BG4117U1 - Hybrid plasma pen for ablation and sterilization of tissues through low temperature plasma - Google Patents

Abstract

The utility model relates to a hybrid plasma pen with low temperature plasma applicable in medicine and cosmetics for generating low temperature plasma. There are two operating modes, the first (A), for sterilization of wounds or for removal of skin deformities, lesions, the range of which may include microscopic formations and growths of tumors on the skin and mucosa, the second (B), for removal of devitalized tissue, removal of bacterial biofilm, control of bacterial load and stimulation of wound healing process by stimulating dermal cell proliferation, collagen synthesis and epidermal regeneration. It is characterized by small size, mobility, high level of automation, high efficiency, increased energy efficiency at low supply voltage and long battery life. It consists of a processor (10) connected to four buttons (11,12,13,14) for manual control and a fifth button (17) for pulse control. The processor (10) is connected to a stabilizer (15), through a high-voltage transformer (18), a winding coil (19) to the electrode head (8) with an electrode (9).

Description

Field of technology

The utility model refers to a hybrid plasma pen with low temperature plasma for ablation and sterilization of tissues applicable in medicine and cosmetics. It is used to sterilize wounds or to remove skin deformities, lesions. whose range may include microscopic formations and growths of tumors on the skin and mucous membranes. In particular, this utility model relates to a portable plasma device, with various attachments, directing / concentrating electrical voltage to tissues for a wide variety of applications, including medical procedures such as: disinfection and stimulation of wound healing, tissue ablation, resection, electrosurgery and others.

BACKGROUND OF THE INVENTION

The field of electrosurgery includes a number of loosely related surgical techniques that have a common application of electrical energy to change the structure or integrity of human tissue. Electrosurgical procedures usually work by applying high-frequency currents and charges to cut or ablate tissues, and the operation can be mono-polar or bi-polar. Mono-polar techniques rely on a separate electrode to return the current, which is placed away from the treated area, and the surgical device determines only one electrode pole, which provides the surgical effect. Bipolar devices contain two or more electrodes on the same support to apply current between their surfaces.

Electrosurgical procedures and devices are particularly advantageous, as they usually reduce bleeding and trauma associated with traditional cutting methods. In addition, some electrosurgical ablation procedures cannot be replaced by an alternative method.

Radio frequency (RF) energy is used in a wide range of surgical procedures, as it provides effective resection and coagulation of tissues and relatively easily reaches the target tissues, through a precise tip. Conventional monopolar high-frequency electrosurgical devices typically work by creating a voltage difference between the active electrode and the target tissue, resulting in the formation of an electric arc through the physical gap between the electrode and the tissue. At the point of contact of the electric arcs with the tissue, rapid heating of the tissues occurs due to the high current density between the electrode and the tissue. This high current density causes cellular fluids to be converted into steam, thus evaporating and producing an "ablation" effect through localized tissue heating.

Electrical devices to change the structure or integrity of human cauterine tissue contain a bottle of gases such as helium and argon. This type of plasma coagulation / ablation device typically uses radio frequency generators that are large, heavy, and non-portable. Due to their size, patients could only benefit from current plasma coagulation / ablation technologies by traveling to a hospital or clinic to receive treatment. This limitation makes such treatments expensive and often restricts or hinders the patient's access to its benefits. For easier operation, the electric cauter is divided into two modules. The first module is a multi-component high-frequency radio frequency converter and has a complex circuit, 220 V power cables, cooling system and manual voltage regulator. As a result, many patients do not have access to this expensive and limited but useful technology, which can only be used in hospitals and clinics. The second module is a nozzle electrically connected by cables that transfer high voltage to the precise tip of the nozzle. There is a handle made of insulating material for convenience and safety during operation. Despite these conveniences, the device is not suitable for mass use.

Characteristic of it is that it has a complex multi-component circuit, cables, high power consumption and the possibility of overheating. In addition, it is difficult and impractical to manually adjust the voltage, as the wrong current flowing to the tissue can lead to unwanted burns and damage to healthy tissue.

