WO2020183931A1

WO2020183931A1 - Electrical stimulus application device and determination method

Info

Publication number: WO2020183931A1
Application number: PCT/JP2020/002372
Authority: WO
Inventors: 直樹豊島; 矢口　喜明
Original assignee: テルモ株式会社
Priority date: 2019-03-14
Filing date: 2020-01-23
Publication date: 2020-09-17
Also published as: JPWO2020183931A1; JP7342105B2

Abstract

This electrical stimulus application device applies an electrical stimulus to a biological body or biological tissue in a state wherein an electroconductive gel has been applied. The electrical stimulus application device comprises: a main electrode exposed to the exterior on one surface of the electrical stimulus application device for outputting the electrical stimulus; a plurality of detection electrodes disposed in the vicinity of the main electrode on the one surface; and a control unit determining the applied state of the electroconductive gel on the one surface, according to the impedance between the main electrode and each of the plurality of detection electrodes.

Description

Electrical stimulation application device and judgment method

The present disclosure relates to an electrical stimulation application device and a determination method.

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.

International Publication No. 2017/065239 JP-A-2009-125549

The treatment with the above-mentioned device is performed in a state where the device is attached to a living body or a living tissue via a sheet material provided with a conductive gel. Electrical stimulation is applied to a living body or a living tissue via a conductive gel.

Here, the conductive gel is not attached at an appropriate position with respect to the above-mentioned device, and as a result, for example, the electrical stimulation is performed in a state where the electrode that outputs the electrical stimulation in the device is in direct contact with the living body or the biological tissue. When output, a strong current can flow locally in the living body or tissue. In this case, the patient being treated may experience pain due to electrical stimulation and may be burned where the skin contacts the electrodes.

An object of the present disclosure is to provide an electrical stimulus application device and a determination method capable of determining a state in which a conductive gel is attached to an electrical stimulus application device when an electrical stimulus is applied to a living body or a living tissue.

The electrical stimulation application device as the first aspect of the present disclosure is an electrical stimulation application device that applies electrical stimulation to a living body or a biological tissue in a state where a conductive gel is attached, and is one aspect of the electrical stimulation application device. A main electrode that is exposed to the outside and outputs the electrical stimulus, a plurality of detection electrodes arranged around the main electrode on one surface thereof, the main electrode, and the plurality of detection electrodes. A control unit for determining the sticking state of the conductive gel on the one surface is provided according to the impedance between the two.

In the electrical stimulation application device as one embodiment of the present disclosure, the control unit is said to be conductive when the impedance between the main electrode and each of the plurality of detection electrodes is all equal to or less than a predetermined threshold value. It is determined that the state of application of the sex gel is appropriate.

In the electrical stimulation application device as one embodiment of the present disclosure, the control unit is said to be conductive when the impedance between the main electrode and each of the plurality of detection electrodes is all larger than the predetermined threshold value. It is determined that the sex gel is not attached or the electrical stimulation application device has failed.

In the electrical stimulation application device as one embodiment of the present disclosure, in the control unit, at least one of the impedances between the main electrode and each of the plurality of detection electrodes is equal to or less than the predetermined threshold value. In addition, when at least one of them is larger than the predetermined threshold value, it is determined that the state in which the conductive gel is attached is not appropriate.

In the electrical stimulus application device as one embodiment of the present disclosure, the control unit outputs the electrical stimulus when it is determined that the state in which the conductive gel is attached is appropriate.

The electric stimulus application device as one embodiment of the present disclosure further includes a notification unit for notifying information, and the control unit notifies the information of the determination result from the notification unit.

The determination method as the second aspect of the present disclosure is an electric stimulus applying device capable of outputting an electric stimulus in a state where the conductive gel is attached, and is exposed to the outside on one surface of the electric stimulus applying device. A determination method using an electrical stimulus application device including a main electrode that outputs an electrical stimulus and a plurality of detection electrodes arranged around the main electrode on one surface thereof. The step includes measuring the impedance between each of the plurality of detection electrodes, and determining the sticking state of the conductive gel on the one surface according to the measured impedance.

According to the present disclosure, it is possible to provide an electrical stimulus application device and a determination method capable of determining the state of attachment of a conductive gel to an electrical stimulus application device when an electrical stimulus is applied to a living body or a living tissue.

It is a schematic external perspective view of the electric stimulus application device which concerns on one Embodiment. It is an external perspective view of the electric stimulation application device of FIG. 1 when viewed from the back surface side. 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. It is a figure which shows an example of the position of the conductive gel when a sheet material is attached to an electric stimulus application device. It is a functional block diagram which shows the schematic structure of the electric stimulus application device of FIG. It is an example of the schematic circuit diagram of the power output related part of FIG. It is a flowchart which shows an example of the determination process of the sticking state executed by the control part of FIG. It is the schematic which shows an example of the improper sticking state of a conductive gel. 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. It is a flowchart which shows an example of the process which the control part of FIG. 5 executes in a setting stage. It is a flowchart which shows an example of the process which the control part of FIG. 5 executes in a treatment stage. It is a figure for demonstrating the relationship of predetermined time T ₁ , T ₂ and T ₃ .

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.

FIG. 1 is a schematic external perspective view of the electrical stimulus applying device 1 according to the embodiment. The electric stimulus applying device 1 applies an electric 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 electrical stimulation.

The electrical stimulus applied by the electrical stimulus application device 1 may be a weak electrical stimulus. In the present specification, it will be described below assuming that the electrical stimulus applied by the electrical stimulus application device 1 is a weak electrical stimulus. However, in the present disclosure, the electrical stimulus applied by the electrical stimulus application device 1 is not limited to 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 bring about muscle contraction or a feeling of stimulation to the living body, the user (patient) cannot sense the applied electrical stimulation. 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.

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. 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.

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.

