WO2024256925A1 - Dispositif de conduction osseuse asymétrique - Google Patents

Dispositif de conduction osseuse asymétrique Download PDF

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Publication number
WO2024256925A1
WO2024256925A1 PCT/IB2024/055512 IB2024055512W WO2024256925A1 WO 2024256925 A1 WO2024256925 A1 WO 2024256925A1 IB 2024055512 W IB2024055512 W IB 2024055512W WO 2024256925 A1 WO2024256925 A1 WO 2024256925A1
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WO
WIPO (PCT)
Prior art keywords
housing
asymmetrical
piezoelectric
medical device
recipient
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.)
Ceased
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PCT/IB2024/055512
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English (en)
Inventor
Kristian Gunnar Asnes
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cochlear Ltd
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Cochlear Ltd
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Filing date
Publication date
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Publication of WO2024256925A1 publication Critical patent/WO2024256925A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Electric hearing aids
    • 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; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R17/00—Piezoelectric transducers; Electrostrictive transducers
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R2460/00—Details of hearing devices, i.e. of ear- or headphones covered by H04R1/10 or H04R5/033 but not provided for in any of their subgroups, or of hearing aids covered by H04R25/00 but not provided for in any of its subgroups
    • H04R2460/13—Hearing devices using bone conduction transducers

Definitions

  • the present disclosure relates generally to bone conduction devices.
  • Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades.
  • Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component).
  • Medical devices such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, piezoelectric actuators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
  • implantable medical devices now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.
  • an implantable medical device in one aspect, includes a piezoelectric bender having a fixed end and a free end, opposite the fixed end. The free end is configured to flex relative to the fixed end.
  • the implantable medical device also includes a housing configured to enclose the piezoelectric bender.
  • the housing includes a first end configured to enclose the fixed end and a second end configured to enclose the free end.
  • the first end includes a first dimension
  • the second end includes a second dimension that is greater than the first dimension.
  • the implantable component includes a piezoelectric bender and a housing that encloses the piezoelectric bender, and the housing includes a first end having a first dimension and a second end having a second dimension that is greater than the first dimension.
  • the method includes surgically forming a cavity in a skull of the recipient and inserting the implantable component into the cavity to position the first end of the housing of the implantable component proximate to an ear canal of the recipient and to position the second end of the housing distal to the ear canal of the recipient.
  • a medical device in yet another aspect, includes a piezoelectric element having a first end and a second end, a bone fixture configured to secure the first end of the piezoelectric element to a skull bone of a recipient, a mass attached to the second end of the piezoelectric element, and an asymmetrical housing configured to enclose the piezoelectric element and the mass.
  • the mass is configured to move relative to the first end in response to bending of the piezoelectric element.
  • FIG. 1 is a perspective view of an exemplary bone conduction device, in accordance with certain embodiments presented herein;
  • FIG. 2 is a functional block diagram of a bone conduction device, in accordance with certain embodiments presented herein;
  • FIG. 3 is a side view of an exemplary bone conduction device implemented in a recipient, in accordance with certain embodiments presented herein;
  • FIG. 4 is a perspective view of an exemplary asymmetrical implantable component of a bone conduction device, in accordance with certain embodiments presented herein;
  • FIG. 5 is a side view of the asymmetrical implantable component of FIG. 4;
  • FIG. 6 is a perspective cross-sectional view of the asymmetrical implantable component of FIG. 4;
  • FIG. 7 is a side cross-sectional view of the asymmetrical implantable component of FIG. 4;
  • FIG. 8 is a perspective cross-sectional view of an internal assembly of the asymmetrical implantable component of FIG. 4;
  • FIG. 9 is a flowchart of a method for implanting an asymmetrical implantable component of a bone conduction device in a recipient, in accordance with certain embodiments presented herein.
  • the asymmetrical implantable component includes an asymmetrical housing and a mechanical actuator/transducer disposed within the asymmetrical housing having a first end coupled to a rigid structure (e.g., bone) of the recipient, and an opposing second end.
  • the mechanical actuator generates vibrations that are output by the asymmetrical implantable component at the first end and transferred to a cochlea of the recipient to evoke perception of a sound by the recipient.
  • the first end of the asymmetrical housing is relatively smaller than the second end, where the smaller size of the first end enables the first end (e.g., where the vibrations are output) to be positioned adjacent to an ear canal of the recipient, and therefore more adjacent to the cochlea.
  • the adjacent positioning of the first end of the asymmetrical housing relative to the cochlea enables the vibrations output by the asymmetrical implantable component at the first end to be efficiently transferred to the cochlea.
