Cochlear electrode array with positioning stylet

• US 6,119,044 A
• Filed: 03/01/1999
• Issued: 09/12/2000
• Est. Priority Date: 06/02/1997
• Status: Expired due to Fees

• Current Assignee: Advanced Bionics AG (Sonova Holding AG)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Kuzma, Janusz A.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/259,199
• Time in Patent Office: 561 Days
• Field of Search: 607/116, 607/137, 607/37, 607/122, 607/125, 600/595, 600/373, 600/377, 600/379
• US Class Current: 607/137
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

An implantable electrode array, adapted for insertion into either a left or right cochlea, assumes a spiral shape so as to hug the modiolar wall of the cochlea after insertion into the cochlea. All of the electrode contacts are spaced apart along one edge or side of the array, termed the "medial side", which medial side resides on the inside of the spiral. The electrode contacts are thus positioned in close proximity to the modiolar wall, closest to the ganglion cells that are to be stimulated by the electrode array. A positioning stylet made from a suitable memory wire is inserted into a longitudinal channel of the array. The stylet is made from memory wire and has properties selected to return to a desired memory spiral shape at or near body temperature (e.g., approximately 37° C. or 98.6° F.). The positioning stylet is cooled and bent as needed to assume a relatively straight, or non-spiral shape. While relatively straight, the stylet is slidably inserted into the longitudinal channel of the electrode array. The electrode array is then inserted into the cochlea in conventional manner. As the stylet within the electrode array warms to body temperature, it returns to its spiral memory shape, thereby causing the electrode array to also assume a spiral shape, thus positioning the electrode contacts of the electrode array against the modiolar wall.

Claims

1. An implantable electrode array insertable into a curved cavity for use with a tissue stimulation device the array comprising:

a flexible carrier having a proximal end, a distal end, a medial side, and a longitudinal channel passing from the proximal end to the distal end, the longitudinal channel being closed at the distal end;

at least eight electrodes having an exposed surface area on the medial side of the flexible carrier, the electrodes having an embedded portion behind the exposed surface area that extends into the flexible carrier;

a multiplicity of wires embedded within the flexible carrier, at least one wire of the multiplicity of wires being electrically and physically connected to a respective electrode;

wherein each electrode comprises first and second metallic strips formed in a "IT" shape, wherein a leg of the "T" is folded back over itself and holds at least one of the multiplicity of wires therebetween, the wire being electrically bonded to the folded T leg, and wherein sides of the "T" are folded upwardly into the flexible carrier; and

a positioning stylet insertable into the channel of the flexible carrier, the positioning stylet comprising a memory wire having properties selected to coil the wire in a spiral shape when warmed to a temperature near 37°

C.;

wherein when the electrode array is insertable in the curved cavity, with the medial side of the flexible carrier facing an inner wall of the curved cavity, and the positioning stylet is inserted into the channel and warmed to a temperature near 37°

C., the flexible carrier assumes the spiral shape of the wire and is adopted to position the medial side of the flexible carrier against the inner wall, whereby the exposed surface area of the at least eight electrodes is adopted to be positioned adjacent the inner wall of the curved cavity.

2. The implantable electrode array of claim 1 wherein the positioning stylet comprises a memory wire having properties selected to form the spiral shape, the spiral shape matching an average curvature of a cochlear modiolus when warmed to a temperature near 37°

C., and wherein the curved cavity into which the electrode array is insertable comprises a cochlea having a modiolar wall as the inner wall, whereby the at least eight electrodes are adopted to hug the modiolar wall when the positioning stylet is warmed to a temperature near 37°

C.

3. The implantable electrode array of claim 2 wherein the memory wire is permanently held in the channel of the flexible carrier.

4. The implantable electrode array of claim 1 wherein a most distal electrode of the at least eight electrodes comprises a first electrode, and wherein a most proximal electrode comprises an nth electrode, where n is an integer of at least 8, and wherein the multiplicity of wires comprises at least n+1 wires, at least one wire being connected to each of the second through nth electrodes, and at least two wires being connected to the first electrode.

