Preparation for treatment of armpit odor or hyperhidrosis, anesthetic for use in said treatment, and device for treating armpit odor or hyperhidrosis using said preparation or said anesthetic

Abstract

Provided are a preparation for the treatment of armpit odor or hyperhidrosis, an anesthetic for use in the treatment, and a device for treating armpit odor or hyperhidrosis using the preparation or the anesthetic, with which it is possible to improve an odor suppressing effect at a site being treated by a thermotherapy on a sweat gland using a therapeutic device for treating armpit odor or hyperhidrosis and it is also possible to improve thermal conductivity during the thermotherapy.　A preparation for the treatment of armpit odor or hyperhidrosis and an anesthetic for use in the treatment according to one embodiment of the present invention are characterized by containing polyphenol and at least one of biocompatible metals, and being capable of improving an odor suppressing effect at a site being treated by a thermotherapy on a sweat gland using a therapeutic device for treating armpit odor or hyperhidrosis and also being capable of improving thermal conductivity during the thermotherapy.

Description

Treatment preparation for underarm odor or hyperhidrosis, therapeutic anesthetic, and treatment device for underarm odor or hyperhidrosis using the same

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

[0002] A conventional 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 the sweat glands with such a puncture device, it is possible to suppress excessive sweat secretion from, for example, apocrine glands or eccrine glands.

[0003] Patent No. 6025828

[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 puncture is performed using the lancing device a predetermined time after the anesthetic is injected using the syringe, which means 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 re-check 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.

[0006] The therapeutic preparation for underarm odor or hyperhidrosis according to the first aspect of the present invention is characterized by using a solution containing magnesium.

[0007] A second aspect of the present invention provides a local anesthetic for treating underarm odor or hyperhidrosis, characterized by using a solution containing magnesium.

[0008] The therapeutic preparation for underarm odor or hyperhidrosis according to the third aspect of the present invention is characterized by containing polyphenols.

[0009] A fourth aspect of the present invention provides a local anesthetic for treating underarm odor or hyperhidrosis, characterized in that it contains a polyphenol.

[0010] The local anesthetic for treating axillary odor or hyperhidrosis of the fifth 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 at least one of a polyphenol and a biocompatible metal, and is characterized in that when injected into the treatment area before thermal treatment of the sweat glands with a treatment device for treating axillary odor or hyperhidrosis, it reduces the odor of the treatment area and improves the temperature distribution during thermal treatment.

[0011] The sixth aspect of the present invention is a local anesthetic for treating axillary odor or hyperhidrosis, which is the same as the fifth aspect of the local anesthetic for treating axillary odor or hyperhidrosis, characterized in that it contains xylocaine or xylocaine with epinephrine as a local anesthetic.

[0012] The seventh aspect of the present invention is a local anesthetic for treating axillary odor or hyperhidrosis, which is the same as the local anesthetic for treating axillary odor or hyperhidrosis of the fifth aspect, characterized in that the polyphenol contains pentagalloyl glucose, or penta-O-galloyl-β-D-glucose hydrate as the pentagalloyl glucose.

[0013] The eighth aspect of the present invention is a local anesthetic for treating axillary odor or hyperhidrosis, which is the same as the fifth aspect of the local anesthetic for treating axillary odor or hyperhidrosis, characterized in that it contains at least one metal selected from the group consisting of magnesium, zinc, manganese, copper, and iron as a biocompatible metal.

[0014] The ninth 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 one of the second, fourth, fifth to eighth aspects, and is characterized in that the treatment device is a thermal treatment device that uses at least one of RF waves, microwaves, or lasers.

[0015] A tenth aspect of the present invention is a treatment device for axillary odor or hyperhidrosis, which is the ninth aspect of the treatment device for axillary odor or hyperhidrosis, characterized in that the treatment device is equipped with a puncture needle that is punctured into a site to be punctured of a living body and supplies energy to the site to be punctured, the puncture needle having a hollow hole and one or more communication holes that communicate with the hollow hole, and an anesthetic for treating axillary odor or hyperhidrosis is injected into the treatment site through the communication holes.

[0016] According to at least one of the therapeutic preparation for axillary odor or hyperhidrosis, the therapeutic anesthetic, and the therapeutic 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 therapeutic device for axillary odor or hyperhidrosis, and to improve the thermal conductivity during the thermal treatment. Furthermore, when a therapeutic preparation for axillary odor or hyperhidrosis containing magnesium or polyphenols is used, the magnesium or polyphenols can provide a therapeutic effect for axillary odor or hyperhidrosis.

[0017] According to the first aspect of the present invention, the therapeutic preparation for underarm odor or hyperhidrosis can suppress sweating by using a solution containing magnesium to locally block the action of acetylcholine.

[0018] According to the second aspect of the present invention, a local anesthetic for treating axillary odor or hyperhidrosis can be used to suppress sweating by locally blocking the action of acetylcholine using a solution containing magnesium, and can also improve the temperature distribution during hyperthermia treatment.

[0019] According to the third aspect of the present invention, the preparation for treating axillary odor or hyperhidrosis contains polyphenols, thereby suppressing the odor of axillary odor.

[0020] According to the fourth aspect of the present invention, the local anesthetic for treating axillary odor or hyperhidrosis contains polyphenols, which can suppress the odor of axillary odor and improve the temperature distribution during thermal treatment.

