HK1237292B - Apparatus for treating blood vessels in skin - Google Patents

Description

Device for treating blood vessels in the skin

Technical Field

The present invention relates to a device for treating blood vessels associated with the skin and skin appendages using electrical signals, and more specifically to a device for treating blood vessels within the skin, wherein high-frequency, radio-frequency, or other electrical signals are transmitted into the skin by inserting electrodes into the skin, so that the thermal reaction of the electrical signals to the blood vessels is more concentrated than that to the skin tissue, thereby treating the blood vessels associated with the skin and skin appendages.

Background Art

Moles, vascular nevi, severe pigmentation, hypopigmentation, rosacea, flushing, erythema or telangiectasia may not be clearly detected before they occur, and their causes are presumed to be sun exposure, pregnancy, medication, hormonal changes in the body, genetic factors, etc.

Unlike in the past, the number of people seeking treatment for conditions such as hair loss, hair removal, excessive sebum secretion, hyperhidrosis, and body odor is rapidly increasing. However, the effectiveness of current treatment devices is limited. Therefore, in order to achieve better treatment results, research and development of improved treatment devices is becoming increasingly important.

On the other hand, existing skin treatments, including those using lasers and those using multi-wavelength light such as pulsed light (IPL), are not only unable to guarantee therapeutic effects on the blood vessels that are the cause of the above symptoms and are located deep within the skin, but also face technical obstacles such as side effects such as excessive heat damage.

Specifically, burns and scalds caused by intensive pulsed light (IPL), one of the existing treatments, often occur. Figure 1 shows the state of postinflammatory hyperpigmentation (PIH) after laser treatment.

Summary of the Invention

Technical issues

Therefore, an object of the present invention is to provide a therapeutic device that generates electrical signals that act on blood vessels in the skin, for use in treating moles, vascular nevi, pigmentation, rosacea, flushing, or microvascular dilation. Appropriate thermal damage can be applied to the blood vessels in the dermis or epidermis that are the cause or exacerbating factors of moles, vascular nevi, pigmentation, rosacea, flushing, or microvascular dilation. This can not only restore the abnormal excessive proliferation of the causal blood vessels to normal and induce phagocytosis or apoptosis of the vascular cells of the causal blood vessels, thereby improving the therapeutic effect, but can also reduce the side effects caused by excessive thermal damage to the blood vessels in existing treatment methods and reduce the recurrence rate of moles, vascular nevi, pigmentation, rosacea, flushing, or microvascular dilation caused by the reformation of removed blood vessels.

Means of solving the problem

In order to achieve the above-mentioned purpose, the treatment device for blood vessels in the skin of the present invention includes: a plurality of electrodes inserted into the skin of the surgical object, for applying electrical signals to the above-mentioned blood vessels in the skin; an electrical signal generating unit, electrically connected to the above-mentioned plurality of electrodes; and a power supply unit, for supplying power to the above-mentioned electrical signal generating unit.

Preferably, the electrical signal conducted by the electrodes is repeatedly conducted with at least one delay time.

Furthermore, the blood vessels in the skin are located between two electrodes among the plurality of electrodes.

Furthermore, an electric field is formed between the plurality of electrodes.

Furthermore, an alternating current (A.C.) electric field is formed between the plurality of electrodes.

Furthermore, the plurality of electrodes include a bipolar system.

Furthermore, the plurality of electrodes are adjacently inserted into the intracutaneous blood vessels.

Furthermore, the purpose of using the above-mentioned intradermal blood vessel treatment device is to improve at least one symptom of melasma, dermal melasma, severe hyperpigmentation, hypopigmentation, rosacea, flushing, erythema and telangiectasia.

Furthermore, the above-mentioned device for treating blood vessels in the skin can affect and treat blood vessels related to hair loss, hair removal, excessive sebum secretion, hyperhidrosis, body odor, etc.

Furthermore, the electrical signal applied to the portion of the electrode inserted into the skin of the surgical subject may cause thermal damage to blood vessels in the skin.

Furthermore, the electrical signal applied to the portion of the electrode inserted into the skin of the surgical subject causes thermal damage to the epidermal layer of blood vessels in the skin.

Furthermore, in the skin tissue where the electrodes are inserted, thermal damage is caused to the electrode adjacent region, the blood vessels in the skin, and the blood vessel adjacent region.

Furthermore, in the skin tissue where the electrode is inserted, thermal damage is caused to the skin tissue region between the electrode adjacent region and the tissue region adjacent to the intracutaneous blood vessels.

Furthermore, the plurality of electrodes are inserted into the dermis layer of the skin of the surgical subject.

Furthermore, the electrical signal generating unit is a high frequency signal generating device with a frequency of 0.1 to 100 MHz.

Furthermore, the electrical signal generating unit is a radio frequency signal generating device.

Furthermore, at least one of the depth of insertion of the electrode into the skin of the surgical object, the voltage value applied by the electrode, the electric power value transmitted from the electrode, the time for the electrode to apply the electric signal, and the delay time for the electrode not to apply the electric signal can be pre-set.

Furthermore, the device further includes an electrode module having a fixing portion for fixing the plurality of electrodes.

Furthermore, the device further includes a driving unit for driving the electrodes or the electrode modules to insert the electrodes into the skin.

Furthermore, the above-mentioned intradermal vascular treatment device can be used for intratissue vascular treatment in all medical fields including dermatology.

Effects of the Invention

According to the present invention, appropriate thermal damage can be applied to the blood vessels in the dermis or epidermis that are the cause or exacerbating factors of moles, vascular nevi, pigmentation, rosacea, flushing or microvascular dilation. This can not only restore the abnormal excessive proliferation of the causative blood vessels to normal and induce phagocytosis or apoptosis of the vascular cells of the causative blood vessels, thereby improving the treatment effect; the electrodes inserted into the skin can more accurately control the degree of direct thermal damage, thereby reducing the side effects caused by excessive thermal damage to the blood vessels in existing treatment methods. Instead of applying heat to the entire skin, concentrated heat is applied to the blood vessels, which can reduce the side effects such as burns caused by excessive thermal damage to the entire skin in existing treatment methods, and reduce the recurrence rate of moles, vascular nevi, pigmentation, rosacea, flushing, erythema or microvascular dilation caused by the reformation of removed blood vessels.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram showing side effects caused by conventional therapeutic devices.

