Direct-current electrical signal output control apparatus

Abstract

The present disclosure relates to a direct-current electrical signal output control apparatus and a beauty treatment method. The direct-current electrical signal output control apparatus comprises a control module and a direct-current electrical signal generation module. The control module is configured to: if the direct-current electrical signal generation module is connected to a first-type output module, control the direct-current electrical signal generation module to generate a direct-current voltage signal, and provide the direct-current voltage signal to the first-type output module, so that a first active electrode in the first-type output module outputs plasma to act on a first site; if the direct-current electrical signal generation module is connected to a second-type output module, control the direct-current electrical signal generation module to generate a direct current signal, and provide the direct current signal to the second-type output module, so that a second active electrode in the second-type output module applies the direct current signal to a second site. Thus, the present invention has a wider application range and can be used in a variety of scenarios.

Description

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 Technology

[0003] Plasma discharge technology is not new. The basic electrical principles have been used in medicine and healthcare for many years. Medical applications based on electrical technology and standardized electrocoagulation are even more widespread. It allows electrical energy to be converted into heat energy for dissociation and coagulation, and has applications in many different fields. This type of direct current electric field is also used in the beauty industry, believed to help improve the metabolism of skin surface cells.

[0004] Electrostimulation is a technique that uses electrical current to stimulate biological tissues to produce specific physiological responses. It is widely used in fields such as medicine, sports rehabilitation, and beauty.

[0005] Existing electrical stimulation devices typically utilize direct current to achieve various therapeutic purposes, covering areas including:

[0006] 1. Gynecological applications: vaginal rejuvenation, urinary incontinence treatment, mucosal regeneration (e.g., patents CZ306263B6, WO2020057676A1). The device applies a stable direct current to the vaginal mucosa, improving blood circulation and promoting tissue regeneration. It includes a portable device with electrodes, which enhances vaginal mucosal elasticity and health through electrical pulse stimulation.

[0007] 2. Skin electrocautery and drying: The device used 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 by means of electric current.

[0009] Existing patents show that direct current has a wide range of applications 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] Currently available 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 conditions, the membrane potential is approximately -70 mV (in the resting state of most cells). An external electric field can artificially alter the membrane potential, affecting ion channel behavior. The cell membrane, as an insulator, separates the charges inside and outside the cell; in the resting state, the intracellular charge is negatively charged than the extracellular charge, primarily due to Na+. + / K + Pump (actively transports 3 Na) + Emergence, 2 K + (Ion entry into cells) and the selective permeability of the membrane to specific ions are maintained. 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 (such as depolarization from -70mV to -55mV) can open sodium ion channels, triggering action potentials (such as in nerve cells). Electric current can simulate natural nerve or muscle impulses.

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

[0014] Temporary membrane disruption – electroporation: High-intensity, short-pulse currents can temporarily disrupt membrane structures, allowing macromolecules to pass through. Electroporation technology is used in gene editing (DNA delivery) and tumor chemotherapy (enhancing drug permeability). After the pulse ends, the membrane usually repairs itself, allowing macromolecules to enter during the process. Summary of the Invention

[0015] This 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 that acts on a first portion. 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 being respectively connected to two output terminals of the DC signal generation module, and the application surface of the first active electrode being spaced apart from the first portion by a first distance. The first grounding electrode establishes a conductive path with other parts besides 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, 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 grounding electrode. The second active electrode and the second grounding 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 grounding electrode establishes a conductive path with other parts besides 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, and the control module determines whether the second type of output module forms a circuit 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 circuit with the human body.

[0018] Optionally, the DC signal output control device can treat at least one of the following conditions or achieve 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.

[0019] Optionally, the DC signal output control device can treat at least one of the following conditions or achieve at least one of the following therapeutic purposes by outputting plasma: blepharitis, dry eye syndrome, ptosis, entropion, xanthelasma palpebrae, conjunctival laxity, periocular cosmetic surgery, 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, blepharitis, blepharitis, multidrug treatment for pet conjunctivitis secondary to glaucoma, 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, 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 whose direction and intensity remain unchanged. The single-pulse DC current signal is a current whose direction remains unchanged but whose intensity changes 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. The 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, 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.

[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, 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.

[0026] Optionally, the DC signal output control device further includes: 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.

[0027] Optionally, the second active electrode includes a first probe for gynecological treatment, the first probe including a gripping portion and an insertion portion, the insertion portion being designed for insertion into the vagina.

[0028] Optionally, the second functional 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 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.

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

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

[0034] The frequency ranges from 0 Hz to 1 MHz.

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

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

[0037] The frequency ranges from 0 Hz to 100 kHz.

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

[0039] Optionally, the first distance is 0.1 mm to 5 mm.

[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 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.

[0043] Optionally, the second part 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. 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. 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 human body impedance based on the following formula: Z = R + X

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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 acting electrode, a second acting 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 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.

[0049] 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 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.

[0050] 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 active electrode, or controls the output module to output the first prompt information.

[0051] This disclosure can output plasma or DC current signals to act on specific parts as needed, thus having a wider range of applications. Attached Figure Description

[0052] The above and other objects, features and advantages of this disclosure will become more apparent from the more detailed description of exemplary embodiments thereof taken in conjunction with the accompanying drawings, wherein like reference numerals generally denote like parts.

[0053] Figure 1 shows a schematic diagram of a DC signal output control device according to an embodiment of the present disclosure.

[0054] Figure 2A shows a schematic diagram of treating conjunctival laxity using plasma output mode.

[0055] Figure 2B shows a schematic diagram of the treatment marks after treatment.

[0056] Figure 3 shows a schematic diagram of the correspondence between the first output gear and the first distance.

[0057] Figure 4 shows a schematic diagram of a dual-pulse mode.

[0058] Figure 5 shows a schematic diagram of some combined output methods.

[0059] Figure 6 shows several schematic diagrams of the second working electrode.

[0060] Figure 7 shows a schematic diagram of a second working electrode suitable for gynecological use.

[0061] Figure 8 shows another schematic diagram of the structure of the second working electrode suitable for gynecological use.

[0062] Figure 9 shows a schematic diagram of the structure when the second working electrode acts on the cervical mucosa.

[0063] Figures 10 to 12 show schematic diagrams of the application surface of the second working electrode used for cervical mucosal body treatment.

[0064] Figure 13 shows a schematic diagram of the application surface of the second working electrode used for peri-mucosal treatment of the cervix.

[0065] Figure 14 shows a schematic diagram of the second working electrode acting on the vagina.

[0066] Figure 15 shows another schematic diagram of the structure of the second working electrode.

[0067] Figure 16 shows a schematic diagram of a DC signal output control device according to another embodiment of the present disclosure.

[0068] Figure 17 shows a schematic diagram of the impedance power curves at different speeds.

[0069] Figure 18 shows a schematic diagram of the correspondence between the second output setting and human body impedance.

[0070] Figure 19 shows a schematic flowchart of a cosmetic method according to an embodiment of the present disclosure.

[0071] Figure 20 shows a schematic flowchart of a cosmetic method according to another embodiment of the present disclosure.

[0072] Figure 21 shows a schematic flowchart of a cosmetic method according to another embodiment of the present disclosure.

[0073] Figure 22 shows a schematic diagram of the hardware structure of a DC signal output control device according to an embodiment of the present disclosure. Detailed Implementation

[0074] Preferred embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While preferred embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that the present disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0075] Those skilled in the art will understand that the terms "first," "second," etc., in this disclosure are used to distinguish similar objects, rather than to describe a specific order or sequence, and do not have any additional limiting effect.

[0076] Figure 1 shows a schematic diagram of a DC signal output control device according to an embodiment of the present disclosure.

[0077] As shown in Figure 1, the DC signal output control device includes a control module 110 and a DC signal generation module 120.

[0078] The DC signal generation module 120 is connected to the control module 110 and generates DC signals under the control of the control module 110. The DC signals include DC voltage signals and DC current signals.

[0079] 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 DC voltage signals or DC current signals with specific parameters within a specific time period as needed.

[0080] The DC signal generation module 120 can be connected to either a first-type output module or a second-type output module. The 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 both a first-type and a second-type output module.

[0081] 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 single 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. Among them, the first working electrode 131 does not contact the human tissue 210, while the second working electrode 132 and the ground electrode 133 contact the human tissue. It should be understood that the contact mentioned in this disclosure includes both direct contact 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 (such as conductive gel). That is to say, contact with human tissue can refer to either direct contact or indirect contact.

[0082] The DC signal generation module 120 has two output terminals, namely a positive output terminal and a negative output terminal. The first active electrode 131 and the second active 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.

[0083] In some embodiments, the first working electrode 131 and the second working electrode 132 are both negative electrodes, adapted to be connected 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, adapted to be connected to the positive output terminal of the DC signal generation module 120.

[0084] The front end of the first active electrode 131 is a discharge tip, used to output plasma to act on the first site without close contact. That is, the discharge tip of the first active electrode 131 is spaced apart from the first site by a first distance. The first distance can be a small value (i.e., close distance). For example, the first distance can be 0.1 mm to 5 mm. The first grounding electrode, while connecting to another output terminal (e.g., the positive terminal) of the DC signal generation module, also establishes a conductive path with other sites besides the first site. That is, the first grounding electrode can contact the skin of other locations on the patient besides the first site. In this disclosure, a site (e.g., the first site, the second site) refers to a body part of a living organism (such as a human or pet). Taking a human as an example, a site can refer to human tissue.

[0085] The front end of the second active electrode 132 is an application surface (e.g., a treatment surface) adapted to the shape of the second site. The shape of the application surface may include, but is not limited to, a flat, pointed, spherical, or ellipsoidal shape. The second active electrode 132 is used to output a direct current signal to the second site when in contact with it (e.g., the treatment site). That is, the application surface of the second active electrode establishes a conductive path with the second site. The second grounding electrode can contact other sites besides the second site, such as the skin at other locations. For example, the second grounding electrode can be contacted via hand-held contact or a patient body patch. Furthermore, the first and second sites mentioned above can be the same site or different sites.

[0086] For the same type of active electrode, 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 tip of the first active electrode is made of gold. The tip of the second active electrode is made of a metal material (e.g., stainless steel, aluminum alloy, etc.).

[0087] 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, which is then provided to the first type of output module, causing the first active electrode 131 in the first type of output module to output plasma that acts on the first part. 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 active electrode 131) and the first part. Continuously outputting plasma allows a certain current to be transmitted between the first active electrode and the first part; 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.

[0088] 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 provide 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 may be ≤10mA; and / or the pulse width is 0ms–1000ms; and / or the frequency is 0Hz–100kHz. More preferably, the frequency may be 10Hz–50Hz. Referring to the following description of the DC current signal, the DC current signal in this disclosure may 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 may be ≤10mA (e.g., 0.1mA to 10mA), and the corresponding voltage signal may be, for example, between 0.01V and 10V. The frequency mentioned herein may also be referred to as the pulse train repetition frequency, pulse repetition frequency, or pulse frequency, which characterizes the number of pulsed DC current signals output per unit time. The pulse train repetition frequency is equal to 1 / pulse duty cycle. Wherein, the pulse duty cycle is equal to the pulse width (pulse duration, i.e., effective working time) + pulse interval (idle time). For example, the pulse train repetition frequency may be 0Hz to 100Hz, more preferably, for example, 0Hz to 50Hz.

[0089] Furthermore, the DC signal output control device also involves the concept of operating frequency. Operating frequency is the ratio of the total number of operations to a unit of time (e.g., 1 second), measured in Hz. The total number of operations refers to the number of times the output signal (e.g., a DC current signal) occurs. The operating frequency can be determined according to the treatment plan. Operating frequency can affect the energy characteristics of the output signal and tissue penetration, among other things. The operating frequency can be set according to the required tissue thickness to be penetrated. For example, the operating frequency is 0Hz to 1000kHz, and more preferably, for example, 0Hz to 100Hz.

