signal output method is not working. In this case, the output method can be adjusted, for example, by increasing the device's output energy. If A...

Claims

1. A DC signal output control device, comprising: Control module and DC signal generation module, The control module is configured as follows: If the DC signal generation module is connected to the first type of output module, the DC signal generation module is controlled to generate a DC voltage signal and provide the DC voltage signal to the first type of output module, so that the first working electrode in the first type of output module outputs plasma to act on the first part. The first type of output module includes the first working electrode and the first ground electrode. The first working electrode and the first ground electrode are respectively connected to the two output terminals of the DC signal generation module, and the application surface of the first working electrode is spaced apart from the first part by a first distance. The first ground electrode establishes a conductive path with other parts other than the first part. If the DC signal generation module is connected to the second type of output module, then the DC signal generation module is controlled to generate a DC current signal and provide the DC current signal to the second type of output module, so that the second active electrode in the second type of output module applies the DC current signal to the second part. The second type of output module includes a second active electrode and a second ground electrode. The second active electrode and the second ground electrode are respectively connected to the two output terminals of the DC signal generation module, and the application surface of the second active electrode establishes a conductive path with the second part, and the second ground electrode establishes a conductive path with other parts other than the second part.

2. The DC signal output control device according to claim 1 further includes: An impedance detection module is used to detect human body impedance when the DC signal generation module is connected to the second type of output module. Based on the human body impedance, the control module determines whether the second type of output module forms a circuit with the human body, and if it determines that the second type of output module forms a circuit with the human body, it controls the DC signal generation module to generate a DC current signal.

3. The DC signal output control device according to claim 1, wherein, The DC signal output control device treats at least one of the following conditions or achieves at least one of the following therapeutic purposes by outputting the DC current signal: hair growth, meibomian gland dysfunction, dry eye syndrome, cervical dysplasia, cervical bleeding, ablation of Nabothian cysts, treatment of cervical eversion, cervical inflammation, leukoplakia, metaplasia, treatment of transformation zone, cervical mucosal irregularities, adenomyosis, endometriosis, cytological abnormalities, HPV positivity, prevention of cervical insufficiency during pregnancy, contact bleeding, decreased cervical mucus, stress urinary incontinence, vaginal laxity, and tightening of facial and vulvar skin.

4. The DC signal output control device according to claim 1, wherein, The DC signal output control device treats at least one of the following conditions or achieves at least one of the following therapeutic purposes by outputting plasma: blepharitis, dry eye syndrome, ptosis, entropion, xanthelasma palpebrae, conjunctival laxity, periorbital cosmetic surgery, blepharoplasty, condyloma acuminata, treatment of benign tumors, and removal of epidermal lesions.

5. The DC signal output control device according to claim 1, wherein, The DC signal output control device treats at least one of the following conditions in pets by outputting the plasma and / or the DC current signal: evaporative and mixed dry eye, blepharitis, blepharitis, multidrug treatment for glaucoma secondary to conjunctivitis in pets, chalazion, infectious inflammation of eyelid glands, trichiasis and difilariasis, ectopic cilia, benign tumors of the eyelids and body, peripheral facial paralysis, alopecia, Demodex mites, body keratosis, and papilloma.

6. The DC signal output control device according to claim 1, wherein, The second site is the anterior lip of the eyelid. The second active electrode penetrates the second site, and the DC signal output control device treats trichiasis and / or tangled eyelashes by outputting the DC current signal.

7. The DC signal output control device according to claim 1, wherein, The DC current signal includes at least one of a constant DC current signal, a single-pulse DC current signal, and a multi-pulse DC current signal. The constant DC current signal is a current whose direction and intensity remain unchanged. The single-pulse DC current signal is a current whose direction remains constant and whose intensity varies with time. The multi-pulse DC current signal is a current obtained by superimposing at least two currents with equal amplitude but different frequencies.

8. The DC signal output control device according to claim 7, wherein, When the DC signal generation module is connected to the second type of output module, the control module controls the DC signal generation module to generate a first-mode DC current signal during a first time period, and controls the current generation module to generate a second-mode DC current signal during a second time period. The output process includes at least one first time period and at least one second time period, wherein the DC current signal of the first mode and the DC current signal of the second mode are taken from two of the constant DC current signal, the single-pulse DC current signal and the multi-pulse DC current signal.

9. The DC signal output control device according to any one of claims 1, 7, and 8, further comprising: Injection module, The injection module is used to deliver drugs or active ingredients to the first site after the plasma is applied to the first site to change the permeability of the stratum corneum of the skin at the first site, or The injection module is used to deliver ionic drugs or active ingredients to the second site during the process of applying the DC current signal to the second site. Under the action of the DC electric field of the DC current signal, the permeability of the cell membrane of the second site is increased, thereby facilitating the introduction of the ionic drugs or active ingredients into the second site.

10. The DC signal output control device according to claim 9, wherein, The injection module includes a storage module, a transport module, and a delivery module. The storage module stores the ionic drug or active ingredient to be introduced. The transport module is connected to the control module, which controls the operating parameters of the transport module. During the process of applying the DC current signal to the second site, the transport module, under the control of the control module, transports the ionic drug or active ingredient to the delivery module, which then delivers the ionic drug or active ingredient to the second site.

11. The DC signal output control device according to claim 1, further comprising: The first type of output module and the second type of output module, wherein the front end of the first working electrode is a discharge tip, and the front end of the second working electrode is an application surface adapted to the second part.