[0021] The local anesthetic for treating axillary odor or hyperhidrosis in the fifth aspect of the present invention contains polyphenols and / or biocompatible metals, and when injected into the treatment area before thermal treatment of the sweat glands using a treatment device for treating axillary odor or hyperhidrosis, it can reduce the odor of the treatment area and improve the temperature distribution during the thermal treatment.

[0022] The local anesthetic for treating axillary odor or hyperhidrosis in the sixth aspect of the present invention contains xylocaine or xylocaine with epinephrine as a local anesthetic, and therefore can provide an appropriate local anesthetic effect before thermal treatment.

[0023] The seventh aspect of the present invention is a local anesthetic for treating axillary odor or hyperhidrosis, which contains pentagalloyl glucose as a polyphenol, or penta-O-galloyl-β-D-glucose hydrate as the pentagalloyl glucose, and therefore can suppress the odor of axillary odor and improve the temperature distribution in thermal treatment.

[0024] The local anesthetic for treating axillary odor or hyperhidrosis according to the eighth aspect of the present invention contains at least one biocompatible metal selected from the group consisting of magnesium, zinc, manganese, copper, and iron, thereby improving the temperature distribution during hyperthermia treatment. Furthermore, when magnesium is selected, sweating can be suppressed by locally blocking the action of acetylcholine.

[0025] According to the ninth aspect of the device for treating axillary odor or hyperhidrosis of the present invention, a therapeutic preparation or therapeutic anesthetic for axillary odor or hyperhidrosis of any one of the first to eighth aspects is used, the therapeutic preparation or therapeutic anesthetic is administered to the treatment area from the administration section, and thermal treatment of the area to be treated is performed by the thermal treatment section, thereby improving the odor suppression effect of the treatment area due to thermal treatment of the sweat glands by the device for treating axillary odor or hyperhidrosis, and improving the thermal conductivity during thermal treatment.

[0026] In a tenth 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, and has a hollow hole and a plurality of communication holes that connect the hollow hole to the outside. The puncture needle can inject the treatment preparation or therapeutic anesthetic for the treatment of axillary odor or hyperhidrosis through the communication holes, 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 complexity of the treatment.

[0027] FIG. 5A is a diagram showing a lancing device according to an embodiment of the present invention. FIG. 5B is a diagram showing a side view of a lancing device according to an embodiment of the present invention. FIG. 5A is a diagram showing a top view of a lancing device according to an embodiment of the present invention. FIG. 5B is a diagram showing a contact portion of a lancing device according to an embodiment of the present invention. FIG. 5A is a VA-VA cross-sectional view of FIG. 2, and FIG. 5B is a schematic cross-sectional view of the puncture site sensor of FIG. 5A. FIG. 5B is a diagram showing a state before a cartridge is attached to a main body of a lancing device according to an embodiment of the present invention. FIG. 5B is a diagram showing a state after a drive unit of a lancing device according to an embodiment of the present invention has been activated. FIG. 5B is a diagram showing a state before a puncture needle of a lancing device according to an embodiment of the present invention is protruded. FIG. 5C is a diagram showing a state after a puncture needle of a lancing device according to an embodiment of the present invention has reached a membrane. FIG. 11A is a graph showing the change over time in the tip position of a puncture needle when a lancing device according to an embodiment of the present invention is operated, and FIG. 11B is a graph showing the change over time in temperature detected by a sensor needle. 12A shows the results of measuring the temperature distribution at a predetermined time point when an RF current is applied to a puncture device of one embodiment of the present invention without using a cooling plate 24, and FIG. 12B shows the results of measuring the temperature distribution at a predetermined time point when an RF current is applied using a cooling plate 24. An example of culture medium treatment in Comparative Example 1. An example of cancer cell treatment in Comparative Example 2. An explanatory diagram of the temperature distribution when a solvent containing a metal is used. An explanatory diagram of the temperature distribution when a solvent containing zinc or magnesium is used. An explanatory diagram of the temperature measurement results of Experimental Example 1. A thermographic image of Experimental Example 1. An explanatory diagram of the temperature measurement results of Experimental Example 2. A thermographic image of Experimental Example 2. An explanatory diagram of the temperature measurement results of Experimental Example 3. A thermographic image of Experimental Example 3. (Old Figure 17) An explanatory diagram of the structure of the puncture needle of embodiment 2.

[0028] 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.

[0029] 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.

[0030] [Lancing Device] First, a description will be given of the puncturing device 1 used in this embodiment. However, the puncturing device of this embodiment is not limited to the puncturing device 1, and may include any thermotherapy device that uses RF waves, microwaves, lasers, etc., as long as it is for thermotherapy.

[0031] 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 the lancing device 1 according to an embodiment of the present invention. Fig. 3 is a diagram showing a top view of the lancing device 1 according to an embodiment of the present invention. Fig. 4 is a diagram showing a contact portion 20 of the lancing device 1 according to an embodiment of the present invention. Fig. 5A is a cross-sectional view taken along line VV in Fig. 2, and Fig. 5B is a schematic cross-sectional view of the puncture site sensor in Fig. 5A.