Here, the electric stimulus application device 1 according to the present embodiment outputs the electric stimulus in a state where the conductive gel is attached. The electric stimulus applying device 1 determines the state in which the conductive gel is attached to the electric stimulus applying device 1 when executing the output of the electric stimulus. The conductive gel may be provided on, for example, a sheet material. When it is determined that the state in which the conductive gel is attached is appropriate, the electric stimulus applying device 1 performs treatment by outputting the electric stimulus.

Further, 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. In the present specification, the step of setting the output intensity of a weak electrical stimulus, which is performed before starting the treatment, is hereinafter simply referred to as a “setting step”. 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.

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. In the present embodiment, the application unit 20 is formed in a rectangular shape having a long side and a short side. 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. The back side corresponds to "one side" in the present disclosure.

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. 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.

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 the detection of the electrical stimulus. 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 a main electrode that outputs an electrical stimulus, a heater that generates heat, and a detection electrode that is used for determining the state in which the conductive gel is attached. 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. As shown in FIG. 2, the application unit 20 includes two main electrodes, a first main electrode 102a and a second main electrode 102b. The first main electrode 102a and the second main electrode 102b are exposed to the outside on the back surface side. For example, an electrical stimulus is output by grounding one of the first main electrode 102a and the second main electrode 102b and changing the voltage of the other main electrode. In the present specification, when the first main electrode 102a and the second main electrode 102b are not distinguished, they are collectively referred to as "main electrode 102".

In the present embodiment, the main electrode 102 has a substantially semicircular shape. That is, in the present embodiment, as shown in FIG. 2, the main electrode 102 has an outer edge formed by the straight portion 120 and the arc portion 121 on the back surface side of the application portion 20. The main electrode 102 is arranged so that the straight portion 120 is parallel to the short side of the application portion 20. Further, the main electrode 102 is arranged so that the arc portion 121 is closer to the short side of the application portion 20 than the straight portion 120.

As shown in FIG. 2, the application unit 20 includes three detection electrodes corresponding to each main electrode 102. Specifically, the application unit 20 includes a first detection electrode 110a, a second detection electrode 110b, and a third detection electrode 110c corresponding to the first main electrode 102a. Further, the application unit 20 includes a fourth detection electrode 110d, a fifth detection electrode 110e, and a sixth detection electrode 110f corresponding to the second main electrode 102b. In the present specification, the detection electrode corresponding to the main electrode means a detection electrode used for determining the state in which the conductive gel is attached to the main electrode.

The first detection electrode 110a, the second detection electrode 110b, the third detection electrode 110c, the fourth detection electrode 110d, the fifth detection electrode 110e, and the sixth detection electrode 110f are exposed to the outside on the back surface side. In this specification, the first detection electrode 110a, the second detection electrode 110b, the third detection electrode 110c, the fourth detection electrode 110d, the fifth detection electrode 110e, and the sixth detection electrode 110f are distinguished from each other. If not, these are collectively referred to simply as "detection electrode 110".

The detection electrode 110 is arranged around the main electrode 102 on the back surface of the application unit 20. In the present embodiment, as shown in FIG. 2, the first detection electrode 110a and the second detection electrode 110b are arranged in the vicinity of the position where the linear portion 120 and the arc portion 121 of the first main electrode 102a intersect. Further, the fourth detection electrode 110d and the fifth detection electrode 110e are arranged near the position where the linear portion 120 and the arc portion 121 of the second main electrode 102b intersect. Further, the third detection electrode 110c is arranged in the vicinity of the position closest to the short side of the application portion 20 in the arc portion 121 of the first main electrode 102a. Further, the sixth detection electrode 110f is arranged in the vicinity of the position closest to the short side of the application portion 20 in the arc portion 121 of the second main electrode 102b. However, the arrangement of the detection electrodes 110 is not limited to this. The plurality of detection electrodes 110 may be arranged around the corresponding main electrodes 102.

Further, in the present embodiment, the case where the application unit 20 includes three detection electrodes 110 corresponding to one main electrode 102 has been described, but the detection electrode 110 corresponding to one main electrode 102 has been described. The number of sheets is not limited to three. The detection electrode 110 may include a plurality of detection electrodes 110 corresponding to one main electrode 102. The number of detection electrodes 110 may be appropriately determined according to, for example, the size and shape of the main electrode 102.

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. Therefore, in the present embodiment, the frame portion 31 is formed in a rectangular shape having an outer shape having a long side and a short side. The frame portion 31 has two openings (through holes) for arranging the two conductive gels 32. When the sheet material 30 is attached to the back surface side of the application portion 20, the first main electrode 102a and the second main electrode 102b, and the three detection electrodes 110 corresponding to each main electrode 102 are arranged in the two openings. It is formed at a position that matches the position where it is.

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 main electrode 102a and the second main 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. Further, 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 configured to be in contact with the detection electrodes 110 corresponding to the main electrodes 102. That is, the sheet material 30 is configured so that the conductive gel 32 has a size and a shape that allows the conductive gel 32 to come into contact with the main electrode 102 and the detection electrode 110 corresponding to the main electrode 102.

In the present embodiment, for example, as shown in FIG. 3, the conductive gel 32 has a substantially semicircular shape. That is, in the present embodiment, as shown in FIG. 3, the conductive gel 32 has an outer edge formed by the straight portion 130 and the arc portion 131. The conductive gel 32 is arranged so that the straight line portion 130 is parallel to the short side of the frame portion 31. Further, the conductive gel 32 is arranged so that the arc portion 131 is closer to the short side of the frame portion 31 than the straight portion 130.

FIG. 4 is a diagram showing an example of the position of the conductive gel 32 when the sheet material 30 is attached to the electrical stimulation application device 1. In FIG. 4, the description of the frame portion 31 in the sheet material 30 is omitted. In the example shown in FIG. 4, one conductive gel 32 is attached to the first main electrode 102a and the first main electrode 102a in a state where the sheet material 30 is attached to the back surface of the application portion 20 of the electrical stimulation application device 1. It is in contact with all of the three corresponding detection electrodes 110 (first detection electrode 110a, second detection electrode 110b, and third detection electrode 110c). As described above, the conductive gel 32 is configured to have a size and shape that can cover the entire one main electrode 102 and the three detection electrodes 110 corresponding to the main electrode 102. Further, the three detection electrodes 110 are applied so that the conductive gel 32 comes into contact with the entire main electrode 102 when the conductive gel 32 is in contact with all of the three detection electrodes 110. Is placed in.