FIG. 2 is a diagram showing the structure of a treatment device for generating an electrical signal that acts on blood vessels in the skin according to an embodiment of the present invention.

FIG3 is a diagram illustrating the blood vessel treatment principle of a treatment device that generates an electrical signal that acts on blood vessels in the skin according to an embodiment of the present invention.

4 to 12 are diagrams showing animal experiments and clinical effects of a treatment device for generating electrical signals acting on blood vessels in the skin according to an embodiment of the present invention.

FIG. 13 is a diagram showing the waveform of an electrical signal generated by a treatment device in one embodiment of the present invention.

DETAILED DESCRIPTION

The present invention will be described in more detail below with reference to the accompanying drawings. It should be noted that the same structural elements in the drawings are represented by the same figure marks, and the detailed description of well-known functions and structures that are not necessary for the gist of the present invention will be omitted.

First of all, according to recent research, we can understand that moles, vascular nevi, severe pigmentation, hypopigmentation, rosacea, hot flashes, erythema, microvascular dilation, hair removal, hair loss, excessive sebum secretion, hyperhidrosis, body odor and other lesions are highly correlated with the number, size, shape and function of blood vessels in the lesions.

For example, lesions such as vascular nevi, pigmentation, rosacea, erythema, and vasodilation show a significant increase in the number and size of blood vessels in the dermis or epidermis compared to the surrounding normal-looking skin, both clinically and histologically.

At the same time, depending on the state of the lesion, changes in the blood vessels within the lesion can have a beneficial effect on the treatment.

Specifically, by promoting the dilation of blood vessels with poor blood circulation and increasing blood circulation, it may be possible to treat hair loss. Symptoms such as excessive sebum secretion and hyperhidrosis, where the number and size of blood vessels are increased, may be treated by reducing the above phenomena.

On the other hand, rosacea, flushing, erythema, or capillary dilation are representative skin cosmetic symptoms due to vascular problems. The causes of moles, vascular nevi, severe pigmentation, hypopigmentation, etc. are also closely related to vascular problems.

At the same time, in addition, hair removal, hair loss, excessive sebum secretion, hyperhidrosis, body odor and other diseases are also related to the overdevelopment or low development of blood vessels supplying nutrients.

Based on this, the present invention is a device that utilizes the differences in impedance, conductivity, and permittivity between the various layers of skin tissue, various appendages, and various tissues to transmit electrical signals into the skin through invasive electrodes, thereby selectively affecting specific tissues within the skin, and is particularly a device that can selectively treat blood vessels with high impedance.

Furthermore, in order to adjust the degree of thermal reaction occurring in blood vessels, the present invention is a device capable of adjusting the intensity of the transmitted electrical signal, and is therefore a therapeutic device capable of selectively inducing desired effects from effects such as congestion, regeneration, remodeling, growth, regrowth, degradation, and degeneration of vascular tissue.

At the same time, the present invention is based on the above-mentioned vascular changes and is a device that can be used to treat moles, vascular nevi, severe pigmentation, hypopigmentation, rosacea, flushing, erythema, telangiectasia, hair loss, hair removal, etc.

Furthermore, the present invention is a device that can be used to treat hyperseborrhea, hyperhydrosis, and the like, and may be used to treat conditions related thereto.

Furthermore, the present invention is a device that can induce appropriate thermal responses in the blood vessels of the dermis or epidermis, or the blood vessels of the skin appendages, which are the cause or aggravating factors, thereby increasing the blood flow of the cause blood vessels, or restoring abnormal hyperplasia to normal, or inducing phagocytosis or apoptosis of the vascular cells of the cause blood vessels. This device can not only improve the therapeutic effect, but also reduce the side effects of the existing treatment methods that cause excessive thermal damage to the blood vessels, and reduce the recurrence rate of lesions related to the hyperplasia and reformation of the removed blood vessels.

Furthermore, in addition to treating blood vessels, the present invention is a therapeutic device capable of improving the pathological structure and function of melanocytes and basement membranes in the skin, and affecting the content and function of vascular endothelial growth factor (VEGF) from blood vessels.

On the other hand, existing invasive high-frequency treatment technologies are mainly aimed at the production of collagen in the skin, and are therefore limited to technologies that heat and solidify the skin tissue itself, and technologies that directly use high heat to cauterize blood vessels to stop bleeding.

However, the present invention is different from the above. It is a device that forms an electric field in the skin to treat blood vessels in the skin. Specifically, the present invention is a technology that inserts two or more electrodes into the skin to form an electric field.

Specifically, rather than directly cauterizing blood vessels, a uniform electric field is formed in a specific area, thereby selectively heating the blood vessels. This allows for the treatment of the various pathological conditions described above. Unlike conventional techniques, the present invention was developed by realizing that when an electric field under specific conditions is formed within tissue, blood vessels are preferentially affected by the electrical signal compared to tissues other than blood vessels.

That is, the existing high-frequency treatment technology requires a longer conduction time because its main purpose is to promote the production of collagen in the skin. The present invention only requires a shorter conduction time. Of course, the effect of the present invention cannot be achieved by conduction time alone. It can only be achieved when other conditions such as voltage, electric power, and skin impedance are all met. Complex conditions are necessary.

Furthermore, according to the present invention, due to the high conductivity of blood vessels, the blood vessels can be solidified before the epidermis or dermis solidifies.

