US20200238088A1 - Cochlear implants and magnets for use with same - Google Patents

Cochlear implants and magnets for use with same Download PDF

Info

Publication number
US20200238088A1
US20200238088A1 US16/852,457 US202016852457A US2020238088A1 US 20200238088 A1 US20200238088 A1 US 20200238088A1 US 202016852457 A US202016852457 A US 202016852457A US 2020238088 A1 US2020238088 A1 US 2020238088A1
Authority
US
United States
Prior art keywords
magnet
cochlear implant
housing
implant
antenna
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US16/852,457
Inventor
James George Elcoate Smith
Sung Jin Lee
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Advanced Bionics AG
Original Assignee
Advanced Bionics AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Bionics AG filed Critical Advanced Bionics AG
Priority to US16/852,457 priority Critical patent/US20200238088A1/en
Publication of US20200238088A1 publication Critical patent/US20200238088A1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0541Cochlear electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/08Arrangements or circuits for monitoring, protecting, controlling or indicating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/08Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A61N1/086Magnetic resonance imaging [MRI] compatible leads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
    • A61N1/36038Cochlear stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37217Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source

Definitions

  • the present disclosure relates generally to the implantable portion of implantable cochlear stimulation (or “ICS”) systems.
  • ICS implantable cochlear stimulation
  • ICS systems are used to help the profoundly deaf perceive a sensation of sound by directly exciting the intact auditory nerve with controlled impulses of electrical current.
  • Ambient sound pressure waves are picked up by an externally worn microphone and converted to electrical signals.
  • the electrical signals are processed by a sound processor, converted to a pulse sequence having varying pulse widths, rates and/or amplitudes, and transmitted to an implanted receiver circuit of the ICS system.
  • the implanted receiver circuit is connected to an implantable electrode array that has been inserted into the cochlea of the inner ear, and electrical stimulation current is applied to varying electrode combinations to create a perception of sound.
  • the electrode array may, alternatively, be directly inserted into the cochlear nerve without residing in the cochlea.
  • ICS sound processors include, but are not limited to, the HarmonyTM BTE sound processor, the NaidaTM CI Q Series sound processor and the NeptuneTM body worn sound processor, which are available from Advanced Bionics.
  • some ICS systems include an implantable cochlear stimulator (or “cochlear implant”), a sound processor unit (e.g., a body worn processor or behind-the-ear processor), and a microphone that is part of, or is in communication with, the sound processor unit.
  • the cochlear implant communicates with the sound processor unit and, some ICS systems include a headpiece that is in communication with both the sound processor unit and the cochlear implant.
  • the headpiece communicates with the cochlear implant by way of a transmitter (e.g., an antenna) on the headpiece and a receiver (e.g., an antenna) on the implant. Optimum communication is achieved when the transmitter and the receiver are aligned with one another.
  • the headpiece and the cochlear implant may include respective positioning magnets that are attracted to one another, and that maintain the position of the headpiece transmitter over the implant receiver.
  • the implant magnet may, for example, be located within a pocket in the cochlear implant housing.
  • the cochlear implant 10 includes a flexible housing 12 formed from a silicone elastomer or other suitable material, a processor assembly 14 , a cochlear lead 16 with a flexible body 18 and an electrode array 20 , and an antenna 22 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit.
  • a cylindrical positioning magnet 24 with north and south magnetic dipoles that are aligned in the axial direction of the disk, is located within the housing 12 . The magnet 24 is used to maintain the position of a headpiece transmitter over the antenna 22 .
  • the magnet 24 is also relatively thin in conventional cochlear implants in order to provide a relatively thin implant.
  • the positioning magnet 24 is carried within an internal magnet pocket 26 and can be inserted into, and removed from, the housing pocket by way of a magnet aperture 28 that extends through the housing top wall 30 .
  • the positioning magnet 24 has a diameter of 10.5 mm and a thickness of 2.2 mm.
  • the magnet 22 is larger than the magnet aperture 28 , i.e., the outer perimeter of the magnet is greater than the perimeter of the magnet aperture.
  • the portion of the top wall 30 between the aperture 28 and the outer edge 32 of the magnet 24 forms a retainer 34 that, absent deformation of the aperture and retainer, prevents the magnet from coming out of the housing 12 .
  • the aperture 28 and retainer 34 are stretched or otherwise deformed so that the magnet 24 can pass through the aperture 28 .
  • magnet rotation may be avoided by surgically removing the magnet prior to the MRI procedure.
  • the presence of the magnet aperture 28 can lead to the formation of biofilm and can allow ingress of bacteria and microbes. Accordingly, the present inventors have determined that a solution which allows an MRI procedure to be performed without magnet removal/replacement surgery, thereby eliminating the need for the magnet aperture, would be desirable.
  • a cochlear implant in accordance with one of the present inventions includes a cochlear lead, a housing, a magnet apparatus, located within the flexible housing, including a first partial disk shaped magnet member and a second partial disk shaped magnet member spaced apart from the first partial disk shaped magnet member, an antenna within the housing, and a stimulation processor.
  • the present inventions also include systems with such a cochlear implant in combination with a headpiece, as well as systems with such a cochlear implant in combination with both a headpiece and a sound processor.
  • a cochlear implant in accordance with one of the present inventions includes a cochlear lead including a plurality of electrodes, a flexible housing including a magnet pocket, a top wall above the magnet pocket that does not include an opening into the magnet pocket, and a bottom wall below the magnet pocket that does not include an opening into the magnet pocket, a magnetic element, located within the magnet pocket, that defines a diameter, a thickness and the diameter to thickness ratio (“DtoT ratio”) that is 2.5 or less, an antenna within the housing, and a stimulation processor.
  • the present inventions also include systems with such a cochlear implant in combination with a headpiece, as well as systems with such a cochlear implant in combination with both a headpiece and a sound processor.
  • FIG. 2 is a section view taken along line 2 - 2 in FIG. 1 .
  • FIG. 3 is a section view showing the conventional cochlear implant as an MRI magnetic field is being applied.
  • FIG. 7 is a portion of FIG. 6 with the magnet apparatus removed.
  • FIG. 8 is a perspective view of a portion of the cochlear implant illustrated in FIG. 5 .
  • FIG. 9 is a section view taken along line 9 - 9 in FIG. 8 .
  • FIG. 11 is a section view showing the result of the application of the MRI magnetic field to the cochlear implant illustrated in FIG. 10 .
  • FIG. 12 is a section view of a cochlear implant in accordance with one embodiment of a present invention.
  • FIG. 14 is a section view taken along line 14 - 14 in FIG. 13 .
  • FIG. 15 is a partial section view of a cochlear implant in accordance with one embodiment of a present invention.
  • FIG. 17 is a perspective view of a portion of the cochlear implant illustrated in FIG. 15 .
  • FIG. 18 is a side view of a portion of the cochlear implant illustrated in FIG. 15 in a partially rotated state.
  • FIG. 19 is a side view of a portion of the cochlear implant illustrated in FIG. 15 in a partially rotated state.
  • FIG. 20 is a section view of a cochlear implant in accordance with one embodiment of a present invention.
  • FIG. 20 is a diagrammatic representation of FIG. 20 .
  • FIG. 24 is a block diagram of a cochlear implant system in accordance with one embodiment of a present invention.
  • the exemplary cochlear implant 100 includes a resilient flexible housing 102 formed from a silicone elastomer or other suitable material (e.g., with a hardness from 50 to 70 Shore A), a processor assembly 104 , a cochlear lead 106 , and an antenna 108 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit.
  • a resilient flexible housing 102 formed from a silicone elastomer or other suitable material (e.g., with a hardness from 50 to 70 Shore A)
  • a processor assembly 104 e.g., with a hardness from 50 to 70 Shore A
  • a cochlear lead 106 e.g., with a hardness from 50 to 70 Shore A
  • an antenna 108 e.g., with a hardness from 50 to 70 Shore A
  • the exemplary magnet apparatus 124 includes first and second magnet portions 126 a and 126 b which have complementary shapes that together define the overall shape of the magnet apparatus.
  • the magnet apparatus 124 has an overall frustoconical shape with a circular (or substantially circular) bottom and a circular (or substantially circular) top.
  • the first and second magnet portions 126 a and 126 b each have a partial disk shape and, to that end, have respective partial disk shaped top surfaces 128 a and 128 b , partial disk shaped bottom surfaces 130 a and 130 b , outer side surfaces 132 a and 132 b , and inner side surfaces 134 a and 134 b that face one another.
  • a “partial disk shaped” includes an arcuate edge of about 180 degrees (i.e., 180 degree ⁇ 5%) and a non-arcuate edge that extends from one end of the arcuate edge to the other.
  • the first magnet portion 126 a has parallelogram shape (with rounded corners) and the second magnet portion 126 b has a trapezoid shape (with rounded corners).
  • the first and second magnet portions 126 a and 126 b also have the same N-S orientation.
