RU2796872C1 - Device for transcranial phototherapy in the state of deep sleep - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to devices for physiotherapeutic exposure to light radiation, mainly for newborns. The technical result is achieved by the fact that the device for transcranial phototherapy in a state of sleep includes a housing for placement on the patient's head and functional units for irradiation, power supply and control of the phototherapy process. The body is made in the form of a headdress — a textile cap, in which internal pockets are made to accommodate functional units connected by flexible connecting tires, and the irradiation unit is located in the back of the head.

EFFECT: possibility of an autonomous safe personalized phototherapeutic transcranial effect on the patient's brain in a state of deep sleep using an autonomous device.

12 cl, 6 dwg

Description

SUBSTANCE: invention relates to medical equipment, namely, to devices for physiotherapeutic exposure to light radiation, mainly for newborns.

Known apparatus for transcranial physiotherapy magnetic laser exposure "Transcranio" (see T.G. Tyshkevich, O.E. Gurskaya, A.F. Gurchin, R.Yu. Seliverstov, Yu.M. Raigorodsky, G.A. Suslova, N Solomkina, Magnetolaser therapy in the rehabilitation of children with the consequences of perinatal encephalopathy, Physiotherapy, Balneology and Rehabilitation, No. 2, 2013, pp. 11-14.). The device "TRANSCRANIO" is intended for drug-free treatment of a number of diseases in adults associated with impaired cerebral circulation, impaired autonomic regulation of cranial nerve trophism, electroencephalographic parameters, impaired homeostasis and adaptation, as well as a decrease in the activity of regulatory structures of the brain, in particular, the hypothalamic-limbic systems. In addition, the device is intended for the treatment of neurological pathology in children, in particular the consequences of perinatal CNS lesions using transcranial exposure and the treatment of perinatal lesions of the cervical spine using paravertebral exposure.

The disadvantages of the device include the significant weight and size of the irradiators, which are fixed on a special bed for the patient and cannot be directly fixed on the head of a newborn child.

The design of the device and the method of its use does not imply its use for phototherapy in a state of deep sleep.

A device for laser phototherapy is known (see RU137201, IPC A61N 5/00, published on February 10, 2014), consisting of a hard helmet containing laser irradiators, a cooling system, temperature sensors and an impedancemeter unit.

The disadvantages of this device should also include the bulky design and the impossibility of therapy in a state of deep sleep.

Other known devices for photostimulation of the brain also have similar disadvantages - a bulky design in the form of a helmet, the impossibility of autonomous use (see CN204815395, IPC A61H39/00, publ. .2007).

A device for automated photobiomodulation is known (US 2020/0360715, IPC A61B5/00, publ. 11/19/2020), consisting of a flexible or rigid headband for recording an electroencephalogram (EEG), on which, in addition to EEG electrodes and sensors of physiological parameters, optical emitters are located intended for therapeutic effects on the brain.

The disadvantages of this device include the presence of remote instrumentation units that are connected to the headband by means of cables, as well as a bulky structure containing a large number of elements placed over the entire surface of the head, which can only be used by adult patients and interferes with the normal position of the head in a state of sleep.

The closest solution is a photobiomodulation device (WO2022010952, IPC A61N5/06, publ. 01/13/2022), which is a body, the shape of which corresponds to the shape of the outer surface of the human head in the region of the frontal lobes of the brain, which is fixed on the head with an elastic band and contains a lot of infrared LED emitters that provide photo exposure according to a given program. The design of the device provides screening of the patient's head from electromagnetic fields caused by the operation of electronic control circuits, and also provides the ability to control the device through a wireless connection with portable devices such as smart watches, tablets, smartphones. The location of the main elements of the device in the forehead area of the patient does not interfere with its use in a state of normal sleep.

The disadvantages include the impossibility of irradiating the occipital regions of the brain, as well as the impossibility of autonomous use of the device to detect the state of deep sleep, in addition, the use of a non-replaceable housing reduces the hygienic qualities of the device.

A technical problem is the need for a device that provides autonomous phototherapy of the occipital lobes of the patient's brain in a state of deep sleep, which can be used, in particular, for the rehabilitation and treatment of perinatal lesions in newborns.

The technical result of the invention is the possibility of an autonomous safe personalized phototherapeutic transcranial effect on the patient's brain in a state of deep sleep using an autonomous device.

The technical result is achieved by the fact that in a device for transcranial phototherapy in a state of sleep, mainly for newborns, including a housing for placement on the patient's head and functional units for irradiation and controlling the phototherapy process, according to the solution, the housing is made in the form of a headdress - a textile cap, in which has internal pockets for accommodating functional units connected by a flexible connecting bus, and the unit for irradiation is located in the back of the head.

