Miniature implantable array and stimulation system suitable for eyelid stimulation

• US 20030023297A1
• Filed: 05/31/2002
• Published: 01/30/2003
• Est. Priority Date: 06/18/2001
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Fey, Kate E., Schnittgrund, Gary D., Byers, Charles L., Weisner, Ralph M.
• Granted Patent: US 6,792,314 B2
• Time in Patent Office: Days
• US Class Current: 607/141
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14
• CPC Class Codes: A61N 1/0543 Retinal electrodes

Abstract

An implantable miniature eyelid electrode apparatus that causes a paralyzed eyelid to close or open by passing an electrical stimulating current to a nerve or muscle, is comprised of a longitudinally flexible, nonconductive body containing electrodes that pass an electrical signal to the nearby nerve or muscle, which closes or opens the eyelid. The apparatus is electrically actuated by a source that may be located remotely from the apparatus. The electrical signal passes along wires from the source to the apparatus. The apparatus is biocompatible with the environment in the living tissue and is electrically insulated from the surrounding tissue, except where the electrodes contact the living tissue. The apparatus is very small and is not obvious to visual inspection when implanted.

Claims

1. An implantable electrode apparatus suitable for providing or sensing signals from an eyelid, said apparatus comprising:

a body of flexible material;

at least one flexible leg portion of said body;

at least one electrically conductive electrode that is contained by said at least one flexible leg portion; and

at least one lead wire in electrical contact with said conductive electrode wherein said lead wire is attached to said conductive electrode.

2. The implantable electrode apparatus according to claim 1 wherein said body of flexible material is made of silicone having a hardness of about 70 or less on the Shore A scale as measured with a durometer.

3. The implantable electrode apparatus according to claim 1 wherein said at least one flexible leg portion is made of silicone having a hardness of about 70 or less on the Shore A scale as measured with a durometer.

4. The implantable electrode apparatus according to claim 1 wherein said at least one flexible leg portion has an aperture on one surface which allows said conductive electrode to contact living tissue.

5. The implantable electrode apparatus according to claim 1 wherein said at least one electrically conductive electrode is comprised of platinum or a platinum alloy.

6. The implantable electrode apparatus according to claim 1 wherein said at least one electrically conductive electrode is comprised of iridium or an iridium alloy.

7. The implantable electrode apparatus according to claim 1 wherein said at least one electrically conductive electrode is capable of being operated as an anode, a cathode, or a ground.

8. The implantable electrode apparatus according to claim 1 wherein said at least one lead wire is comprised of MP35N metal alloy.

9. The implantable electrode apparatus according to claim 1 wherein said at least one lead wire is comprised of platinum or a platinum metal alloy.

10. The implantable electrode apparatus according to claim 1 wherein said at least one lead wire is comprised of a stainless steel metal alloy.

11. The implantable electrode apparatus according to claim 1 wherein said means for attaching said lead wire to said conductive electrode is welding.

12. The implantable electrode apparatus according to claim 1 wherein said means for attaching said lead wire to said conductive electrode is crimping.

13. The implantable electrode apparatus according to claim 1 wherein said body of flexible material includes anchor holes.

14. The implantable electrode apparatus according to claim 1 additionally comprising a controller mounted on said body of flexible material.

15. A system for providing blink stimulation of an eyelid, the apparatus comprising:

a body of flexible material having at least one flexible leg portion;

at least one electrically conductive electrode that is contained by said at least one flexible leg portion;

at least one lead wire in electrical contact with said at least one electrically conductive electrode; and

a pulse generator that is electrically connected to said at least one lead wire.

16. The system of claim 15 wherein said body of flexible material is made of silicone having a hardness of about 70 or less on the Shore A scale as measured with a durometer.

17. The system of claim 15 wherein said at least one flexible leg portion is made of silicone having a hardness of about 70 or less on the Shore A scale as measured with a durometer.

18. The system of claim 15 wherein said at least one flexible leg portion has an aperture on one surface which allows said conductive electrode to contact living tissue.

19. The system of claim 15 wherein said at least one electrically conductive electrode is comprised of platinum or a platinum alloy.

