WO2013100776A1

WO2013100776A1 - Method for autonomous programmable electrical muscle stimulation and device for implementing same

Info

Publication number: WO2013100776A1
Application number: PCT/RU2011/001031
Authority: WO
Inventors: Дмитрий Вячеславович ИШУТИН; Дмитрий Владимирович СКВОРЦОВ
Original assignee: Ishutin Dmitrij Vjachyeslavovich; Skvortsov Dmitrij Vladimirovich
Priority date: 2011-12-28
Filing date: 2011-12-28
Publication date: 2013-07-04

Abstract

The invention relates to the field of medicine, in particular to traumatology, orthopaedics and neuropathology, prosthetics, angiology and rehabilitation, and can be used for the remedial treatment of patients with various diseases of the locomotor, nervous and vascular systems, such as osteochondrosis, peripheral and central paralyses and pareses, extremity defects and spinal pathology, and for the treatment of children with cerebral palsy and other associated pathology. The technical result of the present invention consists in the possibility of ensuring accurate programmable electrical muscle stimulation and correction of movement in various periodic locomotions and conducting locomotor-oriented stimulation for immobilized patients both under conditions in a medical institution and outside such a medical institution independently by the patient himself. This problem is solved by virtue of the fact that, in the present invention, a channel for electrical muscle stimulation during walking and during various periodic locomotions other than walking, including locomotions of the upper extremities and the torso, is in fact formed autonomously in one housing with a power supply source, a control processor, synchronizing inertial sensors (accelerometers and gyroscopes), an electromyogram recording channel, a bidirectional channel for radio data transmission and control from a software package over a radio channel from a control computer via a wireless communication device which is connected thereto.

Description

METHOD OF AUTONOMOUS PROGRAMMABLE ELECTRIC STIMULATION OF MUSCLES AND DEVICE FOR ITS IMPLEMENTATION

DESCRIPTION

The invention relates to medicine, in particular, traumatology, orthopedics and neuropathology, prosthetics, angiology, rehabilitation and can be

used for reconstructive treatment of patients with various diseases of the musculoskeletal, nervous and vascular systems, such as osteochondrosis, peripheral and central paralysis and paresis, limb defects, spinal pathology, for the treatment of children with cerebral palsy and other combined pathologies.

In Russia and abroad, in recent decades, various types of functional electrical stimulators have been developed.

In subsequent similar developments, all the necessary adjustments were assigned to the control computer program, which is not only much more convenient, but also allows you to flexibly change the stimulation program (RF patent N2 2082452, 1997). In order to avoid the use of a long cable connecting the patient and the control computer, a device was developed where the cable is replaced

radio channel (RF patent N2 2126276, 1999). The use of the radio channel makes the patient autonomous, but on the other hand, independent movement of the patient can lead to the fact that he will be outside the coverage of the transceiver. This device has the ability to select the installation

goniometric sensors on the knee or hip joint, however

using sensors on both joints at the same time is not possible. In addition, the technical design does not allow the stimulator unit to be carried out in one housing adapted to be worn by the patient, therefore, the unit was divided into stationary and wearable.

The Ogonyok company, Moscow, developed the Multimiostim - AKorD-08 device. This device is designed for electrical stimulation of muscles when walking, has eight channels muscle stimulation and a goniometric sensor for the knee joint and is a stand-alone device that is connected to a computer only to download the stimulation program. Autonomous operation of the device is one of

its attractive qualities. This device has rough settings for stimulation modes and the most important drawback is the inaccurate setting of the temporary stimulation program. The step cycle in the program of this device is divided into only 16 parts. Therefore, the maximum, theoretically possible installation accuracy

the temporary work program of the muscle is much lower than the permissible level. A significant disadvantage of this device is that it allows synchronization from only one knee motion sensor, i.e. both sides (right and left) are synchronized from the sensor located on one of the sides. The indicated design feature significantly limits the possibility of using this device, which can only be used for almost periodic walking, provided that the knee joint is intact.

The device itself consists of a battery-worn unit on the belt, stimulating electrodes and a motion sensor in the knee joint.