In addition, functional units have housings with non-slip outer coatings and rounded corners, which are shielded from electromagnetic radiation and have a wedge shape.

The invention is illustrated by drawings, where in Fig. 1 shows a general view of the device, Fig. 2 - the position of the device on the head of the patient, Fig. 3 is a variant of the printed circuit board of the phototherapy process control unit, FIG. 4 - external view of the model of the device on the dummy, the inset shows the operation of the LED indicator of the laser irradiator unit, fig. 5 is a fragment of a recording of one EEG channel of a patient in deep sleep, fig. 6 - change in the EEG signal during the transition of the patient to a state of deep sleep.

Positions in the drawings indicate:

1. Beanie;

2. Headband;

3. Instrument module (phototherapy process control unit);

4. Irradiator;

5. Irradiator control unit;

6. EEG electrodes;

7. Battery module;

8. Connector for connecting EEG electrodes;

9. Input amplifier;

10. Amplifier of the second stage;

eleven. Analog to digital converter;

12. microcontroller;

13. USB bus interface;

14. USB connector;

15. Wireless interface module.

The device contains a cap 1 made of textile material, which is provided on the inside with pockets for accommodating functional units. The device may contain a headband 2 in the form of a flexible tire for connecting functional units.

The device may include a set of sensors for recording the physical and physiological parameters of the patient and the environment, including an autonomous EEG recorder, as well as a computing device designed for automated detection of the state of deep sleep. In addition, the device can provide real-time broadcast of the recorded parameters and receive control signals from an external portable device.

The device in the embodiment shown in the drawings includes the following functional units:

- node for controlling the process of phototherapy - instrumental module 3;

- an irradiation unit consisting of a flexible low-profile irradiator 4 (a system of fiber-optic light guides or a flexible board with distributed emitters in the form of light-emitting diodes) and an irradiator control unit 5;

- power unit - battery module 7.

The printed circuit board of module 3 contains a connector 8 intended for connecting electrodes 6 for recording the patient's EEG. The module provides simultaneous recording of two EEG channels, each recording channel includes an input amplifier 9, an amplifier of the second stage 10 and an analog-to-digital converter 11. A microcontroller 12 is used to control the process of EEG recording, data transmission and detection of a deep sleep state, programming the instrument module, its operation and data transfer is carried out using the universal serial bus interface USB 13, 14, as well as using the wireless interface 15 .

Functional nodes 3, 4, 5, 7 of the device are placed in the inner pockets of the headgear (cap) 1 (Fig. 1), corresponding to the size of the patient's head, the slots of the pockets and the headband 2 are hidden under the forehead (lapel) of the cap. The length of the headband 2 can be adjusted to exactly match the size of the patient's head.

Headband 2 is a flexible bus with conductors that provide electrical connections between functional units. In front of the headband, an instrument module 3 is fixed, which contains a microprocessor control system for the device, a memory card for recording data, a wireless control and data transmission interface, an electroencephalogram recording and analysis unit, and

also environmental sensors (temperature, humidity, light sensors, accelerometer, microphone, etc.).

In the occipital part of the headband there is a phototherapeutic device consisting of an irradiator 4 designed for uniform distribution of laser radiation energy over the surface of the patient's head and an irradiator control unit 5, which contains semiconductor laser sources of infrared radiation, a cooling system and power supply for laser radiation sources. The irradiator 4 is located outside the pocket or in a transparent pocket and provides unhindered uniform exposure of the occipital part of the patient's head with laser radiation. In the body of the irradiation unit 4, 5, there is also a photoplethysmographic sensor for pulse and blood oxygenation, which is in contact with the patient's scalp and is used to obtain information about the state of the cardiovascular system and detect the state of deep sleep. As the main means of detecting the state of deep sleep, registration and analysis of the electrophysiological activity of the patient's brain in real time is used. To register the EEG, several electrodes 6 are used, attached to the headband, as well as a reference electrode, which is glued to the patient's skin behind the ear (not shown in the drawing). The device is powered by batteries placed in the battery module 7, also attached to the headband. The headband and all functional units are made waterproof, have a non-slip soft outer coating and rounded corners, the wedge shape of the cases ensures their secure fixation in the pockets of the hat. The design of the housings provides shielding of electromagnetic radiation associated with the operation of the device. The design of the device allows you to use it with hats of various types - insulated or lightweight ventilated. Between the pockets of the cap, volumetric inserts of soft ventilated material can be made, which hide the protruding housings of the modules. The irradiator 4 can be made low-profile (thin) and flexible, for example, using fiber optic light guides, to ensure maximum comfort for the patient in the supine position.

The appearance of the cap with the device modules placed in it is shown in Fig. 4.