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. However, when the sheet material 30 is replaced, the state of attachment of the sheet material 30 to the application portion 20 may change. The electrical stimulus application device 1 according to the present embodiment can determine whether or not the sticking state of the sheet material 30 is appropriate.

In the present embodiment, as described above, two main electrodes, the first main electrode 102a and the second main electrode 102b, are arranged in one constituent device called the application unit 20. However, the first main electrode 102a and the second main electrode 102b may be arranged separately in different constituent devices, for example. When two main electrodes are arranged in one constituent device as in the present embodiment, as compared with the case where the two main electrodes are separately arranged in different constituent devices, a living body or the like Since the number of component devices attached to the can be reduced, the convenience of the user is improved.

FIG. 5 is a functional block diagram showing a schematic configuration of the electrical stimulation application device 1 of FIG. As shown in FIG. 5, the electrical stimulation application device 1 includes an input unit 101, a control unit 103, a display unit 104, a timer unit 105, a storage unit 106, a power supply unit 107, a heater 108, and temperature measurement. A unit 109 is provided. The input unit 101, the control unit 103, the display unit 104, the timer unit 105, the storage unit 106, and the power supply unit 107 are provided in, for example, the main body unit 10. 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.

As shown in FIG. 5, the electrical stimulation application device 1 further includes a power output related unit 40. The power output-related unit 40 is a set of functional units that execute a process of determining the sticking state of the conductive gel 32 and a process of outputting an electrical stimulus. Details of the power output related unit 40 are shown as a circuit diagram in FIG. Details of the power output related unit 40 will be described later.

In FIG. 5, 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.

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.

The control unit 103 determines the sticking state of the conductive gel 32 on the back surface side of the application unit 20. The control unit 103 determines the sticking state of the conductive gel 32 according to the impedance between the main electrode 102 and each of the plurality of corresponding detection electrodes 110. The details of the process of determining the sticking state of the conductive gel 32 by the control unit 103 will be described later.

The control unit 103 controls the output of electrical stimulation from the main electrode 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 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 is an aspect of a notification unit that notifies information. 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.

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 instead of the display unit 104 or as a notification unit for notifying the user of information 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. The notification unit is not limited to the example shown here, and may be any mechanism capable of transmitting information to the user.

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. 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.

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.

FIG. 6 is an example of a schematic circuit diagram of the power output related unit 40 of FIG. The power output-related unit 40 is a set of functional units that execute a process of determining the sticking state of the conductive gel 32 and a process of outputting an electrical stimulus. Each functional unit shown in FIG. 6 is controlled by, for example, the control unit 103 of FIG. FIG. 6 schematically shows the conductive gel 32 in contact with the main electrode 102 and the detection electrode 110.

As shown in FIG. 6, the power output-related unit 40 includes a main electrode 102, a detection electrode 110, a plurality of detection electrode changeover switches, a plurality of current measurement units, a treatment voltage generation circuit 113, and a determination voltage generation. A circuit 114, a first circuit changeover switch 115, and a second circuit changeover switch 116 are provided.

In the present embodiment, the plurality of detection electrode changeover switches are six individual switches, that is, the first switch 111a, the second switch 111b, the third switch 111c, the fourth switch 111d, the fifth switch 111e, and the sixth switch 111f. It is composed of. Hereinafter, in the present specification, when the first switch 111a, the second switch 111b, the third switch 111c, the fourth switch 111d, the fifth switch 111e, and the sixth switch 111f are not distinguished, they are simply referred to as ". It is described as "detection electrode changeover switch 111".

Further, in the present embodiment, the plurality of current measuring units are composed of two current measuring units, a first current measuring unit 112a and a second current measuring unit 112b. Hereinafter, in the present specification, when the first current measuring unit 112a and the second current measuring unit 112b are not distinguished, they are collectively referred to as "current measuring unit 112".

The main electrode 102 outputs an electrical stimulus with the voltage supplied from the treatment voltage generation circuit 113. As described above, the main electrode 102 is composed of two main electrodes, a first main electrode 102a and a second main electrode 102b.

The detection electrode 110 is an electrode used for determining the sticking state of the conductive gel 32. As described above, in the present embodiment, three detection electrodes, a first detection electrode 110a, a second detection electrode 110b, and a third detection electrode 110c, are provided corresponding to the first main electrode 102a. Three detection electrodes, a fourth detection electrode 110d, a fifth detection electrode 110e, and a sixth detection electrode 110f, are provided corresponding to the two main electrodes 102b.

The detection electrode changeover switch 111 is a switch for selecting a detection electrode for detecting the impedance between the detection electrode 102 and the main electrode 102 among the three detection electrodes 110 corresponding to one main electrode 102. In the process of determining the sticking state of the conductive gel 32, the control unit 103 selects one of the three detection electrodes 110, and detects the detection electrodes so that the selected detection electrodes 110 conduct. Controls the changeover switch 111.

Specifically, in the present embodiment, as shown in FIG. 6, the first detection electrode 110a, the second detection electrode 110b, the third detection electrode 110c, the fourth detection electrode 110d, the fifth detection electrode 110e, and the sixth detection electrode The electrodes 110f are electrically connected to the first switch 111a, the second switch 111b, the third switch 111c, the fourth switch 111d, the fifth switch 111e, and the sixth switch 111f, respectively, via the resistor R. In the sticking state determination process, the first switch 111a, the second switch 111b, and the third switch 111c are made to conduct any of the first detection electrode 110a, the second detection electrode 110b, and the third detection electrode 110c. The on and off states are controlled. Similarly, in the pasting state determination process, any one of the fourth detection electrode 110d, the fifth detection electrode 110e, and the sixth detection electrode 110f conducts with the fourth switch 111d, the fifth switch 111e, and the sixth switch 111f. As such, the on and off states are controlled.

