JP6373647B2 - Ultrasonic irradiation apparatus and diagnostic system - Google Patents

Description

  The present invention relates to an ultrasonic irradiation apparatus and a diagnostic system. In particular, the present invention relates to an ultrasonic irradiation apparatus and a diagnostic system for irradiating a local area other than a lesioned part of a living body with ultrasonic waves to exert a systemic effect including blood pressure lowering.

  Conventionally, ultrasonic treatment using an ultrasonic irradiation apparatus has obtained a local effect on a lesioned part by irradiating the lesioned part of the living body with ultrasonic waves. In such an ultrasonic irradiation method or ultrasonic irradiation apparatus, based on the irradiation time and the thermal information of the irradiated part for the purpose of more reliably irradiating the affected area and more safely irradiating. Thus, methods and apparatuses for driving and controlling the irradiation of ultrasonic waves have been proposed (see Patent Documents 1, 2, 3, 4, 5, and 6). In addition, based on the periodic movement of the heart rate, the infarcted part of the heart is confirmed on the ultrasound diagnostic image, and therapeutic ultrasound is irradiated at the timing when the infarcted part coincides with the ultrasound focus, There has also been proposed an ultrasonic irradiation apparatus that irradiates ultrasonic waves in a limited manner depending on the region (see Patent Document 7).

The value of ultrasonic intensity that is commonly used in clinical in the ultrasonic treatment, with 1.5MHz or 3MHz frequency is ^{0.01W / cm 2 ~2W / cm 2} . For example, a pulse wave (LIPUS) having a low output intensity that is used internationally for fracture treatment is an ultrasonic wave with intermittent transmission of 30 mW / cm ² and 20% Duty at a frequency of 1.5 MHz. Also, usually, the value of ultrasonic output intensity in the healing of soft tissue, for the acute conditions is a value in the range of 100mW ^/ cm ² ~300mW ^/ cm 2 to the lesion locally, the output intensity of the ultrasonic wave value It has been reported medically that it can be increased to a maximum of 800 mW / cm ² for chronic conditions and should not be greater than 1 W / cm ² (see Non-Patent Documents 1 and 2).

In recent years, a low frequency of 20 kHz to 100 kHz has been applied to sonophoresis (percutaneous drug delivery), dentistry, eye surgery, body contouring (a technique for making a body contour beautiful), and the like. These low-frequency ultrasonic irradiation apparatuses include those that output at a high output intensity (5 W / cm ² or more) and those that output at a low output intensity (0.125 to 3 W / cm ² ) (non-) (See Patent Document 3).
Furthermore, in the ultrasonic irradiation apparatus that irradiates the subcutaneous fat accumulation site in the living body and decomposes the fat at the irradiation site, the output intensity is higher than 10 mW / cm ^{2 in} the frequency range of ultrasonic waves from 180 kHz to 700 kHz, and the frequency is from 700 kHz. In the range of 1.3 MHz, it is set to be larger than 800 mW / cm ² (see Patent Document 8).

JP 2000-225161 A JP 2000-210300 A JP-A-6-285107 JP-A-8-33666 JP 2003-38514 A JP 2003-33365 A JP 2008-22876 A Japanese Patent No. 3416909

Watson T, Young SR, "Therapeutic ultrasound. In: Watson T. Electrotherapy Evidence-Based Practice", UK, Churchill Livingstone, 2008, p. 179-200 Children's SG, "Stimulators of bone healing. Biological and biomechanical", Ortho Nurs, 2003, No. 22, p. 421-428 Ahmadi F, McLoughlin IV, Chauhan S, ter-Haar G, “Bio-effects and safety of low-intensity, low frequency ultra sul, Bio 20”, Prog. 119-138

In the conventional ultrasonic irradiation apparatus, the frequency and output intensity of the ultrasonic wave used to irradiate the ultrasonic region to the lesioned part and treat the lesioned part when the frequency is higher than 1.5 MHz. The output intensity is 30 mW / cm ² or more. In the case of a low frequency of 20 kHz to 100 kHz, the output intensity is regulated to 0.125 W / cm ² or more even at a low output intensity. For this reason, when the conventional ultrasonic irradiation apparatus is continuously driven, the surface temperature of the oscillating element that irradiates the ultrasonic waves may rise, and there is a risk of causing local burns or the like. For this reason, there is a problem in safety for the patient to operate the ultrasonic irradiation apparatus by himself and irradiate the ultrasonic wave, and the ultrasonic wave cannot be irradiated to the patient unless under the control of a doctor or the like. In addition, systemic effects other than local irradiation with ultrasonic waves could not be obtained.

  In addition, when irradiating with ultrasonic waves, in order to increase the adhesion between the oscillating element and the local area where the oscillating element is brought into contact, and improve the conductivity of the ultrasonic wave, A gel layer composed of applied gel or the like is provided between the local area to which the sound wave is irradiated. For this reason, the patient felt the applied gel etc. uncomfortable.

  Moreover, since the measurement of the output intensity of the ultrasonic wave when receiving approval by the Pharmaceutical Affairs Law for the ultrasonic irradiation apparatus is performed in water in which the ultrasonic wave is almost attenuated, an accurate value cannot be obtained. For this reason, even if an ultrasonic irradiation apparatus is prepared in order to use an apparatus that irradiates an ultrasonic wave with a predetermined output intensity in a predetermined application, the apparatus actually does not have an ultrasonic output with a predetermined output intensity. It is considered that there is a high possibility that the sound wave cannot be irradiated.

  Therefore, the present invention can irradiate the local area with ultrasonic waves without causing a burn or the like without going through the gel layer, and can ensure safety even if the patient operates himself / herself. An object of the present invention is to provide an ultrasonic irradiation apparatus that can obtain a systemic effect other than the local effect by irradiating the lens.

(1) an ultrasonic wave irradiation unit having an oscillation element that is in contact with a local part of a living body and irradiates an ultrasonic wave without passing through a gel layer;
Drive control means for driving and controlling the oscillation element,
The drive control means includes a single oscillation element according to a method for measuring the output intensity of ultrasonic waves in a US FDA examination at a continuous drive time of 60 minutes or less at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz. An ultrasonic irradiation apparatus characterized in that the oscillation element is driven and controlled to irradiate ultrasonic waves with an output intensity in a range of 40 mW ± 20% to 85 mW ± 20%.

  According to the invention of (1), an ultrasonic wave having an output frequency in the range of 500 ± 50 kHz or more and 800 ± 50 kHz or less is continuously driven for a relatively long period of 60 minutes or less compared to the case of treating lesions. Therefore, it is possible to irradiate with a very small output intensity in the range of 40 mW ± 20% or more and 85 mW ± 20% or less per oscillation element by the ultrasonic output intensity measurement method in the US FDA examination.

  As a result, the invention of (1) suppresses an increase in the surface temperature of the oscillation element because the output intensity is extremely small as compared with the case where the lesion is treated by irradiating the lesion with ultrasonic waves. Therefore, safety can be ensured even if the patient manipulates himself / herself, and ultrasonic waves can be irradiated to a local area other than the lesioned part to obtain a more significant systemic effect. In addition, because the range of the output intensity value was specified by the ultrasonic output intensity measurement method in the US FDA examination, it was possible to reliably suppress the rise in the surface temperature of the oscillation element, and to ensure safety and more reliably. In addition, a systemic effect can be obtained.

(2) The drive control means drives and controls the oscillation element to continuously irradiate ultrasonic waves at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz,
The ultrasonic irradiation unit includes a pad main body that houses the oscillation element, and the pad main body has a local contact surface that contacts the local part of the living body,
The ultrasonic irradiation unit is based on the temperature of the local contact surface immediately before the ultrasonic irradiation unit emits ultrasonic waves at room temperature without the gel layer being provided on the local contact surface. 10 minutes after starting to irradiate ultrasonic waves, the maximum rate of increase of the temperature of the local contact surface where the gel layer is not provided is 1.3 or less, and after 20 minutes, the gel layer is not provided. The maximum rate of increase of the temperature of the local contact surface is 1.3 or less, and the maximum rate of increase of the temperature of the local contact surface after 30 minutes without the gel layer is 1.3 or less. The ultrasonic irradiation section having a maximum temperature rise rate of the local contact surface on which the gel layer is not provided after 60 minutes is 1.3 or less. 2. The ultrasonic irradiation apparatus according to 2.

According to the invention of (2), it is possible to irradiate ultrasonic waves having an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz within a predetermined temperature increase rate range. The range of the predetermined temperature increase rate is the temperature of the local contact surface immediately before the ultrasonic irradiation unit emits ultrasonic waves at room temperature without the gel layer being provided on the local contact surface. The maximum increase rate of the temperature of the local contact surface on which the gel layer is not provided 10 minutes after the ultrasonic irradiation unit starts irradiating the ultrasonic wave as a reference is 1.3 or less, and 20 minutes later The maximum rate of increase in the temperature of the local contact surface without the gel layer is 1.3 or less, and the maximum rate of increase in the temperature of the local contact surface without the gel layer after 30 minutes However, it is 1.3 or less, and the maximum rate of increase in the temperature of the local contact surface where the gel layer is not provided after 60 minutes is 1.3 or less. Thus, the subject does not feel uncomfortable or suffers from burns, and can obtain a systemic effect.
(3) An ultrasonic irradiation device for irradiating the local part other than the lesioned part of the living body with ultrasonic waves to exert a systemic effect,
The local part other than the lesioned part of the living body is a part from the elbow part to the distal part, and the ultrasonic irradiation part is a position where the longitudinal direction of the ultrasonic irradiation part coincides with the direction from the elbow part to the distal part. It is an ultrasonic irradiation unit for arm irradiation that is fixed to the local part and irradiates ultrasonic waves to a part from the elbow part to the peripheral part, or the local part other than the lesion part of the living body is an ankle The ultrasonic irradiation unit is fixed to the local part in a positional relationship in which the longitudinal direction of the ultrasonic irradiation unit coincides with the direction from the heel toward the toes, and from the ankle to the distal part. It is an ultrasonic irradiation unit for foot irradiation that irradiates a part of the ultrasonic wave,
Among the above-mentioned ultrasonic irradiation, blood pressure lowering, cardiac output reduction, vascular endothelial function increase, autonomic nerve activation, autonomic nerve activity balance adjustment, body temperature increase, blood glucose level decrease, neck to lumbar back pain relief effect The ultrasonic irradiation apparatus according to claim 1, wherein at least one effect is exhibited.

  According to the invention of (3), the ultrasonic irradiation unit for arm irradiation as the ultrasonic irradiation unit has a positional relationship in which the longitudinal direction of the ultrasonic irradiation unit coincides with the direction from the elbow to the distal part. Ultrasound can be applied to a part from the elbow to the distal part while being fixed to the local part. Alternatively, the ultrasonic irradiation unit for foot irradiation as the ultrasonic irradiation unit is fixed to the local part in a positional relationship in which the longitudinal direction of the ultrasonic irradiation unit coincides with the direction from the heel toward the toes, and is distal from the ankle. An ultrasonic wave can be irradiated to a part up to the part.

  As a result, the invention of (3) irradiates a local area other than a lesioned part of a living body with ultrasonic waves, thereby causing a systemic effect, that is, lowering blood pressure, lowering cardiac output, increasing vascular endothelial function, activating autonomic nerves. It is possible to obtain at least one of the following effects: adjustment of autonomic nerve activity balance, increase in body temperature, decrease in blood glucose level, and analgesic effect from the neck to the back of the back. Further, since the ultrasonic irradiation unit is brought into contact with a local area other than the lesioned part of the living body without going through the gel layer, the ultrasonic irradiation part is brought into contact with a local part other than the lesioned part of the living body through the gel layer In comparison, a systemic effect can be obtained easily and without the discomfort caused by the gel.

  Here, the “systemic effect” in the present invention means an improvement effect of hypertension, a reduction effect of pulse pressure, a reduction effect of pulse rate, a reduction effect of cardiac output, a reduction effect of myocardial load coefficient, an autonomic nerve balance It includes a regulating effect, an effect of alleviating pain and numbness other than the irradiated part, an effect of increasing the skin temperature other than the irradiated part, and the like.

