High-frequency electrotherapy device for non-healing wounds

Abstract

A high-frequency electrotherapy device for promoting the healing of chronic, non-healing wounds, comprising: a signal generation module configured to generate a high-frequency alternating electrical signal in the range of 1.0 MHz to 1.8 MHz with a waveform selected from sinusoidal or pulsed sinusoidal profiles; a power amplification circuit electrically coupled to the signal generation module and configured to boost the signal to a therapeutic voltage in the range of 200 V to 500 V RMS; a dielectrically coated glass electrode containing a noble gas selected from neon, argon, or xenon, the electrode being shaped for direct surface application to skin wounds and being removably coupled to the output of the power amplification circuit via a high-voltage coupling capacitor; a microcontroller-based feedback system configured to monitor skin impedance in real time and dynamically modulate output amplitude and treatment duration to maintain local tissue exposure within predefined bioimpedance and thermal safety thresholds; a safety locking mechanism comprising a capacitive proximity sensor embedded in the electrode rod, wherein signal output is only permitted upon proven contact with human skin within a calibrated pressure and proximity range; and a programmable user interface configured to execute wound-specific treatment protocols that include predefined exposure durations, modulation frequencies, and rest intervals optimized for diabetic ulcers, pressure ulcers, and post-operative wounds.

Description

Field of the invention

[0001] The present invention relates to the field of biomedical engineering and medical therapy devices and, in particular, to high-frequency electrotherapy systems for the treatment and accelerated healing of non-healing wounds and chronic skin ulcers. Background of the invention

[0002] The treatment of non-healing wounds and chronic ulcers represents a persistent challenge in medical practice, particularly in patients with underlying conditions such as diabetes mellitus, peripheral vascular disease, and immunocompromised systems. Conventional approaches such as antibiotics, debridement, vacuum-assisted wound closure, and skin grafting often reach their limits due to high recurrence rates, risk of infection, and patient discomfort. Modern physiotherapy and dermatological technologies utilize the application of electrical stimulation to promote wound healing. Various devices provide low-frequency or pulsed current. However, these systems have limitations in their tissue penetration, application specificity, and antimicrobial efficacy.

[0003] High-frequency electrotherapy, which typically operates in the range of 500 kHz to 10 MHz, or more specifically, 1 MHz to 3 MHz for dermatological applications, has proven to be an effective method for promoting microcirculation, improving tissue oxygenation, reducing inflammation, and stimulating cell regeneration. In dermatology, these devices are already being used with positive results to treat acne, wrinkles, scars, and inflammation. However, their adaptation to the structured, safe, and targeted treatment of chronic wounds is still underutilized in current wound treatment protocols. Furthermore, conventional devices lack the integration of additional antimicrobial mechanisms, intelligent feedback systems, and versatile electrode interfaces, limiting their broader application and therapeutic precision.

[0004] Chronic, non-healing wounds continue to pose a significant burden in clinical medicine, particularly in the elderly, diabetics, and patients with compromised vascular or immune systems. These wounds include diabetic foot ulcers, pressure ulcers, venous leg ulcers, and surgical site infections, which are often not treated with standard wound healing protocols. The persistence of such wounds is often due to impaired circulation, reduced oxygenation, repeated trauma, biofilm-forming bacterial colonization, and an inadequate cellular response to the healing process. Conventional wound care typically includes debridement, dressings, topical antimicrobials, negative pressure therapy, and systemic antibiotics. While these treatments provide partial relief or delay disease progression, their effectiveness is limited in wounds with complex pathophysiology.Furthermore, long-term antibiotic use has contributed to the growing problem of antibiotic resistance and has necessitated non-pharmacological interventions that can promote wound healing while minimizing systemic toxicity.

[0005] In recent decades, numerous complementary technologies have been developed to support wound healing. Hyperbaric oxygen therapy (HBOT), for example, delivers oxygen at elevated atmospheric pressure to enhance oxygen diffusion in hypoxic tissue. Although HBOT has proven successful in treating some chronic ulcers, the equipment is expensive, immobile, and requires long, supervised treatment courses. Furthermore, patients with certain comorbidities or claustrophobia may not tolerate HBOT well, limiting its universal applicability.