The current measuring unit 112 measures the current flowing between the main electrode 102 and the detection electrode 110 selected by the detection electrode changeover switch 111. In the present embodiment, the first current measuring unit 112a is electrically connected to the first detection electrode 110a, the second detection electrode 110b, and the third detection electrode 110c via the detection electrode changeover switch 111. Therefore, the first current measuring unit 112a transfers the current flowing between the first main electrode 102a and the detection electrode selected from the first detection electrode 110a, the second detection electrode 110b, and the third detection electrode 110c. taking measurement. Further, the second current measuring unit 112b is electrically connected to the fourth switch 111d, the fifth switch 111e, and the sixth switch 111f via the detection electrode changeover switch 111. Therefore, the second current measuring unit 112b transfers the current flowing between the second main electrode 102b and the detection electrode selected from the fourth detection electrode 110d, the fifth detection electrode 110e, and the sixth detection electrode 110f. taking measurement.

The current measuring unit 112 can be configured by a known current measuring mechanism. In the present embodiment, the case where the current measuring unit 112 is composed of two functional units, the first current measuring unit 112a and the second current measuring unit 112b, has been described, but the current measuring unit 112 does not necessarily have two functions. It does not have to be composed of parts. The current measuring unit 112 may be configured by one or more functions.

The treatment voltage generation circuit 113 is a circuit that generates a voltage of electrical stimulation applied to a living body or the like in the setting stage and the treatment stage. Power is supplied to the treatment voltage generation circuit 113 from the power supply unit 107 of FIG.

The determination voltage generation circuit 114 is a circuit that generates the voltage of the electric power output from the main electrode 102 in the determination process of the attached state, and outputs a predetermined voltage for impedance measurement. Power is supplied to the determination voltage generation circuit 114 from the power supply unit 107 of FIG.

The first circuit changeover switch 115 switches the connection destination of the first main electrode 102a between the treatment voltage generation circuit 113 and the determination voltage generation circuit 114 based on the control by the control unit 103. Specifically, the first circuit changeover switch 115 switches the switch so that the first main electrode 102a conducts with the determination voltage generation circuit 114 when the determination process of the sticking state is executed. As a result, when the determination process of the sticking state is executed, power is supplied to the first main electrode 102a from the determination voltage generation circuit 114. Further, the first circuit changeover switch 115 switches the switch so that the first main electrode 102a is conductive with the treatment voltage generation circuit 113 when the processing of the setting stage and the treatment stage is executed. As a result, power is supplied from the treatment voltage generation circuit 113 to the first main electrode 102a when the processing of the setting stage and the treatment stage is executed.

The second circuit changeover switch 116 switches the connection destination of the second main electrode 102b between the determination voltage generation circuit 114 and the ground (GND) based on the control by the control unit 103. Specifically, the second circuit changeover switch 116 switches the switch so that the second main electrode 102b conducts with the determination voltage generation circuit 114 when the determination process of the sticking state is executed. As a result, power is supplied to the second main electrode 102b from the determination voltage generation circuit 114 when the determination process of the sticking state is executed. Further, the second circuit changeover switch 116 changes the switch so that the second main electrode 102b is connected to the ground when the processing of the setting stage and the treatment stage is executed. As a result, the second main electrode 102b is grounded when the processing of the setting stage and the treatment stage is executed.

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.

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 electrical stimulation application device 1 by, for example, pressing the first input unit 101a. The user can start the process by the electric stimulus applying device 1 by pressing the second input unit 101b.

The electrical stimulus application device 1 first executes a process of determining the sticking state of the conductive gel 32. FIG. 7 is a flowchart showing an example of the pasting state determination process executed by the control unit 103. FIG. 7 is a flow showing a process of determining the state in which the conductive gel 32 is attached to one of the first main electrode 102a and the second main electrode 102b. Therefore, the control unit 103 executes the flow shown in FIG. 7 for the first main electrode 102a and the second main electrode 102b, respectively, so that the control unit 103 is conductive for both the first main electrode 102a and the second main electrode 102b. It is possible to determine the sticking state of the gel 32.

At the start of FIG. 7, it is assumed that the detection electrode changeover switches 111 are all off, that is, the detection electrode 110 and the current measuring unit 112 are not conducting with each other. Further, at the start of FIG. 7, the first circuit changeover switch 115 and the second circuit changeover switch 116 connect the main electrode 102 to any of the treatment voltage generation circuit 113, the determination voltage generation circuit 114, and the ground. It is assumed that it is not in the state.

First, the control unit 103 electrically connects the main electrode 102 to the determination voltage generation circuit 114 (step S10). For example, when determining the state in which the conductive gel 32 is attached to the first main electrode 102a, the control unit 103 controls the first circuit changeover switch 115 to determine the first main electrode 102a and the determination voltage generation circuit 114. And conduct.

Next, the control unit 103 measures the current flowing between the main electrode 102 and each of the three corresponding detection electrodes 110 (step S11). For example, when determining the state in which the conductive gel 32 is attached to the first main electrode 102a, the control unit 103 determines the current flowing between the first main electrode 102a and the first detection electrode 110a, and the first main electrode 102a. The current flowing between the second detection electrode 110b and the current flowing between the first main electrode 102a and the third detection electrode 110c are measured. The control unit 103 can cause the first current measuring unit 112a to measure these currents by turning on the first switch 111a, the second switch 111b, and the third switch 111c in order.

The control unit 103 calculates the impedance between the main electrode 102 and each of the three corresponding detection electrodes (step S12). For example, when determining the state in which the conductive gel 32 is attached to the first main electrode 102a, the control unit 103 determines the impedance between the first main electrode 102a and the first detection electrode 110a, and the first main electrode 102a and the first. 2. The impedance between the detection electrode 110b and the impedance between the first main electrode 102a and the third detection electrode 110c are calculated. The control unit 103 can calculate the impedance based on, for example, the voltage of the electric power output from the determination voltage generation circuit 114 and the current measured by the first current measurement unit 112a.