(4) A diagnostic system comprising: the ultrasonic irradiation device according to claim 1; and a diagnostic device that diagnoses the living body irradiated with ultrasonic waves on the local portion by the ultrasonic irradiation device. ,
The diagnostic device comprises:
The biological information of the living body irradiated with ultrasonic waves by the ultrasonic irradiation device was calculated by power spectrum analysis of the systolic pressure value, the diastolic pressure value, the pulse value, and the frequency component of the pulse fluctuation. Acquire at least one of an LF / HF value indicating a ratio of an LF value indicating a low frequency component and an HF value indicating a high frequency component, a TP value indicating autonomic nerve activation, and a surface temperature of a part other than the local part Acquisition means;
A determination unit that determines whether the biological information acquired by the acquisition unit is greater than or equal to a predetermined threshold or less than a threshold;
Storage means for storing diagnostic information according to the determination result of the determination means;
A diagnostic system comprising: a diagnostic control unit that extracts the diagnostic information according to the determination result of the determination unit with reference to the storage unit and displays the content of the diagnostic information on a display unit .

  According to the invention of (4), after irradiating a local area other than the lesioned area with ultrasonic waves by the ultrasonic irradiation apparatus of (1) to (3), the systolic pressure value, the diastolic pressure value, the pulse value, LF Diagnostic information can be displayed from at least one biological information of / HF, a TP value indicating autonomic nerve activation, a value, and a surface temperature of a portion other than a local part.

  Here, the systolic pressure value, the diastolic pressure value, and the pulse value are indicators for determining the blood pressure state of the living body. The systolic pressure value is a value indicating the blood pressure when the blood vessel is expanded (when the heart contracts), and the diastolic pressure value is a value indicating the blood pressure when the blood vessel is contracted (when the heart is expanded). When the systolic pressure value is 140 mmHg or more, when the diastolic pressure value is 90 mmHg or more, or when the pulse value is 90 / min or more, it is determined that the blood pressure is high, and these values need to be lowered. In the case of suffering from obesity or diabetes, it is determined that the blood pressure is high when the systolic pressure value is 135 mmHg and the diastolic pressure is 85 mmHg or more.

  The LF value is an index indicating the activity of the sympathetic nervous system, and the HF value is an index indicating the activity of the parasympathetic nervous system. That is, if the LF / HF value is greater than 1, it indicates that the activity of the sympathetic nervous system is superior, and if it is less than 1, the activity of the parasympathetic nervous system is superior. For example, when the threshold value is 1.3 or more and 0.7 or less as a threshold, it is necessary to adjust the balance between the activity of the sympathetic nervous system and the activity of the parasympathetic nervous system by approaching 1 There is.

By the way, with the recent spread of home-use sphygmomanometers and pulse meters, patients can measure biological information such as systolic pressure values, diastolic pressure values, and pulse values at home, without going to medical institutions. it can. However, a patient who does not have medical knowledge may not know that the measured value has the meaning shown above even if the biological information is measured.
Furthermore, even if the patient measures biological information and knows that the measured value has the meaning shown above, is this value temporary or requires a doctor's prescription? It cannot be determined whether it is due to a particular disease.

Therefore, according to the invention of (4), first, the ultrasonic information is applied to the local area other than the lesioned area by the ultrasonic irradiation apparatus of (1) to (3), and the whole body effect is obtained, whereby the biological information is predetermined. Can be suppressed within the threshold value range (normal value range). However, if the biological information after ultrasonic irradiation is outside the predetermined threshold range, it can be estimated that the biological information is not temporary. In this case, according to the invention of (4), it is possible to display diagnostic information corresponding to the determination result for the biological information estimated to be not temporary.
Thereby, a patient can irradiate an ultrasonic wave to a local part by own operation, and can obtain more accurate diagnosis information from his / her own judgment from subsequent biological information. Therefore, it is possible to prevent the disease from progressing due to an erroneous judgment of the patient. In particular, it is effective for blood collection and blood glucose self-measurement (SMBG) of diabetic patients who are difficult to produce blood. It is also effective for treatment of drug-resistant hypertension and diabetes.

(5) The drive control means drives and controls the oscillation element to irradiate ultrasonic waves at an output frequency in a range of 500 ± 50 kHz to 800 ± 50 kHz,
The ultrasonic irradiation unit includes a pad main body that houses the oscillation element, and the pad main body has a local contact surface that contacts the local part of the living body,
When a piezoelectric element having the same frequency as the output frequency of the oscillation element is brought into contact with the oscillation element without passing through the local contact surface and the gel layer, the piezoelectric element outputs an AC voltage of 2 Vrms or more. The ultrasonic irradiation apparatus according to claim 1, wherein the ultrasonic irradiation apparatus is an ultrasonic irradiation unit that irradiates ultrasonic waves.

  According to the invention of (5), the ultrasonic wave irradiation unit applies a piezoelectric element having the same frequency as the output frequency of the oscillation element to the oscillation element via the local contact surface without passing through the gel layer. When contacted, ultrasonic waves are applied so that the piezoelectric element outputs an alternating voltage of 2 Vrms or higher.

  As a result, regardless of the material constituting the pad body of the ultrasonic irradiation unit, it is possible to irradiate the ultrasonic wave having a certain range of vibration intensity from the ultrasonic irradiation unit, and reliably obtain a systemic effect. Can do.

  According to the present invention, it is possible to irradiate an ultrasonic wave locally without causing a burn or the like without going through the gel layer, and it is possible to ensure safety even if the patient himself operates, and the ultrasonic wave is locally applied to a part other than the lesioned part. The ultrasonic irradiation apparatus which can irradiate and can obtain the systemic effect other than a local part can be provided.

It is a figure showing the whole ultrasonic irradiation device composition concerning a 1st embodiment of the present invention. It is a figure which shows the structure of the ultrasonic irradiation pad provided with two ultrasonic oscillation elements which concern on the said 1st Embodiment. It is explanatory drawing of the ultrasonic irradiation pad and fixing device which concern on the said 1st Embodiment. It is a figure which shows the method to measure the intensity | strength of the vibration of the ultrasonic wave irradiated from the ultrasonic irradiation pad of the ultrasonic irradiation apparatus which concerns on the said 1st Embodiment. It is a figure which shows the function structure of the ultrasonic irradiation apparatus which concerns on the said 1st Embodiment. It is a figure explaining Example 4 which applied the ultrasonic irradiation apparatus to the test subject. It is a figure explaining Example 5 which applied the ultrasonic irradiation apparatus to the test subject. (A) is a graph comparing the average RHI values of a plurality of subjects before and after ultrasonic irradiation for each output frequency. (B) is a graph showing the difference in average RHI values before and after ultrasonic irradiation for each output frequency in (a). It is a figure which shows the function structure of the ultrasonic irradiation system which concerns on the application example of the said 1st Embodiment. It is a figure explaining the information diagnostic table of the ultrasonic irradiation system which concerns on the application example of the said 1st Embodiment. It is a flowchart explaining the diagnostic operation | movement flow of the ultrasonic irradiation system which concerns on the said application example. It is explanatory drawing of the ultrasonic irradiation pad which concerns on 2nd Embodiment. It is explanatory drawing of the ultrasonic irradiation pad which concerns on 2nd Embodiment. It is explanatory drawing of the ultrasonic irradiation pad which concerns on 2nd Embodiment.

<First Embodiment>
Hereinafter, a first embodiment of the present invention will be described in detail with reference to the drawings. In the following description of the first embodiment, the same constituent elements are denoted by the same reference numerals, and the description thereof is omitted or simplified.

FIG. 1 is a diagram showing an overall configuration of an ultrasonic irradiation apparatus 60 according to the first embodiment of the present invention.
The ultrasonic irradiation device 60 includes a main body 61, an ultrasonic irradiation pad 110 as an ultrasonic irradiation unit and an ultrasonic irradiation unit for irradiating an arm, and a fixing device 120. The main body 61 has an operation panel 62. The ultrasonic irradiation pad 110 is connected to the connector 65 of the main body 61 via the composite cable 110a. The fixing device 120 fixes the ultrasonic irradiation pad in a state of being in contact with the forearm 50 of the living body. In addition, the number of the ultrasonic irradiation pads 110 can be an arbitrary number including one.
Details of the main body 61 of the ultrasonic irradiation device 60 will be described later with reference to FIG.

FIG. 2 is a diagram illustrating a configuration of the ultrasonic irradiation pad 110 including two ultrasonic oscillation elements 112 according to the first embodiment.
The ultrasonic irradiation pad 110 includes a pad main body 111 and an ultrasonic oscillation element 112. The pad body 111 is formed in a substantially rectangular shape having a long side 110b. The ultrasonic oscillator 112 is accommodated in the pad main body 111 and generates ultrasonic waves.

The pad main body 111 has an upper surface formed of silicon rubber, and a lower surface of the pad main body 111 that comes into contact with a living body portion is formed of conductive silicon rubber. The hardness of the conductive silicon rubber forming the lower surface of the pad main body 111 is 40 to 60 in terms of the value of international rubber hardness (IRHD) in accordance with JIS K6253. In this embodiment, the hardness is about 50. Have
Two ultrasonic oscillators 112 are arranged along the long side 110 b of the pad body 111. Note that the number of the ultrasonic oscillation elements 112 can be an arbitrary number of two or more. The lower surface of the pad main body 111 of the ultrasonic oscillating element 112 is in direct contact with the forearm of the living body without going through the applied gel or through the gel layer formed by the gel sheet. Therefore, the lower surface of the pad main body 111 constitutes a local contact surface that contacts the local part of the living body. Here, the gel sheet refers to a sheet formed by impregnating a nonwoven fabric with gel. Further, the area (irradiation area) of the portion of one ultrasonic oscillation element 112 that is in contact with the living body is 6.16 cm ² . That is, the irradiation area of the ultrasonic irradiation pad 110 including the two ultrasonic oscillation elements 112 is 12.32 cm ² .

FIG. 3 is an explanatory diagram of the ultrasonic irradiation pad 110 and the fixing device 120 according to the first embodiment.
As shown in FIG. 3, the fixing device 120 is configured by a band that can be wound around the forearm 50, and the long side 121 thereof is disposed so as to be orthogonal to the direction from the elbow of the forearm 50 toward the periphery, The ultrasonic irradiation pad 110 is fixed in a state in which the ultrasonic irradiation pad 110 is in direct contact with the forearm 50 without going through the gel layer. Specifically, the fixing device 120 fixes the ultrasonic irradiation pad 110 to the forearm 50 in a state where the long side 110 b of the ultrasonic irradiation pad 110 intersects the long side 121 of the fixing device 120. That is, the local part other than the lesioned part of the living body is a part from the elbow part to the peripheral part. The ultrasonic irradiation pad 110 is fixed to the local portion in a positional relationship in which the extending direction of the long side 121, which is the longitudinal direction of the ultrasonic irradiation pad 110, coincides with the direction from the elbow portion toward the distal portion. Ultrasonic wave is irradiated to a part of up to. In the first embodiment, one ultrasonic irradiation pad 110 is fixed to the forearm 50. For example, when the ultrasonic irradiation device 60 includes two ultrasonic irradiation pads 110, the fixing device 120 is The forearm 50 is sandwiched between two ultrasonic irradiation pads 110 and fixed.

FIG. 5 is a diagram showing a functional configuration of the ultrasonic irradiation apparatus 60 according to the first embodiment.
The main body 61 includes an operation panel 62 that receives an operation of the operator, a drive control unit 63 that performs drive control of the ultrasonic oscillation element 112 based on the operation of the operator received on the operation panel 62, and a time of 0 to 60 minutes. Timer setting means 64 that transmits time information to the drive control means 63, and a connector 65 that can connect the composite cables 110a of the two ultrasonic irradiation pads 110, respectively. The number of connectors 65 can be any number including one.

  In response to an input operation from the operation panel 62, the drive control means 63 causes the ultrasonic oscillation element 112 of the ultrasonic irradiation pad 110 connected to the connector 65 to emit ultrasonic waves of a predetermined output frequency with a predetermined output intensity. , Drive control to continuously transmit.

The predetermined output frequency in the first embodiment is placebo irradiation (0 kHz), 500 kHz ± 5 kHz, or 800 kHz ± 5 kHz. Further, the predetermined output intensity in the first embodiment is a method of measuring the output intensity of ultrasonic waves in the examination of the US FDA (US Food and Drug Administration), and is 40 mW ± 20% or more and 85 mW ± 20% or less per oscillation element. Take a range value. This value is the output intensity when the effective radiation area (AER) in one oscillation element is 2.82 cm ^{2 to} 3.91 cm ² , and the effective radiation area does not match the area of one oscillation element. The apparatus used in the measurement method of the ultrasonic output intensity in the US FDA examination is an ultrasonic hydrohorn manufactured by Dapco (Ceramic needle-type Hydrophone, model number: NP10-3, S / N5460).
In the first embodiment, the output frequency is set to 500 kHz ± 5 kHz or 800 kHz ± 5 kHz. However, the output frequency of the present invention includes 500 kHz ± 50 kHz or more and 800 kHz ± 50 kHz as an error due to a difference between ultrasonic output devices and measuring instruments. The following ranges are included.

