TWI724835B - Low frequency electro stimulation therapy with primo waveform - Google Patents

Low frequency electro stimulation therapy with primo waveform Download PDF

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TWI724835B
TWI724835B TW109110092A TW109110092A TWI724835B TW I724835 B TWI724835 B TW I724835B TW 109110092 A TW109110092 A TW 109110092A TW 109110092 A TW109110092 A TW 109110092A TW I724835 B TWI724835 B TW I724835B
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TW202123992A (en
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趙正淳
李慧貞
朴正訓
文常豪
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南韓商王冠醫療器公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0072Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus with application of electrical currents

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Abstract

本發明的低頻電刺激治療儀在預先設置的脈衝接通時間期間,以脈衝的振幅從脈衝峰值(Peak value)逐漸減小而達到0,且所述振幅的減小速度為逐漸減小的普利莫波形而輸出,從而可以更有效地使治療效果最大化。另外,陽極與陰極之間不發生短路,直接傳遞到人體內,從而可以校正人體病變部位的離子不均衡,無副作用地使細胞組織正常再生。 During the preset pulse on time, the low-frequency electrical stimulation treatment instrument of the present invention gradually decreases the amplitude of the pulse from the peak value to zero, and the rate of decrease of the amplitude is gradually reduced. Limo waveform is output, so that the treatment effect can be maximized more effectively. In addition, there is no short circuit between the anode and the cathode, and it is directly transmitted to the human body, so that the imbalance of ions in the diseased part of the human body can be corrected, and the cell tissue can be regenerated normally without side effects.

Description

具有普利莫波形的低頻電刺激治療儀 Low-frequency electrical stimulation treatment instrument with primo waveform

本發明涉及具有普利莫(Primo)波形的低頻電刺激治療儀,更詳細而言,涉及一種將脈衝輸出為普利莫波形而能夠使治療效果最大化的低頻電刺激治療儀。 The present invention relates to a low-frequency electrical stimulation treatment instrument with a Primo waveform. More specifically, it relates to a low-frequency electrical stimulation treatment instrument that outputs pulses as a Primo waveform to maximize the therapeutic effect.

以往的醫療用電治療儀利用直流(DC)、交流(AC)、脈動電流(PC)等,使用了物理治療儀(高頻、中頻、低頻)等。 Conventional medical electrical therapy devices used direct current (DC), alternating current (AC), pulsating current (PC), etc., and physical therapy devices (high frequency, intermediate frequency, low frequency), etc. were used.

但是,以往的電治療儀本身流出的陽極(+)和陰極(-)在同一電路中流出,彼此為親和型的相對關係,因而以人體為導體,引起短路作用。因此,與人體的疾病部位不具有授受關係,僅發揮電氣導體作用,無法去除疾病的原因物質。因此,作為以往的治療儀,除了基於熱或振動及刺激的暫時性物理效果之外,無法獲得其他效果,反而給人體帶來危險。 However, the anode (+) and cathode (-) flowing out of the conventional electrotherapy device itself flow out in the same circuit, and they are in an affinity-type relative relationship. Therefore, the human body is used as a conductor, which causes a short-circuit effect. Therefore, it does not have a relationship with the diseased parts of the human body. It only functions as an electrical conductor and cannot remove the causative substances of the disease. Therefore, as a conventional treatment device, in addition to the temporary physical effects based on heat, vibration and stimulation, no other effects can be obtained, and instead it is dangerous to the human body.

為了消除如上所述的問題,近來提出了單極治療儀,但這只使用電氣兩極中的單極,因而在人體內誘導單向變化,存在反而在人體組織與細胞內導致電位不均衡的缺點。 In order to eliminate the above-mentioned problems, a unipolar therapeutic device has recently been proposed, but this only uses the unipolar of the electrical two poles, which induces unidirectional changes in the human body, which has the disadvantage of causing an imbalance in the potential of human tissues and cells. .

為了消除這種缺點,韓國授權專利第10-0483970號申請了非短路陽極電治療儀,但在實際使用中發現少量的短路作用,因而能夠更安全地使用的電治療儀的必要性越來越高。 In order to eliminate this shortcoming, Korean Patent No. 10-0483970 applied for a non-short-circuit anode electrotherapy device, but a small amount of short-circuit effect was found in actual use, so there is an increasing need for an electrotherapy device that can be used more safely. high.

本發明目的在於提供一種能夠同時提高安全性與治療效果的具有普利莫(Primo)波形的低頻電刺激治療儀。 The purpose of the present invention is to provide a low-frequency electrical stimulation therapeutic instrument with Primo waveform that can simultaneously improve safety and therapeutic effect.