[0090] Therefore, the DC signal output control device of this disclosure can provide two output modes: plasma output mode and DC current output mode. These two output modes can be used selectively or in combination. Combined use refers to applying plasma and DC current signals to the same site at different times during a complete treatment process to address the same symptom or achieve the same purpose. That is, plasma and DC current signals can be applied to the same site at different times under the influence of different electrodes.

[0091] The following is a further explanation of the details involved in this disclosure.

[0092] I. Plasma Output Mode

[0093] 1) Mechanism of action

[0094] Plasma is the fourth state of matter, a state of matter composed of ionized gas. Plasma stimulates the formation of new collagen and elastin fibers, thereby reducing tissue inflammation and offering many other benefits.

[0095] The continuous plasma output mode allows current to conduct within a range of 1 to 4 millimeters from the skin or mucous membrane. This mode generates a highly concentrated plasma flame that penetrates tissue, effectively eliminating squamous metaplasia and scar tissue obstructing the meibomian gland openings.

[0096] The biological effects of plasma arise from complex mechanisms. The effects that plasma can produce (including biological and physical effects) may include, but are not limited to, the effects listed below.

[0097] Controlled heating effect (Joule heating)

[0098] Instantaneous heat is generated between the micro-discharge channel and the adjacent surface tissue to achieve superficial coagulation / hemostasis or stratum corneum modification.

[0099] 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 greater stability and precision, and provides a finer ablation area than plasma generated by alternating current. Therefore, the plasma output mode of this disclosure meets the need for precise treatment using the thermal effects of plasma.

[0100] 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.

[0101] Reactive Oxygen and Nitrogen Species (RONS) Effect

[0102] Plasma can generate O3 (ozone) and NO in air / air gap. x (nitrogen oxides), ·OH (hydroxyl radicals) 1 Reactive particles such as O2 (singlet oxygen) 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.

[0103] Electric field and charge interaction

[0104] An applied electric field and directional charge flow cause transient changes in the transmembrane potential of the cell membrane (depolarization / repolarization), which can regulate the activity of keratinocytes, fibroblasts, and other cells, as well as paracrine signals.

[0105] During plasma output, a directional electric field exists between the tip and the first part of the first active electrode. This directional electric field alters the ion distribution and transmembrane potential across the cell membrane, inducing cell membrane polarization. This change in cell membrane polarization allows for the exchange of substances within the cell. Specifically, a resting 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. Plasma output modes can stimulate and improve this process.

[0106] Stimulate metabolism

[0107] Plasma can stimulate skin metabolism and activate keratinocytes, thereby improving skin appearance. However, this technology works very superficially on the skin's surface and can be used without disrupting the skin's protective barrier, making it suitable for non-medical professionals such as estheticians. Plasma can also generate temperature changes at deeper cellular levels, triggering cellular metabolism and initiating internal processes such as catalyzing chemical reactions.

[0108] Adjunctive drug / active ingredient delivery

[0109] Plasma can alter the permeability of the skin's 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.

[0110] 2) Indications

[0111] Based on the aforementioned mechanism of action of plasma output mode, plasma output mode can be used to treat a variety of diseases. The following provides illustrative examples of some typical indications for plasma output mode.

[0112] ① Ophthalmology

[0113] Plasma output mode can reduce eyelid flora, kill bacteria and mites, and reduce inflammation and biological burden, making it suitable for blepharitis. However, its application is not limited to this. In some specific treatment plans, direct current discharge can be combined with plasma discharge. Furthermore, this output method combining direct current discharge and plasma discharge has also shown efficacy in other conditions, such as minimally invasive ophthalmic plastic surgery, periorbital and facial rejuvenation, and ablation surgery.

[0114] Therefore, plasma is suitable for treating ophthalmic conditions including but not limited to blepharitis, ptosis, entropion, xanthelasma, conjunctivochalasis, periocular cosmetic procedures (such as crow's feet, eye bags, etc.), blepharoplasty, etc.

[0115] The following example illustrates the process of treating conjunctival laxity and upper eyelid lift using plasma output mode. It should be understood that the procedures described below can also be used to treat other similar conditions.

[0116] Conjunctival laxity

[0117] Figure 2A shows a schematic diagram of treating conjunctival laxity using plasma output mode.

[0118] 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 1 mm to 4 mm above the surface of the palpebral conjunctiva to ablate the loose conjunctival tissue.

[0119] Figure 2B shows a schematic diagram of the treatment marks after treatment.

[0120] Referring to Figure 2B, treatment marks caused by plasma stimulation can be observed on the palpebral conjunctiva.

[0121] In this embodiment, the application surface of the first active electrode is made of gold. Preferably, during treatment, the first active 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 points of extraocular muscles.

[0122] upper eyelid lift

[0123] First, preoperative preparations can be performed. These 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 as the primary electrode; and selecting from 1 to 8 operating levels (see below for details on the levels).

[0124] After preparation, place the first active electrode 0.1mm to 4mm above the treatment area and slowly apply it using a dotted method. The dotted method involves placing the first active electrode at different points and treating each point sequentially. Under the influence of the plasma emitted by the first active electrode, the tissue at the treatment area will coagulate, carbonize, and keratinize.

[0125] After plasma therapy, drug spray can be used for interventional treatment.

[0126] Finally, a gentle massage can be performed, and treatment parameters should be recorded.

[0127] Plasma in alternating current mode cannot form a continuous output. The plasma output mode disclosed herein is direct current mode, which can form a continuous output. In upper eyelid lifting treatment, continuous scanning plus single-point scanning can be performed within the target area.

[0128] Continuous scanning refers to starting the scan from a point approximately 0.1mm to 10mm from the inner corner of the eye, gently contacting the second active electrode with the skin at an angle of 45° to 60°. This angle ensures that the plasma energy is applied evenly and effectively to the skin tissue, avoiding excessive energy concentration or dispersion. Following a pre-designed scanning path, the scan proceeds slowly and smoothly from the starting point along the contour of the upper eyelid towards the outer corner. The scanning path is a slightly upward-curving arc or zigzag line, conforming to the natural physiological curve of the upper eyelid to ensure uniform plasma energy application across the entire upper eyelid area. The scanning speed is controlled at 1mm to 2mm per second, a speed that allows the plasma energy to fully penetrate the skin tissue without causing excessive damage. During the scan, the contact pressure between the second active electrode and the skin is kept uniform, avoiding electrode jitter or excessive pressure.

[0129] Single-point scanning refers to identifying N single-point locations at the junction of the upper eyelid and the outer corner of the eyebrow, and below the brow tail. The second active electrode is vertically aligned with each point, gently touching the skin surface or maintaining a distance of 0.1mm to 10mm. Plasma energy is applied to each point for 1 to 5 seconds, with a plasma output power of 0.1W to 5W. During this single-point application, the second active electrode is kept stable to ensure the plasma energy is concentrated on the target location, stimulating the skin tissue and promoting collagen regeneration and fibrous tissue contraction, thereby achieving a better lifting effect.

[0130] Furthermore, the plasma output mode can also be used to selectively thermally coagulate the lacrimal punctum openings of the upper and lower eyelids, partially or completely closing them, thereby reducing tear drainage through the lacrimal ducts and prolonging the retention time of the tear film on the corneal and conjunctival surfaces. This is a form of lacrimal punctum occlusion, commonly used to treat 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 treat related conditions, such as dry eye syndrome.

[0131] This concludes the illustrative explanation of the indications for plasma output modes in ophthalmology.

[0132] The application of plasma output modes in ophthalmology 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 a cornerstone for the comprehensive treatment of various ocular, periocular, and facial aesthetic conditions, marking a milestone in modern ophthalmology and periocular and facial cosmetic medicine.

[0133] ② Beauty industry

[0134] In the field of cosmetic dermatology, plasma influences cellular biochemical processes, tissue regeneration, wound scab formation, reduction of elastic fibers, scar treatment, and the treatment of wrinkles, age spots, and signs of aging. Furthermore, it can be applied to other treatment scenarios, such as hyperhidrosis and cellulite.

[0135] 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 primarily composed of keratinocytes. The interaction between these cells and the plasma is crucial. The plasma output mode operates continuously at the same energy level using direct current, generating ions under the influence of an electric field. These ions can cross the cell membrane and be released, thereby altering cell membrane permeability. Improvements in skin quality can be observed during this process.

[0136] Plasma is a state of matter composed of ionized gas with a specific radiation frequency. It can be used in blepharoplasty, reducing benign tumors, and removing epidermal lesions. Depending on the treatment, using active ingredients can yield better results.

[0137] The inventors of this disclosure have also experimentally verified the accuracy of infrared thermal imagers in detecting temperature increases in skin areas after plasma application. Analysis of patients showed an average local temperature increase of 2.4°C above the application site. These results can quantitatively determine the temperature increase and indicate the potential for skin regeneration, wrinkle reduction, and stimulation of biosensors through plasma therapy.

[0138] When using plasma output modes for cosmetic purposes, micro-plasma can generate relatively low temperatures that act on the epidermis. This technology generates heat by allowing charged particles to penetrate the target tissue area. The heat generation causes the dermal tissue to strengthen, starting with the immediate contraction and denaturation of collagen fibers. Over a period of time, new collagen is formed.

[0139] For example, the indications for plasma output mode in the field of beauty 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.

[0140] ③ Benign tumors, genital warts

[0141] The plasma output mode can also be used to treat benign tumors and vulvar condyloma acuminata.

[0142] The benign tumors that can be treated by plasma output mode include, but are not limited to, seborrheic keratosis, milia, squamous cell papilloma, and basal cell papilloma.

[0143] Genital warts, also known as condyloma acuminata, are a very common sexually transmitted disease. Clinically observed genital warts represent only a small fraction of HPV infections. More than 20 HPV subtypes are associated with genital warts, with types 6 and 11 being the most common causes.

[0144] When treating genital warts using plasma output mode, the use of plasma follows the principle of electrocautery, involving the application of electrical energy in the form of a 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 genital warts, especially on the vulva. However, it is not recommended for large lesions as it may cause permanent scarring. The use of energy on the skin or mucous membranes requires randomization and trial control to produce a high clearance rate (e.g., 94%).

[0145] 3) Output parameters

[0146] Under the condition that the first grounding electrode is in complete contact with the human tissue and the first active electrode is at a distance d (i.e., the first distance mentioned above) from the tissue without contact, the control module controls the DC signal generation module to establish a high potential difference Uo between the first active electrode and the first grounding electrode. When the air gap electric field strength E=Uo / d≥3kV / mm between the first active electrode and the first part is broken down and ionized, cold plasma (containing electrons, ions and active neutral particles) characterized by micro-discharge is generated.

[0147] 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.

[0148] The first ground 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.

[0149] 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).

[0150] The output energy value in 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 with an energy output value and corresponding to a distance range. The equipment operator can select the matching level according to the distance between the application surface of the first working electrode and the first part to output appropriate energy.

[0151] In plasma output mode, a large amount of energy is instantly generated on the human body surface, causing single-point damage. Therefore, it is necessary to use cold spray technology to repair the patient's epidermis after plasma treatment. The plasma output instantly damages the human epidermis; the addition of cold spray technology at this time can effectively reduce the residual temperature of the epidermis, protecting it from excessive damage, reducing pain during treatment, and providing a good guarantee for subsequent repair.

[0152] II. DC Current Output Mode

[0153] 1) Loop detection

[0154] The DC output mode outputs a 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, this disclosure proposes that the DC signal output control device may further include an impedance detection module, which is used to automatically determine whether a circuit has been formed with the human body.

[0155] 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 loop with the human body, and if it determines that the second type of output module forms a loop with the human body, it controls the DC signal generation module to generate a DC current signal.

