Anesthetic for treating armpit odor or hyperhidrosis, and device for treating armpit odor or hyperhidrosis using the same

Abstract

To provide a therapeutic preparation for armpit odor or hyperhidrosis that can improve the odor suppression effect of a treatment area through thermal treatment of sweat glands by a treatment device for armpit odor or hyperhidrosis and improve thermal conductivity during thermal treatment, and to provide a treatment device for armpit odor or hyperhidrosis that uses the same.SOLUTION: An anesthetic for treating armpit odor or hyperhidrosis according to one embodiment of the present invention contains a local anesthetic as a main ingredient, and further contains polyphenol, biocompatible metal, or a combination of the polyphenol and the biocompatible metal. By injecting the anesthetic into a treatment area before thermal treatment of sweat glands using a treatment device for armpit odor or hyperhidrosis, the anesthetic improves temperature distribution during thermal treatment and reduces odor at the treatment area.SELECTED DRAWING: Figure 13

Description

[Technical Field]

[0001] The present invention relates to a therapeutic anesthetic for underarm odor or hyperhidrosis, and a therapeutic device for underarm odor or hyperhidrosis using the same. [Background technology]

[0002] Conventionally, a puncture device has been disclosed as a treatment device for underarm odor or hyperhidrosis, which includes an electrode needle and a contact part formed with a through-hole through which the electrode needle can be inserted, and which protrudes the electrode needle by bringing the contact part into close contact with the epidermal surface of a living body (see Patent Document 1). By destroying sweat glands with such a puncture device, it is possible to suppress excessive sweat secretion from, for example, apocrine glands or eccrine glands. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 6025828 Summary of the Invention [Problem to be solved by the invention]

[0004] In the lancing device of Patent Document 1, an anesthetic may be injected into the treatment area using a syringe before treatment in order to puncture the skin with an electrode needle for sweat gland treatment. In this case, the anesthetic is injected using the syringe, and then the lancing device is used to perform the puncture a predetermined time later. This means that the patient has to undergo multiple punctures during treatment, which is a burden to the patient. In addition, the treatment procedure requires the patient to recheck the treatment area after anesthesia and then set up the lancing device, which complicates the treatment procedure. Furthermore, some components of the anesthetic may interfere with the transmission of RF waves.

[0005] The present invention has been made in consideration of the above-mentioned circumstances, and aims to provide a therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis that uses the same, which can improve the odor suppression effect of the treatment area through thermal treatment of the sweat glands using a therapeutic device for axillary odor or hyperhidrosis, and can improve the thermal conductivity during thermal treatment, and also aims to obtain a therapeutic effect for axillary odor or hyperhidrosis using the active ingredients when a therapeutic preparation for axillary odor or hyperhidrosis is used. [Means for solving the problem]

[0006] The anesthetic for treating axillary odor or hyperhidrosis of the first aspect of the present invention is an anesthetic for treating axillary odor or hyperhidrosis, which contains a local anesthetic as a main ingredient, and further contains a polyphenol, a biocompatible metal, or a polyphenol and a biocompatible metal, and is characterized in that by being injected into the treatment area before thermal treatment of the sweat glands using a treatment device for treating axillary odor or hyperhidrosis, the temperature distribution during thermal treatment is improved and the odor at the treatment area is reduced.

[0007] A second aspect of the present invention is a local anesthetic for treating axillary odor or hyperhidrosis, which is the same as the first aspect of the local anesthetic for treating axillary odor or hyperhidrosis, characterized in that the polyphenol contains pentagalloyl glucose (PGG), or the pentagalloyl glucose is penta-O-galloyl-β-D-glucose hydrate (PCG).

[0008] The third aspect of the local anesthetic for treating axillary odor or hyperhidrosis of the present invention is characterized in that, in the local anesthetic for treating axillary odor or hyperhidrosis of the first aspect, the biocompatible metal contains at least one metal selected from the group consisting of zinc (which has diverse efficacy and is easy for the human body to use), manganese, copper (needle coating), and iron.

[0009] A fourth aspect of the local anesthetic for treating axillary odor or hyperhidrosis of the present invention is characterized in that, in the local anesthetic for treating axillary odor or hyperhidrosis of any of the first to third aspects, it contains xylocaine or xylocaine with epinephrine as a local anesthetic.

[0010] A fifth aspect of the present invention is a treatment device for axillary odor or hyperhidrosis that uses a local anesthetic for treating axillary odor or hyperhidrosis of any of the first to third aspects, and is characterized in that the treatment device comprises an administration section that administers the therapeutic preparation or therapeutic anesthetic to the treatment site, and a thermal treatment section that performs thermal treatment.

[0011] A sixth aspect of the present invention is a treatment device for axillary odor or hyperhidrosis, which is the fifth aspect of the treatment device for axillary odor or hyperhidrosis, characterized in that the thermal treatment unit is equipped with a puncture needle that is inserted into the treatment area to supply energy to the treatment area, the puncture needle also serves as the administration unit, has a hollow hole and a plurality of communication holes that connect the hollow hole to the outside, and the puncture needle injects the treatment preparation or therapeutic anesthetic for axillary odor or hyperhidrosis into the treatment area through the communication holes. [Effects of the Invention]

[0012] According to at least one of the therapeutic anesthetic for axillary odor or hyperhidrosis and the treatment device for axillary odor or hyperhidrosis using the same according to one aspect of the present invention, it is possible to improve the odor suppression effect of the treatment area by thermal treatment of the sweat glands using the treatment device for axillary odor or hyperhidrosis, and to improve the thermal conductivity during thermal treatment.

[0013] According to the first aspect of the present invention, when the therapeutic preparation for axillary odor or hyperhidrosis is injected into the treatment area before the thermal treatment of sweat glands using a therapeutic device for axillary odor or hyperhidrosis, the action of polyphenols, biocompatible metals, or polyphenols and biocompatible metals improves the temperature distribution during the thermal treatment and reduces odor at the treatment area. The use of magnesium, zinc, manganese, copper, iron, etc. as biocompatible metals produces favorable effects.

[0014] According to the second aspect of the local anesthetic for treating axillary odor or hyperhidrosis of the present invention, by using pentagalloyl glucose (PGG) as the polyphenol or penta-O-galloyl-β-D-glucose hydrate (PCG) as the pentagalloyl glucose, it is possible to suppress the odor of axillary odor and improve the temperature distribution in thermal treatment.

[0015] According to the third aspect of the present invention, the therapeutic preparation for axillary odor or hyperhidrosis uses at least one metal selected from the group consisting of zinc, manganese, copper, and iron as a biocompatible metal, thereby improving the temperature distribution during thermal treatment and reducing odor at the treatment site, thereby achieving favorable therapeutic effects.

[0016] According to the fourth aspect of the present invention, the local anesthetic for treating axillary odor or hyperhidrosis contains xylocaine or xylocaine with epinephrine as a local anesthetic, and therefore can provide an appropriate local anesthetic effect before thermal treatment.

[0017] According to the fifth aspect of the treatment device for axillary odor or hyperhidrosis of the present invention, the treatment device is equipped with an administration section that administers a therapeutic anesthetic to the treatment area and a thermal treatment section that performs thermal treatment.Therefore, by using a local anesthetic for treating axillary odor or hyperhidrosis of any of the first to third aspects, administering the therapeutic anesthetic to the treatment area from the administration section, and performing thermal treatment on the area to be treated by the thermal treatment section, it is possible to improve the odor suppression effect of the treatment area due to the thermal treatment of the sweat glands by the treatment device for treating axillary odor or hyperhidrosis, and to improve the thermal conductivity during thermal treatment.

[0018] In a sixth aspect of the present invention, the thermal treatment unit includes a puncture needle that is inserted into the treatment area to supply energy to the treatment area, and the puncture needle also serves as the administration unit, having a hollow hole and a plurality of communication holes that connect the hollow hole to the outside, and the puncture needle can inject an anesthetic for treating the axilla or hyperhidrosis through the communication holes into the treatment area, eliminating the need for a separate syringe or the like, thereby reducing the number of punctures required during treatment and easing the burden on the patient. Furthermore, a single operation can be used to provide local anesthesia and thermal treatment, for example, by applying RF waves as energy to the treatment area, thereby simplifying the treatment procedure and eliminating the need for complicated treatment. [Brief explanation of the drawings]

[0019] [Figure 1] 1 is a diagram showing a lancing device according to an embodiment of the present invention; [Figure 2] 1 is a side view of a lancing device according to an embodiment of the present invention; [Figure 3] 1 is a diagram showing the top surface of a lancing device according to an embodiment of the present invention. [Figure 4] 1A and 1B are views showing a contact portion of a lancing device according to an embodiment of the present invention. [Figure 5] 5A is a cross-sectional view taken along the line VA-VA in FIG. 2, and FIG. 5B is a schematic cross-sectional view of the puncture site sensor in FIG. 5A. [Figure 6] FIG. 2 is a view showing a state before a cartridge is attached to a main body of a lancing device according to an embodiment of the present invention. [Figure 7] FIG. 10 is a diagram showing a state in which a drive unit of the lancing device according to the embodiment of the present invention is activated. [Figure 8] 1 is a diagram showing a state before a puncture needle of a puncture device according to an embodiment of the present invention is projected. FIG. [Figure 9] 1 is a view showing a state in which a puncture needle of a puncture device according to an embodiment of the present invention is protruded. FIG. [Figure 10] 10 is a view showing a state in which the puncture needle of the puncture device according to the embodiment of the present invention has reached a membrane. FIG. [Figure 11] FIG. 11A is a graph showing the change in the tip position of the puncture needle over time when the puncture device of one embodiment of the present invention is operated, and FIG. 11B is a graph showing the change in temperature detected by the sensor needle over time. [Figure 12] Figure 12A shows the results of measuring the temperature distribution at a predetermined time point when RF current is passed through a puncture device of one embodiment of the present invention without using a cooling plate 24, and Figure 12B shows the results of measuring the temperature distribution at a predetermined time point when RF current is passed through the puncture device using a cooling plate 24. [Figure 13] 1 shows an example of treatment of the medium in Comparative Example 1. [Figure 14] 1 shows an example of cancer cell treatment in Comparative Example 2. [Figure 15] FIG. 10 is an explanatory diagram of the temperature distribution when a solvent containing a metal is used. [Figure 16] FIG. 10 is an explanatory diagram of the temperature distribution when a solvent containing zinc or magnesium is used. [Figure 17] FIG. 10 is an explanatory diagram of the temperature measurement results of Experimental Example 1. [Figure 18] 1 shows thermography images of Experimental Example 1. [Figure 19] FIG. 10 is an explanatory diagram of the temperature measurement results of Experimental Example 2. [Figure 20] 1 shows thermography images of Experimental Example 2. [Figure 21] FIG. 10 is an explanatory diagram of the temperature measurement results of Experimental Example 3. [Figure 22] 10 is a thermography image of Experimental Example 3. [Figure 23] (Old Figure 17) An explanatory diagram of the structure of the puncture needle of embodiment 2. DETAILED DESCRIPTION OF THE INVENTION

[0020] The following describes a therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis according to embodiments of the present invention with reference to the drawings. However, the embodiments shown below are merely examples of a therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis that embody the technical concept of the present invention, and are not intended to limit the present invention to these examples, and may be equally applicable to other embodiments included in the scope of the claims.

