WO2020183928A1 - Device for applying electrical stimulation and method for applying electrical stimulation - Google Patents

Device for applying electrical stimulation and method for applying electrical stimulation Download PDF

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Publication number
WO2020183928A1
WO2020183928A1 PCT/JP2020/002361 JP2020002361W WO2020183928A1 WO 2020183928 A1 WO2020183928 A1 WO 2020183928A1 JP 2020002361 W JP2020002361 W JP 2020002361W WO 2020183928 A1 WO2020183928 A1 WO 2020183928A1
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WO
WIPO (PCT)
Prior art keywords
output
electrical stimulation
electrical
intensity
control unit
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Application number
PCT/JP2020/002361
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French (fr)
Japanese (ja)
Inventor
直樹 豊島
矢口 喜明
栄次 有田
Original Assignee
テルモ株式会社
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Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2021505561A priority Critical patent/JPWO2020183928A1/ja
Publication of WO2020183928A1 publication Critical patent/WO2020183928A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/08Warming pads, pans or mats; Hot-water bottles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Definitions

  • the present disclosure relates to an electrical stimulation application device and an electrical stimulation application method.
  • Patent Documents 1 and 2 by applying a weak current as an electrical stimulus and heat to a living body or a living body tissue, a neurodegenerative disease, a cancer disease, xeroderma pigmentosum, and systemic A device for treating diseases such as autoimmune diseases and organ-specific autoimmune diseases is disclosed.
  • the above-mentioned device is used by being attached to, for example, a living body during treatment.
  • the device executes a treatment process, for example, in a state of being attached to the abdomen corresponding to a part of a user who is a living body.
  • the user is wearing, for example, clothing while being treated with the device, in which case the device attached to the abdomen is covered with clothing. Therefore, for example, the user may not notice even if the device outputs a sound by a buzzer or emits a light by an LED (light emitting diode: Light Emitting Diode) in order to notify the user of information. ..
  • LED light emitting diode: Light Emitting Diode
  • An object of the present disclosure is to provide an electrical stimulus application device and an electrical stimulus application method capable of more reliably notifying a user of information regarding a device that applies weak electrical stimulation and heat to a living body or a living tissue.
  • the electric stimulus applying device as the first aspect of the present disclosure is an electric stimulus applying device that applies a weak electric stimulus to a living body or a living tissue, and has an input unit that receives an operation input from a user and the electric stimulus.
  • the control unit includes a control unit that controls the output, and the control unit can change the output intensity of the electrical stimulation, and the output of the electrical stimulation that is output when the first operation input to the input unit is detected.
  • the electrical stimulus that is output when the electrical stimulus is applied to the living body or tissue at a predetermined output intensity lower than the intensity and a second operation input to the input unit is detected at a predetermined timing.
  • the electrical stimulus is applied to the living body or the living body tissue with a notification intensity higher than the output intensity of.
  • control unit when the control unit outputs the electric stimulus while gradually increasing the output intensity of the electric stimulus and gradually increases the output intensity of the electric stimulus.
  • a predetermined output intensity higher than the output intensity of the electrical stimulus output when the second operation input is detected is set as the notification intensity.
  • the electrical stimulation application device as one embodiment of the present disclosure further includes a heater for heating the living body or the living tissue, and the control unit detects the second operation input to the input unit, and then the second operation input is detected.
  • the living body or living tissue is heated by a heater, and when the heater reaches a predetermined temperature or higher, the electrical stimulation is applied to the living body or living tissue at the predetermined output intensity.
  • control unit has a coefficient of 1 or more with respect to the output intensity of the electrical stimulation output when the second operation input to the input unit is detected.
  • the output intensity multiplied by a large coefficient is set as the notification intensity.
  • the control unit when the control unit outputs the electric stimulus while gradually reducing the output intensity of the electric stimulus and gradually reduces the output intensity of the electric stimulus.
  • the electrical stimulus is applied to the living body or tissue at a predetermined output intensity lower than the output intensity of the electrical stimulus output when the first operation input to the input unit is detected.
  • the predetermined output intensity is relative to the output intensity of the electrical stimulation output when the first operation input to the input unit is detected.
  • the output intensity multiplied by a coefficient less than 1.
  • the electric stimulus application device when the control unit detects a second operation input to the input unit while gradually increasing the output intensity of the electric stimulus, the electric stimulus is said to be electric.
  • the electrical stimulus is applied while gradually decreasing the output intensity of the electrical stimulus from the output intensity of the electrical stimulus output when the second operation input to the input unit is detected while the output intensity of the stimulus is gradually increased. Output.
  • the predetermined timing is the continuous electrical stimulation by the predetermined output intensity before the application of the continuous electrical stimulation by the predetermined output intensity. It includes at least one of the following after the application is performed and when an abnormality occurs in the electrical stimulation application device.
  • control unit changes the output pattern of the electrical stimulation applied to the living body or the biological tissue at the predetermined timing according to the type of notification.
  • the method of applying an electrical stimulus as a second aspect of the present disclosure is a method of applying an electrical stimulus by an electrical stimulus applying device, which is provided with an input unit that receives an operation input from a user and can output a weak electrical stimulus.
  • an electrical stimulus application device and an electrical stimulus application method capable of more reliably notifying a user of information regarding a device that applies weak electrical stimulation and heat to a living body or a living tissue.
  • FIG. 1 is a schematic external perspective view of the electrical stimulus applying device 1 according to the embodiment.
  • the electrical stimulus application device 1 applies a weak electrical stimulus to a living body or a living tissue (hereinafter, also simply referred to as “living body or the like”).
  • the disease is treated by applying a weak electrical stimulus.
  • Weak electrical stimulation is a level of electrical stimulation that does not cause depolarization of the living body. Since a level of electrical stimulation that does not induce depolarization does not cause muscle contraction or a feeling of stimulation to the living body, the user (patient) cannot sense the electrical stimulation to be applied.
  • the electrical stimulation is applied to a living body or the like as, for example, a pulsed direct current.
  • the pulsed direct current is applied at a frequency of, for example, 55 Hz.
  • the pulse width of the pulsed direct current is, for example, 100 ⁇ sec.
  • the electrical stimulation is not limited to this, and an appropriate electrical stimulation effective in treating a disease may be used.
  • the frequency of the pulsed direct current may be other than 55 Hz
  • the pulse width of the pulsed direct current may be other than 100 ⁇ sec.
  • the electrical stimulus application device 1 further heats the living body and the like. That is, the electrical stimulation application device 1 applies heat to a living body or the like. Therefore, the electric stimulus application device 1 can apply the electric stimulus and the heat to a living body or the like in combination. In this case, the disease is treated by applying a weak electric stimulus and heat.
  • the heat is several degrees higher than the normal temperature of the living body.
  • the heat may be a temperature of 38 ° C. or higher and 45 ° C. or lower, which is several degrees higher than the normal body temperature of the human body.
  • the treatment by the electric stimulus applying device 1 is performed in a state where the electric stimulating applying device 1 is attached to at least a part of a living body or the like.
  • the electrical stimulation application device 1 is attached to a living body or the like via a sticky sheet material.
  • a user (patient) of the electric stimulus applying device 1 can start treatment with the electric stimulus applying device 1 for the electric stimulus applying device 1.
  • treatment is performed by applying electrical stimulation and heat.
  • the electrical stimulation application device 1 sets the intensity of the weak electrical stimulation applied to the living body or the like before starting the actual treatment. Further, the electric stimulus applying device 1 sets the output intensity of the electric stimulus applied to the living body or the like at a predetermined timing before starting the actual treatment.
  • the output intensity of the electrical stimulus applied to the living body or the like by the electrical stimulus applying device 1 at a predetermined timing is hereinafter also referred to as “notification intensity” in the present specification.
  • the notification intensity is the output intensity that can be perceived by the user.
  • the step of setting the output intensity of electrical stimulation which is performed before starting the treatment, is also simply referred to as "setting step” below.
  • the stage of actually performing treatment is also simply referred to as “therapeutic stage” below. Therefore, when the user of the electric stimulus applying device 1 performs a predetermined operation input for starting the treatment by the electric stimulus applying device 1 to the electric stimulus applying device 1, the electric stimulus applying device 1 sets the setting stage. By performing, the intensity of electrical stimulation at the treatment stage is set, and then by performing the treatment stage, the user is treated.
  • the electrical stimulation application device 1 is configured by combining the main body portion 10 and the application portion 20.
  • the main body 10 is configured as a housing.
  • the application unit 20 is formed in a flat plate shape.
  • the main body portion 10 is coupled to the application portion 20 on one surface of the flat plate-shaped application portion 20.
  • the surface to which the main body portion 10 is bonded is referred to as a surface.
  • the surface opposite to the front surface to which the main body portion 10 is not bonded is referred to as a back surface.
  • the main body 10 configured as a housing has various functional parts inside for controlling the operation of the electrical stimulus applying device 1. Further, the main body unit 10 is provided with an input unit that receives an operation input from the user. In the example shown in FIG. 1, the main body unit 10 includes a first input unit 101a, a second input unit 101b, and a third input unit 101c as input units.
  • the first input unit 101a, the second input unit 101b, and the third input unit 101c may all be configured as operation buttons (operation keys) that can be pressed, as shown in FIG. 1, for example.
  • the form of the first input unit 101a, the second input unit 101b, and the third input unit 101c is not limited to the operation buttons that can be pressed.
  • the number of input units included in the main body unit 10 is not limited to three.
  • the arrangement of the first input unit 101a, the second input unit 101b, and the third input unit 101c is not limited to the arrangement shown in FIG.
  • the first input unit 101a, the second input unit 101b, and the third input unit 101c are operation buttons that execute different functions.
  • the first input unit 101a is an operation button for switching the power on / off of the electric stimulus applying device 1.
  • the second input unit 101b is an operation button for starting the treatment by the electrical stimulation application device 1.
  • the third input unit 101c is an operation button for the user to input whether or not the electric stimulus is detected. The sensing of electrical stimulation will be described later.
  • the back surface of the application unit 20 is attached to a living body or the like via a sticky sheet material.
  • the application unit 20 includes an electrode unit that outputs an electrical stimulus and a heater that generates heat.
  • the application unit 20 applies electrical stimulation and heat to the living body or the like with the back surface attached to the living body or the like.
  • FIG. 2 is an external perspective view of the electrical stimulation application device 1 of FIG. 1 when viewed from the back surface side.
  • the application unit 20 includes two electrodes, a first electrode 102a and a second electrode 102b, as an electrode unit.
  • the first electrode 102a and the second electrode 102b are exposed to the outside on the back surface side.
  • the electrode unit outputs an electrical stimulus by, for example, grounding one of the first electrode 102a and the second electrode 102b and changing the voltage of the other electrode.
  • the application unit 20 is provided with a heater inside. That is, the application unit 20 includes a heater between the front surface and the back surface. By heating the heater, the heat is transmitted to the living body or the like with the back surface attached to the living body or the like, and the living body or the like is warmed.
  • FIG. 3 is an external perspective view showing a schematic configuration of a sheet material 30 used when the electrical stimulus applying device 1 is attached to a living body or the like.
  • the sheet material 30 includes a frame portion 31 and two conductive gels 32.
  • the frame portion 31 is made of a non-conductive material such as resin.
  • the outer shape of the frame portion 31 is formed to be substantially the same size as the outer shape of the application portion 20.
  • the frame portion 31 has two openings (through holes) for arranging the two conductive gels 32. The two openings are formed at positions corresponding to the positions where the first electrode 102a and the second electrode 102b are arranged when the sheet material 30 is attached to the back surface side of the application portion 20.
  • the two conductive gels 32 are arranged in the two openings of the frame portion 31.
  • the space between the two conductive gels 32 is insulated by a non-conductive frame portion 31. Since the conductive gel 32 has adhesiveness, the electrical stimulus applying device 1 can be attached to a living body or the like.
  • the two conductive gels 32 are in one-to-one contact with the first electrode 102a and the second electrode 102b, respectively.
  • the electric stimulus applying device 1 is attached to the living body or the like by the sheet material 30, and the electric stimulus is output from the electrode portion, the electric stimulus is applied to the living body or the like via the two conductive gels 32. It is applied.
  • the user replaces and uses the sheet material 30 on a regular or irregular basis. That is, the user regularly or irregularly uses the new sheet material 30 to attach the electrical stimulus application device 1 to a living body or the like. As a result, it is possible to prevent the properties of the conductive gel 32 of the sheet material 30 from changing and the conductivity from deteriorating. Further, by using the new sheet material 30, it is possible to prevent the electrical stimulation application device 1 from being peeled off from the living body or the like due to deterioration of the adhesiveness.
  • two electrodes are arranged in one constituent device called the application unit 20.
  • the first electrode 102a and the second electrode 102b may be arranged separately in different constituent devices, for example.
  • the two electrodes are attached to a living body or the like as compared with the case where the two electrodes are arranged separately in different constituent devices. Since the number of constituent devices to be used can be reduced, the convenience of the user is improved.
  • FIG. 4 is a functional block diagram showing a schematic configuration of the electrical stimulation application device 1 of FIG.
  • the electrical stimulation application device 1 includes an input unit 101, an electrode unit 102, a control unit 103, a display unit 104, a timer unit 105, a storage unit 106, a power supply unit 107, and a heater. It includes 108, a temperature measuring unit 109, and an electrical stimulation output unit 110.
  • the input unit 101, the control unit 103, the display unit 104, the timer unit 105, the storage unit 106, the power supply unit 107, and the electrical stimulation output unit 110 are provided in, for example, the main body unit 10.
  • the electrode unit 102, the heater 108, and the temperature measuring unit 109 are provided in, for example, the applying unit 20.
  • the applying unit 20 whether each functional unit is provided in the main body unit 10 or the application unit 20 is not limited to the example shown here as long as the functions described in the present specification are exhibited.
  • the input unit 101 receives an operation input from the user, and is composed of, for example, operation buttons.
  • the input unit 101 is composed of three operation buttons, a first input unit 101a, a second input unit 101b, and a third input unit 101c.
  • the input unit 101 may be configured by, for example, a touch screen, display an input area for receiving an operation input from the user on a part of the display device, and may accept the touch operation input by the user.
  • an operation input is made to the input unit 101 by the user, for example, an electric signal corresponding to the operation input is transmitted to the control unit 103.
  • the electrode unit 102 outputs an electrical stimulus based on the signal received from the electrical stimulus output unit 110.
  • the electrode portion 102 is composed of two electrodes, a first electrode 102a and a second electrode 102b, for example.
  • the control unit 103 controls and manages the entire electrical stimulus application device 1, including each functional unit of the electrical stimulus application device 1.
  • the control unit 103 includes at least one processor.
  • the control unit 103 is composed of a processor such as a CPU (Central Processing Unit) that executes a program that defines a control procedure, or a dedicated processor that specializes in processing each function.
  • a processor such as a CPU (Central Processing Unit) that executes a program that defines a control procedure, or a dedicated processor that specializes in processing each function.
  • the control unit 103 controls the output of electrical stimulation from the electrode unit 102.
  • the control unit 103 can change the output intensity of the electrical stimulation.
  • the control unit 103 can change the output intensity of the electrical stimulus by, for example, changing the magnitude of the pulsed direct current.
  • the control unit 103 controls the processing of the treatment executed by the electrical stimulation application device 1. Specifically, the control unit 103 controls the setting of the output intensity of the weak electric stimulus in the setting stage and the treatment in the treatment stage by controlling each functional unit of the electric stimulus applying device 1.
  • the control unit 103 notifies the user at a predetermined timing by applying an electrical stimulus having a notification intensity set in the setting stage to the living body or the like. The details of the process executed by the control unit 103 will be described later.
  • the display unit 104 is a display device such as a liquid crystal display, an organic EL display, or an inorganic EL display.
  • the display unit 104 displays various information based on the control by the control unit 103.
  • the display unit 104 may display, for example, the stage of processing executed by the electrical stimulation application device 1, that is, the setting stage or the treatment stage.
  • the display unit 104 may display, for example, the progress of treatment.
  • the degree of progression of treatment is the degree of progression at the stage of treatment.
  • the progress of treatment may be information indicating, for example, when the time of the treatment stage is set, how much of the time is completed.
  • the display unit 104 may display the content of the detected operation input.
  • the display unit 104 may display any other information to be notified to the user in relation to the treatment. Note that in FIG. 1, the display unit 104 is not shown.
  • the electrical stimulus application device 1 does not necessarily have to include the display unit 104.
  • the electrical stimulation application device 1 may include another mechanism for notifying the user of information in place of the display unit 104 or together with the display unit 104.
  • the electrical stimulation application device 1 may include a speaker that notifies the user of information by sound.
  • the electrical stimulation application device 1 may include an oscillator that notifies the user of information by vibration.
  • information can be notified by the output of the electric stimulus by the electric stimulus applying device 1, so that the electric stimulus applying device 1 does not necessarily notify the display unit and other information. It is not necessary to have a functional unit to perform the function.
  • the timer unit 105 measures the time based on the control of the control unit 103. For example, the timer unit 105 measures the elapsed time from the start of the treatment stage. Further, for example, the timer unit 105 measures the elapsed time after applying the electrical stimulation of the pulsed direct current.
  • the storage unit 106 can be composed of a semiconductor memory, a magnetic memory, or the like.
  • the storage unit 106 stores, for example, various information and a program for operating the electrical stimulation application device 1.
  • the storage unit 106 may also function as a work memory.
  • the power supply unit 107 is a battery that supplies electric power to each functional unit of the electrical stimulation application device 1.
  • Heater 108 applies heat.
  • the heater 108 is composed of a member that generates heat by supplying electric power, such as a heating wire.
  • the heater 108 generates heat by receiving electric power from, for example, the power supply unit 107.
  • the heater 108 generates heat, the heat is transmitted to the living body or the like to which the electric stimulus applying device 1 is attached.
  • the temperature measuring unit 109 measures the temperature of the heater 108.
  • the temperature measuring unit 109 is configured to include a sensor capable of detecting the temperature, such as a thermometer.
  • the temperature measuring unit 109 transmits information regarding the measured temperature to the control unit 103 by transmitting an electric signal corresponding to the measured temperature to the control unit 103.
  • the electrical stimulation output unit 110 outputs an electrical stimulation from the electrode unit 102 based on the control of the control unit 103.
  • the electrical stimulation application device 1 will be described as being used by being attached to the abdomen of a user who is a living body. That is, here, it is described that the treatment is performed in the abdomen of the user.
  • the user attaches the electrical stimulation application device 1 to the abdomen using the sheet material 30. Then, the user turns on the power of the electric stimulus applying device 1 by, for example, pressing the first input unit 101a. The user can start the treatment by the electric stimulus applying device 1 by pressing the second input unit 101b. That is, the electrical stimulation application device 1 starts the treatment performed by the setting stage and the treatment stage.
  • FIG. 5 is a control chart schematically showing an example of control of the output of electrical stimulation and heat by the control unit 103 of FIG.
  • FIG. 5 shows a chart of the output of the electrical stimulation and a chart of switching the heater 108 on and off.
  • the horizontal axis represents time.
  • the vertical axis of the electrical stimulation output chart indicates the electrical stimulation output intensity.
  • the vertical axis of the chart for switching the heater 108 on and off indicates the on and off states of the heater 108.
  • FIG. 6 is a flowchart showing an example of processing executed by the control unit 103 of FIG. 4 at the setting stage.
  • FIG. 7 is a flowchart showing an example of processing executed by the control unit 103 of FIG. 4 in the treatment stage.
  • the time t 1 in FIG. 5 is the start time of the setting stage. Further, it is assumed that the heater 108 is in the off state at the start of the setting stage.
  • the control unit 103 outputs the electrical stimulus from the electrode unit 102 so as to gradually increase the output intensity of the electrical stimulus. Specifically, the control unit 103 first outputs an electrical stimulus (step S10). At this time, the control unit 103 outputs the electrical stimulus at the lowest output intensity P 1 in the process of gradually increasing the output intensity of the electrical stimulus.