The control unit 103 determines the sticking state of the conductive gel 32 according to the impedance between the main electrode 102 and each of the corresponding detection electrodes 110.

Specifically, when the impedance between the main electrode 102 and each of the corresponding detection electrodes 110 is all equal to or less than a predetermined threshold value, the control unit 103 determines that the conductive gel 32 is in an appropriate state of attachment. judge. That is, the control unit 103 determines whether or not all the three impedances calculated in step S12 are equal to or less than a predetermined threshold value (step S13).

For example, when the conductive gel 32 is in contact with both the main electrode 102 and the detection electrode 110, the impedance between the main electrode 102 and the detection electrode 110 is such that the main electrode 102 and the detection electrode 110 are conductive. Since it is electrically connected via the electrode gel 32, the impedance is lower than the impedance calculated when the conductive gel 32 is not in contact with the electrode. The predetermined threshold value is set in advance as a value capable of determining whether or not the conductive gel 32 is in contact with the main electrode 102 and the detection electrode 110, and may be stored in, for example, the storage unit 106. The control unit 103 compares the three impedances calculated in step S12 with a predetermined threshold value stored in the storage unit 106.

When the control unit 103 determines that the impedances between the main electrode 102 and each of the corresponding detection electrodes 110 are all equal to or less than a predetermined threshold value (Yes in step S13), the control unit 103 determines that the sticking state is appropriate. (Step S14). When the impedance between the main electrode 102 and each of the corresponding detection electrodes 110 is all equal to or less than a predetermined threshold value, the conductive gel 32 causes the main electrode 102 and the corresponding three detection electrodes 110 to be connected to each other. It can be said that it is in contact with everything. Since the three detection electrodes 110 are arranged around the main electrode 102, when the conductive gel 32 is in contact with all of the three detection electrodes 110 corresponding to the main electrode 102, for example, FIG. As shown in 4, it is presumed that the entire main electrode 102 is covered with the conductive gel 32. Therefore, in such a case, the control unit 103 determines that the sticking state of the conductive gel 32 is appropriate.

On the other hand, when the control unit 103 determines that at least one of the impedances between the main electrode 102 and each of the corresponding detection electrodes 110 is larger than a predetermined threshold value (No in step S13), the main electrode 102 And, it is determined whether or not the impedance between each of the corresponding detection electrodes 110 is larger than a predetermined threshold value (step S15).

The control unit 103 is conductive when at least one of the impedances between the main electrode 102 and each of the corresponding detection electrodes 110 is equal to or less than a predetermined threshold value and at least one is greater than a predetermined threshold value. It is determined that the sticking state of the gel 32 is not appropriate. That is, in step S15, the control unit 103 is attached when at least one of the impedances between the main electrode 102 and each of the corresponding detection electrodes 110 is equal to or less than a predetermined threshold value (No in step S15). It is determined that the state is not appropriate (step S16).

When No is determined in step S13, at least one of the impedances between the main electrode 102 and each of the corresponding detection electrodes 110 is larger than a predetermined threshold value, so that at least one of the detection electrodes 110 is It is presumed that they are not in contact with the conductive gel 32. On the other hand, when No is determined in step S15, at least one of the impedances between the main electrode 102 and each of the corresponding detection electrodes 110 is equal to or less than a predetermined threshold value, so that at least one of the detection electrodes It is presumed that 110 is in contact with the conductive gel 32. In this case, for example, as shown as an example in FIG. 8, the conductive gel 32 is in contact with some of the detection electrodes 110 among the plurality of detection electrodes 110, and the remaining detection electrodes 110 are in contact with each other. It means that they are not in contact. In the example shown in FIG. 8, the conductive gel 32 is not in contact with the first detection electrode 110a, but is in contact with the second detection electrode 110b and the third detection electrode 110c. In this case, as shown in FIG. 8, a part of the main electrode 102 may not be covered with the conductive gel 32. When an electrical stimulus is output while the portion of the main electrode 102 not covered with the conductive gel 32 is in contact with a living body or the like, electricity from the portion of the main electrode 102 not covered with the conductive gel 32 is obtained. The irritation may cause pain and the skin in contact with the main electrode 102 may be burned. Therefore, the control unit 103 determines that such a sticking state is an inappropriate sticking state.

When the impedance between the main electrode 102 and each of the corresponding detection electrodes 110 is larger than a predetermined threshold value, the control unit 103 is in a state where the conductive gel is not attached or the electrical stimulation application device 1 has failed. Determined to be in a state. That is, in step S15, when the impedance between the main electrode 102 and each of the corresponding detection electrodes 110 is all larger than a predetermined threshold value (Yes in step S15), the control unit 103 conducts to the back surface of the application unit 20. It is determined that the sex gel 32 is not attached or the electrical stimulation application device 1 is out of order.

If Yes is determined in step S15, there is a possibility that the conductive gel 32 is not in contact with the main electrode 102 and all the corresponding detection electrodes 110. Further, for example, when the circuit inside the electric stimulus applying device 1 fails, there is a possibility that appropriate power is not supplied to the main electrode 102. Therefore, when the impedances between the main electrode 102 and each of the corresponding detection electrodes 110 are all larger than a predetermined threshold value, the control unit 103 has the conductive gel 32 attached to the back surface of the application unit 20. It is determined that the electrical stimulation application device 1 is not in the state of failure or the electrical stimulation application device 1 is out of order.

When the control unit 103 determines any of the results shown in steps S14, S16 and S17, the information of the determined result may be notified from the notification unit (step S18). By the notification, the user can know the determination result.

The control unit 103 may change the means and method of notification according to the content of the determination result. For example, when the notification unit is composed of the display unit 104, the control unit 103 may perform different displays depending on the determination result. In this case, the user can know the content of the determination result.

