Miniature implantable array and stimulation system suitable for eyelid stimulation

• US 6,792,314 B2
• Filed: 05/31/2002
• Issued: 09/14/2004
• 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: Schnittgrund, Gary D., Weisner, Ralph M., Fey, Kate E., Byers, Charles L.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/160,804
• Publication Number:
  US 20030023297A1
• Time in Patent Office: 837 Days
• Field of Search: 607/53, 607/54, 607/116, 607/117, 607/118, 607/141, 607/48
• US Class Current: 607/53
• 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 comprisisng:

a body of a formed flexible material;

at least one flexible leg portion of said body;

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

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

a controller mounted on said body.

2. The implantable electrode apparatus according to claim 1 wherein said body of formed flexible material comprising 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 comprising 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 includes 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 comprises platinum or a platinum alloy.

6. The implantable electrode apparatus according to claim 1 wherein said at least one electrically conductive electrode comprises 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 comprises MP35N metal alloy.

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

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

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

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

a body for formed 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;

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

wherein said pulse generator is mounted on said body.

13. The system of claim 12 wherein said body of formed flexible material comprises silicone having a hardness of about 70 or less on the Shore A scale as measured with a durometer.

14. The system of claim 12 wherein said at least one flexible leg portion comprises silicone having a hardness of about 70 or less on the Shore A scale as measured with a durometer.

15. The system of claim 12 wherein said at least one flexible leg portion comprises an aperture on one surface which allows said conductive electrode to contact living tissue.

16. The system of claim 12 wherein said at least one electrically conductive electrode comprises platinum or a platinum alloy.

17. The system of claim 12 wherein said at least one electrically conductive electrode comprises iridium or an iridium alloy.

18. The system of claim 12 wherein said at least one electrically conductive electrode is capable of being operated as an anode, a cathode, or a ground.

19. The system of claim 12 wherein said at least one lead wire comprises MP35N metal alloy.

20. The system of claim 12 wherein said at least one lead wire comprises platinum or a platinum metal alloy.

21. The system of claim 12 wherein said at least one lead wire comprises a stainless steel metal alloy.

22. The system of claim 12 wherein said body of formed flexible material includes anchor holes.

23. 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 electode 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 adapted to provide a stimulation pulse; and

master control unit means for triggering said at least one electric pulse generator to provide a stimulation pulse to said at least one electrode, wherein said mater control unit means receives signals from a functioning eyelid and transmits signals to trigger said electric pulse generator, aid signal being an RF signal.

24. The control system according to claim 23 wherein said master control unit means for triggering said at least one electric pulse generator is an electric signal generated by a functioning eyelid.

25. The control system according to claim 23 wherein said means master control unit means for triggering to said at least one electric pulse generator is an alternating magnetic field.

26. A control system for periodically roducing 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 adapted to provide a stimulation pulse; and

master control unit means for triggering said at least one electric pulse generator to provide a stimulation pulse to said at least one electrode, wherein said master control unit means receives signals from a functioning eyelid and transmits signals to trigger said electric pulse generator, said signal being a propagated radio signal.

27. The control system according to claim 26 wherein said means for determining when said at least one electric pulse generator will stimulate said at least one electrode is an electric signal generated by a functioning eyelid.

28. The control system according to claim 26 wherein said master control unit means for triggenng to said at least one electric pulse generator is an alternating magnetic field.

29. 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;

wirelessly 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.

30. The method of claim 29 wherein said transmission to said stimulating device is by RF signal.

31. The method of claim 29 wherein said transmission to said stimulating device is by propagated radio signals.

32. The method of claim 29 wherein said transmission to said stimulating device is by alternating magnetic fields.

33. The method of claim 29 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.

34. The method of claim 29 wherein said providing said stimulating electric signal comprises responding to a need to cause the eyelid to blink.

35. The method of claim 29 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.