[0156] In some exemplary embodiments, the impedance detection module can acquire impedance values ​​between the positive and negative electrodes (i.e., the second working electrode and the second ground electrode) at predetermined time intervals (e.g., 0.2s) at different frequencies. At each acquisition moment, the frequency of the electrical stimulation (i.e., the output DC current signal) is linearly swept from 0.5kHz to 5kHz, with each frequency change step being 0.1kHz, and the corresponding impedance value is recorded. A total of 10 sets of data are acquired, each set containing 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 data, for example, by using a median filtering algorithm to remove outliers. Then, the average and standard deviation of the impedance values ​​at different frequencies in each set of data are calculated. Based on these statistical parameters, a curve of impedance versus frequency is constructed. Through observation and analysis of the curve, it is found that the impedance curve exhibits a relatively stable trend within the normal frequency range, and the average and standard deviation are both within the preset impedance range of normal electrode contact. The processed impedance characteristics are compared with preset judgment criteria. Since the impedance value and its variation characteristics meet the standard for normal contact, it can be determined that the positive and negative electrodes are in complete contact at the application site on the human body, and the DC output mode can proceed 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 application site on the human body, the display and alarm module can display the message "Electrode contact is good" on the display screen, and no alarm signal will be issued.

[0157] 2) Mechanism of action of pulsed direct current stimulation

[0158] Existing electrical stimulation devices typically use a constant direct current with unchanged direction and intensity to achieve the corresponding therapeutic purpose.

[0159] 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 whose direction remains constant and whose intensity varies with time. It should be understood that the DC signal generation module can also generate a constant DC current signal in the DC current output mode.

[0160] Furthermore, the terms "pulse," "oscillation," and "pulsation" used in this disclosure are used interchangeably. That is, pulsed direct current can also be called oscillating direct current or pulsating direct current. Additionally, "low-frequency pulsed direct current" as used in this disclosure refers to pulsed direct current with a relatively low frequency; for example, pulsed direct current with a frequency between 0.1 Hz and 300 Hz can be called low-frequency pulsed direct current. Exemplarily, the current intensity of low-frequency pulsed direct current can fluctuate periodically and with low amplitude within a small range. For example, the reference current intensity fluctuation of low-frequency pulsed direct current can be between ±5% and ±20%, and the duration of a single oscillation can be between 10 ms and 1000 ms.

[0161] For an explanation of the mechanism of action of constant direct current, please refer to the description in the background section.

[0162] The mechanism of action of pulsed direct current stimulation is described in detail below.

[0163] After in-depth research, the inventors of this disclosure discovered several significant differences between pulsed direct current (e.g., low-frequency pulsed direct current) and constant direct current.

[0164] A constant direct current signal provides a continuous unidirectional flow of charge. Due to this continuous current flow, 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, while acidic products (HCl) are produced 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. In other words, a constant direct current can cause electrolytic decomposition, ion formation, and pH changes, thereby potentially damaging cells and tissues.

[0165] 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.

[0166] 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, promoting better exchange of nutrients and waste products.

[0167] The electric field generated by pulsed direct current is a dynamic electric field with a constant direction but dynamically changing intensity. This dynamic electric field can promote cell activity and tissue regeneration, improve the transport of nutrients and waste products across the cell membrane, and activate various intracellular signaling pathways, promoting cell growth and division. It also stimulates cells to produce growth factors, such as IGF-1, which is crucial for tissue regeneration and improves microcirculation within tissues, increasing the supply of oxygen and nutrients.

[0168] Proteins such as Wnt, Notch, and Hedgehog are part of signaling pathways that regulate cell proliferation and differentiation. These molecules play crucial roles in embryonic development and maintaining tissue homeostasis. Important proteins affecting 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 transition 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 a signaling cascade that leads to cell proliferation. Proteins like p53 and Rb (retinoblastoma protein) regulate the cell cycle, preventing uncontrolled cell proliferation. When DNA is damaged, these proteins can stop the cell cycle, initiating DNA repair or apoptosis.

[0169] On the other hand, a constant direct current without oscillation causes more pronounced electrolytic decomposition, leading to ion formation and pH changes, which can damage cells and tissues. A constant current cannot provide the same dynamic stimulation for cellular processes as an oscillating current. Therefore, DC oscillations can more effectively influence cell proliferation and differentiation by activating membrane transport and altering gene expression.

[0170] The fundamental process occurring 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 crucial role, and monitoring thermal effects to avoid thermal damage to the battery is also important.

[0171] The hydrophobic lipid bilayer of the plasma membrane can be viewed as a simple capacitor, storing charge and acting 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. They then diffuse within and around the cell, causing the cathode-facing side 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 membrane’s dielectric strength (typically around 500 mV), the membrane undergoes osmosis, leading to the formation of hydrophobic pores that allow water movement and restrict ion flow. With increasing field time, the destabilized 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 duration of 0.05 ms, while for DNA transfection with the same field strength, the pulse duration 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.

[0172] Direct current oscillation helps clear damaged cells and initiate programmed cell death—apoptosis. Because damaged or infected cells are more sensitive to external influences, they are preferentially eliminated, giving healthy cells with full regenerative potential the opportunity to replace them in infected or damaged tissue. This process is crucial for maintaining tissue health and preventing cancer. The oscillating electric field activates signaling pathways, leading to apoptosis of damaged cells, thus ensuring their effective clearance.

[0173] Direct current oscillations have a significant impact on pathogens and infections, which is crucial for combating various infectious diseases. This effect is caused by several mechanisms induced by the oscillating electric field. One of the main mechanisms is the disruption of pathogen cell membranes. The oscillating electric field also causes changes in membrane polarization, leading to membrane instability and thus disrupting cell integrity. This process results in the dissolution (decomposition) of pathogen cells, an effective method for eliminating infectious agents from the body.

[0174] Another important mechanism is the induction of apoptosis in damaged or infected cells. Oscillating direct current activates signaling pathways that lead to apoptosis, thereby ensuring the effective clearance 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.

[0175] The oscillation of direct current can 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.

[0176] Furthermore, oscillating electric fields can influence 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.

[0177] In summary, DC oscillation is a promising approach to combating pathogens and infections. This technique offers several advantages, including the ability to disrupt pathogen cell membranes, induce apoptosis in damaged cells, improve the microenvironment, and promote immune responses.

[0178] 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 influence cellular processes and contributing to a better understanding and utilization of these techniques in medicine. Low-frequency direct current oscillations, through slight intensity fluctuations, reduce the risk of continuous stimulation by constant direct current, minimizing the risk of tissue damage while maintaining a moderate permeation-promoting effect on biological barriers.

[0179] 3) Types of pulsed DC current signals

[0180] Pulsed DC current signals include single-pulse DC current signals and multi-pulse DC current signals.

[0181] The output waveform of a single-pulse DC mode can include, but is not limited to, square wave, spike wave, triangle wave, sine wave, exponential wave, sawtooth wave, 0 amplitude wave, 1 amplitude wave, star wave, circular wave, and trapezoidal wave.

[0182] Compared to constant direct current signals, single-pulse direct current signals break down direct current into short pulses and intervals, for example, each pulse lasting on the order of microseconds, with pauses between pulses (duty cycle <100%). Due to these "off" intervals, the continuous electrolytic effect is significantly reduced, thus minimizing chemical stimulation to tissues. Furthermore, single-pulse direct current signals accumulate charge within each pulse sequence, exhibiting a polarity effect. Under the influence of directional current forms such as direct current or single-pulse direct current, the fixed direction of the current causes different physical, chemical, or biological effects in the anodic and cathodic regions of the medium through which the current flows (such as biological tissue, electrolyte solutions, etc.). This asymmetric effect caused by the difference in current polarity (direction) is called the polarity effect.

[0183] In short, a constant direct current signal has a fixed polarity, generating a continuous electric field and significant chemical effects. Simulating the intrinsic electric field of a wound can induce effects such as electrochemoattraction and electrophoresis, but prolonged high current may irritate tissues. A single-pulse direct current signal is an intermittent current pulse with the same polarity, but because the pulse interval avoids charge accumulation, its chemical effects are minimal. By adjusting the frequency and duty cycle, both therapeutic efficacy and safety can be balanced, improving patient tolerance.

[0184] A multi-pulse DC current signal is a current obtained by superimposing at least two currents with equal amplitudes but different frequencies. Multi-pulse modes include a double-pulse mode. A double-pulse mode is a current obtained by superimposing two currents with equal amplitudes but different frequencies. Figure 4 shows a schematic diagram of a double-pulse mode.

[0185] As shown in Figure 4, the dual-pulse mode can be obtained by superimposing a low-frequency current with an intermediate-frequency current of equal amplitude. The low-frequency current can refer to a current with a frequency of 0–1000 Hz, and the intermediate-frequency current can refer to a current with a frequency of 1 kHz–1 MHz. Superimposing the low-frequency current with an intermediate-frequency current of equal amplitude is essentially amplitude modulation of the intermediate-frequency current using the low-frequency current.

[0186] The dual-pulse mode can be viewed as a weighted dual-pulse mode of a mid-frequency current modulated by a low-frequency current. The modulated dual-pulse mode contains both mid-frequency and low-frequency electrical components. Therefore, the dual-pulse mode belongs to the mid-to-low frequency current category. The electrical stimulation effect of the dual-pulse mode avoids the drawbacks of low-frequency current, which only acts on the skin surface, causing significant skin irritation and electrolysis. Simultaneously, the impedance of human tissues decreases significantly in the mid-to-low frequency mode, resulting in more stable output, no electrolysis, better muscle treatment effects, and less patient 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 time, the nervous system and muscle tissue gradually adapt to this stimulation signal, the therapeutic indication gradually weakens, and even requires continuously increasing stimulation intensity to achieve the initial effect. The dual-pulse mode avoids the shortcomings of a single stimulation mode, thereby reducing patient adaptation.

[0187] 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 during a first time period, and controls the current generation module 120 to generate a second-mode DC current signal during a second time period. Each output process includes at least one first time period and at least one second time period. The first-mode and second-mode DC current signals are derived 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 site at different time periods during an output process, the same site can receive different electrical stimulation effects, thus supporting the improvement of the final therapeutic effect.

[0188] 4) Combined output method

[0189] 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 site. 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 length can be set according to the treatment needs.

[0190] Figure 5 shows a schematic diagram of some combined output methods.

[0191] In Figure 5, the horizontal axis represents time, and the vertical axis represents current amplitude. As shown in Figure 5, the combined outputs include: 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.

[0192] The dual-pulse + single-pulse combined output method refers to the alternating output of single-pulse DC current signals and dual-pulse DC current signals, allowing these two signals to act alternately on the same area. This method offers at least the following advantages: 1) Flexible energy output adjustment: Single pulses provide a high-energy instantaneous impact, while multi-pulses output at lower energy and higher frequency, suitable for gentle, continuous stimulation of tissues. Combining the two allows for flexible adjustment of the energy output according to treatment needs. For example, during treatment, single pulses can be used for initial high-intensity treatment, followed by multi-pulses for subsequent consolidation and conditioning, optimizing the treatment effect. 2) Reduced risk of tissue damage: The high energy of single pulses may pose a certain risk of tissue damage, but the low energy and multiple stimulation methods of multi-pulses can mitigate this risk to some extent. Multiple gentle stimulations from multi-pulses help tissues adapt to energy changes, promoting tissue self-repair and adjustment. In some physical therapies, single pulses can be used initially for necessary treatment, but to avoid excessive damage, multi-pulses are used subsequently for restorative stimulation, ensuring treatment effectiveness while reducing the risk of tissue damage and improving treatment safety and comfort.

