RU2325931C2 - Device for treatment and diagnostics of gastrointestinal tract - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, specifically to equipment for medical treatment and diagnostics designed for analysis of structure functional changes of organs and tissues and diseases treatment with possibility to control treatment process with electrostimulation if necessary. Device for treatment and diagnostics of gastrointestinal tract contains power supply, actuator, including multielectrode probe plug-type connected to processing and mapping block including memory unit, microcontroller connected to ADC and D to A converter, gage unit, PC interface, display and keyboard. Actuator includes identification element designed as microchip and plug-type connected to processing and mapping block. Current driver of processing and mapping block is designed as analogue switch connected to sources of probe and stimulating current, and gage unit is designed as series analogue switch, adjustable amplifier and detector.

EFFECT: increased electrostimulation of gastrointestinal tract.

3 cl, 1 dwg

Description

The invention relates to medical equipment, to medical diagnostic equipment, intended both for assessing the structural and functional changes in organs and tissues of the gastrointestinal tract, and for treating diseases with the possibility of controlling, if necessary, the treatment process by means of electrical stimulation.

Known devices [SU 1063419, 1264952, 1287841, 1806590], intended for exposure to electrical stimulation with one or another element of parameter control.

However, this group of devices is not intended for diagnosis as such, and the control elements are reduced to the possibility of registering electrical stimulation parameters only during exposure.

An attempt to correct this drawback has been made in some autonomous stimulators, stimulator probes, as well as electrical stimulants for percutaneous electrical stimulation [patents RU 2264237, 2195972, 2091089, 2266762]. In all these devices, the environmental impedance is measured and, depending on its change, the stimulation parameters change or the device turns off. This has no diagnostic value, and the change of parameters occurs automatically in the “average” version, without taking into account other indicators, which is a significant drawback.

A device for electrical stimulation [RU 2067461] is also known, which includes sensors for recording pulse and rhythm of respiration, which allows you to coordinate the effect with the rhythm of blood flow at the site of stimulation. However, this device does not detect changes in the blood supply to tissues at the site of stimulation and is not able to evaluate structural and functional changes.

The ability to obtain diagnostic information through the stimulation channel is implemented in some devices: in the gastrointestinal tract electrical stimulators [patents RU 2066554 and RU 2075980], in which the environmental monitoring unit is introduced, as well as in electrical stimulators-probes, in which it is possible to connect to the device for measuring the bioelectric activity of stimulated sections of the gastrointestinal tract in the inventions [SU 1811379, RU 2240842].

Despite the obvious value of the information received, indicating the function of the stimulated organ, it does not reflect structural changes and microcirculation disorders.

Autonomous stimulators have wider possibilities of stimulation [patents RU 2107519, 2129028] due to their movement along the gastrointestinal tract. They contain electrodes, which are electrically isolated parts of a drug capsule, a power source located inside the capsule. Their differences are that inside the drug capsule there is a microcontroller, the outputs of which are connected to the electrodes, sensors configured to receive signals of internal organs and / or signals of an external transmitter, the outputs of which are connected to the inputs of the microcontroller, additional electrodes coated with microelements or preparations connected to individual outputs of the microcontroller.

However, in this case, it is difficult to assess the localization of the stimulator at a particular point in time. In addition, the obtained diagnostic information when changing the position of the stimulator loses its meaning for the correction of stimulation parameters, and when the stimulator moves, the possibility of a longer exposure to individual zones requiring repeated stimulation is excluded.

A device for stimulation [RU 2135225] is also known, comprising a power supply unit, a control unit, a serially connected generator, a pulse shaper, a power amplifier, a measuring unit, a drain tube probe with an olive capsule, a boost unit, a pressure sensor, a temperature sensor located inside olive-capsules, as well as a microprocessor, a storage device, an indication unit. The olive capsule is made in the form of two isolated parts-electrodes, and the side surface of the tube near the capsule has perforation. The input of the boost unit is connected to the output of the pulse shaper, and the output of the boost unit is connected to the input of the power amplifier. The pressure sensor input is connected to a drain tube probe, and the output is connected to a measuring unit. The output of the temperature sensor is connected to the measuring unit, and the measuring unit contains three separate channels. The microprocessor is connected to a generator, a pulse shaper, a forcing unit, a control unit, a storage device, an indication unit and a power supply unit.

