KR20210083634A - Low Frequency Electro Stimulation Therapy With Slope Waveform - Google Patents

Abstract

In a low frequency electrical stimulation treatment instrument according to the present invention, an amplitude of a pulse during preset pulse-on time gradually decreases from a pulse peak value and becomes zero, and a decreasing rate of the amplitude is output in a gradually decreasing shape, thereby effectively maximizing a treatment effect. In addition, since positive and negative electrodes are delivered into the human body as they are without short-circuit, ion imbalance around a lesion portion of the human body can be corrected and cell tissues can be normally regenerated without side effects.

Description

Low Frequency Electro Stimulation Therapy With Slope Waveform

The present invention relates to a low-frequency electrical stimulation therapy device having a slope waveform, and more particularly, to a low-frequency electrical stimulation therapy device capable of maximizing a therapeutic effect by outputting a pulse as a slope waveform.

Conventional medical electrotherapy devices used physical therapy devices (high frequency, medium frequency, low frequency) using direct current (DC), alternating current (AC), pulsating current (PC), and the like.

However, the anode (+) and cathode (-) flowing out from the conventional electrotherapy device itself are leaked from the same circuit and have a friendly relative relationship with each other, so a short circuit occurs with the human body as a conductor. Therefore, it does not have a hand-to-hand relationship with the diseased part of the human body and only serves as a conductor of electricity, so the causative agent of the disease could not be removed. Therefore, more than a temporary physical effect due to heat, vibration, and stimulation could not be obtained with the conventional treatment device, but rather a danger to the human body.

In order to solve the above problems, a unipolar therapy device has been recently proposed, but this induces a unilateral change in the human body by using only a single pole among the positive poles of electricity, thereby reducing the imbalance of potential in human tissues and cells. There were downsides to bringing it.

In order to solve this drawback, a non-short circuit bipolar electrotherapy device was applied for in Korean Patent Registration No. 10-0483970, but a small amount of short circuit action was found in actual use, and the need for an electrotherapy device that can be used more safely has emerged.

Korean Patent Registration No. 10-0483970

An object of the present invention is to provide a low-frequency electrical stimulation therapy device having a slope waveform that can improve both safety and therapeutic effect.

The present invention relates to a low-frequency electrical stimulation therapy device for applying low-frequency electrical stimulation to a contact area by contacting the human body, wherein the waveform of the pulse output to apply the electrical stimulation has an amplitude for a preset pulse ON time during a pulse period It gradually decreases from a peak value and becomes 0, and the rate of decrease of the amplitude is output in a constant linear shape.

The pulse period is 2 to 3.5 ms, and the pulse-on time has a slope waveform of 5 to 100 μs.

The low-frequency electrical stimulation treatment device according to the present invention can more effectively maximize the treatment effect by outputting the pulse amplitude in a shape in which the pulse amplitude decreases from the pulse peak value to 0 during the preset pulse-on time.

In addition, since a short circuit between the positive and negative electrodes does not occur and is delivered into the human body as it is, the ion imbalance in the lesion site of the human body can be corrected and cell tissues can be regenerated normally without side effects.

1 is a diagram showing a circuit diagram of a low-frequency electrical stimulation therapy device having a gradient waveform according to an embodiment of the present invention.
Figure 2 is a view showing the slope waveform of the pulse of the low-frequency electrical stimulation therapy device having a slope waveform according to an embodiment of the present invention.

Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings.

The low-frequency electrical stimulation treatment device according to an embodiment of the present invention is a device for treating the contact portion by applying low-frequency electrical stimulation to the contact portion by contacting the shoulder, back, waist, etc. of the human body.

1 is a diagram showing a circuit diagram of a low-frequency electrical stimulation therapy device having a gradient waveform according to an embodiment of the present invention.

Referring to Figure 1, the low-frequency electrical stimulation therapy device having a gradient waveform according to an embodiment of the present invention, a pulse generator 70, and outputting the pulse generated by the pulse generator 70 as a pulse having a gradient waveform and a slope waveform output unit (10).

