Cryotherapy device

Abstract

This cryotherapy device is provided with a head, a cooling mechanism, and a control unit. The head has a probe that forms an active surface that comes close to or comes into contact with the surface of the skin to be treated. And the cooling mechanism is used for cooling the probe. The control unit controls the cooling mechanism so as to maintain the probe at a target temperature of 0 DEG C or less. The probe is configured so that pathological cells including at least nevus cells can be selectively apoptotic by freezing the tissue of the skin through the active surface.

Description

Technical Field

[0001] This invention relates to cryotherapy devices. Background Technology

[0002] Patent Document 1 discloses a system having an electrosurgical probe system for excising tissue from a patient's epidermis or peridermis. The tissue to be excised may include, for example, abnormal tissue, moles, superficial spots, malignant melanoma, or malignant tumor tissue.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Publication No. 11-501555 Summary of the Invention

[0006] The technical problem that the invention aims to solve

[0007] Patent Document 1 discloses an electrosurgical probe system comprising an active electrode and a return electrode connected to a high-frequency voltage source. When a high-frequency voltage is applied to the active electrode and the return electrode, the active electrode generates an energy source at its tip, causing necrosis of the tissue in contact with or near the tip. However, such an electrosurgical probe system is invasive in damaging skin tissue and may leave residual inflammation, scarring, and scar contractures. Therefore, there is a need for a treatment device capable of removing skin lesions such as nevus cells and less likely to leave scars.

[0008] The purpose of this invention is to provide a cryotherapy device that can suppress the formation of scars and other abnormalities and remove lesions containing at least nevus cells.

[0009] Technical means for solving technical problems

[0010] A cryotherapy apparatus according to a first aspect of the present invention includes a head, a cooling mechanism, and a control unit. The head has a probe forming an action surface for approaching or contacting the surface of the skin to be treated. The cooling mechanism cools the probe. The control unit controls the cooling mechanism to maintain the probe at a target temperature below 0°C. The probe is configured to selectively induce apoptosis in diseased cells, at least those containing nevus cells, by freezing the skin tissue via the action surface.

[0011] The first aspect of the cryotherapy device utilizes a probe cooled to below 0°C to selectively induce the natural death of lesion cells containing at least nevus cells (apoptosis of small cell fragments while the cell membrane remains intact). Conventional methods for removing lesion cells containing nevus cells include invasive surgical excision, laser treatment, electrosurgical treatment, and cryotherapy using cryo-liquid gases. These methods not only cause necrosis of the lesion cells (necrosis due to cell membrane rupture and release of cell contents) but also necrosis of nearby normal cells without lesions, leading to frequent scarring, scar contractures, and inflammation. The inventors conducted in-depth research and found that when both nevus cells and normal cells are cooled to below 0°C, the proportion of nevus cells undergoing apoptosis is significantly higher than the proportion of normal cells undergoing apoptosis. This is believed to be because nevus cells are more temperature-sensitive than normal cells. Based on this understanding, the cryotherapy device can preserve more normal cells and preferentially induce apoptosis in the more temperature-sensitive lesion cells.

[0012] Furthermore, in the cryotherapy apparatus of the first aspect, the tissue of the skin to be treated is frozen via the action surface of a probe that is cooled to below 0°C. Therefore, it is not necessary to prepare cryogenic liquefied gases such as liquid nitrogen or carbon dioxide, and there is no burden of complex safety management operations for high-pressure gases.

[0013] In the cryotherapy apparatus of the second aspect of the present invention, in the cryotherapy apparatus of the first aspect, the probe further forms a pair of opposite faces intersecting the action surface, and the cooling mechanism has a pair of cooling elements capable of cooling the probe, the pair of cooling elements each forming a first face capable of absorbing heat from the opposite face.

[0014] According to the cryotherapy device of the second aspect, the cooling capacity of the cooling element for the probe can be further improved.

[0015] In the cryotherapy apparatus of the third aspect of the present invention, in the cryotherapy apparatus of the first or second aspect, the pair of cooling elements further form a second surface capable of releasing heat absorbed from the first surface, and the cooling mechanism further has a cooling jacket in which a refrigerant capable of absorbing heat from the second surface circulates.

[0016] According to the cryotherapy device in the third aspect, the cooling efficiency of the probe can be further improved.

[0017] In the cryotherapy apparatus of the fourth aspect of the present invention, in any of the cryotherapy apparatuses of the first to third aspects, the head further comprises: a housing that houses at least a portion of the probe, the pair of cooling elements, and the cooling sleeve; and a heat insulation member disposed between the housing and the cooling sleeve.

[0018] According to the cryotherapy device in the fourth aspect, the cooling efficiency of the probe can be further improved.

[0019] In the cryotherapy apparatus of the fifth aspect of the present invention, in any of the cryotherapy apparatuses of the first to fourth aspects, the head further comprises an imaging device capable of acquiring an image of a lesion cell containing at least the nevus cell or its vicinity.

[0020] According to the cryotherapy device in the fifth aspect, even when the diseased cells or their vicinity are obscured by the head and difficult to observe visually, the condition of the diseased cells or their vicinity can be easily observed.

[0021] In the cryotherapy apparatus of the sixth aspect of the present invention, in any of the cryotherapy apparatuses of the first to fifth aspects, the control unit controls the cooling mechanism to maintain the probe at a target temperature above -30°C.

[0022] In the cryotherapy apparatus of the seventh aspect of the present invention, in any of the cryotherapy apparatuses of the first to sixth aspects, the control unit controls the cooling mechanism to maintain the probe at a first target temperature above -30°C and below -25°C.

[0023] In the cryotherapy apparatus of the eighth aspect of the present invention, in any of the cryotherapy apparatuses of the first to seventh aspects, the control unit controls the cooling mechanism such that the probe is maintained at the first target temperature for a time less than a first time.

[0024] According to the eighth aspect, the cooling mechanism is controlled by the control unit to maintain the probe at a first target temperature of -30°C to -25°C for a time of less than a first time. Therefore, it is possible to avoid freezing the skin of the treatment subject to the required time for an extended period.

[0025] In the cryotherapy apparatus of the ninth aspect of the present invention, the first time is 1 minute in any of the cryotherapy apparatuses of the first to eighth aspects.

[0026] In the cryotherapy apparatus of the tenth aspect of the present invention, in any of the cryotherapy apparatuses of the first to ninth aspects, the control unit controls the cooling mechanism to maintain the probe at a second target temperature of -4°C or higher and 0°C or lower.

[0027] In the cryotherapy apparatus of the eleventh aspect of the present invention, in any one of the cryotherapy apparatuses of the first to tenth aspects, the control unit controls the cooling mechanism such that the probe is maintained at the second target temperature for a time less than a second time.

[0028] According to the eleventh aspect, the cooling mechanism is controlled by the control unit to maintain the probe at a second target temperature of -4°C to 0°C for a period of time less than a second time. Therefore, it is possible to avoid prolonged freezing of the skin to be treated for the required duration.

[0029] In the cryotherapy apparatus of the twelfth aspect of the present invention, in any of the cryotherapy apparatuses of the first to eleventh aspects, the second time is 5 minutes.