[0006] Another widely used method is low-level laser therapy (LLLT). It uses photobiomodulation to stimulate mitochondrial activity and increase cell proliferation. LLLT is generally non-invasive and safe, but its clinical benefit is inconsistent due to variable dosimetry, wavelength limitations, and the need for specialized training. Furthermore, LLLT does not penetrate particularly deeply into tissue structures and is therefore less suitable for ulcers with underlying ischemia or necrotic tissue.

[0007] Ultrasound therapy is another tool in modern wound care. It works primarily by stimulating cell migration and increasing blood flow through mechanical sound waves. Although ultrasound devices are effective for some superficial wounds, they often require frequent and prolonged use. Their mechanical energy can sometimes cause discomfort or further tissue damage if improperly calibrated. Furthermore, their effectiveness against microbial biofilms is limited, requiring the concomitant use of antimicrobial agents for significant results.

[0008] Negative-pressure wound therapy (NPWT) has also proven to be a promising approach. It applies local negative pressure to the wound to evacuate fluids, reduce edema, and promote granulation tissue formation. NPWT is particularly useful for large or deep wounds, but its use is limited by several factors. These include high cost, complex device maintenance, the need for skilled clinical staff, and its relative ineffectiveness for wounds with low exudate or in anatomically difficult locations. Complications such as bleeding or maceration may occur with NPWT treatment in patients with sensitive skin or at high risk of infection.

[0009] Topical agents, including silver-based dressings, iodine, honey, hydrocolloids, and enzymatic wound cleansers, are also popular in wound management. Many of these agents have antibacterial or moisture-retaining properties, but their effectiveness depends on careful wound assessment and regular reapplication. Furthermore, these agents may lose their effectiveness in the presence of biofilm-forming, multidrug-resistant organisms. The static application of topical dressings contributes little to stimulating deeper tissue healing mechanisms such as angiogenesis or fibroblast activation.

[0010] Electrotherapy, particularly high-voltage pulsed current therapy, has also been investigated for wound healing. These systems deliver monophasic pulsed currents to promote epithelialization and fibroblast activity. However, they typically operate at low frequencies and often cannot generate ozone or thermal effects, limiting their antimicrobial range and tissue penetration. Furthermore, the fixed pulse shapes and intensities may not adapt to dynamic wound healing stages, which can compromise overall efficacy.

[0011] In recent years, high-frequency electrotherapy has been recognized as a potential solution that can address many of the drawbacks of traditional wound treatment methods. This form of therapy, which typically operates in the frequency range of 500 kHz to 10 MHz, offers both thermal and non-thermal benefits. The thermal component increases local tissue temperature, thereby improving blood flow, nutrient delivery, and cellular metabolism. At the same time, the high-frequency alternating current stimulates ion movement, improves nerve conduction, and can promote muscle relaxation in the surrounding tissue. Despite these advantages, commercially available high-frequency devices are often used for cosmetic applications, such as acne treatment, skin tightening, and wrinkle smoothing.Their therapeutic potential in the field of non-healing wounds remains poorly understood, mainly due to device limitations, lack of standardized protocols, and insufficient integration of antimicrobial functionalities.

[0012] Furthermore, most high-frequency devices on the market use fixed electrode shapes and delivery systems, making them suboptimal for wounds with irregular contours or difficult anatomical positioning. The inability to customize electrode configuration and energy delivery limits treatment precision and patient comfort. Furthermore, the lack of integrated feedback mechanisms in many consumer or semi-professional devices complicates real-time monitoring of therapeutic parameters such as tissue temperature, impedance, or healing progress, which are critical for patient safety and treatment efficacy.

[0013] A major disadvantage of current electrotherapy devices is their limited antimicrobial effect. Bacterial colonization and biofilm formation are the main reasons for poor wound healing. Conventional electrotherapy devices lack mechanisms to directly combat microbial growth. Studies show that electrical stimulation can disrupt biofilms and damage bacterial cell walls; however, this effect is often insufficient without accompanying antiseptic agents. Since most devices lack an integrated ozone generator module, their local disinfection potential is underutilized. Ozone, a triatomic oxygen molecule, has well-documented antimicrobial, antifungal, and virucidal properties. In safe, localized concentrations, it can oxidize bacterial cell membranes and inactivate pathogens without promoting resistance.However, dedicated ozone generators are typically standalone devices that are rarely integrated into wound therapy devices. This leads to cumbersome installations and inefficiencies in clinical workflows.

