WO2002045796A1 - Signal et appareil therapeutique emettant ce signal pour traiter des troubles fonctionnels de l'estomac et des intestins - Google Patents

Signal et appareil therapeutique emettant ce signal pour traiter des troubles fonctionnels de l'estomac et des intestins Download PDF

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Publication number
WO2002045796A1
WO2002045796A1 PCT/CN2001/001606 CN0101606W WO0245796A1 WO 2002045796 A1 WO2002045796 A1 WO 2002045796A1 CN 0101606 W CN0101606 W CN 0101606W WO 0245796 A1 WO0245796 A1 WO 0245796A1
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WIPO (PCT)
Prior art keywords
waveform
treatment
therapeutic
minute
frequency
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Application number
PCT/CN2001/001606
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English (en)
Chinese (zh)
Inventor
Yuhu Fang
Huaizhi Ke
Shengzhe Chen
Original Assignee
Hangzhou Tsbio Science & Technology Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hangzhou Tsbio Science & Technology Co., Ltd. filed Critical Hangzhou Tsbio Science & Technology Co., Ltd.
Priority to AU2002218946A priority Critical patent/AU2002218946A1/en
Publication of WO2002045796A1 publication Critical patent/WO2002045796A1/fr

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Classifications

    • 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
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control

Definitions

  • the invention relates to a medical treatment device, in particular to a treatment device for treating gastrointestinal diseases.
  • gastrointestinal diseases are second only to cardiovascular diseases, and it is the second largest disease endangering human health.
  • digestive diseases such as superficial gastritis (digestive diseases can be divided into organic diseases and functional diseases), of which about 40-50 are patients with gastrointestinal functional diseases %.
  • Gastrointestinal dysfunction includes gastrointestinal neurosis, gastrointestinal rhythm syndrome, small bowel malabsorption syndrome, postoperative intestinal dysfunction, irritable bowel syndrome, habitual constipation, bradycardia (rapid), function Sexual or diabetic gastric tension is too low, stomach sagging, etc., and such diseases are easily induced by nervousness, fatigue, careless diet, etc.
  • Clinical manifestations are abdominal pain, diarrhea, nausea, vomiting, early satiety, constipation, anorexia, postprandial fullness , Radon, etc.
  • the gastrointestinal tract of normal human body has its basic electrical rhythm.
  • the frequency of gastric electrical rhythm is about 3 cycles per minute
  • the frequency of duodenal electrical rhythm is about 11-12 cycles per minute.
  • the frequency is approximately 6-8 cycles per minute.
  • This periodic and constant frequency is due to the existence of a "pacemaker" that governs gastrointestinal electricity. It is now proved that the human gastric bulging area is located at about 1/3 of the large curvature of the stomach body to the head end, and the starting point of the small intestine is located about 4 cm from the pylorus of the duodenal bulb.
  • the occurrence of gastrointestinal functional diseases is related to gastrointestinal electrical rhythm disorders.
  • Gastrointestinal pacing is a new treatment method in recent years.
  • the basic principle is to drive the "starting point" existing in various parts of the gastrointestinal tract with external currents of different frequencies, just like the cardiac pacing, so that the gastrointestinal tract returns to normal. Electrical rhythm to achieve the purpose of treatment.
  • the internal pacemaker is like the Enterra therapy system produced by Medtronic in the United States. It is an implantable gastrointestinal pacemaker (that is, the pacemaker is placed under the serosa at the starting point of the stomach during surgery, and the electrodes are led out from the body surface. Promote gastrointestinal motility by electrical stimulation). This system is mainly aimed at patients with severe gastrointestinal disorders where conventional treatments do not work. The United States Food and Drug Administration (FDA) approved the device to market in April 2000. Because this method requires surgery on the patient, it is not easy to work, especially for patients with functional gastrointestinal diseases, the treatment is obviously too painful and inconvenient.
  • FDA United States Food and Drug Administration
  • Body surface pacing is performed by applying an electrical signal (stimulus) containing the spectrum to the appropriate part of the patient's body surface (projection of the gastrointestinal starting point on the surface of the human body).
  • the electrical signal synchronization is commonly known as the "follow" effect. After a certain period of stimulation treatment, the electrical rhythms become normal, and the gastrointestinal motility becomes normal, so that the gastrointestinal motility is restored, and the disease symptoms are improved and disappeared.
  • In vivo pacing usually uses simple low-frequency pulse waveforms (such as USP6, 115, 635). Some people have proposed that the use of artificial simulated gastric electrical waveforms (slow wave superimposed peak potentials) for body surface pacing can achieve a satisfactory driving effect (but the specific waveform is not clearly specified), and the simple DC pulse current on the gastric starting point The modulation effect is not obvious. Note that the difference in the "drive" waveform does have a significant impact on the effect of the treatment.