  • the magnet pockets 136 a and 136 b are surrounded by, and defined by, a bottom wall 138 that is located under the magnet pockets (in the illustrated orientation), a top wall 140 that is located above the magnet pockets (in the illustrated orientation), a side wall 142 that is lateral of, and extends around, the magnet pockets and a divider wall 144 that is located between the magnet pockets as well as between the magnet portions 126 a and 126 b .
  • the silicone elastomer (or other suitable resilient material) is stiff enough to maintain the magnet portions 126 a and 126 b in the illustrated orientation, in the absence of a strong external magnet filed, despite the N-N and S-S polar alignment of the magnet portions.
  • the resilient material will, however, allow the magnet portions 126 a and 126 b to rotate in the manner described below with reference to FIGS. 10 and 11 when exposed to a MRI magnetic field.
  • a lubricious coating may be applied to the exterior of the magnet portions 126 a and 126 b to reduce the friction between magnet portions and the housing 102 , thereby reducing torque.
  • Suitable lubricious coatings include hydrophilic hydrogel and diamond-like carbon, both of which would significantly reduce friction and are biocompatible.
  • Such housing materials may, in some instances, be non-magnetic or paramagnetic.
  • Suitable materials include, but are not limited to, titanium or titanium alloys, polyether ether ketone (PEEK), low-density polyethylene (LDPE), high-density polyethylene (HDPE) and polyamide.
  • exemplary metals include commercially pure titanium (e.g., Grade 2) and the titanium alloy Ti-6Al-4V (Grade 5).
  • the top diameter may be about 10.6 to 12.6 mm
  • the bottom diameter may be about 12.3 to 14.3 mm
  • the thickness T ( FIG. 9 ) may be about 2.2 to 3.0 mm.
  • Reorientation of the magnet portions 126 a and 126 b of the exemplary magnet apparatus 124 causes significantly less stress on the dermis and, accordingly, less pain than conventional implant magnets. Such rotation may be imparted by an MRI magnetic field.
  • the distance D 1 between the skull bone below the cochlear implant and the skin above the implant is relatively small. This distance is approximately the same as distance D 1 PA ( FIG. 3 ) of the conventional cochlear implant.
  • the distance between the bone and skin increases only slightly by difference ⁇ D to distance D 2 when the implant magnet portions 126 a and 126 b rotate separately about their own axis of rotation AR ( FIG. 9 ) to the orientation illustrated in FIG.
  • FIG. 11 which shows the exemplary cochlear implant in a distended state.
  • Such rotation also causes the portions of the housing 102 that define the magnet pockets 136 a and 136 b (as well as the pockets themselves) to stretch and distort.
  • the resilience of the housing material will typically drive the implant magnet portions 126 a and 126 b to their flat-state orientations when the MRI magnetic field is removed. In some instances, however, the clinician may need to press on the skin over the magnet apparatus to drive the magnet portions back to their flat-state orientations.
  • the distances ⁇ D and D 2 ( FIG. 11 ) associated with the implant magnet portions 126 a and 126 b are considerably less than the distances ⁇ D PA and D 2 PA ( FIG. 4 ) of the conventional cochlear implant magnet 24 .
  • This difference stems from the fact that the width W of the magnet portions 126 a and 126 b is far smaller than the diameter of the convention disk-shaped magnet 24 .
  • the magnet portions In a cross-section perpendicular to the inner side surfaces 234 , the magnet portions have a rectangular shape (with rounded corners).
  • the magnet portions 226 a and 226 b also each include a magnetic element 246 and a thin hermetically sealed housing 248 formed from the materials described above. When exposed to an MRI magnetic field, the magnet apparatus 224 will behave in the manner described above with reference to FIGS. 10 and 11 .
  • the exemplary cochlear implant 300 is similar to cochlear implant 200 and similar elements are represented by similar reference numerals.
  • the magnet apparatus 324 includes two partial disk shaped magnet portions 226 a and 226 b that are tethered to one another in a manner that allows magnet portions 226 a and 226 b to rotate, but limits the rotation to a predetermined amount.
  • the housing 302 includes a single magnet pocket 336 to accommodate tethered arrangement.
  • the magnet portions 226 a and 226 b are tethered to one another with a flexible strap 350 .
  • the flexible strap 350 includes end portions 352 a and 352 b , which are respectively secured to the magnet portions 226 a and 226 b , and an intermediate portion 354 that is not secured to either magnet portion.
  • the end portions 352 a and 352 b may be secured to the bottom surfaces 230 of the magnet portions 226 a and 226 b with an adhesive or other suitable instrumentality.
  • the end portions 352 a and 352 b are not secured to any other surfaces.
  • the end portions 352 a and 352 b may be secured to more than one surface of one or both of the magnet portions 226 a and 226 b and/or may be secured to different surfaces (or sets of surfaces) on the magnet portions 226 a and 226 b .
  • Suitable materials for the flexible strap 250 include, but are not limited to, a nylon cloth strap or Kapton® (polyimide film) tape, including those with reinforcing fibers (e.g., Kevlar® or polyethylene fibers).
  • the housing 302 may be formed in two steps, with a bottom cap overmolded onto the remainder of the housing (and formed from the same material as the remainder of the housing) after the tethered magnet portions 226 a and 226 b have been inserted into the pocket 336 .
  • the flexible strap 350 in the illustrated implementation allows the magnet portions 226 a and 226 b to rotate up to approximately 135 degrees form the flat-state orientation illustrated in FIGS. 15-17 in response to the presence of an MRI magnetic field.
  • the magnet portions 226 a and 226 b may, for example, rotate to the orientation illustrated in FIG. 18 in some instances. Rotation beyond the orientation illustrated in FIG. 19 is, however, prevented by the strap 250 . As a result, an MRI magnetic field will not cause the N-S orientations of the magnet portions 226 a and 226 b to be completely reversed.
  • the stress on the skin (and associated pain) may also be reduced by employing particular magnet diameter to thickness ratios (“D/T ratios”).
  • the exemplary cochlear implant 400 illustrated in FIG. 20 is similar to cochlear implant 300 and similar elements are represented by similar reference numerals.
  • the magnet apparatus 424 is a unitary structure which does not include a pair of magnet portions.
  • the magnet apparatus 424 has a cylindrical disk shape and includes a circular top surface 428 , a circular bottom surface 430 , and an outer side surface 432 , and is formed from a magnetic element 446 and a thin hermetically sealed housing 448 that covers the outer surface of, and has the same overall shape as, the magnetic element.
  • the magnet apparatus 424 In a cross-section through the diameter, the magnet apparatus 424 has a rectangular shape (with rounded corners).
  • the exemplary magnetic element 446 may have a DtoT ratio of 2.5 or less. To that end, the exemplary magnetic element 446 has a diameter DIA of 7.1 mm, a thickness T of 2.8 mm, and a DtoT ratio of 2.5. In another exemplary embodiment, the magnetic element may have a diameter DIA of 6.5 mm, a thickness T of 3.5 mm, and a DtoT ratio of 1.9. In other embodiments, the DtoT ratio may range from 2.5 to 1.9, with magnetic element diameters of 7.1 or less, and magnet thicknesses of 2.8 or more.
  • the dimensions magnet apparatus also include the thin housing 448 , which adds about 0.2 to 0.3 mm to the diameters and thicknesses discussed above.
  • the conventional magnet 24 illustrated in FIGS. 1-4 which has a diameter of 10.5 mm and a thickness of 2.2 mm, has a DtoT ratio of 4.8.
  • Suitable material for the magnetic element 446 includes N52 grade neodymium, and suitable materials for the housing 448 include the housing materials described above.
  • the exemplary cochlear implant system 50 includes the cochlear implant 100 (or 200 or 300 or 400 ), a sound processor, such as the illustrated body worn sound processor 200 or a behind-the-ear sound processor, and a headpiece 300 .
  • the exemplary body worn sound processor 500 in the exemplary ICS system 50 includes a housing 502 in which and/or on which various components are supported. Such components may include, but are not limited to, sound processor circuitry 504 , a headpiece port 506 , an auxiliary device port 508 for an auxiliary device such as a mobile phone or a music player, a control panel 510 , one or microphones 512 , and a power supply receptacle 514 for a removable battery or other removable power supply 516 (e.g., rechargeable and disposable batteries or other electrochemical cells).
  • the sound processor circuitry 504 converts electrical signals from the microphone 512 into stimulation data.
  • the headpiece 600 transcutaneously transmits the stimulation data, and in many instances power, to the cochlear implant 100 by way of a wireless link between the antennas.
  • the stimulation processor 118 converts the stimulation data into stimulation signals that stimulate the electrodes 114 of the electrode array 112 .
  • the cable 612 will be configured for forward telemetry and power signals at 49 MHz and back telemetry signals at 10.7 MHz. It should be noted that, in other implementations, communication between a sound processor and a headpiece and/or auxiliary device may be accomplished through wireless communication techniques. Additionally, given the presence of the microphone(s) 512 on the sound processor 500 , the microphone 606 may be also be omitted in some instances. The functionality of the sound processor 500 and headpiece 600 may also be combined into a single head wearable sound processor. Examples of head wearable sound processors are illustrated and described in U.S. Pat. Nos. 8,811,643 and 8,983,102, which are incorporated herein by reference in their entirety.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Prostheses (AREA)