Existing tissue ablation devices have a limitation in their service life due to the fact that high voltage and a large high voltage transformer are required to generate the plasma peak to the tissue. They usually last up to 1 hour in constant operation, which in itself predisposes to constant charging of the electric cauter. This is also characterized by high power consumption. They have the same type of nozzle, which makes it difficult to handle, according to each individual situation. With different voltages applied to the same nozzle and poor pulse control, the possibility of unwanted burning of healthy surrounding tissue increases many times over.

Numerous medical studies have shown that plasma in combination with ozone and ultraviolet rays generated by plasma charge have a good sterilizing effect. They can also effectively kill viruses, spores, fungi and bacteria, such as Enterococcus fecalis, which are extremely resistant to antibiotics.

Plasma treatment after tissue damage prevents secondary tissue infection due to its sterilizing action and is effective in healing wounds with rapid hemostatic action. If the plasma treatment of venous ulcer is repeated for two minutes a day, the healing process is increased many times over. After 11 treatments at the wound site, no bacteria were detected (Gregory, Plasma Chern Plasma Process 26, 2006).

Periodic treatment with plasma on the skin also stimulates skin cells to increase collagen in the dermal layer and due to increased secretion of SERF (Vascular Endothelial Growth Factor), new blood vessels are responsible for nourishing new cells and thus an anti-aging effect can be expected. . Therefore, plasma can be very useful in improving the healing process in both healthy patients and patients with blood diseases (Heilin, J Dtsch Dermatol Ges 8, 2010).

A system for reducing microbes by cold plasma is known from U.S. Pat. No. 100,290,225. It contains a housing, one end of which is closed with a cap, and the other end is a cone with a hole in the middle. On the cap there is a USB input through which a power source is connected to a battery, such as

BG4117 UI in the housing is located circuit board is electronic elements and control circuit for control circuit. A fan is mounted on the board and is connected to a pulse piezotransformer connected to an electrode head, which is located in the hole of the cone. The treated area is insulated with a dielectric film. The ventilator produces reduced pressure in the isolated space in which the cold plasma is ignited, which destroys bacteria or manipulates the patient's tissue.

It is characteristic of the well-known system for reducing microbes by cold plasma that it has the same type of tip, a complex scheme that makes it difficult to process, according to each individual situation. With different voltage applied to the same nozzle and poor pulse control, there is increased energy consumption, and a complex scheme for processing and manipulation of tissue.

Technical essence of the utility model

The task of the utility model is to create a hybrid plasma pen with low temperature plasma providing simple and efficient cuts by ablation of different types of tissues, the action is on the treated area, compact, with a simple scheme and low power consumption, diverse plasma depending from the set mode, long battery life, with power to generate and maintain plasma relative to the operating mode when using different electrode tips.

The problem is solved by a hybrid, low-temperature plasma pen, consisting of a housing, one end of which is closed with a cap and the other end is a cone with a hole in the middle, USB input, which is connected to a battery, as in the housing has a circuit board and an electrode head. The hybrid plasma pen differs from the known ones in that a processor is mounted on the board. The first input, which is connected to the first button for manual control to change the mode and is mounted on the housing. The second input of the processor is connected to second buttons to increase the pulse rate, mounted above the first button on one side. The third input of the processor is connected to the third button to reduce the degree of pulses mounted against the second button. The fourth input of the processor is connected to a fourth button mounted opposite the first button, with the possibility of controlling a voltage stabilizer. An LCD display connected to the first output of the processor 10 is mounted between the four buttons and the cap. The fourth input of the processor is connected to a voltage stabilizer. Between the first button and the cone is mounted a fifth button for applying pulses to the electrode in the electrode head. The second output of the processor is connected to a voltage stabilizer, which is connected to the battery and through a high-voltage transformer winding to the electrode head mounted in the hole of the cylindrical cone. The USB input is located on the side of the LCD display.

To increase sterilization, the working bodies of the electrodes for ablation or sterilization are made of silver.

For better performance, the mounting body consists of a straight part and an inclined part at an angle of 45 °.

To increase the reliability of operation, the plug of the sterilization electrode is covered by a cap fixed to the fixing body.

