WO2002045796A1

WO2002045796A1 - A waveform and a therapeutic apparatus which outputs said waveform for treat the disease of stomach and intestine functions

Info

Publication number: WO2002045796A1
Application number: PCT/CN2001/001606
Authority: WO
Inventors: Yuhu Fang; Huaizhi Ke; Shengzhe Chen
Original assignee: Hangzhou Tsbio Science & Technology Co., Ltd.
Priority date: 2000-12-08
Filing date: 2001-12-06
Publication date: 2002-06-13
Also published as: AU2002218946A1; CN1357395A

Abstract

The present invention discloses a waveform and a therapeutic apparatus of body surface which outputs said waveform for treat the disease of stomach and intestine functions, the waveform is a kinf of pulsation sine waveform, the regular of change of amplitude envelop is approximately sine wave, the mathematical expression of said waveform is X(n)=A+Asin(2π nf/fs) which includes main frequency spectrum of stomach and intestine points of a healthy body, the treat efficiency of the apparatus is notable; the human-computer interface of the therapeutic apparatus which outputs said waveform in the invention comprises of singlechip, membrane, keyboard, display screen, line controller and buzzer, said interface can be conveniently operated and can be clearly displayed, the whole apparatus has high reliability, multi groups waveforms can be modified, set and memoried.

Description

Waveform for treating gastrointestinal function diseases and therapeutic instrument outputting the same Waveform

The invention relates to a medical treatment device, in particular to a treatment device for treating gastrointestinal diseases. Background

According to statistics, the incidence of gastrointestinal diseases is second only to cardiovascular diseases, and it is the second largest disease endangering human health. At least 70% of Chinese suffer from 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. For example, the frequency of gastric electrical rhythm is about 3 cycles per minute, and 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. These patients have ectopic starting points in other parts of the gastrointestinal tract and may produce regular or disordered electrical activities that exceed or lower than the frequency of electrical rhythms. It is manifested as tachycardia / bradycardia or electrical rhythm disturbance, which causes a series of symptoms of functional gastrointestinal 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.

At present, there are two methods of internal and external pacing.

1

Confirm this 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.

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.

It has not been determined which wave form of body surface pacing can achieve the best results. 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.

In addition, there is currently no therapeutic device for this special waveform. There are some patents in China, such as "Gastrointestinal Therapy Apparatus" (CN1051308A), "Gastric Ulcer and Gastrointestinal Disease Diagnosis and Treatment Device" (CN2045268U), "Stomach Motility Disease Diagnosis and Treatment Apparatus" (CN2313541Y), "Gastritis DC Electrotherapy Machine" (CN2030486U ), "Portable gastrointestinal pacemaker" (CN1128673A), foreign patents such as USP6, 115, 635, etc. The technologies and instruments provided by these patents are difficult to implement in vivo pacing abroad, and simple pulse waveforms are used. The domestic treatment instrument is too simple and rough, and the whole machine is at the level of 1970s and 1980s. In particular, it failed to indicate what waveform was used, as well as frequency, intensity, and so on. Object of the invention

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. Summary of invention

In order to achieve the above object, 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.

The mathematical formula for this waveform is

1, 2, ... N, where f is the frequency of the waveform and fs is the sampling frequency;

(A 7. 5 volts, 2 times / minute <f <15 times / minute, 20 times / minute f s 1200 times / minute, 1 (K N 80, N = 16 is a typical application.

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. High, can modify, set, store multiple sets of waveforms, save power, can use small dry batteries or rechargeable batteries as power, is conducive to the miniaturization of the instrument, use the keyboard to adjust, save the amplitude and frequency modulation potentiometer, simplify The structure. BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described below with reference to the accompanying drawings and embodiments.

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.