Therefore, in the present invention, the short conduction time capable of causing selective blood vessel solidification mainly refers to a time within 50 msec, more preferably within 100 msec, and even more preferably within 300 msec.

On the other hand, in the present invention, in order to prevent excessive thermal reaction of skin tissue other than blood vessels and to concentrate thermal reaction on blood vessels, the electrical signal that can be generated has at least one delay time (delay time) of a certain period of time, for example, 5 to 100 msec, to be repeatedly transmitted.

In other words, in the present invention, since an electrical signal with a delayed time and repetition is generated and the applied voltage is relatively increased, a relatively wide interval can be formed between electrodes 153 and 153. Since the applied voltage is relatively increased, the reaction degree in the blood vessels can be made more obvious even within the same conduction time. In addition, since the conduction time is relatively short, the impact on peripheral tissues outside the blood vessels can be minimized.

In other words, in the present invention, by increasing the applied voltage by delaying the time, the blood vessels can be accelerated to react, and the delaying time can also prevent tissues other than the blood vessels from reacting.

On the other hand, the repeated conduction time may vary according to various conditions of the device. The length of each conduction time may be the same or different. Furthermore, the length of each delay time may also be different.

At the same time, the conduction time of the present invention may vary depending on the voltage, power, current of the electrical signal, the size, thickness, and number of blood vessels in the skin, and may also vary depending on the depth of electrode insertion during surgery, the thickness, spacing, and polarity configuration of the electrodes.

At the same time, the present invention is a device having a bipolar structure of electrodes inserted into the skin, and can also be used for any conditions aimed at treating blood vessels in the skin, in addition to direct electrical cauterization of blood vessels.

Specifically, lesions such as nevi, vascular nevi, pigmentation, rosacea, erythema, or telangiectasias show a significant increase in the number and size of blood vessels in the skin compared to surrounding normal-appearing skin, both clinically and histologically.

Such vascular changes seen in patients with moles, vascular nevi, pigmentation, rosacea, flushing, or microvascular dilation are associated with angiogenesis and vasodilation related to increases in vascular endothelial growth factor.

Furthermore, the number of blood vessels distributed within the skin of lesions such as moles, vascular nevi, pigmentation, rosacea, redness, or telangiectasia is closely related to the pigment content within the lesion skin, and therefore plays an important role in the occurrence or aggravation of vascular lesions, vascular nevi, pigmentation, rosacea, redness, or telangiectasia within the lesion skin.

Therefore, the present invention proposes a treatment device for removing the causative blood vessels of the neovascularization or dilated blood vessels that cause the above-mentioned symptoms.

Figure 2 is a diagram showing the structure of a treatment device 100 for generating electrical signals that act on blood vessels in the skin in one embodiment of the present invention. Referring to Figure 2, in one embodiment of the present invention, the treatment device 100 for generating electrical signals that act on blood vessels in the skin includes a power supply unit 110, an electrical signal generating unit 130, an electrode module 150, a driving unit 170, an input unit 180 and a control unit 190.

First, the electrode module 150 includes a fixing part 151 for fixing two or more electrodes 153, and the power supply part 110 is used to supply power from the outside to the electrical signal generating part 130. The electrical signal generating part 130 transmits the electrical signal to the electrode 153 of the electrode module 150 through electrical conductive materials such as the electrical signal guide wire 135.

On the other hand, in the embodiment of the present invention, the electrode 153 can be independently connected to the electrical signal generating unit 130 and the driving unit 170 directly or indirectly without the electrode module 150 .

Meanwhile, in the embodiment of the present invention, the electrode 153 or the electrode module 150 can be electrically connected to the electrical signal generating unit 130 in any form, directly or indirectly.

On the other hand, in the embodiment of the present invention, the electrode 153 may be a needle-type electrode made of a conductive material and in the shape of a needle.

The electrical signal generated by the electrical signal generating unit 130 is mainly in the form of an electromagnetic wave, particularly a signal with a frequency range of 300 Hz to 300 GHz.

In the embodiment of the present invention, the electrical signal generating unit 130 can generate an electrical signal having a frequency in the intermediate frequency, high frequency, radio frequency, electromagnetic wave, or ultrasonic wave range.

The electrical signal generated by the electrical signal generating unit 130 generates an electromagnetic wave of a predetermined frequency. The electrical signal is transmitted to at least two electrodes 153. The electrical signal transmitted to the skin 200 in the lesion through the electrodes 153 then heats the blood vessels or the tissue 300 surrounding the blood vessels.

On the other hand, in the embodiment of the present invention, the operator can directly insert the electrode 153 into the diseased skin 200 by hand, or insert the electrode 153 fixed to the electrode module 150 into the diseased skin 200.

Furthermore, in the embodiment of the present invention, a driving unit 170 capable of driving the electrode 153 or the electrode module 150 so as to automatically insert the electrode 153 or the electrode module 150 to a preset depth may also be provided.

On the other hand, in such a situation, the driving unit 170 may be directly connected to the electrode 153 or the electrode module 150 , or may be indirectly connected via other intermediate devices.

Furthermore, under normal circumstances, the driving unit 170 and the electrode 153 or the electrode module 150 may be in a disconnected state, and only when driven, the electrode 153 or the electrode module 150 is pushed to be inserted into the skin.

The driving unit 170 transmits force directly or indirectly to the two or more electrodes 153 so that the electrodes 153 can be inserted into the skin 200 to a predetermined depth (approximately 1 mm to 2.5 mm).

On the other hand, in an embodiment of the present invention, after two or more electrodes 153 are inserted into the skin, they can be inserted into the epidermis 210 to an appropriate depth (approximately 0.2 mm to 1 mm), or can be inserted to a specified depth (approximately 1 mm to 4 mm) to reach the dermis 220 of the skin 200. The insertion depth of the electrode 153 into the skin 200 of the surgical subject can be 0.2 mm to 4 mm.

