RU2722852C1 - Cochlear implantation device - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment. Cochlear implantation device comprises an implant for controlling an electrode array, a head piece and a speech processor. Headpiece contains a permanent magnet and an inductance coil. Power output of the speech processor through the head piece and through the skin of the patient is connected by an inductive coupling to the inductive input of the implant, which is connected through an inductance coil of the implant to the power supply unit to form supply voltages for all implant units. Speech processor includes a shaper, band-pass filters, a memory unit and a communication unit. Microphone is connected to the second input of band-pass filters, the second output of which is connected to the input of the speaker. Implant comprises a controller, a memory unit and a transceiver. Implant controller is connected to the electrode array, to the implant memory unit and to the implant transceiver. Implant transceiver is configured to use an implant coil connected to it in antenna mode, which is part of the second wireless link of the communication node of the processor.

EFFECT: provides the possibility of hearing restoration not only to the patients completely deprived of hearing ability, but also to people with residual hearing, which completely do not perceive sounds only in certain range of audio frequencies; reduction of delay in appearance of electric pulses on electrodes of electrode matrix in patient's cochlea relative to speaker signals, which significantly attenuates echo effect in patient's ear; in addition, the delay between the formation of a command action of the speech processor on the implant is reduced and the reciprocal reaction of the implant is memorized in the speech processor by said command action.

1 cl, 2 dwg

Description

FIELD OF THE INVENTION

The invention relates to medical equipment, in particular to implantable cochlear devices. Specifically, to devices for improving or enabling hearing in a patient with insufficient auditory capabilities by implanting the components of the device under the patient’s skin and providing a transdermal contactless connection between the implanted and non-implanted components.

State of the art

The effect of medical cochlear devices to enable hearing in patients with hearing loss is to provide current signals to the electrodes that were implanted into the patient's cochlear cochlea as a result of a surgical operation. Current signals on the electrodes are perceived by the patient as audio signals. The supply of current signals to the matrix of electrodes is controlled by a special implanted controller, which is part of the implantable components (implant). The nutrition of the components of the implant forms a power node, which receives energy through the inductive channel from unimplanted components (speech processor). In general, implanted and non-implanted components of the device are interconnected via wireless channels.

In particular, phonetic speech messages for the patient are transmitted to the microphone, converted to the form necessary for wireless communication in the shaper of the speech processor, and fed to the implant via the inductive channel, where they are transmitted to the controller that controls the electrodes whose signals replace the patient’s lost hearing.

In medical cochlear implantation devices, for the functioning of the inductive channel, it is necessary to ensure strict correspondence between the location of the implant being implanted under the patient’s skin and directly affecting the patient’s cochlea, and the unimplanted components of the speech processor, including an inductor forming energy transfer to the implant. Therefore, the implant and the speech processor contain sufficiently powerful permanent magnets to ensure their exact relative position. For convenience, the coil and the permanent magnet of the speech processor (with an additional frame) are placed in a separate unit, called the “headpiece” in English - in translation “headpiece” or “head part”, which is connected to the main speech processor with a special cable.

The term "headdress" will be used in the text of this invention.

For the electrodes inserted into the cochlea of the patient, it is necessary to ensure the best functioning, therefore, information signals from the electrodes are transmitted (usually via an inductive channel) to the speech processor, in which commands are formed that improve the operation of the electrodes in the cochlea of the patient.

That is, the speech processor serves to transmit power, text and command messages to the implant by providing inductive coupling between them.

However, the presence of an implant with a powerful permanent magnet under the skin of a patient (usually a child) can create certain inconveniences for him. In particular, such inconvenience may occur when a patient with an implant undergoes a medical examination using magnetic resonance imaging (MRI). An external magnetic field arising during MRI can create a torque on the permanent magnet of the implant. This torque can cause the magnet to shift, causing damage to the patient’s tissues surrounding the magnet. Therefore, according to medical indicators, a surgical operation is required to remove the magnet before an MRI and a second surgical operation is to install a magnet under the patient’s skin after an MRI. (https://advancedbionics.com/us/en/home/professional/mri-safety.hmtl).

