WO2018000650A1 - 一种用于辅助治疗炎性疼痛的穴位电刺激方法及装置 - Google Patents

一种用于辅助治疗炎性疼痛的穴位电刺激方法及装置 Download PDF

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WO2018000650A1
WO2018000650A1 PCT/CN2016/101462 CN2016101462W WO2018000650A1 WO 2018000650 A1 WO2018000650 A1 WO 2018000650A1 CN 2016101462 W CN2016101462 W CN 2016101462W WO 2018000650 A1 WO2018000650 A1 WO 2018000650A1
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electrical stimulation
frequency
wave
pulse generator
inflammatory pain
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PCT/CN2016/101462
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French (fr)
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周杰
方剑乔
梁宜
龚杰
庄晟坚
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浙江中医药大学
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/002—Using electric currents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/10—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy

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  • the present invention relates to an apparatus and method for analgesia, and more particularly to a method and apparatus for acupoint electrical stimulation for assisting in the treatment of inflammatory pain.
  • Pain is a complex subjective sensation caused by noxious stimuli. It is like a “double-edged sword”. On the one hand, it provides a warning signal when the body is threatened, and protects the tissue by promoting behavior and reflective defense. Injury is an indispensable protective function of the body; on the other hand, severe or long-term pain can cause physical dysfunction and psychological discomfort, which is a major clinical problem. Inflammatory pain is the most common type of pain in the clinic. For example, various arthritis, gout, and rheumatoid arthritis are all inflammatory pains.
  • Non-steroidal anti-inflammatory drugs for the treatment of inflammatory pain gold standards, such as commonly used futaline, fenbide, etc., but it will certainly cause serious gastrointestinal damage to patients, long-term use of painkillers to bring huge economic pressure on patients And serious physical injuries, and even major side effects such as gastrointestinal bleeding, can be life-threatening. Therefore, non-steroidal anti-inflammatory drugs targeting a single target do not solve clinical problems.
  • Percutaneous nerve electrical stimulation analgesia has been used abroad for more than half a century, domestic scientists combined it with the traditional Chinese medicine meridian points, invented the "percutaneous acupoint electrical stimulation" has a good analgesic effect.
  • the invention of the device outputs a specific pulse wave, which can solve these problems excellently.
  • the device combines the acupoint theory in traditional Chinese medicine to mobilize the endogenous opioid peptide mechanism to generate analgesic effect and inhibit the body.
  • the secretion of inflammatory substances is a safe and non-toxic side-effect, long-term use of analgesic health care equipment.
  • the object of the present invention is to overcome the shortcomings of the existing non-steroidal anti-inflammatory drugs, such as poor efficacy and large side reactions, and the existing electrical stimulators are ineffective, and most of them are not subject to strict scientific research and demonstration;
  • a combination of modern electronic technology and acupuncture theory of Chinese medicine, acupoint electrical stimulation device and acupoint electrical stimulation method for assisting analgesia for inflammatory pain For non-therapeutic purposes, a combination of modern electronic technology and acupuncture theory of Chinese medicine, acupoint electrical stimulation device and acupoint electrical stimulation method for assisting analgesia for inflammatory pain.
  • a method for acupoint electrical stimulation for assisting treatment of inflammatory pain adopts a sparse wave for electrical stimulation, and the magnitude of the current of the sparse wave is 0.1-50 mA.
  • the voltage is 0.1 ⁇ 4V; the current pulse frequency is 2/120Hz.
  • the wave width is 400 ⁇ s.
  • the frequency is 120Hz, the wave width is 100 ⁇ s, and the thinning and dense waves each last for 3 seconds.
  • An acupoint electrical stimulation device for assisting treatment of inflammatory pain, comprising a pulse generator and an electrode, wherein the pulse generator electrically stimulates the acupuncture point through the electrode; the pulse signal emitted by the pulse generator comprises a sparse wave, a dense wave
  • the current is 0.1 ⁇ 50mA
  • the voltage is 0.1 ⁇ 4V
  • the current pulse frequency is 2/120Hz
  • the wave width is 400 ⁇ s when the frequency is 2Hz
  • the wave width is 100 ⁇ s when the frequency is 120Hz
  • the acupoint electrical stimulation device further comprises a liquid crystal display connected to the pulse generator to display the current working frequency, the wave width and the remaining working time.
  • the device further includes a button group and a single chip microcomputer, wherein the button group is connected to the pulse generator through a single chip microcomputer, the button group includes a current enhancement button and a current reduction button, and the size of the stimulation current is adjusted, and the adjustment step is 1 mA. .