[0014] To overcome these numerous limitations, a compact high-frequency electrotherapy device combining adjustable waveform modulation, multi-electrode adaptability, real-time feedback control, and integrated ozone-assisted wound sterilization represents a technologically promising solution. Such a system would overcome the barriers of existing treatment modalities by enabling targeted, non-invasive, and highly customizable treatment that not only promotes tissue regeneration and angiogenesis but also actively combats the microbial burden without the need for systemic antibiotics. Thanks to user-friendly interfaces and portable design features, such a device could be used not only in clinical settings but also in rural or home settings, thus improving access to high-quality wound care and reducing hospitalization rates.The technical basis of such a device is based on existing principles of dielectric heating, capacitive coupling, and ion-induced oxidation. However, its integration and functional optimization for the treatment of chronic wounds represents a significant improvement over the state of the art.

[0015] However, there remains a significant gap in the current technology landscape regarding a robust, efficient, and adaptable high-frequency device specifically designed for the treatment of chronic wounds. The present invention aims to close this gap and set a new standard in electrotherapeutic wound treatment. Summary of the invention

[0016] The present invention relates to a novel high-frequency electrotherapy device specifically designed for the treatment of chronic, non-healing wounds, ulcers, and associated skin conditions. The device utilizes controlled high-frequency alternating currents in the range of 1 to 3 MHz, directed through a series of specialized electrodes to optimize energy delivery to the wound. The core functionality of the device is to penetrate the epidermal and subdermal layers, stimulate fibroblast activity, promote neovascularization, and improve tissue oxygenation.

[0017] The integrated local ozone generation module is unique. It uses corona discharges to generate ozone gas during therapy, which is simultaneously released into the treatment area. This enhances the antibacterial and antimicrobial efficacy of the treatment without the need for external antiseptics or medications. The system also features an intelligent control unit that dynamically adjusts the output parameters based on the impedance feedback of the treated tissue. This ensures optimal therapeutic effect and minimizes the risk of thermal damage or overstimulation.

[0018] The device architecture includes a main console with a digital interface, frequency and intensity controls, and multiple electrode ports. Interchangeable electrodes—including mushroom, spark, and pointed electrodes—are included to enable precise treatment of different anatomical areas and wound geometries. The overall system is portable, lightweight, and ergonomically optimized for clinical and home use. It features a rechargeable power supply and safe thermal insulation. Thanks to its advanced design and versatility, the high-frequency electrotherapy device offers a safe, non-invasive, and highly effective method for accelerating wound healing and improving patient outcomes.

[0019] The primary objective of the present invention is to provide a high-frequency electrotherapy device specifically designed to accelerate the healing of non-healing and chronic wounds. It combines advanced tissue stimulation, thermal modulation, and antimicrobial functions in a single compact unit. The goal of this invention is to overcome the limitations of conventional wound treatment therapies, such as limited penetration depth, inconsistent clinical outcomes, inadequate microbial control, and high treatment costs. The invention offers a synergistic, non-invasive solution that promotes angiogenesis, improves microcirculation, enhances fibroblast activity, and simultaneously sterilizes the wound surface.

[0020] Another objective of the invention is the adaptive, real-time control of therapeutic parameters such as frequency, waveform, power intensity, and treatment duration via a programmable and user-friendly interface. This ensures precise adjustment of energy delivery to individual wound characteristics such as size, depth, moisture content, and tissue conductivity. This maximizes therapeutic efficacy while minimizing discomfort and the risk of thermal injury. The use of various electrode configurations—such as point, flat, or roller probes—further supports the treatment of wounds in anatomically complex or sensitive regions, ensuring even energy distribution and greater adaptability for the user.

[0021] Another objective of the invention is the integration of an ozone generation module directly into the radiofrequency device to enable localized, controlled ozone therapy. The introduction of low-concentration ozone at the wound site enhances the antimicrobial effect by oxidizing bacterial cell walls and disrupting biofilms. This reduces the microbial load without the need for systemic antibiotics. This dual function—the combination of electrotherapy and ozone-based disinfection—provides an effective complementary tool for the treatment of wounds infected with multidrug-resistant organisms or recurrent microbial colonization.

