Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
2000-10-06
2003-04-01
Hindenburg, Max F. (Department: 3736)
Surgery
Surgically implanted vibratory hearing aid
Reexamination Certificate
active
06540661
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to an implantable arrangement for mechanical coupling of an output-side driver member of an active or passive hearing system, the driver member being adapted to be excited to mechanical vibrations, to a preselected coupling site on the ossicular chain, the footplate of the stapes or a membrane which closes the round window or an artificial window in the cochlea, in the vestibulum or in the labyrinth (equilibrium organ), via a coupling arrangement which has a coupling rod which can be excited to mechanical vibrations by the driver member, and a coupling element which can be connected to said preselected coupling site, the coupling rod and the coupling element being interconnected via at least one coupling and at least a section of the coupling element which in the implanted state contacts the coupling site being designed for vibratory input to the coupling site.
2. Description of Related Art
Partially implantable or fully implantable active hearing systems for direct mechanical stimulation are known. In these hearing systems the acoustic signal is converted into an electrical signal by a converter (microphone) and is amplified in an electronic signal processing unit; this amplified electrical signal is supplied to an implanted electromechanical converter the output-side mechanical vibrations of which are supplied directly, i.e. with direct mechanical contact, to the middle ear or inner ear. This applies regardless of whether pure labyrinthine deafness with a completely intact middle ear or combined deafness (middle ear and inner ear damaged) is to be rehabilitated. Therefore, implantable electromechanical converters and processes for direct coupling of the mechanical converter vibrations to the intact middle ear or to the inner ear for rehabilitation of pure labyrinthine deafness and also to the remaining ossicles of the middle ear in an artificially or pathologically altered middle ear for treatment of conductive deafness and their combinations have been described in the more recent scientific and patent literature.
Basically all physical conversion principles can be used as electromechanical converter processes, such electromagnetic, electrodynamic, magnetostrictive, dielectric, and piezoelectric. In recent years various research groups have focused essentially on two of these processes: electromagnetic and piezoelectric. An outline of these converter versions can be found in Zenner and Leysieffer (HNO 1997, Vol. 45, pp. 749 -774).
In the piezoelectric process, mechanically direct coupling of the output-side converter vibrations to the middle ear ossicle or directly to the oval window is necessary. In the electromagnetic principle, the force coupling, on the one hand, can take place via an air gap (“contactless”), i.e. only a permanent magnet is placed by permanent fixation in direct mechanical contact with a middle ear ossicle. On the other hand, it is possible to dispose the entire converter within a housing (the coil and the magnet being coupled with the smallest possible air gap) and to transfer the output-side vibrations via a mechanically stiff coupling element with direct contact to the middle ear ossicle (Leysieffer et al., HNO 1997, Vol. 45., pp. 792-800).
The patent literature contains some of the aforementioned versions of both electromagnetic and also piezoelectric hearing aid converters: U.S. Pat. No. 5,707,338 (Adams et al.), WO 98/06235 (Adams et al.), WO 98/06238 (Adams et al.), WO 98/06236 (Kroll et al.), WO 98/06237 (Bushek et al.), U.S. Pat. No. 5,554,096 (Ball), U.S. Pat. No. 3,712,962 (Epley), U.S. Pat. No. 3,870,832 (Fredrickson), U.S. Pat. No. 5,277,694 (Leysieffer et al.), published European Patent Application Nos. EP-A-0 984 663 and EP-A-0 984 665 (corresponding to commonly owned U.S. Patent Application Nos. 09/275,872 and 09/311,563, respectively) (Leysieffer), U.S. Pat. No. 5,015,224 (Maniglia), U.S. Pat. No. 3,882,285 (Nunley), and U.S. Pat. No. 4,850,962 (Schaefer).
The partially implantable piezoelectric hearing system of the Japanese group of Suzuki and Yanigahara presupposes for implantation of the converter the absence of the middle ear ossicles and an empty tympanic cavity in order to be able to couple the piezoelement to the stapes (Yanigahara et al.: Efficacy of the partially implantable middle ear implant in middle and inner ear disorders, Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 149-159; Suzuki et al.: Implantation of partially implantable middle ear implant and the indication, Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 160166). Similarly, in the process of an implantable hearing system for those suffering from labyrinthine deafness in accordance with U.S. Pat. No. 4,850,962 (Schaefer), basically, the incus is removed in order to be able to couple a piezoelectric converter element to the stapes. This also applies especially to other developments which are based on the Schaefer technology and which are documented in the aforementioned patents (U.S. Pat. No. 5,707,338, WO 98/06235, WO 98/06238, WO 98/06236, and WO 98/06237).
Conversely, the electromagnetic converter of BALL (“Floating Mass Transducer FMT”, U.S. Pat. No. 5,624,376, and U.S. Pat. No. 5,554,096) is fixed with titanium clips directly to the long process of the incus when the middle ear is intact. The electromagnetic converter of the partially implantable system of FREDRICKSON (Fredrickson et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121) is mechanically coupled directly to the body of the incus when the ossicular chain of the middle ear is likewise intact. The same applies to the piezoelectric and electromagnetic converters of LEYSIEFFER (Leysieffer et al.: An implantable piezoelectric hearing aid converter for patients with labyrinthine deafness, HNO 1997/45, pp. 792-800; U.S. Pat. No. 5,277,694, U.S. Patent Application Nos. 09/275,872 and 09/311,563 (Leysieffer)). Also, in the electromagnetic converter system of MANIGLIA (Maniglia et al: Contactless semi-implantable electromagnetic middle ear device for the treatment of sensorineural hearing loss, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 121-141), when the ossicular chain, is intact, a permanent magnet is permanently fixed mechanically to the ossicular chain but is, however, mechanically driven via an air gap coupling by a coil.
In the described converter and coupling versions, basically, two implantation principles can be distinguished:
a) On the one hand, the electromechanical converter with its active converter element is located itself in the middle ear region in the tympanic cavity and the converter is directly connected there to an ossicle or the inner ear (U.S. Patent No. 4,850,962, U.S. Pat. No. 5,015,225, U.S. Pat. No. 5,707,338, WO 98/06235, WO 98/06238, WO 98/06236, WO 98/06237, U.S. Pat. No. 5,624,376, and U.S. Patent No. 5,554,096).
b) On the other hand, the electromagnetic converter with its active converter element is located outside of the middle ear region in an artificially formed mastoid cavity. The output-side mechanical vibrations are then transmitted to the middle or inner ear by means of mechanically passive coupling elements via suitable surgical accesses (the natural aditus ad antrum, opening of the chorda-facialis angle or via an artificial hole from the mastoid) (Fredrickson et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121; U.S. Pat. No. 5,277,694; U.S. patent application Ser. Nos. 09/275,872 and 09/311,563 (Leysieffer)).
In a)-type versions, the converter can be made as a so-called “floating mass”converter, i.e. the converter element does not require any “reaction”,via secure screwing to the skull bone, rather it vibrates based on the laws of mass inertia with its converter housing and tran
Hindenburg Max F.
Nixon & Peabody LLP
Phonak AG
Safran David S.
Szmal Brian
LandOfFree
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