The present application is a non-provisional of U.S. Provisional Patent Application No. 61/089,522, filed Aug. 16, 2008, titled IMPLANTABLE MIDDLE EAR TRANSDUCER HAVING IMPROVED FREQUENCY RESPONSE, herein incorporated by reference in its entirety.
The present invention is related generally to implantable medical devices. More specifically, the present invention is related to implantable transducers, which can be used in partial middle ear implantable or total middle ear implantable hearing aid systems.
In some types of partial middle ear implantable (P-MEI) or total middle ear implantable (T-MEI) hearing aid systems, sounds produce mechanical vibrations within the ear which are converted by an electromechanical input transducer into electrical signals. These electrical signals are in turn amplified and applied to an electromechanical output transducer. The electromechanical output transducer causes an ossicular bone to vibrate in response to the applied amplified electrical signals, thereby improving hearing.
An electromechanical transducer used for the purpose of vibrating or sensing from any or all elements of the ossicular chain may be mounted in or near the middle ear. The transducer is generally contained in a housing or enclosure, forming a driver or sensor assembly that facilitates the placement of the transducer within the middle ear.
In previous designs, applicant has noticed unwanted resonances within the audible frequency range, which can be disconcerting to the person having the implant.
What would be desirable are transducers which more accurately convert the electrical signal received into vibrations which can be coupled to the ossicular chain.
Some embodiments of the present invention provide an implantable transducer assembly for implanting into a middle ear region, the transducer assembly including an elongate transducer adapted to receive an electrical signal and produce a vibration in response to the electrical signal, in which the vibration occurs substantially in a first plane which extends through the transducer. The transducer can have a length, a free vibrating end, and a base region opposite the free end for operable coupling to a bone. The transducer can also have a pair of fins operably coupled to the transducer base region, the fins having a thickness dimension, and in which the fins lie substantially in a second plane which is normal to the first plane.
Some transducer assembly embodiments also have a protective layer covering the transducer, in which the fins are not directly coupled to the transducer, and in which the fins are secured to the protective layer, such that the operable coupling is made through the protective layer. Some transducer assemblies may have a base member, in which the transducer base region is coupled to the base member, and in which the fins are not directly coupled to the base member, such that the vibrating in the first plane moves the fins in a direction orthogonal to the fin thickness dimension.
Some transducer assembly embodiments have a base member, in which the transducer base region is coupled to the base member, and in which the fins each have a free edge disposed near the base member, such that the vibrating in the first plane moves the fins in a direction orthogonal to the fin thickness dimension. In some embodiments, the protective layer includes a metallic sheet, which may be formed of titanium less than about 3 mils thick. Some fins may be triangular shaped, others may have a nominal triangular shape but with convex outer edges, some others may have a nominal triangular shape but with concave outer edges, and still others may have rounded outer edges.
Some fins have a length at least about 20 percent of the length of the transducer, and some may have a length less than about 80 percent of the length of the transducer. In some embodiments, the fins have a length of less than about ½ inch. The transducer is less than about 1inch long in some embodiments. Some transducer assemblies also include a biocompatible bone mount assembly coupled to the transducer base for securing to a bone. In some embodiments, the transducer is hermitically sealed.
The present invention also includes systems for treating hearing loss, the systems comprising all the systems described herein and combinations thereof.
Methods are also provided for aiding hearing. One method includes receiving an acoustic signal near a human ear; converting the acoustic signal to an electrical signal; transmitting the electrical signal to a vibratory transducer; and vibrating the transducer in a first plane responsive to the received electrical signal. The vibration can be attenuated in a second plane orthogonal to the first plane by a pair of fins disposed substantially in the second plane where the fins are operably coupled to the vibratory transducer. In one method, the transducer is coupled to a base member, and the fins are not directly coupled to the base member, such that the vibrating in the first plane moves the fins with respect to the base member. In one embodiment method, the transducer is coupled to a base member, and the fins have free edges not coupled to the base member, such that the vibrating in the first plane moves the fins with respect to the base member, such that the fin edges near the base member are free to move in the second plane relative to the base member. In one method, the transducer is covered by a protective layer, and the fins are secured to the protective layer, such that transducer vibrations are transmitted through the protective layer.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings depict selected embodiments and are not intended to limit the scope of the invention. It will be understood that embodiments shown in the drawings and described below are merely for illustrative purposes, and are not intended to limit the scope of the invention as defined in the claims.
Some embodiments of the invention provide an electromechanical transducer which is particularly advantageous when used in a middle ear implantable hearing aid system, such as a partial middle ear implantable (P-MEI), total middle ear implantable (T-MEI), or other hearing aid system. A P-MEI or T-MEI hearing aid system assists the human auditory system in converting acoustic energy contained within sound waves into electrochemical signals delivered to the brain and interpreted as sound.
