SYSTEM FOR CONTROL AND RESPIRATORY FUNCTION MAINTENANCE

Abstract

The invention relates to medicine, The technical result of the present invention is to increase the efficiency of treatment of the respiratory system pathologies. The system includes a communication unit connected to a ventilator, a human-machine interface unit, a data processing, storage and management unit, an algorithmic unit, a pulse generation unit, a unit of electromyography electrodes and a stimulation.

Claims

1. A system for control and respiratory function maintenance by neurostimulation of patients on mechanical ventilation comprising: a communication unit connected to a ventilator, a human-machine interface unit, a data processing, storage and management unit, an algorithmic unit. a pulse generation. unit, a unit of electromyography electrodes, and a stimulation. (EMG unit), wherein the communication unit is connected to a ventilator through a communication interface capable of receiving data on parameters of the ventilator and sensors that determine an amount of carbon dioxide, an amount of oxygen, a volume of the air entering the lungs, and inspiration and expiration frequency, and of transmitting data to a control unit of the ventilator for parameters of the pulse generating device, and a human-machine interface unit including a data input means for a pulse generation unit control and an information output means, and a data processing, storage and management unit is associated with ensuring a receipt and transmission of data, with the communication unit connected to the ventilator, to the human-machine interface unit and to the algorithmic unit, and wherein an input of algorithmic unit is connected to an output of EMG unit, and an output of algorithmic unit is connected to the pulse generation unit to control stimulation electrodes, and wherein the algorithmic unit is configured to synchronize data received from the sensors of EMG unit and to output data transmitted to a pulse generation unit, and wherein the pulse generation unit is configured to generate pulses to stimulate the intercostal muscles, diaphragm, abdominal muscles, cervical and thoracic spinal cord with different pulse parameters for each muscle type.

2. The system of claim 1, wherein the data processing, storage and management unit receives parameters characterizing a mode of operation of stimulating electrodes.

3. The system of claim 1, wherein parameters of the pulse generation. unit include parameters characterizing data received from a unit of electromyography electrodes and stimulation.

4. The system of claim 1, wherein data on operation of the pulse generation unit includes device settings, statistical parameters and operating mode parameters.

Description

BRIEF DESCRIPTION OF THE ATTACHED DRAWINGS

[0035] The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

[0036] In the drawings:

[0037] FIG. 1 the general diagram of the interaction between the components of the complex, which includes a pulse generation unit.

[0038] FIG. 2 is a structural diagram of a pulse generation unit for a respiratory monitoring system in patients connected to artificial lung ventilation devices.

[0039] FIG. 3 is a diagram of external devices connection to a human-machine interface unit.

[0040] FIG. 4 is a schematic of electrodes connection to impulses generating device for a respiratory monitoring system in patients connected to ventilators.

[0041] FIG. 5 is a schematic of electrodes connection to impulses generating device for a respiratory monitoring system in patients connected to ventilators.

[0042] FIG. 6 is a schematic of electrodes connection to impulses generating device for a respiratory monitoring system in patients connected to ventilators.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0043] Reference will now be made in detail to the preferred embodiments of the present invention, examples of which are illustrated in the accompanying drawings.

[0044] The device for generating impulses (hereinafter DGI) is a component of the “Neuro-lungs” complex. The generalized structure of interaction between the components of the “Neuro-lungs ” complex is shown on FIG. 1.

[0045] The main functional purpose of the DGI device: [0046] Receiving information from external systems; [0047] Transmission of information to external systems; [0048] Formation and delivery of electrical impulses with established electrical and time characteristics to external connected electrodes; [0049] Registration of electrical activity of muscles (8-channel EMG system); [0050] Provision of a human-machine interface for input of tuning parameters, as well as displaying information about the operation of the complex (via the Device for Parameters Setting).

[0051] To perform these functions, the DGI was designed with the following set of units: 1—a data processing, storage and management unit; 2—a communication unit; 3—a human-machine interface unit (HMI); 4—an algorithmic unit; 5—a pulse generation unit, 6—an EMG unit. In addition, the transfer of information to external systems (the so-called “feedback”) must be ensured. The transmitted information should describe the operating modes of the DGI device and its individual components. The sets of parameters transmitted from the DGI to external systems are adjusted depending on the need and type of external device connected.

[0052] Basically, there are 3 groups of parameters: [0053] output parameters for DGI (characterizing the operating mode of the electrodes); [0054] input parameters for the DGI (characterizing the EMG [0055] internal parameters of the DGI (operating mode, tuning parameters, statistical, etc.).