Abstract

A cochlear implant including a cochlear lead, a housing, a magnet apparatus located within the flexible housing and including a first partial disk shaped magnet member and a second partial disk shaped magnet member spaced apart from the first partial disk shaped magnet member, an antenna within the housing, and a stimulation processor.

Description

    CROSS-REFERENCE TO RELATED APPLICATIONS
  • This application claims priority to U.S. Prov. App. Ser. No. 62/422,548, filed Nov. 15, 2016, which is incorporated herein by reference.
  • BACKGROUND 1. Field
  • The present disclosure relates generally to the implantable portion of implantable cochlear stimulation (or “ICS”) systems.
  • 2. Description of the Related Art
  • ICS systems are used to help the profoundly deaf perceive a sensation of sound by directly exciting the intact auditory nerve with controlled impulses of electrical current. Ambient sound pressure waves are picked up by an externally worn microphone and converted to electrical signals. The electrical signals, in turn, are processed by a sound processor, converted to a pulse sequence having varying pulse widths, rates and/or amplitudes, and transmitted to an implanted receiver circuit of the ICS system. The implanted receiver circuit is connected to an implantable electrode array that has been inserted into the cochlea of the inner ear, and electrical stimulation current is applied to varying electrode combinations to create a perception of sound. The electrode array may, alternatively, be directly inserted into the cochlear nerve without residing in the cochlea. A representative ICS system is disclosed in U.S. Pat. No. 5,824,022, which is entitled “Cochlear Stimulation System Employing Behind-The-Ear Sound processor With Remote Control” and incorporated herein by reference in its entirety. Examples of commercially available ICS sound processors include, but are not limited to, the Harmony™ BTE sound processor, the Naida™ CI Q Series sound processor and the Neptune™ body worn sound processor, which are available from Advanced Bionics.
  • As alluded to above, some ICS systems include an implantable cochlear stimulator (or “cochlear implant”), a sound processor unit (e.g., a body worn processor or behind-the-ear processor), and a microphone that is part of, or is in communication with, the sound processor unit. The cochlear implant communicates with the sound processor unit and, some ICS systems include a headpiece that is in communication with both the sound processor unit and the cochlear implant. The headpiece communicates with the cochlear implant by way of a transmitter (e.g., an antenna) on the headpiece and a receiver (e.g., an antenna) on the implant. Optimum communication is achieved when the transmitter and the receiver are aligned with one another. To that end, the headpiece and the cochlear implant may include respective positioning magnets that are attracted to one another, and that maintain the position of the headpiece transmitter over the implant receiver. The implant magnet may, for example, be located within a pocket in the cochlear implant housing.
  • One example of a conventional cochlear implant (or “implantable cochlear stimulator”) is the cochlear implant 10 illustrated in FIGS. 1 and 2. The cochlear implant 10 includes a flexible housing 12 formed from a silicone elastomer or other suitable material, a processor assembly 14, a cochlear lead 16 with a flexible body 18 and an electrode array 20, and an antenna 22 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit. A cylindrical positioning magnet 24, with north and south magnetic dipoles that are aligned in the axial direction of the disk, is located within the housing 12. The magnet 24 is used to maintain the position of a headpiece transmitter over the antenna 22. The magnet 24 is also relatively thin in conventional cochlear implants in order to provide a relatively thin implant.
  • There are some instances where it is necessary to remove the magnet from a conventional cochlear implant, and then reinsert the magnet, in situ, i.e., with the cochlear implant accessed by way of an incision in the skin. To that end, the positioning magnet 24 is carried within an internal magnet pocket 26 and can be inserted into, and removed from, the housing pocket by way of a magnet aperture 28 that extends through the housing top wall 30. The positioning magnet 24 has a diameter of 10.5 mm and a thickness of 2.2 mm. The magnet 22 is larger than the magnet aperture 28, i.e., the outer perimeter of the magnet is greater than the perimeter of the magnet aperture. The portion of the top wall 30 between the aperture 28 and the outer edge 32 of the magnet 24 forms a retainer 34 that, absent deformation of the aperture and retainer, prevents the magnet from coming out of the housing 12. During installation and removal, the aperture 28 and retainer 34 are stretched or otherwise deformed so that the magnet 24 can pass through the aperture 28.
  • The present inventors have determined that conventional cochlear implants are susceptible to improvement. For example, removal and replacement of the implant magnet by way of the aperture may be required because some conventional cochlear implants are not compatible with magnetic resonance imaging (“MRI”) systems. As illustrated in FIG. 3, the implant magnet 24 produces a magnetic field M in a direction that is perpendicular to the patient's skin and parallel to the axis A. This magnetic field direction is not aligned with, and may be perpendicular to (as shown), the direction of the MRI magnetic field B. The misalignment of the interacting magnetic fields M and B is problematic for a number of reasons. The dominant MRI magnetic field B (typically 1.5 Tesla or more) may generate a significant amount of torque T on the implant magnet 24. The torque T may be sufficient to deform the retainer 34, dislodge the implant magnet 24 from the pocket 26 and reorient the magnet in the manner illustrated in FIG. 4. In some instances, the implant magnet 24 may rotate 180 degrees, thereby reversing the N-S orientation of the magnet. The present inventors have determined that such reorientation (and reversal) may also occur if there is no aperture in the flexible housing, and the magnet is embedded within a closed pocket, due to the softness of the material (e.g., silicone) used to form the housing.
  • Reorientation of the magnet 24 can place significant stress on the dermis (or “skin”), which cause significant pain. Prior to rotation (FIG. 3), the distance D1 PA between the skull bone below the cochlear implant and the skin above the implant is relatively small, i.e., slightly greater than the thickness of the implant magnet 24. The distance between the bone and skin greatly increases to distance D2 PA when the implant magnet 24 rotates to the orientation illustrated in FIG. 4. In fact, because the diameter of the magnet 24 is far greater than the thickness, the difference ΔDPA is significantly greater than the original distance D1 PA.
  • As alluded to above, magnet rotation may be avoided by surgically removing the magnet prior to the MRI procedure. However, in addition to the issues associated with the removal/replacement surgery, the presence of the magnet aperture 28 can lead to the formation of biofilm and can allow ingress of bacteria and microbes. Accordingly, the present inventors have determined that a solution which allows an MRI procedure to be performed without magnet removal/replacement surgery, thereby eliminating the need for the magnet aperture, would be desirable.
  • SUMMARY
  • A cochlear implant in accordance with one of the present inventions includes a cochlear lead, a housing, a magnet apparatus, located within the flexible housing, including a first partial disk shaped magnet member and a second partial disk shaped magnet member spaced apart from the first partial disk shaped magnet member, an antenna within the housing, and a stimulation processor. The present inventions also include systems with such a cochlear implant in combination with a headpiece, as well as systems with such a cochlear implant in combination with both a headpiece and a sound processor.
  • A cochlear implant in accordance with one of the present inventions includes a cochlear lead including a plurality of electrodes, a flexible housing including a magnet pocket, a top wall above the magnet pocket that does not include an opening into the magnet pocket, and a bottom wall below the magnet pocket that does not include an opening into the magnet pocket, a magnetic element, located within the magnet pocket, that defines a diameter, a thickness and the diameter to thickness ratio (“DtoT ratio”) that is 2.5 or less, an antenna within the housing, and a stimulation processor. The present inventions also include systems with such a cochlear implant in combination with a headpiece, as well as systems with such a cochlear implant in combination with both a headpiece and a sound processor.
  • There are a number of advantages associated with such apparatus and systems. For example, when torque applied to the magnet apparatus by a strong magnetic field rotates the magnet apparatus, the increase in distance between the bone and skin (as well as the associated stress on the dermis and pain) will be far less than that associated with a conventional cochlear implant. As a result, surgical removal of the cochlear implant magnet prior to an MRI procedure, and then surgical replacement thereafter, is not required and the magnet aperture may be omitted.
  • The above described and many other features of the present inventions will become apparent as the inventions become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • Detailed descriptions of the exemplary embodiments will be made with reference to the accompanying drawings.
  • FIG. 1 is a plan view of a conventional cochlear implant.
  • FIG. 2 is a section view taken along line 2-2 in FIG. 1.
  • FIG. 3 is a section view showing the conventional cochlear implant as an MRI magnetic field is being applied.