[0030] In the cryotherapy apparatus of the thirteenth aspect of the present invention, in any of the cryotherapy apparatuses of the first to twelfth aspects, the probe is made of metal.

[0031] According to aspect thirteen, it can efficiently cool the probe.

[0032] In the cryotherapy apparatus of the fourteenth aspect of the present invention, in any one of the cryotherapy apparatuses of the first to thirteenth aspects, the head includes a temperature sensor for detecting the temperature of the probe, and the control unit performs feedback control on the temperature of the probe based on the output signal of the temperature sensor.

[0033] According to aspect 15, the temperature range of the probe can be maintained with higher accuracy.

[0034] In the cryotherapy apparatus of the sixteenth aspect of the present invention, in any of the cryotherapy apparatuses of the first to fifteenth aspects, the head further comprises a heat-insulating portion forming a surface surrounding the action surface.

[0035] According to the fifteenth aspect, it is possible to suppress undesirable effects on cells surrounding tissues that are close to or in contact with the action surface.

[0036] In the cryotherapy apparatus of the sixteenth aspect of the present invention, in any of the cryotherapy apparatuses of the first to fifteenth aspects, the cooling mechanism has a cooling element for cooling the probe and a cooler for cooling the cooling element, wherein the probe, the cooling element and the cooler are connected in sequence with respect to the working surface.

[0037] According to the sixteenth aspect, by using the cooling element connected to the probe as part of the cooling mechanism, it is possible to miniaturize the entire cryotherapy device.

[0038] In the cryotherapy apparatus of the seventeenth aspect of the present invention, in any one of the cryotherapy apparatuses of the first to sixteenth aspects, the control unit controls the cooling mechanism according to at least two different operating conditions that pre-combine the target temperature of the probe and the time for which the target temperature is to be maintained, and the cryotherapy apparatus further includes a condition setting unit for allowing a user to specify one of the at least two different operating conditions.

[0039] According to the seventeenth aspect, the cryotherapy device can be selectively operated under at least two operating conditions. This allows for more effective treatment based on the diseased cells.

[0040] Invention Effects

[0041] According to the present invention, a cryotherapy device is provided that can remove lesion cells containing at least nevus cells while inhibiting the formation of scars, etc. Attached Figure Description

[0042] Figure 1 This is a schematic diagram illustrating a structural example of the cryotherapy apparatus according to the first embodiment.

[0043] Figure 2 This is a cross-sectional schematic diagram illustrating a structural example of the head.

[0044] Figure 3 This is a plan view of the head when viewed from the side of the action surface.

[0045] Figure 4 It is a block diagram showing the electrical structure of the control unit.

[0046] Figure 5 This is a schematic diagram illustrating a structural example of the cryotherapy apparatus according to the second embodiment.

[0047] Figure 6A This is a perspective view of the head in the second embodiment.

[0048] Figure 6B This is a cross-sectional schematic diagram showing an example of the head structure in the second embodiment.

[0049] Figure 7 This is a flowchart illustrating an example of the operation process of a cryotherapy device.

[0050] Figure 8A This is a perspective view showing the external appearance of a structural example of the probe according to the second embodiment.

[0051] Figure 8B This is a perspective view showing the external appearance of a structural example of the probe according to the second embodiment.

[0052] Figure 8C This is a perspective view showing the external appearance of a structural example of the probe according to the second embodiment.

[0053] Figure 8D This is a perspective view showing the external appearance of a structural example of the probe according to the second embodiment.

[0054] Figure 9A This is a side view of the probe used in the experiment.

[0055] Figure 9B Is with Figure 8A The probe has a side view of an interchangeable probe.

[0056] Figure 10 These are microscope photographs showing the inventor's experimental results (Example 1 and Comparative Example).

[0057] Figure 11 These are microscope photographs showing the inventor's experimental results (Example 2).

[0058] Figure 12 These are microscope photographs showing the inventor's experimental results (Example 3).

[0059] Figure 13 These are microscope photographs showing the inventor's experimental results (Example 4).

[0060] Figure 14 These are microscope photographs showing the inventor's experimental results (Example 5).

[0061] Figure 15 These are microscope photographs showing the inventor's experimental results (Example 6).

[0062] Figure 16 These are microscope photographs showing the inventor's experimental results (Example 7). Detailed Implementation

[0063] Hereinafter, several embodiments of the cryotherapy apparatus of the present invention will be described with reference to the accompanying drawings. In the following drawings, for ease of explanation, some constituent elements are sometimes omitted. Furthermore, the dimensions of the constituent elements shown in the following drawings may not always correspond to the actual dimensions of the constituent elements.

[0064] <1-1. Structure of the cryotherapy apparatus according to the first embodiment>

[0065] Figure 1This is a schematic diagram illustrating a structural example of the cryotherapy device 1 according to the first embodiment. The cryotherapy device 1 is a device for suppressing the formation of scars, scar contractures, and inflammation, and for treating lesion cells containing at least nevus cells (including giant nevus cells). Medical professionals are envisioned as its primary users. The lesion cells targeted by the cryotherapy device 1 are simply cells that appear on the skin surface and are more heat-sensitive than normal cells; there are no particular limitations. Besides nevus cells, it also includes pigment cells (melanocytes), inflammatory cells, etc. Examples of target diseases include acanthosis nigricans, melanoma, senile lentigines, flat nevi, acquired melanocytosis (ADM), seborrheic keratosis (senile warts), neurofibroma, dermatofibroma, hypertrophic scars, keloids, etc.

[0066] like Figure 1 As shown, the cryotherapy device 1 includes a head 2, a cooling mechanism 3 connected to the head 2, a control unit 4, and a condition setting unit 5. It is powered by a power source (not shown), and each part operates as described below. Each part will be described below.

[0067] [head]

[0068] Figure 2 This is a cross-sectional schematic diagram showing a structural example of head 2. Figure 3 This is a plan view viewed from the action surface 200 side of the head 2. The head 2 is a part used by the user to hold and apply it to the surface of the skin that is the treatment object during treatment. The head 2 has a probe 20, a temperature sensor 21, a heat insulation part 22, an illumination 24, and a housing 23. The housing 23 houses at least a portion of the probe 20, the temperature sensor 21, the illumination 24, and the heat insulation part 22, and at least a portion of the cooling element 30 and the heat dissipation part 31 of the cooling mechanism 3 (described later). The material constituting the housing 23 is not particularly limited, but it is preferably a material with a lower thermal conductivity than the material constituting the probe 20, such as hard resins. The housing 23 may also be configured as a gripping part for the user to hold and operate the probe 20.

[0069] The probe 20 is a component integrally formed of metal, forming an action surface 200 for contacting the surface of the skin that is the object of treatment. Hereinafter, the side with the action surface 200 of the probe 20 is defined as the front end side of the probe, and the opposite side of the action surface 200 is defined as the rear end side of the probe 20. In this embodiment, the action surface 200 is a flat, circular surface when viewed from the front end side, but the shape of the action surface 200 is not particularly limited and can be appropriately changed. When the action surface 200 is circular or square, its diameter or the length of one side is preferably 1 mm or more and 10 mm or less. In addition, the action surface 200 may also be exposed from the housing 23.