On the other hand, if the purpose of the present invention of treating blood vessels in the skin can be achieved, the electrode 153 may not be inserted into the skin but may only contact the skin surface.

Therefore, the electrode 153 may be inserted into the skin 200 of the surgical target to a depth of less than 4 mm. On the other hand, in areas with thicker skin, the electrode 153 may be inserted into the skin 200 of the surgical target to a depth deeper than 4 mm, to the full thickness of the skin.

On the other hand, in an embodiment of the present invention, the driving unit 170 may be an actuator, a motor, a linear motor, a stepping motor, an electromagnet, a piezoelectric component, etc., which can be used to make the electrode 153 or the electrode module 150 perform linear motion.

The input unit 180 has an input device for the operator to input control commands. The control commands input through the input unit 180 can be commands for controlling the energy of the electrical signal, such as the voltage, current, resistance value at this time, tissue impedance or electrical signal guidance time guided to the electrode 153 via the electrical signal generating unit 130, or can be commands for controlling the depth of insertion of the electrode 153 into the skin through control commands.

The control unit 190 controls the energy of the electrical signal such as the voltage, current, resistance, impedance ratio or voltage guidance time guided to at least two electrodes 153 through the electrical signal generating unit 130 according to the control command from the input unit 180 .

At the same time, the control unit 190 controls the power supply unit 110 so that the power supply unit 110 can repeatedly supply power to the electrical signal generating unit 130 at specific intervals, or as shown in Figure 13, directly controls the electrical signal generating unit 130 so that the electrical signal generating unit 130 can repeatedly generate electrical signals at specific intervals.

In an embodiment of the present invention, under a measurement reference of 100Ω loading, the applied voltage V1 can be 10 volt to 400 volt (preferably 20 to 300 volt), the delay time can be 0.1 msec (millisecond) to 500 msec (preferably 5 to 300 msec), and the conduction time can be 1 to 450 msec (preferably 5 to 300 msec).

Specifically, if the delay time is too short (less than 0.1 msec), tissues other than the causal vessel 300 may suffer thermal damage. If it is too long (greater than 500 msec), the continuity of the signal directed to the causal vessel 300 may be affected, resulting in an insufficient thermal response to the causal vessel 300. Conversely, if the conduction time is too long (greater than 450 msec), tissues other than the causal vessel 300 may experience an excessive thermal response. If it is too short (less than 1 msec), the thermal response to the causal vessel 300 may be insufficient.

On the other hand, the number of times the electrical signal is repeatedly conducted with an interval delay time is closely related to the applied voltage, electric power, conduction time, delay time, etc. If the number of repeated conductions is too few, the thermal reaction is not sufficient. If the number of repeated conductions is too many, it may cause excessive thermal reaction in tissues outside the blood vessel 300.

On the other hand, the inventors have verified through experiments that, compared with continuously guiding a low-power voltage, discontinuously and repeatedly guiding a relatively high-power voltage through the aforementioned delay time has a better therapeutic effect.

On the other hand, in the embodiment of the present invention, the electrical signal generating unit 130 can generate a pulse signal as shown in FIG13 . Compared with a DC pulse signal, an AC pulse signal can more accurately induce a thermal reaction.

That is, in an embodiment of the present invention, the two electrodes inserted between the blood vessels 300 are bipolar electrodes 153. When inserted into the skin, the electrodes 153 can guide high-frequency pulse signals of AC polarity and form an alternative current pulsed typed electric field in the skin tissue.

Specifically, the high-frequency pulse signal of AC polarity causes water molecules in the tissue of the blood vessel 300 to vibrate, thereby causing a thermal reaction to occur, and is therefore more beneficial than a DC signal.

Therefore, in the present invention, by guiding the high-frequency pulse signal of alternating polarity, it is easier to induce a selective thermal response in the cause blood vessel 300 than in the case of applying the high-frequency pulse signal of direct polarity.

Therefore, in the embodiment of the present invention, the electric field 250 formed between the two electrodes 153 located between the cause blood vessels 300 is preferably an alternating current electric field 250 .

On the other hand, when conducting high-power voltage, a more uniform and strong electric field can be formed over a wider area than when conducting low-power voltage. Of course, high-power voltage electric fields are more likely to induce thermal reactions in blood vessels 300, and accordingly, the conduction time needs to be shortened.

On the other hand, the operator can input the depth of the electrode 153 inserted into the skin through the input unit 180 , and the control unit 190 controls the driving degree of the driving unit 170 accordingly.

That is, the operator inputs at least one or more numerical values such as the voltage value or electric power value of the electrical signal, the voltage guidance time, etc. through the input unit 180. When setting the insertion depth of the electrode 153, the control unit 190 controls the electrical signal generating unit 130 to generate a predetermined electrical signal accordingly. The electrical signal generating unit 130 converts the AC or DC power from the power supply unit 110 into the form of a predetermined electrical signal, and the electrical signal is guided out through the electrode 153.

On the other hand, based on the depth of the electrode 153 inserted into the skin set by the operator through the input unit 180, the control unit 190 can control the driving degree of the driving unit 170. The driving unit 170 moves the electrode 153 or the electrode module 150 based on the depth of the electrode 153 inserted into the skin set by the operator to insert the electrode 153 into the above-mentioned skin 200.

FIG3 is a diagram illustrating the blood vessel treatment principle of a treatment device that generates an electrical signal that acts on blood vessels in the skin according to an embodiment of the present invention.

As shown in FIG3 , the patient's skin layer 200 includes an epidermis 210 and a dermis 220 . Blood vessels (i.e., blood vessels 300 ) that may be the cause of nevus, vascular nevus, pigmentation, rosacea, flushing, capillary dilation, or vasodilation are mainly distributed in the dermis 220 .

On the other hand, depending on different situations, the causative blood vessels 300 may be distributed in the epidermis 210 , or the blood vessels 300 may be distributed in both the epidermis 210 and the dermis 220 .