[0056] To ensure the synchronization function of the process of stimulation with the respiratory function, the device circuitry provides a unit for processing signals received from the ventilator. The transmission of information from external systems is implemented by using electrical interfaces (Ethernet, RS232, USB, etc.). The interface type, exchange parameters, as well as the exchange protocol are set depending on the availability of such in external systems. Communication unit 2 with external systems must contain hardware and software modules. Hardware modules are responsible for the physical implementation of the selected interface. Software modules are part of the firmware and are a set of drivers of the corresponding protocols.

[0057] Human-machine interface unit 3 (hereinafter HMI) provides an interface between a user and a “Neurolungs” complex. The control/parameters settlement/complex setting in different operation modes is accomplished using this unit. Also, this unit is used to display all the information of the “Neurolungs” complex to the user. HMI unit provides the work in two basic modes: settlement mode, monitoring mode.

[0058] FIG. 3 schematically shows the options for using unit 3 in the described modes, where in the monitoring mode 16 unit 3 includes the information output device 11 connected via HDMI 13 interface and information input device 12 connected via USB interface 14.

[0059] The tuning/settlement mode 17 is used by the operator of the complex to enter the necessary tuning parameters, the task of operating modes for a specific selected case. This mode allows the system user (namely, the medical personnel responsible for treating the patient) to control the complex, to set the necessary parameter values. For these purposes, a personal computer PC 15 connected via the USB 14 interface under control of the OS is used (a portable/laptop PC is recommended). To perform the described actions, the Host application must be installed on the PC.

[0060] The monitoring mode is used for the process of monitoring the patient's condition, as well as the operation of the entire complex. For the settlement mode, namely for outputting information, the information output device 11 (external monitor) must be used. Connection to the DGI device is carried out through a graphical interface. Video signal is transmitted with parameters of 720p@ 50/60 Hz.

[0061] In addition, for the settlement mode, it is possible to enter (correct) the set of operating parameters in real time. To accomplish this task, it is necessary to provide for the connection of an information input device 12 via an interface (USB or other) 14.

[0062] Data processing, storage and management unit 1 provides the receiving, storing and transmitting of all data to/from the complex accomplishes the mathematical processing, computing, control of the work of all the constituent units of DGI devices. Unit 1 is a set of hardware and software tools—a computer, the main modules of which are: a microprocessor, random access memory (RAM), read-only memory (ROM), system or micro ss-board, bus controllers. Software means of unit 1: operating system; control program; built-in software (for some versions).

[0063] For the basis for the implementation of hardware can be selected baseboards with processor modules: SOM

[0064] (System On Module); ETX; microProcessor modules; PICO; SMARC or others.

[0065] Algorithmic unit 4 is responsible for implementing the algorithms of the complex, and namely for forming and issuing electrical pulses defined by electrical and timing characteristics to multiple electrode 9.

[0066] Additionally, unit 4 performs the function of receiving and processing data obtained from EMG.

[0067] This unit is a software. Separated from all other software components of the system, since designed to perform the basic algorithms of the “Neurolungs” complex.

[0068] A pulse generation unit 5 is responsible for the formation of electrical pulses with the required characteristics (amperage, voltage, frequency, flow rate, pulse shape, etc.) and is a hardware unit of the analog output stage (at least 8 channels for connecting with multiple electrode 9).

[0069] For peripheral control of respiration, impulses are used to stimulate the following muscles:

[0070] Internal and external intercostal muscles: [0071] Scalenus muscles; [0072] Serratus dorsalis inspirator and expiratory muscles; [0073] Abdominal muscles; [0074] Iliocostalis muscle; [0075] Musculus transversus thoracis; [0076] Diaphragm;

[0077] For facilitation and maintenance of the rhythmic respiratory activity, impulses are used to stimulate the spinal cord using non-invasive and invasive approaches: [0078] Cervical segments of the spinal cord; [0079] Thoracic segments of the spinal cord.

[0080] For each of these types of muscles or stimulated spinal cord segments, and the parameters of electrical impulses are different. In addition, the parameters of electrical impulses for a specific muscle group differ for each patient and are calculated each time separately depending on the age, height, weight of the patient, his general condition, the data obtained on muscle contraction during stimulation, the mode of operation of the ventilator, data from gas sensors. O.sub.2 and CO.sub.2 in blood (for example, optical spectrometric sensors), respiratory frequency, volume of air entering the lungs calculated using the data obtained from flow and pressure sensors.

[0081] The number of channels for connecting electrodes in the DGI device is at least 8 channels.

[0082] For each channel, it is possible to generate electrical impulses with the following characteristics: [0083] Minimum pulse duration—1 ms; [0084] Frequency range of filling a pulse with a modulated signal—from 100 Hz to 10 kHz (with a step of 10 Hz); [0085] Amperage—from 20 to 150 mA.