[0070] The probe 20 of this embodiment has a generally flat base 201 on its rear end side. The base 201 is connected to the cooling element 30 such that its rear end side surface faces the first surface 300 of the cooling element 30. The connection between the base 201 and the cooling element 30 can be made, for example, by fixing with screws, or by the presence of thermally conductive grease or the like. From the viewpoint of effectively cooling the probe 20, it is preferable that the shape and size of the base 201 when viewed from the rear end side are the same as the shape and size of the first surface 300 of the cooling element 30, and that the rear end side surface of the base 201 overlaps the first surface 300 on its entire surface. In this embodiment, the first surface 300 is generally rectangular, so the base 201 when viewed from the rear end side is also generally rectangular. Therefore, the probe 20 of this embodiment has a generally frustum-shaped appearance that rises continuously from the base 201 in a generally circular shape, extends towards the front end side while narrowing in diameter, and is continuous with the periphery of the working surface 200. However, the appearance of the probe 20 is not limited to this and can be appropriately changed according to the shape of the working surface 200, the cooling element 30, etc.

[0071] There are no particular limitations on the metals that constitute the probe 20, as long as they do not cause harm to the human body. Examples include medical-grade metals and aluminum. These metals can be surface-treated within a range that does not affect the thermal conductivity of the working surface 200.

[0072] Temperature sensor 21 is disposed within a space 202 formed inside probe 20. In this embodiment, space 202 is a space that extends from the side peripheral surface 203 of probe 20 into the interior of probe 20 and is closed on one side. Here, the side peripheral surface 203 of probe 20 refers to the surface that extends continuously between the periphery of the working surface 200 and the base 201. In order to minimize the temperature difference between the temperature detected by temperature sensor 21 and the temperature of working surface 200, space 202 is preferably formed near working surface 200. Temperature sensor 21 detects the temperature of probe 20 and continuously sends an output signal representing the detected temperature to control unit 4, which will be described later. As described later, control unit 4 performs feedback control of cooling mechanism 3 based on the sent output signal. The output signal can be sent via communication line 7 in a wired manner or wirelessly. Temperature sensor 21 is not particularly limited as long as it can detect the temperature of probe 20, and can be any known temperature sensor such as a resistance temperature sensor, thermocouple, thermistor sensor, or thermostat.

[0073] The heat insulation portion 22 is a portion within the housing 23 that surrounds the probe 20 and forms a surface 220 surrounding the action surface 200. In this embodiment, the surface 220 is formed to be coplanar with the action surface 200. According to the heat insulation portion 22, it is possible to suppress undesirable effects on cells surrounding tissues in contact with the action surface 200. Undesirable effects refer to, for example, the air surrounding normal cells (not the target of treatment) being accidentally cooled due to the action surface 200, which could induce apoptosis in these normal cells.

[0074] As for the material constituting the heat insulation part 22, there are no particular limitations as long as it is a material with a lower thermal conductivity than the metal constituting the probe 20 and does not cause harm to the human body; any known heat insulation component can be used. In this embodiment, the heat insulation part 22 is made of polystyrene foam.

[0075] The probe 20 in this embodiment also includes an illumination 24. The illumination 24 is not particularly limited as long as it can illuminate the skin surface facing the action surface 200; known light sources such as lasers or LEDs can be used. For example, the illumination 24 can be arranged to surround the action surface 200, allowing light to be irradiated onto the skin surface from between the action surface 200 and the surface 220. Thus, the illumination 24 assists in ensuring that the action surface 200 properly approaches or contacts the skin surface as the target. Furthermore, the illumination 24 and the temperature sensor 21 are appropriately connected to a power source via wires (not shown).

[0076] [Cooling mechanism]

[0077] The cooling mechanism 3 includes a cooling element 30, a heat dissipation component 31, and a cooling unit 32. As described above, in this embodiment, the cooling element 30 and the heat dissipation component 31 are housed in the housing 23. Therefore, with the working surface 200 as a reference, the probe 20, the cooling element 30, and the heat dissipation component 31 are sequentially connected and assembled into a single unit by the housing 23. The cooling unit 32 is connected to the heat dissipation component 31 via a first pipe 320 and a second pipe 321. The heat dissipation component 31, the first pipe 320, the second pipe 321, and the cooling unit 32 form a refrigerant circulation path for dissipating heat from the cooling element 30. This will be described below.

[0078] The cooling element 30 is a component capable of cooling the probe 20 from the first surface 300 side. In this embodiment, a Peltier element is used as the cooling element 30. Therefore, in this embodiment, the cooling element 30 is connected to a wire 6 for carrying direct current. A pair of wires 6 are connected to one cooling element 30, and opposite sides of the pair of wires 6 are connected to the control unit 4. The control unit 4 applies a direct current to the cooling element 30, making the first surface 300 the heat-absorbing side and the second surface 301 the heat-generating side. As will be described later, the control unit 4 controls the operation of the cooling element 30 by controlling the direct current flowing through it, so as to maintain the probe 20 at a predetermined target temperature below 0°C.

[0079] The heat dissipation component 31 is a component used to release heat generated on the second surface 301 side of the cooling element 30. In this embodiment, the heat dissipation component 31 has a generally flat surface shape. The heat dissipation component 31 is connected to the cooling element 30 such that one side of it faces the second surface 301 of the cooling element 30. The connection between the heat dissipation component 31 and the cooling element 30 can be made, for example, by fixing with screws, or by using thermally conductive grease or the like. From the viewpoint of effectively dissipating heat from the cooling element 30, it is preferable that the aforementioned surface of the heat dissipation component 31 overlaps the entire surface of the second surface 301.

[0080] A flow path 310 for refrigerant flow is formed inside the heat dissipation component 31. The flow path 310 is a continuous flow path connected at one end to the first piping 320 and at the other end to the second piping 321. The shape of the flow path 310 is not particularly limited and can be appropriately modified considering factors such as cooling efficiency. In this embodiment, the flow path 310 is configured such that the refrigerant cooled by the cooling unit 32 flows in through the first piping 320, and the refrigerant flows out through the second piping 321 after completing its flow in the flow path 310. The heat dissipation component 31 and the refrigerant are not particularly limited as long as they can remove the heat from the cooling element 30; for example, known water-cooled radiators and coolants can be used.

[0081] Cooling unit 32 is a device that circulates refrigerant within the first piping 320, the second piping 321, and the heat dissipation component 31, and can utilize a known cooling water circulation device. Cooling unit 32 includes: a water tank 322 for storing and circulating refrigerant, a cooler 323 for cooling the refrigerant within the water tank 322, and a heat exchange unit 324. The refrigerant within the water tank 322 is supplied from the first piping 320 to the heat dissipation component 31 (see reference 321) via a pump (not shown). Figure 1 (Arrow A0). On the other hand, the refrigerant that has absorbed heat at the heat dissipation component 31 returns to the water tank 322 from the second pipe 321 (see...). Figure 1(Arrow A1). The heat of the returned refrigerant is removed by the cooler 323. Thus, the refrigerant becomes cooled and is sent again from the water tank 322 to the first piping 320 and the heat dissipation component 31, repeating the cycle. The cooler 323 is not particularly limited, and for example, a known cooling coil in which the refrigerant flows internally on the cooling unit side can be used.