[0193] The dual-pulse + constant DC combined output method refers to the alternating output of dual-pulse DC current signals and constant DC current signals, allowing these two signals to act alternately on the same area. This method offers at least the following advantages: 1) Promotes tissue repair and regeneration: The DC energy in the DC mode provides continuous energy support to tissues (such as the treatment area), helping to maintain normal cell metabolism and physiological functions. The dual-pulse energy in the dual-pulse mode can activate cell activity and promote cell division and proliferation through frequent pulse stimulation. 2) Improves the uniformity of treatment effects: While the DC energy of a single-pulse DC current signal is relatively uniformly distributed in the tissue, the energy intensity may decrease with depth. The multi-pulse energy in the multi-pulse mode 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 more uniform throughout the treatment area. Furthermore, DC energy can improve skin texture overall, while multi-pulse energy can provide supplementary treatment for skin problems at different levels, ensuring better improvement across all skin layers and enhancing the uniformity of treatment effects.

[0194] The single-pulse + constant DC combined output mode refers to the alternating output of single-pulse DC current signals and constant DC current signals, allowing these two signals to act alternately on the same site. This mode offers at least the following advantages: 1) Enhanced treatment depth: DC energy in DC mode has strong penetrability, reaching deep into tissues and providing continuous energy. The single-pulse DC energy in single-pulse mode can deliver an additional high-energy impact at specific moments, further enhancing the effect on deep lesions on top of the DC energy, allowing the treatment energy to reach deeper tissues more effectively, increasing the depth and intensity of treatment. 2) Optimized treatment precision: DC energy in DC mode provides a stable basic energy field, keeping tissues in a relatively stable energy state. The single-pulse DC energy in single-pulse mode can be precisely released at specific locations and times according to the specific condition of the lesion, achieving a "targeted strike." DC mode maintains a certain level of nerve excitability, while single-pulse DC mode can precisely stimulate specific nerve fibers, improving treatment precision and better regulating nerve function.

[0195] When outputting a combination of at least two current modes, the output can be continuous or intermittent. Continuous output means that the current is output without interruption. For example, referring to the dual-pulse + constant DC combined output method in Figure 5, a constant DC current signal is output immediately after the dual-pulse DC signal output ends, without any interruption. Intermittent output means that the current is not continuously present during an output process, but rather there is a set interval during which the current is not output. The specific interval duration can be flexibly adjusted as needed. For example, referring to the dual-pulse + single-pulse combined output method in Figure 5, after the first output of the dual-pulse and single-pulse combination, the dual-pulse and single-pulse combination can be output again after a certain interval, and the interval duration can be increased.

[0196] The intermittent output setting is primarily based on the following considerations: 1) Adapting to different tissue characteristics: Different tissues absorb and respond to energy differently. 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 adjustable energy for different locations and tissues, accurately matching treatment needs. 2) Reducing tissue damage: The intermittent 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 varying tolerance and responses to energy therapy. The intermittent output mode allows doctors to make personalized adjustments based on the patient's specific situation. 4) Reducing the risk of adverse reactions: By precisely setting the time interval of the intermittent output, adverse reactions caused by excessively high energy or excessively long application time can be avoided.

[0197] Different types of currents elicit different biological responses in tissue cells, thus having different applications. For example, typical applications of direct current stimulation include microcurrent wound treatment, iontophoresis / electroporation, and transcranial direct current stimulation; typical applications of alternating current stimulation include TENS (Transcutaneous Electrical Nerve Stimulation) analgesia, EMS (Electrical Muscle Stimulation) muscle training, and high-frequency radiofrequency heating; typical applications of pulsed direct current stimulation include HVPC (High Voltage Pulsed Current) wound therapy and neuromodulation, such as pacemakers and DBS (Deep Brain Stimulation).

[0198] Since each type of electrical stimulation has its corresponding typical application scenario, existing electrical stimulation protocols typically select one of the three current forms mentioned above for output based on the current treatment scenario. That is, different current forms are output independently for different scenarios.

[0199] Unlike existing electrical stimulation schemes, this disclosure can output multiple types of direct current for use in the same scenario.

[0200] Specifically, this disclosure combines different current modes, applying at least two current modes to the same treatment site in a single output process (i.e., a single treatment process). The combined output of different current modes refers to outputting different current modes at different times to act on the same treatment site, rather than outputting multiple current modes to act on the same treatment site simultaneously.

[0201] Combinations of different current modes can provide diverse electrical stimulation signals. By applying these signals to the same treatment site at different times, the signals can complement each other, enhancing the stimulation effect in multiple dimensions. During treatment, the specific combination of different current modes can be flexibly adjusted according to individual needs to improve treatment uniformity, safety, comfort, and more.

[0202] 5) Indications

[0203] Typical conditions suitable for treatment using direct current output mode are mainly divided into three categories: ophthalmology, gynecology, and medical aesthetics.

[0204] In this disclosure, the DC output mode operates in two ways: contact DC and electro-ionized DC.

[0205] Contact direct current (DC) refers to a treatment method that relies on the physical effects of current, with the core principle of "direct current acting on tissue." The electrode contact requirement for the second active electrode in contact DC is that it is attached to the surface of the second treatment site (i.e., non-invasive contact). The current intensity of contact DC can be adjusted according to treatment needs, directly stimulating or inhibiting nerves and muscles through current. The tissue response to contact DC is primarily based on physical effects (electrical stimulation). The technical characteristic of contact DC is its broad-spectrum treatment method based on the physical effects of current.

[0206] Electrolytic direct current (DC) (also known as DC-electrolytic deionization) is based on an "electrochemical reaction," with current acting as the medium to initiate the reaction. The electrode contact requirement for the second working electrode in electrolytic DC is that it needs to penetrate the hair follicle (e.g., a fine needle-like electrode) (i.e., minimally invasive). Electrolytic DC uses low current intensity and is primarily used to generate the electrolytic reaction. The tissue reaction type caused by electrolytic DC is mainly chemical damage (decomposition of hair follicle proteins). The key technical characteristic of electrolytic DC is its targeted hair follicle destruction technology based on an electrochemical reaction.

[0207] In public, electrolytic direct current is mainly used to treat trichiasis / trichiasis in the field of ophthalmology.

[0208] When using direct current output mode to treat conditions other than trichiasis / clumps, it is all considered contact direct current.

[0209] ① Ophthalmology

[0210] Direct current (DC) output mode therapy is suitable for treating primarily Meibomian gland dysfunction (MGD), or evaporative dry eye caused by MGD. The main treatment mechanism is as follows: the DC current signal generates ionization, causing the lipids that cause MGD to be expelled from the body; simultaneously, the DC current signal also generates a slight vibration effect, further promoting the discharge of meibomian gland secretions and the uniform distribution of the tear film lipid layer.

[0211] When using direct current output mode to treat dry eye syndrome, direct current biostimulation can address the root cause of dry eye, reduce inflammation, and effectively relieve symptoms. Specifically, the second action electrode acts on the meibomian conjunctiva, promoting the secretion of mucin by goblet cells. It can also act on the eyelid margin, promoting the regeneration and healing of eyelid margin epithelial cells. By outputting pulsed direct current signals, the second action electrode can promote the periodic contraction and emptying of the meibomian glands, improving glandular obstruction, reducing keratin buildup, and disrupting the eyelid margin biofilm.

[0212] When treating meibomian gland dysfunction using direct current output mode, the second working electrode can be a planar metal working electrode with a flat application surface and a metal material (such as silver). The modulated direct current energy can be conducted to the conjunctiva through the planar metal working electrode, softening the lipids blocking the meibomian glands, promoting lipid discharge through astringent effect, improving the lipid ratio of the tear film, reducing tear evaporation, and alleviating meibomian gland inflammation.

[0213] In the field of ophthalmology, the DC signal output control device disclosed herein can also be combined with high-end intraocular lenses. For example, patients who undergo refractive cataract surgery and receive high-end intraocular lenses (such as the Hanita pentafocal Intensity Lens) often experience varying degrees of ocular surface diseases (such as meibomian gland dysfunction and dry eye) before and after surgery. Therefore, the DC signal output control device disclosed herein can be used in conjunction with these treatments before and after surgery to improve these 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 disclosed herein can be used. Depending on the cause of dry eye, low-frequency biocurrent stimulation of the meibomian glands or plasma mode treatment of conjunctival laxity can be applied to enhance meibomian gland secretion, improve tear film stability, and reduce the risk of intraoperative irritation. In the postoperative stage, the ocular surface repair status can be monitored based on impedance feedback. If local impedance reflects slow tissue repair, electrical stimulation therapy can be performed to promote epithelial recovery and tissue tightening.

[0214] For example, the entire treatment process can be combined with the type of intraocular lens and surgical parameters, using a preset therapy template. Based on the treatment template, the matching output mode, energy density, and probe type can be automatically invoked. In this way, personalized perioperative treatment can be achieved, which helps to improve postoperative visual quality and patient satisfaction.

[0215] When treating trichiasis / clumped eyelashes using direct current output mode, the second treatment site is the anterior lip of the eyelid margin. The second electrode can penetrate into this second site, where the electrolytic effect of the output direct current signal can treat trichiasis and / or clumped eyelashes. Specifically, the second electrode can penetrate along the hair shaft of the trichiasis (or clumped eyelashes) into the hair follicle to near the papilla area (without penetrating the dermis), and then output a direct current signal (such as a constant direct current signal). In this way, electrolysis and a local increase in pH (OH-) occur in the vicinity of the second electrode (such as the tip of the second electrode). - (Enrichment), Na in tissues + With OH - NaOH is formed, inducing denaturation / chemical coagulation of proteins in the hair follicle papilla and outer root sheath. This action has extremely low 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 dose of the DC current signal in a constant current + timing manner. For example, the output parameters for treating ingrown eyelashes / clumped eyelashes may include: a constant DC current of 0.1mA to 1.0mA, preferably 0.2mA to 0.6mA; a single energizing duration 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 acting electrode is negative, and the second grounding electrode is positive and connected to the human body via a patch.

[0216] The following is an illustrative example of how to treat dry eye syndrome using direct current output mode.

[0217] First, preoperative preparations can be performed. These preparations include: cleaning and disinfecting the inside of the eye with a cleaning spray; applying numbing cream, corneal protection, and conductive gel to the treatment site; using a 3mm diameter treatment head as the second electrode; selecting from 1 to 8 operating levels (see description below for details on the levels); operating current less than 1mA; and low-frequency pulses between 0-300Hz.

[0218] After preparation, the second electrode is brought into contact with the treatment area inside the eyelid. Then, the second electrode is moved slowly and uniformly (e.g., at a speed of 1 mm / s to 10 mm / s) to release a direct current signal to the currently contacted treatment area inside the eyelid. Through reversible electroporation and cell membrane depolarization caused by the direct current signal, dry eye syndrome can be treated.

[0219] After the direct current signal therapy is completed, drug spray interventional therapy can be used.

[0220] Finally, a gentle massage can be performed, and treatment parameters should be recorded.

[0221] ②Gynecology

[0222] Direct current signals (especially pulsed direct current) can affect living tissues (such as mucous membranes, skin, and cervical mucosa) through cell membrane depolarization, eliminating cervical mucosal HPV infection and inflammation, urinary incontinence, vaginal dryness and atrophy, cervical mucosal swelling and erosion, etc.

[0223] By applying pulsed direct current (including single-pulse and double-pulse direct current) to the cervical mucosal cell membrane infected with HPV, cellular immunity can be enhanced, HPV infection can be corrected, and inflammation of the cervical mucosa and tissues can be reduced. This treatment method, which delivers pulsed direct current to the target site, can treat precancerous cervical lesions that do not require conization, and also has a preventative effect. It is suitable for healthy women and patients who have undergone cervical conization.

[0224] In addition, the DC 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).

