EP1181950A2 - Système auditif implantable comportant des moyens de mesure de la qualité d'accouplement - Google Patents

Système auditif implantable comportant des moyens de mesure de la qualité d'accouplement Download PDF

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Publication number
EP1181950A2
EP1181950A2 EP01118060A EP01118060A EP1181950A2 EP 1181950 A2 EP1181950 A2 EP 1181950A2 EP 01118060 A EP01118060 A EP 01118060A EP 01118060 A EP01118060 A EP 01118060A EP 1181950 A2 EP1181950 A2 EP 1181950A2
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EP
European Patent Office
Prior art keywords
impedance
converter
measuring
coupling
hearing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP01118060A
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German (de)
English (en)
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EP1181950A3 (fr
EP1181950B1 (fr
Inventor
Hans Dr.-Ing. Leysieffer
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Cochlear Ltd
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Cochlear Ltd
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Publication of EP1181950A3 publication Critical patent/EP1181950A3/fr
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    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/40—Arrangements for obtaining a desired directivity characteristic
    • H04R25/407—Circuits for combining signals of a plurality of transducers
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/60—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles
    • H04R25/604—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers
    • H04R25/606—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers acting directly on the eardrum, the ossicles or the skull, e.g. mastoid, tooth, maxillary or mandibular bone, or mechanically stimulating the cochlea, e.g. at the oval window
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R2225/00—Details of deaf aids covered by H04R25/00, not provided for in any of its subgroups
    • H04R2225/67—Implantable hearing aids or parts thereof not covered by H04R25/606

Definitions

  • the present invention relates to an at least partially implantable hearing system for rehabilitation a hearing disorder with at least one sensor for recording sound signals and their conversion into corresponding electrical sensor signals, an electronic signal processing unit for audio signal processing and amplification of the sensor signals, one electrical power supply unit, the individual components of the system with electricity supplied, as well as with at least one electromechanical output converter for mechanical Stimulation of the middle and / or inner ear.
  • hearing impairment is intended to combine all types of inner ear damage Inner and middle ear damage as well as occasional or permanent ear noises (Tinnitus) can be understood.
  • Implantable hearing systems differ from conventional hearing aids: the sound signal is converted into an electrical signal using an adequate microphone and amplified in an electronic signal processing stage; this reinforced however, the electrical signal is not fed to an electroacoustic transducer (loudspeaker), but an implanted electromechanical transducer, the output side mechanical vibrations directly, i.e. with direct mechanical contact, the Middle or inner ear can be supplied or indirectly by a frictional connection via an air gap in, for example, electromagnetic converter systems.
  • the partially implantable, piezoelectric hearing system of the Japanese group around Suzuki and Yanigahara implies the absence of the middle ear and one for implantation of the transducer open tympanic cavity in advance to be able to couple the piezo element to the stapes (Yanigahara et al .: "Efficacy of the partially implantable middle ear implant in middle and inner ear disorders ", Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 149-159. Suzuki et al .: "Implantation of partially implantable middle ear implant and the indication", Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 160-166).
  • the electromagnetic converter according to Ball (Floating Mass Transducer FMT”; among others US-A-5 624 376 (Ball et al.)), On the other hand, is direct with an intact middle ear with titanium clips fixed to the long extension of the anvil.
  • the electromagnetic transducer of the semi-implantable Systems according to Fredrickson (Fredrickson et al .: "Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss ", Otolaryngologic Clinics Of North America, Vol. 28/1 (1995), pp. 107-121) is also published by intact ossicle chain of the middle ear mechanically coupled directly to the anvil body.
  • an advantage of the variants according to a) is that the converter is known as a "floating" Mass “converter can be designed, that is, the transducer element does not require a" reaction " via a tight screw connection to the skull bone, but it swings due to Mass inertia laws with its transducer housing and transmits them directly to a middle ear crossbar.
  • this variant means disadvantageously that voluminous artificial elements have to be introduced into the tympanic cavity and their long-term and biostability especially in the case of temporary pathological changes of the middle ear (e.g.
  • a certain disadvantage of the converter variants according to b) is the fact that the converter housing attached to the skull cap with implantable positioning and fixation systems Need to become.
  • Another disadvantage of the variants according to b) is that, preferably by means of suitable lasers, recesses have to be made in the target ossicles, to be able to apply the coupling element.
  • this is technically complex and expensive and, on the other hand, involves risks for the patient.
  • the main advantage of these converter embodiments according to b) is, however, that the middle ear remains largely free and the coupling access to the middle ear without any major Facial nerve potential can occur.
  • implantable electromechanical hearing aid converters became numerous coupling elements developed and described the mechanical vibration energy of the transducer as possible optimally and long-term stable to the coupling location of the middle or inner ear.
  • Implantable hearing systems were also specified, in which not only one, but several electromechanical transducers are used to stimulate the damaged hearing in order to optimally simulate the multi-channel cochlear amplifier and thus to achieve a further rehabilitation of the damaged hearing than with just one converter.
  • electromechanical transducers are used to stimulate the damaged hearing in order to optimally simulate the multi-channel cochlear amplifier and thus to achieve a further rehabilitation of the damaged hearing than with just one converter.
