Ultrasonic stimulator

Abstract

To solve the problem that a patient cannot be treated or treatment efficiency is reduced due to discomfort and stress to a burn based on heat generation of a probe.SOLUTION: An ultrasonic stimulation apparatus including a main body unit, a probe that outputs an ultrasonic wave oscillated by an ultrasonic transducer through a cover in which the ultrasonic transducer is disposed, and an electric floor pad that supplies negative charges, in which the main body unit includes an electric signal generation unit that outputs an ultrasonic wave supply electric signal, a negative charge circuit unit that outputs a negative charge supply electric signal, and a control unit that controls the electric signal generation unit and the negative charge circuit unit, and the electric signal generation unit can output a first electric signal of a first frequency and a second electric signal of a second frequency, the control unit controls output of the second electric signal and the negative charge supply electric signal on the basis of information indicating that a current of the first electric signal exceeds or falls below a threshold.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an ultrasonic device used in an ultrasonic treatment device or beauty device that utilizes the thermal or vibration effects of ultrasound, or an ultrasonic diagnostic device that displays images of the internal tissue of a patient's living body. [Background technology]

[0002] When ultrasound is irradiated onto the human body, the heat generated by the ultrasound absorbed by the body warms the irradiated area to a relatively deep depth, resulting in a hyperthermic effect. Furthermore, the vibrational action of ultrasound creates microscopic bubbles inside the body as a mechanical effect, and the phenomenon of their creation, resonant vibration, and collapse is known as cavitation, which can directly provide physical stimulation to biological tissue in the microscopic region. These bubble generation phenomena due to thermal and mechanical effects are utilized in medical and cosmetic devices. Furthermore, the stimulation caused by the mechanical and vibrational effects of ultrasound is known to promote bone fusion at the fracture site, and so ultrasound is used as a fracture treatment device.

[0003] Ultrasound generators for therapeutic and cosmetic applications utilize ultrasonic probes with ultrasonic oscillation capabilities. When a probe is simply brought into contact with human tissue, air is present at the contact surface. Furthermore, the acoustic impedance of air is quite low. This difference in acoustic impedance between the probe and the human tissue creates large reflected waves at the contact surface, making it difficult to perform appropriate treatments, cosmetic procedures, or diagnoses. Therefore, ultrasound gels with acoustic impedances similar to those of human tissue are typically used as acoustic coupling agents. Ultrasound gels are typically jelly-like, water-soluble gels made from polymers, ethanol, glycerin, and other materials. Hereinafter, they will simply be referred to as gels. Ultrasound gels have acoustic impedances similar to those of human tissue, and their viscosity improves the slipperiness of the probe at the contact surface, enhancing operability.

[0004] Hereinafter, in this specification, examples of ultrasonic stimulation devices that irradiate or supply ultrasound to the human body include therapeutic devices, diagnostic devices, and cosmetic devices, but these will be simply referred to as therapeutic devices, and the performance of treatment, diagnosis, or cosmetic treatment will simply be referred to as treatment or treatment.Furthermore, in this specification, the part of the human body to be treated will simply be referred to as the affected area, the person who performs treatment using a therapeutic device, diagnosis using a diagnostic device, or treatment using a cosmetic device will be referred to as the user, and the person who receives these treatments, diagnoses, or cosmetic treatments will simply be referred to as the patient.Therefore, unless otherwise specified, the term therapeutic device does not exclude diagnostic devices or cosmetic devices, and the term patient does not only refer to people with injuries or illnesses, but also to people who undergo examinations or cosmetic treatments. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2006-181291 Summary of the Invention [Problem to be solved by the invention]

[0006] Generally, the probes used in ultrasound treatments, i.e., the probes used to deliver ultrasound to the affected area, have a head that is the part that comes into contact with the affected area, which becomes hot, as will be described later. Although it may seem that the use of gel would reduce the effect of heat from the head, in many cases the gel is pre-warmed before being applied to the skin, and in reality the effect of heat from the head is not reduced as much as expected, and the user may experience discomfort due to the heat from the head.

[0007] Furthermore, the IEC 60601-2-5 standard for ultrasound physiotherapy equipment stipulates that the contact surface temperature of the head used for treatment must not exceed 43°C. However, when ultrasound is continuously output, for example, the emitting surface of the head used for treatment, which is the surface that contacts the body and delivers ultrasound to the affected area, may heat up due to the ultrasonic vibrations used. This continuous heat generation can cause the emitting surface or the head on which the emitting surface is located to unintentionally become hot. Sudden contact of the head with the skin can cause discomfort to the patient or even burns to the affected area. Therefore, by monitoring the output of the electrical signal supplied to the probe, it is possible to determine whether the head is in contact with the affected area. If the head is in contact with the affected area, the output of ultrasound can be controlled to start, increase, or maintain, and if the head is not in contact with the affected area, the output of ultrasound can be stopped or reduced (hereinafter sometimes referred to as auto-contact) (see, for example, Patent Document 1). This allows ultrasound to be output only when the head is in contact with the affected area, preventing unnecessary temperature increases due to ultrasound output. However, if the ultrasonic transducer used does not have a high-frequency electrical signal output with high output efficiency, the output of the monitored electrical signal may be unstable, preventing proper auto-contact. This can lead to discomfort and stress from burns, leading to resistance to ultrasound treatment, making treatment impossible or reducing treatment efficiency. Furthermore, when negative charge is used in combination, a high-voltage potential is required to supply the negative charge, but constantly outputting this high-voltage potential is inappropriate due to safety concerns. [Means for solving the problem]

[0008] (1) In order to achieve the above object, the present invention provides the following: an ultrasonic stimulation device including a main body, a probe that outputs ultrasonic waves generated by an ultrasonic transducer via a cover in which the ultrasonic transducer is disposed, and an electric pad that supplies a negative charge, wherein the main body includes an electric signal generating unit that outputs an ultrasonic supply electric signal that is an electric signal supplied to the ultrasonic transducer, a negative charge circuit unit that outputs a negative charge supply electric signal that is an electric signal supplied to the electric pad, and a control unit that controls the electric signal generating unit and the negative charge circuit unit, wherein the electric signal generating unit is capable of outputting a first electric signal of a first frequency and a second electric signal of a second frequency as the ultrasonic supply electric signals, the first electric signal being temporarily output while the second electric signal is stopped, and the control unit controls the output of the second electric signal and the output of the negative charge supply electric signal based on information based on the current of the first electric signal temporarily output by the electric signal generating unit, the information indicating that the current exceeds or falls below a predetermined threshold.

[0009] (2) Furthermore, the ultrasonic stimulation device of the present invention is characterized in that the output efficiency of the ultrasonic waves generated by the second electric signal is lower than the output efficiency of the ultrasonic waves generated by the first electric signal. [Effects of the Invention]

[0010] The present invention solves the above problems and provides an ultrasonic stimulation device that prevents discomfort caused by heat generation due to ultrasound or avoids burns, reduces stress caused by discomfort or burns caused by ultrasound, eliminates resistance to treatment using ultrasound, improves treatment efficiency, and enables highly safe, stress-free, and comfortable treatment. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is an explanatory diagram illustrating an ultrasonic stimulation device according to the present invention. [Figure 2] 1 is a block diagram of an ultrasonic stimulation device according to the present invention. [Figure 3] FIG. 2 is an explanatory diagram illustrating control of an electrical signal according to the present invention. [Figure 4] FIG. 2 is an explanatory diagram illustrating control of ultrasonic waves according to the present invention. [Figure 5] FIG. 2 is an explanatory diagram illustrating control of an electrical signal according to the present invention. [Figure 6] FIG. 2 is an explanatory diagram illustrating control of an electrical signal according to the present invention. [Figure 7] 1 is an explanatory diagram illustrating an ultrasonic stimulation device in which a negative charge is also used according to the present invention. FIG. [Figure 8] FIG. 1 is a block diagram of an ultrasonic stimulation device that also uses a negative charge according to the present invention. [Figure 9] 1 is an explanatory diagram illustrating an ultrasonic stimulation device in which a negative charge is also used according to the present invention. FIG. [Figure 10] FIG. 1 is a block diagram of an ultrasonic stimulation device that also uses a negative charge according to the present invention. [Figure 11] FIG. 2 is an explanatory diagram illustrating control of an electrical signal according to the present invention. [Figure 12] FIG. 2 is an explanatory diagram illustrating control of an electrical signal according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0012] An embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a diagram showing the configuration of an ultrasonic stimulation device A1 used to describe the present invention in this embodiment. The ultrasonic stimulation device A1 applies ultrasonic waves to a treatment area or a surgical site to perform treatment or therapy, thereby providing ultrasonic therapeutic effects, massage effects, cosmetic effects, or cavitation effects. It can be used as a treatment device, massage device, or cosmetic device. The ultrasonic stimulation device A1 is used by connecting a probe 12 that outputs ultrasonic waves to a main body A11. The probe 12 can output ultrasonic waves to the affected area in response to an electrical signal supplied as described below. Note that in this specification, the affected area or skin to which ultrasonic waves are supplied may also be simply referred to as the "subject." A display unit 17, an encoder 18, and a switch 16 are provided on the front of the main body A11 of the ultrasonic stimulation device A1. A connection unit A217 to which the cable A13 of the probe 12 is connected is provided on the right side of the main body A11. A main power supply 15 is provided on the top of the main body A11. A circuit board A19, described below, is also provided inside the main body A11.