  • FIG. 4 is a section view showing the result of the application of the MRI magnetic field to the conventional cochlear implant.
  • FIG. 5 is a plan view of a cochlear implant in accordance with one embodiment of a present invention.
  • FIG. 6 is a section view taken along line 6-6 in FIG. 5.
  • FIG. 7 is a portion of FIG. 6 with the magnet apparatus removed.
  • FIG. 8 is a perspective view of a portion of the cochlear implant illustrated in FIG. 5.
  • FIG. 9 is a section view taken along line 9-9 in FIG. 8.
  • FIG. 10 is a section view of the cochlear implant illustrated in FIG. 5 prior to the application of a MRI magnetic field.
  • FIG. 11 is a section view showing the result of the application of the MRI magnetic field to the cochlear implant illustrated in FIG. 10.
  • FIG. 12 is a section view of a cochlear implant in accordance with one embodiment of a present invention.
  • FIG. 13 is a perspective view of a portion of the cochlear implant illustrated in FIG. 12.
  • FIG. 14 is a section view taken along line 14-14 in FIG. 13.
  • FIG. 15 is a partial section view of a cochlear implant in accordance with one embodiment of a present invention.
  • FIG. 16 is a side view of a portion of the cochlear implant illustrated in FIG. 15.
  • FIG. 17 is a perspective view of a portion of the cochlear implant illustrated in FIG. 15.
  • FIG. 18 is a side view of a portion of the cochlear implant illustrated in FIG. 15 in a partially rotated state.
  • FIG. 19 is a side view of a portion of the cochlear implant illustrated in FIG. 15 in a partially rotated state.
  • FIG. 20 is a section view of a cochlear implant in accordance with one embodiment of a present invention.
  • FIG. 21 is a side view of a portion of the cochlear implant illustrated in FIG. 20.
  • FIG. 22 is a plan view of a portion of the cochlear implant illustrated in
  • FIG. 20.
  • FIG. 23 is a section view showing the result of an application of a MRI magnetic field to the cochlear implant illustrated in FIG. 20.
  • FIG. 24 is a block diagram of a cochlear implant system in accordance with one embodiment of a present invention.
  • DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
  • The following is a detailed description of the best presently known modes of carrying out the inventions. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the inventions.
  • One example of a cochlear implant (or “implantable cochlear stimulator”) in accordance with the present inventions is the cochlear implant 100 illustrated in FIGS. 5-9. Referring first to FIG. 5, the exemplary cochlear implant 100 includes a resilient flexible housing 102 formed from a silicone elastomer or other suitable material (e.g., with a hardness from 50 to 70 Shore A), a processor assembly 104, a cochlear lead 106, and an antenna 108 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit. The cochlear lead 106 may include a flexible body 110, an electrode array 112 at one end of the flexible body 102, and a plurality of wires (not shown) that extend through the flexible body from the electrodes 114 (e.g., platinum electrodes) in the array 112 to the other end of the flexible body. The exemplary antenna 108 is a coil antenna with one or more loops (or “turns”), and three loops are shown in the illustrated embodiment. The exemplary processor assembly 104, which is connected to the electrode array 112 and antenna 108, includes a printed circuit board 116 with a stimulation processor 118 that is located within a hermetically sealed case 120. The stimulation processor 118 converts stimulation data into stimulation signals that stimulate the electrodes 114 of the electrode array 112. The hermetically sealed case 120 is located within a processor portion 122 of the housing 102. A positioning magnet apparatus 124 is located within an antenna portion 125 of the housing 102. The magnet apparatus 124, which is used to maintain the position of a headpiece transmitter over the antenna 108, is centered relative to the antenna 108.
  • Turning to FIGS. 6-9, the exemplary magnet apparatus 124 includes first and second magnet portions 126 a and 126 b which have complementary shapes that together define the overall shape of the magnet apparatus. In the illustrated implementation, the magnet apparatus 124 has an overall frustoconical shape with a circular (or substantially circular) bottom and a circular (or substantially circular) top. The first and second magnet portions 126 a and 126 b each have a partial disk shape and, to that end, have respective partial disk shaped top surfaces 128 a and 128 b, partial disk shaped bottom surfaces 130 a and 130 b, outer side surfaces 132 a and 132 b, and inner side surfaces 134 a and 134 b that face one another. As used herein, a “partial disk shaped” includes an arcuate edge of about 180 degrees (i.e., 180 degree±5%) and a non-arcuate edge that extends from one end of the arcuate edge to the other. In a cross-section extending through the inner side surface 134 a and 134 b, the first magnet portion 126 a has parallelogram shape (with rounded corners) and the second magnet portion 126 b has a trapezoid shape (with rounded corners). The first and second magnet portions 126 a and 126 b also have the same N-S orientation.
  • The exemplary first and second magnet portions 126 a and 126 b are respectively located within magnet pockets 136 a and 136 b in the housing antenna portion 125 which, in their unstressed states, have sizes and shapes corresponding to those of the first and second magnet portions. In the illustrated implementation, the magnet portions 126 a and 126 b are embedded within the housing 102 such that, when the cochlear implant 100 is in its flat state (FIG. 6) without any rotation of the magnet portions 126 a and 126 b, the magnet portions are in contact with the resilient material that forms the housing and there are no gaps between the magnet portions and the inner surfaces of the magnet pockets. In particular, the magnet pockets 136 a and 136 b are surrounded by, and defined by, a bottom wall 138 that is located under the magnet pockets (in the illustrated orientation), a top wall 140 that is located above the magnet pockets (in the illustrated orientation), a side wall 142 that is lateral of, and extends around, the magnet pockets and a divider wall 144 that is located between the magnet pockets as well as between the magnet portions 126 a and 126 b. There are no openings in the bottom wall 138 or the top wall 140 for removal of the magnet apparatus 124. It should also be noted that the silicone elastomer (or other suitable resilient material) is stiff enough to maintain the magnet portions 126 a and 126 b in the illustrated orientation, in the absence of a strong external magnet filed, despite the N-N and S-S polar alignment of the magnet portions. The resilient material will, however, allow the magnet portions 126 a and 126 b to rotate in the manner described below with reference to FIGS. 10 and 11 when exposed to a MRI magnetic field. In some instances, a lubricious coating may be applied to the exterior of the magnet portions 126 a and 126 b to reduce the friction between magnet portions and the housing 102, thereby reducing torque. Suitable lubricious coatings include hydrophilic hydrogel and diamond-like carbon, both of which would significantly reduce friction and are biocompatible.
  • Although the present inventions are not so limited, the magnet portions 126 a and 126 b of the exemplary magnet apparatus 124 include respective magnetic elements 146 a and 146 b (FIG. 6) formed from a ferromagnetic material (e.g., N35 grade neodymium) and thin hermetically sealed housings 148 a and 148 b formed from, for example, biocompatible metals and/or plastics.
  • Such housing materials may, in some instances, be non-magnetic or paramagnetic. Suitable materials include, but are not limited to, titanium or titanium alloys, polyether ether ketone (PEEK), low-density polyethylene (LDPE), high-density polyethylene (HDPE) and polyamide. In particular, exemplary metals include commercially pure titanium (e.g., Grade 2) and the titanium alloy Ti-6Al-4V (Grade 5). With respect to the overall size of the magnet apparatus 124, the top diameter may be about 10.6 to 12.6 mm, the bottom diameter may be about 12.3 to 14.3 mm, and the thickness T (FIG. 9) may be about 2.2 to 3.0 mm. So configured, the width of the magnet portions 126 a and 126 b, i.e. the dimension perpendicular to the thickness T and to the axis of rotation AR, may be about 5.9 to 6.2 mm. The divider wall 144 adds about 1.0 mm to the diameters in the direction perpendicular to the wall.
  • Reorientation of the magnet portions 126 a and 126 b of the exemplary magnet apparatus 124 causes significantly less stress on the dermis and, accordingly, less pain than conventional implant magnets. Such rotation may be imparted by an MRI magnetic field. Prior to rotation when the cochlear implant is in the flat state (FIG. 10), the distance D1 between the skull bone below the cochlear implant and the skin above the implant is relatively small. This distance is approximately the same as distance D1 PA (FIG. 3) of the conventional cochlear implant. The distance between the bone and skin increases only slightly by difference ΔD to distance D2 when the implant magnet portions 126 a and 126 b rotate separately about their own axis of rotation AR (FIG. 9) to the orientation illustrated in FIG. 11, which shows the exemplary cochlear implant in a distended state. Such rotation also causes the portions of the housing 102 that define the magnet pockets 136 a and 136 b (as well as the pockets themselves) to stretch and distort. The resilience of the housing material will typically drive the implant magnet portions 126 a and 126 b to their flat-state orientations when the MRI magnetic field is removed. In some instances, however, the clinician may need to press on the skin over the magnet apparatus to drive the magnet portions back to their flat-state orientations.