This device cannot be recognized in terms of technical capabilities to meet the modern requirements for devices of this class, neither in terms of memory capacity nor in the accuracy of information. In addition, according to medical and technical principles, it cannot be considered correct. The disadvantage of this device is the use of additional sensors, which complicates the design, but does not provide a sufficient amount of diagnostic information through the stimulation channel itself. In this device, as well as in all the previous ones, the voltage of the stimulation current or probe current is evaluated regardless of its parameters, therefore, the information obtained indicates only the electrical conductivity of the environment or the presence of muscle spasm. This channel is not used to assess microcirculation.

However, the above devices do not provide the ability to perform rheography. A limited number of electrodes should also be considered a disadvantage, which is determined by the size of the olive and does not allow influencing several zones simultaneously.

Closest to the claimed therapeutic and diagnostic device is a device for accumulating information in the evaluation of therapy [US 2005222643], which refers to modern multifunctional devices designed to control several physiological parameters during therapeutic exposure. It contains a multi-electrode probe connected to the information processing and display unit, which includes a processor (microcontroller with DAC and ADC - standard execution), storage device, sensor, telemetry means (measuring unit), computer interface, display, keyboard. The medical devices and diagnostic sensors in this case are separate devices that can be implanted in the patient’s tissue and most often associated with nerve structures.

However, the disconnectedness of the medical device and the diagnostic sensor and the need for their implantation in the patient’s tissue makes the device design complicated, and the very procedure of research and therapy traumatic and in some cases dangerous due to invasiveness. And although the device can be used as a complex for stimulating the gastrointestinal tract, it does not allow controlling the internal environment, the properties of the mucous membrane and blood flow in the wall, especially at a given level in the stimulation zone.

The task of the invention is the possibility of both treating the patient with electrical stimulation and the possibility of an objective detailed diagnosis of organs and tissues as an independent process, as well as the simultaneous combination of both of these processes - treatment and control during stimulation. In addition, the objective of the claimed device also includes the possibility of diagnosing after the treatment process to assess the effectiveness of stimulation, as well as storing the diagnostic results in the memory of the claimed complex when monitoring.

The essence of the claimed invention lies in the fact that in the diagnostic and treatment device of the gastrointestinal tract containing a power source, an actuator including a multi-electrode probe connected through a connector to an information processing and display unit including a storage device, a microcontroller connected to the ADC and DAC , a measuring unit, a computer interface, a display and a keyboard, an identification element is connected to the actuator, which is connected through a connector to the information processing and display unit, the current driver of the processing and display unit is made in the form of an analog switch connected to the sources of probing and stimulating currents, and the measuring unit is made in the form of series-connected analog switch, an adjustable amplifier and detector.

A device with the above characteristics is also claimed in which the identification element is made in the form of a microchip.

An improvement of the aforementioned device is also claimed, which for the possibility of carrying out rheographic studies in the information processing and display unit has a scaling element connected to a power source, a microcontroller and a measuring unit.

Another improvement of the above device is a storage device made in the form of a NAND storage device.

NAND memory, in other words, NAND memory is a modern term for a class of devices with non-volatile flash memory. The need for non-volatile flash memory is growing in proportion to the degree of advancement of computer systems in the field of mobile applications. Reliability, low power consumption, small size and low weight are the obvious advantages of flash-based media compared to disk drives. Given the constant reduction in the cost of storing a unit of information in flash memory, media based on it provide more and more advantages and functionality to mobile platforms and portable equipment using such memory. Among the variety of memory types, flash memory based on NAND cells is the most suitable basis for building non-volatile devices for storing large amounts of information.