Many patents for medical cochlear implantation devices related to the construction of permanent magnets that would not require surgery before an MRI.

Finally, such cochlear implantation devices have been described, in the composite cochlear magnets of which there are no restrictions for free rotation, and there is no danger to the patient. They are described in utility model CN 207980177 U, IPC A61N 1/36, A61N 1/375 (published October 19, 2018) and in the description of the patent for invention CN 107308543 IPC A61N 1/36; A61N 1/375 (published on November 3, 2017).

From this moment, it can be considered that clarity has been achieved in patent materials for cochlear implantation devices for constructing an unimplanted speech processor with a separate headgear and an implant with an electrode matrix.

The unimplanted part includes a microphone, a speech processor with a driver, and a headpiece with a magnet and a transmitting inductance coil. And as part of the implanted part, a magnet, an inductor, a power unit, a controller and an electrode matrix are considered.

Examples of patent materials with minimal interest in the permanent magnets that make up the implant and the speech processor are the patent descriptions WO 2019083540 IPC A61N 1/36; H04R 25/00 (published May 2, 2019); WO 2019160555 IPC A61N 1/36; A61N 1/372 (published on 08/22/2019); WO 2019046133 IPC A61N 1/05; A61N 1/378 (published March 7, 2019); US 2019134397 IPC A61N 1/36; H04R 25/00 (published May 8, 2019); US 2019261099 IPC A61N 1/36; A61N 1/372; A61N 1/378; H04R 25/00 (published 08/22/2019) and US 2019 261103 IPC A61N 1/05; A61N 1/36; A61N 1/372; A61N 1/378; H04R 25/00 (published 08/22/2019).

The speech processor for this group of cochlear implantation devices includes a special unit for storing the implant reactions to control command actions. These reactions are transmitted from the implant through the patient’s headgear to the speech processor, where they are decrypted and stored (usually in the form of a code).

A common drawback of such devices is a fairly narrow circle of users - only patients with complete hearing loss.

This disadvantage was overcome in the closest in technical essence to the claimed invention (that is, in the prototype). The prototype is the device described in the patent for invention US 2017326366, IPC A61N 1/05; A61N 1/36; H04R 25/00 (published on 11/16/2017).

This is a cochlear implantation device, which includes an implant configured to control the matrix of electrodes, a headpiece, which includes a permanent magnet and an inductor, a speech processor, the power output of which is connected through the headgear and through the skin of the patient inductive to the inductive the implant input, which is connected through the implant inductor to a power unit configured to generate supply voltages for all implant units, and the speech processor includes a shaper, the first input of which is connected to the first output of the bandpass filters, the first input of which is connected to the first output of the shaper , the second input of which is connected to the output of the processor memory block, the input of which is connected to the second output of the driver, the third input and third output of which are connected, respectively, to the output and input of the processor communication unit, a microphone, the output of which is connected to the second input of the bandpass filters, the second output of which is connected to the speaker input.

The known device solves a technical problem consisting in providing the possibility of expanding the circle of users.

The technical result of the prototype is the ability to restore hearing not only to patients who are completely unable to hear, that is, to perceive audio signals, but also to people with residual hearing, who perceive audio signals only in a certain frequency range (residual frequency range, for example, below 1 kHz) and not completely perceive sounds in an inadequate range of sound frequencies.

However, this possibility has a clear drawback. Audio signals enter the patient in two different ways: through the speaker - for residual frequencies - and in the form of electrical pulses applied to the electrodes of the electrode matrix in the patient's cochlea - for insufficient frequencies. The delay in the appearance of electrical pulses on the electrodes of the electrode matrix compared to the speaker signals (as shown by the measurements made by the Applicant) is from 700 to 900 ms. With such a large delay, an “echo effect” occurs in the ear, making it difficult for the patient to get used to the wearable implant. As a result of this getting used to the echo effect, the patient begins to understand speech (both male and female), but music for him will forever remain only an unpleasant noise.