[0086] Unit 5 is controlled by algorithmic unit 4, which sends information about the parameters of the electrical impulse. Unit 5 performs exclusively generation.

[0087] Unit 5 may contain a different composition of submodules with different functional purposes. In this case, the stimulation unit contains a unit of digital-to-analog converters, the output of each of which is connected through an amplifier with an electrode from multiple electrodes 9, through which electrostimulation is carried out and from which EMG data is taken directly during the rehabilitation procedure (FIG. 4).

[0088] According to the circuit shown on FIG. 5, and the measuring unit includes comparators, where the connection points of each electrode are disposed on both sides of the resistor connected after the amplifier and transmits the obtained value to the algorithmic unit.

[0089] According to the scheme on FIG. 6, the measuring unit includes the unit for test signals generation, comprising data acquisition system to which the electrode is connected across the test amplifier and a measuring amplifier also connected to the electrode of the test circuit.

[0090] As sensors are used the adhesive reusable electrodes comprising a substrate of non-woven insulation material, e.g., polyethylene terephthalate, conductive element and biocompatible conductive hydrogel adhesive, and connected to the measuring and stimulating minutes chain by plugs.

[0091] Algorithmic unit 4 performs the function of EMG signal processing, digital filtering and diagnostics and as well, if necessary, and the preparation and transmission of EMG processed data, stimulation parameters for further processing and correction of stimulation parameters to the data processing, storage and management unit.

[0092] A generation device is a single housing hard- wired connected to electrodes, a control unit of the ventilator, sensors of respiratory characteristics and a human-machine interface unit. Units mentioned above are connected to a controller comprising an EMG signal processing module and a signal processing unit from sensors and a ventilator. The device operates both from a power network while the battery is being charged, and from a portable battery.

[0093] The device works as follows.

[0094] All information on the state of the device, the quality of electrode placement, data received from the ventilator, and recorded EMG signals is transmitted to the data processing, storage and management unit from the moment the device is turned on.

[0095] After placing the electrodes and turning on the device with the help of the keyboard, the device connects with EMG unit and the interelectrode impedance is estimated using an algorithmic unit. In the case of discrepancy of impedance to specified range, the error is displayed on the indicator indicating the incorrect installation of electrodes, it is recommended to reinstall the electrodes and to make the secondary evaluations of impedance.

[0096] The hardware and software unit for processing of input signals determines the connection and operability of the multiple electrode 9 for stimulation and EMG removal, indicates their operability in the information output device 14 and enables the program of the information data processing, storage and management unit to synchronize the operation of the stimulation pulse shaping unit with the EMG data using the algorithmic unit.

[0097] Next, the rhythm and volume of breathing is assessed (how optimally the lungs inhale air and exhale). In this case, the standard parameters of the rhythm and volume are taken as 100%, and the real ones are adjusted to them with the help of stimulation, by adjusting the frequency, amplitude and duration of the signal. Respiratory rhythm and volume are a more inert indicator than the data from the EMG unit, but nevertheless, the time for a sufficient collection of data is 1-2 minutes. The received data from the feedback of the ventilator and respiration sensors allow to select the optimal stimulation parameters for a given patient.

[0098] Finally, the content of gases (O.sub.2 and CO.sub.2) is estimated. This is the most inert parameter, the assessment of which often depends on the disease, the state of the lungs and the circulatory system. When a signal on a gas content is received that differs from the preset for a given patient, the stimulation parameters are selected to achieve 100% of the preset gas content. If, despite the stimulation, received information shows the insufficient amount of a gas content in the blood, then it is concluded that, in the current state, only the selection of stimulation parameters is not enough, and it is also necessary to additionally regulate the oxygen supply to the body.

[0099] The further mode of operation of the device is determined by the program of the rehabilitation procedure. Each program has its own set of stimulation parameter values and is designed for a specific problem. With the help of the information input device 12, it is possible to promptly control the stimulating effect (stimulation amplitude). The possibility to connect an information output device allows the doctor to observe all the information received from EMG sensors and from external systems (the ventilator and the O.sub.2, CO.sub.2 sensors used in it, the volume of air entering the lungs, the frequency of entry/exhalation), form complex synchronizing connections and stimulation parameters depending on the signals of the respiration sensors, the ventilator and EMG, other patient data and the results of stimulation, and, in fact, form a program for the therapeutic and rehabilitative use of the device.

[0100] Having thus described a preferred embodiment, it should be apparent to those skilled in the art that certain advantages of the described method and apparatus have been achieved.

[0101] It should also be appreciated that various modifications, adaptations and alternative embodiments thereof may be made within the scope and spirit of the present invention. The invention is further defined by the following claims.