  • the device further includes a button group and a single chip microcomputer, wherein the button group is connected to the pulse generator through a single chip microcomputer, and the button group includes a timing button for setting an electrical stimulation time.
  • the invention has the beneficial effects that the invention is based on the theory of gate control and the mechanism of endogenous opioid peptide, and has been confirmed by experiments to have anti-inflammatory and analgesic effects, can significantly improve central endogenous opioid analgesic substances, and inhibit peripheral inflammation. factor. Studies have confirmed that the present invention can promote the secretion of ⁇ -endorphin and spinal enkephalin in the hypothalamus, inhibit the production of proinflammatory cytokines such as peripheral IL-1 ⁇ , help to alleviate inflammatory pain in patients, and reduce the application of painkilling drugs for patients.
  • the instrument solves the pain and provides intelligent operation, which can improve the quality of life of patients with pain.
  • FIG. 1 is a schematic structural view of an acupoint electrical stimulation device
  • FIG. 2 is a schematic view showing the connection of components of the acupoint electrical stimulation device
  • Figure 3 is a schematic view showing the connection of components of the acupoint electrical stimulation device
  • Figure 4 is a comparison of pain thresholds of CFA rats with different frequency electrical stimulation
  • Figure 5 is a comparison of ⁇ -endorphin content in the hypothalamus of CFA rats by pulsed electrical stimulation at different frequencies
  • Figure 6 is a comparison of enkephalin content in the hypothalamus of CFA rats by pulsed electrical stimulation at different frequencies
  • Figure 7 is a comparison of IL-1 ⁇ content in the foot of CFA rats by pulsed electrical stimulation at different frequencies.
  • the invention provides a non-therapeutic purpose, a combination of modern electronic technology and acupuncture theory of Chinese traditional medicine, an acupoint electrical stimulation device for assisting analgesia and acupoint electrical stimulation method. It has been proved by a large number of experiments that the specific pulse electrical stimulation method has a good effect on inflammatory pain.
  • the main feature is that the frequency of the bidirectional symmetric rectangular current pulse is 2/120 Hz, the frequency width is 400 ⁇ s when the frequency is 2 Hz, and the frequency is 120 Hz.
  • the wave width is 100 ⁇ s, and the sparse and dense waves each last for 3 seconds.
  • the above-mentioned acupoint electrical stimulation method has been proved to improve the analgesic effect of inflammatory pain in the rat experiment, which is superior to other similar instruments on the market. details as follows:
  • CFA Complete freund's adjuvant
  • the present invention also provides an acupoint electrical stimulation device, comprising a pulse generator and an electrode, wherein the pulse generator electrically stimulates the acupuncture point through the electrode; the pulse generator comprises a button group, and the output is selected through the button group
  • the electric pulse signal has a current of 0.1 to 50 mA and a voltage of 0.1 to 4 V; a bidirectional symmetric rectangular current pulse has a frequency of 2/120 Hz, and when the frequency is 2 Hz, the wavelength is 400 ⁇ s and the frequency is 120 Hz.
  • the wave width is 100 ⁇ s, and the thinning and dense waves each last for 3 seconds.
  • pulse generators generally include a single chip system and a constant current output circuit.
  • the single-chip computer system is the control core of the whole system. It can use STC industrial micro-controller.
  • the control system works according to normal requirements to control the output of different pulse signals.
  • the pulse signal can be adjusted through the button group.
  • the constant current output circuit is shown in Figure 3. .
  • the high-precision constant current source circuit can realize 0-4V voltage control 0-50mA current output, and adopts high-reliability operational amplifier OPA211 as the most constant current source output drive.
  • the low-impedance characteristics of the MOS transistor are particularly suitable for the constant current source output circuit, and the entire system is driven by an active amplifier.
  • the long-time operating temperature is small and the output is stable.
  • the circuit with higher output than the conventional triode output has high stability and high precision.
  • the above apparatus may further include a liquid crystal display connected to the pulse generator to display the current working frequency, the wave width, and the remaining working time.
  • the button group can set the output bidirectional symmetric rectangular current pulse with the frequency of 2/120Hz, the wave width is 400 ⁇ s when the frequency is 2Hz, the wave width is 100 ⁇ s when the frequency is 120Hz, and the thinning and the dense wave each last for 3 seconds. It can also include a current boost button and a current reduction button to adjust the amount of stimulation current in steps of 1 mA. A timing button is also included to set the electrical stimulation time.