[0225] The direct current output mode can be used to correct the invasion of human papillomavirus (HPV) into cervical mucosal cells and reduce inflammation in the cervical mucosa and tissues. This is achieved by enhancing the immunity of the invaded HPV cells through pulsed direct current and a high-intensity electric field on these cell membranes.

[0226] In some embodiments, the open-circuit voltage in DC output mode can reach up to 20kV and is modulated by a carrier frequency on the order of tens of kHz (typically 70kHz), then switched in repetitive bursts on the order of Hz (typically 1Hz-100Hz). The circuit is closed, allowing the patient to be conductively connected to the positive field via a ground electrode, and the cervical mucosa with a neutral gel layer is treated by the conductive portion of the intravaginal applicator, which is connected to the negative field of the power supply. The power supply is equipped with an adjustable current limiter, and a DC modulated current flows through the treatment site, generating a high-intensity pulsed electric field on the cervical mucosal cell membrane.

[0227] Using direct current output, precancerous cervical cancer can be treated without conization. This method also has a preventative effect and is recommended for healthy patients and those who have undergone embolization.

[0228] In general, the DC output mode is suitable for treating gynecological conditions including but not limited to: cervical dysplasia, cervical bleeding, ablation of Nabothian cysts, treatment of cervical eversion, cervicitis, leukoplakia, metaplasia, treatment of transformation zones, 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.

[0229] The following examples illustrate some typical gynecological conditions that are suitable for treatment using DC power output mode.

[0230] vulvar and vaginal laxity

[0231] Weakened pelvic floor muscles and vaginal wall syndrome, especially after vaginal delivery, can lead to laxity in the vulva and vaginal area. The primary 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.

[0232] One consequence is urinary incontinence due to changes in the pelvic floor muscles, as well as sexual dysfunction. Besides decreased tightness, elasticity, and sensitivity, this is also closely related to women's psychological problems. During menopause, declining ovarian function and reduced estrogen secretion lead to vaginal mucosal atrophy.

[0233] The vaginal mucosa is composed of multiple layers of non-keratinized stratified squamous epithelium. Due to declining 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. Furthermore, the naturally acidic pH of the vaginal mucosa becomes more alkaline; therefore, the vaginal mucosa is more prone to infection. Infections of the vaginal mucosa can lead to increased vaginal discharge and itching.

[0234] Vulvar and vaginal laxity can also worsen after vaginal delivery, and pelvic floor muscle fatigue is one of the most common negative consequences.

[0235] During vaginal delivery, the pelvic floor is subjected to pressure from adjacent areas. This outward pressure can lead to anatomical and functional changes. Approximately 30% of women experience pelvic floor fibrosis after vaginal delivery. Other factors include estrogen deficiency.

[0236] These changes can be reversed by treatment with pulsed direct current stimulation from electrodes, which promotes tissue regeneration through technological stimulation.

[0237] For example, the output parameters for treating vaginal laxity may include: a direct current of 0.1mA to 10mA, preferably 1mA to 4mA; and a single energizing duration of 5min to 20min. Low-frequency pulses of 0-300Hz can be added to improve treatment efficiency and comfort.

[0238] Menopausal urogenital syndrome

[0239] Genitourinary syndrome of menopause (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 them.

[0240] The potential therapeutic mechanism of 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.

[0241] Urinary incontinence

[0242] Stress urinary incontinence (SUI) is the most common type of urinary incontinence. It occurs when the natural supporting structures beneath the bladder (pelvic floor muscles and fascia) are damaged by increased intra-abdominal pressure, leading to urine leakage. In healthy individuals, these supporting structures maintain the position of the bladder. However, in various pathological conditions, such as vaginal delivery and estrogen deficiency, these supporting structures may weaken. The therapeutic effect has been demonstrated by intentionally improving this support using plasma energy.

[0243] Experiments showed that, through electrode stimulation, with each treatment lasting 15 minutes and repeated 3 to 6 times, patients experienced reduced involuntary urinary leakage and improved sexual function. Overall, the treatment was generally well-tolerated and positively evaluated for its comfort.

[0244] In summary, applying direct current signals to the vaginal mucosa can improve vaginal laxity and symptoms associated with atrophy, including but not limited to pain and unsatisfactory sexual activity, stress and urge urinary incontinence.

[0245] Under the stimulation of a 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 papillae form in the submucosal tissue. The fascia on the anterior and posterior vaginal walls, composed of collagen, closes and hardens. It closes the pelvic floor fascia, supports the relaxed bladder, and restores urinary incontinence. The complex of these changes and mucosal reactions 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 rejuvenates the atrophied 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 life.

[0246] Therefore, in some embodiments, a direct current signal is applied to the vaginal mucosa using a direct current output mode. 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; and ultimately reducing vaginal dryness, itching, irritation, and dyspareunia through mucosal thickening and vascularization. The procedure is painless, requires no local anesthesia, and is 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.

[0247] During the application of a direct current signal to the vaginal mucosa using a direct current output mode, a second working electrode outputs a direct current signal for treating the vaginal mucosa, and a 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 gripping portion 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 treatment, the insertion portion of the first probe can be gradually inserted into the vagina and pulled out.

[0248] The following is an example of how to treat gynecological conditions using direct current output mode.

[0249] First, pre-operative preparations can be performed. These preparations include: cleaning and disinfecting the vagina with a cleaning spray; applying numbing cream and conductive gel to the treatment area; the second electrode can be a roller or a long strip (S-shaped as described below) treatment head; the operating settings can be selected from 1 to 8 (see the description below for settings), and the operating current is less than 4mA.

[0250] After preparation, the second active electrode is brought into contact with the vaginal wall. The electrode is then slowly moved, releasing a direct current signal that acts on the currently contacted vaginal wall. The tissue and mucosal remodeling and collagen regeneration effects generated by the direct current signal achieve the desired therapeutic effect.

[0251] After the direct current signal therapy is completed, drug spray interventional therapy can be used.

[0252] Finally, a gentle massage can be performed, and treatment parameters should be recorded.

[0253] ③ Cosmetic Medicine

[0254] The application of DC power output mode in medical aesthetics mainly includes facial and vulvar tightening (collagen regeneration) and hair growth.

[0255] Direct current signals can stimulate fibroblasts to produce collagen, promote cell division and extracellular matrix repair, and therefore can be used for facial and vulvar tightening.

[0256] In some embodiments, the DC output mode can be combined with the delivery of active ingredients (such as vitamin C) to achieve skin brightening and facial rejuvenation. Applicable sites may include the face and body surface. Output parameters may include, but are not limited to: a constant DC current signal (current intensity up to 2mA; meeting the upper limit of current density); a second active electrode with a diameter less than or equal to 20mm, and a contact surface that can be a hydrophilic conductive interface; a second ground electrode that can be a patch type, with an area 1.5 times that of the second active electrode; and the device may integrate functions such as impedance detection, maximum dose detection, and abnormal shutdown.

[0257] For example, when the application area is the face, a 1mA-2mA, low-frequency pulse of 0-300Hz is commonly used. This allows the second active electrode to be controlled to move in a "C" shape / grid pattern for 10-30 minutes (3-5 round trips per unit area), maintaining current density limits, attaching to the circuit electrode, and completing a 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. 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 Nonapeptide-1, shiitake mushroom extract, and GigaWhite can also be selected. TM (A complex of extracts from 7 alpine plants), or one or more of the following: bearberry extracts.

[0258] The second active electrode can also contact the scalp, outputting a direct current signal to promote hair growth. When using a direct current signal to promote hair growth, the output parameters can be similar to those used 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 hyaluronic acid (HA) and exosomes to stimulate hair growth. Experimental results showed an increase in growth factors in the biotinylated peptide region three months after treatment. At the end of treatment, new hair growth was observed, while existing hair loss remained unchanged.

[0259] Electrical stimulation can induce apoptosis of adipocytes, thus 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 active electrode can be inserted into the fat layer beneath the epidermis or dermis; that is, 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, achieving fat ablation.

[0260] For example, the output parameters for fat ablation may include: a constant DC current of 0 to 20 mA, preferably 5 mA to 10 mA; and a single-point energizing time of 5 to 30 s.

[0261] 6) The influence of DC current signal parameters on the effect of electrical stimulation

[0262] The parameters of a DC current signal include, but are not limited to, current density, pulse frequency, pulse width, and duty cycle.

[0263] Current density refers to the distribution of current intensity relative to the electrode contact area. Current density affects the acceptable stimulation intensity and safety for cells. Extremely low densities (microampere levels, such as tens of μA / cm²) are considered safe. 2 Microcurrents, approaching physiological current levels, do not trigger action potentials but can activate cellular repair pathways. For example, microcurrents (<1 mA) are comparable to the body's endogenous healing current and are known as "subthreshold" stimulation, increasing ATP (adenosine triphosphate) production and protein synthesis, thus promoting cellular metabolism. Medium-density (hundreds of μA / cm²) stimulation... 2 – several mA / cm 2 This can induce sensory nerve excitation and cell membrane depolarization, triggering signals such as calcium ion influx, thereby affecting gene expression (e.g., growth factors). High density (> several mA / cm²) 2 If the stimulation is close to the pain threshold or even the damage threshold, it will cause forced neuromuscular excitation or thermal effects. Tissue damage should usually be avoided by applying it in pulses or for a limited time.

[0264] For pulsed direct current (including single and double pulses), the frequency determines the speed of pulse repetition and has a significant impact on neuromuscular responses and cellular signal rhythms. Low-frequency (Hz level) pulses trigger discrete cellular events, such as each pulse inducing a neuronal firing 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. Medium-frequency (tens to hundreds of Hz) pulses can induce sustained sensory / motor effects; for example, pulsed currents of 50Hz–100Hz have an analgesic effect on sensory nerves and produce tetanic contractions in muscles, which helps 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 contractions. 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, applying a high-frequency pulsed DC current signal may temporarily block pain transmission by causing a prolonged refractory period of the nerve membrane through rapid and repeated depolarization, thus serving as a pain management tool. However, a trade-off needs to be struck. High frequencies also increase the risk of charge accumulation, so they are often combined with biphasic or duty cycle control.

[0265] Pulse width refers to the duration of each pulse, while duty cycle is the percentage of pulse duration relative to the total cycle. Both determine the total charge delivered by a single pulse and the degree of resemblance to direct current. Short pulses / low duty cycles (e.g., pulse widths of tens of microseconds, duty cycle <1%) approximate peak currents, with minimal charge per pulse, thus producing no significant electrolytic products. HVPC falls into this category: typical pulse widths are 20–100 μs, with a duty cycle of approximately 1% (99% of the time is without current). This results in a total average current of HVPC as low as 1 mA–2 mA but with high instantaneous voltage, effectively stimulating tissue while avoiding skin pH changes and burning. Longer pulses / higher duty cycles gradually approach a constant direct current.

[0266] 100% duty cycle equates to pure direct current (DC). Studies show that duty cycle significantly affects cellular effects: under the same intensity of 200 μA and 2 Hz, applying different duty cycles to human skin fibroblasts resulted in the highest expression of healing-promoting α-SMA protein and TGF-β1 genes with pulses of medium duty cycle (10%), while high duty cycle (500%–90%) led to decreased cell viability. This indicates that appropriate intervals are beneficial for cell recovery and signal optimization; excessively long pulses may cause stress and toxicity. While continuous DC (100% duty cycle) can most strongly polarize the cell membrane and upregulate the expression of collagen, TGF-β, etc., long-term use may lead to excessive cell contraction and apoptosis, requiring careful dose control.

[0267] In summary, different parameter combinations determine the biological action patterns 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.

[0268] III. Combination drug / active ingredient delivery

[0269] 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 either 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.