  • the coupling quality of the mechanical stimulus is influenced by many parameters, and it contributes decisively to the rehabilitation of hearing damage and the perceived hearing quality at. Intraoperatively, this quality of coupling is difficult or impossible to assess, since the movement amplitudes of the vibrating parts even at the highest stimulation levels are in a range around or far below 1 ⁇ m and therefore not by direct visual inspection are assessable. Even if this can be achieved using other technical measurement methods, for example by intraoperative laser measurements (for example by laser Doppler vibrometry), there remains the uncertainty of a long-term stable, secure coupling, since this is under through necrosis, new tissue formation, changes in air pressure and others external and internal influences can be negatively influenced.
  • WO-A-98/36711 proposes a method which uses objective hearing test methods such as ERA (electric response audiometry), ABR (auditory brainstem response) or electrocochleography for partially and fully implantable systems with mechanical or electrical stimulation of the damaged or failed Hearing works.
  • objective hearing test methods such as ERA (electric response audiometry), ABR (auditory brainstem response) or electrocochleography
  • ERA electric response audiometry
  • ABR auditory brainstem response
  • electrocochleography electrocochleography
  • the electromechanical output converter the implanted hearing system is technically reproducible and quantified electrically controlled directly; this will falsify the stimulation level avoided, such as by headphone or in particular acoustic Free-field performances of the audiometric test sound can occur because of this Sensor or microphone function with all associated variabilities in the psychoacoustic Measurement is included.
  • this procedure has the advantage that, for example, frequency-specific hearing threshold measurements with pure sine tones or narrowband signals (for example Third-octave noise) can be reproduced very well even with larger, temporal examination intervals are. Furthermore, the method also allows reproducible psychoacoustic to be obtained Data above the threshold, such as loudness scaling. About that In addition, by offering pure signals, such as sinusoidal signals, non-linearities can also occur subjectively queried, for example due to a deterioration in the coupling quality can arise and are heard as "clinking". Such investigations are through the above-mentioned objective measurement methods based on evoked potentials only limited or not possible at all.
  • electromechanical transducers have the drawbacks that either a subjective assessment of the patient is included in the result or physiological Interfaces are included in the measurement; both aspects make the measurement result insecure and therefore represent a non-optimal one, especially with regard to reproducibility Solution.
  • the invention has for its object an at least partially implantable hearing system to create an objective, even intraoperatively, in a particularly reliable manner Measurement of the coupling quality enables.
  • At least partially implantable Hearing system for the rehabilitation of a hearing disorder with at least one sensor for recording of sound signals and their conversion into corresponding electrical sensor signals, one electronic signal processing unit for audio signal processing and amplification of the Sensor signals, an electrical power supply unit, the individual components of the Systems powered, as well as with at least one electromechanical output converter for mechanical stimulation of the middle and / or inner ear
  • the hearing system for the objective determination of the coupling quality of the output transducer with an impedance measuring arrangement for determining the mechanical impedance of the implanted Provide the condition of the biological load structure coupled to the output converter is.
  • the principle of the present invention has the particular advantage that the coupling quality of the transducer (s) intraoperatively immediately after coupling to the biological one Hearing structure can be assessed and, if necessary, improved intraoperatively, before the implantation is completed without precise knowledge of the coupling success is because the patient is usually operated under total anesthesia and therefore psychoacoustic Measurements are not possible.
  • the present invention also offers the advantage that in the postoperative state Coupling quality of the converter or converters can be objectively observed for a long time can without the patient having to undergo any special procedure. This is done, for example, in such a way that the software interface with which the audiologist or Hearing aid acoustician adjusts the patient's implant to the individual hearing damage, contains a module with which the software is initialized automatically or by active Retrieval of an implant-side impedance measurement is triggered and the corresponding data be transmitted telemetrically to the software interface for further evaluation and evaluation.
  • the Measurement results as digital data in a memory area of the implant provided for this purpose be stored from outside until called up.
  • the impedance measuring arrangement can be an arrangement for measuring the electrical input impedance the or the coupled to the biological load structure have electromechanical output converter (s).
  • the amount and phase data of this electrical input impedance namely reflect the coupled load components, because this is via the electromechanical coupling of the converter (s) appear transformed on the electrical side and are therefore measurable.
  • the relevant output converter to the driver unit is connected via a measuring resistor and a measuring amplifier is provided the input signals that drop across the measuring resistor and are proportional to the converter current Measuring voltage and the converter terminal voltage are present.
  • the voltage drop across the measuring resistor is expediently high-resistance and ground free, and the measuring resistor is advantageously dimensioned such that the Sum of the resistance value of the measuring resistor and the amount of the complex electrical input impedance of the electromechanical coupled to the biological load structure Output converter large compared to the internal resistance of the driver unit is.
  • There are also - preferably digital - means for forming the quotient from converter terminal voltage and converter current are provided.
  • the impedance measuring arrangement can also be used for direct Measurement of the mechanical impedance of the electromechanical output converter coupled biological load structure designed and in the output converter on its Actuator output side can be integrated, preferably the impedance measuring arrangement is designed to generate measurement signals based on the amount and phase of the biological Load structure acting force or the speed of the coupling element at least are approximately proportional.
  • the measurement signals advantageously provided a two-channel measuring amplifier with multiplexer function, and there are corresponding - preferably digital - means for forming the quotient from the measurement signal corresponding to the force acting on the biological load structure and the measurement signal the fast of the coupling element available.
  • the electromechanical output converter and the impedance measuring arrangement can be accommodated in a common housing, which if necessary also houses the measuring amplifier.