  • the output intensity P 1 is preferably a weak electrical stimulus at a level that does not cause depolarization for almost all users. That is, the output intensity P 1 is preferably a weak electrical stimulus at a level at which almost all users do not perceive the electrical stimulus.
  • the output intensity P 1 may be preset in the electrical stimulation application device 1. As shown in FIG. 5, the control unit 103 may output the pulsed direct current of the electrical stimulation of the output intensity P 1 a plurality of times in a predetermined cycle.
  • the user presses the third input unit 101c when the electrical stimulus is detected. That is, the pressing operation input that is first performed on the third input unit 101c after the setting stage starts is input when the electrical stimulation is sensed.
  • the operation input performed when the electric stimulus is sensed is also referred to as "sensing input” below.
  • the sensory input corresponds to the second operation input in the present disclosure.
  • the control unit 103 determines whether or not the sensory input is detected by the user when the output of the electrical stimulus in step S10 is executed (step S11). That is, the control unit 103 determines whether or not the third input unit 101c is pressed by the user when the output of the electrical stimulation in step S10 is executed.
  • step S12 the control unit 103 may increase the output intensity of the electrical stimulation by, for example, a predetermined intensity range set in advance. In the example shown in FIG. 5, the control unit 103 outputs the electrical stimulus at the output intensity P 1 , and when the sensing input is not detected, then outputs the electrical stimulus at the output intensity P 2 .
  • control unit 103 may start the output of the electric stimulus in the step S10 with the intensity of the electric stimulus increased in the step S12 after a predetermined time after starting the output of the electric stimulus in the step S10.
  • the control unit 103 starts the output of the electrical stimulation of the output intensity P 1 in step S10 at the time t 1 , and then the electrical stimulation of the output intensity P 2 at the time t 2 after a predetermined time. Is starting to output.
  • the control unit 103 repeats the increase in the intensity of the electrical stimulus in step S12 and the output of the electrical stimulus in step S10 until it is determined in step S11 that the sensing input has been detected. By repeating this, the control unit 103 can gradually increase the output intensity of the electrical stimulation. In the example shown in FIG. 5, the control unit 103 increases the output intensity of the electrical stimulation in the order of P 1 , P 2 , P 3 , P 4 , P 5 , P 6 , and P 7 to output. The times t 1 , t 2 , t 3 , t 4 , t 5 , t 6 and t 7 in FIG.
  • the output intensities P 1 , P 2 , P 3 , P 4 , P 5 , P 6 and P 7 Indicates the time when the output of the electrical stimulus was started.
  • the length of time for outputting the pulsed DC current of the electrical stimulus at each output intensity may be constant.
  • the length of time for outputting a pulse direct current electrical stimulation at each output intensity in either case the output intensity may be T A.
  • control unit 103 When the control unit 103 detects a predetermined operation input to the input unit 101, the control unit 103 sets the notification intensity of the electrical stimulation. In the present embodiment, the control unit 103 sets the notification intensity when the sensing input to the third input unit 101c is detected.
  • the control unit 103 when the control unit 103 detects the sensing input (Yes in step S11), the control unit 103 stores the output intensity of the electrical stimulus output when the sensing input is detected in the storage unit 106 (step S13).
  • the output intensity of the electrical stimulus output when the sensing input is detected is referred to as the first reference output intensity P up .
  • FIG. 5 shows an example in which a sensing input is detected while outputting an electrical stimulus with an output intensity P 7 .
  • the first reference output intensity P up P 7 is established.
  • the control unit 103 sets the notification intensity based on the first reference output intensity P up (step S14). In step S14, the control unit 103 sets a predetermined output intensity higher than the first reference output intensity P up as the notification intensity.
  • the method of setting the notification intensity may be appropriately determined.
  • the control unit 103 may set an output intensity higher than the first reference output intensity P up by a predetermined intensity as the notification intensity. Further, for example, the control unit 103 may set the output intensity obtained by multiplying the first reference output intensity P up by a coefficient larger than 1 as the notification intensity.
  • notification intensity setting in step S14 does not necessarily have to be executed before step S15.
  • the setting of the notification intensity in step S14 may be completed by the end of the setting step, that is, by the end of the flow of FIG.
  • the control unit 103 outputs the electrical stimulus from the electrode unit 102 so as to gradually reduce the output intensity of the electrical stimulus at the setting stage.
  • the control unit 103 first outputs an electrical stimulus (step S15).
  • control unit 103 may output the pulsed direct current of the electrical stimulation of the output intensity P 7 a plurality of times in a predetermined cycle.
  • the processing of outputting so as to gradually decrease the output intensity of the electrical stimulus at time t 8 is started.
  • the user presses the third input unit 101c again when the electrical stimulation is no longer sensed. That is, the pressing operation input performed on the third input unit 101c for the second time after the setting stage starts is input when the detection of the electrical stimulus is lost.
  • the operation input performed when the detection of the electrical stimulus is lost is also referred to as "non-sensing input” below.
  • the non-sensing input corresponds to the first operation input in the present disclosure.
  • the control unit 103 determines whether or not a non-sensing input is detected by the user when the output of the electrical stimulation in step S15 is executed (step S16). That is, the control unit 103 determines whether or not the third input unit 101c is pressed by the user when the output of the electrical stimulation in step S15 is executed.
  • step S17 the control unit 103 may reduce the output intensity of the electrical stimulation by, for example, a predetermined intensity range.
  • the gradient when the control unit 103 gradually reduces the output intensity of the electrical stimulation from step S15 to step S17 is compared with the gradient when the control unit 103 gradually increases the output intensity of the electrical stimulation from step S10 to step S12. It may be gentle. Specifically, for example, the control unit 103 may make the decrease in the output intensity of the electrical stimulus in step S17 smaller than the increase in the output intensity of the electrical stimulus in step S12. Alternatively, for example, the control unit 103 takes the time to output the pulsed direct current in step S15 until the output intensity of the electrical stimulus is lowered in step S17, and the pulsed direct current in step S10 until the output intensity of the electrical stimulus is increased in step S12. It may be longer than the time to output the current.
  • the control unit 103 reduces the output intensity of the electrical stimulation in step S17 by the same width as when the output intensity of the electrical stimulation is increased in step S12. That is, in the example shown in FIG. 5, in the process of outputting the electrical stimulus while gradually reducing the output intensity, the control unit 103 changes from the electrical stimulus of the output intensity P 7 to the output intensities P 6 , P 5 , and P 4 . , Lower the output strength.
  • the length of time for outputting the pulsed DC current of the electric stimulus at each output intensity is the time for outputting the pulsed DC current of the electric stimulus at each output intensity when the output intensity of the electric stimulus is gradually increased. longer than the length T a.
  • T B> T A is satisfied.
  • the control unit 103 repeats the decrease in the intensity of the electrical stimulus in step S17 and the output of the electrical stimulus in step S15 until it is determined in step S16 that the non-sensing input has been detected. By repeating this, the control unit 103 can gradually reduce the output intensity of the electrical stimulation.
  • the control unit 103 outputs the output intensity of the electrical stimulation by decreasing it in the order of P 7 , P 6 , P 5 , and P 4 .
  • the output of the electrical stimuli of the output intensities P 7 , P 6 , P 5 and P 4 is started in the process of gradually reducing the output intensity of the electrical stimulus. Indicates the time of day.
  • control unit 103 When the control unit 103 detects a non-sensing input to the input unit 101, the control unit 103 sets the output intensity of the electrical stimulus used in the treatment process in the treatment stage.
  • the output intensity of the electrical stimulus used in the treatment process at the therapeutic stage is also hereinafter referred to as "therapeutic intensity" in the present specification.
  • the control unit 103 sets the treatment intensity when it detects a non-sensing input.
  • the control unit 103 when the control unit 103 detects the non-sensing input (Yes in step S16), the control unit 103 stores the output intensity of the electrical stimulus output when the non-sensing input is detected in the storage unit 106 (step S18). ).
  • the output intensity of the electrical stimulus output when a non-sensing input is detected is referred to as a second reference output intensity P down .
  • Figure 5 is a non-sensitive input indicates an example of a case where it is detected when the output of the electrical stimulation in output intensity P 4.
  • the second reference output intensity P down P 4 is established.
  • the control unit 103 sets the treatment intensity based on the second reference output intensity P down (step S19). In step S19, the control unit 103 sets a predetermined output intensity lower than the second reference output intensity P down as the therapeutic intensity.
  • the method for setting the treatment intensity may be appropriately determined.
  • the control unit 103 may set an output intensity lower than the second reference output intensity P down by a predetermined intensity as the therapeutic intensity. Further, for example, the control unit 103 may set the output intensity obtained by multiplying the second reference output intensity P down by a coefficient less than 1 as the therapeutic intensity.
  • step S19 does not necessarily have to be executed before step S20.
  • the setting of the treatment intensity in step S19 may be completed by the end of the setting step, that is, by the end of the flow of FIG.
  • the control unit 103 After detecting a predetermined operation input (non-sensing input in this example) to the input unit 101, the control unit 103 heats the living body or the like with the heater 108, and when the heater 108 reaches a predetermined temperature or higher. , The treatment phase may be started. Such heating by the heater 108 may be performed at the setting stage.
  • control unit 103 turns on the heater 108 when the non-sensing input is detected and the treatment intensity is set (step S20).
  • electric power is supplied to the heater 108, and the heater 108 starts to generate heat.
  • the heat generated by the heater 108 warms the abdomen of the user who is a living body.
  • the control unit 103 monitors the temperature of the heater 108 based on the signal transmitted from the temperature measurement unit 109. Specifically, the control unit 103 determines whether or not the temperature of the heater 108 has reached a predetermined temperature (step S21).
  • the predetermined temperature is, for example, a temperature suitable for treatment by the electric stimulus application device 1, and may be predetermined.
  • control unit 103 determines that the temperature of the heater 108 has not reached the predetermined temperature (No in step S21)
  • the control unit 103 repeats step S21 while keeping the heater 108 in the ON state.
  • step S21 When the control unit 103 determines that the temperature of the heater 108 has reached a predetermined temperature (Yes in step S21), the control unit 103 turns off the heater 108 (step S22). Chart shown in Figure 5, at time t 13, indicating that the heater 108 is turned off.
  • step S22 When the control unit 103 turns off the heater 108 in step S22, the setting step ends. That is, in the chart shown in FIG. 5, setting out is finished at time t 13. When the setting stage is completed, the control unit 103 then starts processing in the treatment stage.
  • the treatment stage may be automatically started by the control unit 103, for example, when the setting stage is completed.
  • control unit 103 performs treatment processing by applying an electrical stimulus to a living body or the like at a therapeutic intensity, and at a predetermined timing, notifies by outputting an electrical stimulus at a notification intensity.
  • the control unit 103 performs the treatment process by applying a continuous electrical stimulus at the treatment intensity as a pulsed direct current.
  • the predetermined timing at which the control unit 103 gives a notification may be predetermined.
  • the control unit 103 will be described as notifying the start and end of the treatment process.
  • the predetermined timing at which the control unit 103 gives the notification is before the start and after the end of the treatment process.
  • the start of the treatment treatment is before the application of the continuous electrical stimulation at the treatment intensity and immediately before the application of the continuous electrical stimulation at the treatment intensity.
  • the notice given prior to the start of the treatment process is also referred to herein as the "start notice”.
  • the continuous electrical stimulation at the treatment intensity is applied for a predetermined time, and immediately after the continuous electrical stimulation at the treatment intensity is applied for a predetermined time.
  • the predetermined time here corresponds to the predetermined time T 4 described later.
  • the notice given after the end of the treatment process is also referred to herein as the "end notice”.
  • the control unit 103 In the treatment stage, first, the control unit 103 outputs an electrical stimulus of the start notification (step S30). At this time, the control unit 103 outputs the electrical stimulus with the notification intensity set in step S14 of the flow of FIG. As shown in FIG. 5, the control unit 103 may output the electrical stimulation of the start notification as a pulsed direct current a plurality of times in a predetermined cycle. For example, as shown in FIG. 5, the control unit 103, after starting the output of the pulse direct current of the start notification of the electrical stimulation at time t 14, to the time t 15, continues to output the electrical stimulation of the start notification You may go.
  • the notification intensity is higher than the first reference output intensity P up when the user performs the sensing input
  • the user to whom the electrical stimulus of the start notification is applied at the notification intensity receives the electrical stimulus of the start notification. Can be sensed. Sensing the electrical stimulus allows the user to recognize that the treatment process is initiated.
  • the control unit 103 starts the treatment process. Specifically, the control unit 103 starts the treatment time timer by the timer unit 105 (step S31).
  • the treatment time timer is a timer that measures the treatment time.
  • the treatment time may be, for example, the elapsed time from the start of the treatment process, or the time during which the pulsed direct current output process is performed in the treatment process.
  • the elapsed time from the start of the treatment processing is the time during which the output processing of the pulsed direct current is performed in the treatment processing. Is equal to.
  • the control unit 103 outputs a pulsed direct current as an electrical stimulus in the treatment process (step S32). At this time, the control unit 103 outputs a pulsed direct current at the treatment intensity Pm set in step S19 of the flow of FIG.
  • the electrical stimulation interval timer is a timer for measuring an interval for outputting a pulsed direct current as an electrical stimulation.
  • the electrical stimulation interval timer is a timer for measuring the time from the output of the pulsed direct current to the output of the next pulsed direct current.
  • the control unit 103 when the control unit 103 outputs the pulsed direct current in step S32, the control unit 103 starts the heater ON interval timer by the timer unit 105 (step S34).
  • the heater ON interval timer is a timer for measuring the interval (time) from the output of the pulsed direct current as an electrical stimulus to the turning on of the heater 108.
  • control unit 103 executes step S33 and step S34 at the same time. That is, it is preferable that the control unit 103 starts the electrical stimulation interval timer and the heater ON interval timer at the same time.
  • the control unit 103 determines whether or not a predetermined time T 1 has elapsed since the heater ON interval timer was started (step S35).
  • the predetermined time T 1 is the time from the output of the pulsed direct current as the electrical stimulation in the treatment process to the turning on of the heater 108, and may be set in advance, for example.
  • Step S35 is repeated until it is determined.
  • step S35 When the control unit 103 determines that the predetermined time T 1 has elapsed since the heater ON interval timer was started (Yes in step S35), the control unit 103 turns on the heater 108 (step S36).
  • the control unit 103 turns on the heater 108, and after a predetermined time T 2 elapses, turns the heater 108 off (step S37).
  • the on / off control of the heater 108 in step S36 and step S37 may be executed as a pulse wave. That is, in this case, the control unit 103 may turn on the heater 108 in step S36 and then turn off the heater 108 in step S37 after a predetermined time T 2 corresponding to the pulse width has elapsed.
  • the control unit 103 determines whether or not a predetermined time T 3 has elapsed since the electrical stimulation interval timer was started (step S38).
  • the predetermined time T 3 is the time from the output of the pulsed direct current as the electrical stimulus to the output of the next pulsed direct current, and may be set in advance, for example.
  • Control unit 103 when it is determined from the start electrical stimulation interval timer that the predetermined time T 3 has not elapsed (No in step S38), a predetermined time T 3 from the start electrical stimulation interval timer has elapsed Step S38 is repeated until it is determined.
  • FIG. 8 is a diagram for explaining the relationship between T 1 , T 2, and T 3 for a predetermined time, and is, for example, an enlarged view of a portion surrounded by a broken line in FIG.
  • t 21 is the time when the output of the pulsed DC current of the nth treatment intensity in the treatment process is started.
  • the time at which the heater 108 is turned on and t 22 the subsequent time at which the heater 108 is turned off and t 23.
  • the time at which the output of the n + 1th pulse DC current in the treatment stage is started is set to t 24 . Times t 21 , t 22 , t 23 and t 24 are arranged in chronological order in this order.
  • the predetermined time T 1 is represented by t 22 ⁇ t 21 because it is the time from the output of the pulsed direct current as the electrical stimulus to the turning on of the heater 108. Since the predetermined time T 2 is the time from when the heater 108 is turned on to when it is turned off, it is represented by t 23 ⁇ t 22 . Since the predetermined time T 3 is the time from the output of the pulsed direct current as the electrical stimulus to the output of the next pulsed direct current, it is represented by t 24- t 21 . Therefore, as described above, the predetermined time T 3 is longer than the sum of the predetermined time T 1 and the predetermined time T 2 . The specific lengths of the predetermined times T 1 , T 2 and T 3 may be appropriately determined according to the purpose, means and method of treatment.
  • the predetermined time T 4 is a treatment time, and may be set in advance, for example.
  • the predetermined time T 4 is, for example, one hour.
  • step S39 When the control unit 103 determines that the predetermined time T 4 has not elapsed since the treatment time timer was started (No in step S39), the control unit 103 proceeds to step S32 and outputs a pulsed direct current. In this way, the control unit 103, since the start of the treatment time the timer at step S39 until it is determined that the predetermined time T 4 has elapsed, repeats the step S39 from step S32. By repeating steps S32 to S39 in this way, a weak electrical stimulus with a therapeutic intensity of Pm is continuously applied to the user to perform treatment. Further, at this time, since the heater 108 is turned on in step S36, appropriate heat is applied, which makes it easier to maintain the temperature of the abdomen.
  • control unit 103 determines that the predetermined time T 4 has elapsed since the treatment time timer was started (Yes in step S39), the control unit 103 ends the treatment process.
  • the control unit 103 outputs an electrical stimulus for the end notification (step S40).
  • the control unit 103 outputs the electrical stimulus with the notification intensity set in step S14 of the flow of FIG.
  • the control unit 103 may output the electrical stimulation of the start notification as a pulsed direct current a plurality of times in a predetermined cycle. For example, as shown in FIG.
  • the control unit 103 after starting the output of the pulse direct current electrical stimulation termination notification at time t 16, up to time t 17, continues to output the electrical stimulation of the end notification You may go. Similar to the start notification, the user can sense the electrical stimulus of the end notification. By sensing the electrical stimulus, the user can recognize that the treatment process is complete.
  • the user who recognizes that the treatment has been completed can peel off the electrical stimulation application device 1 from the abdomen and terminate the treatment by the electrical stimulation application device 1.
  • the control unit 103 outputs the second reference output intensity P down of the electrical stimulation when the first operation input to the input unit 101 is detected.
  • a notification higher than the first reference output intensity P up of the electrical stimulus output when the second operation input to the input unit 101 is detected at a predetermined timing while outputting the electrical stimulus with a treatment intensity Pm lower than that.
  • An electrical stimulus is applied to a living body or the like at an intensity Pa. In the treatment process, the electrical stimulus is applied at a treatment intensity Pm lower than the second reference output intensity P down when the user no longer senses the electrical stimulus, so that the user actually performs the electrical stimulus in the treatment process. Does not detect whether or not is applied.
  • the user to whom the electrical stimulus is applied at the notification intensity senses the electrical stimulus of the notification. can do. By sensing the electrical stimulus, the user can recognize the notification. In this way, according to the electrical stimulation application device 1 according to the present embodiment, it is possible to more reliably notify the user of information regarding the device that applies weak electrical stimulation and heat to a living body or the like.
  • the control unit 103 inputs a sensing input when the user senses the electrical stimulus.
  • the notification intensity Pa is set to be higher than the first reference output intensity P up that is output when the sensing input is input. Therefore, the control unit 103 can set the notification intensity Pa to an intensity that is easy for the user to perceive.
  • the control unit 103 when the output intensity of the electrical stimulus is gradually reduced in the setting stage, the control unit 103 inputs a non-sensing input when the user no longer senses the electrical stimulus.
  • the treatment intensity Pm is set to be weaker than the second reference output intensity P down which is output when the non-sensing input is input. Therefore, the control unit 103 can set the treatment intensity Pm to a weak level that the user does not perceive.
  • the electric stimulus applying device 1 heats a living body or the like by a heater 108 after detecting a predetermined operation input to the input unit 101, and when the heater 108 reaches a predetermined temperature or higher, a treatment stage. To start.