BG 4117 UI

Hybrid plasma pen with low temperature plasma, has a low current consumption - 0.5 A. and the device itself has a very precise pointing process, high efficiency and small volume achieved with the manual control button - 'push-pull of the high voltage transformer and lithium ion battery Efficiency and precision are achieved through a combination of continuous spark discharge and heat energy. During ablation, the electrode with a continuous spark discharge is narrow and concentrated, which provides intact surrounding and healthy tissue around the treatment area. The spark discharge itself forms the plasma, which arises due to the high voltage, which varies from 15 to 20 kV. Prolongs battery life while reducing the weight and volume of the device. Replacing the electrode heads is easy and is done manually by attaching them to the electrode head. The operating mode can also be controlled manually, with different degrees that change the length and the pause between pulses. The difference in pulse and frequency changes the strength of the current flowing through the electrode head, and different characteristics are used in the application of each head.

The advantages of the proposed hybrid plasma pen for ablation and sterilization of tissues using low temperature plasma are:

• Hybrid device with two applications for quality and efficient performance of plasma ablation and plasma sterilization of tissues.

• The lack of cables and the long durability of the batteries allows practical and convenient operation in various fields.

• Ability to work and apply different electrode heads, according to the specifics of the situation, and their replacement is quick and easy.

• Ability to work with silver electrodes, which when generating plasma through the electrode releases silver ions, which further enhance and improve the healing process.

• The processor provides the effective depth of the incision in case of ablation or even and smooth sterilization, depending on the size and type of injury.

• Use of different electrode heads.

• Reduced size and extended battery life achieved with the application of the manual control button, .push-pull - voltage stabilizer with high voltage transformer, as well as precise regulation of the frequency, shape and length of the output pulses.

• During ablation, possible electrical discharges are avoided due to the passage of current to the patient. For these reasons, the device proves to be the ideal tool for treating sensitive areas. For example, as around the eye area, when performing blepharoplasty. without risk of optic nerve damage.

• During ablation, the treated area is cooled on its own by evaporating the lesion fluids during surgery without overheating the surrounding tissues.

• During sterilization, the plasma acts directly on the wound, which enhances the sterilizing effect, while the high voltage electric field stimulates the wound surface to accelerate local blood circulation, thus facilitating wound healing.

BG4117 UI • During sterilization, the plasma is below 40 ° C, which is completely safe for the human body and can be in direct contact with the skin.

Explanation of the attached figures

An exemplary embodiment of the hybrid plasma pen with low temperature plasma, the object of this utility model is shown in the attached figures, which only illustrate but do not limit it, where:

Figure 1 - Elements of a low temperature plasma hybrid plasma pen;

Figure 2 - Hybrid plasma pen with low temperature plasma with control elements;

Figure 3 - USB and controls;

Figure 4 - Forms of electrode types for tissue ablation;

Figure 5 - Forms of electrode types for tissue sterilization.

Example of utility model implementation

Figure 1 shows a hybrid plasma pen with low temperature plasma consisting of a housing 1 of medical plastic, one end of which is closed with a cap 2. and the other end is a cone 3 with a hole 4 in the middle, USB input 5, through which is connected power source not shown in the drawing to the battery 6, in the housing 1 is a board 7. In the hole 4 is mounted an electrode head 8 with the possibility of placing an electrode 9. On the board 7 is mounted a processor 10. The first input to which it is connected with a first button 11 with the possibility of manual control to change the mode and is mounted on the housing 1. The second input of the processor 10 is connected to a second button 12 with the possibility of increasing the pulses and is mounted above the button 11 on one side. The third input of the processor 10 is connected to a third pulse-reducing button 13 mounted against the second button 12. The fourth input of the processor 10 is connected to a fourth button 14 mounted against the first button 11. The fourth button 14 is manually operated of the stabilizer 15. Between the fourth button 14 and the cap 2 is mounted LCD display 16 connected to the first output of the processor 10. Figure 2 LCD display 16 shows the battery status 6 in percent, operating mode and degree of operation. Between the first button and the cone 3 on the body 1 is mounted a fifth button 17 for manual supply of pulses to the electrode head 8.