The ossicular chain 37 includes three primary components: a malleus 40, an incus 45, and a stapes 50. The malleus 40 includes manubrium and head portions. The manubrium of the malleus 40 attaches to the tympanic membrane 30. The head of the malleus 40 articulates with one end of the incus 45. The incus 45 normally couples mechanical energy from the vibrating malleus 40 to the stapes 50. The stapes 50 includes a capitulum portion, comprising a head and a neck, connected to a footplate portion by means of a support crus comprising two crura. The stapes 50 is disposed in and against a membrane-covered opening on the cochlea 60. This membrane-covered opening between the cochlea 60 and middle ear 35 is referred to as the oval window 55. Oval window 55 is considered part of cochlea 60 in this patent application. The incus 45 articulates the capitulum of the stapes 50 to complete the mechanical transmission path.
Normally, prior to implantation of the hearing aid system according to some embodiments of the invention, tympanic vibrations are mechanically conducted through the malleus 40, incus 45, and stapes 50, to the oval window 55. Vibrations at the oval window 55 are conducted into the fluid filled cochlea 60. These mechanical vibrations generate fluidic motion, thereby transmitting hydraulic energy within the cochlea 60. Pressures generated in the cochlea 60 by fluidic motion are accommodated by a second membrane-covered opening on the cochlea 60. This second membrane-covered opening between the cochlea 60 and middle ear 35 is referred to as the round window 65. Round window 65 is considered part of cochlea 60 in this patent application. Receptor cells in the cochlea 60 translate the fluidic motion into neural impulses which are transmitted to the brain and perceived as sound. However, various disorders of the tympanic membrane 30, ossicular chain 37, and/or cochlea 60 can disrupt or impair normal hearing.
Hearing loss due to damage in the cochlea is referred to as sensorineural hearing loss. Hearing loss due to an inability to conduct mechanical vibrations through the middle ear is referred to as conductive hearing loss. Some patients have an ossicular chain 37 lacking sufficient resiliency to transmit mechanical vibrations between the tympanis membrane 30 and the oval window 55. As a result, fluidic motion in the cochlea 60 is attenuated. Thus, receptor cells in the cochlea 60 do not receive adequate mechanical stimulation. Damaged elements of ossicular chain 37 may also interrupt transmission of mechanical vibrations between the tympanic membrane 30 and the oval window 55.
Implantable hearing aid systems have been developed, utilizing various approaches to compensate for hearing disorders. For example, cochlear implant techniques implement an inner ear hearing aid system. Cochlear implants electrically stimulate auditory nerve fibers within the cochlea 60. A typical cochlear implant system may include an external microphone, an external signal processor, and an external transmitter, as well as an implanted receiver and an implanted probe. A signal processor converts speech signals transduced by the microphone into electrical stimulation that is delivered to the cochlea 60.
A particularly interesting class of hearing aid systems includes those which are configured for disposition principally within the middle ear space 35. In middle ear implantable (MEI) hearing aids, an electrical-to-mechanical output transducer couples mechanical vibrations to the ossicular chain 37, which is optionally interrupted to allow coupling of the mechanical vibrations to the ossicular chain 37. Both electromagnetic and piezoelectric output transducers have been used to effect the mechanical vibrations upon the ossicular chain 37.
One example of a partial middle ear implantable (P-MEI) hearing aid system having an electromagnetic output transducer comprises: an external microphone transducing sound into electrical signals; external amplification and modulation circuitry; and an external radio frequency (RF) transmitter for transdermal RF communication of an electrical signal. An implanted receiver detects and rectifies the transmitted signal, driving an implanted coil in constant current mode. A resulting magnetic field from the implanted drive coil vibrates an implanted magnet that is permanently affixed only to the incus. Such electromagnetic output transducers have relatively high power consumption, which limits their usefulness in total middle ear implantable (T-MEI) hearing aid systems.
A piezoelectric output transducer is also capable of effecting mechanical vibrations to the ossicular chain 37. An example of such a device is disclosed in U.S. Pat. No. 4,729,366, issued to D. W. Schaefer on Mar. 8, 1988. In the '366 patent, a mechanical-to-electrical piezoelectric input transducer is associated with the malleus 40, transducing mechanical energy into an electrical signal, which is amplified and further processed. A resulting electrical signal is provided to an electrical-to-mechanical piezoelectric output transducer that generates a mechanical vibration coupled to an element of the ossicular chain 37 or to the oval window 55 or round window 65. In the '366 patent, the ossicular chain 37 is interrupted by removal of the incus 45. Removal of the incus 45 prevents the mechanical vibrations delivered by the piezoelectric output transducer from mechanically feeding back to the piezoelectric input transducer.