In the embodiment of the present invention, the insertion position of the electrode 153 can be adjusted according to the distribution of the causative blood vessels 300 , so that the electrode 153 is inserted only into the epidermis 210 or into the dermis 220 .

In this specification, a blood vessel 300 that is a cause of a nevus, a vascular nevus, hyperpigmentation, hypopigmentation, rosacea, flushing, erythema, or capillary dilation is referred to as a cause blood vessel 300 .

As shown in Figure 3, when the blood vessels 300 only exist in the dermis 220, the electrode 153 is preferably inserted into the skin up to the dermis 220 of the skin. Depending on the type or energy of the electrical signal (voltage or electrical power value, conduction time), the electrode 153 may be inserted into the skin only up to the epidermis 210.

Furthermore, even if the electrode 153 is not inserted into the skin, the electrode 153 may only contact the surface of the skin as long as the condition is sufficient to induce a thermal reaction in the causative blood vessel 300 .

On the other hand, the electrode 153 inserted into the dermis 220 of the skin is located between the blood vessels 300 causing nevus, vascular nevus, pigmentation, rosacea, flushing, or telangiectasia within the lesion.

Furthermore, the causative blood vessel 300 may also be located between the two electrodes 153. Meanwhile, when the causative blood vessel 300 is located between the two electrodes 153, an electric field 250 may be formed between the two electrodes as shown in FIG. 3 .

Moreover, in an embodiment of the present invention, the causative blood vessel 300 may be located deeper than the electrode 153, and may be located below the electrode 153 depending on the situation. As long as the causative blood vessel 300 is located within the electric field 250 formed by the electrode 153, there is no problem in causing the induced thermal reaction regardless of its actual location.

On the other hand, in the embodiment of the present invention, the electric field 250 formed between the two electrodes 153 inserted between the cause blood vessels 300 is preferably an alternating current electric field 250 .

That is, in the present invention, the two bipolar electrodes 153 inserted between the cause blood vessels 300 can guide the high-frequency signal of AC polarity when inserted into the skin, thereby inducing a selective thermal response only to the blood vessel tissue in the skin.

By using the AC electric field 250 to induce a localized thermal response (selective thermal response) only in the causative blood vessel 300, it is possible to selectively treat only the blood vessel while minimizing the impact and damage to the surrounding tissues.

On the other hand, in the embodiment of the present invention, the high-frequency signal guided by the electrode 153 preferably has a frequency between 0.1 MHz and 100 MHz.

On the other hand, depending on the situation, the causative blood vessel 300 may be adjacent to or relatively far away from the electrode 153. In an embodiment of the present invention, the operator can select the type of electrical signal, or adjust the voltage, electrical power or conduction time of the electrical signal based on the distance between the electrode 153 and the causative blood vessel 300.

More specifically, the electrode 153 inserted into the skin 200 receives an electrical signal via the electrical signal guide wire 135 , and the electrical signal conducted from the site where the electrode 153 is inserted into the skin causes damage to the blood vessel 300 .

At this time, the electrical signal guide line 135 can be directly connected to the electrode 153, or indirectly connected to the electrode 153 through a printed circuit board, soldering, an electrical needle (a needle that can conduct electricity, can be bent and stretched, for example, a metal elastic needle for electrical conduction such as a spring inside), a single-pin spring connector (pogo pin), an electrical conduction plate, an electrical conduction rod or an electrical connector to guide the electrical signal.

First, the mechanism by which the electrical signal causes damage to the causative blood vessel 300 will be briefly described. The electrical signal guided into the lesion is particularly concentrated around the causative blood vessel 300, generating heat, and the causative blood vessel 300 is treated by the generated heat.

In other words, the treatment device 100 of the present invention that generates an electrical signal that acts on blood vessels in the skin is a device that applies an electrical signal through the electrode 153 to generate appropriate heat in the source blood vessel 300 or the surrounding area.

On the other hand, the inventors discovered the following facts during clinical trials conducted to develop the treatment device 100 of the present invention for generating electrical signals that act on blood vessels in the skin.

Most of the blood vessels 300 that cause moles, vascular nevi, pigmentation, rosacea, flushing, or capillary dilation are neovascular vessels (i.e., immature blood vessels). Compared to normal blood vessels, the cell-cell junctions that make up the walls of neovascular vessels are looser, and the thickness is thinner than that of normal blood vessels. The cell structure of the blood vessel wall is weaker, and therefore, unlike normal blood vessels, they are more easily damaged by weak electrical stimulation.

Based on this, some people believe that simply applying an electrical signal to the causative blood vessel 300 and causing damage can easily treat moles, vascular nevi, pigmentation, rosacea, hot flashes, or capillary dilation, but this is not actually the case.

The reason is that in order to cause appropriate damage to the causative blood vessel 300, an electrical signal that is neither too weak nor too strong must be transmitted, and therefore the electrical signal generating unit 130 must be precisely controlled. This is because when the causative blood vessel 300 is artificially stimulated, burned, removed, or severely damaged by a relatively inappropriate electrical signal that is too weak or too strong, the vascular reimbursement mechanism will be further strengthened, accelerating the recurrence of vascular hyperplasia and the recovery of new blood vessels.

Based on this, a treatment method that simply applies a meaningless electrical signal of artificial intensity to the causative blood vessels 300 of moles, vascular nevi, pigmentation, rosacea, hot flashes or capillary dilation to destroy them will instead induce excessive vascular proliferation or post-inflammatory pigmentation that worsens the condition of moles, vascular nevi, pigmentation, rosacea, hot flashes or capillary dilation compared to before treatment.

The changes in the diseased skin caused by the electrical signals found during clinical trials conducted to develop the therapeutic device 100 of the present invention for generating electrical signals that act on blood vessels in the skin are as follows.