  • the gastric waveform measured by a normal electrogastrograph is the above-mentioned slow wave superimposed peak potential, although in theory, it is better to apply a fully simulated gastric electric waveform (slow wave superimposed peak potential) to the starting point of the stomach. Effect, but since the human body is not a pure resistance, but is similar to an impedance system, when the simulated gastric electrical waveform is applied to the body surface for pacing, another deformed waveform actually passes through the starting point of the stomach. To achieve the best driving effect. At the same time, since this simulated gastric electrical waveform is difficult to control with a few simple parameters in practical applications, the previously published data did not show that this waveform can be truly and effectively simulated.
  • One of the objectives of the present invention is to provide a new type of waveform that acts on the starting point of the gastrointestinal tract at the body surface projection to more effectively treat gastrointestinal functional diseases.
  • Another object of the present invention is to provide a therapeutic apparatus that outputs the above-mentioned waveform.
  • the solution of the present invention is: a waveform for treating functional gastrointestinal diseases, which is characterized in that: the waveform is a pulsating sine wave, and the amplitude envelope variation law approximates a sine.
  • a therapeutic instrument is characterized in that its output waveform is a pulsating sine wave with an amplitude envelope.
  • the variation law is approximately sine.
  • the man-machine dialogue interface of the therapy device is composed of a single-chip computer, a membrane keyboard switch board, a display screen, a wire controller, a buzzer, and a waveform memory;
  • the treatment instrument is provided with an output current detection circuit, and an acoustic and light alarm signal is issued when the treatment current reaches a predetermined threshold;
  • the therapy device can set the treatment time, count down to 0, automatically cut off the treatment current at the end, and send out a music reminder signal.
  • the pulsating sine wave provided by the present invention can control the waveform by using several parameters, and each cycle contains a specific number of pulses, and each pulse has a specific amplitude and width, so it is easy to operate and implement.
  • This waveform contains the main spectrum of gastrointestinal electricity in a healthy human body and has significant therapeutic effects.
  • the therapeutic device for outputting the above-mentioned waveform is composed of a single-chip computer, a membrane keyboard switch board, a display screen, a wire controller, a buzzer, etc., which constitutes a man-machine dialogue interface, which is convenient to operate, has a clear and intuitive display, and has a relatively reliable machine.
  • FIG. 1 is a schematic diagram of a pulsating sine wave waveform provided by the present invention.
  • FIG. 2 is a schematic diagram of an embodiment of a pulsating sine wave waveform provided by the present invention.
  • Fig. 3 is a block diagram of the main components of the therapeutic apparatus provided by the present invention.
  • FIG. 4 is a schematic diagram of an operation keyboard of an embodiment of the therapeutic apparatus provided by the present invention. Summary of the Invention
  • a new type of waveform provided by the present invention is a pulsating sine wave, which is characterized in that each cycle of the waveform is composed of several pulses of equal width, and the variation law of the amplitude envelope approximates a sine.
  • A is the peak value of the pulsating sine wave, which ranges from 0 volts to 7.5 volts;
  • f is the frequency of the pulsating sine wave, whose range is 2 times / minute f 15 times / minute, that is, 2-15 per minute Period;
  • fs is the component frequency (ie, sampling frequency) of each period of the pulsating sine wave, and its range is 20 times / minutes fs 1200 times / minute.
  • the amplitude resolution of X (n) V DD 0.1 volt, that is, the amplitude of each stage pulse is a multiple of 0.1 volt M, and the range of M is 0 ⁇ M ⁇ 150.
  • the ordinate is the amplitude of a pulsating sine wave
  • A is the pulsation Peak of a sine-like wave.
  • the abscissa is time and the unit is minute. Calculate a cycle from 0 ⁇ N.
  • Each cycle consists of N pulses.
  • Each pulse is 0 ⁇ 1 ⁇ 2 ⁇ N / 4 ⁇ ... ⁇ N / 2 ⁇ ⁇ / 2 + 1 ⁇ ... ⁇ N / 4 * 3 ⁇ ... ⁇ N.
  • the variation of the amplitude envelope of the waveform is approximately sine; however, it is not a sine that alternates between positive and negative, but a superimposed DC potential with a sine-like peak amplitude, that is, a positive value is guaranteed after superimposing the DC potential. .
  • the amplitude envelope of the waveform changes more and more sinusoidally. If the value of N is too small, the waveform shape will be similar to a simple pulse waveform. In both cases, the deviation from the sine-like waveform will result. It is required to select 10 ⁇ N ⁇ 80 for better treatment effect. In the present invention, when the number of pulses N is 16, there is a better therapeutic effect.