[0022] Another objective of the invention is to ensure portability, ergonomic handling, and ease of use, allowing the device to be used not only in specialized clinical settings, but also in remote, rural, or home settings where access to advanced wound care is limited. The invention is equipped with modular components and safety interlocks that enable easy maintenance, minimize user errors, and ensure consistent performance across different patient populations and wound types. Integrated thermal and impedance sensors also monitor treatment response in real time and enable dynamic adjustment of parameters for personalized therapy.

[0023] Furthermore, the invention aims to provide a cost-effective, reusable, and durable solution that minimizes dependence on consumables such as medical dressings, frequent dressing changes, or systemic pharmacological agents. By accelerating wound closure and reducing the incidence of secondary infections or complications, the invention also aims to reduce treatment time and healthcare burden associated with chronic wound care. Through these integrated goals, the present invention creates a novel and highly effective platform for treating complex wound conditions, improves patient outcomes, and sets new standards in non-pharmacological wound healing technology. SHORT DESCRIPTION OF THE FIGURE

[0024] These and other features, aspects, and advantages of the present invention will become more readily understood when the following detailed description is read in conjunction with the accompanying drawings, in which like characters represent like parts throughout. Fig. Figure 1 shows a block diagram of a high-frequency electrotherapy device for non-healing wounds.

[0025] Those skilled in the art will also appreciate that the elements in the drawings are shown for convenience and are not necessarily to scale. For example, the flowcharts illustrate the method by key steps to enhance understanding of aspects of the present disclosure. Furthermore, with respect to device construction, one or more components of the device may be represented in the drawings by conventional symbols. The drawing may show only the specific details relevant to understanding embodiments of the present disclosure in order not to clutter the drawing with details that would be readily apparent to those skilled in the art from the present description. Detailed description of the invention

[0026] To facilitate an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and a clear description thereof. However, the scope of the invention is not limited thereby. Changes and further modifications to the illustrated system, as well as further applications of the principles of the invention, are possible, as would normally occur to one skilled in the art to which the invention pertains.

[0027] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be limiting thereof.

[0028] References in this specification to "one aspect," "another aspect," or similar language mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Therefore, the language "in one embodiment," "in another embodiment," and similar language throughout this specification may or may not refer to the same embodiment.

[0029] The terms "comprises," "comprising," or other variations thereof are intended to cover non-exclusive inclusion, such that a process or method comprising a list of steps may include not only those steps, but also additional steps not expressly listed or inherent in that process or method. Likewise, the statement "comprises" for one or more devices, subsystems, elements, structures, or components does not exclude, without further limitation, the existence of other devices, subsystems, elements, structures, components, or additional devices, subsystems, elements, structures, or components.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. The systems, methods, and examples provided herein are for illustrative purposes only and should not be considered limiting.

[0031] Embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings.

[0032] Figure 1 shows a block diagram of a high-frequency electrotherapy device for non-healing wounds. The system 100 comprises: a signal generation module (102) that generates a high-frequency alternating electrical signal in the range of 1.0 MHz to 1.8 MHz with a waveform selected from sinusoidal or pulsed sinusoidal profiles; a power amplification circuit (104) electrically connected to the signal generation module and boosting the signal to a therapeutic voltage in the range of 200 V to 500 V RMS; a dielectrically coated glass electrode (106) containing a noble gas selected from neon, argon, or xenon, the electrode being shaped for direct surface application to skin wounds and removably connected to the output of the power amplification circuit via a high-voltage coupling capacitor (106a);a microcontroller-based feedback system (108) configured to monitor skin impedance in real time and dynamically modulate the output amplitude and treatment duration to maintain local tissue exposure within predetermined bioimpedance and thermal safety thresholds; a safety interlock mechanism (110) comprising a capacitive proximity sensor (110a) embedded in the electrode rod, wherein signal output is only permitted upon verified contact with human skin within a calibrated pressure and proximity range; and a programmable user interface (112) configured to execute wound-specific treatment protocols (112a) comprising predefined exposure durations, modulation frequencies, and rest intervals optimized for diabetic ulcers, pressure ulcers, and post-surgical wounds.