The closest solution selected for the prototype is a method and device for programmed electrical stimulation of muscles (RF Patent N2 2265461). The device allows for accurate, metered electrical stimulation with the possibility of preliminary biomechanical diagnostics and stimulation control in real time. This is the most perfect complex of analogues. However, in it communication with the patient is carried out by cable, which significantly limits his freedom. In addition, the traditional biomechanical sensors and electrodes used require the installation of a significant number of squeezing limbs or the body of elastic cuffs. Each electrode or

a synchronizing biomechanical sensor is connected to the stimulating unit by cable, so that the maximum number of cables on a patient can reach up to 20 pieces.

Any of the above devices has common features for the claimed device: the presence in the design of the actual stimulator block, electrodes mounted on the muscles, synchronizing biomechanical sensors, a computer with a control program, trunks, and accessories.

The listed analogues, in addition, have a number of common limitations listed below, which significantly affect the possibility of using the method of functional electrical stimulation for various categories of patients.

The limitations are as follows:

1. The inability to use programmed stimulation outside the walls of the hospital, which is associated with several factors:

A) The complexity of installing electrodes, synchronizing sensors, which requires appropriate skills and qualifications and in some cases cannot be performed by the patient himself due to the anatomical features of the structure of the human body.

B) The transmission of control signals and the receipt of information from synchronizing sensors is via cable. In those systems where disconnection from the cable occurs, the stimulation process continues automatically without transmitting information about the operation of stimulating channels and synchronizing sensors wirelessly.

B) The method of programmed stimulation involves daily procedures lasting up to 1 hour, a course of 10-15 procedures. This circumstance also significantly limits the throughput in a hospital setting and has economic limitations associated with the ability to engage qualified medical personnel.

2. The inability to use synchronizing biomechanical sensors in the form of separate devices (goniometers of movements in the joints and support sensors for the foot) without the help of qualified medical personnel. The complexity of their installation on the patient’s body.

Each sensor requires the use of a special mount on the patient's body and the presence of a long cable connecting it to the stimulation unit. Mounts of goniometric sensors compress the limb and interfere with its normal blood supply. The long cable of the synchronizing biomechanical sensor also requires special laying on the body in order to allow the limbs to move freely and not to touch outside obstacles. 3. The inability to use for synchronization of biomechanical events associated with the movement of various segments of the body.

The use as synchronizing sensors of the angle of motion in the joint and support sensors only requires constant monitoring of the treatment process and

accordingly, the work of highly qualified medical personnel, since the characteristics recorded by them are subject to change, including as a result of the programmable stimulation itself, patient fatigue, weakening of the fastening of goniometric sensors, and displacement of reference sensors. In addition, these types of synchronizing sensors can not always be used, for example, if the frequency of movement in the joints is violated or the foot steps on the support.

4. Impossibility, and for a number of diseases - significant difficulties in

using existing systems.

Existing analogues have a number of limitations when using, since they are, to a large extent, oriented to work in the patient’s walking mode, which significantly reduces the possibilities of programmed stimulation for the treatment of pathology of the upper limbs and spine, where walking is not the main locomotion.

5. In the described devices, a technical solution is implemented using one stimulating unit, from which the cables of the stimulating channels and

synchronizing sensors. This greatly complicates the installation procedure for the entire set of equipment. Stimulating electrodes are usually attached

circular cuffs that impede movement and blood flow in the limb. Each electrode has its own cable, which must be mounted on the patient so that it does not interfere with movement and cannot be touched and pulled out of the socket.

6. The inability to arbitrarily increase the number of stimulating channels.

In existing complexes, the number of stimulating channels is fixed and is determined by the design of the stimulating block (usually not more than 8), so their number cannot be changed.

7. The inability to conduct a diagnostic electromyographic study in in the form of a functional surface electromyogram during movement.

The technology of programmed electrical stimulation is aimed at changing the phase bioelectric activity of the muscle. However, existing devices for its implementation do not have the ability to register the actual functional electromyogram.