[0021] A therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis according to a first embodiment of the present invention will be described with reference to FIGS. 1 to 22. FIG.

[0022] [Puncture device] First, we will explain the treatment device used in this embodiment, which is the puncture device 1. However, the treatment device of this embodiment is not limited to the puncture device 1, and includes any thermotherapy device that uses RF waves, microwaves, lasers, etc., as long as it is for thermotherapy.

[0023] Fig. 1 is a diagram showing a lancing device 1 according to an embodiment of the present invention. Fig. 2 is a diagram showing a side view of lancing device 1 according to an embodiment of the present invention. Fig. 3 is a diagram showing a top view of lancing device 1 according to an embodiment of the present invention. Fig. 4 is a diagram showing abutment part 20 of lancing device 1 according to an embodiment of the present invention. Fig. 5A is a VV cross-sectional view of Fig. 2, and Fig. 5B is a schematic cross-sectional view of the puncture site sensor of Fig. 5A.

[0024] Lancing device 1 of the present embodiment includes at least puncture needle 10 to be inserted into a site to be punctured of a living body, sensor needle 11 to measure the temperature of the site to be punctured of the living body, contact unit 20 to contact the site to be punctured, drive unit 40 to drive puncture needle 10, main body 30 to house drive unit 40, operation unit 50 to operate drive unit 40, and cartridge 60. In the present invention, the site to be punctured of a living body refers to a site of the living body that can be punctured by puncture needle 10. Lancing device 1 of the present embodiment punctures a site to be punctured that includes sweat glands with puncture needle 10, and supplies thermal energy by supplying energy from energy supply unit 2, thereby destroying the sweat glands and suppressing excessive sweating.

[0025] The puncture needle 10 is made of a conductive metal material such as stainless steel. The tip 10a of the puncture needle 10 is tapered to enable puncture. The rest of the puncture needle 10, other than the tip 10a, is covered with an insulating film 10b made of an electrically insulating material. To safely and reliably destroy sweat glands, it is preferable to expose the tip 10a and cover the rest of the puncture needle 10 with the insulating film 10b. However, it is not necessary for the insulating film 10b to cover the rest of the puncture needle 10. It is sufficient for the puncture needle 10 to have a portion made of a conductive metal material and a portion of the metal material covered with the insulating film 10b made of an electrically insulating material. Furthermore, even if the puncture needle 10 is not covered with the insulating film 10b, thermal energy can be supplied from the energy supply unit 2 to the puncture site, including the sweat gland, although this may result in reduced safety.

[0026] The exposed length of tip portion 10a can be, for example, about 0.1 to 2.0 mm, or about 0.1 to 1.5 mm. If the exposed length of tip portion 10a is short, such as 0.1 to 0.2 mm, accurate processing becomes difficult. If the exposed length of tip portion 10a is long, such as 0.6 mm or more, current will not concentrate on tip portion 10a, resulting in a drop in temperature. A more preferable exposed length of tip portion 10a is about 0.2 to 0.6 mm. This is determined from the perspective of ensuring that the thermal energy supplied from energy supply unit 2 is distributed equally throughout the site to be punctured, including the sweat glands.

[0027] A plurality of puncture needles 10 are arranged in a matrix and fixed to a holder 12 made of a plastic material or the like and having, for example, a rectangular plate shape. The number of puncture needles 10 is not particularly limited, and there may be only one. When a plurality of puncture needles 10 are arranged, it is preferable to arrange, for example, about 20 to 40 needles (or more), and it is preferable to set the interval between adjacent puncture needles 10 to, for example, about 0.5 to 3 mm (more preferably, 1 to 3 mm). The thickness of each puncture needle 10 is preferably, for example, about 0.1 to 0.3 mm. The arrangement shape of the plurality of puncture needles 10 may be various shapes such as a circle or a polygon, in addition to a matrix. These are arranged or set from the viewpoint of ensuring that the thermal energy supplied by the energy supply unit 2 is distributed equally throughout the site to be punctured, including the sweat glands.

[0028] The tip 10a of the puncture needle 10 may be formed as a blunt needle (a non-bevel needle with no cutting edge at the tip) that penetrates the skin (epidermis) and subcutaneous tissue of a living body but does not penetrate the membrane tissue between the subcutaneous tissue and the muscle layer. This allows safe puncture only at depths where sweat glands may be present. The insertion depth of the puncture needle 10 is preferably adjustable between 1.0 and 8.0 mm, as the optimal insertion depth varies from patient to patient.

[0029] As shown in FIG. 5B , the sensor needle 11 has a structure in which a temperature sensor 81 for measuring the temperature of the site to be punctured is attached to the closed end of the hollow needle 11a. The hollow needle 11a is made of, for example, stainless steel (SUS) hollow needle 81a with a closed end. Its outer surface is gold-plated to improve thermal conductivity, and the surface is further coated with glass for insulation (both not shown). Here, an ultrafine thermocouple is used as the temperature sensor 81, and its output is transmitted to the control unit 70 via an ultrafine lead wire 81c with an insulating coating 81b. The sensor needle 11 is installed alongside the puncture needle 10 in an empty space in the holder 12 where the puncture needle 10 is not installed. The sensor needle 11 is formed to be the same length as the puncture needle 10 and moves in the same manner as the puncture needle 10. While a single sensor needle 11 is used in this embodiment, installing multiple sensor needles allows for more precise measurement of the temperature distribution of the site to be punctured.

[0030] Contact portion 20 includes a cooling section capable of cooling the site to be punctured and its vicinity, and is equipped with Peltier element 22, cooling plate 24, and heat dissipation block 26. Peltier element 22 has a known configuration in which a p-type semiconductor and an n-type semiconductor are thermally arranged in parallel, with cooling plate 24 provided on the heat absorption side of Peltier element 22 and heat dissipation block 26 provided on the heat generation side of Peltier element 22. A plurality of Peltier elements 22 of appropriate sizes are arranged in a matrix. Cooling plate 24 and heat dissipation block 26 have a plurality of openings 24a, 26a formed in the gaps between the plurality of Peltier elements 22, and the opposing openings 24a, 26a form a plurality of through-holes 28 that penetrate the front and back surfaces of contact portion 20.

[0031] The contact portion 20 of this embodiment is supported by the main body 30 via a support arm 21 (see FIG. 6). The contact portion 20 may be detachable from the main body 30 or the cartridge 60 via a terminal portion 30a (see FIG. 4), and the puncture needle 10, the plurality of Peltier elements 22, the temperature sensor 81, and the surface temperature sensor 82 may each be electrically connected to the control unit 70. This allows the main body 30 to energize the Peltier element 22, and also allows the outputs of the puncture needle 10, the temperature sensor 81, and the surface temperature sensor 82 to be transmitted to the control unit 70. The terminal portion 30a may be provided on the cartridge 60.

[0032] The main body 30 has a cylindrical portion 34 with an opening 34a formed facing downward in Fig. 5. A hole 34b is formed on the surface of the cylindrical portion 34 opposite the opening 34a. The main body 30 and the cylindrical portion 34 may be integral or separate.

[0033] The drive unit 40 of this embodiment includes a drive motor 42 such as a servo motor, an encoder 44 that detects the number of rotations of the drive motor 42, and a rod 46 that moves forward and backward as the drive motor 42 rotates.

[0034] With the above-described configuration of the drive unit 40, the rod 46 can be advanced in the direction of arrow B in FIG. 5 by the rotation of the drive motor 42, and the amount of advancement of the rod 46 can be controlled based on the detection by the encoder 44.

[0035] The rod 46 moves forward and backward, causing the tip 10a of the puncture needle 10 to protrude and retract from the contact surface 24b. The amount by which the puncture needle 10 protrudes from the bottom surface of the contact surface 24b is not particularly limited, but can be set to, for example, about 0.1 to 10 mm depending on the target sweat gland. When multiple puncture needles 10 (for example, about 20 to 40 or more) are arranged, it is preferable that the protrusion amounts of all the puncture needles 10 be within the above numerical range, and it is more preferable that the protrusion amounts of all the puncture needles 10 be approximately equal.

[0036] The control unit 70 controls the drive of the drive unit 40 through operation of the operation unit 50, causing the puncture needle 10 to extend and retract. It is preferable that the control unit 70 controls the drive of the drive unit 40 so that the tip 10a of the puncture needle 10 stops at each heating depth position stored in advance. The control unit 70 may be built into the main body 30, or may be configured externally using a smartphone, personal computer, or the like.

[0037] Furthermore, control unit 70 applies electricity to contact unit 20 to cool contact surface 24b that contacts the epidermis, etc. During cooling, it is preferable that the temperatures inside and on the surface of the living body are measured by puncture site temperature sensor 81 and surface temperature sensor 82, respectively, and control unit 70 controls the cooling temperature of contact surface 24b in accordance with the measured values.

[0038] Furthermore, the control unit 70 sequentially supplies energy including thermal energy from the tip 10a to the target tissue such as sweat glands at each heating depth position. The energy including thermal energy is supplied from the energy supply unit 2. Here, sequential supply means supplying energy including thermal energy from the tip 10a of the puncture needle 10 while gradually increasing the distance from the epidermis or the like of the tip 10a of the puncture needle 10. This allows uniform heating along the depth direction of the area to be punctured, and efficiently destroys all of the sweat glands present in this region.