In Figure 1, the second output of the processor 10 is connected to a voltage regulator 15 connected to the battery 6 and through a high voltage transformer 18, a winding 19 to the electrode head 8.

In Figure 3, a USB input 5 is located on the side of the LCD display 16.

Figures 4 and 5 show different types of electrodes 9, which have different applications and differ in size, diameter or shape. Each of them is customized to treat a specific part of the body, type of tissue, or type of wound. The electrode 9 has a plug 20 connected through a mounting body 21 to a working body 22.

Figure 4 shows different versions of the working bodies of the electrodes 9.1 applicable to tissue ablation: 22.1 in the form of a flame, 22.2 in the form of a loop, 22.3 in the form of a rectangle

BG4117 UI from 0.2 mm x 12 mm to 08 mm x 12 mm. 21.4 with the shape of a cylinder from D = 01 mm x Η = 12 mm to D = 03 mm x H = 12 mm, 22.5 with the shape of a sphere with radius - r from 02 mm to 1.5 mm, 22.6 with the shape of a rod.

The fastening body 21 consists of a straight part 21.1 and an inclined part 21.2 at an angle of 45 °.

The plug 20 is covered by a cap 23 fixed to the body 21.

Figure 5 shows different variants of working bodies of electrodes 9.2 for sterilization of tissues: 22.7 in the form of a sphere with a radius of 1.6 mm to 15 mm, 21.8 in the form of an ellipse with eccentricity - is from 07 to 09, 21.9 in the form of ellipse c is 0.1 to 07, 21.10 elliptical c is 0.1 to 07 and knurled on the surface.

To increase the quality of work and increase the scope of application of the hybrid plasma pen with low-temperature plasma, the working bodies 22 of the electrodes 9.1,9.2 are made of silver.

The hybrid plasma pen with low-temperature plasma works as follows: The main mode of operation is to sterilize tissues and stimulate the healing process by directing plasma to a specific area of the human body. The plasma is generated by means of a high-voltage transformer 18 and an electrode head 8 with an electrode 9 directed towards the human body. Man appears as mass or earth, and electrode 9 is a source of high frequency voltage. During tissue treatment, hyper-charged ions, ultraviolet rays and ozone are generated from the plasma. These 3 elements themselves have a good sterilizing effect, and when using silver electrode heads, silver ions are also released, which further enhance the effect of the device. Removal of digitalized tissue, removal of bacterial biofilm and control of bacterial load, repeatedly improves and stimulates the healing process of tissue.

The second mode of operation of the hybrid plasma pen allows simple and effective ablation and cutting of organic tissue using plasma. It is used mainly for small skin and surgical procedures. Efficiency is achieved through a combination of continuous spark discharge and heat energy. The spark discharge itself forms the plasma, which occurs at high voltage, which varies from 15 to 20 kV. When the intensity is set to a high value, the heat energy destroys the skin cells. The ablation electrode 9 is thin and narrow, and the generated low-temperature plasma from the spark discharge is precise and concentrated. This is the reason for the undamaged healthy surrounding tissue surrounding the area, unlike the high-frequency DC knife and the AC burner. The spark discharge generated by them expands conically to the surface of the treated tissue. Also, during plasma ablation, the treated area is cooled on its own by evaporating the lesion fluids during surgery without overheating the surrounding tissues.

In order to understand the advantages, nature and characteristics of this utility model, a detailed description and method of implementation are provided, which are given as an example and not as a limitation with respect to the figures. Although some embodiments are shown and described in detail, it should be understood that various changes and modifications may be made without departing from the scope of the appended claims. The scope of implementation of this utility model will in no way be limited to the number of its constituent components, their materials, their shapes, their relative position, etc.