As shown in FIG4 and FIG5, when the treatment device 100 of the present invention is used to apply an electrical signal to the skin of a micro pig, it can be observed that the blood vessels in the dermis react selectively without causing damage to the blood vessels or excessive intradermal bleeding.

On the other hand, referring specifically to FIG5 , light pink thermally damaged tissue can be observed inside the peripheral tissue area A where the electrode 153 is inserted in part (a) of FIG5 , and light pink selectively thermally damaged tissue can also be observed near the vascular wall inside the peripheral tissue area B of the causal blood vessel 300.

Specifically, the enlarged photograph of the tissue region B around the causative blood vessel 300 in FIG5(a) is FIG5(b) , where the light pink selectively thermally damaged tissue can be more clearly observed near the blood vessel wall.

On the other hand, the tissue between the peripheral tissue region A where the electrode 153 is inserted and the peripheral tissue region B located around the causative blood vessel 300 does not suffer any thermal damage.

On the other hand, as shown in Figures 6 and 7, in order to more clearly see the selective response of blood vessels, the following experiment was conducted using liver tissue, which is mainly composed of hepatocytes and blood vessels and has relatively uniform tissue impedance, conductivity, and permittivity except for blood vessels, compared to skin. Using the treatment device 100 of the present invention, an electrical signal was applied to the liver tissue of a cow, and the selective response of the blood vessels in the liver tissue was confirmed.

Furthermore, the electrical signal primarily causes a thermal reaction around the outer surface of the vascular structure and transmits its influence along the vascular wall.

At this time, the main tissue changes observed are those in the tunica adventitia of the blood vessels, which are caused by the thermal response to the electrical signal, while the tissues of the tunica intima and tunica media are relatively preserved.

When blood vessels in the affected skin are excessively damaged in a non-selective manner, the lesions may be aggravated by excessive proliferation of blood vessels and overexpression of vascular endothelial growth factor, which promotes angiogenesis.

However, when the electrical signal selectively induces a thermal response to the causal blood vessel 300 or the outer membrane of the blood vessel 300, it will promote the regeneration of the causal blood vessel 300 structure in the diseased skin into a normal skin blood vessel structure, reducing the risk of side effects caused by excessive physical non-selective vascular destruction. Clinically, it can be observed that there are improvements in moles, vascular nevi, pigmentation, rosacea, flushing or microvascular dilation.

On the other hand, during clinical trials conducted to develop the therapeutic device 100 of the present invention, the inventors discovered that the therapeutic device 100 of the present invention does not cause excessive physical damage to the causative blood vessels 300, such as moles, vascular nevi, pigmentation, rosacea, flushing, or capillary dilation. Instead, it applies heat to the vessel wall and inflicts appropriate damage to the endothelial cells of the vessel, thereby restoring the abnormal overgrowth of the causative blood vessels 300 to normal, or restoring the increased content or concentration of vascular endothelial growth factor to normal, thereby reducing the associated angiogenesis and significantly reversing the phenomenon of vasodilation.

On the other hand, applying appropriate damage to vascular cells can induce phagocytosis (or apoptosis) of vascular cells, thereby improving the therapeutic effect.

Furthermore, as shown in FIG11 and FIG12 , the regeneration rate of the removed blood vessels was significantly reduced by inducing the spontaneous phagocytosis or apoptosis of vascular cells.

The technical principle of applying appropriate damage to the vascular cells of the vessels 300 that are the cause of nevus, vascular nevus, pigmentation, rosacea, flushing, or telangiectasia using the treatment device 100 of the present invention is as follows.

Moles, vascular nevi, pigmentation, rosacea, hot flashes, or capillary dilation are all caused by these factors. The blood within blood vessels 300 is mostly composed of water, so its conductivity is higher. Compared to other tissues within the skin, the electrical signals within the electric field are first attracted to it. The impedance difference between the blood vessel wall and the blood is greater, and the permittivity of the blood vessel wall is higher. As a result, the charge vibration concentrated in the vessel wall causes a thermal reaction. Incidentally, water molecules and ions are vibrated by the electromagnetic wave-like electrical signals, and the friction caused by the vibrations further generates heat.

At this time, the electrical signal leaks through the blood in contact with the inner side of the blood vessel, so the inner layer of the blood vessel wall is less likely to react thermally. In addition, the heat is dispersed by the flowing blood, so the inner layer of the blood vessel wall is less likely to react thermally and is concentrated in the outer layer of the blood vessel wall.

If the conduction time of the electrical signal increases, more heat will be generated overall, and more blood vessel damage will be caused due to the increased heat.

On the other hand, the heat generated in the blood vessel wall can induce thermal damage to vascular cells.

Therefore, the treatment device 100 of the present invention is a treatment device that does not cause damage to the surrounding skin tissue other than the blood vessel 300 tissue that causes moles, vascular nevi, pigmentation, rosacea, hot flashes or capillary dilation, and only induces heat in the blood vessel wall.

In other words, the treatment device 100 of the present invention is a device that can induce thermal damage only to the vascular cells of a specific blood vessel 300, and uses an electrical signal that can induce vibration between water and ionic substances and generate frictional heat to apply thermal damage to the blood vessel.

The therapeutic device 100 of the present invention can restore abnormal excessive proliferation of vascular cells to normal, and restore the increased content of vascular endothelial growth factor or the concentration in diseased skin to normal, thereby treating the associated angiogenesis or hyperplasia of blood vessels.

At the same time, the therapeutic device 100 according to the present invention can produce a therapeutic effect by inducing phagocytosis or apoptosis of vascular cells.

On the other hand, in order to induce phagocytosis or apoptosis of vascular cells through thermal damage, an appropriate level of thermal damage must be caused to the vascular cells. To find the driving conditions for the treatment device 100 that can cause an appropriate level of thermal damage, the inventors repeatedly conducted clinical trials. The results are shown in Table 1 below.