[0032] The puncture device 1 of this embodiment includes at least a puncture needle 10 that is inserted into a site to be punctured of a living body, a sensor needle 11 that measures the temperature of the site to be punctured of the living body, a contact unit 20 that contacts the site to be punctured, a drive unit 40 that drives the puncture needle 10, a main body 30 that houses the drive unit 40, an operation unit 50 that activates the drive unit 40, and a 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 the puncture needle 10. The puncture device 1 of this embodiment punctures the site to be punctured, which includes sweat glands, with the puncture needle 10, and supplies thermal energy by supplying energy from the energy supply unit 2, thereby destroying the sweat glands and suppressing excessive sweating.

[0033] 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 other than the tip 10a with the insulating film 10b. However, it is not necessary for the insulating film 10b to cover the rest of the puncture needle 10 other than the tip 10a; 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, it can still supply thermal energy from the energy supply unit 2 to the puncture site, including the sweat gland, although this will result in a compromised level of safety.

[0034] The exposed length of tip portion 10a can be, for example, approximately 0.1 to 2.0 mm, or approximately 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. Furthermore, 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 approximately 0.2 to 0.6 mm. This is determined from the perspective of ensuring that the thermal energy supplied by energy supply unit 2 is distributed equally throughout the site to be punctured, including the sweat glands.

[0035] A plurality of puncture needles 10 are arranged in a matrix and fixed to a holder 12, e.g., a rectangular plate, made of plastic or the like. The number of puncture needles 10 is not particularly limited, and a single puncture needle may be used. When a plurality of puncture needles 10 are arranged, it is preferable to arrange, for example, approximately 20 to 40 needles (or more), and it is preferable to set the spacing between adjacent puncture needles 10 to, for example, approximately 0.5 to 3 mm (more preferably, 1 to 3 mm). The thickness of each puncture needle 10 is preferably, for example, approximately 0.1 to 0.3 mm. The arrangement of the plurality of puncture needles 10 may be in various shapes, such as a matrix, a ring, or a polygon. These are arranged or set from the perspective of ensuring that the thermal energy supplied by the energy supply unit 2 is distributed equally throughout the area to be punctured, including the sweat glands.

[0036] 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 of only the depth region 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 depending on the patient.

[0037] 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, a stainless steel (SUS) hollow needle 81a with a closed end. Its outer surface is gold-plated for improved thermal conductivity, and the surface is further coated with glass for insulation (both not shown). The temperature sensor 81 uses an ultrafine thermocouple, 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 the empty space of the holder 12 where the puncture needle 10 is not attached. The sensor needle 11 is formed to 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.

[0038] Contact portion 20 includes a cooling section capable of cooling the site to be punctured and its vicinity, and is equipped with a Peltier element 22, a cooling plate 24, and a 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.

[0039] 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 also be provided on the cartridge 60.

[0040] 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.

[0041] 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.

[0042] 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 rotation of the drive motor 42, and the amount of advancement of the rod 46 can be controlled based on detection by the encoder 44.

[0043] 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, approximately 0.1 to 10 mm depending on the target sweat gland. When multiple puncture needles 10 (for example, approximately 20 to 40 needles or more) are arranged, it is preferable that the protrusion amounts of all of the puncture needles 10 be within the above numerical range, and it is more preferable that the protrusion amounts of all of the puncture needles 10 be approximately equal.

[0044] 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 pre-stored heating depth position. The control unit 70 may be built into the main body 30, or may be configured externally as a smartphone, personal computer, or the like.

[0045] 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.

[0046] 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 of the tip 10a of the puncture needle 10 from the epidermis, etc. 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.

[0047] 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 for measuring the temperature of the site 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, the state in which the temperature measured by temperature sensor 81 is equal to or higher than a predetermined temperature can be maintained 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 site to be punctured and efficiently destroy the sweat glands.

[0048] The energy including thermal energy supplied from the puncture needle 10 may be changed 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 sweat gland being treated, but the amount of energy required may be determined in advance by experiment, etc. This also applies to thermal energy.

[0049] The epidermal surface is cooled around the puncture site by the intimate contact of the 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 epidermal surface with which the contact surface 24b is in close contact. When the contact surface 24b is configured to spray cooling gas onto the epidermal surface, starting the spray of cooling gas immediately before the puncture needle 10 punctures the epidermal surface can provide good burn prevention and pain relief.

[0050] 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 according to one embodiment of the present invention. Figure 7 is a diagram showing the state after drive unit 40 of lancing device 1 according to one embodiment of the present invention has been activated.

[0051] 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.

[0052] 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.

[0053] 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 body S will be described with reference to FIGS. 8 to 11. FIG. 8 shows the state before the lancing needle 10 of the lancing device 1 according to the embodiment of the present invention is extended. FIG. 9 shows the state after the lancing needle of the lancing device according to the embodiment of the present invention has extended. FIG. 10 shows the state after 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.

[0054] First, let's discuss the subcutaneous tissue. Eccrine glands (E glands) are found throughout the body except for the lips and nails, while 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 an average of 60 Japanese cases, the A gland measured 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 E gland measured 0.57 mm on average, but 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 cases, and may change with increasing number of cases, and may not necessarily be consistent depending on race, etc.

[0055] 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.

[0056] 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 formed into a blunt needle (a non-bevel 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 that can 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, thereby appropriately setting the pressing force of the puncture needle 10. Furthermore, a configuration for determining the depth region in advance, as described below, may be added to these adjustments or settings.