本發明的低頻電刺激治療儀作為接觸人體並對接觸部位施加低頻電刺激的低頻電刺激治療儀,其中,為了施加所述電刺激而輸出的脈衝的波形在脈衝周期中,在預先設置的脈衝接通(ON)時間期間,以振幅從脈衝峰值(Peak value)逐漸減小而達到0且所述振幅的減小速度為逐漸減小的普利莫波形而輸出。 The low-frequency electrical stimulation treatment instrument of the present invention is used as a low-frequency electrical stimulation treatment instrument that contacts the human body and applies low-frequency electrical stimulation to the contact part, wherein the waveform of the pulse output for applying the electrical stimulation is in the pulse period and is set in advance. During the ON time, the amplitude is gradually reduced from the pulse peak value (Peak value) to reach 0, and the amplitude of the reduction speed is gradually reduced, and output is a primordial waveform.

所述脈衝周期為2至3.5ms,所述脈衝接通時間為5至100μs。 The pulse period is 2 to 3.5 ms, and the pulse on-time is 5 to 100 μs.

所述脈衝峰值為400至1500V。 The peak value of the pulse is 400 to 1500V.

所述脈衝包括藉由陽極變壓器和陽極整流電路輸出的陽極脈衝、藉由陰極變壓器和陰極整流電路輸出的陰極脈衝。 The pulse includes an anode pulse output by an anode transformer and an anode rectifier circuit, and a cathode pulse output by a cathode transformer and a cathode rectifier circuit.

本發明另一方面的低頻電刺激治療作為接觸人體並對接觸部位施加低頻電刺激的低頻電刺激治療儀,其中,為了施加所述電刺激而輸出的脈衝的波形在脈衝周期中,在預先設置的脈衝接通(ON)時間期間,以振幅從脈衝峰值(Peak value)逐漸減小而達到0且所述振幅的減小速度為逐漸減小的普利莫波形而輸出,所述脈衝周期為2至3.5ms,所述脈衝接通時間為5至100μs,所 述脈衝峰值為400至1500V,所述脈衝包括藉由陽極變壓器和陽極整流電路輸出的陽極脈衝、藉由陰極變壓器和陰極整流電路輸出的陰極脈衝。 Another aspect of the present invention is low-frequency electrical stimulation therapy as a low-frequency electrical stimulation therapy device that contacts the human body and applies low-frequency electrical stimulation to the contact site, wherein the waveform of the pulse output for applying the electrical stimulation is set in advance in the pulse period During the ON time of the pulse, the amplitude is gradually reduced from the peak value (Peak value) to reach 0, and the amplitude of the reduction speed is gradually reduced, and the pulse period is 2 to 3.5 ms, the pulse on time is 5 to 100 μs, so The pulse peak value is 400 to 1500V, and the pulse includes an anode pulse output by an anode transformer and an anode rectifier circuit, and a cathode pulse output by a cathode transformer and a cathode rectifier circuit.

本發明的低頻電刺激治療儀在預先設置的脈衝接通時間期間,以脈衝的振幅從脈衝峰值(Peak value)逐漸減小而達到0且所述振幅的減小速度為逐漸減小的普利莫波形而輸出,從而可以更有效地使治療效果最大化。 During the preset pulse on time, the low-frequency electrical stimulation therapeutic apparatus of the present invention gradually decreases the amplitude of the pulse from the peak value of the pulse to reach 0, and the rate of decrease of the amplitude is gradually reduced. It is output in a waveform, which can more effectively maximize the treatment effect.

另外,陽極與陰極之間不發生短路,直接傳遞到人體內,從而可以校正人體病變部位的離子不均衡,無副作用地使細胞組織正常再生。 In addition, there is no short circuit between the anode and the cathode, and it is directly transmitted to the human body, so that the imbalance of ions in the diseased part of the human body can be corrected, and the cell tissue can be regenerated normally without side effects.