  • the treatment can be started after the living body or the like is heated to a temperature suitable for the treatment.
  • it is not necessary to heat the heater 108 before starting the treatment stage.
  • the process executed by the control unit 103 of the electrical stimulus applying device 1 is not limited to the above-mentioned process.
  • the control unit 103 may execute a process different from the above-mentioned process or an additional process in addition to the above-mentioned process, depending on the purpose, means, method, and the like of the treatment.
  • control unit 103 heats the heater 108 after detecting the non-sensing input by the user in the setting stage.
  • the control unit 103 may heat the heater 108 before outputting the electrical stimulation, for example, in step S10 of FIG.
  • the control unit 103 may heat the heater 108 before outputting the electrical stimulation, for example, in step S10 of FIG.
  • the user can input whether or not the electrical stimulus is detected in the heated state. Therefore, the presence or absence of detection of electrical stimulation is input under conditions closer to the treatment stage. Therefore, it may be easy to set the treatment intensity and the notification intensity at the treatment stage to an appropriate level.
  • control unit 103 executes a process of outputting an electric stimulus from the electrode unit 102 so as to gradually increase and decrease the output intensity of the electric stimulus in the setting stage. ..
  • processing in the setting stage is not limited to the gradual increase and gradual increase in the output intensity of the electrical stimulation by the control unit 103.
  • the electrical stimulus application device 1 may change the output intensity of the electrical stimulus based on the user's operation input at the setting stage.
  • the electrical stimulation application device 1 may further include an output intensity adjusting unit that receives an operation input from the user for changing the output intensity of the electrical stimulation.
  • the output strength adjusting unit can be realized in various forms, and may be composed of, for example, a rotary knob (knob), a slide knob, a spin box, and the like.
  • the control unit 103 performs a process of changing the output intensity of the electrical stimulus according to the input to the output intensity adjusting unit by the user. In this way, the output intensity of the electrical stimulus output from the electrical stimulus application device 1 can be changed at the setting stage by the operation input from the user.
  • control unit 103 of the electric stimulus applying device 1 outputs the notification by the electric stimulus as a pulsed direct current a plurality of times in a predetermined cycle.
  • the notification of the electrical stimulation output by the control unit 103 is not limited to this aspect.
  • control unit 103 may output the electrical stimulation in a predetermined pattern.
  • the control unit 103 can output electrical stimuli in various patterns by changing the output power. Specifically, the control unit 103 changes and outputs an electrical stimulation pattern by changing at least one of voltage, current, pulse width, frequency, stimulation time, and pause time as output power. Can be done.
  • FIG. 9 is a diagram for explaining an output pattern of electrical stimulation output as a notification.
  • the control unit 103 can change the output intensity Pa as the output pattern of the electrical stimulation shown in FIG. 9 by changing the voltage and the current of the electrical stimulation. Further, the control unit 103 can change the pulse width PL and the frequency. Further, the control unit 103 can change the total length TW of applying the electrical stimulus as a notification by changing the stimulation time (output time) of the electrical stimulus. Further, as shown in FIG. 9, the control unit 103 can provide a pause time TB or change the length of the pause time TB. The pause period is the period during which the pulsed direct current is not output. By providing a rest period, intermittent electrical stimulation is applied to the user. In this way, the control unit 103 can make the user sense different electrical stimuli by changing the output pattern of the electrical stimuli.
  • control unit 103 notifies the start and end of the treatment process. That is, in the above-described embodiment, the case where the predetermined timing for the control unit 103 to notify is before and after the start and end of the treatment process has been described.
  • the notification given by the control unit 103 by the output of the electrical stimulus is not limited to the start and end of the treatment process.
  • the control unit 103 may give other notifications by the output of the electrical stimulus.
  • the control unit 103 may notify the abnormality generated in the electric stimulus applying device 1 by the output of the electric stimulus.
  • the control unit 103 of the electric stimulus applying device 1 notifies the user by outputting the electric stimulus with the notification intensity. It can be carried out.
  • the control unit 103 can notify the start and end of the treatment process and the occurrence of an abnormality. That is, the predetermined timing at which the control unit 103 outputs the electrical stimulus with the notification intensity is before and after the start and end of the treatment process, and when an abnormality occurs. It should be noted that the predetermined timing does not necessarily have to include all of these timings. That is, the predetermined timing may include at least one of before and after the start and end of the treatment process, and when an abnormality occurs. Further, the predetermined timing may include a timing other than the timing described here. Predetermined timing may be appropriately set in relation to any event that can be notified to the user during the treatment phase.
  • the pattern of the electrical stimulation applied to the living body or the like may be changed according to the type (content) of the notification.
  • the control unit 103 gives three types of notifications of the start of the treatment process, the end of the treatment process, and the occurrence of an abnormality by the output of the electrical stimulus
  • the control unit 103 has three different types of notifications according to the three types of notifications. It may be output in the pattern of electrical stimulation.
  • the patterns of electrical stimulation can be varied, for example, by changing at least one of voltage, current, pulse width, frequency, stimulation time, and pause time, as described with reference to FIG.
  • the control unit 103 may set two different notification intensities.
  • the two different notification intensities are the notification intensity output by the electrical stimulation of the start notification and the notification intensity output by the electrical stimulation of the end notification. That is, the notification intensity output by the electrical stimulation of the start notification and the notification intensity output by the electrical stimulation of the end notification may be the same intensity as in the above embodiment, or may be different in intensity. ..
  • the notification intensity output by the electrical stimulation of the start notification and the notification intensity output by the electrical stimulation of the end notification may be higher than the treatment intensity.
  • the electrical stimulation of the start notification and the electrical stimulation of the end notification may have the same stimulation time or different lengths.
  • the stimulation time of the electrical stimulation of the start notification and the electrical stimulation of the end notification is, for example, several seconds each. Further, the electrical stimulation of the start notification and the electrical stimulation of the end notification may be intermittent electrical stimulation having a rest period.
  • the electrical stimulus application device is not limited to the configuration specified in the above-described embodiment, and can be variously modified within a range that does not deviate from the gist of the invention described in the claims.
  • the functions included in each component and each step can be rearranged so as not to be logically inconsistent, and a plurality of components or steps can be combined or divided into one. Is.
  • the present disclosure relates to an electrical stimulation application device.
  • Electrode unit 102a First electrode 102b: Second electrode 103: Control unit 104: Display unit 105: Timer unit 106: Storage unit 107: Power supply unit 108: Heater 109: Temperature measurement unit 110: Electrical stimulation output unit

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Abstract

This device for applying electrical stimulation applies weak electrical stimulation to a living body or to living tissue and is provided with an input unit for receiving operation input from a user and a control unit for controlling output of the electrical stimulation. The control unit is capable of changing the output intensity of the electrical stimulation. The electrical stimulation is applied to the living body or living tissue at a predetermined output intensity lower than the output intensity of the electrical stimulation to be output when first operation input to the input unit is detected, and the electrical stimulation is applied to the living body or living tissue at a notification intensity higher than the output intensity of the electrical stimulation to be output when second operation input to the input unit is detected at a predetermined timing.

Description

電気刺激印加装置及び電気刺激印加方法Electrical stimulation application device and electrical stimulation application method
 本開示は、電気刺激印加装置及び電気刺激印加方法に関する。 The present disclosure relates to an electrical stimulation application device and an electrical stimulation application method.
 従来、脱分極を惹起させないレベルの微弱な電気刺激と、温熱とを生体又は生体組織に印加することにより、様々な疾患の治療を行う装置が知られている。例えば、特許文献1及び特許文献2には、電気刺激としての微弱な電流と、温熱とを、生体又は生体組織に印加することにより、神経変性疾患、癌疾患、色素性乾皮症、全身性自己免疫疾患、臓器特異性自己免疫疾患等の疾患の治療を行う装置が開示されている。 Conventionally, there are known devices that treat various diseases by applying a weak electrical stimulus at a level that does not cause depolarization and heat to a living body or a living body tissue. For example, in Patent Documents 1 and 2, by applying a weak current as an electrical stimulus and heat to a living body or a living body tissue, a neurodegenerative disease, a cancer disease, xeroderma pigmentosum, and systemic A device for treating diseases such as autoimmune diseases and organ-specific autoimmune diseases is disclosed.
国際公開第2017/065239号International Publication No. 2017/065239 特開2009-125549号公報JP-A-2009-125549
 上述の装置は、治療に際して、例えば生体等に貼付して使用される。具体的には、当該装置は、例えば、生体であるユーザの一部に該当する腹部に貼付された状態で、治療の処理を実行する。ユーザは、当該装置による治療を受けている間、例えば衣服を着ており、この場合、腹部に貼付された装置は、衣服に覆われた状態となる。そのため、例えば、当該装置から、ユーザに情報を通知するために、ブザーにより音を出力したり、LED(発光ダイオード:Light Emitting Diode)により光を発したりしても、ユーザは気付かないことがある。 The above-mentioned device is used by being attached to, for example, a living body during treatment. Specifically, the device executes a treatment process, for example, in a state of being attached to the abdomen corresponding to a part of a user who is a living body. The user is wearing, for example, clothing while being treated with the device, in which case the device attached to the abdomen is covered with clothing. Therefore, for example, the user may not notice even if the device outputs a sound by a buzzer or emits a light by an LED (light emitting diode: Light Emitting Diode) in order to notify the user of information. ..
 本開示の目的は、微弱な電気刺激と温熱とを生体又は生体組織に印加する装置に関して、情報をより確実にユーザに通知可能な電気刺激印加装置及び電気刺激印加方法を提供することである。 An object of the present disclosure is to provide an electrical stimulus application device and an electrical stimulus application method capable of more reliably notifying a user of information regarding a device that applies weak electrical stimulation and heat to a living body or a living tissue.
 本開示の第1の態様としての電気刺激印加装置は、微弱な電気刺激を生体又は生体組織に印加する電気刺激印加装置であって、ユーザからの操作入力を受け付ける入力部と、前記電気刺激の出力を制御する制御部と、を備え、前記制御部は、前記電気刺激の出力強度を変更可能であり、前記入力部に対する第1の操作入力を検出したときに出力される前記電気刺激の出力強度よりも低い、所定の出力強度で、前記生体又は生体組織に前記電気刺激を印加するとともに、所定のタイミングにおいて、前記入力部に対する第2の操作入力を検出したときに出力される前記電気刺激の出力強度よりも高い通知強度で、前記生体又は生体組織に前記電気刺激を印加する。 The electric stimulus applying device as the first aspect of the present disclosure is an electric stimulus applying device that applies a weak electric stimulus to a living body or a living tissue, and has an input unit that receives an operation input from a user and the electric stimulus. The control unit includes a control unit that controls the output, and the control unit can change the output intensity of the electrical stimulation, and the output of the electrical stimulation that is output when the first operation input to the input unit is detected. The electrical stimulus that is output when the electrical stimulus is applied to the living body or tissue at a predetermined output intensity lower than the intensity and a second operation input to the input unit is detected at a predetermined timing. The electrical stimulus is applied to the living body or the living body tissue with a notification intensity higher than the output intensity of.
 本開示の1つの実施形態としての電気刺激印加装置において、前記制御部は、前記電気刺激の出力強度を漸増させながら前記電気刺激を出力し、前記電気刺激の出力強度を漸増させている際に前記第2の操作入力を検出したときに出力される前記電気刺激の出力強度よりも高い所定の出力強度を、前記通知強度として設定する。 In the electric stimulus application device as one embodiment of the present disclosure, when the control unit outputs the electric stimulus while gradually increasing the output intensity of the electric stimulus and gradually increases the output intensity of the electric stimulus. A predetermined output intensity higher than the output intensity of the electrical stimulus output when the second operation input is detected is set as the notification intensity.
 本開示の1つの実施形態としての電気刺激印加装置は、前記生体又は生体組織を加温するヒータをさらに備え、前記制御部は、前記入力部に対する前記第2の操作入力を検出した後、前記ヒータにより前記生体又は生体組織を加温し、前記ヒータが所定温度以上となったときに、前記所定の出力強度で、前記生体又は生体組織に前記電気刺激を印加する。 The electrical stimulation application device as one embodiment of the present disclosure further includes a heater for heating the living body or the living tissue, and the control unit detects the second operation input to the input unit, and then the second operation input is detected. The living body or living tissue is heated by a heater, and when the heater reaches a predetermined temperature or higher, the electrical stimulation is applied to the living body or living tissue at the predetermined output intensity.
 本開示の1つの実施形態としての電気刺激印加装置において、前記制御部は、前記入力部に対する前記第2の操作入力を検出したときに出力される前記電気刺激の出力強度に対して、1より大きい係数を乗じた出力強度を、前記通知強度として設定する。 In the electrical stimulation application device as one embodiment of the present disclosure, the control unit has a coefficient of 1 or more with respect to the output intensity of the electrical stimulation output when the second operation input to the input unit is detected. The output intensity multiplied by a large coefficient is set as the notification intensity.
 本開示の1つの実施形態としての電気刺激印加装置において、前記制御部は、前記電気刺激の出力強度を漸減させながら前記電気刺激を出力し、前記電気刺激の出力強度を漸減させている際に前記入力部に対する前記第1の操作入力を検出したときに出力される前記電気刺激の出力強度よりも低い、所定の出力強度で、前記生体又は生体組織に前記電気刺激を印加する。 In the electric stimulus application device as one embodiment of the present disclosure, when the control unit outputs the electric stimulus while gradually reducing the output intensity of the electric stimulus and gradually reduces the output intensity of the electric stimulus. The electrical stimulus is applied to the living body or tissue at a predetermined output intensity lower than the output intensity of the electrical stimulus output when the first operation input to the input unit is detected.
 本開示の1つの実施形態としての電気刺激印加装置において、前記所定の出力強度は、前記入力部に対する前記第1の操作入力を検出したときに出力される前記電気刺激の出力強度に対して、1未満の係数を乗じた出力強度である。 In the electrical stimulation application device as one embodiment of the present disclosure, the predetermined output intensity is relative to the output intensity of the electrical stimulation output when the first operation input to the input unit is detected. The output intensity multiplied by a coefficient less than 1.
 本開示の1つの実施形態としての電気刺激印加装置において、前記制御部は、前記電気刺激の出力強度を漸増させている際に前記入力部に対する第2の操作入力を検出した場合に、前記電気刺激の出力強度を漸増させている際に前記入力部に対する第2の操作入力を検出したときに出力される前記電気刺激の出力強度から、前記電気刺激の出力強度を漸減させながら前記電気刺激を出力する。 In the electric stimulus application device as one embodiment of the present disclosure, when the control unit detects a second operation input to the input unit while gradually increasing the output intensity of the electric stimulus, the electric stimulus is said to be electric. The electrical stimulus is applied while gradually decreasing the output intensity of the electrical stimulus from the output intensity of the electrical stimulus output when the second operation input to the input unit is detected while the output intensity of the stimulus is gradually increased. Output.
 本開示の1つの実施形態としての電気刺激印加装置において、前記所定のタイミングは、前記所定の出力強度による連続的な電気刺激の印加を行う前、前記所定の出力強度による連続的な電気刺激の印加を行った後、及び、当該電気刺激印加装置における異常が発生したとき、の少なくともいずれかを含む。 In the electrical stimulation application device as one embodiment of the present disclosure, the predetermined timing is the continuous electrical stimulation by the predetermined output intensity before the application of the continuous electrical stimulation by the predetermined output intensity. It includes at least one of the following after the application is performed and when an abnormality occurs in the electrical stimulation application device.
 本開示の1つの実施形態としての電気刺激印加装置において、前記制御部は、通知の種類に応じて、前記所定のタイミングに前記生体又は生体組織に印加する前記電気刺激の出力パターンを変化させる。 In the electrical stimulation application device as one embodiment of the present disclosure, the control unit changes the output pattern of the electrical stimulation applied to the living body or the biological tissue at the predetermined timing according to the type of notification.
 本開示の第2の態様としての電気刺激印加方法は、ユーザからの操作入力を受け付ける入力部を備え、微弱な電気刺激を出力可能な、電気刺激印加装置による電気刺激印加方法であって、前記電気刺激の出力強度を変更しながら前記電気刺激を出力するステップと、前記入力部に対して第1の操作入力が入力されたときに出力される前記電気刺激の出力強度よりも低い、所定の出力強度で、生体又は生体組織に前記電気刺激を印加するステップと、所定のタイミングにおいて、前記所定の出力強度よりも強い通知強度で、前記生体又は生体組織に前記電気刺激を印加するステップと、を含む。 The method of applying an electrical stimulus as a second aspect of the present disclosure is a method of applying an electrical stimulus by an electrical stimulus applying device, which is provided with an input unit that receives an operation input from a user and can output a weak electrical stimulus. A predetermined step of outputting the electrical stimulus while changing the output intensity of the electrical stimulus and a predetermined output intensity of the electrical stimulus lower than the output intensity of the electrical stimulus output when the first operation input is input to the input unit. A step of applying the electrical stimulus to a living body or a biological tissue at an output intensity, and a step of applying the electrical stimulus to the living body or a biological tissue at a predetermined timing with a notification intensity stronger than the predetermined output intensity. including.
 本開示によれば、微弱な電気刺激と温熱とを生体又は生体組織に印加する装置に関して、情報をより確実にユーザに通知可能な電気刺激印加装置及び電気刺激印加方法を提供できる。 According to the present disclosure, it is possible to provide an electrical stimulus application device and an electrical stimulus application method capable of more reliably notifying a user of information regarding a device that applies weak electrical stimulation and heat to a living body or a living tissue.
一実施形態に係る電気刺激印加装置の概略的な外観斜視図である。It is a schematic external perspective view of the electric stimulus application device which concerns on one Embodiment. 図1の電気刺激印加装置を裏面側から見た場合の外観斜視図である。It is an external perspective view of the electric stimulation application device of FIG. 1 when viewed from the back surface side. 電気刺激印加装置を生体等に貼付する際に用いられるシート材の概略構成を示す外観斜視図である。It is an external perspective view which shows the schematic structure of the sheet material used when attaching an electric stimulus application device to a living body or the like. 図1の電気刺激印加装置の概略構成を示す機能ブロック図である。It is a functional block diagram which shows the schematic structure of the electric stimulus application device of FIG. 図4の制御部による電気刺激と温熱との出力の制御の一例を模式的に示す制御チャートである。It is a control chart which shows typically an example of the control of the output of electrical stimulation and heat by the control unit of FIG. 図4の制御部が設定段階において実行する処理の一例を示すフローチャートである。It is a flowchart which shows an example of the process which the control part of FIG. 4 executes in a setting stage. 図4の制御部が治療段階において実行する処理の一例を示すフローチャートである。It is a flowchart which shows an example of the process which the control part of FIG. 4 executes in a treatment stage. 所定時間T1、T2及びT3の関係について説明するための図である。It is a figure for demonstrating the relationship of predetermined time T 1 , T 2 and T 3 . 通知として出力される電気刺激の出力パターンについて説明するための図である。It is a figure for demonstrating the output pattern of the electrical stimulus output as a notification.
 以下、本開示に係る電気刺激印加装置の実施形態について図面を参照しながら説明する。各図において共通する部材には同一の符号を付している。 Hereinafter, embodiments of the electrical stimulation application device according to the present disclosure will be described with reference to the drawings. The common members in each figure are designated by the same reference numerals.
 図1は、一実施形態に係る電気刺激印加装置1の概略的な外観斜視図である。電気刺激印加装置1は、微弱な電気刺激を生体又は生体組織(以下、単に「生体等」とも称する)に印加する。微弱な電気刺激の印加により、疾患の治療が行われる。 FIG. 1 is a schematic external perspective view of the electrical stimulus applying device 1 according to the embodiment. The electrical stimulus application device 1 applies a weak electrical stimulus to a living body or a living tissue (hereinafter, also simply referred to as “living body or the like”). The disease is treated by applying a weak electrical stimulus.