To overcome the above limitations, the proposed complex of diagnostics and programmed stimulation with isolated

radio-controlled channels.

The technical result of the present invention is the ability to provide accurate programmable electrical stimulation of muscles and movement correction in various periodic locomotions and conducting locomotor-oriented stimulation for immobilized patients, both in a medical institution and outside it by the patient himself.

Brief Description of the Drawings

Figure 1 shows the principle of operation of the device for electrical stimulation of muscles, where 1 is the patient’s muscle, 2 is the channel of electrical stimulation in a separate building, 3 is the control computer, 4 is a wireless communication device.

Figure 2 shows the structural device of the electrostimulation channel (a - block diagram of the internal device, b - bottom view, c - side view), where 5 is the power source, 6 are synchronization sensors, 7 is the registration channel of the electromyogram, 8 is a two-way channel data transmission (wireless device), 9 - control processor, 10 - electrical contacts on the housing, 11 - adhesive electrodes.

This problem is solved due to the fact that (see Fig. 1, Fig. 2) in the present invention, the actual channel of muscle electrical stimulation when walking and with various

periodic locomotion other than walking, including locomotion of the upper limbs and trunk, made autonomous in one building (2) with a power source (5), a control processor (9), inertia-type synchronization sensors (6) (accelerometers and gyroscopes), a recording channel electromyograms (7), a two-way channel (8) for transmitting data via radio and control from a software package over a radio channel from a control computer (3) through a wireless device (4) connected to it. Moreover, the number of simultaneously used autonomous channels can increase arbitrarily. The method of programmed muscle electrical stimulation during periodic patient locomotion, which consists in the fact that muscle electrical stimulation is performed

stimulating pulses from electrodes mounted on predefined muscle groups, stimulating pulses are synchronized with

biomechanical inertial sensors, characterized in that the moment

synchronization is determined by the phase and amplitude of each type of biomechanical inertial sensors, and three-component accelerometers and gyroscopes are used as biomechanical sensors, and adhesive electrodes connected to the housing of the stimulating device, in which

install all used sensors. The moment of synchronization is determined by the phase and amplitude of movement, rotation, tilt. Quantity at the same time

used individual devices build up arbitrarily. The setting of stimulation modes is carried out taking into account the result of the registration of an electromyogram.

In order to simplify the technique and the possibility of its implementation by the patient

independently, the stimulation channel is built into the body of the stimulating device, which is equipped with its own power supply, a control processor and built-in synchronization sensors, and the mode of its operation is set by the doctor. The control of the stimulation procedure and the necessary correction of its parameters is carried out by means of communication via the radio channel of the device with

standard wireless devices that receive and transmit data on the Internet.

A device for autonomous programmable electrical stimulation of a patient’s muscles, comprising a unit including a stimulation channel, a recording channel

electromyograms, inertial biomechanical sensors, two-way radio communication channel, power supply, electrodes mounted on the patient’s muscles, a computer with a control program and a wireless device,

characterized in that the device is arranged to independent synchronization from own sensors or from similar sensors of another of the same device with the implementation of data transmission over the air, the device is placed in a separate compact housing and is configured to be attached to the patient’s body by means of adhesive electrodes located on the outside of the housing. The stimulating channel can be made in one housing with synchronizing sensors, a power source and a control processor. The device as an option contains inertial sensors three-component gyroscopes and accelerometers, the function of which is synchronization.

The implementation of the invention

The sequence of the stimulation procedure consists of:

installation of the device (2) on the stimulated muscle (1) of the patient with

using glued electrodes (11), contacts (10) mounted on the electrical outlet on the device body (2), which do not cause squeezing of the limb and make it easy to install the device on the muscle (1) of any segment of the body (trunk, limbs);

^• registration of electromyogram data (7) and inertial sensors (6) during test patient movements with their transmission over the air (8) in real time;

^• analysis of an electromyogram (7) and data of inertial sensors (6) in

specialized software and setting the mode of stimulation and synchronization in phase and amplitude from one or more inertial sensors (6), as well as rotation, tilt of the body (2) of the device;

^• checking the operation of the stimulating channel and synchronization with its work with the movement of the patient in real time.