  • X (n) A + A * s in (2 ⁇ ⁇ I fs)
  • the amplitude of each pulse from 0 ⁇ N can be calculated.
  • the 0, 4, 8, 12, and 16 pulses have amplitudes of 5, 10, 5, 0, and 5 volts, respectively; the amplitude of the first pulse is 6.9 volts [X (n)]
  • a frequency of 2 to 4 cycles per minute is used, and the center frequency is 3 cycles per minute.
  • a frequency of 8 to 15 cycles per minute is used.
  • the gradual "driving" is used to make the disordered gastrointestinal electrical law "follow" the aforementioned driving waves to reach normal.
  • the frequency of the treatment current should be higher than it by 0.2 to 0. times / minute, but not more than 3 times / rain.
  • the patient's gastric electrical frequency is higher than 3 times / minute Min, should also be treated with a low frequency of 0.2-2. 4 times / min, and also not less than 3 times / min.
  • the pulsation-type sine wave therapeutic apparatus is a therapeutic apparatus composed of a single-chip microcomputer 201 as a core and corresponding hardware circuits and application programs.
  • the waveform data memory 202 stores the required waveform data.
  • the required waveform is formed by the D / A converter 204, and further amplified by the amplifier 205, and then applied to a specific part of the patient's skin through the body surface treatment electrode 206 .
  • Operation keyboard and membrane switch 209, remote control switch 210, display 212 (can be LCD Or vacuum fluorescent display) and its driving circuit 211 and buzzer 203 constitute a man-machine dialogue interface.
  • the user sets various parameters through the membrane switch keyboard 209, and displays the set results in a digital form on the display screen 212, which can be prompted by sound and light alarms.
  • the frequency of treatment is shown on the display 212 in numbers.
  • the default value of the treatment frequency of the machine (that is, the frequency determined as soon as the machine is turned on) is set to the two most commonly used treatment frequencies, 3.0 times / minute and 10.0 times / minute.
  • the machine is equipped with a "wire controller” 210, which enables patients to hold the "wire controller” to adjust the treatment current at any time to achieve the best treatment effect.
  • the remote controller is a 2 * 2 membrane switch, which is connected to the port of the microcontroller through a cable, and is used to modulate the amplitude of the treatment current.
  • Waveform generator part As shown in FIG. 3, it is composed of single-chip microcomputer 201, waveform data memory 202, operation keyboard and membrane switch board 209, display screen 212, and D / A conversion circuit 204.
  • the operation keyboard, the membrane switch board 209, and the display screen 212 constitute a man-machine dialogue interface.
  • the operation keyboard 209 is composed of a 5 * 5 matrix switch circuit, and is connected to a single chip 201 port through a signal line.
  • the liquid crystal display or vacuum fluorescent display 212 is connected to the single-chip microcomputer 201 by using an I 2 C serial bus display module.
  • the set values of the expressed waveform parameters are input by the numeric keys and function keys of the operation keyboard 209 and displayed by a liquid crystal or vacuum fluorescent display 212. Press the corresponding function keys of the operation keyboard 209 to realize the operation of different functions.
  • the ENTER key stores the waveform data into the random data memory of the single-chip microcomputer 201, which can be consulted and modified at any time.
  • the waveform data memory 202 is formed by the E 2 PR0M of the I 2 C bus. It can store 4 sets of waveform data, and the data will not be lost when the power is turned off. You can freely call out a group of waveforms to send out.
  • the PC port of the one-chip computer 201 is connected to the R-2R resistor network 204 to complete the digital / analog conversion function.
  • the pulsating sine wave is composed of N pulses per cycle, 1 ( ⁇ 80, that is, the range of the step number is 10-80.
  • the value of N is adjustable.
  • the number of pulses included in each week period is different, and the waveform is also different. Within the range of N, there will be more than 30 kinds of waveforms to choose from.
  • Frequency of pulsating sine wave f The range is 2 times to 15 times / minute, adjustable. For the convenience of use, the LCD screen uses frequency value display, each step step is 0.1 times / minute. Enter the frequency taken and each After the number of pulses N in each cycle, the pulse width is automatically calculated by the instrument? .
  • Peak value of pulsating sine wave (A) The range is 0-7. 5 volts, adjustable. After inputting the sine wave-like peak value, the instrument automatically calculates the amplitude of each pulse.
  • the pulse height (amplitude) M of the pulsating sine wave is set to 0-150 level. With the amplifier in the instrument, an appropriate amplification factor is selected so that the output voltage is the product of 0.1 volt and M, which is 0-15 volt output.