  • the described impedance measurements are in no way related to a measuring frequency or limited a measurement level. Both indirect and direct measurement of the mechanical Rather, the impedance of the biological load structure is advantageous - preferably digital - Means for determining the mechanical impedance of the implanted to the Output transducers coupled biological load structure depending on the frequency and / or the level of the stimulation signal emitted by the output transducer intended.
  • the stimulation level range of the hearing implant in question can be in the postoperative observation phase important detailed statements about linear and especially non-linear variations the coupling quality of the electromechanical transducer become. For example, mechanical non-linearity can be expected the coupling to a middle ear ("clink”), which the transmitted sound quality can influence negatively, determined by electrical level variation of the impedance measurement can be.
  • means for Determining the spectral position of resonance frequencies in the course of the measured impedance above the stimulation rate and to determine the difference between the two the impedance measured values occurring at the resonance frequencies can be provided. That difference provides information about the mechanical vibration quality.
  • the procedure explained can basically be applied to all known electromechanical Conversion principles such as electromagnetic, electrodynamic, magnetostrictive, dielectric and especially in piezoelectric transducers, so that the System design of the hearing implant with regard to the transducer shape (s) in principle no restriction exists and thus also mixed forms with multi-channel actuator system design different transducer principles for optimal hearing stimulation are possible.
  • the electromechanical output converter can be implanted with the biological one Load structure via a passive coupling element and / or via a coupling rod in mechanical Connect, and the impedance measuring arrangement can in the coupling rod be inserted.
  • the electronic signal processing unit is preferably also for processing the signals the impedance measuring arrangement.
  • the signal processing unit advantageously has a digital signal processor for processing the sound sensor signals and / or for generating of digital signals for tinnitus masking and for processing the signals the impedance measuring arrangement.
  • the signal processor can briefly interrupt the hearing system's audio signal, in order to feed in the corresponding measurement signals, for example from the signal processor be generated yourself.
  • the electrical transducer impedance measurement can be performed also take place below the resting hearing threshold of the individual patient not to disturb the patient by the measurement signals. To do this, the individual, spectral Resting threshold data of the patient in question in a memory area of the system to which the measurement software of the signal processor then relates takes.
  • the signal processor can be designed statically in such a way that corresponding software modules based on scientific knowledge, once in a program memory of the signal processor are stored and remain unchanged. But then lie later Example based on recent scientific knowledge improved algorithms for Speech signal processing and processing and if these are to be used, must be followed by an invasive, operative patient intervention for the entire implant or the implant module, which contains the corresponding signal processing unit against a new one with the changed one Operating software to be replaced. This intervention harbors new medical risks for the patient and involves a lot of effort.
  • the signal processor for recording and playback of an operating program repeatedly writable, implantable memory arrangement is assigned, and at least Parts of the operating program by an external unit via a telemetry device transmitted data can be changed or exchanged. That way After the implantable system is implanted, the operating software, including Software for controlling the switchable clutch arrangement explained above, as change or replace them completely, as is the case for other known systems for the rehabilitation of hearing disorders in DE-C-199 15 846 is explained.
  • the design is preferably such that it also applies to fully implantable systems also operating parameters known per se, that is to say patient-specific Data, such as audiological adaptation data, or changeable implant system parameters (for example as a variable in a software program to control the switchable clutch arrangement or for regulating a battery recharge) after the Implantation transcutaneously, i.e. wirelessly through the closed skin, into the implant can be transferred and thus changed.
  • patient-specific Data such as audiological adaptation data, or changeable implant system parameters (for example as a variable in a software program to control the switchable clutch arrangement or for regulating a battery recharge) after the Implantation transcutaneously, i.e. wirelessly through the closed skin, into the implant can be transferred and thus changed.
  • the software modules are preferred dynamic, or in other words capable of learning, designed to be as optimal as possible Rehabilitation of the particular hearing disorder to come.
  • the software modules be designed adaptively, and a parameter adjustment can be carried out by "training" the implant carrier and other aids are made.
  • the signal processing electronics can contain a software module that a The best possible stimulation based on an adaptive neural network reached.
  • This neural network can be trained by the implant carrier and / or with the help of other external aids.
  • the memory arrangement for storing operating parameters and the memory arrangement for recording and playback of the operating program can be independent of each other Memory implemented; however, it can also be a single memory in which can be used to store both operating parameters and operating programs.
  • the present solution allows the system to be adapted to circumstances that only after Implantation of the implantable system can be detected.
  • the sensory (sound sensor or microphone) and actuator (output stimulator) biological interfaces always depend on the anatomical, biological and neurophysiological conditions, for example of the inter-individual healing process.
  • These interface parameters can in particular also be time-variant individually.
  • the transmission behavior of an implanted microphone can be due to of tissue layers and the transmission behavior of one coupled to the inner ear electromechanical transducer due to different coupling quality interindividually and vary individually.
  • Such differences in interface parameters, which are reflected in the devices known from the prior art not even by replacement of the implant can be reduced or eliminated by changing this Optimized or improved signal processing of the implant become.
  • the means a rechargeable battery system
  • these electrical energy storage devices are progressing Technology ever longer lifetimes and thus increasing dwell times in the patient enable. It can be assumed that basic and application research advances rapidly for signal processing algorithms. The need or the patient's wish to adapt or change the operating software is therefore expected to expire before the life of the implant-internal energy source enter.