Further, the control unit 103 may perform notification only when a specific determination result is obtained. For example, the control unit 103 may not give a notification when it is determined that the sticking state is appropriate, and may give a notification only when it is determined as another result. In this case, the user does not take any action when the sticking state is appropriate, and conversely, when it is not determined that the sticking state is appropriate, the user is notified of the information and takes some action. be able to.

In this way, the control unit 103 can determine the sticking state of the conductive gel 32. After determining the sticking state, the control unit 103 starts the processing in the setting stage. It is preferable that the control unit 103 starts the processing in the setting stage only when it is determined that the sticking state is appropriate. When starting the processing in the setting stage, the control unit 103 controls the first circuit changeover switch 115 to conduct the first main electrode 102a and the treatment voltage generation circuit 113, and to make the second circuit changeover switch 116 conductive. By controlling, the second main electrode 102b is connected to the ground.

Next, the processing of the setting stage and the treatment stage executed by the control unit 103 will be described. FIG. 9 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. 9 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. 9, the horizontal axis represents time. In FIG. 9, the vertical axis of the electrical stimulation output chart indicates the electrical stimulation output intensity. In FIG. 9, 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. 10 is a flowchart showing an example of processing executed by the control unit 103 of FIG. 5 at the setting stage. FIG. 11 is a flowchart showing an example of a process executed by the control unit 103 of FIG. 5 in the treatment stage.

Here, with reference to FIGS. 9 and 10, details of the processing executed by the control unit 103 in the setting stage will be described. The time t _{1 in} FIG. 9 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.

At the setting stage, the control unit 103 outputs the electrical stimulus from the main electrode 102 so as to gradually increase the output intensity of the electrical stimulus. Specifically, the control unit 103 first outputs an electrical stimulus (step S20). 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. 9, 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.

When the setting stage is started, the user presses the third input unit 101c when the electrical stimulus is detected. When the output of the electrical stimulus in step S20 is executed, the control unit 103 determines whether or not an input indicating that the electrical stimulus has been detected by the user is detected (step S21). 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 S20 is executed.

When the control unit 103 does not detect the input indicating that the electrical stimulus has been detected (No in step S21), the control unit 103 increases the output intensity of the electrical stimulus (step S22). Then, the process proceeds to step S20, and the electrical stimulus is output again with the output intensity increased in step S22 (step S20). In step S22, 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. 9, when the control unit 103 outputs an electrical stimulus at the output intensity P ₁ and does not detect an input indicating that the electrical stimulus is detected, the control unit 103 then outputs the electrical stimulus at the output intensity P _2. doing. Further, the control unit 103 may start the output of the electric stimulus in the step S20 with the intensity of the electric stimulus increased through the step S22 after a predetermined time after starting the output of the electric stimulus in the step S20. In the example shown in FIG. 9, the control unit 103 starts the output of the electrical stimulation of the output intensity P ₁ in step S20 at the time t ₁ , and then at the time t ₂ after a predetermined time, the electrical stimulation of the output intensity P ₂ Is starting to output.

The control unit 103 repeats the increase in the intensity of the electrical stimulus in step S22 and the output of the electrical stimulus in step S20 until it is determined in step S21 that the input indicating that the electrical stimulus has been detected is detected. By repeating this, the control unit 103 can gradually increase the output intensity of the electrical stimulation. In the example shown in FIG. 9, the control unit 103 increases the output intensity of the electrical stimulation in the order of P ₁ , P ₂ , P ₃ , P ₄ , and P ₅ , and outputs the power. The times t ₁ , t ₂ , t ₃ , t ₄ and t ₅ in FIG. 9 indicate the times when the output of the electrical stimulation of the output intensities P ₁ , P ₂ , P ₃ , P ₄ and P ₅ was started, respectively.

When the control unit 103 detects a predetermined operation input to the input unit 101, the control unit 103 sets the output intensity of the electrical stimulation used in the treatment stage. The output intensity of the electrical stimulus used in the treatment stage is also hereinafter referred to as "therapeutic intensity" in the present specification. In the present embodiment, the control unit 103 sets the treatment intensity when the operation input of pressing the third input unit 101c is detected.

That is, when the control unit 103 detects an input indicating that the electrical stimulus has been detected (Yes in step S21), the control unit 103 sets the treatment intensity (step S23). That is, in the present embodiment, when the control unit 103 detects an input indicating that the electrical stimulus has been detected while gradually increasing the output intensity of the electrical stimulus, the control unit 103 sets the treatment intensity (step S23). In the chart of FIG. 9, when the electric stimulus is output at the output intensity P ₅ , the user senses the electric stimulus and presses the third input unit 101c, and the control unit 103 indicates that the third input unit 101c is pressed. Shows an example when is detected.

In step S23, the control unit 103 is based on the output intensity of the electrical stimulus output when the control unit 103 detects a predetermined operation input to the input unit 101 (in this example, the operation input of pressing the third input unit 101c). A predetermined output intensity, which is also low, is set as the therapeutic intensity. Here, in the present specification, the output intensity of the electrical stimulus output when a predetermined operation input to the input unit 101 is detected is referred to as a detection output intensity Ps. In the example here, the output intensity at the time of detection Ps = P ₅ is established.

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 detection output intensity Ps by a predetermined intensity as the therapeutic intensity. Further, for example, the control unit 103 may set the output intensity obtained by multiplying the detected output intensity Ps by a coefficient less than 1 as the therapeutic intensity. Here, it will be described below assuming that the control unit 103 sets the output intensity obtained by multiplying the detected output intensity Ps by 0.8 as a coefficient as the therapeutic intensity Pm. That is, in the example described here, the therapeutic intensity Pm = 0.8 × the output intensity P ₅ is established.

It should be noted that the setting of the treatment intensity in step S23 does not necessarily have to be executed before step S24. The setting of the treatment intensity in step S23 may be completed by the end of the setting step, that is, by the end of the flow of FIG.