  • It should be noted here that for a given rotational magnitude (e.g., about 75 degrees in FIGS. 4 and 11), the distances ΔD and D2 (FIG. 11) associated with the implant magnet portions 126 a and 126 b are considerably less than the distances ΔDPA and D2 PA (FIG. 4) of the conventional cochlear implant magnet 24. This difference stems from the fact that the width W of the magnet portions 126 a and 126 b is far smaller than the diameter of the convention disk-shaped magnet 24.
  • The present magnet assembles (and associated magnet portions) are not limited to the configuration illustrated in FIGS. 5-11. To that end, the exemplary cochlear implant 200 illustrated in FIGS. 12-14 is identical to the implant 100 but for the magnet apparatus 224 and slightly differently shaped pockets 236 a and 236 b in housing 202. The magnet apparatus 224 has an overall cylindrical disk shape (as opposed to a frustoconical disk shape) defined by partial disk shaped magnet portions 226 a and 226 b. The magnet portions 226 a and 226 b are identical to one another and each include a partial disk shaped top surface 228, a partial disk shaped bottom surface 230, an outer side surface 232, and an inner side surface 234. In a cross-section perpendicular to the inner side surfaces 234, the magnet portions have a rectangular shape (with rounded corners). The magnet portions 226 a and 226 b also each include a magnetic element 246 and a thin hermetically sealed housing 248 formed from the materials described above. When exposed to an MRI magnetic field, the magnet apparatus 224 will behave in the manner described above with reference to FIGS. 10 and 11.
  • Turning to FIGS. 15-17, the exemplary cochlear implant 300 is similar to cochlear implant 200 and similar elements are represented by similar reference numerals. Here, however, the magnet apparatus 324 includes two partial disk shaped magnet portions 226 a and 226 b that are tethered to one another in a manner that allows magnet portions 226 a and 226 b to rotate, but limits the rotation to a predetermined amount. The housing 302 includes a single magnet pocket 336 to accommodate tethered arrangement. In the illustrated implementation, the magnet portions 226 a and 226 b are tethered to one another with a flexible strap 350. The flexible strap 350 includes end portions 352 a and 352 b, which are respectively secured to the magnet portions 226 a and 226 b, and an intermediate portion 354 that is not secured to either magnet portion. For example, the end portions 352 a and 352 b may be secured to the bottom surfaces 230 of the magnet portions 226 a and 226 b with an adhesive or other suitable instrumentality. The end portions 352 a and 352 b are not secured to any other surfaces. In other implementations, the end portions 352 a and 352 b may be secured to more than one surface of one or both of the magnet portions 226 a and 226 b and/or may be secured to different surfaces (or sets of surfaces) on the magnet portions 226 a and 226 b. Suitable materials for the flexible strap 250 include, but are not limited to, a nylon cloth strap or Kapton® (polyimide film) tape, including those with reinforcing fibers (e.g., Kevlar® or polyethylene fibers). It should also be noted here that the housing 302 may be formed in two steps, with a bottom cap overmolded onto the remainder of the housing (and formed from the same material as the remainder of the housing) after the tethered magnet portions 226 a and 226 b have been inserted into the pocket 336.
  • Although the amount of allowed rotation may vary from one implementation to another, the flexible strap 350 in the illustrated implementation allows the magnet portions 226 a and 226 b to rotate up to approximately 135 degrees form the flat-state orientation illustrated in FIGS. 15-17 in response to the presence of an MRI magnetic field. The magnet portions 226 a and 226 b may, for example, rotate to the orientation illustrated in FIG. 18 in some instances. Rotation beyond the orientation illustrated in FIG. 19 is, however, prevented by the strap 250. As a result, an MRI magnetic field will not cause the N-S orientations of the magnet portions 226 a and 226 b to be completely reversed.
  • Referring to FIGS. 20-23, the stress on the skin (and associated pain) may also be reduced by employing particular magnet diameter to thickness ratios (“D/T ratios”). To that end, the exemplary cochlear implant 400 illustrated in FIG. 20 is similar to cochlear implant 300 and similar elements are represented by similar reference numerals. Here, however, the magnet apparatus 424 is a unitary structure which does not include a pair of magnet portions. The magnet apparatus 424 has a cylindrical disk shape and includes a circular top surface 428, a circular bottom surface 430, and an outer side surface 432, and is formed from a magnetic element 446 and a thin hermetically sealed housing 448 that covers the outer surface of, and has the same overall shape as, the magnetic element. In a cross-section through the diameter, the magnet apparatus 424 has a rectangular shape (with rounded corners).
  • The exemplary magnetic element 446 may have a DtoT ratio of 2.5 or less. To that end, the exemplary magnetic element 446 has a diameter DIA of 7.1 mm, a thickness T of 2.8 mm, and a DtoT ratio of 2.5. In another exemplary embodiment, the magnetic element may have a diameter DIA of 6.5 mm, a thickness T of 3.5 mm, and a DtoT ratio of 1.9. In other embodiments, the DtoT ratio may range from 2.5 to 1.9, with magnetic element diameters of 7.1 or less, and magnet thicknesses of 2.8 or more. The dimensions magnet apparatus also include the thin housing 448, which adds about 0.2 to 0.3 mm to the diameters and thicknesses discussed above. For purposes of comparison, the conventional magnet 24 illustrated in FIGS. 1-4, which has a diameter of 10.5 mm and a thickness of 2.2 mm, has a DtoT ratio of 4.8. Suitable material for the magnetic element 446 includes N52 grade neodymium, and suitable materials for the housing 448 include the housing materials described above.
  • Referring to FIG. 23, the magnet apparatus 424 will rotate in a manner similar to the conventional magnet 24 when exposed to an MRI magnetic field. However, the distances ΔD and D3 associated with the magnet apparatus 424 are considerably less than the distances ΔDPA and D2 PA of the conventional cochlear implant. This difference stems from the fact that the diameter of the magnet apparatus 424 is smaller than the diameter of the convention disk-shaped magnet 24. As a result, reorientation of the magnet apparatus 424 causes significantly less stress on the dermis and, accordingly, less pain than the conventional implant magnet 24.
  • As illustrated in FIG. 24, the exemplary cochlear implant system 50 includes the cochlear implant 100 (or 200 or 300 or 400), a sound processor, such as the illustrated body worn sound processor 200 or a behind-the-ear sound processor, and a headpiece 300.
  • The exemplary body worn sound processor 500 in the exemplary ICS system 50 includes a housing 502 in which and/or on which various components are supported. Such components may include, but are not limited to, sound processor circuitry 504, a headpiece port 506, an auxiliary device port 508 for an auxiliary device such as a mobile phone or a music player, a control panel 510, one or microphones 512, and a power supply receptacle 514 for a removable battery or other removable power supply 516 (e.g., rechargeable and disposable batteries or other electrochemical cells). The sound processor circuitry 504 converts electrical signals from the microphone 512 into stimulation data. The exemplary headpiece 600 includes a housing 602 and various components, e.g., a RF connector 604, a microphone 606, an antenna (or other transmitter) 608 and a positioning magnet apparatus 610, that are carried by the housing. The magnet apparatus 610 may consist of a single magnet or may consist of one or more magnets and a shim. The headpiece 600 may be connected to the sound processor headpiece port 506 by a cable 612. The positioning magnet apparatus 610 is attracted to the magnet apparatus 124 of the cochlear stimulator 100, thereby aligning the antenna 608 with the antenna 108. The stimulation data and, in many instances power, is supplied to the headpiece 600. The headpiece 600 transcutaneously transmits the stimulation data, and in many instances power, to the cochlear implant 100 by way of a wireless link between the antennas. The stimulation processor 118 converts the stimulation data into stimulation signals that stimulate the electrodes 114 of the electrode array 112.
  • In at least some implementations, the cable 612 will be configured for forward telemetry and power signals at 49 MHz and back telemetry signals at 10.7 MHz. It should be noted that, in other implementations, communication between a sound processor and a headpiece and/or auxiliary device may be accomplished through wireless communication techniques. Additionally, given the presence of the microphone(s) 512 on the sound processor 500, the microphone 606 may be also be omitted in some instances. The functionality of the sound processor 500 and headpiece 600 may also be combined into a single head wearable sound processor. Examples of head wearable sound processors are illustrated and described in U.S. Pat. Nos. 8,811,643 and 8,983,102, which are incorporated herein by reference in their entirety.
  • Although the inventions disclosed herein have been described in terms of the preferred embodiments above, numerous modifications and/or additions to the above-described preferred embodiments would be readily apparent to one skilled in the art. By way of example, but not limitation, the inventions include any combination of the elements from the various species and embodiments disclosed in the specification that are not already described. It is intended that the scope of the present inventions extend to all such modifications and/or additions and that the scope of the present inventions is limited solely by the claims set forth below.