10:普利莫波形輸出部 10: Primo Waveform Output Section

11:陽極普利莫波形輸出器 11: Anode Primo Waveform Exporter

12:陰極普利莫波形輸出器 12: Cathode Primo Waveform Exporter

70:脈衝發生部 70: Pulse generator

OUT1:陽極輸出端子 OUT1: anode output terminal

OUT2:陰極輸出端子 OUT2: cathode output terminal

P1:第一脈衝 P1: first pulse

P2:第二脈衝 P2: second pulse

R1:陽極整流器 R1: anode rectifier

R2:陰極整流器 R2: Cathode rectifier

T:脈衝周期 T: pulse period

T1:陽極變壓器 T1: Anode transformer

T2:陰極變壓器 T2: Cathode transformer

t:時間 t: time

t1:第一時間點 t1: the first point in time

t2:第二時間點 t2: second time point

ton:脈衝接通時間 t on : pulse on time

V:振幅 V: amplitude

VP:脈衝峰值 V P : Pulse peak value

θ 1:第一傾斜度 θ 1: the first inclination

θ 2:第二傾斜度 θ 2: second inclination

圖1是顯示本發明實施例的具有普利莫波形的低頻電刺激治療儀的電路圖的圖。 Fig. 1 is a diagram showing a circuit diagram of a low-frequency electrical stimulation treatment instrument with a primordial waveform according to an embodiment of the present invention.

圖2是顯示本發明實施例的具有普利莫波形的低頻電刺激治療儀的脈衝的普利莫波形的圖。 Fig. 2 is a diagram showing the primo waveform of the pulse of the low-frequency electrical stimulation treatment instrument with primo waveform according to the embodiment of the present invention.

下面參照附圖,對本發明的實施例進行說明。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.

本發明實施例的低頻電刺激治療儀是接觸人體的肩膀、背、腰等,對接觸部位施加低頻電刺激而治療接觸部分的設備。 The low-frequency electrical stimulation therapeutic apparatus of the embodiment of the present invention is a device that contacts the shoulder, back, waist, etc. of the human body, and applies low-frequency electrical stimulation to the contact part to treat the contact part.

圖1是顯示本發明實施例的具有普利莫波形的低頻電刺激治療儀的電路圖的圖。 Fig. 1 is a diagram showing a circuit diagram of a low-frequency electrical stimulation treatment instrument with a primordial waveform according to an embodiment of the present invention.

如果參照圖1,本發明實施例的具有普利莫波形的低頻電刺激治療儀包括脈衝發生部70、將所述脈衝發生部70發生的脈衝輸出為具有普利莫波形的脈衝的普利莫波形輸出部10。 If referring to FIG. 1, the low-frequency electrical stimulation treatment apparatus with a primordial waveform according to an embodiment of the present invention includes a pulse generator 70, and a primordial pulse generator that outputs the pulses generated by the pulse generator 70 as pulses with a primordial waveform. Wave output unit 10.

所述脈衝包括從彼此獨立的電路分別輸出的陽極脈衝和陰極脈衝。 The pulses include anode pulses and cathode pulses respectively output from circuits independent of each other.

所述脈衝發生部70包括:放大電路(圖上未示出),所述放大電路將藉由CPU(圖上未示出)接受輸入的頻率發生訊號放大為既定水平;電晶體電路(圖上未示出),所述電晶體電路連接於所述放大電路(圖上未示出)並發生脈衝。 The pulse generator 70 includes: an amplifying circuit (not shown in the figure) that amplifies the frequency generating signal received by the CPU (not shown in the figure) to a predetermined level; a transistor circuit (not shown in the figure) (Not shown), the transistor circuit is connected to the amplifying circuit (not shown in the figure) and pulses are generated.

所述普利莫波形輸出部10包括:陽極普利莫波形輸出器11,所述陽極普利莫波形輸出器11接受輸入所述脈衝發生部70發生的第一脈衝P1,輸出為普利莫波形的陽極脈衝;陰極普利莫波形輸出器12,所述陰極普利莫波形輸出器12接受輸入所述脈衝發生部70發生的第二脈衝P2,輸出為普利莫波形的陰極脈衝。 The primordial waveform output unit 10 includes: an anode primordial waveform outputter 11, which receives the first pulse P1 generated by the pulse generator 70 and outputs it as primordial The anode pulse of the waveform; the cathode primordial waveform output device 12, the cathode primordial waveform output device 12 receives and inputs the second pulse P2 generated by the pulse generator 70, and outputs the cathode pulse of the primordial waveform.

所述陽極普利莫波形輸出器11包括:陽極變壓器T1,所述陽極變壓器T1接受輸入所述脈衝發生部70發生的第一脈衝P1並將其變換為交流;陽極整流電路(Rectifier circuit)R1,所述陽極整流電路R1將從所述陽極變壓器T1出來的+、-交流訊號變換成具有一種極性的+訊號。 The anode primordial waveform output device 11 includes: an anode transformer T1, the anode transformer T1 receives and inputs the first pulse P1 generated by the pulse generator 70 and converts it into alternating current; an anode rectifier circuit R1 The anode rectifier circuit R1 transforms the + and-AC signals from the anode transformer T1 into a + signal with one polarity.