[0082] The heat exchange unit 324 is a device that removes and discharges heat from the refrigerant flowing inside the cooler 323 on the cooling unit side while circulating the refrigerant on the cooling unit side. There are no particular limitations on the heat exchange unit 324; a known heat exchange circuit including a compressor, condenser, fan, and expansion valve that compresses the refrigerant on the cooling unit side to a high temperature can be used. The refrigerant on the cooling unit side circulates in the heat exchange circuit of the heat exchange unit 324, repeatedly absorbing heat from the refrigerant in the water tank 322 via the cooler 323 and dissipating heat itself. In this embodiment, the heat exchange unit 324 is air-cooled and configured to draw in and exhaust air using a fan.

[0083] [Control Department]

[0084] Figure 4 This is a block diagram showing the electrical structure of the control unit 4. The control unit 4 can be constructed from a general-purpose computer unit such as a microcontroller unit (MCU). The control unit 4 in this embodiment includes a CPU 40 (Central Processing Unit), RAM (Random Access Memory) 41, an I / O interface 42, ROM (Read Only Memory) 43, and a non-volatile and rewritable storage device 44. These elements are electrically connected to each other via a bus and can communicate with each other. A program 430 can be written to the ROM 43 via network communication, communication with other computers, or a non-volatile computer-readable medium. Thus, the control unit 4 of this embodiment can be manufactured. Alternatively, the program 430 can be written to the storage device 44 instead of the ROM 433.

[0085] The CPU 40 reads and executes the program 430, virtually functioning as the temperature receiving unit 400, current regulating unit 401, display control unit 402, and condition reading unit 403. The operation of each part 400-403 will be described later. The RAM 41 is appropriately used for the CPU 40's operations.

[0086] The storage device 44 is composed of a hard disk, an optical disk, or a flash memory. At least two different operating conditions predetermined for the cryotherapy device 1 are stored in the storage device 44. Operating conditions refer to conditions that, based on the state of the tissue being treated, pre-combine the target temperature of the probe 20 and the time during which the target temperature should be maintained in order to provide more appropriate and effective treatment. The time during which the target temperature should be maintained can also be described as the time during which the probe 20 at the target temperature should maintain contact between the action surface 200 and the skin surface. In this embodiment, for a first target temperature of -30°C or higher and -25°C or lower, a first time during which this temperature should be maintained is determined, and for a second target temperature of -4°C or higher and 0°C or lower, a second time during which this temperature should be maintained is determined. Hereinafter, the combination of the first target temperature and the first time will be referred to as the first operating condition, and the combination of the second target temperature and the second time will be referred to as the second operating condition. According to the inventors' research, the first time is preferably 1 minute, more preferably 15 seconds. Alternatively, the first time is preferably a predetermined time of less than 1 minute, more preferably a predetermined time of less than 15 seconds. Furthermore, the second time is preferably 5 minutes, more preferably 60 seconds. Alternatively, the second time is preferably a specified time of less than 5 minutes, and more preferably a specified time of less than 60 seconds.

[0087] I / O interface 42 functions as an interface for data input / output with temperature sensor 21, condition setting unit 5, display unit 8, and other computers via wired or wireless means. Condition setting unit 5 and display unit 8 are electrically connected to control unit 4, and in this embodiment, they are housed together in the same housing to form a control unit. Condition setting unit 5 and display unit 8 will be described below.

[0088] [Conditions Specifying Section]

[0089] The condition specification unit 5 is a part operated by the user to specify one of the at least two different operating conditions to the control unit 4. The structure of the condition specification unit 5 is not particularly limited and can be composed of buttons, a switch lever, a dial, a keypad, a touch panel, or a voice recognition module. The specification of operating conditions can be performed, for example, by inputting numbers or symbols assigned to the operating conditions selected via the condition specification unit 5; selecting the aforementioned numbers or symbols via the condition specification unit 5; or inputting a voice indicating the operating conditions to the condition specification unit 5. Furthermore, the condition specification unit 5 can also be configured not only to specify operating conditions but also to allow the user to input other instructions to the control unit 4.

[0090] [Display Department]

[0091] The display unit 8 can be composed of a liquid crystal display, an organic EL display, a plasma display, or a liquid crystal element, etc. In the case of a touch panel display, it can also function as a condition setting unit 5. The display unit 8 displays various information to the user of the cryotherapy device 1. The displayed information may include, for example, information on operating conditions specified by the user, or timer information indicating the elapsed first or second time. The operation of the display unit 8 is controlled by the display control unit 402 of the control unit 4.

[0092] Based on the instructions of the control unit 4, other components such as speakers that emit sound and voice to the user can be appropriately added to the control unit.

[0093] <1-2. Structure of the cryotherapy device according to the second embodiment>

[0094] Figure 5 This is a schematic diagram illustrating a structural example of the cryotherapy apparatus 1A according to the second embodiment. The cryotherapy apparatus 1A, like the cryotherapy apparatus 1, includes a head 2A, a cooling mechanism 3A connected to the head 2A, a control unit 4A, and a condition setting unit 5A. The main difference is the structure of the head 2A. Hereinafter, the cryotherapy apparatus 1A will be described primarily focusing on its structure, which differs from that of the cryotherapy apparatus 1. Descriptions of structures identical to those in the cryotherapy apparatus 1 will be omitted as appropriate.

[0095] [head]

[0096] Figure 6A This is a 3D view of the head (2A). Figure 6B This is a cross-sectional schematic diagram showing a structural example of the head 2A. The head 2A has a probe 20A, a temperature sensor 21A, a heat insulation member 22A, and a housing 23A. The housing 23A includes a main body 230A and a cover 231A, and is similarly made of, for example, a rigid resin. The rigid resin is preferably an engineering plastic with excellent heat resistance, such as POM (polyoxymethylene). The main body 230A has a front end portion 2300A forming an opening and a rear end portion 2301A connected to the sleeve member 26A. The sleeve member 26A will be described later. The main body 230A houses at least a portion of the probe 20A, the temperature sensor 21A, and the heat insulation member 22A, and houses at least a portion of a pair of cooling elements 30A and a pair of cooling sleeves 31A, which will be described later. Inside the main body 230A, a pair of cooling elements 30A are arranged to clamp the probe 20A, and a pair of cooling sleeves 31A are arranged to clamp the pair of cooling elements 30A from the outside. The heat insulation element 22A is disposed between a pair of cooling jackets 31A and the main body 230A.

[0097] The cover 231A is a component that can be externally mounted to the outer surface of the main body 230A. The cover 231A has a retaining groove 2310A for retaining the imaging device 25A, which will be described later. By fixing the cover 231A to the main body 230A with the retaining groove 2310A facing the main body 230A, the imaging device 25A can be fixed to the head 2A and used as a single unit.

