Totally implantable cochlear implant system and use

Abstract

Disclosed in the present invention are a totally implantable cochlear implant system and a use. The totally implantable cochlear implant system comprises an external microphone system, an internal implantation system, and an in-vitro charging part for supplying power to the internal implantation system. The external microphone system collects sound signals and converts same into electrical signals, and wirelessly transmits the electrical signals to the internal implantation system by means of a wireless transmission part. The internal implantation system comprises an antenna part, an in-vivo charging part, a sound processing part, and a stimulation system. The antenna part comprises an antenna monitoring part and an antenna assembly. The antenna monitoring part acquires working state information of the antenna assembly and transmits the working state information to the sound processing part. According to the totally implantable cochlear implant system of the present invention, the problem of signal attenuation and in-vivo noise interference caused by subcutaneous implantation of a microphone is avoided; in addition, the use is convenient, the operation is simple, and the long-term reliability is high.

Description

A fully implantable cochlear implant system and its application Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a fully implantable cochlear implant system and its application. Background Art

[0002] The traditional cochlear implant system includes an implant inside the body and a sound processing unit outside the body. The sound processing unit converts the acoustic signals in the environment into electrical signals, which are then transmitted to the implant. The implant sends the signals to the stimulating electrodes inside the cochlea in the form of electrical stimulation. The stimulating electrodes stimulate the auditory nerve fibers, and finally the brain recognizes the electrical signals as sound and produces hearing. Currently, traditional cochlear implant systems are divided into an internal implant and an external part. The external part worn behind the ear brings many inconveniences to the user, such as: 1. The implant recipient or his / her family has to take care of and maintain the external part every day, which creates a daily burden; 2. The external part hangs behind the ear, which puts pressure on the ear, especially for children whose ears are softer, which can easily cause discomfort; 3. The external part is prone to collision / falling, causing damage or loss, which limits the implant recipient's participation in daily activities; 4. The external part is easily damaged by sweat or daily water splashing, which limits the implant recipient's bathing and water activities; 5. For many implant recipients, especially the elderly, the external part worn behind the ear is a manifestation of hearing impairment, which has a negative psychological impact on their self-esteem and self-confidence, and hinders normal social interaction. Many hearing-impaired people would rather not hear than wear hearing aids or cochlear implants.

[0003] The various inconveniences and negative effects brought to users by the above-mentioned external cochlear implant devices have made the recipients urgently need the existence of a fully implanted cochlear implant system.

[0004] Currently, microphones are a technical challenge for fully implantable cochlear implants. Existing fully implantable cochlear implant microphones generally utilize two technical approaches: First, the microphone is implanted subcutaneously. Due to the obstruction of the scalp flap, the acoustic signal is severely weakened, distorted, and distorted, resulting in significant signal attenuation. Furthermore, microphones implanted within the human body are subject to interference from various human sounds, such as blood flow, breathing, heartbeat, and even muscle and joint movement. This noise can significantly interfere with the clarity of the sound received. Published literature indicates that the speech recognition rates of these implantable microphones are significantly lower than those of conventional cochlear implants. The second technical approach involves placing the microphone in the middle ear, picking up vibrations of the auditory ossicles and converting them into electrical signals. This approach avoids the signal attenuation and internal noise interference associated with subcutaneous microphones. However, securing this microphone in the middle ear canal is difficult, the surgery is complex, and time-consuming, and the long-term reliability of this type of microphone is poor, limiting its application.

[0005] In summary, the current fully implantable cochlear implant system still has problems such as severe sound interference, difficult surgery and poor long-term reliability.

[0006] Summary of the Invention

[0007] In order to solve the above problems, the technical solution of the present invention is as follows: a fully implanted cochlear implant system, comprising an external microphone system, an internal implant system, and an external charging unit for supplying power to the internal implant system; wherein,

[0008] The external microphone system includes an external microphone and a wireless transmission unit. The external microphone collects sound signals and converts them into electrical signals, and the wireless transmission unit wirelessly transmits the electrical signals to the internal implant system.

