Cochlear electrode system including detachable flexible positioner

• US 6,397,110 B1
• Filed: 11/19/1999
• Issued: 05/28/2002
• Est. Priority Date: 08/26/1998
• Status: Expired due to Fees

• Current Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Kuzma, Janusz A.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/443,627
• Time in Patent Office: 921 Days
• Field of Search: 607/137
• US Class Current: 607/137
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

An electrode system includes (1) an electrode array, made in a straight or curved shape, but made on a flexible carrier so that it can easily bend within a curved body cavity, such as the cochlea; and (2) a flexible positioner, molded in a curved or straight shape from a silicone polymer so as to make it easy to slide into the body cavity. Some embodiments may further include an electrode and/or a positioner guiding insert. One embodiment of the positioner includes keeper tabs at its distal end, and side walls at its proximal end, to help maintain the positioner in a desired position along the back side of the electrode array during and after the insertion process. Engagement members at a distal end of the positioner also allow detachable engagement with corresponding or mating members near the distal end of the electrode array during the insertion process, thereby allowing insertion of the positioner to cause engagement of the positioner with the electrode array, and to provide for deeper insertion of the electrode array as the positioner is inserted deeper into the cochlea. One method of insertion involves first inserting an electrode array into the scala tympani, and then second inserting the positioner into the scala tympani so as to lie between the electrode array and the outer wall of the scala tympani, thereby forcing the electrode array against the modiolar wall.

Claims

1. A cochlear electrode system comprising:

an electrode array comprising

a first elongate flexible carrier having a distal end and a proximal end adapted to be inserted into a human cochlea,

a plurality of spaced-apart contacts carried by the flexible carrier,

a plurality of wires carried within the flexible carrier, at least one wire of the plurality of wires being electrically connected to one of the plurality of electrode contacts, each of the plurality of wires having a proximal end that may be coupled to electronic circuitry, and

a first engagement member on the flexible carrier near the distal end of the electrode array; and

a positioner comprising

an elongate flexible member having a distal tip and a proximal end adapted to be inserted into the human cochlea alongside the electrode array,

a second engagement member on the flexible member near the distal tip of the positioner, wherein the second engagement member is detachably engageable with the first engagement member of the electrode array when the positioner is inserted into the cochlea alongside the electrode array;

wherein the positioner further has a first pair of keeper tabs protruding from the flexible member in the vicinity of the second engagement member, and wherein one tab of the first pair of keeper tabs is adapted to lie against one side of the electrode array, and the other tab of the first pair of keeper tabs is adapted to lie against an opposite side of the electrode array, to thereby keep the distal end of the positioner alongside the distal end of the electrode array when the positioner is inserted into the cochlea.

2. The cochlear electrode system of claim 1 wherein the positioner has a second pair of keeper tabs protruding from the flexible member near the first pair of tabs, wherein one tab of the second pair of keeper tabs is adapted to lie against one side of the electrode array, and the other tab of the second pair of keeper tabs is adapted to lie against an opposite side of the electrode array, to thereby further keep the distal end of the positioner alongside the distal end of the electrode array when the positioner is inserted into the cochlea.

3. The cochlear electrode system of claim 2 wherein the tabs of the first and second pair of tabs a re flexible, forming an integral part o f the flexible member.

4. The cochlear electrode system of claim 2 wherein a space of at least 0.5 mm separates a proximal edge of the tabs of the first pair of keeper tabs from a distal edge of the tabs of the second pair of keeper tabs.

5. The cochlear electrode system of claim 4 wherein the first pair of keeper tabs is locate d a distance of no more than about 1.0 mm from the distal tip of the positioner.

6. The cochlear electrode system of claim 4 wherein a distal edge of the tabs of the first pair of keeper tabs is located at the distal tip.

7. The cochlear electrode system of claim 6 wherein the distal tip of the positioner is formed to define a frontal edge of the positioner that lies at about a 45°

angle with respect to a longitudinal axis of the positioner.