如果參照圖2,所述陽極普利莫波形輸出器11輸出的陽極脈衝的波形是在脈衝周期T中,在預先設置的脈衝接通(ON)時間ton期間,振幅V從脈衝峰值(Peak value)Vp逐漸減小而達到0,且所述振幅V的減小速度逐漸減小的波形。 If referring to FIG. 2, the waveform of the anode pulse output by the anode primordial waveform output device 11 is in the pulse period T. During the preset pulse ON time t on , the amplitude V changes from the peak value) A waveform in which V p gradually decreases to reach 0, and the decreasing speed of the amplitude V gradually decreases.

對所述波形的切線傾斜度小於0,隨著時間t逐漸增加。例如,可知第二時間點t2的切線的第二傾斜度tan(θ 2),比第一時間點t1的切線的第一傾斜度tan(θ 1)增加。 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 second inclination tan (θ 2) of the tangent at the second time point t2 is greater than the first inclination tan (θ 1) of the tangent at the first time point t1.

這種波形是不同於原有方波(Square wave)或正弦波(Sine wave)形狀的波形,定義為普利莫波形(普利莫waveform)。所述普利莫波形為向下凸出的曲線形狀。 This waveform is different from the original square wave or sine wave, and is defined as a primo waveform. The primordial waveform is a downwardly convex curved shape.

所述陽極脈衝的脈衝周期T為2至3.5ms,所述陽極脈衝的脈衝接通時間ton為5至100μs,所述陽極脈衝的脈衝峰值Vp為400至1500V。 The pulse period T of the anode pulse is 2 to 3.5 ms, the pulse on time t on of the anode pulse is 5 to 100 μs, and the pulse peak value V p of the anode pulse is 400 to 1500V.

所述陽極脈衝輸出時最初振幅與峰值相應,在所述陽極脈衝持續的所述脈衝接通時間期間,所述脈衝的振幅從所述峰值逐漸減小而達到0。所述脈衝的振幅減小時的減小速度逐漸減小。在經過所述脈衝接通時間後,振幅為0。 When the anode pulse is output, the initial amplitude corresponds to the peak value, and during the pulse on time during which the anode pulse lasts, the amplitude of the pulse gradually decreases from the peak value to zero. The rate of decrease when the amplitude of the pulse decreases gradually decreases. After the pulse on time has elapsed, the amplitude is zero.

所述陽極普利莫波形輸出器11連接有輸出所述陽極脈衝的陽極輸出端子OUT1。 The anode primordial waveform output device 11 is connected to an anode output terminal OUT1 that outputs the anode pulse.

所述陰極普利莫波形輸出器12包括:陰極變壓器T2,所述陰極變壓器T2接受輸入所述脈衝發生部70發生的第二脈衝P2並將其變換成交流;陰極整流電路(Rectifier circuit)R2,所述陰極整流電路R2將從所述陰極變壓器T2出來的+、-交流訊號變換成具有一種極性的-訊號。 The cathode primordial waveform output device 12 includes: a cathode transformer T2, which receives and inputs the second pulse P2 generated by the pulse generator 70 and converts it into alternating current; a cathode rectifier circuit R2 The cathode rectifier circuit R2 transforms the + and-AC signals from the cathode transformer T2 into a-signal with one polarity.

所述陰極普利莫波形輸出器12輸出的陰極脈衝的波形與所述陽極脈衝的波形相同。 The waveform of the cathode pulse output by the cathode primordial waveform output device 12 is the same as the waveform of the anode pulse.

如果參照圖2,所述陰極脈衝的波形是在脈衝周期中,在預先設置的脈衝接通(ON)時間期間,振幅從脈衝峰值(Peak value)逐漸減小而達到0,且所述振幅的減小速度為逐漸減小的普利莫波形。 If referring to Figure 2, the waveform of the cathode pulse is in the pulse period. During the pre-set pulse ON time, the amplitude gradually decreases from the peak value of the pulse to 0, and the amplitude is The decreasing speed is a gradually decreasing primo waveform.

對所述波形的切線的傾斜度小於0,隨著時間t而逐漸增加。例如,可知第二時間點t2的切線的第二傾斜度tan(θ 2)比第一時間點t1的切線的第一傾斜度tan(θ 1)增加。 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 second inclination tan(θ 2) of the tangent at the second time point t2 is greater than the first inclination tan(θ 1) of the tangent at the first time point t1.

所述陰極脈衝的脈衝周期T為2至3.5ms,所述陰極脈衝的脈衝接通時間ton為5至100μs,所述陰極脈衝的脈衝峰值Vp為400至1500V。 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.

