Patent Application
20170203101
Field of the Invention
The present invention relates generally to implantable sound sensors, and more particularly, to an implantable sound sensor for hearing prostheses.
Related Art
Implantable hearing prostheses primarily comprise an implantable stimulator that provides electrical, mechanical, optical or other stimulation to a recipient's inner and/or middle ear. Such prostheses also include a microphone, that is configured to receive and transform an acoustic sound into an electrical signal that is supplied to a sound processor. The sound processor utilizes the signal to drive the implantable stimulator.
One type of implantable hearing prosthesis, referred to as a cochlear implant, delivers electrical signals to a recipient's auditory nerves via electrodes implanted in the recipient's cochlea. The delivered electrical signals cause the recipient's brain to perceive a hearing sensation resembling the natural hearing sensation normally delivered by the auditory nerve. Another type of implantable hearing prosthesis is the auditory brainstem implant that delivers electrical stimulation signals directly to a recipient's brain, thereby bypassing the auditory nerve. A still other type of implantable hearing prosthesis is the middle ear implant that uses an actuator to provide mechanical stimulation signals (vibration) to a recipient's middle or inner ear.
In some implantable hearing prostheses, the microphone is also implanted in the recipient. Implantable microphones are conventionally implanted subcutaneously in proximity of the ear. A drawback of subcutaneous microphones is that they are sensitive to body noise which may originate from the circulatory, respiratory, skeletal, digestive or other systems.
In accordance with one embodiment of the present invention, a sound sensor implantable in a recipient of a hearing device is disclosed. The sound sensor comprises a biocompatible housing comprising a cavity having an opening at a first end of the housing; a membrane attached to the housing so as to hermetically seal the opening, wherein the membrane vibrates in response to vibration of at least one of a structure of the recipient's ear and fluid within one of the recipient's body cavities; a vibrational sensor disposed in the housing configured to detect vibrations of the membrane, and configured to generate signals representative of the detected vibrations; and a transmitter configured to provide the generated signals to one or more other components implanted in the recipient.
In accordance with another embodiment of the present invention, an implantable hearing prosthesis is disclosed. The hearing prosthesis comprises: an implantable unit comprising a sound processor and a stimulator unit configured to generate stimulation signals for delivery to a recipient's ear; and an implantable sound sensor, comprising: a biocompatible housing comprising a cavity having an opening at a first end of the housing; a membrane attached to the housing so as to hermetically seal the opening, wherein the membrane vibrates in response to vibration of at least one of a structure of the recipient's ear and fluid within one of the recipient's body cavities; a vibrational sensor disposed in the housing configured to detect vibrations of the membrane, and to generate signals representative of the detected vibrations; and a transmitter configured to provide the generated signals to the stimulator unit.
Embodiments of the present invention are described below with reference to the attached drawings, in which:
Aspects of the present invention are generally directed to sound sensor implantable in a recipient of a hearing device. The sound sensor is configured to detect sound through the use of vibrations of structures of the recipient's ear, or through pressure variations that occur in the recipient's body cavities.
In embodiments of the present invention, the sensor comprises a hermetically sealed biocompatible housing having a membrane attached thereto. The membrane is configured to vibrate in response to vibration of at least on a structure of the recipient's ear and fluid within one of the recipient's body cavities. A vibrational sensor, disposed in the housing, and detects vibrations of the membrane and generates signals representative of the detected vibrations.
Embodiments of the present invention are described herein primarily in connection with one type of implantable hearing prosthesis, namely a totally or fully implantable cochlear prosthesis (commonly referred to as a cochlear prosthetic device, cochlear implant, cochlear device, and the like; simply “cochlear implants” herein). As used herein, a totally implantable cochlear implant refers to an implant that is capable of operating, at least for a period of time, without the need for any external device. It would be appreciated that embodiments of the present invention may also be implemented in a cochlear implant that includes one or more external components. It would be further appreciated that embodiments of the present invention may be implemented in any partially or fully implantable hearing prosthesis now known or later developed, including, but not limited to, acoustic hearing aids, auditory brain stimulators, middle ear mechanical stimulators, hybrid electro-acoustic prosthesis or other prosthesis that electrically, acoustically and/or mechanically stimulate components of the recipient's outer, middle or inner ear.