[http://www.gaw.ru/html.cgi/txt/publ/memory/index.htm]

The technical result of the claimed device is to increase the efficiency of stimulation due to changes in exposure parameters, taking into account the registered changes in the stimulated organs. The inventive device allows on the basis of common blocks to perform the functions of both an analyzing and diagnostic device, both an independent device and a therapeutic stimulating or therapeutic device with the ability to monitor the course of treatment during it. This technical combination leads to compactness, if necessary, to miniaturization, ease of technical implementation, to increase manufacturability and reduce the cost of the complex. The ability to analyze the condition of the patient can be fully thoroughly and reliably implemented and be an independent task without subsequent treatment, which was not possible in other analogues presented. The technical result of the invention also lies in the possibility of obtaining information from one of the claimed complex on the magnitude of the impedance and on the microcirculation of blood according to the results of rheography. The presence in the inventive complex of the electrode-sensor assembly in the form of a multi-electrode probe allows you to expand technical capabilities both in treatment and in diagnosis by simultaneously taking characteristics from several points of the study area, and during treatment - due to the possibility of simultaneous exposure to them. The change in the mode of operation of the complex in the claimed invention is technically solved by the introduction of current sources - stimulating and probing into the current driver. The introduction of NAND storage device allows us to attribute the claimed solution to a class of modern level, which will provide long-term monitoring of medical processes due to electronic memory up to 1 GB. The introduction of an identification element in the form of a microchip in the electrode-sensor assembly allows automatic selection of boot parameters when the device is turned on. In addition, the original circuit and the connections of the constituent blocks in it provide a technical result for a new medical device. In contrast to the prototype [US 2005222643] in the inventive device, the diagnosis and therapeutic effect are carried out through one channel. And despite the fact that in the diagnostic mode only the electrical conductivity of the tissues surrounding the electrodes or body fluids is evaluated, the obtained data carry information on several physiological parameters - the pH of the medium, muscle activity, the degree of morphological changes in tissues and blood microcirculation (rheography). It all depends on the parameters of the probing current (current frequency, duration of information taking) and the method of processing information. Theoretically, other parameters can also be recorded (heart rate, respiratory rate and depth, etc.). The technique is not invasive and not traumatic.

The claimed therapeutic and diagnostic device of the gastrointestinal tract is illustrated using the drawing, in which positions 1-22 indicate the blocks and elements of the claimed device:

1 - actuator;

2 - electrode-sensor unit;

3 - identification element;

4 - connector;

5 - block processing and displaying information;

6 - current driver;

7 - analog switch;

8 - probe current source;

9 - measuring unit;

10 - analog switch;

11 - adjustable amplifier;

12 - detector;

13 - microcontroller;

14 - ADC;

15 - DAC;

16 - power source;

17 - computer interface;

18 - display;

19 - keyboard;

20 - NAND storage device;

21 - element scaling;

22 - a source of stimulating current.

The treatment and diagnostic device of the gastrointestinal tract consists of an actuator 1 made in the form of an electrode-sensor assembly 2 and an identification element 3 connected through a connector 4 to an information processing and display unit 5, which contains a current driver 6, an analog switch 7, a source probing current 8, a measuring unit 9, including an analog switch 10, an adjustable amplifier 11, a detector 12 connected in series, a microcontroller 13, an ADC 14 and a DAC 15, as well as a power source 16. After the bottom creates the necessary voltage to power the above elements and blocks: microcontroller 13, ADC 14 and DAC 15, current driver 6, measuring unit 9, computer interface 17, display 18, NAND storage device 20, scaling element 21, stimulating current source 22 The last elements and blocks are connected as follows: the first input of the scaling element 21 is connected to the output of the measuring unit 9, detector 12 and the first ADC channel 14, the second input is connected to the output of the DAC 15, and the output to the second channel ohm ADC 14. The stimulating current source 22 is connected to the analog switch 7 of the current driver 6. Identification element 3 is connected via connector 4 to the microcontroller 13, the ADC 14 and the DAC 15.

The inventive device operates as follows. When the power source 16 is turned on, the microcontroller 13 sets all the blocks and elements to their initial state, interrogates the identification element 3 of the actuator 1, tests the voltage of the power supply 16 and the current driver 6. If a malfunction is detected, the corresponding diagnostic message is displayed on display 18, otherwise the menu is displayed , offering to choose one of the operating modes: diagnostics or treatment, which is selected by pressing the corresponding keys of the keyboard 19. When working in the diagnostic mode a lot of the electrode probe 2, the impedance of the zones formed by the pairs of electrodes of the probe 2 is sequentially measured by applying to the selected electrodes using the analog switch 7 from the current source 8 a current generator 6 measuring an amplitude-stable alternating current in the form of a meander, for example, with a frequency of 10 kHz, amplitude 0.6 mA or 200 kHz, amplitude up to 1 mA.