[0039] Control unit 70 may control the amount of energy, including thermal energy, supplied from energy supply unit 2, according to the temperature measured by temperature sensor 81, which measures the temperature of the part to be punctured. That is, the amount of energy, including thermal energy, required to destroy the target sweat gland is determined according to the type of sweat gland, and energy supply unit 2 can be controlled accordingly. For example, it is possible to maintain the temperature measured by temperature sensor 81 at or above a predetermined temperature for a predetermined period of time. By controlling the amount of energy, including thermal energy, in this way, it is possible to accurately heat the part to be punctured and efficiently destroy the sweat glands.

[0040] The energy including thermal energy supplied from the puncture needle 10 may be varied according to the depth interval, and may be configured so that the greater the depth interval, the greater the energy including thermal energy supplied. The supply of energy including thermal energy may be performed using high frequency waves, radio waves, microwaves, lasers, etc. In these cases, the amount of energy supplied from the energy supply unit 2 will vary depending on the target sweat gland, and the required amount of energy may be determined in advance by experiment, etc. This also applies to thermal energy.

[0041] The epidermis surface is cooled around the puncture site by the close contact of contact surface 24b, preventing burns and providing good pain relief during puncture and thermal energy supply. Anesthesia cream may be applied in advance to the epidermis surface with which contact surface 24b is in close contact. When contact surface 24b is configured to spray cooling gas onto the epidermis surface, starting the spray of cooling gas immediately before puncturing the epidermis surface with puncture needle 10 can provide good burn prevention and pain relief effects.

[0042] Next, the operation of the lancing device 1 having the above configuration will be described with reference to Figures 6 and 7. Figure 6 is a diagram showing the state before cartridge 60 is attached to main body 30 of lancing device 1 of one embodiment according to the present invention. Figure 7 is a diagram showing the state after drive unit 40 of lancing device 1 of one embodiment according to the present invention has been activated.

[0043] First, the cartridge 60 equipped with the puncture needle 10 is attached to the main body 30. The cartridge 60 can be attached to the main body 30 by sliding it along the engagement rail 36 in the direction of arrow C in FIG.

[0044] 1, the drive motor 42 of the drive unit 40 rotates. When the drive motor 42 rotates, the rotary shaft 42a and the shaft 43 rotate. The nut 46a is threadedly engaged with the shaft 43, but the rod 46 is unable to rotate because the protrusion 46b is engaged with the groove 34c. Therefore, as shown in FIG. 7, the rod 46 moves in the direction of arrow D according to the amount of rotation of the drive motor 42, and each puncture needle 10 gradually protrudes from the abutment surface 24b.

[0045] Next, an example of use of the lancing device 1 according to the embodiment described above in destroying sweat glands E and A in a living organism S will be described with reference to Figs. 8 to 11. Fig. 8 is a diagram showing the state before the lancing needle 10 of the lancing device 1 according to the embodiment of the present invention is protruded. Fig. 9 is a diagram showing the state when the lancing needle of the lancing device according to the embodiment of the present invention is protruded. Fig. 10 is a diagram showing the state when the lancing needle of the lancing device according to the embodiment of the present invention has reached the membrane. Fig. 11A is a graph showing the change over time in the tip position of the lancing needle when the lancing device according to the embodiment of the present invention is operated, and Fig. 11B is a graph showing the change over time in the temperature detected by the sensor needle.

[0046] First, let's discuss the tissues beneath the skin. Eccrine glands (E glands) are found throughout the body, except for those on the lips and nails. Apocrine glands (A glands) are distributed from the armpits to the chest, ears, areola, navel, and hem. Treatment areas vary depending on the patient. Both A and E glands are located below the dermis (deeper than the dermis). For example, in a study of 60 Japanese patients, the average size of the A gland was 0.48 mm, with its most superficial depth measuring 0.812 mm subcutaneously and its deepest depth measuring 2.591 mm, and its center measuring 1.51 mm subcutaneously. Similarly, the average size of the E gland was 0.57 mm, but it was elongated with a long axis (vertical axis) of 1.47 mm and a short axis (horizontal axis) of 0.57 mm, its most superficial depth measuring 0.72 mm and its deepest depth measuring 3.01 mm, and its center measuring 1.74 mm subcutaneously. However, this is an average of 60 Japanese patients, and may change with increasing number of cases. It may not necessarily be consistent with other factors, such as race.

[0047] Next, by operating the operating unit 50 shown in Fig. 1, the drive motor 42 of the drive unit 40 is rotated as shown in Fig. 7. When the drive motor 42 of the drive unit 40 is rotated, each puncture needle 10 gradually protrudes from the abutment surface 24b, as shown in Fig. 9. As the amount of protrusion of the puncture needle 10 from the abutment surface 24b increases, the tip of the puncture needle 10 penetrates from the epidermis S1 into the dermis S2.

[0048] As the protrusion of the puncture needle 10 from the contact surface 24b increases, the tip of the puncture needle 10 penetrates from the epidermis S1 through the dermis S2 and into the subcutaneous tissue S3. However, when the puncture needle 10 reaches the membrane F between the subcutaneous tissue S3 and the muscle layer S4, the puncture needle 10 cannot penetrate the membrane F, and the puncture depth of the puncture needle 10 is maintained constant. To prevent the puncture needle 10 from penetrating the membrane F, the tip 10a of the puncture needle 10 may be blunted (a non-beveled needle with no cutting edge at the tip), as described above, the diameter of the puncture needle 10 may be adjusted depending on the performance of the drive motor 42 of the drive unit 40, or a pressure sensor or the like may be provided to measure the pressing force of the puncture needle 10, and the control unit 70 may control the rotation of the drive motor 42 of the drive unit 40 depending on the detection result of the pressure sensor or the like to appropriately set the pressing force of the puncture needle 10. Furthermore, a configuration for determining the depth range in advance, as described below, may be added to these adjustments or settings.

[0049] When the puncture depth of the puncture needle 10 is maintained constant for a predetermined time, the control unit 70 stops the drive unit 40. The protrusion amount of the puncture needle 10 at this time may be calculated from the value of the encoder 44 and stored in memory as maximum depth information (unless the protrusion amount of the puncture needle 10 from the abutment surface 24b is a predetermined maximum protrusion amount). Thereafter, the control unit 70 reversely rotates the drive motor 42 to move the puncture needle 10 in the direction of withdrawing it from the site to be punctured, and the tip of the puncture needle 10 is buried above the abutment surface 24b. As with the membrane F, it is preferable that the thickness and pressing force of the puncture needle 10 be appropriately set so that the tip 10a does not reach the muscle layer S4 and remains reliably within the subcutaneous tissue S3.

[0050] The maximum depth information thus obtained, i.e., information relating to the depth to membrane F, corresponds to the depth range where sweat glands such as apocrine glands are present at the site to be punctured. Therefore, by knowing this depth range in advance and also knowing the relative position of contact portion 20 with respect to the epidermis of the living body (position in a plane direction perpendicular to the protrusion direction of puncture needle 10; the same applies below), when repeatedly performing treatment on the same epidermal surface S0 (or epidermis, etc. S1), the user may operate operation portion 50 to select automatic mode and set for efficient treatment.

[0051] That is, when the automatic mode is set, the control unit 70 first sets a plurality of heating depth positions based on the maximum depth information. The heating depth positions can be determined, for example, from a depth interval determined by comparing the maximum depth value with a predetermined reference value.

[0052] After determining the multiple heating depth positions, the control unit 70 may control the driving of the drive unit 40 so that the tip 10a of the puncture needle 10 stops at each heating depth position while applying electricity to the contact unit 20 to cool the epidermal surface S0 with which the contact surface 24b is in close contact, and supply thermal energy from the tip 10a to the target tissue at each heating depth position. By repeating these steps, it is possible to perform uniform heating along the depth direction of the area to be punctured, and to efficiently and reliably destroy all of the sweat glands present in this area.

[0053] For example, to supply thermal energy to a depth of 0.4 mm from the epidermal surface S0, first, the tip 10a of the puncture needle 10 is inserted sequentially to a depth of 0.4 mm over the entire area of ​​the epidermal surface S0 to be treated, and electrical current is passed through to treat it; then, to supply thermal energy to a depth of 0.8 mm from the epidermal surface S0, the tip 10a of all the puncture needles 10 is inserted to a depth of 0.8 mm over the area, and electrical current is passed through to treat it; by repeating this process, uniform heating can be achieved along the depth direction of the area to be punctured.

[0054] The thermal energy supplied from the puncture needle 10 may be varied according to the depth interval, and may be configured to supply greater thermal energy as the depth interval increases. This takes into consideration that different sweat glands are targeted depending on the depth interval, and therefore different amounts of thermal energy are required. The thermal energy or energy supply can be achieved using a variety of sources, including high frequency, radio waves, microwaves, and lasers.

[0055] In the puncture device 1 of one embodiment of the present invention, an alternating current (hereinafter sometimes referred to as "RF current") selected from the range of 100 Hz to 3 THz is passed between the puncture needle 10 and a large-area surface electrode (not shown) attached to, for example, the thigh, to generate heat near the tip of the puncture needle 10. This heat generation occurs because the RF current density flowing at the tip of the puncture needle 10 increases, causing heat generation near the tip of the puncture needle 10. From the standpoints of stability and efficiency, this RF current is preferably a low-frequency alternating current of about 100 Hz to 1000 Hz. A voltage of about 100 to 400 V is used as the applied voltage, with a high voltage being used when the application time is short and a low voltage being used when the application time is long.

[0056] A desirable temperature is 50°C or higher, for example, 50 to 150°C. This temperature can be set by the control unit 70. Depending on this setting, it is possible to set it to, for example, 50 to 120°C, or 50 to 100°C, or it can also be set to 70°C or higher. A predetermined RF current is supplied from the tip of the puncture needle 10 so as to achieve this set temperature. Note that, although not particularly limited, the magnitude of this RF current can be set by the RF wave applied voltage; specifically, the peak-to-peak voltage of the RF wave can be set as the target voltage.