[0033] In one embodiment, the dielectrically coated electrode (102) has a surface roughness of less than 0.5 micrometers Ra and a tip radius of no more than 2.5 mm. Furthermore, a thermistor is embedded within it to measure the surface temperature at the skin contact point. The thermistor is connected to the microcontroller to interrupt signal transmission if the skin surface exceeds 42°C during continuous operation.

[0034] In one embodiment, the high voltage coupling capacitor A (106a) is made of a ceramic dielectric with a dielectric constant greater than 10,000 and is designed for continuous operation at 1.5 times the maximum therapeutic voltage, with the thermal shutdown circuit being activated when the internal capacitor temperature exceeds 85°C.

[0035] In one embodiment, the signal generation module (102) includes a digitally tunable frequency oscillator implemented via a direct digital synthesis (DDS) chip, enabling stepwise frequency increases of 10 kHz within said therapeutic range, while maintaining waveform distortion below 3% total harmonic distortion (THD) at full output load.

[0036] In one embodiment, the microcontroller-based feedback system (108) is coupled to a 12-bit analog-to-digital converter (ADC) that measures skin impedance at a rate of 100 samples per second and uses a proportional-integral-derivative (PID) control technique to adjust the voltage amplitude in real time based on the detected impedance variability.

[0037] In one embodiment, the capacitive proximity sensor (110a) embedded in the electrode rod has a parallel plate architecture with an effective sensing field depth of 2-5 mm and is shielded to suppress electromagnetic interference from the high-frequency oscillator.

[0038] In one embodiment, the programmable user interface (112) consists of a 2.4-inch TFT LCD touchscreen with capacitive touch support, allowing selection of protocol presets and real-time visualization of waveform output, impedance curves, and a treatment progress bar updated every 250 milliseconds.

[0039] In one embodiment, the wound-specific treatment protocols (112a) are stored in a non-volatile flash memory and executed via finite state machine (FSM) logic, each protocol comprising at least three sequential treatment phases: initial microcirculation stimulation, collagen induction in the middle phase, and microbial control in the final phase by ozone-enhanced spark pulses.

[0040] In one embodiment, the ozone generation produced during the radiofrequency discharge is passively controlled by a multilayer carbon-impregnated mesh embedded in the discharge orifice of the electrode to reduce the ozone concentration to ≤ 0.02 ppm while maintaining therapeutic antimicrobial efficacy.

[0041] In one embodiment, the entire system is enclosed in an electromagnetically shielded dual-chamber enclosure consisting of an inner Faraday cage and an outer conductive polymer enclosure. This configuration attenuates radiated emissions in the frequency range of 1 to 10 MHz by at least 60 dB, measured in an anechoic chamber.

[0042] The high-frequency electrotherapy device described here promotes the healing of chronic, non-healing wounds such as diabetic ulcers, pressure ulcers, and post-surgical wounds. The device consists of several key components that work together to deliver targeted therapeutic treatment. The central element of the device is a signal generation module that generates a high-frequency alternating current signal in the therapeutic range of 1.0 to 1.8 MHz. This signal is designed to stimulate the wound area, thus promoting microcirculation and tissue regeneration without damaging healthy tissue. The signal can be generated as a sinusoidal or pulsed sinusoidal waveform, with the frequency and amplitude precisely controlled to ensure that the therapeutic effects are tailored to the patient's specific needs.

[0043] The high-frequency signal generated by the signal generation module is passed to a power amplification circuit. This circuit amplifies the signal to a therapeutic voltage level suitable for clinical use, typically between 200 V and 500 V RMS. To ensure that the signal remains safe and effective during therapy, the power amplification system is coupled to a dielectric-coated glass electrode. The electrode, which contains a noble gas such as neon, argon, or xenon, is designed for direct application to the wound. Its shape is optimized to ensure maximum contact area with minimal discomfort or risk to the patient. The use of noble gases in the electrode enables the generation of ozone, which has antibacterial properties.This ozone generation is a key feature of the device as it helps prevent infection in non-healing wounds while promoting tissue healing.