[0057] 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). The control unit 70 then reverses the rotation of the drive motor 42 to move the puncture needle 10 in the direction of withdrawing it from the site to be punctured, thereby burying the tip of the puncture needle 10 above the abutment surface 24b. It is preferable that the thickness and pressure of the puncture needle 10 be appropriately set, similar to the membrane F, so that the tip 10a does not reach the muscle layer S4 but remains reliably within the subcutaneous tissue S3.

[0058] 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 unit 50 to select automatic mode and set it to perform efficient treatment.

[0059] 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.

[0060] 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 energizing the contact unit 20 to cool the epidermal surface S0 with which the contact surface 24b is in close contact, thereby supplying 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.

[0061] 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 entire 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.

[0062] 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 various sources, such as high frequency, radio waves, microwaves, and lasers.

[0063] 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, a low-frequency alternating current of approximately 100 Hz to 1000 Hz is preferred as this RF current. A voltage of approximately 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.

[0064] 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 the temperature to, for example, 50 to 120°C, or 50 to 100°C, or it is also possible to set it to 70°C or higher. A predetermined RF current is supplied from the tip of the puncture needle 10 so as to reach 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.

[0065] 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 which it is heated to 50°C or higher for a predetermined period of time, after which the temperature drops when the current is stopped. The longer the current application time, the greater the sweat gland destruction effect. 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 so that the tips of the puncture needles 10 reach 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.

[0066] Fig. 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 Fig. 11A and Fig. 11B are in the states shown in Fig. 8. Note that Fig. 11A and Fig. 11B are an example of the operation of puncture device 1, and the operation of puncture device 1 is not limited to this.

[0067] 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. In Figures 12A and 12B, the site to be punctured is a cream-like medium that simulates human skin.

[0068] Temperature measurement points line 0 to line 4 are set from shallow to deep in the depth direction, with the middle line 2 roughly corresponding to the depth of the tip of the puncture needle 10 .

[0069] 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. Because the depth position of the temperature sensor 81 is approximately the same as the depth position of the tip of the puncture needle 10, 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, allowing for 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, providing multiple temperature sensors 81 along the length of a single sensor needle 11 allows the single sensor needle 11 to detect temperatures at multiple depth positions. Furthermore, feeding back temperatures at multiple depth positions allows for more appropriate control of the temperature distribution in the depth direction.

[0070] 12B, in which the cooling plate 24 is provided, the temperature of line 0 close to the epidermis surface S0 is relatively lower than that of FIG. 12A, in which the cooling plate 24 is not provided, and it can be seen that the cooling plate 24 has a cooling effect on the epidermis surface S0. 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.

[0071] The epidermal surface S0 is cooled around the puncture site by the intimate contact of the contact surface 24b, preventing burns and providing good analgesia during puncture and thermal energy supply. An anesthetic cream may be applied in advance to the epidermal surface S0 to which the contact surface 24b is in intimate contact. Alternatively, instead of or in addition to applying an anesthetic cream, the contact surface 24b may spray cooling gas onto the epidermal surface S0. In this case, starting the spray of cooling gas immediately before the puncture needle 10 punctures the epidermal surface S0 can provide good burn prevention and analgesia. Furthermore, spraying cooling gas onto the epidermal surface S0 from the opening 24a during the puncture period can maintain a longer cooling effect, thereby providing better burn prevention and analgesia.

[0072] After the thermal energy is supplied, the drive unit 40 is activated to raise the puncture needle 10 and re-insert it into 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 as detachable and replaceable in this way, sterilization of the puncture needle 10 is not required each time, allowing for rapid treatment. The contact portion 20 can also be removed from the main body 30 and replaced with a new one, but it may also be fixed.

[0073] 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.

[0074] [Injection of local anesthetic] Before thermal treatment for underarm odor or hyperhidrosis, such as RF wave, 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.

[0075] [Local anesthetic] The main component of the local anesthetic for treating axillary hyperhidrosis in this embodiment is xylocaine (lidocaine) liquid, for example, xylocaine containing epinephrine, etc. However, the type of local anesthetic used as the main component is not limited to xylocaine liquid, and other general local anesthetics may also be used.

[0076] 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.

[0077] Table 1 shows the thermal conductivity of metals. The metal to be added to the local anesthetic can be one or more biocompatible metals selected from those listed in Table 1 (Source: Mechanical Engineering Notes). Examples of biocompatible metals include magnesium, zinc, manganese, copper, and iron. The thermal conductivity ranking is silver > copper > gold > aluminum > magnesium > zinc > iron > tin > lead. In local anesthesia administered before RF treatment, an injectable agent containing the following substances, in addition to the local anesthetic, increases the thermal conductivity of RF waves. These substances are safe, improve thermal conductivity, and enhance the therapeutic effects of RF treatment.

[0078] When adding a biocompatible metal, drugs such as, but not limited to, Magnesol (Tables 2 and 3), Magcent (Table 4), Eleject (Tables 5 and 6), Volbix (Tables 7 and 8), and Elementmic (Tables 9 and 10) can be used.