20. The system of claim 15 wherein said at least one electrically conductive electrode is comprised of iridium or an iridium alloy.

21. The system of claim 15 wherein said at least one electrically conductive electrode is capable of being operated as an anode, a cathode, or a ground.

22. The system of claim 15 wherein said at least one lead wire is comprised of MP35N metal alloy.

23. The system of claim 15 wherein said at least one lead wire is comprised of platinum or a platinum metal alloy.

24. The system of claim 15 wherein said at least one lead wire is comprised of a stainless steel metal alloy.

25. The system of claim 15 wherein said body of flexible material includes anchor holes.

26. The system of claim 15 wherein said pulse generator is mounted on said body of flexible material.

27. A control system for periodically producing stimulation pulses to an eyelid, said system comprising:

at least one implantable eyelid stimulator having at least one leaflet body and an electrode lead body suitable for implantation proximal to an eyelid;

at least one electrode in said at least one leaflet body;

at least one electric pulse generator coupled to said at least one electrode in said at least one leaflet body; and

means for determining when said at least one electric pulse generator will communicate with said at least one electrode.

28. The control system according to claim 27 wherein said means for determining when said at least one electric pulse generator will stimulate said at least one electrode is an electric signal that is generated by a functioning eyelid.

29. The control system according to claim 27 further comprising a master control unit and wherein said means for determining when said at least one electric pulse generator will stimulate said at least one electrode is an electric signal that is generated by said master control unit, wherein said master control unit receives signals from a functioning eyelid and transmits signals to said at least one electric pulse generator.

30. The control system according to claim 29 wherein said means for transmitting an electrical signal between said at least one electric pulse generator and said master control unit is an RF signal.

31. The control system according to claim 29 wherein said means for transmitting an electrical signal between said at least one electric pulse generator and said master control unit is a propagated radio signal.

32. The control system according to claim 29 wherein said means for transmitting an electrical signal between said at least one electric pulse generator and said master control unit is an alternating magnetic field.

33. The control system according to claim 27 wherein said eyelid stimulator has dimensions less than about 20 mm in length by less than about 10 mm in width and less than about 0.50 mm in thickness.

34. A method of controlling operation of an implantable electronic device proximal to a nerve in living tissue, said method comprising:

detecting a signal from a functioning eyelid with a first sensing device;

transmitting said detected signal to a stimulating device;

generating a stimulating electric signal in said stimulating device in response to said detected signal; and

providing said stimulating electric signal to living tissue.

35. The method of claim 34 wherein said transmission to said stimulating device is by RF signal.

36. The method of claim 34 wherein said transmission to said stimulating device is by propagated radio signals.

37. The method of claim 34 wherein said transmission to said stimulating device is by alternating magnetic fields.

38. The method of claim 34 further comprising:

generating a response signal from the stimulated living tissue;

detecting said response signal with a second sensing device;

transmitting said response signal to said stimulating device; and

modifying said stimulating electric signal in response thereto.

39. The method of claim 34 wherein said providing said stimulating electric signal comprises responding to a need to cause the eyelid to blink.

40. The method of claim 34 wherein said providing said stimulating electric signal comprises responding to a need to provide a therapeutic electrical stimulation to an eye for beneficial effect on degenerative eye diseases.

41. An eyelid stimulator, comprising:

at least two signal electrodes electrically connected together inside an eyelid;

at least two ground electrodes electrically connected together inside the eyelid; and

an electrical circuit for providing a signal between said signal electrodes and said ground electrodes.

42. An eyelid stimulator, comprising:

at least one signal electrode inside an eyelid;

at least one ground electrode remote to said eyelid stimulator; and

an electrical circuit for providing a signal between said at least one signal electrode and said at least one ground electrode.

43. An eyelid stimulator, comprising:

at least two signal electrodes inside an eyelid, wherein said at least two signal electrodes are controlled independently of each other;

at least one ground electrode remote to said eyelid stimulator; and

an electrical circuit for providing a signal between said signal electrode and said ground electrode.

44. An eyelid stimulator, comprising:

at least two or more signal/ground electrode pairs where each said pair is controlled independently; and

an electrical circuit for providing a signal between said signal electrode and said ground electrode.