Method for monitoring the state of a cortical brain implant user

Abstract

The invention relates to cortical brain implants for monitoring the state of health of a user. The present method includes placing a module in a user's head or on the surface thereof, registering a change in the position of the head and transmitting corresponding signals to a signal processing unit, comparing the obtained values with normal values and, in the event of an abnormality, transmitting a signal to a computer. In another embodiment, the method includes the steps of placing sensor modules on the surfaces of or inside the limbs and head of a user, registering a change in the position of the head and limbs and transmitting corresponding signals via a signal processing unit to a computer on which a model of the user's movement is generated, registering further changes in the position of the head and limbs and transmitting signals to the computer, where the obtained values are compared with normal values, and, in the event of an abnormality, issuing a corresponding signal. The inventions are directed toward increasing the accuracy of detecting abnormalities in the state of health of a cortical brain implant user and increasing the effectiveness of the rehabilitation process after installation of a brain implant.

Description

[0001] METHOD FOR MONITORING THE CONDITION OF A USER OF A CORTICAL NEUROIMPLANT

[0002] The present group of inventions relates to the field of bioengineering technologies and can be used in cortical neuroimplants to monitor the health status of its user.

[0003] In bioengineering, it is known that nervous tissue can be artificially stimulated and activated by implantable devices that generate electrical impulses. The passage of current through nervous tissue causes changes in the electrical potentials of neuronal membranes, which can lead to the occurrence of an action potential necessary for the transmission of information in the nervous tissue. Thus, through an implantable device (neuroimplant), it is possible to introduce information into the tissues of the central nervous system by means of a sequence of electrical impulses in which information for influence or control is encoded. Using this approach, it is possible to restore the dysfunctional capabilities of individual areas of the human brain after strokes or other head injuries, as well as partially restore lost sensory functions, such as hearing (using cochlear prostheses), vision (using visual prostheses), etc.

[0004] The first researcher to show how electrical impulses in the brain can control actions was Roberts Bartholomew. The American neurosurgeon demonstrated in 1874 that the human body can be manipulated by electrical stimulation [see Bartholow, R. Experimental investigations into the functions of the human brain. The American Journal of the Medical Sciences, 1874, 134, 305-313]. Thus, the concept of brain implants was born. One of the earliest applications of brain implants on living beings was demonstrated in 1952 [see Delgado JMR. Permanent Implantation of Multi-lead Electrodes in the Brain. Yale J. Biol. Med. 1952, 24, 351-8]. Jose Delgado demonstrated the ability to control the behavior of a bull using implanted electrodes, stopping a charging bull. The first attempts to implant neurostimulators into the human brain were made in the mid-1990s.Neurotrophic electrodes were implanted in paralyzed people, which allowed the person to control the computer cursor. It was these studies that served as a powerful impetus for the development of neuroimplants. Since the 1960s, developments have also been actively carried out in the field of cochlear and visual prostheses, which have now led to the emergence of ready-made technological solutions (such as Argus, Gennaris, Nestor, etc.).

[0005] One type of neuroimplant is cortical, which is a system that can replace motor, sensory, or cognitive functions of a person that may have been damaged by injury or disease. Cortical neuroimplants are located in direct connection with the cerebral cortex and can consist of a complex of external and internal (implanted) devices. By directly interacting with various areas of the cerebral cortex, a cortical neuroimplant can provide stimulation of the immediate area of ​​the brain and provide various benefits, depending on its design and location. Despite the rapid development of the implantable neuroprosthesis industry, many issues related to the durability of products and safety for users still remain unresolved.Active implantable brain devices may cause significant morphological changes in brain tissue due to neuroimplant rejection, which may lead to serious disruptions of vital human functions. Users of cortical neuroimplants (neurostimulators, cochlear, visual and other implants) must have their health continuously monitored to detect early any disruptions that may arise due to, for example, neuroimplant rejection by body tissues.