In a fully functional ear, outer ear 101 comprises an auricle 110 and an ear canal 102. An acoustic pressure or sound wave 103 is collected by auricle 110 and channeled into and through ear canal 102. Disposed across the distal end of ear cannel 102 is a tympanic membrane 104 which vibrates in response to sound wave 103. This vibration is coupled to oval window or fenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109 and the stapes 111. Bones 108, 109 and 111 of middle ear 105 serve to filter and amplify sound wave 103, causing oval window 112 to articulate, or vibrate in response to vibration of tympanic membrane 104. This vibration sets up waves of fluid motion of the perilymph within cochlea 140. Such fluid motion, in turn, activates tiny hair cells (not shown) inside of cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.
As shown, cochlear implant 100 comprises one or more components which are temporarily or permanently implanted in the recipient. Cochlear implant 100 is shown in
In the illustrative arrangement of
Cochlear implant 100 comprises an internal energy transfer assembly 132 which may be positioned in a recess of the temporal bone adjacent auricle 110 of the recipient. As detailed below, internal energy transfer assembly 132 is a component of the transcutaneous energy transfer link and receives power and/or data from external device 142. In the illustrative embodiment, the energy transfer link comprises an inductive RF link, and internal energy transfer assembly 132 comprises a primary internal coil 136. Internal coil 136 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. Positioned substantially within the wire coils is an implantable microphone system (not shown). As described in detail below, the implantable microphone assembly includes a microphone (not shown), and a magnet (also not shown) fixed relative to the internal coil.
Cochlear implant 100 further comprises a main implantable component 120 and an elongate electrode assembly 118. In embodiments of the present invention, internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In embodiments of the present invention, main implantable component 120 includes a sound processing unit (not shown) to convert the sound signals received by the implantable microphone in internal energy transfer assembly 132 to data signals. Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongate electrode assembly 118.
Elongate electrode assembly 118 has a proximal end connected to main implantable component 120, and a distal end implanted in cochlea 140. Electrode assembly 118 extends from main implantable component 120 to cochlea 140 through mastoid bone 119. In some embodiments electrode assembly 118 may be implanted at least in basal region 116, and sometimes further. For example, electrode assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, electrode assembly 118 may be inserted into cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through round window 121, oval window 112, the promontory 123 or through an apical turn 147 of cochlea 140.
Electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes 148, sometimes referred to as electrode array 146 herein, disposed along a length thereof. Although electrode array 146 may be disposed on electrode assembly 118, in most practical applications, electrode array 146 is integrated into electrode assembly 118. As such, electrode array 146 is referred to herein as being disposed in electrode assembly 118. As noted, a stimulator unit generates stimulation signals which are applied by electrodes 148 to cochlea 140, thereby stimulating auditory nerve 114.
As noted, cochlear implant 100 comprises a totally implantable prosthesis that is capable of operating, at least for a period of time, without the need for external device 142. Therefore, cochlear implant 100 further comprises a rechargeable power source (not shown) that stores power received from external device 142. The power source may comprise, for example, a rechargeable battery. During operation of cochlear implant 100, the power stored by the power source is distributed to the various other implanted components as needed. The power source may be located in main implantable component 120, or disposed in a separate implanted location.
Stimulator 132 receives a signal generated by an implanted sound sensor 150, in this embodiment, via a cable 162. Sound sensor 150 is implanted in a cavity formed in mastoid bone 119 so as to extend, in this embodiment, into the middle ear cavity. Sound sensor 150 is configured to detect sound received in a recipient's ear through the use of vibrations or pressure variations that occur in or along the natural path that is followed by acoustic waves in the ear. More specifically, sound sensor 150 senses vibration of a structure of the recipient's ear or vibration of fluid within one of the recipient's body cavities, such as recipient's middle ear cavity, inner ear canals, cochlear ducts, etc. The vibration of the recipient's ear structure, or the vibration of the fluid within a body cavity is a result of the receipt of acoustic waves that travel from the recipient's outer ear to the middle and inner ear. That is, the received acoustic waves result in the vibration of the middle or inner ear structures, or travel through the middle ear cavity, creating vibration of the fluid within the cavities. In the embodiment illustrated in
An embodiment of implantable sound sensor 150 is described next below with reference to
In the embodiments of
Housing 258 is closed at the opposing end 264, that is, the end remote from membrane 248, by a closure 260. Closure 260 also provides a hermetical seal. Hence, housing 258, membrane 248 and closure 260 form a biocompatible hermetically sealed enclosure that is substantially impenetrable to air and body fluids.