  • Amplifying circuit 205 It consists of a three-stage DC operational amplifier. The DC pulsating sine wave signal from the D / A conversion circuit 204 is amplified to ensure that it reaches the required amplitude and phase, and then passes through the automatic current detection circuit and The body surface treatment electrode 206 reaches human skin. The magnitude of the current is adjusted by the membrane switch keyboard 209.
  • the default value of the machine output amplitude (the output determined when the machine is turned on) is set to the minimum value of the treatment current output, and the 'step type' is adopted, that is, each time the key is pressed, only a small increase is added. Make sure to increase the output "step by step".
  • the treatment current intensity is combined with the patient's personal feeling and the treatment current set by the machine to achieve the best treatment effect.
  • the treatment current output from the amplifier 205 flows through the sampling resistor while passing through the human skin, and the signal on the resistance is amplified by the comparison amplifier to push the two-color light-emitting diode 208 to emit light, so that the treatment current value of the light-emitting tube is set to 0.1 — 0.2 mA, which is the lower limit of the usual therapeutic current value.
  • the light-emitting tube 208 on the front of the machine is illuminated (the stomach and intestine are in different colors), which can prompt the doctor and the patient, and the magnitude of the treatment current is displayed on the display 212 at the same time.
  • the function of this circuit is completed by the membrane switch keyboard 209 and the single-chip microcomputer 201.
  • the machine can be set by the patient or doctor in the range of 0-60 minutes, and then counts down to 0, indicating that the treatment time is up. At this time, the machine automatically cuts off the treatment current, and a buzzer sends out a sound reminder signal to remind the patient and doctor.
  • Clinical validation has shown that setting a treatment time of 30 minutes is appropriate, for which the machine default is 30 minutes. In this way, the labor intensity of the doctor can be reduced, and the efficiency can be improved.
  • Model design There are two types of this machine: one is a hospital model, which uses AC 220 volts for power supply, with a variety of built-in voltage regulators 5V, ⁇ 15V, 27V, 2. 7V, etc., and can perform 110-220V Conversion, the display system uses a vacuum fluorescent display (VFD), high brightness and beautiful.
  • VFD vacuum fluorescent display
  • the other is a personal model, which is powered by a battery or a rechargeable battery, and the display uses a liquid crystal (LCD), which saves power and is lightweight.
  • LCD liquid crystal
  • the liquid crystal display screen is on, displaying the default frequency, amplitude and treatment time of the treatment current.
  • Value that is, the most commonly used value
  • the stomach frequency is 3.0 times / minute
  • the treatment time is 30 minutes
  • the waveform is 1 (that is, the waveform of N-16)
  • the amplitude is the minimum value. It can also be adjusted through the keyboard or remote control as required.
  • the treatment electrodes are installed and placed on the appropriate part of the patient's body surface.
  • the patient can adjust the appropriate current intensity through the wire controller.
  • the light-emitting tube of the detection circuit lights up, indicating that the treatment current passes through the skin and the patient feels.
  • the timer circuit counts down. When the treatment time is set, the instrument automatically cuts off the treatment current and issues a musical tone.
  • the LCD display time is 0. After the treatment is completed, remove the electrode and turn off the power switch of the instrument.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention concerne un signal et un appareil thérapeutique, destinés à être utilisés sur la surface du corps humain, qui émet ledit signal pour traiter des troubles fonctionnels de l'estomac et des intestins. Ce signal présente une forme sinusoïdale du type pulsé et la régularité des variations de l'enveloppe d'amplitude correspond approximativement à une onde sinusoïdale. L'expression mathématique de ladite forme d'onde est la suivante: X(n) = A + Asin (2πnf/fs). Elle inclut le spectre principal de fréquences des points stomacaux et intestinaux d'un corps sain. L'efficacité thérapeutique de cet appareil est considérable. L'interface homme-ordinateur dudit appareil thérapeutique émettant ledit signal est constituée d'une puce unique, d'une membrane, d'un clavier, d'un écran d'affichage, d'un contrôleur de ligne et d'un vibreur. Ladite interface permet un actionnement pratique et offre un affichage clair. L'appareil dans son ensemble est d'une grande fiabilité, des signaux de groupes multiples pouvant être modifiés, réglés et mémorisés.
PCT/CN2001/001606 2000-12-08 2001-12-06 Signal et appareil therapeutique emettant ce signal pour traiter des troubles fonctionnels de l'estomac et des intestins WO2002045796A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002218946A AU2002218946A1 (en) 2000-12-08 2001-12-06 A waveform and a therapeutic apparatus which outputs said waveform for treat thedisease of stomach and intestine functions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN00127842.8 2000-12-08
CN 00127842 CN1357395A (zh) 2000-12-08 2000-12-08 一种治疗胃肠功能性疾病的波形及输出该波形的治疗仪

