阅读说明：本技术 复合式人工听觉植入装置及其人工耳蜗或听觉脑干植入 (Combined artificial auditory implantation device and artificial cochlea or auditory brainstem implantation thereof ) 是由 吴皓 贾欢 于 2021-01-05 设计创作，主要内容包括：本申请提供复合式人工听觉植入装置及其人工耳蜗或听觉脑干植入,包括：电极单元；植入体单元；连接单元,至少包括用于连接所述ABI电极和植入体单元的第一连接线,以及用于连接所述CI电极和植入体单元的第二连接线；其中,所述电极单元至少包括ABI电极和CI电极；所述ABI电极和CI电极被控制选通后进行电极间切换或同时使用。本发明同时兼顾了耳蜗与蜗核的电刺激,设计了一种复合式人工听觉植入装置,实现“一次手术,两种植入”的预期目标,减少了手术次数,也从一定程度上降低了医疗成本；另外还可在ABI电极和CI电极之间进行随意切换,可实现刺激、参考、记录等多种功能。(The application provides a combined artificial auditory implantation device and artificial cochlea or auditory brainstem implantation thereof, including: an electrode unit; an implant unit; a connection unit including at least a first connection line for connecting the ABI electrode and the implant unit, and a second connection line for connecting the CI electrode and the implant unit; wherein the electrode unit comprises at least an ABI electrode and a CI electrode; the ABI electrode and the CI electrode are switched between electrodes or used simultaneously after being controlled and gated. The invention simultaneously considers the electrical stimulation of the cochlea and the cochlear nucleus, designs the combined artificial auditory implantation device, realizes the expected target of 'one operation and two implants', reduces the operation times and also reduces the medical cost to a certain extent; in addition, the ABI electrode and the CI electrode can be switched randomly, and multiple functions of stimulation, reference, recording and the like can be realized.)

1. A composite artificial hearing implant device, comprising:

an electrode unit;

an implant unit;

a connection unit including at least a first connection line for connecting the ABI electrode and the implant unit, and a second connection line for connecting the CI electrode and the implant unit;

wherein the electrode unit comprises at least an ABI electrode and a CI electrode; the ABI electrode and the CI electrode are switched between electrodes or used simultaneously after being controlled and gated.

2. The composite artificial hearing implant device of claim 1, comprising an in vivo unit; the in vivo unit is connected with the in vitro unit; the in-vitro unit is used for acquiring and processing audio signals and then sending the audio signals to the in-vivo unit; the in vivo unit strobes the ABI or CI electrodes upon receiving a signal from the in vitro unit to stimulate the auditory nerve through the electrodes.

3. The hybrid artificial hearing implant device of claim 2, wherein the extracorporeal unit comprises an audio signal acquisition module and a signal processing module; the signal processing module includes:

the microphone is connected with the audio signal acquisition module and used for converting the acquired audio signals into analog signals;

the analog-to-digital conversion module is connected with the microphone and is used for converting an analog signal into a digital signal;

the processor is connected with the analog-to-digital conversion module and is used for carrying out signal processing and coding on the digital signal to obtain a sound coding signal;

and the radio frequency modulation module is connected with the processor and is used for modulating the sound coding signals into corresponding radio frequency signals.

4. The composite artificial hearing implant device of claim 2, wherein the intrabody unit comprises:

a temporo-extraosseous unit being the implant unit, connected to the extrasomatic unit;

the temporobone internal unit is one part of the electrode unit, comprises a CI electrode and is connected with the temporobone external unit;

an intracranial unit, being a part of the electrode unit, including an ABI electrode, connected to the extratemporal unit.