[0044] A microcontroller-based feedback system within the device monitors and adjusts treatment parameters in real time. This system continuously monitors skin impedance during treatment. By measuring impedance, the system can dynamically adjust the output amplitude and duration of the radiofrequency signal to ensure that the delivered energy is safe and effective for the tissue being treated. This feedback system prevents overheating and tissue damage while maintaining optimal conditions for tissue regeneration. Real-time impedance monitoring also allows the system to respond to changes in skin properties during treatment and adjust therapeutic parameters accordingly.

[0045] The technique used to control this feedback system is based on a PID (proportional-integral-derivative) control loop, which is commonly used in systems that require real-time adjustments. The PID controller receives the impedance data from the microcontroller's integrated analog-to-digital converter (ADC). This ADC, with a sampling rate of 100 samples per second, converts the impedance values from analog to digital, allowing the controller to make rapid adjustments to the output signal. The PID controller works by adjusting the amplitude of the output signal based on three parameters: proportional, integral, and derivative. The proportional term adjusts the output based on the current impedance value, the integral term accounts for cumulative changes over time, and the derivative term predicts future impedance changes.Together, these parameters allow for smooth and precise regulation of the signal amplitude to ensure that the wound receives the appropriate amount of therapeutic energy, thereby improving the effectiveness of the treatment.

[0046] The feedback system is further supported by a thermistor integrated into the electrode head. This measures the surface temperature of the electrode during application and ensures that the temperature does not exceed a predefined threshold (typically 42°C). If the temperature exceeds this threshold, the microcontroller triggers an automatic shutdown mechanism and stops the signal output to prevent burns or thermal damage to the patient's skin. This additional protective measure is crucial for patient safety during longer treatments, especially for larger or deeper wounds.

[0047] In addition to the therapeutic benefits of high-frequency current, the device also features an ozone generation function. This is created by the interaction of the high-frequency signal with the noble gases in the electrode. The ozone possesses natural antimicrobial properties that contribute to the sterilization of the wound area, killing harmful bacteria and preventing infection. The ozone concentration is carefully controlled. The system is designed to limit ozone production to a level that allows for effective wound sterilization without endangering the patient. A carbon-impregnated mesh embedded in the outlet opening of the electrode regulates the ozone concentration and ensures that the concentration remains within safe limits (typically ≤ 0.02 ppm).

[0048] The device features a programmable user interface that allows physicians to select from various wound-specific treatment protocols. These protocols, stored in non-volatile flash memory, contain predefined sequences of treatment steps for specific wound types, such as diabetic ulcers or pressure ulcers. Each protocol includes parameters such as exposure duration, modulation frequency, and rest intervals between radiofrequency pulses. This ensures that the treatment is both effective and individually tailored to the patient. The user interface displays real-time treatment data, including waveform output, impedance curves, and treatment progress. This allows physicians to monitor therapy and make adjustments as needed.

[0049] To ensure safety and prevent misuse, the system features a capacitive proximity sensor integrated into the electrode rod. This sensor detects the proximity of the electrode to the skin and only emits a signal upon proper skin contact. This feature prevents accidental high-voltage discharges and ensures that the device only functions under controlled conditions. Additionally, the system incorporates a safety lock mechanism that restricts device operation to certified medical personnel using RFID authentication. This prevents unauthorized use and ensures that the device is operated by individuals trained in its safe and effective use.

[0050] The entire system is housed in an electromagnetically shielded enclosure that attenuates radiation emissions, ensuring compliance with EMC standards. The enclosure has a two-part design consisting of an inner Faraday cage and an outer conductive polymer housing. These reduce electromagnetic interference and ensure the device operates without interfering with nearby medical devices.

[0051] In summary, the high-frequency electrotherapy device combines state-of-the-art signal generation and amplification technology, real-time impedance monitoring and control, ozone generation for antimicrobial action, and safety features to protect both patient and user. The system's technology-based feedback mechanism ensures continuous adjustment of treatment parameters for optimal wound healing, making it a valuable tool for the treatment of chronic, non-healing wounds.