  The intensity of the vibration of the ultrasonic wave irradiated from the ultrasonic irradiation pad 110 can be specified by the effective value (Vrms) of the AC voltage by the following measurement using the piezoelectric element 201 and the oscilloscope 202. First, as shown in FIG. 4, the piezoelectric element 201 having the same frequency as the output frequency of the ultrasonic oscillation element 112 is substantially disc-shaped through the lower surface of the pad main body 111 as a local contact surface without going through the gel layer. The ultrasonic oscillation element 112 having a shape is brought into contact with the lower surface.

  Here, the piezoelectric element 201 having the same frequency as the output frequency of the ultrasonic oscillation element 112 is, for example, a 500 kHz piezoelectric element 201 (resonance frequency 516 kHz) if the ultrasonic output frequency of the ultrasonic oscillation element 112 is 500 kHz. Means. The gel layer means either a gel to be applied or a gel sheet.

  Next, the piezoelectric element 201 is connected to the oscilloscope 202 and ultrasonic waves are emitted from the ultrasonic oscillation element 112. At this time, an AC voltage corresponding to the intensity of the ultrasonic vibration is generated in the piezoelectric element 201 due to the ultrasonic vibration from the ultrasonic oscillator 112. Specifically, the ultrasonic irradiation pad 110 having the ultrasonic oscillation element 112 not provided with the gel layer is an ultrasonic irradiation pad that irradiates an ultrasonic wave so that the piezoelectric element 201 outputs an AC voltage of 2 Vrms or more. It is.

  The ultrasonic irradiation pad 110 is an ultrasonic irradiation pad having the following temperature rise rate. That is, the ultrasonic irradiation pad 110 is not provided with a gel layer on the lower surface of the pad main body 111 as a local contact surface, and the local area immediately before the ultrasonic irradiation pad 110 irradiates ultrasonic waves at room temperature. The maximum rate of increase in the temperature of the local contact surface on which the gel layer is not provided 10 minutes after the ultrasonic irradiation unit starts irradiating ultrasonic waves, based on the temperature of the contact surface, is 1.3 or less. The maximum rate of increase in temperature of the local contact surface without the gel layer after 20 minutes is 1.3 or less, and the local contact surface without the gel layer after 30 minutes The ultrasonic irradiation pad has a maximum temperature increase rate of 1.3 or less and a maximum temperature increase rate of the local contact surface on which the gel layer is not provided after 60 minutes is 1.3 or less. is there.

  Further, the drive control unit 63 starts driving control of the ultrasonic oscillation element 112 at a preset timing based on the time information transmitted from the timer setting unit 64, and performs a predetermined time (for example, 3 minutes, 5 minutes). The drive control is performed so that the ultrasonic waves are continuously transmitted for an arbitrary time of 60 minutes or less, such as 10 minutes or 30 minutes.

  In addition, the ultrasonic irradiation device 60 includes biological information (for example, systolic pressure value, diastolic pressure value, pulse value, LF / HF value, TP value indicating autonomic nerve activation) (Acquisition means for acquiring the surface temperature of other parts). For example, the acquisition unit may be an input unit that allows an operator to input a value of biometric information, or a reception unit that receives a value measured by another device. Other devices include blood pressure measuring devices that measure systolic pressure values, diastolic pressure values, pulse values, autonomic nerve balance measuring devices that measure LF / HF values, and temperature measuring devices that measure the surface temperature of living bodies. Etc. are included.

  Moreover, the ultrasonic irradiation apparatus 60 can also be interlocked with the other devices. In this case, the drive control means 63 receives drive start information that triggers driving from another device, and transmits drive end information indicating that drive control has ended to the other device.

  In addition, the ultrasonic irradiation device 60 may include a display having a relatively high color developability and being easy on the eyes, such as an organic EL (Organic Electro-Luminescence), as a display unit whose display is controlled by the drive control unit 63. In this case, the drive control unit 63 refers to various image data stored in the storage unit when driving and controlling the ultrasonic oscillation element 112, and according to the operation of the operator or the biological information acquired by the acquisition unit. The displayed image is displayed on the display means. Such an image is, for example, an image that promotes mental stability. Thereby, a more significant whole body effect can be obtained by a synergistic effect by irradiation of ultrasonic waves and visual recognition of an image. In addition, since the display means is composed of organic EL, it can be displayed easily for an operator with relatively weak visual acuity.

  The ultrasonic irradiation device 60 having the above configuration irradiates the above-mentioned ultrasonic waves to a local area other than a lesioned part of a living body, thereby causing a systemic effect, that is, lowering blood pressure, lowering cardiac output, increasing vascular endothelial function, It exhibits at least one of autonomic nerve activation, autonomic nerve activity balance adjustment, body temperature increase, blood glucose level decrease, and analgesic effect from the neck to the back of the back. Furthermore, since the systemic effect can be obtained by directly contacting the ultrasonic irradiation pad 110 with a local area other than the lesioned part of the living body without using the gel layer, the ultrasonic irradiation pad 110 is attached to the sole of the foot through the gel layer. Compared with the case of making it contact | abut, it can obtain a systemic effect easily and without obtaining the discomfort by a gel.

  Moreover, the following ultrasonic irradiation treatment method can be implemented using the ultrasonic irradiation apparatus 60 by the above structure.

It is an ultrasonic irradiation treatment method for irradiating a local area other than a lesion part of a living body to exert a systemic effect,
An ultrasonic irradiation pad 110 as an ultrasonic irradiation unit having an oscillation element is brought into contact with the local part of the living body without going through a gel layer, and the oscillation element of the ultrasonic irradiation pad 110 with respect to the local part of the living body 112 having an ultrasonic irradiation step of irradiating ultrasonic waves from 112,
The local part other than the lesion part of the living body is a part from the elbow part to the peripheral part, or the local part other than the lesion part of the living body is a part from the ankle to the peripheral part,
In the ultrasonic irradiation step, the ultrasonic irradiation pad 110 is fixed to the local portion in a positional relationship in which the longitudinal direction of the ultrasonic irradiation pad 110 coincides with the direction from the elbow portion toward the distal portion, and from the elbow portion to the peripheral portion. The ultrasonic irradiation pad 110 irradiates a part of the ultrasonic irradiation pad 110 or the ultrasonic irradiation pad 110 has a positional relationship in which the longitudinal direction of the ultrasonic irradiation pad 110 coincides with the direction from the heel toward the toes. Is applied to the part from the ankle to the distal part,
Of the ultrasonic irradiation step, blood pressure lowering, cardiac output reduction, vascular endothelial function increase, autonomic nerve activation, autonomic nerve activity balance adjustment, body temperature increase, blood sugar level decrease, analgesic effect from neck to lumbar back An ultrasonic irradiation treatment method that exhibits at least one effect.

In the ultrasonic irradiation treatment method described above, the ultrasonic irradiation pad includes a pad main body 111 that houses the oscillation element 112, and the pad main body 111 is in contact with the local portion of the living body. Have
In the ultrasonic irradiation step, ultrasonic waves are continuously irradiated from the oscillation element 112 of the ultrasonic irradiation pad 110 at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz,
The gel irradiation layer is not provided on the local contact surface, and the ultrasonic irradiation unit is based on the temperature of the local contact surface immediately before the ultrasonic irradiation pad 110 irradiates ultrasonic waves at room temperature. 10 minutes after starting to irradiate ultrasonic waves, the maximum rate of increase in the temperature of the local contact surface where the gel layer is not provided is 1.3 or less, and after 20 minutes, the gel layer is provided. The maximum rate of increase in the temperature of the local abutment surface that is not present is 1.3 or less, and the maximum rate of increase in the temperature of the local abutment surface that is not provided with the gel layer after 30 minutes is 1.3 or less The maximum rate of temperature increase after 60 minutes at the local contact surface where the gel layer is not provided is 1.3 or less.

  Further, in the ultrasonic irradiation treatment method described above, in the ultrasonic irradiation step, at the output frequency in the range of 500 ± 50 kHz or more and 800 ± 50 kHz or less, the continuous driving time of 60 minutes or less and the ultrasonography in the US FDA review. In the method of measuring the output intensity of the sound wave, the output intensity of the ultrasonic irradiation pad 110 from the oscillation element 112 is higher than the local part of the living body at an output intensity in the range of 40 mW ± 20% to 85 mW ± 20% per oscillation element. It is characterized by irradiating sound waves.

[Example 1 in which ultrasonic irradiation device 60 is applied to a subject]
In the first embodiment, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) is applied to the ultrasonic wave in the US FDA examination by the ultrasonic wave irradiation device 60 including one ultrasonic wave irradiation pad 110 having two ultrasonic wave oscillating elements 112. The right forearm 50 of 20 subjects with high blood pressure in a range of 40 mW ± 20% to 85 mW ± 20% (average output intensity 62.5 mW) per one oscillating element in the method of measuring the output intensity of sound waves. For 30 minutes. Note that the intensity of the ultrasonic vibration corresponds to the intensity of the ultrasonic vibration to the extent that an AC voltage of 2 Vrms or more is output in the measurement using the piezoelectric element 201 and the oscilloscope 202 described above.
In the present example, a systolic pressure, a diastolic pressure, a pulse pressure, a heart rate, a cardiac output, a peripheral vascular resistance, and a myocardial load are measured using a pulse wave / Korotkoff sound recorder (Paramatec Corporation: GP-303). The coefficient was measured. The systolic pressure, diastolic pressure, pulse pressure, heart rate, cardiac output, peripheral vascular resistance, and myocardial load coefficient are all desirably low for hypertensive patients.
The cardiac output indicates the amount of blood delivered from the heart in one minute, and is calculated by the calculation formula “one cardiac output X pulse”.
The peripheral vascular resistance indicates a pressure received when blood passes through the peripheral blood vessel, and is calculated by a calculation formula “average blood pressure (mmHg) −central venous pressure (mmHg) X1332”.
The myocardial load coefficient is a value having a very high correlation with myocardial oxygen consumption, which is an index of cardiac load, and is calculated by the calculation formula “systolic pressure X heart rate”.

Table 1 shows an ultrasonic wave with an output frequency of 800 kHz (± 50 kHz) in the range of 40 mW ± 20% or more and 85 mW ± 20% or less (average output) per oscillation element by the method of measuring ultrasonic output intensity in the US FDA examination. Intensity of 62.5 mW), that is, measurement using the piezoelectric element 201 and the oscilloscope 202 described above, that is, continuous irradiation for 30 minutes at an intensity of ultrasonic vibration that can output an AC voltage of 2 Vrms or more. Group (20 persons), Table 2 shows the systolic pressure, diastolic pressure, pulse pressure, heart rate before and after 30 minutes of irradiation in the placebo irradiated (no ultrasonic irradiation) group (20 persons). The cardiac output, peripheral vascular resistance and myocardial load coefficient are shown as mean ± standard error. According to this example, in the systolic pressure, diastolic pressure, pulse pressure, heart rate, cardiac output, and myocardial load coefficient, a significant decrease was observed in the irradiated group compared to the placebo group. In addition, ultrasonic waves with an output frequency of 500 kHz (± 50 kHz) are measured in the range of 40 mW ± 20% to 85 mW ± 20% per average oscillation element (average output intensity) by the ultrasonic output intensity measurement method in the US FDA examination. 62.5 mW), that is, measurement using the piezoelectric element 201 and the oscilloscope 202 described above, in the case of continuous irradiation for 30 minutes with the intensity of ultrasonic vibration that can output an AC voltage of 2 Vrms or more. The same effect as in this example was also observed. In addition, when the ultrasonic irradiation time was set to 60 minutes instead of 30 minutes, the same effect as in the case of 30 minutes could be obtained.
On the other hand, a group of subjects irradiated continuously for 30 minutes with an output intensity exceeding 85 mW per oscillation element at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz, using an ultrasonic output intensity measurement method in the US FDA examination. However, no significant decrease was observed in systolic pressure, diastolic pressure, pulse pressure, heart rate, cardiac output, and myocardial load coefficient.