BG4117 UI

Hybrid plasma pen with low temperature plasma from lithium-ion battery 6 - 4400 mAh. The batteries are powered via the USB 5 socket, and their durability depends on their mode of operation and the electrode head 8 used. After switching on the device with the fourth button 14 for controlling the voltage stabilizer 15, the pen goes into operation. All components are located on the main board 7. The processor 10 recognizes the electrodes 9 along the length of the mounting body 21. Therefore, the frequency and pulse length will be properly configured relative to the individual, there will be no undesirable consequences associated with manual settings of the device. With respect to the length of the fastening body 21, the processor 10 recognizes the electrode head 8 and sends the necessary signal. Despite the automation of the process, the device also has a manual control mode. The operating mode change button 11 determines the frequency and energy of the current, while the manual pulse reduction button 13 and the manual pulse increase button 12 determine not only the pulse length and strength, but also the pause between pulses. They control the strength of the current flowing to the tissue. The voltage of 5 V supplied by the voltage stabilizer 15 is constant and does not affect the strength, type and condition of the generated plasma, these characteristics are fully controlled by the signals supplied by the processor 10. The signal from the processor 10 is fed directly to the high voltage transformer 18. realizes a continuous and stable discharge for the generation of plasma at normal temperature. Through the windings 19 the generated high voltage electricity is transmitted to the electrode head 8 with the electrode 9.

A Push-Pull transformer circuit based on a ferrite high-voltage transformer is applied to generate plasma. This increases the efficiency and reduces the size of the output transformer and characterizes the device with increased energy efficiency at low supply voltage, and hence the size of the batteries and the device itself. Electrodes 9 made entirely of silver are used. In the presence of plasma, hypercharged ions, ozone and ultraviolet rays are formed.

The electrode head 8 must fit snugly until the insulating cap 23 rests on the housing 1. This ensures correct recognition of the electrode head and the possible uncontrolled / undesirable skipping of the spark charge. Larger and denser working bodies such as 22.7; 22.8; 22.9; 22.10 are used in tissue sterilization mode. While thinner electrode tips like 22.1; 22.2; 22.3; 22.4; 22.5; 22.6 are used in tissue ablation mode.

Wound healing involves a complex and dynamic process of angiogenesis, cell proliferation, deposition of extracellular matrix and wound shrinkage. In this process, the devitalized tissue acts as a physical barrier to reepithelialization and prevents direct contact of the applied topical therapeutic agents with the target tissue to ensure its beneficial properties. As an example of devitalized tissue, the presence of necrotic tissue in the middle of the wound prevents angiogenesis, the formation of granulation tissue, epidermal regeneration and the formation of a normal extracellular matrix (ECM). In addition, devitalized tissue can serve as a food source for bacteria that promote the formation of

BG4117 UI biofilms and antibiotic resistance. This makes tissue sterilization an important step in wound healing and preparing target tissue for reepithelialization.

The current utility model includes a portable wound healing and sterilization system. It is characterized by the fact that it is portable, small in size, easy to operate, without the need for external inert gas, high energy efficiency and therefore high durability of the battery. It also generates low-temperature plasma under the influence of normal atmospheric pressure. By using operating mode (B), sterilization of target tissue is provided in order to stimulate wound healing and to facilitate the removal of devitalized tissue and bacterial biofilm. Also to control the bacterial load. In addition to sterilization, it also stimulates the healing process and accelerates wound closure by promoting dermal cell proliferation, collagen synthesis and epidermal regeneration.

Accordingly, the utility model is a portable device for wound sterilization and tissue ablation, as described above, and allows patients to receive plasma-based treatment. As a hybrid plasma pen for ablation and sterilization of tissues by low temperature plasma can be used to promote control of bacterial stress, reepithelialization, neovascularization and ultimately, leads to earlier healing and wound closure. Clinical studies have shown successful treatment of chronic ulcers with low-temperature plasma. In addition, the portable wound healing system can provide current coagulation and / or ablation of target tissue and benign skin lesions such as: Keratoses. Fibroma, Veroka, Telangiatheasia, Basal Carcinoma and others. Operating mode (A) is used for ablation. The size and weight of the device allow its mass operation, without requiring the patient to travel to a hospital or clinic.