  • the techniques presented herein are primarily described with reference to a specific hearing device in the form of an active transcutaneous bone conduction device. However, it is to be appreciated that the techniques presented herein could also or alternatively be implemented in/with a number of other types of medical devices. For example, the techniques presented herein could be implemented in other types of hearing devices, where the term “hearing device” is to be broadly construed as any device that acts on an actual or potential auditory perception of an individual, including to improve perception of sound signals, to reduce perception of sound signals, etc.
  • a hearing device can deliver sound signals to a user in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc., and/or can operate to suppress all or some sound signals.
  • a hearing device can be a device for use by a hearing-impaired person (e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy device systems, combinations or variations thereof, etc.), a device for use by a person with normal hearing (e.g., consumer devices that provide audio streaming, consumer headphones, earphones, and other listening devices), a hearing protection device, etc.
  • a hearing-impaired person e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro
  • the techniques presented herein can be implemented by, or used in conjunction with, various implantable medical devices, such as vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation devices, etc.
  • various implantable medical devices such as vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation devices, etc.
  • FIG. 1 is a perspective view of an active transcutaneous bone conduction device 100 in which certain embodiments presented herein may be implemented.
  • a recipient of the bone conduction device 100 has an outer ear 101, a middle ear 102, and an inner ear 103.
  • the outer ear 101 includes an auricle 105 and an ear canal 106.
  • a sound wave or acoustic pressure 107 is collected by the auricle 105 and channeled into and through the ear canal 106.
  • a tympanic membrane 104 Disposed across the distal end of the ear canal 106 is a tympanic membrane 104, which vibrates in response to the sound wave 107.
  • This vibration is coupled to an oval window or fenestra ovalis 110 through three bones of the middle ear 102, collectively referred to as ossicles 111 (e.g., an ossicular chain) and including a malleus 112, incus 113, and stapes 114.
  • the ossicles 111 of the middle ear 102 serve to fdter and amplify the sound wave 107, causing the oval window 110 to vibrate.
  • Such vibration sets up waves of fluid motion within a cochlea 139.
  • Such fluid motion activates hair cells (not shown) that line the inside of the cochlea 139. Activation of the hair cells causes appropriate nerve impulses to be transferred through spiral ganglion cells and auditory nerve 116 to the brain (not shown), where they are perceived as sound.
  • FIG. 1 also illustrates the positioning of the bone conduction device 100 relative to the outer ear 101, the middle ear 102, and the inner ear 103 of the recipient.
  • the bone conduction device 100 includes an external component 118, which is positioned behind the outer ear 101 of the recipient and includes one or more sound input elements 126 to receive sound signals.
  • the sound input elements 126 may include, for example, a microphone, a telecoil, etc.
  • the sound input element 126 is a microphone located, for example, on or in the external component 118.
  • the sound input element 126 could be located on a cable extending from the external component 118, physically separated from a remainder ofthe external component 118 (e.g., an in-the-ear microphone in wireless communication with another component of the external component 118).
  • the sound input elements 126 convert received sound signals (e.g., the sound wave 107) into drive signals. These drive signals are processed by a sound processor (not shown) of the external component 118.
  • the bone conduction device 100 also includes an asymmetrical implantable component 120, which is configured to be implanted within the recipient, such as within the skin/tissue adjacent to the outer ear 101 and fixed to a rigid structure, such as a temporal bone 136, of the recipient.
  • the asymmetrical implantable component 120 includes a coil 122 and an actuator 124 (e.g., a vibrating actuator).
  • the coil 122 is typically a wire antenna coil that includes multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire.
  • the electrical insulation of the coil 122 is provided by a flexible molding (e.g., silicone molding).
  • the external component 118 and the asymmetrical implantable component 120 are configured to magnetically engage one another to enable the external component 118 and the asymmetrical implantable component 120 to communicate with one another.
  • each of the external component 118 and the asymmetrical implantable component 120 includes a magnet and/or is composed of a magnetic material that enables the external component 118 and the asymmetrical implantable component 120 to magnetically attract one another.
  • the magnetic engagement between the external component 118 and the asymmetrical implantable component 120 positions the external component 118 against the skin of the recipient and adjacent to the coil 122 ofthe asymmetrical implantable component 120.
  • the coil 122 enables receipt of power and data from the external component 118 and, potentially, transfer of data to the external component 118.
  • various types of energy transfer such as infrared (IR), electromagnetic, capacitive, and inductive, may be used to transfer power and/or data between the external component 118 and the asymmetrical implantable component 120.
  • the external component 118 provides the drive signals processed by the sound processor to the coil 122 of the asymmetrical implantable component 120.
  • the asymmetrical implantable component 120 e.g., a signal generator, another sound processor
  • the actuator 124 receives the electrical signals, converts the electrical signals into vibrations, and delivers the vibrations to the recipient via the ossicles 111.