8. The cochlear electrode system of claim 1 wherein the positioner further includes a pair of side walls protruding from the flexible member near a proximal end of the positioner, and wherein one side wall of the pair of side walls is adapted to lie against one side of the proximal end of the electrode array, and the other side wall of the pair of side walls is adapted to lie against an opposite side of the proximal end of the electrode array, the space between the side walls defining a proximal channel adapted to receive the proximal end of the electrode array, the proximal channel being adapted to keep the proximal end of the positioner alongside the proximal end of the electrode array when the positioner is inserted into the cochlea.

9. The cochlear electrode system of claim 8 wherein each side wall has a length, measured from a proximal edge of each side wall to a distal edge of each side wall, of from 3 to 7.5 mm.

10. The cochlear electrode system of claim 8 wherein each side wall has a maximum height, measured from a top edge of each side wall to the side of the flexible member opposite the channel, that is about 1.7 mm.

11. The cochlear electrode system of claim 8 wherein each side wall has a minimum height, measured from a top edge of each side wall to the side of the flexible member opposite the channel, that is about 0.9 mm.

12. The cochlear electrode system of claim 8 wherein each side wall has a height, measured from a top edge of each side wall to the side of the flexible member opposite the channel, that varies from a maximum height of about 1.7 mm at a proximal edge of the side wall to a height of about 0.9 mm at a distal edge of the side wall.

13. The cochlear electrode system of claim 8 wherein the proximal channel has a depth that varies from a first depth at the proximal end of the proximal channel to a second depth at a distal end of the proximal channel, the depth being measured as the distance from a floor of the proximal channel to a top edge of the side wall.

14. The cochlear electrode system of claim 13 wherein the floor of the proximal channel is raised a distance f1, with respect to the side of the flexible member opposite the proximal channel, near the proximal end of the positioner.

15. The cochlear electrode system of claim 14 wherein the amount the floor of the proximal channel is raised with respect to the side of the flexible member opposite the proximal channel varies as a function of distance from the proximal end of the positioner.

16. The cochlear electrode system of claim 15 wherein the amount the floor of the proximal channel is raised with respect to the side of the flexible member opposite the proximal channel is largest near the proximal end of the positioner and gradually decreases as the distance from the proximal end of the positioner increases.

17. The cochlear electrode system of claim 8 wherein the positioner has an opening passing longitudinally therethrough, the opening being adapted to receive a stylet wire when the positioner is being inserted into the cochlea.

18. The cochlear electrode system of claim 17 wherein the opening passing longitudinally through the positioner is closed at the distal tip of the positioner.

19. The cochlear electrode system of claim 18 further including a metal marker sealed in the closed end of the opening that passes longitudinally through the positioner, wherein the metal marker provides an identifiable reference location detectable through an imaging system.

20. The cochlear electrode system of claim 19 wherein the metal marker is made from platinum or an alloy of platinum.

21. The cochlear electrode system of claim 1 wherein the first engagement member comprises at least one engaging flap formed on the surface of the flexible carrier near the distal end of the electrode array, said at least one engaging flap having a slant associated therewith that points the flap in the general direction of the proximal end of the electrode array.

22. The cochlear electrode system of claim 21 wherein the first engagement member comprises at least five engaging flaps formed on the surface of the flexible carrier near the distal end of the electrode array, each of said engaging flaps having a slant associated therewith that points the flap in the general direction of the proximal end of the electrode array.

23. The cochlear electrode system of claim 21 wherein the second engagement member comprises a slanting frontal edge formed at the distal tip of the positioner, and wherein the slanted frontal edge is adapted to engage with the at least one engaging flap on the electrode array as the positioner is placed alongside the electrode array.

24. The cochlear electrode system of claim 23 wherein the slanted frontal edge of the positioner lies at about a 45°

angle with respect to a longitudinal axis of the positioner.

25. The cochlear electrode system of claim 21 wherein the second engagement member comprises a plurality of engaging fins formed on the surface of the flexible member near the distal tip of the positioner, each of said engaging fins having a slant associated therewith that slants the fin in the general direction of the distal end of the positioner, and wherein the slanted fins are oriented so that at least one of the fins engages with the at least one engaging flap on the electrode array as the positioner is placed alongside the electrode array inside of the cochlea.