[0006] A method for monitoring the process of rejection of neuroimplants and disruption of normal tissue functioning by monitoring the temperature of surrounding tissues is known (see patent US7306621B1, published 12 / 11 / 2007), in which the operation of the heat transfer device is based on the Peltier heat transfer effect for cooling the surface of the retinal device facing the retina by dissipating / transferring the collected heat from the retina to the iris or the anterior part of the eye. According to the design of the device, a heat pump is formed in the second substrate of the retinal device, controlling the temperature measuring device activated when a predetermined temperature limit is exceeded. The temperature measuring device switches off the heat pump when the temperature of the retinal device falls below a certain temperature value.An increase in the temperature of biological tissue above the limit values ​​may indicate the occurrence of inflammatory processes near the neuroimplant or excessive thermal impact on the tissue through heat dissipation from the implant. A known method for monitoring the process of rejection of neuroimplants and disruption of tissue functioning by measuring tissue impedance (see patent application W02021059016A1, published on 01.04.2021), including: determining a transimpedance matrix for a plurality of electrodes of an implanted stimulator, detecting the characteristics of new tissue formation near at least one of the plurality of electrodes based on the transimpedance matrix and performing a therapeutic action based on the characteristics of new tissue formation. Measuring impedance makes it possible to monitor the processes of connective tissue formation (fibrous, scar tissue) near the neuroimplant and the degree of its proliferation.

[0007] However, a local increase in temperature or the formation of connective tissue may not always indicate the presence of more systemic problems. Therefore, another approach is needed to identify more serious clinical signs of systemic disorders. One of the signs of brain disorders may be voluntary rapid oscillatory movements of individual body parts, such as the head, deviations in the coordination of body parts or body position. Therefore, monitoring the position of individual body parts and assessing the nature of movements will help to identify serious clinical signs of systemic disorders at early stages. The proposed invention allows recording these deviations, analyzing the severity of the disorders and reporting this.

[0008] The problem that the claimed invention is aimed at solving is to ensure monitoring of the health status of the user of a cortical neuroimplant based on information about the movement of parts of his body.

[0009] The technical result of the inventions consists in increasing the accuracy of identifying deviations in the health status of the user of a cortical neuroimplant during its use, as well as in increasing the efficiency of the rehabilitation process after installation of a cortical neuroimplant.

[0010] The technical result is achieved by the first version of the method for monitoring the state of the user of a cortical neuroimplant by means of data on the position of parts of his body (hereinafter referred to as the monitoring method), including the stages of placing a sensor module with the ability to determine a change in the position of the head on the surface or inside the head of the neuroimplant user; recording each change in the position of the head of the neuroimplant user by means of the sensor module, transmitting the corresponding signals to an external signal processing unit; comparing the obtained values ​​of the head position in the signal processing unit with normal values ​​for a healthy user of the neuroimplant and, in the event of a deviation, transmitting the corresponding signal via a communication channel to a computer.

[0011] The technical result is achieved by the first version of the system for monitoring the state of the user of the cortical neuroimplant (hereinafter referred to as the monitoring system), consisting of a sensor module designed with the ability to determine a change in the position of the head of the user of the neuroimplant, as well as a signal processing unit and a computer with pre-installed software with the ability to compare data on changes in the position of the head of the user of the neuroimplant with normal ones, wherein the signal processing unit and the computer are coupled via a communication channel, and the sensor module is connected via a communication channel to the signal processing unit.

[0012] The sensor module can be designed with the possibility of being implanted into the body of the neuroimplant user and connected via a communication channel to the signal processing unit through the neuroimplant microprocessor via its receiving and transmitting antennas.

[0013] The sensor module may include an accelerometer, or a gyroscope, or an encoder.

[0014] The technical result is achieved by a second version of the control method, including the stages of placing sensor modules on the surface or inside the limbs and head of the neuroimplant user with the ability to determine a change in the position of the head and limbs on which they are installed; recording each change in the position of the head and limbs of the neuroimplant user by means of the sensor modules, transmitting the corresponding signals to an external signal processing unit connected to a computer to which at least one means for detecting and identifying movements is connected via a communication channel, while recording a change in the position of the head and limbs of the neuroimplant user using said means for detecting and identifying movements, transmitting signals to said computer;on the specified computer, using pre-installed software, a model of the neuroimplant user's movement is formed based on signals from the sensor modules and the means for detecting and identifying movements; each subsequent change in the position of the head and limbs of the neuroimplant user is recorded using the sensor modules, the corresponding signals are transmitted to the signal processing unit, where they are collected and transmitted to the specified computer, where the obtained values ​​of the head and limb positions are compared with those normal for the model of the neuroimplant user's movement and, in the event of a deviation, a corresponding signal is issued.