  • the actuator 124 imparts motion onto the temporal bone 136 to which the asymmetrical implantable component 120 is mounted, and such motion is conducted along the temporal bone 136 and to the ossicles 111.
  • the vibration imparted to the ossicles 111 by the actuator 124 will, in turn, cause the oval window 110 to articulate (vibrate) in response thereto. Similar to the case with normal hearing, the vibration of the oval window 110 sets up waves of fluid motion of the perilymph within the cochlea 139 to, in turn, activate the hair cells inside of the cochlea 139 and enable perception of sound by the recipient.
  • FIG. 2 is a functional block diagram of the bone conduction device 100 illustrating further details regarding how sound signals are used to generate vibrations for delivery to the recipient, in accordance with certain embodiments presented herein.
  • the bone conduction device 100 includes an external component and an asymmetrical implantable component that communicate with one another to generate and deliver the vibrations.
  • the bone conduction device 100 includes the one or more sound input elements 126, an electronics module 152, the actuator 124, a power module 154, and a user interface module 156.
  • the sound input element(s) 126 e.g., microphone
  • the sound input element(s) 126 output the drive signals 158 to the electronics module 152.
  • the electronics module 152 is configured to convert the drive signals 158 into electrical signals 160 (e.g., adjusted/processed drive signals). That is, the electronics module 152 is configured to apply one or more processing operations (e.g., filtering, noise reduction, automatic gain control/adjustment, loudness compression) to the drive signals 158.
  • the electronics module 152 may include a digital signal processor.
  • the electronics module 152 provides the electrical signals 160 to the actuator 124.
  • the electrical signals 160 drive (activate) the actuator 124 that, in turn, generate corresponding vibrations. That is, using the electrical signals 160, the actuator 124 generates a mechanical output force that is delivered to the temporal bone of the recipient. Delivery of this output force causes one or more of motion of vibration of the recipient’s temporal bone and ossicles, thereby activating the hair cells in the cochlea via cochlea fluid motion and, in turn, evoking perception by the recipient of the received sound waves 107.
  • the electrical signals 160 may be amplified (i.e., the time-varying voltage or current is increased), and the amplified electrical signals 160 are provided to the actuator 124 to generate the vibrations.
  • the bone conduction device 100 includes a power module 154.
  • the power module 154 e.g., a battery or other energy storage component
  • the power module 154 has been shown as being connected to the electronics module 152 and to the user interface module 156.
  • the power module 154 can be used to supply power to any electrically powered circuits/components of the bone conduction device 100, including the sound input element(s) 126, the actuator 124, etc.
  • the user interface module 156 of the bone conduction device 100 allows the recipient or other user to interact with the bone conduction device 100.
  • the user interface module 156 can allow the recipient to adjust the volume, alter the speech processing strategies, power on/off the bone conduction device 100, etc.
  • the bone conduction device 100 further includes an external interface module 162.
  • the external interface module 162 can be used to connect the electronics module 152 to a separate device, such as a fitting system. Using the external interface module 162, the separate device can obtain information from the bone conduction device 100 (e.g., current parameters, data, alarms) and/or modify parameters of the bone conduction device 100 used in processing received sounds and/or performing other functions.
  • FIG. 3 is a side view of the bone conduction device 100 that includes the external component 118 and the asymmetrical implantable component 120.
  • the asymmetrical implantable component 120 is implanted within the recipient, such as beneath fat 128 and skin 132 of the recipient, within muscle 134 of the recipient, and onto the temporal bone 136 of the recipient.
  • the external component 118 is configured to be held against the skin 132 of the recipient, such as via magnetic engagement with the asymmetrical implantable component 120.
  • the external component 118 includes the one or more sound input elements 126.
  • the sound input element(s) 126 convert sound into drive signals to be provided to the actuator 124 through the skin 132 of the recipient via a transmitter coil 200.
  • the transmitter coil 200 uses a magnetic inductance link to transmit the drive signals to an implanted receiver coil 202 of the asymmetrical implantable component 120 located in coil housing 204 of the asymmetrical implantable component 120.
  • the implanted receiver coil 202 is made of a ferromagnetic material, that can be in the form of a permanent magnet that generates and/or is reactive to a magnetic field, or that otherwise permits the establishment of a magnetic attraction between the external component 118 and the asymmetrical implantable component 120 to hold the external component 118 against the skin 132 of the recipient.
  • Components (not shown) in the coil housing 204 such as a signal generator or an implanted sound processor, then generate electrical signals to be delivered to the actuator 124 via an electrical lead assembly 206.
  • the actuator 124 is configured to convert electrical signals into vibration to facilitate perception of sound by the recipient.