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Abstract

一种用于辅助治疗炎性疼痛的穴位电刺激方法及装置，该方法是通过输出频率为2/120Hz的双向对称矩形脉冲电流，频率为2Hz时，波宽为400μs，频率为120Hz时，波宽为100μs，疏波和密波各持续3秒，针对炎性疼痛实现镇痛。实现该方法的装置包括脉冲发生器和电极，该方法能显著提高中枢内源性脑啡肽、β-内啡肽分泌，抑制外周IL-1β产生，起到抗炎镇痛作用，用利于减轻炎性疼痛，为患者自行使用仪器解决疼痛提供智能化操作，可以提高疼痛病人生活质量。

Description

一种用于辅助治疗炎性疼痛的穴位电刺激方法及装置 技术领域
本发明涉及一种用于镇痛的装置和方法，特别是涉及一种用于辅助治疗炎性疼痛的穴位电刺激方法及装置。
背景技术
疼痛是由伤害性刺激引起的一种复杂的主观感觉，它像一把“双刃剑”，一方面，它能提供躯体受到威胁时的警报信号，通过促使行为和反射性防御使组织免受伤害，是机体不可缺少的一种保护功能；另一方面，剧烈的或长期的疼痛会引起机体生理上的功能障碍和心理上的不适，是临床的一大难题。炎性疼痛是临床上最常见的疼痛类型，如各种关节炎、痛风、类风湿性关节炎等均属于炎性疼痛，可以说只要有炎症就有“炎性疼痛”。非甾体类抗炎药治疗炎症性疼痛的金标准，如常用的扶他林、芬必得等，但其必定会给患者造成严重的胃肠道损害，长期服用止痛药给患者带来巨大的经济压力和严重的身体伤害，甚至出现消化道出血等重大副作用，可危及生命。因此，针对单一靶点的非甾体类抗炎药并不能解决临床问题。经皮神经电刺激镇痛术国外已使用了半个多世纪，国内科学家把其与中医经络穴位组合在一起，发明了“经皮穴位电刺激”具有很好的镇痛作用。它对局部疼痛、全身疼痛、内脏痛等均有明显的治疗效果，并且具有起效快、疾病谱广、整体调节效应好、副作用少等优势，可用于治疗各种急慢性疼痛，这一多靶向性的疗法已成为国内外公认的主要绿色镇痛手段，是“绿色镇痛”的典型代表。本装置的发明输出特定的脉冲波，可以极好的解决这些问题，该装置结合我国传统医学中的穴位理论，通过电刺激穴位调动人体内源性阿片肽机制来产生镇痛效应，并抑制体内炎性物质分泌，是一种安全无毒副反应、可长期使用的镇痛保健仪器。
发明内容
本发明的目的在于：克服现有非甾体类抗炎药疗效不佳、副反应大等不足，现有电刺激器疗效不确切，大多未经严格的科学研究论证等缺陷；从而提供一种非治疗目的的，将现代电子技术与我国中医的针灸理论相结合的，针对炎性疼痛进行辅助镇痛的穴位电刺激装置和穴位电刺激方法。
本发明的目的是通过以下技术方案实现的：一种用于辅助治疗炎性疼痛的穴位电刺激方法，该方法该方法采用疏密波进行电刺激，疏密波的电流大小为0.1～50mA，电压大小为0.1～4V；电流脉冲的频率为2/120Hz，当频率为2Hz时，波宽为400μs，当频率为120Hz时，波宽为100μs，疏波和密波各持续3秒。
一种用于辅助治疗炎性疼痛的穴位电刺激装置，包括脉冲发生器和电极，脉冲发生器通过电极向穴位进行电刺激；所述脉冲发生器发出的脉冲信号包括疏密波，疏密波的电流大小为0.1～50mA，电压大小为0.1～4V；电流脉冲的频率为2/120Hz，频率为2Hz时，波宽为400μs，频率为120Hz时，波宽为100μs，疏波和密波各持续3秒。
进一步地，所述穴位电刺激装置还包括液晶显示器，液晶显示器与脉冲发生器相连，显示当前工作的频率、波宽以及剩余工作时间。
进一步地，所述装置还包括按键组和单片机，所述按键组通过单片机与脉冲发生器相连，所述按键组包括电流增强按键和电流减小按键，调节刺激电流的大小，调节步长为1mA。
进一步地，所述装置还包括按键组和单片机，所述按键组通过单片机与脉冲发生器相连，所述按键组包括定时按钮，用于设定电刺激时间。