  • the system described here allows such an adjustment of the Operating programs of the implant even in the already implanted state.
  • an intermediate storage arrangement in which of the data transmitted to the external unit via the telemetry device before being forwarded to the signal processor can be cached.
  • the Complete the transfer process from the external device to the implanted system, before the data transmitted via the telemetry device is forwarded to the signal processor become.
  • a check logic can be provided in the buffer arrangement stored data before being passed to the signal processor of a review subjects.
  • a microprocessor module in particular a microcontroller, can be used for Intra-implant control of the signal processor can be provided via a data bus, wherein expediently the checking logic and the buffer arrangement in the microprocessor module are implemented and where via the data bus and the telemetry device also program parts or entire software modules between the outside world, the microprocessor module and can be transmitted to the signal processor.
  • the microprocessor module is preferably an implantable memory arrangement for Save a work program for the microprocessor module assigned, and at least Parts of the work program for the microprocessor module can be carried out by the External unit changed or exchanged data transmitted via the telemetry device become.
  • At least two storage areas can be accommodated and playback of at least the operating program of the signal processor is provided his. This contributes to the reliability of the system by the multiple existence the memory area which contains the operating program or programs, for example after an external transfer or when the implant is switched on the software can be checked for errors.
  • the buffer arrangement can also have at least two memory areas for recording and playback from the external unit via the telemetry device have transmitted data, so that after data transmission from the external unit a check of the error-free nature of the transmitted data in the buffer area Data can be made.
  • the memory areas can, for example complementary storage of the data transmitted by the external unit.
  • At least one of the storage areas of the intermediate storage arrangement can also be used for Recording only part of the data transmitted by the external unit, in this case, checking the accuracy of the transmitted data section by section he follows.
  • the signal processor rewritable permanent storage area can be assigned in which the for a "minimal operation" instructions and parameters required by the system are stored, for example Instructions following a "system crash" at least to ensure error-free operation the telemetry device for receiving an operating program and instructions for Ensure that it is saved in the control logic.
  • the telemetry device is advantageously except for reception of operating programs from the external unit also for the transmission of operating parameters designed between the implantable part of the system and the external unit, so on the one hand such parameters from a doctor, a hearing care professional or the Carrier of the system itself can be adjusted (for example volume), on the other hand the system can also transmit parameters to the external unit, for example to check the status of the system.
  • a fully implantable hearing system of the type explained here can be on the implant side in addition to the actuator stimulation arrangement and the signal processing unit at least have an implantable sound sensor and a rechargeable electrical storage element, in which case a wireless transcutaneous charging device for charging of the storage element can be provided.
  • a primary cell or another energy supply unit can also be present, that does not require transcutaneous recharge. This is especially true if you take into account that in the near future, mainly through further development of processor technology with essential Reduction in the energy requirement for electronic signal processing is, so that new forms of energy supply are practically applicable for implantable hearing systems for example an energy supply like the Seebeck effect is described in DE-C 198 27 898.
  • a wireless remote control is also preferably used Control of the implant functions by the implant carrier available.
  • the hearing system is partially implantable, there is at least one sound sensor electronic signal processing unit, the power supply unit and a modulator / transmitter unit in an external on the body, preferably on the head above the implant, external module to be carried.
  • the implant has the electromechanical on the output side Converter and the switchable clutch arrangement, but is energetically passive and receives its operating energy and control data for the output converter and the switchable coupling arrangement via the modulator / transmitter unit in the external Module.
  • a hearing disorder in both ears has two system units, each one of the are assigned to both ears.
  • the two system units can essentially each other be equal. But it can also be the one system unit as the master unit and the system unit other than slave unit controlled by the master unit.
  • the Signal processing modules of the two system units can in any way, in particular via a wired implantable line connection or via a wireless Connection, preferably a bidirectional radio frequency link, a structure-borne noise Ultrasonic path or the electrical conductivity of the tissue of the implant carrier exploiting data transmission path, communicate with each other in such a way that Optimized binaural signal processing and converter array control in both system units is achieved.
  • the external sound signal is recorded via one or more sound sensors (microphones) 10a to 10n and converted into analog electrical signals.
  • these sensor functions are not required.
  • the electrical sensor signals are passed to a unit 11, which is part of an implantable electronic module 12 and in which the sensor signal or signals are selected, preprocessed and converted into digital signals (A / D conversion).
  • the preprocessing can consist, for example, of an analog linear or non-linear pre-amplification and filtering (for example antialiasing filtering).
  • the digitized sensor signal or signals are fed to a digital signal processor (DSP) 13, which performs the intended function of the hearing implant, such as audio signal processing in a system for inner ear deafness and / or signal generation in the case of a tinnitus masker or noiser.
  • DSP digital signal processor
  • the signal processor 13 contains a non-rewritable permanent memory area S 0 , in which the instructions and parameters required for "minimal operation" of the system are stored, and a memory area S 1 , in which the operating software for the intended function or functions of the implant system are stored. This memory area is preferably provided in duplicate (S 1 and S 2 ).
  • the program memory which can be written repeatedly, for accommodating the operating software can be based on EEPROM or RAM cells, in which case it should be ensured that this RAM area is always “buffered" by the implant-internal energy supply system.
  • the digital output signals of the signal processor 13 are in a digital-to-analog converter (D / A) 14 converted to analog signals.
