KR102145819B1 - Low Frequency Electro Stimulation Therapy With Primo Waveform - Google Patents

Abstract

The present invention relates to a low frequency electrical stimulation therapy apparatus having a primo waveform. According to the invention, during a preset pulse-on time, an amplitude of a pulse gradually decreases from a pulse peak value and then becomes 0, and a reduction rate of the amplitude is output in a gradually decreasing shape, so that a treatment effect can be more effectively maximized. In addition, since a short circuit between a positive electrode and a negative electrode does not occur and is transferred into a human body as it is, ionic imbalance at a lesion site of the human body is corrected and a cellular tissue can be normally regenerated without side effects. The low frequency electrical stimulation therapy apparatus includes a positive primo waveform output device and a negative primo waveform output device.

Description

Low Frequency Electro Stimulation Therapy With Primo Waveform

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

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

However, since the positive (+) and negative (-) discharged from the conventional electrotherapy device itself flow out from the same circuit and are mutually friendly relative relationship, a short-circuit action occurs using the human body as a conductor. Therefore, the disease-causing substance could not be removed because it did not have a transfer relationship with the diseased part of the human body and played only the role of an electric conductor. Therefore, it was not possible to obtain more than the temporary physical effects caused by heat, vibration, and stimulation with the conventional treatment device, but rather gave a danger to the human body.

In order to solve the above problems, a unipolar treatment device has been proposed in recent years, but it induces a one-sided change in the human body by using only a unipolar electrode among the anodes of electricity, thereby reducing the imbalance of potential in the human tissue and cells. There was a drawback to bring.

In order to solve these shortcomings, a non-short-circuit bipolar electrotherapy device was filed in Korean Patent Registration No. 10-0483970, but a small amount of short-circuit action was discovered 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 treatment device having a primo waveform capable of improving both safety and therapeutic effect.

In the low-frequency electrical stimulation treatment device according to the present invention, in a low-frequency electrical stimulation treatment device that applies low-frequency electrical stimulation to a contact portion by contacting a human body, the waveform of the pulse output to apply the electrical stimulation is preset pulse ON (ON ) During time, the amplitude gradually decreases from the pulse peak value and then becomes 0, and the rate of decrease of the amplitude gradually decreases.

The pulse period is 2 to 3.5 ms, and the pulse on time is 5 to 100 μs.

The pulse peak value is 400 to 1500V.

The pulse includes an anode pulse output through the anode transformer and the anode rectifier circuit, and a cathode pulse output through the cathode transformer and the cathode rectification circuit.

In the low-frequency electrical stimulation treatment device according to another aspect of the present invention, in a low-frequency electrical stimulation treatment device that applies low-frequency electrical stimulation to a contact portion by contacting a human body, the waveform of the pulse output to apply the electrical stimulation is a preset pulse among pulse cycles. During the ON time, the amplitude gradually decreases from the pulse peak value and then becomes 0, and the rate of decrease of the amplitude gradually decreases. The pulse period is 2 to 3.5 ms, and the pulse is on. The time is 5 to 100 μs, the pulse peak value is 400 to 1500 V, and the pulse includes a positive pulse output through a positive transformer and a positive rectifier circuit, and a negative pulse output through a negative transformer and a negative rectifier circuit. do.

In the low-frequency electrical stimulation treatment apparatus according to the present invention, the amplitude of the pulse gradually decreases from the pulse peak value to 0 during a preset pulse-on time, and then becomes 0, and the rate of decrease of the amplitude gradually decreases. It can effectively maximize the therapeutic effect.

In addition, since a short circuit between the positive electrode and the negative electrode does not occur and is delivered as it is to the human body, ionic imbalance at the lesion site of the human body can be corrected and the cellular tissue can be regenerated normally without side effects.

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

Hereinafter, embodiments 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 a contact portion by applying low-frequency electrical stimulation to a contact portion by contacting a shoulder, back, or waist of a human body.

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

Referring to FIG. 1, a low-frequency electrical stimulation treatment device having a primo waveform according to an embodiment of the present invention outputs a pulse generated by a pulse generator 70 and the pulse generator 70 as a pulse having a primo waveform. Includes a primo waveform output unit 10.

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

The pulse generator 70 includes an amplifier circuit (not shown) for amplifying 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. It includes a circuit (not shown).

The primo waveform output unit 10 includes a bipolar primo waveform output unit 11 for receiving the first pulse P1 generated by the pulse generator 70 and outputting a bipolar pulse of the primo waveform, and the pulse generator And a cathode primo waveform output unit 12 for receiving the pulse P2 generated in 70 and outputting the cathode pulse of the primo waveform.