[0098] Probe 20A, like probe 20, is a component integrally constructed of metal. Probe 20A differs from probe 20 in that it is generally plate-shaped. Specifically, probe 20A forms at least an active surface 200A and two opposing surfaces 201A and 202A that intersect the active surface 200A. Here, "intersecting" means that the normals of the surfaces intersect. In this embodiment, the opposing surfaces 201A and 202A are parallel to each other, forming the front and back sides of the generally plate-shaped probe 20A. Furthermore, either of the opposing surfaces 201A and 202A can be considered the front (or back). The opposing surfaces 201A and 202A are respectively opposite to the first surface 300A of the pair of cooling elements 30A described later. The first surface 300A is a surface capable of absorbing heat from the opposing surfaces 201A and 202A. Probe 20A preferably has a shape that narrows towards the front end. Thus, the working surface 200A can be formed to a size suitable for contact with ordinary nevus cells, and on the other hand, the two surfaces 201A and 202A can be formed to a size sufficient to be cooled by the cooling element 30A.

[0099] The working surface 200A is a flat, circular surface when viewed from the front end of the probe 20A, and is orthogonal to the opposite surfaces 201A and 202A. The periphery of the working surface 200A may also be spaced apart from the periphery of the opposite surfaces 201A and 202A. That is, the working surface 200A may also be configured to be continuous with the opposite surfaces 201A and 202A via other surfaces. The shape and size of the working surface 200A are described in the same way as those of the working surface 200. In this embodiment, the front end of the probe 20A, which includes the working surface 200A, protrudes outward from the top end 2300A of the main body 230A. A space 203A is formed inside the front end of the probe 20A. A temperature sensor 21A is built into the space 203A. The structure of the temperature sensor 21A is the same as that of the temperature sensor 21.

[0100] The heat insulation component 22A is a part used to prevent heat from being easily transferred from the pair of cooling jackets 31A to the main body 230A. The heat insulation component 22A can be configured arbitrarily as long as it hinders heat exchange between the pair of cooling jackets 31A and the main body 230A. Preferably, the heat insulation component 22A is arranged to surround the pair of cooling jackets 31A from the outside. The material constituting the heat insulation component 22A is not particularly limited, as long as it has a lower thermal conductivity than the material constituting the cooling jackets 31A and sufficient heat resistance; it can be any of mineral-based, resin-based, or naturally derived materials. From a processability point of view, resin-based foams such as rigid polyurethane foam, phenolic foam, polystyrene foam, and polyester foam are preferred.

[0101] The wire 6A and communication line 7A have the same structure as the wire 6 and communication line 7, respectively. In this embodiment, the wire 6A and communication line 7A extend into the sleeve 26A through a through hole (not shown) formed in the rear end portion 230A within the main body 230A. The sleeve 26A in this embodiment houses the wire 6 and communication line 7, and also houses the refrigerant pipes 311A ​​and 312A connected to a pair of cooling sleeves 31A. The refrigerant pipes 311A ​​and 312A will be described later. The sleeve 26A is not particularly limited, and for example, a known flexible tube such as a spiral tube or corrugated tube can be used. Furthermore, similar to the cryotherapy device 1, if the temperature sensor 21A can transmit an output signal wirelessly, the communication line 7A can be omitted.

[0102] Imaging device 25A is provided for the purpose of acquiring an image of a lesion cell containing at least nevus cells or its vicinity. As for imaging device 25A, it is not particularly limited as long as it can image the object; for example, it can be constructed from a general-purpose camera. Imaging device 25A can also be connected to a general-purpose display 9A. Thus, the user can view the image acquired by imaging device 25A in real time on display 9A.

[0103] [Cooling mechanism]

[0104] The cooling mechanism 3A includes a pair of cooling elements 30A, a pair of cooling jackets 31A, and a cooler 32A. The pair of cooling elements 30A cools the probe 20A, and also dissipates heat from the pair of cooling elements 30A. Each cooling element 30A can be a Peltier element forming a first surface 300A and a second surface 301A, similar to the cooling element 30. The control unit 4A applies a direct current to each cooling element 30A in such a way that the first surface 300A of each cooling element 30A is the heat-absorbing side and the second surface 301A is the heat-generating side.

[0105] A pair of cooling jackets 31A each have a generally plate-like appearance. Each cooling jacket 31A is configured to face the second surface 301A, and each cooling element 30A is sandwiched between the surface 201A and the probe 20A and between the probe 20A and the surface 202A. A flow path 310A is formed inside each cooling jacket 31A, in which refrigerant capable of absorbing heat from the second surface 301A circulates. In this embodiment, an inlet (not shown) for allowing refrigerant to flow into the flow path 310A and an outlet (not shown) for allowing refrigerant to flow out of the flow path 310A are formed on the rear end side of each cooling jacket 31A. The flow path 310A can, for example, be formed to extend from the inlet to the front end of the cooling jacket 31A, make a U-shaped bend at the front end, and extend to the outlet. The inlet of each cooling jacket 31A is connected to the first piping 320A via two refrigerant pipes 311A ​​branching upstream of the inlet. Furthermore, the outlet of each cooling jacket 31A is connected to the second piping 321A via two refrigerant pipes 312A that branch off downstream of the inlet. The pair of cooling jackets 31A in this embodiment are made of aluminum, but are not limited to this. The other structures of each cooling jacket 31A and the refrigerant are the same as those of the heat dissipation component 31 and the refrigerant in the first embodiment.

[0106] A pair of cooling jackets 31A, refrigerant pipes 311A ​​and 312A, a first piping 320A, a second piping 321A, and a cooler 32A form a refrigerant circulation path for dissipating heat from a pair of cooling elements 30A. The first piping 320A, the second piping 321A, and the cooler 32A each have a structure shared with the first piping 320, the second piping 321, and the cooler 32.

[0107] [Control Department, etc.]

[0108] The control unit 4A and the condition specifying unit 5A each have a structure shared with the control unit 4 and the condition specifying unit 5, respectively. Furthermore, the display unit 8A is electrically connected to the control unit 4A and together with the control unit 4 and the condition specifying unit 5, constitutes a control unit. The structure of the control unit can be shared with the control unit of the first embodiment. Additionally, the display unit 8A can have a structure shared with the display unit 8, or it can be configured to also function as a display 9A.

[0109] <2. Operation of the cryotherapy device>

[0110] Figure 7 This is a flowchart illustrating an example of the operation of cryotherapy devices 1 and 1A. Figure 7 The operation shown is performed, for example, when the power supply to cryotherapy devices 1 and 1A is turned on and the refrigerant in the refrigerant circulation path is sufficiently cooled. The operation of cryotherapy device 1 will be described below as an example, but the same explanation can be used for the operation of cryotherapy device 1A.

[0111] First, the temperature receiving unit 400 sequentially receives the time-series output signals sent from the temperature sensor 21 (step S1). The temperature receiving unit 400 converts the received output signals into temperature data as needed and temporarily stores them in the RAM 41 or in the storage device 44.

[0112] Next, the control unit 4 receives the operating condition designation from the user (step S2). After selecting either the first or the second operating condition, the user can operate the condition designation unit 5 to designate the selected operating condition to the control unit 4.