After detecting a predetermined operation input to the input unit 101 (in this example, the operation input of pressing the third input unit 101c), the control unit 103 heats the living body or the like by the heater 108, and the heater 108 The treatment phase may be initiated when the temperature rises above a predetermined temperature. Such heating by the heater 108 may be performed at the setting stage.

Specifically, the control unit 103 detects an input indicating that an electrical stimulus has been detected, sets the treatment intensity, and turns on the heater 108 (step S24). Chart shown in Figure 9, at time t _6, shows 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.

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 S25). The predetermined temperature is, for example, a temperature suitable for treatment by the electric stimulus application device 1, and may be predetermined.

When the control unit 103 determines that the temperature of the heater 108 has not reached the predetermined temperature (No in step S25), the control unit 103 repeats step S25 while keeping the heater 108 in the ON state.

When the control unit 103 determines that the temperature of the heater 108 has reached a predetermined temperature (Yes in step S25), the control unit 103 turns off the heater 108 (step S26). Chart shown in Figure 9, at time t _7, indicating that the heater 108 is turned off.

When the control unit 103 turns off the heater 108 in step S26, the setting step ends. That is, in the chart shown in FIG. 9, the setting stage ends at time t ₇ . When the setting stage is completed, the control unit 103 then starts processing in the treatment stage.

Next, with reference to FIGS. 9 and 11, details of the processing 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.

First, the control unit 103 starts the treatment time timer by the timer unit 105 (step S30). 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 stage, or the time during which the output processing of the pulsed direct current is performed in the treatment stage. 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 stage is equal to the time during which the output processing of the pulsed direct current is performed in the treatment stage. Become.

The control unit 103 outputs a pulsed DC current as an electrical stimulus (step S31). At this time, the control unit 103 outputs the pulsed direct current at the treatment intensity set in the setting stage, that is, the treatment intensity Pm set in step S23 of the flow of FIG.

When the control unit 103 outputs the pulsed direct current in step S31, the control unit 103 starts the electrical stimulation interval timer by the timer unit 105 (step S32). 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.

Further, when the control unit 103 outputs the pulsed direct current in step S31, the control unit 103 starts the heater ON interval timer by the timer unit 105 (step S33). 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.

It is preferable that the control unit 103 executes step S32 and step S33 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. Further, it is preferable that the control unit 103 executes step S32 and step S33 at the same time as step S31. 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 when the pulsed direct current is output.

The control unit 103 determines whether or not a predetermined time T ₁ has elapsed since the heater ON interval timer was started (step S34). The predetermined time T ₁ is the time from when the pulsed direct current as the electrical stimulus is output until the heater 108 is turned on, and may be set in advance, for example.

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 S34), the predetermined time T ₁ has elapsed since the heater ON interval timer was started. Step S34 is repeated until it is determined.

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 S34), the control unit 103 turns on the heater 108 (step S35).

Then, the control unit 103 turns on the heater 108, and after a predetermined time T ₂ elapses, turns the heater 108 off (step S36). Here, the on and off control of the heater 108 in steps S35 and S36 may be executed as a pulse wave. That is, in this case, the control unit 103 may turn on the heater 108 in step S35 and then turn off the heater 108 in step S36 after a predetermined time T ₂ corresponding to the pulse width has elapsed.

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 S37). 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 S37), a predetermined time T ₃ from the start electrical stimulation interval timer has elapsed Step S37 is repeated until it is determined.

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 S37), whether or not the predetermined time T ₄ has elapsed since the start of the treatment time timer. Is determined (step S38). 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.

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 S38), the control unit 103 proceeds to step S31 and outputs a pulsed direct current. In this way, the control unit 103 repeats steps S31 to S38 from the start of the treatment time timer in step S38 until it is determined that the predetermined time T ₄ has elapsed. By repeating steps S31 to S38 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, when the heater 108 is turned on in step S35, heat is appropriately applied, which makes it easier to maintain the temperature of the abdomen.

When the control unit 103 determines that the predetermined time T ₄ has elapsed since the treatment time timer was started (Yes in step S38), the control unit 103 ends the flow of FIG. This ends the treatment phase. At this time, the control unit 103 may notify the user that the treatment stage has been completed by displaying it on the display unit 104 or driving another mechanism. When the treatment stage is completed, the user peels off the electrical stimulation application device 1 from the abdomen to end the treatment.

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. 12 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. 12, let t ₁₁ be the time when the output of the nth pulse DC current in the treatment stage is started. After the output of the nth pulse DC current, the time when the heater 108 is turned on is set to t _12, and the time when the heater 108 is turned off after that is set to t ₁₃ . Further, the time at which the output of the n + 1th pulse DC current in the treatment stage is started is t ₁₄ . Times t ₁₁ , t ₁₂ , t ₁₃ and t ₁₄ are arranged in chronological order in this order.

At this time, the predetermined time T ₁ is represented by t _{12 −} t ₁₁ 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 _{13 −} t ₁₂ . 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 _{14 −} t ₁₁ . 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.

As described above, according to the electrical stimulation application device 1 according to the present embodiment, the control unit 103 determines the conductive gel 32 according to the impedance between the main electrode 102 and each of the plurality of corresponding detection electrodes 110. Can determine the sticking state of. Therefore, the electric stimulus applying device 1 can determine the state of attachment of the conductive gel 32 to the electric stimulus applying device 1 when applying the electric stimulus to a living body or the like.

Further, according to the electrical stimulation application device 1 according to the present embodiment, when the impedance between the main electrode 102 and each of the corresponding plurality of detection electrodes 110 is all equal to or less than a predetermined threshold value, the conductive gel 32 Judge that the sticking state of is appropriate. In this way, the electrical stimulus application device 1 can determine the case where the conductive gel 32 is in an appropriate state of attachment.

Further, according to the electrical stimulation application device 1 according to the present embodiment, when the impedance between the main electrode 102 and each of the corresponding plurality of detection electrodes 110 is larger than a predetermined threshold value, the conductive gel 32 is formed. It is determined that the device is not attached or the electrical stimulation application device 1 is in a failed state. In this way, the electric stimulus applying device 1 can determine that the conductive gel 32 is not attached and that the electric stimulating applying device 1 is out of order.