Claims (10)

1-10. (canceled)
11. A cochlear implant, comprising:
a cochlear lead including a plurality of electrodes;
a flexible housing including a magnet pocket, a top wall above the magnet pocket that does not include an opening into the magnet pocket, and a bottom wall below the magnet pocket that does not include an opening into the magnet pocket;
a magnet apparatus, located within the magnet pocket, including a magnetic element, which defines an outer surface, a diameter, a thickness and the diameter to thickness ratio (“DtoT ratio”) that is 2.5 or less, and a hermetically sealed housing that covers the outer surface of the magnetic element;
an antenna within the housing and adjacent to the magnet pocket; and
a stimulation processor operably connected to the antenna and to the cochlear lead.
12. A cochlear implant as claimed in claim 11, wherein
the magnet apparatus defines a cylindrical shape.
13. A cochlear implant as claimed in claim 11, wherein
the hermetically sealed housing is 0.2 to 0.3 mm thick.
14. A cochlear implant as claimed in claim 11, wherein
the diameter of the magnetic element is 7.1 mm or less; and
the thickness of the magnetic element is 2.8 mm or more.
15. A cochlear implant as claimed in claim 11, wherein
the antenna and the magnet apparatus are embedded in the flexible housing.
16. A cochlear implant as claimed in claim 11, wherein
the respective configurations of the flexible housing and the magnet apparatus are such that the magnet apparatus will rotate and distort the flexible housing in response to the presence of a magnetic field of at least 1.5 T.
17. A cochlear implant as claimed in claim 11, wherein
the DtoT ratio ranges from 2.5 to 1.9.
18. A system, comprising
a cochlear implant as claimed in claim 11; and
a headpiece including
an antenna, and
a headpiece magnet associated with the antenna that is attracted to the implant magnet.
19. A system, comprising
a cochlear implant as claimed in claim 11;
a sound processor; and
a headpiece, operably connected to the sound processor, including
an antenna, and
a headpiece magnet associated with the antenna that is attracted to the implant magnet.
US16/852,457 2016-11-15 2020-04-18 Cochlear implants and magnets for use with same Abandoned US20200238088A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US16/852,457 US20200238088A1 (en) 2016-11-15 2020-04-18 Cochlear implants and magnets for use with same

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662422548P 2016-11-15 2016-11-15
US15/805,025 US10646718B2 (en) 2016-11-15 2017-11-06 Cochlear implants and magnets for use with same
US16/852,457 US20200238088A1 (en) 2016-11-15 2020-04-18 Cochlear implants and magnets for use with same

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US15/805,025 Division US10646718B2 (en) 2016-11-15 2017-11-06 Cochlear implants and magnets for use with same

Publications (1)

Publication Number Publication Date
US20200238088A1 true US20200238088A1 (en) 2020-07-30

Family

ID=62106487

Family Applications (2)

Application Number Title Priority Date Filing Date
US15/805,025 Active 2038-06-21 US10646718B2 (en) 2016-11-15 2017-11-06 Cochlear implants and magnets for use with same
US16/852,457 Abandoned US20200238088A1 (en) 2016-11-15 2020-04-18 Cochlear implants and magnets for use with same

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US15/805,025 Active 2038-06-21 US10646718B2 (en) 2016-11-15 2017-11-06 Cochlear implants and magnets for use with same

Country Status (1)

Country Link
US (2) US10646718B2 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10821279B2 (en) 2015-12-18 2020-11-03 Advanced Bionics Ag Cochlear implants having MRI-compatible magnet apparatus and associated methods
US11097095B2 (en) 2017-04-11 2021-08-24 Advanced Bionics Ag Cochlear implants, magnets for use with same and magnet retrofit methods
US11287495B2 (en) 2017-05-22 2022-03-29 Advanced Bionics Ag Methods and apparatus for use with cochlear implants having magnet apparatus with magnetic material particles
US11364384B2 (en) 2017-04-25 2022-06-21 Advanced Bionics Ag Cochlear implants having impact resistant MRI-compatible magnet apparatus
US11471679B2 (en) 2017-10-26 2022-10-18 Advanced Bionics Ag Headpieces and implantable cochlear stimulation systems including the same
US11638823B2 (en) 2018-02-15 2023-05-02 Advanced Bionics Ag Headpieces and implantable cochlear stimulation systems including the same
KR102652857B1 (en) * 2023-04-21 2024-04-01 주식회사 토닥 Cochlear implant with magnet array using rigid structure

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3302689B1 (en) 2015-05-28 2019-02-27 Advanced Bionics AG Cochlear implants having mri-compatible magnet apparatus
EP3377172B1 (en) 2015-11-20 2021-07-28 Advanced Bionics AG Cochlear implants and magnets for use with same
EP3389766B1 (en) 2015-12-18 2019-11-20 Advanced Bionics AG Cochlear implants having mri-compatible magnet apparatus and associated methods
US10646712B2 (en) 2017-09-13 2020-05-12 Advanced Bionics Ag Cochlear implants having MRI-compatible magnet apparatus
EP3956013B1 (en) * 2019-04-15 2024-06-05 Cochlear Limited Magnet management mri compatibility by shape