 微弱な電気刺激は、生体等に対して、脱分極を惹起させないレベルの電気刺激である。脱分極を惹起させないレベルの電気刺激は、筋収縮や刺激感を生体にもたらさないため、ユーザ(患者)は印可される電気刺激を感知することができない。電気刺激は、例えばパルス直流電流として、生体等に印加される。パルス直流電流は、例えば55Hzの周波数で印加される。パルス直流電流のパルス幅は、例えば100μ秒である。ただし、電気刺激は、これに限られず、疾患の治療に効果のある適宜の電気刺激が用いられてよい。例えば、パルス直流電流の周波数は55Hz以外であってもよく、パルス直流電流のパルス幅は100μ秒以外であってもよい。 Weak electrical stimulation is a level of electrical stimulation that does not cause depolarization of the living body. Since a level of electrical stimulation that does not induce depolarization does not cause muscle contraction or a feeling of stimulation to the living body, the user (patient) cannot sense the electrical stimulation to be applied. The electrical stimulation is applied to a living body or the like as, for example, a pulsed direct current. The pulsed direct current is applied at a frequency of, for example, 55 Hz. The pulse width of the pulsed direct current is, for example, 100 μsec. However, the electrical stimulation is not limited to this, and an appropriate electrical stimulation effective in treating a disease may be used. For example, the frequency of the pulsed direct current may be other than 55 Hz, and the pulse width of the pulsed direct current may be other than 100 μsec.
 電気刺激印加装置1は、さらに生体等を加温する。すなわち、電気刺激印加装置1は、生体等に対して温熱を印加する。従って、電気刺激印加装置1は、電気刺激と温熱とを組み合わせて、生体等に印加することができる。この場合、微弱な電気刺激と温熱との印加により、疾患の治療が行われる。 The electrical stimulus application device 1 further heats the living body and the like. That is, the electrical stimulation application device 1 applies heat to a living body or the like. Therefore, the electric stimulus application device 1 can apply the electric stimulus and the heat to a living body or the like in combination. In this case, the disease is treated by applying a weak electric stimulus and heat.
 温熱は、生体等の平常時の温度よりも数度高い温熱である。例えば、電気刺激印加装置1を人体に対して適用する場合、温熱は、人体の平常時の体温よりも数度高い、38℃以上45℃以下の温度であってよい。 The heat is several degrees higher than the normal temperature of the living body. For example, when the electrical stimulation application device 1 is applied to the human body, the heat may be a temperature of 38 ° C. or higher and 45 ° C. or lower, which is several degrees higher than the normal body temperature of the human body.
 電気刺激印加装置1による治療は、電気刺激印加装置1を生体等の少なくとも一部に貼付した状態で実行される。例えば、電気刺激印加装置1は、粘着性のあるシート材を介して、生体等に貼付される。電気刺激印加装置1が生体等に貼付された状態で、例えば、電気刺激印加装置1のユーザ(患者)が、電気刺激印加装置1に対して、電気刺激印加装置1による治療を開始するための所定の操作入力を行うと、電気刺激及び温熱を印加することによる治療が行われる。 The treatment by the electric stimulus applying device 1 is performed in a state where the electric stimulating applying device 1 is attached to at least a part of a living body or the like. For example, the electrical stimulation application device 1 is attached to a living body or the like via a sticky sheet material. In a state where the electric stimulus applying device 1 is attached to a living body or the like, for example, a user (patient) of the electric stimulus applying device 1 can start treatment with the electric stimulus applying device 1 for the electric stimulus applying device 1. When a predetermined operation input is performed, treatment is performed by applying electrical stimulation and heat.
 ここで、本実施形態に係る電気刺激印加装置1は、実際の治療を開始する前に、生体等に印加する微弱な電気刺激の強度を設定する。また、電気刺激印加装置1は、実際の治療を開始する前に、所定のタイミングで生体等に印加する電気刺激の出力強度を設定する。電気刺激印加装置1が所定のタイミングで生体等に印加する電気刺激の出力強度を、以下、本明細書において、「通知強度」とも称する。通知強度は、ユーザが感知可能な出力強度である。 Here, the electrical stimulation application device 1 according to the present embodiment sets the intensity of the weak electrical stimulation applied to the living body or the like before starting the actual treatment. Further, the electric stimulus applying device 1 sets the output intensity of the electric stimulus applied to the living body or the like at a predetermined timing before starting the actual treatment. The output intensity of the electrical stimulus applied to the living body or the like by the electrical stimulus applying device 1 at a predetermined timing is hereinafter also referred to as “notification intensity” in the present specification. The notification intensity is the output intensity that can be perceived by the user.
 本明細書において、治療を開始する前に行われる、電気刺激の出力強度を設定する段階を、以下、単に「設定段階」とも称する。また、本明細書において、実際に治療を行う段階を、以下、単に「治療段階」とも称する。従って、電気刺激印加装置1のユーザが、電気刺激印加装置1に対して、電気刺激印加装置1による治療を開始するための所定の操作入力を行うと、電気刺激印加装置1は、設定段階を実行することにより、治療段階における電気刺激の強度を設定し、その後、治療段階を実行することにより、ユーザの治療を行う。 In the present specification, the step of setting the output intensity of electrical stimulation, which is performed before starting the treatment, is also simply referred to as "setting step" below. Further, in the present specification, the stage of actually performing treatment is also simply referred to as "therapeutic stage" below. Therefore, when the user of the electric stimulus applying device 1 performs a predetermined operation input for starting the treatment by the electric stimulus applying device 1 to the electric stimulus applying device 1, the electric stimulus applying device 1 sets the setting stage. By performing, the intensity of electrical stimulation at the treatment stage is set, and then by performing the treatment stage, the user is treated.
 図1に示すように、電気刺激印加装置1は、本体部10と印加部20とが結合されて構成される。本体部10は、筐体として構成されている。印加部20は、平板形状に構成されている。本体部10は、平板形状の印加部20の一方の面において、印加部20と結合されている。本明細書では、平板形状の印加部20において、本体部10が結合されている面を表面という。また、平板形状の印加部20において、表面とは反対側の、本体部10が結合されていない面を裏面という。 As shown in FIG. 1, the electrical stimulation application device 1 is configured by combining the main body portion 10 and the application portion 20. The main body 10 is configured as a housing. The application unit 20 is formed in a flat plate shape. The main body portion 10 is coupled to the application portion 20 on one surface of the flat plate-shaped application portion 20. In the present specification, in the flat plate-shaped application portion 20, the surface to which the main body portion 10 is bonded is referred to as a surface. Further, in the flat plate-shaped application portion 20, the surface opposite to the front surface to which the main body portion 10 is not bonded is referred to as a back surface.
 筐体として構成されている本体部10は、内部に、電気刺激印加装置1の動作を制御するための各種機能部を有する。また、本体部10には、ユーザからの操作入力を受け付ける入力部が設けられている。図1に示す例では、本体部10は、入力部として、第1入力部101a、第2入力部101b及び第3入力部101cを備える。 The main body 10 configured as a housing has various functional parts inside for controlling the operation of the electrical stimulus applying device 1. Further, the main body unit 10 is provided with an input unit that receives an operation input from the user. In the example shown in FIG. 1, the main body unit 10 includes a first input unit 101a, a second input unit 101b, and a third input unit 101c as input units.
 第1入力部101a、第2入力部101b及び第3入力部101cは、例えば図1に示すように、いずれも押下可能な操作ボタン(操作キー)として構成されていてよい。ただし、第1入力部101a、第2入力部101b及び第3入力部101cの形態は、押下可能な操作ボタンに限られない。また、本体部10が備える入力部の数量は3個に限られない。さらに、第1入力部101a、第2入力部101b及び第3入力部101cの配置は、図1に示す配置に限られない。 The first input unit 101a, the second input unit 101b, and the third input unit 101c may all be configured as operation buttons (operation keys) that can be pressed, as shown in FIG. 1, for example. However, the form of the first input unit 101a, the second input unit 101b, and the third input unit 101c is not limited to the operation buttons that can be pressed. Further, the number of input units included in the main body unit 10 is not limited to three. Further, the arrangement of the first input unit 101a, the second input unit 101b, and the third input unit 101c is not limited to the arrangement shown in FIG.
 本実施形態では、第1入力部101a、第2入力部101b及び第3入力部101cは、それぞれ異なる機能を実行させる操作ボタンである。具体的には、第1入力部101aは、電気刺激印加装置1の電源のオンとオフとを切り替える操作ボタンである。第2入力部101bは、電気刺激印加装置1による治療を開始させるための操作ボタンである。第3入力部101cは、ユーザが電気刺激の感知の有無を入力するための操作ボタンである。電気刺激の感知については、後述する。 In the present embodiment, the first input unit 101a, the second input unit 101b, and the third input unit 101c are operation buttons that execute different functions. Specifically, the first input unit 101a is an operation button for switching the power on / off of the electric stimulus applying device 1. The second input unit 101b is an operation button for starting the treatment by the electrical stimulation application device 1. The third input unit 101c is an operation button for the user to input whether or not the electric stimulus is detected. The sensing of electrical stimulation will be described later.
 印加部20は、粘着性のあるシート材を介して、裏面が生体等に貼付される。印加部20は、電気刺激を出力する電極部と、発熱するヒータを備える。印加部20は、裏面が生体等に貼付された状態で、生体等に電気刺激と温熱とを印加する。 The back surface of the application unit 20 is attached to a living body or the like via a sticky sheet material. The application unit 20 includes an electrode unit that outputs an electrical stimulus and a heater that generates heat. The application unit 20 applies electrical stimulation and heat to the living body or the like with the back surface attached to the living body or the like.
 図2は、図1の電気刺激印加装置1を裏面側から見た場合の外観斜視図である。図2に示すように、印加部20は、電極部として、第1電極102aと第2電極102bとの、2枚の電極を備える。第1電極102a及び第2電極102bは、裏面側において、外部に露出している。電極部は、例えば、第1電極102a及び第2電極102bのうち、1枚の電極を接地し、もう1枚の電極について電圧を変化させることにより、電気刺激を出力する。 FIG. 2 is an external perspective view of the electrical stimulation application device 1 of FIG. 1 when viewed from the back surface side. As shown in FIG. 2, the application unit 20 includes two electrodes, a first electrode 102a and a second electrode 102b, as an electrode unit. The first electrode 102a and the second electrode 102b are exposed to the outside on the back surface side. The electrode unit outputs an electrical stimulus by, for example, grounding one of the first electrode 102a and the second electrode 102b and changing the voltage of the other electrode.
 印加部20は、内部にヒータを備える。すなわち、印加部20は、表面と裏面との間に、ヒータを備える。ヒータを加熱することにより、裏面が生体等に貼付された状態で、生体等に温熱が伝達されて、生体等が温められる。 The application unit 20 is provided with a heater inside. That is, the application unit 20 includes a heater between the front surface and the back surface. By heating the heater, the heat is transmitted to the living body or the like with the back surface attached to the living body or the like, and the living body or the like is warmed.
 図3は、電気刺激印加装置1を生体等に貼付する際に用いられるシート材30の概略構成を示す外観斜視図である。シート材30は、フレーム部31と、2枚の導電性ゲル32とを備える。 FIG. 3 is an external perspective view showing a schematic configuration of a sheet material 30 used when the electrical stimulus applying device 1 is attached to a living body or the like. The sheet material 30 includes a frame portion 31 and two conductive gels 32.
 フレーム部31は、例えば樹脂等の非導電性材料により構成される。フレーム部31の外形は、印加部20の外形とほぼ同じ大きさに形成されている。フレーム部31は、2枚の導電性ゲル32を配置するための2つの開口(貫通孔)を有する。2つの開口は、シート材30を印加部20の裏面側に貼付した場合に、第1電極102a及び第2電極102bが配置されている位置に一致する位置に形成されている。 The frame portion 31 is made of a non-conductive material such as resin. The outer shape of the frame portion 31 is formed to be substantially the same size as the outer shape of the application portion 20. The frame portion 31 has two openings (through holes) for arranging the two conductive gels 32. The two openings are formed at positions corresponding to the positions where the first electrode 102a and the second electrode 102b are arranged when the sheet material 30 is attached to the back surface side of the application portion 20.
 2枚の導電性ゲル32は、フレーム部31の2つの開口に配置される。2枚の導電性ゲル32の間は、非導電性のフレーム部31によって絶縁されている。導電性ゲル32は、粘着性を有することにより、電気刺激印加装置1を生体等に貼付することができる。シート材30が印加部20の裏面側に貼付された状態において、2枚の導電性ゲル32は、それぞれ、第1電極102a及び第2電極102bと1対1に対応して接触する。これにより、電気刺激印加装置1がシート材30により生体等に貼付されて、電極部から電気刺激が出力された場合に、当該電気刺激が、2枚の導電性ゲル32を介して生体等に印加される。 The two conductive gels 32 are arranged in the two openings of the frame portion 31. The space between the two conductive gels 32 is insulated by a non-conductive frame portion 31. Since the conductive gel 32 has adhesiveness, the electrical stimulus applying device 1 can be attached to a living body or the like. In a state where the sheet material 30 is attached to the back surface side of the application portion 20, the two conductive gels 32 are in one-to-one contact with the first electrode 102a and the second electrode 102b, respectively. As a result, when the electric stimulus applying device 1 is attached to the living body or the like by the sheet material 30, and the electric stimulus is output from the electrode portion, the electric stimulus is applied to the living body or the like via the two conductive gels 32. It is applied.
 ユーザは、定期的又は不定期的に、シート材30を取り替えて使用する。つまり、ユーザは、定期的又は不定期的に、新たなシート材30を用いて電気刺激印加装置1を生体等に貼付して使用する。これにより、シート材30の導電性ゲル32の性質が変化して、導電性が劣化することを防ぐことができる。また、新たなシート材30を使用することにより、粘着性が劣化して電気刺激印加装置1が生体等からはがれることを防ぐことができる。 The user replaces and uses the sheet material 30 on a regular or irregular basis. That is, the user regularly or irregularly uses the new sheet material 30 to attach the electrical stimulus application device 1 to a living body or the like. As a result, it is possible to prevent the properties of the conductive gel 32 of the sheet material 30 from changing and the conductivity from deteriorating. Further, by using the new sheet material 30, it is possible to prevent the electrical stimulation application device 1 from being peeled off from the living body or the like due to deterioration of the adhesiveness.
 なお、本実施形態では、上述したように、印加部20という1つの構成機器に、第1電極102a及び第2電極102bという2枚の電極が配置されている。しかしながら、第1電極102a及び第2電極102bは、例えば、異なる構成機器に別々に配置されていてもよい。本実施形態のように、1つの構成機器に2枚の電極が配置されている場合には、2枚の電極が異なる構成機器に別々に配置されている場合と比較して、生体等に貼付する構成機器の数量を減らすことができるため、ユーザの利便性が高まる。 In the present embodiment, as described above, two electrodes, the first electrode 102a and the second electrode 102b, are arranged in one constituent device called the application unit 20. However, the first electrode 102a and the second electrode 102b may be arranged separately in different constituent devices, for example. When two electrodes are arranged in one constituent device as in the present embodiment, the two electrodes are attached to a living body or the like as compared with the case where the two electrodes are arranged separately in different constituent devices. Since the number of constituent devices to be used can be reduced, the convenience of the user is improved.
 図4は、図1の電気刺激印加装置1の概略構成を示す機能ブロック図である。図4に示すように、電気刺激印加装置1は、入力部101と、電極部102と、制御部103と、表示部104と、タイマ部105と、記憶部106と、電源部107と、ヒータ108と、温度測定部109と、電気刺激出力部110とを備える。入力部101、制御部103、表示部104、タイマ部105、記憶部106、電源部107、及び電気刺激出力部110は、例えば本体部10に設けられる。電極部102、ヒータ108、及び温度測定部109は、例えば印加部20に設けられる。ただし、各機能部が本体部10及び印加部20のいずれに設けられるかについては、本明細書に記載の機能を発揮する限り、ここで示した例に限られない。 FIG. 4 is a functional block diagram showing a schematic configuration of the electrical stimulation application device 1 of FIG. As shown in FIG. 4, the electrical stimulation application device 1 includes an input unit 101, an electrode unit 102, a control unit 103, a display unit 104, a timer unit 105, a storage unit 106, a power supply unit 107, and a heater. It includes 108, a temperature measuring unit 109, and an electrical stimulation output unit 110. The input unit 101, the control unit 103, the display unit 104, the timer unit 105, the storage unit 106, the power supply unit 107, and the electrical stimulation output unit 110 are provided in, for example, the main body unit 10. The electrode unit 102, the heater 108, and the temperature measuring unit 109 are provided in, for example, the applying unit 20. However, whether each functional unit is provided in the main body unit 10 or the application unit 20 is not limited to the example shown here as long as the functions described in the present specification are exhibited.
 入力部101は、ユーザからの操作入力を受け付けるものであり、例えば、操作ボタンにより構成される。本実施形態では、入力部101は、上述したように、第1入力部101a、第2入力部101b及び第3入力部101cという3つの操作ボタンにより構成される。なお、入力部101は、例えばタッチスクリーンにより構成され、表示デバイスの一部にユーザからの操作入力を受け付ける入力領域を表示して、ユーザによるタッチ操作入力を受け付けてもよい。ユーザにより、入力部101に対する操作入力が行われると、例えば操作入力に応じた電気信号が制御部103に送信される。 The input unit 101 receives an operation input from the user, and is composed of, for example, operation buttons. In the present embodiment, as described above, the input unit 101 is composed of three operation buttons, a first input unit 101a, a second input unit 101b, and a third input unit 101c. The input unit 101 may be configured by, for example, a touch screen, display an input area for receiving an operation input from the user on a part of the display device, and may accept the touch operation input by the user. When an operation input is made to the input unit 101 by the user, for example, an electric signal corresponding to the operation input is transmitted to the control unit 103.
 電極部102は、電気刺激出力部110から受信した信号に基づき、電気刺激を出力する。電極部102は、例えば上述したように、第1電極102a及び第2電極102bという2枚の電極により構成される。 The electrode unit 102 outputs an electrical stimulus based on the signal received from the electrical stimulus output unit 110. As described above, the electrode portion 102 is composed of two electrodes, a first electrode 102a and a second electrode 102b, for example.
 制御部103は、電気刺激印加装置1の各機能部をはじめとして、電気刺激印加装置1の全体を制御及び管理する。制御部103は、少なくとも1つのプロセッサを含んで構成される。制御部103は、制御手順を規定したプログラムを実行するCPU(Central Processing Unit)等のプロセッサ又は各機能の処理に特化した専用のプロセッサで構成される。 The control unit 103 controls and manages the entire electrical stimulus application device 1, including each functional unit of the electrical stimulus application device 1. The control unit 103 includes at least one processor. The control unit 103 is composed of a processor such as a CPU (Central Processing Unit) that executes a program that defines a control procedure, or a dedicated processor that specializes in processing each function.
 制御部103は、電極部102からの電気刺激の出力を制御する。制御部103は、電気刺激の出力強度を変更可能である。制御部103は、例えば、パルス直流電流の大きさを変化させることにより、電気刺激の出力強度を変更可能である。制御部103は、電気刺激印加装置1により実行される治療の処理を制御する。具体的には、制御部103は、電気刺激印加装置1の各機能部を制御することにより、設定段階における微弱な電気刺激の出力強度の設定と、治療段階における治療とを制御する。また、制御部103は、所定のタイミングで、設定段階において設定した通知強度の電気刺激を生体等に印加することにより、ユーザに対して通知を行う。制御部103が実行する処理の詳細については、後述する。 The control unit 103 controls the output of electrical stimulation from the electrode unit 102. The control unit 103 can change the output intensity of the electrical stimulation. The control unit 103 can change the output intensity of the electrical stimulus by, for example, changing the magnitude of the pulsed direct current. The control unit 103 controls the processing of the treatment executed by the electrical stimulation application device 1. Specifically, the control unit 103 controls the setting of the output intensity of the weak electric stimulus in the setting stage and the treatment in the treatment stage by controlling each functional unit of the electric stimulus applying device 1. In addition, the control unit 103 notifies the user at a predetermined timing by applying an electrical stimulus having a notification intensity set in the setting stage to the living body or the like. The details of the process executed by the control unit 103 will be described later.