Piezoelectric output transducers have several advantages over electromagnetic output transducers. The smaller size or volume of the piezoelectric output transducer advantageously eases implantation into the middle ear 35. The lower power consumption of the piezoelectric output transducer is particularly attractive for T-MEI hearing aid systems, which may include a limited longevity implanted battery as a power source.
A piezoelectric output transducer is typically implemented as a ceramic piezoelectric bi-element transducer, which is a cantilevered double plate ceramic element in which two opposing plates are bonded together such that they amplify a piezoelectric action in a direction normal to the bonding plane. Such a bi-element transducer vibrates according to a potential difference applied between the two bonded plates. A proximal end of such a bi-element transducer is typically cantilevered from a transducer mount which is secured to a temporal bone within the middle ear. A distal end of such a bi-element transducer couples mechanical vibrations to an ossicular element such as stapes 50.
Electronics unit 95 may couple an electrical signal through lead wires 85 and 90 to any convenient respective connection points on respective opposing elements of bi-element transducer 70.
In response to the electrical signals received from electronics unit 95, bi-element transducer 70 bends with respect to a longitudinal plane between its opposing elements. The bending is resisted by inertial mass 80 which may be connected to bone through the use of adhesive or bone cement or a mechanical connector, for example a screw, thus mechanically coupling a force to stapes 50 through bi-element transducer 70. This force upon stapes 50 is in turn transmitted to cochlea 60 at oval window 55.
Bi-element transducer 70 may also be secured only to other auditory elements for receiving mechanical vibrations, such as incus 45 or tympanic membrane 30. Vibrations of malleus 40 cause, at the proximal end of bi-element transducer 70, vibratory displacements that are opposed by inertial mass 80 which may be connected to bone through the use of adhesive or bone cement or a mechanical connector, for example a screw. As a result, bi-element transducer 70 bends with respect to the longitudinal plane between its opposing elements. A resulting electrical signal is provided at any convenient connection point on respective opposing elements of bi-element transducer 70, through respective lead wires 92 and 93 to electronics unit 95.
The elements of the transducer assembly 100 may be made of metallic or non-metallic implantable materials that can be hermetically sealed, for example, titanium, gold, platinum, platinum-iridium, stainless steel, or plastic. In one embodiment, the transducer assembly 100 is made out of a thin-walled metallic or non-metallic material that preferably can be made to minimize spring constant and mass while providing a hermetic barrier. In another embodiment, the transducer assembly 100 has a wall thickness ranging from about 0.0005 inches to 0.01 inches and may be made by die forming, hydroforming, electro deposition, or thin film deposition. Elements of the transducer assembly 100 may be connected together by gluing, soldering, brazing, or welding, for example.
The transducer assembly 100 may also be provided with one or more coatings that may enhance the mechanical and/or biological characteristics of the devices. The coatings may be organic or inorganic and may provide one or more of the following characteristics while maintaining low spring rate and mass loading: scratch and/or moisture resistance, biocompatibility, tissue adhesion resistance, microbial resistance, for example. For instance, a medical adhesive coating or a conformal coating may be applied from a point just proximal the pin 140 to the housing 130. In one embodiment, a medical adhesive may be applied to the pin 140.
In another embodiment, the transducer assembly 100 may be formed by coating the bi-element transducer 70 with organic or inorganic coatings. Inorganic coatings may consist of a single or multiple layers of formed or deposited metals including titanium, platinum, gold, nickel, copper, palladium cobalt, for example. Organic materials may include Teflon, silicone, parylene, polyolefin, polyurethane, for example. Coatings may be applied by several well known techniques including dipping the transducer assembling in the materials, rolling it, spraying it on, vapor depositing, electrostatic, ion beam, plasma and vacuum depositing for example. The coating or coatings may also be surface modified to incorporate desired properties.
The transducer assemblies according to the embodiments described herein can be hermetically sealed to provide a fully implantable device.
Applicant has learned that vibration in the intended/primary direction is well damped by the cochlear fluid, but that the cochlea has limited damping in the lateral direction. A resonance not in the primary direction will result in large displacements due to the low damping. The large displacements can result in poor performance or mechanical feedback.
Inspection of
Applicant believes that the fins, wings, or gussets, allow vibration in the intended direction while reducing or controlling an apparent resonance which can be set up in a direction orthogonal to the desired direction, which distorts the desired vibratory output. Further, the combination of fins 150 and diaphragm 120 has moved the antiresonance frequency to a higher frequency thereby increasing bandwidth.
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