[0113] Next, the condition reading unit 403 reads the operating condition information (target temperature and time) from the storage device 44 according to the accepted operating condition specification (step S3). In addition to step S3, the display control unit 402 may also cause the display unit 8 to display the specified operating conditions and send a message to the user to confirm whether the operating conditions are appropriate. In this case, the cryotherapy device 1 may also be configured to determine the operating conditions displayed by the display unit 8 by using the user operation condition specification unit 5, or to accept the re-specification of operating conditions.

[0114] When the operating conditions are determined in step S3, feedback control of the DC current flowing through the cooling element 30 is initiated via the current regulating unit 401 and the temperature receiving unit 400 (step S4). Specifically, the current regulating unit 401 adjusts the magnitude of the DC current flowing through the cooling element 30 based on the latest output data of the temperature sensor 21 received by the temperature receiving unit 400, so as to maintain the probe 20 at the target temperature determined by the currently specified operating conditions.

[0115] When the temperature control accuracy based on the feedback control in step S4 stabilizes within a certain range, the next step S5 is executed. In step S5, the display control unit 402 causes the display unit 8 to display a message urging the user to issue a start instruction.

[0116] Upon confirming the message, the user operation condition specification unit 5 instructs the control unit 4 to begin the treatment. Simultaneously, the user holds the head 2, bringing the action surface 200 into contact with or close to the surface of the skin being treated. The control unit 4 then receives the instruction to begin the treatment and begins counting the time determined by the currently specified operating conditions (step S6).

[0117] When the time determined by the currently specified operating conditions has elapsed, step S7 is executed. In step S7, the current regulating unit 401 terminates the feedback control that began in step S4, stopping the flow of direct current in the cooling element 30. Additionally, the display control unit 402 causes the display unit 8 to display a message notifying that the time determined by the operating conditions has ended. Alternatively, or instead of this display, the control unit 4 may be configured to emit a sound or voice notification of the end of the aforementioned time via a speaker (not shown).

[0118] <3. Characteristics>

[0119] The cryotherapy devices 1 and 1A described above are configured, based on the inventors' insights, to freeze skin cells using probes 20 and 20A maintained at a target temperature above -30°C and below 0°C, selectively inducing nevus cell apoptosis. In this way, cryotherapy devices 1 and 1A are based on mechanisms different from surgical excision, laser ablation, electrosurgical excision, and cryotherapy based on cryoliquefied gases, which cause necrosis in both nevus cells and normal cells. According to cryotherapy device 1, damage to normal cells is suppressed, thus reducing the likelihood of scarring, scar contracture, and inflammation after nevus cell removal, enabling procedures that further consider cosmetic aspects.

[0120] In the cryotherapy devices 1 and 1A described above, the metal probes 20 and 20A are cooled by Peltier elements. Therefore, miniaturization of the heads 2 and 2A is possible, improving user operability. Furthermore, temperature control of probes 20 and 20A can be performed with high precision. Moreover, the need for high-voltage and high-pressure gas eliminates the burden of equipment management.

[0121] In the cryotherapy apparatuses 1 and 1A of the above embodiments, the combination of the target temperature of probes 20 and 20A and the time for which the target temperature should be maintained is predetermined as at least two operating conditions. Therefore, appropriate treatment can be provided according to the condition of the diseased cells.

[0122] Furthermore, in the cryotherapy devices 1 and 1A of the above embodiments, the aforementioned control based on the control units 4 and 4A can be executed according to the operating conditions specified by the user. This prevents situations where the user mistakenly believes the target temperature of probes 20 and 20A should be maintained for an appropriate duration, thus preventing proper treatment from being performed.

[0123] In the cryotherapy apparatus 1 of the above embodiment, the working surface 200 is surrounded by the surface 220 of the heat insulation portion 22. This allows for more reliable protection of normal cells surrounding the tissue in contact with the working surface 200. Furthermore, because the surface 220 is configured to be coplanar with the working surface 200, the provision of the heat insulation portion 22 does not hinder the operation of bringing the working surface 200 into contact with the skin.

[0124] The cryotherapy apparatus 1A of the above embodiment is configured such that, in the probe 20A, instead of cooling the surface parallel to the action surface by a cooling element, a pair of cooling elements 30A cools the two opposing surfaces 201A and 202A that intersect the action surface 200A. This reduces constraints on the formation of the action surface 200A, making it easier to reduce its area. Furthermore, it allows the relatively larger surface of the probe 20A to face the heat-absorbing surface of the cooling element 30A. Therefore, the probe 20A can be cooled via two relatively large surfaces, thus further improving cooling efficiency.

[0125] In the cryotherapy apparatus 1A of the above embodiment, a pair of cooling elements 30A are sandwiched between a pair of generally plate-shaped cooling sleeves 31A with the probe 20A as the center. This further improves the cooling efficiency of the pair of cooling elements 30A. Furthermore, in the head 2A, the probe 20A, the pair of cooling elements 30A, and the pair of cooling sleeves 31A, each having a generally plate-shaped appearance, are stacked together. This allows for a more compact overall size of the head 2A.

[0126] In the cryotherapy apparatus 1A of the above embodiment, the condition of the treated skin can be confirmed on the display 9A using the imaging device 25A as needed. This improves the operability of the head 2A.

[0127] <4. Variations>

[0128] The present invention has been described above as one embodiment, but the present invention is not limited to the above embodiment, and various modifications can be made without departing from its spirit. For example, the following modifications can be made. In addition, the spirit of the following variations can be appropriately combined.

[0129] (1) In the above embodiment, the target temperature for the operating conditions stored in the storage device 44 is listed as a first target temperature of -30°C or higher and -25°C or lower, and a second target temperature of -4°C or higher and 0°C or lower. However, the range of target temperatures is not limited to these and can be appropriately changed. Furthermore, even if the target temperature of probes 20 and 20A is a specified temperature of -25°C or higher and -4°C or lower, it can still exert the same effect as the first and second target temperatures in selectively inducing lesions containing nevus cells to apoptosis. That is, the target temperature of probe 20 can be any target temperature of -30°C or higher and 0°C or lower. The time to maintain the target temperature can be appropriately determined according to the target temperature. That is, there can be more than three operating conditions stored in the storage device 44 in advance, and there can also be different operating conditions for maintaining the same target temperature for different times. In addition, the cryotherapy devices 1 and 1A can also be configured such that, without specifically determining the above operating conditions, the user specifies at least one of an appropriate target temperature and the time to maintain the target temperature to the control units 4 and 4A.

[0130] (2) At least one of the temperature sensor 21 and the heat insulation part 22 may be omitted. Similarly, the illumination 24 is not necessary and may be omitted, or its placement and quantity may be changed. In addition, the surface 220 of the heat insulation part 22 may not be coplanar (flush) with the working surface 200. For example, the heat insulation part 222 may protrude from the working surface 200 toward the skin surface, so that when the surface 220 contacts the skin surface, the working surface 200 is close to the skin surface at a certain distance from the skin surface. In addition, at least one of the condition setting part 5, the display part 8, and the storage device 44 may be omitted, or may be configured separately from the housing of the storage control part 4. The same applies to the condition setting part 5A, the display part 8A, and the control part 4A. In addition, the housing 23 may have the same components as the housing 23A that can fix the imaging device 25A.