12. The DC signal output control device according to claim 11, wherein, The second active electrode includes a first probe for gynecological treatment, the first probe including a gripping part and an insertion part, the insertion part being designed for insertion into the vagina.

13. The DC signal output control device according to claim 11, wherein, The second functional electrode includes a second probe for medical aesthetics and / or eye diseases.

14. The DC signal output control device according to claim 1, wherein, The first grounding electrode and the second grounding electrode are the same electrode.

15. The DC signal output control device according to claim 1, wherein, The first part and the second part are the same part.

16. The DC signal output control device according to claim 1, wherein, The DC voltage signal is greater than or equal to the breakdown voltage between the first working electrode and the first part, and / or the plasma allows a maximum current of 3mA to be transmitted between the first working electrode and the first part.

17. The DC signal output control device according to claim 1, wherein, The DC current signal is ≤20mA; and / or The pulse width is 0ms to 5000ms; and / or The frequency ranges from 0 Hz to 1 MHz.

18. The DC signal output control device according to claim 17, wherein, The DC current signal is ≤10mA; and / or The pulse width is 0ms to 1000ms; and / or The frequency ranges from 0 Hz to 100 kHz.

19. The DC signal output control device according to claim 18, wherein, The frequency ranges from 10Hz to 50Hz.

20. The DC signal output control device according to claim 1, wherein, The first distance is 0.1mm to 5mm.

21. The DC signal output control device according to claim 1, wherein, The tip of the first active electrode is made of gold; and / or The front end of the second working electrode is made of metal.

22. The DC signal output control device according to claim 2, wherein, The control module sets a second output level based on the human body impedance, and controls the DC signal generation module to ensure that the energy applied to the second part per unit time does not exceed a second threshold. The second output level is positively correlated with the human body impedance, and the second threshold is positively correlated with the second output level.

23. The DC signal output control device according to claim 2, wherein, The control module determines whether there is an indication based on the change in the human body impedance, and sets the output strategy of the DC current signal according to the determination result.

24. The DC signal output control device according to claim 2, wherein, The second part is the eye, which includes at least one of the eyelid, eyelid margin, conjunctiva, and sclera. The DC signal output control device is used to treat dry eye syndrome. When the control module determines that dry eye syndrome is an indication based on the change in the human body impedance, it sets the energy applied to the eye per unit time based on the degree of change in the human body impedance. The energy applied to the eye per unit time is negatively correlated with the degree of change in the human body impedance, and / or If the control module determines that dry eye syndrome is not an indication based on the change in the human body impedance, it resets the output strategy of the DC current signal.

25. The DC signal output control device according to claim 2, wherein, The control module calculates human body impedance based on the following formula. Z = R + X Where Z represents human body impedance, R represents the real part of human body impedance resistance, X represents the imaginary part of human body impedance resistance, A represents the impedance compensation constant, w represents the angular frequency, P(w) represents the resistivity of the second part corresponding to the angular frequency w, d represents the distance between the two electrodes of the second type of output module, s represents the area of ​​the current acting on the second part, ε1 represents the real part of the dielectric constant, and ε2 represents the imaginary part of the dielectric constant.

26. The DC signal output control device according to claim 1, wherein, The DC signal generation module includes a boost circuit and a signal modulator. The signal modulator is used to modulate the output signal of the boost circuit, wherein the open-circuit voltage is adjustable to 20kV, the current is adjustable to 20mA, the operating frequency is 0Hz to 1000kHz, and the pulse train repetition frequency is 0Hz to 100Hz.

27. The DC signal output control device according to claim 26, wherein, The current is adjustable up to 10mA, the operating frequency is 0Hz to 100kHz, and the pulse train repetition frequency is 0Hz to 50Hz.

28. A DC signal output control device, comprising: The system comprises a control module, a DC signal generation module, a first working electrode, a second working electrode, and a ground electrode, wherein the ground electrode is connected to the first output terminal of the DC signal generation module. One end of the second active electrode is connected to the second output terminal of the DC signal generation module, and the other end of the second active electrode contacts the target area. The control module controls the DC signal generation module to generate a DC current signal and provides the DC current signal to the second active electrode, so that the second active electrode applies the DC current signal to the target area. In response to the output duration of the DC current signal being greater than or equal to a first threshold, and / or the effect of the DC current signal on the target area being less than expected, the second output terminal is connected to the first action electrode, the other end of the first action electrode is spaced apart from the target area by a first distance, the control module controls the DC signal generation module to generate a DC voltage signal, and provides the DC voltage signal to the first action electrode, so that the first action electrode outputs plasma to act on the target area.

29. The DC signal output control device according to claim 28, further comprising: An impedance detection module is used to detect human body impedance when the second output terminal is connected to the second active electrode. The switching module and / or output module, wherein the control module determines whether there is an indication based on the change in the human body impedance value, and if it determines that there is no indication, instructs the switching module to connect the second output terminal to the first active electrode, or controls the output module to output a first prompt message, the first prompt message being used to prompt the switching of the active electrode currently connected to the DC signal generation module.

30. The DC signal output control device according to claim 29, wherein, The target area is the eye, which includes at least one of the eyelid, palpebral margin, conjunctiva, and sclera. The DC signal output control device is used to treat dry eye syndrome. In response to the decrease in human body impedance falling below a third threshold during a first output duration of the DC current signal, the control module adjusts the output parameters of the DC current signal to increase the output power. In response to the decrease in human body impedance being less than a fourth threshold during a subsequent second output duration of the DC current signal, the control module instructs the switching module to connect the second output terminal to the first active electrode, or controls the output module to output the first prompt information.

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