The present invention relates to a hearing implant, and more specifically to fitting a middle ear implant to an implanted patient.
A normal ear transmits sounds as shown in
Hearing is impaired when there are problems in the ear's ability to transduce external sounds into meaningful action potentials along the neural substrate of the cochlea 104. To improve impaired hearing, various types of hearing prostheses have been developed. For example, when a hearing impairment is related to the operation of the middle ear 103, a conventional hearing aid, a bone conduction implant, or a middle ear implant (MEI) device may be used to provide acoustic-mechanical vibration to the auditory system.
U.S. Patent Publication 20070191673 (incorporated herein by reference) described another type of implantable hearing prosthesis system which uses bone conduction to deliver an audio signal to the cochlea for sound perception in persons with conductive or mixed conductive/sensorineural hearing loss. An implanted floating mass transducer (FMT) is affixed to the temporal bone. In response to an externally generated electrical audio signal, the FMT couples a mechanical stimulation signal to the temporal bone for delivery by bone conduction to the cochlea for perception as a sound signal. A certain amount of electronic circuitry must also be implanted with the FMT to provide power to the implanted device and at least some signal processing which is needed for converting the external electrical signal into the mechanical stimulation signal and mechanically driving the FMT.
One problem with implantable hearing prosthesis systems arises when the patient undergoes Magnetic Resonance Imaging (MRI) examination. Interactions occur between the implant magnet and the applied external magnetic field for the MRI. The external magnetic field from the MRI may create a torque on the implant magnet, which may displace the magnet or the whole implant housing out of proper position and/or may damage the adjacent tissue in the patient. The implant magnet may also cause imaging artifacts in the MRI image, there may be induced voltages in the receiving coil, and hearing artifacts due to the interaction of the external magnetic field of the MRI with the implanted device.
Thus, for existing implant systems with magnet arrangements, it is common to either not permit MRI or at most limit use of MRI to lower field strengths. Other existing solutions include use of a surgically removable magnets, spherical implant magnets (e.g. U.S. Pat. No. 7,566,296), and various ring magnet designs (e.g., U.S. Provisional Patent 61/227,632, filed Jul. 22, 2009). Among those solutions that do not require surgery to remove the magnet, the spherical magnet design may be the most convenient and safest option for MRI investigations even at very high field strengths. But the spherical magnet arrangement requires a relatively large magnet much larger than the thickness of the other components of the implant, thereby increasing the volume occupied by the implant. This in turn can create its own problems. For example, some systems, such as cochlear implants, are implanted between the skin and underlying bone. The “spherical bump” of the magnet housing therefore requires preparing a recess into the underlying bone. This is an additional step during implantation in such applications which can be very challenging or even impossible in case of very young children.
U.S. Patent Publication 20120029267 (incorporated herein by reference) described an implantable hearing prosthesis two planar implant magnets connected by a flexible connector member which are fixable to underlying skull bone. Each of the implant magnets was in the specific form of a center disk having magnetic polarity in one axial direction. Around the disk magnet was another ring magnet having an opposite magnetic polarity in a different direction. This ring/disk magnet arrangement had less magnetic interaction with an external magnetic field such as an MRI field.
Embodiments of the present invention are directed to an implantable floating mass transducer for a hearing implant system in an implant patient. A cylindrical transducer housing contains a cylindrical inner mass magnet having an inner magnetic field with a first field direction. One or more signal drive coils are on the outer housing surface for conducting a transducer drive signal current to produce a signal magnetic field that interacts with the inner magnetic field to create vibration of the inner mass magnet which is coupled by the transducer housing to the internal hearing structure for sound perception by the implant patient. A ring-shape outer offset magnet is positioned around the outer housing surface with an outer magnetic field having a second field direction opposite to the first field direction so as to offset the inner magnetic field to minimize their combined magnetic field and thereby minimize magnetic interaction of the transducer with any external magnetic field.
Specific embodiments may also include an inner magnet spring such as a spring plate connected to each cylindrical end of the inner mass magnet suspending the inner mass magnet within the interior volume of the transducer housing. There may be outer springs suspending the outer offset magnet around the outer housing surface and/or anti-torque springs connecting the inner mass magnet to the transducer housing. There may be a signal drive coil on the outer housing surface over each cylindrical end of the inner mass magnet. The inner mass magnet and/or the outer offset magnet may include a pair of cylindrical magnets of opposite magnetic polarity positioned end to end. And there may be an outer transducer cover around the outside of the transducer.
The hearing implant system may be a middle ear implant system, a round window implant system, or a bone conduction implant system.
Various embodiments of the present invention are directed to an implantable floating mass transducer arrangement for a hearing implant system in an implant patient which has a reduced overall magnetic field so as to be suitable for undergoing MRI examination. An outer ring-shaped offset magnet surrounds a conventional FMT, and the magnetic moments of the inner FMT magnet and the outer offset magnet are substantially the same magnitude but in opposite directions.
A ring-shape outer offset magnet 208 is suspended on one or more resilient outer springs 209 (e.g., of silicone or titanium) around the outer surface of the implant housing 202. The outer offset magnet 208 include a lead opening 210 through which pass one or more signal leads 207 to deliver the drive signal to the drive coils 205. The magnetic field of the outer offset magnet 208 has a second field direction opposite to the first field direction of the inner mass magnet 201. Here in
As shown in
It is important that the inner mass magnet 201 be able to move along the longitudinal cylindrical axis with very low friction for efficient transfer of vibrational energy. However, the magnetic attraction between the inner mass magnet 201 and the outer offset magnet 208 can generate torque on the inner mass magnet 201 that in turn increases the friction with longitudinal movement. It may therefore be advantageous in some embodiments to include one or more anti-torque springs 401 as shown in
Alternatively or in addition, the triangular magnet springs 204 may be replaced by spring plates 501 (e.g. made of titanium) as shown in
The entire transducer 200 may be covered by an outer transducer cover layer (e.g. made of titanium and/or silicone) which should provide a hermetically sealed feed-through for the electrode lead 207. Alternatively, the outer offset magnet 208 may be enclosed in a housing (e.g. titanium) that is securely connected to the transducer housing 208.
One significant advantage of such transducer arrangements is the compatibility and safety with regards to MRI examination. In addition, the implantable transducer provides a larger vibrating inertial mass that are appropriate to drive more massive anatomical (e.g. skull) and/or artificial (CI electrode lead) structures. And since the new offset magnet fits around a conventional FMT, an existing implantable transducer may retrofit and upgraded by the addition of an outer offset magnet to make an MRI-compatible transducer arrangement.
Although various exemplary embodiments of the invention have been disclosed, it should be apparent to those skilled in the art that various changes and modifications can be made which will achieve some of the advantages of the invention without departing from the true scope of the invention. For example, although embodiments are described in the specific context of middle ear implant systems, the principles of the invention are equally relevant to other types of hearing implant systems such as bone conduction implant systems.
This application claims priority from U.S. Provisional Patent Application 61/817,473, filed Apr. 30, 2013, which is incorporated herein by reference.
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