[0270] 1) Plasma output mode + drug / active ingredient delivery

[0271] The permeability of the skin area is increased after plasma treatment, so the plasma output mode can be combined with drug / active ingredient delivery to promote the penetration of drugs / active ingredients into deep skin tissues and achieve efficient transdermal drug delivery.

[0272] In some embodiments, the injection module can 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 has been altered by applying plasma to the first site.

[0273] 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 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 pretreat 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 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.

[0274] 2) DC output mode + drug / active ingredient delivery

[0275] In the DC current signal output mode, the DC current signal can produce effects such as electroporation / electrophoresis on human tissue. Drugs or active ingredients of the same polarity can be applied or sprayed onto the target area. Under the effect of electroporation / electrophoresis, the drugs or active ingredients are precisely delivered to the target area to achieve deep (such as penetrating the dermis) treatment effects.

[0276] The injection module includes a storage module (i.e., a storage device), a transport module (e.g., a micropump), and a delivery module (e.g., a nozzle). The storage module stores the drug (e.g., an ionic drug) or active ingredient to be introduced. The transport module is connected to a control module, which controls the operating parameters of the transport module (e.g., parameters controlling the drug delivery rate). During the application of a direct 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 influence of the direct current electric field, the permeability of the cell membrane at the second site increases, 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.

[0277] In some embodiments, the injection module may be integrated into the active electrode (first active electrode or second active electrode). Thus, the active electrode may also have a drug delivery function. In this case, the active electrode may also be referred to as a drug applicator or a medicated applicator.

[0278] When using DC output mode to assist in drug / active ingredient delivery, any one or more combinations of the three types of DC current signals mentioned above can be used to achieve drug or active ingredient delivery. For example, a stable constant DC current can be used for drug delivery; a single-pulse DC current signal can be used; a multi-pulse DC current signal can be used; or a constant DC current plus pulsed (including single-pulse or multi-pulse) DC current signal can be used. 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 based on the required depth and uniformity of delivery.

[0279] The following example, using drug delivery, illustrates the positive role of direct current signals (especially combinations of different types of direct current signals) in the drug delivery process. It should be understood that direct current signals can also achieve similar effects in the delivery of active ingredients as in drug delivery.

[0280] The electric field of direct current drives charged drug molecules to move toward electrodes with opposite polarity, thus enhancing drug targeting and local concentration. Many drug molecules have difficulty penetrating the stratum corneum or mucosal barriers. Direct current alters 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 drugs to bypass the barriers of the skin and mucosa during delivery. Direct current itself may also produce certain physiological effects on tissues, such as promoting local blood circulation and relieving inflammation. This, combined with the delivered nebulized drugs such as anti-inflammatory drugs, analgesics, and neurotrophic drugs, creates a synergistic effect, further enhancing the therapeutic effect.

[0281] When using a combination of "dual-pulse DC current + single-pulse DC current" for drug delivery, the dual-pulse DC current signal, being a low-to-medium frequency current, avoids the limitation of low-frequency currents acting only on the skin's surface. The single-pulse DC current signal intermittently delivers the drug to the treatment site, forming an ion pool and prolonging the drug's duration of action. Combining these two methods further enriches the current stimulation modes.

[0282] 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, increase the drug penetration channels, and when combined with the constant DC current, it can improve the depth and efficiency of drug delivery, and also give full play to the polarity effect of the constant DC current.

[0283] When using a combination of "dual-pulse DC current + constant DC current" for drug delivery, the dual-pulse DC current reduces tissue impedance, allowing the current to penetrate deeper and more stably into deeper tissues, thus promoting more effective drug delivery to the target site. The constant DC current provides a stable electric field, ensuring the directional migration of drug ions. The combination of these two technologies leverages the advantages of dual-pulse current to reduce skin irritation and avoid electrolysis, while the directional delivery characteristics of constant DC current enhance the accuracy and effectiveness of drug delivery.

[0284] 3) Delivery technology

[0285] When delivering drugs or active ingredients to the skin surface using a delivery module (such as a nozzle), technologies such as ultrasonic spraying, pressure spraying, and electrostatic spraying can be employed, but are not limited to. The following example of drug delivery will illustrate these spraying technologies.

[0286] Ultrasonic atomization technology refers to the use of an ultrasonic generator to produce high-frequency vibrations (typically 1MHz to 5MHz). These vibrations are transmitted to the surface of the medication, causing intense mechanical vibration and breaking it into fine droplets. For example, the medication formulation can be added to the medication tank of the ultrasonic atomization device, ensuring full contact between the medication and 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, depending on the drug properties and administration requirements. Under the compression of a powerful airflow, the droplets are subjected to pressure, propelling the atomized spray from the treatment surface through a conduit.

[0287] Pressure atomization technology refers to using compressed gas as a power source to apply pressure to a drug solution or suspension within a sealed container. When the atomization 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 introduced into the container to maintain a certain pressure, typically 0.2 MPa to 1.5 MPa, with the specific pressure value determined based on the drug characteristics and atomization requirements. Furthermore, a dedicated atomization valve and nozzle are installed. The nozzle orifice diameter is 0.01 mm to 0.5 mm, and its shape can be direct, protruding, or concealed, to control droplet size and spray pattern. In use, pressing the valve causes the drug to be sprayed out from the nozzle under pressure, forming a mist.

[0288] Electrostatic spraying technology involves placing a high-voltage electrode at the spray nozzle to charge the sprayed droplets. This charge is utilized to improve droplet adhesion to the target surface by leveraging the repulsion between charges and the electrostatic attraction between the droplets and the target surface. The drug formulation is loaded into the spray device's storage tank and connected to a high-voltage power supply (DC voltage 5kV–30kV) to the nozzle electrode. The spray flow rate and high-voltage electric field strength are adjusted to ensure uniform droplet charging. During spraying, the charged droplets move directionally under the influence of the electric field and adhere to the target drug delivery site.

[0289] IV. Structure of the Working Electrode

[0290] The tip of the first working electrode should be designed as a discharge tip to generate plasma.

[0291] The overall shape of the first working electrode can be pen-shaped; therefore, the first working electrode can also be called a plasma pen.

[0292] The tip of the second active electrode should be an application surface adapted to the second site to be contacted. This adaptation includes both shape and size. For example, when the second active electrode is used for external skin tightening, the application surface should be designed as a plane, and its size should be on the order of magnitude of the external skin to be tightened. As another example, when the second active electrode is used to treat ophthalmic conditions, the size of its application surface should be designed to be small to achieve precise treatment.

[0293] For example, the application surface of the second working electrode may include, but is not limited to, a plane, a sphere, and other curved surfaces.

[0294] For example, the second action electrode may include a first probe for gynecological treatment, the first probe including a gripping portion and an insertion portion, the insertion portion being designed to be inserted into the vagina.

[0295] For example, 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. Based on the mechanism of action, the second probe can be divided into two types. The first type has its action site located on the skin surface, and the tip of the second probe does not need to be inserted below the epidermis. For example, for eye diseases such as meibomian gland dysfunction and dry eye syndrome, as well as medical aesthetic purposes such as facial tightening and hair growth, the action site of the direct current signal is located on the tissue surface. The second type has its action site located inside the tissue, rather than on the skin surface, and the tip of the second probe needs to be inserted below the epidermis. For example, for fat ablation (such as for 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 or 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 region. 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. Accordingly, the tip of the second type of probe should be designed as a sharp point to penetrate deep into the tissue.

[0296] Figure 6 shows several schematic diagrams of the second working electrode.

[0297] 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 smaller 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.

[0298] Referring to the right-hand 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 also 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.

[0299] The second working electrode may be made of EN AW 5038 (aluminum-magnesium alloy), AISI 302 (high carbon austenitic stainless steel), AISI 304 (general austenitic stainless steel), or other materials with similar properties.

[0300] Figure 7 shows a schematic diagram of a second working electrode suitable for gynecological use.

[0301] The second active electrode shown in Figure 7 corresponds to the first probe mentioned above. The first probe can also be called a gynecological probe or a gynecological applicator. As shown in Figure 7, the second active 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 active electrode, which is 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.

[0302] Figure 8 shows another schematic diagram of the structure of the second working electrode suitable for gynecological use.

[0303] The second active electrode shown in Figure 8 corresponds to the first probe described above. Referring to Figure 8, the second active electrode is generally S-shaped with a wavy appearance. The second active 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.

[0304] Figure 9 shows a schematic diagram of the structure when the second working electrode acts on the cervical mucosa.

[0305] 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 a modulated pulsed direct 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 direct current to achieve the corresponding therapeutic purpose. The second working electrode in Figure 9 can also be called a cervical treatment head. The foremost section of the cervical treatment head in Figure 9 can be considered as the application surface. This application surface has a certain length, and its shape is adapted to the contact area for proper insertion. The shape of the foremost application surface of the cervical treatment head shown in Figure 9 can be circular or conical.

[0306] Figures 10 to 12 show schematic diagrams of the application surface of the second working electrode used for cervical mucosal body treatment.

[0307] As shown in Figures 10 to 12, the application surface of the second working electrode for the 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 the outwardly convex structure 121 can be a disc 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 deep cervical mucosa, while the outwardly convex structure 121 can be used to treat the periphery of the cervical mucosa.

[0308] Figure 13 shows a schematic diagram of the application surface of the second working electrode used for peri-mucosal treatment of the cervix.

[0309] As shown in Figure 13, the application surface of the second electrode for the cervical mucosa can also remove the first segment 122, and only include the outwardly convex structure 121 and the second segment 123. During treatment, only the outwardly convex structure 121 can contact the periphery of the cervical mucosa.

[0310] It should be understood that the specific dimensional data shown in Figures 10 to 13 are merely illustrative. In practical applications, various other dimensional data can be set to suit different patients.

[0311] Figure 14 shows a schematic diagram of the second working electrode acting on the vagina.

[0312] Referring to Figure 14, the second active electrode may include a holding portion 125 and an insertion portion 126. The insertion portion 126 is adapted for insertion into the vagina to treat vaginal conditions. Specific treatable vaginal conditions are described above.

[0313] Figure 15 shows another schematic diagram of the structure of the second working electrode.

[0314] Referring to Figure 15, the front end of the second active electrode is a metal probe 128, the length of which can be approximately 0.5 mm. The number of metal probes 128 on the same second active 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 active electrode besides 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 subepidermal fat layer, outputting a direct current signal to act on the fat layer, inducing apoptosis of fat cells through electrical stimulation, thereby achieving fat ablation. Specifically, it can be used to treat conditions related to fat ablation, such as eye bags and double chins.

[0315] V. Several optional functions that can be realized based on impedance sensing

[0316] (1) Impedance matching

[0317] Human body impedance is dynamic and varies. Different parts of the body have different impedances. Therefore, it is necessary to detect human body impedance in real time and adjust the impedance characteristics of the circuit accordingly to achieve impedance matching.

[0318] Figure 16 shows a schematic diagram of a DC signal output control device according to another embodiment of the present disclosure.

[0319] 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 signal energy transmission and reducing reflection.

[0320] 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 ensuring that the current output is in a state of impedance matching in real time. By configuring the electrical stimulation device 100 with impedance detection and impedance matching functions, 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.

[0321] In some embodiments, the impedance characteristic of the impedance matching module 140 is adjustable. The control module 110 can adjust the impedance characteristic of the impedance matching module 140 via the feedback adjustment module 160, so that impedance matching can be achieved after adjustment. In other embodiments, the impedance characteristic of the impedance matching module 140 can be a fixed value that is not adjustable. The control module 110 can adjust the impedance characteristic of the feedback adjustment module 160 itself via the feedback adjustment module 160 to achieve impedance matching.

[0322] 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.

[0323] 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, 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 a signal amplification module for signal amplification processing.

