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高电位治疗仪的研制

Design of High Electric Potential Therapy Equipment

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【Author in Chinese】 高铁旦

【Supervisor】 陈超敏

【Author's Information】 南方医科大学, 生物医学工程, 2013, 硕士

【Abstract in Chinese】 21世纪以来,人们的生活方式发生了很大的变化,生活压力越来越大,环境污染日益严重,同时我国的人口老龄化现象越来越严重,目前亚健康以及慢性疾病已成为公认的危害人们健康的重要原因。据统计,我国已有多达2.6亿人确诊为慢性病,给我国居民的健康和生命状况造成严重的威胁,也为患者和家庭带来了严重的经济负担。慢性病给人们带来的各种问题已经成为当前不可忽视的社会问题。人们对高电位疗法在医学临床上使用的探索已经有很长的历史,最早在18世纪中期在欧美的一些国家已经有较多学者研究高电位疗法,但是由于受到当时设备和技术等原因的限制,这种方法在当时受到了很大的限制。到了20世纪20年代后期,电子技术的各个领域都得到广泛的发展,一些日本科学家再次开始研究交流高压电位治疗仪,原敏之博士成功进行了人体实验,并且使用高电位治疗仪治疗人体的一些慢性疾病,这标志着高电位电疗法有了取得了重要突破。高压电位疗法就是在人体的周围产生一个交流的高压电场,将人体置于该电场中治疗。交流高压电位疗法又被一些学者称为交流高压电界疗法,是通过类似自然界电场原理,来影响人体的内循环调节,以达到对人体的多种疾病进行治疗的目的。该疗法具有多种生物物理特性:第一,带电物体的周围空间中存在电场,如果将导体放置在该电场中,则导体中的可移动电荷迅速向电场的两极移动,电荷在导体的两极聚集产生感应电荷。同样,人体属于导体,当将人体放置在高压电场中时,人体细胞膜的电位会发生改变,在机体中会产生大约0.1mA~0.2mA的微弱电流,该电流能够提升细胞的活力。第二,当人体处于高压电场中时,人体内的所含的带正、负离子电荷会发生一定的极性变化。离子会根据周围电场的方向重新做有规则的排列,体内的蛋白质会根据电场的方向附着在离子的各级,在体内发生一系列的生物效应。第三,高压电场可以使周围的空气电离,产生大量的空气离子,当患者接触到治疗电极的时候,空气中的离子流作用于皮肤,对人体产生一种类似于维西按摩刺激的反应。根据帕哈诺霍夫所做的实验研究以及临床试验,如果人体受到电风的作用,可以加快伤口的愈合,电风对于溃疡等也具有良好的治疗效果。第四,周围的空气在高压电场的作用下可以产生臭氧,使用者在使用高电位进行治疗的时候,周围的空气中会产生少量的臭氧,臭氧含量可达到0.0014~0.00148mg·L。少量臭氧可以刺激人体的植物神经,提高其兴奋性。进入呼吸系统的臭氧,会通过血液循环影响人体新陈代谢。此外,臭氧是一种非常不稳定的气体,当臭氧分解时会释放出一种氧化剂——活性氧,活性氧可以杀细菌,加速伤口的愈合。同时臭氧还能够提升血液中高氧化血红素的含量,提升其还原作用,增加血液中红细胞数量等。高电位疗法通过人体体液、内分泌、神经等系统作用于人体的各个系统、器官以及细胞组织,提升细胞活性,增强细胞膜的通透性,调节人体电解质平衡以及酸碱平衡,加强人体自然免疫力,提升机体自然自愈能力,修复机体处于亚健康或者病变状态的组织细胞,最终达到改善和提高人体各系统和器官功能的目的。国内外的多种动物、人体试验以及多年来大量的临床实践表明,高电位疗法对于人体的多种慢性疾病有效。高电位治疗仪设备是将市电处理之后,输出高压治疗电场的一种设备。通常输出的高压电场为工频电场、中频电场和负电位电场。本文中所设计的高电位治疗仪输出为工频电场。本文中高电位治疗仪以AVR单片机ATmega1280-16AU作为控制器,该芯片具有128KB的Flash空间,86个通用Ⅰ/0接口,以及丰富的其它片上资源,工作速度快,性能优越。