Cochlear electrode with modiolar-hugging system including a flexible positioner

• US 6,038,484 A
• Filed: 08/26/1998
• Issued: 03/14/2000
• Est. Priority Date: 09/02/1997
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Kuzma, Janusz A.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/140,034
• Time in Patent Office: 566 Days
• Field of Search: 607/136, 607/137, 607/55-57, 600/585, 600/379, 606/129
• 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, typically molded in a curved shape from a silicone polymer so as to make it easy to slide into the body cavity. Some embodiments may further include an electrode guiding insert. Yet other embodiments include only a flexible positioner adapted to fill space within a human cochlea so as to force an electrode array against a modiolar wall of the cochlea. Insertion of the electrode array is performed using one of two methods. A first method involves first inserting the flexible positioner into the scala tympani (one of the channels of the cochlea) to a desired depth, which desired depth typically involves a rotation of about 360 degrees and causes the positioner to rest against the outer or lateral wall of the scala tympani, leaving an opening slightly larger than the cross-section of the electrode array adjacent the inner wall of the scala tympani, and then second inserting the electrode array into the opening defined by the positioner and inner wall. The guiding insert may be used, in some embodiments, to assist guiding the electrode array into this opening. A second 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 inner wall of the scala tympani. Insertion of the positioner into scala tympani after the electrode array has been at least partially inserted therein further carries the electrode array deeper into the scala tympani to a desired final position, and maintains it in that position.

Claims

1. An electrode system adapted for use with a tissue stimulation device comprising:

a flexible electrode array having a multiplicity of electrode contacts along one surface thereof;

a flexible positioner adapted for insertion into a body cavity, said flexible positioner having front and rear sides, said body cavity having front and back walls, said flexible positioner being adapted for insertion into the body cavity so that the positioner assumes a position within the body cavity having its rear side lie against the back wall of the cavity, and leaving an open channel between the front side of the positioner and the front wall of the body cavity; and

an electrode-guiding insert adapted for insertion into the open channel created between the front side of the positioner and the front wall of the body cavity;

wherein the flexible electrode array is insertable through the electrode-guiding insert into the open channel so that the electrode contacts are positioned adjacent the front wall of the body cavity.

2. The electrode system as set forth in claim 1 wherein the flexible positioner is adapted for insertion within a human cochlea and comprises a curved flexible positioner having a groove or channel running longitudinally along its front side.

3. The electrode system as set forth in claim 1 wherein a distal portion of the electrode array and a distal portion of the positioner each contain engaging barbs adapted to interface with each other and secure the electrode array in a desired position wherein the electrode contacts are held against the front wall of the body cavity.

4. A flexible positioner for insertion into a body cavity, said flexible positioner having front and rear sides, said body cavity having front and back walls, said flexible positioner being adapted for insertion into the body cavity so that the positioner assumes a position within the body cavity having its rear side lie against the back wall of the cavity, and leaving an open channel between the front side of the positioner and the front wall of the body cavity, and wherein a tracing marker, having properties that facilitate seeing the tracing marker on an imaging system, is embedded in a distal end of the positioner.

5. The flexible positioner as set forth in claim 4 wherein the flexible positioner comprises a curved flexible positioner having a side groove or channel running longitudinally along its front side.

6. The flexible positioner as set forth in claim 5 wherein the positioner is adapted to fill space within the body cavity along with an electrode array, and wherein the positioner has a cross-sectional area sized such that insertion of the positioner within the body cavity into which the electrode array has already been at least partially inserted causes the electrode array to be carried deeper into the body cavity by friction created between engaging walls of the electrode array and positioner.

7. The flexible positioner as set forth in claim 4 wherein a distal portion of the positioner has engaging barbs adapted to interface with other engaging barbs of an electrode array positioned to reside within the side groove of the positioner inside the body cavity.

8. The flexible positioner as set forth in claim 4 further including a channel passing longitudinally through the positioner for removably receiving a guiding stylet.

9. The flexible positioner as set forth in claim 8 wherein the channel is sealed at its distal end.

10. An electrode system adapted for insertion into the scala tympani of a human cochlea as part of a cochlear stimulation system, the electrode system comprising:

a flexible electrode array having a multiplicity of electrode contacts, and

a flexible positioner adapted for use with the flexible electrode array, said flexible positioner comprising an elongate, flexible body having dimensions that facilitate its insertion fully into the scala tympani, the scala tympani having front and back walls;

wherein the elongate flexible body of the positioner is made from a silicone polymer formed in a generally curved shape, and the elongate flexible body is separate and detached from the electrode array;

wherein the elongate flexible body of the positioner has a proximal end and a distal end, and wherein the elongate flexible body is tapered, having a larger cross sectional area at the proximal end than at the distal end, and wherein, when inserted into the scala tympani, the flexible positioner is adapted to assume a position within the scala tympani against the back wall of the scala tympani; and

wherein the flexible electrode array is adapted to be inserted into the scala tympani and positioned therein so that the flexible electrode array lies between the positioner and the front wall of the scala tympani.

11. The electrode system of claim 10 wherein the elongate flexible body of the positioner naturally assumes a shallow hook shape, wherein the distal end of the positioner bends more than 90 degrees from a longitudinal axis of the positioner at the proximal end.

12. The electrode system of claim 10 further including a hole passing longitudinally through the elongate flexible body of the positioner from its proximal end to its distal end.

13. The electrode system of claim 12 further including a smooth rounded distal tip formed at the distal end of the positioner, wherein the smooth rounded distal tip plugs the hole at the distal end of the positioner.

14. The electrode system of claim 12 further including a tracing marker placed in the hole at the distal end of the positioner, and the smooth rounded tip being formed on the distal side of the tracing marker, wherein the smooth rounded tip plugs the hole at the distal end of the positioner.

15. The electrode system of claim 10 further including a side channel formed along a front side of the positioner from the proximal end to the distal end.

16. The electrode system of claim 10 further including a handle formed at the proximal end of the positioner, the handle pointing in the same direction as the curve formed in the positioner.

17. The electrode system of claim 10 wherein each of the multiplicity of spaced-apart electrode contacts of the flexible electrode array lie along a front surface of the electrode array, the front surface of the electrode array comprising that surface nearest the front wall of the scala tympani when the positioner and electrode array are inserted into the scala tympani.

18. The electrode system of claim 17 wherein a distal portion of the positioner has engaging barbs thereon, and a distal portion of the electrode array also has engaging barbs thereon, the engaging barbs of the positioner being adapted to detachably interface with the engaging barbs of the electrode array when the positioner and electrode array combine to form the electrode system.