所述陰極脈衝輸出時最初振幅與峰值相應,在所述陰極脈衝持續的所述脈衝接通時間期間,所述脈衝的振幅從所述峰值逐漸減小而達到0。所述脈衝的振幅減小時的減小速度逐漸減小。在經過所述脈衝接通時間後,振幅為0。 When the cathode pulse is output, the initial amplitude corresponds to the peak value, and during the pulse on time during which the cathode pulse lasts, the amplitude of the pulse gradually decreases from the peak value to zero. The rate of decrease when the amplitude of the pulse decreases gradually decreases. After the pulse on time has elapsed, the amplitude is zero.

所述陰極普利莫波形輸出器12連接有輸出所述陰極脈衝的陰極輸出端子OUT2。 The cathode primordial waveform output device 12 is connected to a cathode output terminal OUT2 that outputs the cathode pulse.

所述陽極脈衝和陰極脈衝同時輸出。 The anode pulse and the cathode pulse are output at the same time.

在如上所述構成的本發明的實施例中,所述陽極脈衝和所述陰極脈衝從互不影響的獨立的電路輸出。因此,陽極與陰極之間不出現短路,直接傳遞給人體,從而可以校正人體病變部位的離子不均衡,使細胞組織正常再生。 In the embodiment of the present invention constructed as described above, the anode pulse and the cathode pulse are output from independent circuits that do not affect each other. Therefore, there is no short circuit between the anode and the cathode, and it is directly transmitted to the human body, thereby correcting the imbalance of ions in the diseased parts of the human body and allowing the normal regeneration of cell tissues.

另外,所述陽極脈衝和所述陰極脈衝分別輸出為所述普利莫波形,從而可以提高治療效果。 In addition, the anode pulse and the cathode pulse are respectively output as the primo waveform, so that the therapeutic effect can be improved.

為了瞭解本發明的具有普利莫波形的低頻電刺激治療儀的效果而如下進行實驗。 In order to understand the effect of the low-frequency electrical stimulation treatment device with a primordial waveform of the present invention, experiments were conducted as follows.

<實驗例> <Experimental example>

- 年齡:55周歲以上 -Age: 55 years old and above

- 人員:55名 -Personnel: 55

- 期間:4周 -Duration: 4 weeks

- 對象:失眠症持續6個月以上且藥物治療中的患者 -Target: Patients whose insomnia lasts for more than 6 months and are under medication

- 方法:每週5天以上,在失眠症相關藥物服用時間30分鐘前,使用低頻電刺激治療儀既定時間,應用於肩膀和頸部。 -Method: More than 5 days a week, 30 minutes before the insomnia-related medicine is taken, use a low-frequency electrical stimulation treatment device for a predetermined time and apply it to the shoulder and neck.

一天平均使用時間(min)為40.4±8.92,總使用天數(day)為23.5±3.81,總使用時間(min)為959.5±302.37,平均電流強度為1.3mA以內。 The average use time per day (min) is 40.4±8.92, the total use days (day) is 23.5±3.81, the total use time (min) is 959.5±302.37, and the average current intensity is within 1.3mA.

所述陽極脈衝和所述陰極脈衝的各脈衝周期為2.5ms,所述陽極脈衝和所述陰極脈衝的各脈衝接通時間為100μs以內,所述陽極脈衝和所述陰極脈衝的各脈衝峰值為900V,以如上條件進行實驗。 The pulse period of each of the anode pulse and the cathode pulse is 2.5 ms, the on-time of each pulse of the anode pulse and the cathode pulse is within 100 μs, and the peak value of each pulse of the anode pulse and the cathode pulse is 900V, the experiment was carried out under the above conditions.

在共55名標本中,同意退出6名(使用設備,存在皮膚相關不便),失眠惡化2名,低血糖症1名,疲勞感1名,死亡1名(與設備使用無關的墜亡事故),上述樣本中途放棄,針對44名測量了有效性分析指標。 Of the 55 specimens in total, 6 agreed to withdraw (the use of equipment, there was skin-related inconvenience), 2 had worsening of insomnia, 1 had hypoglycemia, 1 had fatigue, and 1 died (accidents related to the use of equipment) , The above sample gave up halfway and measured the effectiveness analysis index for 44 people.