The waveform amplitude change rule can be expressed by the following mathematical formula: X (n) = A + A sin (2 π nf I fs), n = 0, 1, 2 N. Where: 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. N is the number of pulses in each period of the pulsating sine wave, and its range is 1 (N 80, the width of each pulse is the same. For example, take the frequency of the pulsating sine wave f = 2 times / minute, and the sampling frequency fs is 20 Times / minute, each cycle consists of N = 10 pulses, and the width of each pulse is 3 seconds, n = 0, 1, 2 10.

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.

Specific description is further given in conjunction with FIG. 1. The ordinate is the amplitude of a pulsating sine wave, and 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 → Ν / 2 + 1 → ... → N / 4 * 3 → ... → N. It can be seen that 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. .

As the number of pulses (N) increases, 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.

Specific description is further made in conjunction with FIG. 2. Figure 2 shows that the peak value of a sine-like wave is 5 volts, the frequency of the sine-like wave is f = 2 times / minute, each cycle consists of N = 16 pulses, and the sampling frequency is fs = 32, then the width of each pulse is 1. 875 seconds. According to the formula X (n) = A + A * s in (2 π ηί I fs), the amplitude of each pulse from 0 → N can be calculated. For example, 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)] The resolution V _DD = 0.1 volts], that is, M = 69.

When used for the treatment of stomach disorders, a frequency of 2 to 4 cycles per minute is used, and the center frequency is 3 cycles per minute. For the treatment of intestinal diseases, a frequency of 8 to 15 cycles per minute is used.

In the treatment, the gradual "driving" is used to make the disordered gastrointestinal electrical law "follow" the aforementioned driving waves to reach normal. For example, when the patient's gastric electrical frequency is lower than 3 times / min, 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. When 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.

As shown in FIG. 3, the pulsation-type sine wave therapeutic apparatus provided by the present invention 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. Under the control of the single-chip microcomputer 201, 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. In order to facilitate the operation, 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.

In order to facilitate patient adjustment, 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.

Description of the main parts of the instrument:

1. 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.

Its functions and operations are as follows:

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. For example, 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 main parameters and description of the waveform generator are as follows:

1) The pulsating sine wave is composed of N pulses per cycle, 1 (ί 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.

2) 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? . The range of P is 50 亳 seconds P <3 seconds, corresponding to the lower limit of the frequency (frequency f = 2 times / minute, N = 10, P = 3 seconds at this time) and the upper limit (frequency f = 15 times / minute, N = 80, at this time P = 0.05 seconds).

3) 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.

Operation of the waveform generator:

1) Press the RESET key 405, the LCD display enters the main menu, and then press the number key 9 to enter the waveform design mode. The LCD displays the waveform setting menu, that is, the number of pulses N during the week, which can be set and modified using the number keys. Number limitation The valid range is 10—80. Press ENTER key 404 to confirm, the LCD will go to the next menu. · Frequency setting menu.

On the frequency setting menu, you can use the number keys to set and modify. The number limits the effective range from 20 to 150 (because the frequency scale is 0.1 times / minute, 15 times / minute is equivalent to 150 steps). Press ENTER key 404 to confirm, the LCD will enter the peak setting menu.

On the peak setting menu, you can use the number keys to set and modify. The number limits range from 0 to 150. Press ENTER to confirm.

2) Press the DOWN key 402 or the HP key 403 on the operation keyboard to view the setting downwards or upwards.

3) Press the CLEAR key 404 on the operation keyboard to clear the number at the end of the LCD display to "0", and then press the number keys to reset and return to the main menu.

4) Press # on the keyboard to end the current operation and return to the main menu.

5) In any case, just press the RESET key 405 to immediately reset to the initial power-on state and display the main menu.

6) In the case of the main menu, press 1, 2, 3 or 4 keys on the operation keyboard to store the currently designed waveform data. Press 1, 2, 3 or 4 to store the waveform data at the specified position in the waveform data memory.

7) In the case of the main menu, press 5, 6, 7 or 8 keys on the operation keyboard to set the numbers as 1, 1, 3 or 4 waveform data is recalled from the data memory.

8) In the case of the main menu, press the 0 key on the operation keyboard to output the designed waveform.

2. 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.