[0052] The invention comprises an electrotherapy device housed in a compact, insulated housing made of medical-grade thermoplastic polymer with an antimicrobial surface treatment. The main housing contains the key electronic components, including a high-frequency oscillator capable of generating AC signals between 1 MHz and 3 MHz. The oscillator is connected to a step-up transformer and a frequency tuning circuit that allows precise control of the signal shape, amplitude, and duty cycle. These parameters are adjustable via a capacitive touchscreen on the top of the console, which also displays real-time output readings and patient-specific data inputs.

[0053] A microcontroller-based feedback system connected to a real-time impedance monitor is integrated into the oscillator circuit. This subsystem measures the electrical resistance of the tissue in contact with the electrode and dynamically regulates the output power to prevent overheating, overpenetration, or tissue desiccation. The system includes a preprogrammed library of treatment protocols tailored to different wound types, anatomical locations, and patient profiles, including settings for acute lesions, diabetic ulcers, and postoperative non-healing wounds.

[0054] The device includes three main electrode types: a mushroom electrode with a wide glass applicator for superficial skin treatment and improving microcirculation; a spark electrode with a pointed tip and higher energy density for deeper lesions or infected tissue; and a fine electrode for narrow or inaccessible wounds. Each electrode is attached to a handpiece connected to the main console via a shielded cable. This can be sterilized or replaced as needed. The electrodes are encased in dielectric glass or quartz to ensure safe application while maintaining electrical insulation from the user's hand.

[0055] The device is powered by a rechargeable lithium-polymer battery housed within the housing. An integrated battery management system (BMS) ensures safe charging and discharging cycles. The system can be charged with both AC and DC current. Thermal sensors near the electrode base monitor the temperature and transmit the data to the control unit, which automatically shuts off the device if it overheats.

[0056] To ensure safety, the device is equipped with electrical insulation according to IEC 60601 for medical devices and has an integrated fuse and earthing system.

[0057] During operation, the user selects the appropriate electrode and treatment mode via the user interface, adjusts the frequency and intensity to the wound profile, and gently applies the electrode to the wound. The electrode emits high-frequency electrical currents that penetrate the skin layers, triggering a thermal and mechanical response that promotes blood flow and fibroblast activation. At the same time, the generated ozone is directed onto the wound surface to kill pathogenic microorganisms, reduce bioburden, and minimize the risk of secondary infections. The treatment session typically lasts 10 to 15 minutes and can be repeated daily or as prescribed by a physician.

[0058] The invention is particularly suitable for outpatient clinics, rehabilitation centers, dermatology departments, and home care settings, offering a non-invasive and drug-free method for treating difficult-to-treat wounds. Its portability, combined with intelligent treatment control and antimicrobial properties, provides a complete solution for both practitioner and patient. The high-frequency electrotherapy device thus represents a significant advance in wound care technology by combining electrotherapeutic stimulation with ozone-assisted sterilization in a compact, user-friendly, and clinically effective system.

[0059] The invention relates to the field of medical devices, particularly those for wound healing and tissue regeneration. More specifically, the invention relates to an electrotherapy device that uses high-frequency alternating currents to treat chronic, non-healing wounds, promote tissue repair, and prevent infection. The device incorporates advanced features such as real-time impedance monitoring, ozone generation for antimicrobial effects, and a controlled feedback system to ensure patient safety and efficacy. This high-frequency electrotherapy device finds applications in dermatology, wound care, rehabilitation, and physical therapy, offering a non-invasive, cost-effective, and safe treatment method for patients with chronic or difficult-to-heal wounds.

[0060] The drawings and the foregoing description show examples of embodiments. Those skilled in the art will recognize that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be separated into multiple functional elements. Elements of one embodiment may be added to another embodiment. For example, the order of the processes described herein may be changed and is not limited to the manner described herein. Furthermore, the actions of a flowchart need not be performed in the order shown; nor do all actions necessarily have to be performed. Also, actions that are not dependent on other actions may be performed in parallel with the other actions. The scope of the embodiments is in no way limited by these specific examples.Numerous variations, whether explicitly stated in the specification or not, such as differences in structure, dimensions, and use of materials, are possible. The scope of the embodiments is at least as broad as indicated in the following claims.