 表示部104は、液晶ディスプレイ、有機ELディスプレイ、又は無機ELディスプレイ等の表示デバイスである。表示部104は、制御部103による制御に基づき、様々な情報を表示する。表示部104は、例えば、電気刺激印加装置1が実行している処理の段階、つまり設定段階又は治療段階を表示してよい。また、表示部104は、例えば、治療の進行度を表示してよい。治療の進行度は、治療段階における進行の程度である。具体的には、治療の進行度は、例えば治療段階の時間が定められている場合、その時間のうちどの程度の割合が終了したかを示す情報であってよい。表示部104は、例えば、制御部103がユーザによる入力部101への操作入力を検出したとき、検出した操作入力の内容を表示してもよい。表示部104は、その他、治療に関連してユーザに通知する任意の情報を表示してよい。なお、図1では、表示部104の図示を省略している。 The display unit 104 is a display device such as a liquid crystal display, an organic EL display, or an inorganic EL display. The display unit 104 displays various information based on the control by the control unit 103. The display unit 104 may display, for example, the stage of processing executed by the electrical stimulation application device 1, that is, the setting stage or the treatment stage. In addition, the display unit 104 may display, for example, the progress of treatment. The degree of progression of treatment is the degree of progression at the stage of treatment. Specifically, the progress of treatment may be information indicating, for example, when the time of the treatment stage is set, how much of the time is completed. For example, when the control unit 103 detects an operation input to the input unit 101 by the user, the display unit 104 may display the content of the detected operation input. The display unit 104 may display any other information to be notified to the user in relation to the treatment. Note that in FIG. 1, the display unit 104 is not shown.
 電気刺激印加装置1は、必ずしも表示部104を備えていなくてもよい。電気刺激印加装置1は、表示部104に代えて、又は表示部104とともに、情報をユーザに通知する他の機構を備えていてもよい。例えば、電気刺激印加装置1は、音により情報をユーザに通知するスピーカを備えていてもよい。例えば、電気刺激印加装置1は、振動により情報をユーザに通知する振動子を備えていてもよい。なお、本開示においては、後述するように、電気刺激印加装置1による電気刺激の出力により、情報を通知することができるため、電気刺激印加装置1は、必ずしも、表示部や、その他情報を通知する機能部を備えていなくてもよい。 The electrical stimulus application device 1 does not necessarily have to include the display unit 104. The electrical stimulation application device 1 may include another mechanism for notifying the user of information in place of the display unit 104 or together with the display unit 104. For example, the electrical stimulation application device 1 may include a speaker that notifies the user of information by sound. For example, the electrical stimulation application device 1 may include an oscillator that notifies the user of information by vibration. In the present disclosure, as will be described later, information can be notified by the output of the electric stimulus by the electric stimulus applying device 1, so that the electric stimulus applying device 1 does not necessarily notify the display unit and other information. It is not necessary to have a functional unit to perform the function.
 タイマ部105は、制御部103の制御に基づき、時間を計測する。例えば、タイマ部105は、治療段階を開始してからの経過時間を計測する。また、例えば、タイマ部105は、パルス直流電流の電気刺激を印加してからの経過時間を計測する。 The timer unit 105 measures the time based on the control of the control unit 103. For example, the timer unit 105 measures the elapsed time from the start of the treatment stage. Further, for example, the timer unit 105 measures the elapsed time after applying the electrical stimulation of the pulsed direct current.
 記憶部106は、半導体メモリ又は磁気メモリ等で構成することができる。記憶部106は、例えば、各種情報及び電気刺激印加装置1を動作させるためのプログラム等を記憶する。記憶部106は、ワークメモリとしても機能してもよい。 The storage unit 106 can be composed of a semiconductor memory, a magnetic memory, or the like. The storage unit 106 stores, for example, various information and a program for operating the electrical stimulation application device 1. The storage unit 106 may also function as a work memory.
 電源部107は、電気刺激印加装置1の各機能部に電力を供給するバッテリである。 The power supply unit 107 is a battery that supplies electric power to each functional unit of the electrical stimulation application device 1.
 ヒータ108は、温熱を印加する。ヒータ108は、例えば電熱線等の、電力の供給により発熱する部材により構成されている。ヒータ108は、例えば電源部107から電力の供給を受けて発熱する。ヒータ108が発熱すると、電気刺激印加装置1が貼付された生体等に、温熱が伝達される。 Heater 108 applies heat. The heater 108 is composed of a member that generates heat by supplying electric power, such as a heating wire. The heater 108 generates heat by receiving electric power from, for example, the power supply unit 107. When the heater 108 generates heat, the heat is transmitted to the living body or the like to which the electric stimulus applying device 1 is attached.
 温度測定部109は、ヒータ108の温度を測定する。温度測定部109は、例えば温度計等の、温度を検出可能なセンサを含んで構成されている。温度測定部109は、測定した温度に応じた電気信号を制御部103に送信することにより、測定した温度に関する情報を制御部103に伝達する。 The temperature measuring unit 109 measures the temperature of the heater 108. The temperature measuring unit 109 is configured to include a sensor capable of detecting the temperature, such as a thermometer. The temperature measuring unit 109 transmits information regarding the measured temperature to the control unit 103 by transmitting an electric signal corresponding to the measured temperature to the control unit 103.
 電気刺激出力部110は、制御部103の制御に基づき、電極部102から電気刺激を出力させる。 The electrical stimulation output unit 110 outputs an electrical stimulation from the electrode unit 102 based on the control of the control unit 103.
 次に、電気刺激印加装置1の制御部103による制御の詳細について、電気刺激印加装置1の使用方法とあわせて説明する。ここでは、電気刺激印加装置1は、生体であるユーザの腹部に貼付して使用されるとして説明する。すなわち、ここでは、ユーザの腹部において治療を行うとして説明する。 Next, the details of the control by the control unit 103 of the electric stimulus applying device 1 will be described together with the usage method of the electric stimulating applying device 1. Here, the electrical stimulation application device 1 will be described as being used by being attached to the abdomen of a user who is a living body. That is, here, it is described that the treatment is performed in the abdomen of the user.
 電気刺激印加装置1の使用にあたり、ユーザは、電気刺激印加装置1を、シート材30を用いて腹部に貼付する。そして、ユーザは、例えば第1入力部101aを押下することにより、電気刺激印加装置1の電源のオンにする。ユーザは、第2入力部101bを押下することにより、電気刺激印加装置1による治療を開始させることができる。すなわち、電気刺激印加装置1は、設定段階と治療段階とにより行われる治療を開始する。 When using the electrical stimulation application device 1, the user attaches the electrical stimulation application device 1 to the abdomen using the sheet material 30. Then, the user turns on the power of the electric stimulus applying device 1 by, for example, pressing the first input unit 101a. The user can start the treatment by the electric stimulus applying device 1 by pressing the second input unit 101b. That is, the electrical stimulation application device 1 starts the treatment performed by the setting stage and the treatment stage.
 図5は、図4の制御部103による電気刺激と温熱との出力の制御の一例を模式的に示す制御チャートである。図5には、電気刺激の出力のチャートと、ヒータ108のオン及びオフの切替えのチャートとが示されている。図5のチャートにおいて、横軸は時刻を示す。図5において、電気刺激の出力のチャートの縦軸は、電気刺激の出力強度を示す。図5において、ヒータ108のオン及びオフの切替えのチャートの縦軸は、ヒータ108のオン及びオフの状態を示す。 FIG. 5 is a control chart schematically showing an example of control of the output of electrical stimulation and heat by the control unit 103 of FIG. FIG. 5 shows a chart of the output of the electrical stimulation and a chart of switching the heater 108 on and off. In the chart of FIG. 5, the horizontal axis represents time. In FIG. 5, the vertical axis of the electrical stimulation output chart indicates the electrical stimulation output intensity. In FIG. 5, the vertical axis of the chart for switching the heater 108 on and off indicates the on and off states of the heater 108.
 図6は、図4の制御部103が設定段階において実行する処理の一例を示すフローチャートである。図7は、図4の制御部103が治療段階において実行する処理の一例を示すフローチャートである。 FIG. 6 is a flowchart showing an example of processing executed by the control unit 103 of FIG. 4 at the setting stage. FIG. 7 is a flowchart showing an example of processing executed by the control unit 103 of FIG. 4 in the treatment stage.
 ここで、図5及び図6を参照して、設定段階における制御部103が実行する処理の詳細について説明する。図5の時刻t1は、設定段階の開始時刻である。また、設定段階の開始時点において、ヒータ108はオフの状態であるとする。 Here, the details of the processing executed by the control unit 103 in the setting stage will be described with reference to FIGS. 5 and 6. The time t 1 in FIG. 5 is the start time of the setting stage. Further, it is assumed that the heater 108 is in the off state at the start of the setting stage.
 制御部103は、設定段階において、電気刺激の出力強度を漸増させるように、電極部102から電気刺激を出力する。具体的には、制御部103は、まず電気刺激を出力する(ステップS10)。このとき、制御部103は、電気刺激の出力強度の漸増の処理において、最も低い出力強度P1で電気刺激を出力する。出力強度P1は、ほとんど全てのユーザにとって脱分極を惹起させないレベルの微弱な電気刺激であることが好ましい。すなわち、出力強度P1は、ほとんど全てのユーザが電気刺激を感知しないレベルの微弱な電気刺激であることが好ましい。出力強度P1は、電気刺激印加装置1において、予め設定されていてよい。制御部103は、図5に示すように、出力強度P1の電気刺激のパルス直流電流を、所定の周期で複数回出力してよい。 At the setting stage, the control unit 103 outputs the electrical stimulus from the electrode unit 102 so as to gradually increase the output intensity of the electrical stimulus. Specifically, the control unit 103 first outputs an electrical stimulus (step S10). At this time, the control unit 103 outputs the electrical stimulus at the lowest output intensity P 1 in the process of gradually increasing the output intensity of the electrical stimulus. The output intensity P 1 is preferably a weak electrical stimulus at a level that does not cause depolarization for almost all users. That is, the output intensity P 1 is preferably a weak electrical stimulus at a level at which almost all users do not perceive the electrical stimulus. The output intensity P 1 may be preset in the electrical stimulation application device 1. As shown in FIG. 5, the control unit 103 may output the pulsed direct current of the electrical stimulation of the output intensity P 1 a plurality of times in a predetermined cycle.
 設定段階が開始した場合、ユーザは、電気刺激を感知したときに、第3入力部101cを押下する。すなわち、設定段階が開始してから最初に第3入力部101cに対して行われる押下の操作入力は、電気刺激の感知がある状態となったときに入力されるものである。この電気刺激の感知がある状態となったときに行われる操作入力を、本明細書では、以下、「感知入力」とも称する。感知入力は、本開示における第2の操作入力に該当する。 When the setting stage is started, the user presses the third input unit 101c when the electrical stimulus is detected. That is, the pressing operation input that is first performed on the third input unit 101c after the setting stage starts is input when the electrical stimulation is sensed. In the present specification, the operation input performed when the electric stimulus is sensed is also referred to as "sensing input" below. The sensory input corresponds to the second operation input in the present disclosure.
 制御部103は、ステップS10における電気刺激の出力を実行したときに、ユーザにより感知入力が検出されたかを判定する(ステップS11)。すなわち、制御部103は、ステップS10における電気刺激の出力を実行したときに、ユーザにより第3入力部101cが押下されたか否かを判定する。 The control unit 103 determines whether or not the sensory input is detected by the user when the output of the electrical stimulus in step S10 is executed (step S11). That is, the control unit 103 determines whether or not the third input unit 101c is pressed by the user when the output of the electrical stimulation in step S10 is executed.
 制御部103は、感知入力を検出していない場合(ステップS11のNo)、電気刺激の出力強度を上げる(ステップS12)。そして、ステップS10に移行し、ステップS12で上げた出力強度で、再度電気刺激を出力する(ステップS10)。ステップS12において、制御部103は、電気刺激の出力強度を、例えば予め定められた所定の強度幅で、上げてよい。図5に示す例では、制御部103は、出力強度P1で電気刺激を出力し、感知入力を検出していない場合、次に、出力強度P2で電気刺激を出力している。また、制御部103は、ステップS10における電気刺激の出力を開始してから、所定時間後に、ステップS12を経て上昇させた電気刺激の強度で、ステップS10における電気刺激の出力を開始してよい。図5に示す例では、制御部103は、時刻t1において、ステップS10における出力強度P1の電気刺激の出力を開始した後、所定時間後の時刻t2に、出力強度P2の電気刺激の出力を開始している。 When the control unit 103 does not detect the sensing input (No in step S11), the control unit 103 increases the output intensity of the electrical stimulation (step S12). Then, the process proceeds to step S10, and the electrical stimulus is output again with the output intensity increased in step S12 (step S10). In step S12, the control unit 103 may increase the output intensity of the electrical stimulation by, for example, a predetermined intensity range set in advance. In the example shown in FIG. 5, the control unit 103 outputs the electrical stimulus at the output intensity P 1 , and when the sensing input is not detected, then outputs the electrical stimulus at the output intensity P 2 . Further, the control unit 103 may start the output of the electric stimulus in the step S10 with the intensity of the electric stimulus increased in the step S12 after a predetermined time after starting the output of the electric stimulus in the step S10. In the example shown in FIG. 5, the control unit 103 starts the output of the electrical stimulation of the output intensity P 1 in step S10 at the time t 1 , and then the electrical stimulation of the output intensity P 2 at the time t 2 after a predetermined time. Is starting to output.
 制御部103は、ステップS11において、感知入力を検出したと判定するまで、ステップS12における電気刺激の強度の上昇と、ステップS10における電気刺激の出力を繰り返す。この繰り返しにより、制御部103は、電気刺激の出力強度を漸増させることができる。図5に示す例では、制御部103は、電気刺激の出力強度を、P1、P2、P3、P4、P5、P6、P7の順に上昇させて、出力している。図5における時刻t1、t2、t3、t4、t5、t6及びt7は、それぞれ出力強度P1、P2、P3、P4、P5、P6及びP7の電気刺激の出力を開始した時刻を示す。電気刺激の出力強度を漸増させる処理において、各出力強度での電気刺激のパルス直流電流を出力させる時間の長さは、一定であってよい。例えば、図5に示すように、各出力強度での電気刺激のパルス直流電流を出力させる時間の長さは、いずれの出力強度の場合も、TAであってよい。 The control unit 103 repeats the increase in the intensity of the electrical stimulus in step S12 and the output of the electrical stimulus in step S10 until it is determined in step S11 that the sensing input has been detected. By repeating this, the control unit 103 can gradually increase the output intensity of the electrical stimulation. In the example shown in FIG. 5, the control unit 103 increases the output intensity of the electrical stimulation in the order of P 1 , P 2 , P 3 , P 4 , P 5 , P 6 , and P 7 to output. The times t 1 , t 2 , t 3 , t 4 , t 5 , t 6 and t 7 in FIG. 5 are the output intensities P 1 , P 2 , P 3 , P 4 , P 5 , P 6 and P 7 , respectively. Indicates the time when the output of the electrical stimulus was started. In the process of gradually increasing the output intensity of the electrical stimulus, the length of time for outputting the pulsed DC current of the electrical stimulus at each output intensity may be constant. For example, as shown in FIG. 5, the length of time for outputting a pulse direct current electrical stimulation at each output intensity, in either case the output intensity may be T A.
 制御部103は、入力部101に対する所定の操作入力を検出すると、電気刺激の通知強度を設定する。本実施形態では、制御部103は、第3入力部101cに対する感知入力を検出した場合に、通知強度を設定する。 When the control unit 103 detects a predetermined operation input to the input unit 101, the control unit 103 sets the notification intensity of the electrical stimulation. In the present embodiment, the control unit 103 sets the notification intensity when the sensing input to the third input unit 101c is detected.
 具体的には、制御部103は、感知入力を検出した場合(ステップS11のYes)、感知入力を検出したときに出力される電気刺激の出力強度を記憶部106に記憶する(ステップS13)。ここで、本明細書において、感知入力を検出したときに出力される電気刺激の出力強度を、第1基準出力強度Pupという。図5は、出力強度P7で電気刺激の出力をしているときに感知入力が検出された場合の例を示している。この例では、第1基準出力強度Pup=P7が成立する。 Specifically, when the control unit 103 detects the sensing input (Yes in step S11), the control unit 103 stores the output intensity of the electrical stimulus output when the sensing input is detected in the storage unit 106 (step S13). Here, in the present specification, the output intensity of the electrical stimulus output when the sensing input is detected is referred to as the first reference output intensity P up . FIG. 5 shows an example in which a sensing input is detected while outputting an electrical stimulus with an output intensity P 7 . In this example, the first reference output intensity P up = P 7 is established.
 制御部103は、第1基準出力強度Pupに基づき、通知強度を設定する(ステップS14)。ステップS14において、制御部103は、第1基準出力強度Pupよりも高い所定の出力強度を、通知強度として設定する。 The control unit 103 sets the notification intensity based on the first reference output intensity P up (step S14). In step S14, the control unit 103 sets a predetermined output intensity higher than the first reference output intensity P up as the notification intensity.
 通知強度の設定方法は、適宜定められてよい。例えば、制御部103は、第1基準出力強度Pupよりも所定強度高い出力強度を、通知強度として設定してよい。また、例えば、制御部103は、第1基準出力強度Pupに対して、1より大きい係数を乗じた出力強度を、通知強度として設定してよい。ここでは、制御部103は、第1基準出力強度Pupに対して、係数として1.2を乗じた出力強度を、通知強度Paとして設定するとして、以下説明する。すなわち、ここで説明する例においては通知強度Pa=1.2×第1基準出力強度Pupが成立する。 The method of setting the notification intensity may be appropriately determined. For example, the control unit 103 may set an output intensity higher than the first reference output intensity P up by a predetermined intensity as the notification intensity. Further, for example, the control unit 103 may set the output intensity obtained by multiplying the first reference output intensity P up by a coefficient larger than 1 as the notification intensity. Here, the control unit 103 will be described below assuming that the output intensity obtained by multiplying the first reference output intensity P up by 1.2 as a coefficient is set as the notification intensity Pa. That is, in the example described here, the notification intensity Pa = 1.2 × the first reference output intensity P up is established.
 なお、ステップS14における通知強度の設定は、必ずしもステップS15の前に実行されなくてもよい。ステップS14における通知強度の設定は、設定段階が終了するまで、すなわち図6のフローが終了するまでに完了していればよい。 Note that the notification intensity setting in step S14 does not necessarily have to be executed before step S15. The setting of the notification intensity in step S14 may be completed by the end of the setting step, that is, by the end of the flow of FIG.
 次に、制御部103は、設定段階において、電気刺激の出力強度を漸減させるように、電極部102から電気刺激を出力する。具体的には、制御部103は、まず電気刺激を出力する(ステップS15)。このとき、制御部103は、電気刺激の出力強度を漸増させている際に入力部101に対する感知入力を検出したときに出力される電気刺激の出力強度、つまり第1基準出力強度Pupから、電気刺激の出力強度を漸減させながら、電気刺激を出力してよい。つまり、図5に示す例の場合、制御部103は、電気刺激の出力強度の漸減を開始する際に、まず第1基準出力強度Pup=P7で、電気刺激を出力してよい。このようにすることで、電気刺激の出力強度を漸減させる処理において、過度に強い電気刺激を生体等に与えることがない。 Next, the control unit 103 outputs the electrical stimulus from the electrode unit 102 so as to gradually reduce the output intensity of the electrical stimulus at the setting stage. Specifically, the control unit 103 first outputs an electrical stimulus (step S15). At this time, from the output intensity of the electrical stimulus output when the control unit 103 detects the sensing input to the input unit 101 while gradually increasing the output intensity of the electrical stimulus, that is, from the first reference output intensity P up . The electrical stimulus may be output while gradually reducing the output intensity of the electrical stimulus. That is, in the case of the example shown in FIG. 5, when starting the gradual decrease of the output intensity of the electrical stimulus, the control unit 103 may first output the electrical stimulus with the first reference output intensity P up = P 7 . By doing so, in the process of gradually reducing the output intensity of the electrical stimulus, an excessively strong electrical stimulus is not applied to the living body or the like.