[0013] The probe 12 is composed of a head portion 125 and a cable A13 and is connected to the main body A11. The cable A13 is connected to the proximal end of the head portion 125, and a cover 121 made of, for example, stainless steel is disposed at the distal end opposite the head portion 125. An ultrasonic vibrator, for example, a piezoelectric element, is disposed inside the cover 121. The cover 121 further has an emission surface 123 that is in contact with an object and emits ultrasonic waves oscillated from the ultrasonic vibrator through the cover 121 to the object. Hereinafter, contact between the emission surface 123 and the skin on the surface of the affected area may also be expressed as the cover 121 contacting the affected area (or skin) or the probe 12 contacting the affected area (or skin).

[0014] FIG. 2 shows a block diagram of the circuit board A19. The circuit board A19 is arranged inside the main body A11 and is composed of an electrical signal generator 204, which is an output circuit that outputs an ultrasonic supply electrical signal, which is an electrical signal supplied to the ultrasonic transducer arranged in the probe 12; a control unit A203 that controls the operation of the main body A11, including the electrical signal generator 204; a timer 207; a user IF unit 201; a power supply unit 206; and a memory 205. Hereinafter, the ultrasonic supply electrical signal will be simply referred to as the electrical signal. The control unit A203 incorporates a CPU, internal memory, and an interface unit that connects to the above-mentioned components. The control unit A203 is connected to the electrical signal generator 204 that generates the electrical signal, the timer 207 that manages the output time, the user IF unit 201 connected to the display unit 17, and the memory 205, and transmits and receives information to and controls them. The circuit board A19 also includes a detector 52 that detects the current value of the electrical signal output by the electrical signal generator 204. However, the detector 52 may be provided within the electrical signal generator 204. The electrical signal output from the electrical signal generating unit 204 is supplied to terminals A215 and B216. When the cable A13 connected to the connection unit A217 comes into contact with the terminals A215 and B216, the electrical signal is supplied to an ultrasonic transducer disposed on the surface (back surface) opposite the radiation surface 123 of the cover 121 of the probe 12 to which the cable A13 is connected. The ultrasonic transducer generates ultrasonic waves in response to the supplied electrical signal. One of the terminals A215 and B216, for example, terminal B216, may be connected to the ground of the circuit board A19. The power consumed by each component is supplied from a battery 208 as a power source, which is controlled by the power supply unit 206 to a predetermined constant voltage, for example, 5 V or 12 V, and supplied to each component via the control unit A203. Instead of the battery 208, the power source may be configured to supply power from an outlet or the like.

[0015] The ultrasonic stimulation device A1 is used as follows. First, the user turns on the main power supply 15. When the main power supply 15 is turned on, the display unit 17 displays buttons that serve as an interface for displaying the status of the main unit A11 and for various settings, including buttons for selecting or setting modes such as a beauty mode or a treatment mode and an output level. The display unit 17 may be, for example, a touch-panel LCD display, and also serves as an input unit or an operation unit. When the user taps the displayed output level display, the encoder 18 is enabled. By rotating the encoder 18, which functions as an output setting unit, the user can set the amplitude of the electrical signal, for example, the current value, which is the output of the electrical signal, and thereby set the intensity of the ultrasound output from the probe 12. In other words, by changing the frequency and amplitude, which are parameters of the electrical signal output by the electrical signal generation unit 204, the frequency and intensity of the ultrasound output from the probe 12 can be changed. Hereinafter, the magnitude of the amplitude and output of the current value of the electrical signal that drives the ultrasonic transducer to emit ultrasound, or the magnitude of the ultrasound, may also be referred to as "intensity," and may also be used to indicate the voltage and power of the electrical signal.

[0016] When the user selects a first mode (described later) as the treatment mode using the display unit 17, the user IF unit 201 detects this information and transmits it to the control unit A203. The control unit A203 then reads necessary information, such as parameters specifying the electrical signal for outputting ultrasound waves used in the selected first treatment mode, from the memory 205 and supplies this information to the electrical signal generator 204. When the user then presses the switch 16, the information is transmitted to the control unit A203 via the user IF unit 201, and the control unit A203 instructs the electrical signal generator 204 to output the electrical signal used in the first mode. The electrical signal generator 204 outputs the electrical signal according to the supplied parameters, i.e., in response to the instruction from the control unit A203 to output the electrical signal used for treatment. The electrical signal output from the electrical signal generator 204 is supplied to the head unit 125 via the cable A13 connected to the connection unit A217 of the main unit A11, and the electrical signal is then supplied to the ultrasound transducer located in the cover 121 and converted into ultrasound waves by the ultrasound transducer. The ultrasonic waves are supplied to the affected area from the emission surface 123 as ultrasonic waves used in the first mode. In this specification, the supply of the electrical signal output from the electrical signal generation unit 204 to the ultrasonic vibrator arranged in the cover 121 is referred to as "the electrical signal output from the electrical signal generation unit 204 or from the main body A11 is supplied to the probe 12, the head unit 125, or the cover 121." Furthermore, the emission of ultrasonic waves from the emission surface 123 may be simply referred to as "ultrasound being output, emitted, supplied, emitted, etc." from the probe 12, the head unit 125, or the cover 121.

[0017] Information indicating that the output of the electrical signal has started is sent to the timer 207, which starts measuring time, for example, 20 minutes, which is the treatment time during which the electrical signal is continuously or periodically output by the electrical signal generating unit 204, i.e., the time during which ultrasonic waves are continuously or periodically output from the emitting surface 123. The user starts ultrasonic treatment by bringing the emitting surface 123 into contact with the affected area and supplying ultrasonic waves to the affected area. The treatment time may be stored in the memory 205 as part of the above parameters.

[0018] Information regarding the measurement by the timer 207, for example, information indicating that a predetermined time has elapsed, is fed back to the control unit A203, and in response to this feedback, the control unit A203 stops the output of the electrical signal by controlling the electrical signal generation unit 204 to stop power supply, thereby stopping the emission of ultrasound from the emission surface 123. The treatment time is not limited to 20 minutes, and may be longer or shorter than 20 minutes, and may be configured so that the user can set or adjust it as appropriate taking into account the condition of the affected area. Note that the output of the electrical signal is stopped by pressing the switch 16 again while the electrical signal is being output.

[0019] In the first mode, the ultrasonic stimulation device A1 outputs ultrasound waves at a first frequency (described later, in this embodiment, a frequency of 1 MHz). The electrical signal generated by the electrical signal generator 204 and supplied to the probe 12 to emit therapeutically effective ultrasound waves from the radiation surface 123 is referred to as the "first electrical signal." That is, the electrical signal generator 204 outputs the first electrical signal as an ultrasound supply electrical signal. While the frequency of the electrical signal typically varies somewhat depending on the characteristics of the probe 12, the head unit 125, the cover 121, and the ultrasonic transducers disposed therein, as well as the method of attachment to the cover 121, for the sake of convenience, the frequency of the electrical signal and the frequency of the actually output ultrasound waves are treated as being equal in this specification. Therefore, the frequency of the ultrasound waves output at the first frequency is also the first frequency. If the ultrasound waves at the first frequency are 1 MHz, the frequency of the first electrical signal is also treated as 1 MHz.

[0020] Furthermore, in this specification, the frequency of the electrical signal at which the output of ultrasound is greatest in response to the electrical signal supplied to the ultrasonic transducer is referred to as the frequency with the highest output efficiency or the first frequency. In other words, the frequency at which the ratio (referred to as output efficiency) of the intensity of the ultrasound actually oscillated by the ultrasonic transducer to the intensity of the electrical signal supplied to the ultrasonic transducer to cause the ultrasonic transducer to emit ultrasound is the highest is referred to as the frequency with the highest output efficiency or the first frequency. In other words, this indicates that the first mode, which is the specific treatment mode described above, uses the first frequency, which is the frequency with the highest output efficiency, and in this embodiment, 1 MHz corresponds to the first frequency. Note that the first frequency can also be referred to as the frequency at which the ultrasonic transducer used most efficiently outputs ultrasound. Here, the first frequency does not only refer to the frequency of ultrasound, but also to the electrical signal output by the electrical signal generating unit 204. Therefore, the electrical signal of the first frequency can refer to the frequency of the electrical signal at which ultrasound is most efficiently output. In this embodiment, in the first mode, the main body A11 outputs an electrical signal of 1 MHz, which is the first frequency with the highest output efficiency, to the probe 12, and the probe 12 outputs an ultrasonic wave of the first frequency.