Family Cites Families (101)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE32947E (en) 1980-09-30 1989-06-13 Baptist Medical Center Of Oklahoma, Inc. Magnetic transcutaneous mount for external device of an associated implant
US4352960A (en) 1980-09-30 1982-10-05 Baptist Medical Center Of Oklahoma, Inc. Magnetic transcutaneous mount for external device of an associated implant
US4595390A (en) 1983-07-21 1986-06-17 Salomon Hakim Magnetically-adjustable cerebrospinal fluid shunt valve
US4618949A (en) 1984-03-19 1986-10-21 Lister Clive R B Self-orienting directionally sensitive geophone
US4606329A (en) 1985-05-22 1986-08-19 Xomed, Inc. Implantable electromagnetic middle-ear bone-conduction hearing aid device
US5290281A (en) 1992-06-15 1994-03-01 Medicon Eg Surgical system
US5554096A (en) 1993-07-01 1996-09-10 Symphonix Implantable electromagnetic hearing transducer
US5824022A (en) 1996-03-07 1998-10-20 Advanced Bionics Corporation Cochlear stimulation system employing behind-the-ear speech processor with remote control
US5755762A (en) 1996-06-14 1998-05-26 Pacesetter, Inc. Medical lead and method of making and using
US7608035B2 (en) 1996-09-10 2009-10-27 Gradient Technologies, Llc Method and morphologically adaptable apparatus for altering the charge distribution upon living membranes with functional stabilization of the membrane physical electrical integrity
AU8011898A (en) 1997-06-20 1999-01-04 Coloplast A/S A hydrophilic coating and a method for the preparation thereof
US5945762A (en) 1998-02-10 1999-08-31 Light Sciences Limited Partnership Movable magnet transmitter for inducing electrical current in an implanted coil
US6348070B1 (en) 1998-04-17 2002-02-19 Med-El Elektromedizinische Gerate Ges.M.B.H Magnetic-interference-free surgical prostheses
US6178353B1 (en) 1998-07-27 2001-01-23 Advanced Bionics Corporation Laminated magnet keeper for implant device
US6217508B1 (en) 1998-08-14 2001-04-17 Symphonix Devices, Inc. Ultrasonic hearing system
DE60024437T2 (en) 1999-03-17 2006-07-13 Medtronic, Inc., Minneapolis TOOL FOR ADJUSTING AN IMPLANTABLE AND ADJUSTABLE FLOW RATE VALVE
US6292678B1 (en) 1999-05-13 2001-09-18 Stereotaxis, Inc. Method of magnetically navigating medical devices with magnetic fields and gradients, and medical devices adapted therefor
US6227820B1 (en) 1999-10-05 2001-05-08 Robert Jarvik Axial force null position magnetic bearing and rotary blood pumps which use them
US6358281B1 (en) 1999-11-29 2002-03-19 Epic Biosonics Inc. Totally implantable cochlear prosthesis
US6599321B2 (en) 2000-06-13 2003-07-29 Edward R. Hyde, Jr. Magnetic array implant and prosthesis
US7680525B1 (en) 2001-11-26 2010-03-16 Fonar Corporation Method for lateral motion magnetic resonance imaging
US7881800B2 (en) 2002-03-08 2011-02-01 Cochlear Limited Cochlear implant having a repositionable implantable housing
US9295425B2 (en) 2002-04-01 2016-03-29 Med-El Elektromedizinische Geraete Gmbh Transducer for stapedius monitoring
AU2003233025B2 (en) 2002-04-01 2008-04-10 Med-El Elektromedizinische Geraete Gmbh Reducing effect of magnetic and electromagnetic fields on an implants magnet and/or electronic
US8013699B2 (en) 2002-04-01 2011-09-06 Med-El Elektromedizinische Geraete Gmbh MRI-safe electro-magnetic tranducer
US7190247B2 (en) 2002-04-01 2007-03-13 Med-El Elektromedizinische Geraete Gmbh System and method for reducing effect of magnetic fields on a magnetic transducer
AUPS192202A0 (en) 2002-04-23 2002-05-30 Cochlear Limited Mri-compatible cochlear implant
AU2002950754A0 (en) 2002-08-09 2002-09-12 Cochlear Limited Mechanical design for a cochlear implant
AU2002950755A0 (en) 2002-08-09 2002-09-12 Cochlear Limited Fixation system for a cochlear implant
AU2003901696A0 (en) 2003-04-09 2003-05-01 Cochlear Limited Implant magnet system
US8811643B2 (en) 2003-05-08 2014-08-19 Advanced Bionics Integrated cochlear implant headpiece
US8270647B2 (en) 2003-05-08 2012-09-18 Advanced Bionics, Llc Modular speech processor headpiece
AU2003902964A0 (en) 2003-06-13 2003-06-26 Cochlear Limited Adjustment mechanism for a coil magnet
US20080195178A1 (en) 2003-12-30 2008-08-14 Kuzma Janusz A Fixation methods and systems for cochlear implant component or other implantable devices
US8550977B2 (en) 2005-02-16 2013-10-08 Cochlear Limited Integrated implantable hearing device, microphone and power unit
US7774069B2 (en) 2005-04-29 2010-08-10 Medtronic, Inc. Alignment indication for transcutaneous energy transfer
US20070053536A1 (en) 2005-08-24 2007-03-08 Patrik Westerkull Hearing aid system
US20110009925A1 (en) 2006-10-17 2011-01-13 Cochlear Limited Transcutaneous receiving antenna device for implant
US9162054B2 (en) 2007-01-22 2015-10-20 Cochlear Limited Implantable component interface
KR101450932B1 (en) 2007-03-07 2014-10-14 메드-엘 엘렉트로메디지니쉐 게라에테 게엠베하 Implantable device with removable magnet
US7609061B2 (en) 2007-07-13 2009-10-27 Med-El Elektromedizinische Geraete Gmbh Demagnetized implant for magnetic resonance imaging
US8133215B2 (en) 2007-08-13 2012-03-13 Cochlear Limited Independently-manufactured drug delivery module and corresponding receptacle in an implantable medical device
US20130079749A1 (en) 2007-08-29 2013-03-28 Advanced Bionics, Llc Modular Drug Delivery System for Minimizing Trauma During and After Insertion of a Cochlear Lead
WO2009048999A1 (en) 2007-10-12 2009-04-16 Med-El Elektromedizinische Geraete Gmbh Implant magnet insertion and removal tools
US8401213B2 (en) 2008-03-31 2013-03-19 Cochlear Limited Snap-lock coupling system for a prosthetic device
WO2009124045A1 (en) 2008-03-31 2009-10-08 Cochlear Americas Implantable microphone system
KR20110059562A (en) 2008-04-02 2011-06-02 코치리어 리미티드 An adjustable transcutaneous energy transfer system
FR2931076B1 (en) 2008-05-15 2010-06-25 Neurelec IMPLANTABLE SUB-CUTANE DEVICE
KR20110021730A (en) 2008-06-03 2011-03-04 메드-엘 엘렉트로메디지니쉐 게라에테 게엠베하 Conductive coating of implants with inductive link
WO2010000027A1 (en) 2008-07-03 2010-01-07 Cochlear Limited Removable implantable battery positioned inside implant coil
US8280524B2 (en) 2008-08-08 2012-10-02 Med-El Elektromedizinische Geraete Gmbh External button processor with a rechargeable battery
US20110218605A1 (en) 2008-09-10 2011-09-08 Adrian Cryer Upgradeable implantable device
US8321028B1 (en) 2008-12-02 2012-11-27 Advanced Bionics Impact resistant implantable antenna coil assembly
WO2010083554A1 (en) 2009-01-20 2010-07-29 Cochlear Limited Medical device and fixation
DK2456517T3 (en) 2009-07-22 2017-10-23 Med-El Elektromedizinische Geräte GmbH MAGNETIC FIXING DEVICE FOR IMPLEMENTABLE DEVICE
US20120296155A1 (en) 2009-07-22 2012-11-22 Vibrant Med-El Hearing Technology Gmbh Magnetic Attachment Arrangement for Implantable Device
WO2011037845A2 (en) 2009-09-22 2011-03-31 Cedar Ridge Research, Llc. Multilevel correlated magnetic system and method for using same
AU2011223744A1 (en) 2010-03-02 2012-10-18 Vibrant Med-El Hearing Technology Gmbh Hearing system
EP4074373B1 (en) 2010-04-23 2023-09-27 MED-EL Elektromedizinische Geräte GmbH Mri-safe disk magnet for implants
US9491530B2 (en) 2011-01-11 2016-11-08 Advanced Bionics Ag Sound processors having contamination resistant control panels and implantable cochlear stimulation systems including the same
WO2012116130A1 (en) 2011-02-24 2012-08-30 Vibrant Med-El Hearing Technology Gmbh Mri safe actuator for implantable floating mass transducer
US8787608B2 (en) 2011-05-24 2014-07-22 Cochlear Limited Vibration isolation in a bone conduction device
WO2013028390A1 (en) 2011-08-23 2013-02-28 Torax Medical, Inc. Medical implant with floating magnets
EP2758125B1 (en) 2011-09-22 2017-03-01 Advanced Bionics AG Retention of a magnet in a cochlear implant
AU2012328636B2 (en) 2011-10-27 2015-09-24 Med-El Elektromedizinische Geraete Gmbh Fixture and removal of hearing system external coil
US9736601B2 (en) 2012-07-16 2017-08-15 Sophono, Inc. Adjustable magnetic systems, devices, components and methods for bone conduction hearing aids
AU2012358871B2 (en) 2011-12-22 2015-06-18 Med-El Elektromedizinische Geraete Gmbh Magnet arrangement for bone conduction hearing implant
US8891795B2 (en) 2012-01-31 2014-11-18 Cochlear Limited Transcutaneous bone conduction device vibrator having movable magnetic mass
US9393428B2 (en) 2012-03-29 2016-07-19 Advanced Bionics Ag Implantable antenna assemblies
EP2869890B1 (en) 2012-07-03 2017-09-06 Med-El Elektromedizinische Geraete GmbH Mri-safe implant magnet with angular magnetization
US9420388B2 (en) 2012-07-09 2016-08-16 Med-El Elektromedizinische Geraete Gmbh Electromagnetic bone conduction hearing device
WO2014046662A1 (en) 2012-09-20 2014-03-27 Advanced Bionics Ag Implantable body with a lead and with engagement wings
US8790409B2 (en) 2012-12-07 2014-07-29 Cochlear Limited Securable implantable component
US8733494B1 (en) 2013-03-01 2014-05-27 Cochlear Limited Coil retention systems for implantable medical devices
CN105188839B (en) * 2013-03-13 2018-05-22 领先仿生公司 The magnet installation system and method used for cochlear implant
US9126010B2 (en) 2013-03-14 2015-09-08 Medtronic Xomed, Inc. Device and method for finding the center and reading the setting of an implantable medical device
DK2853289T3 (en) 2013-09-26 2019-07-15 Oticon Medical As Device that can be implanted under the skin
DK2853287T3 (en) 2013-09-26 2018-01-15 Oticon Medical As IMPLANTABLE DEVICE WITH REMOVABLE MAGNET
US9339660B2 (en) 2013-10-04 2016-05-17 Boston Scientific Neuromodulation Corporation Implantable medical device with one or more magnetic field sensors to assist with external charger alignment
EP3062874B1 (en) 2013-10-31 2018-02-21 Advanced Bionics AG Headpieces and implantable cochlear stimulation systems including the same
US10118043B2 (en) 2014-03-18 2018-11-06 Cochlear Limited Coil for signal transmission to implantable device
US9931501B2 (en) 2014-06-20 2018-04-03 Cochlear Limited Implantable auditory prosthesis having isolated components
US20150382114A1 (en) 2014-06-25 2015-12-31 Marcus ANDERSSON System for adjusting magnetic retention force in auditory prostheses
US10091594B2 (en) 2014-07-29 2018-10-02 Cochlear Limited Bone conduction magnetic retention system
EP3302689B1 (en) 2015-05-28 2019-02-27 Advanced Bionics AG Cochlear implants having mri-compatible magnet apparatus
US10130807B2 (en) 2015-06-12 2018-11-20 Cochlear Limited Magnet management MRI compatibility
US20160381473A1 (en) 2015-06-26 2016-12-29 Johan Gustafsson Magnetic retention device
WO2016207856A1 (en) 2015-06-26 2016-12-29 Cochlear Limited Magnetic retention device
WO2017027046A1 (en) 2015-08-13 2017-02-16 Advanced Bionics Ag Cochlear implants having a lateral magnet insertion and removal channel
WO2017027045A1 (en) 2015-08-13 2017-02-16 Advanced Bionics Ag Cochlear implants having bone-anchored magnet apparatus and associated methods
US20170050027A1 (en) 2015-08-18 2017-02-23 Marcus ANDERSSON Implantable Magnet Arrangements
WO2017034530A1 (en) 2015-08-21 2017-03-02 Advanced Bionics Ag Cochlear implant with a magnet restraint anchored to restraint anchors and a method for securing a magnet
US9872115B2 (en) 2015-09-14 2018-01-16 Cochlear Limited Retention magnet system for medical device
EP3377172B1 (en) 2015-11-20 2021-07-28 Advanced Bionics AG Cochlear implants and magnets for use with same
US10321247B2 (en) 2015-11-27 2019-06-11 Cochlear Limited External component with inductance and mechanical vibratory functionality
WO2017105511A1 (en) 2015-12-18 2017-06-22 Advanced Bionics Ag Cochlear implants having mri-compatible magnet apparatus
EP3389766B1 (en) 2015-12-18 2019-11-20 Advanced Bionics AG Cochlear implants having mri-compatible magnet apparatus and associated methods
US11426593B2 (en) 2016-03-29 2022-08-30 Med-El Elektromedizinische Geraete Gmbh Cochlear implant with clippable magnet
US11287495B2 (en) 2017-05-22 2022-03-29 Advanced Bionics Ag Methods and apparatus for use with cochlear implants having magnet apparatus with magnetic material particles
US10646712B2 (en) 2017-09-13 2020-05-12 Advanced Bionics Ag Cochlear implants having MRI-compatible magnet apparatus
EP3752245B1 (en) 2018-02-15 2022-04-06 Advanced Bionics AG Headpieces and implantable cochlear stimulation systems including the same