  • the actuator 124 is disposed within and mechanically coupled to an actuator housing 208.
  • the actuator housing 208 and the actuator 124 collectively form a vibrating element.
  • the actuator housing 208 is substantially rigidly attached to a bone fixture 210, such as via a fastener 212.
  • the actuator housing 208 includes a through hole that is contoured to the outer contours of the bone fixture 210. That is, the through hole thus forms a bone fixture interface section that is contoured to the exposed section of the bone fixture 210 to enable coupling of the bone fixture 210 to the actuator housing 208.
  • the sections are sized and dimensioned such that at least a slip fit or an interference fit exists with respect to the sections.
  • the fastener 212 then compresses the actuator housing 208 against the bone fixture 210.
  • the actuator housing 208 such as a silicon layer 214 of the actuator housing 208, is in abutment with the temporal bone 136 to mechanically couple the actuator 124 to the temporal bone 136. Because the actuator 124 is mechanically coupled to the temporal bone 136, the vibrations output by the actuator 124 are transferred to the temporal bone 136 and eventually to the cochlea.
  • an actuator e.g., vibrating actuator
  • the actuator has a particular shape to facilitate implementation and/or operation of an asymmetrical implantable component.
  • the actuator is asymmetrically shaped and includes a first end having a smaller dimension than a second end that is disposed opposite to the first end.
  • the smaller dimension of the first end relative to the second end enables the first end to be positioned relatively closer to a cochlea of a recipient than an actuator having a larger first end (e.g., a first end having a similarly sized dimension as that of the second end) to improve efficient operation of the actuator to output vibrations that move the cochlea.
  • the first end is shaped to enable a fastener to extend therethrough to secure the actuator to the recipient.
  • the fastener is positioned away from a more centrally located internal volume to enable other components of the actuator to be positioned within the internal volume, thereby facilitating ease of packaging the components of the actuator.
  • FIG. 4 is a perspective view of an asymmetrical implantable component 300 of a bone conduction device, in accordance with certain embodiments presented herein.
  • FIG. 5 is a side view of the asymmetrical implantable component 300.
  • the asymmetrical implantable component 300 includes an asymmetrical housing 302 configured to enclose and shield internal components of the asymmetrical implantable component 300.
  • the asymmetrical housing 302 protects the internal components from dust, debris, liquid, and any other elements to prolong a useful lifespan of the internal components.
  • the asymmetrical housing 302 includes a first end 304 and a second end 306.
  • the asymmetrical housing 302 also includes a main body 308 extending between the first end 304 and the second end 306.
  • the main body 308 defines an internal volume in which the internal components of the asymmetrical implantable component 300 are disposed.
  • the first end 304 is configured to secure to a recipient of the asymmetrical implantable component 300, such as to a rigid structure (e.g., the temporal bone).
  • the asymmetrical housing 302 includes a mounting portion 310 (e.g., a flange, a lip) extending from the main body 308 at the first end 304.
  • the mounting portion 310 includes a hole 312 extending therethrough.
  • the hole 312 is configured to receive a fastener 314 (e.g., a screw) that secures the asymmetrical housing 302 to the rigid structure.
  • the fastener 314 is tightened to provide a force that compresses the mounting portion 310, and therefore the asymmetrical housing 302, against a fixture (e.g., the bone fixture 210) coupled to the rigid structure of the recipient.
  • the fastener 314 is positioned to secure the asymmetrical housing 302 to the recipient via the mounting portion 310 without extending through the internal volume of the asymmetrical housing 302. That is, because the mounting portion 310 extends away from the main body 308, the fastener 314 inserted through the mounting portion 310 is external and offset from the internal volume defined by the main body 308.
  • such an arrangement to position the fastener 314 away from the internal volume enables more efficient usage of the internal volume to facilitate ease of packaging of the internal components within the internal volume.
  • the asymmetrical implantable component 300 e.g., a piezoelectric actuator positioned within the internal volume of the main body 308 outputs vibrations that propagate through the rigid structure to which the asymmetrical housing 302 is secured.
  • the vibrations are conducted through the rigid structure and to the ossicles, and the vibrations of the ossicles cause the cochlea of the recipient to move, thereby activating hair cells to enable the recipient to perceive sound.
  • the first end 304 includes a first dimension 316 (e.g., a first width), and the second end 306 includes a second dimension 318 (e.g., a second width).
  • the first dimension 316 is smaller than the second dimension 318.
  • first end 304 includes a third dimension 350 (e.g., a first height/thickness) and the second end 306 includes a fourth dimension 352 (e.g., a second height/thickness), and the third dimension 350 is smaller than the fourth dimension 352.