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

Referring to Figure 2, the waveform of the bipolar pulse output from the bipolar primo waveform output unit 11, the amplitude (V) of the pulse peak value during a preset pulse-on (ON) time (t _on ) of the pulse period (T) It gradually decreases at (Peak value)(V _p ) and becomes 0, but the rate of decrease of the amplitude V is a waveform that gradually decreases.

The slope of the tangent to the waveform is less than 0 and gradually increases with time (t). For example, it can be seen that the slope tan(θ2) of the tangent line at the second time point t2 increases than the slope tan(θ1) of the tangent line at the first time point t1.

Such a waveform is a waveform having a shape different from that of a conventional square wave or sine wave, and is defined as a primo waveform. The primo waveform is a curved downward convex shape.

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

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 continues, 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 gradually decreases. 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 primo waveform output device 11.

The negative primo waveform output unit 12 includes a negative transformer T2 that receives the pulse P2 generated from the pulse generator 70 and converts the pulse P2 into AC, and the +,- output from the negative transformer T2. It includes a negative rectifier circuit (R2) that changes to a -signal having only one polarity of the AC signal.

The waveform of the negative pulse output from the negative primo waveform output unit 12 is the same as the waveform of the positive pulse.

Referring to FIG. 2, the waveform of the cathode pulse gradually decreases from a pulse peak value to 0 during a preset pulse ON time in a pulse period, but the rate of decrease of the amplitude gradually decreases. This is the Primo waveform.

The slope of the tangent to the waveform is less than 0 and gradually increases with time (t). For example, it can be seen that the slope tan(θ2) of the tangent line at the second time point t2 increases than the slope tan(θ1) of the tangent line at the first time point t1.

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 1500 V.

When the cathode pulse is output, the initial amplitude corresponds to a peak value, and during the pulse-on time during which the cathode pulse continues, 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 gradually decreases. 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 primo waveform output device 12.

The positive pulse and the negative pulse are simultaneously output.

In the embodiment of the present invention configured as described above, the positive pulse and the negative pulse are output from separate circuits that do not affect each other. Accordingly, a short circuit between the positive electrode and the negative electrode does not occur and is transferred to the human body as it is, thereby correcting the ionic imbalance at the lesion site of the human body and regenerating the cellular tissue normally.

In addition, the positive pulse and the negative pulse are each output as the primo waveform, thereby improving a treatment effect.

In order to find out the effect of the low-frequency electrical stimulation treatment device having a primo waveform according to the present invention, an experiment was conducted as follows.

<Experimental Example>

-Age: 55 years old or older

-Number of people: 55

-Duration: 4 weeks

-Subject: Patients with insomnia symptoms persisting for more than 6 months and undergoing medication

-Method: A low-frequency electrical stimulation therapy device was used for a certain period of time for more than 5 days a week, 30 minutes before the insomnia-related drug consumption, and applied to the shoulders and neck.

The average daily use time (min) was 40.4±8.92, the total use day (day) was 23.5±3.81, the total use time (min) was 959.5±302.37, and the average current intensity was within 1.3mA.

Each pulse period of the positive pulse and the negative pulse was 2.5 ms, the pulse-on time 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 900 V. .

Out of a total of 55 samples, 6 withdrawal of consent (using devices, skin-related discomfort), 2 worsening insomnia, 1 hypoglycaemia, 1 fatigue, 1 death (fall accident irrelevant to the use of the device) gave up, 44 The efficacy analysis index was measured for people.

In the sleep diary and survey, each subject completed a sleep diary the morning after each night electrical stimulation session. The diary checklist includes sleep incubation period, time in bed, sleep delay, intensity and duration of TENS use, and medication dosage. Indices of efficacy analysis of sleep quality (Pittsburgh Sleep Quality IndexㆍPSQI), daytime sleepiness scale (ESS), and insomnia severity (Insomnia Severity IndexㆍISI) were measured, and vital signs including blood pressure and pulse were also checked. Since an individual's mood or pain state can influence the symptoms of insomnia, 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, sleep quality (11.0±3.71 at PSQI=12.42±3.73, P=0.001) and insomnia severity (12.10±6.08 at ISI=13.88±7.23, P=0.004) in the last 44 subjects analyzed were tested as shown in Table 1 Significantly decreased after.