The pulses include positive and negative pulses respectively output from circuits independent of each other.

The pulse generator 70 includes an amplifier circuit (not shown) that amplifies a frequency generation signal input through a CPU (not shown) to a predetermined level, and a transistor connected to the amplifier circuit (not shown) to generate a pulse. circuit (not shown).

The gradient waveform output unit 10 includes a bipolar gradient waveform outputter 11 that receives the first pulse P1 generated by the pulse generator 70 and outputs it as a bipolar pulse of the gradient waveform, and the pulse generator and a negative slope waveform outputter 12 that receives the pulse P2 generated in step 70 and outputs negative pulses of the slope waveform.

The anode gradient waveform output unit 11 includes a bipolar transformer T1 that receives the pulse P1 generated by the pulse generator 70 and converts it into alternating current, and +,- output from the bipolar transformer T1. and a bipolar rectifier circuit (R1) for changing the AC signal to a + signal having only one polarity.

Referring to FIG. 2 , the waveform of the bipolar pulse output from the bipolar gradient waveform outputter 11 has an amplitude (V) of a pulse peak value during _{a preset pulse ON time (t on ) during a pulse period (T).} It is a linear waveform that decreases from (Peak value)(V _{p ) to 0.}

The slope of the tangent to the waveform is less than zero and is constant with time t.

Such a waveform is a waveform of a shape different from that of a conventional square wave or sine wave, and is defined as a slope waveform. The inclination waveform has a linear shape.

The pulse period (T) of the bipolar pulse is 2 to 3.5 ms, the pulse on time (t _on ) of the bipolar pulse is 5 to 100 μs, and the pulse peak value (V _p ) of the bipolar pulse is 400 to 1500V.

When the bipolar pulse is output, the initial amplitude corresponds to a peak value, and during the pulse-on time during which the bipolar pulse is continued, the amplitude of the pulse gradually decreases from the peak value and reaches zero. As the amplitude of the pulse decreases, the rate of decrease is constant. After the pulse-on time has elapsed, the amplitude is zero.

A positive output terminal OUT1 for outputting the positive pulse is connected to the positive slope waveform outputter 11 .

The negative slope waveform outputter 12 includes a negative transformer T2 that receives the pulse P2 generated by the pulse generator 70 and converts it into alternating current, and +,- output from the negative transformer T2. It contains a negative rectifier circuit (R2) that converts the alternating signal into a -signal having only one polarity.

The waveform of the negative pulse output from the negative slope waveform outputter 12 is the same as that of the positive pulse.

Referring to FIG. 2 , in the waveform of the negative pulse, the amplitude gradually decreases from the pulse peak value to 0 during a preset pulse ON time during the pulse period, and the rate of decrease of the amplitude is a constant straight line. It is an inclined waveform of the shape.

The slope of the tangent to the waveform is less than zero and is constant with time t.

The pulse period (T) of the cathode pulse is 2 to 3.5 ms, the pulse-on time (t _on ) of the cathode pulse is 5 to 100 μs, and the pulse peak value (V _p ) of the cathode pulse is 400 to 1500V.

When the negative pulse is output, the initial amplitude corresponds to a peak value, and during the pulse-on time during which the negative pulse is continued, the amplitude of the pulse gradually decreases from the peak value and reaches zero. As the amplitude of the pulse decreases, the rate of decrease is constant. After the pulse-on time has elapsed, the amplitude is zero.

A negative output terminal OUT2 for outputting the negative pulse is connected to the negative slope waveform outputter 12 .

The positive pulse and the negative pulse are output simultaneously.

In the embodiment of the present invention configured as described above, the positive pulse and the negative pulse are output from independent circuits that do not affect each other. Therefore, a short circuit between the positive and negative electrodes does not occur and is delivered to the human body as it is, thereby correcting the ion imbalance in the lesion site of the human body and regenerating cell tissues normally.

