Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
2000-07-26
2003-03-25
Hindenburg, Max F. (Department: 3736)
Surgery
Surgically implanted vibratory hearing aid
Reexamination Certificate
active
06537199
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to an implantable arrangement for mechanical coupling of an output driver part of an active or passive hearing system 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 element which can be connected, preferably by force-fit, to a preselected coupling site, the driver part being adapted to be excited to mechanical vibrations.
2. Description of Related Art
Partially implantable or fully implantable hearing systems for direct mechanical stimulation are known. In these hearing systems, the acoustic signal is converted into an electrical signal with a converter (microphone) and is amplified in an electronic signal processing stage, this amplified electrical signal is supplied to an implanted electromechanical converter with output-side mechanical vibrations 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, respectively, 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 as 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, 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 hand, can take place via an air gap (“contactless”), i.e., only one 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. 1997 (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. Nos. 5,707,338 (Adams et al.), 5,554,096 (Ball), 3,712,962 (Epley), 3,870,832 (Fredrickson), 5,277,694 (Leysieffer et al.), 5,015,224 (Maniglia), 3,882,285 (Nunley), and 4,850,962 (Schaefer), International Patent Application publication Nos. WO 98/06235 (Adams et al.), WO 98/06238 (Adams et al.), WO 98/06236 (Kroll et al.) and WO 98/06237 (Bushek et al.), and published European Patent Application Nos. EP-A-0 984 663 (corresponding to commonly owned, U.S. Application Ser. No. 09/275,872) (Leysieffer), and EP-A-0 984 665 (corresponding to commonly owned U.S. Application Ser. No. 09/311,563) (Leysieffer).
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 in middle and inner ear disorders. Adv. Audiol, Vol. 4, Karger Basel (1998), pp. 149-159; Suzuki et al.: Implantation of partially implantable middle ear implant and the indication. Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 160-166). Similarly, in the process of a partially implantable hearing system for those suffering from labyrinthine deafness according to 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 Schaefer technology and which are documented in the aforementioned disclosures (U.S. Pat. No. 5,707,338, and International Patent Application publication Nos. WO 98/06235, WO 98/06238, WO 98/06236, WO 98/06237).
Conversely, the electromagnetic converter of BALL (“Floating Mass Transducer FMT,” U.S. Pat. Nos. 5,624,376 and 5,554,096) is fixed with titanium clips directly on 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 sever 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, and published European Patent Application Nos. EP-A-0 984 663 and EP-A-0 984 665). 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) In the case of the one principle 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. Pat. Nos. 4,850,962, 5,015,225, 5,707,338, 5,624,376, 5,554,096, and International Patent Application publication Nos. WO 98/06235, WO 98/06238, WO 98/06236, and WO 98/06237).
b) In the other principle 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 Clinic of North America, Vol. 28/1 (1995), pp. 107-121: U.S. Pat. No. 5,277,694; published European Application Nos. EP-A-0 984 663, EP-A-0 984 665).
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, but it vibrates based on the laws of mass inertia with its converter housing and transmits these vibrations directly to a middle ear ossicle (U.S. Pat. Nos. 5,624,376, 5,554,096, and 5,707,338, and International Patent Application publication no. WO 98/06236). On the one hand, this means that an implantable fixation system on the
Leysieffer Hans
Müller Gerd M.
Hindenburg Max F.
Nixon & Peabody LLP
Phonak AG
Safran David S.
Szmal Brian
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