在睡眠日記和問卷調查中,各受試者在各自的夜間電刺激時間的次日早晨完成睡眠日記。對日記的檢查目錄包括睡眠潛伏期、臥床時間、睡眠遲延、TENS的使用強度和期間、藥物服用量。測量了睡眠品質(Pittsburgh Sleep Quality Index:PSQI)、白天嗜睡症(Epworth sleepiness scale:ESS)、失眠症嚴重度(Insomnia Severity Index:ISI)的有效性分析指標,還確認了包括血壓和心率在內的生命體征,由於個人的情緒或疼痛狀態會對失眠症症狀產生影響,因而還測量了焦慮抑鬱評估量表(HADS)和數值評估量表(NRS),測量結果如表1所示。 In the sleep diary and questionnaire survey, each subject completed the sleep diary on the morning of the next day after their nighttime electrical stimulation time. The checklist of the diary includes sleep latency, bed time, sleep delay, the intensity and duration of TENS use, and the amount of medication taken. The effectiveness of sleep quality (Pittsburgh Sleep Quality Index: PSQI), daytime narcolepsy (Epworth sleepiness scale: ESS), and insomnia severity (Insomnia Severity Index: ISI) was measured. It was also confirmed that blood pressure and heart rate were included. Because the individual’s mood or pain state will affect the symptoms of insomnia, the anxiety and depression assessment scale (HADS) and the numerical evaluation scale (NRS) were also measured. The measurement results are shown in Table 1.

Figure 109110092-A0305-02-0009-3
Figure 109110092-A0305-02-0009-3
Figure 109110092-A0305-02-0010-4
Figure 109110092-A0305-02-0010-4

如表1所示,在最後分析的44名中,睡眠品質(從PSQI=12.42±3.73變為11.0±3.71,P=0.001)和失眠症嚴重度(從ISI=13.88±7.23變為12.10±6.08,P=0.004)在實驗後顯著減小。 As shown in Table 1, in the last 44 people analyzed, sleep quality (from PSQI=12.42±3.73 to 11.0±3.71, P=0.001) and insomnia severity (from ISI=13.88±7.23 to 12.10±6.08) , P=0.004) significantly decreased after the experiment.

標本中6名患者在治療後,苯二氮平類藥物服用量減少,23名患者表現出治療反應(57.5%響應率)。比較治療組及非治療組的睡眠日記中出現的睡眠變數的變化,睡眠等待時間減少(從44.46±26.9分變為30.26±17.55,p<0.001,Cohen's d=0.625),睡眠時間增加(從308.7±82.2變為347±77.66分,p=0.001,Cohen's d=0.479)。治療預測了ESS分數基線增加和HADS分數基線增加。兩個分數均是調整了年齡、性別、其他精神疾病、失眠症病期、治療量與強度之後的。與非治療組(從13.7±9.1變為14.5±11.9)相比,治療組的後腦區域的相對δ功率減小(從16.5±9.7變為10.9±8.9)。 After treatment, 6 patients in the specimens had reduced benzodiazepine dosages, and 23 patients showed treatment response (57.5% response rate). Comparing the changes in sleep variables in the sleep diaries of the treatment group and the non-treatment group, sleep waiting time decreased (from 44.46±26.9 minutes to 30.26±17.55, p<0.001, Cohen's d=0.625), and sleep time increased (from 308.7) ±82.2 becomes 347±77.66 points, p=0.001, Cohen's d=0.479). Treatment predicted a baseline increase in ESS scores and a baseline increase in HADS scores. Both scores are adjusted for age, gender, other mental illnesses, insomnia disease period, amount and intensity of treatment. Compared with the non-treatment group (from 13.7±9.1 to 14.5±11.9), the relative δ power of the hindbrain region of the treatment group decreased (from 16.5±9.7 to 10.9±8.9).

低頻電治療後睡眠等待時間及喚醒時間減小。另外,藉由會有助於失眠症治療相關改善的多導睡眠監測,發現了慢波形睡眠和總δ睡眠顯著增加。不同於δ在睡眠期間的積極作用,在諸如腦組織損傷及認知功能低下的多種病理學狀態下記錄了清醒時δ波增加。清醒狀態下的δ波一般顯示為因失眠症導致疲勞與精神倦怠的結果,在喚醒狀態下,相對δ功率出現顯著減少。這與失眠症程度的主觀性減少有關,在本實驗中,治療組與非治療組之間相對δ 功率減少的差異,可以視為喚醒狀態減小的δ功率是因使用低頻電刺激而產生的治療效果。 After low-frequency electric therapy, the sleep waiting time and wake-up time are reduced. In addition, polysomnography, which will help improve insomnia treatment-related improvement, has found a significant increase in slow wave sleep and total delta sleep. Different from the positive effect of δ during sleep, the increase of δ waves during wakefulness is recorded in various pathological conditions such as brain tissue damage and cognitive decline. The delta wave in the awake state is generally shown as the result of fatigue and mental fatigue due to insomnia. In the awake state, the relative delta power is significantly reduced. This is related to the subjective reduction of the degree of insomnia. In this experiment, the relative δ between the treatment group and the non-treatment group The difference in power reduction can be regarded as the reduced delta power in the arousal state due to the therapeutic effect produced by the use of low-frequency electrical stimulation.