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10821279B2 (en) 2015-12-18 2020-11-03 Advanced Bionics Ag Cochlear implants having MRI-compatible magnet apparatus and associated methods
US11986656B2 (en) 2015-12-18 2024-05-21 Advanced Bionics Ag Cochlear implants having MRI-compatible magnet apparatus and associated methods
US11097095B2 (en) 2017-04-11 2021-08-24 Advanced Bionics Ag Cochlear implants, magnets for use with same and magnet retrofit methods
US11779754B2 (en) 2017-04-11 2023-10-10 Advanced Bionics Ag Cochlear implants, magnets for use with same and magnet retrofit methods
US11364384B2 (en) 2017-04-25 2022-06-21 Advanced Bionics Ag Cochlear implants having impact resistant MRI-compatible magnet apparatus
US11752338B2 (en) 2017-04-25 2023-09-12 Advanced Bionics Ag Cochlear implants having impact resistant MRI-compatible magnet apparatus
US11287495B2 (en) 2017-05-22 2022-03-29 Advanced Bionics Ag Methods and apparatus for use with cochlear implants having magnet apparatus with magnetic material particles
US11471679B2 (en) 2017-10-26 2022-10-18 Advanced Bionics Ag Headpieces and implantable cochlear stimulation systems including the same
US11638823B2 (en) 2018-02-15 2023-05-02 Advanced Bionics Ag Headpieces and implantable cochlear stimulation systems including the same
KR102652857B1 (en) * 2023-04-21 2024-04-01 주식회사 토닥 Cochlear implant with magnet array using rigid structure

Also Published As

Publication number Publication date
US10646718B2 (en) 2020-05-12
US20180133486A1 (en) 2018-05-17

Similar Documents

Publication Publication Date Title
US20200238088A1 (en) Cochlear implants and magnets for use with same
US20210170167A1 (en) Cochlear implants and magnets for use with same
US10532209B2 (en) Cochlear implants having MRI-compatible magnet apparatus and associated methods
US11986656B2 (en) Cochlear implants having MRI-compatible magnet apparatus and associated methods
US11779754B2 (en) Cochlear implants, magnets for use with same and magnet retrofit methods
US10646712B2 (en) Cochlear implants having MRI-compatible magnet apparatus
US11752338B2 (en) Cochlear implants having impact resistant MRI-compatible magnet apparatus
EP3302689B1 (en) Cochlear implants having mri-compatible magnet apparatus
WO2017027045A1 (en) Cochlear implants having bone-anchored magnet apparatus and associated methods
US20210299456A1 (en) Headpieces, implantable cochlear stimulation systems including the same and associated apparatus and methods
WO2017027046A1 (en) Cochlear implants having a lateral magnet insertion and removal channel
WO2017034530A1 (en) Cochlear implant with a magnet restraint anchored to restraint anchors and a method for securing a magnet
US20220331598A1 (en) Multipole magnet for medical implant system
US20230115968A1 (en) Cochlear implants having mri-compatible magnet apparatus and associated systems and methods

Legal Events

Date Code Title Description
STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: FINAL REJECTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE AFTER FINAL ACTION FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: NOTICE OF ALLOWANCE MAILED -- APPLICATION RECEIVED IN OFFICE OF PUBLICATIONS

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO PAY ISSUE FEE