In one embodiment of the utility model, the device can generate radio frequency energy through an electrically conductive element by generating plasma. This element can be a monopolar electrode head and as an example can be used for ablation of organic tissues, such as: skin, mucous membranes, adipose tissue, epithelium and connective tissue. When high voltage is generated, it is concentrated on the target tissue by means of an electrode head. The plasma spark (discharge) produced by highly energized ions is strong enough to break the molecular bonds in soft tissues to cause their ablation. Accordingly, the hybrid plasma pen for ablation and sterilization of tissues by low temperature plasma can remove or ablate microscopic formation and growth of tumors on the skin and mucous membranes using low temperature plasma, leading to minimal or no lateral damage to healthy surrounding tissue.

In one embodiment, the hybrid plasma pen for ablation and sterilization of tissues by low temperature plasma has an output frequency of 200-300 kHz and a voltage of 15 to 20 kW. as it does not need additional cooling. In the second embodiment of the utility model output frequency of 66-70 kHz and voltage of 15 to 20 kW.

BG4117 UI

As described above, the device for sterilizing the target tissue and thus stimulating the healing process by forming a plasma field between the electrode head and the tissue. The energy in the formed plasma field is strong enough to break the organic molecular bonds in the soft tissues, thus causing it to close. Accordingly, the hybrid plasma pen for ablation and sterilization of tissues by low temperature plasma is also able to perform ablation of organic tissue through the processor, which determines the frequency and current, as the energy is concentrated to the target tissue without direct contact between the conductive element and tissue .

The hybrid plasma pen for ablation and sterilization of tissues by low-temperature plasma will find its application in various medical fields, especially for the treatment of pathologically altered tissues. It can be used in dermatology, dentistry, surgery, gynecology, proctology. urology, otolaryngology and other areas in which pathological tissue must be removed or a cell destroyed by electroding. The device uses plasma for concentrated or peripheral ablation of target tissue at different depths, and in a completely benign way can reform the epithelium. In addition, ablation can be used to treat / abscess benign and malignant tissue growth. The strength of the current and the method of treatment can be adjusted depending on the type of tissue and the desired depth of ablation. The ablation procedure can be used not only to treat Barrett's esophagus and esophageal dysplasia, colon polyps, gastrointestinal bleeding, endometrial ablation, pulmonary ablation, but also to treat any mucosal, submucosal or peripheral lesions such as inflammatory lesions tumors, polyps and vascular lesions.

The above embodiments are used only to illustrate the general application, nature and nature of this utility model. The hybrid plasma pen for ablation and sterilization of tissues by low temperature plasma is not limited to the embodiment described herein, and any minor changes and substitutions made by those skilled in the art based on the present utility model are within the scope of the claimed device.

Claims (1)

The hybrid plasma pen for ablation and sterilization of tissues by low-temperature plasma, consisting of a housing (1), one end of which is closed with a cap (2), and the other end is a cone (3) with a hole (4) in the middle , USB input (5) connected to a battery (6), in the housing (1) is a board (7), characterized in that in the hole (4) is mounted an electrode head (8) with the possibility of placing electrode (9), a processor (10) being mounted on the board (7), the first input of which is connected to a first button (11) with the possibility of manual control for changing the mode and is mounted on the housing (1), at wherein the second input of the processor (10) is connected to a second pulse-increasing button (12) mounted above the first button (11) on one side, wherein the third input of the processor (10) is connected to a third button ( 13) with the possibility of reducing the pulses mounted against the second button (12), wherein the fourth input of the processor (10) is connected to a fourth button (14) mon tyrant against the first button (11), with the possibility of controlling the voltage stabilizer (15), as between the fourth button (14) and the cap (2) is mounted an LCD display (16) connected to the first output of the processor (10), as between the first button (11) and the cone (3) is mounted a fifth button (17) for manual supply of pulses through the electrode head (8) to the electrode (9), the second output of the processor (10) is connected to a voltage regulator (15) connected to the battery (6) and through a high-voltage transformer (18), a coil (19) to the electrode head (8), as a USB input (5) is located laterally on the LCD display (16), and the electrode (9) has plug (20) connected via a fastening body (21) to a working body (22)