Modiolar hugging electrode array

• US 6,374,143 B1
• Filed: 08/18/1999
• Issued: 04/16/2002
• Est. Priority Date: 08/18/1999
• Status: Expired due to Term

• Current Assignee: MED-EL Elektromedizinische Gerate GmbH (MED-EL Corporation)
• Original Assignee: Epic Biosonics Inc.
• Inventors: Klosowski, Henryk, Lupin, Alan J., Berrang, Peter G., Bluger, Henry V.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/376,918
• Time in Patent Office: 972 Days
• Field of Search: 607/116, 607/118, 607/137, 607/55-57, 600/379, 600/393
• US Class Current: 607/137
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

A multi-bipolar configured electrode array and means to uniquely position said array within the scalae of the human cochlea is described. Said array is inserted into the scala tympani, scala vestibuli or both, by a surgeon. The electrode array may be pre-formed to lightly hug the modiolar wall of a scala so as to position the electrodes in close proximity to the cochlear spiral lamina and spiral ganglia in the modiolus. Mechanical features within said array allow the surgeon to further position said array against the modiolar wall of the scala, post insertion, and to mechanically retain such positioning of said array. Such positioning is in close proximity to surviving neural sites in the spiral lamina and/or spiral ganglion cells in the modiolus to efficiently stimulate functioning auditory neural elements. The multi-bipolar electrode configuration achieves a high degree of spatial selectivity, thus improving the implantee'"'"'s speech percepts.

Claims

1. A cochlear electrode array for stimulating auditory processes, comprising a bio-inert film with at least two conductor lines and at least two electrodes, said film being formed into an elongated tube-like configuration, said electrodes comprising a plurality of groups of at least two electrodes, the electrodes within each group being disposed in a substantially radial bipolar arrangement and the plurality of said groups being disposed along the longitudinal axis of said tube-like configuration.

2. The array of claim 1 wherein a plurality of cut-outs are provided in said film, each of said cut-outs being located between two groups of electrodes.

3. The array of claim 2 wherein the film is flexible but has been treated to preferentially adopt a pre-determined shape.

4. The array of claim 3 wherein said shape is a conical helix.

5. The array of claim 3 wherein said shape is a two dimensional spiral.

6. A method of fabricating the electrode array assembly of claim 1 whereby the electrodes are made of platinum and conductor lines are encapsulated between two layers of polyfluorocarbon film using a photo-lithographic process involving electroplating platinum through a photo-mask and applying first one layer of FEP film and then the other layer of FEP film using a heated vacuum press and electroplating a thin layer of irridium over the platinum, and wherein said step of electroplating a thin layer irridium is performed after the application of the first and other layer of FEP film by opening at least one layer of film to expose the electrode surfaces and performing said step of electroplating said thin layer of irridium.

18. The electrode array of claims 1 or 17 wherein the portion of the film containing only the conductors, being that portion leading away from the electrodes, is pleated to allow for lineal expansion of said conductors to accommodate cochlear and head growth.

7. A cochlear electrode array assembly for stimulating auditory processes, comprising an elongated bio-inert film holding at least two conductor lines and at least two electrodes, and an elongated bio-inert carrier, said film being formed into a tube-like configuration around said carrier wherein the assembly has been treated to preferentially adopt a conical helix shape.

8. A cochlear electrode array assembly for stimulating auditory processes, comprising an elongated bio-inert film holding at least two conductor lines and at least two electrodes, and an elongated bio-inert carrier, said film being formed into a tube-like configuration around said carrier and wherein a plurality of partially circumferential notches are disposed along at least a portion of the length of said carrier.

9. A cochlear electrode array assembly for stimulating auditory processes, comprising an elongated bio-inert film holding at least two conductor lines and at least two electrodes, and an elongated bio-inert carrier, said film being formed into a tube-like configuration around said carrier, and wherein at least one partially circumferential notch is provided in said carrier.

10. The assembly of claim 9 wherein a plurality of said notches are disposed along at least a portion of the length of said carrier.

11. The assembly of claim 10 wherein said electrodes are disposed along one longitudinal half of the tube-like configuration and the notches are disposed substantially along the opposite longitudinal half of the tube-like configuration.