The impedance is calculated in each zone for two current frequency values. In the standard position of the multi-electrode probe, nine of its electrodes are located along the entire lesser curvature of the stomach, and two electrodes remain in the distal part of the esophagus. Low-frequency impedance makes it possible to judge the electrical conductivity of the intragastric medium, which depends on secretory activity, and gastric peristalsis. In this mode, gastroesophageal reflux can be recorded.

When operating in the rheography mode, the process of changing the impedance in the selected zone of the multi-electrode probe 2 is monitored. A measuring amplitude-stable alternating current in the form of a meander with a frequency of 200 kHz and an amplitude of up to 1 mA is supplied to the selected zone through an analog switch 7. The measuring unit 9 receives the signal from the desired pair of electrodes through the analog switch 10, amplifies the signal through an adjustable amplifier 11, detects it using the detector 12 for subsequent digitization in the ADC 14. The signal at the output of the detector 12 contains information about the measured impedance of the selected area of the multi-electrode probe. The measured voltage processed in the measuring unit 9, as described above, is supplied to the first input of the scaling element 21, and the bias voltage from the DAC 15 is supplied to the second input. Data is input to the control input of the scaling element 21 to set the required scale factor from the microcontroller 13. Dedicated thus, the impedance change voltage from the output of the scaling unit is supplied to the second input of the ADC 14. The impedance change voltage converted to digital data is used for visual presentation on the display 18 in the form of a rheogram.

In both modes, the data obtained is stored in a NAND memory 20 having a volume sufficient to record the values thus obtained for a long period of time up to a day or more. This feature allows you to use the device offline without the use of computers. As NAND storage device 20 can be used such media as SD, MMS memory cards and others based on NAND memory chips. The interface unit with the computer 17 allows you to transfer information stored in the NAND storage device 20, for further processing, as well as receive control commands from an external computer.

When operating in stimulation mode due to hardware, namely the presence of a microcontroller 13, ADC 14 and DAC 15, it is possible to change parameters such as the amplitude of the current of stimulating pulses, the repetition rate of stimulating pulses, the frequency of filling of stimulating pulses, the duration of a series of stimulating pulses, and the duration of a pause between series of pulses.

For example, the analog device used by the ADuC7020 series of the Analog Device company can successfully perform hardware and calculation tasks.

All schemes are made in the form of classical devices known from textbooks and books on electronics [for example: V.A. Pryanishnikov. Electronics: Lecture Course. St. Petersburg: Crown print, 1998, P. Horowitz, W. Hill. The art of circuitry. M .: Mir, 2003].

The proposed technical solution is implemented in the tested sample of the device, in which, for stimulation and diagnostic information, a multi-electrode probe is used, which is a rubber tube with eleven cylindrical electrodes connected to a connector for connecting to an information processing and display unit. The device undergoes clinical testing in a medical institution and is intended for electrical stimulation of the stomach, monitoring of the intragastric medium by measuring high and low frequency impedance, as well as intragastric rheography. According to preliminary experimental and clinical observations, the inventive device, equipped with similar probes, can be recommended for therapeutic effects on organs having a similar anatomical structure, such as ureters, fallopian tubes, vagina, intestines. Changing the design of the electrodes greatly expands the capabilities of the claimed device. Important advantages of the claimed device are the high efficiency of stimulation, the ability to change exposure parameters taking into account structural and functional changes in the stimulated organs, wide diagnostic capabilities, simplicity of design and control, and safety of use.

Claims (3)

1. The treatment and diagnostic device of the gastrointestinal tract, containing a power source, an actuator including a multi-electrode probe connected through a connector to an information processing and display unit, including a storage device, a microcontroller connected to the ADC and DAC, a measuring unit, and a computer interface , display and keyboard, characterized in that the actuator includes an identification element made in the form of a microchip and connected through a connector to the information processing and display unit, form The current equalizer of the information processing and display unit is made in the form of an analog switch connected to the sources of probing and stimulating currents, and the measuring unit is made in the form of a series-connected analog switch, an adjustable amplifier, and a detector. 2. The device according to claim 1, characterized in that for the possibility of carrying out rheographic studies, the information processing and display unit has a scaling element connected to a power source, a microconverter containing a microcontroller, and a measuring unit. 3. The device according to claim 1, characterized in that the storage device is made in the form of a NAND storage device.