To ensure the safety and effectiveness of treatment, 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.

It is difficult to overcome the differences caused by individual differences based on the setting of the treatment current by the doctor alone. It has been clinically proven that the sensitivity of different individuals to the treatment current varies greatly. The combination of the two not only improves the treatment effect, but also makes the patient feel painless and comfortable during the treatment.

3. Therapeutic current comparison detection circuit:

It consists of a sampling resistor and a comparison amplifier 207 and a light emitting diode 208. 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.

When the value of the treatment current reaches the set value of the machine, 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.

4. Treatment time setting circuit:

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. One person manages multiple machines. It also enables the patient to understand the treatment time, which is conducive to the patient's self-perception and cooperation with the doctor. 5. Power circuit and model:

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.

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.

For example, using the therapeutic apparatus of the present invention to treat patients with gastric functional dyspepsia: when in use, turn on the power of the therapeutic apparatus and turn on the power switch. At this time, 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), and the amplitude is the minimum value. It can also be adjusted through the keyboard or remote control as required.

After the parameters are determined, 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.

Using the pulsating sine wave provided by the present invention, 39 patients with gastric functional dyspepsia (without excluding superficial inflammation) were treated to treat postprandial fullness, epigastric pain, belching, nausea, early satiety, anorexia, The total effective rate of functional symptoms such as vomiting was 89.4%, of which the effective rate was as high as 54.1%, which was significantly higher than the total effective rate of 49.7% and the effective rate of 2.9% in the blank group. Another 49 patients with functional gastric dyspepsia were treated. The total effective rate for symptoms of upper abdominal fullness, early satiety, nausea, belching, anorexia, upper abdominal pain and vomiting was 94.3%, of which the effective rate was 36.0. %, While the effective rate of the blank control group was 0%, and the total effective rate was 6.9%. Compared with the treatment of slow wave superimposed peak potential, the effective rate and markedly effective rate are also significantly increased. According to reports, common functional symptoms such as abdominal pain, bloating, diarrhea, appetite, nausea, nausea, vomiting, tenderness, etc. were alleviated after treatment of slow-wave superimposed peak potential waveforms for 121 patients with functionally altered gastrointestinal diseases. The total effective rate of recovery or cure was only 84.2%, of which the significant efficiency was 32.6%. [Ou Shou. Journal of Clinical Internal Medicine. 1999, 16 (2): 70-72]

The invention is not limited to what is described in the above embodiments.

Claims

Shuli Yaoli

1. A waveform for treating gastrointestinal functional diseases, characterized in that: the waveform is a pulsating sine wave, and the amplitude envelope variation law is approximately sinusoidal.

2. A waveform for treating gastrointestinal functional diseases according to claim 1, characterized in that: the mathematical formula of the waveform is X (n) = A + Asin (2raf / fs), n = 0, 1, 2, ...... N, where f is the frequency of the waveform and fs is the sampling frequency.

3. The waveform for treating gastrointestinal functional diseases according to claim 2, characterized by: (A <7.5 volts, 2 times / ^ <f 15 times / minute, 20 times / minute <fs < 1200 times / minute, 10 <N <80 _o

The waveform for treating gastrointestinal functional diseases according to claim 3, wherein: N = 16.

5. A therapeutic instrument, characterized in that its output waveform is a pulsating sine wave, and the amplitude envelope change law is approximately sine.

6. A therapeutic device, characterized in that the human-machine dialogue interface of the therapeutic device is composed of a single-chip microcomputer, a membrane, a keyboard switch board, a display screen, a wire controller, a buzzer, and a waveform memory.

7. The therapeutic apparatus according to claim 6, wherein: the therapeutic apparatus is provided with an output current detection circuit, and emits an acoustic and optical alarm signal when the therapeutic current reaches a predetermined threshold.

8. The treatment device according to claim 6 or 7, characterized in that: the treatment device can set a treatment time, count down to 0, automatically cut off the treatment current at the end, and send a Pule reminder signal.