[0079] About "Magnesol for Intravenous Use" (Source: JAPIC) ・Brand Name: Magnesol for Intravenous Use 20mL ・Active Ingredients: 2g of JP magnesium sulfate hydrate and 2g of JP glucose per 20mL ・Contains 16.2mEq of magnesium per tube. ・Brand Name: Magnesol for Intravenous Use 20mL ・Description: Clear, colorless injection ・pH 3.5-6.0 ・Osmolality Ratio: Approximately 4 (compared to saline) ・Indications: Prevention and treatment of eclampsia in severe pregnancy-induced hypertension ・Dosage and Administration: Administer an initial dose of 40mL (4g of magnesium sulfate hydrate) intravenously over 20 minutes, followed by continuous intravenous infusion at 10mL (1g) per hour. Depending on symptoms, the dose may be increased by 5mL (0.5g) per hour, up to a maximum of 20mL (2g) 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 caused by 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" (common name: magnesium sulfate hydrate), molecular formula: MgSO4·7H2O, molecular weight: 246.47, properties: colorless or white crystals, bitter, refreshing, and salty taste. It is highly soluble in water and practically insoluble in ethanol. It is soluble in dilute hydrochloric acid. "Glucose" is the general name, its chemical name is D-Glucopyranose, and its molecular formula is CH 12 O6, 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.

[0080]

[0081] About Magcent Injection 100mL (Source: JAPIC) Brand Name: Magcent Injection 100mL Active Ingredients per 100mL: JP Magnesium Sulfate Hydrate 10g JP Glucose 10g Each vial contains 81mEq of magnesium. Description: Clear, colorless injection. pH: 3.5-6.0. Osmolality: Approximately 4 (relative to saline). Indications: Suppression of uterine contractions during threatened preterm labor, prevention and treatment of eclampsia in severe pregnancy-induced hypertension. Dosage and Administration: <Suppression of uterine contractions during threatened preterm labor> Administer an initial dose of 40mL (4g of magnesium sulfate hydrate) intravenously over 20 minutes, followed by continuous intravenous infusion at 10mL (1g) per hour. If uterine contractions are not suppressed, increase the dose by 5mL (0.5g) per hour, up to a maximum of 20mL (2g) per hour. After uterine contractions are suppressed, the dosage should be gradually reduced while observing symptoms, and discontinued if it is confirmed that uterine contractions do not recur. This drug should be administered using a continuous infusion pump. <Prevention and treatment of eclampsia in severe pregnancy-induced hypertension> The initial dose is 40mL (4g of magnesium sulfate hydrate) administered intravenously over 20 minutes or more, followed by continuous intravenous administration at 10mL (1g) per hour. The dose should be increased by 5mL (0.5g) per hour depending on symptoms, up to a maximum of 20mL (2g) per hour. This drug should be administered using a continuous infusion pump, except for the initial dose. - Mechanism of action <Mechanism of action for suppressing uterine contractions in threatened preterm labor> Magnesium blocks Ca channels and inhibits the influx of calcium from outside the cell into the cell. Na+, K+, -ATPase and Ca 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 stores (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 myosin light chain kinase is not activated, 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 injected intramuscularly or intravenously, it reduces 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 believed that magnesium sulfate inhibits 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. <Uterine contractility> Magnesium sulfate hydrate alone inhibited spontaneous uterine motility and uterine contractions induced by acetylcholine or PGF2α in late-pregnant rats. Furthermore, the combined use of magnesium sulfate hydrate and ritodrine hydrochloride enhanced the inhibitory effect on uterine smooth muscle contractions (in vitro and in situ). Physical and chemical information regarding the active ingredient: "Magnesium sulfate hydrate" is commonly known as magnesium sulfate hydrate, has the molecular formula 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 (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 12 O6, 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.

[0082] "Eleject Injection Syringe" (Source: JAPIC)

[0083]

[0084] - Indications or effects: Supplementation of zinc, iron, copper, manganese, and iodine when oral and enteral nutritional supplementation is impossible or insufficient and high-calorie parenteral nutrition is the only option. Normally, for adults, 2mL is added to high-calorie parenteral nutrition infusion solution 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 become sufficient, administration of this drug should be discontinued immediately (trace elements are usually supplied by oral and enteral nutrition).

[0085] "Volubix Injection" (Source: JAPIC)

[0086]

[0087] Efficacy: Supplementation of zinc, iron, copper, manganese, and iodine for patients who are unable or inadequately able to receive oral or enteral nutrition and must rely on high-calorie parenteral nutrition. Dosage: For adults, 2 mL per day is typically added to high-calorie parenteral nutrition and administered intravenously. The dose may be adjusted depending on age and symptoms. Pharmacology: A comparative study was conducted on trace element-deficient rats and normal rats, comparing the effects of a trace element supplement in a group receiving high-calorie parenteral nutrition with a 20 μmol manganese-containing trace element preparation and a group receiving high-calorie parenteral nutrition without the preparation for one week.9) The group not receiving the trace element preparation exhibited decreased trace element concentrations in plasma and tissues, and symptoms of anemia, alkaline phosphatase activity, and decreased triiodothyronine and thyroxine concentrations, which are thought to be due to trace element deficiency, were observed. However, in the group receiving the trace element preparation, these changes either returned to normal or tended to return to normal levels.