In the first embodiment, the ultrasonic irradiation device 60 including one ultrasonic irradiation pad 110 having two ultrasonic oscillation elements 112 is used to measure two piezoelectric elements 201 and oscilloscope 202 in the measurement using the piezoelectric element 201 and the oscilloscope 202. In each of the ultrasonic oscillators 112, the intensity of vibration is such that an AC voltage of 2 Vrms or more (specific values are 2.018 Vrms, 2.312 Vrms) is output, and continuous for 20 minutes for a 72-year-old woman. Irradiated. The output frequency of the ultrasonic wave is 500 kHz (± 50 kHz). And the systolic pressure, the diastolic pressure, and the pulse rate before and after the ultrasonic irradiation and 20 minutes after the ultrasonic irradiation started were measured. The results are as shown in Table 1A.

In addition, as a comparative example, an ultrasonic wave having an output frequency of 500 kHz (± 50 kHz) is generated by the ultrasonic wave irradiation device 60 including one ultrasonic wave irradiation pad 110 having two ultrasonic wave oscillating elements 112. In the measurement using the oscilloscope 202, each of the two ultrasonic oscillators 112 has a vibration intensity at which an AC voltage of less than 2 Vrms (specific values are 1.849 Vrms, 1.794 Vrms) is output. A 71-year-old woman was irradiated continuously for 20 minutes. The results are as shown in Table 1B.

According to this example, significant reductions were observed in systolic pressure, diastolic pressure, and pulse rate. Under the same conditions, three other subjects (a 63-year-old man, a 65-year-old man and a woman) were also irradiated with ultrasound in the same manner, but a significant decrease was observed as in Table 1A. It was. In addition, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) is continuously measured for 20 minutes at an intensity of ultrasonic vibration that can output an alternating voltage of 2 Vrms by measurement using the piezoelectric element 201 and the oscilloscope 202 described above. Also when irradiated, the same effect as the present Example was recognized. In addition, when the ultrasonic irradiation time was set to 60 minutes instead of 20 minutes, the same effect as in the case of 20 minutes could be obtained.
On the other hand, no significant decrease was observed in the comparative example. Under the same conditions, four other subjects (56-year-old man, 58-year-old man, 71-year-old woman, and 76-year-old woman) were similarly irradiated with ultrasonic waves. Similar to 1B, no significant decrease was observed.

From these results, it can be understood that the following effects can be obtained.
The drive control means 63 of the ultrasonic irradiation device 60 drives and controls the oscillation element 112 so as to irradiate ultrasonic waves at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz. The ultrasonic irradiation pad 110 includes a pad main body 111 that accommodates the oscillation element 112, and the pad main body 111 has a lower surface as a local contact surface that comes into contact with a local part of a living body. The ultrasonic irradiation pad 110 causes the piezoelectric element 201 having the same frequency as the output frequency of the oscillation element 112 to contact the oscillation element 112 via the local contact surface without using a gel layer such as a gel sheet. Sometimes it is an ultrasonic irradiation pad that irradiates ultrasonic waves so that the piezoelectric element 201 outputs an alternating voltage of 2 Vrms or higher. With this configuration, it is possible to exert systemic effects such as systolic pressure, diastolic pressure, and pulse rate by irradiating a local area other than the lesioned part of the living body with ultrasonic waves.

  Similarly, in all other examples and embodiments that were able to exert a systemic effect, the intensity of ultrasonic vibration was measured using the piezoelectric element 201 and the oscilloscope 202 described above, and the alternating current was 2 Vrms. This is the intensity of the ultrasonic vibration to the extent that a voltage is output. Therefore, all the systemic effects obtained in other examples and embodiments are recognized by the intensity of vibration of this ultrasonic wave.

[Example 2 in which ultrasonic irradiation device 60 is applied to a subject]
In the second embodiment, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) is generated by an ultrasonic irradiation device 60 including one ultrasonic irradiation pad 110 having two ultrasonic oscillating elements 112. Right of the subject who lacks the balance of 20 autonomic nerves with an output intensity in the range of 40mW ± 20% to 85mW ± 20% (average output intensity 62.5mW) per one oscillating element in the method of measuring the output intensity of sound waves The forearm 50 was irradiated continuously for 10 minutes.

In the present embodiment, using an autonomic nerve balance measuring device (manufactured by Tokyo Medical Research Co., Ltd.), the ratio of SDNN (Standard Deviation NN), TP (Total power), LF (Low Frequency) and HF (High Frequency) is used. A certain LF / HF was measured.
SDNN is a value indicating a standard deviation with respect to RR (NN) interval, and a larger value indicates healthierness.
TP is a value indicating autonomic nerve activation, and the larger the value, the higher the autonomic nerve adjustment ability.
LF is a value indicating an intermediate frequency component of an analysis result obtained by analyzing a power spectrum of a frequency component of a periodic variation of a heartbeat of a living body, and an HF value is a value indicating a high frequency component.
LF is an index indicating the activity of the sympathetic nervous system, and HF is an index indicating the activity of the parasympathetic nervous system. That is, if LF / HF is a value greater than 1, it indicates that the activity of the sympathetic nervous system is dominant, and if it is less than 1, it indicates that the activity of the parasympathetic nervous system is dominant.
In this example, the activity of the parasympathetic nervous system is dominant (LF / HF <1.0), and 10 subjects are dominated by the activity of the sympathetic nervous system (LF / HF> 1.0). The ultrasonic wave was irradiated.

Table 3 shows the average values of SDNN, TP, and LF / HF before and after the ultrasonic irradiation in 10 subjects whose parasympathetic nervous system activity is dominant (LF / HF <1.0). Shown in ± standard error. Table 4 shows the average values of SDNN, TP, and LF / HF before and after ultrasonic irradiation in 10 subjects whose sympathetic nervous system activity is dominant (LF / HF> 1.0). Shown in ± standard error.

As shown in Tables 3 and 4, according to the present example, the SDNN can be used in both cases of a subject who has a dominant parasympathetic nervous system activity and a subject who has a dominant sympathetic nervous system activity. In TP and LF / HF, significant changes close to normal could be confirmed.
As a result, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) is measured within a range of 40 mW ± 20% or more and 85 mW ± 20% or less (average output) per oscillation element by the method of measuring the ultrasonic output intensity in the US FDA examination. It was confirmed that the method of continuously irradiating the subject for 10 minutes with an output intensity of 62.5 mW) has an effect of adjusting the autonomic balance. Further, when the ultrasonic wave irradiation time was set to 60 minutes instead of 10 minutes, the same effect as in the case of 10 minutes could be obtained.
On the other hand, a group of subjects irradiated continuously for 10 minutes with an output intensity exceeding 85 mW per oscillation element at an output frequency in the range of 500 ± 50 kHz or more and 800 ± 50 kHz or less in the US FDA examination method of ultrasonic output intensity In SDNN, TP and LF / HF, no significant change close to normal was observed.

[Example 3 in which ultrasonic irradiation device 60 is applied to a subject]
In the third embodiment, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) is generated by an ultrasonic irradiation device 60 including one ultrasonic irradiation pad 110 having two ultrasonic oscillating elements 112. The measurement method of the output intensity of sound waves has an output intensity in the range of 40 mW ± 20% or more and 85 mW ± 20% or less (average output intensity 62.5 mW) per oscillation element, and is applied to the right forearm 50 of 18 subjects for 30 minutes. Continuous irradiation. In addition, ultrasonic irradiation according to this example was performed at a room temperature of 25 ° C.

  In this example, the body surface temperature (° C.) of the right hand back, left hand back, right forearm, left forearm, right foot back and left foot back was measured using thermography.

Table 5 shows the body surface temperatures of the right, back, right forearm, right forearm, left forearm, right foot back and left foot back of the 15 subjects of the present example before and after the ultrasonic irradiation, as an average value ± standard. Shown in error.

According to the present Example, the significant difference was confirmed in the body surface temperature of the right hand back and the left hand back. Moreover, temperature rise was confirmed also in the body surface temperature of a right forearm, a left forearm, a right foot back, and a left foot back.
As a result, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) is measured within a range of 40 mW ± 20% or more and 85 mW ± 20% or less (average output) per oscillation element by the method of measuring the ultrasonic output intensity in the US FDA examination. It was confirmed that the method of continuously irradiating the subject for 30 minutes with an output intensity of 62.5 mW) has the effect of increasing the surface temperature of the extremities other than the irradiated part. In addition, when the ultrasonic irradiation time was set to 60 minutes instead of 30 minutes, the same effect as in the case of 30 minutes could be obtained.

Moreover, in addition to the said Examples 1-3, the following effects have been confirmed by irradiating a test subject with an ultrasonic wave with the ultrasonic irradiation apparatus 60. FIG.
The test subject was a 40-year-old male diabetic patient who had persistent sciatica, felt low-frequency orthopedic pain and did not heal even with ganglion block, and MRI showed lumbar disc herniation. One ultrasonic contact pad 110 including two ultrasonic oscillation elements 112 is brought into contact with the subject from the forearm, the waist, and the buttocks to the back of the thigh one by one, and 800 kHz (± 50 kHz) or 500 kHz (± (50 kHz) output frequency ultrasonic waves are continuously irradiated for 30 minutes at an output intensity in the range of 40 mW ± 20% or more and 85 mW ± 20% or less per oscillation element according to the ultrasonic output intensity measurement method in the US FDA examination. did. As a result, the pain disappeared and the subject was completely cured by one irradiation.

  The test subject was a diabetic patient in her 70s who suddenly developed sciatica and was unable to walk. One ultrasonic contact pad 110 including two ultrasonic oscillation elements 112 is brought into contact with the subject from the forearm, the waist, and the buttocks to the back of the thigh one by one, and 800 kHz (± 50 kHz) or 500 kHz (± (50 kHz) output frequency ultrasonic waves are continuously irradiated for 30 minutes at an output intensity in the range of 40 mW ± 20% or more and 85 mW ± 20% or less per oscillation element according to the ultrasonic output intensity measurement method in the US FDA examination. did. As a result, the subject was able to walk with less pain.

  In addition, the test subject was a diabetic patient in whom a woman in her 40s had obesity, and had chronic neck pain (traffic trauma). An ultrasonic irradiation pad 110 including two ultrasonic oscillation elements 112 is brought into contact with the forearm of this test subject, and an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) is output as an ultrasonic output intensity in the US FDA examination. In this measurement method, continuous irradiation was performed for 10 minutes at an output intensity in the range of 40 mW ± 20% to 85 mW ± 20% per oscillation element. As a result, the subject's neck pain relieved and disappeared.

  Further, in another example, an ultrasonic irradiation pad 110 including two ultrasonic oscillation elements 112 is brought into contact with the right forearm of six subjects having numbness of diabetic neuropathy, and is 800 kHz (± 50 kHz) or An ultrasonic wave having an output frequency of 500 kHz (± 50 kHz) is output with an output intensity in the range of 40 mW ± 20% or more and 85 mW ± 20% or less per oscillation element according to the measurement method of the ultrasonic output intensity in the US FDA examination, Irradiated continuously for minutes. As a result, the subject disappeared from numbness on both feet. These effects could be obtained even when the ultrasonic wave irradiation time was 60 minutes.

  According to the above example, an ultrasonic wave with an output frequency of 800 kHz (± 50 kHz) or 500 kHz (± 50 kHz) is 40 mW ± 20% or more per one oscillating element by an ultrasonic output intensity measurement method in the US FDA examination. It was confirmed that the method of continuously irradiating the subject for 10 minutes to 60 minutes with an output intensity in the range of 85 mW ± 20% or less has an analgesic effect.

[Example 4 in which ultrasonic irradiation device 60 is applied to a subject]
FIG. 6 is a diagram illustrating Example 4 in which the ultrasonic irradiation device 60 is applied to a subject.
The subject in Example 4 is diagnosed with diabetes by a doctor and is taking a diabetes therapeutic drug. This anti-diabetic drug is being treated with oral hypoglycemic drugs such as insulin secretion stimulants (SU, glinide), insulin action improvers (pioglitazone), biguanides (metformin), and alpha-glucosidase inhibitors (voglibose). And those who are also taking an insulin preparation in addition to the oral drug.

  The subjects in Example 4 had an average age of 63% with an average of 7.0% in both the ultrasonic irradiation group and the non-irradiation group of HbA1c (hemoglobin A1C) showing a control state of blood glucose for 1 to 2 months. Consists of men and women.

  In Example 4, the subject group was divided into an irradiation group (8 persons) irradiated with ultrasonic waves by applying the ultrasonic irradiation device 60, and a placebo group (non-irradiation group) not irradiated with ultrasonic waves (no irradiation group) ( The blood glucose level at 2 hours after meal was first measured in each group. After that, the irradiation group has an output frequency of 500 kHz, and an ultrasonic output intensity of 85 mW ± 20% per oscillation element is applied to the forearm on one side of the subject for 30 minutes by an ultrasonic output intensity measurement method in the US FDA examination. The blood glucose level was measured immediately after irradiation.