本发明的有益效果在于：本发明基于闸门控制学说及内源性阿片肽机制，并经实验证实确有抗炎镇痛功效，能显著提高中枢内源性阿片类镇痛物质，抑制外周致炎因子。研究证实本发明能促进下丘脑β-内啡肽、脊髓脑啡肽分泌，抑制外周IL-1β等致炎因子产生，有利于减轻患者炎性疼痛，减少患者止痛药物的应用，为患者自行使用仪器解决疼痛提供智能化操作，可以提高疼痛病人生活质量。
附图说明
图1为穴位电刺激装置的结构示意图；
图2为穴位电刺激装置的组件连接示意图；
图3为穴位电刺激装置的组件连接示意图；
图4为不同频率电刺激对CFA大鼠痛阈比较；
图5为不同频率脉冲电刺激对CFA大鼠下丘脑β-内啡肽含量的比较；
图6为不同频率脉冲电刺激对CFA大鼠下丘脑脑啡肽含量的比较；
图7为不同频率脉冲电刺激对CFA大鼠足跖IL-1β含量的比较。
具体实施方式
下面结合附图对本发明作进一步说明。
本发明提供一种非治疗目的的，将现代电子技术与我国中医的针灸理论相结合的，辅助镇痛的穴位电刺激装置和穴位电刺激方法。通过大量试验证明，该特定脉冲电刺激方法对炎性疼痛具有较好效果，主要特征为双向对称矩形电流脉冲的频率为2/120Hz，频率为2Hz时，波宽为400μs，频率为120Hz时，波宽为100μs，疏波和密波各持续3秒。上述穴位电刺激方法对提高炎性疼痛镇痛效果己在大鼠实验中得到证明，优于目前市面上其他同类仪器。具体如下：
采用SD大鼠，选用后足跖皮下注射(Complete freund’s adjuvant,CFA)，诱导经典的慢性炎性疼痛模型，将42只大鼠随机分为7组：正常组、模型组、2Hz电刺激组、100Hz电刺激组、120Hz电刺激组、2/100Hz电刺激组、2/120Hz电刺激组，脉冲电波宽设置如下：频率为2Hz时，波宽为400μs；频率为100Hz时，波宽为200μs；频率为120Hz时，波宽为100μs；疏密波各持续3s，电流1mA。选用足三里、昆仑穴，每次治疗30min，经过9天电刺激治疗，检测大鼠机械痛阈，经统计学分析结果显示2/120Hz组在第7、9天镇痛效果最好(均P<0.05)。所示结果参照图4，表1。
表1：不同频率电刺激对CFA大鼠痛阈比较
Figure PCTCN2016101462-appb-000001
进一步，经过9天电刺激治疗，处死大鼠，检测大鼠下丘脑β-内啡肽、脑啡肽，足跖IL-1β含量，结果显示以上5种脉冲电刺激治疗可明显提高炎性疼痛大鼠下丘脑β-内啡肽、脑啡肽含量，并抑制足跖IL-1β含量，与模型组比有统计学意义(P<0.05)。所示结果参照图5-7，表5。
表5 不同频率电刺激治疗对CFA大鼠相关指标的影响
Figure PCTCN2016101462-appb-000002
基于以上电刺激方法，本发明还提供了一种穴位电刺激装置，包括脉冲发生器和电极，脉冲发生器通过电极向穴位进行电刺激；所述脉冲发生器包括按键组，通过按键组选择输出的电脉冲信号，所述电脉冲信号的电流大小为0.1～50mA，电压大小为0.1～4V；双向对称矩形电流脉冲的频率为2/120Hz，频率为2Hz时，波宽为400μs，频率为120Hz时，波宽为100μs，疏波和密波各持续3秒。
作为本领域的公知常识，脉冲发生器一般包括单片机系统和恒流输出电路。单片机系统为整个系统的控制核心，可以采用STC工业微控制器，控制系统按照正常要求工作，来控制输出不同的脉冲信号，脉冲信号可以通过按键组进行调节，恒流输出电路如图3所示。该高精度恒流源电路可实现0-4V电压控制0-50mA电流输出，采用高可靠性运算放大器OPA211最为恒流源输出驱动。MOS管的低阻抗特性，特别适合恒流源输出电路中，且整个系统用有源放大器做为驱动，长时间工作温飘小，输出稳定。比传统的用三极管做输出的电路稳定性高，精度高。
上述装置还可以包括液晶显示器，液晶显示器与脉冲发生器相连，以显示当前工作的频率、波宽以及剩余工作时间。
按键组可以设置输出双向对称矩形电流脉冲，频率为2/120Hz，频率为2Hz时，波宽为400μs，频率为120Hz时，波宽为100μs，疏波和密波各持续3秒。还可以包括电流增强按键和电流减小按键，以调节刺激电流的大小，调节步长为1mA。还包括定时按钮，用于设定电刺激时间。