[0131] (3) The cooling mechanism 3 may also have two or more Peltier elements as cooling elements 30. In addition to Peltier elements, other cooling elements such as heat exchange elements that generate thermionic emission cooling when current flows through them may also be used in the cooling elements 30 and 30A.

[0132] (4) The structures of cooling mechanisms 3 and 3A are only required to control the temperature of probes 20 and 20A, and are not limited to the structures described in the above embodiments. They can be modified appropriately. For example, at least one of the cooling elements 30 and 30A, the heat dissipation component 31 and the cooling sleeve 31A, and the coolers 32 and 32A can be omitted or replaced with other structures. For example, probes 20 and 20A can also be cooled by cryogenic liquefied gas, etc. In addition, coolers 32 and 32A can also be water-cooled. Furthermore, the cooling sleeve 31A can also be configured as a single cooling sleeve 31A that cools a pair of cooling elements 30A together, rather than a pair of cooling sleeves 31A.

[0133] (5) The probe 20 and the action surface 200, as well as the probe 20A and the action surface 200A, may also be made of materials other than metal. In addition, the probe 20 itself may be made of a cooling element. Furthermore, the action surface 200 and the action surface 200A are not limited to direct contact with the surface of the skin that is the object of treatment, but may also be configured to be close to the surface of the skin or to be in indirect contact via other substances.

[0134] (6) At least one of the temperature sensor 21A, heat insulation member 22A, cover 231A and imaging device 25A may be omitted. In addition, the imaging device 25A is not limited to a camera, but may be an imaging device such as an ultrasonic echo device.

[0135] (7) The structure of probe 20A is not limited to the above-described embodiment. For example, it can be as follows: Figures 8A-8D The shape of the working surface 200A of the probe 20A and its surrounding area is changed as shown. Figure 8A Is Figure 6A The example shown is a probe 20A with a generally cylindrical cylindrical portion 204A at its front end. In this example, the circular flat surface of the front end of the cylindrical portion 204A forms an action surface 200A orthogonal to two opposing surfaces 201A and 202A. Figure 8B Is Figure 6A The example shown has a probe 20A with a generally truncated cylindrical portion 205A at its front end. In this example, the front surface of the cylindrical portion 205A constitutes the working surface 200A. The working surface 200A is inclined relative to the central axis of the cylindrical portion 205A. According to... Figure 8A and Figure 8B The structure makes it easier for the action surface 200A to get closer to or contact the skin tissue. Figure 8C It is Figure 8A An example where the front end face of the cylindrical portion 204A is formed as part of a sphere. In this example, the surface other than the periphery of the part of the sphere (the boundary between the part of the sphere and the cylindrical portion) constitutes the working surface 200A. According to... Figure 8CIn addition to making the action surface 200A more accessible to or in contact with the skin tissue, the structure of this example can further reduce the risk of the action surface 200A physically damaging the skin tissue. Figure 8D An example is formed with an extension portion 206A, which extends from... Figure 8A The front end face of the cylindrical portion 204A extends obliquely relative to the central axis of the cylindrical portion 204A, forming a flat surface at the front end. The flat surface of the extension portion 206A forms the working surface 200A. The extension portion 206A can be arbitrarily configured as long as its projected shape when viewed from the central axis direction of the cylindrical portion 204A is different from the projected shape of the cylindrical portion 204A, and the working surface 200A intersects with one pair of opposite faces 201A and 202A. Figure 8D In this structural example, the design freedom of the working surface 200A is further increased, and the field of view is less likely to be obstructed by the probe 20A when it is brought close to or in contact with the skin surface. Furthermore, in Figures 8A-8D In the structural example shown, the cylindrical portion 204A or 205A can also be changed to a generally prismatic shape, a generally oblique cylindrical shape, a generally oblique prismatic shape, a generally frustum-shaped shape, or a generally frustum-shaped shape. In addition, the probe 20A can be integrally formed or composed of two or more parts.

[0136] Example

[0137] The following describes the experiments conducted by the inventors and their results. However, the present invention is not limited thereto.

[0138] <Experiment>

[0139] Multiple skin tissue samples were collected and placed on a hot plate heated to approximately 35°C. The cells in these skin tissues were observed in two scenarios: one where no action was taken (Comparative Example), and another where the working surface of a metal probe was in direct contact with the skin tissue surface and the cooling treatment described above was performed (Example Example). Specifically, after cooling the skin tissues of the Example Example, the skin tissues of both the Example and Comparative Example were cultured together for 12 hours, followed by fixation with formalin. The fixed skin tissues were stained with DAPI, a DNA-binding fluorescent dye, and the fluorescent dye was confirmed using a fluorescence microscope, thereby identifying the cells contained in the skin tissue (1). Additionally, the skin tissues were stained with MART-1, used in immunostaining of melanoma and nevus cells, and the nevus cells contained in the skin tissue were confirmed using a fluorescence microscope (2). However, in Example 3, the skin tissues were stained with α-SMA, which selectively stains vascular smooth muscle, and cells constituting blood vessels, rather than the nevus cells contained in the skin tissue, were identified (2′). Furthermore, following the TUNEL method, skin tissue was stained using a marker that binds to DNA fragmented due to apoptosis, and fluorescence microscopy was used to confirm whether apoptosis had occurred in the cells of the skin tissue (3). In the following figures, the microscopic photographs obtained by taking pictures of each marker using fluorescence microscopy are designated as (1) to (3), and the photograph formed by overlapping the photographs of (1) to (3) is designated as (4). Among them, the photographs of (1) to (4) are obtained by taking cross-sections of the skin tissue, with the epidermal side at the top.

[0140] The cooling process is carried out under the following 7 conditions. Figure 9A This is a side view of the probe used in Examples 1-6. (Example) Figure 9A As shown, the probe has a circular working surface with a diameter of 5 mm, and a side peripheral surface extending from the periphery of the working surface. The side peripheral surface is formed as an R-surface with a radius of 20 mm in the side view. Furthermore, experiments conducted by the inventors have confirmed that, as in... Figure 9B The diagram shows a case where a roughly frustum-shaped probe is used, formed such that its lateral circumferential surface is straight in the side view, and a case where a probe is used... Figure 9A In the case of the probe shown, no significant difference was observed in the temperature change of the dermis over time. In Example 7, using the probe as described... Figure 6A and 6B The probe (head) is shown. The probe has a circular working surface with a diameter of 5 mm. The temperature of the probe is detected by a temperature sensor located inside the probe, and it matches the temperature of the working surface. As the temperature sensor, any one of a Pt100 platinum resistance thermometer, a K thermocouple, or a T thermocouple is used. Figure 9A In the probe shown, the temperature sensor is positioned 7 mm from the working surface.

[0141] Example 1: Probe temperature -25℃, contact time with skin tissue 15 seconds

[0142] Example 2: Hair follicles are present in the skin tissue; the probe temperature is -25°C; and the contact time with the skin tissue is 15 seconds.

[0143] Example 3: The skin tissue contains blood vessels; the probe temperature is -25°C; the contact time with the skin tissue is 15 seconds.

