Totally implantable cochlear prosthesis

• US 6,358,281 B1
• Filed: 11/29/1999
• Issued: 03/19/2002
• Est. Priority Date: 11/29/1999
• Status: Expired due to Term

• Current Assignee: MED-EL Elektromedizinische Gerate GmbH (MED-EL Corporation)
• Original Assignee: Epic Biosonics Inc.
• Inventors: Lupin, Alan J., Berrang, Peter G., Jarvin, Stacey D., Bluger, Henry V.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/450,025
• Time in Patent Office: 841 Days
• Field of Search: 623/10, 607/57, 607/56, 607/137, 600/25, 181/126-131, 381/68-692
• US Class Current: 623/10
• CPC Class Codes: A61N 1/36038 Cochlear stimulation

Abstract

A totally implantable cochlear prosthesis is presented. Said prosthesis is designed to function for hours or days without any external components. An externally-activated subcutaneous pressure switch enables the user to adjust the perceived volume by pressing against the skin with a finger. A similar second pressure switch provides a safety “off/on” feature. A pliable bridge connecting two hermetically sealed housing sections, and corrugated conductor lines, provide for future dimensional changes due to head growth. A titanium encapsulated microphone is positioned underneath the skin in the posterior wall of the external auditory canal. A modiolus-hugging electrode array is inserted into one of the cochlea scala. Periodic charging of the implanted battery (contained within one of the housing sections) is required, such charging accomplished via an external mechanically held head-mounted device containing an external coil, said external coil inductively coupling electrical power to an implanted receiving coil. The external and implanted coils can also be used as a communication link to program the implanted electronics.

Claims

1. A totally implantable cochlear prosthesis comprising a piezoelectric actuator for controlling volume or on/off functions, said actuator being adapted for transcutaneous actuation and further comprising:

at least one hermetically sealed housing section containing various electronics, electrical interconnections, electrical power storage means and said piezoelectric actuator for transcutaneous actuation;

a coil for receiving, from time to time, power and/or data from an external head-mounted means;

an implanted microphone encapsulated in a biocompatible housing;

an electrode array for insertion into one or more scala within the cochlea; and

,

at least one cable containing wires connecting said coil, microphone and electrode array to said housing section.

4. A prosthesis as in claim 1 wherein said connector comprises gold and/or platinum.

8. A prosthesis as in claim 1 wherein said cable is comprised of a polymer film containing lithographically formed wires.

9. A prosthesis as in claim 1 wherein the portion of the cable connecting said coil, microphone and electrode array to the housing section(s) is substantially corrugated.

10. A prosthesis as in claim 9 wherein said cable is also longitudinally folded or pleated at least once so as to minimize the width of said connector line.

11. A prosthesis as in claim 1 wherein the electrical power storage means is a secondary or rechargeable battery.

12. A prosthesis as in claim 1 wherein the electrical power storage means is a capacitor.

13. A prosthesis as in claim 1 wherein the electrical power storage means is a rechargeable thin-film lithium chemistry battery, said battery containing a non-liquid electrolyte.

14. A prosthesis as in claim 1 wherein the housing section is fixed to the skull by suturing to the overlaying skin and/or underlying skull, or by using titanium screws drilled into the skull.

15. A prosthesis as in claim 1 wherein the coil for receiving power and/or data is comprised of one or more turns of wire embedded in a polymer film.

17. A prosthesis as in claim 1 wherein the housing section or parts connected to said section contains embedded markings comprised of gold and/or platinum, said being markings coded for post-operative identification of the implanted prosthesis.

18. A cochlear prosthesis system comprising a prosthesis as in claim 1 and said external head mounted means, said external head mounted means comprising a coil to inductively couple electrical power and/or data to said receiving coil.

19. A cochlear prosthesis system comprising a prosthesis as in claim 1 and said external head mounted means, said external head mounted means comprising a battery, electronics and said coil of said external head mounted means mounted onto that part of standard eyeglass frames held by the pinna, said coil being substantially positioned to overlay the receiving coil when said frames are worn, and for inductively coupling electrical power and/or data to the implanted receiving coil.

20. A system as in claim 19 wherein said coil of said head mounted means is connected via wires to a body-worn unit, said unit containing electronics and a power source, said power source being a primary or secondary battery, or an AC wall plug source.

21. A system as in claim 19 wherein said coil of said head mounted means is connected via wires to a programming unit or computer used to set or adjust the implanted electronics from time to time so as to optimize the user'"'"'s speech percepts.