  • the first end 304 is asymmetrical to the second end 306 about a first central axis 320 (shown in FIG.
  • first end 304 extending along the first dimension 316 and the second dimension 318 and bisecting the main body 308. Additionally, such a configuration of the first end 304 relative to the second end 306 causes the first end 304 to be asymmetrical to the second end 306 about a second central axis 354 (shown in FIG. 5) extending along the third dimension 350 and the fourth dimension 352 and bisecting the main body 308.
  • the smaller size of the first end 304 relative to the second end 306 enables the first end to be positioned at a location within the recipient that improves operation of the asymmetrical implantable component 300, namely more adjacent to the cochlea of the recipient.
  • skin around an ear canal of the recipient may be susceptible to various structural or geometric changes caused by modifications made in a surrounding area. For instance, placing an implant within a threshold distance of the ear canal can cause the skin around the ear canal to stretch, which may then cause discomfort to the recipient. Thus, it is desirable to place the implant at a position beyond the threshold distance of the ear canal.
  • the reduced size of the first end 304 enables the asymmetrical implantable component 300 to be positioned closer to the ear canal without affecting the structure or geometry of the skin around the ear canal (e.g., without stretching the skin).
  • reducing the first dimension 316 also reduces the threshold distance at which the asymmetrical implantable component 300 can be positioned with respect to the ear canal.
  • Positioning of the asymmetrical implantable component 300 closer to the ear canal positions the asymmetrical implantable component 300 closer to the cochlea of the recipient.
  • the vibrations output by the asymmetrical implantable component 300 have a shorter path of travel to cause movement of the cochlea more efficiently. That is, the shorter path of travel of the vibrations through the bones of the recipient reduces mechanical loss of the vibrations (e.g., absorption of the vibrations by the bones, dissipation of the vibrations into tissue of the recipient). In other words, greater integrity of the vibrations is maintained to provide greater movement of the cochlea for activating the hair cells and enabling sound perception.
  • the asymmetrical implantable component 300 can more directly move the cochlea.
  • the asymmetric profile of the asymmetrical implantable component 300 in which the first end 304 is smaller than the second end 306 may reduce a cost of manufacture of the asymmetrical implantable component 300.
  • a relative smaller amount of material may be used to manufacture the asymmetrical housing 302 of the asymmetrical implantable component 300 as compared to an implantable component having a housing that includes ends with similar dimensions or that is otherwise symmetrical.
  • the first end 304 and the second end 306 may enclose different components and/or different parts of a component having different sizes, and the first end 304 and the second end 306 may therefore be manufactured to have different sizes that sufficiently accommodates positioning of the components therein.
  • the second end 306 has a more curved (e.g., circular) profile and the first end 304 has a more linear or prismatic profile.
  • the main body 308 has a geometrically oval stadium shape, a balloon-like shape, or a rounded trapezoidal geometry.
  • the asymmetrical implantable component 300 can have any other suitable profile in which the first end 304 has a smaller dimension than the second end 306, such as a triangular shape.
  • the asymmetrical implantable component 300 includes a first surface 356 (e.g., a bone engaging surface) and a second surface 358, opposite, the first surface 356.
  • Each of the first surface 356 and the second surface 358 extends from the first end 304 to the second end 306.
  • the first surface 356 has a planar or linear profile in the illustrated embodiment to facilitate abutment of the first surface 356 against the rigid structure of the recipient.
  • the flat configuration of the first surface 356 can enable the first surface 356 to be positioned flush against the rigid structure, thereby facilitating securement of the asymmetrical implantable component 300 within the recipient.
  • the first surface 356 can have a different geometry, such as a curved, stepped, or other suitable geometry, that enables positioning of the first surface 356 onto the rigid structure of the recipient.
  • the first surface 356 can have a contour that matches that of the rigid structure to facilitate positioning of the first surface 356 against the rigid structure and therefore securement of the asymmetrical implantable component 300 within the recipient.
  • the second surface 358 has a generally curved profile. Such a profile of the second surface 358 enables the main body 308 to define a suitably sized internal volume in which other components of the asymmetrical implantable component 300 are positioned.
  • extension of the second surface 358 between the first end 304 and the second end 306 provides sufficient space that enables the other components to be positioned within the main body 308 and to move or flex relative to the asymmetrical housing 302.
  • the mounting portion 310 of the asymmetrical implantable component 300 has a fifth dimension 360 (e.g., a third height) that is smaller than the third dimension 350 and the fourth dimension 352.
  • the reduced size of the mounting portion 310 may further facilitate securement of the asymmetrical implantable component 300 within the recipient and/or reduce a cost of manufacture of the asymmetrical implantable component 300.