[0057] Even if the temperature exceeds 100°C, there is no risk of burns if the heating time is short. Empirically, a heating time of 1 to 10 seconds is used, with 2 seconds or more being preferable for reliable treatment. It takes about 1 second for the RF current to be applied to the puncture needle 10 to reach the predetermined temperature. After that, the current is heated to 50°C or higher for a predetermined period of time, after which the temperature drops when the current is turned off. The longer the current application time, the greater the effect of destroying the sweat glands. However, a long current application time increases the burden on the physician holding the puncture needle 10 and increases the risk of burns, so the current application time should be as short as possible. For example, if the puncture needles 10 are spaced 2 mm apart, applying current to heat the tips of the puncture needles 10 to 100°C can raise the temperature of the intermediate portions between the puncture needles 10 to 50°C or higher, for example, approximately 70°C.

[0058] 11A shows an example of the change over time in the tip position of puncture needle 10 when puncture device 1 of one embodiment of the present invention is operated, and FIG. 11B shows an example of the change over time in temperature detected by sensor needle 11. The origin and starting temperature in FIGS. 11A and 11B are in the states shown in FIG. 8. Note that FIGS. 11A and 11B are an example of the operation of puncture device 1, and the operation of puncture device 1 is not limited to this.

[0059] Figure 12A shows the results of measuring the temperature distribution at a predetermined time point when an RF current is applied to a lancing device of one embodiment of the present invention without using cooling plate 24, and Figure 12B shows the results of measuring the temperature distribution at a predetermined time point when an RF current is applied in the same manner using cooling plate 24. Note that Figures 12A and 12B show predetermined moments during heating, and the two times do not coincide. Also, in Figures 12A and 12B, the site to be punctured is a cream-like medium that simulates human skin.

[0060] Temperature measurement points line 0 to line 4 are set from shallow to deep in the depth direction, with line 2 in the middle corresponding to approximately the depth of the tip of the puncture needle 10.

[0061] 12A and 12B, it can be seen that the temperature at line 2, which corresponds to approximately the tip of the puncture needle 10, is the highest. The depth position of the temperature sensor 81 is approximately the same as the depth position of the tip of the puncture needle 10, so the temperature sensor 81 can detect the temperature of the area with the highest temperature at that depth. The temperature sensor 81 feeds back the maximum temperature in the depth direction, enabling appropriate temperature control. However, the temperature detected by the temperature sensor 81 is not limited to the temperature at the depth position corresponding to the tip of the puncture needle 10. For example, the temperature sensor 81 can also detect temperatures at positions shallower or deeper than the depth position corresponding to the tip of the puncture needle 10. Furthermore, for example, the temperature sensor 81 can detect temperatures at multiple depth positions in addition to the temperature at the depth position corresponding to the tip of the puncture needle 10. While multiple sensor needles 11 can be used to detect temperatures at multiple depth positions, it is also possible to detect temperatures at multiple depth positions by providing multiple temperature sensors 81 along the length of a single sensor needle 11. Furthermore, feeding back temperatures at multiple depth positions enables more appropriate control of the temperature distribution in the depth direction.

[0062] 12B, where the cooling plate 24 is provided, the temperature of line 0 close to the skin surface S0 is relatively lower than that of FIG. 12A, where the cooling plate 24 is not provided, and it can be seen that the cooling effect on the skin surface S0 is achieved by the cooling plate 24. That is, in FIG. 12A, when line 3 is 68.9°C and line 4 is 51.5°C, line 0 is 64.4°C, whereas in FIG. 12B, when line 3 is 81.5°C and line 4 is 70.1°C, line 0 is 50.9°C.

[0063] The epidermis surface S0 is cooled around the puncture site by the intimate contact of the contact surface 24b, thereby preventing burns and providing good analgesia during puncture and thermal energy supply. An anesthetic cream may be applied in advance to the epidermis surface S0 to which the contact surface 24b is in intimate contact. Alternatively, instead of or in addition to applying the anesthetic cream, the contact surface 24b may be configured to spray cooling gas onto the epidermis surface S0. In this case, starting the spray of cooling gas immediately before the puncture needle 10 punctures the epidermis surface S0 can provide good burn prevention and analgesia. Furthermore, spraying cooling gas onto the epidermis surface S0 from the opening 24a during the puncture period can maintain a longer cooling effect, thereby providing better burn prevention and analgesia.

[0064] After the thermal energy is supplied, the drive unit 40 is actuated to raise the puncture needle 10 and re-house it in the cartridge 60. This completes the treatment of the target tissue. If subsequent treatment is to be performed on a different living body, the cartridge 60 can be replaced with a new one and treatment can then begin. By configuring the cartridge 60 to be detachable and replaceable in this way, sterilization of the puncture needle 10 is not required each time, and treatment can be performed quickly. The contact portion 20 can also be detachable from the main body 30 and replaced with a new one, but it may also be fixed.

[0065] As described above, the puncture device 1 of this embodiment includes a puncture needle 10 that punctures a site to be punctured of a living body and supplies thermal energy, a sensor needle 11 having a temperature sensor 81 that measures the temperature of the site to be punctured, a holder 12 that holds the puncture needle 10 and the sensor needle 11, a cartridge 60 that stores the puncture needle 10, the sensor needle 11, and the holder 12, a main body 30 to which the cartridge 60 can be attached, an abutment unit 20 that has a through hole 28 that penetrates from front to back and has an abutment surface 24b on the front side that comes into contact with the surface of the site to be punctured, and a drive unit 40 that moves the holder 12 so that the puncture needle 10 and the sensor needle 11 appear and disappear from the abutment surface 24b through the through hole 28. Therefore, it is possible to grasp the degree to which the living body is heated, and to prevent excessive heating and insufficient heating.

[0066] [Local anesthetic injection] Before thermal treatment for underarm odor or hyperhidrosis, such as RF, microwave, or laser treatment, a local anesthetic is injected into the treatment area. The local anesthetic can be injected into the treatment area using, for example, a syringe or needle. When using the RF treatment device described above, an electrode needle is used at the treatment area. By using a needle as this electrode needle, it becomes possible to inject the local anesthetic simultaneously with the insertion of the electrode needle, as described below.

[0067] [Local anesthetic] The main component of the local anesthetic for treating axillary hyperhidrosis in this embodiment is xylocaine (lidocaine) liquid, such as xylocaine containing epinephrine. However, the type of local anesthetic used as the main component is not limited to xylocaine liquid, and other common local anesthetics can also be used.

[0068] In this example, the local anesthetic for treating axillary hyperhidrosis contains, in addition to the main component, a local anesthetic, pentagalloyl glucose (PGG) and a biocompatible metal. PGG, a type of polyphenol, can be, for example, penta-O-galloyl-β-D-glucose hydrate (PCG). Adding PGG or PCG can suppress axillary odor and improve the conductivity of RF waves during VH treatment.

[0069] Table 1 shows the thermal conductivity of metals. As the metal to be added to the local anesthetic, one or more biocompatible metals can be selected from the metals shown in Table 1 (Source: Mechanical Engineering Notes). Examples of biocompatible metals include magnesium, zinc, manganese, copper, and iron. The order of highest thermal conductivity is silver > copper > gold > aluminum > magnesium > zinc > iron > tin > lead. In local anesthesia performed before RF application treatment, the following drugs (substances) can be added to the local anesthetic to increase the thermal conductivity of the RF waves: (1) Mg (Magnesium) (2) Zn (zinc) (3) Mn (manganese) (4)Copper (5) Iron By using an injection containing these ingredients, it is safe, the thermal conductivity is improved, and the therapeutic effect can be enhanced in RF wave application therapy. [Table 1]

[0070] When adding a biocompatible metal, drugs such as, but not limited to, Magnesol (Table 2, Table 3), Magcent (Table 4), Eleject (Table 5, Table 6), Volbix (Table 7, Table 8), and Elementmic (Table 9, Table 10) can be used. [Table 2] [Table 3]

[0071] About "Magnesol for Intravenous Injection" (Source: JAPIC) Brand name: Magnesol 20mL for intravenous injection Active ingredient: 2g of JP magnesium sulfate hydrate per 20mL JP glucose 2g Each tube contains 16.2 mEq of magnesium. Brand name: Magnesol 20mL for intravenous injection ·Characteristics: Colorless and clear injection solution pH 3.5~6.0 Osmotic pressure ratio: approx. 4 (compared to physiological saline) Indications: Prevention and treatment of eclampsia in severe pregnancy-induced hypertension Dosage and Administration: Administer an initial dose of 40 mL (4 g of magnesium sulfate hydrate) intravenously over 20 minutes, followed by continuous intravenous infusion at 10 mL (1 g) per hour. Increase the dose by 5 mL (0.5 g) per hour depending on symptoms, up to a maximum of 20 mL (2 g) per hour. This drug should be administered using a continuous infusion pump, except for the initial dose. Mechanism of action: When magnesium sulfate hydrate is administered intramuscularly or intravenously, blood Mg2+ levels increase, disrupting the equilibrium with Ca2+, resulting in central nervous system depression and skeletal muscle relaxation. The anesthetic-like state seen with rapid intravenous administration of this drug is thought to be due to Mg2+ inhibiting the release of acetylcholine at the neuromuscular junction, blocking the transmission of nerve impulses and causing skeletal muscle relaxation. This neuromuscular effect is antagonized by calcium. Physicochemical information regarding the active ingredient: "Magnesium sulfate hydrate" is commonly known as magnesium sulfate hydrate, has a molecular formula of MgSO4·7H2O, a molecular weight of 246.47, and is a colorless or white crystal with a bitter, refreshing, and salty taste. It is highly soluble in water and practically insoluble in ethanol. It is soluble in dilute hydrochloric acid. "Glucose" The common name is glucose, the chemical name is D-gluco- copyranose, and the molecular formula is CH 12O6, molecular weight 180.16, properties are white crystals or crystalline powder, odorless, sweet taste, easily soluble in water, slightly soluble in ethanol, practically insoluble in diethyl ether.