[0009] The internal implant system includes an antenna portion, an in-body charging portion, a sound processing portion, and a stimulation system;

[0010] The antenna unit is connected to the sound processing unit, receives the electrical signal sent by the external microphone system, and transmits the electrical signal to the sound processor;

[0011] The antenna unit includes an antenna monitoring unit and an antenna assembly, wherein the antenna monitoring unit is connected to the sound processing unit, and the antenna monitoring unit obtains working status information of the antenna assembly and transmits the working status information to the sound processing unit;

[0012] The external charging unit is wirelessly connected to the internal charging unit for supplying energy to the internal charging unit;

[0013] The stimulation system is connected to the sound processing unit and is used to output electrical stimulation;

[0014] Preferably, the external microphone system further includes a sound preprocessing unit for performing noise reduction on the sound signal collected by the external microphone, and converting the noise-reduced sound signal into an electrical signal, which is transmitted to the antenna unit via the wireless transmission unit.

[0015] Preferably, the antenna assembly includes a first antenna and a backup antenna. When the sound processing unit receives abnormal information from the first antenna, the sound processing unit cuts off the connection with the first antenna and starts the connection with the backup antenna.

[0016] Preferably, the in-body charging unit includes a power management unit, a charge and discharge management unit, a rechargeable battery and a charging coil; wherein,

[0017] The charging coil is wirelessly connected to the external charging unit; the charge and discharge management unit is electrically connected to the rechargeable battery, the charging coil and the power management unit, and the power management unit is electrically connected to the sound processing unit and the stimulation system respectively.

[0018] Preferably, it also includes an external remote control unit, which has two-way wireless communication with the built-in implant system and is used to send control information to the built-in implant system, and the built-in implant system responds to the control information and performs an execution action; the execution action includes at least one of opening / closing, program selection, volume adjustment, implant electrode impedance, and implant power.

[0019] Preferably, a packaging component is provided outside the antenna portion.

[0020] Preferably, the wireless transmission operating current between the external microphone system and the built-in implant system is no more than 4 mA.

[0021] An application of a fully implantable cochlear implant system, wherein the antenna part and the wireless transmission part are respectively located on both sides of the eardrum and are both arranged close to the eardrum.

[0022] The beneficial effects of the present invention are:

[0023] 1. Compared with the traditional fully implanted human cochlear implant system, the fully implantable cochlear implant system of the present application has an external microphone, which picks up the sound signal and converts it into an electrical signal; the sound signal is transmitted to the internal implant system wirelessly, avoiding the signal attenuation and body noise interference caused by the subcutaneous implantation of the microphone. At the same time, it is easy to use, the surgery is simple, and the long-term reliability is high.

[0024] 2. In the fully implantable cochlear implant system of the present application, the antenna monitoring component obtains the working status information of the antenna assembly, transmits the working status information to the sound processing unit, and adjusts the antenna assembly, effectively reducing the impact of tissue fluid in the human body on the signal transmission of the antenna unit, thereby further improving the signal transmission efficiency and ensuring the long-term reliability of the system.

[0025] 3. In the fully implantable cochlear implant system of the present application, an internal charging unit is installed and wirelessly connected to an external charging unit, so that the sound processing unit and the stimulation system can be powered at any time; the external remote control unit has two-way wireless communication with the internal implant system, which is used to send control information to the internal implant system, and can control and adjust the internal implant system in real time, which is easy to operate.

[0026] 4. The application of the fully implantable cochlear implant system of the present application further improves the efficiency of wireless transmission by installing the antenna part and the external microphone on both sides of the eardrum and setting them close to the eardrum. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG1 is a schematic diagram of the overall structure of a fully implantable cochlear implant system according to a specific embodiment of the present invention;

[0028] FIG2 is a schematic diagram of the detailed structure of a fully implantable cochlear implant system according to a specific embodiment of the present invention;

[0029] FIG3 is a schematic diagram of corresponding electrical stimulation signals generated by a stimulation system in a fully implantable cochlear implant system according to a specific embodiment of the present invention;

[0030] FIG4 is a circuit diagram of the wireless portion of an external microphone system in a fully implantable cochlear implant system according to a specific embodiment of the present invention;

[0031] FIG5 is a circuit diagram of a wireless receiving portion of a built-in implant system in a fully implantable cochlear implant system according to a specific embodiment of the present invention;

[0032] Explanation of the accompanying symbols: 1. Built-in implant system; 10. In-body charging unit; 110. Charging coil; 120. Charging and discharging management unit; 130. Rechargeable battery; 140. Power management unit; 20. Sound processing unit; 210. DSP chip; 220. Communication co-processing unit; 30. Stimulation system; 310. Stimulator; 320. Stimulation electrode; 40. Antenna unit; 410. Antenna assembly; 411. First antenna; 412. Backup antenna; 420. Antenna monitoring unit; 50. External charging unit; 60. External microphone system; 610. External microphone; 620. Sound pre-processing unit; 630. Wireless transmission unit; 70. External remote control unit; U21. Wireless chip; U22. Balun chip; E2. Transmitting antenna; E1. Receiving antenna; U1. Wireless receiving chip; U2. Filter; U26. Storage chip. DETAILED DESCRIPTION