  • the reduced size of the mounting portion 310 enables a smaller sized fastener 314 (e.g., having a shorter length) to be inserted through the mounting portion 310 to couple to the rigid structure.
  • the reduced size of the mounting portion 310 reduces an amount of material used to manufacture the mounting portion 310, such as in comparison to a mounting portion having a similar dimension as the third dimension 350 or the fourth dimension 352.
  • FIG. 6 is a perspective cross-sectional view of the asymmetrical implantable component 300.
  • the main body 308 of the asymmetrical housing 302 defines an internal volume 400 (e.g., a chamber) in which an internal assembly 402 is disposed.
  • the internal assembly e.g., a chamber
  • the 402 includes a piezoelectric actuator 404 which includes a piezoelectric bender 403 configured to bend within the internal volume 400 during operation of the asymmetrical implantable component 300.
  • the piezoelectric bender 403 is formed from two or more piezoelectric elements and the piezoelectric bender 403 can have, for example, two-layer / three-layer design, a cofired multilayer construction, etc. The bending motion of the piezoelectric bender
  • 403 is caused by one layer being operated in contraction mode, while the other layer is expanding.
  • the piezoelectric bender 403 has a fixed end 406, which is secured to the first end 304 of the asymmetrical housing 302, such as via an interference fit, a fastener, an adhesive, another feature, or any combination thereof.
  • the piezoelectric bender 403 also includes a free end 408, which is enclosed by the second end 306 of the asymmetrical housing 302.
  • the free end 408 of the piezoelectric bender 403 is configured to flex or bend relative to the fixed end 406 of the piezoelectric bender 403 as a result of received electrical signals (e.g., provided by a signal generator).
  • the piezoelectric bender 403 may generally rotate about an axis 409 extending through the fixed end 406 (e.g., and extending along the first dimension 316 and/or the second dimension 318). Movement of the free end 408 relative to the fixed end 406 transfers a force along the piezoelectric bender 403 to the fixed end 406 to output vibrations at the fixed end 406, and the vibrations transfer from the fixed end 406 to the first end 304 of the asymmetrical housing 302, to the mounting portion 310, to the fastener 314, and to the rigid structure of the recipient to cause movement of the cochlea.
  • the internal assembly 402 also includes a mass 410 coupled to the free end 408 of the piezoelectric bender 403.
  • the mass 410 facilitates output of vibrations by the piezoelectric actuator 404.
  • the mass 410 increases transfer of force along the piezoelectric bender 403 to the fixed end 406 during movement of the piezoelectric bender 403 within the asymmetrical housing 302, thereby increasing the vibrations output at the fixed end 406 and eventually conducted to the cochlea of the recipient.
  • the mass 410 may improve the sound perceived by the recipient by providing increased movement of the cochlea.
  • the second end 306 of the main body 308 is sized (e.g., having the second dimension 318, having the fourth dimension 352) to accommodate positioning of the mass 410 having a sufficient shape and/or size to enable desirable output of vibrations during operation of the asymmetrical implantable component 300.
  • the asymmetrical implantable component 300 is implanted in the recipient such that the first end 304 of the asymmetrical housing 302 is positioned adjacent to the ear canal and relatively closer to the cochlea.
  • the vibrations output at the fixed end 406 may conduct more efficiently toward the cochlea.
  • Such positioning of the asymmetrical implantable component 300 in the recipient also arranges the second end 306 of the asymmetrical housing 302 distal to the ear canal and relatively farther away from the cochlea.
  • FIG. 7 is a side cross-sectional view of the asymmetrical implantable component 300.
  • the fastener 314 is offset from the internal volume 400 and therefore does not extend through the internal volume 400.
  • an entirety of the internal volume 400 within the main body 308 is available for positioning of the internal assembly 402.
  • the internal assembly 402 may be more readily manufactured and/or positioned within the internal volume 400.
  • the internal assembly 402 may have any suitable shape and/or be placed at any suitable position without having to accommodate a space occupied by a fastener extending through the internal volume 400.
  • the internal assembly 402 does not have to have a specific shape and/or be placed at a specific position that avoids contact with a fastener extending through the internal volume 400. As such, an ease of implementation of the internal assembly 402 is improved.
  • the piezoelectric bender 403 is in an unactuated configuration in which no electrical signals are received. As such, in the unactuated configuration, the free end 408 has an unactuated position in which the piezoelectric actuator 404 is not bent and vibrations therefore are not transferred to the recipient.
  • the piezoelectric bender 403 may generally extend along (e.g., parallel to) the first surface 356 of the asymmetrical housing 302 in the unactuated position of the free end 408.
  • an air gap 450 is formed between the piezoelectric bender 403 and a third surface 452 of the asymmetrical housing 302, the third surface 452 being opposite the second surface 358 and facing the internal volume 400.