[0072] [Table 4]

[0073] About "Magcent Injection 100mL" (Source: JAPIC) Brand name: Magcent Injection 100mL Active ingredient in 100mL JP Magnesium Sulfate Hydrate 10g JP Glucose 10g Each bottle contains 81mEq of magnesium. Properties: Clear, colorless injection pH: 3.5-6.0 Osmolality: Approximately 4 (compared to physiological saline) Indications: Suppression of uterine contractions in cases of threatened premature labor, prevention and treatment of eclampsia in severe pregnancy-induced hypertension Dosage and Administration <Suppression of uterine contractions in threatened preterm labor> Administer an initial dose of 40 mL (4 g of magnesium sulfate hydrate) intravenously over 20 minutes or more, followed by continuous intravenous administration at 10 mL (1 g) per hour. If uterine contractions are not suppressed, increase the dose by 5 mL (0.5 g) per hour up to a maximum of 20 mL (2 g) per hour. After uterine contractions are suppressed, gradually reduce the dose while observing symptoms, and discontinue administration if no recurrence of uterine contractions is confirmed. This drug should be administered using a continuous infusion pump. <Prevention and treatment of eclampsia in severe pregnancy-induced hypertension> An initial dose of 40 mL (4 g of magnesium sulfate hydrate) is administered intravenously over 20 minutes or more, followed by continuous intravenous infusion at 10 mL (1 g) per hour. Depending on symptoms, the dose may be increased by 5 mL (0.5 g) per hour up to a maximum of 20 mL (2 g) per hour. Except for the initial dose, this drug should be administered using a continuous infusion pump. Mechanism of action <Mechanism of action for inhibiting uterine contractions in threatened preterm labor> Magnesium blocks Ca channels and inhibits calcium influx from the extracellular space into the cells.2+ It activates ATPase and promotes calcium efflux from inside to outside the cell. 37) It inhibits the activity of inositol triphosphate (IP3)-specific phospholipase C, suppresses IP3 production, and inhibits IP3-induced calcium release from intracellular calcium storage sites (endoplasmic reticulum). 38) Ca 2+ Activates ATPase and promotes calcium uptake into the endoplasmic reticulum within the cell.37) Intracellular free calcium is reduced, calmodulin-mediated activation of myosin light chain kinase is inhibited, and muscle contraction due to the sliding of actin and myosin is suppressed. <Mechanism of action for preventing and treating eclampsia in severe pregnancy-induced hypertension> When magnesium sulfate hydrate is administered intramuscularly or intravenously, it increases blood Mg 2+ Increased Ca 2+ The balance between the two is broken, causing depression of the central nervous system and relaxation of skeletal muscles. The anesthetic-like state seen with rapid intravenous administration of this drug is due to the 2+ It is thought that acetylcholine inhibits the release of acetylcholine at the neuromuscular junction, blocking the transmission of nerve impulses and causing skeletal muscle relaxation. This neuromuscular action is antagonized by calcium. <Uterine contractility inhibitory effect> Magnesium sulfate hydrate alone inhibited uterine spontaneous motility and uterine contractions induced by acetylcholine or PGF2α in late-stage pregnant rats. Furthermore, the inhibitory effect on uterine smooth muscle contraction was enhanced by combined administration of magnesium sulfate hydrate and ritodrine hydrochloride (in vitro and in situ). Physicochemical information about the active ingredient: "Magnesium sulfate hydrate" is commonly known as magnesium sulfate hydrate. Its molecular formula is MgSO4·7H2O, its molecular weight is 246.47, and it is a colorless or white crystal with a bitter, refreshing, and salty taste. It is highly soluble in water and practically insoluble in ethanol (95%). It is soluble in dilute hydrochloric acid. The common name for "glucose" is glucose, its chemical name is D-gluco- copyranose, and its molecular formula is CH 12O6, molecular weight 180.16, properties are white crystals or crystalline powder, odorless, sweet taste, easily soluble in water, slightly soluble in ethanol (95), practically insoluble in diethyl ether.

[0074] "Eleject Injection Syringe" (Source: JAPIC) [Table 5]

[0075] [Table 6]

[0076] Indications: Supplementation of zinc, iron, copper, manganese, and iodine when oral or enteral nutrition is not possible or is insufficient and high-calorie parenteral nutrition is the only option. Normally, for adults, 2 mL is added to high-calorie parenteral nutrition infusions and administered intravenously. The dosage may be increased or decreased depending on age and symptoms. Precautions for use related to dosage and administration: Once oral and enteral nutritional supplementation has been achieved, administration of this drug should be discontinued immediately (trace elements are usually supplied by oral and enteral nutrition).

[0077] "Volubix Injection" (Source: JAPIC) [Table 7]

[0078] [Table 8]

[0079] ·Efficacy·Effects Supplementation of zinc, iron, copper, manganese and iodine when oral or enteral nutrition is not possible or is insufficient and high-calorie parenteral nutrition is the only option. Dosage and Administration: The usual adult dosage is 2 mL per day added to high-calorie parenteral nutrition solutions and administered intravenously. The dosage may be adjusted according to age and symptoms. Pharmacology: Trace element deficient rats and normal rats were given a one-week high-calorie infusion containing a trace element preparation containing 20 μmol of manganese, and a group given a high-calorie infusion without the trace element preparation. The effects of supplementing with the trace element preparation were compared. 9) As a result, the group not given the trace element preparation showed a decrease in trace element concentrations in plasma and tissues, and also showed anemia symptoms, decreased alkaline phosphatase activity, and decreased triiodothyronine and thyroxine levels, which are thought to be due to trace element deficiency. However, in the group to which trace element preparations were added, these changes were either restored to normal levels or tended to return to normal levels.

[0080] "Elementic Note" (Source: JAPIC) [Table 9]

[0081] Sales name: Elementmic Note Standard unit: 2mL per tube European trademark name: Elementmic Injection Regulatory classification Regulatory classification: Prescription drugs Note) Regulatory classification notes: Caution: Use only with a doctor's prescription. Japan standard product classification number: 873229 Approval number: 20400AMZ00057 Sales start date: April 1992 Savings method and expiration date Storage method: Store at room temperature Validity period: 3 years Ingredients and properties: Composition is as shown in Table 10 [Table 10] Additive: Sodium chondroitin sulfate Additive: Sodium hydroxide (pH adjuster)

[0082] <Properties of the formulation> Color: Dark reddish brown Dosage form: colloidal solution / liquid / injection <Efficacy and effects> Supplementation of zinc, iron, copper, manganese, and iodine when oral or enteral nutrition is not possible or is insufficient and high-calorie parenteral nutrition is the only option. <Dosage and administration> The usual adult dosage is 2 mL per day added to high-calorie parenteral nutrition solutions and administered intravenously. The dosage may be adjusted according to age and symptoms. Precautions regarding dosage and administration: Some base solutions for high-calorie infusion contain trace elements. Therefore, the amount should be reduced appropriately depending on the amount of trace elements. <Dosage and administration> The usual adult dosage is 2 mL per day added to high-calorie parenteral nutrition solutions and administered intravenously. The dosage may be adjusted according to age and symptoms. <Caution regarding dosage and administration> Some base solutions for high-calorie infusion contain trace elements, so the amount should be reduced appropriately depending on the amount of trace elements. <Pharmacology> Mechanism of action: This drug contains zinc, iron, copper, manganese and iodine, and is added to high-calorie parenteral nutrition solutions to replenish trace elements. Effect of trace element supplementation: Trace element-deficient rats and normal rats were given a one-week high-calorie infusion containing a trace element preparation containing 20 μmol of manganese*, and a comparison was made of the effect of supplementing with a trace element preparation between two groups. The results showed that the group not receiving the trace element preparation had reduced trace element concentrations in plasma and tissues, and also showed symptoms of anemia, decreased alkaline phosphatase activity, and decreased triiodothyronine and thyroxine concentrations, which are thought to be due to trace element deficiency. However, in the group receiving the trace element preparation, these changes returned to normal levels or tended to return to normal. *Combined formulation of manganese 20μmol, iron 35μmol, zinc 60μmol, copper 5μmol, and iodine 1μmol

[0083] [Comparative Example 1] FIG. 13 shows an example of treatment of the culture medium of Comparative Example 1. Using a culture medium that changes color at a temperature of 60°C, RF waves were applied from the puncture needle 10 by the puncture device 1, and the temperature distribution at the site to be punctured was confirmed. The gray parts of the culture medium are parts that have not changed color and have not yet reached a temperature of 60°C. The white parts of the culture medium are parts that have changed color and have not yet reached a temperature of 60°C. The upper figure is a plan view, and the lower figure is a cross-sectional view. Looking at the cross-sectional view, it can be seen that the discolored white area remains within the cylindrical area surrounding the area punctured by the puncture needle 10, and the area between the puncture needles 10 has not changed color, indicating that the temperature has not yet reached 60°C.

[0084] Comparative Example 2 FIG. 14 shows an example of cancer cell treatment in Comparative Example 2. In FIG. 14, a cancer cell culture medium was used, and RF waves were applied from the puncture needle 10 using the puncture device 1 to confirm the range of cancer cell death. Cancer cells in the darker areas of the cancer cell culture medium were not killed. Cancer cells in the lighter areas of the cancer cell culture medium were killed. In the photograph in FIG. 14, the puncture needle 10 was punctured into two locations on the left and right of the cancer cell culture medium, and RF waves were applied. The lighter areas were confined to the cylindrical areas around the puncture points with the puncture needle 10, while the areas between the puncture needles 10 were darker. This indicates that the range of cancer cells that can be treated with RF waves from the puncture needle 10 was confined to the cylindrical areas near the puncture points with the puncture needle 10, and cancer cells were not killed in the areas between the puncture needles 10. Cancer cells are the most difficult cells to kill and are resistant to external forces.

[0085] [Temperature distribution] The temperature distribution when a solvent containing a metal is used will be described with reference to Figures 15 and 16. Figure 15 is an explanatory diagram of the temperature distribution when a solvent containing a metal is used, showing the temperature distribution when RF waves are applied from multiple puncture needles 10. Figure 16A shows the case of saline, Figure 16B shows the case of a solvent of copper ferric chloride, manganese chloride, zinc sulfate hydrate, and copper sulfate, Figure 16C shows the case of a solvent containing zinc, Figure 16D shows the case of a solvent containing manganese, and Figure 16E shows the case of a solvent containing magnesium. In each solvent region, the black areas indicate low temperature areas, and the white areas indicate high temperature areas.