  FIG. 6 shows the difference in blood glucose level measured 30 minutes after the blood glucose level measured 2 hours after meal between the non-irradiated group (white bar graph) and the irradiated group (black bar graph).

The blood glucose level at 2 hours after meal was 176 ± 7 mg / dl in the non-irradiated group and 184 ± 15 mg / dl in the ultrasonic irradiation group, and there was no significant difference between the two groups. In the unirradiated group, the blood glucose level decreased only about 26 ± 5 mg / dl on average after 30 minutes, whereas the blood glucose level in the irradiated group decreased to an average of about 59 ± 7 mg / dl after 30 minutes. There was a significant difference between them (P <0.05 by Student-t test).
That is, the ultrasonic irradiation device 60 is applied to a subject who takes a therapeutic drug for diabetes, and the output intensity is 85 mW ± 20% per oscillation element by an ultrasonic output intensity measurement method in the US FDA examination at an output frequency of 500 kHz. It was found that the blood sugar level was further lowered by irradiating a part of the forearm of the subject for 30 minutes.

  In addition, when an ultrasonic wave with an output frequency of 800 kHz and an ultrasonic output intensity of 85 mW ± 20% per oscillating element is irradiated to the forearm on one side for 30 minutes in the same way by the measurement method of ultrasonic output intensity in the US FDA examination. The blood glucose level decreased on average 71 ± 8 mg / dl from 2 hours to 2.5 hours after meal. That is, it was found that by setting the output frequency to 800 kHz, the blood sugar level tends to decrease more than when the output frequency is 500 kHz. In addition, when the ultrasonic irradiation time was set to 60 minutes instead of 30 minutes, the same effect as in the case of 30 minutes could be obtained.

[Example 5 in which the ultrasonic irradiation device 60 is applied to a subject]
FIG. 7 is a diagram illustrating Example 5 in which the ultrasonic irradiation device 60 is applied to a subject.
In Example 5, the ultrasonic irradiation device 60 was applied to a plurality of subjects, and the state of blood vessels of these subjects was examined. The state of the blood vessel was examined by RHI, which is a value reflecting the endothelial function of the blood vessel. The normal value of RHI is “1.67”, and the larger the value, the better the vascular endothelial function.
Further, in Example 5, the ultrasonic wave irradiation device 60 is used to measure the output intensity of ultrasonic waves in three types of output frequencies of 500 kHz, 800 kHz, and 1000 kHz, and the ultrasonic output intensity is 85 mW ± 20% per oscillation element. Were irradiated for 30 minutes to a part of the forearms 50 of a plurality of subjects, and then the RHI of each subject was measured. In Example 5, the RHI of each subject in the case of no irradiation (0 kHz shown in FIG. 7) was also measured.

FIG. 7A is a graph showing the average value of RHI for a plurality of subjects before and after ultrasonic irradiation for each output frequency. In Fig.7 (a), a white bar graph shows the average value of RHI before ultrasonic irradiation. Moreover, a black bar graph (a bar graph with diagonal lines) shows an average value of RHI before ultrasonic irradiation.
FIG. 7B is a graph showing the difference in average RHI values before and after ultrasonic irradiation for each output frequency in FIG.

As shown in FIG. 7A, the average value of RHI after ultrasonic irradiation was statistically confirmed to be large in the order of output frequencies of 0 kHz, 1000 kHz, 500 kHz, and 800 kHz (ANOVA 2 × 2 test). P <0.05).
Further, as shown in FIG. 7B, the difference in the average value of RHI before and after the ultrasonic irradiation is statistically large in the order of the output frequencies of 0 kHz, 1000 kHz, 500 kHz, and 800 kHz. It was confirmed (P <0.05 by ANOVA 2 × 2 test).
That is, it has been found that an output frequency in the range of 500 kHz to less than 1 MHz has an effect of improving the decrease in vascular endothelial function, and in particular, the output frequency of 800 kHz can be most improved in the decrease in vascular endothelial function. In addition, when the ultrasonic irradiation time was set to 60 minutes instead of 30 minutes, the same effect as in the case of 30 minutes could be obtained.

According to this embodiment, there exist the following effects.
The ultrasonic irradiation device 60 has an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz, and the ultrasonic output intensity measurement method in the US FDA examination is 40 mW ± 20% to 85 mW ± 20% per oscillation element. Ultrasonic waves having an output intensity in the following range can be irradiated from the elbow of the living body to cover a part of the periphery.
By irradiating such an ultrasonic wave covering a part of the periphery from the elbow, vascular disorders throughout the living body can be improved, and vascular complications due to diabetes can be prevented. More specifically, the ultrasonic irradiation device 60 can improve the decrease in vascular endothelial function that is deeply related to the onset of macrovascular disorders. Therefore, the ultrasonic irradiation apparatus 60 can also be expected to be clinically applied as a vascular disorder prevention device and clinical application as a vascular disorder treatment device.

In addition, when the obesity-resolving food is ingested, the ultrasound irradiation device 60 irradiates the ultrasound from the elbow of the living body to cover a part of the periphery, thereby reducing the decrease in vascular endothelial function while reducing the weight.
Furthermore, since the living body can be induced to sleep by irradiating a part of the living body with such an ultrasonic wave, application as a sleep induction device can be expected.

  Moreover, since the ultrasonic irradiation device 60 directly contacts the living body with the ultrasonic irradiation pad 110 that irradiates ultrasonic waves without using a liquid or the like, facilities such as a bathtub are unnecessary. In addition, with the ultrasonic irradiation pad 110, at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz, an ultrasonic output intensity measurement method in the US FDA examination uses 40 mW ± 20% to 85 mW ± per oscillation element. Since the output intensity in the range of 20% or less and the weak ultrasonic wave are irradiated, the drive control means 63 that controls the driving of the ultrasonic irradiation pad 110 can be made compact.

  Moreover, blood sugar can be lowered | hung by irradiating a biological body with an ultrasonic wave with the output frequency of the range of 500 +/- 50kHz or more and 800 +/- 50kHz. For example, a diabetic patient who is a living body usually takes a therapeutic drug for diabetes. By irradiating such a diabetic patient with ultrasonic waves at an output frequency in the range of 500 ± 50 kHz or more and 800 ± 50 kHz or less, the effect of the therapeutic agent for diabetes taken is enhanced, compared with the case where the ultrasonic waves are not irradiated. Significantly lower the blood sugar level.

  In addition, by irradiating a living body with an ultrasonic wave having an output frequency of 800 kHz with a weak output intensity of 85 mW ± 20% per oscillation element by the ultrasonic output intensity measurement method in the US FDA examination, Overall vascular disorders can be improved particularly. Therefore, the ultrasonic irradiation apparatus of the present invention has high expectations for clinical application as a vascular disorder prevention device and clinical application as a vascular disorder treatment device.

  In addition, the ultrasonic irradiation pad 110 is brought into contact with the forearm of a diabetic patient, which is a living body, and is irradiated with ultrasonic waves for longer than 20 minutes and not longer than 30 minutes, or not longer than 60 minutes. Can improve vascular disorders throughout the body. Therefore, since it is not necessary to bring the ultrasonic irradiation pad 110 into contact with the body of the diabetic patient, it is not necessary to force the diabetic patient to have an uncomfortable posture.

[Example 6 in which the surface temperature of the ultrasonic irradiation pad 110 of the ultrasonic irradiation device 60 was measured]
In Example 6, the gel layer is not provided on the surface of the ultrasonic irradiation pad 110 including the two ultrasonic oscillation elements 112.
In this embodiment, the ultrasonic wave irradiation device 60 is set to an output frequency of 800 kHz (± 50 kHz) and an ultrasonic output intensity measurement method in the examination of the US FDA, and 40 mW ± 20% to 85 mW ± 20 per oscillation element. It was continuously driven for 60 minutes at an output intensity in the range of% or less. In this example, the temperatures of the bonding surfaces of the two ultrasonic oscillation elements 112 in the ultrasonic irradiation pad 110 were measured at the elapse of 0 minutes, 10 minutes, 30 minutes, and 60 minutes, respectively. In this example, the above measurement was performed on 32 samples.

  In this example, the individual average temperature of the bonding surface of the two ultrasonic oscillation elements 112 in each sample was calculated. The average temperature of the individual average temperatures of all samples, the standard deviation, the temperature difference between the average temperature at 0 minutes and the average temperature at the time of subsequent measurement, and the rate of increase in average temperature with the average temperature at 0 minutes as 1. Calculated.

  In this example, the maximum temperature of the bonding surfaces of the two ultrasonic oscillation elements 112 in each sample was measured. Then, the average temperature of all the samples, the standard deviation, the temperature difference between the average temperature at 0 minutes and the average temperature at the subsequent measurement, and the rate of increase in average temperature with the average temperature at 0 minutes as 1. did.

Table 6 shows the average temperature, standard deviation, temperature difference, and rate of increase of the individual average temperature on the bonding surface of the ultrasonic oscillation element 112 of the ultrasonic irradiation pad 110 in this example.

Table 7 shows the average temperature, standard deviation, temperature difference, and rate of increase of the maximum temperature on the bonding surface of the ultrasonic oscillation element 112 of the ultrasonic irradiation pad 110 in this example.

  As shown in the sixth embodiment, the ultrasonic irradiation device 60 uses an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) and 40 mW ± 20 per oscillation element by a method of measuring the output intensity of ultrasonic waves in the US FDA examination. % Or more and 85 mW ± 20% or less in the output intensity range for 60 minutes, the individual average temperature or the average temperature of the maximum temperature on the ultrasonic oscillation element 112 bonding surface of the ultrasonic irradiation pad 110 is the gel layer It was confirmed that the temperature had an increase rate of more than 0% and within 10% with respect to the temperature at the drive time of 0 minutes when not provided on the surface.

  Thereby, while the ultrasonic wave is irradiated, the rate of temperature increase on the surface of the ultrasonic irradiation pad 110 is more than 0% and within 10% even when the gel layer is not provided. Even if the patient operates himself, the padded part does not feel uncomfortable or burns.

  On the other hand, when continuously driving for 30 minutes at an output intensity exceeding 85 mW per oscillation element by an ultrasonic output intensity measurement method in the US FDA examination at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz, The individual average temperature or the maximum average temperature on the bonding surface of the ultrasonic oscillation element 112 of the ultrasonic irradiation pad 110 is 25% with respect to the temperature at the driving time of 0 minutes in a state where the gel layer is not provided on the surface. In some cases, the rate of increase was higher. When the average temperature of the individual average temperature or the maximum temperature reaches a rate of increase of 25% or more, depending on the use environment, the subject may feel uncomfortable or get burned, which may cause a safety problem. By performing such a test, the rate of increase in the temperature of the local contact surface on which the gel layer is not provided 30 minutes after the ultrasonic irradiation pad 110 starts irradiating ultrasonic waves is 20% (1. It was found that when the rate of increase exceeds 20), more subjects feel uncomfortable.

  In Example 6, as an embodiment of the present invention, an ultrasonic wave having an output frequency of 500 kHz (± 50 kHz) is obtained by an ultrasonic irradiation device 60 including one ultrasonic irradiation pad 110 having two ultrasonic oscillation elements 112. Irradiation was performed continuously for 30 minutes at an output intensity in the range of 40 mW ± 20% to 85 mW ± 20% (average output intensity 62.5 mW) per oscillation element according to the measurement method of ultrasonic output intensity in the US FDA examination. The ultrasonic irradiation according to this example was performed at a room temperature of 25 ° C. Using this pad body 111, it becomes clear that when the subject is irradiated with ultrasonic waves as in the other examples, the same systemic effect as in the other examples can be obtained. Yes. In addition, room temperature is not limited to 25 degreeC, What is necessary is just in the range of 20 to 25 degreeC.