[0088] "Elementic Note" (Source: JAPIC)

[0089] Japanese brand name: Elemenmic Injection Standard unit: 2mL x 1 tube English brand name: Elemenmic Injection Regulatory classification: Prescription drug Note: Regulatory classification notes: Note: Caution: Use only with a prescription from a doctor, etc. Japan Standard Product Classification Number: 873229 Approval number: 20400AMZ00057 Date of launch: April 1992 Storage method and expiration date: Store at room temperature. Expiration date: 3 years Ingredients and properties: The composition is as shown in Table 10. Additives: Sodium chondroitin sulfate Additives: Sodium hydroxide (pH adjuster)

[0090] <Product characteristics> - Color: Dark reddish brown - Dosage form: Colloid solution / liquid / injection <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. <Dosage and administration> For adults, 2 mL is usually added to high-calorie parenteral nutrition solutions and administered intravenously per day. The dosage may be increased or decreased depending on age and symptoms. Caution regarding dosage and administration: Some high-calorie parenteral nutrition base solutions contain trace elements, so the dosage should be reduced accordingly depending on the amount of trace elements present. <Dosage and administration> For adults, 2 mL is usually added to high-calorie parenteral nutrition solutions and administered intravenously per day. The dosage should be increased or decreased depending on age and symptoms. <Caution regarding dosage and administration> For adults, 2 mL is usually added to high-calorie parenteral nutrition solutions and administered intravenously per day. The dosage should be reduced accordingly depending on age and symptoms. <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. Trace element supplementation effects: Trace element-deficient rats and normal rats were given a high-calorie infusion for one week, with a group receiving a trace element preparation containing 20 μmol of manganese* and a group receiving a high-calorie infusion without the addition of a trace element preparation, and the effects of the supplementation were compared. 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 thought to be due to trace element deficiency, reduced alkaline phosphatase activity, and reduced triiodothyronine and thyroxine concentrations, but in the group receiving the trace element preparation, these changes returned to normal levels or tended to return to normal. *Preparation containing 20 μmol of manganese, 35 μmol of iron, 60 μmol of zinc, 5 μmol of copper, and 1 μmol of iodine

[0091] Comparative Example 1 Figure 13 shows an example of treatment of a culture medium in 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 using the puncture device 1 to confirm the temperature distribution at the puncture site. The gray parts of the culture medium are undiscolored and have not yet reached a temperature of 60°C. The white parts of the culture medium are discolored 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. In the cross-sectional view, the discolored white area is confined to the cylindrical 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.

[0092] Comparative Example 2 Figure 14 shows an example of cancer cell treatment in Comparative Example 2. In Figure 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 Figure 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.

[0093] [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 state of the temperature distribution when RF waves are applied from multiple puncture needles 10. Figure 16A shows the case of physiological saline, Figure 16B shows the case of a solvent containing 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 the regions of each solvent, the black areas indicate low temperature areas, and the white areas indicate high temperature areas.

[0094] Comparing the temperature distributions in Figures 15A to 15E, 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 shows that the order of the extent of the high-temperature regions is magnesium, zinc, and manganese.

[0095] FIG. 16 is an explanatory diagram of the temperature distribution when a solvent containing zinc or magnesium is used, showing the temperature distribution when RF waves are applied from multiple puncture needles 10 in a zinc or magnesium solvent. FIG. 16A shows the temperature distribution for a solvent containing zinc, and FIG. 16B shows the temperature distribution for a solvent containing magnesium. The temperature distribution for zinc was 60.2°C (line 0), 76.4°C (line 1), 79.7°C (line 2), 72.6°C (line 3), and 54.3°C (line 4). The temperature distribution for magnesium was 64.4°C (line 0), 92.0°C (line 1), 100.0°C (line 2), 68.9°C (line 3), and 51.5°C (line 4). 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.

[0096] Measurements of the temperature distribution diagrams in Figures 15 and 16 show that higher thermal conductivity improves temperature distribution characteristics, i.e., the higher the temperature range. Thermal conductivity is highest in the following order: (1) Mg (magnesium), (2) Zn (zinc), (3) Mn (manganese), (4) copper, and (5) iron. A thermal conductive effect was confirmed in all cases where these metals were included. It was shown that adding a solution containing a biocompatible metal, such as magnesium, to a local anesthetic agent improves temperature distribution characteristics more than simply diluting it with saline. Among the agents listed in Tables 2 to 9, adding a magnesium-containing solution produced the greatest improvement in temperature distribution characteristics.

[0097] 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.

[0098] 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 during 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 also antagonized by calcium. It effectively 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.

[0099] [Test Example 1] Magnesol (Tables 2 and 3) To test the thermal conductivity improvement of the axillary odor or hyperhidrosis treatment formulation according to embodiment 1, a test was conducted in Test Example 1 to examine the thermal conductivity improvement when using the formulation 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-fold to equalize the osmotic pressure of both. The "Magnesol 20 mL for Intravenous Injection" formulation 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.

[0100] (Test Method) 1) The experimental formulation of Experimental Example 1 was prepared by diluting the "Magnesol 20 mL for Intravenous Injection" formulation four times. A stock solution of physiological saline (NaCl) was used as a comparative example. 2) Cell culture media injected with the experimental formulation of Experimental Example 1 and cell culture media injected with stock solution of physiological saline were prepared as a comparative example. 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. The cell culture medium used was a gel prepared by solidifying and burning 1% agarose. Note that the cell culture medium used in this embodiment is not limited to this gel; any cell culture medium, whether artificial or natural, can be used as long as experimental reproducibility is ensured. 3) The temperature of the culture medium was 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. Simultaneously, the temperature distribution in the cross-sectional direction of the cell culture medium was photographed using thermography.

[0101] (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 in the experimental preparation of Experimental Example 1, while the average temperature in the comparative example was 28.9°C. The two-sided probability (P value) was 0.0019, indicating a significant difference between the two.