[0015] By means of the said means of detecting and identifying movements, changes in the position of the head and limbs of the user of the neuroimplant can be recorded, transmitting a video signal, or a radar signal, or a lidar signal to the said computer.

[0016] The technical result is achieved by a second version of the control system consisting of sensor modules designed with the ability to determine a change in the position of the head and limbs of the neuroimplant user, a signal processing unit and a computer with pre-installed software with the ability to form and correct a model of movement of the neuroimplant user and compare data on changes in the movements of the head and limbs of the neuroimplant user with normal ones for the specified model of movement, wherein the signal processing unit and the computer are coupled via a communication channel, and the sensor modules are connected via a communication channel to the signal processing unit.

[0017] The sensor module for determining the position of the head can be designed with the possibility of being implanted into the body of the user of the neuroimplant and be connected via a communication channel to the signal processing unit through the microprocessor of the neuroimplant by means of its receiving and transmitting antennas.

[0018] Each sensor module for determining the position of the limbs can be designed with the possibility of implantation into the body of the user of the neuroimplant and contain a pair of receiving and transmitting antennas coupled via a communication channel to a signal processing unit.

[0019] Each sensor module may include an accelerometer, a gyroscope, or an encoder.

[0020] The software pre-installed on the computer can be designed to generate and correct a model of the movement of the neuroimplant user based on signals from video cameras, or bioradars, or lidars.

[0021] The essence of the claimed inventions is explained by illustrations. Fig. 1 shows a general diagram of the control system and the information transmission path, Fig. 2 shows a structural diagram illustrating the first version of the control method, Fig. 3 shows the principle of collecting data for compiling a model of human behavior in accordance with the second version of the method.

[0022] The numbers indicate the following: 1 - sensor module,

[0023] 2 - signal processing unit,

[0024] 3 - computer,

[0025] 4 - neuroimplant microprocessor,

[0026] 5 - receiving and transmitting antenna,

[0027] 6 - electrode matrix of the neuroimplant

[0028] 7 - means of detecting and identifying movements.

[0029] The control system in the first embodiment consists of one sensor module 1, designed with the ability to determine changes in the position of the head (such as tremor, sudden changes in the position of the head, rolling), a signal processing unit 2 and a computer 3. The sensor module 1 can be implanted together with the neuroimplant of the user of the neuroimplant or be installed on the surface of the head of the user of the neuroimplant, if the neuroimplant has already been installed earlier. Any of the known ones can be used as a neuroimplant, for example, the Elvis V cortical neuroimplant (see htps: / / elvis-tech.ru / elvisV). The sensor module 1 includes an accelerometer (single-axis, dual-axis or triaxial), or a gyroscope (single-axis, dual-axis or triaxial), or an encoder.

[0030] In case of implantation of sensor module 1 inside the head of the neuroimplant user, it is covered with a biocompatible material (for example, titanium, ceramics, polymethyl methacrylate, polyethylene and others) or enclosed in a hermetically sealed housing made of such material, together with microprocessor 4, receiving and transmitting antenna 5 and electrode matrix 6, which are elements of the neuroimplant. In addition, the implanted sensor module 1 is interfaced with microprocessor 4 of the neuroimplant via a communication channel. Power supply of sensor module 1 is provided by the battery of the adjustable hoop of the neuroimplant.

[0031] In case of placement of sensor module 1 externally, it is fixed on the head of the neuroimplant user on the adjustable hoop of the neuroimplant or using a solution with any other form factor. Power supply of sensor module 1 is provided from the battery of the adjustable hoop of the neuroimplant or from another external battery.