[0021] When performing skin care or to reduce the discomfort caused by ultrasonic waves on the surface of the affected area, a second frequency of 3 MHz, different from the first frequency, can be selected and output instead of the above-mentioned 1 MHz. Since the first frequency has the highest output efficiency, the output efficiency of the second frequency is inevitably lower, and the second frequency can also be said to be a frequency at which the ultrasonic output efficiency is lower than that of the first frequency. The term "second frequency" does not refer only to the frequency of the ultrasonic waves, but also to the electrical signal output by the electrical signal generating unit 204 and supplied to the probe 12. Therefore, an electrical signal of the second frequency can refer to the frequency of an electrical signal at which, when supplied to an ultrasonic transducer, the output efficiency of the ultrasonic waves emitted by the transducer is lower than that of an electrical signal of the first frequency.

[0022] The frequency of the ultrasound waves to be output may be configured to be selectable using a button displayed on the display unit 17, or may be configured to be changeable by the encoder 18 by pressing a frequency selection button displayed on the display unit 17. Alternatively, if a second frequency is used instead of the first frequency in a second mode different from the first mode, the user may select the second mode instead of the first mode, causing the control unit A203 to read parameters necessary for outputting an electrical signal of the second frequency from the memory 205 and supply them to the electrical signal generating unit 204, so that the electrical signal generating unit 204 outputs a second electrical signal, which is an electrical signal of the second frequency, to the probe 12, and ultrasound waves of the second frequency are supplied to the affected area from the emitting surface 123, thereby enabling the use of ultrasound waves of the second frequency. That is, the electrical signal generating unit 204 may be configured to output the second electrical signal as an ultrasound supply electrical signal.

[0023] The frequency of the ultrasonic waves to be output can be switched by changing the frequency of the electrical signal output from the electrical signal generating unit 204. That is, the frequency of the ultrasonic waves output from the radiation surface 123 can be controlled by changing the frequency of the electrical signal output from the electrical signal generating unit 204. For example, when outputting ultrasonic waves of 1 MHz from the probe 12, the electrical signal generating unit 204 supplies an electrical signal of 1 MHz to the probe 12, and ultrasonic waves of 1 MHz are output from the radiation surface 123. Furthermore, when outputting ultrasonic waves of a frequency of 3 MHz, the electrical signal generating unit 204 supplies an electrical signal of 3 MHz to the probe 12, and ultrasonic waves of 3 MHz are output from the radiation surface 123.

[0024] If the frequency of the output ultrasound is changed, for example, to 3 MHz, a different probe, specially designed for the 3 MHz frequency, other than probe 12 may be used, or probe 12 may be used to output 3 MHz. However, if probe 12's most efficient output, i.e., the frequency at which it can produce maximum output, is 1 MHz, output efficiency will be low when outputting 3 MHz. Depending on the configuration of probe 12 and cover 121 and the parameters of the supplied electronic signal, the maximum output when outputting 3 MHz may be at most, for example, 80% of the output when 1 MHz is supplied. Although this method of use results in a slight decrease in output, it is more desirable because it eliminates the need for multiple expensive probes and eliminates the need for additional probe costs. Furthermore, at the second frequency, the antinode of the ultrasound generates large vibrations near radiating surface 123, i.e., subcutaneously, not on the skin surface, which reduces the apparent intensity of the ultrasound at the skin surface and reduces the ultrasound stimulation on the skin surface, thereby avoiding discomfort caused by ultrasound, reducing resistance to ultrasound treatment, and improving treatment efficiency.

[0025] It is desirable to stop the output of ultrasonic waves when the head unit 125 (emitting surface 123) is not in contact with the affected area. As described above, the piezoelectric element is attached inside the cover 121, i.e., on the opposite side of the emitting surface 123 or the skin, of the part of the cover 121 that faces the affected area during treatment. The piezoelectric element generates heat as it continues to output ultrasonic waves, causing its temperature to rise, and this heat is transferred to the cover 121, causing the cover 121 to become hot. If the cover 121 becomes hot, when the cover 121 is pressed against the affected area, i.e., when the emitting surface 123 comes into contact with the affected area, the heat can cause discomfort to the patient and can even lead to burns.

[0026] Therefore, in the present invention, auto-contact is implemented in which the detection unit 52 detects whether the probe 12, head unit 125, or emitting surface 123 is in contact with the affected area, and when the emitting surface 123 is in contact with the affected area or skin, the ultrasound waves used for treatment are output from the emitting surface 123, and when the emitting surface 123 is not in contact with the affected area or skin, the ultrasound waves used for treatment are not output from the emitting surface 123. The detection unit 52 monitors or detects the current value of the electrical signal output from the electrical signal generation unit 204 and supplied to the probe 12, and can determine whether the emitting surface 123 of the probe 12 is in contact with the affected area. However, contact may include not only direct contact between the emitting surface 123 and the affected area, but also indirect contact between the emitting surface 123 and the affected area via gel or the like, and in this specification, contact includes both direct and indirect contact between the emitting surface 123 and the affected area.

[0027] If the detection unit 52 detects that the radiation surface 123 is not in contact with the affected area, it notifies the control unit A203 of information indicating no contact, or if it detects contact, it notifies the control unit A203 of information indicating contact. Based on this information, the control unit A203 can control the output of ultrasound waves, i.e., the output of the electrical signal supplied from the electrical signal generation unit 204 to the probe 12, to stop or reduce (hereinafter simply referred to as "stop"), or control the output to start, resume, or increase (hereinafter simply referred to as "start") the output. Note that, in this specification, transmission or exchange of information used between circuits to exchange specific information, such as information indicating no contact or information indicating contact, may be expressed, for example, by setting several predefined bits in a digital signal from 1 to 0 or from 0 to 1, and the information may be transmitted between the necessary circuits. Alternatively, information may be transmitted and received between circuits by changing the voltage of a signal line provided between specific circuits, for example, from 5 V to 0 V or from 0 V to 5 V.

[0028] Figure 3 shows a flowchart of this auto-contact process. First, the detection unit 52 monitors or detects the current value Io (hereinafter, sometimes simply referred to as Io) of the electrical signal output from the electrical signal generation unit 204 to the probe 12 (S1). The current value Io is large when the radiation surface 123 is in contact with the affected area or the skin, and is small when the radiation surface 123 is in a non-contact state, such as when the radiation surface 123 is separated from the skin by an air gap. Therefore, the detection unit 52 monitors, detects, or measures the current value Io, and when Io becomes equal to or greater than a first threshold current value Ith1 (S2), it notifies the control unit A203 of information indicating that Io has become equal to or greater than Ith1 as a contact signal, which is information indicating that the radiation surface 123 is in contact with the affected area or the skin (S3). The first threshold is a threshold used for the current value of the electrical signal output from the electrical signal generating unit 204. If Io exceeds the first threshold, it can be determined that the radiating surface 123 (probe 12) is in contact with the affected area, and this threshold is used to determine that the radiating surface 123 is in contact with the affected area or the skin. Conversely, if Io detected by the detecting unit 52 becomes smaller than the current value Ith2, which is the second threshold (S4), the detecting unit 52 notifies the control unit A203 of information indicating that Io has become smaller than Ith2 as a non-contact signal, which is information indicating that the radiating surface 123 is not in contact with the affected area or the skin, or that the desired ultrasound treatment is not being performed. The second threshold is a threshold used for the current value of the electrical signal output from the electrical signal generating unit 204. If Io is smaller than the second threshold, it can be determined that the radiating surface 123 is not in sufficient contact with the affected area, and this threshold is used to determine that the radiating surface 123 is not in contact with the affected area or the skin, or that the radiating surface 123 is not in contact with the affected area or the skin.

[0029] Next, the control unit A203 controls the electric signal generating unit 204 based on the contact signal or non-contact signal received from the detection unit 52, and controls the start or stop of the output of the electric signal output by the electric signal generating unit 204, for example, the first electric signal, thereby controlling the emission of the ultrasonic waves from the emission surface 123. For example, when the control unit A203 receives a contact signal from the detection unit 52, if the first electric signal is being output, the control unit A203 maintains the output of the first electric signal, and if the first electric signal is not being output (output is stopped), the control unit A203 starts the output of the first electric signal. Conversely, when the control unit A203 receives a non-contact signal from the detection unit 52, if the first electric signal is being output, the control unit A203 stops the output of the first electric signal, and if the first electric signal is not being output (output is stopped), the control unit A203 maintains the stop of the output of the first electric signal.

[0030] Furthermore, since the control unit A203 starts outputting the first electric signal from the electric signal generating unit 204 based on the contact signal, the contact signal may also be referred to as an output start signal, which is a signal indicating the start of output. Similarly, since the control unit A203 stops outputting the first electric signal from the electric signal generating unit 204 based on the non-contact signal, the non-contact signal may also be referred to as an output stop signal, which is a signal indicating the stop of output.