 制御部103は、図5に示すように、出力強度P7の電気刺激のパルス直流電流を、所定の周期で複数回出力してよい。図5に示す例では、時刻t8に電気刺激の出力強度を漸減させるように出力する処理が開始されている。 As shown in FIG. 5, the control unit 103 may output the pulsed direct current of the electrical stimulation of the output intensity P 7 a plurality of times in a predetermined cycle. In the example shown in FIG. 5, the processing of outputting so as to gradually decrease the output intensity of the electrical stimulus at time t 8 is started.
 感知入力を入力した後、ユーザは、電気刺激を感知しなくなったときに、第3入力部101cを、再び押下する。すなわち、設定段階が開始してから2回目に第3入力部101cに対して行われる押下の操作入力は、電気刺激の感知がなくなった状態となったときに入力されるものである。この電気刺激の感知がなくなった状態となったときに行われる操作入力を、本明細書では、以下、「非感知入力」とも称する。非感知入力は、本開示における第1の操作入力に該当する。 After inputting the sensing input, the user presses the third input unit 101c again when the electrical stimulation is no longer sensed. That is, the pressing operation input performed on the third input unit 101c for the second time after the setting stage starts is input when the detection of the electrical stimulus is lost. In the present specification, the operation input performed when the detection of the electrical stimulus is lost is also referred to as "non-sensing input" below. The non-sensing input corresponds to the first operation input in the present disclosure.
 制御部103は、ステップS15における電気刺激の出力を実行したときに、ユーザにより非感知入力が検出されたかを判定する(ステップS16)。すなわち、制御部103は、ステップS15における電気刺激の出力を実行したときに、ユーザにより第3入力部101cが押下されたか否かを判定する。 The control unit 103 determines whether or not a non-sensing input is detected by the user when the output of the electrical stimulation in step S15 is executed (step S16). That is, the control unit 103 determines whether or not the third input unit 101c is pressed by the user when the output of the electrical stimulation in step S15 is executed.
 制御部103は、非感知入力を検出していない場合(ステップS16のNo)、電気刺激の出力強度を下げる(ステップS17)。そして、ステップS15に移行し、ステップS17で下げた出力強度で、再度電気刺激を出力する(ステップS15)。ステップS17において、制御部103は、電気刺激の出力強度を、例えば予め定められた所定の強度幅で、下げてよい。 When the control unit 103 does not detect the non-sensing input (No in step S16), the control unit 103 lowers the output intensity of the electrical stimulation (step S17). Then, the process proceeds to step S15, and the electrical stimulus is output again with the output intensity lowered in step S17 (step S15). In step S17, the control unit 103 may reduce the output intensity of the electrical stimulation by, for example, a predetermined intensity range.
 ここで、制御部103がステップS15からステップS17で電気刺激の出力強度を漸減させるときの勾配は、制御部103がステップS10からステップS12で電気刺激の出力強度を漸増させるときの勾配と比較して、緩やかであってよい。具体的には、例えば、制御部103は、ステップS17における電気刺激の出力強度の下げ幅を、ステップS12における電気刺激の出力強度の上げ幅よりも、小さくしてよい。あるいは、例えば、制御部103は、ステップS17において電気刺激の出力強度を下げるまでにステップS15でパルス直流電流を出力する時間を、ステップS12において電気刺激の出力強度を上げるまでにステップS10でパルス直流電流を出力する時間よりも、長くしてよい。ユーザにとって、電気刺激を感知していない状態から感知している状態への移行の判断よりも、電気刺激を感知している状態から感知していない状態への移行の判断の方が、難しい場合がある。このような場合、上述のように電気刺激の出力強度を漸減させる勾配を緩やかにすることにより、ユーザに、感知していない状態への移行を判断させるために、より長い時間を確保することができる。 Here, the gradient when the control unit 103 gradually reduces the output intensity of the electrical stimulation from step S15 to step S17 is compared with the gradient when the control unit 103 gradually increases the output intensity of the electrical stimulation from step S10 to step S12. It may be gentle. Specifically, for example, the control unit 103 may make the decrease in the output intensity of the electrical stimulus in step S17 smaller than the increase in the output intensity of the electrical stimulus in step S12. Alternatively, for example, the control unit 103 takes the time to output the pulsed direct current in step S15 until the output intensity of the electrical stimulus is lowered in step S17, and the pulsed direct current in step S10 until the output intensity of the electrical stimulus is increased in step S12. It may be longer than the time to output the current. When it is more difficult for the user to judge the transition from the state in which the electrical stimulus is sensed to the state in which the electrical stimulus is not sensed than the judgment of the transition from the state in which the electric stimulus is not sensed to the state in which the electric stimulus is sensed There is. In such a case, by gradually reducing the output intensity of the electrical stimulus as described above, it is possible to secure a longer time for the user to judge the transition to the unsensed state. it can.
 図5に示す例では、制御部103は、ステップS12で電気刺激の出力強度を上げたときと同じ幅で、ステップS17において、電気刺激の出力強度を下げる。つまり、図5に示す例では、制御部103は、出力強度を漸減させながら電気刺激を出力させる処理において、出力強度P7の電気刺激から、出力強度P6、P5、P4のように、出力強度を下げる。このとき、各出力強度での電気刺激のパルス直流電流を出力させる時間の長さは、電気刺激の出力強度を漸増させたときの、各出力強度での電気刺激のパルス直流電流を出力させる時間の長さTAよりも長い。例えば、図5に示すように、電気刺激の出力強度を漸減させる処理において、各出力強度での電気刺激のパルス直流電流を出力させる時間の長さは、いずれの出力強度の場合も、TBであってよい。ここで、TB>TAが成立する。 In the example shown in FIG. 5, the control unit 103 reduces the output intensity of the electrical stimulation in step S17 by the same width as when the output intensity of the electrical stimulation is increased in step S12. That is, in the example shown in FIG. 5, in the process of outputting the electrical stimulus while gradually reducing the output intensity, the control unit 103 changes from the electrical stimulus of the output intensity P 7 to the output intensities P 6 , P 5 , and P 4 . , Lower the output strength. At this time, the length of time for outputting the pulsed DC current of the electric stimulus at each output intensity is the time for outputting the pulsed DC current of the electric stimulus at each output intensity when the output intensity of the electric stimulus is gradually increased. longer than the length T a. For example, as shown in FIG. 5, in the process of gradually decreasing the output intensity of the electric stimulation, the length of time to output a pulse direct current electrical stimulation at each output intensity, in either case the output intensity, T B It may be. Here, T B> T A is satisfied.
 制御部103は、ステップS16において、非感知入力を検出したと判定するまで、ステップS17における電気刺激の強度の下降と、ステップS15における電気刺激の出力を繰り返す。この繰り返しにより、制御部103は、電気刺激の出力強度を漸減させることができる。図5に示す例では、制御部103は、電気刺激の出力強度を、P7、P6、P5、P4の順に下降させて、出力している。図5における時刻t8、t9、t10、及びt11は、電気刺激の出力強度を漸減させる処理において、それぞれ出力強度P7、P6、P5及びP4の電気刺激の出力を開始した時刻を示す。 The control unit 103 repeats the decrease in the intensity of the electrical stimulus in step S17 and the output of the electrical stimulus in step S15 until it is determined in step S16 that the non-sensing input has been detected. By repeating this, the control unit 103 can gradually reduce the output intensity of the electrical stimulation. In the example shown in FIG. 5, the control unit 103 outputs the output intensity of the electrical stimulation by decreasing it in the order of P 7 , P 6 , P 5 , and P 4 . At times t 8 , t 9 , t 10 and t 11 in FIG. 5, the output of the electrical stimuli of the output intensities P 7 , P 6 , P 5 and P 4 is started in the process of gradually reducing the output intensity of the electrical stimulus. Indicates the time of day.
 制御部103は、入力部101に対する非感知入力を検出すると、治療段階における治療の処理で用いる電気刺激の出力強度を設定する。治療段階における治療の処理で用いる電気刺激の出力強度を、本明細書では、以下「治療強度」とも称する。本実施形態では、制御部103は、非感知入力を検出した場合に、治療強度を設定する。 When the control unit 103 detects a non-sensing input to the input unit 101, the control unit 103 sets the output intensity of the electrical stimulus used in the treatment process in the treatment stage. The output intensity of the electrical stimulus used in the treatment process at the therapeutic stage is also hereinafter referred to as "therapeutic intensity" in the present specification. In this embodiment, the control unit 103 sets the treatment intensity when it detects a non-sensing input.
 具体的には、制御部103は、非感知入力を検出した場合(ステップS16のYes)、非感知入力を検出したときに出力される電気刺激の出力強度を記憶部106に記憶する(ステップS18)。ここで、本明細書において、非感知入力を検出したときに出力される電気刺激の出力強度を、第2基準出力強度Pdownという。図5は、出力強度P4で電気刺激の出力をしているときに非感知入力が検出された場合の例を示している。この例では、第2基準出力強度Pdown=P4が成立する。 Specifically, when the control unit 103 detects the non-sensing input (Yes in step S16), the control unit 103 stores the output intensity of the electrical stimulus output when the non-sensing input is detected in the storage unit 106 (step S18). ). Here, in the present specification, the output intensity of the electrical stimulus output when a non-sensing input is detected is referred to as a second reference output intensity P down . Figure 5 is a non-sensitive input indicates an example of a case where it is detected when the output of the electrical stimulation in output intensity P 4. In this example, the second reference output intensity P down = P 4 is established.
 制御部103は、第2基準出力強度Pdownに基づき、治療強度を設定する(ステップS19)。ステップS19において、制御部103は、第2基準出力強度Pdownよりも低い所定の出力強度を、治療強度として設定する。 The control unit 103 sets the treatment intensity based on the second reference output intensity P down (step S19). In step S19, the control unit 103 sets a predetermined output intensity lower than the second reference output intensity P down as the therapeutic intensity.
 治療強度の設定方法は、適宜定められてよい。例えば、制御部103は、第2基準出力強度Pdownよりも所定強度低い出力強度を、治療強度として設定してよい。また、例えば、制御部103は、第2基準出力強度Pdownに対して、1未満の係数を乗じた出力強度を、治療強度として設定してよい。ここでは、制御部103は、第2基準出力強度Pdownに対して、係数として0.8を乗じた出力強度を、治療強度Pmとして設定するとして、以下説明する。すなわち、ここで説明する例においては治療強度Pm=0.8×第2基準出力強度Pdownが成立する。 The method for setting the treatment intensity may be appropriately determined. For example, the control unit 103 may set an output intensity lower than the second reference output intensity P down by a predetermined intensity as the therapeutic intensity. Further, for example, the control unit 103 may set the output intensity obtained by multiplying the second reference output intensity P down by a coefficient less than 1 as the therapeutic intensity. Here, the control unit 103 will be described below assuming that the output intensity obtained by multiplying the second reference output intensity P down by 0.8 as a coefficient is set as the therapeutic intensity Pm. That is, in the example described here, the therapeutic intensity Pm = 0.8 × the second reference output intensity P down is established.
 なお、ステップS19における治療強度の設定は、必ずしもステップS20の前に実行されなくてもよい。ステップS19における治療強度の設定は、設定段階が終了するまで、すなわち図6のフローが終了するまでに完了していればよい。 It should be noted that the setting of the treatment intensity in step S19 does not necessarily have to be executed before step S20. The setting of the treatment intensity in step S19 may be completed by the end of the setting step, that is, by the end of the flow of FIG.
 制御部103は、入力部101に対する所定の操作入力(ここでの例では、非感知入力)を検出した後、ヒータ108により生体等を加温し、ヒータ108が所定温度以上となったときに、治療段階を開始してよい。このようなヒータ108による加温は、設定段階において実行されてよい。 After detecting a predetermined operation input (non-sensing input in this example) to the input unit 101, the control unit 103 heats the living body or the like with the heater 108, and when the heater 108 reaches a predetermined temperature or higher. , The treatment phase may be started. Such heating by the heater 108 may be performed at the setting stage.
 具体的には、制御部103は、非感知入力を検出し、治療強度を設定すると、ヒータ108をオンの状態にする(ステップS20)。図5に示すチャートは、時刻t12において、ヒータ108がオンの状態となったことを示している。これにより、ヒータ108に電力が供給され、ヒータ108が発熱を開始する。ヒータ108の発熱により、生体であるユーザの腹部が温められる。 Specifically, the control unit 103 turns on the heater 108 when the non-sensing input is detected and the treatment intensity is set (step S20). Chart shown in Figure 5, at time t 12, indicating that the heater 108 is turned on state. As a result, electric power is supplied to the heater 108, and the heater 108 starts to generate heat. The heat generated by the heater 108 warms the abdomen of the user who is a living body.
 制御部103は、温度測定部109から伝達される信号に基づき、ヒータ108の温度を監視する。具体的には、制御部103は、ヒータ108の温度が所定温度に到達したか否かを判定する(ステップS21)。所定温度は、例えば、電気刺激印加装置1による治療に適した温度であり、予め定められていてよい。 The control unit 103 monitors the temperature of the heater 108 based on the signal transmitted from the temperature measurement unit 109. Specifically, the control unit 103 determines whether or not the temperature of the heater 108 has reached a predetermined temperature (step S21). The predetermined temperature is, for example, a temperature suitable for treatment by the electric stimulus application device 1, and may be predetermined.
 制御部103は、ヒータ108の温度が所定温度に到達していないと判定する場合(ステップS21のNo)、ヒータ108をオンの状態にしたまま、ステップS21を繰り返す。 When the control unit 103 determines that the temperature of the heater 108 has not reached the predetermined temperature (No in step S21), the control unit 103 repeats step S21 while keeping the heater 108 in the ON state.
 制御部103は、ヒータ108の温度が所定温度に到達したと判定した場合(ステップS21のYes)、ヒータ108をオフの状態にする(ステップS22)。図5に示すチャートは、時刻t13において、ヒータ108がオフの状態となったことを示している。 When the control unit 103 determines that the temperature of the heater 108 has reached a predetermined temperature (Yes in step S21), the control unit 103 turns off the heater 108 (step S22). Chart shown in Figure 5, at time t 13, indicating that the heater 108 is turned off.
 制御部103がステップS22においてヒータ108をオフの状態にすると、設定段階が終了する。すなわち、図5に示すチャートでは、時刻t13に設定段階が終了する。設定段階が終了すると、制御部103は、次に治療段階の処理を開始する。 When the control unit 103 turns off the heater 108 in step S22, the setting step ends. That is, in the chart shown in FIG. 5, setting out is finished at time t 13. When the setting stage is completed, the control unit 103 then starts processing in the treatment stage.
 次に、図5及び図7を参照して、治療段階における制御部103が実行する処理の詳細について説明する。治療段階は、例えば設定段階が終了すると、制御部103により自動的に開始されてよい。 Next, with reference to FIGS. 5 and 7, details of the process executed by the control unit 103 in the treatment stage will be described. The treatment stage may be automatically started by the control unit 103, for example, when the setting stage is completed.
 治療段階において、制御部103は、治療強度で電気刺激を生体等に印加することにより治療の処理を行うとともに、所定のタイミングにおいて、通知強度で電気刺激を出力することにより通知を行う。制御部103は、治療強度で連続的な電気刺激をパルス直流電流として印加することにより、治療の処理を行う。 At the treatment stage, the control unit 103 performs treatment processing by applying an electrical stimulus to a living body or the like at a therapeutic intensity, and at a predetermined timing, notifies by outputting an electrical stimulus at a notification intensity. The control unit 103 performs the treatment process by applying a continuous electrical stimulus at the treatment intensity as a pulsed direct current.
 制御部103が通知を行う所定のタイミングは、予め定められていてよい。ここでは、制御部103は、治療の処理の開始と終了とを通知するとして、説明する。この場合、制御部103が通知を行う所定のタイミングは、治療の処理の開始前及び終了後である。治療の処理の開始前は、治療強度における連続的な電気刺激の印加を行う前であり、治療強度における連続的な電気刺激の印加を行う直前であることが好ましい。治療の処理の開始前に行う通知を、本明細書において、以下、「開始通知」とも称する。治療の処理の終了後は、治療強度における連続的な電気刺激の印加を所定時間行った後であり、治療強度における連続的な電気刺激の印加を所定時間行った直後であることが好ましい。ここでの所定時間は、後述する所定時間T4に対応する。治療の処理の終了後に行う通知を、本明細書において、以下、「終了通知」とも称する。 The predetermined timing at which the control unit 103 gives a notification may be predetermined. Here, the control unit 103 will be described as notifying the start and end of the treatment process. In this case, the predetermined timing at which the control unit 103 gives the notification is before the start and after the end of the treatment process. It is preferable that the start of the treatment treatment is before the application of the continuous electrical stimulation at the treatment intensity and immediately before the application of the continuous electrical stimulation at the treatment intensity. The notice given prior to the start of the treatment process is also referred to herein as the "start notice". After the treatment is completed, it is preferable that the continuous electrical stimulation at the treatment intensity is applied for a predetermined time, and immediately after the continuous electrical stimulation at the treatment intensity is applied for a predetermined time. The predetermined time here corresponds to the predetermined time T 4 described later. The notice given after the end of the treatment process is also referred to herein as the "end notice".
 治療段階において、まず、制御部103は、開始通知の電気刺激を出力する(ステップS30)。このとき、制御部103は、図6のフローのステップS14で設定した通知強度で電気刺激を出力する。制御部103は、図5に示すように、開始通知の電気刺激を、パルス直流電流として所定の周期で複数回出力してよい。例えば、図5に示すように、制御部103は、時刻t14で開始通知の電気刺激のパルス直流電流の出力を開始した後、時刻t15まで、開始通知の電気刺激の出力を継続して行ってよい。 In the treatment stage, first, the control unit 103 outputs an electrical stimulus of the start notification (step S30). At this time, the control unit 103 outputs the electrical stimulus with the notification intensity set in step S14 of the flow of FIG. As shown in FIG. 5, the control unit 103 may output the electrical stimulation of the start notification as a pulsed direct current a plurality of times in a predetermined cycle. For example, as shown in FIG. 5, the control unit 103, after starting the output of the pulse direct current of the start notification of the electrical stimulation at time t 14, to the time t 15, continues to output the electrical stimulation of the start notification You may go.
 通知強度は、ユーザが感知入力を行ったときの第1基準出力強度Pupよりも高い強度であるため、通知強度で開始通知の電気刺激を印加されたユーザは、当該開始通知の電気刺激を感知することができる。電気刺激の感知により、ユーザは、治療の処理が開始されることを認識することができる。 Since the notification intensity is higher than the first reference output intensity P up when the user performs the sensing input, the user to whom the electrical stimulus of the start notification is applied at the notification intensity receives the electrical stimulus of the start notification. Can be sensed. Sensing the electrical stimulus allows the user to recognize that the treatment process is initiated.
 開始通知の電気刺激の出力を終了すると、制御部103は、治療の処理を開始する。具体的には、制御部103は、タイマ部105による治療時間タイマをスタートさせる(ステップS31)。治療時間タイマは、治療時間を計測するタイマである。治療時間は、例えば、治療の処理を開始してからの経過時間であってもよく、治療の処理においてパルス直流電流の出力処理を行っている時間であってもよい。ただし、本実施形態では、治療段階において、パルス直流電流の出力処理が中断されないため、治療の処理を開始してからの経過時間は、治療の処理においてパルス直流電流の出力処理を行っている時間と等しくなる。 When the output of the electrical stimulus of the start notification is finished, the control unit 103 starts the treatment process. Specifically, the control unit 103 starts the treatment time timer by the timer unit 105 (step S31). The treatment time timer is a timer that measures the treatment time. The treatment time may be, for example, the elapsed time from the start of the treatment process, or the time during which the pulsed direct current output process is performed in the treatment process. However, in the present embodiment, since the output processing of the pulsed direct current is not interrupted in the treatment stage, the elapsed time from the start of the treatment processing is the time during which the output processing of the pulsed direct current is performed in the treatment processing. Is equal to.