In the claimed invention, the technical result of the prototype is realized, that is, it is possible to restore hearing not only to patients who are completely deprived of the ability to hear, but also to people with residual hearing, who do not fully perceive sounds only in a certain range of sound frequencies.

In this case, the technical result of the claimed utility model is a significant (more than an order of magnitude) reduction in the delay in the appearance of electrical pulses on the electrodes of the electrode matrix in the cochlea of the patient relative to the speaker signals. This significantly attenuates the echo effect in the patient’s ear.

Also the technical result of the claimed invention is to reduce the delay between the formation of the command action of the speech processor on the implant and storing in the speech processor the response of the implant to the specified command effect.

Disclosure of the invention

Achievement of the indicated technical result is ensured by the fact that the inventive cochlear implantation device includes an implant configured to control an electrode array, a headpiece, which includes a permanent magnet and an inductor, a speech processor, the power supply of which is through the headgear and through the skin the patient’s cover is connected by an inductive coupling to the inductive input of the implant, which is connected through a coil of the implant’s inductance to a power supply unit configured to generate supply voltages for all implant blocks, and the speech processor includes a shaper, the first input of which is connected to the first output of the bandpass filters, the first the input of which is connected to the first output of the shaper, the second input of which is connected to the output of the processor memory block, the input of which is connected to the second output of the shaper, the third input and third output of which are connected, respectively, to the output and input of the communication unit a quarrel, a microphone whose output is connected to the second input of the bandpass filters, the second output of which is connected to the speaker input. At the same time, a controller was introduced into the implant, the first input of which is connected to the outputs of the matrix of electrodes, the inputs of which are connected to the first output of the controller, the second input of which is connected to the output of the implant memory block, the input of which is connected to the second output of the controller, the third input and third output of which are connected respectively, with the first output and the first input of the implant transceiver, configured to use the implant inductance coil connected to it in antenna mode, which is part of the second wireless communication line of the processor communication unit.

Private significant feature of the claimed invention is the following.

Wireless links are made in the form of BLE.

Brief Description of the Drawings

In FIG. 1 shows a block diagram of the inventive device cochlear implantation. Directional arrow communication in FIG. 1 denotes the connection of the output of one of the nodes with the input of another node. Communication in the form of a bidirectional arrow means that in each of the nodes connected in this way, the corresponding input is connected to the corresponding output of the other node. Bold, bidirectional dotted lines indicate wireless.

In FIG. 2 shows a block diagram of an algorithm for changing the settings of a cochlear implantation device.

In FIG. 1 the following notation is used: 1 - microphone, 2 - band-pass filters, 3 - speech processor, 4 - speaker, 5 - driver, 6 - processor memory, 7 - processor communication unit, 8 - implant, 9 - implant inductance coil, 10 - implant transceiver, 11 - headgear, 12 - power supply unit, 13 - controller, 14 - implant memory unit, 15 - electrodes, 16 - remote user, 17 - remote user communication unit.

The implementation of the invention

An implant 8 and electrodes 15 are implanted under the patient’s skin as a result of a surgical operation. In this case, the skin of the patient is indicated in FIG. 1 by two dashed lines between which the designation "Skin" is twice placed.

The electrodes 15 during the surgical operation should be introduced into the cochlea of the patient, forming the so-called electrode matrix.

The implant 8 includes an implant transceiver 10 configured to use the implant inductance coil 9 as a wireless radio antenna. In addition, the implant inductance coil 9 is configured to carry out inductive wireless communication providing energy transfer to the power supply unit 12, configured to generate power voltages for all units and assemblies included in the implant 8. Also, the controller 13 is also included in the implant 8. and an implant memory unit 14.

The external component of the cochlear implantation device that is not implanted into the patient includes a microphone 1, a speech processor 3, a speaker 4, a headgear 11. All these nodes should be located directly on the patient or in close proximity to him. At the same time, the speech processor 3 includes bandpass filters 2, a shaper 5, a processor memory unit 6, and a processor communication unit 7.