[0144] Example 4: Probe temperature -4℃ to -2℃, contact time with skin tissue 60 seconds

[0145] Example 5: Hair follicles are present in the skin tissue; the temperature of the probe is -4℃ to -2℃; and the contact time with the skin tissue is 60 seconds.

[0146] Example 6: Skin tissue contains skin appendages (sebaceous glands); the probe temperature is -4℃ to -2℃; the contact time with the skin tissue is 60 seconds.

[0147] Example 7: The probe temperature was -25°C and the contact time with the skin tissue was 10 seconds.

[0148] <Results>

[0149] Microscopic photographs of the skin tissues from Examples 1-7 and the comparative examples are shown below. Figures 10-16 .exist Figure 10 In comparison between the comparative example and Example 1 (3), almost no labeled fluorescence could be detected in the comparative example, while labeled fluorescence was detected over a wide range in Example 1. The range of fluorescence detected largely overlaps with the range of nevus cells shown in (2). This result confirms that the nevus cells were induced to apoptosis by the cooling treatment described in the above embodiment.

[0150] Figure 11 The dashed lines in (1) to (4) represent hair follicles present in the skin tissue. Figure 11 It can be seen that the cells in the hair follicles were preserved with almost no apoptosis. Based on this result, it can be confirmed that in the cooling treatment of the above embodiment, nevus cells were induced to apoptosis, while damage to hair follicle keratinocytes, which are normal cells, was significantly suppressed. Thus, it can be confirmed that in the cooling treatment of the above embodiment, nevus cell apoptosis can be selectively induced without affecting the hair follicles.

[0151] Figure 12 Images (1) to (4) are magnified versions of the rectangular frames enclosed in the upper images from the lower images. The white dashed lines in the lower images (1) to (4) represent the constituent cells within the blood vessels. Figure 12It is evident that the constituent cells within the blood vessels were preserved with minimal apoptosis. Based on this result, it can be confirmed that the cooling treatment described in the above embodiment has almost no effect on the blood vessels. Therefore, it can be confirmed that the cooling treatment described in the above embodiment can selectively induce nevus cell apoptosis without affecting the blood vessels.

[0152] Depend on Figure 13 It was confirmed that apoptosis was induced within the presence of nevus cells. This result confirms that even at relatively high probe temperatures of -4°C to -2°C, apoptosis of nevus cells can be induced by adjusting the contact time.

[0153] Figure 14 Photos (1) to (4) are photographs of the skin tissue near the hair follicles. Figure 14 It can be seen that the cells in the hair follicles were preserved with almost no apoptosis. This result confirms that even at relatively high probe temperatures of -4℃ to -2℃, apoptosis is selectively induced in nevus cells, while significantly inhibiting damage to normal hair follicle keratinocytes.

[0154] Figure 15 The areas enclosed by the white dashed lines in (1) to (4) represent sebaceous glands present in the skin tissue. Figure 15 It can be seen that the constituent cells of the sebaceous glands were preserved with almost no apoptosis. This result confirms that, in the cooling treatment of the above embodiment, apoptosis of nevus cells was selectively induced, while damage to skin appendages, which are normal cells, was significantly suppressed.

[0155] Figure 16 In the images, apoptosis was induced in the areas where nevus cells were identified. In particular, a large amount of fluorescence was identified in the lower region of the image (3), thus confirming that apoptosis was induced in deeper nevus cells.

[0156] Furthermore, the results of Examples 1-7 confirmed that apoptosis could also be induced to some extent in keratinocytes (epidermal keratinocytes), but the damage to such normal cells was limited to the epidermal level, and the possibility of scarring was sufficiently low.

[0157] Explanation of reference numerals in the attached figures

[0158] 1.1A Cryotherapy Device

[0159] 2.2A Head

[0160] 3. 3A cooling mechanism

[0161] 4. 4A Control Unit

[0162] 5. 5A Conditions Designated Department

[0163] 20, 20A probe

[0164] 21, 21A temperature sensor

[0165] 22 Insulation Section

[0166] 22A thermal insulation components

[0167] 30, 30A cooling elements

[0168] 31 Heat dissipation components

[0169] 31A Cooling Jacket

[0170] 220 sides.

Claims

1. A cryotherapy device, characterized by, comprises: a head portion having a probe that forms an action surface for coming close to or contacting a surface of skin as a treatment target; a cooling mechanism that cools the probe; and a control portion that controls the cooling mechanism so as to maintain the probe at a target temperature of 0°C or lower, the probe being configured to selectively induce apoptosis of lesion cells including nevus cells by freezing tissue of the skin via the action surface.

2. The cryotherapy apparatus according to claim 1, wherein: the probe further forms a pair of surfaces that intersect the action surface, the cooling mechanism has a pair of cooling elements that are capable of cooling the probe, the pair of cooling elements each form a first surface that is capable of absorbing heat from the pair of surfaces.

3. The cryotherapy apparatus according to claim 2, wherein: the pair of cooling elements each further form a second surface that is capable of releasing heat absorbed from the first surface, the cooling mechanism further has a cooling jacket in which a refrigerant that is capable of absorbing heat from the second surface circulates.

4. The cryotherapy apparatus according to claim 3, wherein: the head portion further has: a housing that houses at least a portion of each of the probe, the pair of cooling elements, and the cooling jacket; and a thermal insulator disposed between the housing and the cooling jacket.

5. The cryotherapy apparatus according to claim 1, wherein: the head portion further has an imaging device that is capable of acquiring an image of lesion cells including the nevus cells or a vicinity thereof.

6. The cryotherapy apparatus according to any one of claims 1 to 5, wherein: the control portion controls the cooling mechanism so as to maintain the probe at a target temperature of -30°C or higher.

7. The cryotherapy apparatus according to claim 1 or 2, wherein: the control portion controls the cooling mechanism so as to maintain the probe at a first target temperature of -30°C or higher and -25°C or lower.

8. The cryotherapy apparatus according to claim 7, wherein: the control portion controls the cooling mechanism so that a time period during which the probe is maintained at the first target temperature is equal to or shorter than a first time period.

9. The cryotherapy apparatus according to claim 1 or 2, wherein: the control portion controls the cooling mechanism so as to maintain the probe at a second target temperature of -4°C or higher and 0°C or lower.

10. The cryotherapy apparatus according to claim 9, wherein: the control portion controls the cooling mechanism so that a time period during which the probe is maintained at the second target temperature is equal to or shorter than a second time period.

11. The cryotherapy apparatus according to any one of claims 1 to 5, wherein: the head portion includes a temperature sensor that detects a temperature of the probe, the control portion performs feedback control of the temperature of the probe based on an output signal of the temperature sensor.

12. The cryotherapy apparatus according to claim 1, wherein: the cooling mechanism has a cooling element that cools the probe and a cooler that cools the cooling element, The probe, the cooling element, and the cooler are connected in this order with the working surface as a reference.

13. The cryotherapy device according to any one of claims 1 to 5, characterized in that: The control section controls the cooling mechanism according to at least two different operation conditions in which a target temperature of the probe and a time for which the target temperature is to be maintained are combined in advance, The cryotherapy device further includes a condition setting section for allowing a user to specify one of the at least two different operation conditions.

Images