In the present embodiment, a gel sheet or the like as a gel layer is not attached to the lower surface of the pad main body 111 as a local contact surface. Further, the surface temperature (° C.) of the lower surface of the pad body 111 on which the gel layer was not provided was measured using thermography. Specifically, the surface temperature (° C.) of the two ultrasonic oscillation elements 112 is started before irradiation with ultrasonic waves, 10 minutes after starting irradiation, and 20 minutes after starting irradiation. Measurements were made 30 minutes after the test. Then, the rate of increase after the ultrasonic irradiation pad 110 started to irradiate ultrasonic waves was calculated based on the temperature of the lower surface as the local contact surface immediately before the ultrasonic irradiation pad 110 irradiated the ultrasonic waves. The results are as shown in Table 8 for the individual average temperature, and as shown in Table 9 for the average temperature of the highest temperature. In the table, Ch1 and Ch2 indicate that the ultrasonic irradiation pad 110 connected to one of the two connectors 65 of the main body 61 of the ultrasonic irradiation device 60 is Ch1, and the ultrasonic irradiation pad 110 connected to the other. Is Ch2.

Further, as a comparative example, although the ultrasonic irradiation device 60 includes one ultrasonic irradiation pad 110 having two ultrasonic oscillation elements 112, the present embodiment is implemented as a conductive silicon rubber constituting the lower surface of the pad main body 111. Silicon rubber, which is different from the example, is used, and ultrasonic waves with an output frequency of 500 kHz (± 50 kHz) are used, and 40 mW ± 20% per oscillation element is measured by an ultrasonic output intensity measurement method in the US FDA review. Irradiation was continued for 30 minutes at an output intensity in the range of 85 mW ± 20% or less (average output intensity of 62.5 mW). Using this pad body 111, when the subject was irradiated with ultrasonic waves as in the other examples, the systemic effect similar to the other examples could not be obtained, It has become clear. The results are as shown in Table 10 for the individual average temperature, and as shown in Table 11 for the average temperature of the highest temperature.

  According to this example, the rate of temperature increase of the local contact surface on which the gel layer is not provided 30 minutes after the ultrasonic irradiation pad 110 starts irradiating ultrasonic waves is 1.02 or more. I understood. On the other hand, when the ultrasonic irradiation pad 110 using a different silicon rubber for the pad main body 111 that cannot obtain the same systemic effect as the other embodiments is used, the temperature of the local contact surface The rate of increase was found to be less than 1.02.

  That is, in order to obtain a systemic effect, the rate of increase in the temperature of the local contact surface on which the gel layer is not provided 30 minutes after the ultrasonic irradiation pad 110 starts irradiating ultrasonic waves is 1.02. It turns out that it is above. Moreover, it turns out that the test subject who feels discomfort increases when the rate of temperature increase of the local contact surface exceeds 20% (1.20) as described above. Therefore, if the rate of increase in the temperature of the local contact surface on which the gel layer is not provided 30 minutes after the ultrasonic irradiation pad 110 starts irradiating ultrasonic waves is 1.02 or more and 1.20 or less, It can be seen that the subject is less likely to feel discomfort and can obtain the same systemic effect as the other examples. Moreover, the same result was able to be obtained also when the ultrasonic wave of the output frequency was 800 kHz (± 50 kHz).

  Similarly, in all other examples and embodiments that were able to exert a systemic effect, no gel layer was provided 30 minutes after the ultrasonic irradiation pad 110 started to irradiate ultrasonic waves. The rate of increase in the temperature of the local contact surface is 1.02 or more and 1.22 or less. Thus, with this rate of temperature increase, all systemic effects obtained in other examples and embodiments are observed.

Table 8A shows the change with time of the maximum temperature on the bonding surface of the ultrasonic wave oscillating element 112 of the ultrasonic irradiation pad 110 in this example. That is, the ultrasonic irradiation device 60 is continuously output for 60 minutes at an output frequency of 500 kHz (± 50 kHz) and an output intensity of 40 mW ± 20% per oscillation element by an ultrasonic output intensity measurement method in the US FDA examination. Driven. Table 8A shows that at this time, at room temperature, 10 minutes after the ultrasonic irradiation unit started to irradiate the ultrasonic wave, based on the temperature of the local contact surface immediately before the ultrasonic irradiation unit irradiated the ultrasonic wave. Of the maximum temperature and the maximum rate of increase of the maximum temperature of the local contact surface where the gel layer is not provided, and the maximum temperature and the maximum temperature of the local contact surface where the gel layer is not provided after 20 minutes. The value of the maximum rate of increase, the maximum temperature of the local contact surface without the gel layer after 30 minutes, the value of the maximum rate of increase of the maximum temperature, and the local area without the gel layer after 60 minutes The maximum temperature of the contact surface and the maximum rate of increase of the maximum temperature are shown.

  Similarly, Table 9A shows the change with time of the maximum temperature of the ultrasonic oscillation pad 112 bonding surface of the ultrasonic irradiation pad 110 in this example. That is, the ultrasonic wave irradiation device 60 is continuously output for 60 minutes at an output intensity of 40 mW ± 20% per oscillation element by an ultrasonic output intensity measurement method in the US FDA examination at an output frequency of 800 kHz (± 50 kHz). Driven. Table 9A shows that, at this time, at room temperature, 10 minutes after the ultrasonic irradiation unit starts irradiating the ultrasonic wave, based on the temperature of the local contact surface immediately before the ultrasonic irradiation unit irradiates the ultrasonic wave. Of the maximum temperature and the maximum rate of increase of the maximum temperature of the local contact surface where the gel layer is not provided, and the maximum temperature and the maximum temperature of the local contact surface where the gel layer is not provided after 20 minutes. The value of the maximum rate of increase, the maximum temperature of the local contact surface without the gel layer after 30 minutes, the value of the maximum rate of increase of the maximum temperature, and the local area without the gel layer after 60 minutes The maximum temperature of the contact surface and the maximum rate of increase of the maximum temperature are shown.

同様に、表１０Ａは、本実施例における、超音波照射パッド１１０の超音波発振素子１１２接合表面における最高温度の、時間の経過に伴う変化を示す。即ち、超音波照射装置６０を、５００ｋＨｚ（±５０ｋＨｚ）の出力周波数で、米国ＦＤＡの審査における超音波の出力強度の測定方法で１つの発振素子あたり８５ｍＷ±２０％の出力強度で、６０分間連続駆動した。表１０Ａは、このときに、室温下において、超音波照射部が超音波を照射する直前の局部当接面の温度を基準とした、超音波照射部が超音波を照射し始めてから１０分後の、ジェル層が設けられていない局部当接面の最高温度及び最高温度の最大上昇率の値と、２０分後の、ジェル層が設けられていない局部当接面の最高温度及び最高温度の最大上昇率の値と、３０分後の、ジェル層が設けられていない局部当接面の最高温度及び最高温度の最大上昇率の値と、６０分後の、ジェル層が設けられていない局部当接面の最高温度及び最高温度の最大上昇率の値とを示す。

Similarly, Table 10A shows the change with time of the maximum temperature on the bonding surface of the ultrasonic oscillation element 112 of the ultrasonic irradiation pad 110 in this example. That is, the ultrasonic irradiation apparatus 60 is continuously output for 60 minutes at an output intensity of 85 mW ± 20% per oscillation element at an output frequency of 500 kHz (± 50 kHz) and an ultrasonic output intensity measurement method in the US FDA examination. Driven. Table 10A shows that at this time, at room temperature, 10 minutes after the ultrasonic irradiation unit started to irradiate ultrasonic waves, based on the temperature of the local contact surface immediately before the ultrasonic irradiation unit irradiated the ultrasonic waves Of the maximum temperature and the maximum rate of increase of the maximum temperature of the local contact surface where the gel layer is not provided, and the maximum temperature and the maximum temperature of the local contact surface where the gel layer is not provided after 20 minutes. The value of the maximum rate of increase, the maximum temperature of the local contact surface without the gel layer after 30 minutes, the value of the maximum rate of increase of the maximum temperature, and the local area without the gel layer after 60 minutes The maximum temperature of the contact surface and the maximum rate of increase of the maximum temperature are shown.

Similarly, Table 11A shows the change with time of the maximum temperature of the ultrasonic oscillation pad 112 bonding surface of the ultrasonic irradiation pad 110 in this example. In other words, the ultrasonic irradiation device 60 is continuously used for 60 minutes at an output frequency of 800 kHz (± 50 kHz) and an output intensity of 85 mW ± 20% per oscillation element by a method of measuring ultrasonic output intensity in the US FDA examination. Driven. Table 11A shows that at this time, at room temperature, 10 minutes after the ultrasonic irradiation unit started irradiating the ultrasonic wave, based on the temperature of the local contact surface immediately before the ultrasonic irradiation unit irradiated the ultrasonic wave Of the maximum temperature and the maximum rate of increase of the maximum temperature of the local contact surface where the gel layer is not provided, and the maximum temperature and the maximum temperature of the local contact surface where the gel layer is not provided after 20 minutes. The value of the maximum rate of increase, the maximum temperature of the local contact surface without the gel layer after 30 minutes, the value of the maximum rate of increase of the maximum temperature, and the local area without the gel layer after 60 minutes The maximum temperature of the contact surface and the maximum rate of increase of the maximum temperature are shown.

  From Tables 8A to 11A, 10 times after the ultrasonic irradiation unit started to irradiate ultrasonic waves, based on the temperature of the local contact surface immediately before the ultrasonic irradiation unit irradiated the ultrasonic waves at room temperature. The maximum rate of increase in the temperature of the local abutment surface without the gel layer after 1.3 minutes is 1.3 or less, and the temperature of the local abutment surface without the gel layer after 20 minutes The maximum rate of increase of 1.3 is 1.3 or less, and the maximum rate of increase in temperature of the local contact surface after 30 minutes without the gel layer is 1.3 or less, and after 60 minutes, It can be seen that the maximum rate of temperature increase of the local contact surface where the gel layer is not provided is 1.3 or less. That is, by being within this value range, the subject does not feel uncomfortable with the gel layer, and does not feel uncomfortable due to the heat of the ultrasonic wave or suffers a burn, and obtains a systemic effect. You can see that

According to 6th Embodiment, there exist the following effects.
According to the ultrasonic irradiation device 60, ultrasonic waves having an output frequency in the range of 500 ± 50 kHz or more and 800 ± 50 kHz or less are continuously long for 5 minutes or more and 60 minutes or less as compared with the case of treating lesions. It is possible to irradiate with an output intensity in the range of 40 mW ± 20% or more and 85 mW ± 20% or less per one oscillating element by the measurement method of the ultrasonic output intensity in the examination of the US FDA, which is extremely small.

  Thereby, since the output intensity of the ultrasonic irradiation device 60 is extremely smaller than that for the purpose of treating a lesioned part, an increase in the surface temperature of the ultrasonic oscillation element can be suppressed, and the patient operates by himself / herself. However, it is possible to ensure safety, and to irradiate the local area other than the lesioned part with ultrasonic waves to obtain a more significant systemic effect. Systemic effects include high blood pressure improvement effect, pulse pressure reduction effect, pulse rate reduction effect, cardiac output reduction effect, cardiac load coefficient reduction effect, autonomic balance adjustment effect, extremity other than irradiated part Has an effect of increasing the surface temperature and analgesic effect. In addition, since vascular disorders throughout the body can be improved as a systemic effect, for example, vascular complications due to diabetes can be prevented. More specifically, the ultrasonic irradiation apparatus 60 to which the present invention is applied can improve the decrease in vascular endothelial function, which is closely related to the onset of macrovascular disorders. Therefore, the ultrasonic irradiation apparatus 60 of the present invention can be expected to be clinically applied as a vascular disorder prevention device and clinical application as a vascular disorder treatment device.

Further, in the ultrasonic irradiation device 60, at least two or more ultrasonic oscillation elements 112 are arranged along the long side on the ultrasonic irradiation pad. The fixing device 120 fixes the ultrasonic irradiation pad 110 to the forearm 50 in a state where the long side 110b of the ultrasonic irradiation pad 110 intersects the long side 121 thereof. As a result, at least two or more ultrasonic oscillation elements 112 are arranged from the elbow of the forearm 50 toward the periphery. Therefore, in the forearm 50, it is possible to irradiate not only a specific part (for example, a broken part) but also a wide range from the elbow to the periphery.
As a result, ultrasonic waves having an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz are irradiated over a wide range of the forearm of the living body with a weak output intensity over a continuous period of 5 minutes to 60 minutes. it can.

<Application example>
Next, the ultrasonic irradiation system 1 according to an application example to which the ultrasonic irradiation device 60 of the first embodiment is applied will be described.
[Configuration of ultrasonic irradiation system 1]
FIG. 8 is a diagram illustrating a functional configuration of the ultrasonic irradiation system 1 according to the application example of the first embodiment.
The ultrasonic irradiation system 1 according to the application example includes the ultrasonic irradiation device 60 according to the first embodiment and a measuring device 70 that measures biological information of a living body that emits ultrasonic waves, which is an example of a diagnostic device. Here, in this application example, the measuring device 70 is, for example, a blood pressure measuring device that measures a systolic pressure value, a diastolic pressure value, a pulse value, an autonomic nerve balance measuring device that measures an LF / HF value, or the surface of a living body. Consists of a temperature measuring device that measures temperature.