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WO2002045796A1 true WO2002045796A1 (fr) 2002-06-13

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04338462A (ja) * 1991-05-16 1992-11-25 Hitachi Ltd 超音波治療装置
US5188104A (en) * 1991-02-01 1993-02-23 Cyberonics, Inc. Treatment of eating disorders by nerve stimulation
JPH06218048A (ja) * 1993-01-22 1994-08-09 Nissho Corp 局所性貧血治療用カテーテルおよびこれを用いた治療装置
JPH0984884A (ja) * 1995-09-22 1997-03-31 Nippon Medics:Kk 治療装置
US5836994A (en) * 1997-04-30 1998-11-17 Medtronic, Inc. Method and apparatus for electrical stimulation of the gastrointestinal tract
US5861014A (en) * 1997-04-30 1999-01-19 Medtronic, Inc. Method and apparatus for sensing a stimulating gastrointestinal tract on-demand

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5188104A (en) * 1991-02-01 1993-02-23 Cyberonics, Inc. Treatment of eating disorders by nerve stimulation
JPH04338462A (ja) * 1991-05-16 1992-11-25 Hitachi Ltd 超音波治療装置
JPH06218048A (ja) * 1993-01-22 1994-08-09 Nissho Corp 局所性貧血治療用カテーテルおよびこれを用いた治療装置
JPH0984884A (ja) * 1995-09-22 1997-03-31 Nippon Medics:Kk 治療装置
US5836994A (en) * 1997-04-30 1998-11-17 Medtronic, Inc. Method and apparatus for electrical stimulation of the gastrointestinal tract
US5861014A (en) * 1997-04-30 1999-01-19 Medtronic, Inc. Method and apparatus for sensing a stimulating gastrointestinal tract on-demand

Also Published As

Publication number Publication date
CN1357395A (zh) 2002-07-10
AU2002218946A1 (en) 2002-06-18

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