The remote user 16 is not directly included in the cochlear implantation device, is not indicated in the text of the claims and therefore is shown in FIG. 1 dotted line. It performs purely auxiliary functions and the operation of the cochlear implantation device in the steady state occurs without its participation. The remote user can be a medical worker or parents of a minor patient. At the disposal of the remote user 16 is the communication node 17 of the remote user. It is also not indicated in the text of the claims and is indicated by a dotted line in FIG. 1. The communication node 17 of the remote user may be a smartphone. It is used to establish wireless communication with the processor communication node 7.

In accordance with FIG. 1, the first input and the first output of the shaper 5 are connected, respectively, with the first output and the first input of the bandpass filters 2. The second input of the bandpass filters 2 is connected to the output of the microphone 1. The second output of the bandpass filters 2 is connected to the input of the speaker 4. The second input and the second output of the shaper 5 are connected, respectively, to the output and input of the processor memory unit 6. The third input and the third output of the shaper 5 are connected, respectively, to the output and input of the processor communication unit 7, which is connected via the first wireless link to the remote user communication unit 17. The power output of the speech processor 3, through the headgear 11 and through the patient’s skin, is connected inductively to the inductive input of the implant 8, which is connected to the power supply unit 12 through the implant inductor 9. In this case, the power supply unit 12 is configured to generate supply voltages for all implant units 8.

That is, the percutaneous inductive channel formed by the inductor included in the headgear 11 and the implant inductor 9 provides power to the implant blocks 8. The correct relative position of the headgear 11 and the implant 8, providing the optimal inductive channel for feeding the implant 8, is formed as a result of the attraction of the permanent magnets that are part of the headgear 11 and the implant 8.

The processor communication node 7 on the second wireless link through the implant inductor 9 acting as an external antenna is connected to the implant transceiver 10.

The first input and the first output of the controller 13 are connected, respectively, with the output and input of the matrix of electrodes 15. In this case, the electrodes 15 are placed in the patient’s cochlea as a result of a surgical operation and, according to the signals of the controller 13 of the implant 8, electrically act on various parts of the cochlea, compensating for the destruction of hair cells in a patient. The second input and second output of the controller 13 are connected, respectively, with the output and input of the implant memory unit 14. The third input and the third output of the controller 13 are connected, respectively, with the output and input of the transceiver 10 of the implant.

Microphone 1 can be implemented in the form configured to be placed inside the patient’s auricle.

The speech processor 3 can be implemented as a behind-the-ear unit, designed to be worn by the patient and held in the auricle behind the patient's ear. Using a cable, the speech processor 3 is connected to the headgear 11, which includes a permanent magnet and an inductor.

The headgear 11 is held on the patient’s skin opposite the implant 8 due to the magnetic attraction of the permanent magnets included in the implant 8 and the headgear 11, respectively. This ensures the optimal arrangement of the inductor 8 of the implant and the inductor included in the headgear for induction coupling eleven.

The speaker 4 can be implemented as a loudspeaker located next to or in the cartilaginous region of the ear canal, or in the auricle, or in the bone region of the ear canal. Loudspeakers of this kind are widely known and available in the distribution network.

Bandpass filters 2 can be used to separate the signals of the microphone 1 into frequency bands corresponding to the range of residual frequencies and the range of non-residual frequencies of the patient. Such bandpass filters are described in a wide range of technical publications and are available in the distribution network.

The operation of the claimed device cochlear implantation is as follows. Sound signals enter microphone 1, where they are converted into electrical signals. These electrical signals are transmitted to the bandpass filters 2 of the speech processor 3, which extract the remaining frequency ranges from them (that is, those frequencies for which the patient has sound perception). The signals of the residual frequency range through the speaker 4 in the form of modified sound signals enter the ear canal of the patient, providing the patient with auditory perception in those areas of frequencies that he is able to perceive.