  • D / A converter can vary depending on the implant function can also be designed multiple times or completely eliminated if at Example in the case of a hearing system with an electromagnetic output converter for example pulse width modulated, serial digital output signal of the signal processor 13 is transmitted directly to the output converter.
  • the analog output signal of the digital-to-analog converter 14 is then guided to a driver unit 15 which, depending on the implant function an output-side electromechanical transducer 16 for stimulating the means or Drives inner ear.
  • the signal processing components 11 and 13 to 15 are controlled by a microcontroller 17 (.mu.C) with one or two associated memories S 4 or S 5 via a bidirectional data bus 18.
  • the operating software components of the implant management system for example administrative monitoring and telemetry functions, can be stored in the memory areas S 4 and S 5 .
  • the memories S 1 and / or S 2 externally changeable, patient-specific, such as, for example, audiological adaptation parameters can also be stored.
  • the microcontroller 17 has a memory S 3 that can be written to repeatedly, in which a work program for the microcontroller 17 is stored.
  • the microcontroller 17 communicates with a telemetry system (TS) 20 via a data bus 19.
  • This telemetry system 20 in turn communicates through the closed skin indicated at 21, for example via an inductive coil coupling (not shown), wirelessly bidirectionally with an external programming system (PS) 22.
  • PS external programming system
  • the programming system 22 can advantageously be a PC-based system with appropriate programming, editing, presentation and management software.
  • the operating software of the implant system that is to be changed or completely exchanged is transmitted via this telemetry interface and initially stored temporarily in the memory area S 4 and / or S 5 of the microcontroller 17.
  • the storage area S 5 can be used for a complementary storage of the data transmitted by the external system, and a simple verification of the software transmission by a reading process via the telemetry interface can be carried out to determine the coincidence of the contents of the storage areas S 4 and S 5 check before the content of the rewritable memory S 3 is changed or exchanged.
  • the operating software of the at least partially implantable hearing system should include both the operating software of the microcontroller 17 (for example housekeeping functions such as energy management or telemetry functions) and the operating software of the digital signal processor 13.
  • the operating software of the microcontroller 17 for example housekeeping functions such as energy management or telemetry functions
  • the operating software of the digital signal processor 13 For example, a simple verification of the software transmission can be carried out by means of a reading process via the telemetry interface before the operating software or the corresponding signal processing components of this software are transmitted to the program memory area S 1 of the digital signal processor 13 via the data bus 18.
  • the work program for the microcontroller 17, which is stored, for example, in the repeatedly writable memory S 3 can be changed or exchanged in whole or in part using the external unit 22 via the telemetry interface 20.
  • the D / A converter 14 and the respective converter principle of the output converter 16 adapted driver amplifier 15 follows a measuring system explained in more detail below (IMS) 25 for analog determination of the electrical converter impedance.
  • IMS measuring system explained in more detail below
  • the from the measurement system 25 supplied analog measurement data are via a measurement amplifier 26 and an associated A / D converter 27 amplified and converted into digital measurement data.
  • the digital measurement data will be to the digital signal processor 13 of the hearing system for further processing and / or storage transmitted.
  • This driver and impedance detection system with associated electromechanical Output converter 16 is shown in FIG. 1 shown in dashed lines as a unit 28.
  • the impedance measurement data can be sent to the Outside world to the programming and display system 22 (for example a PC with a corresponding Hardware interface).
  • the unit 28 is accordingly to be provided several times, as shown in FIG. 1 shown in dashed lines is.
  • the respective impedance measurement data are then sent to the digital signal processor 13 via a corresponding digital data bus structure provided (not shown in FIG. 1).
  • All electronic components of the implant system are primary or secondary battery 30 supplied with electrical operating energy.
  • FIG. 2 shows a possible, simple embodiment of the impedance measuring system 25 for a converter channel according to FIG. 1.
  • the digital driver data for the electromechanical converter 16 coming from the digital signal processor 13 are converted into an analog signal by the D / A converter 14 and fed to the converter driver 15.
  • the output of driver 15 is shown as voltage source U o with internal resistance R i .
  • the analog output signal of this driver 15 is fed to the electromechanical converter 16 having a complex electrical impedance Z L via a measuring resistor R m .
  • the respective basic functions of the driver and impedance measuring unit 28 are set by the microcontroller 17 via a digital control bus 31.
  • FIG. 3 shows in an electromechanical equivalent circuit diagram the approximation of a piezoelectric transducer with coupled biological load components.
  • the piezoelectric transducer on the electrical impedance side Z EI is essentially determined by a quiescent capacitance C o and a loss conductance G.
  • the mechanical components of the converter itself, which represent the mechanical impedance Z w follow an electromechanical unit converter 33 with an electromechanical converter factor ⁇ . If a piezoelectric transducer is operated in a highly tuned manner, that is to say if the first mechanical resonance frequency is at the upper end of the spectral transmission range, as is explained in more detail in US Pat. No.
  • the mechanical impedance of the transducer Z w is well approximated by that mechanical components dynamic transducer mass m w , transducer stiffness s w and the transducer friction resistance (real part) W w determined.
  • the biological, mechanical load impedance Z B in the present example should also be due to the three mechanical impedance components mass m B (for example, the mass of a middle ear cross member), stiffness s B (for example, stiffness of the clamping ring band of the stirrup footplate in the oval window) and frictional resistance W B (for Example connective tissue at the coupling point).