[0032] The signal processing unit 2 is a microcomputer with pre-installed software for analyzing data coming from the sensor module 1 and their subsequent transmission to the computer 3, which can be an external server or a computer of a rehabilitation physician. The signal processing unit 2 is located on any part of the body convenient for the user. It is connected via a wireless communication channel to the said computer 3. In the case when the sensor module 1 is implanted inside the head of the neuroimplant user, the signal processing unit 2 is interfaced via a wireless communication channel with the microprocessor 4 of the neuroimplant by means of two receiving and transmitting antennas 5 of the neuroimplant - installed as part of the implanted part of the neuroimplant and an external one, placed on the adjustable hoop of the neuroimplant, and in the case when the sensor module 1 is located on the surface of the head, the signal processing unit is connected via a communication channel to the sensor module 1 directly.The signal processing unit 2 is powered by a battery.

[0033] The operation of the control system according to the first variant of use, as well as the first variant of the method for monitoring the state of the user of the cortical neuroimplant, is carried out as follows. The sensor module 1 of the control system is implanted together with the neuroimplant in a known manner (like any other known cortical neuroimplant) in close proximity to the brain of the user of the neuroimplant to stimulate the cells of the cerebral cortex or is placed on the surface of the head of the user of the neuroimplant. The signal processing unit 2 is put on the user of the neuroimplant.The neuroimplant user switches on the control system independently or with the help of a rehabilitation physician, after which the sensor module 1 starts continuously recording data on the user's head position in space and transmitting the corresponding signals to the signal processing unit 2 - via the receiving and transmitting antennas 5, if the sensor module 1 is implanted inside the head, directly, if the sensor module 1 is placed on the surface. The signal processing unit 2 receives the corresponding signals, analyzes the received data using pre-installed software containing information on the permissible norms for changing the head position of a healthy person in space, and on the compliance of the nature of the neuroimplant user's movements with these norms. In the event of a deviation, the signal processing unit 2 transmits a signal via a wireless communication channel to the computer 3 for a more detailed study of the problem and taking the necessary actions.Thus, the proposed approach allows recording deviations in head movements, analyzing the severity of the disorders and reporting them.

[0034] According to the second embodiment of the control system, its design, in addition to the elements of the first embodiment of the control system, contains sensor modules 1 with the ability to determine changes in the position of the limbs of the neuroimplant user (such as tremor, too abrupt changes in the position of the limbs) and installation on the surface of the limbs of the neuroimplant user or implantation in them. In addition, the computer 3 contains pre-installed software for creating and correcting a model of the movements of the neuroimplant user and comparing the movements of the neuroimplant user with this model, developed on the basis of data mining algorithms. To build a model of the movements of the neuroimplant user, at least one means for detecting and identifying user movements 7 is used to collect information, installed at a distance from the body of the neuroimplant user and monitoring the user's movements.As a means of detecting and identifying movements 7, a video camera is used (or a bioradar, or lidar, etc. can be used), connected via a communication channel to a computer 3 with the ability to construct and correct a computer model of the movement patterns of a specific user of the neuroimplant.

[0035] The sensor modules 1 can be implanted together with the neuroimplant of the neuroimplant user or can be installed on the surface of the head and limbs of the neuroimplant user if the neuroimplant has already been installed earlier. It is also possible to install the sensor module for the head implanted together with the neuroimplant, and the sensor modules for the limbs are located on their surface. Any of the known ones can be used as a neuroimplant, for example, the Elvis V cortical neuroimplant (see https: / / elvis-tech.ru / elvisV). Each sensor module 1 includes an accelerometer (single-axis, dual-axis or triaxial), or a gyroscope (single-axis, dual-axis or triaxial), or an encoder.

[0036] In case of implantation of sensor modules 1 inside the body of the neuroimplant user, they are covered with a biocompatible material (for example, titanium, ceramics, polymethyl methacrylate, polyethylene and others). For sensor module 1 for the head, it is possible to enclose it in a sealed case made of biocompatible material together with microprocessor 4, receiving and transmitting antenna 5 and electrode matrix 6, which are elements of the neuroimplant. In addition, the implanted sensor module 1 for the head is connected to microprocessor 4 of the neuroimplant via a communication channel. Power supply of sensor modules 1 is carried out from the battery of the adjustable hoop of the neuroimplant.