 制御部103は、治療の処理における電気刺激として、パルス直流電流を出力する(ステップS32)。このとき、制御部103は、図6のフローのステップS19で設定した治療強度Pmで、パルス直流電流を出力する。 The control unit 103 outputs a pulsed direct current as an electrical stimulus in the treatment process (step S32). At this time, the control unit 103 outputs a pulsed direct current at the treatment intensity Pm set in step S19 of the flow of FIG.
 制御部103は、ステップS32でパルス直流電流を出力すると、タイマ部105による電気刺激インターバルタイマをスタートする(ステップS33)。電気刺激インターバルタイマは、電気刺激としてのパルス直流電流を出力するインターバルを計測するためのタイマである。言い換えると、電気刺激インターバルタイマは、パルス直流電流を出力してから次のパルス直流電流を出力するまでの時間を計測するためのタイマである。 When the control unit 103 outputs the pulsed direct current in step S32, the control unit 103 starts the electrical stimulation interval timer by the timer unit 105 (step S33). The electrical stimulation interval timer is a timer for measuring an interval for outputting a pulsed direct current as an electrical stimulation. In other words, the electrical stimulation interval timer is a timer for measuring the time from the output of the pulsed direct current to the output of the next pulsed direct current.
 また、制御部103は、ステップS32でパルス直流電流を出力すると、タイマ部105によるヒータONインターバルタイマをスタートする(ステップS34)。ヒータONインターバルタイマは、電気刺激としてのパルス直流電流を出力してから、ヒータ108をオンの状態にするまでのインターバル(時間)を計測するためのタイマである。 Further, when the control unit 103 outputs the pulsed direct current in step S32, the control unit 103 starts the heater ON interval timer by the timer unit 105 (step S34). The heater ON interval timer is a timer for measuring the interval (time) from the output of the pulsed direct current as an electrical stimulus to the turning on of the heater 108.
 制御部103は、ステップS33とステップS34とを同時に実行することが好ましい。つまり、制御部103は、電気刺激インターバルタイマと、ヒータONインターバルタイマとを同時にスタートさせることが好ましい。 It is preferable that the control unit 103 executes step S33 and step S34 at the same time. That is, it is preferable that the control unit 103 starts the electrical stimulation interval timer and the heater ON interval timer at the same time.
 制御部103は、ヒータONインターバルタイマをスタートしてから所定時間T1が経過したか否かを判定する(ステップS35)。所定時間T1は、治療の処理における電気刺激としてのパルス直流電流を出力してからヒータ108をオンの状態にするまでの時間であり、例えば予め設定されていてよい。 The control unit 103 determines whether or not a predetermined time T 1 has elapsed since the heater ON interval timer was started (step S35). The predetermined time T 1 is the time from the output of the pulsed direct current as the electrical stimulation in the treatment process to the turning on of the heater 108, and may be set in advance, for example.
 制御部103は、ヒータONインターバルタイマをスタートしてから所定時間T1が経過していないと判定した場合(ステップS35のNo)、ヒータONインターバルタイマをスタートしてから所定時間T1が経過したと判定されるまで、ステップS35を繰り返す。 When the control unit 103 determines that the predetermined time T 1 has not elapsed since the heater ON interval timer was started (No in step S35), the predetermined time T 1 has elapsed since the heater ON interval timer was started. Step S35 is repeated until it is determined.
 制御部103は、ヒータONインターバルタイマをスタートしてから所定時間T1が経過したと判定した場合(ステップS35のYes)、ヒータ108をオンの状態にする(ステップS36)。 When the control unit 103 determines that the predetermined time T 1 has elapsed since the heater ON interval timer was started (Yes in step S35), the control unit 103 turns on the heater 108 (step S36).
 そして、制御部103は、ヒータ108をオンの状態にしてから、予め定められた所定時間T2経過後に、ヒータ108をオフの状態にする(ステップS37)。ここで、ステップS36及びステップS37におけるヒータ108のオン及びオフの制御は、パルス波として実行されてよい。つまり、この場合、制御部103は、ステップS36においてヒータ108をオンの状態にした後、パルス幅に相当する所定時間T2経過後に、ステップS37においてヒータ108をオフの状態にしてよい。 Then, the control unit 103 turns on the heater 108, and after a predetermined time T 2 elapses, turns the heater 108 off (step S37). Here, the on / off control of the heater 108 in step S36 and step S37 may be executed as a pulse wave. That is, in this case, the control unit 103 may turn on the heater 108 in step S36 and then turn off the heater 108 in step S37 after a predetermined time T 2 corresponding to the pulse width has elapsed.
 次に、制御部103は、電気刺激インターバルタイマをスタートしてから所定時間T3が経過したか否かを判定する(ステップS38)。所定時間T3は、電気刺激としてのパルス直流電流を出力してから次のパルス直流電流を出力するまでの時間であり、例えば予め設定されていてよい。 Next, the control unit 103 determines whether or not a predetermined time T 3 has elapsed since the electrical stimulation interval timer was started (step S38). The predetermined time T 3 is the time from the output of the pulsed direct current as the electrical stimulus to the output of the next pulsed direct current, and may be set in advance, for example.
 制御部103は、電気刺激インターバルタイマをスタートしてから所定時間T3が経過していないと判定した場合(ステップS38のNo)、電気刺激インターバルタイマをスタートしてから所定時間T3が経過したと判定されるまで、ステップS38を繰り返す。 Control unit 103, when it is determined from the start electrical stimulation interval timer that the predetermined time T 3 has not elapsed (No in step S38), a predetermined time T 3 from the start electrical stimulation interval timer has elapsed Step S38 is repeated until it is determined.
 上記フローにおいて、所定時間T3は、所定時間T1及び所定時間T2の和よりも長い。図8は、所定時間T1、T2及びT3の関係について説明するための図であり、例えば、図5の破線で囲った箇所を拡大して示す図である。図8に示すように、治療の処理における第n回目の治療強度のパルス直流電流の出力を開始した時刻をt21とする。第n回目のパルス直流電流の出力後に、ヒータ108がオンの状態となる時刻をt22とし、その後ヒータ108がオフの状態となる時刻をt23とする。また、治療段階における第n+1回目のパルス直流電流の出力を開始する時刻をt24とする。時刻t21、t22、t23及びt24は、この順で時系列に並んでいる。 In the above flow, the predetermined time T 3 is longer than the sum of the predetermined time T 1 and the predetermined time T 2 . FIG. 8 is a diagram for explaining the relationship between T 1 , T 2, and T 3 for a predetermined time, and is, for example, an enlarged view of a portion surrounded by a broken line in FIG. As shown in FIG. 8, t 21 is the time when the output of the pulsed DC current of the nth treatment intensity in the treatment process is started. After the output of the n-th pulse DC current, the time at which the heater 108 is turned on and t 22, the subsequent time at which the heater 108 is turned off and t 23. Further, the time at which the output of the n + 1th pulse DC current in the treatment stage is started is set to t 24 . Times t 21 , t 22 , t 23 and t 24 are arranged in chronological order in this order.
 このとき、所定時間T1は、電気刺激としてのパルス直流電流を出力してからヒータ108をオンの状態にするまでの時間であるため、t22-t21により表される。所定時間T2は、ヒータ108がオンの状態となってからオフの状態となるまでの時間であるため、t23-t22により表される。所定時間T3は、電気刺激としてのパルス直流電流を出力してから次のパルス直流電流を出力するまでの時間であるため、t24-t21により表される。従って、上述のように、所定時間T3は、所定時間T1及び所定時間T2の和よりも長くなる。なお、所定時間T1、T2及びT3の具体的な長さについては、治療の目的、手段及び方法等に応じて、適宜定められてよい。 At this time, the predetermined time T 1 is represented by t 22 −t 21 because it is the time from the output of the pulsed direct current as the electrical stimulus to the turning on of the heater 108. Since the predetermined time T 2 is the time from when the heater 108 is turned on to when it is turned off, it is represented by t 23 − t 22 . Since the predetermined time T 3 is the time from the output of the pulsed direct current as the electrical stimulus to the output of the next pulsed direct current, it is represented by t 24- t 21 . Therefore, as described above, the predetermined time T 3 is longer than the sum of the predetermined time T 1 and the predetermined time T 2 . The specific lengths of the predetermined times T 1 , T 2 and T 3 may be appropriately determined according to the purpose, means and method of treatment.
 制御部103は、電気刺激インターバルタイマをスタートしてから所定時間T3が経過したと判定した場合(ステップS38のYes)、治療時間タイマをスタートしてから所定時間T4が経過したか否かを判定する(ステップS39)。所定時間T4は、治療時間であり、例えば予め設定されていてよい。所定時間T4は、例えば1時間である。 When the control unit 103 determines that the predetermined time T 3 has elapsed since the start of the electrical stimulation interval timer (Yes in step S38), whether or not the predetermined time T 4 has elapsed since the start of the treatment time timer. Is determined (step S39). The predetermined time T 4 is a treatment time, and may be set in advance, for example. The predetermined time T 4 is, for example, one hour.
 制御部103は、治療時間タイマをスタートしてから所定時間T4が経過していないと判定した場合(ステップS39のNo)、ステップS32に移行して、パルス直流電流を出力する。このようにして、制御部103は、ステップS39において治療時間タイマをスタートしてから所定時間T4が経過したと判定するまで、ステップS32からステップS39を繰り返す。このように、ステップS32からステップS39を繰り返すことにより、ユーザに継続的に治療強度Pmという微弱な電気刺激が印加され、治療が行われる。また、このとき、ステップS36においてヒータ108がオンの状態となることにより、適宜温熱が印加され、これによって腹部の温度が維持されやすくなる。 When the control unit 103 determines that the predetermined time T 4 has not elapsed since the treatment time timer was started (No in step S39), the control unit 103 proceeds to step S32 and outputs a pulsed direct current. In this way, the control unit 103, since the start of the treatment time the timer at step S39 until it is determined that the predetermined time T 4 has elapsed, repeats the step S39 from step S32. By repeating steps S32 to S39 in this way, a weak electrical stimulus with a therapeutic intensity of Pm is continuously applied to the user to perform treatment. Further, at this time, since the heater 108 is turned on in step S36, appropriate heat is applied, which makes it easier to maintain the temperature of the abdomen.
 制御部103は、治療時間タイマをスタートしてから所定時間T4が経過したと判定した場合(ステップS39のYes)、治療の処理を終了する。治療の処理が終了すると、制御部103は、終了通知の電気刺激を出力する(ステップS40)。このとき、制御部103は、図6のフローのステップS14で設定した通知強度で電気刺激を出力する。制御部103は、図5に示すように、開始通知の電気刺激を、パルス直流電流として所定の周期で複数回出力してよい。例えば、図5に示すように、制御部103は、時刻t16で終了通知の電気刺激のパルス直流電流の出力を開始した後、時刻t17まで、終了通知の電気刺激の出力を継続して行ってよい。開始通知と同様に、ユーザは、終了通知の電気刺激を感知することができる。電気刺激の感知により、ユーザは、治療の処理が終了したことを認識することができる。 When the control unit 103 determines that the predetermined time T 4 has elapsed since the treatment time timer was started (Yes in step S39), the control unit 103 ends the treatment process. When the treatment process is completed, the control unit 103 outputs an electrical stimulus for the end notification (step S40). At this time, the control unit 103 outputs the electrical stimulus with the notification intensity set in step S14 of the flow of FIG. As shown in FIG. 5, the control unit 103 may output the electrical stimulation of the start notification as a pulsed direct current a plurality of times in a predetermined cycle. For example, as shown in FIG. 5, the control unit 103, after starting the output of the pulse direct current electrical stimulation termination notification at time t 16, up to time t 17, continues to output the electrical stimulation of the end notification You may go. Similar to the start notification, the user can sense the electrical stimulus of the end notification. By sensing the electrical stimulus, the user can recognize that the treatment process is complete.
 治療が終了したことを認識したユーザは、電気刺激印加装置1を腹部からはがして、電気刺激印加装置1による治療を終了することができる。 The user who recognizes that the treatment has been completed can peel off the electrical stimulation application device 1 from the abdomen and terminate the treatment by the electrical stimulation application device 1.
 このように、本実施形態に係る電気刺激印加装置1によれば、制御部103は、入力部101に対する第1の操作入力を検出したときに出力される電気刺激の第2基準出力強度Pdownよりも低い治療強度Pmで電気刺激を出力するとともに、所定のタイミングにおいて、入力部101に対する第2の操作入力を検出したときに出力される電気刺激の第1基準出力強度Pupよりも高い通知強度Paで、生体等に電気刺激を印加する。治療の処理においては、ユーザが電気刺激を感知しなくなったときの第2基準出力強度Pdownよりも低い治療強度Pmで電気刺激が印加されるため、ユーザは、実際に治療の処理において電気刺激が印加されているか否かを感知しない。一方、通知強度Paは、ユーザが感知入力を行ったときの第1基準出力強度Pupよりも高い強度であるため、通知強度で電気刺激を印加されたユーザは、当該通知の電気刺激を感知することができる。電気刺激の感知により、ユーザは、通知を認識することができる。このようにして、本実施形態に係る電気刺激印加装置1によれば、微弱な電気刺激と温熱とを生体等に印加する装置に関して、情報をより確実にユーザに通知可能である。 As described above, according to the electrical stimulation application device 1 according to the present embodiment, the control unit 103 outputs the second reference output intensity P down of the electrical stimulation when the first operation input to the input unit 101 is detected. A notification higher than the first reference output intensity P up of the electrical stimulus output when the second operation input to the input unit 101 is detected at a predetermined timing while outputting the electrical stimulus with a treatment intensity Pm lower than that. An electrical stimulus is applied to a living body or the like at an intensity Pa. In the treatment process, the electrical stimulus is applied at a treatment intensity Pm lower than the second reference output intensity P down when the user no longer senses the electrical stimulus, so that the user actually performs the electrical stimulus in the treatment process. Does not detect whether or not is applied. On the other hand, since the notification intensity Pa is higher than the first reference output intensity P up when the user performs the sensing input, the user to whom the electrical stimulus is applied at the notification intensity senses the electrical stimulus of the notification. can do. By sensing the electrical stimulus, the user can recognize the notification. In this way, according to the electrical stimulation application device 1 according to the present embodiment, it is possible to more reliably notify the user of information regarding the device that applies weak electrical stimulation and heat to a living body or the like.
 例えば、図7を参照して説明したように、治療の処理の開始前及び終了後に、通知強度Paで電気刺激を生体等に印加する場合、治療の処理では、ユーザが電気刺激を感知しない微弱な電気刺激が印加されているため、ユーザは治療の処理が行われているか否か、認識することが困難であるのに対し、治療の処理の開始前及び終了後に通知強度での電気刺激を印加することにより、ユーザは、治療の処理の開始及び終了を認識することができる。 For example, as described with reference to FIG. 7, when an electric stimulus is applied to a living body or the like with a notification intensity Pa before and after the start and end of the treatment process, the user does not sense the electric stimulus in the treatment process. It is difficult for the user to recognize whether or not the treatment process is being performed because the electrical stimulation is applied, whereas the electrical stimulation at the notification intensity is applied before and after the start and end of the treatment process. By applying, the user can recognize the start and end of the treatment process.
 また、図6のフローを参照して説明したように、制御部103は、設定段階において電気刺激の出力強度を漸増させる場合、ユーザが電気刺激を感知したときに感知入力を入力することにより、通知強度Paを、感知入力が入力されたときに出力される第1基準出力強度Pupよりも高い強度に設定する。そのため、制御部103は、通知強度Paを、ユーザが感知しやすい強度に設定できる。 Further, as described with reference to the flow of FIG. 6, when the output intensity of the electrical stimulus is gradually increased in the setting stage, the control unit 103 inputs a sensing input when the user senses the electrical stimulus. The notification intensity Pa is set to be higher than the first reference output intensity P up that is output when the sensing input is input. Therefore, the control unit 103 can set the notification intensity Pa to an intensity that is easy for the user to perceive.
 また、図6のフローを参照して説明したように、制御部103は、設定段階において電気刺激の出力強度を漸減させる場合、ユーザが電気刺激を感知しなくなったときに非感知入力を入力することにより、治療強度Pmを、非感知入力が入力されたときに出力される第2基準出力強度Pdownよりも弱い強度に設定する。そのため、制御部103は、治療強度Pmを、ユーザが感知しない微弱なレベルに設定できる。 Further, as described with reference to the flow of FIG. 6, when the output intensity of the electrical stimulus is gradually reduced in the setting stage, the control unit 103 inputs a non-sensing input when the user no longer senses the electrical stimulus. Thereby, the treatment intensity Pm is set to be weaker than the second reference output intensity P down which is output when the non-sensing input is input. Therefore, the control unit 103 can set the treatment intensity Pm to a weak level that the user does not perceive.
 また、本実施形態に係る電気刺激印加装置1は、入力部101に対する所定の操作入力を検出した後、ヒータ108により生体等を加温し、ヒータ108が所定温度以上となったときに治療段階を開始する。これにより、生体等を、治療に適した温度に加温してから、治療を開始することができる。なお、治療の目的、手段及び方法等によっては、治療段階を開始する前にヒータ108による加温をしなくてもよい。 Further, the electric stimulus applying device 1 according to the present embodiment heats a living body or the like by a heater 108 after detecting a predetermined operation input to the input unit 101, and when the heater 108 reaches a predetermined temperature or higher, a treatment stage. To start. As a result, the treatment can be started after the living body or the like is heated to a temperature suitable for the treatment. Depending on the purpose, means, method, etc. of the treatment, it is not necessary to heat the heater 108 before starting the treatment stage.
 電気刺激印加装置1の制御部103により実行される処理は、上述の処理に限られない。制御部103は、治療の目的、手段及び方法等に応じて、上述した処理とは異なる処理や、上述した処理に加えた追加的な処理を実行してもよい。 The process executed by the control unit 103 of the electrical stimulus applying device 1 is not limited to the above-mentioned process. The control unit 103 may execute a process different from the above-mentioned process or an additional process in addition to the above-mentioned process, depending on the purpose, means, method, and the like of the treatment.
 例えば、上記実施形態では、制御部103は、設定段階において、ユーザによる非感知入力を検出した後、ヒータ108による加温を行うと説明した。しかしながら、制御部103は、例えば図6のステップS10において、電気刺激の出力を行う前にヒータ108による加温を行ってもよい。このように電気刺激を印加する前に加温を行うことにより、ユーザは加温された状態で電気刺激の感知の有無を入力することとなる。そのため、より治療段階に近い条件で、電気刺激の感知の有無が入力される。そのため、治療段階における治療強度及び通知強度を、適切なレベルに設定しやすくなり得る。 For example, in the above embodiment, it has been explained that the control unit 103 heats the heater 108 after detecting the non-sensing input by the user in the setting stage. However, the control unit 103 may heat the heater 108 before outputting the electrical stimulation, for example, in step S10 of FIG. By heating before applying the electrical stimulus in this way, the user can input whether or not the electrical stimulus is detected in the heated state. Therefore, the presence or absence of detection of electrical stimulation is input under conditions closer to the treatment stage. Therefore, it may be easy to set the treatment intensity and the notification intensity at the treatment stage to an appropriate level.