Table 1

The voltage values and electric power values in Table 1 are measured values of the treatment device 100 of the present invention when the load resistance (load resistance) is 100Ω (Ohm).

In other words, the voltage (Vrms unit; Volt) and the electric power are the measured values of the voltage and the electric power under the reference of the load resistance of 100Ω, and refer to the voltage value and the electric power value of the electrical signal guided by the electrode 153 inserted into the skin layer 200 (epidermis 210 or dermis 220) of the surgical object.

On the other hand, the conduction time (msec unit; 0.001 second) in Table 1 refers to the time during which the electrode 153 conducts the electrical signal when the electrode 153 is inserted into the skin layer 200 .

Simply put, it refers to the time during which each shot of an electrical signal is applied to the skin layer 200 of the surgical subject.

On the other hand, in an embodiment of the present invention, one or more of the parameter values in Table 1 may be input through the input unit 180 of the treatment device 100, and then the treatment device may be controlled by a control device such as the control unit 190 with a preset value.

That is, driving condition 1 in Table 1 can improve lesions such as nevus, vascular nevus, pigmentation, rosacea, flushing or microvascular dilation, and under the small-scale driving condition of driving condition 2, the treatment effect of the lesion can be further improved.

Furthermore, when the driving condition 3 is set as compared to the driving condition 2, the therapeutic effect of inducing cell apoptosis or pathology is the best.

At the same time, using the treatment device 100 of the present invention for moles, vascular nevi, pigmentation, rosacea, hot flashes, or microvascular dilation, parameters can be set within the range of driving conditions 2 to 3, that is, various clinical trials can be conducted on humans or animals as subjects, and the results are shown in Figures 4 to 12.

Referring to Figure 4, the results of animal tests using mini pig skin as the subject are compared in part (a) before the test. In part (b) after the test, it can be indirectly observed through tissue changes that when an electrical signal is applied, the blood vessels in the dermis selectively respond without vascular damage or excessive intradermal bleeding, and damage to vascular cells that induces apoptosis can be confirmed.

FIG6 and FIG7 are animal test results using bovine liver as the subject, showing the state after electrical signal guidance.

6 and 7 , when an electrical signal is applied to the cow's liver tissue, the blood vessels within the liver tissue selectively react. It can be observed that the outer membrane (tunica adventitia) of the blood vessels undergoes tissue changes due to thermal damage caused by the electrical signal, while the inner membrane and the media are relatively unaffected.

In addition, Figure 8 shows the skin condition of the first clinical trial patient before treatment (part (a)) and the skin condition after regular treatment once a week for two consecutive months (part (b)). Significant improvements in moles, vascular nevi, pigmentation, rosacea, hot flashes, and capillary dilation can be confirmed.

Figure 9 shows the skin condition of the second clinical trial patient before treatment (part (a)) and the skin condition after regular treatment once a week for two consecutive months (part (b)). Significant improvements in moles, vascular nevi, pigmentation, rosacea, hot flashes, and telangiectasia can be confirmed.

Figure 10 shows the skin condition of the third clinical trial patient before treatment (part (a)) and the skin condition after regular treatment once a week for two consecutive months (part (b)). Significant improvements in moles, vascular nevi, pigmentation, rosacea, hot flashes, and capillary dilation can be confirmed.

Figure 11 shows the skin condition of the fourth clinical trial patient before treatment (part (a), the skin condition after two consecutive months of weekly treatment (part (b), and the skin condition one year after the completion of treatment (part (c)). Significant improvements in moles, vascular nevi, pigmentation, rosacea, flushing, and capillary dilation can be confirmed. Furthermore, unlike existing treatments, the present invention shows no recurrence of lesions even one year after the completion of treatment, and is actually better than after two months of treatment.

Figure 12 shows the skin condition of the fifth clinical trial patient before treatment (part (a), the skin condition after two consecutive months of weekly treatment (part (b), and the skin condition one year after the end of treatment (part (c)). Significant improvements can be seen in nevi, vascular nevi, pigmentation, rosacea, flushing, and capillary dilation. Unlike existing treatments, the present invention does not show any recurrence of lesions even one year after the end of treatment, and is actually better than after two months of treatment.

On the other hand, in the present invention, the thermal reaction caused by the electrical signal guided to the skin tissue varies with the resistance values of the various constituent tissues within the tissue to which the electrical signal is transmitted, and the resulting electrical thermal reaction will also vary.

In an embodiment of the present invention, depending on different conditions, the electrical signal directed to the skin tissue can be transmitted to the skin tissue in a monopolar manner consisting of an active electrode serving as a cathode and a ground electrode serving as an anode, or in a bipolar manner including two active electrodes.

Specifically, compared to the monopolar method, in which the current (electrons) flowing from the active electrode flows through the patient's body to form a circuit to the ground electrode, in the bipolar method, the circuit is limited to the target tissue portion. Therefore, compared with the monopolar method, the bipolar method is safer for the human body and makes it easier to selectively focus treatment on the diseased area.

At the same time, the invasive method of the present invention is to transmit electrical signals after inserting electrodes into the target tissue. Therefore, compared with existing non-invasive methods, the treatment depth can be adjusted more precisely, and the treatment depth can be treated relatively uniformly compared with non-invasive methods. It can also cause the target tissue to form a selective tissue thermal response through discontinuous influence.

Furthermore, since systemic vascular damage is fatal, invasive methods allow for localized treatment and are therefore relatively safe.

At the same time, in the present invention, through the research process, it was found that the hair root structure can serve as an electric current conductor in the skin. When the electrical signal is transmitted to the hair root structure, it is similar to that transmitted through the outer layer of the blood vessel wall in the vascular tissue. In particular, the outer root sheath (outer root sheath) of the outer layer of the hair root structure is a fibrous connective tissue, so the above results can be obtained.

Based on this, by adjusting the intensity of the electrical signal applied to the hair root tissue, it is expected that the treatment effect of hair loss, which is currently intractable, can be improved and permanent hair removal can be achieved.