Claims (5)

  1. 一种用于辅助治疗炎性疼痛的穴位电刺激方法，其特征在于，该方法该方法采用疏密波进行电刺激，疏密波的电流大小为0.1～50mA，电压大小为0.1～4V；电流脉冲的频率为2/120Hz，当频率为2Hz时，波宽为400μs，当频率为120Hz时，波宽为100μs，疏波和密波各持续3秒。
  2. 一种用于辅助治疗炎性疼痛的穴位电刺激装置，其特征在于，包括脉冲发生器和电极，脉冲发生器通过电极向穴位进行电刺激；所述脉冲发生器发出的脉冲信号包括疏密波，疏密波的电流大小为0.1～50mA，电压大小为0.1～4V；电流脉冲的频率为2/120Hz，频率为2Hz时，波宽为400μs，频率为120Hz时，波宽为100μs，疏波和密波各持续3秒。
  3. 根据权利要求2所述的穴位电刺激装置，其特征在于，所述装置还可以包括液晶显示器，液晶显示器与脉冲发生器相连，显示当前工作的频率、波宽以及剩余工作时间。
  4. 根据权利要求2所述的穴位电刺激装置，其特征在于，所述装置还可以包括按键组和单片机，所述按键组通过单片机与脉冲发生器相连，所述按键组包括电流增强按键和电流减小按键，调节刺激电流的大小，调节步长为1mA。
  5. 根据权利要求2所述的穴位电刺激装置，其特征在于，所述装置还可以包括按键组和单片机，所述按键组通过单片机与脉冲发生器相连，所述按键组包括定时按钮，用于设定电刺激时间。
PCT/CN2016/101462 2016-06-28 2016-10-08 一种用于辅助治疗炎性疼痛的穴位电刺激方法及装置 WO2018000650A1 (zh)

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