[0037] In case of placement of sensor modules 1 externally, they are fixed on the head of the neuroimplant user on the adjustable hoop of the neuroimplant and on the user's limbs using, for example, belts or using solutions with any other form factor. Power supply of sensor modules 1 is provided by the battery of the adjustable hoop of the neuroimplant or by another external battery.

[0038] The signal processing unit 2 is a microcomputer with pre-installed software for collecting and transmitting to the computer the data coming from the sensor modules 1, and is placed on any part of the body convenient for the user. It is connected via a wireless communication channel to the said computer 3. In the case when all the sensor modules 1 are implanted in the body of the neuroimplant user, the signal processing unit 2 is connected via a wireless communication channel to the microprocessor 4 of the neuroimplant by means of two transmitting and receiving antennas 5 of the neuroimplant - installed as part of the implanted part of the neuroimplant and an external one, placed on the adjustable hoop of the neuroimplant, as well as with each sensor module of the limbs also by means of a pair of transmitting and receiving antennas.In the case where the sensor module 1 for the head is implanted, and the sensor modules 1 for the limbs are outside, the signal processing unit 2 is connected via a wireless communication channel to the microprocessor 4 of the neuroimplant by means of the receiving and transmitting antennas 5 of the neuroimplant, and is connected directly via a communication channel to the sensor modules 1 for the limbs. In the case where all sensor modules 1 are located on the surface of the body of the neuroimplant user, the signal processing unit 2 is connected to them directly via a communication channel. The power supply of the signal processing unit 2 is carried out from the battery.

[0039] The operation of the control system according to the second variant of use, as well as the second variant of the method for monitoring the state of the user of the cortical neuroimplant, is carried out as follows. The sensor module 1 for the head of the control system is implanted together with the neuroimplant in a known manner (like any other known cortical neuroimplant) in close proximity to the brain of the user of the neuroimplant to stimulate the cells of the cerebral cortex or placed on the surface of the head of the user of the neuroimplant. The sensor modules 1 for the limbs are implanted in a known manner in the user's limbs or placed on their surface. The means for detecting and identifying movements 7 are switched on.The user of the neuroimplant independently or with the help of a rehabilitation physician turns on the control system, after which the sensor modules 1 begin to continuously record data on the position of the user's head and limbs in space and transmit the corresponding signals to the signal processing unit 2 - through the receiving and transmitting antennas or directly, depending on the location of the sensor modules 1. In the signal processing unit 2, by means of software, data are collected on the patterns of movements of the user of the neuroimplant and transmitted to the computer 3. The means for detecting and identifying movements 7 records each movement of the limbs and head of the user of the neuroimplant and transmits a signal (a video signal or a radar signal, or a lidar signal) to the computer 3.On computer 3, using software based on the information received from signal processing unit 2 and means for detecting and identifying movements 7 about movement patterns, a model of normal movements of the neuroimplant user is created. Further movements of the head and limbs of the neuroimplant user are continuously recorded by sensor modules 1 and transmitted to signal processing unit 2, where they are collected and transmitted to computer 3, where, using the same software, the corresponding signals are received and the received data are analyzed with permissible norms for changing the position of the head and limbs of a specific neuroimplant user in space for compliance of the nature of the movements of the neuroimplant user with these norms. In case of observing a deviation, the said software signals about this for a more detailed study of the problem and taking the necessary actions.By using the second version of the method for monitoring the state of the user of the cortical neuroimplant and the control system according to the second version, it is possible to track the user's movements in space and, if necessary, to early identify deviations in the patterns of human movements, as well as to analyze the severity of the disorders.

[0040] The developed control system can be either a part of a specific cortical neuroimplant or an "add-on" to an existing and used one. The use of the inventions allows rehabilitation doctors to detect damage in the central nervous system of the neuroimplant user in advance and promptly take measures to eliminate these disorders.