On the other hand, when using the present invention to treat moles, in order to enhance the treatment effect and reduce the recurrence rate, existing treatments such as laser toning and drug therapy can be performed simultaneously.

In summary, according to the present invention, a thermal reaction can be induced mainly in vascular tissue, thereby preventing unnecessary burns and injuries to other tissues.

At the same time, guiding electrical signals in a pulsed manner with a rest interval can prevent unnecessary damage to surrounding tissues and excessive damage to vascular tissue. By minimizing unnecessary thermal damage to surrounding tissues, the post-operative recovery period can be shortened and the risk of side effects can be reduced.

At the same time, the present invention can easily adjust the degree of thermal reaction to vascular tissue, thereby preventing the occurrence of bruises, over-compensatory vascular hyperplasia, and the like caused by excessive vascular damage during surgery.

At the same time, unlike existing treatment methods, the present invention utilizes invasive electrodes to treat vascular tissue deep within the skin and can evenly treat the vascular tissue within the skin.

Furthermore, by using bipolar electrodes in the present invention, electrical conduction can be confined to local lesions, which is safer than using monopolar electrodes that form an electric field throughout the body. This can reduce the risk of systemic effects on patients undergoing heart disease or cardiac pulse therapy.

At the same time, the present invention can selectively treat only vascular tissue, which can reduce the pain induced by thermal reaction and enable the patient to undergo surgery more comfortably.

At the same time, the skin intravascular treatment device of the present invention is not limited to being used in the field of dermatology, but can be used to treat tissue blood vessels in all medical fields including the field of dermatology, digestive organs such as the mouth, pharynx, larynx, esophagus, stomach, small intestine, large intestine, anus, liver, pancreas, gallbladder, spleen, etc., respiratory organs such as the trachea, lungs, pleura, chest wall, etc., all nervous organs such as the brain and spinal cord, and subcutaneous tissue.

The terms used in this application are intended only to describe specific embodiments and are not intended to limit the invention. Many expressions include one or more expressions that are clearly distinguishable from the context. In this application, the terms "including" or "having" are intended only to indicate the presence of a feature, number, step, action, structural element, part, or combination thereof described in the specification and are not intended to preclude the presence or possibility of additional numbers, steps, actions, structural elements, parts, or combinations thereof.

The above figures and descriptions of the preferred embodiments and application examples of the present invention are intended to illustrate that the present invention is not limited to the specific embodiments and application examples described above. Without departing from the gist of the present invention as claimed in the scope of the patent application, a person having ordinary knowledge in the technical field to which the present invention belongs may perform various modified implementations, which should not be understood as content that is different from the technical concept or prospect of the present invention.

Industrial applicability

The present invention has been recognized for its industrial applicability in the medical device industry.

Claims (10)

1. A treatment device for intradermal blood vessels, characterized in that it comprises: Multiple electrodes are inserted into the skin of the surgical subject to apply electrical signals to the blood vessels within the skin. The electrical signal generator is electrically connected to the aforementioned plurality of electrodes; and The power supply unit is used to supply power to the aforementioned electrical signal generator; Among them, the aforementioned intradermal blood vessels are located between two of the aforementioned multiple electrodes; Among them, the electrical signal applied by the electrode inserted into the skin of the surgical subject causes thermal damage to the blood vessels in the skin. The electrical signals transmitted by the aforementioned electrodes are repeatedly transmitted with at least one delay time. The delay time is in the range of 0.1 milliseconds to 500 milliseconds, and, Specifically, a voltage ranging from 20 volts to 250 volts will be applied to the aforementioned electrodes, the power transmitted to the aforementioned electrodes will be ranging from 4.0W to 625W, and the duration of the electrical signal transmission to the aforementioned electrodes will be ranging from 10 milliseconds to 300 milliseconds. An alternating electric field is formed between the aforementioned multiple electrodes; Among them, the aforementioned electrodes include bipolar systems. 2. The treatment device for intradermal blood vessels according to claim 1, characterized in that the purpose of using the treatment device for intradermal blood vessels is to improve at least one of moles, vascular nevi, severe pigmentation, hypopigmentation, rosacea, flushing, erythema, and microvascular dilation. 3. The treatment device for intradermal blood vessels according to claim 1, characterized in that the electrical signal applied to the portion of the electrode inserted into the skin of the surgical subject causes thermal damage to the epidermal layer of the blood vessels in the skin. 4. The treatment device for intradermal blood vessels according to claim 1, characterized in that thermal damage is caused in the skin tissue in which the electrode is inserted, between the area adjacent to the electrode and the intradermal blood vessels and the area adjacent to the blood vessels. 5. The treatment device for intradermal blood vessels according to claim 1, characterized in that thermal damage is caused in the skin tissue region between the electrode's adjacent area and the adjacent tissue region of the intradermal blood vessel in the skin tissue where the electrode is inserted. 6. The treatment device for intradermal blood vessels according to claim 1, characterized in that the plurality of electrodes are inserted into the dermis of the skin of the surgical subject. 7. The treatment device for intradermal blood vessels according to claim 1, characterized in that the above-mentioned electrical signal generating unit is a high-frequency signal generating device with a frequency of 0.1 to 100 MHz. 8. The treatment device for intradermal blood vessels according to claim 1, characterized in that at least one of the following: the depth of insertion of the electrode into the skin of the surgical subject, the voltage value applied by the electrode, the electrical power value transmitted from the electrode, the time for the electrode to apply the electrical signal, and the delay time when the electrode does not apply the electrical signal, can be preset. 9. The treatment device for intradermal blood vessels according to claim 1, characterized in that it further comprises an electrode module having a fixing part for fixing the plurality of electrodes. 10. The treatment device for intradermal blood vessels according to claim 9, characterized in that it further includes a driving part for driving the electrode or electrode module to insert the electrode into the skin.