[0102] 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 (weak white or gray in the monochrome image) than for the experimental formulation of Experimental Example 1, 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.

[0103] As described above, Experimental Examples 1 to 14 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 the thermal conductivity of 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 the thermal conductivity of the treatment site, is effective not only for RF waves but also for hyperthermia treatments using microwaves or lasers.

[0104] Test Example 2: Elementmic (Tables 9 and 10) Next, to test the thermal conductivity improvement of a therapeutic anesthetic for axillary odor or hyperhidrosis according to Example 1, a test was conducted in Test Example 2 to evaluate the thermal conductivity improvement when using a formulation marketed as "Elementmic Injection." A two-fold dilution of saline (NaCl) was used as a comparative example. To standardize the comparison of thermal conductivity when injected subcutaneously, and to equalize the osmotic pressure of both, Elementmic Injection was used undiluted, while a two-fold dilution of saline (NaCl) was used. The "Elementmic Injection" formulation is a dark reddish-brown colloidal injection solution with a pH of 4.5-6.0 and an osmotic pressure ratio of approximately 0.5 relative to saline. The experimental method was the same as in Test Example 1.

[0105] (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 in the experimental preparation of Test Example 2, while the average temperature in the comparative example was 28.4°C. The two-sided probability (P value) was 0.0025, indicating a significant difference between the two.

[0106] 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.

[0107] 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.

[0108] [Polyphenols] In addition to the main component, the local anesthetic, the local anesthetic for treating axillary hyperhidrosis in this embodiment can contain polyphenols. For example, pentagalloyl glucose (PGG), a type of polyphenol, has an odor-suppressing effect. Furthermore, experiments have shown that it also increases the thermal conductivity during treatment with an RF therapy device. Specific types of PGG are not particularly limited, but for example, penta-O-galloyl-β-D-glucose hydrate (PCG) can be used.

[0109] 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, so for example, adding pentagalloylglucose (PGG) and biocompatible metals to local anesthetics can suppress axillary odor and improve the conductivity of RF waves in VH treatment.

[0110] 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

[0111]

[0112] The properties of this product's PCG are as follows: Quality level 100 Assay ≥ 96% (HPLC) Form Powder Optical activity [α] / D +14 to +26°, c = 0.2 in acetone-d6 Color Light brown Solubility DMSO: ≥ 20 mg / mL Storage temperature 2-8°C

[0113] 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

[0114] <Physiological / Chemical Effects> PGG primarily induces (caspase-dependent) apoptosis 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.

[0115] <Features and Benefits> This compound is a noteworthy product for apoptosis research. <Safety Information> Storage Classification Code: 11 - Combustible Solids WGK: WGK 3 Flash Point (°F): Not applicable Flash Point (°C): Not applicable

[0116] [Test 3] Penta-O-galloyl-β-D-glucose hydrate (PCG) Next, in order to test the improvement in thermal conductivity of a therapeutic anesthetic for the treatment of axillary odor or hyperhidrosis according to embodiment 1, 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 solution. Undiluted saline solution was used as a comparative example. The experimental method was the same as in Test Example 1.

[0117] (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 in the experimental formulation of Experimental Example 3, while the average temperature in the comparative example was 24.2°C. The two-sided probability (P value) was 0.0001, indicating a significant difference between the two.

[0118] 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.

[0119] As described above, 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 by 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.

[0120] [Regarding the therapeutic preparation for underarm odor or hyperhidrosis using a solution containing magnesium] Next, the pharmacology of the therapeutic effect of a solution containing magnesium for underarm odor and hyperhidrosis will be explained. When magnesium, for example, magnesium sulfate hydrate, is administered intramuscularly or intravenously, the 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.

[0121] 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 a magnesium formulation into the treatment area without using the thermal treatment device of Example 1. The magnesium 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 "◯" 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.

[0122]

[0123] [On the Effect of PCG on the Treatment of 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 example, injection of PCG into the treatment site without using the thermal treatment device of embodiment 1 confirmed the odor suppression effect 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 cases of 10 patients. "◎" indicates a good odor suppression effect at the treatment site, "〇" indicates a sweat suppression effect, and "△" indicates no or unknown effect. The pharmacological effect is that sweating is suppressed by the acetylcholine-blocking effect of magnesium. The PCG used was the aforementioned "penta-O-galloyl-β-D-glucose hydrate" (PCG) (chemical formula 1). The pharmacological effect of injecting PCG into a local anesthetic solution to suppress odor 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 treating axillary odor or hyperhidrosis.

[0124]

[0125] [Embodiment 2] A therapeutic preparation for axillary odor or hyperhidrosis, a therapeutic anesthetic, and a therapeutic device for axillary odor or hyperhidrosis according to embodiment 2 of the present invention will be described with reference to Fig. 23. Descriptions of components common to those in Figs. 1 to 22 will be omitted.

[0126] When using the RF treatment machine exemplified in embodiment 1 as the treatment device, an electrode needle is used at the treatment site. By using a needle as this electrode needle, it is 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 using the RF treatment machine exemplified in embodiment 1, 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.

[0127] 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 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 extend radially outward from the hollow hole 110 is set so that α is 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 solution 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 solution is injected. Furthermore, by preparing multiple types of puncture needles 100 with different distributions of the multiple communication holes 100b, it is possible to inject the appropriate injection solution depending on the position and range of the treatment area.