 また、例えば、上記実施形態では、設定段階において、制御部103が、電気刺激の出力強度を漸増及び漸減させるように電極部102から電気刺激を出力するという処理を実行する場合の例について説明した。しかしながら、設定段階における処理は、制御部103による電気刺激の出力強度の漸増及び漸増に限られない。例えば、電気刺激印加装置1は、設定段階において、ユーザの操作入力に基づいて、電気刺激の出力強度を変化させてもよい。 Further, for example, in the above embodiment, an example has been described in which the control unit 103 executes a process of outputting an electric stimulus from the electrode unit 102 so as to gradually increase and decrease the output intensity of the electric stimulus in the setting stage. .. However, the processing in the setting stage is not limited to the gradual increase and gradual increase in the output intensity of the electrical stimulation by the control unit 103. For example, the electrical stimulus application device 1 may change the output intensity of the electrical stimulus based on the user's operation input at the setting stage.
 具体的には、例えば電気刺激印加装置1は、電気刺激の出力強度を変更するためのユーザからの操作入力を受け付ける出力強度調整部を、さらに備えていてよい。出力強度調整部は、多様な形態により実現でき、例えば、回転式のノブ(つまみ)、スライド式のノブ、及びスピンボックス等により構成されていてよい。制御部103は、電気刺激の出力強度を漸増及び漸減させる処理に代えて、ユーザによる出力強度調整部への入力に応じて、電気刺激の出力強度を変更させるように処理を行う。このように、ユーザからの操作入力によっても、設定段階において電気刺激印加装置1から出力される電気刺激の出力強度を変化させることができる。 Specifically, for example, the electrical stimulation application device 1 may further include an output intensity adjusting unit that receives an operation input from the user for changing the output intensity of the electrical stimulation. The output strength adjusting unit can be realized in various forms, and may be composed of, for example, a rotary knob (knob), a slide knob, a spin box, and the like. Instead of the process of gradually increasing and decreasing the output intensity of the electrical stimulus, the control unit 103 performs a process of changing the output intensity of the electrical stimulus according to the input to the output intensity adjusting unit by the user. In this way, the output intensity of the electrical stimulus output from the electrical stimulus application device 1 can be changed at the setting stage by the operation input from the user.
 また、上記実施形態において、電気刺激印加装置1の制御部103は、電気刺激による通知を、パルス直流電流として所定の周期で複数回出力すると説明した。しかしながら、制御部103が出力する電気刺激の通知は、この態様に限られない。 Further, in the above embodiment, it has been explained that the control unit 103 of the electric stimulus applying device 1 outputs the notification by the electric stimulus as a pulsed direct current a plurality of times in a predetermined cycle. However, the notification of the electrical stimulation output by the control unit 103 is not limited to this aspect.
 例えば、制御部103は、電気刺激を、所定のパターンで出力してもよい。制御部103は、出力電力を変化させることにより、多様なパターンで電気刺激を出力することができる。具体的には、制御部103は、出力電力として、電圧、電流、パルス幅、周波数、刺激時間、及び休止時間の少なくともいずれかを変化させることにより、電気刺激のパターンを変化させて出力することができる。 For example, the control unit 103 may output the electrical stimulation in a predetermined pattern. The control unit 103 can output electrical stimuli in various patterns by changing the output power. Specifically, the control unit 103 changes and outputs an electrical stimulation pattern by changing at least one of voltage, current, pulse width, frequency, stimulation time, and pause time as output power. Can be done.
 図9は、通知として出力される電気刺激の出力パターンについて説明するための図である。制御部103は、電気刺激の電圧及び電流を変化させることにより、図9に示す、電気刺激の出力パターンとしての出力強度Paを変えることができる。また、制御部103は、パルス幅PL及び周波数を変化させることができる。また、制御部103は、電気刺激の刺激時間(出力時間)を変化させることにより、通知としての電気刺激を印加する全体の時間の長さTWを変えることができる。また、制御部103は、図9に示すように休止時間TBを設けたり休止時間TBの長さを変化させたりすることができる。休止期間は、パルス直流電流を出力しない期間をいう。休止期間を設けることにより、間欠的な電気刺激がユーザに印加される。このように、制御部103は、電気刺激の出力パターンを変化させることにより異なる電気刺激をユーザに感知させることができる。 FIG. 9 is a diagram for explaining an output pattern of electrical stimulation output as a notification. The control unit 103 can change the output intensity Pa as the output pattern of the electrical stimulation shown in FIG. 9 by changing the voltage and the current of the electrical stimulation. Further, the control unit 103 can change the pulse width PL and the frequency. Further, the control unit 103 can change the total length TW of applying the electrical stimulus as a notification by changing the stimulation time (output time) of the electrical stimulus. Further, as shown in FIG. 9, the control unit 103 can provide a pause time TB or change the length of the pause time TB. The pause period is the period during which the pulsed direct current is not output. By providing a rest period, intermittent electrical stimulation is applied to the user. In this way, the control unit 103 can make the user sense different electrical stimuli by changing the output pattern of the electrical stimuli.
 また、上記実施形態では、制御部103が治療の処理の開始及び終了を通知する場合について説明した。つまり、上記実施形態では、制御部103が通知を行う所定のタイミングが、治療の処理の開始前及び終了後である場合について説明した。しかしながら、制御部103が電気刺激の出力により行う通知は、治療の処理の開始及び終了に限られない。制御部103は、電気刺激の出力により他の通知を行ってもよい。例えば、制御部103は、電気刺激の出力により、電気刺激印加装置1に発生した異常を通知してもよい。例えば、電気刺激印加装置1の制御部103は、治療段階において電気刺激印加装置1が備えるいずれかの機能部に異常が発生したとき、通知強度で電気刺激を出力することにより、ユーザに通知を行うことができる。 Further, in the above embodiment, the case where the control unit 103 notifies the start and end of the treatment process has been described. That is, in the above-described embodiment, the case where the predetermined timing for the control unit 103 to notify is before and after the start and end of the treatment process has been described. However, the notification given by the control unit 103 by the output of the electrical stimulus is not limited to the start and end of the treatment process. The control unit 103 may give other notifications by the output of the electrical stimulus. For example, the control unit 103 may notify the abnormality generated in the electric stimulus applying device 1 by the output of the electric stimulus. For example, when an abnormality occurs in any of the functional units of the electric stimulus applying device 1 in the treatment stage, the control unit 103 of the electric stimulus applying device 1 notifies the user by outputting the electric stimulus with the notification intensity. It can be carried out.
 以上説明したように、制御部103は、治療の処理の開始及び終了、並びに異常の発生を通知することができる。すなわち、制御部103が通知強度で電気刺激の出力を行う所定のタイミングは、治療の処理の開始前及び終了後、並びに異常が発生したときである。なお、所定のタイミングは、必ずしもこれらの全てのタイミングを含んでいなくてもよい。すなわち、所定のタイミングは、治療の処理の開始前及び終了後、並びに異常が発生したとき、の少なくともいずれかを含んでいればよい。また、所定のタイミングは、ここで説明したタイミング以外のタイミングを含んでもよい。所定のタイミングは、治療段階においてユーザに通知可能な任意の事象に関連して、適宜定められてよい。 As described above, the control unit 103 can notify the start and end of the treatment process and the occurrence of an abnormality. That is, the predetermined timing at which the control unit 103 outputs the electrical stimulus with the notification intensity is before and after the start and end of the treatment process, and when an abnormality occurs. It should be noted that the predetermined timing does not necessarily have to include all of these timings. That is, the predetermined timing may include at least one of before and after the start and end of the treatment process, and when an abnormality occurs. Further, the predetermined timing may include a timing other than the timing described here. Predetermined timing may be appropriately set in relation to any event that can be notified to the user during the treatment phase.
 制御部103は、電気刺激の出力による通知を行う場合、通知の種類(内容)に応じて、生体等に印加する電気刺激のパターンを変えてもよい。例えば、制御部103は、治療の処理の開始、治療の処理の終了、及び異常の発生という3種類の通知を電気刺激の出力により行う場合、これらの3種類の通知に応じて、3つの異なる電気刺激のパターンで出力してよい。電気刺激のパターンは、図9を参照して説明したように、例えば、電圧、電流、パルス幅、周波数、刺激時間、及び休止時間の少なくともいずれかを変化させることにより、異ならせることができる。通知の種類に応じて、生体等に印加する電気刺激のパターンを変えることにより、電気刺激を感知したユーザは、通知の内容を区別することができる。つまり、ユーザは、何に関する通知であるかを識別することができる。 When the control unit 103 gives a notification by the output of the electrical stimulation, the pattern of the electrical stimulation applied to the living body or the like may be changed according to the type (content) of the notification. For example, when the control unit 103 gives three types of notifications of the start of the treatment process, the end of the treatment process, and the occurrence of an abnormality by the output of the electrical stimulus, the control unit 103 has three different types of notifications according to the three types of notifications. It may be output in the pattern of electrical stimulation. The patterns of electrical stimulation can be varied, for example, by changing at least one of voltage, current, pulse width, frequency, stimulation time, and pause time, as described with reference to FIG. By changing the pattern of the electrical stimulation applied to the living body or the like according to the type of notification, the user who senses the electrical stimulation can distinguish the content of the notification. That is, the user can identify what the notification is about.
 従って、上記実施形態では、制御部103が1つの通知強度のみを設定する場合について説明したが、制御部103は、2つの異なる通知強度を設定してもよい。2つの異なる通知強度は、開始通知の電気刺激で出力される通知強度と、終了通知の電気刺激で出力される通知強度とである。つまり、開始通知の電気刺激で出力される通知強度と、終了通知の電気刺激で出力される通知強度とは、上記実施形態のように同じ強度であってもよく、異なる強度であってもよい。開始通知の電気刺激で出力される通知強度と、終了通知の電気刺激で出力される通知強度は、治療強度よりも高い強度であればよい。また、開始通知の電気刺激と、終了通知の電気刺激とは、電気刺激の刺激時間が同じ長さであってもよく、異なる長さであってもよい。開始通知の電気刺激と、終了通知の電気刺激との刺激時間は、例えばそれぞれ数秒間である。また、開始通知の電気刺激と、終了通知の電気刺激とは、休止期間を有する間欠的な電気刺激であってもよい。 Therefore, in the above embodiment, the case where the control unit 103 sets only one notification intensity has been described, but the control unit 103 may set two different notification intensities. The two different notification intensities are the notification intensity output by the electrical stimulation of the start notification and the notification intensity output by the electrical stimulation of the end notification. That is, the notification intensity output by the electrical stimulation of the start notification and the notification intensity output by the electrical stimulation of the end notification may be the same intensity as in the above embodiment, or may be different in intensity. .. The notification intensity output by the electrical stimulation of the start notification and the notification intensity output by the electrical stimulation of the end notification may be higher than the treatment intensity. Further, the electrical stimulation of the start notification and the electrical stimulation of the end notification may have the same stimulation time or different lengths. The stimulation time of the electrical stimulation of the start notification and the electrical stimulation of the end notification is, for example, several seconds each. Further, the electrical stimulation of the start notification and the electrical stimulation of the end notification may be intermittent electrical stimulation having a rest period.
 本開示に係る電気刺激印加装置は、上述した実施形態で特定された構成に限定されず、特許請求の範囲に記載した発明の要旨を逸脱しない範囲内で種々の変形が可能である。例えば、各構成部、各ステップなどに含まれる機能などは論理的に矛盾しないように再配置可能であり、複数の構成部又はステップなどを1つに組み合わせたり、或いは分割したりすることが可能である。 The electrical stimulus application device according to the present disclosure is not limited to the configuration specified in the above-described embodiment, and can be variously modified within a range that does not deviate from the gist of the invention described in the claims. For example, the functions included in each component and each step can be rearranged so as not to be logically inconsistent, and a plurality of components or steps can be combined or divided into one. Is.
 本開示は、電気刺激印加装置に関する。 The present disclosure relates to an electrical stimulation application device.
1:電気刺激印加装置
10:本体部
20:印加部
30:シート材
31:フレーム部
32:導電性ゲル
101:入力部
101a:第1入力部
101b:第2入力部
101c:第3入力部
102:電極部
102a:第1電極
102b:第2電極
103:制御部
104:表示部
105:タイマ部
106:記憶部
107:電源部
108:ヒータ
109:温度測定部
110:電気刺激出力部
1: Electrical stimulation application device 10: Main body 20: Application part 30: Sheet material 31: Frame part 32: Conductive gel 101: Input part 101a: First input part 101b: Second input part 101c: Third input part 102 : Electrode unit 102a: First electrode 102b: Second electrode 103: Control unit 104: Display unit 105: Timer unit 106: Storage unit 107: Power supply unit 108: Heater 109: Temperature measurement unit 110: Electrical stimulation output unit

Claims (10)

  1.  微弱な電気刺激を生体又は生体組織に印加する電気刺激印加装置であって、
     ユーザからの操作入力を受け付ける入力部と、
     前記電気刺激の出力を制御する制御部と、
    を備え、
     前記制御部は、
      前記電気刺激の出力強度を変更可能であり、
      前記入力部に対する第1の操作入力を検出したときに出力される前記電気刺激の出力強度よりも低い、所定の出力強度で、前記生体又は生体組織に前記電気刺激を印加するとともに、
      所定のタイミングにおいて、前記入力部に対する第2の操作入力を検出したときに出力される前記電気刺激の出力強度よりも高い通知強度で、前記生体又は生体組織に前記電気刺激を印加する、
    電気刺激印加装置。
    An electrical stimulus application device that applies a weak electrical stimulus to a living body or a living tissue.
    An input unit that accepts operation input from the user,
    A control unit that controls the output of the electrical stimulation,
    With
    The control unit
    The output intensity of the electrical stimulation can be changed,
    The electrical stimulus is applied to the living body or tissue at a predetermined output intensity lower than the output intensity of the electrical stimulus output when the first operation input to the input unit is detected, and the electrical stimulus is applied.
    The electrical stimulus is applied to the living body or tissue with a notification intensity higher than the output intensity of the electrical stimulus output when the second operation input to the input unit is detected at a predetermined timing.
    Electrical stimulation application device.
  2.  前記制御部は、
      前記電気刺激の出力強度を漸増させながら前記電気刺激を出力し、
      前記電気刺激の出力強度を漸増させている際に前記第2の操作入力を検出したときに出力される前記電気刺激の出力強度よりも高い所定の出力強度を、前記通知強度として設定する、
    請求項1に記載の電気刺激印加装置。
    The control unit
    The electrical stimulus is output while gradually increasing the output intensity of the electrical stimulus.
    A predetermined output intensity higher than the output intensity of the electrical stimulus output when the second operation input is detected while the output intensity of the electrical stimulus is gradually increased is set as the notification intensity.
    The electrical stimulation application device according to claim 1.
  3.  前記生体又は生体組織を加温するヒータをさらに備え、
     前記制御部は、
      前記入力部に対する前記第2の操作入力を検出した後、前記ヒータにより前記生体又は生体組織を加温し、
      前記ヒータが所定温度以上となったときに、前記所定の出力強度で、前記生体又は生体組織に前記電気刺激を印加する、
    請求項2に記載の電気刺激印加装置。
    Further provided with a heater for heating the living body or living tissue,
    The control unit
    After detecting the second operation input to the input unit, the living body or living tissue is heated by the heater.
    When the heater reaches a predetermined temperature or higher, the electrical stimulus is applied to the living body or the living tissue at the predetermined output intensity.
    The electrical stimulation application device according to claim 2.
  4.  前記制御部は、前記入力部に対する前記第2の操作入力を検出したときに出力される前記電気刺激の出力強度に対して、1より大きい係数を乗じた出力強度を、前記通知強度として設定する、請求項2又は3に記載の電気刺激印加装置。 The control unit sets the output intensity obtained by multiplying the output intensity of the electrical stimulation output when the second operation input to the input unit is detected by a coefficient greater than 1 as the notification intensity. , The electrical stimulation application device according to claim 2 or 3.
  5.  前記制御部は、
      前記電気刺激の出力強度を漸減させながら前記電気刺激を出力し、
      前記電気刺激の出力強度を漸減させている際に前記入力部に対する前記第1の操作入力を検出したときに出力される前記電気刺激の出力強度よりも低い、所定の出力強度で、前記生体又は生体組織に前記電気刺激を印加する、
    請求項2から4のいずれか一項に記載の電気刺激印加装置。
    The control unit
    The electrical stimulus is output while gradually reducing the output intensity of the electrical stimulus.
    The living body or the living body or the living body has a predetermined output intensity lower than the output intensity of the electrical stimulus output when the first operation input to the input unit is detected while the output intensity of the electrical stimulus is gradually reduced. Applying the electrical stimulation to living tissue,
    The electrical stimulation application device according to any one of claims 2 to 4.
  6.  前記所定の出力強度は、前記入力部に対する前記第1の操作入力を検出したときに出力される前記電気刺激の出力強度に対して、1未満の係数を乗じた出力強度である、請求項2から5のいずれか一項に記載の電気刺激印加装置。 2. The predetermined output intensity is an output intensity obtained by multiplying the output intensity of the electrical stimulation output when the first operation input to the input unit is detected by a coefficient less than 1. The electrical stimulation application device according to any one of 5 to 5.
  7.  前記制御部は、前記電気刺激の出力強度を漸増させている際に前記入力部に対する第2の操作入力を検出した場合に、前記電気刺激の出力強度を漸増させている際に前記入力部に対する第2の操作入力を検出したときに出力される前記電気刺激の出力強度から、前記電気刺激の出力強度を漸減させながら前記電気刺激を出力する、請求項5又は6に記載の電気刺激印加装置。 When the control unit detects a second operation input to the input unit while gradually increasing the output intensity of the electrical stimulation, the control unit refers to the input unit when the output intensity of the electrical stimulation is gradually increased. The electric stimulus applying device according to claim 5 or 6, wherein the electric stimulus is output while gradually reducing the output intensity of the electric stimulus from the output intensity of the electric stimulus output when the second operation input is detected. ..
  8.  前記所定のタイミングは、前記所定の出力強度による連続的な電気刺激の印加を行う前、前記所定の出力強度による連続的な電気刺激の印加を行った後、及び、当該電気刺激印加装置における異常が発生したとき、の少なくともいずれかを含む、請求項1から7のいずれか一項に記載の電気刺激印加装置。 The predetermined timing is before the application of the continuous electrical stimulus by the predetermined output intensity, after the application of the continuous electrical stimulus by the predetermined output intensity, and the abnormality in the electrical stimulus application device. The electrical stimulation application device according to any one of claims 1 to 7, further comprising at least one of the above.
  9.  前記制御部は、通知の種類に応じて、前記所定のタイミングに前記生体又は生体組織に印加する前記電気刺激の出力パターンを変化させる、請求項1から請求項8のいずれか一項に記載の電気刺激印加装置。 The control unit according to any one of claims 1 to 8, wherein the control unit changes the output pattern of the electrical stimulation applied to the living body or the living body tissue at the predetermined timing according to the type of notification. Electrical stimulation application device.
  10.  ユーザからの操作入力を受け付ける入力部を備え、微弱な電気刺激を出力可能な、電気刺激印加装置による電気刺激印加方法であって、
     前記電気刺激の出力強度を変更しながら前記電気刺激を出力するステップと、
     前記入力部に対して第1の操作入力が入力されたときに出力される前記電気刺激の出力強度よりも低い、所定の出力強度で、生体又は生体組織に前記電気刺激を印加するステップと、
     所定のタイミングにおいて、前記所定の出力強度よりも強い通知強度で、前記生体又は生体組織に前記電気刺激を印加するステップと、
    を含む、電気刺激印加方法。
    It is an electrical stimulus application method using an electrical stimulus application device that has an input unit that accepts operation input from the user and can output a weak electrical stimulus.
    The step of outputting the electrical stimulus while changing the output intensity of the electrical stimulus,
    A step of applying the electrical stimulus to a living body or a living tissue at a predetermined output intensity lower than the output intensity of the electrical stimulus output when the first operation input is input to the input unit.
    A step of applying the electrical stimulus to the living body or a living tissue at a predetermined timing with a notification intensity stronger than the predetermined output intensity.
    A method of applying electrical stimulation, including.
PCT/JP2020/002361 2019-03-14 2020-01-23 Device for applying electrical stimulation and method for applying electrical stimulation WO2020183928A1 (en)

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