[0033] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0034] Referring to Figure 1, a fully implantable cochlear implant system includes an external microphone system 60, an internal implant system 1, and an external charging unit 50 for supplying power to the internal implant system 1; wherein the internal implant system 1 includes an antenna unit 40, an internal charging unit 10, a sound processing unit 20, and a stimulation system 30. The external microphone system 60 is wirelessly connected to the antenna unit 40, and the external charging unit 50 is wirelessly connected to the internal charging unit 10, for supplying power to the internal implant system 1. The internal charging unit 10 is respectively connected to the sound processing unit 20 and the stimulation system 30, thereby supplying power to the sound processing unit 20 and the stimulation system 30. The antenna unit 40 is connected to the sound processing unit 20 to transmit the electrical signal received by the antenna unit 40 to the sound processor 20; the stimulation system 30 is connected to the sound processing unit 20 to output electrical stimulation.

[0035] The fully implantable cochlear implant system of the present application operates as follows: an external microphone system 60 collects acoustic signals, converts them into electrical signals, and wirelessly transmits them to the antenna unit 40, thereby transmitting the electrical signals to the sound processing unit 20. The sound processor 20 encodes the electrical signals and transmits them to the stimulation system 30. The stimulation system 30 decodes the signals and stimulates the auditory nerve fibers in the form of electrical stimulation. Finally, the brain recognizes the electrical signals as sound, producing hearing.

[0036] Referring to Figures 1 and 2 , the internal charging unit 10 includes a charging coil 110, a charge-discharge management unit 120, a rechargeable battery 130, and a power management unit 140. The charging coil 110 is wirelessly connected to the external charging unit 50 using the Qi standard. The charge-discharge management unit 120 is electrically connected to the rechargeable battery 130, the charging coil 110, and the power management unit 140 to control the charging and discharging of the rechargeable battery 30. The power management unit 140 is electrically connected to the sound processing unit 10 and the stimulation system 30 to control the discharge process. Specifically, the charging coil 110 receives electrical signals from the external charging unit 50. The charge-discharge management unit 120 controls the charging and discharging process by rectifying the electrical signals received by the charging coil 110 and charging the rechargeable battery 130. When not charging, the rechargeable battery 130, through the charge-discharge management unit 120 and the power management unit 140, supplies power to various circuits, including those in the DSP chip 210 and the stimulation system 30. When the charge level of rechargeable battery 130 is low, it can be charged by external charging unit 50 to internally implant system 1. Charging coil 110 receives the wireless signal from external charging unit 50. The received wireless voltage, typically with a peak voltage of 10-20V, is rectified and stepped down to 5V DC. This voltage is then charged by charge and discharge management unit 120 to recharge rechargeable battery 130. The capacity of rechargeable battery 130 is selected based on the space available for internally implant system 1 and is generally between 200-300mAh.

[0037] The external charging unit 50 can charge the fully implantable cochlear implant system when it is not in use. Specifically, the external charging unit 50 can be a charging pillow, allowing the user to charge the internal implant system 1 while sleeping at night. The external charging unit 50 can also provide real-time power supply; specifically, the external charging unit can be a hat-type wireless charger, which the user wears to charge the internal implant system 1; it can also be a body-worn external wireless charger fixed to the temple of glasses or behind the ear.

[0038] The external microphone system 60 includes an external microphone 610, a sound preprocessing unit 620 and a wireless transmission unit 630. The external microphone 610 collects sound signals, performs noise reduction preprocessing on the sound signals through the sound preprocessing unit 620, and encodes the sound signals after noise reduction preprocessing into electrical signals, which are wirelessly transmitted to the built-in implant system through the wireless transmission unit 630. Wireless transmission methods include Bluetooth, RF and other transmission methods. Specifically, the working current of wireless transmission is not more than 4mA, thereby effectively reducing power consumption and extending battery life; the wireless signal transmission frequency can be Bluetooth 2.4GHz or other suitable frequencies. The external microphone 610 can be an ear canal microphone, an auricle microphone, etc., which is small in size and easy to be invisible. Specifically, the range of sound received by the external microphone system 60 is concentrated between 100HZ and 8KHZ.