5. The implantable electrode array of claim 4 wherein the at least n+1 wires are separated into two bundles, a first bundle being routed along one lateral side of the electrode array and a second bundle being routed along the other lateral side of the electrode array, wherein both wire bundles are engaged by the electrodes they pass by, and wherein both wire bundles are embedded within the flexible carrier, and wherein at least one wire connected to the first electrode comes from the first bundle, and wherein at least one other wire connected to the first electrode comes from the second wire bundle.

6. The implantable electrode array of claim 1 further including a hump formed on the medial side of the array in the space between the exposed surface area of each electrode.

7. The implantable electrode array of claim 1 wherein the electrode array comprises an implantable cochlear electrode array adapted for insertion into a cochlea of a patient, and wherein each electrode has an exposed contact surface area no smaller than approximately 0.16 mm².

8. An implantable cochlear electrode array insertable into a human cochlea, the cochlea spiraling around a cochlear modiolus, the cochlear electrode array comprising:

an elongate flexible carrier having a proximal end, a distal end, a medial side, a longitudinal axis, and a longitudinal channel passing through the flexible carrier in substantial alignment with the longitudinal axis, the channel being open at the proximal end of the flexible carrier and closed at the distal end of the flexible carrier;

at least n spaced-apart electrodes embedded within the flexible carrier, each electrode having a surface area exposed on the medial side of the flexible carrier, where n is an integer of at least 8, and wherein a most distal electrode comprises a first electrode, and wherein a most proximal electrode comprises an nth electrode;

at least n+1 wires embedded within the flexible carrier, at least one wire being connected to each of the second through nth electrodes, and at least two wires being connected to the first electrode; and

a positioning memory wire insertable into the channel, the positioning memory wire having properties selected to produce a transformation to a spiral shape at temperatures near body temperature, and allowing the memory wire to be straightened at temperatures substantially less than body temperature;

wherein the spiral shape of the memory wire at temperatures near body temperature comprises a shape resembling the average curvature of the cochlear modiolus; and

whereby when the array is insertable into the cochlea with the carrier medial side facing the modiolus, and when the memory wire is inserted into the channel, the electrode array is adapted to hug the modiolus, with the exposed surface area of the electrodes adapted to be positioned adjacent the modiolus.

9. The implantable cochlear electrode array as set forth in claim 8 further including a hump formed on the elongate flexible carrier on the medial side in the space between the exposed surface area of each electrode.

10. The implantable cochlear electrode array of claim 8 wherein the electrode array is more flexible in a medial direction than in a lateral direction, where the medial direction comprises a direction perpendicular to the medial side, and where the lateral direction comprises a direction perpendicular to the medial direction and the longitudinal axis.

11. The implantable cochlear electrode array as set forth in claim 10 wherein the elongate flexible carrier has a natural curve in the medial direction.

12. An implantable cochlear electrode array insertable into a human cochlea, the cochlea spiraling around a cochlear modiolus, the cochlear electrode array comprising:

an elongate flexible carrier having a proximal end, a distal end, a medial side, and positioning means carried by the flexible carrier for transforming the flexible carrier to a spiral shape at temperatures near body temperature, the spiral shape comprising a shape resembling the average curvature of the cochlear modiolus;

at least eight spaced-apart electrodes embedded within the flexible carrier, each electrode having a surface area exposed on the medial side of the flexible carrier;

at least nine wires embedded within the flexible carrier, at least two wires being connected to a most distal electrode, and at least one wire being connected to each of the remaining electrodes; and

wherein when the array is insertable into the cochlea with the medial side facing the modiolus, the electrode array warms to body temperature, transforms to the spiral shape, and is adopted to hug the modiolus, with the exposed surface area of the electrodes adopted to be positioned adjacent the modiolus.

13. The implantable cochlear electrode array of claim 12 wherein the positioning means carried by the flexible carrier comprises a positioning memory wire carried within the flexible carrier, the positioning memory wire having properties selected to produce a transformation to the spiral shape at temperatures near body temperature, and allowing the memory wire to be straightened at temperatures substantially less than body temperature.

14. The implantable cochlear electrode array of claim 12 wherein the flexible carrier has a channel passing longitudinally therethrough, and wherein the positioning means comprises a positioning memory wire removably insertable within the channel of the flexible carrier, the positioning memory wire having properties selected to produce a transformation to the spiral shape at temperatures near body temperature, and allowing the memory wire to be straightened at temperatures substantially less than body temperature.