In embodiments of the present invention, membrane 248 is substantially flexible and is configured to vibrate. The thickness of membrane 248 is selected depending on, for example, the material of which it is made and the body location in which sound sensor 250 will be implanted. Additionally, membrane 248 and housing 258 may be each made from the same or different titanium or a titanium alloy. However, it would be appreciated that other biocompatible materials may also be used. For example, in one alternative embodiment, closure 260 may be manufactured of a biocompatible ceramic material.
A coupling mechanism 252 is secured to the exterior surface of membrane 248. In the embodiment illustrated in
A vibrational sensor 272, such as a microphone, is disposed inside housing 258. In certain such embodiments, vibrational sensor is a pressure sensitive transducer configured to generate an electrical signal in response to detected pressure waves. Microphone 272 may be arranged such that the microphone's sensing element is located proximal to membrane 248 with a defined gas layer 275 positioned between the microphone's sensing element and the membrane. The microphone's sensing element is typically a diaphragm.
In the above embodiments, as coupling mechanism 252 vibrates membrane 248, the excitation of the membrane is transmitted to the inside of housing 258, where it is sensed by microphone 272. Microphone 272 may be an electret microphone, such as from Sonion (Denmark) or Knowles (USA). Other types of microphones may be used as well, such as: magnetic, dynamic, piezo-electric, optical, or electro-mechanical.
In an alternative embodiment, vibrational sensor 272 is an accelerometer suitable for sensing vibrations of membrane 248. In one particular embodiment, vibrational sensor 272 is a micro-electromechanical system accelerometer.
Vibrational sensor 272 is connected to housing 258 by means of a fluid suspension 276, which is preferably made of, or that comprises, silicone. It should be appreciated that in alternative embodiments other mechanisms may be implemented to isolate vibrational sensor 272 from the motion of sound sensor 250.
Implantable sound sensor 250 further comprises a transmitter for transmitting the signal generated by vibrational sensor 272, either raw or processed, to an element outside of sound sensor 250, such as to an implantable stimulation device or other component of an implantable hearing prosthesis.
The transmitter may comprise an electronic circuit 270 mounted inside housing 258 that is coupled to microphone 272 by wires 262. Electronic circuit 270 may be configured to process the signal generated by the microphone 272 for transmission to an implantable stimulation device.
Electronic circuit 270 may be configured to convert alternating electrical current (AC) to direct electrical current (DC) and to deliver electrical power to the microphone 272. In the embodiment of
At least one feed through 266 is preferably provided for passing electrical wires 262 to through housing 258. Feed through 266 is preferably provided through closure 260. In certain embodiments, feed through 266 is formed in closure 260; in other words, they are unitary.
Electrical wires 262 may be configured to pass electrical power to implantable device 250. Wires 262 may be configured to transmit the processed microphone signal to the exterior of sound sensor 250. In the latter case, electronic circuit 270 may be configured to modulate the signal on the power wires.
In an alternative embodiment, the transmission is wireless. In such embodiments the implantable device 250 may be provided with an electromagnetic antenna (not shown).
The enclosure, formed by housing 258, membrane 248 and closure 260, is, in certain embodiments, filled with an inert gas, such as nitrogen or argon.
In the embodiment illustrated in
In the illustrative embodiments of
As used herein, the terms “sound” and “acoustic waves” refer to pressure waves, which can be perceived by the hearing organ of a healthy person or animal (mammal). Sound in the a frequency spectrum between about 20 Hz and 20 kHz is generally perceivable by a human having normal, functional hearing.
Implantable sound sensors according to certain embodiments of the present invention are configured as to enable a surgeon to surgically implant the implantable sound sensors with relative ease when compared to conventional surgical procedures for implantation of devices adjacent a recipient's middle or inner ears. For example, this relatively easy surgical method is generally to drilling a canal from the outside of a patient's head to the location where the distal end of the housing 258, 358 is exposed to the relevant cavity, and/or coupling mechanism 252 is secured to the desired vibrating structure of the ear. Next, implantable sound sensor 250, 350 is secured to the recipient.
It is generally desirable that the size of the drilled canal be kept as small as possible. As such, the implantable sound sensors according to certain embodiments of the invention have a small aspect ratio. As is well know, the aspect ratio of a device refers to ratio of the device's width to the device's height. The length of the implantable sensors refers to the total size, measured along the longitudinal axis of the elongate housing, from membrane 248, 348 to, and including, closure 260,360, respectively. In determining the length of the implantable device, the length of any external wires protruding out of closure 260,360 are not included. The breadth or width of the implantable sound sensor refers to the smallest dimension of the cross-section of the sensor measured perpendicular to the longitudinal axis of the tubular housing. In embodiments of the present invention, the aspect ratio of the breadth (width) to the length of the implantable device 250, 350 is smaller than 1. The housing 258, 358 have thus preferably an elongate shape.