[0061] Advantages, further benefits, and solutions to problems have been described above with reference to specific embodiments. However, the advantages, advantages, solutions to problems, and any components that may result in or enhance an advantage, advantage, or solution are not to be construed as critical, required, or essential features or components of any or all of the claims. REFERENCES 100 A high frequency electrotherapy device for non-healing wounds. 102 Signal generation module 104 Power amplification circuit 106 Dielectric coated glass electrode 106a high-voltage coupling capacitor 108 Microcontroller-based feedback system 110 Safety locking mechanism 110a Capacitive proximity sensor 112 Programmable user interface 112a Wound-specific treatment protocols

Claims

[1] A high-frequency electrotherapy device for promoting the healing of chronic, non-healing wounds, comprising: a signal generation module configured to generate a high-frequency alternating electrical signal in the range of 1.0 MHz to 1.8 MHz with a waveform selected from sinusoidal or pulsed sinusoidal profiles; a power amplification circuit electrically coupled to the signal generation module and configured to boost the signal to a therapeutic voltage in the range of 200 V to 500 V RMS; a dielectrically coated glass electrode containing a noble gas selected from neon, argon, or xenon, the electrode being shaped for direct surface application to skin wounds and being removably coupled to the output of the power amplification circuit via a high-voltage coupling capacitor; a microcontroller-based feedback system configured to monitor skin impedance in real time and dynamically modulate output amplitude and treatment duration to maintain local tissue exposure within predefined bioimpedance and thermal safety thresholds; a safety locking mechanism comprising a capacitive proximity sensor embedded in the electrode rod, wherein the signal output is only permitted upon proven contact with human skin within a calibrated pressure and proximity range; and a programmable user interface configured to execute wound-specific treatment protocols that include predefined exposure durations, modulation frequencies, and rest intervals optimized for diabetic ulcers, pressure ulcers, and post-surgical wounds. [2] The device of claim 1, wherein the dielectric coated electrode has a surface roughness of less than 0.5 micrometers Ra and a tip radius of at most 2.5 mm and is further provided with an embedded thermistor to measure the surface temperature at the skin contact point, the thermistor being connected to the microcontroller to interrupt the signal transmission when the skin surface exceeds 42 °C during continuous operation. [3] The device of claim 1, wherein the high voltage coupling capacitor is made of a dielectric ceramic material having a dielectric constant greater than 10,000 and is designed for continuous operation at 1.5 times the maximum therapeutic voltage, with a thermal shutdown circuit activated when the temperature inside the capacitor exceeds 85°C. [4] The apparatus of claim 1, wherein the signal generation module comprises a digitally tunable frequency oscillator implemented via a direct digital synthesis (DDS) chip, enabling stepwise frequency increases of 10 kHz within said therapeutic range while maintaining waveform distortion below 3% total harmonic distortion (THD) at full output load. [5] The apparatus of claim 1, wherein the microcontroller-based feedback system is coupled to a 12-bit analog-to-digital converter (ADC) that measures skin impedance at a rate of 100 samples per second and uses a proportional-integral-derivative (PID) control technique to adjust the voltage amplitude in real time based on the detected impedance variability. [6] The device of claim 1, wherein the capacitive proximity sensor embedded in the electrode rod has a parallel plate architecture with an effective sensing field depth of 2-5 mm and is shielded to suppress electromagnetic interference from the high frequency oscillator. [7] The device of claim 1, wherein the wound-specific treatment protocols are stored in a non-volatile flash memory and executed via a finite state machine (FSM) logic, each protocol comprising at least three sequential treatment phases: initial microcirculation stimulation, collagen induction in the middle phase, and microbial control in the final phase by ozone-enhanced spark pulses. [8] The device of claim 1, wherein the ozone generation generated during the radiofrequency discharge is passively controlled by a multi-layer carbon-impregnated mesh embedded in the discharge opening of the electrode to reduce the ozone concentration to ≤ 0.02 ppm while maintaining therapeutic antimicrobial efficacy. [9] The apparatus of claim 1, wherein the entire system is housed in a dual-chamber electromagnetically shielded enclosure consisting of an inner Faraday cage and an outer conductive polymer enclosure, the configuration attenuating radiated emissions in the frequency range 1 to 10 MHz by at least 60 dB, as measured in an anechoic chamber.

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