26. The cochlear electrode system of claim 25 wherein the first engagement member comprises a multiplicity of engaging flaps formed on the surface of the flexible carrier near the distal end of the electrode array, each of said engaging flaps having a slant associated therewith that points the flap in the general direction of the proximal end of the electrode array, and wherein the slanted fins of the positioner are oriented so that a plurality of the fins engage with a corresponding plurality of engaging flaps on the electrode array as the positioner is placed alongside the electrode array inside of the cochlea.

27. The cochlear electrode system of claim 1 wherein the first engagement member comprises a plurality of serrations formed on the surface of the flexible carrier near the distal end of the electrode array, each of said serrations having a slant associated therewith that points the serration in the general direction of the proximal end of the electrode array.

28. The cochlear electrode system of claim 1 wherein the first engagement member comprises a hump formed on the surface of the flexible carrier near the distal end of the electrode array, the hump being adapted to be detachably engaged with the second engagement member of the positioner as the positioner is placed alongside the electrode array inside of the cochlea.

29. The cochlear electrode system of claim 1 wherein the second engagement member comprises a plurality of serrations formed on the surface of the flexible member near the distal tip of the positioner, each of said serrations having a slant associated therewith that slants the serration in the general direction of the distal end of the positioner.

30. The cochlear electrode system of claim 1 wherein the second engagement member comprises a blade-shaped distal tip formed on the surface of the positioner, wherein the blade-shaped distal tip is adapted to engage the first engagement member of the electrode array as the positioner is inserted into the cochlea, and is further adapted to disengage the first engagement member of the electrode array when the positioner is pulled out of the cochlea.

31. A cochlear electrode system comprising:

an electrode array, the electrode array having a first engagement member formed thereon;

a positioner, the positioner having a second engagement member formed thereon that is detachably engageable with the first engagement member of the electrode array when the positioner is inserted into the cochlea alongside the electrode array; and

a removable guide tube through which the positioner is inserted into the cochlea alongside the electrode array after the electrode array has been inserted into the cochlea.

32. A cochlear electrode system comprising:

an electrode array comprising an elongate flexible carrier body having a distal end and a proximal end, a plurality of spaced-apart electrode contacts along one surface of the carrier body, and a first engagement member near the distal end of the flexible carrier body;

a positioner, the positioner having a second engagement member formed thereon that is detachably engageable with the first engagement member of the electrode array when the positioner is inserted into the cochlea alongside the electrode array; and

a guide tube through which the positioner is initially inserted into the cochlea alongside the electrode array once the electrode array has been inserted into the cochlea, and which guide tube is removable once the positioner has been inserted into the cochlea.

33. A cochlear electrode system comprising:

an electrode array comprising an elongate flexible carrier body and a plurality of spaced-apart electrode contacts exposed on the carrier body, wherein the electrode array is adapted to be inserted into a human cochlea as part of a cochlear stimulation system;

a positioner, wherein the positioner is adapted to be inserted into the cochlea alongside the electrode array and thereby better position the electrode contacts within the cochlea; and

a guide tube through which the positioner is initially inserted into the cochlea alongside the electrode array once the electrode array has been inserted into the cochlea, and which guide tube is removable once the positioner has been inserted into the cochlea.

34. The cochlear electrode system of claim 33 wherein the electrode array has a distal end and a proximal end, and further includes first engagement means located near the proximal end for engaging with the positioner as the positioner is inserted deeper into the cochlea alongside the electrode array.

35. The cochlear electrode system of claim 34 wherein the positioner has a distal tip and a proximal end, and further includes second engagement means located at or near the distal tip for engaging with the first engagement means of the electrode array as the positioner is inserted deeper into the cochlea alongside the electrode array.

36. The cochlear electrode system of claim 35 wherein the positioner has a distal tip and a proximal end, and further includes distal keeper means near the distal tip of the positioner for keeping the distal tip of the positioner alongside the electrode array.

37. The cochlear electrode system of claim 36 wherein the positioner further includes proximal keeper means near the proximal end of the positioner for keeping the proximal end of the positioner alongside the electrode array when the positioner is inserted into the cochlea.