Further, according to the electrical stimulation application device 1 according to the present embodiment, at least one of the impedances between the main electrode 102 and each of the corresponding plurality of detection electrodes 110 is equal to or less than a predetermined threshold value, and When at least one is larger than a predetermined threshold value, it is determined that the sticking state of the conductive gel 32 is not appropriate. In this way, the electric stimulus applying device 1 can determine the case where the conductive gel 32 is not properly attached.

Further, the control unit 103 applies a weak electric stimulus to the living body or the like at the treatment stage by outputting the electric stimulus at the treatment intensity Pm lower than the output intensity Ps at the time of detection. Therefore, by inputting a predetermined operation input when the user senses the electrical stimulus, the control unit 103 outputs the electrical stimulus at the treatment stage with a strength weaker than the intensity of the electrical stimulus sensed by the user. Can be done. In this way, the electric stimulus applying device 1 facilitates setting the intensity of the electric stimulus to an appropriate level when applying a stimulus that combines a weak electric stimulus and heat to a living body or the like.

In particular, as described with reference to the flow of FIG. 10, when the output intensity of the electrical stimulus is gradually increased in the setting stage, the control unit 103 inputs a predetermined operation input when the user senses the electrical stimulus. Therefore, the treatment intensity Pm is set to be weaker than the output intensity Ps at the time of detection. As a result, the control unit 103 can set the treatment intensity Pm to a weak level that the user does not detect.

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.

For example, in the above embodiment, it has been explained that the control unit 103 heats the third input unit 101c by the heater 108 after detecting the input to the third input unit 101c at the setting stage. However, the control unit 103 may heat the heater 108 before outputting the electrical stimulus, for example, in step S20 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 at the treatment stage to an appropriate level.

Further, for example, in the above embodiment, an example in which the control unit 103 executes a process of outputting an electrical stimulus from the main electrode 102 so as to gradually increase the output intensity of the electrical stimulus has been described in the setting stage. However, the processing in the setting stage is not limited to the 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.

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 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.

Further, in the above embodiment, it has been explained that the control unit 103 determines the sticking state of the conductive gel 32 based on the impedance calculated in step S12. However, the control unit 103 may determine another state based on the impedance calculated in step S12. For example, the control unit 103 may determine the deteriorated state of the attached conductive gel 32 based on the impedance calculated in step S12. When the conductive gel 32 is used for a long period of time, its properties may change, and the change in properties may be reflected in the impedance. The control unit 103 may determine the deterioration state of the conductive gel 32 from the impedance calculated in step S12 by using, for example, a predetermined threshold value capable of detecting a change in the properties of the conductive gel 32.

The electrical stimulus application device 1 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.

The present disclosure relates to an electrical stimulation application device.

1: Electrical stimulation application device 10: Main body 20: Application part 30: Sheet material 31: Frame part 32: Conductive gel 40: Power output related part 101: Input part 101a: First input part 101b: Second input part 101c : Third input unit 102: Main electrode 102a: First main electrode 102b: Second main electrode 103: Control unit 104: Display unit 105: Timer unit 106: Storage unit 107: Power supply unit 108: Heater 109: Temperature measurement unit 110 : Detection electrode 110a: First detection electrode 110b: Second detection electrode 110c: Third detection electrode 110d: Fourth detection electrode 110e: Fifth detection electrode 110f: Sixth detection electrode 111: Detection electrode changeover switch 111a: First switch 111b: 2nd switch 111c: 3rd switch 111d: 4th switch 111e: 5th switch 111f: 6th switch 112: Current measuring unit 112a: 1st current measuring unit 112b: 2nd current measuring unit 113: Treatment voltage generation circuit 114: Judgment voltage generation circuit 115: First circuit changeover switch 116: Second circuit changeover switch 120, 130: Straight portion 121, 131: Arc portion

Claims

An electrical stimulus application device that applies electrical stimulus to a living body or tissue with a conductive gel attached.
A main electrode that is exposed to the outside on one surface of the electrical stimulation applying device and outputs the electrical stimulation,
A plurality of detection electrodes arranged around the main electrode on the one surface,
A control unit that determines the sticking state of the conductive gel on the one surface according to the impedance between the main electrode and each of the plurality of detection electrodes.
A device for applying an electrical stimulus.
The control unit determines that the state in which the conductive gel is attached is appropriate when the impedances between the main electrode and each of the plurality of detection electrodes are all equal to or less than a predetermined threshold value. The electrical stimulation application device according to 1.
When the impedance between the main electrode and each of the plurality of detection electrodes is larger than the predetermined threshold value, the control unit is in a state where the conductive gel is not attached or the electrical stimulation application device. The electrical stimulation application device according to claim 2, wherein it is determined that the device is in a failed state.
When at least one of the impedances between the main electrode and each of the plurality of detection electrodes is equal to or less than the predetermined threshold value and at least one is greater than the predetermined threshold value, the control unit is used. The electrical stimulation application device according to claim 2 or 3, wherein it is determined that the state in which the conductive gel is attached is not appropriate.
The electrical stimulus application device according to any one of claims 2 to 4, wherein the control unit outputs the electrical stimulus when it is determined that the state in which the conductive gel is attached is appropriate.
It also has a notification unit that notifies information.
The control unit notifies the information of the result of the determination from the notification unit.
The electrical stimulation application device according to any one of claims 1 to 5.
An electrical stimulus applying device capable of outputting an electrical stimulus in a state where a conductive gel is attached, and a main electrode that is exposed to the outside on one surface of the electrical stimulus applying device and outputs an electrical stimulus, and the one surface. In the determination method by an electric stimulus applying device including a plurality of detection electrodes arranged around the main electrode.
A step of measuring the impedance between the main electrode and each of the plurality of detection electrodes,
A step of determining the sticking state of the conductive gel on the one surface according to the measured impedance, and
Judgment method including.