The band-pass filters 2 also extract signals from the microphone 1 that are not sufficient frequency ranges, that is, those signals for which frequencies the patient has lost hearing. These signals of insufficient frequency ranges are transmitted to the shaper 5 of the speech processor 3, where they are converted taking into account the information from the processor memory unit 6 to the form necessary for wireless radio communication. The converted signals are sent to the processor communication unit 7 and in the form of radio signals (frequency about 2.4 GHz) via BLE (Bluetooth Low Energy) wireless communication, transmitted through the patient’s skin to the implant 8, where they are transferred to the implant inductor 9 and then to the transceiver 10 implant. In this case, the implant transceiver 10 can serve as a BLE transceiver module without a built-in antenna, widely known in a number of modifications and available in the distribution network. Such a small module is easily placed in the implant 8. In this case, the implant inductor 9 acts as an antenna for the radio signals of the implant transceiver 10.

In this case, the power to the transceiver 10 of the implant (and to the other nodes and blocks of the implant 8) is supplied via an inductive wireless channel for transmitting energy from the speech processor 3, which should include the power supply of the cochlear implantation device (not shown in Fig. 1). Wireless energy transfer is carried out through an inductive line with a pump frequency of not higher than 1 MHz, through a headgear 11, which includes an external transmitting coil, to the implant inductor 9, which in this mode acts as an external receiving coil of the inductive channel. Next, the energy enters the power node 12, in which the incoming energy is converted into the supply voltage of the nodes and blocks included in the implant 8.

Energy transfer with a frequency of no higher than 1 MHz does not prevent the use of an implant inductor 9 as an antenna for the radio signals of the implant transceiver 10, whose frequency (about 2.4 GHz) is thousands of times higher. The distance between the speech processor 3 and the implant 8 does not exceed several centimeters. At the applicant enterprise, studies were carried out that confirmed the possibility of using the implant inductor 9 as an antenna of the implant transceiver 10 when transmitting information messages wirelessly up to ten centimeters. Thus, the inductive line is practically not connected with the transmission of information messages. The induction line transfers only the power for implant 8.

Questions about conducting MRI in a patient are not specifically addressed in this invention. It is assumed that either a permanent magnet is removed from the implant 8 before an MRI, or a special design is used in the permanent magnet in the implant 8, allowing an MRI to be performed without removing the permanent magnet from the implant 8.

As mentioned above, the converted information messages are transmitted wirelessly from the processor communication unit 7 to the implant 8. In the implant 8, information messages through the implant inductor 9 and the implant transceiver 10 are sent to the controller 13, where according to these signals, taking into account the information from block 14 Implant memory generates current pulses for the electrodes 15 included in the electrode matrix introduced into the cochlea of the patient. For each of the electrodes 15, an optimal set of current pulses is provided, according to which the patient is provided with the perception of audio signals of insufficient frequency ranges, that is, taking into account the sound signals of speaker 4, hearing is returned to the patient.

Since the inductive communication channel is not used when transmitting audio signals of the insufficient frequency ranges to the controller 13, the delay of the signals of the insufficient ranges relative to the signals of the residual ranges coming from speaker 4, studies have shown, does not exceed five milliseconds. This is a hundred-odd times less than the prototype (which corresponds to the achieved technical result). Thus, the "echo effect" in the ear of the user cannot occur.

In the work of the proposed device cochlear implantation provides, in addition to the above-described operating mode, the transition to official, control modes. The sets of signals for activating each of the control modes are programmed and stored in the processor memory unit 6 and the implant memory unit 14.

FIG. 2 illustrates in block diagram form the operation of a cochlear implantation device in each control mode. The review of the work begins with the formation of the resulting signal for strictly defined effects on the cochlear implantation device in some current control mode.

The resulting signal may be unfavorable. In this case, the code of the current control mode should be provided with a sign of prohibition (inadmissibility) when saved. The current monitoring mode should be interrupted promptly. In the future, this control mode should not be used.