[0086] Comparing the temperature distributions in Figures 15A to 15E, it can be seen that the white areas are wider in the metal-containing solvents in Figures 15B to 15E than in the saline solution in Figure 15A, indicating that the high-temperature regions are more widely distributed in the solvent. Furthermore, comparing Figures 15C to 15E, it can be seen that the order of the extent of the high-temperature regions is magnesium, zinc, and manganese.

[0087] FIG. 16 is an explanatory diagram of the temperature distribution when a solvent containing zinc or magnesium is used. It shows the temperature distribution when RF waves are applied from multiple puncture needles 10 in a zinc or magnesium solvent. FIG. 16A shows the case of a solvent containing zinc, and FIG. 16B shows the case of a solvent containing magnesium. The temperature distribution for zinc was: line 0 = 60.2°C, line 1 = 76.4°C, line 2 = 79.7°C, line 3 = 72.6°C, and line 4 = 54.3°C. The temperature distribution for magnesium was: line 0 = 64.4°C, line 1 = 92.0°C, line 2 = 100.0°C, line 3 = 68.9°C, and line 4 = 51.5°C. Comparing FIG. 16A and FIG. 16B shows that the temperature distribution for the magnesium solvent has a larger high-temperature region than the zinc solvent.

[0088] Measurement of the temperature distribution diagrams in Figures 15 and 16 shows that the higher the thermal conductivity, the better the temperature distribution characteristics can be, i.e., the wider the high temperature region becomes. The thermal conductivity is (1) Mg (Magnesium) (2) Zn (zinc) (3) Mn (manganese) (4)Copper (5) Iron The order of effectiveness is highest. When these metals were included, a thermal conductivity effect was confirmed in all cases. It was shown that mixing a solution containing a biocompatible metal such as Mg as an additive to a local anesthetic improves the temperature distribution characteristics more than when only physiological saline is used for dilution. Of the agents in Tables 2 to 9, the addition of a magnesium solution containing Mg was able to improve the temperature distribution characteristics the most.

[0089] Figures 15 and 16 show measurements of the temperature distribution in a solvent containing a metal. Even when measuring the temperature distribution when RF waves are applied to a cell culture medium, it is clear that injecting a local anesthetic with an added solution containing a biocompatible metal such as Mg improves the temperature distribution characteristics of the cell culture medium, i.e., increases the extent of the high temperature region.

[0090] Injecting local anesthetics containing magnesium into the treatment area before using an RF therapy device has the following pharmacological effects. When magnesium sulfate hydrate is administered intramuscularly or intravenously, it increases blood Mg2+ levels, disrupting the equilibrium with Ca2+, resulting in central nervous system depression and skeletal muscle relaxation. The anesthetic-like state observed with rapid intravenous administration of this agent is thought to be due to magnesium inhibiting the release of acetylcholine at the neuromuscular junction, blocking the transmission of nerve impulses and causing skeletal muscle relaxation. This neuromuscular effect is antagonized by calcium. It suppresses sweating by locally blocking the activity of acetylcholine in sweat glands. In over 80% of cases, hyperhidrosis improved, and sweating volume was reduced by more than half. Thus, the use of local anesthetics containing magnesium not only improved temperature distribution during RF wave application, but also improved hyperhidrosis.

[0091] [Test Example 1] Magnesol (Table 2, Table 3) In order to test the improvement in thermal conductivity of the therapeutic preparation for axillary odor or hyperhidrosis according to embodiment 1, a test was conducted in Test Example 1 to examine the improvement in thermal conductivity when using the preparation with the trade name "Magnesol 20 mL for Intravenous Injection." A stock solution of saline (NaCl) was used as a comparative example. To standardize the comparison of thermal conductivity when injected subcutaneously, Magnesol was diluted four times to equalize the osmotic pressure of both. The "Magnesol 20 mL for Intravenous Injection" preparation is a clear, colorless injection solution with a pH of 3.5 to 6.0 and an osmotic pressure ratio of approximately 4 relative to saline.

[0092] (Test Method) 1) The preparation "Magnesol 20 mL for intravenous injection" was diluted four-fold to prepare the experimental preparation for Experimental Example 1. As a comparative example, a stock solution of physiological saline (NaCl) was used. 2) A cell culture medium injected with the experimental preparation of Experimental Example 1 and a cell culture medium injected with undiluted physiological saline solution as a comparative example were prepared, and RF waves were applied to each cell culture medium using the puncture device 1 of this embodiment, and the temperature of the cell culture medium was measured. A gel prepared by solidifying and burning 1% agarose was used as the cell culture medium. Note that the cell culture medium used in this embodiment is not limited to this gel, and any cell culture medium, whether artificial or natural, can be used as long as the reproducibility of the experiment can be ensured. 3) The temperature of the culture medium is measured using a thermometer inserted in the depth direction of the cell culture medium at the center position between the tips of adjacent puncture needles. At the same time, the temperature distribution in the cross-sectional direction of the cell culture medium is photographed using a thermograph.

[0093] (Test results) Figure 17 is an explanatory diagram of the temperature measurement results of Experimental Example 1. As can be seen from Figure 17, the average temperature rose to 32.5°C for the experimental preparation of Experimental Example 1, while the average temperature for the comparative example was 28.9°C. The two-sided probability (P value) was 0.0019, indicating a significant difference between the two.

[0094] Figure 18 shows thermographic images of Experimental Example 1. For the experimental formulation of Experimental Example 1 (right side of Figure 18), the thermographic image of the space between the tips of the puncture needles in the cell culture medium is bright (strong white in the monochrome image), and the temperature of the cell culture medium rose by 32.2°C. In contrast, for the comparative example (left side of Figure 18), the thermographic image of the space between the tips of the puncture needles in the cell culture medium is darker in color than for the experimental formulation of Experimental Example 1 (weak white or gray in the monochrome image), and the temperature rise in the cell culture medium was only 28.6°C, a smaller temperature rise than for the experimental formulation of Experimental Example 1.

[0095] As described above, Experimental Examples 1 and 2 demonstrate that the experimental preparation of Experimental Example 1 significantly improves thermal conductivity compared to the comparative example in hyperthermia treatment in which RF waves are applied to a cell culture medium using the puncture device 1 of this embodiment. Furthermore, the experimental results of Experimental Example 1 are not limited to hyperthermia treatments using RF waves. Similar to the experimental results of Experimental Example 1, it was found that the experimental preparation of Experimental Example 1 contributes to improving thermal conductivity during hyperthermia treatments using microwaves or lasers. In other words, improving thermal conductivity at the treatment site during hyperthermia treatments is not limited to RF waves. Furthermore, because the therapeutic effect of thermal energy in microwave or laser treatments is enhanced, this embodiment, which improves thermal conductivity at the treatment site, is effective not only for RF waves but also for hyperthermia treatments using microwaves or lasers.

[0096] [Test Example 2] Elementmic (Table 9, Table 10) Next, in order to test the improvement in thermal conductivity of the therapeutic preparation for axillary odor or hyperhidrosis according to embodiment 1 and the therapeutic anesthetic, an experiment was conducted in Test Example 2 to examine the improvement in thermal conductivity when a preparation sold under the trade name "Elementmic Injection" was used. As a comparative example, a solution obtained by diluting physiological saline (NaCl) two-fold was used. In order to standardize the comparison of thermal conductivity when injected subcutaneously and to make the osmotic pressure of both the preparations the same, Elementmic Injection was used in its original form, and a solution obtained by diluting physiological saline (NaCl two-fold) was used. The "Elementmic Injection" preparation is a dark reddish-brown colloidal injection solution with a pH of 4.5 to 6.0 and an osmotic pressure ratio of approximately 0.5 relative to physiological saline. The experimental method was the same as in Test Example 1.

[0097] (Test results) Figure 18 is an explanatory diagram of the temperature measurement results of Test Example 2. As can be seen from Figure 18, the average temperature rose to 31.1°C for the experimental preparation of Test Example 2, while the average temperature for the comparative example was 28.4°C. The two-sided probability (P value) was 0.0025, indicating a significant difference between the two.

[0098] Figure 19 shows thermographic images of Test Example 2. For the experimental formulation of Test Example 2 (right side of Figure 19), the thermographic image of the space between the tips of the puncture needles in the cell culture medium is bright (strong white in the monochrome image), and the temperature of the cell culture medium rose by 32.5°C. In contrast, for the comparative example (left side of Figure 19), the thermographic image of the space between the tips of the puncture needles in the cell culture medium is darker in color than for the experimental formulation of Test Example 2 (weak white or gray in the monochrome image), and the temperature rise in the cell culture medium was only 28.6°C, a smaller temperature rise than for the experimental formulation of Test Example 1.

[0099] Thus, Test Example 2 shows that the experimental preparation of Test Example 2 significantly improves thermal conductivity compared to the comparative example in hyperthermia treatment in which RF waves are applied to a cell culture medium using the puncture device 1 of this embodiment. Furthermore, the experimental results of Test Example 2 are not limited to hyperthermia treatments using RF waves. Similar to the test results of Test 2, it was found that the test preparation of Test Example 2 contributes to improving thermal conductivity during hyperthermia treatments using microwaves or lasers. In other words, improving thermal conductivity at the treatment site during hyperthermia treatment is not limited to RF waves. Furthermore, because the therapeutic effect of thermal energy in microwave or laser treatments is enhanced, this embodiment, which improves thermal conductivity at the treatment site, is effective not only for RF waves but also for hyperthermia treatments using microwaves or lasers.

[0100] [Polyphenols] In addition to the main component, the local anesthetic for treating axillary hyperhidrosis in this embodiment can contain polyphenols. For example, pentagalloyl glucose (PGG), a type of polyphenol, has the effect of suppressing odor. Furthermore, experiments have shown that it has the effect of increasing thermal conductivity during treatment with an RF therapy device. The specific type of PGG is not particularly limited, but for example, penta-O-galloyl-β-D-glucose hydrate (PCG) can be used.

[0101] About "Penta-O-galloyl-β-D-glucose hydrate" (PCG) (Source: Merck website) Penta-O-galloyl-β-D-glucose hydrate (PCG) is used as an inhibitor of abdominal aortic aneurysm (AAA) and matrix metalloproteinase (MMP)-related metastatic activity. PCG has excellent odor suppression effects and, when injected into the treatment area, also has excellent effects of improving the temperature distribution characteristics at the treatment site. Metals such as magnesium have the ability to increase thermal conductivity. For example, adding pentagalloyl glucose (PGG) and biocompatible metals to local anesthetics can suppress axillary odor and improve the conductivity of RF waves in VH treatment.