[Configuration of measuring instrument 70]
The measuring instrument 70 is controlled by the measuring instrument controller 71 that controls the operation of the measuring instrument 70, the measuring instrument 72 that is controlled by the measuring instrument controller 71, and acquires the biological information of the living body, and the measuring instrument controller 71. A display unit 73 that is controlled to display and a diagnostic information storage unit 74 that is referred to by the measuring instrument control unit 71.
The measuring instrument control unit 71 includes measuring instrument control means 711, timer setting means 712, calculation means 713, determination means 714, diagnosis control means 715, and transmission / reception means 716.

First, the functional configuration of the measuring instrument control means 711 and the calculating means 713 when the measuring instrument 70 is constituted by a blood pressure measuring instrument will be described.
The measuring instrument control means 711 pressurizes the forearm of the living body with a predetermined pressure (for example, 160 mmHg or 200 mmHg), and depressurizes the measuring unit 72 after a predetermined time, thereby acquiring biological information.
The timer setting unit 712 transmits time information for counting the time since the measuring device control unit 711 pressurizes the forearm of the living body to the measuring unit 72 with a predetermined pressure, to the measuring device control unit 711.
The calculation means 713 indicates the systolic pressure value and the diastolic pressure indicating the systolic pressure of the living body from the biological information acquired by the measuring section 72 after the measuring section 72 is depressurized under the control of the measuring instrument control means 711. A diastolic pressure value and a pulse value indicating the pulse are calculated. Then, the calculation means 713 performs control to display the calculated systolic pressure value, diastolic pressure value, and pulse value on the display unit 73.

Next, the functional configuration of the measuring instrument control means 711 and the calculating means 713 when the measuring instrument 70 is constituted by an autonomic nerve balance measuring instrument will be described.
The measuring device control means 711 controls the measuring unit 72 to acquire biological information. Specifically, the measuring instrument control unit 711 obtains biological information indicating a pulse wave for 3 to 5 minutes after performing a preliminary measurement for 1 minute.
The computing means 713 measures the heart rate variability for each beat of the living body from the biometric information, and performs a power spectrum analysis on the frequency component of the period variation of the heartbeat. The calculating means 713 calculates SDNN, TP, LF value, HF value, and LF / HF value in the result of the analysis. Then, the calculation unit 713 performs control to display the calculated SDNN, TP, LF value, HF value, and LF / HF value on the display unit 73.

  Note that the measuring instrument control unit 711 may receive drive end information from the ultrasonic irradiation device 60 via the transmission / reception unit 716. In this case, the measuring device 70 may start measuring biometric information when the drive end information is received.

  The determination unit 714 refers to the diagnosis information storage unit 74 that stores the information diagnosis table, and determines whether the value calculated by the calculation unit 713 from the biological information acquired by the measurement unit 72 is greater than or less than a predetermined threshold value. Determine whether or not.

FIG. 9 is a diagram for explaining an information diagnosis table of the ultrasonic irradiation system 1 according to the application example of the first embodiment.
In the information diagnosis table, a plurality of types of biological information, a predetermined threshold value of each biological information, and contents of diagnostic information when the information is equal to or greater than or less than the threshold value are associated and stored in the diagnostic information storage unit 74. ing.

For example, when the measuring device 70 is configured as a blood pressure measuring device, the determining unit 714 uses the calculating unit 713 to calculate a systolic pressure value of 140 mmHg or more, a calculated diastolic pressure value of 90 mmHg or more, or When the calculated pulse value is 90 / min or more, it is determined that the biological information is an abnormal value, and in other cases, it is determined as a normal value.
In addition, when the measuring device 70 is configured by an autonomic nerve balance measuring device, the determination unit 714 calculates biological information when the LF / HF value calculated by the calculation unit 713 is 1.3 or more or 0.7 or less. Is an abnormal value, otherwise it is determined to be a normal value.

Returning to FIG. 8, the diagnosis control unit 715 refers to the information diagnosis table (see FIG. 9) stored in the diagnosis information storage unit 74, extracts the diagnosis information according to the determination result of the determination unit 714, and displays it. The contents of the diagnostic information are displayed on the unit 73.
For example, in the example shown in FIG. 9, when the determination unit 714 determines that the systolic pressure value / diastolic pressure value is an abnormal value, the diagnostic control unit 715 displays “ “Treatment” is displayed.

  The diagnosis control unit 715 generates drive start information that triggers driving of the ultrasonic irradiation device 60 when the determination unit 714 determines that the value is an abnormal value, and starts the drive via the transmission / reception unit 716. Information may be transmitted to the ultrasonic irradiation device 60.

For example, when the measuring device 70 is constituted by a blood pressure measuring device, the measuring unit 72 is formed of a cuff that is pressurized or depressurized by the bag being formed into a belt-like body and air being poured into and out of the inside. .
For example, when the measuring device 70 is configured by an autonomic nerve balance measuring device, the measuring unit 72 has a pulse wave sensor and is attached to, for example, the left two fingers.

  The display unit is formed of a display that displays the value calculated by the computing means 713 and the contents of the diagnostic information whose display is controlled by the diagnostic control means 715.

  Here, when the drive control means 63 (see FIG. 5) of the ultrasonic irradiation device 60 receives the drive start information from the measuring instrument 70, the ultrasonic irradiation pad 110 (see FIG. 5) is held for 5 minutes or more. With a continuous drive time of 60 minutes or less, for example, at an output frequency of 800 kHz (± 50 kHz), an ultrasonic output intensity measurement method in the US FDA examination is 40 mW ± 20% or more and 85 mW ± 20% or less per oscillation element. Drive control is performed to irradiate the living body with ultrasonic waves with an output intensity in the range (average output intensity 62.5 mW).

  In addition, after the continuous drive time has elapsed, the drive control unit 63 ends the drive control of the ultrasonic irradiation pad 110 and transmits drive end information indicating that the drive control has ended to the measuring device 70.

  When receiving the drive end information transmitted from the ultrasonic irradiation device 60 by the transmission / reception unit 716, the measuring device 70 calculates and determines a value based on the biological information again, and determines the diagnostic information according to the determination result. Control to display the contents.

  In this application example, the measuring device is configured as an example of the diagnostic device. However, the diagnostic device is not limited thereto, and the biological information is not measured, for example, instead of the measurement unit. It is possible to perform control for determining the value input from the input unit and displaying the contents of the diagnostic information according to the determination result.

[Operation Flow of Ultrasonic Irradiation System 1]
FIG. 10 is a flowchart for explaining a diagnostic operation flow of the ultrasonic irradiation system 1 according to the application example.
First, before making the ultrasonic irradiation system 1 perform a diagnostic operation, the gel sheet is not attached to the lower surface of the pad main body 111 of the ultrasonic irradiation pad 110 of the ultrasonic irradiation device 60. Then, the ultrasonic irradiation pad 110 is directly brought into contact with and fixed to one forearm of the living body which is a local area other than the lesioned part by the fixing device 120. Then, the ultrasonic irradiation device 60 irradiates ultrasonic waves with a predetermined output intensity at a predetermined frequency for a predetermined time.
Next, the measuring unit 72 of the measuring instrument 70 is attached to the living body.
Then, the measuring device 70 of the ultrasonic irradiation system 1 starts a diagnostic operation. The diagnostic operation of the measuring device 70 may be started when the driving end information is received from the wave irradiation device 60.

  In step S1, the measuring instrument control means 711 controls the measuring unit 72 to acquire biological information.

  In step S2, the calculation means 713 calculates, for example, systolic pressure value, diastolic pressure value, pulse value, LF / HF value, or peripheral surface temperature of the living body from the biological information acquired by the measuring instrument control means 711 in step S1. And the control to display the calculated value on the display unit 73 is performed.

  In step S3, the determination unit 714 refers to the information diagnosis table (see FIG. 9) and determines whether the value calculated by the calculation unit 713 in step S2 is greater than or equal to a predetermined threshold value. When the measuring device 70 determines that the value is greater than or equal to a predetermined threshold value or less than the threshold value, the measuring device 70 proceeds to step S5, and when it determines that the value is not greater than or equal to the predetermined threshold value or less than the threshold value, The process is moved to S4.

  In step S4 and step S5, the diagnosis control unit 715 refers to the information diagnosis table (see FIG. 9), extracts the diagnosis information according to the determination result of the determination unit 714, and displays the contents of the diagnosis information on the display unit 73. indicate.

In step S5, the diagnosis control unit 715 may generate drive start information and transmit the drive start information to the ultrasonic irradiation device 60 via the transmission / reception unit 716.
In this case, the drive control means 63 of the ultrasonic irradiation device 60 receives the drive start information from the measuring device 70, and the ultrasonic irradiation pad 110 is continuously driven for 5 minutes to 60 minutes, for example, with an output frequency of 800 kHz. (± 50 kHz), the output intensity of the ultrasonic wave in the US FDA examination is over 40 mW ± 20% to 85 mW ± 20% (average output intensity 62.5 mW) Drive control for irradiating a living body with sound waves is performed. In addition, after the continuous drive time has elapsed, the drive control unit 63 ends the drive control of the ultrasonic irradiation pad 110 and transmits drive end information indicating that the drive control has ended to the measuring device 70.
Thereby, the ultrasonic irradiation system 1 acquires the biological information of the living body before irradiating the ultrasonic wave, for example, and when the value of the biological information is determined to be an abnormal value, the living body is irradiated with the ultrasonic wave, Thereafter, the biological information is acquired again, and it can be determined whether or not the value of the biological information is an abnormal value. That is, since biometric information before and after ultrasonic irradiation can be acquired, a diagnosis that compares these biometric information is also possible. Specifically, for example, a systolic pressure value, a diastolic pressure value, and a pulse value are calculated as biological information before and after ultrasonic irradiation. From these changes in values, it becomes possible to distinguish between transient hypertension due to white coat hypertension or stress and morbid hypertension, and the necessity of pharmacotherapy can be determined.

According to this application example, the following effects can be obtained.
According to the ultrasonic irradiation system 1, after the ultrasonic irradiation device 60 irradiates a local area other than the lesioned part with ultrasonic waves, the systolic pressure value, the diastolic pressure value, the pulse value, the LF / HF value, and other than the local area Diagnostic information can be displayed from at least one biological information of the surface temperature of the part.
Thereby, a patient can irradiate an ultrasonic wave to a local part by own operation, and can obtain more accurate diagnosis information from his / her own judgment from subsequent biological information. Therefore, it is possible to prevent the disease from progressing due to an erroneous judgment of the patient.

  As described above, each means of the ultrasonic irradiation apparatus 60 and the measuring instrument 70 described above is configured by hardware included in a computer and its peripheral devices, and software that controls the hardware.

  The hardware includes a CPU (Central Processing Unit) and a storage unit. Examples of the storage unit include a memory (RAM: Random Access Memory, ROM: Read Only Memory, etc.), a hard disk drive (HDD: Hard Disk Drive), and an optical disk (CD: Compact Disc, DVD: Digital Versatile Drive, etc.). Can be mentioned. Moreover, as a display part, various displays, such as a liquid crystal display and a plasma display, can be provided, for example. As an input device, for example, a keyboard and a pointing device (mouse, tracking ball, etc.) can be provided.

  The software includes a computer program and data for controlling the hardware. The computer program and data are stored in the storage unit, and are appropriately executed and referenced by each control unit.

Second Embodiment
Below, 2nd Embodiment of this invention is described in detail based on drawing. The second embodiment is different from the first embodiment in that an ultrasonic irradiation pad 110 as an ultrasonic irradiation unit is an ultrasonic irradiation unit that applies ultrasonic waves to the sole. Since the configuration other than this is the same as the configuration of the first embodiment, in the following description of the second embodiment, the same components as those in the first embodiment are denoted by the same reference numerals, and the description thereof is omitted. Simplify.