Six patients in the sample had reduced doses of the benzodiazepine drug after treatment, and 23 patients showed a treatment response (57.5% response rate). When the changes in the sleep diaries of the treatment group and the non-treatment group were compared, sleep waiting time decreased (30.26±17.55 at 44.46±26.9 minutes, 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 of the HADS score. Both scores were after adjusting the age, sex, other mental disorders, duration of insomnia, and the amount and intensity of treatment. The relative delta power in the occipital region decreased in the treatment 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 waiting time and waking time decreased after low-frequency electrotherapy. They also found significant increases in slow waveform sleep and total delta sleep through polysomnography, which may contribute to improvement in the treatment of insomnia. Unlike the positive role of delta during sleep, delta waves increased in arousal have been recorded in a number of pathological conditions, such as brain tissue damage and cognitive decline. Delta waves in awake state generally appear as a result of fatigue and mental boredom due to insomnia, and a significant decrease in relative delta power appears in 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 treatment group and the non-treatment group in this experiment can be seen that the decreased delta power of 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 conducted at less than 1 mA in the trapezius muscle using a 30 to 60 minute session for more than 20 days (average 137-138 μA). Selecting the area to be stimulated is the appropriate duration and extent of the electrical stimulation. It's just as important as choosing. In particular, since the anatomical and functional innervation of the neck nerve in the trapezius muscle was confirmed, psychological dissatisfaction with sleep disturbance is a strong predictor of the increased muscle response of the upper trapezius, so insomnia patients receive muscle relaxation treatment at the sleep clinic. When high muscle tension of the trapezius is generally observed, it is preferable to perform low-frequency electrical stimulation on the neck or shoulder area.

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

When superficial EMG is recorded in both directions in the trapezius and deltoid muscles, people with physiological problems such as sleep disturbances show increased muscle contraction. Since the positive relationship between muscle relaxation and improvement of sleep quality is clear, the effect of low-frequency electrical stimulation in the muscle has been shown to increase muscle extension and reduce stiffness in patients with cerebral palsy. In addition, blood supply, skin temperature, and muscle oxidation are improved, and inflammatory cytokines are suppressed. Second, the neurophysiological effects of the brain can be induced by low-frequency electrical stimulation.

In the comparison before and after the low-frequency electrical stimulation treatment, a significant improvement in PSQI and ISI was observed, which showed the therapeutic effect of the low-frequency electrical stimulation treatment device for insomnia, and the low-frequency electrical stimulation through the low-frequency electrical stimulation treatment device of the present invention had no significant side effects. More than half of the patients were effective in reducing the severity of insomnia. 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 drowsiness and depression-anxiety, the higher the effect.

The low-frequency electrical stimulation treatment device of the present invention as described above does not cause a short circuit between the positive electrode (+) and the negative electrode (-) and is delivered into the human body as it is, thereby correcting the ionic imbalance at the lesion site and helping to treat insomnia without side effects. , It can be easily detached and attached to the appropriate location of the user, and the treatment range can be expanded by using an anode or multi-pole to reduce the treatment time and reduce the treatment time according to the condition of the affected area. Since it can be used by adjusting the amount of positive or multi-pole, there is a very useful effect that can maximize the therapeutic effect.

The present invention has been described with reference to the embodiments shown in the drawings, but these are merely exemplary, and those of ordinary skill in the art will appreciate that various modifications and equivalent other embodiments are possible therefrom. Therefore, the true technical protection scope of the present invention should be determined by the technical spirit of the appended claims.

10: Primo Waveform Output 11: Bipolar Primo Waveform Output
12: negative primo waveform output

Claims (5)

In a low-frequency electrical stimulation treatment device that contacts the human body and applies low-frequency electrical stimulation to the contact area,
A positive primo waveform output device for receiving a first pulse generated from a pulse generator and outputting a positive pulse, and a negative primo waveform output device receiving a second pulse generated from the pulse generator and outputting a negative pulse,
The positive primo waveform output device includes a positive transformer and a positive rectifier circuit, and a positive output terminal for outputting the positive pulse to a human body is connected,
The negative primo waveform output device includes a negative transformer and a negative rectifier circuit, and a negative output terminal for outputting the negative pulse to the human body is connected,
The positive pulse and the negative pulse are each simultaneously output from an independent circuit and discharged to the human body,
The waveforms of the positive pulse and the negative pulse output to apply the electrical stimulation gradually decrease from the pulse peak value to zero during a preset pulse ON time in each pulse period, and the amplitude The decreasing speed of outputs the primo waveform of the gradually decreasing shape,
The primo waveform is a downwardly convex curved shape,
The pulse period is 2 to 3.5 ms,
The pulse on time is 5 to 100 μs,
The pulse peak value is a low-frequency electrical stimulation treatment device having a primo waveform of 400 to 1500V. delete delete delete delete

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