[0102] Synonyms: 1,2,3,4,6-Pentagalloyl β-D-glucose, 1,2,3,4,6-Penta-O-galloyl-bD-glucopyranose, 1,2,3,4,6-Pentakis(3,4,5-trihydroxybenzoic acid)-bD-glucopyranose, PGG, glucopyranose, pentagallate, bD, penta-1,2,3,4,6-O-galloyl-bD-glucose, penta-O-galloyl-β-D-glucose, gallic acid, bD-glucopyranose-containing pentaester CAS number: 14937-32-7 Molecular weight: 940.68 (anhydrous basis) MDL number:MFCD18632553 UNSPSC Code: 12352200 PubChem Substance ID:329799964 NACRES:NA.77

[0103] [ka]

[0104] The PCG characteristics of this product are as follows: Quality level 100 Assay ≥ 96% (HPLC) Shape: powder Optical activity [α] / D +14 to +26°, c = 0.2 in acetone-d6 color light brown Solubility in DMSO: ≧20 mg / mL Storage temperature 2-8℃

[0105] SMILES notation O=C(O[C@H]([C@H]([C@@H]([C@@H](COC(C1=CC(O)=C(O)C(O)=C1)=O)O2)OC(C3=CC(O)=C(O)C(O)=C3) =O)OC(C4=CC(O)=C(O)C(O)=C4)=O)[C@@H]2OC(C5=CC(O)=C(O)C(O)=C5)=O)C6=CC(O)=C(O)C(O)=C6.O InChI 1S / C41H32O26.H2O / c42-17-1-12(2-18(43)28(17)52)36(57)62-11-27-33(64-37(58 )13-3-19(44)29(53)20(45)4-13)34(65-38(59)14-5-21(46)30(54)22(47)6-14)35( 66-39(60)15-7-23(48)31(55)24(49)8-15)41(63-27)67-40(61)16-9-25(50)32(56) 26(51)10-16; / h1-10,27,33-35,41-56H,11H2;1H2 / t27-,33-,34+,35-,41+; / m1. / s1 InChI Key:JCJIMLXECAATFH-ZSJSDXHXSA-N

[0106] <Physicochemical / Physiological Effects> PGG primarily induces apoptosis (caspase-dependent) in DU145 and LNCaP cells, thereby inducing autophagy in the more resistant PC3 and TRAMP-C2 cells. PGG appears to target downstream signaling pathways rather than mTOR itself. Polyphenol pyranose has been reported to inhibit plasminogen activator inhibitor type 1 (PAI-1) (J Biol Chem. 2010, 285 (11), 7892-902). Penta-O-galloyl-β-D-glucose hydrate (PCG) is a polyphenolic gallotannin compound produced by plants. PCG has the ability to inhibit matrix metalloproteinase (MMP)-associated metastatic activity. Therefore, PCG can be used to suppress the metastatic activity of squamous cell carcinoma. Furthermore, PCG is a promising drug for stabilizing small abdominal aortic aneurysms.

[0107] <Features and Benefits> This compound is a hot product for apoptosis research. <Safety information> Storage Classification Code: 11 - Combustible Solids WGK:WGK 3 Flash point (°F): Not applicable Flash point (℃):Not applicable

[0108] [Test 3] Penta-O-galloyl-β-D-glucose hydrate (PCG) Next, in order to test the improvement in thermal conductivity of a therapeutic preparation for axillary odor or hyperhidrosis according to embodiment 1 using a therapeutic anesthetic, an experiment was conducted as Test Example 3 to test the improvement in thermal conductivity when a preparation with the trade name "penta-O-galloyl-β-D-glucose hydrate" (hereinafter referred to as "PCG") was used. The experimental preparation used in Test Example 3 was prepared by adding 2.5 mg of PCG per 1 ml of undiluted saline. Undiluted saline was used as a comparative example. The experimental method was the same as in Test Example 1.

[0109] (Test results) Figure 21 is an explanatory diagram of the temperature measurement results of Experimental Example 3. As can be seen from Figure 21, the average temperature rose to 26.9°C for the experimental preparation of Experimental Example 3, while the average temperature for the comparative example was 24.2°C. The two-sided probability (P value) was 0.0001, indicating a significant difference between the two.

[0110] Figure 22 shows thermographic images of Experimental Example 1. For the experimental formulation of Experimental Example 3 (right side of Figure 22), the thermographic image of the space between the tips of the puncture needles in the cell culture medium is bright (strong white in the monochrome image), and the temperature of the cell culture medium rose by 27.4°C. In contrast, for the comparative example (left side of Figure 22), the thermographic image of the space between the tips of the puncture needles in the cell culture medium is darker in color than for the experimental formulation of Experimental Example 3 (weak white or gray in the monochrome image), and the temperature rise in the cell culture medium was only 23.7°C, a smaller temperature rise than for the experimental formulation of Experimental Example 3.

[0111] Thus, Experimental Example 3 shows that the experimental formulation of Experimental Example 3 significantly improves thermal conductivity compared to the comparative example in hyperthermia treatment in which RF waves are applied to a cell culture medium using the puncture device 1 of this embodiment. Furthermore, the experimental results of Experimental Example 3 are not limited to hyperthermia treatments that use RF waves, and it was found that the experimental formulation of Experimental Example 3 also contributes to improving thermal conductivity during hyperthermia treatments that use microwaves or lasers, similar to the experimental results of Experimental Example 3.

[0112] [About a treatment for underarm odor or hyperhidrosis using a solution containing magnesium] Next, we will explain the pharmacological effects of magnesium-containing solutions in the treatment of axillary hyperhidrosis. When magnesium, for example, magnesium sulfate hydrate, is administered intramuscularly or intravenously, it increases blood Mg 2+ Increased Ca 2+This disrupts the balance between acetylcholine and serotonin, resulting in central nervous system depression and skeletal muscle relaxation. The anesthetic-like state seen when this drug is rapidly administered intravenously is thought to be caused by magnesium inhibiting the release of acetylcholine at the neuromuscular junction, blocking the transmission of nerve impulses and causing skeletal muscle relaxation. This neuromuscular effect is antagonized by calcium. Sweating can be suppressed by locally blocking the activity of acetylcholine in sweat glands.

[0113] [Test Example 4] Test Example 4 describes the therapeutic effect of a treatment formulation for axillary odor or hyperhidrosis using a magnesium-containing solution according to this example. Magnesol, the same magnesium used in Test Example 1, was used. In this test example, sweating was confirmed to be suppressed by injecting the Mg formulation into the treatment area without using the thermal treatment device of Embodiment 1. The Mg formulation was mixed with a local anesthetic and administered to 10 patients with axillary hyperhidrosis. All patients demonstrated sweating suppression. Table 11 shows the 10 cases. "◎" indicates a good sweating suppression effect, and "〇" indicates a confirmed sweating suppression effect. The pharmacology of this study is that sweating is suppressed by the acetylcholine inhibitory effect of magnesium. The Mg formulation is not limited to magnesol; any Mg formulation can be used. This test example demonstrates the efficacy of a treatment formulation for axillary odor or hyperhidrosis using a magnesium-containing solution.

[0114] [Table 11]

[0115] [About the therapeutic effect of PCG on axillary hyperhidrosis] [Test Example 5] As described above, PCG was used as an example. A test to evaluate the thermal conductivity improvement effect of a polyphenol preparation confirmed improvement in all cases. Furthermore, the polyphenol preparation was confirmed to have the effect of suppressing odor at the treatment site. In this test, we confirmed that injecting PCG into the treatment site without using the thermal treatment device of embodiment 1 had the effect of suppressing odor at the treatment site for axillary hyperhidrosis. When PCG was mixed with a local anesthetic and administered to 10 patients with axillary hyperhidrosis, odor suppression at the treatment site was observed in 8 out of 10 patients. Table 12 shows the 10 cases. "◎" indicates a good effect in suppressing odor at the treatment site, "◯" indicates a confirmed effect in suppressing sweating, and "△" indicates no or unknown effect. The pharmacology of this treatment is that sweating is suppressed by the acetylcholinesterase inhibitory effect of magnesium. The PCG used was the aforementioned "penta-O-galloyl-β-D-glucose hydrate" (PCG) (chemical formula 1). The pharmacological effect of the odor suppression effect of PCG mixed with local anesthetic solution is due to the bactericidal action of PCG against axillary odor bacteria. The polyphenol preparation is not limited to "penta-O-galloyl-β-D-glucose hydrate" (PCG), and any polyphenol preparation can be used. Test Example 5 demonstrates the efficacy of a polyphenol-containing preparation for the treatment of axillary odor or hyperhidrosis.

[0116] [Table 12]

[0117] [Embodiment 2] A therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis according to a second embodiment of the present invention will be described with reference to Fig. 23. Descriptions of components common to Figs. 1 to 22 will be omitted.

[0118] When the RF treatment machine illustrated in embodiment 1 is used as the treatment device, an electrode needle is used at the treatment site. By using a needle as this electrode needle, it becomes possible to inject a local anesthetic simultaneously with the puncture of the electrode needle, as described below. The puncture needle 100 has a hollow hole 100a and one or more communication holes 100b that communicate with the hollow hole 100a. A local anesthetic is supplied to the hollow hole 100a by a predetermined pressure from a compressor. Furthermore, when the RF treatment machine illustrated in embodiment 1 is used, the electrode needle is driven electrically, so it is preferable to use a multi-hole needle with multiple communication holes 100b as the electrode needle.

[0119] The puncture needle 100 is provided with multiple communication holes 100b, which are arranged radially outward from the hollow hole 110. Furthermore, when the downward angle of the communication holes 100b in the axial direction of the hollow hole 110 is defined as 0° and the direction perpendicular to the axial center of the hollow hole 110 is defined as 90°, the angle α at which the communication holes 100b are directed radially outward from the hollow hole 110 is set so that it satisfies the following condition: 0°<α≦90°. Conventional injection needles have an injection hole at the tip of the needle for injecting an injection solution. However, in this embodiment, it is not necessary to provide communication holes 100b at the tip of the puncture needle 100 in the extension direction of the axial center of the hollow hole 110. This makes it easier to design the puncture needle 100 to be thin. Furthermore, by providing multiple communication holes 100b in the radial direction, it is possible to inject an injection solution over a wide range of the treatment area both in the depth direction and radial direction of the puncture needle 100. Furthermore, by setting the angle α at which the communication holes 100b point radially outward from the hollow hole 110, it becomes easier to inject the injection liquid into the treatment area. Furthermore, these features can also reduce the pain felt by the patient when the puncture needle 100 punctures the area or when the injection liquid is injected. Furthermore, by preparing multiple types of puncture needles 100 with different distribution states of the multiple communication holes 100b, it is possible to inject the appropriate injection liquid depending on the position and range of the treatment area.