[0324] The signal, amplified by the signal amplification module, is transmitted via a high-speed ADC. A high-speed ADC is used because it allows for specific frequency selection, filtering the signal and transmitting it quickly without interference from external frequencies. To achieve real-time impedance matching, the impedance signal value needs rapid processing. Since FPGAs have the capability for rapid signal processing, this disclosure does not directly transmit the digital signal converted by the high-speed ADC to the control module 110 for processing; instead, it 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 then calculates the human body impedance based on a preset algorithm.

[0325] Human body impedance includes both resistive and capacitive components. The algorithm Z = V / I treats the human body as a real resistance, which does not reflect reality and has a large error. In view of this, this disclosure presents a new formula for calculating human body impedance.

[0326] The formula for calculating the capacitive component (i.e., capacitance value) of human body impedance can be expressed as follows:

[0327] Where C is the capacitance value. A is the impedance compensation constant. ε is the dielectric constant, where ε1 represents the real part of the dielectric constant and ε2 represents the imaginary part. d represents the distance between the two electrodes of the second type of output module, and d can be considered as the length of the human tissue in the circuit. When one electrode (i.e., the second acting electrode) contacts or is close to the second site, and the other electrode (i.e., the second grounding electrode) contacts other locations on the human body to form a circuit, d can also be expressed as the distance between the other electrode and the second site. s represents the area of ​​the treatment site to which the current acts, and this area can refer to the cross-sectional area.

[0328] The formula for calculating the real resistance of the human body can be expressed as follows:

[0329] Where R represents the real part of the human body impedance; w is the angular frequency; e(w) represents the conductivity of biological tissue (such as the second site) at the angular frequency w; and P(w) represents the resistivity of biological tissue (such as the second site) at the angular frequency w.

[0330] The formula for calculating the imaginary part impedance of the human body can be expressed as follows:

[0331] Therefore, the control module 110 can calculate the human body impedance based on the following formula: Z = R + X

[0332] For the meaning of each symbol in the formula, please refer to the relevant description above. The specific value of the angular frequency *w* can be determined through signal acquisition and processing, for example, based on the frequency domain signal processed by the field-programmable gate array (FPGA) mentioned above. 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), which can be obtained by querying. Therefore, once 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 pre-set default values. 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 fixed values. Alternatively, the values ​​of *d* and / or *s* can also be determined through on-site measurement. The impedance compensation constant *A* can be obtained through simulation, for example, by building a circuit model using simulation software (such as Ansys) and simulating the interaction of biological tissue at the human treatment site to obtain the impedance compensation constant *A*.

[0333] (2) Gear setting

[0334] In some embodiments, the control module 110 can also set a second output level based on the detected human body impedance, and control the DC signal generation module 120 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 human body impedance, and the second threshold is also positively correlated with the second output level. That is, the higher the human body impedance, the higher the second output level, the higher the second threshold, and the higher the energy (i.e., power) that can be applied to the second part per unit time.

[0335] Figure 17 shows a schematic diagram of the impedance power curves at different speeds.

[0336] In Figure 17, the horizontal axis represents current and the vertical axis represents power. As shown in Figure 17, the second output setting can be set to an adjustable mode of 1-8 levels. With each level increase, the energy applied per unit time increases, and the impedance bandwidth also increases. Therefore, as shown in Figure 17, each level has an optimal human body impedance point. At the optimal impedance point, the energy output is maximum, and there is no reflection. Therefore, impedance detection and matching are particularly important.

[0337] For example, this disclosure can pre-set a correspondence table between the second output level and human body impedance. Figure 18 shows a schematic diagram of the correspondence table between the second output level and human body impedance. As shown in Figure 18, the correspondence table can record the relationship between the range of human body impedance and the second output level, as well as the maximum energy output value under different second output levels.

[0338] Therefore, after detecting the 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 detected impedance of the human treatment site is 300Ω, the recommended second output level is level 3 or 4, and the output energy can be limited to 0.0028W of level 5.

[0339] (3) Determine if the indication exists

[0340] In some embodiments, the control module 110 can also determine whether an indication exists based on changes in the human body impedance. Determining whether an indication exists is equivalent to determining whether the current output method is effective in treating the symptoms to be addressed. Changes in human body impedance (such as the impedance of the treatment site) can, to some extent, reflect the effectiveness of the treatment. Therefore, the existence of an indication can be determined based on changes in human body impedance.

[0341] The following example, using dry eye syndrome, illustrates the correlation between changes in human body impedance and the existence of an indication for treatment. The main cause of dry eye syndrome is abnormal tear secretion or excessively rapid tear evaporation, leading to an imbalance in the ocular surface microenvironment. Although human body 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 ocular moisture content and ion concentration are variable factors. These factors can reflect whether electrotherapy for dry eye syndrome is effective and, specifically, what kind of effect it has. This allows us to determine the existence of an indication by observing changes in impedance values ​​and make corresponding adjustments accordingly.

[0342] Specifically, if the user has 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 in the eye is low and the ion concentration is low, so A should be a relatively large value. The detected human body impedance value A at the beginning of treatment can refer to the impedance detected when determining the connection of the positive and negative electrodes to 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 treatment of dry eye has improved and dry eye syndrome is an indication. Moreover, the larger the difference between A and B, the better the treatment effect of dry eye. Therefore, the difference between A and B can also be used as a basis for judging whether dry eye still exists. For example, if the difference between A and B is greater than a predetermined threshold, it indicates that dry eye has been greatly relieved. If a DC current signal continues to be output, the output energy of the device can be reduced. If A = B, it means that the treatment of dry eye has no effect and the current output mode of the DC current signal has not played a role. At this time, the output mode can be adjusted, such as increasing the output energy of the device. If A < B, it means that the dry eye symptoms have worsened. At this time, the treatment plan can be stopped and changed, the reasons for the aggravation can be analyzed, and corresponding corrections can be made.

[0343] That is to say, the second part mentioned above is the eye, which can specifically include but is not limited to the eyelid, eyelid margin, conjunctiva, and scleral tissue. The DC signal output control device is used to treat dry eye syndrome. When the control module 110 determines that dry eye syndrome is an indication based on the numerical change of the human body impedance, it sets the energy acting on the eye per unit time based on the degree of numerical change of the human body impedance. Among them, the energy acting on the eye per unit time is negatively correlated with the degree of numerical change of the human body impedance. When the control module 110 determines that dry eye syndrome is not an indication based on the numerical change of the human body impedance, it can reset the output strategy of the DC current signal (such as increasing the output power). After outputting the DC current signal according to the reset output strategy for a period of time, it can be determined again whether it is dry eye syndrome.

[0344] In summary, the control module 110 can not only judge whether there is an indication according to the numerical change of the human body impedance, but also set the output strategy of the DC current signal according to the judgment result. Thus, during the process of outputting the DC current signal, it can be judged in real time whether there is an indication, and the output strategy can be modulated accordingly to avoid the risk of over-treatment or under-treatment.

[0345] In some exemplary embodiments, the combined output of at least two modes described above can be determined by the control module 110 based on the numerical change of human body impedance. For example, after determining that the second type of output module 130 forms a circuit with the human body, the control module 110 can first control the DC current signal generation module 120 to output the first mode to act on the treatment site. The first mode can be used as the default electrotherapy scheme for the current problem to be solved (such as dry eye syndrome). After a certain period of time (such as the first time period), the current electrotherapy effect can be determined based on the numerical change relationship between the currently detected human body impedance and the human body impedance detected at the beginning of the electrotherapy, and the second mode to be output subsequently can be determined accordingly.

[0346] VI. Some Specific Embodiments

[0347] Example 1

[0348] In this embodiment, the DC signal output control device includes 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 the first output terminal (e.g., the positive output terminal) of the DC signal generation module.

[0349] One end of the second active electrode is connected to the second output terminal (e.g., the negative output terminal) of the DC signal generation module, and the other end of the second active electrode (i.e., the application surface) contacts the target area. The control module controls the DC signal generation module to generate a DC current signal, which is then provided to the second active electrode, causing the second active electrode to apply the DC current signal to the target area.

[0350] In response to the output duration of the DC signal being greater than or equal to a first threshold, and / or the effect of the DC signal on the target area being lower than expected, the negative output terminal of the DC signal generation module is connected to the first action electrode, and the other end of the first action electrode (i.e. the application surface) 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.

[0351] Therefore, for a specific ailment or to achieve a particular purpose (such as cosmetic purposes), a safer and more user-acceptable direct current output mode can be used first, applied to the target area. When the therapeutic effects of the direct current output modes overlap, the system can then switch to the plasma output mode of the first active electrode.

[0352] In some embodiments, the DC signal output control device further includes the impedance detection module, switching module, and / or output module described above. The control module can determine whether an indication exists based on changes in human body impedance. If no indication is found, it instructs the switching module to connect the negative output terminal of the DC signal generation module to the first active electrode, or controls the output module to output a first prompt message. The first prompt message is used to prompt the switching of the active electrode currently connected to the DC signal generation module.

[0353] Taking the eye (including eyelids, palpebral margins, conjunctiva, and sclera) as the target area, and using a DC signal output control device for treating dry eye syndrome as an example, the control module adjusts the output parameters of the DC signal to increase the output power in response to the decrease in human body impedance falling below a third threshold during the first output duration of the DC signal. In response to the decrease in human body impedance falling below a fourth threshold during the subsequent second output duration of the DC signal, the control module instructs the switching module to connect the negative output terminal of the DC signal generation module to the first active electrode, or controls the output module to output a first prompt message.

[0354] Example 2

[0355] This disclosure also proposes a beauty method.

[0356] It should be understood that this method can also be used in various disease scenarios, thus realizing a treatment method.

[0357] Figure 19 shows a schematic flowchart of a cosmetic method according to an embodiment of the present disclosure.

[0358] Referring to Figure 19, in step S1610, the target tissue area to be treated is marked. The target tissue area includes multiple points, and the distance between any two adjacent points is greater than or equal to the fifth threshold.

[0359] For example, each wrinkle in the target tissue area can be marked, such as by marking a row of points about 1 mm below each wrinkle. A spacing of at least 3 mm should be maintained between the points.

[0360] In step S1620, multiple points are traversed. For the currently traversed point, the first active electrode is controlled to output plasma to act on the point for a period of time so that the plasma can act on the dermis at the point.

[0361] The first working electrode is connected to the DC signal generation module, which in turn is connected to the control module. The control module controls the DC signal generation module to generate a DC voltage signal. For details on the device structure, please refer to the relevant description above.

[0362] When plasma is applied to specific areas, it can improve the skin quality at those areas. As mentioned above, plasma can alter cell membrane permeability, thereby improving skin quality. Furthermore, the heat generated by the plasma can enhance dermal tissue, starting with the immediate contraction and denaturation of collagen fibers, leading to muscle contraction and lifting, and collagen proliferation.

[0363] Therefore, plasma can be output point-by-point from multiple marked locations. The duration of action at each location can be 3 to 4 seconds. Compared with traditional techniques, this allows for greater retraction and the generation of new tissue.

[0364] In some implementations, the energy value applied to the point per unit time can be set according to the skin type to which the point belongs. For example, for deeper wrinkles, the energy value applied to that skin location per unit time can be increased.

[0365] The microchannels generated by plasma output mode enable deeper penetration, thus allowing for combination with drug delivery to reach deeper tissue layers and form reservoirs. This allows for more effective utilization of active ingredients, enhancing their functions such as whitening, improving skin texture, and increasing moisturizing effects.

[0366] Therefore, in some embodiments, the active ingredient solution may also be applied dropwise to the target tissue area. The active ingredient solution may include, but is not limited to, at least one or any combination of vitamin C, vitamin E, hyaluronic acid, collagen, exosomes, and retinoic acid. After applying the active ingredient solution to the target tissue area, it may be gently massaged for a few minutes.