[0039] After the microphone is placed externally, the sound signal is picked up by the external microphone 610 and converted into an electrical signal; it is transmitted wirelessly to the internal implant system 1, avoiding the signal attenuation and interference of body noise caused by the microphone being implanted subcutaneously. At the same time, it is easy to use, the operation is simple, and the long-term reliability is high.

[0040] The antenna unit 40 is connected to the sound processor 20 and is used to receive electrical signals from the external microphone system 60 and transmit them to the sound processing unit 20. The antenna unit 40 includes an antenna monitoring unit 420 and an antenna assembly 410. The antenna monitoring unit 420 is connected to the sound processing unit 20. The antenna monitoring unit 420 obtains operating status information of the antenna assembly 410 and transmits this operating status information to the sound processing unit 20. The antenna assembly 410 includes a first antenna 411 and a backup antenna 412. When the sound processing unit 20 receives abnormal information from the first antenna 411, it disconnects from the first antenna 411 and activates the backup antenna 412. Because the antenna unit is located inside the body, its signal is easily interfered with by human tissue fluid. Therefore, by providing the above-mentioned antenna unit 40, the operating status of the antenna assembly 410 can be monitored in real time. When an abnormality occurs, the antenna can be switched to another one, thereby ensuring normal signal transmission. To further improve signal transmission, the antenna unit 40 is provided with an external packaging member (not shown). Specifically, the packaging member can be made of a biocompatible material, such as medical silicone.

[0041] As shown in Figures 2 and 3, the sound processing unit 20 includes a DSP chip 210 and a communication co-processing unit 220. After receiving the electrical signal transmitted through the antenna unit 40, the communication co-processing unit 220 further transmits it to the DSP chip 210. The DSP chip 210 encodes the received electrical signal and transmits it to the stimulation system 30.

[0042] As shown in Figures 2 and 3, the stimulation system 30 generates corresponding electrical stimulation signals after receiving the instruction of the DSP chip 210. The stimulation system 30 comprises a stimulator 310 and a stimulation electrode 320. The input of the stimulator 310 is connected to the sound processor 20, and the output is connected to the stimulation electrode 320. The stimulator 310 decodes the coded signal received and stimulates the auditory nerve fibers in the form of electrical stimulation through the stimulation electrode 320. Finally, the brain recognizes the electrical signal as sound and produces hearing. The stimulation system 30 can also feed back the stimulation situation to the sound processing unit 20, thereby monitoring and adjusting the stimulation situation in real time. In order to ensure the safety of electrical stimulation to human tissue, the stimulation signal is generally a pulse stimulation signal that is first negative and then positive, has adjustable pulse width and amplitude, and is symmetrical in positive and negative phases.

[0043] Figure 4 shows the circuit diagram of the wireless portion of the wireless transmission unit 630 of the external microphone system 60. The wireless chip U21 acts as the master control chip, sending data or control commands to the internal implant system 1. The balun chip U22 filters the wireless signal, converting the differential signal from the wireless chip U21 into a single-ended signal, which is then transmitted via the transmitting antenna E2. The wireless signal transmission frequency can be between 2.402 GHz and 2.480 GHz, with a transmission power of less than 20 dBm. The receiving sensitivity is approximately -70 dBm to -82 dBm, with a maximum receiving sensitivity of -95 dBm.

[0044] As shown in Figure 5, the circuit diagram of the wireless receiving portion of the antenna portion 40 of the internal implant system 1 is shown. The receiving antenna E1 receives wireless signals transmitted from the external microphone system 60 outside the body, and the filter U2 filters the received wireless signals. The wireless receiving chip U1 performs preliminary processing on the received wireless signals, and then passes them to the DSP chip 210 for further processing to control the stimulation system 30 to produce stimulation. The memory chip U26 can store some private parameters. When necessary, the wireless receiving chip U1 can also send wireless signals to the external microphone system 60 outside the body. The external and internal systems can achieve two-way communication. The operating frequency of the wireless receiving circuit of the internal implant system 1 can be set to 2.402GHz-2.480GHz, with a maximum receiving sensitivity of -97dBm. When necessary, the circuit of the internal implant system 1 can send wireless signals to the external part. The maximum transmission power of the wireless circuit of the internal implant system 1 is less than 20dBm.

