Coated electrode array having uncoated electrode contacts

• US 7,949,412 B1
• Filed: 06/01/2006
• Issued: 05/24/2011
• Est. Priority Date: 06/02/2005
• Status: Active Grant

• Current Assignee: Advanced Bionics AG (Sonova Holding AG)
• Original Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Inventors: Colvin, Michael S, Balkany, Thomas J, Kuzma, Janusz A, Harrison, William Vanbrooks
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): Dietrich; Joseph M
• Application Number:
  US11/421,742
• Time in Patent Office: 1,818 Days
• Field of Search: 607/137, 607/116, 607/117, 607/136
• US Class Current: 607/137
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

Implantable electrode leads, e.g. cochlear, spinal cord stimulation, or any type of neurostimulation leads, used in a patient'"'"'s body to stimulate muscle or nerve tissue, provide enhanced stimulation for treating, e.g., hearing loss or chronic pain. One such lead includes, an implantable electrode array, adapted for insertion into a cochlea, which lead provides improved stability of electrode contact direction. In-line electrodes are spaced-apart along one side of a flexible carrier having non-conductive bumps coated with a bioresorbable material spaced apart between each electrode contact. Over time the bioresorbable material is absorbed thereby reducing chronic placement pressure caused during the insertion of the electrode array into the cochlea. The bioresorbable material may also serve as a carrier for drugs or other materials that would improve performance of the electrode for any type of lead.

Claims

1. An implantable device comprising:

a lead having an electrode array at a distal end, the electrode array having a medial surface on which are located a plurality of spaced apart exposed electrode contacts; and

a coating of bioresorbable material positioned on the medial surface of the electrode array at one or more locations other than where the electrode contacts are positioned such that the electrode contacts remain uncoated, wherein the coating of bioresorbable material is configured to be absorbed over time to reduce chronic pressure following lead implantation.

2. The implantable device of claim 1 wherein the bioresorbable material is selected from the group consisting of:

polydioxanone, polycaprolactone, polyhydroxybutyrate, polyamino acid, polymers formed of alpha hydroxy acids, lactic acids, poly-L-lactic acids, polylactic-coglycolic acid polymers, polysaccharides, and suitable combinations thereof.

3. The implantable device of claim 1 wherein the bioresorbable material is selected from the group consisting of:

glycoaminoglycans, hydroxyethyl cellulose, oxidized celluloses, and suitable combinations thereof.

4. The implantable device of claim 1 wherein the bioresorbable material serves as a carrier for a steroid.

5. The implantable device of claim 1 wherein the bioresorbable material serves as a carrier for a neuro-trophin.

6. The implantable device of claim 1 wherein the bioresorbable material has a thickness of H2, wherein H2 is between 10 μ

m and 30 μ

m.

7. The implantable device of claim 6 wherein H2 is 20 μ

m.

8. The implantable device of claim 1 wherein the electrode array comprises an implantable cochlear electrode array adapted for insertion into a cochlea of a patient.

9. The implantable device of claim 1 further comprising a hump formed on the medial side of the array in the space between the exposed electrode contacts, wherein the hump is coated with the bioresorbable material.

10. An implantable electrode array for use with a tissue stimulation device comprising:

a flexible carrier having a medial side;

a multiplicity of in-line electrodes having an exposed surface area only on the medial side of 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 in-line electrode; and

a hump formed on the medial side of the array in the space between the exposed surface area of each electrode, wherein the hump is coated with a bioresorbable material such that the electrode contacts remain uncoated, wherein the coating of bioresorbable material is configured to be absorbed over time to reduce chronic pressure following lead implantation; and

wherein the electrode array is more flexible in a medial direction than in a direction lateral to the medial direction, where the medial direction comprises the direction faced by the exposed contact surface area of the in-line electrodes.

11. The implantable electrode array of claim 10 wherein the multiplicity of in-line electrodes comprises n electrodes, 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.

12. The implantable electrode array of claim 11 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.

13. The implantable electrode array of claim 10 further including a tip at the distal end of the electrode array made from a material that is softer than the flexible carrier.