  • the piezoelectric bender 403 transitions to an actuated configuration by bending toward the third surface 452, thereby placing the free end 408 in an actuated position. That is, the free end 408 of the piezoelectric bender 403 moves across at least a portion of the air gap 450 in the actuated configuration of the piezoelectric bender 403 to transition to the actuated position.
  • Such movement of the piezoelectric bender 403 also drives movement of the mass 410 relative to the fixed end 406 and toward the third surface 452.
  • the mass 410 is sized (e.g., to have a particular thickness 454), the second surface 358 is shaped, and/or the internal assembly 402 is positioned within the internal volume 400 to offset the mass 410 from the third surface 452 by a threshold distance 456 in the unactuated configuration of the piezoelectric bender 403.
  • the distance between the third surface 452 and the mass 410 is reduced. Indeed, sufficient flexure of the piezoelectric bender 403 may move the mass 410 into contact with the third surface 452.
  • sufficient flexure of the piezoelectric bender 403 may cause the mass 410 to move the threshold distance 456 onto the third surface 452 and may correspondingly cause the free end 408 to move the threshold distance 456 away from the unactuated position.
  • the asymmetrical housing 302 may then block further movement of the mass 410 and therefore further flexure of the piezoelectric bender 403. That is, the piezoelectric bender 403 has a maximum allowable flexure within the internal volume 400 to move the mass 410 into abutment with the third surface 452, and abutment between the mass 410 and the third surface 452 blocks additional movement of the piezoelectric bender 403 past the maximum allowable flexure.
  • the threshold distance 456 is selected such that the maximum allowable flexure does not reduce the structural integrity of the piezoelectric actuator 404 (e.g., cause elastic deformation or permanent geometric changes to the piezoelectric bender 403), while still enabling such movement of the piezoelectric bender 403 to output sufficient vibrations to cause the recipient to perceive sound.
  • FIG. 8 is a perspective cross-sectional view of the internal assembly 402 of the asymmetrical implantable component 300 coupled to the first end 304 of the asymmetrical housing 302. A remainder of the asymmetrical housing 302 has been omitted to facilitate visualization of the internal assembly 402.
  • the piezoelectric bender 403 is attached to the first end 304 of the asymmetrical housing 302 and to the mass 410 via interference fits.
  • the piezoelectric bender 403 can additionally or alternatively be attached to the first end 304 of the asymmetrical housing 302 and/or to the mass 410 using any other suitable feature, such as a fastener or an adhesive.
  • the coupling of the piezoelectric bender 403 to the mass 410 enables movement (e.g., flexure) of the piezoelectric bender 403 to drive movement of the mass 410, and the coupling of the piezoelectric bender 403 to the asymmetrical housing 302 enables movement of the piezoelectric bender 403 to transfer vibrations to the asymmetrical housing 302.
  • the piezoelectric bender 403 includes a plurality of layers 500 (e.g., piezoelectric layers, piezoceramic layers).
  • the plurality of layers 500 receives electric signals that cause bending of the piezoelectric bender 403.
  • a first subset 502 of the plurality of layers 500 at a first side 503 of the plurality of layers 500 can receive a first voltage
  • a second subset 504 of the plurality of layers 500 at a second side 505, opposite the first side 503, of the plurality of layers 500 can independently receive a second voltage.
  • the voltages cause deformation of the first subset 502 and/or of the second subset 504 of the plurality of layers 500 to cause flexure of the piezoelectric bender 403.
  • the voltages can cause relative expansion and contraction of the first subset 502 and/or the second subset 504 of the plurality of layers 500 to cause the piezoelectric bender 403 to bend in a first direction 506 (e.g., toward the third surface 452) or in a second direction 508 (e.g., away from the third surface 452) about the axis 409.
  • a voltage being applied to cause bending of the illustrated piezoelectric actuator 404 may be relatively lower than, for example, that used to bend an embodiment in which a central portion of a piezoelectric actuator is coupled to the asymmetrical housing 302 (e.g., an embodiment in which the fastener extends through the internal volume of the housing such that vibrations transfer from the central portion to the fastener) .
  • a resonance frequency used to move the piezoelectric bender 403 to generate vibrations may be relatively lower.
  • a relatively increased length of the piezoelectric bender 403 is available for movement. That is, the lever arm of the piezoelectric bender 403 is increased.
  • a relatively lower force e.g., provided by a relatively lower voltage
  • a relatively lower force can be applied to cause movement of the piezoelectric bender 403.
  • less power is used to enable bending of the piezoelectric bender 403, thereby reducing power consumption to operate the asymmetrical implantable component 300 and output vibrations.