積極的結果出現在使用20天以上、使用時間30~60分鐘、在斜方肌處以1mA以下實施的低頻電刺激中(平均137-138μA)。選擇給以刺激的部位與選擇電刺激的適宜時間和程度一樣重要。特別是確認了斜方肌內頸神經的解剖學及功能性神經分佈,因此,對睡眠障礙的心理焦慮是上部斜方肌肌肉反應增加的強預測因數,因而失眠症患者在睡眠治療中接受肌肉放鬆治療時,一般觀察到斜方肌肌肉高度緊張,因此,優選對頸或肩膀部位進行低頻電刺激。 Positive results appeared in low-frequency electrical stimulation performed at the trapezius muscle at less than 1 mA (average 137-138 μA) after use for more than 20 days, use time for 30 to 60 minutes, and less than 1 mA. Choosing the site for stimulation is as important as choosing the appropriate time and degree of electrical stimulation. In particular, the anatomy and functional nerve distribution of the cervical nerves in the trapezius muscle have been confirmed. Therefore, psychological anxiety for sleep disorders is a strong predictor of the increase in the upper trapezius muscle response. Therefore, patients with insomnia receive muscles during sleep therapy. During relaxation therapy, high tension of the trapezius muscle is generally observed. Therefore, it is preferable to perform low-frequency electrical stimulation on the neck or shoulders.

利用低頻電刺激來緩解失眠症的機制作用,第一是電刺激對神經肌肉的效果。 Using low-frequency electrical stimulation to alleviate the mechanism of insomnia, the first is the effect of electrical stimulation on neuromuscular.

表面肌電圖在斜方肌與三角肌區域進行雙向記錄時,表現出具有諸如睡眠障礙的心理性問題的人,肌肉收縮增加。由於肌肉放鬆及提高睡眠品質的積極關係明確,因而肌肉中的低頻電刺激效果表現為肌肉擴張增加,腦源性麻痹患者的強直減少。另外,還具有提高血液供應、皮膚溫度、肌肉氧化功能,抑制炎症性細胞因數的效果。第二,低頻電刺激可以誘發大腦的神經生理學效果。 When the surface electromyography is recorded in both the trapezius and deltoid regions, it shows that people with psychological problems such as sleep disorders have 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 muscles is manifested as increased muscle expansion and decreased stiffness in patients with cerebral palsy. In addition, it also has the effect of improving blood supply, skin temperature, muscle oxidation function, and inhibiting inflammatory cytokine. Second, low-frequency electrical stimulation can induce neurophysiological effects in the brain.

在低頻電刺激治療後的比較中,觀察到PSQI、ISI顯著好轉,這顯示出低頻電刺激治療儀對失眠症的治療效果,藉由本發明低頻電刺激治療儀的低頻電刺激,在一半以上的慢性失眠症中,對減輕失眠症嚴重度有效,且無明顯副作用。另外,電刺激不僅有助於一些患者減少睡眠藥物使用,而且白天嗜睡症及抑鬱-焦慮度越高,效果越高。 In the comparison after low-frequency electrical stimulation treatment, PSQI and ISI were observed to improve significantly, which shows the therapeutic effect of the low-frequency electrical stimulation treatment instrument on insomnia. The low-frequency electrical stimulation of the low-frequency electrical stimulation treatment instrument of the present invention is more than half of the In chronic insomnia, it is effective in reducing the severity of insomnia without obvious side effects. In addition, electrical stimulation not only helps some patients reduce the use of sleep drugs, but the higher the degree of daytime narcolepsy and depression-anxiety, the higher the effect.

如上所述的本發明低頻電刺激治療儀不出現陽極(+)與陰極(-)之間的短路,使得直接傳遞到人體內,不僅校正人體病變部位的離子不均衡,對治療失眠症帶來幫助且無副作用,而且可以容易地附著於使用者的適當位置,使用兩極或多極,擴大治療範圍,與原有低頻治療儀相比,可以在更大範圍同時使用,縮短治療時間,根據患處狀態調節兩極或多極的量使用,因而具有可以使治療效果最大化的很有用的效果。 The low-frequency electrical stimulation treatment instrument of the present invention as described above does not have a short circuit between the anode (+) and the cathode (-), so that it is directly transmitted to the human body. It is helpful and has no side effects, and can be easily attached to the appropriate position of the user, using two or more poles to expand the treatment range. Compared with the original low-frequency treatment instrument, it can be used in a larger range at the same time, shortening the treatment time, according to the affected area The amount of state adjustment bipolar or multipolar is used, so it has a very useful effect that can maximize the therapeutic effect.