The design of the device complies with the sanitary and hygienic requirements for medical devices and allows disinfection. The body of the device (cap) is made interchangeable. The use of an individual removable cap that completely hides the functional units ensures the psychological comfort of the staff and parents of the newborn, as the device has a familiar look and differs little from the usual item of children's clothing.

The device works as follows: due to the pronounced individuality of the electrophysiological picture of deep sleep in newborns, before starting regular use, a preliminary adjustment of the deep sleep state detector is performed. To do this, the maximum number of electrodes is used to record the patient's EEG, and the readings of other sensors that are part of the device are taken into account: an accelerometer that records motor activity, a temperature sensor, humidity sensor, data from a photoplethysmographic sensor regarding pulse and blood oxygenation.

In FIG. 5 shows an EEG signal characteristic of a deep sleep state. In this state, there is an increase in the amplitude of the EEG signal and the predominance of low-frequency fluctuations in it in the delta range (0.5 - 3.5 Hz) [see. Iber C. et al. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications, 1st ed.: Westchester, Illinois: American Academy of Sleep Medicine, 2007; Kovalzon V. M. Fundamentals of somnology: physiology and neurochemistry of the wake-sleep cycle. - M.: BINOM. Knowledge Laboratory, 2012. - 239 p.; Wayne A.M., Hecht K. Human sleep: Physiology and pathology: (USSR - GDR). - M.: Medicine; Berlin: People and health, 1989. - 269 p.]. The transition point to the deep sleep state is shown in detail in FIG. 6, starting from the 65th second, the amplitude increases and the frequency of the EEG signal decreases.

Based on the received data, a signal is generated about the onset of a deep sleep state, which is transmitted via a wireless interface to the terminal of the operator-observer in real time. The observer gets the opportunity to view the recording of physiological parameters performed by the device and visually assess the state of the sleeping patient. Based on this data, the observer can accept or reject the signal. Also, data labeling can be carried out on the basis of a complete recording of physiological parameters by the device.

The presetting of the deep sleep state detection system provides a personalized physiotherapy treatment for the patient. Once configured, the device can be used completely autonomously, minimizing patient exposure to wireless interface radiation. In therapeutic mode, the device continuously records the values of the patient's physiological parameters, analyzes them in real time, and, upon detecting a state of deep sleep, generates a command to turn on the laser emitter in accordance with the specified program of therapeutic exposure. During the operation of the laser emitter, the signal LED indicators located at the top of the irradiator turn on 4 (FIG. 2) as shown in FIG. 3. The brightness and mode of the indicators can be adjusted using the wireless interface. The signal to turn on the laser emitter is also transmitted to the operator's terminal via a wireless interface.

The use of this invention makes it possible to implement a method for stimulating the lymphatic system of the brain RU2766527 (IPC A61N5/00, publ. 03/15/2022) based on increasing the efficiency of photo exposure when irradiating the patient's brain in a state of deep sleep.

Claims (13)

1. A device for transcranial phototherapy in a state of sleep, including a housing for placement on the patient's head and functional units for controlling the process of phototherapy, power supply and irradiation, characterized in that the body is made in the form of a headdress - a textile cap, in which internal pockets are made to accommodate functional control, power supply and irradiation units connected by a flexible connecting bus, while the irradiation unit is located in the back of the head. 2. The device according to claim. 1, characterized in that the cap has a lapel, and the flexible tire is made in the form of a headband placed in the lapel of the cap. 3. The device according to claim 1, characterized in that the body is made in the form of a headdress for newborns. 4. The device according to claim 1, characterized in that volumetric inserts are made between the pockets of the cap. 5. The device according to claim. 1, characterized in that the body is made interchangeable. 6. The device according to claim 1, characterized in that the functional units have housings with non-slip outer coatings and rounded corners. 7. The device according to claim 6, characterized in that the cases of functional units are shielded from electromagnetic radiation and have a wedge shape. 8. The device according to claim 1, characterized in that it is equipped with sensors for recording the physical and physiological parameters of the patient: an electroencephalogram recorder, a photoplethysmographic pulse sensor and blood oxygenation, an accelerometer and a temperature sensor; and humidity and ambient temperature sensors. 9. The device according to claim 8, characterized in that the phototherapy process control unit is configured to automatically detect a deep sleep state based on data recorded by the sensors. 10. The device according to claim. 1, characterized in that it is made with the possibility of wireless interactive control of the photo-exposure process. 11. The device according to claim 1, characterized in that the irradiation unit contains a low-profile irradiator in the form of a flexible board with distributed emitters in the form of diodes and an irradiator control unit. 12. The device according to claim 11, characterized in that the irradiator control unit is programmed to implement personalized therapy, taking into account the individual characteristics of the patient. 13. The device according to claim 1, characterized in that the functional units are waterproof.

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