22. A cochlear prosthesis system comprising a prosthesis as in claim 1 and said external head mounted means, said external head mounted means comprising a battery, electronics and an external coil mounted onto a behind-the-ear type support structure, said structure held by the pinna, where said external coil is substantially positioned for overlay over the implanted coil when said structure is worn, and said external coil inductively coupling electrical power to the implanted coil.

23. A system as in claim 22 wherein said external head mounted means comprises an external coil mounted onto a behind-the-ear type support structure, held by the pinna, said external coil substantially positioned for overlay over the implanted coil when said structure is worn and for inductively coupling electrical power to the implanted coil, said external coil being connected via wires to a body-worn unit, said unit containing electronics and a power source, said power source being a primary or secondary battery, or an AC wall plug source.

24. A system as in claim, 22 wherein said head mounted means comprises an external coil mounted onto a behind-the-ear type support structure, held by the pinna, said external coil substantially positioned for overlay over the implanted coil when said structure is worn, and for inductively coupling data to/from the implanted coil, said coil being connected via wires to a programming unit, such as a computer, said programming unit used to set or adjust the implanted electronics from time to time so as to optimize the user'"'"'s speech percepts.

26. A cochlear prosthesis system comprising a prosthesis as in claim 1 and said external head mounted means, said external head mounted means comprising a device containing two magnets, a battery, electronics and an external coil, said device held to the head by two opposing magnets within the implanted housing, said external coil substantially positioned to overlay the implanted coil when the device is used, and said external coil inductively coupling electrical power to the implanted coil and wherein said two magnets in the head mounted means have opposite magnetic polarities, one to the other, and the two magnets in the implanted housing section have opposite magnetic polarities, one to the other, such magnetic arrangement creating, upon the two pairs of magnets interacting, a unique rotational alignment between the external and implanted coils, said arrangement substantially aligning the external coil and implanted coils one over the other.

2. A totally implantable cochlear prosthesis comprising a piezoelectric actuator for controlling volume or on/off functions, said actuator being adapted for transcutaneous actuation wherein said piezoelectric actuator comprises a snap dome.

5. A prosthesis as in claim 2 wherein gold and/or platinum foil is used as a cover over said snap dome, such foil being both biocompatible and pliable, so as to provide a means for activating said snap dome, and thus the piezoactuator, by pushing against the outside skin overlaying said foil.

6. A prosthesis as in claim 2 wherein said snap dome comprises air or gas, such air or gas being adapted to be slightly pressurized so as to allow said snap dome to readily “

snap”

when pushed at a specified force.

3. An implantable cochlear prosthesis comprising at least two thin housings operatively connected to one another wherein said housings are operatively connected to one another by a pliable connector adapted to allow the sections to be bent relative to one another so as to fit the curvature of the skull and to adapt to changes in skull size over time.

7. A totally implantable cochlear prosthesis comprising a piezoelectric actuator for controlling volume or on/off functions, said actuator being adapted for transcutaneous actuation wherein the piezoelectric actuator is made from a piezoceramic, a piezocrystal, or a PVDF (or PVDF copolymer) piezo film.

16. A totally implantable cochlear prosthesis comprising a coil and at least one housing containing control electronics, wherein said coil is located outside said housing but is operatively connected to said housing wherein said coil contains embedded markings comprised of gold and/or platinum, said markings being coded for post-operative identification of the implanted prosthesis.

25. A totally implantable cochlear prosthesis comprising:

at least one hermetically sealed housing section containing various electronics, electrical interconnections, two magnets, electrical power storage means, means for adjusting volume and/or controlling panic “

off/on”

functions;

a coil for receiving, from time to time, power and/or data from an external head-mounted means;

an implanted microphone encapsulated in a biocompatible housing;

an electrode array for insertion into one or more scala within the cochlea; and

,

at least one cable containing wires connecting said coil, microphone and electrode array to said housing section.

27. A totally implantable cochlear prosthesis comprising:

at least one hermetically sealed housing section containing various electronics, electrical interconnections, electrical power storage means, means for adjusting volume and/or controlling panic “

off/on”

functions;

an emergency turn “

off/on”

switch for controlling electrical power to the electrodes using a magnetic sensor contained within a housing section;

a coil for receiving, from time to time, power and/or data from an external head-mounted means;

an implanted microphone encapsulated in a biocompatible housing;

an electrode array for insertion into one or more scala within the cochlea; and

,

at least one cable containing wires connecting said coil, microphone and electrode array to said housing section.

28. A prosthesis as in claim 27 comprising a reed switch, such switch activated by holding a magnet near or against the skin in the vicinity of the implanted reed switch.