  • m B for example, the mass of a middle ear cross member
  • stiffness s B for example, stiffness of the clamping ring band of the stirrup footplate in the oval window
  • frictional resistance W B for Example connective tissue at the coupling point.
  • FIG. 4 shows the equivalent circuit diagram of the electrical converter impedance Z L according to FIG. 3, the coil L M reflecting the sum of the masses m w and m B , the capacitance C M the mechanical parallel connection of the stiffnesses sw and s B and the resistance R M the mechanical parallel connection of the components Ww and W B.
  • FIG. 5 shows the course of the amount of the electrical converter impedance / Z L / over the frequency f according to FIG. 4 in double logarithmic representation.
  • the series resonance occurring at f 1 and the parallel resonance at f 2 are determined by the components L M and C M with C o .
  • the size ⁇ / Z L / provides information about the mechanical vibration quality.
  • very precise information about the coupling quality and its course over time can be obtained, especially if the impedance measurements represent the entire spectral and level range of the hearing implant.
  • FIG. 6 shows a fully implantable hearing system largely in accordance with the system according to FIG. 1, but with the variant of direct mechanical impedance measurement.
  • a unit 35 accommodated in a housing 34 with an output-side electromechanical converter 36 which has an electromechanically active element 37, for example a piezoelectric and / or electromagnetic system .
  • an electromechanically active element 37 for example a piezoelectric and / or electromagnetic system
  • a mechanical impedance measuring system 38 is integrated in the converter 36, which in the implanted state measures the force F acting on the coupled biological load structure and the speed v of a coupling element 39 according to amount and phase.
  • the biological load structure is not shown.
  • the impedance measuring system 38 supplies electrical, analog measuring signals S F and S v , which are proportional to the force F and the rapid v . These analog measurement signals are converted into digital measurement data via a corresponding two-channel measurement amplifier 40 with multiplexer function and associated A / D converter 27 and transmitted to the digital signal processor 13 of the hearing system for further processing and / or storage.
  • This driver and impedance detection system with associated electromechanical converter 36 is shown in dashed lines as a unit 41.
  • the impedance measurement data can be transmitted to the outside world via the microcontroller 17 and the telemetry unit 20 to the programming and display system 22 (for example a PC with a corresponding hardware interface).
  • the unit 41 surrounded by dashed lines is to be supplemented accordingly, as shown in FIG. 6 is also shown in dashed lines.
  • the respective impedance measurement data are the digital Signal processor 13 is then available via a corresponding digital data bus structure provided (not shown in FIG. 6).
  • FIG. 7 shows a fully implantable hearing system with the variant of direct mechanical Impedance measurement according to FIG. 6, with the corresponding two-channel measuring amplifier 40 with multiplexer function and the associated A / D converter 27 for detection of the force and fast signals are integrated into the housing 34 of the unit 35.
  • the electromechanical active element of the converter 36 and the measuring system for determining the mechanical Load impedance are shown here together as element 42.
  • the coupling element for biological load is again designated 39.
  • FIG. 8 shows an example of the structure of the unit 35 according to FIG. 6 with a piezoelectric Transducer system according to US-A 5 277 694 and an additional measuring system for determination the mechanical impedance.
  • unit 35 has a biocompatible, cylindrical housing 34 made of electrically conductive material, for example Titanium, which is filled with inert gas.
  • a vibratable, electrical conductive membrane 46 of the output-side electromechanical transducer 36 is arranged.
  • the membrane 46 is preferably circular and it is on its outer edge with the Housing 34 firmly connected.
  • a thin Disc 47 made of piezoelectric material, for example lead zirconate titanate (PZT).
  • the the side of the piezo disk 47 facing the membrane 46 is electrically connected to the membrane 46 conductive connection, expediently via an electrically conductive adhesive connection.
  • the piezo disk 47 On the side facing away from the membrane 46, the piezo disk 47 has a contacted thin, flexible wire, which is part of a signal line 48 and in turn via a hermetic housing lead-through 49 with an outside of the housing 34 Converter feed line 50 is connected.
  • a ground connection 53 is from the converter feed line 50 via the housing bushing 49 led to the inside of the housing 34.
  • An electro-mechanical output side Transducer 36 of this type typically has a relatively high mechanical output impedance, in particular a mechanical output impedance that is higher than the mechanical load impedance the biological agent and / or coupled to the transducer in the implanted state Inner ear structure.
  • a coupling rod 55 and a passive coupling element 56 which is connected to the converter 36 remote end of the coupling rod 55 is attached or from this coupling rod end itself is formed.
  • the coupling of the output side of the converter 36 to the biological one Load structure, for example a target ossicle, is carried out via the mechanical impedance measuring system 38, which with the in FIG. 8 upper side of the membrane 46, preferably in the center the membrane is in mechanical connection.
  • the impedance measuring system 38 can also be used its membrane-side end directly on the membrane 46 and with its other end engage at the membrane-side end of the coupling rod 55; but it can also be in the Coupling rod 55 may be inserted.
  • the coupling rod 55 extends at least approximately in the illustrated embodiment perpendicular to the membrane 46 through an elastically resilient polymer seal 57 from the outside into the interior of the housing 34.
  • the polymer seal 57 is designed so that it allows axial vibrations of the coupling rod 55 in the implanted state.
  • the impedance measuring system 38 is housed within the housing 34.
  • the analog measuring signals S F and S v are transmitted from the impedance measuring system 38 via measuring lines 59, 60, internal signal feedthroughs 61 and the housing feedthrough 49 to the converter feed line 50.