[0031] Note that even when the output of the first electrical signal is stopped or maintained stopped based on a non-contact signal or an output stop signal, a third electrical signal may be output instead of the first electrical signal. That is, the electrical signal generating unit 204 may be configured to output a third electrical signal as an ultrasonic supply electrical signal. The third electrical signal may have the same frequency as the first electrical signal, but with a reduced output. The third electrical signal causes weak ultrasonic waves of the first frequency to be output from the emitting surface 123. Even if the output of ultrasonic waves from the third electrical signal is weak, as long as the frequency is the first frequency, the output current Io can be stably detected, and therefore it can be detected that Io changes depending on whether or not the emitting surface 123 is in contact with the skin. Therefore, when the third electrical signal is being output, a predetermined third threshold, Ith12, is used instead of Ith1. When Io exceeds Ith12 (S2 in FIG. 3), this corresponds to when Io generated by the first electrical signal exceeds Ith1. The detection unit 52 notifies the control unit A203 of a contact signal (corresponding to S3 in FIG. 3), and the control unit A203 may change the output of the electrical signal generation unit 204 from the third electrical signal to the first electrical signal. That is, even when the third electrical signal is being used, the control of FIG. 3 can be used by setting Ith12 instead of Ith1. When the control unit A203 uses the third electrical signal instead of the first electrical signal to control the electrical signal output from the electrical signal generation unit 204 in response to contact or non-contact between the probe 12 and the affected area, the output of the third electrical signal is smaller than the output of the first electrical signal, and therefore the detected current Io is also smaller. Therefore, Ith12, the third threshold used for the third electrical signal, is smaller than Ith1, the first threshold. The output of the third electrical signal is sufficient to reliably detect whether or not the probe 12 is in contact with the affected area, but when a normal electrical signal of the first frequency is used, the output can be very small, so heat generated by the vibrator does not contribute significantly to the temperature rise of the cover 121.

[0032] In this embodiment, the timer 207 continues to measure the treatment time even when the radiation surface 123 and the affected area are not in contact with each other during treatment. However, the timer 207 may stop measuring the time when the radiation surface 123 and the affected area are not in contact with each other or when the ultrasound used for treatment is stopped by a non-contact signal. This is more preferable if the non-contact state continues for a long time, since it prevents the time missed due to the non-contact state from being counted as treatment time, thereby ensuring the treatment time. Alternatively, if the non-contact state continues for a certain period of time, for example, in a single treatment, i.e., when the timer 207 measures 20 minutes as the treatment time, if the non-contact state continues for a certain period of time, for example, 5 minutes, the timer 207 may be controlled to measure the time by subtracting the time the non-contact state continued from the measured time. In this way, even when the timer 207 temporarily stops measuring the time or ignores the non-contact time, the control unit A203 can determine contact between the radiation surface 123 and the affected area by the electrical signal generator 204 continuing to output the third electrical signal.

[0033] On the other hand, when the second frequency is used, that is, when a frequency at which the ultrasonic output efficiency of the ultrasonic transducer is low is used, the current value Io of the electrical signal output from the electrical signal generating unit 204 is likely to become unstable. Therefore, when the control as shown in Fig. 3 is applied to the second frequency, that is, when contact or non-contact is determined only by the second electrical signal of the second frequency, the detecting unit 52 cannot adequately detect contact or non-contact between the emitting surface 123 and the affected area, and for example, there is a case where a non-contact signal is sent to the control unit A203 even though there is contact. In this case, the control unit A203 stops outputting the electrical signal, so that ultrasonic waves are not output from the emitting surface 123. In particular, since the user cannot directly know the output of ultrasonic waves, he or she cannot notice that the ultrasonic waves have stopped. Therefore, the treatment operation continues even though the ultrasonic waves have stopped, and the treatment effect is not obtained, resulting in a decrease in treatment efficiency.

[0034] Similarly, because the current value Io for the second frequency is unstable, there are cases where the detection unit 52 sends a contact signal to the control unit A203 even when the radiation surface 123 is not in contact with the affected area, and in this case the control unit A203 continues to output the electrical signal. In particular, because the user cannot directly know the output of ultrasound, the output of ultrasound from the radiation surface 123 is maintained, and the temperature of the radiation surface 123 continues to rise. Therefore, if the user brings the radiation surface 123 into contact with the affected area again, the radiation surface 123, whose temperature has increased, will be pressed against the affected area unintentionally, causing discomfort to the patient or making it more likely to be burned, resulting in ineffective treatment and reduced treatment efficiency.

[0035] Therefore, in the present invention, control as shown in Figure 4 is performed particularly in the second mode. Figure 4 shows the output of 3 MHz and 1 MHz ultrasound (the first frequency electrical signal and the second frequency electrical signal output from the electrical signal generating unit 204) radiated from the radiating surface 123 when 3 MHz is used for treatment in the ultrasonic stimulation device A1, i.e., in the second mode in which ultrasound of the second frequency generated by the second electrical signal of the second frequency is used for treatment. The horizontal axis represents time, and the vertical axis represents ON / OFF of the output. ON represents a state in which ultrasound is being output, i.e., a state in which an electrical signal is being output from the electrical signal generating unit 204 to the probe 12, and OFF represents a state in which ultrasound is not being output, i.e., a state in which an electrical signal is not being output from the electrical signal generating unit 204 to the probe 12. Note that ON and OFF may be considered to represent the ON / OFF of an electrical signal for outputting ultrasound, such as the first frequency electrical signal or the second frequency electrical signal.

[0036] As treatment begins at time T1, the 3 MHz ultrasound begins to be output and turns ON. Thereafter, the ultrasound continues to be output (remains ON) until time T2, at which point the output is temporarily stopped (turned OFF). The 3 MHz ultrasound remains OFF until time T3, at which point it begins to be output and turns ON. The ON state is maintained until time T4, at which point the output is temporarily stopped, and this cycle is repeated until time T6, when the treatment time expires. That is, if the time from T1 to T2 is TW1 and the time from T2 to T3 is TW2, the 3 MHz ultrasound repeats ON and OFF cycles, with the sum of TW1 and TW2 being one cycle. Therefore, the output of the second electrical signal begins at time T1, T3, T5, T7, T9, T11, etc., and the output of the second electrical signal is stopped at time T2, T4, T6, T8, T10, T12, etc. In this way, the timing at which the output of the second electrical signal is periodically started, such as at time T1, time T3, time T5, etc., is referred to as the output start timing, and the timing at which the output of the second electrical signal is periodically stopped, such as at time T2, time T4, time T6, etc., is referred to as the output stop timing.

[0037] However, when a second frequency, for example, 3 MHz, is used (second mode), as shown in FIG. 4, an electrical signal of the first frequency, 1 MHz, is temporarily output instead of the second frequency, 3 MHz, and ultrasound waves generated by these electrical signals are output instead of the second frequency. In FIG. 4, the 1 MHz ultrasound wave begins to be output and turns ON at time T41, when the 3 MHz output is OFF. The output (ON) continues until time T42, at which point the output stops and turns OFF. The 1 MHz ultrasound wave then remains OFF until time T43, at which point it starts to be output and turns ON. At time T44, the output stops and turns OFF, and this cycle is repeated until the end of the treatment time, T6. If the time from T41 to T42 is TW3 and the time from T42 to T43 is TW4, the 1 MHz ultrasound wave repeats with a cycle equal to the sum of TW3 and TW4. That is, when 3 MHz ultrasound waves of the second frequency are used for treatment, the 3 MHz ultrasound waves of the second frequency are temporarily turned off, and while the second frequency is turned off, ultrasound waves of the first frequency, 1 MHz ultrasound waves, are temporarily output instead of the electrical signal of the second frequency. While FIG. 4 shows ON / OFF control of ultrasound waves, it can also be said to show ON / OFF of the electrical signal output by the electrical signal generating unit 204. While FIG. 4 shows a case where temporary ON / OFF control is repeatedly performed, such as for 1 MHz and 3 MHz ultrasound waves, this can be expressed as, for example, periodic or regular control, and in this specification, these may also be simply referred to as temporary.

[0038] When the first frequency of 1 MHz is used for treatment, contact between the emitting surface 123 and the affected area can be detected without any problem, so the control shown in Fig. 4 is not necessary, and the ON state can be maintained while the probe 12 is in contact with the affected area, without periodically repeating ON and OFF during treatment. Furthermore, during treatment using the second frequency of 3 MHz, the frequency of the ultrasound temporarily output when the 3 MHz frequency is OFF can be the first frequency of 1 MHz as described above, but as long as it is possible to detect contact or non-contact between the probe 12 and the affected area, a third frequency different from 1 MHz and the second frequency used for treatment can be used instead of the first frequency. Although it has been described above that when using the first frequency of 1 MHz, particularly when the radiating surface 123 is not in contact with the affected area, a third electrical signal having the same frequency as the first frequency but a weaker output can be used, instead of the third electrical signal, an electrical signal having the same output as the second electrical signal may be output instead, i.e., the first electrical signal may be temporarily output to detect the current Io and determine the contact state between the radiating surface 123 and the affected area. Ultimately, the magnitude of the output of the first electrical signal having the first frequency, which is temporarily used to determine whether the probe 12 is in contact with the affected area instead of the second electrical signal having the second frequency, is not particularly limited as long as it can reliably detect whether the probe 12 is in contact with the affected area and does not cause the temperature rise of the radiating surface 123 to exceed a predetermined temperature, e.g., 43°C. However, in order to prepare for unforeseen circumstances or to reduce power consumption, it is most desirable from the standpoint of safety and power consumption to use a third electrical signal having the first frequency but a lower output, rather than the first electrical signal having a relatively high output. In FIG. 4, the third electrical signal is used as the electrical signal of the first frequency that is temporarily used.