本發明以附圖中圖示的實施例為參考進行了說明,但這只不過是示例性,只要是所屬技術領域中具有通常知識者便會理解,可以由此變化出多樣的變形及等同的其他實施例。因此,本發明真正的技術保護範圍應由附帶的申請專利範圍的技術思想確定。 The present invention has been described with reference to the embodiments illustrated in the drawings, but this is only an example, as long as it is understood by those with ordinary knowledge in the technical field, various modifications and equivalents can be changed from this. Other embodiments. Therefore, the true technical protection scope of the present invention should be determined by the technical ideas of the attached patent application scope.

T:脈衝周期 T: pulse period

t:時間 t: time

t1:第一時間點 t1: the first point in time

t2:第二時間點 t2: second time point

ton:脈衝接通時間 t on : pulse on time

V:振幅 V: amplitude

VP:脈衝峰值 V P : Pulse peak value

θ 1:第一傾斜度 θ 1: the first inclination

θ 2:第二傾斜度 θ 2: second inclination

Claims (4)

一種具有普利莫(Primo)波形的低頻電刺激治療儀,該低頻電刺激治療儀接觸人體並對接觸部位施加低頻的一電刺激,其中,為了施加該電刺激而輸出的一脈衝的波形,在一脈衝周期中,在預先設置的一脈衝接通(ON)時間期間,以振幅從一脈衝峰值(Peak value)逐漸減小而達到0且所述振幅的減小速度為逐漸減小的普利莫波形而輸出;其中,該脈衝峰值為400至1500V。 A low-frequency electrical stimulation treatment instrument with a Primo waveform. The low-frequency electrical stimulation treatment instrument contacts the human body and applies a low-frequency electrical stimulation to the contact part, wherein the waveform of a pulse output for applying the electrical stimulation is In a pulse period, during a preset ON time of a pulse, the amplitude gradually decreases from a pulse peak value to zero, and the rate of decrease of the amplitude is gradually reduced. Limo waveform and output; among them, the pulse peak value is 400 to 1500V. 如請求項1所述的具有普利莫波形的低頻電刺激治療儀,其中,該脈衝周期為2至3.5ms,該脈衝接通時間為5至100μs。 The low-frequency electrical stimulation therapeutic apparatus with a primordial waveform according to claim 1, wherein the pulse period is 2 to 3.5 ms, and the pulse on-time is 5 to 100 μs. 如請求項1所述的具有普利莫波形的低頻電刺激治療儀,其中,該脈衝包括藉由一陽極變壓器和一陽極整流電路輸出的一陽極脈衝、藉由一陰極變壓器和一陰極整流電路輸出的一陰極脈衝。 The low-frequency electrical stimulation therapy device with a primordial waveform according to claim 1, wherein the pulse includes an anode pulse output by an anode transformer and an anode rectifier circuit, and an anode pulse output by a cathode transformer and a cathode rectifier circuit. A cathode pulse output. 一種具有普利莫波形的低頻電刺激治療儀,該低頻電刺激治療儀接觸人體並對接觸部位施加低頻的一電刺激,其中,為了施加該電刺激而輸出的一脈衝的波形,在一脈衝周期中,在預先設置的一脈衝接通(ON)時間期間,以一振幅從該脈衝峰值(Peak value)逐漸減小而達到0且該振幅的減小速度逐漸減小的波形而輸出,該脈衝周期為2至3.5ms,該脈衝接通時間為5至100μs,該脈衝峰值為400至1500V, 該脈衝包括藉由一陽極變壓器和一陽極整流電路輸出的一陽極脈衝、藉由一陰極變壓器和一陰極整流電路輸出的一陰極脈衝。 A low-frequency electrical stimulation treatment instrument with a primordial waveform. The low-frequency electrical stimulation treatment instrument contacts the human body and applies a low-frequency electrical stimulation to the contact part, wherein the waveform of a pulse output for applying the electrical stimulation is a pulse In the cycle, during a preset ON time of a pulse, output as a waveform whose amplitude gradually decreases from the pulse peak value (Peak value) to reach 0 and the rate of decrease of the amplitude gradually decreases. The pulse period is 2 to 3.5 ms, the pulse on-time is 5 to 100 μs, and the pulse peak value is 400 to 1500V. The pulse includes an anode pulse output by an anode transformer and an anode rectifier circuit, and a cathode pulse output by a cathode transformer and a cathode rectifier circuit.
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