12. The assembly of claim 10 wherein said electrodes are disposed along one longitudinal half of the tube-like configuration and the notches are disposed substantially along the same longitudinal half of the tube-like configuration.

13. The assembly of claim 9 or 10 wherein at least one end of said carrier is rounded.

14. The assembly of claim 10 wherein a plurality of cut-outs are provided in said film.

15. The assembly of claim 9 or 10 wherein said electrodes comprise a plurality of groups of electrodes, the electrodes within each group being disposed in a substantially radial bipolar arrangement on said tube.

16. The assembly of claim 9 wherein a plurality of cut-outs are disposed along the length of the tube-like configuration.

17. A cochlear electrode array assembly for stimulating auditory processes, said assembly having a generally cylindrical configuration and comprising an elongated bio-inert film holding at least two conductor lines and at least two electrodes, an elongated bio-inert carrier with a hole, and an elongated bio-inert beading adapted to slide within said hole.

19. The assembly of claim 17 wherein said assembly has been treated to preferentially adopt a pre-determined shape.

20. The assembly of claim 19 wherein said predetermined shape is a conical helix.

21. The assembly of claim 19 wherein said predetermined shape is a two dimensional spiral.

22. The assembly of claim 17 wherein said hole is tapered along its longitudinal extent.

23. The assembly of claim 22 wherein said hole and said beading are both tapered so that their basal ends are larger than their apical ends.

24. The assembly of claim 17 wherein said beading is attached at one end of the carrier.

25. The assembly of claim 24 wherein said end is the apical end of the carrier.

26. The assembly of claim 17 wherein said hole is offset from the longitudinal axis of said carrier.

27. The assembly of claim 17 wherein a plurality of partially circumferential notches are disposed along at least a portion of the length of said carrier.

28. The assembly of claim 27 wherein said electrodes are disposed along one longitudinal half of the assembly and the notches are disposed substantially along the opposite longitudinal half of the assembly.

29. The assembly of claim 27 wherein said electrodes are disposed along one longitudinal half of the assembly and the notches are disposed substantially along the same longitudinal half of the assembly between said electrodes.

30. The assembly of claim 29 for placement in a cochlea wherein the beading is anchored to the carrier at the basal end so as to hold it slightly in tension whereby to cause the assembly to hug the modiolar wall.

31. The assembly of claim 27 wherein a plurality of cut-outs are provided in said film.

32. The assembly of claim 31 wherein at least one of said cut-outs overlays at least one of said notches.

33. The assembly of claim 17 wherein said electrodes comprise at least one group of at least two electrodes, the electrodes within each group being disposed in a substantially radial bipolar arrangement on said assembly.

34. The assembly of claim 33 wherein a plurality of cut outs are provided in said film.

35. The assembly of claim 17 or 33 wherein said beading is attached at the apical end of said carrier.

36. The assembly of claim 17 or 33 wherein said beading is attached at the basal end of said carrier.

37. The assembly of claim 17 wherein the cross sectional shape of the beading is different from the cross sectional shape of the hole.

38. The electrode array of claim 17 wherein the film, carrier or beading is substantially comprised of a polyfluorocarbon, polyethylene, polypropylene, polyimide, polyamide, silicone, or other polymer material.

39. The assembly of claim 17 wherein at least one partially circumferential notch is provided in said carrier so as to allow the assembly to preferentially bend in a particular direction about said notch.

40. The assembly of claim 39 wherein a plurality of said notches are disposed substantially along the same longitudinal half of said assembly and a plurality of said electrodes are disposed substantially along the opposite longitudinal half of said assembly.

41. The assembly of claim 40 in place in a cochlea wherein the beading is anchored to the carrier at the basal end so as to hold it slightly in compression for causing the assembly to hug the modiolar wall.

42. The assembly of claim 17 or 39 wherein the carrier and the beading are flexible and the carrier preferentially adopts a pre-determined shape.

43. A method of positioning an electrode array according to claim 17 or 39 in a cochlea wherein the beading is withdrawn from the carrier by the surgeon after insertion.

44. A method of surgically implanting an assembly as in claim 17 or 39 wherein the surgeon selectively withdraws or inserts the beading within the carrier during insertion into the cochlea so as to cause bending or straightening of the assembly.

45. The array of claim 17 or 39 wherein said beading is memory shape wire and preferentially adopts a pre-determined shape.