采用芯片T6963C驱动的24064点阵显示屏作为人机交互界面,驱动方便,成本低。高电位治疗仪的客户群面向中老年人,故机器采用按键作为控制输入方式。光线的强弱对于使用者观察显示屏有很大的影响,机器采用采用光线传感器,实时探测周围光线的强弱,当外界光线比较明亮时,机器自动调亮显示屏的背光;反之亦然。此外,机器配有红外遥控器,方便使用者在一定的距离之内操作机器。该设备共有全身、局部两个输出口,有全身、局部、睡眠、固定等四种治疗模式,配有绝缘垫、电子笔、睡眠垫、高压导线、通电垫、脚踏板等配件。其中绝缘垫是将人体与大地以及周围的导体隔离开来,使人体处于绝缘状态,加在人体上的高压电只会产生很微弱的电流。电子笔、睡眠垫与设备的局部输出口连接使用,电子笔与局部治疗模式配合使用,睡眠垫与睡眠模式配合使用。通电垫和脚踏板通过高压导线与设备的全身输出口连接,与全身、固定治疗模式配合使用。使用全身治疗模式输出时,设备具有负峰值3000V、7000V、9000V、14000V等四种输出电压选择,每种输出电压有四种输出波形可以选择,治疗时间有15分、30分、45分、60分可供选择,每5分钟自动循环切换组合,根据治疗时间的不同每次全身治疗模式有三种或者四种组合,每种组合为四种输出电压之一和四种输出波形之一的输出组合。局部治疗模式输出时,设备具有负峰值1100V、1700V、2100V等三种输出电压选择,每种输出电压有三种输出波形,治疗时间固定为15分钟。使用局部治疗模式输出时,根据选择的输出电压每5分钟自动切换输出波形。使用睡眠治疗模式输出时,输出电压固定为负峰值1100V,治疗时间为15分钟至8个小时可调,根据治疗时间的不同,每5分钟自动循环切换输出波形。固定治疗输出模式与全身模式比较相似,具有相同的输出电压和输出波形,但是按照编程时设定好的组合方式自动每5分钟循环切换组合,治疗时间固定为60分钟。按照国家医疗器械注册管理分类,高电位治疗仪属于Ⅲ类医疗设备。为了防止使用者接触带电设备时造成电击的危险,通常采用多种安全措施。如果该措施不仅仅是设备的外壳和带电部分之间的基本绝缘,而且将外壳通过保护接地导线和家庭或其他场所的固定地线相连接,就认为此种设备属于Ⅰ类设备:如果设备上面,使用者可以接触到的外壳没有与场所中的地线连接,但是外壳和带电部分之间的绝缘不是基本绝缘,而是比基本绝缘防电击能力更强的加强绝缘或者双重绝缘,就认为该设备属于Ⅱ类设备。本文中所设计的高电位治疗仪设备按照对电击的防护分类属于Ⅰ类设备。高电位治疗仪为医疗设备的一种,由于它本身的特殊性,在设计产品以及说明书时需要注意设备的特性。在说明书中严格限定了设备的使用范围、使用方式、使用对象。使用时使用者必须处于绝缘的状态;如果身体内植入了其他的电子医疗设备,则不可以使用高电位治疗仪;身体有严重异常的患者应该咨询医生的意见以确认是否可以使用该设备。由于电位治疗仪的实际治疗电压受环境等因素的影响,如电极的大小、位置、距离、空气中的湿度等的影响,所以实际检测时都用输出开路时的电压作为该设备性能的度量。由于高电位治疗仪的电压比较高,综合考虑设备的安全性、有效性、性能以及成本控制,认为设备的输出电压和输出频率误差不大于±10%即为合格。设备的治疗原理是在人体身上施加高的交流电压,以在人体周围产生高压交流电场。虽然设备要求使用者在绝缘的状态下使用,还是需要避免在使用者无意识使自己处于非绝缘状态下时发生危险。这样就需要设备的输出能量,为了保障患者的安全在输出电路回路中串入了13MΩ的保护阻抗网络,严格限制短路电流的值,保证意外短路接地时使用者的安全。为了更好的杜绝使用者意外接地的危险,该设备时刻监控设备的输出电流,在输出电流大于设定的阈值的时候,自动切换输出并且报警提示,配合保护阻抗网络更好的保证使用者的安全。通过实验和验证,本文中设计的高电位治疗仪设备符合预期设计的技术指标,也符合相关标准的要求。为了配合产品实际生产、检测以及注册的需要,制定了与之相适应的产品标准和临床方案,通过了相关工作者的审核和认可。在本文的最后,我们对该高电位治疗仪设备的相关工作进行了讨论,并对今后的工作进行了展望。