[0039] While Fig. 4 shows a case where the probe 12 and the affected area, i.e., the radiation surface 123 and the skin, are always in contact, Fig. 5 shows a case where the radiation surface 123 and the skin are temporarily out of contact. That is, in the control shown in Fig. 4, the control of the electrical signal output by the electrical signal generating unit 204 is shown when the probe 12 and the skin are not always in contact but are out of contact, and the control of the electrical signal that outputs the ultrasonic waves or the ultrasonic waves when the skin and the probe 12 are in contact or out of contact in the second mode is shown. Fig. 5 shows a case where the radiation surface 123 and the affected area are in contact until time T1 when treatment starts, where the radiation surface 123 and the skin are out of contact at time T51, where the out-of-contact state is maintained from time T51 to time T52, and where the radiation surface 123 and the affected area are again in contact at time T52. The horizontal axis of Fig. 5 represents time, (a) of Fig. 5 represents the ON / OFF of the third electrical signal that causes the ultrasonic vibrator in the probe 12 to emit an ultrasonic wave of 1 MHz, (b) of Fig. 5 represents the current Io due to the electrical signal output by the electrical signal generating unit 204 to the probe 12 detected by the detecting unit 52, and (c) of Fig. 5 represents the ON / OFF of the second electrical signal that outputs an ultrasonic wave of 3 MHz. It can also be said that (a) and (c) of Fig. 5 represent the ON and OFF of the ultrasonic waves of 1 MHz (first frequency) and 3 MHz (second frequency) output from the emitting surface 123, respectively.

[0040] Even in the case of Fig. 5, the detection unit 52 can determine whether the radiation surface 123 is in contact with the skin or not, for example, by the control shown in Fig. 3. However, because the third electrical signal is used, the third threshold Ith12 is used instead of Ith1, and the fourth threshold Ith22, which will be described later, is used instead of Ith2 in the control of Fig. 3. In Fig. 5, the radiation surface 123 is in contact with the skin until time T51, so that the current Io, which is the current due to the output 1 MHz electrical signal, is detected as a value greater than the threshold Ith12 between time T41 and time T42. In this case, the detection unit 52 notifies the control unit A203 of information indicating that a current value Io greater than the threshold Ith12 has been detected, as a contact signal, which is information indicating that the radiation surface 123 is in contact with the affected area or the skin.

[0041] When contact between the radiation surface 123 and the affected area is repeatedly detected while a 3 MHz signal is being output, the detection unit 52 may again send contact information each time, which is information indicating that the radiation surface 123 and the affected area are in contact, but when a 3 MHz electrical signal is being repeatedly output or when it is known that the radiation surface 123 and the affected area are in contact, the contact information does not need to be sent again. In this embodiment, the detection unit 52 sends contact information each time contact between the probe 12 and the affected area is detected.

[0042] When the radiation surface 123 and the skin are not in contact at time T51, the current Io output between time T43 and time T44 decreases and falls below the threshold Ith22. In this case, the detection unit 52 notifies the control unit A203 of information indicating that a current value Io smaller than the threshold Ith22 has been detected as a non-contact signal, which indicates that the radiation surface 123 is not in contact with the affected area or the skin, or that the desired ultrasound treatment is not being performed. The threshold Ith22 is used for the current value of the third electrical signal, and if Io falls below Ith22, it indicates that the probe 12 is not in contact with the affected area. This is the fourth threshold used to determine whether the probe 12 is not in contact with the affected area when using the third electrical signal. When the control unit A203 receives the non-contact information from the detection unit 52, it transmits information to the electrical signal generation unit 204 indicating that the output of the 3 MHz electrical signal (second electrical signal) is to be stopped in order to stop the 3 MHz ultrasound used for treatment.

[0043] 5, based on the acquisition of non-contact information, the output of the 3 MHz electrical signal, which would have started if the probe 12 had been in contact with the affected area, is stopped from time T5, which is the 3 MHz output start timing immediately after the acquisition of the non-contact information. Note that once the 3 MHz output is stopped based on the non-contact information, the output remains stopped until the control unit A203 subsequently acquires a contact signal from the detection unit 52, or until treatment is stopped and then started again.

[0044] Subsequently, when the radiation surface 123 and the affected area come into contact at time T52, the current Io due to the 1 MHz electrical signal (third electrical signal) output between time T45 and time T46 is detected to be greater than the threshold value Ith12. In this case, the detection unit 52 notifies the control unit A203 of the contact information, and the control unit A203 transmits information indicating the start of outputting a 3 MHz electrical signal based on the contact information to the electrical signal generation unit 204, and the second electrical signal is output by the electrical signal generation unit 204. In Figure 5, based on the acquisition of the contact information, the output of the 3 MHz electrical signal is resumed from time T11, which is the output start timing of the 3 MHz electrical signal immediately after the acquisition of the contact information.

[0045] In FIG. 5 , the threshold Ith12 is used to detect contact between the radiation surface 123 and the affected area, but the present invention is not limited to this. The threshold Ith12 is used for the third electrical signal. However, in the control shown in FIGS. 4 and 5 , the first-frequency electrical signal is not output continuously but is used temporarily. Therefore, it contributes little to the temperature rise of the cover 121 or the radiation surface 123, and there is not much need to reduce the output of the first-frequency electrical signal. Therefore, the output of the temporarily used first-frequency electrical signal may be the same as the output of the second electrical signal (3 MHz), i.e., the first electrical signal. The thresholds used may be Ith1 instead of Ith12 and Ith2 instead of Ith22. The output of the third electrical signal may be a value obtained by multiplying the output of the second electrical signal by a fixed ratio, or may be a constant value regardless of the output of the second electrical signal. In other words, it may be a LOW output, as described below.

[0046] When acquiring non-contact information or contact information and stopping or starting the 3 MHz output used for treatment, the output may be turned on or off in units of one cycle of the 3 MHz output as shown in Figure 5, but the output of the 3 MHz electrical signal or ultrasound, which is the second frequency, may also be turned on or off immediately upon acquiring non-contact information or contact information.

[0047] In the control shown in Figures 4 and 5, when the ultrasonic stimulation device A1 of the present invention uses ultrasound of the second frequency (3 MHz) for treatment, it also uses ultrasound of the first frequency to detect the contact state between the radiation surface 123 and the affected area. Alternatively, when the ultrasonic stimulation device A1 outputs an electrical signal used to output ultrasound of the second frequency (3 MHz), it also uses the electrical signal used to output ultrasound of the first frequency to detect the contact state between the radiation surface 123 and the affected area. That is, when the ultrasonic stimulation device A1 of the present invention uses ultrasound of the second frequency for treatment, it temporarily stops its output and outputs ultrasound of the first frequency while the output is stopped to detect the contact state between the radiation surface 123 and the skin. Note that ultrasound or electrical signals of a third frequency may be used instead of ultrasound or electrical signals of the first frequency to detect the contact state between the radiation surface 123 and the affected area.

[0048] In the present embodiment, the detection unit 52 is arranged independently of the control unit A203 and the electrical signal generation unit 204. However, the present invention is not limited to this. The function of the detection unit 52 may be provided in the control unit A203, or the control unit A203 may function as the detection unit 52. The control unit A203 may acquire information indicating the current Io from the electrical signal generation unit 204 and generate a contact signal or a non-contact signal within the control unit A203. Alternatively, the function of the detection unit 52 may be provided in the electrical signal generation unit 204. In this case, the electrical signal generation unit 204 may generate a contact signal or a non-contact signal within the electrical signal generation unit 204 based on the information indicating the current Io, and the electrical signal generation unit 204 may transmit the generated contact signal or non-contact signal to the control unit A203. In the above embodiment, the control unit A203 acquires the contact signal or non-contact signal from the detection unit 52. However, the only difference is that the source of the signal is now the electrical signal generation unit 204, and there is no significant change in the control or operation of the control unit A203.

[0049] In the control shown in FIG. 5 , even when the radiating surface 123 is not in contact with the affected area, the first electrical signal is repeatedly output over one cycle defined by the sum of TW3 and TW4. That is, regardless of the state of contact between the radiating surface 123 and the affected area, the controller A203 controls the ON / OFF of the first frequency electrical signal at a fixed cycle. The present invention is not limited to this. The controller A203 may change the ON / OFF control of the first frequency electrical signal based on the state of contact between the radiating surface 123 and the affected area. For example, the controller A203 may change the ON / OFF cycle of the first frequency electrical signal. For example, when the radiating surface 123 is not in contact with the affected area, TW4 may be replaced with TW5, which is smaller than TW4. That is, the sum of TW3 and TW5 may be used to repeatedly turn the first frequency electrical signal ON and OFF. That is, the control cycle for turning the first frequency electrical signal ON and OFF may be shorter than the cycle when the radiating surface 123 is in contact with the affected area. This control corresponds to determining the contact state between the radiation surface 123 and the affected area more frequently when they are not in contact than when they are in contact.