Similarly, other devices are tuned in terms of the number of muscles stimulated. The last stage of the operation check can be performed for all working devices at once. Once the operating mode of the devices is set, they can function independently without communication with the software package. Moreover, if several devices are working simultaneously on the same patient for synchronization not only their own inertial sensors of this device can be used, but those of any of the devices with the transmission of information over the air.

In contrast to the synchronization sensors used in similar systems in the form of goniometers and reference sensors for the foot, the inertial sensors proposed in this device - three-component accelerometers and gyroscopes respond to the movement of this body segment independently of other segments. This is most important for the operation of the autonomous channel, since in normal mode it is necessary to use to synchronize the movement of the same segment of the body where this device is located.

For accurate adaptation and tuning of the temporary stimulation program, the following features of the autonomous channel are provided:

- determination of the duration of the step cycle or other movement of the patient,

- continuous current analysis of the duration of the step cycle or cycle of another movement with the adjustment of stimulation parameters for the last cycle,

- determination of the rhythm of the step or the rhythm of another cyclic movement (when the rhythm of the step changes, the stimulation stops and resumes when the rhythm of the movement is restored, including when the time of the movement cycle has changed).

To adapt the stimulating impulse to a specific patient, a smooth installation of the intensity of the stimulating impulse from the control software package is provided. If it is necessary to change the intensity of stimulation by the patient himself, this can be done using the control buttons on the device itself or via a radio channel.

If the patient is not able to make movements, then the device can conduct rhythmic stimulation in accordance with the established time program. When using multiple devices, you can arrange

radio channel stimulation, for example, in walking mode or other rhythmic movements.

The proposed complex is a diagnostic device and programmable electrical stimulation of muscles and consists of equipment installed on the patient and equipment mounted separately. An autonomous device (2) is fixed directly on the patient’s muscle (1) by means of two adhesive electrodes (11).

To obtain and analyze diagnostic information, as well as set stimulation modes, software is used for computers and other devices that incorporate or allow connecting standard types of wireless communications.

Depending on the condition of the patient, an electrical stimulation session is carried out, as a rule, daily, lasting 20-60 minutes. The total number of procedures is up to 10 or more to achieve the desired effect.

Claims

CLAIM

1. The method of programmed muscle electrical stimulation during periodic patient locomotion, which consists in the fact that muscle electrical stimulation is performed

biomechanical inertial sensors, characterized in that the moment

install all used sensors.

2. The method according to p. 1 characterized in that the synchronization moment is determined by the phase and amplitude of movement, rotation, tilt.

3. The method according to p. 1, characterized in that the number of simultaneously used individual devices is increased arbitrarily.

4. The method according to claim 1, characterized in that the setting of the stimulation modes is carried out taking into account the result of the registration of the electromyogram.

5. The method according to claim 1, characterized in that, in order to simplify the methodology and the possibility of its implementation by the patient, the stimulation channel is built into the stimulator device body, which is equipped with its own power supply, control processor and built-in synchronization sensors, and its operation mode is set by the doctor.

6. The method according to p. 1 characterized in that the control of the stimulation procedure and the necessary correction of its parameters is carried out through communication

a device’s radio channel with standard wireless devices that receive and transmit data on the Internet.

7. Device autonomous programmable electrical stimulation of the muscles of the patient, containing a block including a stimulation channel, a registration channel

electromyograms, inertial biomechanical sensors, two-way radio communication channel, power source, electrodes mounted on the patient’s muscles, a computer with a control program and a wireless communication device, characterized in that the device is capable of independently synchronizing from its own sensors or from similar sensors of another of the same devices by transmitting data via a radio channel, the device being placed in a separate compact housing and configured to fastening to the patient’s body by means of adhesive electrodes located on the outside of the case.

8. The device according to claim 7, characterized in that the stimulating channel is made in one housing with synchronizing sensors, a power source and a control processor.

9. The device according to claim 7, characterized in that it contains inertial sensors, three-component gyroscopes and accelerometers, the function of which is synchronization.