5. The composite artificial hearing implant device of claim 4, wherein the extratemporal unit comprises:

a receiving coil for remotely receiving the radio frequency signal emitted by the extracorporeal unit;

the stimulator is connected with the receiving coil and is used for converting the radio-frequency signals into corresponding electric pulse signals; the stimulator is respectively connected with the ABI electrode and the CI electrode so as to stimulate the electrodes through electric pulse signals;

the gating control module is connected with the stimulator and sends a gating instruction to the stimulator;

and the signal receiving module is connected with the CI electrode, the ABI electrode and the gating control module and is used for receiving working signals of the CI electrode and the ABI electrode, judging whether the working signals are in a normal working state or not and adjusting the gating control module according to the working signals.

6. The composite artificial auditory implant device according to claim 1, wherein the operation mode of the electrode unit includes any one of a stimulation mode, a reference mode and a recording mode.

7. A cochlear implant of the hybrid type, comprising:

the composite artificial auditory implant device according to any one of claims 1 to 6;

an extracorporeal device; the extracorporeal device is connected with the compound artificial auditory implanting device; the in-vitro device is used for collecting and processing audio signals and then sending the audio signals to the combined artificial auditory implanting device; the composite artificial auditory implant device receives signals and then gates ABI electrodes or CI electrodes so as to stimulate auditory nerves through the electrodes.

8. An auditory brainstem implant comprising the composite artificial auditory implant device of claim 1.

Technical Field

The present application relates to the field of artificial auditory implants, and in particular to peripheral and central auditory implants.

Background

A Cochlear Implant (CI) is an electronic device, in which an external speech processor converts sound into an electrical signal in a certain coding form, and an electrode system implanted in the body directly excites the auditory nerve to restore or reconstruct the auditory function of the deaf. In recent years, with the development of electronic technology, computer technology, phonetics, electrophysiology, materials science and otomicrosurgery, the cochlear implant has entered clinical application from experimental research, and the cochlear implant is now used as a conventional method for treating severe deafness to deafness all over the world.

The artificial Auditory Brainstem Implant (ABI) bypasses the inner ear and auditory nerve of lesion, the electrode is implanted into the surface of the fourth ventricle side recess brainstem, and the sound signal is converted into the electric signal to directly stimulate the cochlear nucleus complex of the brainstem, so that the auditory sense of a patient who cannot be implanted by the artificial cochlea is recovered to a certain degree.

In some clinical cases, there is some debate in the academia as to which hearing reconstruction technique (ABI or CI) is used. After extirpation of a tumor, such as an acoustic neuroma retaining cochlear nerve, if directly implanted with ABI, it is generally less effective (if functioning properly) than CI. Therefore, in the current practical clinical operation, the CI operation is usually performed only in advance, and whether the ABI operation is performed is determined according to the hearing recovery condition, however, the secondary operation inevitably brings a certain personal safety risk to the patient, and in addition, the medical cost is also improved to a certain extent, and the effect is not good (the effect of postoperative adhesion and the like) due to the loss of the best opportunity of performing ABI is also caused.

Disclosure of Invention

In view of the above-mentioned shortcomings of the prior art, the present application aims to provide a composite artificial hearing implant device and an artificial cochlea or auditory brainstem implant thereof, which are used for solving the problem that both ABI and CI cannot be considered in the prior art.

To achieve the above and other related objects, a first aspect of the present application provides a composite artificial auditory implant device comprising: an electrode unit; an implant unit; a connection unit including at least a first connection line for connecting the ABI electrode and the implant unit, and a second connection line for connecting the CI electrode and the implant unit; wherein the electrode unit comprises at least an ABI electrode and a CI electrode; the ABI electrode and the CI electrode are switched between electrodes or used simultaneously after being controlled and gated.

In some embodiments of the first aspect of the present application, the composite artificial auditory implant device comprises an in vivo unit; the in vivo unit is connected with the in vitro unit; the in-vitro unit is used for acquiring and processing audio signals and then sending the audio signals to the in-vivo unit; the in vivo unit strobes the ABI or CI electrodes upon receiving a signal from the in vitro unit to stimulate the auditory nerve through the electrodes.