[0128] When the switch on the hollow hole operating unit 50 is operated, electricity is applied to the drive unit 40, and the holder 110 (corresponding to holder 12 in embodiment 1 (FIGS. 5 to 7)) that holds the puncture needle 100 and the sensor needle 11 is driven so that the puncture needle 100 protrudes, causing the puncture needle 100 to penetrate 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, allowing the local anesthetic to 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 a separate syringe or other puncture, 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 then inserting the puncture needle 100 subcutaneously into the treatment area, thereby simplifying the treatment procedure and eliminating the need for complicated treatment.

[0129] [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 Figures 1 to 17 will be omitted.

[0130] 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 a laser, 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.

[0131] 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.

[0132] In a laser treatment device, the apocrine and eccrine glands are destroyed by irradiating the deep dermis layer where they are concentrated with a laser from a laser generator. The laser generator is set to destroy sweat glands, and by using two types of wavelengths, for example, by switching between two types of wavelengths or using them simultaneously, it is possible to treat both the shallow and deep layers within the depth range where sweat glands are present through dual-layer irradiation, thereby treating the entire depth range where sweat glands are present.

[0133] 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 application, 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.

[0134] 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.

[0135] [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 are described. In Embodiment 1, we described the use of a local anesthetic to which polyphenols and / or biocompatible metals are added, which is injected into the treatment site before treatment with the treatment device. However, as described above, polyphenols and / or biocompatible metals themselves have the effect of improving the therapeutic effect of the treatment device, i.e., reducing odors 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.

[0136] The therapeutic effect of the treatment device can be improved by injecting a treatment 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.

[0137] For example, the use of a preparation containing polyphenols can suppress the odor of body odor. For example, by adding PGG, a type of polyphenol, and especially PCG, which has an excellent odor suppressing effect, a treatment preparation for body odor or hyperhidrosis can be made.

[0138] 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.

[0139] 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.

[0140] <Modifications> 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.

[0141] For example, in the above-described embodiments, the aspects of the treatment device for thermal treatment exemplified are merely examples, and other aspects 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 aspect of the 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.

[0142] 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.

[0143] DESCRIPTION OF SYMBOLS 1...Lancing device 2...Energy supply unit 3...Deepest part 10...Lancing needle 10a...Tip part 10b...Insulating film 11...Sensor needle 11a...Hollow needle 12...Holder 20...Abutment part 21...Support arm 22...Peltier element 24...Cooling plate 24a...Opening 24b...Abutment surface 24b...Abutment surface 26...Heat dissipation block 26a...Opening 28...Through hole 30...Main body 30a...Terminal part 34...Cylindrical part 34a...Opening 34b...Hole 34c...Groove part 36...Engagement rail 40...Drive part 42...Drive motor 42a...Rotary shaft 43...Shaft 43a...Threaded part 44...Encoder 46...Rod 46a...Nut 46b...Protrusion 46d...Tip part 50...Operation part 60...Cartridge for lancing device 62...Cartridge body 62a...Engagement groove 62b...Through hole 62c...Insertion hole 64...Membrane 70...Controller 81...Temperature sensor 81...Temperature sensor for site to be punctured 81a...Hollow needle 81b...Insulating coating 81c...Lead wire 82...Surface temperature sensor 100...Puncture needle 100a...Hollow hole 100b...Communicating 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. A therapeutic preparation for underarm odor or hyperhidrosis, characterized by using a solution containing magnesium.

2. A local anesthetic for treating underarm odor or hyperhidrosis, characterized by using a solution containing magnesium.

3. A therapeutic preparation for underarm odor or hyperhidrosis, characterized by containing polyphenols.

4. A local anesthetic for treating underarm odor or hyperhidrosis, characterized by containing polyphenols.

5. An anesthetic for treating axillary odor or hyperhidrosis, comprising a local anesthetic as a main ingredient and further comprising polyphenols and / or biocompatible metals, and characterized in that when injected into the treatment area prior to thermal treatment of the sweat glands with a treatment device for treating axillary odor or hyperhidrosis, it reduces the odor at the treatment area and improves the temperature distribution during thermal treatment.

6. An anesthetic for treating underarm odor or hyperhidrosis as described in claim 5, characterized in that it contains xylocaine or xylocaine with epinephrine as a local anesthetic.

7. An anesthetic for treating underarm odor or hyperhidrosis as described in claim 5, characterized in that the polyphenol contains pentagalloyl glucose (PGG), or penta-O-galloyl-β-D-glucose hydrate (PCG) as the pentagalloyl glucose.

8. An anesthetic for treating underarm odor or hyperhidrosis as described in claim 5, characterized in that the biocompatible metal contains at least one metal selected from the group consisting of magnesium, zinc, manganese, copper, and iron.

9. A treatment device for axillary odor or hyperhidrosis that uses a therapeutic preparation or therapeutic anesthetic for axillary odor or hyperhidrosis described in any one of claims 1 to 8, 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.

10. A treatment device for axillary odor or hyperhidrosis as described in claim 9, characterized in that the thermal treatment section 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 section and has a hollow hole and a number of communication holes that connect the hollow hole to the outside, and the puncture needle injects the axillary odor or hyperhidrosis treatment preparation or therapeutic anesthetic from the communication holes into the treatment area.

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