[0045] The external remote control unit 70 communicates bidirectionally with the internal implant system 1, sending control information to the internal implant system 1. Communication between the external remote control unit and the implant system utilizes 2.4 GHz Bluetooth or other suitable frequencies (e.g., 401-406 MHz, 433.92 MHz, etc.). In response to this control information, the internal implant system 1 executes an action. This action may include at least one of: power on / off, program selection, volume adjustment, implant electrode impedance, or implant power. Power on / off activates the entire internal implant system 1 for normal operation or enters a low-power sleep state. Program selection switches between specific DSP operating modes. The DSP chip can store multiple stimulation modes, and the external remote control 70 can remotely switch between different stimulation modes via radio frequency. The stimulation level (or volume level for the recipient) of the internal implant system 1 can also be adjusted via the external remote control 70. Implant electrode impedance testing can verify the proper functioning of the stimulation electrodes. The battery level of the internal implant system 1 is also monitored to prevent malfunctions caused by low battery levels in the rechargeable battery 130. This can remind the recipient to recharge the battery promptly, allowing the recipient to check the implant's battery level at any time.

[0046] In addition, the external microphone system 60 can also be set in the external remote control unit 70 or in the mobile phone used daily, both of which can achieve the same usage effect, are more convenient to carry, and do not affect the user's normal social interactions.

[0047] The application of the fully implantable cochlear implant system of the present application is to arrange the antenna part 40 and the wireless transmission part 630 on both sides of the human eardrum respectively, and both are arranged close to the eardrum, so that the distance between the two is closer, which is more convenient for wireless signal transmission.

[0048] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention and are not limiting. Although the present invention has been described in detail through the above preferred embodiments, those skilled in the art should understand that various changes can be made in form and details without departing from the scope defined by the claims of the present invention.

Claims

1. A fully implantable cochlear implant system, characterized in that: It includes an external microphone system, an internal implant system, and an external charging unit for supplying power to the internal implant system; wherein, The external microphone system includes an external microphone and a wireless transmission unit, wherein the external microphone collects sound signals and converts them into electrical signals, and wirelessly transmits the electrical signals to the internal implant system through the wireless transmission unit; The internal implant system includes an antenna part, an in-body charging part, a sound processing part and a stimulation system; The antenna unit is connected to the sound processing unit, receives the electrical signal sent by the external microphone system, and transmits the electrical signal to the sound processor; The antenna unit includes an antenna monitoring unit and an antenna assembly, the antenna monitoring unit is connected to the sound processing unit, the antenna monitoring unit obtains the working status information of the antenna assembly and transmits the working status information to the sound processing unit; The external charging unit is wirelessly connected to the internal charging unit and is used to supply energy to the internal charging unit; The in-body charging unit is electrically connected to the sound processing unit and the stimulation system respectively to provide energy to the sound processing unit and the stimulation system; The stimulation system is connected to the sound processing unit and is used to output electrical stimulation.

2. A fully implantable cochlear implant system according to claim 1, characterized in that: The external microphone system also includes a sound preprocessing unit, which is used to reduce the noise of the sound signal collected by the external microphone, and convert the noise-reduced sound signal into an electrical signal, which is transmitted to the antenna part via the wireless transmission part.

3. A fully implantable cochlear implant system according to claim 1, characterized in that: The antenna assembly includes a first antenna and a backup antenna. When the sound processing unit receives abnormal information from the first antenna, the sound processing unit cuts off the connection with the first antenna and starts the connection with the backup antenna.

4. A fully implantable cochlear implant system according to claim 1, characterized in that: The in-vivo charging unit includes a power management unit, a charge and discharge management unit, a rechargeable battery and a charging coil; wherein the charging coil is wirelessly charged and connected to the external charging unit; the charge and discharge management unit is electrically connected to the rechargeable battery, the charging coil and the power management unit, and the power management unit is electrically connected to the sound processing unit and the stimulation system respectively.

5. The fully implantable cochlear implant system according to claim 1, characterized in that: It also includes an external remote control unit, which has two-way wireless communication with the built-in implant system and is used to send control information to the built-in implant system; the built-in implant system responds to the control information and performs an execution action; the execution action includes at least one of turning on / off, program selection, volume adjustment, implant electrode impedance, and implant power.

6. A fully implantable cochlear implant system according to claim 1, characterized in that: A packaging component is arranged outside the antenna part.

7. The fully implantable cochlear implant system according to claim 1, characterized in that: The wireless transmission operating current between the external microphone system and the built-in implant system is no more than 4 mA.

8. An application of a fully implantable cochlear implant system, characterized in that: The antenna part and the wireless transmission part described in any one of claims 1 to 7 are respectively located on both sides of the eardrum, and are both arranged close to the eardrum.

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