In some embodiments of the first aspect of the present application, the extracorporeal unit comprises an audio signal acquisition module and a signal processing module; the signal processing module includes: the microphone is connected with the audio signal acquisition module and used for converting the acquired audio signals into analog signals; the analog-to-digital conversion module is connected with the microphone and is used for converting an analog signal into a digital signal; the processor is connected with the analog-to-digital conversion module and is used for carrying out signal processing and coding on the digital signal to obtain a sound coding signal; and the radio frequency modulation module is connected with the processor and is used for modulating the sound coding signals into corresponding radio frequency signals.

In some embodiments of the first aspect of the present application, the in vivo unit comprises: a temporo-extraosseous unit connected to the extracorporeal unit; the temporoosseous unit comprises a CI electrode and is connected with the temporoosseous unit; an intracranial unit comprising an ABI electrode connected to the extratemporal unit.

In some embodiments of the first aspect of the present application, the extratemporal unit comprises: a receiving coil for remotely receiving the radio frequency signal emitted by the extracorporeal unit; the stimulator is connected with the receiving coil and is used for converting the radio-frequency signals into corresponding electric pulse signals; the stimulator is respectively connected with the ABI electrode and the CI electrode so as to stimulate the electrodes through electric pulse signals; the gating control module is connected with the stimulator and sends a gating instruction to the stimulator; and the signal receiving module is connected with the CI electrode, the ABI electrode and the gating control module and is used for receiving working signals of the CI electrode and the ABI electrode, judging whether the working signals are in a normal working state or not and adjusting the gating control module according to the working signals.

In some embodiments of the first aspect of the present application, the operation mode of the electrode unit comprises any one of a stimulation mode, a reference mode and a recording mode.

To achieve the above and other related objects, a second aspect of the present application provides a combined cochlear implant comprising the combined artificial hearing implant device and an extracorporeal device; the extracorporeal device is connected with the compound artificial auditory implanting device; the in-vitro device is used for collecting and processing audio signals and then sending the audio signals to the combined artificial auditory implanting device; the composite artificial auditory implant device receives signals and then gates ABI electrodes or CI electrodes so as to stimulate auditory nerves through the electrodes.

To achieve the foregoing and other related objects, a third aspect of the present application provides an auditory brainstem implant.

As described above, the composite artificial auditory implant device and the artificial cochlea or auditory brainstem implant thereof of the present application have the following beneficial effects: the invention simultaneously considers the sound and electricity stimulation of the cochlea and the cochlear nucleus, designs the composite artificial auditory implanting device, realizes the expected target of 'one operation and two implants', reduces the operation times and also reduces the medical cost to a certain extent; in addition, the ABI electrode and the CI electrode can be switched randomly, and multiple functions of stimulation, reference, recording and the like can be realized.

Drawings

Fig. 1 is a schematic mechanical diagram of a composite artificial auditory implant device according to an embodiment of the present application.

FIG. 2A is a schematic diagram of the number of CI electrode channels in an embodiment of the present application.

FIG. 2B is a schematic diagram of ABI electrode channel data in an embodiment of the present application.

Fig. 3 is a schematic circuit diagram of a composite artificial auditory implant device according to an embodiment of the present application.

Detailed Description

The following description of the embodiments of the present application is provided by way of specific examples, and other advantages and effects of the present application will be readily apparent to those skilled in the art from the disclosure herein. The present application is capable of other and different embodiments and its several details are capable of modifications and/or changes in various respects, all without departing from the spirit of the present application. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.

It is noted that in the following description, reference is made to the accompanying drawings which illustrate several embodiments of the present application. It is to be understood that other embodiments may be utilized and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present application. The following detailed description is not to be taken in a limiting sense, and the scope of embodiments of the present application is defined only by the claims of the issued patent. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Spatially relative terms, such as "upper," "lower," "left," "right," "lower," "below," "lower," "above," "upper," and the like, may be used herein to facilitate describing one element or feature's relationship to another element or feature as illustrated in the figures.