38. A positioner for use with an electrode array, the electrode array being adapted to be inserted into a human cochlea, the positioner comprising

an elongate flexible member having a distal tip and a proximal end adapted to be inserted into the human cochlea alongside the electrode array, and

an engagement member on the flexible member near the distal tip of the positioner, wherein the engagement member is detachably engageable with a distal portion of the electrode array when the positioner is inserted into the cochlea alongside the electrode array;

wherein the positioner further has a first pair of keeper tabs protruding from the flexible member in the vicinity of the engagement member, and wherein one tab of the first pair of keeper tabs is adapted to lie against one side of the electrode array, and the other tab of the first pair of keeper tabs is adapted to lie against an opposite side of the electrode array, to thereby keep the distal end of the positioner alongside the distal portion of the electrode array when the positioner is inserted into the cochlea.

39. The positioner of claim 38 wherein the positioner has a second pair of keeper tabs protruding from the flexible member near the first pair of tabs, wherein one tab of the second pair of keeper tabs is adapted to lie against one side of the electrode array, and the other tab of the second pair of keeper tabs is adapted to lie against an opposite side of the electrode array, to thereby further keep the distal end of the positioner alongside the distal portion of the electrode array when the positioner is inserted into the cochlea.

40. The positioner of claim 39 wherein the tabs of the first and second pair of tabs are flexible, forming an integral part of the flexible member.

41. The positioner of claim 40 wherein a distal edge of the tabs of the first pair of keeper tabs is located at the distal tip.

42. The positioner of claim 41 wherein the distal tip of the positioner is formed to define a frontal edge of the positioner that lies at about a 45°

angle with respect to a longitudinal axis of the positioner.

43. The positioner of claim 38 wherein the positioner further includes a pair of side walls protruding from the flexible member near the proximal end of the positioner, and wherein the space between the side walls defines a proximal channel adapted to receive the electrode array, the proximal channel being adapted to keep the proximal end of the positioner alongside the electrode array when the positioner is inserted into the cochlea.

44. The positioner of claim 43 wherein each side wall has a length measured from a proximal edge of each side wall to a distal edge of each side wall, of from 3 to 7.5 mm.

45. The positioner of claim 43 wherein each side wall has a height, measured from a top edge of each side wall to the side of the flexible member opposite the channel, that varies from a maximum height of about 1.7 mm at a proximal edge of the side wall to a height of about 0.9 mm at a distal edge of the side wall.

46. The positioner of claim 43 wherein the proximal channel has a depth that varies from a first depth at the proximal end of the proximal channel to a second depth at a distal end of the proximal channel, the depth being measured as the distance from a floor of the proximal channel to a top edge of the side wall.

47. The positioner of claim 46 wherein the floor of the proximal channel is raised a prescribed distance, with respect to the side of the flexible member opposite the proximal channel, near the proximal end of the positioner.

48. The positioner of claim 47 wherein the amount the floor of the proximal channel is raised with respect to the side of the flexible member opposite the proximal channel is largest near the proximal end of the positioner and gradually decreases as the distance from the proximal end of the positioner increases.

49. The positioner of claim wherein 38 the positioner has an opening passing longitudinally therethrough, the opening being adapted to receive a stylet wire when the positioner is being inserted into the cochlea.

50. The positioner of claim 49 wherein the opening passing longitudinally through the positioner is closed at the distal tip of the positioner.

51. The positioner of claim 50 further including a metal marker sealed in the closed end of the opening that passes longitudinally through the positioner, wherein the metal marker provides an identifiable reference location detectable through an imaging system.

52. A positioner for use with an electrode array, the electrode array being adapted to be inserted into a human cochlea, the positioner comprising

an elongate flexible member having a distal tip and a proximal end adapted to be inserted into the human cochlea alongside the electrode array, and

an engagement member on the flexible member near the distal tip of the positioner, wherein the engagement member is detachably engageable with a distal portion of the electrode array when the positioner is inserted into the cochlea alongside the electrode array;

an opening passing longitudinally therethrough, the opening being adapted to receive a stylet wire when the positioner is being inserted into the cochlea,

wherein the opening passing longitudinally through the positioner is closed at the distal tip of the positioner;

wherein the opening that passes longitudinally through the positioner further includes a metal marker sealed in the closed end of the opening.