[0367] When using the plasma output mode, only 30% of the target tissue area needs to be anesthetized. Therefore, anesthesia can be administered to 30% of the target tissue area before the plasma output from the first acting electrode is applied to different points within the target tissue area.

[0368] Example 3

[0369] Figure 20 shows a schematic flowchart of a cosmetic method according to another embodiment of the present disclosure.

[0370] Referring to Figure 20, in step S1710, the second active electrode is controlled to move and contact the target tissue area to be treated in order to scan the target tissue area; during the movement, the second active electrode outputs a DC current signal to act on the currently contacted target tissue to improve skin quality.

[0371] Similar to how plasma improves skin quality, electrical stimulation can also achieve muscle contraction and lifting, and collagen proliferation, thereby improving skin quality. For example, it can be used for skin lifting and wrinkle removal.

[0372] In step S1720, after the scan is completed, one or more points in the target tissue area are traversed. For the currently traversed point, the first active electrode is controlled to output plasma to act on the point for a period of time so that the plasma can act on the dermis at the point and further improve skin quality.

[0373] For information on the first and second working electrodes, please refer to the relevant descriptions above.

[0374] Therefore, the cosmetic procedure can be divided into two stages. In the first stage, a direct current signal is applied to the entire target tissue area through contact scanning to provide electrical stimulation and achieve the cosmetic effect. After the first stage of electrical stimulation, plasma can be output to perform a second cosmetic procedure on areas within the target tissue area where the electrical stimulation effect was not particularly good.

[0375] Example 4

[0376] Figure 21 shows a schematic flowchart of a cosmetic method according to another embodiment of the present disclosure.

[0377] Referring to Figure 21, in step S1810, conductive gel is applied to the target tissue area to be treated.

[0378] For example, sterile gloves can be worn, and the conductive gel can be applied to the skin using a spatula or brush.

[0379] In step S1820, a first DC current signal is output using an electrode of the first size and applied to the target tissue area.

[0380] In step S1830, a second DC current signal is output using the second-sized active electrode to act on the target tissue region to further heat the target tissue region.

[0381] In step S1840, a third direct current signal is output from the third-sized electrode and applied to the target tissue area to perform wrinkle removal treatment on the target tissue area.

[0382] The first dimension is larger than the second dimension, the second dimension is larger than the third dimension, the current density of the first DC current signal is smaller than the second DC current signal, and the current density of the second DC current signal is smaller than the third DC current signal.

[0383] One end of the currently used working electrode contacts the target tissue area, and the other end of the currently used working electrode is connected to the DC signal generation module. The DC signal generation module is connected to the control module, and the control module controls the DC signal generation module to generate a DC current signal that matches the currently used working electrode.

[0384] The first-sized active electrode can be, for example, a second active electrode with a diameter of 20 mm on the application surface. The second-sized active electrode can be, for example, a second active electrode with a diameter of 10 mm on the application surface. The third-sized active electrode can be, for example, a second active electrode with a diameter of 5 mm or 3 mm on the application surface.

[0385] Therefore, different application surface sizes of the active electrode can be used in descending order, and the active electrode with the smallest surface size can be used to precisely target skin wrinkles, making the skin appear softer.

[0386] In some exemplary embodiments, the currently used electrode is always perpendicular to the target tissue region. The currently used electrode can also be controlled to move within the target tissue region in one or more directions, with the number of movements in each direction being less than or equal to three. For example, the electrode can be moved back and forth over wrinkles, such as in a zigzag pattern. A maximum of three movements are allowed in both directions. No pressure should be applied to the skin during treatment; the touch must be gentle and comfortable.

[0387] In some exemplary embodiments, a 20 mm diameter flat electrode is used for initial heating of the target tissue area. A 10 mm diameter flat electrode is used for further heating of the treatment area. A 5 mm diameter flat electrode is used for nasolabial folds. A 3 mm diameter flat electrode is used directly for wrinkle removal.

[0388] Example 5

[0389] Figure 22 shows a schematic diagram of the hardware structure of a DC signal output control device according to an embodiment of the present disclosure.

[0390] Referring to Figure 22, the main control MCU is equivalent to the control module 110 mentioned above. The impedance detection circuit is equivalent to the impedance detection module mentioned above. The feedback adjustment circuit is equivalent to the feedback adjustment module mentioned above. The impedance matching circuit is equivalent to the impedance matching module mentioned above. The crystal oscillator, frequency adjustment circuit, PWM system circuit, power amplifier circuit, and filter circuit are equivalent to the DC signal generation module 120 mentioned above. The positive and negative electrodes are equivalent to the output modules mentioned above (for example, they could refer to the second type of output module).

[0391] For example, the DC signal output control device may also include a timing mechanism, a power supply, buttons, a display screen, and other components. The timing mechanism can be used to set the treatment time. The power supply provides power to all components. The buttons and display screen provide human-computer interaction services for the user. For example, the main control MCU exchanges and controls information with the buttons and display screen. The main control MCU also controls the impedance transformation judgment logic, monitors the human body impedance value in real time, and provides impedance matching parameter level guidance on the display screen to ensure the safety and effectiveness of the output.

[0392] Under the control of the main MCU, either a DC voltage signal or a DC current signal can be output. That is, there is a difference in output energy between the DC current output mode and the plasma output mode, but both output modes can utilize a single hardware circuit structure to provide the corresponding DC signal. The main MCU can control the generation of a DC voltage signal or DC current signal that matches the currently selected output mode. The main MCU can also determine the energy of the DC current to be output by impedance judgment, such as determining whether the current impedance is the human body circuit impedance. For example, when plasma therapy mode is required, the PWM system amplifier circuit in Figure 22 will output a corresponding high-voltage signal to meet the plasma output requirements; while when a DC current signal is required, the DC current output by the PWM system amplifier circuit is low-energy, thus constituting the contact therapy mode.

[0393] In some exemplary embodiments, two "frequency adjustment circuits + PWM system circuit power amplifier circuits" can also be set. The purpose is to superimpose waveforms from two different frequencies to form a multi-pulse mode. One circuit (i.e., the "frequency adjustment circuit + PWM system circuit power amplifier circuit") first generates a low-frequency pulse waveform with a frequency of 0-1000Hz and an amplitude within a preset value to allow the intermediate frequency current to be modulated. The other circuit generates an intermediate frequency pulse waveform with a frequency of 1kHz to 1MHz, and its amplitude must be the same as the amplitude of the low-frequency waveform; otherwise, modulation cannot be performed. The overall amplitude changes with the frequency and amplitude of the controlled low-frequency current.

[0394] This disclosure supports adjusting the waveform frequency within the range of 0 to 1 MHz and the pulse width within the range of 0 to 5000 ms. This effectively solves the problem of existing technologies being unable to flexibly adjust output parameters according to actual conditions.

[0395] In some exemplary embodiments, direct current can be output for treatment. The workflow is as follows.

[0396] When outputting direct current, the electrodes are fully connected to the human tissue to form a circuit and detect the human body's impedance value. The detected impedance value will be displayed as interactive feedback on the screen. Simultaneously, the maximum energy output value can be limited based on the correspondence between the human body impedance range and the second output level, as shown in Figure 7. With this design, a single output therapy session can begin, and this cycle can be repeated.

[0397] In some exemplary embodiments, pulsed direct current can also be output for treatment. The workflow is as follows.

[0398] First, treatment parameters, including waveform type, frequency, and pulse width, can be set via buttons or touchscreen. The control module receives these settings. Next, the impedance detection module checks the connection between the negative and positive electrodes on the body. If the connection is successful, energy modulation output is performed; otherwise, a reconnection prompt is displayed.

[0399] In pulsed DC output mode, the frequency multiplication can be selected by controlling the MCU to modulate the system crystal oscillator frequency, which can effectively modulate different frequencies. Frequency modulation via crystal oscillator tuning offers better stability. The pulse width setting time in the modulation output is 0–5000 ms. 0 ms indicates continuous output mode; when a time setting is available, it is a pulse width interval output mode. This control logic—pulse output—pulse width interval—pulse output—effectively and safely controls energy, avoiding skin damage that may occur during continuous treatment.

[0400] The PWM system circuit and power amplifier circuit can output any preset waveform. Through precise modulation by software algorithm, the modulated waveform will be filtered, impedance matched and other processes to obtain a stable pulse waveform (as shown in Figure 10).

[0401] During treatment, impedance changes are monitored in real time and fed back to the main control MCU, which then adjusts the maximum threshold of output energy through a feedback adjustment circuit.

[0402] Multi-pulse mode also has a pulse width output mode. When the pulse width time is equal to 0ms, it is a continuous output mode. When the pulse width time is set, it is a pulse width modulation output mode.

[0403] Taking the treatment of dry eye as an example, the DC signal output control device disclosed herein can be implemented as a dry eye treatment device.

[0404] In some embodiments, the operation flow of the DC signal output control device of this disclosure is as follows.

[0405] 1. Press (if the user presses) the power switch to start the device. The system will load the software and enter the function selection mode.

[0406] 2. At this time, there will be corresponding treatment indication modes to choose from: "Dry Eye Treatment Mode"; "Gynecological Treatment Mode"; "Medical Aesthetic Peeling Mode"; "Ionization Treatment Mode", etc.

[0407] 3. Select the corresponding treatment mode to enter. The display interface shows parameter settings: "Treatment Time"; "Energy Level"; "DC, Pulse DC, Multi-Pulse DC" + "DC, Pulse DC, Multi-Pulse DC"; "Standby / Ready". It also features real-time "Impedance Detection Display" and "Correct Circuit Connection" interfaces.

[0408] 5. Its positive electrode can be connected through human hand contact, patient body patch contact, etc.

[0409] 4. The treatment handle is designed to be placed close to the patient's treatment site, and conductive medications such as gel may be added to the tissue area for auxiliary treatment if necessary. The treatment handle forms a circuit with the positive electrode, at which point impedance detection will be activated and feedback will be sent to the interface. Once the system is ready, stepping on the foot switch will start the output of electrical energy to begin treatment.

[0410] 5. The treatment handle is used for contact or near-contact non-contact treatment of the treatment area on the body. The operation technique involves sliding movement to ensure uniform treatment of the treatment surface until the treatment is completed.

[0411] 6. The corresponding treatment will be carried out according to this treatment process.

[0412] It should be understood that the DC signal output control device disclosed herein has a wide range of applications. All conditions for which plasma technology and DC stimulation technology are applicable fall within the scope of application of the DC signal output control device disclosed herein.

[0413] Example 6

[0414] In this embodiment, the DC signal output control device can treat at least one of the following conditions in pets by outputting plasma and / or DC current signals: evaporative and mixed dry eye, blepharitis, blepharitis, multidrug treatment for pet conjunctivitis secondary to glaucoma, 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.

[0415] For example, evaporative and mixed dry eye syndrome, hair loss, ectopic cilia, and trichiasis in pets can be treated by applying a direct current signal to the corresponding treatment area.

[0416] For example, blepharitis, glaucoma secondary to conjunctivitis in pets requiring multidrug therapy, chalazion, infectious inflammation of eyelid glands, benign tumors of the eyelids and body, peripheral facial paralysis, alopecia, Demodex mites, body keratosis, and papilloma can be treated by applying plasma to the corresponding treatment site.

[0417] The treatment principles for the above-mentioned conditions can be found in the relevant descriptions above.

[0418] The DC signal output control device according to this disclosure has been described in detail above with reference to the accompanying drawings.

[0419] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible implementations of systems and methods according to various embodiments of this disclosure. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions marked in the blocks may occur in a different order than those marked in the drawings. For example, two consecutive blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, may be implemented using a dedicated hardware-based system that performs the specified function or operation, or using a combination of dedicated hardware and computer instructions.

[0420] The various embodiments of this disclosure have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles, practical application, or improvement of the technology in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

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 to be inserted 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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