In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "retained," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as appropriate.

Also, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It will be further understood that the terms "comprises," "comprising," and/or "comprising," when used in this specification, specify the presence of stated features, operations, elements, components, items, species, and/or groups, but do not preclude the presence, or addition of one or more other features, operations, elements, components, items, species, and/or groups thereof. The terms "or" and/or "as used herein are to be construed as inclusive or meaning any one or any combination. Thus, "A, B or C" or "A, B and/or C" means "any of the following: a; b; c; a and B; a and C; b and C; A. b and C ". An exception to this definition will occur only when a combination of elements, functions or operations are inherently mutually exclusive in some way.

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions in the embodiments of the present invention are further described in detail by the following embodiments in conjunction with the accompanying drawings. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Fig. 1 is a schematic diagram showing a mechanical structure of a composite artificial auditory implant device according to an embodiment of the present invention. The hearing implant device of the present embodiment includes an electrode unit 11, a connection unit 12, and an implant unit 13, the connection unit 12 being configured to connect the electrode unit 11 and the implant unit 13. The connection unit 12 in this embodiment includes two connection lines, the electrode unit 11 includes an ABI electrode 111 and a CI electrode 112, one of the two connection lines connects the ABI electrode 111 and the implant unit 13, and the other connection line connects the CI electrode 112 and the implant unit 13.

It should be noted that the CI electrode refers to a cochlear implant (cochlear implant), and an external speech processor converts sound into an electric signal in a certain coding form, and directly excites auditory nerve through an electrode system implanted in a human body to recover or reconstruct the auditory function of the deaf. The ABI electrode is an auditory brainstem implant (auditory brainstem implant) which bypasses the inner ear and auditory nerve of lesion, the electrode is implanted on the surface of the recess brainstem at the side of the fourth ventricle, and a sound signal is converted into an electric signal to directly stimulate a brainstem cochlear nucleus complex, so that the auditory sense of a patient who cannot be implanted by the artificial cochlea is recovered to a certain degree.

The number of stimulation electrode channels of the ABI device and the CI device is about 16-24, and the number of the started stimulation channels can be reduced to 8-12 according to actual requirements. The number of the channels of the electrode part is set to be 8 to 16 by combining the ecological and practical clinical needs of the existing industry. FIG. 2A shows a schematic diagram of the number of CI electrode channels, wherein 12 stimulation channels 1121 are formed on the CI electrode 112; fig. 2B shows a data diagram of the ABI electrode channel, and 13 stimulation channels 1111 are formed in the ABI electrode 111. In addition, the connecting unit 12 and the implant unit 13 are similar to the conventional ABI device and CI device in function and design, and thus are not described again. It should be understood that the above examples are provided for illustrative purposes and should not be construed as limiting.

Fig. 3 is a schematic circuit diagram of a composite artificial auditory implant device according to an embodiment of the present invention. The composite artificial auditory implant device of the present embodiment is connected to the extracorporeal unit 32, and the intracorporeal unit 31 is further subdivided into an extratemporal unit 311, an intratemporal unit 312, and an intracranial unit 313 according to the intracorporeal location where the intracorporeal unit is located. The modules included in each unit are described in detail below.

The extracorporeal unit 32 comprises an audio signal acquisition module 321 and a signal processing module 322, which together form the external unit part of the device. The audio signal acquisition module 321 is configured to acquire an external audio signal; the signal processing module 322 mainly includes a microphone, an analog-to-digital conversion module, a processor, a radio frequency modulation module, a power management module, and the like; the microphone is used for converting the collected audio signals into corresponding analog signals; the analog-to-digital conversion module is connected with the microphone and is used for converting an analog signal into a corresponding digital signal; the processor (such as a DSP processor, an ARM processor, an SOC processor, an MCU processor or an FPGA processor) is connected with the analog-to-digital conversion module and is used for performing signal processing and coding on the converted digital signal to obtain a sound coding signal; the radio frequency modulation module is connected with the processor and is used for modulating the sound coding signals into corresponding radio frequency signals; the power management module is used for providing power of each required voltage grade for each module.