[0050] If the period of the electrical signal of the first frequency used when the radiating surface 123 is in contact with the affected area is defined as the first period, then, for example, if TW3 is 2 seconds and TW4 is 8 seconds, then the first period is 10 seconds. In this case, the period controlling the ON / OFF of the second frequency (3 MHz) is the first period, and therefore the period of the second electrical signal is also 10 seconds. If the period of the electrical signal of the first frequency used when the radiating surface 123 is not in contact with the affected area is defined as the second period, then, if TW3 is 2 seconds and TW4 is 5 seconds, then the second period is 7 seconds. If the second period is long, for example, 10 seconds, the same as the first period, when the radiating surface 123 changes from a non-contact state to a contact state, a change in the current Io due to contact between the radiating surface 123 and the affected area cannot be detected for up to 10 seconds. Therefore, the ultrasound remains OFF, treatment cannot be performed, and treatment efficiency is not improved. Therefore, it is desirable to make the second period shorter than the first period. As an example in which the control unit A203 controls the ON / OFF of the electrical signal of the first frequency based on the contact state between the radiation surface 123 and the affected area, the ON / OFF of the electrical signal of the first frequency has been described above, but the present invention is not limited to this. When the probe 12 is not in contact with the affected area, the ON / OFF control of the first frequency is not performed, and control may be such that the third electrical signal is continuously output and maintained in the ON state.

[0051] The controls shown in Figures 4 and 5 above illustrate the auto-contact control used in the second mode, but the auto-contact control shown in Figure 3 is also used in the first mode. However, the ultrasonic frequency used in the first mode is the first frequency, and since contact / non-contact determination can be made accurately as described above, the complex auto-contact control shown in Figures 4 and 5 is not necessary. The auto-contact control in the first mode is shown in Figure 6. In Figure 6, (a) shows the control of the output of an electrical signal (first electrical signal) of 1 MHz, which is the first frequency, (b) of Figure 6 is the output current value Io of the electrical signal of the first frequency (first electrical signal) detected by the detection unit 52, and (c) of Figure 6 shows the contact / non-contact state between the probe 12 and the affected area.

[0052] First, at time T61, a first electrical signal having a first frequency is output. The output level of the first electrical signal is set by the user to a level sufficient to output ultrasound waves used in treatment. For convenience, this electrical signal level is referred to as HIGH. That is, HIGH refers to the output level used in treatment, and in the above embodiment, it indicates the output level set by the user using an output setting means such as the encoder 18. At time T61, the first electrical signal begins to be output at a HIGH level, and the detection unit 52 detects the output Io of the first electrical signal. Thereafter, when the probe 12 and the affected area are no longer in contact with each other at time T62, Io decreases. When Io falls below Ith2, the detection unit 52 notifies the control unit A203 of this, i.e., sends a non-contact signal, according to the control of FIG. 3 (S5). When the control unit A203 receives the non-contact signal from the detection unit 52, it lowers the output level of the first electrical signal from HIGH to LOW at time T63. That is, when the radiation surface 123 of the probe 12 comes out of contact with the affected area at time T62, the control unit A203 automatically reduces the output of the first electrical signal at time T63, and also reduces the output of the ultrasound emitted from the radiation surface 123 of the probe 12.

[0053] The output of the first electrical signal is reduced from a HIGH level, which realizes the intensity of the ultrasound used in treatment, to a LOW level, which outputs ultrasound waves weaker than those used in treatment. However, even at the LOW output, the output must be strong enough to detect contact between the probe 12 and the affected area, and the temperature of the radiation surface 123 must not exceed 43°C even if the LOW output is continued. Therefore, the LOW output is an output smaller than the HIGH level of the first electrical signal used in treatment, which allows the detection unit 52 to detect whether the probe 12 is in contact with the affected area, and which prevents a temperature rise in the contact surface 123, and corresponds to the third electrical signal described above. In other words, the LOW output is an output at which the current value Io detected by the detection unit 52 is smaller than Ith12 when the probe 12 is not in contact with the affected area, and which prevents the temperature of the radiation surface 123 from rising to a predetermined temperature, such as 43°C or higher. The LOW output electrical signal, which has the first frequency, corresponds to the third electrical signal. The LOW output to be used may be set independently of the magnitude of the set HIGH output, or may be controlled according to the magnitude of the set HIGH output, for example, by multiplying the magnitude of the HIGH output by a constant and setting it according to the LOW output.

[0054] After treatment is initiated at time T61 with the probe 12 in contact with the affected area, when the probe 12 and the affected area are no longer in contact at time T62, the current Io decreases to below the threshold Ith2, and the detection unit 52 notifies the control unit A203 of a no-contact signal. Based on the no-contact signal, the control unit A203 switches the output of the first electrical signal from HIGH to LOW at time T63, and the LOW output is maintained thereafter. When the probe 12 comes into contact with the affected area at time T64, Io exceeds the threshold Ith12, and the detection unit 52 notifies the control unit A203 of a contact signal. Based on the contact signal acquired from the contact detection unit 52, the control unit A203 performs control to change the output to HIGH at time T65.

[0055] As described above, auto-contact control can be applied to the control in Fig. 6 by using threshold value Ith12 instead of threshold value Ith1 in the control in Fig. 3. Note that in Fig. 6, when probe 12 is not in contact with the affected area, the output of the electrical signal of the first frequency is reduced and the third electrical signal is continuously output, but this is not limited to this. When probe 12 is not in contact with the affected area, as explained based on Fig. 4 and Fig. 5, an electrical signal of the first frequency, for example, the first electrical signal, may be temporarily output to determine whether probe 12 is in contact with the affected area.

[0056] As described above, in the present invention, when the probe 12 is not in contact with the affected area, high-intensity or high-output ultrasound waves that are used in treatment are not continuously output, so the head portion is not unintentionally heated, and the person receiving treatment is free from the discomfort or risk of burns caused by a hot head portion, making it possible to provide an ultrasound-based device that allows for comfortable treatment.

[0057] In the above, when the second frequency is supplied to the ultrasonic vibrator disposed in the probe 12, not only is the output of the ultrasonic waves lower than when the first frequency is supplied as described above, but the output of the ultrasonic waves oscillated at the second frequency tends to be very peaky. The magnitude of the ultrasonic waves output when the second frequency of 3 MHz is supplied can easily vary due to mass-production variations in the probes 12, such as mass-production variations in the ultrasonic vibrators disposed in the probes 12 and variations in attachment to the cover 121. When the second frequency is 3 MHz, some probes 12 may output sufficient 3 MHz ultrasonic waves, but other probes 12 may output insufficient ultrasonic waves due to mass-production variations. If the output is insufficient, the therapeutic effect cannot be sufficiently obtained, resulting in reduced therapeutic efficiency or a problem in which the therapeutic efficiency cannot be improved.

[0058] Therefore, the probe 12 in this embodiment checks in advance which second frequency is most appropriate as the second frequency, and stores information indicating the most appropriate second frequency in a memory chip 218 (not shown) disposed within the probe 12. When the probe 12 is connected to the ultrasonic stimulation device A1 or when the ultrasonic stimulation device A1 is powered on by the main power supply 15, the control unit A203 reads the information from the memory chip 218, and based on the acquired information, the control unit A203 controls the frequency of the electrical signal output from the electrical signal generation unit 204 to finely adjust the frequency from the second frequency.

[0059] The most appropriate second frequency is a frequency close to the second frequency, which indicates the frequency at which the greatest ultrasonic output is obtained, and is also the frequency at which the output efficiency exhibits a maximum value relative to the frequency. Therefore, the most appropriate second frequency may be 3.00 MHz for one probe 12, but may be 3.02 MHz or 2.97 MHz for another probe 12, depending on variations in mass production of the probes 12. For example, if the electrical signal generating unit 204 supplies 3.04 MHz to a probe 12 whose most appropriate second frequency is 3.04 MHz, the desired output can be obtained, but if 3.00 MHz is supplied, the ultrasonic output will be significantly reduced. Therefore, it is desirable that the memory chip 218 in the probe 12, in which the most appropriate second frequency is 3.04 MHz, stores information indicating the most appropriate second frequency of 3.04 MHz, and that the control unit A203 controls the frequency of the electrical signal output from the electrical signal generating unit 204 to 3.04 MHz instead of 3.00 MHz in accordance with the information indicating the most appropriate second frequency of 3.04 MHz that is input from the memory chip 218 to the control unit A203 and supplies it to the probe 12.

[0060] The information indicating the most appropriate second frequency may be information that directly indicates the second frequency, or information that indirectly indicates the second frequency. For example, an index corresponding to the most appropriate second frequency may be used as the indirect information. For example, index In01 may be set to 3.00 MHz, index In02 to 3.02 MHz, and index In03 to 3.04 MHz, and one of the indices, for example, index In02, may be stored in memory chip 218 depending on probe 12. The controller A203 may instruct electrical signal generator 204 to output a 3.02 MHz electrical signal corresponding to In02 when it reads In02, or a 3.04 MHz electrical signal corresponding to In03 when it reads In03, thereby controlling the frequency of the electrical signal output by electrical signal generator 204.