If the resulting signal is standard (analysis of the signal gives a standard result), then it makes sense, without making any changes to the settings of the cochlear implantation device, to switch to the next control mode.

If the resulting signal is not standard, then this may mean that there is a tendency for improvement in the operation of the cochlear implant device. In this case, in the shaper 5, proposals can be developed for adjusting the bandpass filters 2, which through the processor communication unit 7 will be transmitted over the wireless communication line to the controller 13, in which adequate proposals for correcting the effects on the matrix of electrodes 15 should be formed.

These suggestions for adjustments in the speech processor 3 and the implant 8 should be evaluated by the remote user 16. He must decide whether to carry out the proposed adjustments. In principle, three options are possible:

- Ignore the adjustment. In this case, the cochlear implantation device will continue to work without any changes. It is this option that must be executed if, for example, the remote user 16, for one reason or another, cannot familiarize himself with the proposed adjustment;

- Do not make adjustments. In this case, without any changes, the last control mode will be repeated;

- Carry out the proposed adjustment. In this case, the proposed adjustment will first be carried out (possibly with some additions from the remote user 16), and then the last control mode will be carried out taking into account the adjustment.

Based on the results of such a repetition, the remote user 16 must decide on the usefulness of introducing the proposed adjustment.

Naturally, the transition to the next control regime should not occur too often. In FIG. 2 shows that before work in each control mode, a "Pause" should occur. Naturally, during a pause, the cochlear implant device should function in the operating mode. The pause duration can vary from tens of seconds (in the first days after implant 8 installation) to units of hours (several months after implant 8 installation, when the patient is already accustomed to it). If during a pause no external influences on the cochlear implantation device are performed, then at the end of the pause there will be a transition to the control mode with the next number.

However, by directly influencing the processor memory unit 6, it is possible to arbitrarily select the number of the next control mode. To do this, users (for example, parents of a minor patient) can use the controls of the speech processor 3.

A similar choice is possible from a remote user 16, which may be a medical worker or the same parents of a minor patient. The command to select the next control mode in this case is entered into the processor communication unit 7 wirelessly (since, as mentioned above, the processor communication unit 7 can be a standard communication unit, for example, BLE). When a command is entered, the remote user can use the communication node 17 of the remote user, which can be a smartphone. After the command arrives at the processor communication unit 7, it is transmitted through the driver 5 to the processor memory unit 6. Thus, the next control mode will be selected.

It is important here that in the control modes, as well as in the operating mode, information messages are not transmitted through the inductive communication line, which is used for the sole purpose of transferring power to the implant 8.

Thus, the functioning of the proposed device cochlear implantation is fully considered, and the achievement of the technical result is confirmed both in operating and in control modes.

Claims (2)

1. Cochlear implantation device, which includes an implant made with the possibility of controlling the matrix of electrodes, a headpiece, which includes a permanent magnet and an inductor, a speech processor, the power supply of which is connected through an inductance through the headpiece and through the skin of the patient by inductive coupling to the implant’s inductive input, which is connected through the implant’s inductor to a power supply unit capable of generating supply voltages for all implant blocks, and the speech processor includes a shaper, the first input of which is connected to the first output of the bandpass filters, the first input of which is connected to the first output shaper, the second input of which is connected to the output of the processor memory block, the input of which is connected to the second output of the shaper, the third input and the third output of which are connected, respectively, to the output and input of the processor communication node, a microphone, the output of which is connected to the second input of the bandpass iltrov, the second output of which is connected to the speaker input, characterized in that a controller is introduced into the implant, the first input of which is connected to the outputs of the electrode array, the inputs of which are connected to the first output of the controller, the second input of which is connected to the output of the implant memory block, the input of which is connected with a second controller output, the third input and the third output of which are connected respectively to the first output and the first input of the implant transceiver, configured to use the implant inductance coil connected to it in antenna mode, which is part of the second wireless link of the processor communication node. 2. The cochlear implantation device according to claim 1, wherein the wireless communication lines are made in the form of a BLE.

Images