The extratemporal unit 311 includes a receiving coil 3111, a stimulator 3112, a gating control module 3113 and a signal receiving module 3114; the temporal endosteal unit 312 includes CI electrodes; the intracranial unit includes an ABI electrode. The receiving coil 3111 includes a magnet for remotely receiving the rf signal from the extracorporeal unit 31 and transmitting the rf signal to the stimulator 3112, the stimulator 3112 includes signal conversion electronics, and is covered with a titanium alloy or ceramic sealed housing for converting the received rf signal into a corresponding electrical pulse signal, and transmitting the electrical pulse signal to the CI electrode or the ABI electrode, so as to stimulate the patient through the CI electrode or the ABI electrode. Gating control module 3113 is coupled to stimulator 3112 and sends gating instructions to stimulator 3112 to control the operation of the CI and ABI electrodes. The signal receiving module 3114 is connected to the CI electrode, the ABI electrode, and the gate control module 3113, and is configured to receive working signals of the CI electrode and the ABI electrode, determine whether the working signals are in a normal working state, and adjust the gate control module 3113 accordingly.

For example, the gating control module 3113 controls both the ABI electrode and the CI electrode to be in a working state, the ABI electrode and the CI electrode transmit working signals to the signal receiving module 3114, and after the signal receiving module 3114 receives the signals, if it is determined that both the ABI electrode and the CI electrode are in a normal working state, the gating control module 3113 is not adjusted; if one of the electrodes is determined to be in an abnormal working state, the gate control module 3113 is adjusted to change the working state of the electrode.

The temporal intra-osseous unit 312 is a CI electrode and the intracranial unit 313 is an ABI electrode, and the number of stimulation electrode channels of both can be adjusted between 8 and 16. In addition, the two modes can be divided into a stimulation mode, a reference mode and a recording mode in terms of working modes. In the stimulation mode, the electrode plays the original stimulation function; in the recording mode, the electrode itself can be regarded as a recording electrode; in the reference mode, the electrode itself can be considered as a reference electrode.

The invention also provides a combined artificial cochlea which comprises the combined artificial auditory implanting device and an external device; the extracorporeal device is connected with the compound artificial auditory implanting device; the in-vitro device is used for collecting and processing audio signals and then sending the audio signals to the combined artificial auditory implanting device; the composite artificial auditory implant device receives signals and then gates ABI electrodes or CI electrodes so as to stimulate auditory nerves through the electrodes. It should be noted that, the combined artificial cochlea of the present embodiment is similar to the above-mentioned combined artificial auditory implant device, and therefore, the description thereof is omitted.

The invention also provides auditory brainstem implantation, which comprises the composite artificial auditory implantation device. It should be noted that, the auditory brainstem implantation of the present embodiment is similar to the above embodiment of the composite artificial auditory implantation device, and therefore, the description thereof is omitted.

In summary, the application provides the composite artificial auditory implant device and the composite artificial cochlea applied by the same, simultaneously considers the acoustoelectric stimulation of the cochlea and the cochlear nucleus, designs the composite artificial auditory implant device, realizes the expected targets of 'one operation and two implants', reduces the operation times and also reduces the medical cost to a certain extent; in addition, the ABI electrode and the CI electrode can be switched randomly, and multiple functions of stimulation, reference, recording and the like can be realized. Therefore, the application effectively overcomes various defects in the prior art and has high industrial utilization value.

The above embodiments are merely illustrative of the principles and utilities of the present application and are not intended to limit the application. Any person skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present application. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical concepts disclosed in the present application shall be covered by the claims of the present application.