Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
1997-07-21
2001-11-13
Lacyk, John P. (Department: 3736)
Surgery
Surgically implanted vibratory hearing aid
38
Reexamination Certificate
active
06315710
ABSTRACT:
BACKGROUND
Some types of partial middle ear implantable (P-MEI), total middle ear implantable (T-MEI), cochlear implant, or other hearing assistance systems utilize components disposed within the middle ear or inner ear regions. Such components may include an input transducer for receiving sound vibrations or an output stimulator for providing mechanical or electrical output stimuli based on the received sound vibrations.
An example of one such 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 a malleus bone in the patient's middle ear. The malleus vibrates in response to sounds received at the patient's tympanic membrane (eardrum). The piezoelectric input transducer transduces a mechanical energy of the malleus vibrations into an electrical signal, which is amplified and further processed by an electronics unit. A resulting electrical signal is provided to an electrical-to-mechanical piezoelectric output transducer that generates a mechanical vibration that is coupled to a stapes bone in the ossicular chain or to an oval window or round window of a cochlea. In the '366 patent, the ossicular chain is interrupted by removal of an incus bone. Removal of the incus prevents the mechanical vibrations delivered by the piezoelectric output transducer from mechanically feeding back to the piezoelectric input transducer.
Piezoelectric transducers are one example of a class of electromechanical transducers that require contact to sense or provide mechanical vibrations. For example, the piezoelectric input transducer in the '366 patent contacts the malleus for detecting mechanical vibrations. In another example, the piezoelectric output transducer in the '366 patent contacts a stapes bone or the oval or round window of the cochlea.
Proper positioning of the transducer and good contact between the transducer and the malleus is essential to properly transducing the received mechanical vibrations into a resulting electrical signal for hearing assistance processing. For example, there is a need in the art to ascertain whether too much force between the transducer and the malleus can mechanically load the vibrating malleus and attenuate the desired mechanical vibration signal or alter its frequency characteristics. It may be likely that, in an extreme case, too much force can damage or break either the malleus or the transducer. It may also be likely that too little force between the transducer and the malleus may be insufficient to detect the mechanical vibration signal, and is more likely to result in a complete loss of signal detection if the transducer and the malleus become dissociated.
Good contact between the transducer and the stapes is also critical for assisting hearing by providing mechanical stimulation. For example, there is a need in the art to ascertain whether too much force between the stimulating transducer and the stapes can attenuate the mechanical vibration signal provided by the transducer or alter its frequency characteristics. It may be likely that, in an extreme case, too much force can damage or break either the stapes or the transducer. It may also be likely that too little force between the stimulating transducer and the stapes may be insufficient to vibrate the stapes, and is more likely to result in a complete loss of assisted mechanical vibrations if the stimulating transducer and the stapes become dissociated. There is a need in the art to better control contact between the transducer and an auditory element such as the malleus or the stapes.
For the reasons stated above, and for other reasons stated below which will become apparent to those skilled in the art upon reading and understanding the present specification, there is a need in the art for improved transducer positioning and contact to an auditory element while sensing and providing middle ear sound vibrations.
SUMMARY
The present invention provides an improved hearing assistance system that obtains more precise positioning and contact between a vibrating auditory element and a transducer that senses or provides such mechanical vibrations, such as by providing a controllable, adjustable, or calibrated force.
In one embodiment, the present invention provides an apparatus that includes a first member, proportioned for disposition in a middle ear. A second member, proportioned for disposition in the middle ear, threadably engages the first member. A transducer, proportioned for disposition in the middle ear, is attached to the second member. This embodiment allows accurate and reliable positioning of a transducer for contact with an auditory element.
In another embodiment, the present invention includes a transducer mount that includes movably engaged first and second members, and an elastically deformable coupler couplable to each of the first and second members. This embodiment is capable of providing a controllable, adjustable, or calibrated force between the transducer and the auditory element.
In another embodiment, the first member includes a mounting portion and an engaging portion extending from the mounting portion. The engaging portion includes a guide. The second member slidably engages the first member. A spring couples the first and second members. One end of the spring is mechanically couplable to the first member and the other end of the spring is mechanically couplable to the second member. A first stop, which is attached to the first member, abuts one end of the spring. A second stop is attached to the second member.
According to one aspect of the invention, the first and second members are proportioned for disposition within a middle ear and the first stop engages the guide. The first stop is adjustably attached to the first member. A third member is coupled to the first member and threadably coupled to the first stop for providing an adjustable spacing therebetween. A spacer is mechanically couplable to one of the first and second stops, such that a spatial relationship between the first and second stops is limited by the spacer engaging the other of the first and second stops. The spring provides between the transducer and the auditory element a force that varies in response to the adjustable spacing between the first stop and the first member.
Another aspect of the present invention provides a method of coupling a transducer to an auditory element. A transducer mount is disposed in a middle ear. The transducer mount includes a first member and also includes a second member carrying a transducer. The first member includes a threaded member that is threadably engaged with the second member. The transducer is coupled to the auditory element by turning the threaded member to adjust a spatial relationship between the first and second members.
In another embodiment, a method of coupling a transducer to an auditory element includes disposing a transducer mount in a middle ear. The transducer mount includes a first member and also includes a second member carrying a transducer and movably engaged with the first member by an elastically deformable coupler. The transducer is coupled to an auditory element. A spatial relationship between the first and second members is adjusted to provide a desired coupling force between the transducer and the auditory element. In one embodiment, the desired coupling force between the transducer and the auditory element is obtained by compressing the elastically deformable coupler. In another embodiment, the desired coupling force is obtained by engaging the first and second members with a spacer to limit a spatial relationship between the first and second members, such as for limiting the compression of the elastically deformable coupler.
In another embodiment, the present invention provides a method of sensing mechanical vibrations of a malleus. A piezoelectric transducer is disposed in the middle ear. A portion of the transducer is positioned to contact the malleus. A force between the transduce
Bushek Donald J.
Kroll Kai
Meyerson Scott C.
Fredrikson & Byron , P.A.
Lacyk John P.
St. Croix Medical, Inc.
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