[0061] By storing the second frequency for each probe 12 in this way, the problem of different ultrasonic output depending on the probe 12 due to variations in mass production can be resolved, and an ultrasonic stimulation device A1 can be realized that can ensure stable ultrasonic output and maintain good ultrasonic treatment efficiency.

[0062] Figure 7 shows an ultrasonic stimulation device B6, another example of the present invention. The ultrasonic stimulation device B6 can perform treatments and therapies using both ultrasonic waves and negative charges. The combined use of ultrasonic waves and negative charges not only offers the advantage of being able to simultaneously perform both ultrasonic treatment and negative charge treatment, but also provides the following unique advantages of the present invention, in addition to the advantage of simultaneously performing both ultrasonic treatment and negative charge treatment. The ultrasonic stimulation device B6 uses a probe 12 to irradiate ultrasonic waves, i.e., performs negative charge treatment using the probe 12 while irradiating the affected area with ultrasonic waves from the probe 12.

[0063] Ultrasound therapy has the effects of promoting blood circulation, alleviating pain, suppressing inflammation, and accelerating the healing of acute trauma. Even when focused solely on beauty, it can be expected to have a thermal effect, a massage effect, reduce swelling, improve skin quality, tighten skin, cleanse pores, promote fat burning, and other benefits. On the other hand, negative charge therapy is expected to promote blood circulation, relieve stiffness and pain, and alleviate fatigue. Even when focused solely on beauty, it can be expected to improve skin quality and promote skin metabolism. However, these effects vary from person to person and are not equally attainable for everyone. For example, when only ultrasound is applied, there are rare cases where fat burning effects are achieved but swelling is insufficient. Similarly, there are also cases where skin quality is improved but the tightening effect is insufficient, and vice versa. Effects vary from person to person. Similarly, even when using only negative charge therapy, the results vary depending on the individual patient. Furthermore, there are various patterns of results depending on the user's know-how, knowledge, and skill.

[0064] Therefore, in the past, the need to find a treatment tailored to each patient sometimes required trial and error to find an effective treatment method for each patient, which required time and money. Specifically, ultrasound treatment was performed to determine its effectiveness, and if that was insufficient, negative charge treatment was performed. If that was not effective, EMS (Electrical Muscle Stimulation) or weak current treatment was tried, which resulted in significant time and financial costs. For example, when alleviating stiffness, ultrasound treatment was performed to determine its effectiveness, and if that was not effective, negative charge treatment was performed. If that was not effective, EMS (Electrical Muscle Stimulation) or acupuncture treatment was tried, which resulted in significant time and financial costs.

[0065] The ultrasonic stimulation device B6 simultaneously performs treatment using ultrasound and negative charge, significantly reducing the time and financial costs involved. Specifically, in patients whose symptoms were not sufficiently improved despite the application of both ultrasound and negative charge when treated separately, the simultaneous application of both ultrasound and negative charge achieved sufficient improvement. In other words, the simultaneous use of ultrasound and negative charge achieved effects that could not be achieved with either ultrasound or negative charge alone, or even when administered separately. Therefore, trial and error is no longer necessary to find the appropriate treatment method for each patient, and the unique effect of the present invention, which allows for simultaneous improvement in treatment efficiency and effectiveness, can be achieved.

[0066] The ultrasound stimulation device B6 includes a main body B600. The same reference numerals as those in the above-described embodiments are used, and therefore their explanations are omitted. The main difference in appearance between Figures 1 and 7 is the electric pad 604 and the connection portion B602. The electric pad 604 includes a cable B601 and a pad portion 603, and is connected to the connection portion B602 provided on the main body B600. The pad portion 603 is a conductive elastic member, e.g., a conductive base material made of conductive silicone or the like, coated with an insulating material. The insulating material may be, for example, a resin such as polyvinyl chloride resin or rubber, e.g., insulating silicone rubber, natural rubber, or urethane rubber. The conductive base material may also be conductive urethane rubber or a thin metal plate, e.g., a thin stainless steel plate.

[0067] 8 shows a circuit board B704 disposed in the main body B600 in place of the circuit board A19. The circuit board B704 includes a negative charge circuit unit 701 that outputs a negative charge supply electrical signal, which is an electrical signal output to the electric pad 604 when a negative charge is supplied to the human body, a terminal C702 to which the negative charge supply electrical signal output from the negative charge circuit unit 701 is supplied at the connection unit B602, and a control unit B703 that controls the electrical signal generation unit 204, the negative charge circuit unit 701, and other components. The negative charge supply electrical signal is different from the ultrasound supply electrical signal and is an electrical signal supplied to the electric pad 604. The negative charge supply electrical signal output from the negative charge circuit unit 701 is supplied to the terminal C702, and when the cable B601 connected to the connection unit B602 comes into contact with the terminal C702, the negative charge supply electrical signal is supplied to the pad unit 603 to which the cable B601 is connected. As described below, since the probe 12 is also used, the negative charge supply electrical signal output from the negative charge circuit section 701 flows to the electrical circuit formed by the negative charge circuit section 701 via the negative charge circuit section 701, terminal C702, cable B601, pad section 603, the human body, radiation surface 123 (cover 121), cable A13, connection section A217, and terminal B216, which is the common ground of the circuit board B704.

[0068] The negative charge supply electric signal output by the negative charge circuit section 701 is, for example, a DC signal of -500 V, and the negative charge circuit section 701 has a built-in protective resistor of 2 MΩ in consideration of unforeseen circumstances. The negative charge supply electric signal is not limited to -500 V, and commonly used voltages range from -50 V to -800 V, and preferably may be, for example, -200 V or -600 V. Furthermore, the signal is not limited to a DC signal, and may be, for example, a pulse train with a negative amplitude, or may be, for example, a square wave with a negative amplitude.

[0069] Treatment using negative charge and ultrasound with the ultrasonic stimulation device B6 is performed as follows: The user places the electric pad 604 on, for example, a chair or treatment bed, and the patient sits in the chair or lies on the treatment bed. Alternatively, the electric pad 604 may be wrapped around an arm or leg. Treatment is then initiated on the affected area using the probe 12. To begin treatment, the user selects the third mode displayed on the display unit 17. The third mode is a mode in which, in the first mode described above, the negative charge circuit unit 701 is driven to output a negative charge supply electrical signal. In other words, this mode uses both the ultrasound and negative charge output in the first mode, and the control of ultrasound in the first mode is the same as in the first mode described above for the ultrasonic stimulation device A1. When the user selects the third mode, that information is detected by the user IF unit 201 and transmitted to the control unit B703, and the control unit B703 reads out from the memory 205 the necessary information, for example, parameters specifying the electrical signal for outputting the ultrasound used in the selected first treatment mode, and parameters necessary for outputting the negative charge supply electrical signal from the negative charge circuit unit 701, and supplies these to the electrical signal generation unit 204. When the user then presses the switch 16, that information is sent to the control unit B703 via the user IF unit 201, and the control unit B703 instructs the electrical signal generation unit 204 to output the electrical signal for the ultrasound used in the first mode and also instructs the negative charge circuit unit 701 to output the negative charge supply electrical signal. The electrical signal generation unit 204 and the negative charge circuit unit 701 output these electrical signals in accordance with the supplied parameters, i.e., in response to instructions from the control unit B703.

[0070] The electrical signal output from the electrical signal generating unit 204 is converted into ultrasound waves used in the first mode and supplied to the affected area from the radiation surface 123. The negative charge supply electrical signal output from the negative charge circuit unit 701 is supplied to the electric pad 604 connected to the connection unit B602 of the main body B600. Therefore, in the third mode in which the probe 12 and the electric pad 604 are used in combination, both the ultrasound treatment output in the first mode and the negative charge treatment can be received simultaneously by the radiation surface 123.

[0071] In addition to the operation in the third mode, which uses both ultrasonic waves in the first mode and a negative charge as described above, the ultrasonic stimulation device B6 can also operate in a fourth mode, which uses both ultrasonic output in the second mode and a negative charge as described above. In the fourth mode, ultrasonic waves are output in the second mode instead of the first mode, and the control of the output ultrasonic waves is the same as the control in the second mode of the ultrasonic stimulation device A1, so a description thereof will be omitted.

[0072] In the third and fourth modes described above, until the treatment time expires or until switch 16 is pressed again during output of ultrasound or a negative charge supply electrical signal to stop the output, control unit B703 does not control negative charge circuit unit 701 to stop the negative charge supply signal, and the negative charge supply signal continues to be output by negative charge circuit unit 701 throughout the treatment time. In a normal device that uses a negative charge, the conductor used to supply the negative charge is attached and fixed to the human body, so the contact between the conductor and the human body is stable and the negative charge supply electrical signal is supplied stably to the human body, so the negative charge supply signal is not controlled to be turned on or off during treatment.

[0073] However, as described above, because the negative charge supply electrical signal is a very high-voltage electrical signal, safety considerations have been taken into account, such as covering the pad section 603 with an insulating material to prepare for unforeseen circumstances and providing a protective resistor in the negative charge circuit section 701. However, in situations where the probe 12 repeatedly comes into and out of contact with the human body, it is more desirable and safer to control the output or stop of the negative charge supply signal as needed, compared to the above-mentioned state in which the signal is always output. Therefore, we will explain the ultrasonic stimulation device C7, which controls both the output of ultrasound and the negative charge supply signal depending on whether the probe 12 is in contact with the affected area or not.