14. The implantable electrode array of claim 10 wherein the flexible carrier is made from a silicone rubber material of a first hardness, and the humps are made from a silicone rubber material of a second hardness, where the first hardness is harder than the second hardness.

15. The implantable electrode array of claim 10 wherein the electrode array comprises an implantable cochlear electrode array adapted for insertion into a cochlea of a patient.

16. The implantable electrode array of claim 10 wherein the bioresorbable material is selected from the group consisting of:

polydioxanone, polycaprolactone, polyhydroxybutyrate, polyamino acid, polymers formed of alpha hydroxy acids, lactic acids, poly-L-lactic acids, polylactic-coglycolic acid polymers, polysaccharides, and suitable combinations thereof.

17. The implantable electrode array of claim 10 wherein the bioresorbable material is selected from the group consisting of:

glycoaminoglycans, hydroxyethyl cellulose, oxidized celluloses, and suitable combinations thereof.

18. The implantable electrode array of claim 10 wherein the bioresorbable material serves as a carrier for a steroid.

19. The implantable electrode array of claim 10 wherein the bioresorbable material serves as a carrier for a neuro-trophin.

20. The implantable electrode array of claim 10 wherein the bioresorbable material has a thickness of H2, wherein H2 is between 10 μ

m and 30 μ

m.

21. The implantable electrode array of claim 20 wherein H2 is 20 μ

m.

22. An implantable device comprising:

a lead having an electrode array at a distal end, the electrode array having a plurality of spaced apart exposed electrode contacts; and

a coating of bioresorbable material positioned on an outer surfaceof the contact side of the electrode array at one or more locations other than where the electrode contacts are positioned such that the electrode contacts remain uncoated, wherein the coating of bioresorbable material is configured to be absorbed over time to reduce chronic pressure following lead implantation.

23. The implantable device of claim 22 wherein the bioresorbable material is selected from the group consisting of:

polydioxanone, polycaprolactone, polyhydroxybutyrate, polyamino acid, polymers formed of alpha hydroxy acids, lactic acids, poly-L-lactic acids, polylactic-coglycolic acid polymers, polysaccharides, and suitable combinations thereof.

24. The implantable device of claim 22 wherein the bioresorbable material is selected from the group consisting of:

glycoaminoglycans, hydroxyethyl cellulose, oxidized celluloses, and suitable combinations thereof.

25. The implantable device of claim 22 wherein the bioresorbable material serves as a carrier for a steroid.

26. The implantable device of claim 22 wherein the bioresorbable material serves as a carrier for a neuro-trophin.

27. The implantable device of claim 22 wherein the bioresorbable material has a thickness of between 10 μ

m and 30 μ

m.

28. An implantable device comprising:

a lead having an electrode array at a distal end, the electrode array having a plurality of spaced apart exposed electrode contacts; and

a coating of bioresorbable material positioned on an outer surface of the distal end of the lead at one or more locations other than where the electrode contacts are positioned such that the electrode contacts remain uncoated, wherein the coating of bioresorbable material is configured to be absorbed over time to reduce chronic pressure following lead implantation.

29. The implantable device of claim 28 wherein the bioresorbable material is selected from the group consisting of:

polydioxanone, polycaprolactone, polyhydroxybutyrate, polyamino acid, polymers formed of alpha hydroxy acids, lactic acids, poly-L-lactic acids, polylactic-coglycolic acid polymers, polysaccharides, and suitable combinations thereof.

30. The implantable device of claim 28 wherein the bioresorbable material is selected from the group consisting of:

glycoaminoglycans, hydroxyethyl cellulose, oxidized celluloses, and suitable combinations thereof.

31. The implantable device of claim 28 wherein the bioresorbable material serves as a carrier for a steroid.

32. The implantable device of claim 28 wherein the bioresorbable material serves as a carrier for a neuro-trophin.

33. The implantable device of claim 28 wherein the bioresorbable material has a thickness of between 10 μ

m and 30 μ

m.

34. The implantable device of claim 28 wherein the electrode array has a thickness of between about 0.6 mm and about 0.8 mm.

35. The implantable device of claim 28 wherein the exposed electrode contact has a width of approximately 0.4 mm±

10%.