In addition, since the positive pulse and the negative pulse are respectively output as the gradient waveform, a treatment effect may be improved.

In order to investigate the effect of the low-frequency electrical stimulation therapy device having a slope waveform according to the present invention, an experiment was performed as follows.

<Experimental example>

- Age: 55 years or older

- Number of people: 55

- Duration: 4 weeks

- Subject: Patients with insomnia symptoms lasting more than 6 months and receiving medication

- Method: A low-frequency electrical stimulation device was used for at least 5 days a week, 30 minutes before taking insomnia-related drugs, and applied to the shoulder and neck.

The average daily usage time (min) was 40.4±8.92, the total usage days were 23.5±3.81, the total usage time (min) was 959.5±302.37, and the average current strength was within 1.3mA.

Each pulse period of the positive pulse and the negative pulse was 2.5 ms, the pulse on time of each of the positive pulse and the negative pulse was within 100 μs, and the peak value of each pulse of the positive pulse and the negative pulse was 900V. .

Out of a total of 55 subjects, 6 people withdrew consent (device use, skin-related discomfort), 2 people with worsening insomnia, 1 patient with hypoglycemia, 1 patient with fatigue, and 1 patient with death (fall accident unrelated to device use), 44 Efficacy analysis index was measured for each person.

In the sleep diary and survey, each subject completed a sleep diary the morning after each nightly electrical stimulation session. A checklist for the diary includes sleep latency, time in bed, sleep delay, intensity and duration of use of TENS, and medication dosage. Efficacy analysis indicators of sleep quality (Pittsburgh Sleep Quality Index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), and insomnia severity (Insomnia Severity Index, ISI) were measured, and vital signs including blood pressure and pulse were also confirmed. Since an individual's mood or pain state can affect insomnia symptoms, the Anxiety Depression Rating Scale (HADS) and the Numerical Rating Scale (NRS) were also measured, and the measurement results are shown in Table 1.

Pre-treatment Post-treatment P-value PSQI
Sleep latency
Time in bed
total sleep time
sleep efficiency 12.42±3.73
56.00±43.03
408.60±78.64
311.28±87.00
77.17±18.59 11.0±3.71
37.77±23.49
430.12±67.40
334.42±85.92
78.6±19.07 0.001**
0.001**
0.033**
0.004**
0.506 ISI 13.88±7.23 12.10±6.08 0.004** ESS 3.74±3.79 4.10±3.33 0.408 Sleep Diary
sleep quality
daytime function
QOL
2.33±1.24
1.55±1.04
1.38±1.41
2.38±1.32
1.55±1.11
1.19±1.17
0.728
1.000
0.160 HADA 13.81±8.15 13.72±7.78 0.881 NRS 2.72±2.38 2.88±2.37 0.534

As shown in Table 1, in the last 44 patients analyzed, sleep quality (PSQI=12.42±3.73 to 11.0±3.71, P=0.001) and insomnia severity (ISI=13.88±7.23 to 12.10±6.08, P=0.004) were tested. decreased significantly after that.

Six patients in the sample had their benzodiazepine doses reduced after treatment, and 23 patients showed a response to treatment (57.5% response rate). Comparing the changes in sleep parameters in the sleep diaries of the treated and untreated groups, sleep waiting time decreased (44.46±26.9 minutes to 30.26±17.55, p<0.001, Cohen's d=0.625), and sleep time increased (308.7±82.2). at 347±77.66 min, p=0.001, Cohen's d=0.479). Treatment was predicted by an increase in the baseline of the ESS score and an increase in the baseline in the HADS score. Both scores were adjusted for age, sex, other mental disorders, duration of insomnia, and amount and intensity of treatment. The relative delta power in the occipital region was decreased in the treated group (16.5±9.7 to 10.9±8.9) compared to the untreated group (13.7±9.1 to 14.5±11.9).