【Abstract】 With the lifestyle changing, the pressure of living increasing, the state of environment declining, as well as our population aging, sub-health and chronic diseases have become recognized as the important reasons that harm people’s health. According to statistics, the number of the patients with chronic diseases in china has arrived at260million. It is not only a serious threat to the health and lives of the residents, but also a heavy economic burden of the patients and their family, becoming an ignored current social problem.High potential therapy applied in clinical medicine has a long history, as early as the18th century in some countries of the Europe and the United States, which was restricted latter, due to the equipment and technology. In the later of1920s, Dr.Yuan Minzi, a Japanese scientist, set out to study the Ac high voltage potential therapeutic apparatus and succeeded with the body load experiment which made some patients with chronic disease got effective treatment, marking this ancient electric therapy had been a remarkable development. The whole body is in an AC high voltage electric field during high potential therapy to produce a therapeutic effect on the human body. The Ac high potential therapy has also been referred to as a high voltage therapy in Ac electricity, which is similar to the nature electric field to influence the physiological functions of the human body (especially the function of the nervous system and the metabolic system), achieving the therapeutic purposes.It possesses of many biophysical properties:First, there exists an electric field around the object with charges. The free charges of a conductor placed in a potential field move quickly to the two poles of the electric field, so that the conductor ends to induced charge. When the human body is under the high potential in the field of the high voltage potential, the membrane potential of the body is changed and the organization produce weak current with0.1~0.2mA, making part of the charged cells with sufficient vigor. Second, the dipolar molecules with negative or positive charges will change in polarity in the electrolyte, when the body in the field of high voltage potential. The dipole arranged regularly again according to the direction of the positive polarity attracting each other, while they originally arranged messily. The protein in the body fluids will be oriented to the direction of the electric field and the polarization charges are added to its respective zwitterionic pole (induced dipoles), then the charges in whole body will be increased, thereby generating a series of biological effect. Third, the air produce a large amount of air ions due to the high voltage potential filed. Patient can feel good as the breeze is winding around him, which is a similar subtle air ion flow sensor to the skin massage stimulation reactions. According to Paharohauf" study and the clinical experiments, we discovered that the electric wind have a good effect on the slow-healing wounds and ulcers, when they are partially subjected to wind. Forth, the air produce ozone due to the high voltage potential filed. The ozone content in the air that patient breathe is0.0014~0.00148mg·L during the high potential therapy. As we all know, ozone can irritate strongly the neural system. It not only effects on the respiratory system but also on the electricity and gas metabolism etc through the blood circulation. Ozone is an unstable gas, easily reduced to release the active oxygen, is an oxidizing agent, and contributes to the sterilization and promotes the wound healing. Ozone can raise the blood levels of oxidized hemoglobin content and reduction, at the same time can increases the number of red blood cells in the blood.High potential therapy can increase the tissue cell viability and the cell membrane permeability, can adjust the fluid electrolyte and acid-base balance, strengthen the body’s natural immune system and improve the natural healing ability, repair the tissue cell in the sub-healthy or which has been diseased by acting on the various systems of the body such as the nervous system, endocrine system, the humoral-systemic etc, organs and tissue cells. Finally the human body system and organ function get improved and enhanced. It is proved that High Electrical Potential Therapy Equipment has curative effect on a variety of chronic diseases, through various animal and human experiments both in China and abroad, as well as years of clinical practice.High potential therapy equipment is one of treatment equipments owe to the high voltage electric field, including power frequency electric field, intermediate frequency electric field, and the negative potential electric field. The output of the high potential therapeutic apparatus in this article is the power frequency electric field.The high potential therapeutic apparatus in this paper takes ATmega1280-16AU AVR microcontroller as controller, which has128KB of Flash space,86general-purpose I/O interface, and a wealth of other on-chip resources, fast working, and superior performance.24064dot matrix display, as a man-machine interface, drivers chip T6963C. It is convenient to drive, as well as low-cost. Its customers base for the elderly, so the machine uses key as a control input. The intensity of light has a great impact for users to observe the display. The machine uses light sensor for real-time