  • a cost associated with operation of the asymmetrical implantable component 300 is also reduced.
  • FIG. 9 is a flowchart of a method 550 for implanting an asymmetrical implantable component of a bone conduction device in a recipient.
  • the operations of the method 550 are manually performed (e.g., by a surgeon). In additional or alternative embodiments, the operations of the method 550 are automatically performed (e.g., by robotic surgical equipment).
  • a cavity is surgically formed in a skull of the recipient. For example, the cavity is formed in the temporal bone adjacent to an ear canal of the recipient.
  • the asymmetrical implantable component is inserted into the cavity.
  • the asymmetrical implantable component includes an asymmetrical housing having a first end with a first dimension and a second end with a second dimension that is greater than the first dimension.
  • the asymmetrical implantable component is positioned within the cavity such that the first end of the asymmetrical housing is proximate to the ear canal and the second end of the asymmetrical housing is distal to the ear canal.
  • the asymmetrical implantable component is secured to the skull.
  • a fastener is inserted through the asymmetrical housing of the asymmetrical implantable component at the first end of the asymmetrical housing to compress the asymmetrical housing against the skull, thereby securing the asymmetrical implantable component to the skull.
  • Securement of the asymmetrical implantable component to the skull enables the asymmetrical implantable component to output vibrations that cause movement of a cochlea of the recipient to enable the recipient to perceive sound.
  • the asymmetrical implantable component includes a piezoelectric actuator (e.g., a piezoelectric bender, a piezoelectric element) positioned within and secured to the asymmetrical housing, and the piezoelectric actuator is configured to move (e.g., flex) within the asymmetrical housing during operation of the asymmetrical implantable component. Movement of the piezoelectric actuator causes vibration of the asymmetrical housing, which is then transferred to and along the skull and eventually to the cochlea. Because the first end is positioned proximate to the ear canal, the first end is also positioned more proximate to a cochlea of the recipient. Thus, the vibrations output by the asymmetrical implantable component more efficiently transfer to the cochlea, thereby increasing efficiency of operation of the asymmetrical implantable component to enable the recipient to perceive sound.
  • a piezoelectric actuator e.g., a piezoelectric bender, a piezoelectric element
  • systems and non-transitory computer readable storage media are provided.
  • the systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure.
  • the one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.
  • steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

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  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Acoustics & Sound (AREA)
  • Signal Processing (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Neurosurgery (AREA)
  • Prostheses (AREA)

Abstract

Un dispositif médical implantable asymétrique comprend un boîtier conçu pour renfermer un élément de flexion piézoélectrique. Le dispositif de flexion piézoélectrique comprend une extrémité fixe accouplée au boîtier et une extrémité libre conçue pour fléchir par rapport à l'extrémité fixe de manière à se déplacer par rapport au boîtier. Le boîtier comprend une première extrémité conçue pour enfermer l'extrémité fixe du dispositif de flexion piézoélectrique et une seconde extrémité conçue pour enfermer l'extrémité libre du dispositif de flexion piézoélectrique. La première extrémité et la seconde extrémité du boîtier sont asymétriques l'une par rapport à l'autre.
PCT/IB2024/055512 2023-06-12 2024-06-05 Dispositif de conduction osseuse asymétrique Ceased WO2024256925A1 (fr)

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US202363507493P 2023-06-12 2023-06-12
US63/507,493 2023-06-12

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070156011A1 (en) * 2006-01-02 2007-07-05 Patrik Westerkull Hearing aid system
WO2010142018A1 (fr) * 2009-06-09 2010-12-16 Dalhousie University Actionneur et système de prothèse auditive à conduction osseuse piézo-électrique sous-cutanée
US20130096366A1 (en) * 2011-10-12 2013-04-18 Wim Bervoets Implantable medical device
US20160183017A1 (en) * 2008-09-22 2016-06-23 Earlens Corporation Transducer devices and methods for hearing
US10477332B2 (en) * 2016-07-18 2019-11-12 Cochlear Limited Integrity management of an implantable device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070156011A1 (en) * 2006-01-02 2007-07-05 Patrik Westerkull Hearing aid system
US20160183017A1 (en) * 2008-09-22 2016-06-23 Earlens Corporation Transducer devices and methods for hearing
WO2010142018A1 (fr) * 2009-06-09 2010-12-16 Dalhousie University Actionneur et système de prothèse auditive à conduction osseuse piézo-électrique sous-cutanée
US20130096366A1 (en) * 2011-10-12 2013-04-18 Wim Bervoets Implantable medical device
US10477332B2 (en) * 2016-07-18 2019-11-12 Cochlear Limited Integrity management of an implantable device

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