[0120] When the switch on the hollow hole operating unit 50 is operated to energize the drive unit 40 and drive the holder 110 (corresponding to the holder 12 in embodiment 1 (Figures 5 to 7)) that holds the puncture needle 100 and the sensor needle 11 so that the puncture needle 100 protrudes, the puncture needle 100 penetrates subcutaneously into the treatment area. In this state, a local anesthetic is supplied to the hollow hole 100a by a predetermined pressure from a compression device, and the local anesthetic can be injected into the treatment area through the communication hole 100b. In this way, the local anesthetic can be injected into the treatment area using the device for treating axillary odor or hyperhidrosis of this embodiment, eliminating the need for puncturing with a separate syringe or the like, thereby reducing the number of punctures required during treatment and easing the burden on the patient. Furthermore, as a treatment procedure, local anesthesia and application of RF waves can be performed by a single operation of driving the holder 110 so that the puncture needle 100 protrudes and inserting the puncture needle 100 subcutaneously into the treatment area, thereby simplifying the treatment procedure and eliminating the need for complicated treatment.

[0121] [Embodiment 3] A therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis according to embodiment 3 of the present invention will be described. Descriptions of components common to those in Figs. 1 to 17 will be omitted.

[0122] For thermal treatment of axillary odor or hyperhidrosis, in addition to the puncture treatment device using RF waves described in embodiment 1, treatment devices using microwaves, lasers, etc. can also be used. Before using a treatment device using microwaves or lasers, local anesthesia is administered by injecting a local anesthetic into the treatment area, as in the thermal treatment of embodiment 1. By using a local anesthetic containing polyphenols and / or biocompatible metals described in embodiment 1, the thermal conductivity of the treatment area can be increased, improving the temperature distribution during thermal treatment and also improving the odor suppression effect.

[0123] In microwave treatment devices, microwaves are emitted from a microwave generator to the deep dermis layer where apocrine and eccrine glands are concentrated. Also, by cooling the dermis from the epidermis, it protects it from heat. Furthermore, because the microwaves are set to be concentrated in the depth range where sweat glands are concentrated, it is possible to prevent them from affecting the deeper fat layer.

[0124] The laser treatment device destroys the apocrine and eccrine glands by irradiating the deep dermis where they are concentrated with a laser from the laser generator. The laser generator is set to destroy sweat glands, and by using two wavelengths at different wavelengths, or by using them simultaneously, it is possible to treat both the shallow and deep layers of the depth range where sweat glands are present through dual irradiation, thereby treating the entire depth range where sweat glands are present.

[0125] In treatment devices using high frequencies, the frequencies used may be called RF waves, radio waves, high frequencies, etc. depending on the frequency band and purpose, but there are various treatment devices with different effects depending on the structure and specifications of the treatment device. In addition, the frequency of the treatment device is not limited to high frequencies, and devices using medium or low frequencies can also be used as long as they contribute to the treatment of underarm odor or hyperhidrosis.

[0126] In the treatment preparation for axillary odor or hyperhidrosis, therapeutic anesthetic, and treatment device for axillary odor or hyperhidrosis according to this embodiment, a local anesthetic is injected into the treatment area before treatment with the treatment device, which not only provides local anesthesia but also improves the temperature distribution in thermal treatment and also improves the odor suppression effect, so any treatment device may be used as long as it is thermal treatment accompanied by local anesthesia.

[0127] [Embodiment 4] A therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis according to embodiment 4 of the present invention will be described. In embodiment 1, we described the use of a local anesthetic to which polyphenols and / or biocompatible metals have been added, which is injected into the treatment site before treatment with the treatment device. However, as mentioned above, polyphenols and / or biocompatible metals themselves have the effect of improving the therapeutic effect of the treatment device, i.e., reducing the odor caused by axillary odor or hyperhidrosis. Therefore, a therapeutic preparation for axillary odor or hyperhidrosis can be prepared by using not only a local anesthetic but also polyphenols and / or biocompatible metals themselves.

[0128] The therapeutic effect of the treatment device can be improved by injecting a therapeutic preparation for axillary odor or hyperhidrosis into the treatment area using an injection or needle before treatment with the treatment device. The treatment device in this case is not limited to the one for thermal treatment using RF waves, microwaves, or lasers described in embodiment 1, but any treatment device for axillary odor or hyperhidrosis can be used, and it can also be used for treatments that do not require local anesthesia before using the treatment device, such as a treatment device that irradiates light using an LED.

[0129] For example, the use of preparations containing polyphenols can suppress the odor of body odor. For example, by adding PGG, a type of polyphenol, or PCG, which is particularly effective in suppressing odor, a treatment preparation for body odor or hyperhidrosis can be made.

[0130] For example, magnesium preparations have the effect of suppressing sweating by locally blocking the activity of acetylcholine in the sweat glands. Therefore, adding magnesium preparations can be used to treat axillary odor or hyperhidrosis. Furthermore, adding polyphenols and biocompatible metal preparations can be used to treat axillary odor or hyperhidrosis, suppressing sweating and suppressing axillary odor.

[0131] Furthermore, simply injecting a therapeutic preparation for axillary odor or hyperhidrosis into the treatment area with an injection or needle can have the effect of suppressing sweating and suppressing the odor of axillary odor. The use of a therapeutic preparation for axillary odor or hyperhidrosis is not limited to injections, but can also be, for example, an oral or topical medication. Topical medications can also be, for example, patches, ointments, creams, etc.

[0132] <Modification> The above-described embodiments are examples of a therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis to embody the technical concept of the present invention, but the present invention is not limited to these, and can be equally applied to other embodiments, such as those in which the present embodiment is modified or that combine the technologies described in the present embodiment.

[0133] For example, in the above-described embodiments, the form of the treatment device for thermal treatment exemplified is merely an example, and other forms of treatment devices for thermal treatment can be adopted as the treatment device of this embodiment. Furthermore, in the case of the treatment preparation for axillary odor or hyperhidrosis of embodiment 4, it can be applied to treatment with any form of treatment device for axillary odor or hyperhidrosis, and even treatment that simply involves injecting the treatment preparation for axillary odor or hyperhidrosis into the treatment area can achieve the effect of reducing the odor of axillary odor or hyperhidrosis.

[0134] For example, in the above-described embodiments, the exemplified drugs are merely examples, and any drug can be used as long as it has a common active ingredient. [Explanation of symbols]

[0135] 1...Puncture device 2...Energy supply unit 3...Deepest part 10...puncture needle 10a...tip portion 10b...insulating film 11...sensor needle 11a...hollow needle 12...holder 20...contact portion 21...support arm 22...Peltier element 24...Cooling plate 24a...Opening 24b...Abutment surface 24b...contact surface 26...heat dissipation block 26a...opening 28...Through hole 30...Body 30a...Terminal part 34...Cylindrical portion 34a...Opening 34b...Hole 34c...groove portion 36...engagement rail 40...drive portion 42...Drive motor 42a...Rotating shaft 43...Shaft 43a...Threaded portion 44...Encoder 46...Rod 46a... Nut 46b... Projection 46d... Tip 50...Operation unit 60...Cartridge for lancing device 62...Cartridge body 62a...Engagement groove 62b...through hole 62c...insertion hole 64...member 70...controller 81...temperature sensor 81...temperature sensor for the part to be punctured 81a...Hollow needle 81b...Insulating coating 81c...Lead wire 82...Surface temperature sensor 100...Puncture needle 100a...Hollow hole 100b...Communication hole 110...Holder E…Sweat gland A…Sweat gland F…Membrane L: Cross section S: Living body S0: Epidermal surface S1…epidermis, etc. S2…dermis S3…subcutaneous tissue S4: Muscle layer

Claims

1. An anesthetic for treating underarm odor or hyperhidrosis, It contains a local anesthetic as the main ingredient, and a polyphenol, a biocompatible metal, or a polyphenol and a biocompatible metal; An anesthetic for treating axillary odor or hyperhidrosis, which is injected into the treatment area before thermal treatment of the sweat glands using a treatment device for treating axillary odor or hyperhidrosis, to improve the temperature distribution in the thermal treatment and reduce the odor at the treatment area.

2. 2. An anesthetic for treating axillary odor or hyperhidrosis according to claim 1, characterized in that the polyphenol contains pentagalloyl glucose (PGG), or penta-O-galloyl-β-D-glucose hydrate (PCG) as the pentagalloyl glucose.

3. The anesthetic for treating axillary odor or hyperhidrosis described in claim 1, characterized in that the biocompatible metal includes at least one metal selected from the group consisting of zinc (which has diverse effects and is easy for the human body to use), manganese, copper (needle coating), and iron.

4. An anesthetic for treating axillary odor or hyperhidrosis according to any one of claims 1 to 3, characterized in that it contains xylocaine or xylocaine with epinephrine as a local anesthetic.

5. A device for treating axillary odor or hyperhidrosis, using the therapeutic preparation or therapeutic anesthetic for axillary odor or hyperhidrosis according to any one of claims 1 to 3, The treatment device comprises: an administration unit that administers the therapeutic preparation or therapeutic anesthetic to a treatment site; The hyperthermia treatment department and A device for treating underarm odor or hyperhidrosis, comprising:

6. the thermal treatment unit includes a puncture needle that is inserted into the treatment area and supplies energy to the treatment area; the puncture needle also serves as the administration part, and has a hollow hole and a plurality of communication holes that connect the hollow hole to the outside, 6. The device for treating axillary odor or hyperhidrosis according to claim 5, wherein the puncture needle injects the axillary odor or hyperhidrosis treatment preparation or therapeutic anesthetic into the treatment area through the communication hole.

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