  • the impedance measuring system 38 is also electrically connected to the housing 34 via a ground connection 62 and to the ground connection 53 via this housing.
  • the reference potential of the two measurement signals S F and S v for force and speed is thus the converter housing 34.
  • the impedance measuring system 38 is preferably itself based on piezoelectric converters and therefore active electrical impedance converters are necessary in the measuring system, these can be supplied by an electrical phantom power from Electronics module 12 of the implantable hearing system can be supplied with operating energy via one of the two implant measuring lines 59, 60 for force or speed.
  • FIG. 9 shows an example of a piezoelectric transducer system with a measuring system for determination the mechanical impedance according to FIG. 7, here the measuring amplifier 40 and associated A / D converter 27 in a separate electronic module connected via feed lines 63 64 are accommodated in the converter housing 34.
  • the impedance measuring system 38 and the separate electronics module 64 can be supplied via an electrical phantom power from Electronics module 12 of the implantable hearing system from one of two active implant lines (Signal line 48 for the actuator driver signal or a signal line 65 for the digital A / D output signal) can be supplied with operating energy.
  • FIG. 10 schematically shows the structure of a fully implantable hearing system, which as actuator stimulation arrangement an output-side electromechanical converter 16 or 36, for example the converter according to FIG. 8 or FIG. 9.
  • the output side Electromechanical transducers can generally be used as any electromagnetic, electrodynamic, piezoelectric, magnetostrictive or dielectric (capacitive) transducer be trained.
  • the converter shown in FIGS. 8 and 9 can also be modified in the manner explained in DE-C-198 40 211 in such a way that on the in 8 and 9 the lower side of the piezoelectric ceramic disk 47 is a permanent magnet is attached, in the manner of an electromagnetic transducer with an electromagnetic coil interacts.
  • the electromechanical converter on the output side can also be an electromagnetic one Act converter arrangement as described in EP-A-0 984 663. In each case, the measuring system 25 or 38 explained here is additionally provided.
  • a coupling element in addition to a coupling part for the coupling location in question, has a crimp sleeve, which initially loosely on a rod-shaped part of a provided with a rough surface Coupling rod is pushed on, which is connected to the converter in the manner explained above is.
  • the crimp sleeve can simply be moved relative to the coupling rod and rotated to the coupling part of the coupling element with the intended Align coupling point exactly. Then the crimp sleeve is fixed by using of a crimping tool is plastically cold worked.
  • the coupling element with Reference to the coupling rod can also be set by means of a retractable belt loop.
  • a coupling element on its Coupling ends have a contact surface that matches the surface shape of the coupling point adaptable or adapted surface shape and such a surface quality and surface area that it attaches to by attaching the coupling end the coupling point for a dynamic tension-compression coupling of coupling element and Ossicular chain comes through surface adhesion, which ensures a secure mutual connection of coupling element and ossicle chain is sufficient.
  • the coupling element can be implanted with one State at the coupling point of the attenuator with entropy-elastic Properties are provided to ensure an optimal vibration form of the stirrup footplate or one the round window or an artificial window in the cochlea, in the vestibule or in the labyrinth closing membrane and the risk of damage the natural structures in the area of the coupling point during and after the implantation to keep particularly low (DE-A-199 35 029).
  • the coupling element can according to DE-C-199 31 788 with an actuator for optional adjustment of the coupling element between an open position in which the Coupling element can be brought into and out of engagement with the coupling point, and a closed position be provided in which the coupling element in the implanted state with the coupling point is in force and / or positive connection.
  • a coupling arrangement is also suitable on the ossicle chain (DE-A-199 48 336), which can be set into mechanical vibrations by the transducer Coupling rod and one which can be connected to the preselected coupling point Has coupling element, wherein the coupling rod and the coupling element over at least a coupling are connected to each other and at least one in the implanted state section of the coupling element adjacent to the coupling point for low-loss vibration initiation is designed in the coupling point, a first coupling half of the Coupling an outer contour with at least approximately the shape of a spherical cap has in an inner contour which is at least partially complementary to the outer contour a second coupling half is receivable, and wherein the coupling is reversible against frictional forces pivotable and / or rotatable, but in those occurring in the implanted state dynamic forces is essentially rigid.
  • Such a coupling arrangement has a first coupling half the coupling an outer contour with at least approximately cylindrical, preferably circular cylindrical, shape that is at least partially in an outer contour complementary inner contour of a second coupling half is receivable, one in implanted state at the coupling point of the portion of the coupling element Low-loss vibration initiation is designed in the coupling point, being implanted in the Condition a transfer of dynamic forces between the two coupling halves the coupling essentially in the direction of the longitudinal axis of the first coupling half takes place, and the coupling can be reversibly coupled and uncoupled and reversibly linear and / or rotationally adjustable with respect to a longitudinal axis of the first coupling half, however, is rigid with dynamic forces occurring in the implanted state.
  • fully implantable hearing system also include implantable microphone (sound sensor) 10, a wireless remote control 69 for control the implant functions through the implant carrier and a wireless, transcutaneous charging system with a charger 70 and a charging coil 71 for recharging those in the implant secondary battery 30 ( Figures 1, 6 and 7) to power the hearing system.