Sleep latency and waking time decreased after low-frequency electrotherapy. They also found significant increases in slow-wave sleep and total delta sleep with polysomnography, which may contribute to treatment-related improvements in insomnia. Contrary to the positive role of delta during sleep, increased delta waves in wakefulness have been documented in a number of pathological conditions, such as brain tissue damage and cognitive decline. The delta wave in the waking state usually appears as a result of fatigue and mental boredom due to insomnia, and there is a significant decrease in the relative delta power in the awake state. This is related to the subjective decrease in the degree of insomnia, and the difference in the decrease in relative delta power between the treated group and the non-treated group in this experiment is that the decreased delta power in the arousal state has a therapeutic effect due to the use of low-frequency electrical stimulation. .

Positive results were obtained from low-frequency electrical stimulation of less than 1 mA in the trapezius muscle using a session of 30 to 60 minutes over 20 days (average 137-138 μA). Selecting the area to be stimulated depends on the appropriate duration and degree of electrical stimulation. as important as choosing In particular, since the anatomical and functional innervation of the neck nerve within the trapezius muscle has been confirmed, psychological dissatisfaction with sleep disorders is a strong predictor of the increased muscle response of the upper trapezius, so insomnia patients will receive muscle relaxation treatment at a sleep clinic. When the trapezius muscle tension is generally observed, it is desirable to perform low-frequency electrical stimulation in the neck or shoulder region.

The action of the mechanism of alleviating insomnia with low-frequency electrical stimulation is, first, the effect of electrical stimulation on nerve muscles.

When superficial electromyograms are recorded bidirectionally in the trapezius and deltoid regions, people with physiological problems, such as sleep disorders, show increased muscle contraction. Since the positive relationship between muscle relaxation and sleep quality improvement is clear, the effects of low-frequency electrical stimulation in the muscles are shown to increase muscle extension and decrease spasticity in patients with cerebral palsy. It also improves blood supply, skin temperature, and muscle oxidative function, and has the effect of suppressing inflammatory cytokines. Second, neurophysiological effects in the brain can be induced by low-frequency electrical stimulation.

Significant improvement in PSQI and ISI was observed in comparison before and after low-frequency electrical stimulation treatment, which indicated a therapeutic effect on insomnia of the low-frequency electrical stimulation treatment device. It was effective in reducing the severity of insomnia in more than half of the patients. In addition, electrical stimulation not only contributed to reducing the use of sleeping pills in some patients, but also showed that the higher the daytime sleepiness and depression-anxiety, the higher the effect.

The low-frequency electrical stimulation treatment device of the present invention as described above corrects the ion imbalance in the lesion area of the human body by allowing the anode (+) and cathode (-) to pass into the human body as they are without a short circuit, and helps to treat insomnia without side effects , it can be easily attached to and detached from the user's appropriate location, and it can be used in a wider range than the existing low-frequency treatment device by expanding the treatment range using bipolar or multi-pole, thus shortening the treatment time and reducing the treatment time according to the condition of the affected area. Since it can be used by adjusting the amount of bipolar or multipolar, there is a very useful effect that can maximize the therapeutic effect.

Although the present invention has been described with reference to the embodiment shown in the drawings, which is merely exemplary, it will be understood by those skilled in the art that various modifications and equivalent other embodiments are possible therefrom. Accordingly, the true technical protection scope of the present invention should be determined by the technical spirit of the appended claims.

10: slope waveform outputter 11: bipolar slope waveform outputter
12: negative slope waveform outputter

Claims (2)

In a low-frequency electrical stimulation therapy device that applies low-frequency electrical stimulation to a contact area by contacting the human body,
The waveform of the pulse output to apply the electrical stimulation has an amplitude that gradually decreases from a peak value of the pulse during a preset pulse ON time during the pulse period and becomes 0, and the rate of decrease of the amplitude has a constant linear shape. A low-frequency electrical stimulation therapy device having a slope waveform output to The method according to claim 1,
The pulse period is 2 to 3.5 ms,
The pulse-on time is a low-frequency electrical stimulation therapy device having a gradient waveform of 5 to 100 μs.

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