In certain embodiments of the present invention, the aspect ratio of the breadth to the length of the implantable sensor 250, 350 is smaller than or equal to 0.75. In specific such embodiments, the aspect ratio of sensor 250, 350 is smaller than or equal to 0.6, while in still other embodiments the aspect ratio is smaller than or equal to 0.45.
The size of the membrane refers to the smallest dimension (diameter in the case of a membrane having a circular cross-sectional shape) of the membrane measured perpendicular to the longitudinal axis of the tubular housing. In certain embodiments, the size of membrane 248, 348 is smaller than or equal to 9 mm. In certain such embodiments, membrane 248, 348 has a size smaller than or equal to 7 mm, while in still other embodiments the membrane has a size smaller than or equal to 5 mm, or a size smaller than or equal to 3.5 mm.
In embodiments of the present invention, the length of sensor 250, 350 is smaller than or equal to 20 mm. In specific embodiments, sensor 250, 350 has a length smaller than or equal to 15 mm, or a length smaller than or equal to 12.5 mm. Sensors according to embodiments of the present invention that have a small aspect ratio device provide several benefits. One advantage is that surgical implantation is simplified and the extent of intervention is reduced. A second advantage is that the small breadth of the sensor allows full exposure of the membrane in various cavities of the ear, in particular, exposure in the middle ear cavity. Furthermore, in embodiments in which the membrane is not skin loaded, the attenuation of acoustic waves arriving at the membrane 248, 348 is reduced, resulting in a smaller membrane needed for an equal sensitivity. Finally, the directionality of the acoustic waves, induced by the outer ear, can be fully exploited.
As previously noted, sensor 250, 350 is fixed to the recipient. Sensor 250, 350 may, in certain embodiments, be fixed to a bony structure, such as the temporal bone. This fixation may be performed out by conventional brackets known in the art. Such brackets are configured to be attached to housing 248, 348 and hence provide mechanical coupling between the housing and the bony structure.
The method begins at step 402 with a hearing prosthesis having an implantable sound sensor in accordance with aspects of the present invention is provided. At step 404, a canal is formed such as by drilling from the outside of the patient's head to the middle ear cavity. At step 406, the implantable device (sensor) is inserted into the canal so as to expose at least the membrane of the implantable device to the middle ear cavity. At step 408 a myringotomy may optionally be performed to create a passage through the tympanic membrane in order to reduce the attenuation of acoustic waves by the tympanic membrane. This may include inserting a myringotomy prosthesis across the tympanic membrane in order to keep the incision open.
Then, at step 410, the other components of the hearing prosthesis are implanted. As would be appreciated, the order of steps in
At step 504, the signal generated by the sound sensor is transmitted to one or more other components of the hearing prosthesis. At step 506 the hearing prosthesis provides stimulation based on the signal generated by the implantable sound sensor.
In certain embodiments of the present invention, the sound sensor may be fixed, via a bracket, in or adjacent to inner ear cavity. For example, the sound sensor may be positioned adjacent the elliptical window, circular (round) window, the horizontal canal, the posterior canal or the superior canal.
In accordance with embodiments of the present invention, the housing of the sound sensor has a cylindrical cross-sectional shape and has a diameter (breadth/width) of about 3.5-4 mm. The length of such a sensor may be about 10-15 mm. This allows an electret microphone, such as a Sonion 8009, having an outer diameter of 2.56 mm and a length of 3 mm to be positioned within the housing of the sound sensor. The electronic circuitry for AC-DC conversion may be provided on a board or chip that also fits within the housing and may, in certain embodiments, have length that does not exceed 3 mm.
The invention described and claimed herein is not to be limited in scope by the specific preferred embodiments herein disclosed, since these embodiments are intended as illustrations, and not limitations, of several aspects of the invention. Any equivalent embodiments are intended to be within the scope of this invention. Indeed, various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims.
This application is a National Stage Application of International Application No. PCT/US2009/047422 filed Jun. 15, 2009, and claims priority to U.S. Provisional Application No. 61/061,250, filed Jun. 13, 2008.
| Number | Date | Country | |
|---|---|---|---|
| 61061250 | Jun 2008 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12997788 | Dec 2010 | US |
| Child | 15395234 | US |