detection of the intensity of light around. The machine automatically brightens the backlight of the display; vice versa. In addition, the machine is equipped with an infrared remote control, which is convenient to the user to operate it within a certain distance.This device consists of systemic and local output ports, equipped with insulation pad, electronic pen, sleeping mats, high-voltage wire, electric fitting cushion, foot pedal. It has four treatment modes such as systemic mode, local mode, sleep mode and fixed mode. The Insulating pad segregates the human body from the earth, so that the body is insulated. The high voltage applied to the human body will only have a very weak current. The electronic pen and sleep pad are used in conjunction with local output port, while sleep pad is used with sleep mode and the electronic pen with local treatment mode. The electric fitting cushion and foot pad joint the systemic output port and are used in conjunction with the systemic mode and the fixed mode. When this device is in the state of systemic treatment model, it has a negative peak voltage selection from3000V,7000V,9000V,14000V. The four output waveforms of each output voltage can choose the treatment time of15minutes,30minutes,45points,60points. It automatically cycle through a combination of systemic treatment mode every5minutes. According to the different treatment time, there are three or four combinations while each combination is the combination of one of the four output voltages and the four output waveforms. When this device is in the state of local treatment model, its negative peak of voltage has three selections from1100V,1700V,2100V. Every output voltage has three kinds of waveforms. The treatment time is15minutes fixedly. It automatically changes the output waveform every5minutes. When the device is in the state of sleep treatment mode, its output voltage has a fixed negative peak of1100V and the treatment time can adjust from15minutes to8hours. It automatically loop the output waveform every5minutes with the treatment time changing. The fixed treatment mode is similar with the systemic treatment mode for they have the same output voltage and waveform. However the device automatically changes the combination every5minutes as the program set, as well as the treatment time is60minutes fixedly.High potential therapeutic apparatus belongs to class III in the national medical device registration management classification. The device would be called class I device if its electric shock protection not only relies on basic insulation but also on the fixed wiring with additional safety precautions which makes the metal where can be touched not charged even insulation fails. The device would be called class II device if its electric shock protection not only relies on basic insulation but also on double insulation or reinforced insulation with additional safety precautions without protective earth measures, and not depends on the installed condition. The high potential therapeutic apparatus in this article belongs to class I equipment according to the electric shock protection classification.A kind of medical equipment named high potential therapeutic apparatus, due to the particularity of itself, should be paid attention to its characteristics in the design and specification. It is strictly limited the range, the way, the object to use in the specification. It should be insulated from the earth and is prohibited to use if the patient has implanted medical devices inside or has wear ECG measurement equipment. Moreover, the patient who has obvious abnormal state should consult the doctor to make sure whether the equipment can be used. For actual treatment of the potential therapeutic apparatus can be changed along with environmental factors such as voltage, size, location and distance of the electrodes, humidity in the air, the open circuit voltage is used to measure the performance metrics of the device. The error of the output voltage is within±10%which can satisfy requirements of the use in performance and equipment safety.The treatment principle of equipment is applying high voltage in human body to produce high voltage AC electric field around. Although the equipment is used in insulation condition, it is still needed to make sure that the risks don’t occur in the non-insulation condition when the patient is in unconscious. Thereby it is needed to limit output power of the device. To ensure the safety of the patients, it is necessary to string a13MΩ protective impedance network in the output circuit to strictly limit short circuit current value. The output current is monitored timely. When the output current is greater than the threshold set in advance, the output current changes automatically and the alarm works, which protects users better with the protective impedance network. To coincide with actual production, testing, and registered, we drafted the corresponding product standard and clinical plan. As this device has passed through experiments and got experts’ratification, we conclude that the high potential therapeutic apparatus is in line with the expected design specifications, and meets the requirements of the relevant standards. At the end of this article, we not only discuss the related work of this high potential therapeutic equipment, but also look to the future work.

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