  The local area other than the lesioned part of the living body to which the ultrasonic wave from the ultrasonic irradiation pad 110 is irradiated is a part of the sole and a part from the ankle to the peripheral part. The ultrasonic irradiation pad 110 is fixed to the local portion in a positional relationship in which the longitudinal direction of the ultrasonic irradiation pad 110 coincides with the direction from the heel to the toes, and irradiates ultrasonic waves to a part from the ankle to the distal portion. This is an ultrasonic irradiation unit for foot irradiation. As shown in FIG. 11, the ultrasonic irradiation pad 110 is fixed to the center of the insole 301 so that the longitudinal direction of the ultrasonic irradiation pad 110 coincides with the longitudinal direction of the insole 301 of footwear such as shoes.

  However, the position of the ultrasonic irradiation pad 110 with respect to the insole 301 is not limited to the position shown in FIG. 11. For example, as shown in FIG. 12, the longitudinal direction of the ultrasonic irradiation pad 110 is from the heel to the toe. It may be a position that matches the direction of travel. Alternatively, the position of the ultrasonic irradiation pad 110 with respect to the insole 301 may be a position where the longitudinal direction of the ultrasonic irradiation pad 110 coincides with the direction from the heel toward the little toe of the foot, as shown in FIG. Furthermore, the position of the ultrasonic irradiation pad 110 with respect to the insole 301 may be closer to the insole 301 than the position shown in FIGS. 11 to 13 (lower side of FIGS. 11 to 13). The insole 301 may be closer to the toe than the position shown in FIGS. 11 to 13 (upward from FIGS. 11 to 13).

  The ultrasonic irradiation pad 110 illustrated in FIGS. 11 to 13 is connected to the connector 65 of the main body 61 of the ultrasonic irradiation device 60 (see FIG. 1 and the like) in the same manner as the ultrasonic irradiation pad 110 illustrated in FIG. Although connected via the composite cable 110 a, the composite cable 110 a is not shown in FIGS. 11 to 13 because it is disposed on the back side of the insole 301.

[Example 7 in which ultrasonic irradiation device 60 is applied to a subject]
In Example 7, ultrasonic irradiation was performed on the soles of 6 men and women aged 50 to 70 years. The subject has a chronic neck to lower back pain and is not cured by massage or low frequency therapy. For these subjects, the long side that coincides with the longitudinal direction of the ultrasonic irradiation pad 110 including the two ultrasonic oscillation elements 112 is positioned as a gel layer in a positional relationship that coincides with the direction from the heels of both feet toward the toes. The gel sheet was not contacted and fixed directly by contact. Then, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) or 500 kHz (± 50 kHz) is measured from 40 mW ± 20% to 85 mW ± 20% per oscillation element by a method of measuring the ultrasonic output intensity in the US FDA examination. Irradiation was continued for 20 minutes at an output intensity in the range of. After the irradiation, all six subjects showed a thermal effect and an analgesic effect from the neck to the back of the back. Moreover, the same effect was able to be acquired also when the ultrasonic irradiation time was 60 minutes.

[Embodiment 8 in which ultrasonic irradiation apparatus 60 is applied to a subject]
In Example 8, an ultrasonic irradiation pad 110 including two ultrasonic oscillators 112 on the soles of both feet of six subjects who have superior parasympathetic nervous system activity (LF / HF <1.0) 7 was directly contacted and fixed without using a gel sheet in the same positional relationship as 7, and ultrasonic irradiation was continuously performed for 10 minutes at the same output frequency and output intensity as in Example 7. Table 12 shows average values of SDNN, TP, and LF / HF ± standard error before and after ultrasonic irradiation. Note that SDNN, TP, and LF are as described in Example 2 in the first embodiment.

Further, in Example 8, the ultrasonic irradiation pad 110 including the two ultrasonic oscillation elements 112 is provided on the soles of both feet of six subjects who have superior sympathetic nervous system activity (LF / HF> 1.0). In the same positional relationship as in Example 7, it was fixed directly by contact without using a gel sheet, and ultrasonic irradiation was continuously performed for 10 minutes at the same output frequency and output intensity as in Example 7. Table 13 shows the average values of SDNN, TP, and LF / HF before and after irradiation with ultrasonic waves and the standard error.

  As shown in Tables 12 and 13, according to the present example, the SDNN can be used in both cases of a subject who has superior parasympathetic nervous system activity and a subject who has superior sympathetic nervous system activity. In TP and LF / HF, significant changes close to normal could be confirmed.

  As a result, an ultrasonic wave having an output frequency of 800 kHz (± 50 kHz) or 500 kHz (± 50 kHz) is output from 40 mW ± 20% or more to 85 mW ± 20% per oscillation element by a method of measuring the output intensity of ultrasonic waves in the US FDA examination. It was confirmed that the method of continuously irradiating the subject's foot for 10 minutes with the output intensity in the following range (average output intensity 62.5 mW) has an effect of adjusting the autonomic nerve balance. Further, when the ultrasonic wave irradiation time was set to 60 minutes instead of 10 minutes, the same effect as in the case of 10 minutes could be obtained. On the other hand, at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz, the sole is continuously irradiated for 20 minutes at an output intensity exceeding 85 mW per oscillation element by the ultrasonic output intensity measurement method in the US FDA examination. In the group of test subjects, no significant change approaching normal was observed in SDNN, TP, and LF / HF.

From the above, it can be seen that the following effects can be obtained.
The local part other than the lesioned part of the living body is a part from the ankle to the distal part, and the ultrasonic irradiation pad 110 is locally located in a positional relationship in which the longitudinal direction of the ultrasonic irradiation pad 110 coincides with the direction from the heel to the toes. It is an ultrasonic irradiation part for foot | leg part irradiation which irradiates an ultrasonic wave with respect to a part from an ankle to a peripheral part fixed to. Then, the drive control means 63 oscillates with an ultrasonic output intensity measurement method in the US FDA examination at a continuous drive time of 60 minutes or less at an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz. The oscillation element 112 is driven and controlled to irradiate ultrasonic waves with an output intensity in the range of 40 mW ± 20% to 85 mW ± 20% per element.

  With this drive control, when a piezoelectric element having the same frequency as the output frequency of the oscillation element 112 is brought into contact with the oscillation element 112 via a local contact surface without using a gel sheet such as a gel sheet, the piezoelectric element The ultrasonic irradiation pad 110 irradiates ultrasonic waves with such a vibration intensity that outputs an AC voltage of 2 Vrms or higher. In addition, by this drive control, the maximum rate of increase in the temperature of the local contact surface of the ultrasonic irradiation pad 110 on which the gel sheet as the gel layer is not provided is that the ultrasonic irradiation pad 110 emits ultrasonic waves at room temperature. The maximum rate of increase in the temperature of the local contact surface on which the gel layer is not provided is 10 minutes after the ultrasonic irradiation unit starts irradiating the ultrasonic wave, based on the temperature of the local contact surface immediately before the start. .3 or less, 20 minutes later, the maximum rate of increase in temperature of the local contact surface where the gel layer is not provided is 1.3 or less, and after 30 minutes, the local region where the gel layer is not provided The maximum increase rate of the temperature of the contact surface is 1.3 or less, and the maximum increase rate of the temperature of the local contact surface where the gel layer is not provided after 60 minutes is 1.3 or less.

  It has been found that such a systemic effect that can be brought close to normal in SDNN, TP, and LF / HF by irradiating the sole of the foot from the ultrasonic irradiation pad 110 with ultrasonic waves. Furthermore, since the systemic effect can be obtained by directly contacting the ultrasound irradiation pad 110 to the sole without using the gel layer, the ultrasound irradiation pad 110 is brought into contact with the sole through the gel layer. Compared to the above, a systemic effect can be obtained easily and without the discomfort caused by the gel.

  As described above, the present invention is not limited to the above-described embodiment. The effects described in the embodiments of the present invention are only the most preferable effects resulting from the present invention, and the effects of the present invention are limited to those described in the embodiments of the present invention. is not.

  For example, the fixing device 120 is configured by a band that can be wound around the forearm 50, but is not limited to this configuration. For example, the fixing device may be constituted by a cloth fixing device, or may be constituted by a fastener such as a wristwatch. Further, the fixed appliance may be configured by a cuff of a blood pressure monitor.

  The ultrasonic irradiation unit is configured by the ultrasonic irradiation pad 110, but is not limited to the ultrasonic irradiation pad 110. For example, in the sound wave irradiation unit, the pad main body may be configured by a plastic fixture having a shape different from that of the pad main body 111, a plurality of holes may be formed, and an ultrasonic oscillation element may be fitted into the hole and fixed. . In addition, the sound wave irradiation unit may be configured by a group of a plurality of ultrasonic oscillation elements in which a plurality of ultrasonic oscillation elements are separately fixed to the main body and are arranged side by side.

60 Ultrasonic irradiation device 63 Drive control means 110 Ultrasonic irradiation pad 112 Ultrasonic oscillator

Claims (4)

Without passing through the gel layer, an ultrasonic irradiation unit having an oscillation element that is in contact with a local part of the living body and radiates ultrasonic waves;
Drive control means for driving and controlling the oscillation element,
The drive control means includes
At an output frequency in the range of 500 ± 50 kHz to 800 ± 50 kHz,
With continuous driving time of 60 minutes or less,
US FDA measuring method of the output intensity of the ultrasonic wave in the examination of the so output intensity in the effective radiation area does not coincide with the area of one of said oscillating element is irradiated with ultrasonic waves in the range of 85 mW ± 20% An ultrasonic irradiation apparatus that controls driving of an oscillation element. The drive control means drives and controls the oscillation element so as to continuously irradiate ultrasonic waves at an output frequency in a range of 500 ± 50 kHz to 800 ± 50 kHz.
The ultrasonic irradiation unit includes a pad main body that houses the oscillation element, and the pad main body has a local contact surface that contacts the local part of the living body,
The gel layer is not provided on the local contact surface, and at room temperature, the temperature of the local contact surface immediately before the ultrasonic irradiation unit irradiates ultrasonic waves is a reference.
The maximum rate of increase in the temperature of the local contact surface on which the gel layer is not provided, 10 minutes after the ultrasonic irradiation unit starts irradiating ultrasonic waves, is 1.3 or less,
After 20 minutes, the maximum rate of increase in temperature of the local contact surface where the gel layer is not provided is 1.3 or less,
After 30 minutes, the maximum rate of increase in the temperature of the local contact surface where the gel layer is not provided is 1.3 or less,
2. The ultrasonic wave according to claim 1, wherein the ultrasonic wave irradiation unit has a maximum rate of temperature increase of 1.3 or less after 60 minutes without the gel layer. Irradiation device. An ultrasonic irradiation apparatus that emits ultrasonic waves to the local area other than the lesioned part of the living body to exert a systemic effect,
The local part other than the lesioned part of the living body is a part from the elbow part to the peripheral part,
The ultrasonic irradiator is fixed to the local portion in a positional relationship in which the longitudinal direction of the ultrasonic irradiator coincides with the direction from the elbow to the distal portion, and ultrasonic waves are applied to a part from the elbow to the distal portion. Or the local part other than the lesioned part of the living body is a part from the ankle to the peripheral part,
The ultrasonic irradiation unit irradiates ultrasonic waves to a part from the ankle to the distal part by being fixed to the local part in a positional relationship in which the longitudinal direction of the ultrasonic irradiation unit coincides with the direction from the heel toward the toes. An ultrasonic irradiation unit for foot irradiation,
Among the above-mentioned ultrasonic irradiation, blood pressure lowering, cardiac output reduction, vascular endothelial function increase, autonomic nerve activation, autonomic nerve activity balance adjustment, body temperature increase, blood glucose level decrease, neck to lumbar back pain relief effect The ultrasonic irradiation apparatus according to claim 1, wherein at least one effect is exhibited. A diagnostic system comprising: the ultrasonic irradiation device according to any one of claims 1 to 3; and a diagnostic device that diagnoses the living body irradiated with ultrasonic waves on the local portion by the ultrasonic irradiation device. ,
The diagnostic device comprises:
The biological information of the living body irradiated with ultrasonic waves by the ultrasonic irradiation device was calculated by power spectrum analysis of the systolic pressure value, the diastolic pressure value, the pulse value, and the frequency component of the pulse fluctuation. Acquire at least one of an LF / HF value indicating a ratio of an LF value indicating a low frequency component and an HF value indicating a high frequency component, a TP value indicating autonomic nerve activation, and a surface temperature of a part other than the local part Acquisition means to
A determination unit that determines whether the biological information acquired by the acquisition unit is greater than or equal to a predetermined threshold or less than a threshold;
Storage means for storing diagnostic information according to the determination result of the determination means;
A diagnostic system comprising: a diagnostic control unit that extracts the diagnostic information according to the determination result of the determination unit with reference to the storage unit and displays the content of the diagnostic information on a display unit .

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