  • implantable microphone sound sensor
  • wireless remote control 69 for control the implant functions through the implant carrier
  • a wireless, transcutaneous charging system with a charger 70 and a charging coil 71 for recharging those in the implant secondary battery 30 ( Figures 1, 6 and 7) to power the hearing system.
  • the microphone 10 can advantageously be constructed in the manner known from EP-A-0 831 673 and with a microphone capsule, which is hermetically sealed on all sides in a housing is, and with an electrical bushing arrangement for carrying out at least one electrical connection from the interior of the housing to the outside be, the housing having at least two legs that are at an angle with respect are aligned with each other, one leg receiving the microphone capsule and with a sound inlet membrane is provided, the other leg of the electrical bushing arrangement contains and set back to the level of the sound entry membrane is, and wherein the geometry of the microphone housing is selected so that during implantation of the microphone in the mastoid cavity of the leg containing the sound entry membrane from the mastoid into an artificial hole in the back, bony wall of the auditory canal protrudes and the sound entry membrane touches the skin of the ear canal wall.
  • fixation element US-A-5 999 632 known type can be provided which has a cuff that with a cylindrical housing part encloses the leg containing the sound inlet membrane and can be placed against the side of the ear canal wall facing the ear canal skin, projecting, elastic flange parts is provided.
  • the fixation element includes preferably a holder, which said flange parts before implantation against an elastic restoring force of the flange parts in a push through holds through the hole of the ear canal wall bent position allowed.
  • the charging coil 71 connected to the output of the charger 70 preferably forms in of the type known from US-A-5 279 292 part of a transmission series resonant circuit which with a receiving series resonance circuit, not shown, are inductively coupled can.
  • the receiving series resonance circuit can be part of the implantable electronic module 12 ( Figures 1, 6 and 7) and according to US-A-5 279 292 a constant current source for form the battery 30.
  • the receiving series resonance circuit is located in a battery charging circuit, that depending on the respective phase of the flowing in the charging circuit Charge currents over one or the other branch of a full-wave rectifier bridge is closed.
  • the electronics module 12 is in the arrangement according to FIG. 10 via a microphone line 72 the microphone 10 and via the transducer feed line 50 to the electromechanical transducer 16 or 36 and the measuring system 25 or 38 connected.
  • FIG. 11 schematically shows the structure of a partially implantable hearing system.
  • this partially implantable System are a microphone 10, an electronics module 74 for an electronic Signal processing largely as shown in FIG. 1, 6 or 7 (but without the telemetry system 20), the power supply (battery) 30 and a modulator / transmitter unit 75 in an external one to be worn externally on the body, preferably on the head above the implant Module 76 included.
  • the implant is energetically passive.
  • Its electronics module 77 (without battery 30) receives operating energy and control signals for the converter 16 or 36 and the measuring system 25 or 38 via the modulator / transmitter unit 75 in the external part 76.
  • the electronics module 77 and the modulator / transmitter unit 75 included the necessary telemetry unit to transmit the impedance measurement data to the extracorporeal unit 76 for further evaluation
  • Both the fully implantable and the partially implantable hearing system can be monoaural (as shown in Figures 10 and 11) or binaural.
  • a binaural system for the rehabilitation of a hearing disorder of both ears has two system units, the are each assigned to one of the two ears.
  • the two system units can be essentially the same. But it can also be a system unit as a master unit and the other system unit as the slave unit controlled by the master unit be designed.
  • the signal processing modules of the two system units can be set to any Way, in particular via a wired implantable line connection or over a wireless connection, preferably a bidirectional radio-frequency link structure-borne sound-coupled ultrasound system or the electrical conductivity of the tissue data transmission path utilizing the implant carrier, so communicating with one another, that optimized binaural signal processing is achieved in both system units becomes.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Neurosurgery (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Acoustics & Sound (AREA)
  • Signal Processing (AREA)
  • Prostheses (AREA)
EP01118060A 2000-08-25 2001-07-25 Système auditif implantable comportant des moyens de mesure de la qualité d'accouplement Expired - Lifetime EP1181950B1 (fr)

Applications Claiming Priority (2)

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DE10041726A DE10041726C1 (de) 2000-08-25 2000-08-25 Implantierbares Hörsystem mit Mitteln zur Messung der Ankopplungsqualität
DE10041726 2000-08-25

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EP1181950A2 true EP1181950A2 (fr) 2002-02-27
EP1181950A3 EP1181950A3 (fr) 2004-01-28
EP1181950B1 EP1181950B1 (fr) 2005-10-05

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US (1) US6554762B2 (fr)
EP (1) EP1181950B1 (fr)
AT (1) ATE305808T1 (fr)
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DE (2) DE10041726C1 (fr)

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DE4104358A1 (de) 1991-02-13 1992-08-20 Implex Gmbh Implantierbares hoergeraet zur anregung des innenohres
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EP1517583A3 (fr) * 2003-09-18 2009-12-23 Siemens Audiologische Technik GmbH Appareil auditif pour déterminer le volume du conduit auditif et méthode d'adaptation associée

Also Published As

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US20020026091A1 (en) 2002-02-28
DE10041726C1 (de) 2002-05-23
AU776528B2 (en) 2004-09-16
EP1181950A3 (fr) 2004-01-28
US6554762B2 (en) 2003-04-29
ATE305808T1 (de) 2005-10-15
AU6360901A (en) 2002-02-28
EP1181950B1 (fr) 2005-10-05
DE50107599D1 (de) 2006-02-16

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