Totally implantable cochlear prosthesis

• US 6,648,914 B2
• Filed: 10/15/2001
• Issued: 11/18/2003
• 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:
  US09/975,970
• Publication Number:
  US 20020019669A1
• Time in Patent Office: 764 Days
• Field of Search: 623/10, 607/57, 600/25
• US Class Current: 623/10
• CPC Class Codes: A61N 1/36038 Cochlear stimulation

Abstract

A totally implantable cochlear prosthesis is presented. An externally-activated subcutaneous switch controls functions of the prosthesis. A pliable bridge connecting two hermetically sealed housing sections, and corrugated conductor lines, provide for future dimensional changes due to head growth. An 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 is 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 coil and at least one housing containing control electronics, wherein said coil is located outside said housing but is operatively connected to said housing and wherein said coil is an RF coil and is substantially not RF shielded.

2. The prosthesis of claim 1 wherein said coil comprises a plurality of turns of a biocompatible metal encapsulated in a bioinert carrier.

3. A totally implantable cochlear prosthesis comprising:

at least one hermetically sealed housing containing electrical power storage means and at least one mechanically-actuated electrical switch for controlling volume or on/off functions of the prosthesis, or both;

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

an implanted microphone encapsulated in a biocompatible housing; and

,

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

4. The prosthesis of claim 3 wherein said mechanically-actuated electrical switch includes a snap dome.

5. The prosthesis of claim 4 wherein said housing further contains various electronics and electrical interconnections, and wherein said electronics, electrical interconnections, electrical power storage means and electrical switch are mounted on one or more substrates, which substrate(s) contain a plurality of hermetically sealed electrical lead-throughs.

6. The prosthesis of claim 4 wherein said snap dome is comprised of stainless steel, titanium, plastic material, or any combination thereof.

7. The prosthesis of claim 4 wherein said electrical switch further includes a biocompatible and pliable foil cover comprising gold, platinum, or both.

8. The prosthesis of claim 7 further comprising a cable containing lithographically formed wires connecting said coil, microphone and electrode array to said housing, said cable comprising a polyfluorocarbon film.

9. The prosthesis of claim 8 wherein said cable is corrugated so as to be expandable.

10. The prosthesis of claim 8 wherein the polyfluorocarbon is FEP.

11. The prosthesis of claim 8 wherein the wires are comprised of platinum and/or gold.

12. The prosthesis of claim 7 further comprising a cable containing wires connecting said coil, microphone and electrode array to said housing, and wherein an encapsulant is used to cover the various parts mounted on said substrate(s), which substrate(s) are further bonded to said cable, and wherein said electrical lead-throughs are connected to the wires contained within said cable.

13. The prosthesis of claim 12 wherein the encapsulant contains hollow microballs and/or microcontainers containing a leak detection gas, such as helium, for testing housing hermeticity.

14. The prosthesis of claim 12 wherein the encapsulant is a medical grade epoxy and/or a bioinert polymer.

15. The prosthesis of claim 12 wherein said encapsulant, and said gold and/or platinum foil cover are coated, firstly, with vacuum deposited gold, electroless deposited gold or electroless deposited palladium, such first layer then thickened using gold electro plating to create a hermetic seal over said encapsulant and said foil (covering the snap domes), and at the interface between the edges of the foil cover and the electro plated gold.

16. The prosthesis of claim 15 wherein the electro plated gold layer is substantially covered with a layer of medical grade silicone.

17. The prosthesis of claim 16 wherein the electro plated gold layer is covered with a layer of vacuum deposited titanium and/or vacuum deposited or electro deposited platinum, or a combination thereof.

18. The prosthesis of claim 17 wherein said titanium and/or platinum layer is further covered with a layer of medical grade silicon.

19. The prosthesis of claim 3 wherein said housing further contains various electronics and electrical interconnections, and wherein said electronics, electrical interconnections, electrical power storage means and electrical switch are mounted on one or more substrates, which substrate(s) contain a plurality of hermetically sealed electrical lead-throughs.

20. The prosthesis of claim 3 or 4 wherein said housing further contains various electronics and electrical interconnections, and wherein said electronics, electrical interconnections, electrical power storage means and electrical switch are mounted on one or more substrates, which substrate(s) contain a plurality of hermetically sealed electrical lead-throughs and wherein the substrate(s) material is substantially comprised of ceramic, glass or a combination thereof.

21. An implantable cochlear prosthesis comprising at least two substantially flat, thin housings operatively connected to one another wherein said housing(s) are hermetically sealed with a laser welded titanium enclosure, said enclosure containing a leak detection gas for testing enclosure hermeticity.

22. An implantable cochlear prosthesis comprising at least two substantially flat, thin housings operatively connected to one another wherein the housing(s) are hermetically sealed using a ceramic and/or titanium enclosure.

23. An implantable cochlear prosthesis comprising at least two substantially flat, thin housings operatively connected to one another wherein said housing(s) are hermetically sealed using a ceramic having an edge and wherein said edge is coated with titanium to allow said edge to be subsequently laser welded, and wherein the enclosure contains a leak detection gas for testing enclosure hermeticity.

24. 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, said coil having an inner diameter that is substantially open in a ring-like configuration, such shape allowing skin overlaying said coil to bond to the skull within said open area post implantation.

25. An implantable cochlear prosthesis comprising at least two substantially flat, thin housings operatively connected to one another wherein said housings are disc-shaped and are connected by a pliable connector.

26. A cochlear prosthesis assembly comprising:

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, and provides a magnetic field; and

,

a head-mounted apparatus providing a magnetic field for rotationally aligning a coil within said apparatus in relation to said coil in said prosthesis.

27. 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 and wherein said housing(s) are hermetically sealed with a laser welded titanium enclosure, said enclosure containing a leak detection gas for testing enclosure hermeticity.