Claims

CLAUSE OF INVENTION 1. A method for monitoring the state of a user of a cortical neuroimplant using data on the position of parts of his body, including the steps of a) placing a sensor module on the surface or inside the head of the user of the neuroimplant with the ability to determine a change in the position of the head, b) recording each change in the position of the head of the user of the neuroimplant by means of the sensor module, transmitting the corresponding signals to an external signal processing unit, c) comparing the obtained values of the head position in the signal processing unit with normal values for a healthy user of the neuroimplant and, in the event of a deviation, transmitting the corresponding signal via a communication channel to a computer.

2. A system for monitoring the state of a user of a cortical neuroimplant, consisting of a sensor module designed with the ability to determine a change in the position of the head of the user of the neuroimplant, as well as a signal processing unit and a computer with pre-installed software with the ability to compare data on changes in the position of the head of the user of the neuroimplant with normal ones, wherein the signal processing unit and the computer are coupled via a communication channel, and the sensor module is connected via a communication channel to the signal processing unit.

3. The system according to item 2, in which the sensor module is designed with the possibility of being implanted into the body of the user of the neuroimplant and is connected via a communication channel to the signal processing unit through the microprocessor of the neuroimplant by means of its transmitting and receiving antennas.

4. The system of claim 2, wherein the sensor module includes an accelerometer, or a gyroscope, or an encoder.

5. A method for monitoring the state of a user of a cortical neuroimplant using data on the position of parts of his body, including the steps of a) placing sensor modules on the surface or inside the limbs and head of the user of the neuroimplant with the ability to determine a change in the position of the head and limbs on which they are installed, b) recording each change in the position of the head and limbs of the user of the neuroimplant using the sensor modules, transmitting the corresponding signals to an external signal processing unit connected to a computer to which at least one means for detecting and identifying movements is connected via a communication channel, wherein a change in the position of the head and limbs of the neuroimplant user is recorded using said means for detecting and identifying movements, transmitting signals to said computer, c) on said computer, using pre-installed software, a model of the movement of the neuroimplant user is formed based on signals from the sensor modules and the means for detecting and identifying movements, d) each further change in the position of the head and limbs of the neuroimplant user is recorded by means of the sensor modules, the corresponding signals are transmitted to the signal processing unit, where they are collected and transmitted to said computer, where the obtained values of the position of the head and limbs are compared with the normal values for the model of the movement of the neuroimplant user and, in the event of a deviation, a corresponding signal is issued.

6. A method for monitoring the state of a user of a cortical neuroimplant according to claim 5, in which, by means of said means for detecting and identifying movements, a change in the position of the head and limbs of the user of the neuroimplant is recorded, transmitting a video signal, or a radar signal, or a lidar signal to said computer.

7. A system for monitoring the state of a user of a cortical neuroimplant, consisting of sensor modules designed with the ability to determine a change in the position of the head and limbs of the user of the neuroimplant, a signal processing unit and a computer with pre-installed software with the ability to form and correct a model of movement of the user of the neuroimplant and compare data on changes in the movements of the head and limbs of the user of the neuroimplant with normal data for the specified model of movement, wherein the signal processing unit and the computer are coupled via a communication channel, and the sensor modules are connected via a communication channel to the signal processing unit.

8. The system according to item 7, in which the sensor module for determining the position of the head is designed with the possibility of being implanted into the body of the user of the neuroimplant and is connected via a communication channel to the signal processing unit through the microprocessor of the neuroimplant by means of its receiving and transmitting antennas.

9. The system according to claim 7, in which each sensor module for determining the position of the limbs is designed with the possibility of being implanted into the body of the user of the neuroimplant and contains a pair of receiving and transmitting antennas coupled via a communication channel to a signal processing unit.

10. The system of claim 7, wherein each sensor module includes an accelerometer, or a gyroscope, or an encoder.

11. The system according to item 7, in which the software pre-installed on the computer is designed with the ability to form and correct a model of the movement of the user of the neuroimplant based on signals from video cameras, or bioradars, or lidars.

Images