[0074] As shown in Fig. 9, the ultrasonic stimulation device C7 differs from the ultrasonic stimulation device B6 in appearance in the main body C1000. The main body C1000 is provided with a circuit board C1004 instead of the circuit board B704. As shown in Fig. 10, the circuit board C1004 has a control unit C1003 arranged on it instead of the control unit B703, and in the third and fourth modes, it can control both the output of ultrasound and negative charge depending on whether the probe 12 is in contact with the affected area or not. Note that, apart from the control of negative charge performed by the control unit C1003, the main body B600 and the ultrasonic stimulation device B6 are the same, and therefore a description thereof will be omitted.

[0075] Figure 11 shows the control of ultrasound and negative charge in the third mode when the probe 12 is in contact with or not in contact with the affected area. (a) of Figure 11 shows the output state of the first electrical signal, i.e., the output state of ultrasound of the first frequency from the radiating surface 123. (b) of Figure 11 shows the state of the current Io, (c) of Figure 11 shows the contact state between the probe 12 (radiating surface 123) and the affected area, and (d) of Figure 11 shows the output state of the negative charge, i.e., the output state of the negative charge supply electrical signal output by the negative charge circuit section 701. HIGH and LOW in (a) of Figure 11 correspond to HIGH and LOW in (a) of Figure 6, and Ith12 and Ith2 in (b) of Figure 11 also correspond to Ith12 and Ith2 in (b) of Figure 6, so their explanations are omitted. ON and OFF in (d) of Figure 11 correspond to the state in which the negative charge circuit section 701 is outputting a negative charge supply electrical signal and the state in which it is not outputting a negative charge supply electrical signal, that is, the state in which, for example, -500 V is being supplied to the pad section 603 and the state in which it is not being supplied by the negative charge supply signal, respectively.

[0076] At time T111, the probe 12 is in contact with the affected area, and treatment begins. The electrical signal generator 204 outputs a first electrical signal at HIGH, which is the output used for treatment. The negative charge circuit unit 701 outputs a negative charge supply electrical signal and turns it ON, which is controlled by the control unit C1003. Thereafter, at time T112, the probe 12 is no longer in contact with the affected area, the current Io drops below Ith2, and the detection unit 52 sends a non-contact signal to the control unit C1003. In response to the acquired non-contact signal, the control unit C1003 changes the output of the first frequency electrical signal to LOW at time T113, and the negative charge circuit unit 701 stops outputting the negative charge supply electrical signal and turns it OFF. Because the output of the first frequency electrical signal is set to LOW, the current Io drops below Ith12. However, when the probe 12 comes into contact with the affected area at time T114, Io exceeds Ith12, and the detection unit 52 notifies the control unit C1003 of a contact signal. In response to the acquired contact signal, the control unit C1003 changes the output of the first electrical signal to HIGH at time T115, and performs control such that the negative charge circuit unit 701 resumes output of the negative charge supply electrical signal and turns it ON.

[0077] FIG. 12 is an explanatory diagram of the control performed by the control unit C1003 for the fourth mode, which uses both the second mode and negative charge. (a) of FIG. 12 shows the output state of the third electrical signal, i.e., the output state of the ultrasonic waves of the first frequency from the radiating surface 123. (b) of FIG. 12 shows the state of the current Io, and (c) of FIG. 12 shows the output state of the second electrical signal, i.e., the output state of the ultrasonic waves of the second frequency from the radiating surface 123. (d) of FIG. 12 shows the output state of the negative charge, i.e., the output state of the negative charge supply electrical signal output by the negative charge circuit unit 701. HIGH / LOW, ON / OFF, Ith12, Ith22, and time T in FIG. 12 correspond to HIGH, LOW, and the like in FIG. 5, respectively. (d) in Figure 12 corresponds to (d) in Figure 11, and its ON and OFF correspond to the state in which the negative charge circuit section 701 is outputting a negative charge supply electrical signal and the state in which it is not outputting a negative charge supply electrical signal, i.e., the state in which, for example, -500 V is being supplied to the pad section 603 and the state in which it is not being supplied, respectively.

[0078] Control of ultrasound in the fourth mode, i.e., control of the third and second electrical signals output from the electrical signal generating unit 204, is the same as control of the second electrical signal (FIG. 5). FIG. 12 also shows a state in which the probe 12 (emission surface 123) and the affected area (skin) were in contact until time T51, then became out of contact at time T51, and then re-established contact at time T52. As with the control in FIG. 5, after the ultrasound of the second frequency (3 MHz) is stopped at time T4, the first electrical signal is output at time T43, and the current value Io of the first electrical signal is detected. However, because the probe 12 and the affected area are in a out-of-contact state, Io is below Ith22, and the detection unit 52 notifies the control unit C1003 of a non-contact signal. In response to the acquired non-contact signal, the control unit C1003 controls the negative charge circuit unit 701 to stop outputting the negative charge supply electrical signal and turn it OFF (time T44), and also controls the output of the second electrical signal, which would be output again at time T5, which is the output start timing, to be turned OFF. When the probe 12 comes into contact with the affected area at time T52, the current value Io of the first electrical signal output between time T45 and time T46 exceeds Ith12, and so the detection unit 52 notifies the control unit C1003 of a contact signal. In response to the acquired contact signal, the control unit C1003 controls the negative charge circuit unit 701 to resume output of the negative charge supply electrical signal at time T46 and turn it ON, and also controls the second electrical signal to be turned ON at T11, which is the output start timing immediately thereafter, to resume output of the second electrical signal.

[0079] 12 shows an example in which the third electrical signal is used to detect the contact state between the probe 12 and the affected area, but the present invention is not limited to this, and the first electrical signal may be used, and in this case, the threshold value Ith1 may be used instead of Ith12 to determine the contact state between the probe 12 and the affected area. Also, in FIG. 12, the control of the negative charge supply signal depending on whether the probe 12 is in contact with the affected area is performed in accordance with the first electrical signal used to determine the contact state between the probe 12 and the affected area, but the present invention is not limited to this, and the control may be performed in synchronization with the control by the second electrical signal.

[0080] In the above description, the threshold value used to determine whether the probe 12 is in contact with the affected area and the threshold value used to determine whether the probe 12 is not in contact with the affected area, in other words, the threshold value used to control whether to stop or reduce the output of ultrasound or negative charge supply electrical signals, or conversely, the threshold value used to control whether to increase or start the output, may be set to different values, or may be set to a single value. For example, Ith1 used to determine whether contact has occurred and Ith2 used to determine whether contact has occurred may be set to the same value Ith, and the output of ultrasound or negative charge supply electrical signals may be stopped or reduced below Ith, and may be started or increased above Ith.

[0081] Although one embodiment of the present invention has been described in detail above with reference to the drawings, the specific configuration is not limited to that described above, and various combinations are possible within the scope of the gist of the present invention. [Explanation of symbols]

[0082] 1 Ultrasonic stimulator A 6 Ultrasonic stimulator B 7 Ultrasonic stimulator C 11 Main Unit A 12 probes 13 Cable A 15 Main power 16 Switch 17 Display 18 Encoders 19 Circuit Board A 52 Detection unit 121 Cover 123 Radiating Surface 125 head 201 User IF Department 203 Control Unit A 204 Electrical signal generation unit 205 memory 206 Power supply section 207 Timer 208 Battery 215 Terminal section A 216 Terminal section B 217 Connection A 218 Memory Chip 600 Body B 601 Cable B 602 Connection B 603 Pad section 604 Electric Floor Pad 701 Negative charge circuit section 702 Terminal C 703 Control Unit B 704 Circuit Board B 1000 Main body C 1003 Control part C 1004 Circuit Board C

Claims

1. a main body; a probe that outputs ultrasonic waves generated by an ultrasonic vibrator through a cover in which the ultrasonic vibrator is disposed; a negative charge supply pad; An ultrasound stimulation device having: The main body portion is an electrical signal generating unit that outputs an ultrasonic supply electrical signal that is an electrical signal to be supplied to the ultrasonic transducer; a negative charge circuit section that outputs a negative charge supply electric signal, which is an electric signal to be supplied to the electric floor pad; a control unit that controls the electrical signal generating unit and the negative charge circuit unit, the electrical signal generating unit is capable of outputting a first electrical signal of a first frequency and a second electrical signal of a second frequency as the ultrasonic supply electrical signal; the first electrical signal is temporarily output while the second electrical signal is stopped; The control unit controls the output of the second electrical signal and the output of the negative charge supply electrical signal based on information based on the current of the first electrical signal temporarily output by the electrical signal generating unit, the information indicating that the current exceeds a predetermined threshold or is below the threshold.

2. 2. The ultrasonic stimulation device according to claim 1, wherein an output efficiency of the ultrasonic waves generated by the second electric signal is lower than an output efficiency of the ultrasonic waves generated by the first electric signal.

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